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OECD Unique Identifier details

MON-ØØ6Ø3-6xMON-ØØ81Ø-6
Commodity: Corn / Maize
Traits: Glyphosate tolerance,Lepidoptera resistance
European Union
Name of product applicant: Monsanto
Summary of application:

The genetically modified maize MON-ØØ6Ø3-6xMON-ØØ81Ø-6, as described in the application, is produced by crosses between maize containing MON-ØØ6Ø3-6 and MON-ØØ81Ø-6 events and expresses the CP4 EPSPS protein which confers tolerance to glyphosate herbicides and the Cry1Ab protein which confers protection against certain lepidopteran insect pests (Ostrinia nubilalis, Sesamia spp.).

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Date of authorization: 24/10/2007
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.): Biosafety Clearing House (BCH)
OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the EU relevant links below.
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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:
Event specific real-time quantitative PCR based methods for genetically modified maize MON-ØØ6Ø3-6 and MON-ØØ81Ø-6 maize validated on MON-ØØ6Ø3-6xMON-ØØ81Ø-6 maize. -Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003. Please see the EU relevant links below.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Opinion of the European Food Safety Authority
Method for Detection
Reference Material
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Authorization expiration date (a blank field means there is no expiration date) 23/10/2017
E-mail:
pablo.pindado-carrion@ec.europa.eu
Organization/agency name (Full name):
European Union
Contact person name:
Pablo PINDADO
Website:
Physical full address:
European Commission B232 04/106 1047 Brussels
Phone number:
00 32 2 298 67 06
Fax number:
Country introduction:
The process for authorising a new GMO is based on the EU regulation on GM food and feed (1829/2003). An application for authorising food or feed consisting of or made from a GMO must be submitted to the national authorities. The national authority then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA then makes the application summary available to the public. No matter where in the EU the company applies, EFSA assesses the risks the GMO presents for the environment, human health and animal safety. If the application covers cultivation, EFSA delegates the environmental risk assessment to an EU country which sends EFSA its risk assessment report. After performing the risk assessment, EFSA submits its scientific opinion to the European Commission and to EU countries. The opinion is made available to the public, except for certain confidential aspects. Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Reg. 1829/2003, and on the Joint Research Centre website on the assessment report of the "lead" EU country for applications under Directive 2001/18. Within 3 months of receiving EFSA's opinion, the Commission grants or refuses the authorisation in a proposal. If it differs from EFSA’s opinion, it must explain why. National representatives approve the Commission’s proposal by qualified majority in: (1) The Standing Committee on the Food Chain and Animal Health if the application was submitted under Reg. 1829/2003; (2) The Regulatory Committee under Directive 2001/18/EC if the application was submitted under Dir. 2001/18. The proposal is adopted if the Committee agrees with it. If there is no opinion, the Commission may summon an Appeal Committee where EU countries can adopt or reject the proposal. If the Appeal Committee makes no decision, the Commission may adopt its proposal. Authorisations are valid for 10 years (renewable).
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application:
Commercial Release of corn containing events MON810 and NK603, granting resistance to insects and tolerance to herbicides, respectively, combined by sexual reproduction
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Date of authorization: 17/09/2009
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 (food safety):
Insect resistant and glyhphosate tolerant MON 15895 810 x NK 603 corn was generated by crossing NK 603 corn and MON 810 corn through classical genetic improvement and expresses proteins CP4 EPSPS (NK 603 corn) and Cry1Ab (MON 810 corn). MON 810 corn is the result of genetic modification of “Hi-II” corn with gene Cry1Ab for expression of resistance characteristics towards pest insects of the Lepidoptera order. The product of gene cry1Ab expression is protein Cry1Ab that has insecticide activities on target pests – Spodoptera frugiperda [fall armyworm], Diatrea saccharalis [stalk borer] and Helicoverpa zea [earworm], protecting the plants from damages caused by such insects. Gene cry1Ab was isolated from Bacillus thuringiensis. Protein Cry1Ab produced in MON 810 corn is a protein with selective toxicity for some species of Lepidoptera insects and its action is mediated by specific receptors located in the bowel cells where protein cry1Ab establishes a link in susceptible insects. Mammals, including humans, as well as fish, birds and non-target insects, are devoid of such receptors. NK 603 corn expresses protein CP4-EPSPS (CP4 5-enolpyruvylshikimate-3-phosphate synthase) that promotes expression of the characteristic of tolerance to glyphosate herbicide in the plant. Gene cp4 epsps originates from Agrobacterium sp. Protein CP4-EPSPS, expressed in glyphosate-tolerant genetically modified plants, is an enzyme that is functionally identical to the plant-endogenous EPSPS protein. In conventional plants, the glyphosate bonds to the EPSPS enzyme and blocks the biosynthesis of 5-hydroxy shikimate-3-phosphate, hindering the formation of aromatic amino acids and secondary metabolites. Differently from genetically modified plants, as the NK 603 corn, aromatic amino acids and other metabolites needed in the development of plants continue being produced by the activity of the protein expressed by an alternative metabolic route. Gene cp4epsps, present in MON810 x NK603 corn was inherited from the parental NK 603 corn through classical genetic improvement, while cry1Ab was inherited from MON 810 corn. Proteins CP4-EPSPS and Cry1Ab and their action patterns fail to have any known interaction mechanisms able to cause adverse effects to human or animal health, and to the environment. Proteins CP4-EPSPS and Cry1Ab accumulate in different cell compartments of MON810 x NK603 corn and have distinct and non-interactive metabolic functions. This way, protein CP4-EPSPS is directed to the chloroplast while protein Cry1Ab is accumulated in the cytoplasm and both are expressed in very low levels in each individual event, that is to say, NK 603 and MON 810 corn. MON810 x NK603 corn contains the combination of genetically modified events whose biosafety was analyzed in separate applications passed by CTNBio, and such events were largely tested, in the fields, under different environments within the Brazilian territory. Analysis of the combination of genotype MON810 x NK603 showed that expected tolerance levels to glyphosate are similar to those of the NK 603 corn, while the expected levels of insect resistance were, in the same way, similar to those of MON 810 corn. MON810 x NK603 corn has been marketed in different countries, including: United States, Canada, Mexico, South Africa, Japan, South Korea, Philippines, Argentina and European Union. Proteins CP4-EPSPS and Cry1Ab are expressed in low concentrations in MON810 x NK603 corn, so that any potential exposure to such proteins is extremely low in human and animal food. Studies showed that such proteins are rapidly digested in in vitro digestion essays. Acute oral toxicity tests conducted with purified CP4-EPSPS and Cry1Ab proteins and subchronic toxicity tests, where the proteins were administered in doses substantially higher than the ones found in the normal consumption of corn showed that the proteins fail to produce adverse effects, posing no food safety problem for humans and animals. Because proteins CP4-EPSPS and Cry1Ab do not cause toxicity in the maximum doses tested, the conclusion is that a synergetic interaction between them is highly unlikely in the doses normally found in food. Absence of interaction between proteins CP4-EPSPS and Cry1Ab and absence of damaging effects to humans, animals and the environment is demonstrated by the information on the product of expression of exogenous DNA in the plant (proteins CP4-EPSPS and Cry1Ab), the level of expression of such exogenous proteins in plant tissues, their mechanism of action, the location of the biologic activities of the proteins and the history of safe use of individual and combined events in countries where they were approved and have been used for several years. Therefore, after analyzing the data supplied by applicant and the independent scientific literature, a conclusion is reached that the selective biologic activities of CP4-EPSPS and Cry1Ab proteins were not affected and keep the same metabolic function and efficacy found in NK 603 and MON 810 corn, as well as in MON810 x NK603 corn. This way, the conclusion is that corn containing combined events (MON810 x NK603) is as safe as its conventional isoline. According to Annex I of Ruling Resolution nº 5, of March 12, 2008, applicant shall have a term of thirty (30) days from the publication of this Technical Opinion to adjust its proposal of post commercial release monitoring plan. In the context of Article 14 of Law nº 11,105/05, CTNBio holds that the request complies with the rules of applicable legislation that aim at securing the biosafety of the environment, agriculture, and human and animal health. In the context of Article 14 of Law nº 11,105/05, CTNBio holds that the request complies with the rules of applicable legislation that aim at securing the biosafety of the environment, agriculture, and human and animal health, and reached a conclusion that the stacked MON810 x NK603 corn is substantially equivalent to conventional corn and therefore its consumption is safe for human and animal health. Regarding the environment, CTNBio concluded that cultivation of MON810 x NK603 corn is not a potential cause of significant degradation of the environment and that it keeps with the biota a relation that is identical to that of conventional corn. TECHNICAL OPINION I. GMO Identification GMO name: MON810 x NK603 corn. Applicant: Monsanto do Brasil Ltda. Species: Zea Mays L. Inserted characteristics: Tolerance to glyphosate herbicide and insect resistance Method of insertion: MON810 x NK603 corn, ranked as Risk Class I, was developed by classical genetic improvement, through sexual crossing between genetically modified lineages containing event MON 810 and event NK 603. Prospective use: Free registration, use, essays, tests, sowing, transport, storage, marketing, consumption, import, release and discarding. II. General Information Corn, Zea Mays L., is a species of the family Gramineae, tribe Maydae, sub-family Panicoidae that is separated within the sub-genus Zea and has chromosome number 2n = 20,21,22,24(1). The wild species closest to corn is the teosinte found in Mexico and some regions of Central America, where it is able to cross with cultivated corn in the production fields. Corn has a history of over eight thousand years in the Americas, and is cultivated since the pre-Columbian era. Among higher plants, corn is the best scientifically characterized and is currently the cultivated species that reached the highest degree of domestication and is able to survive in nature only when cultivated by man(2). There are currently over 300 identified races of corn and, within each such race, thousands of cultivars. One of the most important sources of food in the world, corn is an input in the production of a wide range of foodstuff, rations and industrial products. Brazil is one of the largest producers of corn over the world, and the plant is cultivated nearly all over the national territory(3). Occurrence of insects in Earth is larger in the tropics than in temperate regions where the damages caused by such animals are more significant. Among the most damaging corn pests an important place is taken by the fall armyworm, Spodoptera frugiperda. Cruz et al. (4) estimated that the losses in Brazil caused by infestations of S. frugiperda reach 400 million Dollars each year. Other species of the order Lepidoptera are also important pests in the culture of corn, such as the corn earworm (Helicoverpa zea) and stalk borer (Ditraea sacharalis). The main measure to control insects in the corn cultivation has been the use of insecticides. In some areas of the Brazilian Center-West, for instance, tenths of insecticide sprays are needed in a single culture cycle. Another measure to control pests would be the use of resistant cultivars. Compared with conventional corn, MON810 x NK603 corn fails to display greater ability to survive as a pest. The presence of gens granting resistance to Lepidoptera insects and tolerance to glyphosate herbicide give a selective advantage to MON810 x NK603 corn when exposed to the herbicide and submitted to the presence of target-insects. However, such characteristics are not sufficient to make this corn a pest in corn cultivars(5,6). The use of corn containing stacked events represent a future trend – that meets producers' demand – by combining two characteristics of agronomic importance in a same hybrid. Corn with events combined by classical genetic improvement were already approved in Japan, Korea, Argentina, El Salvador, European Union, South Africa, Taiwan and Philippines(7). III. Description of GMO and Proteins Expressed Corn containing event MON 810 is the result of genetic modification of “Hi-II” corn displaying gene cry1Ab that determines expression of resistance to certain pest insects of the Order Lepidoptera. The product of expression of gene cry1Ab is protein Cry1Ab that has insecticide activity on target pests, protecting the plants from damages caused by such pests. Gene cry1Ab was isolated from Bacillus thuringiensis subspecies kurstaki strain HD-1(8,9). NK 603 corn contains gene cp4 epsps coming from Agrobacterium sp. strain CP4 and is responsible for expression of protein CP4-EPSPS (CP4 5 enolpyruvylshikimate-3-phosphate) that determines expression of glyphosate herbicide tolerance. Protein CP4-EPSPS expressed in glyphosate-tolerant genetically modified plants is functionally identical to the plant endogenous EPSPS protein(10). In conventional plants, glyphosate bonds to EPSPS enzyme and blocks the biosynthesis of 5-hydroxy shikimate-3-phosphate, hindering the formation of aromatic amino acids and secondary metabolites(11). In genetically modified glyphosate-tolerant plants, such as NK 603 corn, the aromatic amino acids and other metabolites needed to the plant development, keep being produced by the CP4-EPSPS protein activity(12). The mode of action and biologic activities of proteins CP4-EPSPS and Cry1Ab expressed in MON810 x NK603 corn are separate and fail to have any known interaction mechanism that could cause adverse effects to human and animal health and to the environment. In a certain way, proteins CP4-EPSPS and Cry1Ab present in MON810 x NK603 corn are accumulated in different cell compartments and have separate and non-interactive metabolic functions. This way, protein CP4-EPSPS is directed to the chloroplast while protein Cry1Ab is accumulated in the cytoplasm(4,5). The level of expression of proteins CP4-EPSPS and Cry1Ab is low in individual events (NK 603 and MON 810 corn) and therefore the likelihood that such proteins interact between them is held improbable, a fact that is microscopically ratified by analyzing agronomy and phenotype characteristics related to efficacy and selectivity of MON810 x NK603 corn in field(4,5). IV. Aspects Related to Human and Animal Health Safety aspects of proteins Cry1Ab and EPSPS were thoroughly assayed by CTNBio(4,5). Protein Cry1Ab mode of action is well clarified by scientific literature(15,16). In vitro tests were used to assay increased digestibility of foodstuffs containing pre-heated proteins Cry1Ab and CP4-EPSPS. The study showed that pre-heating increases the protein digestibility in simulated gastric and intestine fluids, suggesting that the likelihood of an eventual allergenic potential of protein Cry1Ab is extremely low for the ease of its digestion, which is an important component in assessing the safety of MON 810 corn(17,18). Further, in vivo and in vitro studies confirmed that protein Cry1Ab expressed in B. thuringiensis and MON810 x NK603 corn is highly selective and do not act on mammals(19,20,21,22,23,24,25). Protein CP4-EPSPS is an enzyme that is present in all plants and in a large number of microorganisms(22), while protein Cry1Ab does not display enzymatic activity in plants and therefore fails to affect the plant metabolism. The likelihood that biochemical interaction takes place between proteins CP4-EPSPS and Cry1Ab in the complex matrix of a plant is limited, since such proteins accumulate in different locations of the cells and in a low level of expression. With this, a potential exposure to such proteins is extremely low in human and animal feeding. Considering that proteins CP4-EPSPS and Cry1Ab fail to produce toxicity in the maximum doses tested, it is highly unlikely that an interaction able to cause additive or synergic effects occurs between such proteins in the normal doses found in foodstuffs. The literature in the area of toxicology of chemical mixtures provides information showing that such interactions are inexistent when the substances are administered in doses substantially below the levels of unobserved adverse effect(26,27,28,29). Due to the rigorous specificity for substrates, enzymes EPSPS bond just S3P, PEP and glyphosate. The only known resulting metabolic product is the 5 enolpyruvylshikimic acid 3-phosphate, which corresponds to the penultimate product of the shikimic acid pathway. Shikimic acid is a precursor for biosynthesis of amino acids (phenylalanine, tyrosine and tryptophan) and a number of secondary metabolites, such as tetrahydrofolate, ubiquinone and vitamin K (30). Though the shikimic acid (or shikimate) pathway and proteins EPSPS do not occur in mammals, fish, birds and insects, they are important to plants. It is reckoned that aromatic molecules, all derived from shikimic acid, represent no less than 35% of a plant’s dry weight(31,32). In vitro assays performed with simulated digestive fluids are widely used tools as a model for animal digestion. This simulated system was used to probe into digestibility of plant proteins(33,34), animal proteins(35), and food additives(36), as well as to assay protein quality(37) and allergenicity potential through absorption of the proteins by the digestive system(38). Finally, the knowledge on the mode of action, specificity and safe use history of protein EPSPS, potential toxic and allergenic effects of such proteins to humans and other mammals were assayed through in vitro digestion tests. The studies used simulated gastric fluids (pH 1.2) and intestinal fluids (pH 7.5). The degradation rate of protein CP4-EPSPS (mature protein with no transit peptide) was assessed through Western blot analyses. The study showed that protein CP4-EPSPS and peptides degrade in less than 15 seconds after being exposed to the gastric fluid. In the simulated intestinal fluid, degradation of CP4-EPSPS protein occurred in less than 10 minutes(39). V. Environmental Aspects Corn is a monoic, allogamic and annual plant, with anemocoric pollination and distances that may be covered by the pollen depend on wind patterns, humidity and temperature. Corn pollen is freely dispersed near the cultivated area, may reach styli-stigmas of the same or different genotypes and, under adequate conditions, starts its germination that will generate the pollinic tube and promote ovule fecundation within an average term of 24 hours. Studies on pollen dispersion have been conducted and show that pollen may travel long distances, though the majority is deposited close to the cultivated area with a very low translocation rate. Over 95% of the pollen may reach distances within 60 m of the pollen source(37). Luna et al. (38) investigated pollen isolation distance and control, where it was shown that crossed pollination occurs within 200 m. However, no crossed pollination, under conditions of non-detasseling, was noticed in distances higher than 300 m from the pollen source. The results indicate that pollen viability is maintained for two hours and that crossed pollination was not observed in distances of 300 m from the pollen source. When compared with concentrations at one meter from the source culture under low-to-moderate winds it was estimated that about 2% of the pollen reaches 60 meters, 1.1% reaches 200 meters, and 0.75% to 0.5% reaches a distance of 500 meters. At a distance of ten meters from the field, the number of pollen grains per unit of area is tenfold lower than the number observed at one meter from the border. Therefore, if established separation distances developed for the production of corn seeds are observed, it may be expected that pollen transfer to surrounding varieties is minimized and that the presence of glyphosate-tolerant genetic materials to be unlikely. From the agronomic viewpoint, coexistence between cultivars of conventional corn (improved or creole) and transgenic corn is possible(41,42). Ancient communities and modern farmers have learned how to live on without trouble with different corn cultivars, while keeping their genetic identities along time. Studies conducted in the field, nursery and laboratory with MON810 x NK603 corn showed that this genetic transformation event is comparable to conventional corn in what regards reproductive, agronomic, food and environment safety characteristics(3,4,18. The use of MON810 x NK603 technology containing the characteristics of being resistant to insects and tolerant to herbicide is becoming an option to control invading species(43) and insects(44). Insecticide Cry proteins are extremely selective to insects of the Lepidoptera Order(45,46,47,48,49), failing to show negative effects on beneficial and non-target insects, including predators, parasitoids, pollinating and other insects(50,51,52,53). On the other hand, protein EPSPS is deemed to be safe and is widely accepted for its characteristic of being ubiquitous, having no history of toxicity, and dissociated from pathogenicity(3,4). The action of corn containing the stacked genes, MON810 x NK603, on non-target organisms was studies in different species(18). In Brazil, studies were conducted to assay the population dynamics of non-target organisms in corn containing the isolated MON 810 event, such as natural enemies and secondary pests(54,55,56). Field studies with corn expressing protein Cry1Ab were conducted in Brazil to assay pest insects and natural enemies in comparison with the ones on conventional corn(57). Studies to assay the control of pest Lepidoptera and interaction with natural enemies found in corn culture were conducted in Barretos, São Paulo; Santa Cruz das Palmeiras, São Paulo; e Capinópolis, Minas Gerais, during the 1999/2000 summer crop(55,58). The results indicated that MON 810 corn promoted an efficient control of Spodoptera frugiperda and Helicoverpa Zea. Besides, there was no interference on the population level of the predator’s complex (Coccinellidae, Sirphydae, Orius sp. and Geocoris sp.), as well as the predator linear earwig (Doru lineare). Impacts that Cry proteins could cause on non-target insects and soil organisms in general have been widely studied as part of the assay on environmental safety of cultures containing the isolated event MON 810, which expresses protein Cry1Ab. Studies demonstrated that the tested terrestrial and soil non-target organisms were not affected by Cry1Ab protein, despite being the level of such protein above the maximum levels that could be measured in case of natural exposure(48,59,60). In addition, a comparison between proteins Cry produced by Bacillus thuringiensis and protein Cry1Ab produced by MON 810 corn demonstrated that they may persist in tropical soils for a longer time due to its bonding to clay particles, although effects on the soil microbiota were not observed(61). Studies published by the scientific literature concluded that the presence of protein Cry1Ab, besides not significantly affecting the microbiota and animals living in soil, was also absorbed by cultures subsequent to the MON 810 corn. Cry proteins from three subspecies of Bacillus thuringiensis did not show microbiocidal or microbiostatic activity against a variety of bacteria, fungi and algae(64). Another environmental issue relates to the gene flow of genetically modified corn and the effects that this flow could cause to conventional corn. The likelihood of crossed pollination between a genetically modified plant and a conventional one, followed by introgression, relates to availability and viability of pollen of the genetically modified parental and the delivery of such pollen to the stigma of the conventional parental. This availability will depend on the time of sowing and agronomic conditions. Regarding the pollen delivery to the stigma, it depends on wind, vectors, distance, precipitation and natural barriers to the pollen movement. Still, the efficiency of crossed pollination will depend simultaneously on the flowering time of the receiving and donor parental plant, viability and competition ability of such pollen. Depending on the heritage pattern of the characteristics, part of the pollen produced by the donor fails to contain the gene of interest. In addition, corn pollen grains are large and heavy, which reduces dispersion distances and the larger deposition takes place nearby the donor plant(65,40). Dispersion of 98% of the pollen takes place within 25 meters of the issuing field and almost 100% within 100 meters. The larger part (99%) of crossed pollination outside the issuing field takes place within 18 to 20 meters from the field borders(41). Climatic conditions (and wind direction) and physical barriers affect pollen dispersion and the rate of corn crossed pollination, and the closer from the field, the more efficient are the barriers. Dispersion of MON810 x NK603 corn pollen may therefore be controlled so that co-existence of conventional, organic and genetically modified cultivars is possible(41), most the same way in which genotypes for different uses (human nutrition, creole races, etc.) are produced in contiguous areas. VI. Restrictions to the Use of the GMO and its Derivatives As established by Article 11 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” The studies submitted by applicant showed that there was no significant difference between corn hybrids derived from unmodified lineages and MON810 x NK603 corn regarding agronomic characteristics, reproduction and dissemination modes, and survival ability. All evidences submitted with the application documents and bibliographic references confirm the risk level of the transgenic variety as being equivalent to the risk level of non transgenic varieties regarding soil microbiota, other plants and human and animal health. Therefore, cultivation and consumption of MON810 x NK603 corn are not potential causes of significant degradation of the environment, nor of risks to human and animal health. For the foregoing, there are no restrictions to the use of such corn and its derivatives, except in locations mentioned by Law nº 11,460, of March 21, 2007. Vertical gene flow to local varieties (the so-called creole corns) of open pollination is possible and poses the same risk as the one caused by commercial genotypes available in the market (80% of conventional corn planted in Brazil comes from commercial seeds that underwent genetic improvement). Coexistence of conventional corn (either improved or creole) cultivars and transgenic corn cultivars is possible from the agronomic viewpoint(41,42) and shall comply with the provisions of CTNBio Ruling Resolution nº 4. After being used for ten years in other countries, no problems were detected to human and animal health and the environment that may be ascribed to transgenic corns. It shall be emphasized that the lack of negative effects resulting from farming transgenic corn plants is far from a guarantee that such problems may not occur in the future. Zero risk and absolute safety do not exist in the biologic world, although there is a significant amount of reliable scientific information and a safe history of ten years underlying the fact that Bt11 x GA21 corn is as safe as the traditional corn versions. Therefore, applicant shall conduct the post-commercial release monitoring according to CTNBio Ruling Resolution nº 3. VII. Consideration on the Particulars of Different Regions of the Country (Information to supervisory agencies) As established by Article 11 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” VIII. Conclusion Whereas the corn (Zea mays) variety MON810 x NK603 belongs to a well characterized species with a solid history of safety for human consumption and that genes Cry1Ab and CP4-EPSPS introduced in this variety codify proteins that are ubiquitous in nature and are present in plants, fungi and microorganisms that are part of human and animal alimentary diet; Whereas insertion of this genotype took place through classic genetic improvement and resulted in insertion of a stable and functional copy of Cry1Ab and CP4-EPSPS genes that granted to the plants tolerance to glyphosate herbicide and resistance to insects; Whereas data on centesimal composition failed to show significant differences between genetically modified and conventional varieties, suggesting a nutritional equivalence between them; Whereas CTNBio conducted a separate assay on the events and issued an opinion favorable to commercial release of the separate events; Whereas: 1. MON810 x NK603 corn is a genetically modified product, displaying resistance to a number of Lepidoptera pests and tolerance to glyphosate herbicide, developed through classic improvement by sexual crossing between lineages containing event MON 810 and event NK 603, previously approved for commercial release; 2. Comparative molecular analysis of MON810 x NK603 corn evidenced that integrity of inserts was maintained during the classic improvement with the purpose of combining both events; 3. Segregation analysis and genetic heritance patterns of MON810 x NK603 corn showed that genes of events MON 810 and NK 603 are independent and segregate on a stable manner along successive generations; 4. Agronomic and efficacy assays of MON810 x NK603 corn indicate that combination of such events by classic genetic improvement methods (sexual crossings) did not lead to expression of any other characteristics, except those already expected, that is to say, resistance to certain insects and tolerance to glyphosate herbicide; 5. Expressions of proteins Cry1Ab and EPSPS in MON810 x NK603 corn are not significantly different from their expression in corns containing the separate events; Therefore, considering the above reasons and internationally accepted criteria in the process of analyzing risks in genetically modified raw-material it is possible to conclude that MON810 x NK603 corn is as safe as its conventional equivalents. In the context of the competences granted to it under Article 14 of Law nº 11,105/05, CTNBio considered that the request complies with the rules and legislation in effect that intend to guaranty environmental and agricultural biosafety and human and animal health, reaching a conclusion that MON810 x NK603 corn is substantially equivalent to conventional corn, being its consumption safe for human and animal health. Regarding the environment, CTNBio’s conclusion was that cultivation of MON810 x NK603 corn is not a potential cause of significant degradation to the environment, keeping with the biota a relation identical to that of conventional corn. CTNBio considers that this activity is not a potential cause of significant degradation to the environment or of harm to human and animal health. Restrictions to the use of the GMO analyzed and its derivatives are conditioned to the provisions of Law nº 11,460, of March 21, 2007, and to CTNBio Ruling Resolution nº 03 and Ruling Resolution nº 04. CTNBio assay took into consideration opinions issued by the Commission members; ad hoc consultants; documents delivered to CTNBio Executive Secretary by applicant; results of planned releases to the environment; and discussions, lectures and papers related to the public hearing held on 03.20.2007. Besides, independent studies and scientific literature of applicant, conducted by third parties, were also considered. According to Annex I to Ruling Resolution nº 5, of March 12, 2009, the applicant shall have a term of thirty (30) days from publication of this Technical Opinion to adjust its proposal to the post-commercial release monitoring plan. IV. Bibliography 1. Food and Agriculture Organization of the United Nations / Word Health Organization. FAO/WHO – 2000a. Grassland Index. Zea mays L. (Available at): http:www.fao.org.WAICENT/faoinfo/agricult/agp/agpc/doc/gbase/data/pf000342.htm). 2. Companhia Nacional de Abastecimento – CONAB. 2007. Milho total (1ª e 2ª safra) Brasil – Série histórica de área plantada: safra 1976-77 a 2006-07. http:www.conab.gov.br/conabweb/download/safra/MilhoTotalSerie Hist.xls. 3. Comissão Técnica Nacional de Biossegurança. CNTBio 2007. Parecer Técnico 1100/2008. Published in the Federal Official Gazette of 09.04.2007, Section nº 1, Page nº 9. 4. Comissão Técnica Nacional de Biossegurança. CNTBio 2008. Parecer Técnico 1597/2008. Published in the Federal Official Gazette of 10.14.2008. Section nº 1. Page nº 3. 5. CRUZ, I.; FIGUEIREDO, M. L. C.; OLIVEIRA, A. C.; VASCONCELOS, C. A. 1999. Damage of Spodoptera frugiperda (Smith) in different maize genotypes cultivated in soil under three levels of aluminium saturation. International Journal of Pest Management 45: 293-296. 6. Nnnn 7. AGBIOS. 2009. GM DataBase, (http://www.agbios.com/dbase.php?action=Submit&evidcode=NK603+x+MON810 available on 10.07.2009). 8. FISCHHOFF, D. A.; BOWDISH, K. S.; PERLAK, F. J.; MARRONE, P. G.; MCCORMICK, S. M.; NIEDERMEYER, J. G.; DEAN, D. A.; KUSANO-KRETZMER, K.; MAYER, E. J.; ROCHESTER, D. E.; ROGERS, S. G.; FRALEY, R. T. Insect tolerant transgenic tomato plants. Bio/technology, v. 5, p. 807-813, 1987. 9. Hofte, H.; Whiteley, H. R. (1989) Insecticidal crystal proteins of Bacillus Thuringiensis. Microbiological Review, 242-255. 10. Padgette, S. R.; G. F. BARRY; D. B. Re; D. A. Eichholtz; M. Weldon; K. Kolacz; e G. M. Kishore. 1993. Purification, cloning and characterization of a highly glyphosate-tolerant 5 enolpytuvylshikimate – 3 – phosphate synthase from Agrobacterium sp. Strain CP4. Monsanto Technical Report MSL 12738. 11. Haslam, E. 1993. Shikimic acid: metabolism and metabolites. University of Sheffield, UK. 12. Steinrücken, H. C.; Amrhein, N. 1980. The herbicide glyphosate is a potent inhibitor of 5 enolpyruvyl-shikimic acid-3-phosphate synthase. Biochem Biophys Res Commun 94: 1207-1212. 13. Padgette, S.; Taylor, N.; Nider, D. 1996a. The composition of glyphosate-tolerant soybean seed is equivalent to that of conventional soybeans. J Nutr 126: 702-716. 14. Padgette, S. R.; D. S. Re; G. F. Barry; D. E. Eichholtz; X. Delannay; R.L. Fuchs; G. M. Kishore; e R. T. Fraley. New weed control opportunities: development of soybeans with a Roundup gene. CRC Handbook 4: 53-84. 15. GILL, S. S.; COWLES, E. A.; PIETRANTONIO, P. V. The mode of action of Bacillus thuringiensis endotoxins. Annu. Rev. Entomol., v. 37, p. 615-36, 1992. 16. ENGLISH, L.; SLATIN, S. L.; Mode of action of delta-endotoxins from Bacillus thuringiensis: a comparison with other bacterial toxins. Insect Biochemica. Molec. Biol., v. 22, n. 1, p. 1-7, 1992. 17. OKUNUKI, H.; TESHIMA, R.; SHIGETA, T.; SAKUSHIMA, J.; AKIYAMA, H.; GODA, Y.; TOYODA, M.; SAWADA, J. Increased digestibility of two products in genetically modified food (CP4-EPSPS and Cry1Ab) after preheating. J. Food Hygienic Soc. Japan., v. 43, p. 68-73, 2002. 18. Monsanto do Brasil. Milho Yieldgard. (http://www.yieldgard.com.br, available on 10/07/2003.) 19. WOLFERSBERG, M. G. V-ATPASE-ENERGIZED EPITHLIA AND BIOLOGICAL INSECT CONTROL. J. EXP. BIOL. 172, 377-386, 1992. 20. Wieczrek, H.; Brown, D.; Grinstein, S.; Ehrenfeld, J. and Harvey, W. R. (1999). Animal plasma membrane energization by proton-motive V-ATPases. Bioessays 21, 637- 648. 21. Griffitts and Aroian, 2005 J. Griffitts and R. Aroian, Many roads to resistance: how invertebrates adapt to Bt Toxins, BioEssays 27 (2005), pp. 614-624. 22. Shimada, N.; Miyamoto, K.; Kanda, K.; Murata, H. 2006a. Bacillus thuringiensis insecticidal Cry1Ab toxin does not affect the membrane integrity of the mammalian intestinal epithelial cells: an in vitro study. In vitro Cellular and Developmental Biology – Animal, 42: 45-49. 23. Shimada, N.; Miyamoto, K.; Kanda, K.; Murata, H. 2006b. Binding of Cry1Ab toxin, a Bacillus thuringiensis insecticidal toxin, to proteins of the bovine intestinal epithelial cell: an in vitro study. Applied Entomology and Zoology, 41: 295-301. 24. Stumpff, F.; Bondzio, Einspanier, A. R. and Martens, H. Effects of the Bacillus thuriengensis toxin Cry1Ab on membrane currents of isolated cells of the ruminal epithelium J, Membr. Biol. 219 (1-3) (2007), pp. 37-47. 25. Bondzio, A.; Stumpff, F.; Schön, J.; Martens, H.; Einspanier, R., 2008. Impact of Bacillus thuringiensis toxin Cry1Ab on rumen epithelial cells (REC) – A new in vitro model for safety assessment of recombinant food compounds. Food and Chemical toxicology, 46: 1976-1984. 26. Groten, J. P.; Schoen, E. D.; Kuper, C. F.; van Bladeren, P. J.; Van Zorge, J. A. and Feron, V. J. Subacute toxicity of a mixture of nine chemicals in rats: detecting interactive effects with a two level factorial design. Fundamental and Applied Toxicology (1997). 27. Jonker, D.; Woutersen, R. A. and Feron, V. J. Toxicity of nephrotoxicants with similar or dissimilar mode of action. Food and Chemical Toxicology 34 (1996), pp. 1075-1082. 28. Jonker, D.; Woutersen, R. A.; van Bladeren, P. J.; Til, H. P.; and Feron, V. J. 4-week oral toxicity study of a combination of eight chemical in rats: comparison with the toxicity of the individual compounds. Food and Chemical Toxicology 28 (1990), pp. 623-631. 29. Jonker, D.; Woutersen, R. A.; van Bladeren, P. J.; Til, H. P.; and Feron, V. J. Subacute (4-wk) oral toxicity of a combination of four nephrotoxins in rats: comparison with the toxicity of the individual compounds. Food and Chemical Toxicology 31(1993), pp. 125- 136. 30. TAYLOR, M. L.; HARTNELL, G.; NEMETH, M.; KARUNANANDAA, K.; GEORGE, B. 2005. Comparison of broiler performance when fed diets containing corn grain with insect-protected (corn rootworm and European corn borer) and herbicide-tolerant (glyphosate) traits, control corn, or commercial reference corn – revisited. Poult. Sci. 84: 1893-1899. 31. TAN, S.; EVANS, R.; SINGH, B. 2006. Herbicidal inhibitors of amino acid biosynthensis and herbicide-tolerant crops. Amino 30: 195-204. 32. SILVA-WERNECK, J. O.; SOUZA, M. T.; DIAS, J. M. C. S.; RIBEIRO, B. M. 1999. Characterization of Bacillus thuringiensis subsp. kurstaki strain S93 effective against the fall armyworm (Spodoptera frugiperda). Canadian Journal of Microbiology 45: 464- 471. 33. XIA, J. Y.; CUI, J. J.; MA, L. H.; DONG, S. X.; CUI, X. I. 1999. The role of transgenic Bt cotton in integrated insect pest management Acta Gossypii Sim 11:57-64. 34. YI, G.; SHIN, Y. M.; CHOE, G.; SHIN, B.; KIM, Y. S.; KIM, K. M. 2007. Production of herbicide-resistant sweet potato plants transformed with the bar gene. Biotechnol. Lett. 29: 669-675. 35. YU, J.; XIE, R.; TAN, L.; XU, W.; ZENG, S.; CHEN, J.; TANG, M.; PANG, Y. 2002. Expression of the full-length and 3’-spliced Cry1Ab gene in the 135-kDa crystal protein minus derivative of Bacillus thuringiensis subsp. kyushuensis. Curr. Microbiol. 45: 133-138. 36. WAQUIL, J. M.; VILLELA, F. M. F.; FOSTER, J. E. 2002. Resistência do milho (zea mays L.) transgênico (Bt) à lagarta-do-cartucho, Spodoptera frugiperda (Smith) (Lepidoptera: Noctuidae). Revista Brasileira de Milho e Sorgo 1(3): 1-11. 37. WATSON, S. A.; RAMSTAD, P. E. 1987. Corn: chemical and technology. St. Paul: American Association of Cereal Chemist, 605p. 38. CARPENTER, J.; FELSOT, ª; GOODE, T.; HAMMING, M.; ONSTAD, D.; SANKULA, S. 2002. Comparative environmental impacts of biotechnology-derived and traditional soybean, corn, and cotton crops (CAST: 1-189). Ames, IA: Council for Agricultural Science and Technology. 39. RAYNOR, G.; OGDEN, E. C.; HAYES, J. V. 1972. Dispersion and deposition of corn pollen from experimental sources. Agron. J. 64: 420-427. 40. LUNA, S. V.; FIGUEROA, J. M.; BALTAZAR, M. B.; GOMEZ, L. R.; TOWNSEND, R. E.; SCHOPER, J. B. 2001. Maize pollen longevity and distance isolation requirements for effective pollen control. Crop Sci. 41: 1551-1557. 41. BROOKES, G.; BARFOOT, P.; MELÉ, E.; MESSEGUER, J.; BÉNÉTRIX, F.; BLOC, D.; FOUEILLASSAR, X.; FABIÉ, A.; POEYDOMENGE, C. 2004. Genetically modified maize: pollen movement and crop co-existence. Dorchester, UK: PG Economics, 20 pp. (www.pgeconomics.co.uk/pdf/Maizepollennov2004final.fdf). 42. MESSEGUER, J.; PEÑAS, G.; BALLESTER, J.; BAS, M.; SERRA, J.; PALAUDELMAS, M.; MELÉ, E. 2006. Pollen-mediated gene flow in maize in real situations of coexistence. Plant Biotechnology Journal. 4: 633-645. 43. Dewar, Alan M. 2009. Weed control in glyphosate-tolerant maize in Europe. Pest Management Science, Volume 65, Number 10, pp. 1047-1058 (12). 44. MENDELSOHN, M.; KOUGH, J.; VAITUZIS, Z.; MATTEWS, K. Are Bt crops safe? Nature Biotechnology, v. 21, n. 9, p. 1003-1009, 2003. 45. DULMAGE, H. T. Microbial control of pests and plant diseases 1970 – 1980. In: BURGES, H. D. (Ed). London: Academic Press, 1981. p. 193-222. 46. KLAUSNER, A. Microbiol insect control. Bio/Technology, v. 2, p. 408-419, 1984. 47. ARONSON, A. I.; BACKMAN, W.; DUNN, P. Bacillus thuringiensis and related insect pathogens. Microbiol. Rev., v. 50, p. 1-24, 1986. 48. MACINTOSH, S. C.; STONE, T. B.; SIMS, S. R.; HUNST, P.; GREENPLATE, J. T.; MARRONE, P. G.; PERLAK, F. J.; FISCHHOFF, D. A.; FUCHS, R. L. Specificity and efficacy of purified Bacillus thuringiensis proteins against agronomically important insects. J. Insect Path., v. 56, p. 258-266, 1990. 49. WHITELEY, H. R.; SCHNEPF, H. E. T he molecular biology of parasporal crystal body formation in Bacillus thuringiensis. Ann. Rev. Microbiol., v. 40, p. 549-576, 1986. 50. CANTWELL, G. E.; LEHNERT, T.; FOWLER, J. Are biological insecticides harmful to the honey bee. Am. Bee J., v. 112, p. 294-296, 1972. 51. KRIEG, A.; LANGENBRUCH, G. A. Susceptibility of arthropod species to Bacillus thuringiensis. In: Microbiol Control of Pests and Plant Diseases. BURGES, H. D. (Ed). London: Academic Press, 1981. p. 837-896. 52. FLEXNER, J. L.; LIGHTHART, B.; CROFT, B. A. The effects of microbial pesticides on non-target beneficial arthropods. Agric. Ecosys. Environ., v.16, p. 203-254, 1986. 53. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY. Guidance for the re- registration of pesticide products containing Bacillus thuringiensis as the active ingredient. Springfield, VA.: US EPA/National Technical Information Service, 1988. v. 89, p. 164-198. 54. SANTOS, B. Estudo da dinâmica populacional de insetos-praga e inimigos naturais em milho Guardian comparativamente com milho convencional. Report of an unpublished study submitted to Monsanto, 2000. 55. FERNANDES, O. D.; CAMPOSILVAN, D.; MONTEZUMA, M. C. Dinâmica de lepidopteros pragas e inimigos naturais predadores em areas com a tecnologia MON 810 e milho convencional. Unpublished internal Monsanto study report. 2000. 56. CRUZ, I. Estudo de dinâmica populacional de insetos em milho Guardian e milho convencional C806. Report of an unpublished study submitted to Monsanto, 2000. 57. Comissão Técnica Nacional de Biossegurança – CNTBio. http://www.cntbio.gov.br/index.php/content/view/3509.html, Available on 10/07/2009. 58. FERNASNDES, O. D. Efeito do milho geneticamente modificado (MON 810) em Spodoptera frugiperda (J. E. Smith, 1797) e no parasitóide de ovos Trichogramma spp. 164 f. Tese (PhD in Entomology) – Departamento de Entomologia, ESALQ, Universidade de São Paulo, Piracicaba, 2003. 59. SIMS, S. R. Bacillus thuringiensis var. kurstaki (Cry1Ac) protein expressed in transgenic cotton: effects on beneficial and other non-target insects. Southwestern Entomol., v. 20, p. 493-500, 1995. 60. SANDERS, P. R.; LEE, T. C.; GROTH, M. E.; ASTWOOD, J. D.; FUCHS, R. L. Safety assessment of insect-protected corn. In: THOMAS, J. A. Biotechnology and Safety Assessment. 2 ed. Taylor and Francis, 1998. p. 241-256. 61. MUCHAONYERWA, P.; WALADDE, S.; NYAMUGAFATA, P.; MPEPERKI, S. E RISTORI, G. G. Persistence and impact on microorganisms of Bacillus thuringiensis proteins in some Zimbabwean soils. Plant and Soil, v. 266, p. 41-46, 2004. 62. STOTZKY, G. Clays and humic acids affect the persistence and biological activity of insecticidal proteins from Bacillus thuringiensis in soil. In: Developments in Soil Science 28B (Soil Mineral-Organic Matter-Microorganism Interactions and Ecosystem Health), p: 1-16, 2002. 63. STOTZKY, G. Persistence and biological activity in soil of the insecticidal proteins from Bacillus thuringiensis, especially from transgenic plants. Plant and Soil, v. 266, p. 77-89, 2004. 64. KOSKELLA, J.; STOTZKY, G. Larvicidal toxins from Bacillus thuringiensis subsp. kurstaki, morrisoni (strain tenebrionis), and israelensis have no microbiocidal or microbiostatic activity against selected bacteria, fungi, and algae in vitro. Can. J. Microbiol., v. 48, n. 3, p. 262-267, 2002. 65. GARCIA, C. M.; FIGUEIROA, J. M.; GÓMEZ, R. L.; TOWNSEND, R.; SCHOPER, J. Pollen control during transgenic hybrid maize development in México. Crop Science, v. 38, p. 1597-1602,1998.
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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 Commission
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Authorization expiration date (a blank field means there is no expiration date) not applicable
E-mail:
gutemberg.sousa@mcti.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:
Useful links
Relevant documents
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)

Japan
Name of product applicant: Monsanto Japan Ltd.
Summary of application:

Maize tolerant to glyphosate herbicide and resistant to Lepidoptera (cp4 epsps, cry1Ab, Zea mays subsp. mays (L.) Iltis).

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Date of authorization: 30/06/2003
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.): BioTrack Product Database
Summary of the safety assessment (food safety):
Please see the link below (in Japanese).
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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: Food safety assessment performed by Ministry of Health, Labour and Welfare of Japan (in Japanese)
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Authorization expiration date (a blank field means there is no expiration date)
E-mail:
fscj-secretariat@cao.go.jp
Organization/agency name (Full name):
Food Safety Commission Secretariat,Cabinet Office,GOJ
Contact person name:
Emi Takagi
Website:
Physical full address:
Akasaka 5-2-20 Minato Ward,Tokyo,Japan
Phone number:
81 3 6234 1122
Fax number:
81 3 3584 7392
Country introduction:
Useful links
Relevant documents
Stacked events:

With regard to stacked events, FSCJ conducts the safety assessment of GM food based on the “Policies Regarding the Safety Assessment of Stacked Varieties of Genetically Modified Plants”.

Even if single events that are stacked have already approved, some products will be considered as new products and some will not.

Please refer to Article 5 and 6 of the MHLW’s notice, which is available at the following URL, for the details.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000053519.pdf

Article 6 was modified in 2014, and the modified version is available at the following URL.

http://www.mhlw.go.jp/file/06-Seisakujouhou-11130500-Shokuhinanzenbu/0000049695.pdf

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Safety Commission of Japan (http://www.fsc.go.jp/english/index.html), Ministry of Health, Labour and Welfare (http://www.mhlw.go.jp/english/policy/health-medical/food/index.html)

Mexico
Name of product applicant: Monsanto Comercial, S.A. de C.V.
Summary of application:

Authorization by COFEPRIS: 22


Maize tolerant to glyphosate herbicide and resistant to Lepidoptera (cp4 epsps, cry1Ab, Zea mays subsp. mays (L.) Iltis).

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Date of authorization: 03/03/2004
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.):
Summary of the safety assessment (food safety):
UI OECD: MON-ØØ603-6 X MON-ØØ81Ø-6 During the risk assessment of this GMO based on existing knowledge to date, no toxic or allergic effects neither substantial nutritional changes are observed. The event is as safe as its conventional counterpart. For more detail please find attached the risk assessment summary in this page.
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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 (a blank field means there is no expiration date)
E-mail:
sortiz@conacyt.mx
Organization/agency name (Full name):
CIBIOGEM
Contact person name:
Dra. Sol Ortiz García
Website:
Physical full address:
San Borja #938, Col. Del Valle • Del. Benito Juárez C.P. 03100, México, D.F.
Phone number:
+52 (55) 5575-6878
Fax number:
Country introduction:
Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Secretaría de Salud / Phone: +52 55 5080 5200 /Email: ralatorre@cofepris.gob.mx%20

Philippines
Name of product applicant: Monsanto Philippines
Summary of application:
Corn MON 810 with resistance to Lepidopteran pests are produced through introduction of the cry1Ab gene from Bacillus thuringiensis subsp. kurstaki. The cry1Ab sequence encodes for the production of a Bt insect toxin.

Corn NK 603 with tolerance to the family of Roundup® herbicides are produced through introduction of the cp4 epsps gene from Agrobacterium sp. Strain CP4. The cp4 epsps sequence encodes for the production of the naturally occurring 5-enolpyruvylshikimate-3-phosphate synthase.

Inbred line, MON 810, was crossed with inbred line, NK 603, resulting in the combined trait product MON 810 x NK 603 with resistance to insects and tolerance to the herbicide glyphosate.
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Date of authorization: 08/01/2010
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 (food safety):
Monsanto Philippines, Inc. has filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notifications for direct use as food, feed and for processing under Department of Agriculture (DA) Administrative Order (AO) No. 8 Part 5 for Combined trait product corn: MON810 x NK603 which has been genetically modified for insect resistance and herbicide tolerance. A safety assessment of combined trait product corn: MON 810 x NK 603 was conducted as per AO 8 Series of 2002. The focus of risk assessment is the gene interactions between the two transgenes. 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 (a blank field means there is no expiration date)
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Merle B. Palacpac
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.

Useful links
Relevant documents
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.

 

Plant Products Carrying Stacked Genes Conferred Through (a) Genetic Engineering or b) Conventional Breeding, with Individual Traits That Have No Prior Approval:

A full risk assessnent as to  food and feed or processing shall be conducted,consistent with Part V of AO No. 8,"Approval Process For the Importation of Regulated Articles for Direct Use as Food and Feed or For Processing for plant products with multiple traits conferred through:

(a) genetic engineering, or

(b) conventional breeding, where the individual traits have no prior approval from the Bureau of Plant Industry (BPI) for direct use as food and feed or processing.

Plant Products Carrying Stacked Genes Conferred through Conventional Breeding:

For plant products with multiple traits conferred through conventional breeding,with all individual events granted prior approval and included in the Approval Registry, a notlfication shall be submitted by the technology developer to the BPI, which shall conduct an evaluation in accordance with the relevant criteria in Annex I of this Memorandum Circular. The list of data contained in Annex I will not preclude the inclusion of other issues and concerns that will be raised by the BPI and the Scientific and Technical Review Panel (STRP) during the course of the desktop review.

Notificatlon Requirement for Plant Products Carrying Stacked Genes

All technology developers shall submit a notification to the Bureau of Plant Industry of their developed plant products carrying stacked genes and shall be required to comply with the relevant approval process listed above.

The Bureau of Plant Industry shall issue a certiflcate as to the approval of the stacked gene product and shall likewise include the transformation event in the official approval registry of plant products for food and feed or processing.

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

Turkey
Name of product applicant: Special case: please show below
Summary of application:

 


Application for direct use as feed


Turkish Biosafety Law, entered in force in 2010, diverges from EU legislations in some points
 such as food and feed use require different separate applications, risk assessments and approvals.
  Addition, our Law forsees prision sentences in some circumtances of Law violation and joint
 reponsibilities for the violation. Therefore, GM product owners avoid to make application for approval
and non product developer have made application till now. Instead, some Turkish assosiations
 such as poultry producers assosiations, animal feed assosiations have applied to get approval
for import of GM products for their members. Thus, name of product applicants are not product
developers for our country.


Turkish Feed Manufacturer's Association
Turkish Poultry Meat Producers and Breeders Association
Turkish Egg Producers Association


 

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Date of authorization: 24/12/2011
Scope of authorization: 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 (food safety):
After the evaluation of reports released by Scientific Risk Assessment Committee and Socio- economic Assessment Committee and also by considering public opinion, Biosafety Board has approved the use of genetically modified maize NK603xMON810 and products thereof for animal feed.
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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 (a blank field means there is no expiration date)
E-mail:
iozkan@tagem.gov.tr
Organization/agency name (Full name):
General Directorate of Agricultural Research and Policy
Contact person name:
İsa Özkan
Website:
Physical full address:
İstanbul Yolu üzeri, Tarım Kampüsü No:38 06171 Yenimahalle/Ankara/Turkey
Phone number:
+90 312 315 52 86
Fax number:
+90 312 315 26 98
Country introduction:

Turkey is party to the Cartagena Protocol on Biosafety (CPB) since Jan 24, 2004. Biosafety applications in Turkey are carried out within the framework of the Biosafety Law (no.5977) which entered into force in 26 September 2010 and its relevant regulations (“The Regulation on Genetically Modified Organisms and Products” and “The Regulation Connected with Working Procedure and Principles of Biosafety Board and Committees”). Biosafety Law and two regulations came into force on 26th September 2010. According to Biosafety Law it is forbidden to cultivate GM crops and animals, in Turkey. Biosafety Board founded in 22nd September 2010 to evaluate applications about GMO and products and perform tasks that are written in Biosafety Law and related regulations. Biosafety Board makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account. To date, 7 types of GM soybean and 25 types of GM maize were approved as feed for import.

 

For food, 29 different varieties (3 soybean, 21 maize, 3 oilseed rape, 1 sugar beet, 1 potato) has been applied and risk assessment for soybean and maize has been opened to public opinion. However, applicants withdrew due to the public pressure so Biosafety Board has not made any decision.

 

Biosafety Board makes a “Decision” about applications on GMO and products via taking Scientific Committees’ risk assessment and socio-economic assessment into account. Application evaluation process is like below:

  • Evaluation of application by Biosafety Board                              90 days
  • Feedback to the applicant                                                         15 days
  • Biosafety Board’s “Decision”                                                     270 days

(Starts from feedback to the applicant)

  • Establishing of Scientific Committees
  • Report preparation of Committees
  • Report’s public release
  • Evaluation of public opinions by Committees
  • Board’s final decision after taking reports and public opinions into account
  • Report’s presentation to Ministry by Board
  • Publishing the Positive Decision                                                30 days
  • Reclamation period to Negative Decision                                   60 days
  • Evaluation of reclamation by Board                                          60 days

 

Table 1: Decisions for GMO’s Depending on Usage

 

Usage

Positive

Negative

Date of desicion

Feed

3 GM soybean

-

Official   Gazette  no 27827 in  26 January    2011

Feed

16 GM maize

-

Official Gazette    no 28152 in  24 December 2011   (13 GM maize)

Official Gazette    no 28271 in  21 April 2012 (3 GM   maize)

Feed

-

6 GM  maize

13. Biosafety   Board Meeting decision

(26 March 2012)

Feed

-

3 GM oilseed rape

16. Biosafety   Board Meeting decision

(19 November 2012)

Feed

-

1 GM sugar beet

16. Biosafety   Board Meeting decision

(19 November 2012)

Bioetanol

-

22 GM maize

16. Biosafety   Board Meeting decision

(19 November 2012)

Feed

3 GM maize

-

Official   Gazette  no 29418 in  16 July 2015

Feed

2 GM soybean

-

Official   Gazette  no 29418 in  16 July 2015

Feed

2 GM soybean

-

Official   Gazette  no 29523 in  5 November 2015

Feed

6 GM maize

-

Official Gazette    no 29523 in  5 November 2015

 

 

Useful links
Relevant documents
Stacked events:
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Uruguay
Name of product applicant: Monsanto Co.
Summary of application:

NK603 x MON810 was produced through cross breeding of the two genetically modified organisms NK603 and MON810. It contains the Cry1Ab which confers protection against the European corn borer and  5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) that allows the plant to survive the otherwise lethal application of glyphosate.

Upload:
Date of authorization: 21/06/2011
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.): BCH
Summary of the safety assessment (food safety):
Please refer to uploaded document
Upload:
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 (a blank field means there is no expiration date)
E-mail:
mibarra@mgap.gub.uy
Organization/agency name (Full name):
Ministerio de Ganadería, Agricultura y Pesca
Contact person name:
Mariela Ibarra
Website:
Physical full address:
Constituyente 1476, Piso 3, Of. 310. Montevideo, Uruguay
Phone number:
+598 2 4104155/59, I
Fax number:
+598 2 4198175
Country introduction:
The uruguayan regulatory framework includes safety assessments of food end feed, environmental risk asessment, risk management, and risk communication. The inter-ministerial National Biosafety Commission (GNBio) is the competent authority on biosafety of GMOs. Integrated by: The Minister of Agriculture, MGAP (chair); Minister of Health (MSP); Minister of Economy and Finance (MEF); Minister of Housing, Territorial Ordering and the Environment (MVOTMA); Minister of Foreign Affairs (MRREE); and Minister of Industry, Energy and Mining (MIEM). This commission is the last responsible to make decisions over a submitted request. It has the authority to define policies to be followed with respect to biosafety in all scopes of GMO application. Other committees of experts and scientists give support to decisones of GNBio through risk analysis of biotechnological products. The Commission for Risk Management (CGR) is composed by one delegate of each of the ministries represented within GNBio. This commission is also chaired by the representative of the Ministry of Agriculture. The CGR advises GNBio on GMO biosecurity issues; elaborates reference terms for risk assessments; manages the participation process; is responsible for follow-up and monitoring of authorized events. The Evaluation of Risk in Biosecurity (ERB) is composed of experts proposed by the CGR and designated by GNBio among specialists in the different areas of risk assessment. Is responsible for considering, on a case-by-case basis, the potential risks and benefits of each new biotech product; assure case-by-case risk assessment evaluation based on scientific methods; writes an operational plan (pre-report) of risk assessment according to CGR directives; advises CGR based on the results of the analysis of risk assessment, and provides information during the consultation process. The Institutional Articulation Committee (CAI) Is a committe of technical experts from different national public and research institutions, which performs technical risk assessment of new events; prepares a technical report. The group is coordinated by the ERB coordinator. It include different groups of assesment. The Ad hoc experts groups are technical-scientific specialists in different areas of knowledge related to the analysis and evaluation of risk on new GMO events like characterization and molecular identification of events (GAHCIM) and human and animal health (GAHSHA).
Useful links
Relevant documents
Stacked events:
Evaluation of the stacked events is focused on the possible interactions between the single events contained in the particular trait. Each staked component must have the individual risk assesment report.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
GNBio office. E-mail: bioseguridad@mgap.gub.uy; Adress: Constituyente 1476, Montevideo, Uruguay.