Food safety and quality
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OECD Unique Identifier details

MON-89Ø34-3xDAS-Ø15Ø7-1xMON-ØØ6Ø3-6
Commodity: Corn / Maize
Traits: Glufosinate tolerance,Glyphosate tolerance,Lepidoptera resistance
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C. and Dow AgroSciences Argentina S.A.
Summary of application:
The stacked event MON89034xTC1507xNK603 of maize confers resistant to certain lepidopteran insects, tolerance to herbicides which active principle is glyphosate and glufosinate ammonium. The single events MON89034, TC1507 and NK603, were stacked by conventional crossing (sexual). The stacked event has two genes, cry1A.105 and cry2Ab2, from MON89034 event, two genes, cry1F and pat, from TC1507 event and cp4 epsps gene from NK603 event. The transgenes are inherited independently, since they presents mendelian segregation. Moreover, the applicant proved the gene stability and the effective levels of the expressed proteins. The proteins Cry1A.105, Cry2Ab2 and Cry1F confer resistance to lepidopteran insects, some affected species are Spodoptera frugiperda, Helicoverpa zea and Diatraea saccharalis. The protein CP4 EPSPS has similar structure and is functionally identical to the endogenous EPSPS enzyme of the plants, but with a reduced affinity to glyphosate. The enzyme phosphinothricin N-acetyltransferase (PAT) eliminates herbicidal activity of glufosinate (phosphinothricin) by acetylation. After comparison of 62 analytes measured in grain and forage, in the compositional analysis study, it's concluded that maize with the stacked event MON89034xTC1507xNK603 is equivalent to the commercial maize and parental lines. The allergenicity and toxicity assessment of proteins of new expression were carried out previously in the singles events. Taking into account the assessment of genetic stability, molecular characterization, products and levels of expression, compositional analyses and morphoagronomic studies, no metabolic interaction is expected that might impact on the food safety when single events are stacked in a conventional way. The MON89034xTC1507xNK603 event is substantial and nutritionally equivalent to its non transgenic counterpart.
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Date of authorization: 31/05/2012
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:
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: Principles for the Assessment of Food and Feed derived from GMO in Argentina - Resolution Nº 412
Decision document of food/feed safety assessment of event MON89034xTC1507xNK603
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Authorization expiration date:
E-mail:
mjunco@senasa.gov.ar
Organization/agency name (Full name):
SENASA (National Service for Agrifood Health and Quality)
Contact person name:
Mariano Junco
Website:
Physical full address:
Paseo Colón Avenue 367, 3° floor, City of Buenos Aires
Phone number:
54 11 4121 5276
Fax number:
54 11 4121 5258
Country introduction:
The food risk assessment process of transformation events, as the result of modern biotechnology, is carried out by the National Service for Agrifood Health and Quality (Senasa), regulatory agency depending on the Ministery of Agriculture, Livestock and Fisheries. The Agrifood Quality Directorate of Senasa, is the area responsible for carrying out this task. It has an specific scientific team and the advise of a Technical Advisory Committee composed of experts from different scientific disciplines representing different sectors involved in the production, industrialization, consumption, research and development of genetically modified organisms.
Useful links
Relevant documents
Stacked events:
Argentina hasn't a specific authorization mechanism for food/feed safety assessment for stacked events. In principle, stacked events are assessed like another single event on a case-by-case basis.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
National Service for Agrifood Health and Quality (Senasa) (http://www.senasa.gov.ar)
Brazil
Name of product applicant: Monsanto do Brasil Ltda. & Dow AgroScience Ltda.
Summary of application:
Commercial release of maize resistant to insects and tolerant to glyphosate and ammonium gluphosinate herbicides containing events MON89034 X TC1507 X NK603
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Date of authorization: 16/12/2010
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.): Center for Environmental Risk Assessment
Summary of the safety assessment:
MON89034 X TC1507 X NK6023 results from crossing, through classical genetic improvement, of parental insect resistant genetically modified maize,MON89034, insect resistant and ammonium gluphosinate herbicide tolerant maize, TC1507 and glyphosate herbicide tolerant maize NK603. Maize containing event MON 89034 contains genes cry1A.105 and cry2Ab2 inserted in its genome that produce, respectively, proteins Cry1A.105 and Cry2Ab2, derived from Bacillus thuringiensis, which are active against insects of the Lepidoptera order, an important pest of maize farming. Maize containing event TC1507 was generated through insertion of genes cry1F and pat, which codify proteins Cry1F and PAT, respectively. Protein Cry1F grants maize protection against Lepidopterans, seen as a maize pest. Maize containing event NK603 has gene cp4 epsps originated from Agrobacterium sp. strain CP4, responsible for expressing protein CP4 EPSPS (CP4 5-enolpyruvylshikimate-3-phosphate synthase) granting the plant the attribute of tolerance to glyphosate herbicide. Efficacy of corn MON 89034 x TC1507 x NK603 insecticide activity was compared to the efficacy of individual events MON 89034 and TC1507, and to conventional control to access foliage damage in plants infested with the armyworm Spodoptera frugiperda. Results enabled a conclusion that combination of individual events MON 89034, TC1507 and NK603 through classical genetic improvement failed to change, in the stacked corn, the insecticide activity against armyworm found in individual events MON 89034 and TC507. Phytotoxicity of glyphosate and ammonium gluphosinate on MON 89034 x TC1507 x NK603 corn was compared to phytotoxicity of this same formulations in individual events NK603, TC1507 and in conventional control. Results showed that combination of events MON 89034, TC1507 and NK603 in the stacked product, through classical genetic improvement failed to change the tolerance characteristic to ammonium gluphosinate expressed in individual event TC1507, as well as tolerance to glyphosate expressed in individual event NK603. Assessment of proteins Cry1A.105 and Cry2Ab2 alimentary safety expressed in MON 89034 corn included characterization of each of them, essays of simulated digestion in gastric and intestinal fluids, studies of acute oral toxicity in mice, bioinformatics assessments and studies on the effect of such proteins on non-target organisms. Studies of acute oral toxicity in mice with proteins Cry1A.105 and Cry2Ab2 showed the expected result that such proteins are not toxic for mammals. Comparative biochemical studies indicated that Cry1A.105 and Cry2Ab2 proteins displayed important differences in their mode of action, specifically in the form with which they bond to receptors at the middle intestine of insects. Studies conducted with MON 89034 x TC1507 x NK603 corn evidenced that the stacked corn is not different from the conventional one regarding morphological and reproductive characteristics, being all original attributes of the domesticated species maintained. Maintenance of botanical characteristics of conventional corn in MON 89034 x TC1507 x NK603 corn is crucial for maintaining the physiological characteristics of the plant and consequently the nutritional quality of forage and grain. Comparative compositional analysis between stacked corn and conventional control corn reveals that MON 89034 x TC1507 x NK603 corn is as safe for human and animal food as common corn. Besides, CTNBio consulted independent scientific literature to assess occurrence of any unexpected effect coming from the crossing among such events. TECHNICAL OPINION I. Identification of GMO. GMO designation: MON 89034 x TC1507 x NK603 corn Applicant: Monsanto do Brasil Ltda. and Dow Agrosciences Industrial Ltda. Species: Zea mays L. Characteristic inserted: Tolerance to glyphosate and ammonium gluphosinate herbicides and tolerance to insects. Characteristic introduction method: MON 89034 x TC1507 x NK603 corn, classified as Risk I Class, was developed through classical genetic improvement by sexual crossing between genetically modified lineages containing event MON 89034, event TC1507 and event NK603. Proposed use: Free registration, use, essays, tests, sowing, transport, storage, marketing, consumption, import, release to the environment and disposal. II. General Information Zea mayz L. corn is a species of the Gramineae family, tribe Maydae, subfamily Panicoidae, which is segregated within the sub-genus Zea, featuring a chromosome number 2n = 20,21,22,24(1). The closest feral species of corn is teosinte, found in Mexico and some regions of Central America, where it may cross withy domesticated corn in production fields. Corn has an history of over eight thousand year in the Americas, and is cultivated since the pre-Columbian period. It is one of the best scientifically characterized higher plants, being today the cultivated species reaching the highest degree of domestication and may only survive when cultivated by man(2). Currently there are about 3000 identified races of corn and, within each race, thousands of cultivars. One of the most important food sources in the world, corn is an input for a range of food products, rations and industrial products. Brazil is one of the largest world producers of corn, which is planted practically all over the national territory(3). Insects occur more abundantly in the tropics than in temperate regions, where damages caused by such animals are more severe. Among the more important corn pests there are the armyworm, Spodoptera frugiperda. Cruz and collaborators(21) estimated the yearly losses caused by infestation of Spodoptera frugiperda in about 400 million Dollars in Brazil. Other lepidopterans also are important corn pests, such as the corn earworm, Helicoverpa zea, and sugarcane borer, Diatraea Saccharilis. The main measure aimed at controlling insects in corn culture has been the use of insecticides. In some areas of the Brazilian Central-West region, dozens of insecticide sprays are needed in a single cycle of culture. Another measure for controlling pests would be the use of resistant cultivars. Brazil is held as third larger consumer of pesticide in the world, with 142 insect killers registered for corn, of which 107 are exclusive for caterpillars. There are already several cases of resistance caused by constant and indiscriminate use of corn culture insecticides in Brazil. Besides, one of the most factors harmful to farmer’s health in Brazil is the use of pesticides, responsible for intoxication of a million of individuals each year(5). The number of cultivars using stacked events is growing around the world. This represents a trend towards meeting the demand of producers when combining two characteristics of agronomic importance in a same hybrid. Following this line, different hybrids of corn containing stacked events through classical genetic improvement are approved in several countries(6). MON 89034 x TC1507 x NK603 corn is the result of a technology partnership among the entities mentioned above and contains the events of genetic transformation MON 89034, TC1507 and NK603. Individual events MON 89034 and NK603 were stacked, through classical corn improvement techniques to event TC1507 to generate MON 89034 x TC1507 x NK603 corn. These individual events were assessed by CTNBio from 2008 to 2009, being granted an opinion approving biosafety(7, 8, 9). Besides Brazil, other countries(6) have already approved such events, either individually or in stacked form. Stacking of events MON 89034 x TC1507 x NK603 in corn enabled insertion of genes cry1A.105 and cry1F, codifying proteins Cry1A.105, Cry2Ab2 and Cry1F that grant resistance against important lepidopteran held as corn pests; as well as genes pat and cp4 epsps, which codify proteins PAT and EPSPS, responsible for tolerance to glyphosate herbicide and herbicides containing ammonium gluphosinate as active ingredient, respectively. III. Description of the GMO and Proteins Expressed MON 89034 x TC1507 x NK603 corn was constructed from a stacking of corn containing event MON 89034 that had genes cry1A.105 and cry2Ab2 inserted in its genome, codifying proteins Cry1A.105 and Cry2Ab2, respectively. Proteins Cry1A.105 and Cry2Ab2 are active against lepidopterans held as corn pests. The second component of MON 89034 x TC1507 x NK603 corn is the one containing event TC1507 that had genes cry1F and pat inserted in its genome. Gene cry1F codifies Cry1F that is active against lepidopterans held as corn pests. Gene pat, in turn, codifies protein PAT, which grants corn tolerance to herbicides containing the active ingredient ammonium gluphosinate. Finally, the third component of MON 89034 x TC1507 x NK603 corn, the one containing event NK603, which had gene cp4 epsps inserted in its genome and expresses protein CP4 EPSPS. Protein CP4 EPSPS grants corn plants tolerance to the glyphosate herbicide. Proteins Cry1A.105 and Cry2Ab2 have additive insecticide activity, which enable each such proteins to be tested independently in security assessment studies. Proteins Cry1A.105 and Cry2Ab2 were tested separately and combined against two species of sensitive lepidopterans: the European corn borer (Ostrinia nubilalis) and the corn earworm (Helicoverpa zea)(10). The insects were exposed to purified proteins Cry1A.105 and Cry2Ab2 in bioessays with the incorporation of such proteins in their diet. Interactions between proteins Cry1A.105 and Cry2Ab2 were assessed using a simple model of similar action (dose addition)(11, 12, 13). This analysis showed that the proteins have additive insecticide activity, without displaying synergistic or antagonistic effects. The results of such study were consistent with the ones of a previous study showing absence of interaction between proteins Cry1AC and Cry2Ab2(14). Biologic activity of protein Cry1F was studies in a range of pest insects that fed on corn plants. The essays were conducted exposing the insects to artificial diets treated with watery formulations of protein Cry1F produced from a microbial source (Pseudomonas fluorescens), validated by Evans(15), demonstrating that the biochemical characteristics of the protein produced in either plant or microbial form are equivalent. Insects essayed were armyworm (Spodoptera frugiperda), sugarcane borer (Diatraea saccharalis), European corn borer (Ostrinia nubilalis), corn earworm (Helicoverpa zea), black cutworm (Agrotis ipsilon), corn stalk borer (Elasmopalpus lignosellus), southwestern corn borer (Diatraea grandiosella), western corn rootworm (Diabrotica virgifera virgifera), corn leaf aphid (Rhopalosiphum maidis) and corn leafhopper (Dalbulus maidis). According to the study, the insects susceptible to protein Cry1F were: armyworm, sugarcane borer, European corn borer, corn earworm, black cutworm, corn stalk borer and southwestern corn borer. The study conducted by Evans(15) failed to detect activity of protein Cry1F on the following insects: western corn rootworm, corn leafhopper and corn leaf aphid. The result showed the specific action of protein Cry1F to some pest lepidopterans. Studies conducted by Hua and collaborators(16) showed specificity of Cry proteins through bonding essays in cell vesicles, evidencing high specificity of interaction of this protein complex to cell receptors of some insects. One peculiarity of proteins Cry1F, Cry2Ab2 and Cry1A.105 is that their domains of protein interaction are unavailable when present inside plant cells, due to the fact that their molecular conformations remain inert and inactive. Activation of Cry proteins will take place after ingested by the insect, its solubilization depending on alkaline pH, and following processing in order to release its active form(17). This enzymatic process is catalyzed by specific proteases that are present in the insects’ intestine. According to this, a conclusion may be reached that proteins Cry, though existing in the same plant cell where other proteins are present, posses isolated and independent action mechanisms, interacting solely with the specific receptors after solubilized and modified inside the target insects’ intestine. Protein CP4 EPSPS (CP4 5-enolpyruvylshikimate-3-phosphate synthase) grants corn tolerance to glyphosate herbicide - expressed in genetically modified plants, is functionally identical to the endogenous protein EPSPS, with the difference that CP4 EPSPS has reduced affinity for glyphosate herbicide(18). In conventional plants, glyphosate bonds to enzyme EPSPS and blocks shikimic acid biosynthesis preventing therefore formation of aromatic amino acids and secondary metabolites(19,20). In glyphosate tolerant genetically modified plants, as in corns containing event NK603, aromatic amino acids and other metabolites needed to plant development keep being produced by the activity of CP4 EPSPS(21,22). PAT protein – phosphinothricin acetyltransferase - presents specific enzymatic activity through an action mechanism widely elucidated in the scientific literature. Studies showed that PAT protein does not interact with proteins other than its target: ammonium gluphosinate. An analysis of its primary sequence shows that the protein is completely dissimilar to other known allergenic proteins and is similar only to other acetyltransferase enzymes, never related to any type of negative effect(23). A number of studies conducted with corn containing event TC1507 indicated that proteins PAT and Cry1F, even when produced in the same plant, fail to show synergistic interaction, evidencing functional independence between PAT and Cry proteins(8). The characteristics of PAT protein, coupled with its use history, enables a conclusion that the likelihood that this protein to display any type of interaction with other proteins of MON 89034 x TC1507 x NK603 corn is not significant. Event NK603 expresses enzyme CP4 EPSPS, which has the same function as proteins EPSPS of conventional plants, in addition to being very similar regarding its composition and structure. Similarity with the endogenous protein secures CP4 EPSPS to act in a natural mechanisms of the plant cell. This characteristic, per se, evidences how improbable an interaction of CP4 EPSPS with other protein, despite being originated from a plant cell itself or coming from the stacked events. The use of databanks enabled a search in silico to identify the possible existence of interaction domains in the proteins inserted in MON 89034 x TC1507 x NK603 corn. The results were that proteins Cry1A.105, Cry2Ab2, Cry1F, PAT and CP4 EPSPS fail to display classic interaction domains among them. Besides, exams in databanks enabled a conclusion that such proteins do not belong to the calmodulins(24). MON 89034 x TC1507 x NK603 corn was generated through classical genetic improvement, by crossing individual events MON 89034, TC1507 and NK603, and for that reason, displays Mendelian legacy of the exogenous genes introduced in the events. Genotypic stability of MON 89034 x TC1507 x NK603 corn was verified through molecular analyses, comparing its DNA with the DNA of individual events to check the presence of gens cry1A.105, cry2Ab2, cry1F, cp4 epsps and pat in the stacked event. With this on mind, the Southern blot technique was used comparing presence and integrity in inserts of different hybrid. This way, one could confirm that in corn MON 89034 x TC1507 x NK603, integrity of inserts that were present in individual events was maintained(25). In addition, genetic stability was studied in each individual event of different generations(26,27). IV. Aspects Related to Human and Animal Health. Essays to show similarity in centesimal composition of MON 89034 x TC1507 x NK603 corn and its conventional correspondent were conducted in Brazil during different sowing periods during 2009 in four different environments. In addition, to assess substantial equivalence, sample composition of hybrids MON 89034 x TC1507 x NK603 were compared with their correspondent conventional hybrid(28). The data obtained showed that the levels of main components quantified in corn forage and grain of the stacked MON 89034 x TC1507 x NK603 corn and those of the control corn are equivalent. Similarly, data on centesimal composition of kernel and fibers for ethereal extract, acid detergent fibers (ADF), neutral detergent fibers (NDF), carbohydrates and ashes reveal that there is no significant difference between the stacked MON 89034 x TC1507 x NK603 corn and the corn used as conventional control. Therefore, one may conclude that both kernels and forage coming from MON 89034 x TC1507 x NK603 corn are equivalent to kernels and forage coming from conventional corn from the viewpoint of composition and nutritional value(29). Besides, the values obtained lay within the intervals of similar analyses found in the literature(30,31,32,33,34,35). Acute toxicity studies were conducted by administering the different recombinant Cry, CP4 and PAT proteins in a large number of mice, and they reveal absence of toxicity, with no adverse effects or detectable changes through histopathologic investigation. Considering the low concentration of such proteins in corn, is practically impossible to result any toxic effect. Digestibility of expressed proteins was demonstrated by the rapid degradation in simulated gastric or enteric juices. This is an additional guarantee of lack of absorption of the whole protein and absence of systemic absorption and is already an indication of the proteins low allergenic potential. Computational analysis was conducted using databases on proteins or allergenic peptides failed to reveal any potential allergies caused by these gene products. Besides, cutaneous tests with protein Cry1Ab in 27 children with a history of inhalatory allergy and 50 individuals with asthma/rhinitis(36) demonstrated that the events on genetically modified corn are safe regarding potential allergenicity to humans. A further study with Japanese patients with allergy to food did not detect significant levels of IgE specific against proteins CP4 EPSPS or Cry9C in the serum of such patients through the ELISA method(37). Safety for human/animal nutrition of Cry proteins was confirmed by different authors, among them Xu and collaborators(38). Another recent 28 days study in mice, conducted by Onose and collaborators(39) revealed that no adverse effect may be attributed to food containing Cry1Ab, since administration of a diet containing protein Cry1Ab had no significant effect on any physiologic or biochemical parameter, except for a very low level of AST (Aspartate Transaminase) in the serum of animals that received such corn, being known that the parameter range of change may be wide in healthy animals. No change in organ weight and no histopathologic change was recorded in organs such as heart, liver and kidneys. Recent studies conducted in bovines and rats displayed results in line with the risk assessment of EPSPS protein. Healy and collaborators(40) showed the results of a thirteen weeks study of feeding rats with kernels of stacked corn expressing CryBb1 and CP4 EPSPS. Responses of rats fed in diets containing this corn variety were comparable to those of rats fed in a diet containing kernels of an variety almost isogenous to such variety, confirming that the stacked corn is as safe and nutritious as the kernels of commercial hybrid corns found in the market. Studies conducted by Herouet and collaborators(41) revealed that PAT is highly specific and fails to display the traits associated to alimentary toxin or allergenic. Likewise, the authors showed that protein PAT is rapidly degraded in experiences of gastric and intestinal fluid simulation with pancreatin and pepsin. Besides, they failed to find mortality or toxicity by administering 1 or 10 mg of protein PAT/kg of corporal weight by intravenous injection in mice, confirming that the PAT protein fails to present acute toxicity (safety factor > 1000) and do not cause adverse effects in mice after intravenous administration of high doses for a period longer than two weeks. Finally, corn containing individual events MON 89034, TC1507 and NK603, as well as corn containing the stacked events (MON 89034 x TC1507 x NK603) were assessed regarding alimentary safety through available and internationally validated protocols. Safety of proteins Cry1A.105, Cry2Ab2, Cry1F, PAT and EPSPS were duly assessed both individually and under the stacked form by CTNBio(8,9,42,43). V. Environmental Aspects Corn is a monoic, alogamic and annual plant, featuring anemochoric pollination and distances travelled by pollen depend on wind, humidity and temperature standards. Corn pollen disperses freely in areas surrounding the culture and may reach style-stigmas of the same or of a different genotype, starts the germination that shall originate the pollinic tube promoting ovule fertilization within a period of 24 hours. Studies on dispersion of pollen have been conducted showing that pollen may travel large distances, though the majority of pollen is deposited close to the tillage with a very low translocation rate and over 95% of pollen may reach up to 60 meters from its source. Luna and collaborators(44) assessed pollen isolation distance and control where it was demonstrated that cross pollination occurs within a maximum of 200 meters, although no cross pollination, under a condition of non-detasseling, was observed in distances not lower than 300 meters from the pollen source. Results indicate that pollen viability is maintained for 2 hours and that cross pollination was not observed in distances of 300 meters from the pollen source. Essays conducted in Brazil in three places with MON 89034 x TC1507 x NK503 corn, with individual events MON 89034, TC1507 and NK603, as well as with conventional control corn, failed to record significant differences on seed viability, germination, plant vigor, flowering, plant architecture and response to main pathogens. These field studies demonstrated that survival characteristics of MON 89034 x TC1507 x NK503 corn are comparable to those of conventional corn. As mentioned for individual events, it is unlikely that sexual crossing of MON 89034 x TC1507 x NK503 corn with compatible species in Brazil may occur. Therefore, the environmental consequence of transfer of MON 89034 x TC1507 x NK503 corn pollen to plant feral species is deemed as being negligible. Studies assessing persistence of proteins Cry1A.105 and Cry2Ab2 on corn MON 89034, proteins Cry1F and PAT in corn TC1507(45), and protein CP4 EPSPS on corn NK603 and on soil, demonstrated that all such proteins are rapidly degradable and do not accumulate, therefore do not pose risks to the soil microbiota. Cry insecticide proteins are extremely selective for insects of the Lepidoptera Order(46, 47, 48, 49, 50), have no noxious effects on insects held as beneficial and non-target, including predators, parasitoids, pollinators and others(51, 52, 53, 54). Agronomic characteristics of stacked corn MON 89034 x TC1507 x NK503 were contrasted with individual events TC1507, MON 89034, NK603 and the corresponding conventional hybrid. The study intended to test the hypothesis that crossing through classical genetic improvement of plants containing individual events fails to alter the stacked corn. Experiments were carried out at the Operating Units of Dow AgroSciences Industrial Ltda., in Brazil, during the 2009 crop year. Essays were conducted in four environments: Cravinhos, São Paulo; Indianópolis, Minas Gerais; and two in Mogi-Mirim, São Paulo (periods 1 and 2) (28). Characteristics, such as kernel production, humidity of kern in harvest, corn husk, plant height, main ear height, male flourishing, female flourishing, ear lodging and breakage, were no different from the hybrids tested. The results showed that the stacked corn MON 89034 x TC1507 x NK503 was not different from individual events TC1507, MON 89034 and NK603, as well as from the conventional control, indicating lack of change of agronomic characteristics on stacked corn obtained by crossing individual events. Therefore, no significant adverse effect took place regarding the characteristics assessed as a consequence of stacking individual events through classical genetic improvement. Besides, experiments carried out in Brazil to assess the effect of corns MON 89034, TC1507 and NK603 on non-target arthropods failed to detect any difference in visitation on the order and morpho-species of the subject arthropods, as compared to conventional corn. Other ecotoxicity studies conducted with parasitoids(55), beneficial arthropods(56), bees(57), earthworms(58), Collembola(59) and Daphnia(60) among others, demonstrated that Cry failed to cause adverse effects to the non-target organisms studied. Scientific literature works published reached a conclusion that presence of Cry proteins fails to significantly affect the microbiota and animals living on soil(60,61). In addition, proteins of three subspecies of Bacillus thuringiensis did not evidence microbiocide or microbiostatic activity against a number of bacteria, fungi and algae(62). Individual events MON 89034, TC1507, NK603 and corn MON 89034 x TC1507 x NK503 failed to cause adverse effects on non-target organisms, such as arthropods that were more abundant in experimental lots, phytophagic organisms (Diabrotica speciosa, Leptoglossus zonauts, Euxesta sp., Rhopalosiphum maidis) and on beneficial arthropods such as earwigs (Doru luteipes), syrphidae (Allograpta sp.), ladybug (Cycloneda Sanguinea), predating diptera (Dolochopodidae) and bees (Apis mellifera). Finally, corn is an exotic species, with no feral kindred sexually compatible in Brazil. It features a high degree of domestication, and there are no scientific reasons to foresee the survival of genetically modified and non-genetically modified plants outside the farm environment. Besides, in absence of selective pressure (use of herbicide and insecticides) expression of the inserted genes fails to grant adaptive advantage. VI. Restrictions on the Use of the GMO and its Derivatives As established in Article 1 of Law nº 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and conservation unit areas”. Data submitted by applicant showed no significant difference between corn hybrids derived from non-modified lineages and MON 89034 x TC1507 x NK503 corn regarding agronomic characteristics, reproduction mode, dissemination or ability to survive. All evidence of the process and bibliographic references confirm the risk level of the transgenic as equivalent to that of non-transgenic varieties regarding soil microflora, as well as to other plants and human and animal health. Therefore, cultivation and consumption of MON 89034 x TC1507 x NK503 corn are not a potential cause of significant degradation of the environment and human and animal health. For the foregoing, there are no restrictions to the use of such corn and its derivatives, except in locations contemplated by Law nº 11,460, of March 21, 2007. Genic flow to local varieties (creole corns) of open pollination is possible and poses the same risk caused by commercial genotypes available in the market (80% of conventional corn farmed in Brazil come from commercial seeds that underwent a process or genetic improvement). Coexistence between conventional corns (either improved or creole) and transgenic cultivars corns is possible from the agronomic viewpoint(64,65). After ten years of use in other countries, no problems were detected to human or animal health or to the environment that may be attributable to transgenic corns. It must be stressed that lack of negative results from cultivation of corn transgenic plants does not mean that they may not happen in the future. Zero risk and absolute safety do not exist in the biologic field, although there is a large amount of reliable scientific information and a safe history of ten years of use that enable us to state that MON 89034 x TC1507 x NK503 corn is as safe as its conventional versions. Therefore, the applicant shall conduct post-commercial release improvement under CTNBio Ruling Resolution nº 3. VII. Considerations on particulars of different regions of the country (assistance to monitoring bodies): As established in Article 1 of Law nº 11,460, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous and conservation unit areas”. VIII. Conclusion Considering that corn (zea mays) variety MON 89034 x TC1507 x NK503 belongs to a well characterized species with a solid safety history to human and animal consumption and that genes cry1A.105, cry2Ab2, Cy1F, pat and cp4 epsps introduced in this variety code for proteins that are ubiquitous in nature, present in plants, fungi and microorganisms that are part of the diet of human and animals; Considering that construction of this genotype took place through classical genetic improvement, resulting in the inheritance of a stable and functional copy of genes cry1A.105, cry2Ab2, Cy1F, pat and cp4 epsps, which grant resistance to insects and tolerance to the glyphosate herbicide and herbicides containing ammonium gluphosinate as active ingredient; Considering that the centesimal composition data fail to evidence significant differences between genetically modified varieties and conventional ones, suggesting their nutritional equivalence; Considering that CTNBio assessed the events separately and issued a favorable opinion regarding its commercial release; Considering that CTNBio approved different corns containing events with protein Cry and, to this moment, there is no record of any effect to human/animal health or to the environment; Whereas 1. Event MON 89034 x TC1507 x NK503 was well characterized at molecular level, remaining attested maintenance of its gene constructs inherited from respective parental corns during the process of genetic improvement; 2. There is no trace of interaction among metabolic paths in which proteins Cry1A.105, Cry2Ab2, cry1F, PAT and CP4 EPSPS; 3. No pleiotropic or epistatic effects were detected, either in parental events or jointly; 4. Expression of proteins Cry1A.105, Cry2Ab2, cry1F, PAT and CP4 EPSPS in MON 89034 x TC1507 x NK503 corn is no significantly different from the expression observed separately in parental events; 5. There are no indications that the expressed proteins may cause allergy or intoxication in humans and animals; 6. Agronomic and efficacy assessments of MON 89034 x TC1507 x NK503 corn indicate that combination of such events by classical genetic improvement (sexual crossing) failed to cause expression of any other characteristics except resistance to certain insects and tolerance to glyphosate herbicide and herbicides in which the active ingredient is ammonium gluphosinate; 7. There was no evidence of morphophysiological changes in MON 89034 x NK 603 that may grant adaptive advantages; 8. The remaining risk analyses conducted by countries that have already assessed the stacked corn MON 89034 x NK603(66,67); 9. The internationally accepted criteria for risk analyses in genetically modified raw materials regarding stacked events(68); we may conclude that MON 89034 x TC1507 x NK503 corn is as safe as its conventional equivalent. Under Article 14 of Law nº 11,105/05, CTNBio held that the application complies with applicable rules and legislation in effect aimed at securing biosafety of the environment, agriculture, human and animal health and concludes that MON 89034 x TC1507 x NK503 corn is substantially equivalent to conventional corn, being therefore its consumption safe for human and animal health. Regarding the environment, CTNBio concluded that farming of MON 89034 x TC1507 x NK503 corn is not potentially a cause of significant degradation of the environment, keeping with the biota a relation identical to that of conventional corn. CTNBio holds that the activity is not a potential cause of significant degradation of the environment or harm to human and animal health. Restrictions to the use of the GMO under analysis and its derivatives are conditioned to the provisions of Law nº 11,460, of March 21, 2007. Regarding post-commercial release monitoring plan, CTNBio determines compliance with instructions and conduction of technical monitoring actions listed below: (I) Instructions: (a) Monitoring shall be conducted in commercial tillage and not in experimental ones. Areas selected for monitoring shall not be segregated from other areas, have planted borders or any other situation strange to commercial practice; (b) monitoring shall be conducted in a comparative model between the conventional cultivation and the GMO cultivation system, being the data collected by sampling; (c) monitoring shall be conducted in biomes that represent the main areas of GMO farming and, whenever possible, contemplate the different types of producers; (d) monitoring shall be conducted for a period of not less than five (5) years; (e) for all monitoring experiences, applicant shall detail information on all activities conducted in post-sowing and sowing, execution of such activities, reporting activities conducted in monitored areas during the cultivation cycle, on harvesting activities and the climate conditions; (f) Any threat to human and animal health shall also be monitored through official adverse event notification systems such as, for instance, SINEPS (Adverse Events related to Health Products Notification System), regulated by ANVISA. (g) analytical methods, results obtained and their interpretation shall be developed in line with independence and transparence principles, except for aspects of commercial secrecy previously justified and defined as such; (h) based on technical and scientific explanations, CTNBio reserves the right to revise this Opinion at its sole discretion. (II) Technical monitoring actions to be conducted: 1. Regarding genes cp4 epsps and pat, granting resistance to the herbicide, the following shall be monitored: (a) Nutritional condition and health of the GMO plants; (b) chemical and physical features of the soil related to fertility and other basic pedologic characteristics; (c) soil microbial diversity; (d) soil dispersion bank; (e) community of invading plants; (f) development of resistance to the herbicide in invading plants; (g) residues of herbicide in soil, kernels and aerial parts; (h) gene flow; 2. Regarding genes cry1A.105, cry2Ab2, and cry1F, granting resistance to insects, the following shall be monitored: (a) Impact on target and non-target insects; (b) impact on indicator soil invertebrates, not belonging to the Insecta Class; (c) residues on insecticide proteins on organic matter in decomposition, in soil and water courses close to the monitoring areas; (d) development of resistance among target insects; (e) gene flow of the three genes inserted. CTNBio analysis considered the opinions issued by the Commission members, documents submitted to the CTNBio Office of the Executive Secretary by applicant and results from commercial releases to the environment. Also considered and consulted were independent studies and scientific publications, both conducted by the applicant and by third parties.
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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: Not Applicable
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
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)
Mexico
Name of product applicant: Maíz (Zea mays) Resistente a insectos lepidópteros y coleópteros, tolerante a glifosato y glufosinato de amonio.
Summary of application:

Usos propuestos:


Para ser procesado y usado en los alimentos de consumo humano y animal, forraje y productos industriales en la misma forma como los productos obtenidos con el maíz convencional.


Descripción del producto de transformación:


Evento TC 1507 (DAS-Ø15Ø7-1)


El vector de transformación PHP8999, fue usado para el desarrollo del maíz B.t. Cry1F evento TC 1507 (DAS-Ø15Ø7-1) y contiene las secuencias de codificación para cry1F y pat y los elementos regulatorios necesarios para la expresión de los genes. Las plantas transgénicas fueron obtenidas mediante el método de bombardeo de microproyectiles. Existe una sola inserción de los genes cry1F y pat en el maíz B.t. Cry1F evento TC 1507 más una copia adicional de la secuencia codificadora de cry1F.


Evento MON 89034 (MON-89Ø34-3):


El evento MON89034 se produjo por medio de la transformación con Agrobacterium, el cual tiene 2 regiones separadas de T-DNA. La primera, designada T-DNA I, contiene las construcciones genéticas, las cuales comprenden los genes cry1A.105 y cry2Ab2.


NK-603 (MON-ØØ6Ø3-6)


El maíz NK603 fue obtenido por transformación con biobalística (pequeñas piezas de oro o tungsteno recubiertas con ADN de interés que se lanzan a altas velocidades sobre el tejido vegetal, con la intención de que las moléculas de DNA exógeno alcancen el núcleo y sean adicionadas al genoma). La construcción genética introducida es de 6706 pb, y contiene 2 cassettes de expresión, cada cassette tiene una copia del gen cp4 epsps.

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Date of authorization: 28/02/2011
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:
Evaluación de la inocuidad: Alergenicidad: Los ensayos de digestión simulada y de estabilidad al calor, así como la comparación informática con alérgenos conocidos, demostraron que la probabilidad de alergenicidad de las proteínas insertadas es baja. Toxicidad: Los estudios de toxicidad aguda y subcrónica, así como la comparación informática con toxinas conocidas, demostraron que la toxicidad de las proteínas insertadas es baja. Nutricional: Los resultados de composición para el maíz MON89Ø34-3 x DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6 confirman la equivalencia sustancial entre el maíz genéticamente modificado y el maíz convencional utilizado como control.
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:
Upload:
Authorization 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:

La Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados está integrada por los titulares de las Secretarías de Medio Ambiente y Recursos Naturales Renovables (SEMARNAT), Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA); Salud (SS); Hacienda y Crédito Público (SHCP); Economía (SE) y Educación Pública (SEP); así como por el Director General del Consejo Nacional de Ciencia y Tecnología (CONACYT).

La presidencia de la Comisión es rotatoria por periodos de dos años, entre los Secretarios de Salud, SAGARPA y SEMARNAT ya que son las Secretarías con un mayor ámbito de competencia en relación con el uso seguro de los Organismos Genéticamente Modificados (OGMs).

Ley de Bioseguridad de Organismos Genéticamente Modificados, estipula que para su implementación la Comisión debe coordinar las acciones pertinentes con las instancias del Gobierno para cumplir su objetivo.

La CIBIOGEM, cuenta con grupos de apoyo que son sus órganos técnicos y consultivos: Comité Técnico, Consejo Consultivo Científico, Consejo Consultivo Mixto y la Secretaría Ejecutiva.

¿Cuál es el propósito de la CIBIOGEM?

Coordinar las políticas de la administración pública federal referentes a diferentes actividades relacionadas con OGMs como son: la producción, importación, exportación, movilización, transporte, siembra, consumo y, en general uso y aprovechamiento de OGMs.

 

-Courtesy Translation-

The Intersecretarial Commission on Biosafety of Genetically Modified Organisms is made up of the heads of the Secreataries of Health (SSA); Agriculture, Livestock, Rural, Development, Fisheries and Food (SAGARPA); Environment and Natural Resources (SEMARNAT); Finance and Public Credit (SHCP); Economy (SE); Public Education, and the General Director of the National Council of Science and Technology.

The chair of the Commission rotates every two years among the Secretaries of Health, SEMARNAT and SAGARPA, the three entities most directly involved in policies concerning the use and biosafety of Genetically Modified Organisms (GMOs).

The Law on Biosafety of Genetically Modified Organisms states that the Commission aims to promote and coordinate the actions of Government agencies. CIBIOGEM receives support from the Executive Secretariat of CIBIOGEM, the Technical Committee, the Scientific Advisory Board and the Joint Advisory Council.

What is the purpose of the CIBIOGEM?

To coordinate the policies and federal regulation of activities related to Genetically Modified Organisms (GMOs) such as: production, import, export, mobilization, transportation, release into the environment, consumption, and general use of GMOs.

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: marriola@cofepris.gob.mx
Mexico
Name of product applicant: Maíz (Zea mays) Resistente a insectos lepidópteros y coleópteros, tolerante a glifosato y glufosinato de amonio.
Summary of application:

Usos propuestos:


Para ser procesado y usado en los alimentos de consumo humano y animal, forraje y productos industriales en la misma forma como los productos obtenidos con el maíz convencional.


Descripción del producto de transformación:


Evento TC 1507 (DAS-Ø15Ø7-1)


El vector de transformación PHP8999, fue usado para el desarrollo del maíz B.t. Cry1F evento TC 1507 (DAS-Ø15Ø7-1) y contiene las secuencias de codificación para cry1F y pat y los elementos regulatorios necesarios para la expresión de los genes. Las plantas transgénicas fueron obtenidas mediante el método de bombardeo de microproyectiles. Existe una sola inserción de los genes cry1F y pat en el maíz B.t. Cry1F evento TC 1507 más una copia adicional de la secuencia codificadora de cry1F.


Evento MON 89034 (MON-89Ø34-3):


El evento MON89034 se produjo por medio de la transformación con Agrobacterium, el cual tiene 2 regiones separadas de T-DNA. La primera, designada T-DNA I, contiene las construcciones genéticas, las cuales comprenden los genes cry1A.105 y cry2Ab2.


NK-603 (MON-ØØ6Ø3-6)


El maíz NK603 fue obtenido por transformación con biobalística (pequeñas piezas de oro o tungsteno recubiertas con ADN de interés que se lanzan a altas velocidades sobre el tejido vegetal, con la intención de que las moléculas de DNA exógeno alcancen el núcleo y sean adicionadas al genoma). La construcción genética introducida es de 6706 pb, y contiene 2 cassettes de expresión, cada cassette tiene una copia del gen cp4 epsps.

Upload:
Date of authorization: 28/02/2011
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:
Evaluación de la inocuidad: Alergenicidad: Los ensayos de digestión simulada y de estabilidad al calor, así como la comparación informática con alérgenos conocidos, demostraron que la probabilidad de alergenicidad de las proteínas insertadas es baja. Toxicidad: Los estudios de toxicidad aguda y subcrónica, así como la comparación informática con toxinas conocidas, demostraron que la toxicidad de las proteínas insertadas es baja. Nutricional: Los resultados de composición para el maíz MON89Ø34-3 x DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6 confirman la equivalencia sustancial entre el maíz genéticamente modificado y el maíz convencional utilizado como control.
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:
Upload:
Authorization 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:

La Comisión Intersecretarial de Bioseguridad de los Organismos Genéticamente Modificados está integrada por los titulares de las Secretarías de Medio Ambiente y Recursos Naturales Renovables (SEMARNAT), Agricultura, Ganadería, Desarrollo Rural, Pesca y Alimentación (SAGARPA); Salud (SS); Hacienda y Crédito Público (SHCP); Economía (SE) y Educación Pública (SEP); así como por el Director General del Consejo Nacional de Ciencia y Tecnología (CONACYT).

La presidencia de la Comisión es rotatoria por periodos de dos años, entre los Secretarios de Salud, SAGARPA y SEMARNAT ya que son las Secretarías con un mayor ámbito de competencia en relación con el uso seguro de los Organismos Genéticamente Modificados (OGMs).

Ley de Bioseguridad de Organismos Genéticamente Modificados, estipula que para su implementación la Comisión debe coordinar las acciones pertinentes con las instancias del Gobierno para cumplir su objetivo.

La CIBIOGEM, cuenta con grupos de apoyo que son sus órganos técnicos y consultivos: Comité Técnico, Consejo Consultivo Científico, Consejo Consultivo Mixto y la Secretaría Ejecutiva.

¿Cuál es el propósito de la CIBIOGEM?

Coordinar las políticas de la administración pública federal referentes a diferentes actividades relacionadas con OGMs como son: la producción, importación, exportación, movilización, transporte, siembra, consumo y, en general uso y aprovechamiento de OGMs.

 

-Courtesy Translation-

The Intersecretarial Commission on Biosafety of Genetically Modified Organisms is made up of the heads of the Secreataries of Health (SSA); Agriculture, Livestock, Rural, Development, Fisheries and Food (SAGARPA); Environment and Natural Resources (SEMARNAT); Finance and Public Credit (SHCP); Economy (SE); Public Education, and the General Director of the National Council of Science and Technology.

The chair of the Commission rotates every two years among the Secretaries of Health, SEMARNAT and SAGARPA, the three entities most directly involved in policies concerning the use and biosafety of Genetically Modified Organisms (GMOs).

The Law on Biosafety of Genetically Modified Organisms states that the Commission aims to promote and coordinate the actions of Government agencies. CIBIOGEM receives support from the Executive Secretariat of CIBIOGEM, the Technical Committee, the Scientific Advisory Board and the Joint Advisory Council.

What is the purpose of the CIBIOGEM?

To coordinate the policies and federal regulation of activities related to Genetically Modified Organisms (GMOs) such as: production, import, export, mobilization, transportation, release into the environment, consumption, and general use of GMOs.

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: marriola@cofepris.gob.mx
Philippines
Name of product applicant: MOnsanto Philippines and Dow AgroSciences
Summary of application:
Corn MON89034 x TC1507x NK603 is a stacked hybrid developed by crossing Event MON89034, Event TC1507 and Event NK603, using conventional breeding techniques.
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Date of authorization: 10/12/2010
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:
Monsanto Philippines and Dow AgroSciences have filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notification for direct use as food, feed and for processing under Administrative Order (AO) No. 8 Part 5 for stacked trait product corn: MON89034 x TC1507x NK603, which has been genetically modified for insect resistance and herbicide tolerance. A safety assessment of combined trait product corn: MON89034 x TC1507x NK603 was conducted as per Department of Agriculture (DA) Administrative Order No. 8 Series of 2002 and Memorandum Circulars Nos. 6 and 8, Series of 2004. The focus of risk assessment is the gene interaction among the 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.
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:
Upload:
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.
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.
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