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OECD Unique Identifier details

SYN-BTØ11-1xSYN-IR162-4xMON-ØØØ21-9
Commodity: Corn / Maize
Traits: Glufosinate tolerance,Glyphosate tolerance,Lepidoptera resistance
Argentina
Name of product applicant: Syngenta Agro S.A.
Summary of application:
The stacked event Bt11xMIR162xGA21 of maize confers resistant to certain lepidopteran insects, tolerance to herbicides which active principle is glyphosate and glufosinate ammonium. The single events were stacked by conventional crossing (sexual). The stacked event has two genes, vip3Aa20 and pmi, from MIR162 event, two genes, cry1Ab and pat, from Bt11 event and mepsps gene from GA21 event. The transgenes are inherited independently, since they present mendelian segregation. Moreover, the applicant proved the gene stability and the effective levels of the expressed proteins. The proteins Cry1Ab and Vip3Aa20 confer resistance to lepidopteran insects (some affected species are Spodoptera frugiperda, Helicoverpa zea and Diatraea saccharalis). The protein mEPSPS 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. The enzyme phosphomannose isomerase (PMI) acts as a selectable marker allowing the use of mannose as a carbon source. After comparison of 60 analytes measured in grain and forage, in the compositional analysis study, it's concluded that maize with the stacked event Bt11xMIR162xGA21 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. A 49 day study, carried out in broiler chicken, demonstrate that no adverse dietary effects on chickens that consumed grains of the stacked maize in the diets. 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 Bt11xMIR162xGA21 event is substantial and nutritionally equivalent to its non transgenic counterpart.
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Date of authorization: 16/09/2011
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.):
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 Bt11xMIR162xGA21
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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: Syngenta Seeds Ltda.
Summary of application:
Commercial release of Bt11xMIR162xGA21 maize Biosafety, resulting from breeding, by means of the classical genetic improvement, from parental plants linked to genetically modified maize
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Date of authorization: 18/11/2011
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.): Center for Environmental Risk Assessment
Summary of the safety assessment:
Bt11xMIR162xGA21 maize Biosafety, resulting from breeding, by means of the classical genetic improvement, from parental plants linked to genetically modified maize, to their release into the environment, marketing, consumption and any other activities related to such maize and progeny derived from it. Every single event, has already obtained a favourable opinion for marketing in Brazil. The Bt11 event has the gene cry1Ab Bacillus thuringiensis, which confers resistance to certain lepidopteran insects, and the pat gene, derived from the soil micro-organism Streptomyces viridochromogenes, used as selection marker during the transformation process. The Cry1Ab protein and proteolytically cleaved in the alkaline gut of lepidopteran insects, becoming insecticidally active. The MIR162 maize was obtained from vip3Aal9 gene, which confers resistance to lepidopteran insects, and from manA gene, which encodes the enzyme phosphomannose isomerase (PMI), used as a selection marker. A modification caused by the transformation process resulted in a difference in two codons of vip3Aa19 inserted gene, being then called vip3Aa20 for the MIR162 maize. This difference resulted in the modification of only one amino acid, located beyond the proteolytic cleavage site of the protein then called Vip3Aa2O, expressed in MIR162 maize, thus maintaining its insecticidal properties against several lepidopterous pest of maize. The manA gene was obtained from Escherichia coli strain K-12 and PMI protein expression was used as a selection marker during the MIR162 maize transformation process. The GA21 Event contains the gene mepsps that expresses the enzyme 5-Synthase enolpyruvyl-shikimate-3-phosphate (mEPSPS). In the process of shikimic acid, the EPSPS is a key enzyme, involved in the biosynthesis of aromatic amino acids (phenylalanine, tyrosine and tryptophan), found naturally in plants, in fungi and bacteria, and absent in animals. The EPSPS is highly sensitive to herbicides containing glyphosate. Maize plants transformed with the mutant gene epsps (mepsps), such as those from GA21 event, synthesize the mEPSPS protein that confers tolerance to herbicides containing glyphosate. The comparative molecular analysis confirmed the genetic integrity of the inserts Bt11, MIR162 and GA21 during the process of classical genetic improvement to obtain the Bt11xMIR162xGA21 maize. The hybridised fragments showed the expected size and demonstrated the integrity of the inserts. Furthermore, an analysis of genetic segregation was conducted. The results of phenotypic segregation obtained by ELISA and genotypic segregation obtained by qPCR were tested for adhesion and indicated that the loci of individual events and of combination were segregated stably and independently. The efficacy and agronomic evaluations indicated that there is differential expression in any other characteristic beyond those expected, i.e. insect resistance and herbicide tolerance. A comparative study was conducted on the concentration of the proteins Cry1Ab, VIP3Aa20 and mEPSPS, and the separated events was performed in Bt11xMIR162xGA21e hybrid maize. The proteins from plant tissues were quantified by ELISA immunoenzymatic tests in various stages of development. For most assessed tissues at different stages of development, there was not a statistically significant difference between the expression of each protein expressed in maize Bt11xMIR162xGA21 and maize containing events alone. Although significant differences have been identified in the expression of Vip3Aa20 in root and pollen at the stage of anthesis, there is no evidence for the results indicating a trend for change in the expression levels of proteins expressed in function of the combination of events. A study of the Bt11xMIR162xGA21 maize influence on the insect community was conducted to verify the possibility of interference concerning (a) primary pests of maize crop in soil and in aerial parts and (b) secondary pests. The results indicated that the combined maize had no adverse effect for the insect community or for the predator Doru luteipes, when compared to its isogenic, unmodified hybrid. Moreover, CTNBio consulted independent scientific literature to assess the occurrence of any unexpected effect from the breeding among these events. TECHNICAL REPORT 1. Identification of GMOs Name of GMO: maize Applicant: Syngenta Seeds Ltda. Species: Zea mays Inserted feature: insect resistance and herbicide tolerance Method to introduce the feature: The Bt11xMIR162xGA21 maize, classified as Risk Class I, was developed by classical genetic improvement, by sexual reproduction among genetically modified maize lines, containing Bt11, GA21, and MIR162 events. Proposed use: Free registration, use, tests, planting, transport, storage, marketing, consumption, release, disposal, and any other activities related to the GMO. II. General information The maize Zea mays L. is a species from Gramineae family, tribe Maydeae, subfamily Panicoidae that is separate from subgenus Zea and presents chromosome number 2n = 20,21,22,24 (FAO/WHO 2000). The closest wild species of maize is the teosinte, which is found in Mexico and in parts of Central America, where it can be bred with cultivated maize in the production field. The Bt11xMIR162xGA21 maize is a genetically modified product that provides resistance to several lepidopteran pests and for tolerance to glyphosate herbicide, developed by means of traditional breeding by sexual reproduction among maize lines containing the Bt11 event, the MIR162 event, and the GA21 event. This maize contains no other event in genetic transformation, besides the events Bt11, MIR162, and GA21. The Bt11 maize, MIR162 maize, and GA21 maize have been approved for commercial release by the National Technical Commission on Biosafety (CTNBio), based on Proceedings 01200.002109/2000-04, 01200.007493/2007-08, and 01200.000062/2006-21 as theTechnical Reports 1255/2008, 2042/2009, and 1597/2008, respectively. The 'combined' or 'pyramided' products, as in the case of Bt11xMIR162xGA21 maize, represent a future trend to cultivate genetically modified plants to meet the demand of producers to combine different characteristics important for agronomy in a single hybrid, allowing to control pests better (Aragão and Andrade, 2010). Besides the tolerance to the herbicide glyphosate by the expression of the GA21 event, the combination of different modes of action of Cry1Ab and VIP3A protein from the events (Bt11, MIR162) allowed to preserve insect technology resistance for a longer period, thereby ensuring its employment to control pests in an integrated manner for maize harvest in Brazil. Maize hybrids containing the events Bt11, MIR162, and GA21 alone and/or combined by classical genetic improvement so approved in several countries and in several other assessments (CERA, 2010). The Bt11 maize is approved for cultivation in Argentina, Brazil, Colombia, Canada, Japan, Philippines, South Africa, USA and Uruguay; and approved for animal and/or human consumption in Argentina, Australia, Brazil, Canada, China, Colombia, EU, Japan, Korea, Mexico, Philippines, Russia, South Africa, Switzerland, Taiwan, UK, USA, and Uruguay. The GA21 maize is approved for cultivation in the USA, Canada, Japan, Argentina, and Brazil; and approved for animal and/or human consumption in Argentina, Australia, Brazil, Canada, China, EU, Japan, Korea, Mexico, Philippines, Russia, Taiwan, South Africa, and the USA. The MIR162 maize is approved for cultivation in Brazil and for animal and/or human consumption in Brazil, Australia, USA, and Taiwan; and is still under investigation in several other countries, including Indonesia, Japan, Korea, Philippines, Russia, Argentina, Colombia , Canada, Mexico, and USA (for cultivation). The Bt11xGA21 maize, obtained by classical genetic improvement from the sexual reproduction of maize lines, containing these events separately, is approved for cultivation in Brazil, USA, Canada, and Japan; and approved for animal and/or human consumption in Brazil, USA, Canada, Japan, Mexico, Philippines, and Korea. The Bt11xMIR162xGA21 maize is under assessment in Japan, Taiwan, Europe, South Africa, Switzerland, Argentina, Colombia, and Uruguay. III. Expressed proteins By using classical genetic improvement, the Bt11xMIR162xGA21 maize was developed by means of sexual reproduction of maize lines, individually containing the events BT11, MIR162, and GA21. The Bt11 event includes cry1Ab gene from Bacillus thuringiensis, which confers resistance to certain lepidopteran insects and the pat gene, derived from the soil micro-organism Streptomyces viridochromogenes, used as selection marker during the transformation process. The Cry1Ab protein is proteolytically cleaved in the alkaline gut of lepidopteran insects, resulting in insecticide active form, which, interacting with a receptor molecule present only in cells of the midgut epithelium of susceptible insects, generates pores in cell membranes, leading to its lysis. Several specific docking sites with high affinity for several Bt proteins have been identified in the midgut epithelium of susceptible insects, showing that the insecticidal protein of cry1Ab gene is highly specific to some lepidopteran insects (Hofte and Whiteley, 1989; Melin and Cozzi, 1990). The molecular description of the Bt11 event and the information for maize risk assessment were presented earlier in the process 01200.002109/2000-04, for commercial release of Bt11 maize. The MIR162 maize was obtained from vip3Aal9 gene, which confers resistance to lepidopteran insects, and from manA gene, which encodes the enzyme phosphomannose isomerase (PMI), used as a selection marker. A modification caused by the transformation process resulted in a difference in two codons vip3Aa19 inserted gene, then was called vip3Aa20 in maize MIR162 (Entrez Accession number DQ539888; NCBI 2006). This difference resulted in the modification of only one amino acid, located beyond the proteolytic cleavage site of the protein then called Vip3Aa20, expressed in MIR162 maize, thus maintaining its insecticidal properties against several lepidopterous pest of maize harvest. The manA gene was obtained from Escherichia coli strain K-12 and PMI protein expression was used as a selection marker during the MIR162 maize transformation process. The molecular description of the MIR162 event and the information for MIR162 maize risk assessment were presented earlier in the process 0 1200.007493/2007-08, for commercial release of MIR162 maize. The GA21 event contains the mepsps gene that expresses the enzyme 5-Synthase enolpyruvyl-shikimate-3-phosphate (mEPSPS). The EPSPS is a key enzyme for the shikimic acid process, involved in the biosynthesis of aromatic amino acids (phenylalanine, tyrosine and tryptophane), found naturally in plants, fungi and bacteria, and absent in animals. The EPSPS is highly sensitive to herbicides containing glyphosate. Maize plants transformed with the mutant gene epsps (mepsps), such as those from GA21 event, synthesise the mEPSPS protein that confers tolerance to herbicides containing glyphosate. The molecular description of the GA21 event and the information for GA21 maize risk assessment were presented earlier in the process 01200.002293/2004-16, for commercial release of GA21 maize. A comparative molecular analysis was performed in order to (a) confirm the genetic integrity of the inserts Bt11, MIR162, and GA21 and (b) to obtain Bt11xMIR162xGA21 maize by using sexual reproduction between maize lines containing these events along the process of classical genetic improvement used. The hybridized fragments Bt11xMIR162xGA21 maize showed the expected size for the events Bt11, MIR162, and GA21. It demonstrates that the integrity of the inserts was maintained during the process of classical genetic improvement to combine such events. These findings are results from Southern blot analysis for all events presented by the applicant. A comparative analysis for the events was conducted. The genomic DNA isolated from leaf tissue of plants for each maize was used. The DNA was digested with restriction enzymes specific for cassettes, as detailed below: • probe specific for cry1Ab, of 1848 PB. The maize genomic DNA was digested with restriction enzymes NdeI , SphI e BglII+EcoRI, and after electrophoresis and membrane transfer, hybridized with a probe specific for cry1Ab (1848 bp). • with the probe specific for vip3Aa19 of 2370 bp. The maize genomic DNA was digested with restriction enzymes KpnI, EcoRV and NcoI and, after electrophoresis and membrane transfer, hybridized with a probe specific for vip3Aa19 (2370 bp). • probe specific for mepsps, of 1338 pb. The maize genomic DNA was digested with restriction enzymes HindIII, SacI and SphI and after electrophoresis and transfer to membrane, hybridized with a probe specific for mepsps (1338 bp). The probe specific for cry1Ab resulted in identical hybridisation bands for Bt11 maize and for Bt11xMIR162xGA21 maize, showing that the Bt11 event was inherited stably in combined maize. The probe for vip3Aa20, of which gene has a single change in a amino acid, hybridized completely and resulted in identical banding patterns for MIR162 maize and Bt11xMIR162xGA21 maize. Thus, it was found that the gene was inherited stably. The probe resulted in mepsps hybridizing bands specific for the gene, identical to the GA21 maize and Bt11xMIR162xGA21 maize, revealing the stable form of inheritance. As shown, all events hybridized, as expected. A segregation analysis by using specific test event was conducted in genetically modified maize plants to conserve the isolated and combined events. The results of segregation obtained by ELISA (phenotypic) and qPCR (genotype) were subjected to adherence test (X2). The data indicate that the loci of isolated events, as well as combined events, segregated independently, with typical Mendelian proportions. IV. Aspects related to human and animal health The safety for animal/human food of Cry proteins was confirmed by several authors, also by Xu et at. (2009). It was observed that the protein was rapidly degraded by Cry1Ab/Ac gastric and intestinal fluids, and showed no adverse effects in mice subjected to an acute dose of 5g (Cry1Ab/Ac protein)/kg of body weight. Again, it was observed that this protein has no sequence homology with known toxins or allergy, or N-linked glycosylation sites, confirming that no harm resulted from the inclusion of protein Cry1Ab/Ac in food or animal feed. Another twenty-eight-day study in rats conducted by Onose et al. (2008) showed no adverse effects can be attributed to diet containing Cry1Ab, whereas the administration of diet containing Cry1Ab protein had no significant effect on any biochemical or physiological parameter, but a lower concentration of aspartate aminotransferase - AST in serum of animals receiving such maize, when compared with control. However, no changes in weight or histopathology were observed in organs such as heart, liver, and kidneys. Also, generally is observed that serum levels of AST are elevated with tissue injury, but the interpretation of relatively small changes in the levels of AST in toxicology studies should be done sparingly, since the range of variation of this parameter can be widespread in healthy animals. The reduction in AST in this experiment, therefore, it is not considered to be toxicologically significant. In addition, Paul et al. (2009) studied the degradation of Cry1Ab protein in GM maize regarding the total protein in the digestion of dairy cows. The results indicated that Cry1Ab protein is increasingly degraded during digestion in these animals in small fragments of 42kDa, 34kDa and 17kDa. As the EPSPS protein, similar to that expressed by the GA21 maize, new studies on the biosafety of the EPSPS protein were released in recent years. Lundry et al. (2009) investigated the differences in the levels of nutrients and anti-nutrients from soya beans expressing EPSPS protein and conventional soy beans, with similar genetic profiles. The results of the comparisons showed that GM soya beans is equivalent in composition and nutritionally equivalent to conventional soya beans marketed currently. Recent studies in mice and cattle showed results consistent with the risk assessment conducted for the EPSPS protein. Healy et al. (2008) presented the results of a study of thirteen weeks of feeding rats with GM maize, expressing CryBb1 and CP4 EPSPS. The responses of rats fed with diets containing this variety of maize were comparable to those of rats fed with a diet containing grains of its nearly isogenic control variety, confirming that GM maize is as safe and nutritious as grain from existing commercial maize hybrids. As EPSPS protein, similar to that expressed by the GA21 maize, new studies on the biosafety of the EPSPS protein were released in recent years. Lundry et al. (2009) investigated the differences in the levels of nutrients and anti-nutrients from soya bean protein expressing EPSPS and conventional soy beans, with similar genetic profiles. The results of the comparisons showed that GM soya beans is equivalent in composition and nutritionally equivalent to conventional soya beans marketed currently. Recent studies in mice and cattle showed results consistent with the risk assessment conducted for the EPSPS protein. The effects of Vip3Aa20 protein in 10 species of non-target organisms were assessed employing parts of maize plants that accumulate the Vip3Aa20 protein or Vip3Aal9 protein. These proteins differ in a single amino acid located at position 129. However, this difference does not change the protein action in its final form: this position is out of place and region of the triptych final peptide that has cytotoxic activity (cleavage of the peptide and performed at the initial position 199). In all cases, samples of maize were tested against a sensitive insect species to be sure of the presence of toxic levels of VIP proteins. Tests with water fleas, ladybugs, lacewings (larvae and adults), earthworms, catfish, bees, and beetles did not reveal significant differences between control and treated plants containing Vip3Aa20 or Vip3Aal9 (Chen et al 2008). V. Environmental aspects The Bt11xMIR162xGA21 maize and a GM product that provides resistance to several lepidopteran pests and for tolerance to glyphosate herbicide, developed by classical breeding by sexual reproduction among maize lines with the Bt11 event, MIR162 event, and GA21 event. Thus, this product contains no other event in genetic transformation, besides the events mentioned. The Bt11 maize, MIR162 maize, and GA21 maize have been approved for commercial release by CTNBio. Every individual matters of biosafety for all such events have already been adequately treated by CTNBio at during the assessment of individual events. Regarding the process of sexual reproduction of these events, there are some important aspects that must be disclosed. A comparative molecular analysis of Bt11xMIR162xGA21 maize showed that the integrity of the inserts was maintained during the process of classical genetic improvement with the aim of combining the events. The segregation analysis of the Bt11xMIR162xGA21 maize showed that genes of Bt11 event, MIR162 event and GA21 event are independent. The agronomic assessment and Bt11xMIR162xGA21 maize efficiency assessment indicated that the combination of these events by classical genetic improvement methods did not lead to expression of any other characteristic other than those expected, i.e. resistance to certain insects and tolerance to the herbicide glyphosate. The expression of proteins Cry1Ab, VIP3Aa20, and mEPSPS observed in Bt11xMIR162xGA21 maize did not show a trend to changes in expression levels. It occurred due to the combination of these events by classical genetic improvement. In the tests, the Bt11xMIRI62xGA21 maize did not present adverse effect on the community of non-target insects. Results showed the effectiveness in controlling Bt11xMIR162xGA21 maize attack by Spodoptera frugiperda, Agrotis ipsilon Elasmopalpus lignosellus and Diatraea saccharalis, when compared with their isogenic non-GM hybrid. Agronomic parameters were assessed as female and male flowering, leaf diseases, plant height, and height of insertion of the ears. The data presented by the applicant showed no differential expression of any other characteristic. The applicant stated that there were no effects different from those expected. The applicant considered the data sets of three locations and the average of the treatments were bought by the Tukey test at 5% significance level. A study was conducted to assess the influence of Bt11xMIR162xGA21 maize on the insect community involving environmental conditions in Brazil during the 2008/2009 harvest. Insect traps were used, samples were taken fortnightly. The abundance and diversity were assessed. The data indicated that BtllxMIR162xGA21 maize did not present adverse effect on the insect community or on the predator Doru luteipes, when compared to its isogenic hybrid, non-GMO. VI. Restrictions on use of GMOs and their derivatives As established in art. 1 of Law 11,460 of 21 March 2007, 'the research and cultivation of GM organisms are banned for indigenous lands and for areas of conservation'. The report submitted by the applicant showed that there was no synergistic effect between events, resulting from crosses conventional in terms of agronomic characteristics, way to reproduce, to disseminate, or to survive. Thus, the cultivation and consumption of Bt11xMIR162xGA21 maize are not potentially cause of significant environmental degradation or risk to human and animal health. For these reasons, there are no restrictions on the use of maize and its derivatives, except in places covered by Law 11,460, of 21 March 2007. It must be emphasized that the lack of negative effects resulting from cultivation of transgenic maize does not mean they cannot happen. Zero risk and absolute security does not exist in the biological world, although there is an accumulation of reliable scientific information and a history of safe use of transgenic varieties in agriculture. Thus, the applicant should lead monitoring post-commercial release in accordance with Normative Resolution No 5 of CTNBio and in accordance with such opinion. VII. Considerations on particularities of different regions of the country (subsidies to monitoring agencies) As established in art. 1 of Law 11,460, of 21 March 2007, 'research and cultivation of GM organisms are banned for indigenous lands and for areas of conservation'. VIII. Conclusion Based on the evidence of current scientific literature available to the proteins Cry1Ab, VIP3Aa20, and mEPSPS and evidence presented on the lack of interaction among the genes for insect resistance in Bt11xMIR162xGA21 maize, CTNBio held that they are as safe as their conventional equivalent, compared to their food and environmental security. Agronomic and effectiveness assessment conducted in Bt11xMIR162xGA21 maize, indicated no consistent pattern to suggest biologically significant changes resulting from the combination of these events, different from those expected, i.e. insect resistance and combined herbicide tolerance. There is a body of evidence obtained in the results of comparative molecular analysis from analysis of the pattern of genetic inheritance and from comparative analysis of expression levels of proteins Cry1Ab, Vip3Aa20, and mEPSPS in Bt11xMIR162xGA2 maize. Thus, this body indicates that exposure levels to non-target organisms and in animal and human food to these proteins are the same as for Bt11 maize, GA21 maize, and MIR162 maize, separately. Moreover, the results from the influence assessment of Bt11xMIR162xGA21 maize on the insect community did not indicate the existence of adverse effects in these non-target organisms. The pyramid in question is the result of conventional breeding of three events already approved for planting and consumption by CTNBio. Every individual matters of biosafety have been properly addressed by the committee. There are four aspects to be assessed in the case of pyramiding, as indicated by regulatory agencies in the world: the stability of building in the breeding, the interaction among metabolic pathways, in which products of inserted genes take part, the change in weediness by the accumulation of phenotypes generated by pyramided genes and identification of events in pyramiding, via PCR with primers, shaping as a ring in flanker regions. In the first case, the experimental data of proponent indicates that the three genetic markers are stable and inherited Mendelianly, as expected. In the second case, the three roads are quite different: only two of them involve the synthesis of products that will not be employed by the plant but swallowed by the target insect, being two toxins with very different mechanisms of action. The third way involves resistance to glyphosate, as can be seen in the review article by Tan et al. (2006). There is no theoretical reason to expect any interaction and the agronomic results of hybrid also do not suggest so. In the third case, resistance to glyphosate did not increase the competitiveness of the hybrid in non-agricultural and insect resistance, per se, has already been discussed in this context in the case of commercial release of the events Bt11 and MIR162. In the fourth case, there are descriptions of primers that uniquely identify the three events pyramided. Recently, Xu et al (2009) described an improvement of real-time PCR, called UP-M-PCR, and demonstrated its applicability in this event on the agenda. The process can, in principle, be applied to any other event pyramid. Taking into account that this genotype was built by using classical genetic improvement, and that it resulted in the inheritance of a stable and functional copies of genes cry1Ab, vip3Aa20, and mEPSPS, which provided resistance to insects and tolerance to glyphosate; Taking into account that composition data showed no significant differences between GM and conventional varieties, suggesting the nutritional equivalence between them; Taking into account that the CTNBio assessed the events separately and gave its favourable opinion to its commercial release; Taking into account also that: 1. The events Bt11, MIR162, and GA21 were characterised during the individual approval, being attested to maintain the integrity of the gene constructs inherited from their parents during the process of classical genetic improvement; 2. There is no evidence of indication among the metabolic pathways that act on proteins Cry1Ab, Vip3A, and mEPSPS 3. There were no reported pleiotropy or epistasis in the parental events and together; 4. The expression of proteins in maize pyramid is not significantly different from the expression events observed in the parental separately; 5. No evidence that the expressed proteins to cause allergic or toxic effect on humans and animals was found; 6. The efficacy and agronomic evaluations of maize indicated that the combination of events by sexual reproduction did not lead to expression of any other features that no one expected, i.e. resistance to some insects and tolerance to glyphosate; 7. There were no botanical changes in the Bt11xMIR162xGA21 maize that may confer adaptive advantages; 8. Internationally accepted criteria in the process of risk analysis of GM raw materials in relation to events pyramided; It is possible to conclude that BtlIxMIR162xGA21 maize is as safe as its conventional equivalent. CTNBio considers that this activity does not potentially cause significant degradation of the environment or of harm to human and animal health. Restrictions on the use of GMOs in analysis and its derivatives are subject to the provisions of Law 11,460 of 21 March 2007. Regarding the monitoring plan post-commercial release, CTNBio determines that instructions are followed and implemented techniques to monitor the actions listed below: I) – Instructions a) Monitoring should be conducted in commercial fields and not in experimental fields. The areas chosen to be monitored should not be isolated from the others, have borders or any situation that is out of standard business. b) Monitoring should be carried out in comparison model between the conventional system of cultivation and cropping system of GMOs, and the data collection done by sampling. c) Monitoring should be conducted in representative biomes of the main areas of cultivation of GMOs and, where possible, involve different types of producers. d) Monitoring should be conducted for at least five years. e) For all monitoring, the proponent should detail information on all activities performed in the pre-planting and planting, on their implementation, with reports of activities conducted in the areas of monitoring during the crop cycle, about the activities of harvest and weather conditions. f) There should also be monitoring for any adverse effects to human and animal health systems by means of official reporting of adverse effects, such as the SINEPS System (Adverse Event Reporting Related to Health Products), regulated by ANVISA. g) The analytical methods, results and their interpretations must be developed in accordance with the principles of independence and transparency, subject to commercial confidentiality issues previously defined and justified as such. h) Based on scientific and technical justifications, CTNBio reserves the right to revise this opinion at any time. II) – Monitoring technique actions to be performed: 1 – Regarding the cp4 epsps gene, which confers resistance to the herbicide should be monitored: a) Nutritional status and health of GM plants. b) Chemical and physical attributes related to soil fertility and other basic soil characteristics. c) Soil microbial diversity. d) Bank of diaspores in the soil. e) Community of weed. f) Development of herbicide resistance in weeds. g) Glyphosate residues in soil, in grain and in aerial parts. h) Gene Flow. 2 – With respect to genes cry1Ab and Vip3A, which confer resistance to insects must be monitored: a) Impact on target insects and non-target insects. b) Impact on soil invertebrates of indicators, not belonging to the class Insecta. c) Residues of insecticidal proteins in decomposing organic matter, soil and waterways near the tracking area. d) Development of resistance among target insects. e) Gene Flow of the two inserted genes. The assessment of CTNBio considered the opinions expressed by members of the Commission, by ad hoc consultants, contributed documents in the Executive Secretariat of CTNBio by the applicant; results of planned releases in the environment, lectures, texts, etc. Independent scientific studies and publications of the applicant were considered and consulted, and also held by third parties. IX. Consulted Bibliography ALVAREZ-ALFAGEME F.; FERRY, N.; CASTANERA, P.; ORTEGO, F.; GATEHOUSE, A.M. Prey mediated effects of Bt maize on fitness and digestive physiology of the red spider mite predator Stethoruspunctillum Weise (Coleoptera: Coccinellidae). Transgenic Research, 17,943-954, 2008. ARAGAO, F.J.L., ANDRADE, P.P. 2010. Variedades com Eventos Piramidados. In: Borem, A. (Ed.). Plantas geneticamente modificadas nos tropicos: desafos e oportunidades. Editora Suprema. 532p ARONSON, A.I., SHAI, Y. Why Bacillus thuringiensis insecticidal toxins are so effective: Unique features of their mode of action. FEMS Microbiological Letter, 195: 1-8, 2001 BABENDREIER, D.; REICHHART, B.; ROMEIS, J.; BIGLER, F. Impact of transgene products on the behaviour and performance of bumble bee microcolonies. Entomologia Experimentalis et Applicata, 126, 148-157, 2008. BOHN, T.; TRAAVIK, T.; PRIMICERIO, R. Demographic responses of Daphnia magna fed transgenic Bt-maize. Ecotoxicology. 2009 Oct 27. [Epub anterior a impressão] PubMed PMID: 19859805. BRAVO, A., SANCHEZ, J., KOUSKOURA, T. AND CRICKMORE, N. N-terminal activation is an essential early step in the mechanism of action of the Bacillus thuringiensis Cry1Ac insecticidal toxin. Journal of Biological Chemistry 277: 23985-23987, 2002. Center for Enviromental Risk Assessment. GM Crop Database 2010 (http://ceramc.or /index.php?action=gm crop database), acessado em 18-11-2010 CHEN M, YE GY, LIU ZC, FANG Q, HU C, PENG YF, SHELTON AM. Analysis of Cry1Ab toxin bioaccumulation in a food chain of Bt rice, an herbivore and a predator. Ecotoxicology, 18,230-2338, 2009. CHODOVA, D.; SALAVA, J.; MARTINCOVA, 0.; CVIKROVA, M. Horseweed with reduced susceptibility to glyphosate found in the czech republic. Journal of Agriculture and Food Chemistry, 57, 6957-6961, 2009. COMBS, D. K.; HARTNELL, G.F. Alfalfa containing the glyphosate-tolerant trait has no effect on feed intake, milk composition, or milk production of dairy cattle., Journal of Dairy Science, 91, 673-678, 2008. COMISSAO TECNICA NACIONAL DE BIOSSEGURANAcA- CTNBio. Parecer Técnico 2042/2009. Source: http://www.ctnbio.gov.br. Accessed on: 5 Dec 2009. CROPLIFE INTERNATIONAL. Regulation of plant biotechnology products containing two or more traits combined by conventional plant breeding. Washington, 2005. DE SCHRIJVER, A., DEVOS, Y., VAN DEN BILCKE, M., CADOT, P., LOOSE, DE LOOSE, M., REHEUL, D. SNEYERS, M. Risk assessment of GM stacked events obtained from crosses between GM events. Trends in Food Science and Technology, 18: 101-109, 2007. DIVELY, G. P. Impact of transgenic VIP3AxCry I Ab lepidopterean-resistant field corn on the nontarget arthropod community. Transgenic Plants and Insects, 34: 1208-1291, 2005. DUAN, J.J.; MARVIER M.; HUESING, J.; DIVELY, G.; HUANG, Z.Y. A meta-analysis of effects of Bt crops on honey bees (Hymenoptera: Apidae). PLoS ONE 3, 1,e1415, 2008. ESTRUCH, J. J., G. W. WARREN, M. A. MULLINS, G. J. NYE, J. A. CRAIG, AND KOZIEL, M. G. Vip3A, a novel Bacillus thuringiensis vegetative insecticidal protein with a wide spectrum of activities against lepidopteran insects. Proceedings of the National Academy of Sciences, 91, 5389-5394, 1996. EFSA. European Food Safety Authority. Guidance Document of the Scientific Panel on (Genetically Modified Organisms for the risk assessment of genetically modified plants containing stacked transformation events. The EFSA Journal (2007) 512, 1-5. FUNKE, T.; YANG, Y.; HAN, H.; HEALY-FRIED, M.; OLESEN, S.; BECKER, A.; SCHONBRUNN, E. Structural basis of glyphosate resistance resulting from the double mutation Thr97 -> Ile and ProlOl -> Ser in 5 -eno lpyruvyl shiki mate- 3 -phosphate synthase from Escherichia coll. Journal of Biological Chemistry, 284, 9854-9860, 2009. Food and Agriculture Organization of the United Nations / World Health Organization. FAO/WHO – 2000a. Grassland Index. Zea mays L. (Source: http://www.fao.org/WAICENT/faoinfo/agricult/agp/agpc/doc/gbase/data/pf D00342.htm). GOMEZ, I., SANCHEZ, J., MIRANDA, R., BRAVO, A. AND SOBERON, M. Cadherin-like receptor binding facilitates proteolytic cleavage of helix alpha-1 in domain I and oligomer pre-pore formation of Bacillus thuringiensis Cry1Ab toxin. FEBS Letter, 513: 242-246, 2002. HEALY, C.; HAMMOND, B.; KIRKPATRICK, J. Results of a 13-week safety assurance study with rats fed grain from corn rootworm-protected, glyphosate-tolerant MON88017 corn. Food Chemistry Toxicology, 46, 2517-2524, 2008 HÖFTE, H.; WHITELEY, H.R. Insecticidal crystal protein of Bacillus thuringiensis. Microbiological Reviews, v.53, n.2, p.242-255, 1989. ICOZ, I.; ANDOW, D.; ZWAHLEN, C.; STOTZKY, G. Is the Cry lAb protein from Bacillus thuringiensis (Bt) taken up by plants from soils previously planted with Bt corn and by carrot from hydroponic culture? Bulletin of Environmental Contamination Toxicology, 83, 4858, 2009. KONRAD, R.; CONNOR, M.; FERRY, N.; GATEHOUSE, A. M.; BABENDREIER, D. Impact of transgenic oilseed rape expressing oryzacystatin-1 (OC-1) and of insecticidal proteins on longevity and digestive enzymes of the solitary bee Osmia bicornis. Journal of Insect Physiology, 55, 305-313, 2009. KONRAD R, FERRY N, GATEHOUSE AM, BABENDREIER D. Potential effects of oilseed rape expressing oryzacystatin-l (OC-1) and of purified insecticidal proteins on larvae of the solitary bee Osmia bicornis. PLoS One, 3, e:2664, 2008. LEBRUN, M.; LEROUX, B.; SAILLAND, A. Chimeric gene for the transformation of plants. 1996. United States Patent 5510471. Source: . Accessed on: 26 Nov 2009. LEE, M-K., WALTERS, F.S., HART, H., PALEKAR, N. AND CHEN, J-S. The mode of action of the Bacillus thuringiensis vegetative insecticidal protein Vip3A differs from that of Cry 1Ab endotoxin. Applied and Environmental Microbiolog, 69:4648-4657, 2003. LEVY-BOOTH, D. J.; GULDEN, R.H.; CAMPBELL, R.G.; POWELL, J.R.; KLIRONOMOS, J.N.; PAULS, K.P.; SWANTON, C. J.; TREVORS, J.T.; DUNFIELD, K.E. Roundup Ready asoybean gene concentrations in field soil aggregate size classes. FEMS Microbiological Letter, 291, 175-179, 2009. LI, Y., MEISSLE, M., ROMEIS, J. Consumption of Bt maize pollen expressing Cry1Ab or Cry3Bb1 does not harm adult green lacewings, Chrysoperla carnea (Neuroptera: Chrysopidae). PLoS One, 3, e2909, 2008. LI, Y.; MEISSLE, M.; ROMEIS, J. Use of maize pollen by adult Chrysoperla carnea (Neuroptera: Chrysopidae) and fate of Cry proteins in Bt-transgenic varieties. Journal of Insect Physiology, PubMed PMID: 19782688, 2009. LUNDRY, D. R.; RIDLEY, W.P.; MEYER, J. J.; RIORDAN, S. G.; NEMETH, M. A.; TRUJILLO, W. A.; BREEZE, M. L.; SORBET, R. Composition of grain, forage, and processed fractions from second-generation glyphosate-tolerant soybean, MON 89788, is equivalent to that of conventional soybean (Glycine max L.). Journal of Agricultural Food Chemistry, 56, 4611-4622, 2008 MAGURRAN, A. E. Ecological diversity and its measurement. London: Chapman & Hall. 178 p. 1991. MALONE, L.A., BURGESS, E.P.J., 2009. Impact of GM crops on pollinators. In: Ferry, N., Gatehouse, A.M.R. (Eds.), Environmental Impact of Genetically Modified Crops. CAB International, Wallingford, UK, 432 pp. MALONE, L.A., PHAM-DELEGUE, M.H. Effects of transgene products on honey bees (Apis mellifera) and bumblebees (Bombus sp.). Apidologie, 32, 287-304, 2001. Melin, B.E. and Cozzi, E.M. (1990) Safety to nontarget invertebrates of lepidopteran strains of Bacillus thuringiensis and their a-exotoxins. In M. Laird, L.A. Lacey and E.W. Davidson (eds.), Safety of Microbial Insecticides. CRC Press, USA, pp. 149- 167. National Center for Biotecnhologia - http://www.ncbi.nlm.nih.gov/nuccore/108782282 acessado em 18/10/2010. ONOSE, J.; IMAI, T.; HASUMURA, M.; UEDA, M.; OZEKI, Y.; HIROSE, M. Evaluation of subchronic toxicity of dietary administered Cry1Ab protein from Bacillus thuringiensis var. Kurustaki HD-1 in F344 male rats with chemically induced gastrointestinal impairment. Food Chemistry Toxicology, 46, 2184-2189, 2008. PAUL, V.; GUERTLER, P.; WIEDEMANN, S.; MEYER, H.H. Degradation of CrylAb protein from genetically modified maize (MON810) in relation to total dietary feed proteins in dairy cow digestion. Transgenic Research, PubMed PMID: 19888668, 2009 PICCIONI, F.; CAPITANI, D.; ZOLLA, L.; MANNINA, L. NMR metabolic profiling of transgenic maize with the CrylAb gene. Journal of Agricultural Food Chemistry, 57, 6041-6049, 2009. PORCAR, M.; GARCIA-ROBLES, I.; DOMINGUEZ-ESCRIBA, L.; LATORRE, A. Effects of Bacillus thuringiensis Cry1Ab and Cry3Aa endotoxins on predatory Coleoptera tested though artificial diet-incorporation bioassays. Bulletin of Entomological Research, 28, 1-6, 2009. PRIESTLEY, A. L.; BROWNBRIDGE, M. Field trials to evaluate effects of Bt-transgenic silage corn expressing the Cry1Ab insecticidal toxin on non-target soil arthropods in northern New England, USA. Transgenic Research, 18,425-423, 2009. RAMIREZ-ROMERO, R.; DESNEUX, N.; DECOURTYE, A.; CHAFFIOL, A.; PHAMDELEGUE, M. H. Does Cry 1 Ab protein affect learning performances of the honey bee Apis mellifera L. (Hymenoptera, Apidae)? Ecotoxicological Environment Safety, 70, 327-333, 2008. RAYBOULD, A. Environmental risk assessment of genetically modified crops: general principles and risks to non-target organisms. BioAssay, v. 2, p. 8, 2007. Source: . Accessed on: 24 Nov 2009. RICROCH, A.; BERGS, J. B.; KUNTZ, M. Is the German suspension of MON810 maize cultivation scientifically justified? Transgenic Research, PubMed PMID: 19548100, 2009. ROSE, R.; DIVELY, G. P. Effects of insecticide-treated and Lepidopteran-active Bt transgenic sweet corn on the abundance and diversity of arthropods. Environmental Entomology, 36, 1254-1268, 2007. SCHMIDT, J.E.; BRAUN, C.U.; L'ABATE, C.; WHITEHOUSE, L.P.; HILBECK, A. Studies on effects of Bacillus thuringiensis-toxins from transgenic insectresistant plants on predaceous lady beetles (Coleoptera: Coccinellidae). Mitteilungen der Deutschen Gesellschaft fur allgemeine undangewandte Entomologie 14, 419-422, 2004. SCHMIDT, J. E.; BRAUN, C.U.; WHITEHOUSE, L. P.; HILBECK, A. Effects of activated Bt transgene products (Cry1Ab, Cry3Bb) on immature stages of the ladybird Adalia bipunctata in laboratory ecotoxicity testing. Arch Environonmental Contamination Toxicology, 56, 221-228, 2009. SCHNEPF, E., CRICKMORE, N., VAN RIE, J., LERECLUS, D., BAUM, J., FEITELSON, J., ZEIGLER D.R. AND DEAN, D.H. Bacillus thuringiensis and its pesticidal crystal proteins. Microbiological Molecular Biological Review, 62: 775-806, 1998. SOUTHWOOD, T.R.E. Ecological methods. London: Chapman and Hall, 39lp.1971 SPENCER, T. M.; MUMM, R.; GWYN, J. Glyphosate resistant maize lines. 2000. United States Patent 6040497. Source: . Accessed on: 24 Nov 2009. TAN, S. et al. Herbicidal inhibitors of amino acid biosynthesis and herbicide-tolerant crops. Amino Acids, v. 30, p. 195- 204, 2006 XU, W.; CAO, S.; HE, X.; LUO, Y.; GUO, X.; YUAN, Y.; HUANG, K. Safety aesessment of CryIAb/Ac fusion protein. Food Chemistry Toxicology, 47, 1459-1465, 2009 YU, C.G.; MULLINS, M. A.; WARREN, G. W.; KOZIEL, M. G.; ESTRUCH, J. J. The Bacillus thuringiensis vegetative insecticidal protein Vip3A lyses midgut epithelium cells of susceptible insects. Applied and Environmental Microbiology, 63: 532-536. 1997. YU, Q.; ABDALLAH, I.; HAN, H.; OWEN, M.; POWLES, S. Distinct non-target site mechanisms endow resistance to glyphosate, ACCase and ALS-inhibiting herbicides in multiple herbicide-resistant Lolium rigidum. Planta, 230, 713-723, 2009. ZAR, J.H. Biostatistical Analysis. Prentice- Hall, Englewood Cliffs, New Jersey. 660 pp. 1999. ZURBRUGG, C.; HONEMANN, L.; MEISSLE, M.; ROMEIS, J.; NENTWIG, W. Decomposition dynamics and structural plant components of genetically modified Bt maize leaves do not differ from leaves of conventional hybrids. Transgenic Research, PubMed PMID: 19609704, 2009.
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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@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:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
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Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
Philippines
Name of product applicant: Syngenta Philippines
Summary of application:
The Bt11 x MIR 162 x GA21 is a combined trait corn line developed by crossing using conventional breeding techniques.

Backcrossing was used to move the trait into an inbred background to generate a fixed inbred for each trait. The fixed transgenic inbreds are then crossed to produce a commercial hybrid containing both events, Bt11 x MIR 162 x GA21
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Date of authorization: 28/07/2010
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:
Syngenta Philippines had 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: Bt11 x MIR162 x GA21 which has been genetically modified for insect resistance and herbicide tolerance. A safety assessment of combined trait product corn: Bt11 x MIR 162 x GA21 was conducted as per Department of Agriculture 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 interactions between/among the transgenes.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
E-mail:
bpibiotechsecretariat@yahoo.com
Organization/agency name (Full name):
Bureau of Plant Industry
Contact person name:
Thelma L. Soriano
Website:
Physical full address:
San Andres St., Malate, Manila
Phone number:
632 521 1080
Fax number:
632 521 1080
Country introduction:
The Philippines is the first ASEAN country to establish a modern regulatory system for modern biotechnology. The country's biosafety regulatory system follows strict scientific standards and has become a model for member-countries of the ASEAN seeking to become producers of agricultural biotechnology crops. Concerns on biosafety in the Philippines started as early as 1987 when scientists from the University of the Philippines Los Banos (UPLB) and International Rice Research Institute (IRRI), the Quarantine Officer of the Bureau of Plant Industry (BPI) and the Director for Crops of the Philippine Council for Agriculture, Forestry and Natural Resources Research and Development (PCARRD) recognized the potential for harm of the introduction of exotic species and genetic engineering. The joint committee formed the biosafety protocols and guidelines for genetic engineering and related research activities for UPLB and IRRI researchers. This proposal was eventually adapted into a Philippine Biosafety policy by virtue of Executive Order No 430, Series of 1990, issued by then President Corazon C. Aquino on October 15, 1990, which created the National Committee on Biosafety of the Philippines (NCBP). The NCBP formulates, reviews and amends national policy on biosafety and formulates guidelines on the conduct of activities on genetic engineering. The NCBP comprised of representative from the Department of Agriculture (DA); Department of Environment and Natural Resources (DENR); Health (DOH); and Department of Science and Technology (DOST), 4 scientists in biology, environmental science, social science and physical science and 2 respected members of the community. The Philippines’ Law, Executive Order No.514 (EO514), Series of 2006 entitled “Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National Committee on Biosafety of the Philippines, and for Other Purposes was also issued. This order sets the establishment of the departmental biosafety committees in the DA, DENR, DOH and DOST. The mandates jurisdiction and other powers of all departments and agencies in relation to biosafety and biotechnology is guided by the NBF in coordination with the NCBP and each other in exercising its power. The Department of Agriculture (DA) issued Administrative Order No 8, Series of 2002, (DA AO8, 2002), which is part of EO 514, for the implementation of guidelines for the importation and release into the environment of plants and plant products derived from the use of modern biotechnology. The DA authorizes the Bureau of Plant Industry (BPI) as the lead agency responsible for the regulation of agricultural crops developed through modern biotechnology. The BPI has adopted a protocol for risk assessment of GM crops for food and feed or for processing based on the Codex Alimentarius Commission’s Guideline for the Conduct of Food Safety assessment of Foods Derived from Recombinant-DNA plants and a protocol for environmental risk assessment in accordance with the Cartagena Protocol on Biosafety and with the recommendation of the Panel of Experts of the Organization for Economic Cooperation and Development (OECD). DA AO8, 2002 ensures that only genetically food crops that have been well studied and found safe by parallel independent assessments by a team of Filipino scientists and technical personnel from the concerned regulatory agencies of the Department are allowed into our food supply and into our environment. The DA AO 8, 2002 has a step by step introduction of GM plant into the environment. The research and development phase would require testing the genetically modified (GM) crop under controlled conditions subject to regulation by the government agencies. The first stage of evaluation for GM crops is testing under contained facilities such as laboratories, greenhouses and screenhouses. After satisfactory completion of testing under contained facilities, confined environmental release or field trial is done. Confined field trial (CFT) is the first controlled introduction of the GM crop into the environment. The approval for field trial shall be based on the satisfactory completion of safety testing under contained conditions. Unconfined environmental release or commercialization of the product would follow after the safe conduct of the CFT. Approval for propagation shall only be allowed after field trials and risk assessment show no significant risk to human and animal health and the environment.
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Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004