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OECD Unique Identifier details

MON-877Ø1-2xMON-89788-1
Commodity: Soyabean / Soybeans
Traits: Glyphosate tolerance,Lepidoptera resistance
Argentina
Name of product applicant: Monsanto Argentina S.A.I.C.
Summary of application:
The stacked event MON87701xMON89788 on soybean confers resistant to certain lepidopteran insects and tolerance to herbicides which active principle is glyphosate. The parental events, MON87701 and MON89788, were stacked by conventional crossing (sexual). The stacked event has the cry1Ac gene from the MON87701 event and the cp4 epsps gene from the MON89788 event. The transgenes are inherited in independent form, since they presents mendelian segregation. Moreover, the applicant proved the gene stability and the effective levels of the expressed proteins. The protein Cry1Ac confers resistance to certain lepidopteran insects and 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. After comparison of 64 analytes measured in grain and forage, in the compositional analysis study, it's concluded that soybean with the stacked event MON87701xMON89788 is equivalent to the commercial soybean and parental lines. The proteins of new expression don't have similarity with allergenic or toxic proteins and have rapid degradation in SGF (simulated gastric fluids). 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 MON87701xMON89788 event is substantial and nutritionally equivalent to its non transgenic counterpart.
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Date of authorization: 01/08/2012
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
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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.
Summary of application:
Commercial release of soybean MON 87701 x MON 89788 soy resulting from crossing, through classical genetic improvement, of genetically modified parental of insect-resistant MON 87701 soy and glyphosate-tolerant MON 89788 soy for the purpose of releasing into the environment, marketing, consumption and any other activity related to this soybean and progenies derived thereto.
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Date of authorization: 20/08/2010
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:
Event MON 87701 has gene cry1Ac coming from Bacillus thuringiensis and event MON 89788 has gene cp4 epsps coming from Agrobacterium sp. These are distinct events, which are expressed in different cell organelles. MON 87701 soy was produced using the transformation methodology mediated by Agrobacterium sp. using plasmid PV-GMIR9, a binary vector. T-DNA I contains gene cry1Ac expression cassette and T-DNA II contains gene cp4 epsps expression cassette, used as a selection marker only. Following identification of the modified plants with cry1Ac, T-DNA II was segregated by classical improvement, issuing plants that contained gene cry1Ac expression cassette and were named MON 87701 soy. Parental soy MON 89788 has the cp4 epsps gene, which grants tolerance to herbicide glyphosate and was introduced in the soy through a transformation system by Agrobacterium tumefaciens in soy meristems. The event differs from event GTS 40-3-2 by having a different FMV (figwort mosaic virus promoter). Results of field experiments conducted in Brazil for phenotypic and agronomic characterization and ecologic interactions of MON 87701 x MON 8978 soy, as well as its parental samples, enabled a conclusion that they are substantially equivalent and that have no greater potential to change into pest plants and fail to cause significant environmental impact when compared to conventional soy. The soy was assessed for its agronomic and phenotypic characteristics, seed vigor and germination, pollen morphology and viability, symbiotic interactions in field and laboratory, ecological interactions in field and voluntary plants. There was no evidence of significant differences for assessment on abiotic stress response, damages caused by diseases and by insects, except for the fact that the expressed characteristic for controlling lepidopterans was effective. Data indicate that MON 87701 x MON 89788 soy fails to cause significant environmental impact and to pose higher risk as a plant pest when compared to conventional soy. Assessment of effects on non-target organisms considered familiarity of CRY proteins mode of action and CRY1AC protein level of expression in soy, environment destination of such protein, feeding tests with representative non-target organisms using CRY1AC protein or soy tissues containing it. Non-target organisms tested included mammals, birds, soil decomposers and beneficial insects. The results support a conclusion that it is unlikely that soy MON 87701 x MON 89788 may cause adverse effects on non-target organisms or species threatened under the usual agricultural practices in soy cultivation. Alimentary safety was assessed through contents of grain and fodder, study of oral acute toxicity in mice, composition of amino acid sequences in CRY1AC and CP4 EPSPS proteins by bioinformatics, study of simulated digestion in gastric bowel fluid, studies concerning the link to human IgE and nutritional analysis to assess performance in broiler chicken. Additional studies conducted include the history of safe use and exposure to proteins CRY1AC and CP4 EPSPS and to genetically modified cultures that express such proteins, knowledge of the security offered by donor organisms and genetic elements included in the expression cassettes of such genes, and knowledge of the protein mode of action. Results of compositional analyses in grains cultivated in Brazil indicated that MON 87701 and MON 89788 parental soy, as well as MON 87701 x MON 89788 soy, are equivalent in terms of nutrient and antinutrient composition to conventional soy and to commercial references, with data composition intervals that are in line with the literature and international databanks. The study conducted with chicken evidenced that there were no biologically relevant differences in the parameters assessed between birds fed with a diet based on MON 87701 x MON 89788 soy and those fed with control and reference diets. Birds performed equally, regarding carcass yield and meat composition, despite of the diet fed to them. Bioinformatics analysis showed that proteins CRY1AC and CP4 EPSPS fail to share any structural similarity with known toxins or biologically active proteins harmful to human or animal health. Acute oral toxicity studies with mice fail to indicate any toxic effect. Proteins CRY1AC and CP4 EPSPS represent a share of 0.012% and 0.04%, respectively, of total grain composition. The data pooled together enable a conclusion that it is highly unlikely that such proteins may cause any toxic effect to humans and animals. Regarding allergenic potential, the proteins are not originated from allergenic sources, do not share any structural and immunological sequence with known allergens, are rapidly digested in gastric and bowel fluids and are a very small portion of proteins that are present in the intercrossed parental soy. Besides the data supplied by the company, CTNBio examined the independent scientific literature to assess safety and occurrence of any unexpected effect stemming from the crossing between the events.   TECHNICAL OPINION I. GMO Identification GMO designation: MON 87701 x MON 89788 soy Applicant: Monsanto do Brasil Ltda. Species: Glycine max (L.) Merr. Inserted characteristics: Tolerance to herbicide and resistance to insects. Method of insertion: MON 87701 x MON 89788 soy, rated as Risk Class I, was produced though classical genetic improvement, through crossing parental genetically modified soy resistant to insects, MON 87701 and soy tolerant to glyphosate MON 89788. Event MON 87701 has gene cry1Ac, originated in Bacillus thuringiensis and event MON 89788 has gene cp4 epsps, coming from Agrobacterium sp. MON 87701 soy was produced by transformation methodology mediated by Agrobacterium sp. using plasmid PV-GMIR9, a binary vector. T-DNA I contains the expression cassette of gene cry1Ac and T-DNA II contains the expression cassette of gene cp4 epsps, used only as a selection marker. After identifying the plants modified by gene cry1Ac, T DNA II was segregated by classical improvement, generating plants that possessed expression cassette of gene cry1Ac and were named MON 87701 soy. Parental soy MON 89788 has gene cp4 epsps, which grants tolerance to glyphosate and was introduced through transformation system by Agrobacterium tumefaciens in soy meristems. This differs from event GTS-40-3-2 by exhibiting a different promoter, the FMV (figwort mosaic virus promoter). Prospective use: Free registration, use, essays, tests, sowing, transport, storage, marketing, consumption, release into the environment and discarding, and any other activities related to such soy and its progenies. II. General Information Insect-resistant soy MON 87701 was developed by introducing gene cry1Ac in the genome of meristematic cells of A5547 soy mediated by Agrobacterium tumefaciens, using the transformation vector PV-GMIR9. The target of this transformation was reducing the use of insecticides to control lepidopteran pests in tropical and subtropical regions, primarily against attacks by Anticarsia gemmatalis, the velvetbean caterpillar and by Pseudoplusia includes, the looper moth, as primary targets, and by Crocidosema aporema, the bean shoot moth, as secondary, through important in South American farms, target. A second generation of glyphosate tolerant soy was named MON 89788, in addition to the CTNBio approved event GTS 40-3-2. The new event offers a variant for expressing gene cp4 epsps through the use of figwort mosaic virus promoter, the FMV promoter. In a way different from the previous modification, where biobalistics was used, this transformation was made by Agrobacterium tumefaciens in tissues of conventional A3244 soy. III. Aspects Related to Human and Animal Health Alimentary safety of MON 87701 and MON 89788 soy, and that of event MON 87701 x MON 89788 was assessed through the following studies: (1) Grain composition and fodder analysis; (2) Studies of acute oral toxicity in animal models (mice): (3) Comparative in silico studies of proteins CRY1AC and CP4 EPSPS regarding their amino acid composition; (4) Digestibility studies of the proteins in simulated gastric and bowel juices; (5) Allergenicity studies with affinity tests of proteins CRY1AC and CP4 EPSPS to human IgE; and (6) Nutritional assessment of broiler chicken fed with the product. A brief report on these studies follows: Results were exhibited for total composition of grain and fodder produced in different Brazilian locations (Mato Grosso, Goiás, Paraná, Minas Gerais and Rio Grande do Sul) for MON 87701 x MON 89788 soy and contrasted to the respective conventional controls and reference materials. Sixty-four analytical components were analyzed in two samples of each cultivation region tested. Studies were conducted with exhibits of test (T), control (C) and references (R). Out of the sixty-four substances analyzed, eleven fatty acids had their analytical values below quantification limits and were not included in the statistical analysis. Charts were shown summarizing values obtained and their statistical analyses with tolerance interval of 99% (p<0.05). data="" on="" composition="" analysis="" were="" also="" given="" conducted="" with="" samples="" collected="" in="" five="" locations="" within="" the="" united="" states="" alabama="" arkansas="" georgia="" illinois="" and="" north="" carolina="" order="" to="" assess="" whether="" levels="" of="" nutrients="" anti-nutrients="" grain="" tissues="" fodder="" derived="" from="" mon="" 87701="" soy="" are="" comparable="" that="" found="" conventional="" cultivar="" a5547="" originated="" twenty="" cultivars="" included="" establish="" natural="" variability="" interval="" for="" each="" component="" examined="" tests="" results="" failed="" show="" significant="" differences="" p="">0.05) for 42 out of the 53 comparisons conducted with the respective conventional controls. Other variables were either within the 99% tolerance interval or were not consistently observed; in addition, the values remained within the intervals found in the literature and ILSI (International Life Science Institute) databanks, a reference for this type of study. Proteins CRY1AC and CP4 EPSPS were also assessed regarding their potential toxicity for humans and animals according to the Codex Alimentarius Commission recommendations. The proteins have a long story of safe use, absence of structural similarity to known toxins or biologically active proteins that may cause harmful effects to mammals, fail to cause acute oral toxicity in mice and are a very small portion of the total protein present in the ration and food derived from MON 87701 x MON 89788 soy. They represent no more than 0.0012% and 0.04% of total protein in soy MON 87701 and MON 89788 soy, respectively. Bioinformatics analysis showed that proteins CRY1AC and CP4 EPSPS do not share structural and sequence similarities to known toxins or biologically active proteins. The non-observed level (NOEL) for oral toxicity in mice was 572 mg/kg for protein CP4 EPSPS and the higher tested doses of protein CRY1AC tested were 1.459 mg/kg for male mice and 1.292 mg/kg for female mice. Studies reached a conclusion that the two proteins do not show acute toxicity and fail to cause adverse effects in high doses. Studies of in silico sequence comparisons were conducted with the use of the FASTA bioinformatics tool used in alignment of protein sequences. The analysis made by the FASTA program compares primary sequences of protein amino acids (linear) with sequences deposited in databanks and enables an inference of similarities between the secondary and tertiary structures. Proteins displaying large sequential similarities between them are usually homolog both in tertiary structures and in biochemical functions. Studies of the CRY1AC conducted with the FASTA tool and proteins of the databank TOXIN6 resulted in 15 alignments, with the highest one displaying 98.981% of sequential identity in a superposition of 1,178 amino acids with one ƒÔ-endotoxin. Delta-endotoxin is a synonym for Bt or Cry proteins. This alignment fails to indicate a potential toxicity for humans or animals. The fourteen additional alignments were found with other Cry proteins. The results showed that no relevant structural similarities exist between protein CRY1AC and any known toxic protein or other biologically active proteins that may threaten human and animal health. Alignments conducted with CP4 EPSPS protein sequence failed to display significant homology with known toxic proteins, the sequences of which had already been determined and included in the databank. Digestibility studies conducted with CRY1AC and CP4 EPSPS in simulated gastric fluid (SGF) were analyzed by SDS-PAGE and Western Blot methods. The studies evidenced that 95% of the CRY1AC protein are degraded within 30 seconds, while 98% of the CP4 EPSPS is degraded within no more than 15 seconds. Proteins CRY1AC and CP4 EPSPS were also submitted to digestibility studies in simulated intestinal fluid (SIF). Results showed that 95% of CRY1AC protein is degraded in less than 5 minutes and that over 50% of CP4 EPSPS is degraded after 10 minutes of incubation. After 100 minutes of incubation there was no detectable protein in the sample. In general, digestibility results in the tested systems (SGF and SIF) with proteins CRY1AC and CP4 EPSPS were consistent with results of proteins that display safety regarding human and animal health. As far as allergenic potential is concerned, one may state that these proteins are not originated by allergenic sources, do not share structural and immunologically relevant similarities with sequences of known amino acid sequences from allergens and are rapidly digested, as shown by the digestibility studies. Regarding safety of donor organisms, the application describes that the gene coding for protein CRY1AC derives from Bacillus thuringiensis var. kurstaki, a soil microorganism found in the environment in an ubiquitous and abundant way. Bacillus thuringiensis formulations display a long history of safe use for controlling plagues in agriculture, and are used for over fifty years as microbial pesticides with no adverse effects to human health. Still related to allergenicity assessment, an experiment was conducted in the linking of MON 87701 and MON 89788 soy with human IgE using the ELISA (Enzyme Linked Immunoabsorbent Assay). Serums of patients clinically documented as being allergic to soy and of non-allergic patients were used to establish the linking interval of IgE to each soy extract. The interval represents a linking interval of IgE of each patient serum with the soy reference extracts. The interval includes 99% of the IgE linking values that feature a statistical confidence interval of 95%. All values coming from analyses of genetically modified soy MON 87701 and MON 89788 and conventional soy A5547 and A3244 used as control remained within the tolerance limits established by commercial references of each serum examined. No soybean cultivar displayed IgE linking with the serum of non-allergic patients. The conclusion is that both MON 87701 soy and MON 89788 soy have no allergenic potential larger than the conventionally marketed soy. In order to assess safety as an alimentary genetically modified raw material, performances of model animals fed with MON 87701 x MON 89788 soy were tested. A forty-two days alimentary study was conducted with broiler chicken (Cobb x Cobb 500), comparing the nutrition value of diets containing MON 87701 x MON 89788 soy, conventional A5547 soy and six commercial cultivars (Anand, Osak, NK S38-T8, NC+2A86 and NK25-J5) used as control. Besides, a ration from other genetically modified soy was added to the study. These nine treatments were assessed in complete random blocks. They were distributed within five blocks of eighteen cages each (nine with males and nine withy female birds), with ten birds per cage, totaling 90 cages and 900 birds. Results indicate that there were no biologically relevant differences in the parameters measured in weight, carcass yield, breast meat and thigh meat analysis among the treatments studied. The diet containing rations from MON 87701 x MON 89788 soy was as nutritious and healthy as those diets containing ration from control or commercial reference soy. MON 87701 x MON 89788 soy exhibits characteristics of parental soy, that is to say, insect resistance (expression of CRY1AC protein) and tolerance to glyphosate (expression of CP4 EPSPS protein). This is why one does not expect MON 87701 x MON 89788 soy to promote adverse effects in the human and animal food chain after its ingestion, based on alimentary safety obtained from parental soy and expressed proteins. The proteins, CRY1AC and CP4 EPSPS are produced in different insect resistant and/or glyphosate resistant cultures already marketed for over 13 years with no record of allergic or toxic reactions. The donor organism of gene cry1Ac, Bacillus thuringiensis, has been commercially employed for several years in formulations derived from bacteria due to insecticide activity. Safety of proteins derived from Bacillus thuringiensis is vouched by decades of experiments where the proteins have displayed absence of toxicity to man and vertebrate animals and absence of adverse effects to non-target organisms and the environment. Besides, commercial formulations of Bacillus thuringiensis containing such proteins have been used in Brazil and other countries to control some farm pests for over 40 years. Cry proteins also possess very specific action and act only by ingestion in some Lepidopteran species. The donor organism of gene cp4 epsps, Agrobacterium sp. strain CP4, is a common soil bacterium that had the gene changed naturally. The mutation caused the gene to codify for production of glyphosate-tolerant CP4 EPSPS enzyme. The enzyme is structurally and functionally similar to the EPSPS enzymes that are endogenous of plants and microorganisms. EPSPS are ubiquitous in nature, have no known toxicity and fail to grant any selective advantage to the organisms that produce it. Dietary safety of proteins CRY1AC and CP4 EPSPS present in foods and rations derived from soy MON 87701 and soy MON 89788, respectively, which are the parental of soy MON 87701 x MON 89788 obtained by classical genetic improvement, was assessed for risks to humans and animals. Studies have shown that both proteins do not feature acute toxicity and fail to cause adverse effects in high doses, 1.459 mg/kg of body weight of male mice and 1.292 mg/kg of body weight in female mice for protein CRY1AC and 572 mg/kg of body weight for CP4 EPSPS. Proteins CRY1AC and CP4 EPSPS are rapidly digested in simulated gastric fluids. The studies were assessed in SDS-PAGE gel and Western Blotting with the two proteins produced by E. coli, in the presence of simulated gastric fluid and simulated bowel fluid. Allergens originated in food are normally resistant to heat, acids and proteases, may be glycosylated and are highly concentrated in food. The fact that the two proteins are promptly digested reduces the likelihood of causing allergies when consumed. Besides, the proteins do not feature similarity with amino acid sequence of known allergens of toxic proteins that cause adverse effects in animals. Considering that soy is known to be an allergenic food culture, the company assessed whether introducing gene cry1Ac and protein CRY1AC in soy did not change the allergenic potential of MON 87701 soy and MON 87701 x MON 89788 soy as compared to the conventional soy cultivars. The studies were carried on assessing the levels of linkage of antibody IgE coming from sera of patients clinically documented as allergic to extracts of soy MON 87701 protein, from a control cultivar and from 17 commercial cultivars that are used to establish a linking interval to IgE. Sera from 13 patients that were clinically documented as allergic to soy and from 5 non-allergic patients were used to establish the linking interval of IgE to each soy extract. The tests were assessed by ELISA and showed that the linking with IgE of soy MON 87701 and control soy are within the established tolerance limits. Similar analysis was conducted with MON 89788 soy to assess the linking of CP4 EPSPS protein to IgE and like results were reached. Regarding chemical and nutritional composition between the food coming from a genetically modified plant and from a non-genetically modified plant, 64 components were assessed. Total composition of grain and fodder from MON 87701 x MON 89788 soy, MON 87701 soy and MON 89788 soy produced in field experiments in four locations in Brazil conducted during the 2007/2008 crop was contrasted to the conventional soy control and commercial references. The averages yielded from MON 87701 x MON 89788 soy appearing to be statistically different from the values of conventional soy control were either within the tolerance interval of 99% established by commercial references or within the intervals published in the relevant literature. Thus, the differences noticed were no relevant in the context of alimentary and nutritional safety. Forty-two day studies with broiler chicken failed to uncover biologically relevant differences in parameters assessed in birds fed with a diet based on MON 87701 x MON 89788 soy and birds fed with the control and reference diets. The birds displayed comparable performance and similar carcass yield and meat composition, despite the diet. The diet containing a ration of MON 87701 x MON 89788 soy proved to be as nutritious and healthy than diets containing the control or commercial reference soy regarding the ability to contribute towards the birds’ rapid growth. Forty-one day nutritional studies with broiler chicken fed with the genetically modified soy expressing protein CRY1AC showed no difference when compared to the conventional soy, an evidence that protein CRY1AC does not interfere in animal performance. The information and studies presented, besides other works in the literature, establish the safety of MON 87701 x MON 89788 soy. This soy variant exhibits low risk to human and animal health and is not likely to change into a plant pest. Insertion of cry1Ac and cp4 epsps genes did not change the product composition or nutritional value. Also evident became the fact that proteins CRY1AC and CP4 EPSPS do not pose any significant risk to human and animal health according to acute oral toxicity and in vitro digestibility studies. Based on the foregoing and keeping in mind that: (1) The isolated proteins, as well as the grains used in the studies indicate that the products have no toxic activity to human and animal health; (2) The history of safe use of the isolated genes has no report of documented adverse effects to human and animal health; (3) There were no observed homologies between sequences of the tested genes and proteins and toxic products or known allergens available in databanks; (4) The proteins are highly digestible in gastric juice and bowel fluid; (5) The proteins are thermolabile; (6) There were no significant differences found between development of animals fed with material from transgenic plants and their respective controls; (7) The differences observed between components present in transgenic plants and their respective controls are either not significant or are within an acceptable tolerance margin for the main international parameters. The conclusion is that soy MON 87701 x MON 89788 is as safe as its non-genetically modified equivalent for human and animal consumption, failing to pose additional risk when contrasted to such equivalent. IV. Environmental Aspects Essays of planned release into the Brazilian environment were conducted, namely in Não-Me-Toques (RS), Cachoeira Dourada (MG), Rolândia (PR) and Sorriso (MT). No signs of pleiotropic or epistatic effects were evidenced. There was no record of morphological, growth or development changes contrasting with conventional soy, except for tolerance to glyphosate herbicide and resistance to pest lepidopterans. The same behavior was evidenced in other countries where similar experiments were conducted, that is to say, there was no record of significant differences in MON 87701 x MON 89788 soy morphology, growth or development. Average values of phenotypic and agronomic features of two consecutive GM soy crops, one obtained by crossing and its parental ones mono-modified, compared to conventional, control and commercial reference soy, failed to significantly differ, except for the height of soy MON 89788 plants. However, the difference kept within the range establisher for this parameter in commercial references cultivated under the same conditions. The disparity was attributed to genetic variability among soy cultivars. Therefore, there are no adverse effects in phenotypic and agronomic characteristics of stacked gene soy, MON 87701 x MON 89788, caused by individual genetic modifications after introduction of the insect-resistance and glyphosate-tolerance genes, as well as by the presence of the two factors in the same plant. Regarding assessment of risk to the environment, it is worth analyzing data related to tests conducted in Brazil, Argentina and the United States. Seed dormancy studies conducted in Brazil and the United States were negative, indicating the unlikelihood that the three assessed soy plants (isolated and stacked events) turn into pest plants. In this same line, pollen viability of GM soy was no more resistant than that of other soy cultivars in low frequency, 0.04% to 3.62% in adjacent plants, and that Glycine species feature no kinship with species of the native flora. Non-target organisms submitted to tests were the collembola and the earthworm, as soil decomposers, and four species of beneficial insects, honeybees, pirate bugs, ladybugs and parasitoid wasps. Test data reveal that MON 87701 x MON 89788 soy and its parental plants do not cause adverse effects to non-target organisms or species held as threatened. Results of molecular characterization of the stacked event MON 87701 x MON 89788 confirm insertion of a functional copy from the cassette containing gene cry1Ac in a single genomic locus. Stability of this locus was assessed for five crossing generations in the parent MON 87701, and for the stacked event no phenotypic change or rearrangement was recorded. Essays conducted in Brazil showed that average levels of the insecticide protein did not change in a substantial way between the single and the stacked event, taking into consideration each plant part assessed: foliage, leaf and grain tissues – and the four locations of collection, in two crops, 07.2008 and 08.2009. The same way, molecular characterization of the stacked event MON 87701 x MON 89788 confirm insertion of a single copy of the functional and intact cassette of gene cp4 epsps in one single genomic locus; the stacked event failed to record any phenotypic change or rearrangement. Also, average levels of exogenous protein have not varied substantially between the single and the stacked event considering each part of the plant assessed and the four collection locations, in two crops, 07.2008 and 08.2009. Soy is a predominantly autogamous species, with crossed pollination rate in the Brazilian cerrado environment, for instance, reaching 0.45% at a distance of 5m; 0.14% at 1m; and detectable absence at a distance of 6m. Soy is an exotic species, with no sexually compatible feral kindred in Brazil. The species has a highly domesticated, so that there are no scientific reasons to foresee survival of GM and non-GM plants away from the farming environment. Besides, in the absence of selective pressure (use of the herbicide and the insecticides), expression of the inserted genes fail to grant any adaptive advantage. V – Restrictions to the use of the GMO and its derivatives. As established by Article 1 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” Studies submitted by applicant demonstrate that there are no significant differences between genetically modified soy and its conventional isoline regarding agronomic characteristics, mean of reproduction, dissemination or survival ability. All evidence submitted in the proceeding and bibliographic references confirm the risk level of the transgenic variety as equivalent to that of non-transgenic varieties regarding soil microbiota, as well as concerning other plants and human and animal health. Therefore, cultivation and consumption of MON 87701 x MON 89788 soy are not potential causes of significant degradation of the environment or threatening to human and animal health. For these reasons, there are no restrictions to the use of this soy and its derivatives, except for locations mentioned by Law 11,460, of March 21, 2007. Soy is an exotic plant in Brazil and there are no feral kindred plants able to cross and generate descendants. Gene flow between soy plants was already studied in tropical conditions. Soy is an autogamous species with full flowers, featuring very low rates of crossed pollination, according to the cultivar type and location. After ten years of use in different countries, no problem has been recorded for human and animal health and the environment that may be attributed to transgenic soy plants. We shall emphasize that the lack of negative effects resulting from farming transgenic soy plants does not mean that these effects will not take place. Zero risks and absolute safety are away from the biologic world, although there is a host of reliable scientific information and a safe history of use related to transgenic varieties in agriculture. Applicant submitted a post commercial release monitoring plan and may accommodate it to the terms of CTNBio Ruling Resolution nº 5 and according to this technical opinion. VI. Consideration on the Particulars of Different Regions of the Country (Information to supervisory agencies) As established by Article 1 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” VII. Conclusion Considering that the soy species is a well characterized plant with a solid history of safety for human and animal consumption and that the genes inserted in this variety codify for proteins that are ubiquitous in nature and well characterized; Considering that centesimal composition data failed to record significant differences between genetically modified varieties and conventional varieties, suggesting their nutritional equivalence; Whereas: 1. Events were well molecularly characterized and there is no trace of interaction between them when joined in the same plant by sexual way; 2. There is no evidence that the proteins expressed cause allergy or intoxication in humans and animals; 3. There was no evidence of botanical alterations in MON 87701 x MON 89788 soy that may grant the plant any adaptive advantage; 4. No pleiotropic or epistatic effects were identified in the parental and joint events. For the foregoing and taking into consideration criteria internationally accepted in the process of risk assessment of genetically modified raw material, a conclusion was reached that MON 87701 x MON 89788 soy is as safe as its conventional equivalents. In the context of duties assigned to it by Article 14 of Law nº 11,105/2005, CTNBio finds that the request complies with the rules and legislation in effect with a view to secure biosafety to the environment, agriculture, human and animal health and concluded that MON 87701 x MON 89788 soy is substantially equivalent to conventional soy and its consumption safe for human and animal health. Regarding the environment, CTNBio concluded that MON 87701 x MON 89788 soy is not a potential cause of significant degradation of the environment, keeping with the biota a relation that is identical to that of conventional soy. CTNBio finds that the activity is not a potential cause of significant environment degradation and not harmful to human and animal health. Restrictions to the use of the GMO and its derivatives are provided by Law nº 11,460, of March 21, 2007. The analysis conducted by CTNBio considered the opinions issued by the Commission members; ad hoc consultants; documents forwarded by the Office of the CTNBio Executive Secretary and by applicant; lectures and related texts. Third party scientific studies and publications independent from applicant were also taken into consideration.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular Traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Comission
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Authorization expiration date: Not 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)