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OECD Unique Identifier details

MON-88913-8xMON-15985-7
Commodity: Cotton
Traits: Glyphosate tolerance,Lepidoptera resistance
Brazil
Name of product applicant: Monsanto do Brasil Ltda.
Summary of application:
commercial release of genetically modified cotton resistant to insects and tolerant to glyphosate, named MON 15985 x MON 88913
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Date of authorization: 16/08/2012
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.): Center for Environmental Risk Assessment
Summary of the safety assessment:
Cotton MON 15985 x MON 88913 results from the crossing, through classical genetic improvement of the parents of genetically modified corn MON 15985 and MON 88913. Regarding MON 15985, genes cry1Ac and cry2ab2 introduced in its genome and also present in the genome of MON 15985 x MON 88913 cotton, come from Bacillus thuringiensis subspecies kurstaki and code for proteins Cry1Ac and Cry2ab2. Proteins Cry2ab2 and Cry1Ac are very specific in action, exhibiting toxic effect only by ingestion and act in specific receptors located in the middle intestine of some insect species of the order Lepidoptera. The proteins have toxic effect on lepidopteran insects that hit the cotton farming in Brazil, such as the fall armyworm, Spodoptera frugiperda, and other species of the genus Spodoptera, in addition to: cotton leafworm (Alabama argillacea); tobacco budworm, Heliothis virescens; corn earworm, Helicoverpa zea, and pink bollworm Pectinophora gossypiella. Regarding cotton MON88913, gene cp4 epsps introduced in its genome and also present in the genome of cotton MON 15985 x MON 88913 originates from Agrobacterium strain CP4 and codes for protein cp4EPSPS (5-enolpyruvilshikimate-3-phosfate synthase), responsible for granting tolerance to herbicide glyphosate. Protein CP4 EPSPS present in cotton MON 88913 is functionally identical to the endogenous plant proteins EPSPS, including that of cotton, except for the fact that protein CP4 EPSPS has a naturally reduced affinity for glyphosate. CTNBio analyzed the reports submitted by applicant as well as independente scientific literature. Analyzes of results in all tests indicated that cotton MON 15985 x MON 88913 is held to be substantially equivalent to other cotton varieties. Zones where cultivation of genetically modified cotton is restricted, as established in MAPA Directive nº 21/2005, shall be strictly observed. TECHNICAL OPINION Identification of GMO GMO name: Genetically modified cotton resistant to insects and tolerant to glyphosate MON 15985 x MON 88913 Applicant: Monsanto do Brasil Ltda. Species: Gossypium hirsutum L. Inserted Characteristic: Resistance to insects and tolerance to glyphosate Method of Introduction: Combined cotton MON 15985 x MON 88913 results from crossing, through classical genetic improvement, of parental genetically modified cotton MON 15985 and MON 88913 Intended Use: Production, from the GMO and its derivatives, of fibers for the textile industry and grain for human and animal consumption I. General Information In Brazil, cotton culture is well developed in the Center-Western and Northeastern regions that, on the 2011-2012 crop year tiled about 872 and 462 hectares, respectively, in an area of about 1392 hectares. Mato Grosso is the main state in seed cotton production, with about 2700 tons according to an estimate of the 2011-2012 crop published by CONAB, representing an increase of 5.4% against the previous harvest(1). The first generations of genetically modified cotton resistant to pests were of the MON 531 cotton variety and that of glyphosate tolerant cotton were variety MON 1455. Both varieties have been widely used by cotton farmers in different countries where the technologies are approved, either individually of combined in a single product, as it is the case of Brazil. Resistance to target pests granted by proteins from Bacillus thuringiensis in the plant have shown to be very efficient in controlling insects, not only in cotton, but also in other crops such as soybean and maize. Tolerance to glyphosate is interesting from the agronomic viewpoint, since it is a non-selective insecticide, used in leaf applications, granting more effective control of annual and perennial weeds that may cause problems during the later stages of the plant development. Cotton MON 15985 and MON 88913 represent the second generation of pest-resistant glyphosate-tolerant cotton since MON 15985 expresses two proteins coming from Bacillus thuringiensis, which increases its effectiveness and helps as a tool in the management of insects; and MON 88913 exhibits increased levels of tolerance to glyphosate, attained by using improved promoter sequences that regulate the expression of gene cp4 epsps, which codes protein CP4 EPSPS and grants the characteristic of tolerance to glyphosate. Therefore, the use of MON 15985 x MON 88913 cotton shall enable more effective control of target pests in cotton farming and the use of glyphosate until later stages of the plant development with minimum risks of damaging the cotton culture. II. Description of the GMO in Expressed Proteins Stacked cotton MON 15985 x MON 88913 results from the crossing, through classical genetic improvement, of parent lines of genetically modified MON 15985 and MON 88913. Regarding cotton MON 15985, genes cry1Ac and cry2ab2 introduced in its genome, and also present in the genome of cotton MON 15985 x MON 88913, originate from Bacillus thuringiensis subspecies kurstaki, respectively, and code for proteins Cry1Ac and Cry2Ab2. The bacterium Bacillus thuringiensis is a gram-positive soil microorganism that has the ability to develop crystals containing endotoxins, proteins with insecticide action, during the sporulation phase of its development cycle(2). Among such toxins, proteins Cry, or δ-endotoxins stand out. Commercial formulations of Bacillus thuringiensis containing such proteins have been used, both in Brazil and in other countries, to control certain agricultural pests for over 50 years. Proteins Cry2Ab2 and Cry1Ac have very specific action, displaying toxic effect only by ingestion and act in specific receptors located at the middle intestine of some species of insects of the Order Lepidoptera. The proteins have a toxic effect on lepidopteran insects that hit cotton culture in Brazil, such as armyworm, Spodoptera frugiperda and other species of the genus Spodoptera, in addition to: cotton leafworm (Alabama argillacea); tobacco budworm (Heliothis virescens); corn earworm, (Helicoverpa zea), and pink bollworm Pectinophora gossypiella. According to applicant, this second generation or pest-resistant cotton is more effective in controlling such pests because it expresses two Cry proteins, besides being an adequate and efficient tool in the management of resistance to insects. One difference from Bollgard cotton is the armyworm control, being that the cause for cotton MON 15985 wider range of control. The genetic transformation process of MON 15985 cotton was bombarding genetically modified cotton MON 531 (Bollgard cotton transformed with vector PV-GHBK04, containing genes cry1Ac, nptll and aad, already commercially approved by CTNBio in 2005 – EPT 513/2005) with particles coated with the genetic material of interest (vector PV-GHBK11 containing genes cry2ab2 and uidA), generating the lineage containing the two genes of Bacillus thuringiensis, namely cry1Ac and cry2ab2. It is known that the action mechanism of Cry proteins is mediated by specific receptors located at the middle intestine of susceptible insects. Association of Cry proteins to the receptors leads to formation of pores that cause the death of the target insect(2). Cotton MON 15985 is classified as an organism of biosafety risk class I. In order to transform cotton MON 15985, the vector PV-GHBK11 was linearized and the fragment containing genes cry2ab2 and uidA, and their regulating elements (PV-GHBK11L), was inserted in the MON 531 cotton genome. Genes originally inserted in cotton MON 531 were cry1Ac, granting resistance to pests, and selection marking genes nptII and aad. However, gene aad has no modification for expression in plants, being used solely as a selection marker in bacterial cells, transformed with the vector containing the genes of interest. Gene uidA, in turn, codes for expression of protein GUS, used as a selection mechanism for transformed cells (selection colorimetrical marker). Gene uidA, also known as gene gus or gusA, derived from E. coli, strain K12, codes for enzyme β-D-glucoronidase (GUS). The bacterium Escherichia coli is na inhabitant of the digestive tract of vertebrates, including humans. Enzyme GUS catalyzes hydrolysis of several β-glucuronides, among which the p-nitrophenyl-β-D-glucuronide that results in a bluish chromogenic compound, which enables the selection of transformants. Therefore, cotton MON 15985 expresses in its DNA proteins Cry1Ac, Cry2Ab2, NPTII and GUS. Molecular characterization depicts cotton MON 15985 as containing only one insertion of this linear fragment PV-GHBK11L, in a single copy of each cassette of expression of genes cry2ab2 and uidA. Molecular characterization of cotton MON 15985 also determined the insert composition and structure, as well as its stability in multiple generations. As the sequences of the vector (replication sequences or other stability elements) are not part of the insert, it is held null any actual potential of horizontal genetic transference between the donor bacterium of the vector and the receiving cotton. Regarding cotton MON 88913, gene CP4 EPSPS introduced in its genome and present in the genome of cotton MON 15985 x MON 88913 originates from Agrobacterium tumefasciens strain CP4 and codes for protein CP4 EPSPS (5-enolpyruvylshikimate-3-phosphate synthase), responsible for granting tolerance to the herbicide glyphosate. This is the same protein CP4 EPSPS produced in the event glyphosate tolerant cotton named MON 1445. The genetic transformation method was the system mediated by Agrobacterium tumefasciens, using the binary vector PV-GHGT35 that contains two expression cassettes of gene cp4 epsps for the production of protein CP4 EPSPS. In plants, protein EPSPS is located within chloroplasts. Protein CP4 EPSPS present in cotton MON 88913 is functionally identical to EPSPS proteins endogenous in plants (including cotton), except for the fact that CP4 EPSPS has a naturally reduced affinity for glyphosate. In conventional plants, glyphosate links to the plant endogenous protein EPSPS, blocking biosynthesis of 5-enolpyruvylshikimate-3-phosphate and causes deficiencies in the production of essential aromatic amino acids and secondary metabolites in plants. In plants genetically modified with gene cp4 epsps, the amino acids and other metabolites requires to plant growth and development are obtained by continuous action of protein CP4 EPSPS tolerant to glyphosate(3). In cotton MON 88913, the gene construct containing gene cp4 epsps contains also the target sequence of the chloroplast, which enables application of the glyphosate over the genetically modified cotton culture until later stages of the plant development, as against cotton MON1445. The extended time for glyphosate application to cotton MON 88913 and cotton MON 15985 x MON 88913 is posible due to the use of improved promoter sequences that regulate expression of coding sequences of gene cp4 epsps. This will enable a more effective control of pests during cultivation, with minimum risks of damages to the cotton culture. Therefore, cotton MON 88913 is a technology that enables this control through the use of glyphosate until the later stages of plant development. The glyphosate has environmental and safety characteristics that favor its use in the management of pest plants(4,5,6). Cotton MON 88913, as well as cotton MON 15985 and cotton MON 15985 x MON 88913, is also classified as a biosafety risk class I. Expression levels of proteins Cry1Ac, Cry2Ab2, NPTII, GUS and CP4 EPSPS were studied in leaves and grains produced in field studies in Brazil, using the ELISA quantification method. The materials were collected in two representative locations of cotton farming in the country, in planned releases in the environment conducted in Cachoeira Grande, State of Minas Gerais, and Sorriso, State of Mato Grosso(7), being the experimental design of chance blocks in four repetitions. Levels of the five proteins were measured in micrograms (μg) per gram (g) of wet weight. Humidity was then measured to generate the values in dry weight. In an identical field experiment, cottons MON 15985 and MON 88913 were cultivated, enabling the levels of proteins Cry1Ac, Cry2Ab2, NPTII, and GUS to be assessed in MON 15985 and protein CP4 EPSPS in MON 88913 with additional information to be submitted to CTNBio, since an adequate comparison should be made against conventional cotton. For protein Cry1Ac, averages in leaf and grain tissue of cotton MON 15985 x MON 88913 collected in the two locations was 23 μg/g and 1.9 μg/g of dry weight, respectively, and that of cotton MON 15985 were 19 μg/g and 1.6 μg/g of dry weight, respectively. For protein Cry2Ab2, averages in leaf and grain tissues of cotton MON 15985 x MON 88913 collected in the two locations were 630 μg/g and 250 μg/g of dry weight, respectively, and that of cotton MON 15985 were 590 μg/g and 250 μg/g of dry weight, respectively. For protein CP4 EPSPS, averages in leaf and grain tissues of cotton MON 15985 x MON 88913 collected in the two locations were 1900 μg/g and 270 μg/g of dry weight, respectively, that of cotton MON 88913 were 2100 μg/g and 280 μg/g of dry weight, respectively. Regarding protein NPTII, averages in leaf and grain tissues of cotton MON 15985 x MON 88913 collected in the two locations were 45 μg/g and 3.8 μg/g of dry weight, respectively, that of cotton MON 15985 were 42 μg/g and 4.1 μg/g of dry weight, respectively. For protein GUS, the average in leaf and grain tissue of cotton MON 15985 x MON 88913 collected in the two locations were 2500 μg/g and 120 μg/g of dry weight, respectively, of cotton MON 15985 were 4400 μg/g and 130 μg/g of dry weight, respectively. The levels of proteins Cry1Ac, Cry2Ab2, CP4 EPSPS, NPTII and GUS in samples of conventional cotton were below essay LOQ and LOD for each type of tissue, except for CP4 EPSPS in just one leaf sample of the location in Sorriso, State of Mato Grosso. Finally, studies were conducted by applicant to assess any possible interaction between proteins Cry1Ac and Cry2Ab2 in the management of resistance to insects(8). In cotton MON 15985, an independent interactive and additive effect was evidenced between the proteins in the answer of target pests (H. virescens, H. zea and S. frugiperda) when fed with tissues of plants expressing only one of the two or both proteins. Different types of tissues were tested and it became clear, through ELISA, that the quantity expressed of each protein is not affected by the presence of the other protein or gene. The conclusion of the study was that the joint action of the proteins is additive and, besides, the greater insecticide effect is granted by Cry2Ab2. Other studies mentioned in the records corroborate this finding, which is an important conclusion to establish that these two proteins in a single plant is a tool for the management of resistance to insects. III. Aspects Related to Human and Animal Health Applicant notes in its document that for cotton MON 15985 and cotton MON 88913, already approved by CTNBio, results were submitted that ratify the alimentary safety results found for cotton MON 15985 x MON 88913. Safety assessment of MON 15985 x MON 88913 for human and animal health involved: biochemical characterization of heterolog proteins produced in the plant; equivalence of such plant-produced proteins with the same proteins produced in bacterium; toxicity and allergenicity potential of heterolog proteins based on studies and available scientific literature; and the centesimal composition as against conventional cotton. Safety assessment of food derived from genetically modified raw materials is based on risk analysis, a scientific methodology that comprises the phases of risk assessment, management and communication. The risk assessment phase, a qualitative and quantitative characterization of potential adverse effects is sought, based on the idea of substantial equivalence, in order to identify possible differences between the new food and its conventional correspondent. Regarding the receiving organism, Gossypium hirsutum, this is a very well characterized species. In the proceedings under examination, a host of information is submitted, encompassing origin, domestication, identity, taxonomy, morphology, genetics, hybridation and crossing of the species. Concerning the gene donor organisms, the species are also well characterized and easily found in nature. Cultures of Bacillus thuringiensis, the donor organism of genes cry, are recorded with Agência Nacional de Vigilância Sanitária – ANVISA, the National Agency for Sanitary Surveillance, under different formulations for application in 40 types of plant cultures for alimentary purposes. They are included in toxicological classification of group IV and there is not any determined upper boundary of residue nor withdrawal period(9). Gene cp4 epsps was obtained from a soil bacterium that is ubiquitous in nature, identified as Agrobacterium sp. Protein NPTII is produced by different prokaryotic organisms found in nature different habitats, including the human and animal microflora(10). Gene nptII is derived from transposon Tn5 of E. coli, a bacterium of the human digestive system. Protein GUS is also largely found in the environment, and no adverse effects were reported despite the large exposure to bacteria and food containing the protein. Its occurrence in different plant and animal species used in human and animal nutrition is well characterized(12,13,14). Proteins Cry1Ac and Cry2Ab2 are δ-endotoxins produced by Bacillus thuringiensis exhibiting specific activity on the digestive tract of some insect families. To remain active, the proteins must be ingested by the target insects and solubilized by the stomach pH. The proteins, by action of proteases, are activated and bond to high affinity specific receptors that are present in insects(2). Proteins Cry1Ac and Cry2Ab2 are toxic solely for the abovementioned target pests, specifically lepidopterans (caterpillars) possessing, in their guts, specific receptors for such proteins. Mammals fail to have such bonding sites and, therefore, human beings, animals and other non-target organisms are not affected by the Cry proteins of Bacillus thuringiensis, including other arthropods and also other natural enemies of the target-pests(15,16,17,18,19). As a result, the proteins display a long history of safe use and the data of studies and literature submitted enable a conclusion about their alimentary safety. It is worth mentioning that genetically modified cultures resistant to pests expressing these same proteins, or other of the same family, have been cultivated in several countries all over the world, including Brazil, with no record of adverse effects to human and animal health. Protein CP4 EPSPS, in turn, has a structure homologous to EPSPS proteins naturally found in plants and other types of food, such as yeasts used to make bread and beverages. There is a similarity between the amino acid sequence of protein CP4 EPSPS produced in cotton MON 15985 x MON 88913 and protein CP4 EPSPS expressed in cultures tolerant to glyphosate already used in several countries. There are no reports that protein CP4 EPSPS may cause adverse effects on human and animal health, and studies submitted by the applicant of the commercial release of cotton MON 15985 x MON 88913 corroborate the conclusion for safety of the protein. The analysis of the chemical composition of the transgenic variety, mainly of the levels of nutrients and eventual toxic components naturally present, aims at securing that this new variety is as nutritious and safe as its commercial equivalent. This way, it is becomes a confirmation that the intended effects of the modification do not compromise its safety and fail to result in any unintended effect. Nutritional composition and centesimal component data shown in the processes of events MON 15985 and MON 88913 are corroborated by centesimal components shown for MON 15985 x MON 88913 cotton, generated from samples collected in two occasions and two different places, in planned released to the environment in Brazil during the 2008/2009(20) crop. Centesimal composition (ashes, fat, humidity, proteins and carbohydrates by calculation) of grain and forage of cotton MON 15985 x MON 88913 was contrasted to the conventional control cotton and commercial references. In all places, the values of centesimal components in forage and cotton grain of MON 15985 x MON 88913 cotton were similar to that of control values. In the analysis by location, average values of centesimal components were within the intervals of control values within each location or within the interval of references calculated in the combined analyses of locations. ILSI databank was used to show that the values found in the study were within the values of the technical literature (sss.cropcomposition.org). The result enables a conclusion for substantial equivalence of cotton MON 15985 x MON 88913 as against conventional cotton, a fundamental component in assessing alimentary safety. The above analyses made the consideration that introduction of genes cry1Ac, cry2ab2, epsps, nptII, and uidA failed to result in any substantial nutritional change cotton MON 15985 x MON 88913, since the profiles of the centesimal composition, coupled with the previously disclosed results for parental events, were similar to those normally observed in other varieties or produced under different cultivation conditions. Besides safety of donor organisms and analyses of centesimal composition, the records displayed other studies supported by scientific literature that ratify the positive assertion on alimentary safety of MON 15985 x MON 88913 cotton. One of such assertions is that alimentary safety of proteins Cry1Ac, Cry2Ab2, NPTII and CP4 EPSPS was assessed in acute oral toxicity studies with mice, showing that the proteins fail to cause any adverse effect, even in the highest doses tested, of 4200,1450, 5000 and 572 mg/kg of body weight, respectively. Essays in simulated gastric and intestinal systems were conducted to assess protein degradability. Proteins Cry1Ac, Cry2Ab2, and CP4 EPSPS are rapidly digested in simulated, and results show that 99% and 98% of the two proteins, Cry1Ac and Cry2Ab2 were digested in no later than 30 seconds and over 95% of protein CP4 EPSPS was digested within 15 seconds of incubation. It shall be stressed that studies with animals were previously submitted by the applicant in the records for commercial release of parental events, already passed by CTNBio. A further assessment uses bioinformatics tools to contrast amino acid sequences in the proteins of interest with proteins recognizedly toxic or allergenic. Bioinformatics analyses were conducted with the sequences of proteins Cry1Ac, Cry2Ab2, NPTII, GUS, and CP4 EPSPS so assess similarity to allergens and identify immunologically relevant peptides. Comparisons were conducted using public databanks containing allergen sequences and failed to reveal significant coincidences between the sequences with that of the proteins analyzed. As far as toxicity is concerned, similarity of biologically relevant sequence with a known toxin (that is to say, the sequence apparently derived from a common ancestor gene) may indicate that additional toxicologic assessments are necessary. Homology is determined by criteria published to find the degree of similarity of amino acids among proteins. The results obtained with proteins Cry1Ac, Cry2Ab2, NPTII, GUS and CP4 EPSPS show that there are no sequence similarities with toxins that may impact the alimentary safety of MON 15985 x MON 88913 corn. Therefore, proteins Cry1Ac, Cry2Ab2, and CP4 EPSPS record no similarity of amino acid sequences with allergens such as gliadins, glutenins or toxic proteins that may harm mammals, which is relevant from the viewpoint of alimentary safety. Cotton may be consumed in natura (seed) by ruminants or in food (cotton seed oil) and processed ration. The records show that cotton MON 15985 x MON 88913 is held at the same level of safety than conventional cotton and, therefore, the use in the abovementioned forms as food or ration would not imply greater risk than that of conventional cotton. IV. Environmental Aspects Applicant mentions, in its submission, that cotton MON 15985 e and cotton MON 88913, already approved by CTNBio, exhibit results that corroborate the results found for MON 15985 x MON 88913 cotton. The results show that MON 15985 x MON 88913 cotton, as well as its parental events, fail to display greater potential as an invading plant when compared with conventional cotton. This conclusion is based on studies carried out in Brazil and the United States and on experimental evidences involving: phenotypic and agronomic characteristics, and ecologic interactions that evidence that MON 15985 x MON 88913 cotton is not a potential cause of negative impacts to the environment nor becoming a weed; assessment of the impact on non-target organisms showing that MON 15985 x MON 88913 cotton, as well as its parental events, fails to cause adverse effects on such organisms in the culture conditions of use. Cotton belongs to genus Gossypium, and the known germplasm may be divided into sylvan and cultivated species, diploid species (2n= 2X=26) and tetraploid (2n=4x=52) and species able and unable to produce textile fibers. Four species of agronomic importance possess commercially valuable fibers, out of which two (Gossypium arboreum and Gossypium herbaceum) are European diploid species and two (Gossypium barbarensis and Gossypium hirsutum) are New World allotetraploid species. The cotton variety used as the recipient of gene cp4 epsps to generate MON 88913 was Coker 312. This is a traditional variety of high ground cotton (Gossypium hirsutum) that was used to generate MON 1445 cotton, MON 531 cotton and MON 15985 cotton. Three species of cotton may be found in Brazil: Gossypium hirsutum L., Gossypium barbadensis L. and Gossypium mustelinium (Miers & Watt). Gossypium hirsutum is represented by two exotic races: the first is Gossypium hirsutum r. latifolium Hutch, native of Mexico and introduced through the United States, widely cultivated in the country and is present almost exclusively under the form of cultivars. The second race is Gossypium hirsutum r. marie galante (Watt) Hutch, known as mocó, or arboreal, cotton, originated in the Antilles and brought to the country by the Dutch or by Africans during colonial times. Species Gossypium barbadensis, that has its domestication center in the Northern Peru and South of Ecuador, was introduced by pre-Columbian peoples, and its use as a textile plant widened before its decadence with the dissemination of the two Gossypium hirsutum races. This species is not found in natural environments and is maintained basically as a backyard plant. The plant is largely distributed, present in almost the whole of the country and its in situ conservation is directly linked to maintenance of use traditions as a medicinal plant. The only active species in Brazil is Gossypium mustelinum, with natural distribution restricted to the semi-arid Brazilian Northeast. Just three small populations are known, two in Bahia and one in Rio Grande do Norte, and the aggregate number of adult plants of all such populations is below two hundred. All species of such cotton found in Brazil are sexually compatible and crossings are mediated by pollinating insects. In the absences of complete sexual barriers, geographic segregation among cultivars and the populations one wishes to protect has been used to reduce the likelihood of such crossings. The United States and Australia used this strategy to avoid occurrence of gene flow between sylvan populations and genetically modified cultivars of cotton. The measure proved to be efficient, since no record of transgene transfer has been, neither its introgression has been reported up to this moment. In Brazil, “Transgenic Cotton Plants Exclusion Zones for preservation of species of Gossypium (native and naturalized)” have been set by Embrapa Algodão Communiqué nº 242 and MAPA Directive nº 21/2005 (Brazil, 2005). These exclusion zones for cultivation of genetically modified cotton contemplate the locations where they occur and feral populations of Gossypium hirsutum r. marie galante (mocó cotton) and Gossypium mustelinum are distributed. Eventual and potential risks to the environment were considered and analyzed, in addition to issues related to distribution of the sylvan form of endemic Gossypium mustelinum in the south of Rio Grande do Norte and Northeast of Bahia, or sub-spontaneous forms of Gossypium barbadense L., in the whole Amazon region, southeastern Piauí and west of Pernambuco, and in the Atlantic Forest, comprising the following states: RN, PB, AL, SE, BA, MG and ES, in an area equivalent to the Brazilian cerrado. As mentioned above, in these areas, farming of MON 15985 x MON 88913 cotton is not recommended. The environmental consequences of pollen transfer from MON 15985 x MON 88913 cotton to other cotton plants or to other species related to Gossypium are held as minimal. This is because the limited movement of cotton pollen, due to the safety of proteins expressed in the plant and also due to the absence of any competitive advantage granted by the exogenous genes. Therefore the potential gene flow in sexually compatible species is unlikely, since the sylvan compatible species are found in few isolated areas in Brazil. Modern agriculture is an activity blamed for significant negative impacts(21,22,23) and therefore risk assessment of any GM event shall be conducted as against the impact already inherent to conventional agriculture(24,25,26). Thus, the CTNBio analysis sought assessing whether environmental impact caused by MON 15985 x MON 88913 cotton is significantly more harmful than the one caused by conventional cotton varieties considering the agriculture practices associated to each system. All species of genus Gossypium have perfect flowers. Fecundation takes place right after anthesis, and self-fecundation or crossed pollination or even both may occur. Cotton plant pollen is relatively large, ranging from 81 to 143 micra (making the grains to adhere to each other), spherical in format, covered by a large amount of spicules, practically not prone to be transported by the wind(27). In the field, its viability extends up to the end of the afternoon, though it may last for 24 hours if kept at temperatures from 2o to 3oC(28). Cotton is usually held as a partial crossed pollination culture, although many developers treat this plant as if it were completely self-fertile and self-pollinating, except for crossed pollination through pollinating insects. One publication shows that the cotton plant features an reproductive system that is intermediate between allogamous and autogamous plants, with pollination rates from 5% to 95%. Self-pollination is the form of hybridation that preferably occurs in cotton culture, though natural crossing may be the case(30). Production of sees ranges from 20 to 30 per fruit when crossing and self-pollination are well performed. Cotton plant flowering time may vary according to environmental conditions and variety, though in general it starts on the 50th day after emergence and extends up to 120 days or more, with the curve peak around 70 to 80 days. Procedures of self-pollination and crossing shall be developed at the most propitious time, 30 to 40 days after flowering. Genetic improvement requires controlled pollination and maintenance of purity through physical barriers or isolation by distance. Cotton pollen grains are heavy and viscous, which makes dispersion by the wind quite unlikely. Pollen transfer is carried out by insects, especially wild bees, bumblebees (Bombus sp.) and honeybees (Apis mellifera) that reach freshly open flowers. In Brazil, genetic cotton improvement programs are targeted to aggregate the most desirable features according to the seeding region, taking into account the components of agricultural production and adequacy, fiber and thread quality, as well as the product characteristics for a specific purpose. Under normal conditions, cotton fails to propagate vegetatively, but does it through bolls or seeds(29). Natural crossing may take place through pollinating insects, since there is no pollen dispersion caused by the wind. However, the reach of pollen tends to be limited among very close cotton flowers, surrounded by bee colonies. The pollen movement is small, just 1.6% of flowers receive materials from other plants. Pollinating insects are used as a tool in plant development programs to attain other varieties. One of the most important effects of crossing, referred as heterosis or hybrid vigor, may be the result of inter-specific, intra-specific and intervarietal crossings. The use of hybrid vigor in cotton proved to be interesting after the evidence that excessive introgression (self-pollination) has detrimental effects(31). The rate of natural crossing recorded in Brazil has ranged from 1% to 100% in the Northeast, and from 0% to 71% in the Center-West. Different crossing rates in regions close to each other may be explained by the presence of native forests and pollinator insects, mainly honeybees. It must be emphasized that crossing rates in the cerrado tillage, reaching around 6%. Yet in the cerrado regions, where native vegetation has wide occurrence, rates change from 19% to 42% and, in areas cultivated by small farmers, the rates are higher (45% to 62%) given forest preservation and high population of bees(26). Phenotypic and ecological assessments were conducted with MON 15985 x MON 88913 cotton and included characteristics as dormancy, vigor and germination, emergence, vegetative and reproductive stages, seed retention and interactions with diseases, insects and abiotic stress. Characteristics analyzed for samples collected in Brazil show that cotton MON 15985 x MON 88913 and control cotton are equivalent. Ability of MON 15985 x MON 88913 cotton to change into a weed when compared to the conventional control cotton was assessed in the 2008/2009 and 2009/2010 harvests, considering phenotypic and agronomic characteristics, ecological interactions, pollen morphology and viability, volunteer plants assessment and germination rates. The results of phenotypic and ecological assessments conducted in Brazil suggest that MON 15985 x MON 88913 cotton has no characteristics that may grant higher risk than conventional cotton to change into a weed or cause ecological impact. Ecological interactions also failed to show higher susceptibility or tolerance to diseases, abiotic stress and insects in MON 15985 x MON 88913 cotton. Phenotypic and ecologic data indicate that the characteristics of resistance to insects and tolerance too glyphosate that are present in cotton MON 15985 x MON 88913 fail to grant it any selective advantage, being the MON 15985 x MON 88913 cotton as safe as conventional cotton. In Brazil, the applicant has conducted assessments of phenotypic and agronomic characteristics of volunteer plants, of vigor and germination and pollen characteristics in the 2008/2009 and 2009/2010 harvests. Experiments were conducted during the 2008/2009 harvest in Sorriso/MT and Cachoeira Dourada/MG. The experimental design used was that of randomized blocks with four repetitions. Cotton MON 15985 x MON 88913 was compared with control cotton and commercial references for emergence (initial stand), vigor, first flower date, 50% flowering date, first open boll date, plant height, physiologic maturation, final stand, yield, grain yield and abundance of non-target organisms. Experiments were also conducted during the 2009/2010 harvest in Sorriso/MT and Cachoeira Dourada/MG. The experimental design was the same as for the 2008/2009 harvest and the same parameters were assessed, except for abundance of non-target organisms. The data were submitted to t test statistical analysis to compare MON 15985 x MON 88913 cotton to the control cotton at a significance level of 5%. Eight varieties of commercial cotton were taken as references, four in each seeding location. The results suggest that MON 15985 x MON 88913 cotton has no characteristics that may grant significant risk of changing into a pest plant or causing ecological impact different from that of conventional control cotton. Impact assessment on usual agronomical practices showed that cultivation of MON 15985 x MON 88913 cotton would not bring impact on cultivation and rotation practices, and even on insect and diseases management. The only difference would be the control of pest lepidopterans. Besides, the use of cotton MON 15985 x MON 88913 enables controlling a large range of grasses and large leaf pest and perennial plants through post-emergence application of the glyphosate herbicide, similar to what happens with MON 1445 and MON 88913 cottons. Regarding environmental safety, phenotypic and agronomic assessments conducted in Brazil for MON 15985 x MON 88913 cotton ratified the data previously submitted for parental events, indicating that MON 15985 x MON 88913 cotton has no characteristics that may grant a significantly changed risk of changing into a pest plant or causing an ecological impact different from that of conventional cotton. Besides, data submitted from ecologic interactions indicate that the new features present in MON 15985 x MON 88913 cotton fail to grant higher susceptibility or tolerance to diseases and abiotic stress and insects. In addition, it was proven that cotton MON 15985 x MON 88913 has no potential to adversely affect beneficial organisms, plants or non-target organisms. Safety of Cry1Ac, Cry2Ab2 and CP4 EPSPS proteins is very well characterized and widely discussed in the proceedings. As a whole, alimentary and environmental safety data of MON 15985 x MON 88913 cotton evidenced that this plant fails to impose any risk to human and animal health and to the environment when compared with conventional cotton. V. Restriction to use of the GMO and its derivatives Technical reports related to agronomic performance reached the conclusion that genetically modified plants are equivalent to conventional ones. Thus, the information suggests that genetically modified plants are not fundamentally different from the non-modified cotton genotypes, except for resistance to lepidopteran insects and tolerance to glyphosate. Besides, there is no evidence of adverse effects in the use of MON 15985 x MON 88913 cotton. Based on the foregoing, there are no restrictions to the use of such cotton and its derivatives as either human of animal food. Aimed at avoiding vertical gene flow to native or naturalized varieties, the seeding of MON 15985 x MON 88913 cotton shall obey the exclusion zones in sowing genetically modified cotton according to Embrapa Algodão Communiqué 242(32) and MAPA Directive nº 21/2005 (Brazil, 2005). The exclusion zones for sowing genetically modified cotton refer to locations where feral populations of G. hirsutum r. marie galante (mocó cotton) and G. mustelinum cotton occur and are distributed. VI. Considerations on particulars of different regions of the Country (subsidies to monitoring bodies): As established by Article 1 of Law 11450, of March 21, 2007, “research and cultivation of genetically modified organisms are forbidden in indigenous lands and areas of preservation units”, VII. Conclusion Whereas: Cotton MON 15985 x MON 88913 (Gossypium hirsutum) belongs to a well characterized species with a solid safety background for human consumption, considering Opinions issued and individually read by the members in charge of analyzing the records and that genes cry1Ac, cry2ab2, nptII, uidA and cp4 epsps introduced in this variety code for known and well characterized proteins, harmless to humans; Stacked cotton MON 15985 x MON 88913 is the result of crossing, through classical genetic improvement, of parental of genetically modified cottons MON 15985 and MON 88913, previously approved by CTNBio (MON 15985 – EPT 1832/2009; MON 88913 – EPT 2956/2011) and held as safe as conventional cotton; Centesimal composition data collected from analyses of plants cultivated in Brazil have ratified the data previously submitted for parental events and failed to show significant differences between cotton MON 15985 x MON 88913 and conventional cotton, suggesting nutritional equivalence between them and their alimentary safety; Data on agronomic and phenotypic characteristics assessed in the Brazilian environment were submitted in detail and also corroborate the previously submitted data for parental events MON 15985 and MON 88913, and failed to record any significant differences between cotton MON 15985 x MON 88913 and conventional cotton, suggesting substantial equivalence between them and their environmental safety; and Whereas 1. The levels of proteins Cry1Ac, Cry2Ab2, NPTII, GUS, and CP4 EPSPS in tissues studied are low, susceptibility to digestion in simulated gastric fluids is large and digestion is fast, there is no acute toxicity in mammals in higher doses tested for all heterolog proteins, and no similarity of sequences of such proteins were found with known allergens or toxic proteins when assessed through bioinformatics tools; 2. The genetic modification introduced in MON 15985 x MON 88913 cotton failed to result in important differences in chemical composition of nutrients, being the result within the normal variation range of conventional varieties; 3. The DNA molecule is a natural component of food, with no evidence that the molecule may have adverse effect for humans when ingested in acceptable amount of food (no direct toxic effect); 4. The applicant prepared his document based on Article 5 of Ruling Resolution nº 5 (published in the Federal Official Gazette nº 50, Section 1, pages 6 to 8, on 03.13.2008), providing on rules for commercial release of Genetically Modified Organisms and their derivatives; 5. The likelihood of a transgenic plant to become a plant pest, as well as the crossing of MON 15985 x MON 88913 cotton with other cotton species originate a plant pest is negligible; 6. Bacillus thuringiensis is a soil microorganism and exposure of living organisms and the environment to this bacterium or to any element thereof is an event of abundant occurrence in nature, with no record of significant risk for soil microbiota; 106/2013 22 29 7. Cultures of Bacillus thuringiensis are registered with Agência Nacional de Vigilância Sanitária – ANVISA under different formulations for application in thirty types of plant cultivation for alimentary use(9); 8. Biopesticides based on the toxins of Bacillus thuringiensis are widely used as an alternative for chemical insecticides, even in organic crops, for its safety for non-target organisms, providing assistance in cases where development of resistance to chemical insecticides has been detected; 9. Plants genetically modified with genes cry ov Bacillus thuringiensis and gene cp4 epsps of Agrobacterium strain CP4 have been approved by regulatory bodies in different countries, including CTNBio, with no record of adverse effects to the environment and human and animal health; 10. Enzymes EPSPS are widely distributed in nature and occur in all plants and protein CP4 EPSPS has safe background of safe consumption through its use of other genetically modified products with gene cp4 epsps; 11. Field studies conducted in Brazil on insect populations present in MON 15985 x MON 88913 cotton fields showed that abundance of non-target insects was not affected when compared to conventional cotton, evidencing the specificity of Cry to targetpests; 12. Among the benefits of using cry genes as opposed to other lepidopteran control methods are the absence of negative effects to non-target insects, mammals and human beings, the high specificity and efficiency against target-insects, the environmental degradability and safe manipulation and use; 13. Any insect-control measure that enables reducing the use of chemical pesticides shall be considered, mainly from the environmental, safety and economic viewpoints; 14. The use history of MON 15985 x MON 88913 cotton in the world is an indication that the variety is as safe to the environment and human and animal health as the conventional cotton that have been used. 15. Since 1996 transgenic cultures have been used in different countries, and over 30 million hectares are currently planted with transgenic cultures (soybeans, maize and cotton) in Brazil, which is the second world producer of GM cultures. 16. The history of transgenic cultures in Brazil during this period of time has no record of any problem to human and animal health and to the environment which may be attributed to these cultures, including transgenic cultures. It must be emphasized that the lack of negative effects from cultivating transgenic cotton plants is not a guarantee that the problems may not happen. Zero risk and absolute safety do not exist in the biological world, although there is a host of scientific information and a safe use history that enable us to conclude that transgenic plants are as safe as conventional versions. Therefore, the applicant shall conduct postcommercial release monitoring according to CTNBio Ruling Resolution nº 9. For the foregoing, and taking into account internationally accepted criteria in the process of analyzing the risk of genetically modified raw materials, it is possible to conclude that cotton MON 15985 x MON 88913 is as safe as its conventional equivalent. CTNBio considers this activity is not a potential cause of significant degradation of the environment nor harmful to human and animal health. Restrictions to the use of the GMO and its derivatives under analysis are conditioned to the provisions of CTNBio Ruling Resolution nº 09, Embrapa Algodão Communiqué nº 242 and MAPA Directive nº 21/2005 (Brazil, 2005). VIII. Bibliographic References 1. CONAB. 2012. Acompanhamento da Safra Brasileira: grãos: levantamento, maio/2012. Companhia Nacional de Abastecimento. Brasília, DF. 2. BETZ, F.S.; HAMMOND, B.G.; FUCHS, R.L. 2000. Safety and advantages of Bacillus thuringiensis-protected plants to control insect pests. Reg. Toxicol. and Pharmacol. 32:156-173. 3. PADGETTE, S.R.; RE, D.; BARRY, G.; EICHHOLTZ, D.; DELANNAY, X.; FUCHS, R.L.; KISHORE, G.; FRALEY, R.T. 1996. New weed control opportunities: Development of soybeans with a Roundup Ready® gene CRC Press, Boca Raton, Florida. 4. GIESY, J.P.; DOBSON, S.; SOLOMON, K.R. 2000. Ecotoxicological risk assessment for Roundup herbicide. Rev. Environ. Contam. Toxicol. 167:35-120. 5. FRANZ, J.; MAO, M.K.; SIKORSKI, J.A. 1997. Glyphosate: a unique global herbicide. ACS Monograph Chapter 3:27-65. 6. EPA. 1993. Re-registration Eligibility Decision (RED): glyphosate. Office of Prevention, Pesticides and Toxic Substances, U.S. Environmental Protection Agency. 7. DEFFENBAUGH, A.E.; NIEMEYER, K. 2010. Assessment of Cry1Ac, Cry2Ab2, CP4 EPSPS, NPTII, and GUS protein levels in leaf and seed tissues from Roundup Ready Flex × Bollgard II Cotton (MON 88913 × MON 15985) produced in Brazilian field trials during 2008-2009. MSL0022709/REG-09-586. 8. GREENPLATE, J.T.; MULLINS, J.W.; PENN, S.R.; DAHM, A.; REICH, B.J.; OSBORN, J.A.; RAHN, P.R.; RUSCHKE, L.; SHAPPLEY, Z.W. 2003. Partial characterization of cotton plants expressing two toxin proteins from Bacillus thuringiensis: relative toxin contribution, toxin interaction, and resistance management. J. Appl. Entomol. 127:340-347. 9. ANVISA. 2006. http://www.anvisa.gov.br/toxicologia/monografias/b01.pdf. Acesso em 15/10/2006. 10. FLAVELL, R.B.; DART, E.; FUCHS, R.L.; FRALEY, R.T. 1992. Selectable marker genes: safe for plants? Bio/Technology 10:141-144. 11. BECK, E.; LUDWIG, G.; AUERSWALD, E.A.; REISS, B.; SCHALLER, H. 1982. Nucleotide sequence and exact localization of the neomycin phosphotransferase gene from transposon Tn5. Gene 19:327-36. 12. GILISSEN, L.J.; METZ, P.L.; STIEKEMA, W.J.; NAP, J.P. 1998. Biosafety of E. coli betaglucuronidase (GUS) in plants. Transgenic Res 7:157-63. 13. HU, C.Y.; CHEE, P.P.; CHESNEY, R.H.; ZHOU, J.H.; MILLER, P.D.; O'BRIEN, W.T. 1990. Intrinsic GUS-like activities in seed plants. Plant cell rep. 9:1-5. 14. HODAL, L.; BOCHARDT, A.; NIELSEN, J.E.; MATTSSON, O.; OKK, F.T. 1992. Detection, expression and specific elimination of endogenous beta-glucuronidase activity in transgenic and non-transgenic plants. Plant Sci. 87:115-122. 15. BROOKES, G.; BARFOOT, P. 2006. Global Impact of Biotech Crops: Socio-Economic and Environmental Effects in the First Tem Years of Commercial Use. AgBioForum 9: 139-151. 16. FAO. 2004. The State of Food and Agriculture 2003-2004. Agricultural Biotechnology: Meeting the needs of the poor? Rome, FAO, 208pp. 17. NUFFIELD COUNCIL ON BIOETHICS. 2003. The use of genetically modified crops in developing countries: a follow-up discussion paper. 144 pp. http://www.agbios.com/docroot/articles/03-363-001.pdf. 18. SHEWRY, P.R.; BAUDO, M.; LOVEGROVE, A.; POWERS, S.; NAPIER, J.A.; WARD, J.L.; BAKER, J.M.; BEALE, M.H. 2007. Are GM and conventionally bread cereals really different? Trends in Food Science & Technology 18: 201-209. 19. WHO – World Health Organization. 2005. Modern food biotechnology, human health and development: an evidence-based study. 84pp. http://www.worldfoodscience.org/pdf/biotech_en.pdf. 20. BREEZE, MALI; RIORDAN, E.G.; RICHARD, K. 2010. Composition analyses of cottonseed collected from MON 15985 × MON 88913 grown in Brazil during the 2008/2009 field season. MSL0022491/REG-09-461. 21. AMMAN, K. 2005. Effects of biothecnology on biodiversity: herbicide-tolerant and insect-resistant GM crops. Trends Biotech. 23:388-394. 22. BARTSCH, D.; SCHUPHAN, I. 2002. Lessons we can learn from ecological biosafety research. J. Biotech. 98: 71-77. 23. CHAPIN, F.S.; ZAVALETA, E.S.; EVINER, V.T.; NAYLOR, R.; VITOUSEK, P.M.; REYNOLDS, H.L.; HOOPER, D.U.; LAVOREL, S.; SALA, O.E.; HOBBIE, S.E.; MACK, M.C.; DIAZ, S. 2000. Consequences of changing biodiversity. Nature 405: 234–242. 24. CONNER, A.J.; GLARE, T. E.; NAP, J-P. 2003. The release of genetically modified crops into the environment. Plant J. 33: 19-46. 25. FREIRE, E.C. 2000. Distribuição, coleta uso e preservação das espécies silvestres de algodão no Brasil. Campina Grande: Embrapa, 22p. 26. FREIRE, E.C. 2002. Viabilidade de cruzamentos entre algodoeiros transgênicos e comerciais e silvestres do Brasil. Rev. Bras. Ol. Fibras, 6: 465-470. 27. NAP, J.; METZ, P.L.J.; ESCALER, M.; CONNER, A.J. 2003. The release of genetically modified crops into the environment. Part I. Overview of current status and regulations. Plant J. 33: 1-18. 28. NILES, G.A.; FEASTER, C.V. 1984. Breeding. In: KOHEL, R.J.; LEWIS, C.F. (eds.) Cotton. American Society of Agronomy, Madison, WI. P. 201-231. 29. OOSTERHUIS, D.M.; JERNSTEDT, J. 1999. Morphology and anatomy of the cotton plant. In: SMITH, C.W.; COTHREN, J.T. (eds.) Cotton: origin, history, technology, and production. John Wiley and Sons, p. 175-206. 30. SIMPSON, D.M.; DUNCAN, E.N. 1953. Stability of cotton varieties. Agr. Jour. 45(9): 448-50. 31. TILMAN, D.; CASSMAN, K.G.; MATSON, P.A.; NAYLOR, R.; POLASKY, S. 2002. Agricultural sustainability and intensive production practices. Nat. 418: 671–677. 32. BARROSO, P.A.V.; FREIRE, E.C.; AMARAL, J.A.B. do; SILVA, M.T. 2005. Zonas de exclusão de algodoeiros transgênicos para preservação de espécies de Gossypium nativas ou naturalizadas. Campina Grande: Embrapa Algodão, 7 p. (Comunicado Técnico, 242).
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date: Not Applicable
E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Flavio Finardi
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: Monsanto Philippines
Summary of application:
A commercial variety with the Roundup Ready Flex trait (MON 88913) was developed by the traditional backcrossing of MON 88913 to a conventional cotton variety thus introgressing the Roundup Ready trait into the genetic background of the commercial conventional variety. Similarly, a commercial variety with the Bollgard II cotton trait (MON 15985) was developed by traditional backcrossing MON 15985 to a conventional cotton variety, thus introgressing the Bollgard II cotton trait into the genetic background of the commercial conventional variety.
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Date of authorization: 20/04/2011
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:
Monsanto Philippines, Inc. has 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 Department of Agriculture (DA)- Administrative Order (AO) No. 8 Part 5 for combined trait cotton product: Bollgard II (MON 15985) x Roundup Ready® Flex (MON 88913) which has been genetically modified for insect protection and glyphosate herbicide tolerance. A safety assessment of combined trait product cotton: MON 15985 x MON 88913 was conducted as per 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 the two transgenes. Review of results of evaluation by the BPI Biotech Core Team in consultation with DA-Biotechnology Advisory Team (DA-BAT) completed the approval process.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
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Authorization expiration date:
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