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OECD Unique Identifier details

SYN-IR162-4
Commodity: Corn / Maize
Traits: Lepidoptera resistance
Argentina
Name of product applicant: Syngenta Agro S.A.
Summary of application:
The maize event MIR162 confers resistance to certain lepidopteran insects through the expression of protein Vip3Aa20, besides express the phosphomannose isomerase protein, PMI, which acts as a selectable marker allowing the use of mannose as a carbon source.
The insecticidal protein Vip3Aa20 (VIP: vegetative insecticidal protein), controls Diatraea saccharalis, with a different action mechanism of Cry proteins, and also other important pests such as Helicoverpa zea and Spodoptera frugiperda.
Regarding genetic stability, both genes segregate according to Mendelian rules of inheritance for a single genetic locus. Moreover, the insert of the MIR162 event shows stability over multiple generations.
The Vip3Aa20 protein has approximately 89 kDa of molecular weight and is composed by 789 amino acid of length. The concentration of the protein is between 34,3 and 91,5 µg/g of dry weight approximately. PMI has approximately 42,8 kDa of molecular weight and 391 amino acids of length. The concentration of the protein is between 2,3 and 8,7 µg/g of dry weight approximately.
The compositional analysis was carried out with the comparison of 65 key components of forage and grain. Considering the evaluation of the significant differences, the average values were inside the range of natural variation; therefore it's concluding they have not a biological significance.
Whereas Vip3Aa20 protein doesn't have similarity with allergenic proteins, the other protein of new expression, PMI, was similar (identity window of 8 aminoacids) to the α-parvalbumin of frog (Rana sp.). However the reaction with serum from an allergic patient was negative, therefore this similarity is not considered as biologically significant. Both proteins of new expression don’t have similarity with toxic proteins, have rapid degradation in SGF (simulated gastric fluid) and are unstable to 65°C or to higher temperatures.
The event MIR162 is substantial and nutritionally equivalent to its non transgenic counterpart, the parental line and conventional varieties.
With the information exposed and having into account the current scientific knowledge available there were no objections to approve the event MIR162 for human and animal consumption.
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Date of authorization: 28/09/2010
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Please see decision document weblinks
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: Principles for the Assessment of Food and Feed derived from GMO in Argentina - Resolution Nº 412
Decision document of food/feed safety assessment of event MIR162
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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.
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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)
Australia
Name of product applicant: Syngenta Seeds Pty Ltd
Summary of application:
Corn line MIR162 has been genetically modified to be resistant to a number of lepidopteran pests of corn, including fall armyworm (Spodoptera frugiperda), corn earworm/cotton bollworm (Helicoverpa zea), black cutworm (Agropis ipsilon) and western bean cutworm (Striacosta albicosta). Protection is conferred by the expression in the plant of the bacterially-derived vip3Aa20 gene, which produces the insecticidal protein Vip3Aa20, a variant of the native insecticidal Vip3Aa1 protein. A selectable marker gene, pmi, encodes phosphomannose isomerase and allows transformed cells to utilise carbon from phosphomannose media.
Unlike Syngenta’s Bt11 corn varieties, MIR162 has no insecticidal activity against European corn borer (Ostrinia nubilalis). The insect protection of MIR162 will be combined with Bt11 by conventional breeding. In regions where corn rootworm infestations are problematic for growers, these two traits will also be combined with Syngenta’s trait, MIR604, which has been genetically modified to be resistant to Western corn rootworm (Diabrotica vigifera vigifera), Northern corn rootworm (Diabrotica berberi), and Mexican corn rootworm (Diabrotica vigifera zeae). Both the Bt11 and MIR604 traits have previously been assessed by FSANZ and food derived from these lines approved for human consumption.
Bt-based formulations are widely used as biopesticides on a variety of cereal and vegetable crops grown organically or under conventional agricultural conditions. Several registered Bt-based microbial pest control products contain Vip3Aa or Vip3Aa-like proteins and it is likely that small quantities of these proteins are present in the food supply.
The majority of grain and forage derived from corn is used in animal feed. Corn grain is also used in industrial products, such as ethyl alcohol by fermentation and highly refined starch by wet milling.
Corn is not a major crop in Australia or New Zealand. Domestic production of corn in
Australia and New Zealand is supplemented by the import of a small amount of corn-based products, largely as high-fructose corn syrup, which is not currently manufactured in either Australia or New Zealand. Such products are processed into breakfast cereals, baking products, extruded confectionery and food coatings. Other corn products such as cornstarch are also imported and used by the food industry for
the manufacture of dessert mixes and sauces. Corn may also be imported in finished
products such as corn chips and canned corn, or dry milled goods such as cornflour.
Corn line MIR162 will be grown in North America and is not intended for cultivation in
Australia or New Zealand. Therefore, if approved, food from this line may enter the Australian and New Zealand food supply as imported food products.
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Date of authorization: 12/02/2009
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment:
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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: Application A1001 - Food derived from Insect-protected Corn Line MIR162
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Authorization expiration date:
E-mail:
janet.gorst@foodstandards.gov.au
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Janet Gorst
Website:
Physical full address:
Boeing Building, 55 Blackall Street, Barton ACT 2600, Australia
Phone number:
+61 2 6271 2266
Fax number:
+61 2 6271 2278
Country introduction:
Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island. The Food Standards Australia New Zealand Act 1991 establishes the mechanisms for the development and variation of joint food regulatory measures and creates FSANZ as the agency responsible for the development and maintenance of a joint Australia New Zealand Food Standards Code (the Code). The Code is read in conjunction with corresponding NZ and State & Territory food legislation as well as other appropriate legislative requirements (e.g. Trade Practices; Fair Trading). Within the Code, Standard 1.5.2 deals with Foods produced using Gene Technology. Applicants seeking to have a GM food approved, request a variation to Std 1.5.2 to have the GM food (from a particular line) included in the Schedule to Std 1.5.2. Only those GM foods listed in the Schedule can legally enter the food supply. An Application Handbook provides information that is required to make an application to vary the Code. This Handbook is a legal document and therefore the specified mandatory information must be supplied. For GM foods, there is also a Guidance Document that, as the name suggests, provides applicants with further details and background information on the data needed for the safety assessment of GM foods. The assessment process must be completed within a statutory timeframe (9 - 12 months depending on the complexity of the application) and involves at least one public consultation period. All GM applications involve an Exclusive Capturable Commercial Benefit i.e. applicants are required to pay a fee (outlined in the Application Handbook). Following the last public consultation, an Approval Report is prepared and is considered by the FSANZ Board who make a decision about whether the requested variation to the Code should be approved or not. The Board's decision is then passed on to the Legislative and Governance Forum on Food Regulation (the Forum), a committee comprising senior goevernment Ministers from Australia and NZ. This Committee has approximately 2 months to review the Board's decision. If the Board's approval is accepted by the Forum, the approval is then gazetted and becomes law.
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Relevant documents
Stacked events:
FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)
Brazil
Name of product applicant: Syngenta Seeds Ltda.
Summary of application:
Commercial release for genetically modified insect resistant corn (Zea mays), namely MIR 162 Corn,
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Date of authorization: 10/09/2009
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for Environmental Risk Assessment
Summary of the safety assessment:
Syngenta Seeds developed MIR 162 corn to offer a corn genotype that is resistant to insect of the Lepidoptera class. For this purpose, the company inserted in the corn genome gene Vip3Aa, which is a protein from Bacillus thuringiensis highly toxic to Helicoverpa zea, Spodoptera frugiperda, Agrotis ipsilon, Ostrinia nubialis and Striacosta albicosta. The insertion had no effect in changing the potential behavior of transformed corns to become more invasive than untransformed hybrids, as evidenced by successive field essays where genetically modified corns were compared with conventional corns. The transformation was mediated by Agrobacterium tumefasciens in immature embryos of corn. The transformation method via Agrobacterium is efficient to the development of transformers containing simple inserts with a low number of copies. The method enables integration of DNA including left and right borders of the transformation plasmid to the target genome, while genetic elements beyond the plasmid borders are not inserted. Among the mentioned sequences, a cassette containing genes Vip3Aa19 and PMI, the promoter of corn polyubiquitin (ZmUbiINT) and 35S of CMV and region 3’ of nopaline synthase polyadenylation. Analyses by Southern and sequencing revealed that the T-DNA contains: I- a single copy of Vip3Aa; II- two copies of ZmUbiINT promoter; III- One copy of NOS terminator; and IV- No sequence of plasmid pNOV1300. Sequential analysis demonstrated two changes in the original sequence of Vip3Aa gene: one silent and another that had as consequence a substitution of one amino acid in the original sequence of Vip3Aa. For this reason, the sequence inserted in the corn was called Vip3Aa20. The transfer of T-DNA failed to interrupt any gene in the corn genome and no new ORF was created by the insertion. The genes inserted segregate in a Mendelian way that remained stable in successive generations, as analyzed. MIR 162 corn also expresses gene manA, obtained from the bacterium Escherichia coli K-2, codifying enzyme phosphomannose isomerase that interconverts mannose-6-phosphate/fructose-6-phosphate, enabling the bacterium to use mannose as a carbon source or, in humans, its importance stems from generating substrata to glycosylation reactions typical of the eukaryotic cell. The gene, introduced in plants, hinders depletion of phosphate sequestered as mannose-6-phosphate that is accumulated when mannose is added to the culture medium, and is a versatile and safe marker to identify transformed cells in plants(44), enabling the selection of plant cells that express the gene in a medium containing mannose as substratum. Bacterium Agrobacterium tumefaciens was used carrying plasmid pNOV1300 with two cassettes of expression: the first containing corn promoter ZmUBiInt, the optimized codifying region of peptide vip3Aa of Bacillus thuringiensis followed by a region containing intron 9 of corn phospoenopyruvate carboxylase (for increased gene expression), ending with terminator region 3’UTR 354S of the cauliflower mosaic virus. The second cassette of expression is formed by corn ZmUBiInt, the codifying region comprising gene manA of Escherichia coli that codifies protein phosphomannose isomerase (PMI), followed by the 3’UTR region of the nopaline synthase gene of Agrobacterium tumefaciens. The constructs were described in detail and have been thoroughly verified by sequencing. The transgenic corn genome was assayed by Southern blot, using total DNA digested by different restriction enzymes and probes corresponding to four regions of the constructs used, confirming the presence of one copy of each cassette in their genome. Insertion took place in region 5.03 of corn chromosome 5 and displayed Mendelian inheritance with phenotypic and molecular stability over three generations. Genomic regions outflanking the cassettes failed to interrupt any corn gene. The commercial construct was generated by crossing with public lineages of American corn germplasm selected (in the United States) for their agronomic performance and insect resistance. Studies of biosafety, agronomic efficiency and insect resistance were conducted in the field (planned release into the environment) in about seventeen occasions in Brazil, countless tests in the USA and about 10 releases conducted in Argentina. Expressed proteins originated by genetic modification of MIR 162 corn, Vip3Aa20 (Vip) and phosphomannose isomerase (PMI), were assayed by ELISA. Vip ranged from 4.34 of dry weight (DW) on the leaf at the moment of senescence at 184.05 μg/g DW in styli and stigmas. In the corn kernel, the main part directed to human and animal consumption, the highest value recorded was 61.33 μg/g DW. PMI protein levels were lower, reaching a maximum of 7.06 μg/g DW in leaves at the anthesis stage. A variant of protein Vip3Aa20 (Vip3Aa19, which differs in one amino acid) was already approved for human and animal consumption in the USA in 2005 (in this case, a genetically modified cotton). Proteins of the same family are already used in commercial formulations of insecticides based on Bacillus thuringiensis proteins. ANVISA already authorizes cultures of this bacterium in 32 types of food cultures, and the formulations belong to toxicologic group IV, unrestricted for maximum level of residue and safety interval. In turn, protein PMI is produced by a wide range of organisms (vertebrates and microorganisms) and is the enzyme of sugar metabolism. Horizontal gene flow between MIR 162 corn and other corn species, even those closely related, is practically unlikely to occur, since wild species related to corn are not native to Brazil. Coexistence between of conventional corn cultivars (either improved or creole) and transgenic corn cultivars is possible from the agronomic viewpoint, and therefore the provisions of CTNBio Ruling Regulation nº 4 shall be observed. Use of insect-resistant genetically modified plants has positive effects also in aspects related to obtaining, distributing and using chemical insecticides, since it reduces significantly the pollution caused by industrial waste and utilization of water used in spraying, in addition to avoiding contamination of man, food, rivers and wellsprings resulting from the use, transportation and storage of insecticides. Hence, one may conclude that cultivation and consumption of MIR 162 corn is not a potential cause of significant degradation of the environment; nor a risk to human and animal health. For the above reasons, there are no restrictions to the use of such corn and its derivatives. Therefore, applicant shall conduct the post-commercial release monitoring according to CTNBio Ruling Resolution nº 3. As established by Article 11 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” Under Article 14 of Law no. 11,105/2005, CTNBio found that the request complies with the applicable rules and legislation securing the biosafety of environment, agriculture, human and animal health. Taking into consideration criteria internationally accepted in the process of assaying genetically modified raw-materials one may conclude that MIR 162 corn is as safe as its conventional counterpart. Under Article 14 of Law no. 11,105/2005, CTNBio found that the request complies with the applicable rules and legislation securing the biosafety of environment, agriculture, human and animal health and reached a conclusion that the MIR 162 corn is substantially equivalent to conventional corn and its consumption is safe for human and animal health. Regarding the environment, CTNBio’s conclusion is that cultivation of MIR 162 corn is not a potential cause of significant environmental degradation, keeping with the biota a relation identical to that of conventional corn. CTNBio TECHNICAL OPINION I. GMO Identification GMO designation: Insect-resistant genetically modified corn, MIR 162 corn. Applicant: Syngenta Seeds Ltda. Species: Zea Mays L. Inserted characteristics: Resistance to insects. Method of insertion: Transformation of immature embryos through bacterium Agrobacterium tumefaciens Prospective use: Production of grain from the GMO and its derivatives for human and animal consumption. II. General Information Corn, (Zea mays L. ssp mays) belongs to the Gramineae family (Poaceae), sub-family Panicoidae, tribe Maydeae, genus Zea and species mays. It is a diploid plant, with 2n=20 chromosomes, displaying therefore ten pairs of chromosomes. Fecundation rate is normally lower than 5%, being an allogamic species with its pollination predominantly done by the wind (Marcos Filho, 2005). The Maydaea tribe is characterized by its monoecism, that is to say, their flowers are unisexuated, generally in male and female inflorescences, separated in the same plant. In botany, corn came to be Zea mays L. ssp Mays and teosinte (the plant that originated corn), Zea mays, having as subspecies: Zea mays L. ssp mexicana, Zea mays parviglums, Zea mays ssp. luxurians, Zea mays ssp. diploperennis. Except for Zea mays ssp. diploperennis, all teosintes are annual plants. There is still another perennial teosinte, the tetraploid 2n=4n=40 chromosomes: Zea mays ssp. perennis(36). However, in Brazil, other species of teosinte are not farmed. Corn, Zea mays L. is a monoic annual plant with height ranging from 1.0 to 4.0 meters(47). The main stem is formed by clearly defined nodes and internodes. Internodes are wide at the base and gradually diminish until the inflorescence at the plant's higher part. Corn leaves alternate along the stem. Corn is the only grassy plant that has both male and female flower structures in the same plant, though located in different places(27). Corn has a history of over eight thousand years in the Americas, and is cultivated since the pre-Columbian era. Among higher plants, corn is the best scientifically characterized and is currently the cultivated species that reached the highest degree of domestication and is unable to survive in nature but when cultivated by man(1). There are currently over 300 identified varieties of corn and, within each such variety, thousands of cultivars. Corn (Zea mays) is one of the most commercially cultivated plants in the world, and about 150 million hectares of corn are sowed each year, contributing for an output of 700 million tons of grain(15,4). The species has been directly used for some centuries in the feeding of humans and domestic animals, and its importance is not restricted to the large annual production but also to the important social and economic role it plays. Corn is one of the most important food sources in the world and is held as input for production of a wide range of food products, rations and industrial products. Brazil is the third largest world producer of corn, with a yield of about 35 million tons in 2005, following the United States of America (282 million tons) and China (139 million tons)(17). Corn is the second most planted culture in Brazil and is cultivated practically in two harvests (summer and safrinha, the second crop) and is cultivated practically all over the Brazilian territory. The largest production is in the Center-South region, representing about 75.68% of the planted area, while the North-Northeast is responsible for about 24.32%. Regarding production, corn is second in a roll of the largest Brazilian cultures, second only to soybeans)(9). Brazil is a large world producer of corn, but it has also a significant consumption of this grain. National consumption is so high that an absence of the second crop would cause the need to import corn to meet national demand. The fall armyworm is considered the most important corn pest in Brazil(10). Controlling the fall armyworm is difficult for the wide range of hosts it has and its wide dispersion during the cultivation period. During the twenties, presence of this pest was reported in several Brazilian states, severely damaging some cultures. Helicoverpa zea (Lepidoptera: Nuctidae) is held as damaging to corn culture in three different ways: attacking corn stigmas, hindering fertilization and consequently causing the culture to fail; feeding from milky grains and destroying them; and, finally, for the bores left by worms in the corn ear at their pupal stage, that are a door open to microorganisms that are a cause of corn rot(21). Another pest that has frequently caused damages to the corn crops, mainly in the central region of Brazil is the stalk borer Diatraea saccharalis (Lepidoptera: Pyralidae), an important sugarcane pest(46). MIR 162 corn contains gene Vip3Aa20 that codifies protein Vip3Aa20, granting resistance to the attack of certain lepidopteran pests as, for instance, the armyworm, and gene manA that codified enzyme phosphomannose isomerase (PMI), used as a selection marker during the transformation process. MIR 162 corn was already approved for commercial release in the United States, Australia and Taiwan. Gene Vip3Aa, is also present in the transgenic stacked corn Bt11 x MIR 162, approved in the United States, and transgenic cotton event Cot 102, approved in the United States and in Australia. III. Description of GMO and Proteins Expressed Syngenta Seeds developed MIR 162 corn to offer a corn genotype resistant to lepidopteran class insects. Therefore, the company inserted in the genome of corns gene Vip3Aa, which is a protein of Bacillus thuringiensis highly toxic to: Helicoverpa zea, Spodoptera frugiperda, Agrotis ipsilon, Ostrinia nubialis and Striacosta albicosta. The insertion failed to have any changing effect on potential behavior of the transformed corns towards becoming more invasive than the untransformed hybrids, as evidenced by successive field assays comparing GM corns with conventional ones. The transformation was mediated by Agrobacterium tumefaciens in immature corn embryos. The Agrobacterium transformation method is efficient to develop transformers containing simple inserts with a low number of copies. The method enables integrating the DNA, introducing the right and left borders of the transformation plasmid in the target genome, while genetic elements beyond the plasmid borders are not inserted. Among the mentioned sequences, a cassette was introduced with genes Vip3Aa and PMI, the promoter of corn polyubiquitine (ZmUbiINT) and 35S of CMV in region 3' of nopaline synthase polyadenylation. Analyses by Southern blot and sequencing revealed that the T-DNA contains: I- a single copy of Vip3Aa; II- two copies of ZmUbiINT promoter; III- One copy of NOS terminator; and IV- No sequence of plasmid pNOV1300. Sequential analysis demonstrated two changes in the original sequence of Vip3Aa gene, one silent and another that had as consequence substitution of one amino acid in the original sequence of Vip3Aa. For this reason, the sequence inserted in the corn was called Vip3Aa20. The transfer of T-DNA failed to interrupt any gene in the corn genome and no new open reading frame (ORF) was created by the insertion. The genes inserted segregate in a Mendelian way that remained stable in successive generations, as analyzed. The native protein Vip3Aa1 from Bacillus thuringiensis strain AB88 contains 789 amino acids and a molecular weight of about 89 kDa. Variant Vip3Aa20 produced in MIR 162 corn also displays 789 amino acids, but differs in two amino acids when compared with the native protein (positions 129 and 284). Variant Vip3Aa19 differs from the native protein in one amino acid in position 284 and from Vip3Aa20 in one amino acid in position 129. Vip3Aa19 and Vip3Aa20 are denominations used for two variants that are genetically modified starting from the native protein, defined by the nomenclature Committee of toxins originated from Bacillus thuringiensis . Bacillus thuringiensis, a gram-positive soil bacterium that produces different proteins acting as toxic to certain types of insects, known as Cry and Vip (from “Vegetative Insecticidal Proteins”) proteins(14). Differently from crystal proteins (Cry) from Bacillus thuringiensis, Vip proteins are produced during the bacterial vegetative development and are secreted as proteins soluble in the extra-molecular medium. Bacillus thuringiensis cultures keep producing the Vip protein during the stationary and sporulation phases of development. Compared to the non-proteinaceous thermostable ƒÒ-exotoxins secreted by strains of Bacillus thuringiensis, Vip proteins are thermolabile(28). Vip3a is the name used for native proteins found in the AB88 strain of Bacillus thuringiensis . MIR 162 corn also expresses gene manA obtained from bacterium Escherichia coli K-12 codifying enzyme phosphomannose isomerase that interconverts mannose-6-phosphate/fructose-6-phosphate enabling the bacterium to use mannose as a carbon sources or, in human beings, it is important by generating substrates for glycosylation reactions typical of the eukaryotic cell. This gene, when introduced in plants, hinders depletion of phosphate sequestrated as mannose-6-phosphate accumulated when mannose is added to the culture medium, being a versatile and safe marker to identify transformed cells in plants(44), enabling selection of plant cells that express it in a medium containing mannose as a substrate. Bacterium Agrobacterium tumefaciens was used carrying plasmid pNOV1300 with two cassettes of expression: one having corn promoter ZmUBiInt, the optimized codifying region of peptide vip3Aa of Bacillus thuringiensis, followed by the region containing intron 9 of corn phosphoenolpyruvate carboxylase (to increase gene expression), ending with the termination region 3’UTR of the cauliflower mosaic virus. The second expression cassette is formed by corn ZmUBiInt, the codifying region constituted by manA gene from Escherichia coli that codifies protein phosphomannose isomerase (PMI), followed by region 3’UTR of gene nopaline synthase of Agrobacterium tumefaciens. The constructs are described in detail and were carefully checked by sequencing. The transgenic corn genome was analyzed by Southern blot using total DNA digested by several restriction enzymes and probes corresponding to four regions of the constructs used, confirming the presence of one copy of each cassette in the genome. Insertion took place in region 5.03 of corn chromosome 5 and showed Mendelian inheritance with phenotipical and molecular stability for three generations. The commercial construct was generated by crossing with public lineages of American corn germplasm selected (in the United States) for their agronomic performance and insect resistance. Studies of biosafety, agronomic efficiency and insect resistance were conducted in the field (planned release into the environment) in about seventeen occasions in Brazil, countless tests in the USA and about 10 releases conducted in Argentina. Expressed proteins originated by genetic modification of MIR 162 corn, Vip3Aa20 (Vip) and phosphomannose isomerase (PMI), were assayed by ELISA. Vip ranged from 4.34 μg/g of dry weight (DW) on the leaf at the moment of senescence at 184.05 μg/g DW in styli and stigmas. In the corn kernel, the main part directed to human and animal consumption, the highest value recorded was 61.33 μg/g DW. PMI protein levels were lower, reaching a maximum of 7.06 μg/g DW in leaves at the anthesis stage. A variant of protein Vip3Aa20 (Vip3Aa19, which differs in one amino acid) was already approved for human and animal consumption in the USA in 2005 (in this case, a genetically modified cotton). Proteins of the same family are already used in commercial formulations of insecticides based on Bacillus thuringiensis proteins. IV. Aspects Related to Human and Animal Health The effect of protein Vip3Aa20 in 10 species of non-target organisms was assayed using parts of corn plants that accumulated either protein Vip3Aa20 or Vip3Aa19(12). These proteins differ from each other by a single amino acid in position 129. The difference, however, does not change the action of the protein in its final form: the position is outside the tryptic cleavage site and the region of the final peptide that has cytotoxic function (cleavage of the initial peptide is made at position 199). In all cases, corn samples were tested with a knowingly sensitive species of insect to ascertain the presence of VIP proteins at toxic levels. Essays with water fleas, ladybugs, chrysops (both larvae and adults), earthworms, catfish, bees and bugs failed to reveal significant differences among control groups and groups treated with plants containing Vip3Aa20 or Vip3Aa19(33,8). Filed essays assessed the permanence, dominance, abundance and frequency of insect species collected in MIR 162 corn and conventional corn fields. There were no significant differences observed between the two groups. Stability of Vip3Aa20 in soil was estimated based on essays using soils from different Brazilian regions and a sample of USA soil to which protein Vip3Aa19 extracted from corn was added. Mortality of lepidopteran Agrotis ipsion exposed to the soil containing the protein enabled a conclusion that the protein half life ranged from 6.6 days (soil from Matão, State of São Paulo) to 12.6 days (soil from Cascavel, State of Paraná). Therefore, the conclusion is that the protein is biodegradable and does not accumulates in the soil. Protein expressed by gene manA (PMI) on corn is also present in plant and animal products and therefore appears normally in low concentrations in the alimentary chain. The human homologue of PMI has its gene expressed in all tissues examined, with maximum levels in the brain, heart and skeletal muscle(37). Due to the low quantity of exogenous proteins in MIR 162 corn, both proteins were expressed in Escherichia coli to produce an amount for toxicological studies. Proteins produced in the bacterium were biochemically and functionally analyzed and were found identical to the proteins produced in the plant. Allergenicity: Studies in silico failed to reveal any allergenicity potential in heterologous proteins expressed in MIR 162 corn. Parameters used as inidicators of allergenic potential were: not less than 30% of identity with a window of 80 amino acids or full identity of not less than 8 contiguous amino acids. Nothing was found regarding VIP, but as far as PMI is concerned, there was some similarity with a frog allergenic peptide. However, an analysis containing serum of a patient who was allergic to the protein showed that the patient’s antibodies were not recognized by the corn protein(24). Potential toxicity: Analyses in silico examine structural similarities to knowingly toxic proteins resulted in negative response for proteins Vip3Aa20 and manA. Digestibility: Using simulated intestinal juice with pancreatin (SIF) and simulated gastric juice containing pepsin (SGF), protein Vip3Aa20p was degraded both in SIF and SGF. Phosphomannose isomerase (PMI), a product of the manA gene was even more sensitive to degradation by SIF and SGF. Besides, there is a history of safe use of Vip3a proteins in formulation of bioinsecticides that use preparations of Bacillus thuringiensis without genetic manipulation. Raw data on digestibility were requested by one of the ad hoc opinion authors and confirmed the original report, though the opinion author considers the digestion of VIP to be partial, since there is a persistent band after treatment with SGF. The same author examined the charts and clarifies: in gel stained for total protein, at one minute of digestion, the intact band of VIP protein (between phosphorilase, 98 kDa and BSA, 62 kDA) it disappears completely, yet a band of ~38 kDa (aligned with the alcohol dehydrogenase marker) persists and weakens gradually until disappearance after 60 minutes of incubation. Since this band seems identical to another band with the same degradation kinetics and present in SGF without addition of recombinant protein, the band is irrelevant. This interpretation is corroborated by the analysis of Figure 2 that now shows the specific detection of the VIP protein using a specific polyclonal antibody. In this case, after one minute just a fragment of ~8 kDA is detectable (above the aprotinine pattern, 6 kDa) that becomes less intense until almost disappearing after 60 minutes of incubation. It shall represent a peptide resulting from the pepsin action and that keeps one of the epitopes recognized by the polyclonal antibody. The same may be said for VIP expressed by plants. In this case only results with Western blot are useful, since the proportion of this protein that is naturally present in plant material is very low. In the Western blot submitted, the first minute shows a band between 49 and 62 kDa and a band in 8 kDa. In subsequent essay times, the higher band disappears while the 8 kDa persists. The presence of a large amount of protein in the plant may be delaying digestion and enabling visualizing a product that is a degradation intermediary (~55 kDa band) and later disappears. Raw data were examined in essays with PMI protein and one may notice a strong PMI band in the sample without pepsin (0X), a band that disappears even in time zero and in two minutes of incubation, confirming the information of high sensitivity of this protein to SGF. One may notice a weak PMI band in time zero with just high dilution of the enzyme (0.001 x). The kinetic loss of the PMI enzymatic activity was measured in SGF with 0.001 x pepsin. In five minutes, activity drops to 50% and in ten minutes activity is almost none (Figure 4). Under treatment with simulated intestinal fluid (SIF – pancreatinin), the PMI band (staining for total protein) totally disappears with 1 x of pancreatinin. With 0.1 x, degradation is visible after two minutes and with higher dilutions it persists apparently intact. The ad hoc advisor that requested the raw data seems concerned with residual bands in the VIP + pepsin experiment. The specialist punctuated her opinion towards increasing precision of the applicant company that has not always supplied the full captions in the figures submitted, some low-resolution figures, in addition to recommending clarification of abbreviations and additional information deemed necessary. Lack of clarification on molecular size of patterns in some figures was solved by consultation to the Invitrogen site of the Internet, which offers apparent molecular sizes in different electrophoresis tampons. It is worth noticing that simulated digestion mimics only partially what the protein will really undergo in the digestive tract: pepsin is not in effect completely degraded and it cleavages the protein where there is tyrosine, phenylalanine and tryptophan, generating polypeptides. These polypeptides pass to the duodenum where there are pancreatic enzymes, such as trypsin, that will break the polypeptides alongside residues of lysine and arginine and other enzymes, such as chimiotrypsin and carboxypeptidases. In the intestine, existing peptides will be additionally degraded by peptidases and the resulting amino acids will be absorbed. However, degradation of these proteins in a real situation will be unquestionable and complete. Acute toxicity: A study was conducted in mice by ingestion of a maximum level of 1250 mg/kg of Vip3Aa20 in a single dose repeated after some hours. After fifteen days the animals were sacrificed and histopathologically examined. There was not any detectable effect with this concentration. For protein PMI, 3030 mg/kg were used in a single dose and mice examined after fifteen days. Again, there was no detectable toxic effect. A detailed description of the toxicity exams was not submitted and one of the ad hoc consultants requested the pertinent information, which were delivered by Syngenta as confidential information (a 32 page document). Syngenta states that the study involved thirteen male and 11 female mice. Organs weighted were the liver, brains, kidney and spleen. Observable clinical signs included skin, fur, eyes, mucosa, somatomotor activities, behavior, salivation, diarrhea, numbness, lethargy and comatose states. Raw data submitted confirm and document the initial description, showing an absence of toxicity in the high doses tested. The ad hoc advisor examined the raw data and concluded for the low oral toxicity of the substance tested. The objection concerned to the use of maximum dose of protein VPI (1250 mg/kg) applied in two different doses in the same day), below the dose recommended by OECD 420 (2000 mg/kg) is justified by the technical impossibility of supplying such amount of recombinant protein to the animal. We shall additionally remember that the amount of VIP in the kernel (0.004% of total protein, or ~44 μg/g) means that to reach 2000 mg/kg requires ingestion of about 45 kg of kernels at one dash. It is clear that patterns shall be analyzed in the context of rational use of the product. Raw data on expression of such proteins (VIP and PMI) in the material used to assay subchronic toxicity were supplied and values informed validate the results obtained in the United States and Brazil. Effect in mammals: Tests in rats conducted for ninety days with 10%, or 45.5% corn in their diet. There was no difference between conventional and GMO MIR 162 corn and the treatment failed to induce any change that might be associated to such consume during the period. Composition: Analysis of MIR 162 compared to isogenic non-transgenic corn and other non-GM hybrids assayed minerals, amino acids, fibers, total carbohydrates, starch and fatty acids. Values were equivalent to normal variation within the range described by International Life Science Institute. As requested by one of the ad hoc advisors, information on centesimal and micronutrient analyses was delivered by Syngenta, confirming the inexistence of significant variations. Microtoxins: The maximum amount tolerated for fumonisines is 2 ppm and aflatoxins is 20 ppb. Alongside adverse effects for human and animal health, presence of microtoxins results in important economic losses. Insect-resistant transgenic corn displays a low content of microtoxins and, financially, the benefits of sowing Bt corn would reach eight billion Dollars (fumonisines) and 14 million Dollars (aflatoxins) according to Wu, 2004(48). The death of 125 individuals in Kenya, in 2004, due to ingestion of corn contaminated with aflatoxin, is sufficient to remind us of how important this consideration may be. Effect in poultry: Poultry (both male and female) were fed during 44 days comparing MIR 162, isogenic non-GMO and commercial corn. There was no difference in survival, growth and energy conversion efficiency(25). The level of heterologous proteins in plant tissues were quantified through immunoenzymatic assay (ELISA). For Vip3Aa20p the range was ~4 to ~150 μg/g of dry weight. There are no experimental evidences that MIR 162 corn is inferior to, nor that it poses any toxicological or nutritional risk for animals when compared with, conventional corn. Therefore, the modification introduced by genetic manipulation, simply promotes expression of a protein that is toxic to certain species of insects that prey on corn. It expresses a small quantity of PMI, an ubiquitous protein that is part of components in a diet of animal or microbian origin. Its lower potential of infection by fungi due to lesions of attacks from insects and lower contamination of the product with pesticides – since the bioinsecticide is expressed in the plant and is of the nature of a protein with no action on vertebrates – suggests that it has potential to exhibit higher food safety than conventional varieties. V. Environmental Aspects Corn is an allogamic and annual plant that is cross-pollinated with the help of the wind, insects, gravity and other agents. The introduction of gene elements characterized in event MIR 162 did not change the plant’s reproductive features. Therefore, the likelihood of cross pollination between hybrids and lineages of non-genetically modified corn will be the same as that of cross pollination between plants of event MIR 162 and other corn plants. In Brazil, there are no kindred species of corn in natural distribution. However, there are populations of the so-called creole corn that may cross with genetically modified corns, if planted in their vicinity. The risk of the transgene to migrate to other individuals in nature and the consequences of such migration, mainly in the context of biodiversity, is undoubtedly one of the direct effects demanding the attention in the case of transgenic plants. Gene flow may be a horizontal flow, changing genetic information between individuals of different, genetically apart, species, or vertical flow, when the migration of genetic information occurs between individuals of the same species. Gene flow in corn may occur through transference of pollen and dispersion of seeds. Dispersion of seeds is easily controlled, since corn domestication has eliminated the ancient mechanisms of seed dispersion and pollen displacement is now the only effective means of gene escape in corn plants. Corn pollen is freely dispersed close to the cultivated area, and may reach styli-stigmas of the same or different genotypes and, under adequate conditions, starts its germination, generating the pollinic tube and promoting the ovule fecundation within an average term of 24 hours. MIR 162 corn was agronomically assayed in field conditions and in nursery house in several experiments conducted in the United States, Australia, Argentina and Brazil. In such studies, several parameters were tested comparing non-transgenic isogenic genotypes. The set of such assays showed that event MIR 162 displayed an agronomic performance at least equal to its isolines, and that and no significant fenotipical difference has been observed that might grant event MIR 162 better or worse adaptability to the environment, except in what refers to resistance to pest insects of the Lepidoptera order. Applicant conducted risk assays with non-target organisms, animals and insects. Animals included twelve different species of wild birds, mammals and fish produced in captivity. Among insects, pollinators and different species of arthropods were included. Protein VIP3A was used in concentrations comparable with the ones that such animals will realistically find in environmental conditions and no adverse effects were noticed. Conclusions enable to assert that MIR 162 corn expressing protein Vip3Aa20 will not have harmful effect except for some lepidopteran species. In order to act, the toxin requires cell receptors that are not found in other species. Bioessays conducted with other non-lepidopteran species fail to reveal any adverse effect. In field conditions the low level of protein Vip3Aa20, according to Applicant, determines a condition of innocuity to non-target species. Applicant indicates that the species of non-target lepidopteran that may be intoxicated by MIR 162 is the Licaiedis Melissa samuelis, which has the habit of collecting pollen from Lupinus perenis, a species of unlikely occurrence in the vicinity of corn fields. Studies conducted to assay the effect of protein VIP3Aa in different non-target organisms such as: water animals (fish, water flea); beneficial insects (ladybug, chrysopes, bees, earwigs) and earthworms lead to a conclusion that event MIR 162 has no adverse effect on insects and other non-target organisms. Studies on protein Vip degradation conducted in Brazilian and United States soils showed that its biologic activity resisted for a range of 6 to 13 days on average, indicating that protein Vip is easily degraded in natural soils. There is no possibility of horizontal gene flow in the Brazilian territory, since there is no close relative of corn in Brazil (Teosinte and Tripsacum occur only in Central America). Vertical gene flow to local varieties (so-called creole corns) of open pollination is possible, but it has the same risk caused by commercial genotypes available in the market. Coexistence between conventional corn (either improved or creole) and transgenic corn cultivars is possible and simple from the agronomic viewpoint. From the agronomic viewpoint, coexistence between cultivars of conventional corn (improved or creole) and transgenic corn is possible. Old communities and modern farmers have learned how to live on without problems with different corn cultivars, while keeping their genetic identities along time. Based on available scientific evidence MIR 162 Corn is as safe as conventional corn varieties and may therefore be used for the same purposes. VI. Restrictions to the Use of the GMO and its Derivatives Technical opinions related to agronomic performance concluded that there is equivalence between conventional and transgenic plants. Therefore, the information suggest that transgenic plants are not fundamentally different from untransformed corn genotypes, except for their resistance to insects. Besides, there is no evidence of adverse reactions to the use of MIR 162 Corn. For the foregoing, there are no restrictions to the use of such corn and its derivatives for both human and animal food. Gene flow to local varieties (so-called creole corns) of open pollination is possible and poses the same risk caused by commercial genotypes available in the market (80% of conventional corn planted in Brazil comes from commercial seeds that underwent genetic improvement). Coexistence between conventional corn (either improved or creole) and transgenic corn cultivars is possible from the agronomic viewpoint(5,34) and shall comply with the provisions of CTNBio Ruling Resolution nº 4. As established by Article 11 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” VII. Consideration on the Particulars of Different Regions of the Country (Information to supervisory agencies) In Brazil, there are no kindred species of corn in natural distribution. As established by Article 11 of Law nº 11,460, of March 21, 2007 “research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units.” VIII. Conclusion Whereas: 1. Corn is the species that reached the highest degree in domestication among cultivated plants, and is unable to survive in nature without human intervention. 2. There are not in Brazil wild species with which corn may intercross, since the closest feral corn species is the teosinte, found only in Mexico and some places of Central America, where it may cross with cultivated corn in production fields. 3. MIR 162 Corn is as safe as conventional corn varieties and therefore may be used for the same purposes. 4. Event MIR 162 fails to display any adverse effect on the insect community and other non-target organisms. 5. Event MIR 162, expressing protein Vip3Aa20, has no harmful effect to non-target organisms, both animals and insects, except for some species of lepidopteran corn pests. 6. MIR 162 Corn is as safe as its conventional equivalent. 7. Studies on degradation of Vip protein in Brazilian and US soils showed that its biological activity remained from 6 to 13 days on average, indicating that the protein Vip is easily degraded in natural soils. 8. The set of assays showed that event MIR 162 displayed equal or better agronomic performance compared with its isolines and that no significant fenotipical difference was observed that could grant event MIR 162 better or worse adaptability to the environment, except in what concerns resistance to pest-insects of the Lepidoptera order. 9. Annex II to the Cartagena Protocol on Biosafety (Decree n 5,705, of February 16, 2006) provides that risks associated to modified living organisms or their derivatives, to wit, improved materials originated from a live modified organism containing new detectable combinations of replicable genetic material obtained through modern biotechnology, shall be considered in the context of the risks posed by non-modified recipients or kindred organisms in the likely recipient medium. 10. There is no evidence that MIR 162 corn is inferior or that it poses any toxicologic or nutritional risk to animals when compared to conventional corn. 11. Old communities and modern farmers have been successful in coexisting, along over 60 years, with no issues, with hundreds of corn cultivars available in the market, while keeping their genetic identities along time. 12. Coexistence of conventional corn cultivars (either improved or creole) and transgenic cultivars is possible from the agronomic viewpoint, indicating that the provisions of CTNBio Ruling Resolution nº 4 shall be observed. Therefore, considering internationally accepted criteria in the process of analyzing risks in genetically modified raw-material it is possible to conclude that MIR 162 corn is as safe as its conventional equivalent. In the context of the competences granted to it under Article 14 of Law nº 11,105/05, CTNBio considered that the request complied with the rules and legislation in effect that intend to guaranty environmental and agricultural biosafety and human and animal health, reaching a conclusion that MIR 162 corn is substantially equivalent to conventional corn, being its consumption safe for human and animal health. Regarding the environment, CTNBio’s conclusion was that the MIR 162 corn is not a potential cause of significant degradation to the environment, keeping with the biota a relation identical to that of conventional corn. Restrictions to the use of the GMO and its derivatives are conditioned to the provisions of CTNBio Ruling Resolution nº 03, and CTNBio Ruling Resolution nº 04. According to Annex I to Ruling Resolution nº 5, of March 12, 2009, the applicant shall have a term of thirty (30) days from publication of this Technical Opinion to adjust its proposal to the post-commercial release monitoring plan. IX. Bibliography 1. BAHIA FILHO, A. F. C.; GARCIA, J. C. 2000. Análise e avaliação do mercado brasileiro de sementes de milho. In: UDRY, C. V.; DUARTE, W. F. (Org.) Uma história brasileira do milho: valor de recursos genéticos. Brasília: Paralelo 15, 167-172. 2. BATES, S. L.; ZHAO, J. Z.; ROUSH, R. T.; et al. NATURE BIOTECHNOLOGY 23: 57-62 Times Cited: 53 Insect resistance management in GM crops: past, present and future (2005). 3. BE, CARRIERE, Y.; DENNEHY, T. J.; et al. JOURNAL OF ECONOMIC ENTOMOLOGY 96: 1031-1038 Times Cited: 125 Insect resistance to transgenic Bt crops: Lessons from the laboratory and field (2003). 4. BRANDALIZZE, V. 2005 Mercado de milho. Inc: Fancelli, A. L.; Dourado-Neto, D. (Eds.). Milho: tecnologia e produção 5. BROOKES, G.; BARFOOT, P.; MELÉ, E.; MESSEGUER, J.; BÉNÉTRIX, F.; BLOC, D.; FOUEILLASSAR, X.; FABIÉ, A.; POEYDOMENGE, C. 2004. Genetically modified maize: pollen movement and crop co-existence. Dorchester, UK: PG Economics, 20 pp. (www.pgeconomics.co.uk/pdf/Maizepollennov2004final.pdf) 6. CHAMTHIA, S. T. et al. 2008. Spore stage of vegetative insecticidal gene increase toxicity of Bacillus thuringiensis subsp. Aizawai SP41 against Spodoptera exigua. Journal of Biotechonology. 136: 310-316. 7. CHEN, J. et al. 2003. Comparison of the expression o Bacillus thuringiensis full-length and N- terminal truncated vip3A gene in Escherichia coli Journal of Applied Microbiology. 95: 310-316. 8. CHEN, M.; ZHAO, J. Z.; COLLINS, H. L.; EARLE, E. D.; CAO, J.; SHELTON, A. M. PLoS ONE. 3 (5): e 2284. A critical assessment of the effects of Bt transgenic plants on parasitoids (2008). 9. COMPANHIA NACIONAL DE ABASTECIMENTO – CONAB. 2007. Milho total (1ª e 2ª safra) Brasil – Série histórica de area plantada: safra 1976-77 a 2006-07. http://www.conab.gov.br/conabweb/download/safra/MilhoTotalSerieHist.xls 10. CRUZ, I.; CUNHA, J. R.; FIGUEREIDO, M. L.C. 2004. Avaliação de diferentes doses do inseticida Akito (betacypermetrina) sobre larvas de S. frugiperda e sobre os predadores Doru luteipes e Chrysoperla externa. In: Congresso Nacional do Milho e Sorgo, 25, Cuiabá, MT. Sete Lagoas: ABMS/ Embrapa Milho e Sorgo. 11. DOSS, V. A. 2002. Cloning and expression of the vegetative insecticidal protein (vip3V) gene Bacillus thuringiensis in Escherichia coli. Protein Expression and Purification. 26: 82-88. 12. DUTTON, A.; ROMEIS, J.; BIGLER, F. BIOCONTROL 48: 611-636 Times Cited: 51 Assessment the risks of insect resistant transgenic plants on entomophagous arthropods: Bt-maize expressing Cry1Ab as a case study (2003). 13. DUVICK, J. ENVIROMENTAL HEALTH PERPECTIVES 109: 337-342 Supplement: Suppl. 2 Times Cited: 23 Prospects for reducing fumonisin contamination of maize though genetic modification (2001). 14. ESTRUCH, J. J.; GREGORY W. WARREN; MARTHA A. MULLINS; GORDON J. NYE; JOYCE A. CRAIG; AND MICHAEL G. KOZIEL PNAS 93: 5389-5394 Vip3A, a novel Bacillus thuringiensis vegetative insecticidal protein with a wide spectrum of activities against lepidoptera insects (1996). 15. FANCELLI, A. L.; DOURADO-NETO. D 2000. Produção de milho. Guaíba: Agropecuária, 360p 16. FANG, J. et al. 2007. Characterization of Chemic Bacillus thuringiensis Vip 3 toxines. Apllied and Environmental Microbiology. 73: 956-961. 17. FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS – FAO. 2007. FAOSTAT. Disponível em: http://faostat.fao.org/site/340/defaut.aspx. 18. FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ) 11 April 2008 – Application a 1001 food derived from insect-protected corn line mir162 – assessment report. 19. FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ) 6 August 2008 – Application a1001 food derived from insect-protected corn line mir162 – approval report. 20. FOOD STANDARDS AUSTRALIA NEW ZEALAND (FSANZ) 17 December 2008 – Application a 1001 food derived from insect-protected corn line mir162 – 1(st) review report. 21. GASSEN, D. N. 1996. Manejo de pragas associadas à cultura da milho. Passo Fundo: Aldeia Norte, 134p. 22. GOULD, F. 1998. Sustainability of transgenic insecticidal cultivars: Integrating pest genetics and ecology. Annual Review of Entomology. 43: 701-726. 23. HAMMOND, B. et al. (2003) Reduction of fumonisin mycotoxins in Bt Corn. The Toxicologist 72 (S-1), 1217. 24. HILGER, C.; GRIGIONI, F.; THILL, L.; MERTENS, L.; AND HENTGES, F. (2002) Severe IgE- mediated anaphylaxis following consumption of fried frog legs: definition of alpha-parvalbumin as the allergen in cause. Allergy 57: 1053-1058. 25. JACOBS, C. M.; UTTERBACK, P. L.; PARSONS, C. M.; RICE, D.; SMITH, B.; HINDS, M.; LIEBERGESELL, M.; SAUBER, T. Performance of laying hens fed diets containing DAS-59122-7 maize grain compared with diets containing nontransgenic maize grain (2008) Jacobs, C.M.; Utterback, P. L.; Parsons, C. M.; Rice, D.; Smith, B.; Hinds, M.; Sauber, T. 26. KEYL, A. C. (1987) Aflatoxicosis in cattle. In: Mycotoxic Fungi, Mycotoxins, Mycotoxicosis, vol. 2: Wyllie, T. D.; Morehouse, L. G.; (Eds), Marcel Dekker: New York, pp. 9-27. 27. KIESSELBACH, T. A. The structure and reproduction of corn. Lincoln: University of Nebraska, 1980. 96p. 28. LEE, M. K.; WALTERS, F. S.; HART, H.; PALEKAR, N.; CHEN, J. S. Appl Environ Microbiol 69: 4648-4657. The mode of action of the Bacillus thuringiensis vegetative insecticidal protein Vip3A differs from that of Cry1Ab delta-endotoxin (2003). 29. LIU, J. 2007. Identification of vip3-type genes from Bacillus thuringiensis strains and charactherization of a novel vip3A-tye gene. Letters in Applied Microbiology 45: 432-438. 30. LOGUERCIO, L. L. et al. 2002. Combined analysis of supernatant-based feeding bioessays and PCR as first-tier screening strategy for Vip-derived activities in Bacillus thuringiensis strains effective against tropical fall armyworm. Journal of Applied Microbiology. 93: 269-277. 31. LUNA, S.V.; FIGUEROA, J. M.; BALTAZAR, M. B.; GOMEZ, L. R.; TOWNSEND, R. E SCHOPER, J. B. 2001. Maize pollen longevity and distance isolation requirements for effective pollen control. Crop Sci. 41: 1551-1557. 32. MARASAS, W. F. O. et al. (2004) Fumonisins disrupt sphingolipid metabolism, folate transport, and neural tube development in embryo culture and in vivo: A potential risk factor for human neural tube defects among populations consuming fumonisin-contaminated maize. J Nutrition 134, 711-716. 33. MARVIER, M.; MCCCREEDY, C.; REGETZ, J.; KAREIVA, P. A meta-analysis of effects of Bt cotton and maize on nontarget invertebrates (2007) Science 316: 1475-1477. 34. MESSEGUER, J.; PEÑAS, G.; BALLESTER, J.; BAS, M.; SERRA, J.; SALVIA, J.; PALAUDEMÀS, M.; MELÉ, E. 2006. Pollen-mediated gene flow in real situations of coexistence. Plant Biotechnology Journal. 4: 633-645. 35. MYCOTOXIN REDUCTION IN BT CORN – F. WU – Environmental and Occupational Health, Unin of Pittsburg, PA, USA, http://www.isb.vt.edu/articles/sep0604.html (18/11/08). 36. PATERNIANI, E.; CAMPOS, M. S. 2001. Melhoramento de milho. Inc: Borém, A. Melhoramento de espécies cultivadas. Viçosa, pp; 491-499. 37. PROUDFOOT, A. E.; TURCATTI, G.; WELL, T. N.; PAYTON, M. A.; SMITH, D. J. (1994) Purification, cDNA cloning and heterologous expression of human phosphomannose isomerase. Eur. J. Biochem. 219: 415-423. 38. ROSE, R.; DIVELY, G. P. Environ Entomol 36: 1254-1268 Effects of insecticide-treated and Lepidoptera-active Bt transgenic sweet corn on the abundance and diversity of arthropods (207). 39. ROSS, P. F. et al. (1992) A review and update of animal toxicoses associated with fumonisin-contaminated feeds and production of fumonisins by Fusarium isolates. Micropathologia 17, 109-114. 40. SAXENA, D.; STEWART, C. N.; ALTOSAAR, I. et al. PLANT PHYSIOLOGY AND BIOCHEMISTRY 42: 383-387 Times Cited: 23 Larvical Cry proteins from Bacillus thuringiensis are released in root exudates of transgenic B-thuringiensis corn, potato, and rice but not of B-thuringiensis canola, cotton and tobacco (2004). 41. SHELTON, A. M.; ZHAO, J. Z.; ROUSH, R. T. ANNUAL REVIEW OF ENTOMOLOGY 47: 845-881 Times Cited: 148 Economic, ecological, food safety, and social consequences of the deployment of Bt transgenic plants (2002). 42. Sustainability of transgenic insecticidal cultivars: Integrating pest genetics and ecology (1998) Gould F ANNUAL REVIEW OF ENTOMOLOGY 43: 701-726 Times Cited: 363. 43. ROSS, P. F. et al. (1992) A review and update of animal toxicoses associated with fumonisin-contaminated feeds and production of fumonisins by Fusarium isolates. Micropathologia 17, 109-114. 44. TODD |R AND TAGUE BW (2001) Phosphomannose isomerase: a versatile selectable marker for Arabdopsis thaliana germ-line transformation. Plant Molecular Biology Reporter 19: 307-319. 45. TURNER, P. C. et al. (2003) Modification of immune function through exposure to dietary aflatoxin in Gambian children. Environmental Health Perspectives 111, 217-20. 46. VENDRAMIN, J. D.; SILVA, F. C.; CAMARGO, A. P. 1989. Avaliação da dimensões da região danificada pelo complexo broca-podridões em seis cultivares de cana-de-açucar. Anais da Sociedade Entomológica do Brasil, Porto Alegre, v. 18, p. 105-118. 47. WATSON, LESLIE. DALLWITZ, MICHAEL, J. The grass genera of world. C.A.B.International. Wallingford, OX. C1992. 48. WU, F.; MILLER, J. D.; & CASMAN, E. A. (2004) Bt corn and mycotoxin reduction: An economic perspective. Journal of Toxicolcogy, Toxin Reviews 23(2-3), 397-424.
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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: Syngenta Philippines
Summary of application:
Syngenta developed a com line resistant to the Lepidopteran com insect pests such as com earworm, black cutworm, fall armyworm, and western bean cutworm. This com line referred to as Corn MIR 162, was developed to provide a method to control yield losses from insect feeding damage without the use of conventional pesticides.
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Date of authorization: 11/02/2010
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Syngenta Philippines, Inc. submitted applications to the Bureau of Plant Industry (BPI), requesting for biosafety permits under DA Administrative Order (AO) No.8 for Com MIR162 for direct use as food, feed or for processing. Com MIR 162 has been genetically modified for insect resistance. Com MIR162 has been evaluated according to BPI’s safety assessment by concerned agencies of the Department of Agriculture, such as the Bureau of Animal Industry (BAI) for feed safety, and Bureau of Fisheries and Product Standards (BAFPS) for food safety, and a Scientific Technical Review Panel (STRP) members. The process involves an intensive analysis of the nature of the genetic modification together with a consideration of general safety issues, toxicological and nutritional issues associated with the modified com. The petitioner/applicant published the application for direct use in two widely circulated newspapers for public comment/review. BPI received no comment on the petition during the 30-day comment period. Review of results of evaluation by the BPI Biotech Core Team, in consultation with DA Biotechnology Advisory Team (DA-BA T), 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.
Useful links
Relevant documents
Stacked events:
Gene stacking in plants can be conferred either through genetic engineering or conventional breeding A full risk assessment as to food and feed or for processing shall be conducted to plant products carrying stacked genes conferred through genetic engineering or conventional breeding, where the individual traits have no prior approval for direct use as food and feed or processing from the Bureau of Plant Industry (BPI) A desktop or documentary risk assessment on the possible or expected interactions between the genes shall be conducted for stacked gene products with multiple traits conferred through conventional breeding and individual events granted prior approval by the Bureau of Plant Industry.
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Bureau of Plant Industry 692 San Andres St, Malate, Manila 1004