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OECD Unique Identifier details

DAS-Ø15Ø7-1xDAS-59122-7
Commodity: Corn / Maize
Traits: Coleoptera resistance,Glufosinate tolerance,Lepidoptera resistance
Brazil
Name of product applicant: Du Pont do Brasil & Dow AgroSicence
Summary of application:
Commercial release of genetically modified maize insect resistant and tolerant to glufosinate ammonium, event TC1507 x DAS-59122-7
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Date of authorization: 20/06/2013
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:
The event TC1507 x DAS-59122-7 was generated by crossing the maize TC1507 and DAS-59122-7, for classical genetic crosses, being possessed of genes and Cry1F/pat Cry34Ab1/Cry35Ab1/pat, and are responsible for the production of proteins Cry1F / phosphinothricin acetyltransferase (PAT) and Cry34Ab1/Cry35Ab1/PAT. Proteins Cry34Ab1 and Cry35Ab1 are directed to the protection of plants against insect pests of the order Coleoptera root while. Cry1F have specific action against insect pests of the order Lepidoptera. Additionally, maize TC1507 × DAS-59122-7 PAT protein expressed in both events parenting, responsible for tolerance to the herbicide glufosinate ammonium. The PAT protein is an enzyme that acts on glufosinate ammonium, being able to modify it, rendering it inactive, phosphinothricin by acetylation of the free amine in its grouping. Protein expression studies were carried out in Brazil with events TC1507, DAS-59122-7 and the combined event TC1507 x DAS-59122-7. For analysis of protein expression corn TC1507 x DAS-59122-7 protein Cry1F, PAT and Cry34Ab1 Cry35Ab1 were measured using the quantitative method of Enzyme Linked Immunosorbent Assay (ELISA) in tissues of leaf, pollen, root, whole plant, forage and grains, resulting in the combined event, compared with simple events, similarity of values​​, corroborating the results obtained for phenotypic, agronomic, compositional and reproductive, indicating absence of gene interaction arising from sexual reproduction. Corn TC1507 × DAS-59122-7 shows Mendelian inheritance expected for independent loci. The phenotypic stability of the event TC1507 x DAS-59122-7 was observed for more than 10 generations during the conversion of production lines and hybrids. In every generation there is the characteristic of tolerance to the herbicide glufosinate ammonium, which is inherited stably. Likewise, the characteristic of resistance to coleopteran and lepidopteran insects pests also remained stable and was transferred as expected for all successive generations of progeny during the conversion process. The expression results also confirm these observations, showing stability of expression levels of proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT maize TC1507 x DAS-59122-7. Substantial equivalence combined corn compared to conventional corn, and rapid denaturation and degradation of proteins Cry1F Cry34Ab1, Cry35Ab1 and PAT during processing, attest to the safety of the consumption of genetically modified maize and products derived from it. Analysis of the nutritional composition of maize TC1507 x DAS-59122-7 opposite to conventional corn show similarity between the two products with respect to the content of protein, fiber, carbohydrates, oils, ash, minerals, fatty acids, amino acids, vitamins, metabolites and anti-nutrients . This similarity confirms data published in scientific-technical literature on maize TC1507 x DAS-59122-7 that the presence of cry genes that confer control of insect pests and the pat gene which determines tolerance to the herbicide glufosinate ammonium does not cause changes the nutritional composition of the GMO, as well as those that may be caused by biotic to abiotic. Proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT no have homology with allergenic proteins considered, either with known toxins. These proteins were tested for acute oral toxicity study in mice to evaluate the potential toxicity to humans and animals. No acute effect, chronic or subchronic was detected due to the consumption of these proteins. Research conducted in Brazil showed that maize TC1507 x DAS-59122-7 did not differ from conventional maize on agronomic, morphological, reproductive, as well as the chemical and nutritional composition, with the exception only of the characteristics of tolerance to the herbicide glufosinate-based ammonium and the characteristics of insect resistance. The agronomic traits for the comparative study of the effect of the event TC1507 x DAS-59122-7 used as a reference control corn with the same genetic background combined event. The comparative analysis of treatments indicated that no statistically significant difference was observed between transgenic maize TC1507 x DAS-59122-7 with respect to conventional corn. The agronomic data, botanic and reproductive behaviors of combined event TC1507 x DAS-59122-7 and its simple events (TC1507 and DAS-59122-7), compared to their conventional hybrids in different germplasm, demonstrated the similarity of the TC1507 × maize DAS-59122-7 and its components with conventional maize. Data from studies of the environmental assessment shows that the introduction of simple event TC1507 and DAS-59122-7 in combined event TC1507 x DAS-59122-7 in maize adapted to the abiotic and biotic Brazilian caused no adverse effect on the morphology, physiology, reproductive characteristics, type of dissemination of plant response to major pathogens, survival characteristics, except for changing the response of plants to control insect pests of shoots and roots of maize. Given the above CTNBio concludes that the cultivation and consumption of maize TC1507 x DAS-59122-7 is not potentially cause significant degradation of the environment, or risks to human and animal health. For this reason, there are no restrictions on the use of this corn and its derivatives. The monitoring shall be submitted by the company in accordance with the standards contained in the Normative Resolution No. 9 of December 2, 2011 CTNBio CTNBio examined the reports submitted by the applicants and independent scientific literature. Under the powers conferred by Art. 14 of the Low 11. 105/05, CTNBio considered that the application meets the standards and legislation to ensure the biosafety of the environment, agriculture, human and animal health and concluded that maize TC1507 x DAS-59122-7 is substantially equivalent to conventional maize consumption being safe for human and animal health. Regarding the environment, CTNBio concluded that cultivation of maize TC1507 x DAS-59122-7 is not potentially cause significant degradation of the environment, biota keeping with the identical relation to conventional corn. CTNBio clarifies that this statement does not exempt the applicant from complying with other existing laws in the country, applicable to the subject of the application.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
molecular traditional methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date: Not Applicable
E-mail:
gutemberg.sousa@mct.gov.br
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Edivaldo Domingues Velini
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556134115516
Fax number:
556133177475
Country introduction:
The Brazilian National Biosafety Commission – CTNBio , is responsible to the technical decision on biological risk as a response to a request from the proponent. The technical decision is given on a definitive basis. Only the National Biosafety Council (CNBS) can revoke the decision (in case of commercial release), based on social-economical reasons and not on biosafety reasons. Once a decision is taken by CTNBio favorable to the commercial release of a new GMO (being it a plant or any other organism), CNBS has 30 days to issue a revoke. After these steps, the new product must be evaluated for conformity to the Brazilian standards by the registration and enforcement agencies (ANVISA – Ministry of Health, Ministry of Agriculture, Ministry of Environment and Ministry of Fisheries, according to the intended use of the product). If it conforms to the standards, it may be offered to the market. Every institution dealing with GMOs (including universities and public research institutes) has to have an Internal Biosafety Commission (CIBio), which is legally responsible of everything that may happen to be done or caused by the GMO
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Relevant documents
Stacked events:
At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio
Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:
Dr. Edivaldo Domingues Velini (President of national Biosafety Commission)
Philippines
Name of product applicant: Pioneer Hi-Bred Phillipines and Dow AgroSciences
Summary of application:
The 1507 x 59122 maize has been obtained from traditional breeding methods between progeny of two genetically modified maize. The two GM maize events are DAS-59122-7 referred to as 59122 maize and DAS-Ø15Ø 7-1, referred to as 1507 maize. No new genetic modification has been introduced in 1507 x 59122 maize.
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Date of authorization: 07/02/2012
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment:
Pioneer Hi Bred Philippines and Dow Agro Sciences of the Philippines have filed an application with attached technical dossiers to the Bureau of Plant Industry (BPI) for a biosafety notification for direct use as food, feed and for processing under Department of Agriculture (DA)- Administrative Order (AO) No. 8 Part 5 for combined trait corn: 1507 x 59122 which has been genetically modified for insect protection and herbicide tolerance. A safety assessment of combined trait product corn: 1507 x 59122 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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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