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Risk Assessment generated by a regulatory process
(RA)
last updated: 17 Apr 2026
Risk assessment of corn event TC1507 & NK603, Technical Opinion No. 2053/2009
EN
15 Oct 2009
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200,Phone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Du Pont do Brasil S.A. (Du Pont - Divisão Pioneer Sementes)Private sector (business and industry)Du Pont do Brasil S.A. - Divisão Pioneer Sementes Endereço: SGAS 902 Lt 74 Cj B Sala 221 a 224 Bloco A - Ed. Athenas - Asa SulBrasília, Distrito Federal
70390-020,Phone: 55 - 61 - 21039111,Fax: 55 - 61 -21039111,Email: goran.kuhar@pioneer.com,Website: http://www.pioneersementes.com.br/,
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DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 - Herculex™ I Roundup Ready™ 2 maize| Dow AgroSciences, Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
- Commercial release 2053-2009.pdf [ Portuguese ]
TC1507 corn was developed from the incorporation of the PHP8999 plasmid DNA containing the gene - cry1F and the gene used as a selective marker: pat. Plants of the TC1507 corn lineage were obtained by microparticle bombardment using a Biolistics PDS-1000He - Bio-Rad accelerator (8). The expression product of the cry1F gene is the Cry1F protein, derived from Bacillus thuringiensis var. aizawai, which exerts insecticidal activity on target pests, protecting plants.
The mode of action and biological activities of CP4 EPSPS and Cry1F proteins expressed in TC 1507 x NK603 corn are distinct and do not have known mechanisms of interaction that could cause adverse effects on human and animal health, nor to the environment.
Field studies were carried out in the 2008/09 harvest at the Dow AgroSciences Operating Units in Indianópolis (MG) and Mogi Mirim (SP), for a comparative analysis of the nutritional composition of plants with the isolated events TC1507 and NK603, and in plants with the combined form TC1507 x NK603. The results showed that the analyzed hybrids are genetically similar, differing only in relation to the introduced events. In addition to these studies, the nutritional composition was evaluated in samples of corn grains and corn silage where the results showed that the pyramided corn TC1507 x NK603, TC1507 corn, NK603 corn and non-GMO corn are substantially equivalent. The comparative data showed that the combined corn TC1507 x NK603 does not differ from its components TC1507 and NK603 for the several nutritional components studied indicating no interaction when event TC1507 is combined with event NK603 by classical breeding
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health.
The safety of Cr1F and EPSPS proteins was duly evaluated by CTNBio (5, 6) . The mode of action of the Cry1F protein is well explained in the scientific literature (15,16). In vitro experiments were used to evaluate the increase in digestibility of foods containing Cry1F and CP4-EPSPS proteins after preheating. This study demonstrated that preheating increases the digestibility of the protein in simulated gastric and intestinal fluids, suggesting that an eventual allergenicity potential of the Cry1F protein is extremely low, due to the ease of digestion, which is another important component in the safety evaluation. of corn containing Cry protein.
From an agronomic point of view, the coexistence of conventional (improved or native) and transgenic corn cultivars is possible (37, 38). Ancient communities and modern farmers have known how to coexist, without problems, with different maize cultivars, maintaining their genetic identities over time. Field, greenhouse and laboratory studies with maize containing event TC1507 and NK603 demonstrated that this genetic transformation event is comparable to conventional maize with respect to its reproductive, agronomic, food safety and environmental characteristics.
TC1507 x NK603 corn is as safe as its conventional counterpart.
CTNBio considers that this activity does not potentially cause significant degradation of the environment or harm to human and animal health. Restrictions on the use of the GMO under analysis and its derivatives are subject to the provision in Law 11,460, of March 21, 2007, in Normative Resolution No. 03.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
