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.):
The maize resistant to insects and tolerant to glufosinate ammonium herbicide TC1507 x MON 810 was produced through conventional breeding technique intersecting corn Herculex I TC1507 event with MON 810 maize. The TC 1507 event includes the cry1F genes conferring protection lepdópteros insects, and Pat conferring tolerance to the herbicide glufosinate ammonium. The Cry1F controls important lepidopteran pests of maize. The PAT protein makes the plant tolerant to herbicides formulated with glufosinate ammonium. MON 810 Maize produces Cry1Ab protein, which also controls lepidopteran insects, pests of maize. The MON 810 and TC 1507 event have already been approved for commercial release by CTNBio, technical advice No. 1,100 / 2007, on 04/09/2007, and No. 1679/2008, on 15/12/2008, respectively. The combination of two events aims to control pests in the same entomological order to add the spectrum of action of the two proteins from Bacillus thuringiensis, as well as serve as an additional tool for resistance management of pests into individual proteins. Field and laboratory tests showed no interaction between the Cry1F and Cry1Ab proteins, and its effect considered additive in pest control, meaning that the events are independent in their contribution for insect control. Changes in the composition or expression of the proteins compared to the individual events were also not detected. Thus, to prove that the stacked event TC1507 x MON810 has the same safety to human / animal health and the environment than conventional commercial strains, or even their genetically modified parental already approved by CTNBio in Brazil and in several other countries , the applicant shall submit test results conducted under restraint and the environment following scientific methodologies, in order to demonstrate the absence of interaction or synergistic effect between genes introduced into the stacked corn or between the expressed proteins, which may cause the emergence of a new feature in the modified plant. Each of parental genetically modified TC1507 and MON810 corn used to obtain the stacked been assessed previously alone or in combinations by CTNBio, having been considered safe for human and animal health and the environment. The levels of Cry1F protein, Cry1Ab and PAT were determined in samples of pollen, leaves, fodder, whole plant and grain grown in planned releases carried out in four regions in Brazil and statistically significant no differences were observed between the mean concentrations of Cry1F protein, Cry1Ab and PAT in samples of leaves, plants, fodder and grains derived from corn TC1507 and TC1507 x MON810. The natural breeding process did not alter the integrity and stability of the inserts in the stacked event; under field conditions of the inserted protein expression levels are similar to individual events. The proximate composition data showed no significant differences between genetically modified and conventional varieties, suggesting nutritional equivalence between them and the agronomic and phenotypic characteristics of the stacked event are kept in field evaluations, and can infer the absence of detectable interactions genes or the proteins expressed in the combined event as well as allowing the expression of any other different characteristics of resistance to lepidopteran insects and tolerance to the herbicide glufosinate ammonium. Given the above it is concluded that the cultivation and consumption of TC1507 x MON810 corn is not potentially cause significant degradation of the environment, or risk to human and animal health. For this reason, there are no restrictions on the use of this corn or its derivatives. CTNBio determines that the post-commercial release monitoring should be conducted on commercial crops rather than experimental. The areas chosen to be monitored should not be isolated from the others, have borders or any situation that is out of commercial standard. Monitoring should be carried out in a comparative model between the conventional system of cultivation and the cultivation of GMOs system, with data collection carried out by sampling. Monitoring should be conducted in representative biomes of the main areas of GMOs culture and, where possible, involve different types of producers. The monitoring should be conducted for a minimum of five years. In our reports should be detailed information on all activities carried out in the pre-planting and planting on their implementation with a report of activities conducted in the areas of monitoring during the crop cycle, on harvesting activities and weather conditions. There should be monitoring of any harm to human and animal health through official systems of reporting of adverse effects, such as the SINEPS (Adverse Event Reporting System related to Health Products) regulated by ANVISA. Analytical methods, results and their interpretations should be developed in accordance with principles of independence and transparency, except aspects of commercial secrecy previously justified and defined as such. With regard to the pat gene, which confer resistance to herbicides should be monitored: the nutritional status and health of GM plants; chemical and physical soil properties related to fertility and other basic soil characteristics; soil microbial diversity; the diaspore bank soil; the community of invasive plants; the development of herbicide resistance in weeds; the herbicide residues in soil, grain and shoot and gene flow of the two inserted genes. With regard to the cry1Ab and cry1F genes which confer insect resistance should be monitored: the impact on target insects and on non-target insects; the impact on soil invertebrates indicators outside the class Insecta; waste of insecticidal proteins in decaying organic matter, soil and waterways near monitoring area; the development of resistance among target insects and gene flow of the two inserted genes.
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:
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
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)