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Risk Assessment generated by a regulatory process
(RA)
last updated: 22 Apr 2013
Risk Assessment of Insect Resistant Maize (TC 1507)
EN
11 Dec 2008
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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, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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DAS-Ø15Ø7-1 - Herculex™ I maize| Dow AgroSciences, Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate)
- National Biosafety Committiee [ English ]
- http://www.ctnbio.gov.br/index.php/content/view/12631.html [ Portuguese ]
Analyses of TC1507 corn regarding quality and quantity standards of metabolites normally found in corn demonstrated that event TC1507 is substantially equivalent to conventional varieties of corn. The assessments were conducted to define individual components that are part of human diet. Centesimal composition data analyses presented in the process encompass profile analysis of proteins, amino acids, fat acids, lipids, carbohydrates, minerals, vitamins, secondary metabolites, and composition of fodder and kernel, comparing event TC1507 with corn plants not genetically modified. The results obtained in Brazil and other countries failed to show variations that exceed the standards commonly found in non-genetically modified corn hybrids and lineages. Therefore, one may assume that TC1507 corn is substantially equivalent to non-genetically modified corn plants. Samples taken from leaves, pollen, kernel and the whole plant (vegetative tissues) of both, TC1507 and conventional corn lineages, were used to detect Cry1F and PAT proteins in transformed plants. Western Blot analyses showed that protein Cry1F is expressed in all tissues, in contrast to protein PAT that was detected only in leaves of the TC1507 lineage. In order to analyze the level of expression, samples of corn leaves, pollen, silk, stalk, whole plant, kernel, both normal and senescent of the TC1507 corn lineage, as well as samples from non-transformed corn plants were collected during the 1998-1999 crop and tested with the ELISA test. The results regarding total protein (TP) showed higher levels of the Cry1F protein expression in the whole plant (1063.8 pg Cry1F/ug TP), senescent whole plant (714.3 pg Cry1F/ug TP), stalk (550.0 pg Cry1F/ug TP) followed by pollen (135.5 pg Cry1F/ug TP), leaf (110.0 pg Cry1F/ug TP), grain (89.9pg Cry1F/ug TP) and silk (50.3 pg Cry1F/ug TP). Dispersion of corn seeds is easily controlled, since domestication of corn eliminated the ancient seed dispersion mechanisms and pollen movement is the only effective means for gene escaping of corn plants. Horizontal gene flow between TC1507 corn and other species, even those closely related, are practically unlikely to happen, since wile species related to corn do not occur naturally in Brazil. Coexistence between cultivars of conventional corn (either cultivated or Creole) and transgenic cultivars is possible from the agronomic viewpoint, and this is a reason to comply with the provisions of CTNBio Ruling Resolution no. 04.
EN
Considering that TC1507 corn is derived from a transformation of common Zea mays corn, a fully characterized species with a solid history of safety for human and animal consumption; that the transformation process caused insertion of a single copy of a DNA fragment containing genetic constructs with pat and cry1f genes
EN
1. Corn is the species that reached the highest domestication level among cultivated plants, and is unable to survive in nature with no human intervention.
2. In Brazil, there are no wild species with which corn may intercross, since the closest wild corn species is teosinte, found only in Mexico and in some Central America locations, where it may cross with corn cultivated in production fields.
3. Protein Cry1F was detected in low levels in tissues analyzed and displayed high susceptibility to digestion in simulated gastric fluids, failing to show acute toxicity in mammals and similarity with known allergens(38).
4. The DNA molecule is a natural component of food and there is no evidence that this molecule may have adverse effect to man when ingested in food in acceptable amounts.
5. There is no evidence that intact genes of plants may be transferred and functionally integrated to the human genome or genome of other mammals exposed to such DNA or to foods manufactured with such elements(50).
6. Applicant answered to all questions mentioned in CTNBio Ruling Instruction no. 05 and there is no issue indicating that this corn may present adverse effects to human and animal health.
7. There is no likelihood that TC1507 corn may perform or cause invasion of uncultivated areas.
8. Proteins Cry1F and PAT are rapidly degraded in gastric conditions, thus minimizing any absorption potential in an intestinal system(51, 40).
9. Bacterium B. thuringiensis may be considered the most potent biological agent to control forest and agricultural pest insects and disease vectors for the specificity of delta-endotoxins to insects and target-invertebrates, and its innocuousness to vertebrates and the environment, including beneficial insects and natural enemies, making this agent a key component in integrated management of pests.
10. Cultures of B. thuringiensis are filed with Agência Nacional de Vigilância Sanitária – ANVISA, the National Sanitary Surveillance Agency, under different formulations for application in thirty types of plant cultures for food use(68).
11. Biopesticides based on such toxin are widely used as an alternative to chemical insecticides in terms of safety to non-target organisms and when development of resistance to chemical insecticides is the case(69).
12. The use of Bt technology in Brazil may contribute to reduce the use of insecticides and, consequently, mitigate the impact resulting from the use of such pesticides to the environment, human and animal health, and to positively affect the preservation of non-target organisms and beneficial insects, facilitating the integrated management of farm pests.
13. This corn variety shows low risk to human health, animal health and is no likely to change into a plant pest.
14. The gene insertion did not change the composition and nutritive value and the presence of protein Cry1F in proportion to the total corn protein does not imply significant contribution to the amount or proteins in human diet.
15. Nutritional, equivalence and toxicological tests have been reported showing the expressed protein to be innocuous(26, 27, 28).
16. Concurrently to resistance to insects, the Bt toxin contributes to reduce mold development in corn ears, which are responsible for production and contamination of corn with mycotoxins(29).
17. No other characteristic of the original organisms that represents risks to human health was modified and there was no record of adverse effects resulting from TC1507 corn in studies related to human health and the environment.
18. Commercial use of TC1507 corn lineage is occurring in the United States since 2001, Argentina (2005), Colombia (2006), China (2004), Mexico (2003), South Africa (2002), Canada (2002), Australia (2003), Japan (2002), Korea (2002), Philippines (2003), Taiwan (2003) and European Union (2006) without any record of problems linked to the agronomic characteristics of the event.
19. Comments, opinions, suggestions and documents resulting from a Public Hearing related to TC1507 corn held on March 20, 2007, failed to register any relevant scientific fact, corroborated by scientific evidence, that may compromise the environmental safety and human and animal health.
20. Coexistence of conventional corn cultivars (improved or Creole) and transgenic cultivars is possible from the agronomic viewpoint, and the provisions of CTNBio Ruling Instruction no. 04 shall be complied with.
For the foregoing, and considering internationally accepted criteria in the process of risk analysis for genetically modified raw-materials, a conclusion emerges that TC1507 corn is as safe as its conventional equivalent.
CTNBio holds that commercial cultivation and consumption of TC1507 corn are not potential causes of significant degradation to the environment or of harm to human and animal health. Restrictions to the use of the GMO analyzed and its derivatives are conditioned to the provisions of CTNBio Ruling Resolutions no. 03 and 04. Additionally, this risk analysis took into consideration and consulted third party independent studies and scientific publication submitted by applicant.
EN
2. In Brazil, there are no wild species with which corn may intercross, since the closest wild corn species is teosinte, found only in Mexico and in some Central America locations, where it may cross with corn cultivated in production fields.
3. Protein Cry1F was detected in low levels in tissues analyzed and displayed high susceptibility to digestion in simulated gastric fluids, failing to show acute toxicity in mammals and similarity with known allergens(38).
4. The DNA molecule is a natural component of food and there is no evidence that this molecule may have adverse effect to man when ingested in food in acceptable amounts.
5. There is no evidence that intact genes of plants may be transferred and functionally integrated to the human genome or genome of other mammals exposed to such DNA or to foods manufactured with such elements(50).
6. Applicant answered to all questions mentioned in CTNBio Ruling Instruction no. 05 and there is no issue indicating that this corn may present adverse effects to human and animal health.
7. There is no likelihood that TC1507 corn may perform or cause invasion of uncultivated areas.
8. Proteins Cry1F and PAT are rapidly degraded in gastric conditions, thus minimizing any absorption potential in an intestinal system(51, 40).
9. Bacterium B. thuringiensis may be considered the most potent biological agent to control forest and agricultural pest insects and disease vectors for the specificity of delta-endotoxins to insects and target-invertebrates, and its innocuousness to vertebrates and the environment, including beneficial insects and natural enemies, making this agent a key component in integrated management of pests.
10. Cultures of B. thuringiensis are filed with Agência Nacional de Vigilância Sanitária – ANVISA, the National Sanitary Surveillance Agency, under different formulations for application in thirty types of plant cultures for food use(68).
11. Biopesticides based on such toxin are widely used as an alternative to chemical insecticides in terms of safety to non-target organisms and when development of resistance to chemical insecticides is the case(69).
12. The use of Bt technology in Brazil may contribute to reduce the use of insecticides and, consequently, mitigate the impact resulting from the use of such pesticides to the environment, human and animal health, and to positively affect the preservation of non-target organisms and beneficial insects, facilitating the integrated management of farm pests.
13. This corn variety shows low risk to human health, animal health and is no likely to change into a plant pest.
14. The gene insertion did not change the composition and nutritive value and the presence of protein Cry1F in proportion to the total corn protein does not imply significant contribution to the amount or proteins in human diet.
15. Nutritional, equivalence and toxicological tests have been reported showing the expressed protein to be innocuous(26, 27, 28).
16. Concurrently to resistance to insects, the Bt toxin contributes to reduce mold development in corn ears, which are responsible for production and contamination of corn with mycotoxins(29).
17. No other characteristic of the original organisms that represents risks to human health was modified and there was no record of adverse effects resulting from TC1507 corn in studies related to human health and the environment.
18. Commercial use of TC1507 corn lineage is occurring in the United States since 2001, Argentina (2005), Colombia (2006), China (2004), Mexico (2003), South Africa (2002), Canada (2002), Australia (2003), Japan (2002), Korea (2002), Philippines (2003), Taiwan (2003) and European Union (2006) without any record of problems linked to the agronomic characteristics of the event.
19. Comments, opinions, suggestions and documents resulting from a Public Hearing related to TC1507 corn held on March 20, 2007, failed to register any relevant scientific fact, corroborated by scientific evidence, that may compromise the environmental safety and human and animal health.
20. Coexistence of conventional corn cultivars (improved or Creole) and transgenic cultivars is possible from the agronomic viewpoint, and the provisions of CTNBio Ruling Instruction no. 04 shall be complied with.
For the foregoing, and considering internationally accepted criteria in the process of risk analysis for genetically modified raw-materials, a conclusion emerges that TC1507 corn is as safe as its conventional equivalent.
CTNBio holds that commercial cultivation and consumption of TC1507 corn are not potential causes of significant degradation to the environment or of harm to human and animal health. Restrictions to the use of the GMO analyzed and its derivatives are conditioned to the provisions of CTNBio Ruling Resolutions no. 03 and 04. Additionally, this risk analysis took into consideration and consulted third party independent studies and scientific publication submitted by applicant.
EN
EN
EN
Corn is an annual plant with low dormancy ability. The corn seed can survive from one cultivation season to another, and may successfully germinate under adequate temperature and moist conditions. These so-called volunteer plants are easily identified and controlled by manual, mechanical and chemical means. Corn does not exhibit tendency to proliferate as a plant pest and is not invasive in natural ecosystems(45). Some species of the Zea genus are sylvan plants developing successfully in Central America without any considerable trend to proliferate as a plant pest.
Event TC1507 was carefully cultivated and monitored in what regards its proliferation ability as plant pest and agronomic behavior in over eighty locations around the world, including Argentina, United States, Chile, Italy, Brazil, France and South Africa. In Brazil, several planned releases to the environment were presented by applicants and duly passed by CTNBio. In all cases, TC1507 corn exhibited a behavior similar to the one expected from non-transgenic corn, without evidencing any development of unforeseen morphologic or phenotypic characteristics.
In experimental and field essays conducted in Brazil by Dow AgroSciences during the 2005-2006 crops to compare TC1507 corn with the conventional material, several agronomic parameters were measured, such as: plant height, ear, stalk breaking, root size and yield, among other agronomic characteristics and resistance to diseases. Results reached in experiments conducted in domestic soil were comparable to those attained in Argentina and United States, where it was demonstrated that the genetic modification does not affect the plant phenotype and field behavior.
Experimental essays conducted all over the world with TC1507 corn lineage since 1997 confirmed that event TC1507 does not show any unexpected change in plant vigor. Assessment by simple observation of field essays showed that the development from an emerging plantlet to one-leaved plantlet, and from three to five leaves plantlet, TC1507 corn lineage is comparable to the non-genetically modified corn.
Applicants additionally conducted field essays in Brazil, where resistance to common rust (Puccinia sorghi), Polysora rust (Puccinia Polysora), cercosporiosis (Cercospora zea-maydis), Northern corn leaf blight (Exserohilum turcicum), Phaeosphaeria leaf spot (Phaeosphaeria maydis), and Diplodia leaf spot (Diplodia macrospora) was assessed. The data indicate that in the four hybrid essayed there was no differences in disease severity between the hybrid with TC1507 event and the correspondent conventional hybrid.
Comparatively, essays were conducted to assess resistance characteristics of hybrids derived from TC1507 corn lineage and their corresponding non-genetically modified corn to diseases such as Exserohilum turcicum leaf spot, Bipolaris maydis leaf spot, Polysora rust, cercosporiosis, Erwinia stewartii bacterial spot, Ustilago zeae smut and resistance to pests, such as armyworm Spodoptera frugiperda, corn earworm Helicoverpa zea, Frankliniella sp. thrips, Aphis sp. aphis, Chaetocnema pulicaria corn flea beetle, red acarus, among others. These essays showed that there was no difference to be recorded on severity of disease symptoms; damage caused by insects, except for organisms identified as susceptible to protein Cry1F among plants of event TC1507 and those of genetically modified corn.
The biological activity of protein Cry1F was studied in a range of pest insects feeding on corn plants. The essays were conducted by exposing insects to artificial diets treated with aqueous formulations of Cry1F protein produced from a microbial source (P. fluorescens). Evans(51) showed that the biochemical characteristics of a protein produced in either plant or microbial form are equivalent. Insects studied were: armyworm (Spodoptera Frugiperda), moth borer (Diatraea saccharalis), European corn borer (Ostrinia nubialis), corn earworm (Helicoverpa zea), black cutworm (Agrotis ipsilon), lesser cornstalk borer (Elasmopalpus lignosellus), Southwest corn borer (Diatraea grandiosella), Western corn rootworm (Diabrotica virgifera virgifera), corn leaf aphid (Rhopalosiphum maidis) and corn leafhopper (Dalbulus maidis). Huang et al.(55) have already assessed Cry proteins specificity through essays in connection with cell vesicles, evidencing the high specificity of this protein complex to insect receptors.
Efficacy essay was conducted in the cities of Itumbiara, (GO), Toledo (PR), Indianápolis (MG), and Jardinópolis (SP) during the 2005 calendar year. Experiments were conducted according to cultural practices recommended for each region. In that same year, a first assessment was made, including incidence of initial pests and predators. Incidence of the lesser cornstalk borer, Elasmopalpus lignoselus (Zeller), was not recorded in any of the localities. Pooled variance analysis of data in the four localities revealed significant difference among the three treatments studied: conventional Pioneer P30F33 corn with application of insecticide, conventional Pioneer P30F33 corn without application of insecticide, and the same hybrid P30F33 – 1507 (Bt), using F test. Analysis of data related to assessment of herbivory and incidence of green stink bug, based on the percentage of plants with damage symptoms, revealed that interaction site x treatment was significant. The result showing the comparison of averages for herbivory is lower for the P30F33 – TC1507 in each site.
Currently there is an indiscriminate use of insecticides in Brazil, including a mix of chemical products, in an attempt to control insects, especially S frugiperda. With the massive employment of these chemical products an agricultural desert is created in certain Brazilian regions, since the natural enemies of such pests are the first to be eliminated. Frequent employment of chemical insecticides contributes to environmental degradation, pollution and an environmental breakdown in corn culture and even in other rotation crops. By adopting insect resistant genetically modified plants, reduction in insecticides has been considerable in countries where this technology has been adopted for over ten year. In the United States, for instance, farmers have obtained reductions of over 8,000 tons of active insecticide ingredient in 2001 alone(52, 53, 54). In China, the employment of insecticides were reduced 67% on average, and reduction in volume of active insecticide ingredient reached 80%(55). In South Africa, the reduction was around 66%(56). For the foregoing, one may argue that the use of the Bt technology in Brazil may contribute towards a reduced employment of insecticides and, consequently, mitigating the impacts to the environment and human and animal health resulting from the use of these pesticides. Furthermore, the use of Bt technologies may positively affect the preservation of non-target populations and beneficial insects, facilitating an integrated management of farm pests(57, 55, 58). In addition, adoption of technologies that minimize the spraying of chemical products in crops may bring secondary benefits such as reduced use of inputs in the production of pesticides, conservation of fuels used to produce, distribute and apply the pesticides and elimination of the need for use and discard of pesticide packing
EN
Event TC1507 was carefully cultivated and monitored in what regards its proliferation ability as plant pest and agronomic behavior in over eighty locations around the world, including Argentina, United States, Chile, Italy, Brazil, France and South Africa. In Brazil, several planned releases to the environment were presented by applicants and duly passed by CTNBio. In all cases, TC1507 corn exhibited a behavior similar to the one expected from non-transgenic corn, without evidencing any development of unforeseen morphologic or phenotypic characteristics.
In experimental and field essays conducted in Brazil by Dow AgroSciences during the 2005-2006 crops to compare TC1507 corn with the conventional material, several agronomic parameters were measured, such as: plant height, ear, stalk breaking, root size and yield, among other agronomic characteristics and resistance to diseases. Results reached in experiments conducted in domestic soil were comparable to those attained in Argentina and United States, where it was demonstrated that the genetic modification does not affect the plant phenotype and field behavior.
Experimental essays conducted all over the world with TC1507 corn lineage since 1997 confirmed that event TC1507 does not show any unexpected change in plant vigor. Assessment by simple observation of field essays showed that the development from an emerging plantlet to one-leaved plantlet, and from three to five leaves plantlet, TC1507 corn lineage is comparable to the non-genetically modified corn.
Applicants additionally conducted field essays in Brazil, where resistance to common rust (Puccinia sorghi), Polysora rust (Puccinia Polysora), cercosporiosis (Cercospora zea-maydis), Northern corn leaf blight (Exserohilum turcicum), Phaeosphaeria leaf spot (Phaeosphaeria maydis), and Diplodia leaf spot (Diplodia macrospora) was assessed. The data indicate that in the four hybrid essayed there was no differences in disease severity between the hybrid with TC1507 event and the correspondent conventional hybrid.
Comparatively, essays were conducted to assess resistance characteristics of hybrids derived from TC1507 corn lineage and their corresponding non-genetically modified corn to diseases such as Exserohilum turcicum leaf spot, Bipolaris maydis leaf spot, Polysora rust, cercosporiosis, Erwinia stewartii bacterial spot, Ustilago zeae smut and resistance to pests, such as armyworm Spodoptera frugiperda, corn earworm Helicoverpa zea, Frankliniella sp. thrips, Aphis sp. aphis, Chaetocnema pulicaria corn flea beetle, red acarus, among others. These essays showed that there was no difference to be recorded on severity of disease symptoms; damage caused by insects, except for organisms identified as susceptible to protein Cry1F among plants of event TC1507 and those of genetically modified corn.
The biological activity of protein Cry1F was studied in a range of pest insects feeding on corn plants. The essays were conducted by exposing insects to artificial diets treated with aqueous formulations of Cry1F protein produced from a microbial source (P. fluorescens). Evans(51) showed that the biochemical characteristics of a protein produced in either plant or microbial form are equivalent. Insects studied were: armyworm (Spodoptera Frugiperda), moth borer (Diatraea saccharalis), European corn borer (Ostrinia nubialis), corn earworm (Helicoverpa zea), black cutworm (Agrotis ipsilon), lesser cornstalk borer (Elasmopalpus lignosellus), Southwest corn borer (Diatraea grandiosella), Western corn rootworm (Diabrotica virgifera virgifera), corn leaf aphid (Rhopalosiphum maidis) and corn leafhopper (Dalbulus maidis). Huang et al.(55) have already assessed Cry proteins specificity through essays in connection with cell vesicles, evidencing the high specificity of this protein complex to insect receptors.
Efficacy essay was conducted in the cities of Itumbiara, (GO), Toledo (PR), Indianápolis (MG), and Jardinópolis (SP) during the 2005 calendar year. Experiments were conducted according to cultural practices recommended for each region. In that same year, a first assessment was made, including incidence of initial pests and predators. Incidence of the lesser cornstalk borer, Elasmopalpus lignoselus (Zeller), was not recorded in any of the localities. Pooled variance analysis of data in the four localities revealed significant difference among the three treatments studied: conventional Pioneer P30F33 corn with application of insecticide, conventional Pioneer P30F33 corn without application of insecticide, and the same hybrid P30F33 – 1507 (Bt), using F test. Analysis of data related to assessment of herbivory and incidence of green stink bug, based on the percentage of plants with damage symptoms, revealed that interaction site x treatment was significant. The result showing the comparison of averages for herbivory is lower for the P30F33 – TC1507 in each site.
Currently there is an indiscriminate use of insecticides in Brazil, including a mix of chemical products, in an attempt to control insects, especially S frugiperda. With the massive employment of these chemical products an agricultural desert is created in certain Brazilian regions, since the natural enemies of such pests are the first to be eliminated. Frequent employment of chemical insecticides contributes to environmental degradation, pollution and an environmental breakdown in corn culture and even in other rotation crops. By adopting insect resistant genetically modified plants, reduction in insecticides has been considerable in countries where this technology has been adopted for over ten year. In the United States, for instance, farmers have obtained reductions of over 8,000 tons of active insecticide ingredient in 2001 alone(52, 53, 54). In China, the employment of insecticides were reduced 67% on average, and reduction in volume of active insecticide ingredient reached 80%(55). In South Africa, the reduction was around 66%(56). For the foregoing, one may argue that the use of the Bt technology in Brazil may contribute towards a reduced employment of insecticides and, consequently, mitigating the impacts to the environment and human and animal health resulting from the use of these pesticides. Furthermore, the use of Bt technologies may positively affect the preservation of non-target populations and beneficial insects, facilitating an integrated management of farm pests(57, 55, 58). In addition, adoption of technologies that minimize the spraying of chemical products in crops may bring secondary benefits such as reduced use of inputs in the production of pesticides, conservation of fuels used to produce, distribute and apply the pesticides and elimination of the need for use and discard of pesticide packing
molecular traditional methods
EN
EN
- Comissão Técnica Nacional de Biossegurança [ Portuguese ]
- National Technical Biosafety Comission [ English ]
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