Long experience with traditional plant improvement techniques, over three decades of experience in research and over one decade of marketing transgenic varieties over the world, in addition  to knowledge advancements in the structure and dynamics of genomes, indicating whether a  certain gene or characteristic is safe, give a sign that the genetic engineering  process, by its own, leaves  little room for appearance of unexpected consequences  that would not be identified or eliminated  during the process of development of commercial GM varieties(14).
Whereas Roundup Ready Cotton Event MON 1445 belongs to  a well characterized species (Gossypium hirsutum)  with  a solid background  of safety for human use and that the cp4 epsps gene introduced  in this variety does not codify a toxic protein, being harmless to humans.
Whereas the  genic construct used to  insert the gene in cotton resulted in a stable insertion of  a functional copy of the cp4 epsps gene, granting the plants  tolerance to glyphosate.
Whereas:
1. Roundup Ready Cotton Event MON 1445 displays genetic stability in different environmental conditions determined in a number of generations of lineages obtained by retrocrossing with elite cultivars, including  a variety adapted for cultivation in Brazil.
2. Proteins CP4 EPSPS and NPTII were expressed in different tissues and development phases of Roundup Ready Cotton Event MON 1445 in extremely low levels.
3. Security assessments  of Roundup Ready Cotton Event MON 1445 and its products  ensured that  the genetically modified variety is safe for both the environment and use as food or food component for animals when compared to the risk posed by conventional  cotton.
4. The new  proteins expressed in the plants, CP4 EPSPS and NPTII  revealed to be safe in all aspects studied.
5. Protein CP4 EPSPS is  rapidly degraded in the gastrointestinal  system of  humans and animals for being a labile  enzyme; and, in addition,  its way of action, specificity  and absence of homology with toxic sequences  make this protein not risky to human health and to the environment.
6. Protein NPTII was assessed by the FDA  in 1994 and was found safe for use in  food. It is rapidly degraded in the human gastrointestinal system and its mode of action, specificity and absence of homology with toxic sequences lead to the conclusion that  the protein is not a toxic risk.
7. Potential allergenicity assessment studies verified that proteins CP4 EPSPS and NPTII  are not detectable in cotton products used as human and animal food and do not pose significant risk as  allergenic and are  not derived from allergenic forms.
8. Phenotypic and agronomic  characteristic studies of Roundup Ready Cotton Event MON 1445 cultivar DP50RR conducted in Brazil have reached results comparable  with experimental and commercial  farming studies  conducted in other regions of the world.
9. Field and farm experiments  conducted with a number of generations  and derivatives of Roundup Ready Cotton Event MON 1445 since 1993 show a stable phenotype of glyphosate tolerance occurring as a monogenic characteristic of high inheritability  that is little affected by the environment  in its expression.
10. Studies with animals show that a paste made of Roundup Ready Cotton Event MON 1445 kernels is  as safe and  nutritive as a paste  of conventional cotton kernel.
11. It is little likely that wild animals   feed on significant amounts of seeds or other parts of the cotton plant.
12. Protein EPSPS is present  in all plants and  also in bacteria, algae and fungi, being therefore widely distributed in nature. For  this reason, all living beings  that feed on plants and  microorganisms are already exposed to  EPSPS proteins.
13. The antibiotics neomycin and kanamycin are  not used in agriculture to control plant diseases originated from the soil. Therefore, it is not likely that the presence of the NPTII protein in the  soil may affect  the microbial  population of  the soil.
14. The transfer of the herbicide-tolerant  characteristic to outside  agriculture areas is extremely unlikely.
15. It is unlikely that the MON 1445 event transgene cp4 epsps be transferred to weeds, making them more invasive. The customary care  with  management  of culture and herbicides, such as rotation of cultures and rotation of  herbicides with different  action mechanisms shall  be the focus to mitigate the appearance of  herbicide-tolerant plants.
16. Data submitted, in addition to those existing in the literature, show that the impacts generated by the release in commercial scale to the field of the cotton event MON 1445 are similar to  those  presented by its kindred and other non-GM varieties currently cultivated in Brazil.
17. Event MON 1445  has already been approved  by several  countries, including U.S.A., Canada, Japan, Australia, Mexico, South Africa, Argentina, China, European Union, Philippines, Colombia and South Korea and has been cultivated  in some of these countries  without negative  effects to human and animal health and to the environment.