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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-BR-294100-1   |   PDF   |   Print   |  
last updated: 17 Apr 2026
General Information
Ris assessment of corn event NK603, Technical Opinion Nº 1596/2008.
EN
18 Sep 2008
Risk assessment details
The cp4 epsps gene, which encodes a glyphosate-tolerant form of the enzyme 5- enolpyruvlyshikimate-3-phosphate synthase (EPSPS), was isolated from the bacterium Agrobacterium tumefaciens strain CP4 and inserted into the maize genome using the bioballistic method (acceleration of particles). The mode of action of glyphosate, causing plant death, is due to its ability to block the activity of the target enzyme (EPSPS) belonging to the biosynthetic pathway of the aromatic amino acids tyrosine, phenylalanine and tryptophan. Thus, plant cells that express the CP4 EPSPS protein continue to produce essential aromatic amino acids when metabolism even in the presence of glyphosate. The CP4 EPSPS protein is one of many EPSPS proteins found in nature, which are produced by plants, bacteria and fungi, but not by animals, since they do not have the metabolic pathway for their synthesis. Therefore, different versions of the EPSPS protein are normally present in all foods derived from plants and microorganisms. The gene donor organism, A. tumefaciens strain CP4 is a bacterium commonly found in soil that causes galls on susceptible plants and there is no scientific evidence to indicate that it can cause adverse effects in humans or in animals. NK603 corn was produced by genetically transforming the LH82XB73 corn line, using a 6706 base pair (bp) linearized DNA fragment that contained two adjacent cassettes of the cp4 epsps gene for expression of the CP4 EPSPS protein. Each of the cassettes, called the proximal (closest to the 5' end) and distal (closest to the 5' end) cassette 3' end), contained a single copy of the cp4 epsps gene and its regulatory sequences.
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Methodology and points to consider
There is solid scientific evidence that NK 603 corn has no adverse effects on human and animal health, and these claims are based on data from the international scientific literature.
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There is no evidence that the transgene or the transformation event causes adverse effects on human and animal health.
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Roundup Ready corn, derived from the NK603 strain, is as safe as its conventional counterpart. Studies and independent scientific publications of the applicant, carried out by third parties, were also considered and consulted.
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Although there is the potential for exposure of corn weeds, pests and pathogens to the CP4 EPSPS and CP4 EPSPS L214P proteins that are expressed in NK603 corn, there are no concerns that such a process will have negative effects on such populations. Through trophic transfer and decomposition process, non-target organisms of CP4 EPSPS and CP4EPSPS L214P proteins, such as predators and prey of corn pests, may be exposed to very low levels of these proteins without, however, evidence of negative effects on these organisms. The environmental safety of the EPSPS family of proteins is well accepted, as these proteins are ubiquitous in nature (bacteria, fungi, algae, and higher plants), have no known toxicity, are not associated with pathogenicity, and do not confer a selective advantage on plants that contain these proteins. proteins. For these reasons, there are no restrictions on the use of this corn or its derivatives for human or animal consumption.
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The adoption of herbicide-tolerant corn, such as NK603 corn, has provided an opportunity for efficient weed management and rotation of herbicide active principles in corn. One of the impacts is the reduction in the use of herbicides in the pre-emergence of the crop. Farmers have reduced rates of pre-emergent herbicides applied to the soil and, through the use of broad-spectrum herbicides such as glyphosate, have effectively controlled weeds. Replacing several herbicides with a broader spectrum herbicide has resulted in savings of approximately $25/ha. Studies carried out in the United States with herbicide tolerant corn suggest positive economic returns from the use of glyphosate alone or glyphosate associated with pre-emergence conventional herbicide treatment. Studies with NK603 corn also demonstrated greater flexibility for the use of post-emergence glyphosate in weed management strategies. These results establish that herbicide tolerant corn, including NK603 corn, provides increased yields while lowering herbicide costs.
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NK603 corn proved to be equivalent to conventional corn, with the exception of the glyphosate tolerance feature. Its basic interactions with other organisms in the environment are not considered to be different from the interactions of conventional corn. Although there is the potential for exposure of weeds, pests and pathogens in corn to the CP4 EPSPS and CP4 EPSPS L214P proteins that are expressed in NK603 corn, there are no concerns that such a process will have negative effects on such populations.
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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 provisions of Normative Resolution No. 03 and Normative Resolution No. 04 of CTNBio.
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Molecular traddicional methods. 
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Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
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