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Risk Assessment
Record information and status
Record ID
113510
Status
Published
Date of creation
2018-02-21 13:16 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2018-06-15 13:42 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk Assessment of maize DAS-40278-9 x NK603
Date of the risk assessment
2015-10-08
Competent National Authority(ies) responsible for the risk assessment
National Technical Biosafety Commission
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5516
Fax:(5561) 3317-7475
Email:ctnbio@mct.gov.br
Url:National Technical Biosafety Comission
Contact details of the main responsible risk assessor
Dra Maria Sueli Felipe Soares
President
National Technical Biosafety Comission (CTNBio)
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5151
Fax:(5561) 3317-7475
Email:msueliunb@gmail.com
Url:National Technical Biosafety Comission
Risk assessment details
Living modified organism
DAS-4Ø278-9 x MON-ØØ6Ø3-6 - Herbicide tolerant maize
Resistance to herbicides - Glyphosate Tolerance to 2,4-Dichlorophenoxyacetic acid Tolerance to aryloxyphenoxypropionate
Show detection method(s)
Scope of the risk assessment
  • LMOs for Contained use
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Risk assessment report / Summary
Methodology and points to consider
Potential adverse effects identified in the risk assessment
This product does not differ from conventional corn in its chemical and nutritional composition, except for the presence and expression of the cp4 epsps and aad-1 genes, which confer tolerance to the herbicides glyphosate and herbicides of the aryloxyalkanoate family, respectively. The cultivation of DAS-40278-9 x NK603 maize and the consumption of the plant or its derivatives do not cause adverse effects on the environment or human and animal health, being as safe as conventional maize, with which it has substantial equivalence. The CP4 EPSPS and AAD-1 proteins encoded by the cp4 epsps and aad-1 genes, respectively, do not show similarity to proteins known as allergens or toxic. DAS-40278-9 x NK603 maize, like conventional maize, shows no tendency to proliferate as a weed and is not invasive in natural ecosystems. No competitive advantage for maize survival or dispersion is provided by the cp4 epsps and aad-1 genes introduced into GM maize when compared to conventional maize.
Likelihood that the potential adverse effects will be realized
The crossing of event DAS-40278-9 with event NK603, giving rise to the pyramidal event DAS-40278-9 x NK603, did not alter the molecular characteristics of the aad-1 and cp4 epsps genes present in the individual events. Southern blot analyzes with add-1 and cp4 epsps probes on DNA samples from events DAS-40278-9, K603 and DAS-40278-9 x NK603 showed that the occurrence of the DNA inserts containing the add-1 and cp4 genes epsps in the DAS-40278-9 x NK603 event represents that originally present in each individual event, with the insertion of a single intact copy of the aad-1 and cp4 epsps expression cassette in the pyramidal maize genome. No additional fragment besides the aad-1 expression cassette and the cp4 epsps expression cassette was identified in event DAS-40278-9 x NK603 and no sequence of the original vector was inserted. Therefore, these results demonstrate the stability of the genes originally inserted in the individual events and that were conserved in the pyramidal event. Expression of the AAD-1 and CP4 EPSPS proteins in DAS-40278-9 x NK603 maize was determined in experiments performed in both Brazil and the United States.
Possible consequences:
During the commercial release evaluations of DAS-40278-9 x NK603 maize,Food safety for human and animal consumption has been thoroughly verified through the toxicity tests, allergenicity, digestibility and
new varieties both in vitro and in vivo as described in Theoretical Rationale, where it can be concluded that the events presented no greater hazards than the varieties parentheses.
In view of the fact that classical genetic improvement did not interfere with the
of the insertions, that the characteristic segregation pattern was independent and stable, that the
phenotypes of the plant do not present new characteristics, it is assumed that no synergistic behavior of the two characteristics occurs in the pyramidal lineage. In addition, the proteins of each event when quantified by Elisa in the different tissues of the plant in several stages of development of the same did not present differences in relation to the expression by the strains containing a single event. These data indicate that no synergistic effect occurs in the pyramidal lineage, which was can be expected since the two inserted proteins act in different metabolic pathways. As far as the environment is concerned, it was concluded that DAS-40278-9 x NK603 maize is not potentially causing significant degradation of the environment, keeping with the biota relation to conventional maize
Estimation of the overall risk
There is no difference between the agronomic performance of transgenic
as there is substantial equivalence between them. Thus, information indicates that transgenic maize plants do not differ fundamentally from untransformed maize genotypes, with the exception of tolerance to 2,4-D herbicides, herbicides from the group of aryloxyphenoxypropionates (haloxyfop-R, quizalofope, etc.) and to glyphosate. There is also no evidence of adverse reactions to the use of DAS-40278-9 x NK603 maize. For this reason, there are no restrictions on the use of this maize or its derivatives, whether for human or animal consumption
Recommendation(s)
The studies carried out in Brazil and the United States showed that the DAS-
40278-9 X NK603 does not differ from conventional corn in agronomic characteristics,
morphological, reproductive, survival characteristics and in the form of
plant propagation, response to major pathogens and pests, as well as chemical and nutritional composition, except for herbicide tolerance characteristics based on 2,4-D, herbicides from the group of aryloxyphenoxypropionates (haloxyfop-R, quizalofope , etc.) and to glyphosate conferred by the presence and expression of the aad-1 and cp4 epsps gene;
Need(s) for further information on specific issues of concern
he inserts had their integrity maintained during the breeding process
classical genetic;
2) The pattern of genetic inheritance has shown that the two events are independent and
segregate steadily over successive generations;
3) Agronomic evaluations indicated that there was no expression of any new
feature than expected;
4) The expression profile of the recombinant proteins is not different from the expression obtained
in the corns containing the events separately;
5) All tests involving animal and food safety of maize DAS-40278-9 x
NK603 demonstrate that there is no toxicological or allergenic evidence;
6) Maize is the species that has reached the highest degree of domestication between plants
cultivated, being unable to survive in nature without human intervention;
7) There are no native wild species in Brazil with which maize can interbreed;
8) The studies carried out in Brazil and the United States showed that the DAS-
40278-9 X NK603 does not differ from conventional corn in agronomic characteristics,
morphological, reproductive, survival characteristics and in the form of
in response to major pathogens and pests, as well
chemical and nutritional composition, with the exception of the tolerance characteristics
herbicides based on 2,4-D, herbicides from the group of aryloxyphenoxypropionates
(haloxyfop-R, quizalofope, etc.) and glyphosate, conferred by the presence and expression of
gene aad-1 and cp4 epsps;
9) The GMO does not present a risk of invasiveness or weed;
10) The biosafety of this event has already been evaluated by the regulatory systems of 05 countries,
being approved in all for the intended use: animal feed and / or human nutrition and / or
planting;
11) The availability of DAS-40278-9 x NK603 maize will provide corn producers
in Brazil an alternative to increase the weed management in the crop,
considering that the integrated management, with rotation of herbicides, is the best way to
reduce the resistance of weeds to herbicides;
12) It is perfectly possible the coexistence in the field between corn crops GM DAS-
40278-9 x NK603 and conventional or Creole maize crops;
13) The information currently available in the scientific literature;
Receiving environment(s) considered
As established in art. 1 of Law 11,460, of March 21, 2007, "are prohibited the research and the cultivation of genetically modified organisms in the indigenous lands and areas of conservation units".
LMO detection and identification methods proposed
molecular traditional methods

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