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Risk Assessment
Record information and status
Record ID
113495
Status
Published
Date of creation
2017-08-29 18:35 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2018-06-15 13:36 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Title of risk assessment
Risk Assessment of sugarcane Insect resistant sugarcane - CTB141175/01-A sugarcane event (CTC20BT™)
Date of the risk assessment
2017-06-07
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
CTC-14117-4 - Sugarcane modified for insect resistance
Dr Wladecir Salles Oliveira Resistance to antibiotics - Kanamycin Resistance to diseases and pests - Insects - Lepidoptera (butterflies and moths)
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
There is no adverse effect identified in the risk assessment.Genetically modified cane behaves agronomically like conventional cane. Brazil does not have tradition of exporting sugarcane as living organism. The main exported products derived from sugarcane are sugar and ethanol which are not LMO and therefore are out of Cartagena Protocol scope
Likelihood that the potential adverse effects will be realized
The likelihood of potential adverse effects was evaluated by CTNBio under the framework of Normative Resolution N°05 and no potential adverse effect was detected.
1. CTB141175/01-A sugarcane expresses the proteins Cry1Ab and NptII preferentially at leaf tissues. Sugarcane leaves are not used for food purposes;
2. The amount of Cry1Ab and NptII proteins at sugarcane juice is extremely low at the limit of quantification of methodology used;
3. Sugarcane is almost totally cultivated to be processed into sugar (~ 99.7% sucrose) and ethanol. It is not possible to detect DNA neither proteins in these final products, which are therefore pure substances;
4. There are no binding sites for the d-endotoxins of Bacillus thuringiensis at the surface of the intestinal cells of mammals, therefore domestic animals and humans are not susceptible to such proteins. Several experiments testing Bt proteins showed the lack of toxicity to man and vertebrates, absence of adverse effects to non-target organisms and to the environment;
5. Sugarcane is an energy crop. It is not considered a nutritional crop as its contents of amino acids, proteins and lipids are minimal.
6. Sugarcane is mainly cultivated due to its potential to accumulate sucrose in the stalks which are further processed to produce sugar and ethanol for food and biofuel uses.
7. Sugarcane does not present known toxicant, allergenics neither antinutrient compounds.
8. Event CTB141175/01-A is nutritional equivalent to non-GM parental controls regarding humidity, ashes, fiber, fiber in neutral detergent, fiber in acid detergent, fatty acids and protein nutritional parameters, according to OECD recommendation to evaluate new sugarcane varieties.
9. Event CTB141175/01-A contributes to reduce the use of insecticides and, consequently, reduces the impacts of such pesticides in the environment, human and animal health;
10. The use of technology such as insect resistant Bt sugarcane may have a positive impact to population preservation of non-target organisms and beneficial insects, making integrated management of crop pests easier;
11. Cultivation of sugarcane event CTB141175/01-A does not cause changes in the soil microorganisms when compared to by conventional sugarcane varieties;
12. Cry1Ab protein have very specific action and act, through ingestion only, in some species of the Lepidoptera order. Therefore, event CTB141175/01-A produces a protein that is toxic to sugarcane borer only, and does not have properties allergenic to mammals;
13. The source organism of proteins Cry1Ab and NptII, Bacillus thuringiensis and Escherichia coli, are not recognized as allergenic;
14. Sugarcane is vegetative propagated crop. There is no possibility of contamination of neighbor plantation via GM pollen;
15. Finally, given the facts detailed above, it is not expected any adverse effect due to CTB141175/01-A sugarcane event.
Possible consequences:
Considering the internationally accepted criteria in the process of risk analysis of genetically modified raw materials, it is possible to conclude that the event in question is as safe as its conventional equivalents, and does not cause significant degradation of the environment, keeping with the biota identical relation To conventional cane. The conclusion of the Human and Animal Subcommittee's analysis was that "in natura consumption or from the industrial processing derivatives of event CTB141175 / 01-A there is no measurable risk to human or animal health
Recommendation(s)
According to Article 1 of Law nº 11,460, of March 21, 2007, "research and cultivation of genetically modified organisms may not be conducted in indigenous lands and areas of conservation units".
Need(s) for further information on specific issues of concern
Annex IV of CTNBio's Normative Resolution No. 5, in its item 3, requests that the possible effects on relevant indicator organisms (symbionts, predators, pollinators, parasites or competitors of the GMO) in the ecosystems where they are intended to be cultivated , Compared to the parental organism of the GMO in a conventional production system. The company presented agronomic and biosafety performance data from 06 localities in the Center-South region. Thus, considering the locations where the biosafety evaluations of CTB141175 / 01-A were conducted, CTNBio should authorize the use of this event only for the Center-South region.
Receiving environment(s) considered
Although sugarcane is not native from Brazil, the country has a long history of safe cultivation of this crop (around 5 centuries).  Today, Brazil is the biggest sugarcane producer in the world, with an estimated planted area of 9.1 million ha almost entirely devoted to sugar and ethanol production. The main environmental points considered are: 
1. Sugarcane cultivars are developed to specific environmental conditions;
2. Due to its high complex genome, GM events are not easily transferred to new cultivars via traditional breeding. Therefore, GM events tend to be cultivar specific.
3. CTB141175/01-A sugarcane event was developed and it is suited for growing at the Brazilian Center-South region.
4. It is not expected that this event is going to be cultivated outside Brazilian Center-South growing region.
5. Sugarcane is originated at Asia Southeast. Brazil is not the center of origin of this crop. Gene flow to wild species is not expected.

LMO detection and identification methods proposed
Molecular Phenotypical Methods

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