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Risk Assessment
Record information and status
Record ID
Date of creation
2020-04-01 12:37 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2020-04-03 14:56 UTC (dema1@itamaraty.gov.br)

General Information
  • Brazil
Title of risk assessment
Risk assessment of the commercial release of the HB4 soybean event (IND-00410-5) and the combination of HB4 events (IND-00410-5) x RR (MON-04032-6) and its derivatives - Thecnical Report 6540/2019
Date of the risk assessment
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
Url:National Technical Biosafety Comission
Contact details of the main responsible risk assessor
Dr Alrexandre Garcia
President of Internal Comission on Biosafety
Internal Ciomssion on Biosafety
Tropical Melhoramento e Genética S/ (TMG)
Rod. Celso Garcia Cid km87
Cambé, Paraná
Brazil, 86183-600
Phone:+55 43 31742500
Fax:+55 43 31742500
Risk assessment details
Living modified organism
IND-ØØ41Ø-5 x MON-Ø4Ø32-6 - Drought and Glyphosate tolerant soybean
Resistance to herbicides - Glufosinate, Glyphosate Tolerance to abiotic stress - Drought, Salinity
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
Studies have been conducted in Brazil, the United States and Argentina with HB4 soybeans, the conventional Williams 82 and several commercial reference varieties for the evaluation of phenotypic, agronomic and environmental interactions. In Brazil, the tests were carried out in Cambé (PR); Costa Rica (MS) and Rondonópolis (MT). There was similarity in germination, growth, susceptibility to pests and response to disease.
It is not expected that the introduction of the characteristic provided by the HB4 event (INDØØ41Ø- 5) in soybeans will confer an undesired selective advantage or atypical behavior to the species compared to conventional soybeans, with the exception of tolerance to the herbicide glufosinate ammonia. In the case of the compound event there is also tolerance to glyphosate
Likelihood that the potential adverse effects will be realized
Studies on the evaluation of agronomic, phenotypic and environmental characteristics (incidence of pests, diseases and natural enemies in plants) and compositional studies showed that there is no difference between HB4 and HB4xRR soybeans in relation to conventional control soybeans and commercial reference standards. There were no significant differences between fertility and pollen diameter of soybeans HB4 and Williams 82. In addition, the general pollen morphology was similar between both genotypes
Possible consequences:
The results of studies carried out in Brazil and other countries and information referenced by the scientific literature, covering: the characterization of the insert being inherited as a monogenic character; agronomic evaluation, expression of exogenous proteins, chemical and nutritional composition; stability to digestion and industrial processing; digestibility, abundance of soil microorganisms, pollen morphology and viability; of voluntary plants; ecological and symbiotic interactions; seed vigor and germination; effectiveness in insect control; soil physical-chemical characteristics; degradation of proteins in Brazilian soils demonstrated that soybean TLC, has no greater potential to cause significant degradation of the environment, or to present adverse effects to human and animal health when compared with conventional soybean. HB4 soybeans are not considered to potentially cause significant degradation of the environment or to human and animal health, keeping the relationship with biota identical to that of conventional soybeans.
Estimation of the overall risk
There are no additional risks to the environment with the planting of HB4 soy in addition to those already caused by the different varieties of conventional soy in use in the country and there was no interaction between the inserts present in soy
There is no difference between the agronomic performance of transgenic and conventional plants, as well as there is substantial equivalence between them. Thus, the information indicates that transgenic plants do not fundamentally differ from unprocessed soybean genotypes, with the exception of the inserted characteristics. . There is also no evidence of adverse reactions to the use of HB4 soy. For this reason, there are no restrictions on the use of this GM soy or its derivatives, either for human or animal feed.
Need(s) for further information on specific issues of concern
considering the national and internationally accepted criteria in the risk analysis process of genetically modified raw materials, it is possible to conclude that HB4 soy is as safe as its conventional equivalents. The data presented in the request comply with the rules and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and allow us to conclude that soy is substantially equivalent to conventional soy, and its consumption is safe for human health and animal. With regard to the environment, it can be concluded that this GM soy is not potentially a cause of significant degradation of the environment
Receiving environment(s) considered
The introduction of the characteristic provided by the HB4 event (INDØØ41Ø- 5) in soybeans is not expected to confer an undesired selective advantage or atypical behavior to the species in comparison to conventional soybeans, with the exception of tolerance to the ammonia glufosinate herbicide
LMO detection and identification methods proposed
Molecular tradicional methods

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