Food safety and quality
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OECD Unique Identifier details

BEM-PV-051-1
Commodity: Bean (common)
Traits: Bean Golden Mosaic Virus (BGMV) resistance
Brazil
Name of product applicant: Embrapa Arroz e Feijão
Summary of application:
Commercial release of genetically modified beans resistant to bean golden mosaic virus in (Bean golden mosaic virus - BGMV), event Embrapa 5.1
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Date of authorization: 15/09/2011
Scope of authorization: Food and feed
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): Center for Environmental Risk Assessment
Summary of the safety assessment (food safety):
of genetically modified beans resistant to bean golden mosaic virus in (Bean golden mosaic virus - BGMV), event Embrapa 5.1, to effect their release into the environment, trade, consumption, and any other activities related to that GMO and progeny derived from it. The event Embrapa 5.1 was generated using the strategy of RNA interference (RNAi) and is highly resistant to golden mosaic virus. The event Embrapa 5.1 has been obtained from the insertion of transgenes into the nuclear genome using the biolistic method. To obtain virus resistance was inserted chimeric gene for expression of an RNA containing a fragment of the rep gene (AC1) of BGMV, placed in sense and antisense (interleaved by an intron). This RNA was designed to form a staple with sequences of double stranded RNA (dsRNA) that are recognized by the cellular machinery for generation of small fragments of RNA (siRNA) that interfere with expression of the viral rep gene. As a consequence of the lack of rep gene expression, viral replication is compromised and the plants become resistant virus. As a selection marker for the shoots was used gene AtAhas. While gene expression AtAhas was very low, judging by the difficulty of detecting the protein AtAHAS in leaf and seed, tissues of bean Embrapa 5.1, analyzes conducted in silico and in vitro show that this protein has no potential allergenicity . In silico analyzes were performed to predict the allergenic potential of proteins AtAHAS and SEC61 (even with the non-detection of transcripts for this sequence) and resulted in no identity with known allergens. Furthermore, comparison of the AHAS protein A. thaliana and Phaseolus vulgaris shows a similarity in amino acid sequence of 83% and 98-100% in the catalytic regions, found in the superfamily of enzymes dependent on thiamine diphosphate (ThDP). The food and feed safety event Embrapa 5.1 was demonstrated by several studies that have confirmed that their composition is substantially equivalent to their parental and compared to other common beans grown in Brazil. Studies were conducted animal feeding that showed no changes in thier witness fed beans Olathe. The composition data were performed in harvested grain fields cultivated in Londrina (PR), Santo Antônio de Goiás (GO) and Sete Lagoas (MG) in 2008 and in Santo Antônio de Goiás (GO) and Sete Lagoas (MG) in 2009. The beans were harvested and subjected to composition analysis to determine composition sugars and vitamins (B1, B2), minerals (aluminum, calcium, copper, iron, phosphorous, magnesium, manganese, potassium, zinc), amino acids (tryptophan, cysteine , methionine, aspartic acid, serine, glutamic acid, glycine, histidine, arginine, threonine, alanine, proline, tyrosine, valine, lysine, isoleucine, leucine, phenylalanine). Moreover, physicochemical analyzes were performed to determine moisture, ash, protein, fat, phytic acid and trypsin inhibitors. Since data were not available for composition of anti-nutritional factors and nutritional present in beans grown in Brazil, a database was generated with the cultivation of beans (varieties BRS Valente, Black Diamond, Pearl, Timbo and Olathe ( Parental event Embrapa 5.1)) in the years 2003, 2004, 2005, 2006 and 2007 in the municipalities of Santo Antônio de Goiás (GO), Simão Dias (SE), Lavras (MG), Ponta Grossa (PR), Anápolis (GO ), Passo Fundo (RS) in different seasons. Comparative data of composition of nutritional elements and anti-nutritional found in the event bean Embrapa 5.1 are purchasable levels found in their parental (Olathe) and the other four conventional varieties cultivated in Brazil. In addition, analyzes were made of the protein profile in harvested grain fields cultivated with Event Embrapa 5.1 and Olathe conventional Santo Antônio de Goiás (GO), Sete Lagoas (MG) and Londrina (PR). We identified the major proteins present in mature grains of beans. The results show that the grains analyzed had the same pattern in different fields and that there was no difference between the 5.1 and genotype event Embrapa receptor gene, Olathe. Environmental security bean Embrapa 5.1 has been shown in studies to identify possible effects on organisms that interact with the plant under field conditions. The tests were conducted in a greenhouse and cultivated fields in three regions of Brazil for a period of two years. We determined the population dynamics and structure of populations of arthropods associated with conventional bean and Embrapa 5.1 and in the shoot and the soil surface. The species known as pests and natural enemies in common bean production systems were identified visually. In these studies few differences were observed in the community of arthropods ground surface between the two treatments, allowing to conclude that the event Embrapa 5.1 has no effect on the diversity of arthropods present on the surface of the soil. Additional studies were performed with a quantitative and qualitative analysis of macro and mesofauna (most abundant species were ground under the influence of bean Embrapa 5.1). There were also no significant differences between the soils cultivated with conventional and transgenic bean Embrapa 5.1 for both macrofauna and for soil mesofauna on any of the three locations studied. Studies for determination of dry matter and nitrogen accumulation were performed. It was concluded that the dry matter production by bean plants varied between experiments with soils from different locations analyzed. However, the comparison between the two genotypes (event Embrapa 5.1 and its parental Olathe) show similar behavior in the face of stressful conditions. These results are consistent with the analyzes of antioxidant defense mechanisms of enzymes: catalase, ascorbate peroxidase and superoxide dismutase (SOD) as well as measures of cellular damage (lipid peroxidation) and damage to proteins using extracts of bean leaves GM (Embrapa 5.1) and its parental non-GM (Olathe). The results showed no differences between genotypes. Nodulation and biological N2 fixation by bean plants was also evaluated and the results showed no significant changes between the event bean Embrapa 5.1 and its parent. The Community of arbuscular mycorrhizal fungi and their association with the roots of bean plants were studied by the density of spores of AMF (arbuscular mycorrhizal fungi) in the rhizosphere of plants, root colonization by AMF indigenous, number of AMF species identified in rhizosphere, species composition of the AMF community. In general there was no significant difference between the 5.1 and bean Embrapa its parental non-GM Olathe, suggesting no change in the ability of mycorrhization due to genetic alteration inserted into the bean. Studies were performed to evaluate gene flow with genetically modified bean transformed with the bar gene. Data from three years of evaluation at two sites showed that gene flow occurred at a very low frequency, not getting to be observed in situations of 1 to 10 meters from the pollen source. When rarely observed, there was only a distance of 6.5 m from the pollen source. Also was not a prevalence toward for outcrossing events. CTNBio reviewed the reports submitted by the applicants and independent scientific literature. Under the powers conferred by Art. 14 of Lei11.105/05, CTNBio considered that the request meets the standards and legislation intended to ensure the biosafety of the environment, agriculture, human and animal health and concluded that bean Embrapa 5.1 is substantially equivalent to conventional beans, and its consumption safe for human and animal health. Regarding the environment, CTNBio concluded that cultivation of beans Embrapa 5.1 is not potentially causing significant environmental degradation, saving relationship with the biota identical to conventional beans.
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
traditional molecular methods
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: National Biosafety Commission
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Authorization expiration date (a blank field means there is no expiration date) Not Applicable
E-mail:
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Paulo Augusto Viana Barroso
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556120335087
Fax number:
Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

Useful links
Relevant documents
Stacked events:

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)

Brazil
Name of product applicant: Embrapa Arroz e Feijão
Summary of application:
Requests exemption from Bean Monitoring Plan EMB-PVØ51-1 and Report - Year 1 - Relative to the first year of cultivation for seed production in the period between October 2019 to September 2020
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Date of authorization: 10/06/2021
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.):
Summary of the safety assessment (food safety):
In view of the above and considering the criteria contained in article 2 of Normative Resolution 24 of CTNBio, CTNBio granted the request for exemption from the monitoring plan for the GMO in question, while also granting the monitoring report for year 1
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Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Molecular traddicional methods.
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment:
Upload:
Authorization expiration date (a blank field means there is no expiration date) not applicable
E-mail:
Organization/agency name (Full name):
National Biosafety Technical Commission
Contact person name:
Paulo Augusto Viana Barroso
Website:
Physical full address:
SPO Area 5 Qd 3 Bl B S 10.1 Brasilia DF
Phone number:
556120335087
Fax number:
Country introduction:

Brazil had the first biosafety law approved in 1995. After the identification of the need to improve the biosafety system of Brazilian genetically modified organisms, a new law was published. The Law 11.105 / 05 establishes a technical committee dedicated to the analysis of the safety aspects of genetically modified organisms and a council of ministers that is dedicated to the analysis of the socioeconomic aspects of the commercial release of genetically modified organisms. In this context, Brazil already has several commercial products that involve genetically modified organisms (plants, human and veterinary vaccines, microorganisms for fuel production) and products derived from new genetic modification techniques.

Useful links
Relevant documents
Stacked events:

At the discretion of, and upon consultation with, CTNBio, a new analysis and issuance of technical opinion may be released on GMOs containing more than one event, combined through classic genetic improvement and which have been previously approved for commercial release by CTNBio

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Dr. Paulo Augusto Viana Barroso (President of national Biosafety Commission)