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Risk Assessment generated by a regulatory process
(RA)
last updated: 16 Jun 2026
Risk assessment of soybean event A5547-127 - Technical Opinion No. 2273/2010.
EN
11 Feb 2010
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Person:Bayer S.ARua Domingos Jorge, 1100, Prédio 9504, 3º Andar Bairro SocorroSão Paulo, SP
04779-900, BrazilPhone: +55 (11) 2165-7803,Fax: +55 (11) 2165-7711,Website: http://www.bayerscheringpharma.com.br,Related OrganizationBayer Schering Pharma ()Private sector (business and industry)Rua Domingos Jorge, 1100, Prédio 9504, 3º Andar Bairro SocorroSão Paulo, SP
04779-900, BrazilPhone: +55 (11) 2165-7803,Fax: +55 (11) 2165-7711,Website: http://www.bayerscheringpharma.com.br,
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ACS-GMØØ6-4 - Liberty Link™ soybean| Bayer CropScience | Resistance to herbicides (Glufosinate)
- Commercial release 2273-2010.pdf [ Portuguese ]
Event A5547-127, called Soy LibertyLink, presents the pat gene, derived from Streptomyces viridochromogenes, which confers tolerance to the herbicide glufosinate ammonium. This exogenous gene codes for the enzyme phosphinothricin N-acetyltransferase (PAT protein) that promotes herbicide inactivation. The pat gene was replicated using the pB2/35SAck plasmid and the nucleotide sequence was inserted into the soybean genome using the particle acceleration technique. The plasmid had the pat gene, promoter and 35S terminator (derived from the Mosaic Virus of Cauliflower – CaMV) and the bla marker gene (antibiotic-ampicillin resistance). The bla gene (β-lactamase derived from E. coli), present in the plasmid vector, was previously fragmented by a restriction enzyme before insertion into the event. Southern blot hybridizations and DNA polymerase chain reaction amplifications were presented to demonstrate the integration of the exogenous DNA fragment into the plant genome, the number of gene copies, the presence or absence of other DNA elements and the location of transgenes. The results presented
indicate that event A5547-127 has only one copy of the pat gene in the 5'-3' orientation.
indicate that event A5547-127 has only one copy of the pat gene in the 5'-3' orientation.
Establish Liberty Link Soy Security, Event A5547-127. This soy variant demonstrates low risk to human and animal health and has no risk of becoming a plant pest.
PAT protein poses no significant risk to human or environmental health according to acute toxicity studies
oral and in vitro digestibility studies. Studies have shown no toxicity in rats and birds fed the PAT protein.
oral and in vitro digestibility studies. Studies have shown no toxicity in rats and birds fed the PAT protein.
It is not potentially causing significant degradation of the environment or harm to human and animal health.
It has chemical composition similar to the unmodified parent; It has no adverse effects on mammals, even when administered in high doses intravenously; The PAT protein has no homology to any allergenic or toxic proteins; The PAT protein has no glycosylation site; The PAT protein is structurally unstable in acidic environments; The PAT protein has substrate-specific activity.
Aspects of safety to the environment were analyzed in local field studies, showing that the strain originated from Event A5547-127 presents the same agronomic behavior and adaptability as the conventional strain, without alteration on the characters that regulate the survival and reproduction of the species. Comparative analyzes of the morphological, phenotypic and agronomic characteristics allowed us to conclude that none of these variables were altered as a result of the modification genetics at the Event. No characters were observed that could confer a selective advantage on GM soybeans or atypical behavior for the species, according to the proponent. In the post-harvest monitoring, carried out in the experimental areas, few remaining soybean plants, however, being easily eliminated. This demonstrates that the VGM does not remain in the agricultural environment without human intervention, nor does it present characteristics that make it more aggressive or invasive in the ecosystem than its conventional parents, according to the proponent. This event is released in Mexico (2003), USA (1998) and in Japan (2006). Considering the internationally accepted criteria in the process of risk analysis of genetically modified plants, it is possible to conclude that event A5547-127 is as safe as its conventional equivalent.
Liberty Link Soy is not potentially causing significant degradation of the environment, keeping the same relationship with the biota as conventional soybeans.
CTNBio considered that the request complies with the norms and legislation in force that aim to guarantee the biosafety of the environment, agriculture, human and animal health, and concluded that the Liberty Link soy is substantially equivalent to conventional soy, and its consumption is safe for human and animal health.
Molecular traddicional methods.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
