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Risk Assessment generated by a regulatory process
(RA)
last updated: 28 Apr 2026
Risk assessment of corn event DP4114-3 - Technical Opinion 7501/2021.
EN
10 Jun 2021
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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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DP-ØØ4114-3 - Insect-Resistant and Herbicide-Tolerant Maize| Pioneer Hi-Bred International Inc. | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate)
- commercial release 7501 - 2021.pdf [ Portuguese ]
Corn DP4114 (OECD Unique Identifier DP-ØØ4114-3) confers resistance to insect pests and tolerance to herbicides containing the active ingredient glufosinate ammonium and was obtained by transformation mediated by Agrobacterium tumefasciens using a single genetic construct for the introduction of cry1F genes ( truncated version), cry34Ab1, cry35Ab1 and the phosphinothricin acetyltransferase – pat gene (optimized for expression in plants).
Within the scope of the powers of art. 14, as well as the internationally accepted criteria for evaluating the safety of food and genetically modified raw materials, I consider that the biosafety data from the event DP-ØØ4114-3 meet the relevant norms and legislation that aim to guarantee the biosafety of the environment, agriculture , human and animal health. Thus, provided the conditions described in the process and in this technical opinion are met, this activity is not potentially causing significant degradation of the environment or human and animal health.
Proteins expressed in DP4114 corn showed no evidence of allergenicity or toxicity, as shown in previous studies. The safety and nutritional equivalence of DP4114 corn grain was evaluated through a rat oral toxicity study consisting of 90 days of repeated dose feeding. The study was conducted according to internationally accepted guidelines (US-EPA, 1998). No toxicologically significant differences related to the consumption of a diet containing DP4114 corn were observed in any of the parameters evaluated. These results support the conclusion that DP4114 maize is as safe and nutritious as non-GMO, isoline control maize.
The DP-ØØ4114-3 event is not potentially causing significant degradation of the environment or human and animal health.
There were no statistical differences in nutrient composition between DP4114 corn and control corn, except for ash, phosphorus, potassium and eicosenoic acid (C20:1); however, all individual data points for these four analytes were within their respective tolerance ranges. Considering the compositional equivalence between DP4114 corn and conventional corn, it was concluded; The potential toxicity of the Cry1F, Cry34Ab1, Cry35Ab1 and PAT proteins was evaluated by comparing the sequence of each protein with the sequences in an internal toxin database. No alignment with an E value ≤ 10-4 was returned between the protein sequence Cry1F, Cry34Ab1, Cry35Ab1 and PAT and any protein sequence in the internal toxin database. Therefore, no toxicity concerns emerged from the bioinformatics evaluations of proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT.
DP4114 corn was evaluated by examining the allergenic potential of corn as a crop and evaluating the allergenic and toxic potential of proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT. Proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT were previously evaluated for maize 1507 and 59122 and were determined to be unlikely to be potential allergens or toxins for humans and animals. Previous evaluations of these proteins have included bioinformatics analyses, digestibility studies and acute protein toxicity studies and are relevant to the evaluation of DP4114 corn. Updated bioinformatics analyzes support the original conclusions that proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT are likely not allergens or toxins. These data support the conclusion that proteins Cry1F, Cry34Ab1, Cry35Ab1 and PAT in DP4114 maize are therefore safe and this maize is suitable for use in food and feed.
The DP-ØØ4114-3 event is not potentially causing significant degradation of the environment or human and animal health.
The biosafety data of the DP-ØØ4114-3 event meet the relevant standards and legislation that aim to guarantee the biosafety of the environment, agriculture, human health and animal. Thus, provided the conditions described in the process and in this technical opinion are met, this activity is not potentially causing significant degradation of the environment or human and animal health.
Molecular traddicional methods.
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EN
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
