The plant and environmental subcommittees of the National Technical Biosafety Commission (CTNBio) granted a request to release the commercial use of genetically modified insect-resistant corn with event MON 95275. The request came from Monsanto do Brasil, currently owned by Bayer.
The technical explanation for the issue is as follows...
The MON 95275 event in corn is produced through transformation mediated by Agrobacterium of the cultivar LH244 with the vector PV-ZMIR525664. MON95275 contains three expression cassettes: (a) the gene mpp75Aa1.1 (CS-mpp75Aa_1-BRELA, formerly known as cryAa1.1) from Brevibacillus laterosporus, which encodes an insecticidal delta endotoxin along with regulatory genetic elements; (b) the gene vpb4Da2 (CS-vip4Da2-BACTU) from Bacillus thuringiensis, which encodes a vegetative insecticidal protein along with regulatory genetic elements; and (c) a DvSnf7 double-stranded RNA transcript (CS-Snf7RNAiu-DIAVI), which leads to suppression of expression of DvSnf7.
The three together provide protection against damage caused by feeding on coleopteran (target) insects.
Molecular characterization of the genetic modification in MON95275 demonstrates that a single copy of the intended T-DNA is stably integrated into a single loci of the maize genome and that no sequence of backbone of the plasmid, the cp4 epsps selectable marker or PVZMOO513642 is present in MON95275.
As expressed in technical documents, event MON 95275 was developed to provide farmers with additional options to help control beetle pests, including those that may develop resistance to current Bt technologies.
The company, in official documents, explains that event MON 95275 will not be offered for commercial use as a stand-alone product, but combined through traditional breeding with other registered or unregulated traits to provide protection against corn pests both above and below the soil, as well as tolerance to multiple herbicides.
These corn products with next generation combined traits will offer farmers wider choice, greater production efficiency, increased durability in pest control and promote a more sustainable agricultural system.
The description of potential effects of using event MON 95275 is presented as follows in documents:
Direct use of MON 95275 as food and feed will not result in harmful effects on humans and animals. Multiple, well-established lines of evidence confirm the food and feed safety and lack of plant pest potential of MON 95275.
Molecular characterization of MON 95275 by next-generation sequencing (NGS) demonstrated that MON 95275 contained a single T-DNA insertion. These whole-genome analyzes provided a comprehensive assessment of MON 95275 to determine the presence and identity of sequences derived from PV-ZMIR525664 and demonstrated that MON 95275 contained a single T-DNA insertion, with no backbone selective marker sequence or cp4 epsps from PV-ZMIR525664 or any sequences of PV-ZM00513642.
Targeted sequencing (Incus-specific PCR, DNA sequencing, and analyses) performed on MON 95275 was used to determine the complete sequence of the single DNA insertion of PV-ZMIR525664, the adjacent flanking genomic DNA, and the 5' insertion-flanking junctions and 3'. This analysis confirmed that, except for a single nucleotide difference in an intervening noncoding sequence, the sequence and organization of the DNA in MON 95275 is identical to the corresponding region in the T-DNA of PV-ZMIR525664 and lacks the cp4 selective marker cassette. epsps.
Furthermore, genomic organization at the insertion site was assessed by comparing the flanking sequences of the T-DNA insertion in MON 95275 with the sequence of the insertion site in conventional maize. This analysis determined that there was a 746-bp deletion following T-DNA integration into MON 95275 and a 6-bp co-insertion within the 3' flanking sequence.
Generational stability analysis by NGS demonstrated that the single T-DNA insertion of PV-ZMIR525664 in MON 95275 was maintained throughout five generations of reproduction, thus confirming the stability of the T-DNA in MON 95275. Segregation analysis corroborates the stability of the insertion demonstrated by NGS and independently establishes the nature of T-DNA as a single chromosomal locus that shows an expected pattern of inheritance.
Taken together, the characterization of the genetic modification in MON 95275 demonstrates that a single copy of the intended T-DNA has been stably integrated into a single locus of the maize genome and that there is no presence of plasmid backbone PV-ZMIR525664, selective marker or sequences from PV-ZM00513642 in MON 95275.
When contacted, Bayer has not yet commented on when it intends to offer commercial varieties based on this technology to producers.
UPDATE ON 16.06.2023/XNUMX/XNUMX: The human and animal health committees also approved the commercial release of insect-resistant genetically modified corn with event MON 95275.
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