Philippines | BCH-RA-PH-115893 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

last updated: 19 Feb 2021
General Information
Determination for the Safety Assessment of Corn MON87419 for Direct Use as Food, Feed and for Processing
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Risk assessment details
  • MON-87419-8 - Dicamba and Glufosinate Tolerant Maize
    | Monsanto | Resistance to herbicides (Glufosinate)
Methodology and points to consider
Corn is a source of key nutrients such as amino acids, fatty acids, carbohydrates, vitamins, minerals, and fiber (OECD, 2002). It is also known to contain anti-nutrients such as phytic acid, 2,4-Dihydroxy-7-methoxy-2H-1,4-benzoaxin-3(4H)-one (DIMBOA), raffinose, trypsin and chymotrypsin inhibitors, and secondary plant metabolites such as furfural, ferulic acid and p-coumaric acid. These anti-nutrients and secondary metabolites have been historically present in corn at levels that would not cause the food to be unsafe.
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Generational stability analysis through NGS/ JSA demonstrate a single T-DNA insert in MON 87419 which is maintained through 5 breeding generation. Stability of the insert and segregation analysis confirm nature of the T-DNA insert at a single chromosomal locus.

Conventional non-transgenic genomic DNA spiked with PV-ZMHT507801 DNA is analized by next generation sequencing and other bioinformatic tools. It was shown that the MON 87419 does not contain sequences from the backbone of the transformation vector PV-ZMHT507801.

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Digestibility and degradation of the DMO protein by pepsin and pancreatin is evaluated through SDS-PAGE and Western blot analysis. It was demonstrated that DMO degrades by 96.5% in pepsin within a reaction time of 30 sec which was confirmed by Western blots that applied specific DMO antibodies. A peptide fragment ~3kDa is seen with the 2-min pepsin treatment but complete digestion is attained in 5 min. About 98.4% of DMO protein degrades in pancreatin within 5 min as shown by 2 peptide fragments with ~12 and ~21 kDa but complete degradation is accomplished within 15 min. Data on digestibility show that large and intact fragments of MON 87419 DMO protein are unlikely to be absorbed in the small intestines after oral ingestion.

It was also shown that the functional activity of DMO is retained at 25°C and 37°C for a heating period of 15 or 30 min. Heating at 55°C and 75°C reportedly caused reduction of functional activity. Heating at 75°C for 30 min caused slight reduction in intensity of bands while heating at 95°C for 30 min resulted to visible reduction in bands. These findings reportedly explain the predictable loss of functional activity and denaturation of the DMO protein at elevated temperature for a relatively longer period of interaction.
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Corn 87419 applied for direct use for food, feed and/or for processing is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and in the environment
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Safety evaluation of DMO and PAT proteins in MON 87419 involves assessment for amino acid sequence similarities to known allergens and toxic proteins, digestibility experiments utilizing proteases in gastrointestinal tract, functional activity after application of heat, acute toxicity assays all provide data to support a conclusion that food and  feed products that contain DMO and PAT proteins from MON 87419 corn and its progenies are safe and nutritious as foods and feeds derived from conventional maize.
A biosafety permit for direct use can be issued for the said event.
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Changes in consumption patterns by humans and animals are not anticipated with the introduction of the MON 87419 event. The transgenic corn event is substantially equivalent in composition and safety with conventional corn other than its ability to withstand dicamba and glufosinate containing herbicides.
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The application of corn MON 87419 is not for propagation. This LMO will be directly used for food, feed and for processing.
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Diagnostic lateral flow strips, ELISA and PCR for routine qualitative and semi-quantitative detection of transgenes. For higher sensitivity, real-time PCR methods may be used.
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Additional information
MON 87419 corn is intended for direct use as food, feed and for processing.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
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