Philippines | BCH-RA-PH-115894 | 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 MZIR098 for Direct Use as Food, Feed and for Processing
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Risk assessment details
  • SYN-ØØØ98-3 - Insect resistant herbicide tolerant maize
    | Syngenta (Novartis (Ciba-Geigy)) | Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi)), Resistance to herbicides (Glufosinate)
Methodology and points to consider
Corn is a source of essential nutrients. It contains macronutrients such as starch/carbohydrates, amino acids, and fatty acids, micronutrients such as beta-carotene and B-vitamins, and minerals like calcium and potassium. Few anti-nutrients are reported to occur in corn. Phytic acid reduces some minerals. It also contains other antinutrients such as raffinose and trypsin inhibitor.

Corn leaves and root tissues contain a potential toxicant. This is 2-4-Dihydroxy-7-methoxy-2H-1,4-benzoxazin-3(4H)-one or DIMBOA. According to OECD (2002), the levels of DIMBOA vary among corn varieties and its amount declines as the plant matures. Corn is also not considered to be a common allergenic food. Corn has been listed as a “less common allergenic food”.
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The source and potential pathogenic or allergenic properties of the transgenes ecry3.1Ab, mcry3A and pat-08 contained in MZIR098 were adequately described. Transgenes ecry3.1Ab and mcry3A that codes for insecticidal proteins were derived from B. thuringiensis, which is a ubiquitous bacterium in the soil. The native Cry1Ab protein originated from Bacillus thuringiensis subsp. kurstaki while the Cry3A protein originated from Bacillus thuringiensis subsp. tenebrionis. Insecticidal Cry Bt proteins have no potential pathogenic or allergenic properties. These have been used and consumed safely for decades.
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Sequence analysis of the MZIR098 insertion site showed that the 24-bp from the corn genomic seqience was deleted during the integration of the MZIR098 insert. Truncation also occurred at the right and left border ends of the T-DNA. Specifically, the right border, along with 10 base pairs of non-coding sequence and 10 bp from the left border were truncated. However, these truncations have no effect on the functionality of the T-DNA.
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MZIR098 corn has food approval in the U.S. (2016), Australia and New Zealand (2016), Japan (2017), and Canada (2016). MZIR098 corn is not materially different in composition, safety, and other relevant parameters from the conventional corn in the market. The transgenic crop will not increase its weediness potential.
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MZIR098 Corn has been approved as food for direct use and processing in countries such as Australia, Canada, New Zealand and USA last 2016. It was also approved as feed for direct use and processing in countries such as Canada, and USA last 2016. A biosafety permit for direct use can be issued for the said event.
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It is anticipated that the introduction of MZIR098 maize will replace some of the maize in existing food and feed products but the food consumption pattern is not expected to change significantly with the introduction of MZIR098.
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The application of corn MZIR098 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
MZIR098 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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Record type Field Record(s)