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Risk Assessment
Record information and status
Record ID
115894
Status
Published
Date of creation
2021-02-19 06:07 UTC (lorelieu5@gmail.com)
Date of publication
2021-02-19 06:07 UTC (lorelieu5@gmail.com)

General Information
Country
  • Philippines
Title of risk assessment
Determination for the Safety Assessment of Corn MZIR098 for Direct Use as Food, Feed and for Processing
Date of the risk assessment
Date not available
Competent National Authority(ies) responsible for the risk assessment
Department of Agriculture
Elliptical Road, Diliman
Quezon City
Philippines, 1100
Phone:+632 920-3986,+632 924-1278 local 2802
Fax:+632 920-3986
Email:osec.da@gmail.com
Url:DA
Risk assessment details
Living modified organism
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
Scope of the risk assessment
  • LMOs for direct use as feed
  • LMOs for direct use as food
  • LMOs for processing
Methodology and points to consider
Potential adverse effects identified in the risk assessment
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".
Likelihood that the potential adverse effects will be realized
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.
Possible consequences:
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.
Estimation of the overall risk
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.
Recommendation(s)
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.
Need(s) for further information on specific issues of concern
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.
Receiving environment(s) considered
The application of corn MZIR098 is not for propagation. This LMO will be directly used for food, feed and for processing.
LMO detection and identification methods proposed
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.
Additional Information
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.