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Risk Assessment generated by a regulatory process
(RA)
last updated: 04 Apr 2025
Safety Assessment of Corn MON87427 x MON89034 x TC1507 x MON87411 x DAS-59122-7 for Direct Use as Food and Feed, or for Processing
EN
16 Oct 2019
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: (02) 8928-8741 to 64 local 2118, 2214, 2215, 2240,Fax:Website: http://www.da.gov.ph,
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Organization:Bureau of Plant Industry (BPI)San Andres, MalateManila, Metro Manila
1004, PhilippinesPhone: 8524-9588 local 230,Fax:Email: bpibiotech@buplant.da.gov.ph,Website: https://biotech.buplant.da.com.ph/,
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MON-87427-7 × MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7 - Insect resistant, herbicide tolerant maize| Monsanto | Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi)), Resistance to herbicides (Glufosinate, Glyphosate)
After reviewing the technical dossier provided by the applicant, the Scientific and Technical Review Panel (STRP), the Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), the Bureau of Animal Industry (BAI), the Department of Environment and Natural Resources Biosafety Committee (DENR-BC), and the Department of Health Biosafety Committee (DOH-BC) concurred that Corn MON87427 x MON89034 x TC1507 x MON87411 x DAS-59122-7 is as safe as its conventional counterpart and shall not pose any significant risk to human and animal health and to the environment.
The gene products— DvSnf7 transcript, cp4EPSPS, Cry1A.105, Cry2Ab2, Cry3Bb1, Cry1F, PAT, Cry34Ab1 and Cry35Ab1— expressed by the multi-stack corn line may pose allergenic or toxic risks. These novel proteins may also interact in the same metabolic pathway such that an unintended adverse effect is created.
The novel proteins have been shown to have distinct modes of action and therefore, is unlikely to interact with each other. The likelihood of interaction among the novel proteins is not considered significant enough to affect the stability and expression level of each other.
The consequences of the potential adverse effects were assessed in terms of the allergenicity and toxicity of the novel proteins. Evidences from in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study were considered. The assessors, through the weight-of-evidence approach, concluded that the novel proteins expressed in the multi-stack corn line is not allergenic nor toxic.
Considering the unlikely probability of interaction among the novel proteins and the absence of allergenic or toxic characteristics of these proteins, the assessors concluded that Corn MON87427 x MON89034 x TC1507 x MON87411 x DAS-59122-7 does not pose risks to human and animal health, and to the environment.
The assesors recommended for the approval and issuance of a biosafety permit for direct use as food and feed, or for processing of Corn MON87427 x MON89034 x TC1507 x MON87411 x DAS-59122-7.
EN
The Department of Environment and Natural Resources (DENR BC), after a thorough scientific review and evaluation of documents and scientific evidence from literature of corn MON 87427 x MON 89034 x TC1507 x MON 87411 x DAS-59122-7, considered the regulated article safe to the environment, particularly on biodiversity and non-target organisms.
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize MON-89Ø34-3, DAS-Ø15Ø7-1, MON-87411-9, DAS-59122-7 and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-87411-9 × DAS-59122-7.
Yes
Yes
Yes
Yes
Yes
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
