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Risk Assessment generated by a regulatory process (RA)
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BCH-RA-PH-278440-1   |   PDF   |   Print   |  
last updated: 23 Apr 2025
General Information
Safety Assessment of Corn MON 87429 for Direct Use as Food, Feed, or for Processing
EN
25 Jun 2020
Risk assessment details
  • MON-87429-9 - Dicamba, glufosinate, quizalofop and 2,4-dicholorophenoxyacetic acid tolerant maize with tissue-specific glyphosate tolerance
    | Monsanto | Resistance to herbicides (Glufosinate, Glyphosate), Tolerance to 2,4-dichlorophenoxyacetic acid, Tolerance to 3,6-dichloro-2-methoxybenzoic acid (dicamba), Tolerance to quizalofop
After reviewing the risk assessment report and the attached technical dossier submitted by the applicant, the Scientific and Technical Review Panel (STRP), Bureau of Animal Industry (BAI), and Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), Department of Health – Biosafety Committee (DOH-BC), Department of Environment and Natural Resources – Biosafety Committee (DENR-BC), and the  and the Department of Health Biosafety Committee (DOST-BC) concurred that (1) Corn MON 87429 is as safe as its conventional counterpart and (2) will not pose any significant risk to human health and the environment. 
EN
Methodology and points to consider
The novel proteins Streptomyces viridochromogenes phosphinothricin N-acetyltransferase (PAT), Stenotrophomonas maltophilia dicamba monooxygenase (DMO), modified version of the RdpA protein from Sphingobium herbicidovorans (FT_T), and CP4 EPSPS derived from Agrobacterium sp. strain CP4 can potentially be new allergens or toxins, or have homology with known allergens or toxins.
EN
In terms of exposure, the assessors noted that the DMO, FT_T and CP4 EPSPS proteins are expected to accumulate in the chloroplast. In contrast, no such contiguous sequence is observed in the pat gene, and the expressed PAT protein then is assumed to accumulate in the cytoplasm. In addition, results showed that the DMO, PAT, FT_T, and CP4 ESPS proteins are easily digested in pepsin or pancreatin. Considering that the expressed proteins would be completely degraded before being absorbed in the gastrointestinal tract, exposure is unlikely. 
EN
The potential allergenicity and toxicity of the novel proteins were investigated through sequence homology analysis where results showed that the DMO, FT_T, and CP4 ESPS proteins have no biological sequence similarities with any other known toxins or other biologically active proteins of concern. In the case of PAT protein, there were 23 alignments with bacterial toxin-antitoxin system proteins. However, this does not provide any indication that the PAT protein would adversely impact human or animal health. 

Results of an acute oral toxicity of the novel proteins showed that there were no observable treatment-related effects on survival, body weight gain, food consumption or any clinical and pathological changes on the experimental animal. Based on the review of the scientific evidences provided, the assessors concluded that the novel proteins DMO, PAT, FT_T, and CP4 EPSPS are not toxic or allergenic.
EN
Digestibility test showed that DMO protein, PAT protein, and CP4 ESPS protein are readily degraded in either pepsin or pancreatic enzyme unlikely to pose a human and animal health concern. In the case of FT_T protein, it was readily degraded in pancreatic enzyme but not in pepsin enzyme alone. However, during the sequential digestion, pepsin enzymes became easily degraded. The assessors further noted that DMO, PAT,  and FT_T are functionally inactivated and degraded by heat treatment at 55°C and above at 15 min or beyond, while the same analyses demonstrated the inactivation of the CP4 EPSPS protein at temperatures above 75°C for exposures at 15 minutes. Additionally, the results of acute oral gavage showed that there were no test substance-related differences in mean body weights, mean body weight changes, or mean food consumption when MON 87429 DMO protein was administered by oral gavage at a dose of 1000 mg/kg body weight in male and female CD-1 mice. This is the same for PAT protein and FT_T protein that were both administered at a dose of 2000 mg/kg body weight in male and female CD-1 mice. There were also no treatment related adverse effects observed in animals dosed with CP4 EPSPS protein at 572 mg/kg body weight. The novel proteins were also compared to allergen and toxin databases and no biologically significant similarities were noted. 

In consideration of the unlikely and the results of the toxicological and allergenicity assessments of the novel proteins DMO, PAT, FT_T, and CP4 EPSPS, the assessors deemed that the overall risk for Corn MON87429 is negligible. 
EN
Based on the evidences presented, the risk assessors concurred that Corn MON87429 is as safe as its conventional counterpart and shall not pose any significant risk to human health or the environment. Therefore, the approval and issuance of a biosafety permit for direct use as food and feed or for processing for Corn MON87429 was recommended. 

Risk assessors additionally set conditions for the transport of Corn MON87429 where the importer shall ensure the proper and secure packaging of the regulated article. 
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Assessors recommended the strict monitoring of the regulated article from the port of entry to the traders/importers storage/warehouse.
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Corn MON87429 is applied for direct use, hence the scope of the risk assessment for the application did not cover considerations on the receiving environment.
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Corn MON87429  is detectable using event-specific real-time quantitative PCR-based method.
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Information sharing with other databases
Yes
Yes
Yes
Yes
Yes
Additional information
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