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Risk Assessment generated by a regulatory process
(RA)
published: 04 Jan 2025
last updated: 28 Mar 2025
Safety Assessment of Corn 5307 for Direct Use as Food, Feed, or for Processing
EN
21 Jun 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:Department of Agriculture (DA)Government agency (National/Federal)Elliptical Road, Diliman, Quezon City PhilippinesQuezon City, Quezon City
1100, PhilippinesPhone: +632 920-3896, +632 924-1278 local 2802, +632 920-3986,Fax:Email: osec.da@gmail.com,Website: https://www.da.gov.ph,
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SYN-Ø53Ø7-1 - Agrisure® Duracade™ Maize| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Western corn rootworm (Diabrotica virgifera), Northern corn rootworm (Diabrotica barberi))
The assessors,- the Scientific and Technical Review Panel (STRP), Bureau of Plant Industry Plant Products Safety Services Division (BPI-PPSSD), and Bureau of Animal Industry Biotech Team (BAI-BT)- after reviewing the Risk Assessment Report and attached technical dossier, found that Corn 5307 is as safe for human food and animal feed as conventional corn. The Department of Environment and Natural Resources Biosafety Committee (DENR-BC) and the Department of Health Biosafety Committee (DOH-BC) concluded that Corn 5307 will not pose any significant risk to health and the environment and, therefore, recommended for the issuance of a biosafety permit for the regulated article provided that the conditions set by the Departments are complied.
The novel proteins- the Bacillus thuringiensis chimeric protein eCry3.1Ab and the Escherichia coli phosphomannose isomerase (PMI) enzyme- may elicit toxic or allergenic responses when ingested.
The expression of eCry3.1Ab and PMI in the edible portions of the plant are at low levels and do not constitute a concern. The assessors noted that the percentages of eCry3.1Ab and PMI from the total protein in the kernels of Corn 5307 are 0.0077% and 0.0025%, respectively. Therefore, the likelihood of exposure to these novel proteins via ingestion is insignificant.
The evidences for the potential toxicity and allergenicity of the novel proteins in Corn 5307 were investigated via in silico analysis of sequence similarity to known allergens and toxins, digestibility assay, heat stability study, and oral gavage study. The results of these tests point to the conclusion that the eCry3.1Ab and PMI proteins expressed in Corn 5307 are not toxic nor allergenic.
Digestibility assays on eCry3.1Ab and PMI proteins demonstrated that these are rapidly degraded, i.e., with no intact protein nor fragments thereof observed using Western blot after 1 minute of incubation in pepsin. Heat stability studies also show that eCry3.1Ab and PMI are denatured and, therefore, loses bioreactivity at 95°C. Additionally, similarity search on toxin and allergen databases indicate the absence of sequence similarity of eCry3.1Ab and PMI with known toxins or allergens. Finally, oral gavage studies in mice resulted in no treatment related effects.
In view of these, the pathway to harm for eCry3.1Ab and PMI proteins cannot be realized. Therefore the overall risk for Corn 5307 is negligible.
In view of these, the pathway to harm for eCry3.1Ab and PMI proteins cannot be realized. Therefore the overall risk for Corn 5307 is negligible.
The risk assessors, after reviewing the comparison of values of nutritional components, concurred that enough evidence supports the substantial equivalence of Corn 5307 with its conventional counterpart. It is therefore concluded that Corn 5307 is as safe as its conventional counterpart. Additionally, the DENR-BC noted that the chances of unintended release or planting of Corn 5307 is very minimal because the potential receiving environments e.g., ports and roads, are not conducive for plant growth. Hence, the regulated article will not cause any lasting effects to the environment.
The assessors agreed that Corn 5307 is as safe as its conventional counterpart to human and animal health and to the environment. The assessors therefore recommended for the issuance of a biosafety permit for direct use as food and feed or for processing for Corn 5307.
The assessors agreed that Corn 5307 is as safe as its conventional counterpart to human and animal health and to the environment. The assessors therefore recommended for the issuance of a biosafety permit for direct use as food and feed or for processing for Corn 5307.
The assessors requested BPI to issue clear instructions to the applicant that Corn 5307 shall be used solely for direct use as food, feed, or for processing and, therefore, shall not be used as planting material.
Corn 5307 was applied solely for direct use, hence, no actual propagation or planting shall be allowed to occur. The scope of this application only covers the importation and use for food and feed, or for processing of Corn 5307 and its derived products in the Philippines. Further, the potential for the regulated article to be propagated is highly unlikely and the possibility for its unintended release, i.e., dispersal during transport, is minimal since areas along the transport route are not conducive for plant growth. Assessors additionally clarified to the applicant that Corn 5307 is approved solely for direct use and is not to be used as planting material.
Corn 5307 can be detected via event-specific quantitative real-time quantitative PCR.
Yes
Yes
Yes
Yes
Yes
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