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Risk Assessment generated by a regulatory process
(RA)
published: 11 Mar 2023
last updated: 27 Feb 2025
Determination for the Safety Assessment of Corn 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 for Direct Use as Food, Feed and for Processing
EN
16 Dec 2016
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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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SYN-E3272-5 × SYN-BTØ11-1 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 - Modified thermostable alpha-amylase, insect-resistant, herbicide-tolerant maize| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate), Selectable marker genes and reporter genes, Use in industrial applications (Biofuel production)
- DA-BPI Biotechnology Office [ English ]
After reviewing the Risk Assessment Report and attachments submitted by the applicant; the Scientific and Technical Review Panel (STRP) member, BPI-Plant Products Safety Services Division (BPI-PPSSD) and Bureau of Animal Industry (BAI) has found no interaction of the resulting gene product of the regulated article applied for direct use as food and feed, or processing based on scientific evidences provided. After thorough scientific review and evaluation of Syngenta’s duly accomplished Environmental Risk Assessment (ERA) and Project Description Report (PDR) forms, the Department of Environment and Natural Resources – Biosafety Committee (DENR-BC), recommended for the issuance of a biosafety permit for this regulated event provided that the conditions set by DENR are complied. Also, the Department of Health – Biosafety Committee (DOH-BC), after a thorough scientific review and evaluation of the accomplished Environmental Health Risk Assessment form, concluded that corn 3272 x Bt11 x MIR604 x TC1507 x 5307 x GA21 will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department.
Amy797E in 3272, Cry1Ab in Bt11, mCry3A in MIR604, Cry1F in TC1507, eCry3.1Ab in 5307, mEPSPS in GA21, PAT in Bt11 and TC1507, and PMI in 3272, MIR604 and 5307 being expressed in the combined trait product, DMO and CP4 EPSPS, will produce new or identified allergen or toxin.
Corn hybrid 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 plants produce the proteins AMY797E, Cry1Ab, mCry3A, Cry1F, eCry3.1Ab, PAT, PMI, MIR604 PMI and mEPSPS. AMY797E catalyses the hydrolysis of starch by cleaving the internal α-1,4-glucosidic bonds into dextrins, maltose and glucose. Cry1Ab, mCry3A, Cry1F and eCry3.1Ab control certain lepidopteran and coleopteran pests. PAT and mEPSPS confer tolerance to herbicide products containing glufosinate-ammonium and glyphosate, respectively. The AMY797E, Cry1Ab, mCry3A, Cry1F, eCry3.1Ab, PAT, PMI, MIR604 PMI and mEPSPS proteins produced in 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 maize are identical to the proteins produced in 3272, Bt11, MIR604, 1507, 5307 and GA21 maize. All of these proteins have been previously assessed individually.
None of the newly expressed proteins, AMY797E, Cry1Ab, mCry3A, Cry1F, eCry3.1Ab, PAT, PMI, MIR604 PMI, and mEPSPS, are structurally or functionally related to proteins which have the potential to adversely affect human or animal health; they are rapidly degraded in in vitro digestibility assays; have no biologically relevant sequence similarity to known or putative mammalian protein toxins; and show no acute oral toxicity in mammalian studies
The probability of horizontal gene transfer (HGT) between the corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 insert and micro-organisms was investigated in silico, and no sequences were identified as being able to promote homologous recombination. The HGT from GM plants to bacteria with subsequent expression of the transgene is regarded as a highly unlikely event under natural conditions, especially in the absence of selective pressure. No changes in the ability of the 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 maize to transfer genetic material to other organisms are expected compared to conventional maize since no sequences have been introduced to allow this to occur.
Maize food and feed products have a long history of safe use. No significant native toxins are reported to be associated with the genus Zea. The information presented in the application confirms that corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 and derived food and feed products are not materially different from those of its conventional maize. The molecular characterization of corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 did not raise any safety concerns or identify any unintended changes as a result of the genetic modification. Data from the compositional analysis suggests that, overall, the corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 and conventional corn are not materially different. The agronomic and phenotypic characteristics of corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 plants, except for the introduced traits, are not different to those of its conventional counterpart comparator, taking into account natural variation. Characterization of AMY797E, Cry1Ab, mCry3A, Cry1F, eCry3.1Ab, PAT, PMI, MIR604PMI and mEPSPS proteins, and evidence of history of safe use of Bt proteins, mEPSPS and PAT, continue to confirm that these proteins are safe for human and animal consumption, and that no adverse effects on human and animal health can be expected. The genetic modification in corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 is not intended to improve the nutritional status of individuals or populations. The product is enhancing the ethanol production and is intended to be commercialized accordingly. The exposure assessment in humans and animals did not indicate any safety concerns, and dietary role of corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 is intended to be the same as the dietary role of conventional maize.
Safety evaluation of DMO and PAT proteins in MON 87419 involves assessment for amino acid sequence similarities to known allergens and toxic proteins, digestibility experiments utilizing proteases in gastrointestinal tract, functional activity after application of heat, acute toxicity assays all provide data to support a conclusion that food and feed products that contain DMO and PAT proteins from MON 87419 corn and its progenies are safe and nutritious as foods and feeds derived from conventional maize.
A biosafety permit for direct use can be issued for the said event.
The presence of Corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 or its derived products in food and feed will not result in any nutritional changes. Therefore, post-market monitoring of 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 maize food/feed is not considered necessary.
Corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 has been developed to enhance the ethanol production and to confer resistance against certain insect pests and to provide tolerance to certain herbicides. However, the scope of this application covers the import and food and feed use of corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 and derived products in the Philippines. Therefore, exposure of target organisms to corn leaves and roots of corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 will be highly unlikely.
Corn hybrid 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 is detectable using the event-specific real-time quantitative PCR methods for 3272, Bt11, MIR604, 1507, 5307 and GA21 corn events, respectively.
Yes
Yes
Yes
Yes
Yes
The genetic modifications in the single events present in Corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 are not intended to change any of the typical crop characteristics of maize (except for the enhancement of the ethanol production and control of certain insect pests and weeds). Observations from field trials have confirmed that the agronomic and phenotypic characteristics of corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 have not changed in comparison with the conventional maize, and therefore, there is no increase or decrease in the potential for plant-to-plant gene transfer of corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 compared to traditional corn. Gene transfer from corn 3272 x Bt11 x MIR604 x 1507 x 5307 x GA21 to other sexually compatible plant species is not possible since there are no indigenous populations of sexually compatible wild relatives in the Philippines. In addition, since the scope of this application does not include authorization for the cultivation, the likelihood of dissemination of pollen to other plants (including cultivated corn plants) is considered to be negligible.
- InfoGM [ English ]
| Record type | Field | Record(s) | |
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| Country's Decision or any other Communication | Risk assessment | 1 | |
