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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 DAS 40278-9 for Direct Use as Food, Feed and for Processing
EN
20 Jan 2017
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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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DAS-4Ø278-9 - Enlist™ Maize| Dow AgroSciences GmbH | Resistance to herbicides, Tolerance to 2,4-Dichlorophenoxyacetic acid, Tolerance to aryloxyphenoxypropionate
- DA-BPI Biotechnology Office [ English ]
The risk assessment conducted by multiple regulatory bodies concluded that corn DAS 40278-9 is as safe as its conventional counterpart for human food and animal feed. The Scientific, Technical Review Panel (STRP), Bureau of Plant Industry - Plant Products Safety Services Division (BPI-PPSSD), and the Bureau of Animal Industry - Biotechnology Team (BAI-BT) agreed on its safety, while the Department of Environment and Natural Resources-Biosafety Committee (DENR-BC) recommended issuing a biosafety permit, provided environmental conditions are met. Similarly, the Department of Health-Biosafety Committee (DOH-BC) found no significant health or environmental risks and supported permit issuance. Additionally, experts on socio-economic, ethical, and cultural considerations also endorsed the approval after evaluating its potential impact.
Unintended compositional changes resulting from the insertion of genes that confer herbicide tolerance
Proximate analysis for grain showed no differences across the six sites between control and transgenic lines for fat ash, NDF and TDF. Fiber was within the reported literature range. A significant overall treatment effect was found for moisture but this did not show significance in the paired t-test or after adjustment for FDR. The differences in the values are not considered biologically meaningful because these were statistically low and in most cases was resolved after applying adjustment for false discovery rate (chance). The values obtained still fall within those reported in the literature. There were also no significant differences in proximate analysis of forage, in control and transgenic lines for moisture, ADF, NDF, Ca and P.
No statistically significant differences were observed between corn event DAS-40278-9 grain (sprayed or unsprayed) for palmitic, stearic. Anti-nutrients like raffinose were below the level of quantification (LOQ) for the transgenic and non-transgenic control lines.
The presence of gene products, residues, and metabolites in terms of animal health and human safety as it relates to the potential transfer of residues into foods of animal origin, and worker and/or bystander exposure to the feed.
The safety of the AAD-1 protein expressed in corn DAS-40278-9 has been extensively tested and found to be safe for consumption. The safety testing involved established methods that assess whether the protein is allergenic or toxic.
In addition to safety testing, corn DAS-40278-9 has also undergone compositional testing to compare its nutrient content with non-GM maize crops. The results of the testing did not show any significant nutritional differences between the two types of maize.
Furthermore, feeding studies conducted on broiler chickens showed no evidence of difference in nutritional performance variables between corn DAS-40278-9 grain and corn grain from non-GM crops.
Taken together, these findings suggest that corn DAS-40278-9 is safe for consumption and does not pose any significant nutritional differences compared to non-GM maize crops.
The risks are acceptable/manageable.
As would be anticipated with a large number of variables being evaluated in a comparison study, there were a number of statistically significant differences observed between some of the individual treatment group. However, when considered within the context of historical values, it was demonstrated that the differences were statistical in nature and not biologically relevant or adverse.
As previously reported toxicology studies with other GM corn crops, there was no evidence of adverse effects in rats consuming diets formulated with corn grain from corn DAS-40278-9. These results support the conclusion that corn grain from DAS-40278-9 is as safe and nutritious as non-GM corn grain.
No competitive advantage was conferred to these plants, other than that conferred by tolerance to 2,4-D and the "fop" (fatty acid synthesis inhibitors) herbicides. Tolerance to these herbicides will not, in itself, render corn weedy or invasive of natural habitats, because none of the reproductive or growth characteristics were modified.
Event-specific Method for the Quantification of Corn DAS-40278-9 using Real-time PCR
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.
Yes
Yes
Yes
Yes
Yes
The low potential toxicity of the AAD-1 protein expressed in corn DAS-40278-9 was demonstrated in a number of ways:
- Bioinformatics analysis of the AAD-1 protein using a BLASTp search algorithm against the GenBank and FASTA program. Results of bioinformatics analysis did not identify any sequence similarity with any known toxins that are harmful to humans or animals.
- An acute oral toxicity study with AAD-1 protein was conducted in mice at a level of 2000 mg AAD-1/kg. No mortality, clinical signs and treatment-related gross pathological observations were reported during the study.
- The thermal stability of the AAD-1 protein was evaluated by heating protein solutions for 30 min at 50, 70 and 95oC. Results of the SDS-PAGE analysis showed that the AAD-1 protein was undetectable upon heating at 50, 70 or 95°C for 30 minutes. Immunoreactivity and enzymatic activity of AAD-1 decreased by 100%uponheattreatment at 50°C. Only 0.2% immunoreactivity and 3.0% enzymatic activity was detected upon heat treatment at 90°C.
- Science Direct [ English ]
