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Risk Assessment generated by a regulatory process (RA)
last updated: 06 Jan 2022
Determination for the Safety Assessment of POTATO X17 for Direct Use as Food, Feed and for Processing
EN
Date not available
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Competent National Authority:Department of Agriculture ()Elliptical Road, DilimanQuezon City,
1100, PhilippinesPhone: +632 920-3986, +632 924-1278 local 2802,Fax: +632 920-3986,Email: osec.da@gmail.com,Website: http://www.da.gov.ph,
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SPS-ØØX17-5 - Innate® Acclimate Ranger Russet Potato| J.R. Simplot Company | Changes in quality and/or metabolite content (Carbohydrates, Pigmentation / Coloration, Protein and amino acids), Resistance to diseases and pests (Fungi)
- http://biotech.da.gov.ph/ [ English ]
Lowered free asparagine - designed to generate dsRNA to down regulate Asn1 transcripts which lowers asparagine formation
Reduce black spot - designed to generate dsRNA to down regulate Ppo5 transcripts which lowers black spot bruise development
| Lowered reducing sugars - designed to generate dsRNA to down regulate PhL transcripts which lowers reducing sugars; downregulates VInv transcripts which lowers reducing sugars
Foliar late blight resistance - confers resistance to potato late blight
The possible allergenic properties of VNT1 protein in potato X17.
The possible allergenic properties of VNT1 protein in potato X17. was determined bioinformatically by looking at sequence homology of X17 VNT1 against the entries in the AllergenOnline.org database. The results indicate that the VNT1 in X17 does not share homology or similarity with known allergens and toxins.
Using the full-length VNT1 sequence, an 80-mer sliding window and 8-mer exact match in AllergenOnline.org database did not yield significant homology of VNT1 to any known allergen.
Bioinformatics analyses comparing the VNT1 amino acid sequence to the National Center for Biotechnology Information (NCBI) showed no relevant structural similarities to actual toxins, proteins involved in the synthesis of toxins in a host, proteins that interact with toxins, proteins involved in the defense or response to infection, or non-toxic proteins from organisms known to produce a toxin. This indicates that VNT1 will not cause toxicity or health risk to human health.
There is scientific evidence that Potato X17 applied for direct use as food and feed or for processing is as safe as its conventional counterpart and shall not pose greater risk to human and animal health.
Statistical differences in means were observed in the levels of some proximates in X17 compared to Ranger Russet. However, the observed levels were all within the tolerance interval and/or combined literature range for conventional potatoes, demonstrating that the nutritional content of X17 lies within the normal range for conventional potatoes. These results indicate that X17 potatoes are compositionally equivalent to conventional potatoes. The nutritional assessment demonstrated that X17 is as safe as conventional potato varieties, which have a history of safe consumption.
The application of Potato X17 is not for propagation. This LMO will be directly used for food, feed and for processing.
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.
No
Potato X17 has been approved as food in Australia, Canada, New Zealand, and United States of America while it was approved as feed in Canada and the United States of America.
- http://biotech.da.gov.ph/ [ English ]
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