Philippines | BCH-RA-PH-258566 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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BCH-RA-PH-258566-1   |   PDF   |   Print   |  

Risk Assessment generated by a regulatory process (RA)

last updated: 06 Jan 2022
General Information
Determination for the Safety Assessment of POTATO Y9 for Direct Use as Food, Feed and for Processing
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Date not available
Risk assessment details
  • SPS-ØØØY9-7 - Innate® Hibernate Atlantic 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)
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; designed to generate dsRNA to down regulate R1 transcripts which lowers reducing sugars; downregulates VInv transcripts which lowers reducing sugars
 
Foliar late blight resistance - confers resistance to potato late blight
 
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Methodology and points to consider
Potato is a natural source of antinutrients such as protease inhibitors and lectins. It is also a natural source of the toxicant class called glycoalkaloids, specifically alpha-chaconine and alpha-solanine. In addition, potato is a source of, and an eliciting agent of allergy, specifically, patatin.
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Antinutrients are readily inactivated by heating/cooking. It is widely known that potato belongs to the group of food allergens. However, allergic reactions are associated mostly in raw potato tubers that are being peeled, and tolerance is common starting 4 years old. Patatin is a storage glycoprotein in the tuber and further processing or heating/cooking of raw tuber result to degradation and lower concentrations.  
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The toxic potential of VNT1 was determined by a bioinformatics approach comparing the VNT1 amino acid sequence to the National Center for Biotechnology Information (NCBI) database queried for protein sequences annotated using the keyword “toxin”. This means that protein sequences evaluated using this method may include 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. Their results were that they did not identify any toxins homologous to the Rpi-vntl (VNT1) coding sequence.

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The VNT1 protein, expressed in POTATO Y9, is indeed non-pathogenic nor allergenic based on the bioinformatic analyses. 

All potentially inserted regulatory elements and backbone sequences, have been adequately described. The regulatory elements were also clearly described, which are essentially cisgenes obtained from a sexually compatible wild relative of potato.
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Potato Y9 will not pose any significant risk to the health and environment and that any hazards could be managed efficiently and effectively.
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The donor organism is the potato plant itself and two other relatives, S. venturii and S. verrucusom. The genes and its expressed proteins do not have a potential toxicogenic or allergenic property in humans or animals, and have a long history of safe use in crop genetic improvement thru recombinant DNA technology.
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The application of Potato Y9 is not for propagation. This LMO will be directly used for food, feed and for processing.

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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.

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Information sharing with other databases
No
Additional information
Field efficacy trials demonstrated that Y9 potatoes were protected against foliar late blight infection, even though the VNT1 protein was undetectable. These results demonstrate that the invertase down regulation and late blight protection traits are functioning as intended in Y9 potatoes, and that the small deletion from the LB end of the T-DNA did not affect the target traits. Southern blot analysis results with a series of probes spanning the plasmid backbone sequence, and the result clearly showed that plasmid backbone was not incorporated in the Y9 genome.
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