Philippines | BCH-RA-PH-115899 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House


Risk Assessment generated by a regulatory process (RA)

last updated: 19 Feb 2021
General information
Determination for the Safety Assessment of Potato E12 for Direct Use as Food, Feed and for Processing
  • - Competent National Authority: BCH-CNA-PH-46524-5 | BCH-CNA-PH-46524-5
    Competent National Authority
    Department of Agriculture ()
    Elliptical Road, Diliman
    Quezon City,
    1100, Philippines
    Phone: +632 920-3986, +632 924-1278 local 2802,
    Fax: +632 920-3986,
Risk assessment details
  • SPS-ØØE12-8 - Innate™ Russet Burbank Potato
    | J.R. Simplot Company | Changes in quality and/or metabolite content (Pigmentation / Coloration, Protein and amino acids)
Methodology and points to consider
Glycoalkaloids are the reported toxicants contained by potato tubers and are found in its periphery (peeling) and internal part. Other potential toxicants include calystegines; multiple heat-labile proteins that can induce hypersensitivity reactions; patatin which induces allergic reactions; and IgE binding component that neutralize the effects of several proteins (OECD, 2002). Processing of the tubers such as washing, peeling, cutting, rinsing and heat treatment usually result in its removal.
Based on the Southern Blot Analysis, deletion of 24 bp was observed in the LB and 119 bp in the RB. It was verified, based on scientific evidences that the deletions observed in the E12 insert do not have the potential for creating novel chimeric ORFs. Elements of the pSIM1278 DNA inserts are specific to potato and have not been used in approved crops other than potato.
Vegetative propagation may alter processes responsible for genetic variation, meiosis, recombination and segregation. The Southern blot analysis on G0 and G3 plants showed consistent banding pattern demonstrating that the integrity of the insert was maintained across vegetative propagation.
Potato E12 does not produce a novel protein. The T-DNA is designed to down-regulate the Asn, Ppo, PhL,and R1 genes in tubers leading to reduced expression of the ASN, PPO, PhL, and R1 proteins. Northern blot analysis showed reduced expression of Asn and Ppo in the tuber and Asn in the flower. Expression of Asn, Ppo, PhL, and R1 genes in the leaves, stems and roots were unchanged.
Potato E12will not pose any significant risk to the health and environment and that any hazards could be managed by the measures set by the department. History of safe use is attributed on the host organism (Solanum tuberosum) and donor organisms (Solanum tuberosum and S. verrucosum) which are not known to be toxic or allergenic to humans and animals. A biosafety permit for direct use can be issued for the said event.
Weight of evidence approach indicate that Potato E12 is as safe as its conventional counterpart with regards to substantial equivalence and food safety.
The application of potato E12 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.
Additional Information
Potato E12 is intended for direct use as food, feed and for processing.

All relevant references submitted by the technology developer in their application; other references requested by the Scientific and Technical Review Panel (STRP) members during the evaluation of this combined trait product.
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