Notice of Submission for Approval of Novel Food, Livestock Feed and Environmental Safety for Innate™ Potatoes with Low Acrylamide Potential and Reduced Black Spot: Events E12 (Russet Burbank); F10 (Ranger Russet); J3 and J55 (Atlantic) from J.R. Simplot Company

Comment period closed: November 2, 2015

Background

The Canadian Food Inspection Agency (CFIA) and Health Canada (HC) received a submission from the J.R. Simplot Company seeking approval for unconfined environmental release, human food, and animal feed use of four potato events designated as E12 (Russet Burbank), F10 (Ranger Russet), J3 (Atlantic), and J55 (Atlantic). Each event was modified to lower expression of native potato genes for improved tuber quality.

To reduce acrylamide, reducing sugars and black spot, four potato genes were targeted for down regulation using RNAi: (1) asparagine synthetase 1 (Asn1) for its role in asparagine production; (2) polyphenol oxidase (Ppo5) for its role in darkening of cut potato tubers resulting in black spot; (3) water dikinase R1 (R1) for its role in converting starch to reducing sugars; and (4) phosphorylase-L (PhL) for its role in converting starch to reducing sugars. Lowering free asparagine and reducing sugar levels reduces the potential for acrylamide formation when potatoes are cooked at high temperatures (see Description of the Novel Traits below).

The submission is in accordance with CFIA guidelines for plants with novel traits (PNTs) for unconfined release, CFIA guidelines for novel feeds from PNTs, and HC guidelines for novel foods. To view information related to the environmental assessment of a plant with novel trait (PNT) or the assessment of a novel feed derived from PNTs, please refer to the CFIA website. To view the information related to the health and safety assessment of a novel food, please refer to the Health Canada website.

Summary of the Submission Package

Description of the Host Plant

Three commercial varieties of potatoes (Russet Burbank, Ranger Russet, and Atlantic) were transformed with the same construct to reduce black spot and to lower the potential for acrylamide formation during processing. More details on potato varieties and potato biology can be found in the CFIA document, The Biology of Solanum tuberosum (L.) (Potatoes).

Description of the Modification

The J. R. Simplot Company improved the tuber quality of three commercial potato varieties transformed with the same construct. The genetic elements used in the T-DNA were derived from potatoes and no marker genes were inserted. In order to assess the safety of the events, the following information was submitted:

  • Development of potato events
  • Description of donor DNA
  • Description of the transformation system
  • Open reading frames associated with the DNA insert
  • Mechanism for gene down-regulation
  • Characterization of inserted DNA
  • Evidence for the absence of vector backbone DNA

Stability of the Introduced Trait

The stability of the insert within each of the events was assessed using molecular approaches.

Description of the Novel Traits

Two potato quality issues were addressed: (1) the role free asparagine and reducing sugars play in the formation of acrylamide upon frying or baking; and (2) susceptibility to darkening when polyphenol oxidase leaks from damaged plastids in bruised or cut potatoes. In order to confirm the novel traits, the following data were submitted:

  • Down-regulation of target genes
  • Trait efficacy
  • Compositional analyses of free amino acids, reducing sugars, and acrylamide

Allergenicity/Toxicity Considerations

An evaluation of toxicity and allergenicity potential was performed for each event. These assessments did not identify any safety concerns and are described in:

  • Toxicology and allergenicity
  • Compositional analyses

Nutritional Evaluation of the Novel Plant

The nutritional composition of each potato event was compared with the corresponding conventional potato variety. Based on the results of these analyses, Simplot has concluded that these events are compositionally equivalent to their conventional varieties with respect to nutrients and anti-nutrients and are as safe and nutritious for food and feed as other conventional potatoes that have a long history of safe consumption.

This assessment is described in the Compositional Assessment section which included:

  • Proximates, total amino acids, vitamins, minerals and glycoalkaloids

Evaluation of the Environmental Impact of the Novel Plant

The four events were reviewed to determine the potential risk to the environment following the five criteria as detailed in Regulatory Directive 94-08:

  • Examination of potential to become a weed of agriculture or be invasive of natural habitats,
  • Examination of potential for gene flow to sexually compatible plants whose hybrid offspring may become more weedy or more invasive,
  • Examination of potential to become a plant pest,
  • Examination of potential impact on non-target species, including humans,
  • Examination of potential impact on biodiversity.

Comparative assessments were made during field trials at multi-locations. A complete review was provided, and this includes the following:

  • Environmental safety assessment
  • Detection methods for potato events
  • Crop introduction and the potato industry

For more information on these potato products, please contact:

J.R. Simplot Company
P.O. Box 27
Boise, ID 83707
U.S.A.
Telephone number: 208-780-6000

The CFIA and Health Canada, including their employees, are not responsible for the content of this Notice of Submission as submitted by the Applicant. All Notices of Submission are the responsibility of the Applicant submitting them and the Applicant does so at their own risk. Submission of this Notice of Submission and its subsequent posting by the CFIA on its website does not in any way whatsoever constitute acceptance, approval or certification by the CFIA or Health Canada of the Plant with Novel Trait(s) subject of the Notice of Submission and the CFIA and Health Canada reserve all their rights under all the pertinent legislation that may be applicable. The CFIA and Health Canada in no way whatsoever waives any of their rights under any of the legislation they enforce or administer by way of the CFIA posting this Notice of Submission.

The Applicant is not required to provide a Notice of Submission. The information that the Applicant voluntarily provides on this Notice of Submission is collected by the CFIA and Health Canada for the purpose of sharing information with the public. Personal Information will be protected under the provisions of the Privacy Act, and will be stored in Personal Information Bank CFIA PPU 125. Information, including personal information, may be accessible or protected as required under the provisions of the Access to Information Act.

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