EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY 

NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL 

REGISTER

EPA Biopesticides and Pollution Prevention Division contact:

SUBMISSION: E-mail the completed template to:

TEMPLATE:

J.R. Simplot Company

5G8375

EPA has received a pesticide petition 5G8375 from J.R. Simplot Company, 5369 

W. Irving St., Boise, ID 83706 proposing, pursuant to section 408(d) of the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to 

establish an amendment/expansion of an existing tolerance exemption for the plantpesticide the VNT1 protein product of the Rpi-vnt1 gene in or on potato. Pursuant to 

section 408(d)(2)(A)(i) of FFDCA, as amended, J.R. Simplot Company has submitted the 

following summary of information, data, and arguments in support of their pesticide 

petition. This summary was prepared by J.R. Simplot Company and EPA has not fully 

evaluated the merits of the pesticide petition. The summary may have been edited by 

EPA if the terminology used was unclear, the summary contained extraneous material, or 

the summary unintentionally made the reader conclude that the findings reflected EPA’s 

position and not the position of the petitioner.

I. J.R. Simplot Company Petition Summary

5G8375

A. Product Name and Proposed Use Practices

Potato containing the VNT1 protein. The VNT1 protein is expressed from the 

Rpi-vnt1 gene and confers resistance to Phytophthora infestans, the cause of late blight 

disease in potato.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues.

The active ingredient that provides late blight resistance in potato is the VNT1 

protein produced from the Rpi-vnt1 resistance gene. The Rpi-vnt1 gene is from the wild 

potato species, Solanum venturii.

 Name: Rpi-vnt1 Resistance Gene and VNT1 protein.
 Chemical Identity: Nucleic acid (including promoter, coding sequence, and 

terminator) and translated amino acid polypeptide.

 Composition: Potato events were generated by Agrobacterium-mediated plant 

transformation. Confirmation of gene insertion was carried out using PCR, 

Southern blot, and immunoblot methods based on the gene and protein sequences.

2. Magnitude of residues at the time of harvest and method used to determine the 

residue.

Less than 30 ppb in tubers as determined by immunoblot detection. It is estimated 

that the active ingredient, VNT1 protein, is less than 0.000003% of potato.

3. A statement of why an analytical method of detecting and measuring the levels 

of the pesticide residue are not needed.

The VNT1 protein concentration is lower than the detectable limit of 30 ppb in 

tubers. As the expression levels of the VNT1 protein are below detection limits it is 

impractical to demonstrate methods for detecting and measuring the levels of the 

pesticide residues.

C. Mammalian Toxicological Profile

Safety assessments of the VNT1 protein and Rpi-vnt1 resistance gene were 

carried out to determine the mode of action, history of safe use, similarity to known 

toxins or allergens, and expression levels in planta. These safety assessments 

demonstrate the safety of the VNT1 protein.

Proteins are not inherently toxic due to rapid denaturation by the acidic conditions 

of the stomach, and degradation by proteases secreted in the intestinal tract.

Resistance genes (R-genes) have a non-toxic mode of action and are found in 

multiple plant species, including: Solanum melongena L. (eggplant), Capsicum annum L. 

(pepper), Solanum lycopersicum L. (tomato), Solanum tuberosum L. (potato), Zea mays

(maize), Glycine max (soybean), Oryza sativa L. (rice), and Triticum aestivum L. (wheat). 

R-genes are an important part of a plants immune response to pathogen infection. They 

are protein receptors that recognize and bind pathogen-secreted proteins. Upon pathogen 

recognition, a form of programmed cell death is activated causing infected plant cells to 

die, blocking the spread of infection.

A NCBI database search for homologs of the VNT1 protein and the Rpi-vnt1 gene 

identified potato and tomato genes with high sequence similarity. An example is the 

tomato gene Tm-2, which provides resistance to the tomato mosaic virus (TMV), and is 

90% similar to Rpi-vnt1 in nucleic acid sequence. The encoded proteins Tm-2 and VNT1 

are 75% identical in amino acid sequence. A search of tomato variety databases and retail 
websites show seventy-eight varieties and two rootstocks of TMV resistant tomato. These 

examples demonstrate a history of safe use for proteins similar to VNT1.

A bioinformatics analysis showed no sequence similarity between the VNT1 

protein or any known allergen or toxin.

A sensitive immunoblot method was used to determine that the VNT1 protein is 

expressed at levels below the detection limit of 30 ppb in tubers. It is estimated that the 

active ingredient, VNT1 protein, is less than 0.000003% of potato. Effects on humans 

and on non-target organisms, including plants, insects, mammals, birds, and aquatic life 

would be negligible because of the lack of exposure.

D. Aggregate Exposure

1. Dietary exposure.

The VNT1 protein is similar to other proteins to which people are exposed in their 

diet without adverse effects. Because of the low expression levels of the VNT1 protein

the exposure to humans is negligible.

i. Food.

The VNT1 protein is expressed in potato. Human exposure is expected from 

eating potato. The VNT1 protein is not similar to any known allergens or toxins. The

VNT1 protein is expressed at low levels. The low exposure minimizes risk associated 

with the VNT1 protein.

ii. Drinking water.

Human exposure is not expected through drinking water.

2. Non-dietary exposure.

The VNT1 protein is a plant-incorporated protectant. Other uses where human 

exposure might occur are not intended or expected.

E. Cumulative Effects

Human exposure to the VNT1 protein from diet, food, drinking water, or other 

occupational or residential use is negligible.

F. Safety Determination

1. U.S. population.
The VNT1 protein is unlikely to pose risk to human health. Study reports 

assessing the safety of the VNT1 protein demonstrate a non-toxic mode of action for the 

VNT1 protein, a history of safe use for homologous proteins in potato and tomato, and no 

significant sequence similarities between VNT1 and known allergens or toxins. The 

VNT1 protein concentration was shown to be below detectable limits, less than 30 ppb in 

tubers. Defining a tolerance limit for the VNT1 protein is not practical considering the 

low expression and low exposure risk of the VNT1 protein.

2. Infants and children.

The VNT1 protein is unlikely to pose risk to infants or children.

G. Effects on the Immune and Endocrine Systems

The VNT1 protein is unlikely to cause effects on the immune and endocrine 

systems.

H. Existing Tolerances

A current temporary exemption from the requirement of a tolerance [EPA-HQOPP-2014-0457; FRL-9922-53] established for residues of the VNT1 protein in potato

expires on December 31, 2015.

I. International Tolerances

None.