EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY

NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL

REGISTER

J.R. Simplot Company

EPA Reg. #8917

EPA has received a pesticide petition #5F8425, 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 VNTl protein product of the Rpi-vntl 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

#5F8425

A. Product Name and Proposed Use Practices

The W8 Russet Burbank, X17 Ranger Russet, and Y9 Atlantic Potato varieties, 

containing the VNTl protein. The VNT l protein is expressed from the Rpi-vntl gene

originating from Solanum venturii 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 VNTl

protein produced from the Rpi-vntl resistance gene from Solanum venturii.

• Name: Rpi-vntl Resistance Gene and VNTl 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 100 ppb in tubers as determined by immunoblot detection. Itis 

estimated that the active ingredient, VNTl protein, is lessthan 0.00001% of potato .

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

of the p esticide residue are not needed.

The VNTl protein concentration is less than 100 ppb in tubers. As the expression

levels of the VNTl 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

Assessments of the VNTl protein and Rpi-vntl resistance gene were carried out

to determine the mode of action, history of safe use, similarity to known toxins or

allergens, and expression levels inplanta. No safety concerns of the VNTl protein were

identified.

Proteins are not inherently toxic and are rapidly denatured by the acidic

conditions of the stomach and 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), S. lycopersicum L. (tomato), S. tuberosum L. (potato), Zea mays (maize),

Glycine max (soybean), Oryza saliva 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 VNTl protein and the Rpi-vntl gene

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

tomato gene Tm-22, which provides resistance to the tomato mosaic virus (TMV), and is

90% similar to Rpi-vntl in nucleic acid sequence. The encoded proteins Tm-22 and VNTl

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 VNTl.
A bioinformatics analysis showed no sequence similarity between the VNTl

protein or any known allergen or toxin demonstrating a low hazard to humans.

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

expressed at less than 100ppb in tubers. Itis estimated that the active ingredient, VNTl

protein, islessthan 0.00001% 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 VNTl 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 VNTl protein

the exposure to humans is negligible.

i.Food.

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

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

VNTl protein is expressed at low levels. The low hazard and low exposure minimizes

risk associated with the VNTl protein.

ii.Drinking water.

Human exposure is not expected through drinking water.

2. Non-dietary exposure.

The VNTl 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 VNTl protein from diet, food, drinking water, or other

occupational or residential use is negligible.

F. Safety Determination

1. U.S. population.

The VNTl protein is unlikely to pose risk to human health. Study reports

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

VNTl protein, a history of safe use for homologous proteins in potato and tomato, and no
significant sequence similarities between VNTI and known allergens or toxins. The

VNTl protein concentration was shown to be less than 100 ppb in tubers. Defining a

tolerance limit for the VNTl protein is not practical considering the low expression and 

low exposure risk of the VNTl protein.

2. Infants and children.

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

G. Effects on the Immune and Endocrine Systems

The VNTI 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 VNTl protein in potato

expires on December 31, 2015. An extension for the temporary tolerance is currently

under review (508375).

I. International Tolerances

None.