EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION

COMPANY NOTICE OF FILING TEMPLATE FOR PESTICIDE PETITIONS

PUBLISHED IN THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: Robert McNally, telephone number: (703) 305

- 7090, email address: BPPDFRNotices@epa.gov

BioProdex , Inc.

3E8181

The E PA has received a pesticide petition ( 3 E8181 ) f rom Interregional Research Project Number 4 (IR

- 4), Rutgers University

, 500 Colleg e Rd. East, Suite 201W, Prin ceton, NJ 08540 p roposing, 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 a n exemption from the requirement of a tolerance for the microbial pesticide

, Tobacco mild green mosaic t obamovirus U2 (TMGMV)

.

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended

, IR

- 4 has submitted the following summary of information, data, a nd arguments i n support of its pesticide petition. This summary was prepared by IR

- 4 , an d the EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by the EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected the EPA’s position and not the position of the petitioner.

I. IR

- 4 Petition Summary

3E8181

A. Product Name and Proposed Use Practices

TMGMV is t he active ingredient in the end

- use pesticide product , SolviN ix ®

LC

. SolviN ix ® LC is a postemergence bioherbicide for the control of the weed
, t ropical s oda a pple ( Solanum viarum ). 1.2 fluid ounces of the pesticide product are diluted with 20 gallons of water and is sufficient to treat 2
, 000 tropical soda a pple plants. The crops for which an exemption from the requirement of a tolerance is being r equested include all the commodities of crop group 17 (grass forage, fodder, and hay group) and crop group 18 (nongrass animal feeds (forage, fod der, straw, and hay) group).

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues

. T MGMV is t he active ingredient in the pesticide product
, Solvi N ix ® LC

.2

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

residue

. TMGM V is a natur ally occurring t obamovirus that is found worldwide. The

i ntended use of the pesticide product is to control the weed
, t ropical s oda a pple.
TMGMV normally occurs in some solanaceous vegetables, tobacco s and some clonally propagat ed ornamental plants

. Us e sites include pasture and non crop

areas ; therefore
, the use of th e pesticide product is not expected to impact the

residues of TM GMV on these crops.

3. A statement of why an analytical method of detecti ng and measuring the levels of the pesticide residue are not needed. T MGMV is a naturally occurring t obamoviru s that is found worldwide. A n exemption from the requirement of a tolerance is being requested. T MGMV normally occurs in some solanaceous vegetables , tobaccos , and some clonally propagated ornamental plants . Since it may already be present in

crops , it is indistinguishable from that which is normally present. In addition
, since an exemption from the requirement of a tolerance is being requested
, there is no need to analyze for residues.

C. Mammalian Toxicological Profile

T MGMV is a naturally occurring t obamovirus that is found worldwide. It is a plant virus tha t does not infect nor is toxic or pathogenic to insects, invertebrates, vertebrates, mammals
, or humans. This is due to the fact that the cell surface plays an important role in the early stages of infection of eukaryotes, especially animal

cells. Animal vi ruses interact specifically with surface components
, and plant

viruses , such as TMGMV, lack the cell surface receptors and can only enter plants through plant wounds.

D

. Aggregate Exposure

1. Dietary exposure.

i. Food. TMGMV is a naturally occurring t obamovirus that is found

worldwide. The intended use of the pesticide product is t o cont rol the weed
, t ropical

s oda a pple. TMGMV normally occurs in some solanaceous vegetables, tobacco s and some clonally p ropagated ornament al plants ; therefore
, hu man s and animals are routinely exposed to TMGMV.

ii. Drinking water

. T MGMV is a naturally occurring t obamovirus that is

found worldwide. The intended use of the pesticide product is to control the weed
, t ropical s oda a pple. It is not intended for direct application in aquatic sites
, and tropical soda apple does not grow in flooded areas.

2. Non

- dietary exposure

. The potential for non

- occupational, non

- dietary exposure to the general population is not expected to be significant. The pesticide product use rate is low and not expected to present any risk of adverse health

effects.3

E . Cumulative Effects

There are no other registered pesticide products containing TMGMV
, and

the t obamovirus does not produce any toxins. There are no expected cumulative

effects as is sometimes the case with other pesticides.

F

. Safety Determination

1. U.S. population. TMGMV i s a naturally occurring t obamovirus t hat is

found worldwide. The intended use of the pesticide product is to control the weed
, t ropical s oda a pple. TMGMV normally occurs in some solanaceous vegetables
, tobaccos , and some clonally propagated ornamental plants . It is a plant virus that does not infect nor is toxic or pathogenic to insects, invertebrates, vertebrates,

ma mmals, or humans.

2. Infants and children

. TMGMV is a naturally occurring t obamovirus that is

found worldwide. The intended use of the pesticide product is to control the weed
, t ropical s oda a pple. TMGMV normally occurs in some solanaceous vegetables
, tobaccos , and some clonally prop agated ornamental plants . Label directions specifically warn not to apply the pesticide product within 300 feet of eggplant, pepper, tomatillo, tobacco, and other crops ; t herefore
, the use of th e pesticide product is not expected to impact the residues of TMGMV on these crops. Further,
TMGMV is a plant virus that does not infect nor is toxic or pathogenic to insects, invertebrates, vertebrates, mammals, or humans.

G. Effects on the Immune and Endocrine Systems

TMGMV normally occurs in some solanaceous vegetables, tobacco s , and some clonally propagated ornamental plants ; therefore
, humans are routinely exposed to this plant virus. There is no known evidence that TMGMV functions in a

mann er similar to any known hormone or that it acts as an endocrine disruptor.

H. Existing Tolerances

There are no known existing tolerances or tolerance exemptions fo r TMGMV . Since it may already be present in crops
, it is indistinguishable from that which is normally present in the environment . An exemption from the requirement of a tolerance is being requested.

I

. International Tolerances

There are no known existing CODEX maximum residue levels or tolerance exemptions for TMGMV.