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 EPA has received a pesticide petition (3E8181) from Interregional 

Research Project Number 4 (IR-4), Rutgers University, 500 College Rd. East, Suite 

201W, Princeton, NJ 08540 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 exemption from the requirement of a tolerance for the microbial pesticide, 

Tobacco mild green mosaic tobamovirus U2 (TMGMV).

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, IR-4 has submitted 

the following summary of information, data, and arguments in support of its pesticide 

petition. This summary was prepared by IR-4, and 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 the active ingredient in the end-use pesticide product, SolviNix®

LC. SolviNix® LC is a postemergence bioherbicide for the control of the weed, 

tropical soda apple (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 apple 

plants. The crops for which an exemption from the requirement of a tolerance is 

being requested include all the commodities of crop group 17 (grass forage, fodder, 

and hay group) and crop group 18 (nongrass animal feeds (forage, fodder, straw, 

and hay) group).

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. TMGMV is the active 

ingredient in the pesticide product, SolviNix® LC.
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2. Magnitude of residues at the time of harvest and method used to determine the 

residue. TMGMV is a naturally occurring tobamovirus that is found worldwide. The 

intended use of the pesticide product is to control the weed, tropical soda apple. 

TMGMV normally occurs in some solanaceous vegetables, tobaccos and some 

clonally propagated ornamental plants. Use sites include pasture and noncrop 

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

residues of TMGMV on these crops.

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

of the pesticide residue are not needed. TMGMV is a naturally occurring tobamovirus

that is found worldwide. An exemption from the requirement of a tolerance is being 

requested. TMGMV 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

TMGMV is a naturally occurring tobamovirus that is found worldwide. It is 

a plant virus that 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 viruses 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 tobamovirus that is found 

worldwide. The intended use of the pesticide product is to control the weed, tropical 

soda apple. TMGMV normally occurs in some solanaceous vegetables, tobaccos and 

some clonally propagated ornamental plants; therefore, humans and animals are 

routinely exposed to TMGMV.

ii. Drinking water. TMGMV is a naturally occurring tobamovirus that is 

found worldwide. The intended use of the pesticide product is to control the weed,

tropical soda apple. 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.
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E. Cumulative Effects

There are no other registered pesticide products containing TMGMV, and 

the tobamovirus 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 is a naturally occurring tobamovirus that is 

found worldwide. The intended use of the pesticide product is to control the weed,

tropical soda apple. 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, 

mammals, or humans.

2. Infants and children. TMGMV is a naturally occurring tobamovirus that is 

found worldwide. The intended use of the pesticide product is to control the weed,

tropical soda apple. TMGMV normally occurs in some solanaceous vegetables, 

tobaccos, and some clonally propagated ornamental plants. Label directions 

specifically warn not to apply the pesticide product within 300 feet of eggplant, 

pepper, tomatillo, tobacco, and other crops; therefore, the use of the 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, tobaccos, 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 

manner 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 for 

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.