### 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: Robert McNally, telephone number: (703) 305

- 7090, email add ress: BPPDFRNotices@epa.gov

BASF Corporation

2F8102

The E PA has received a pesticide petition (2F8102) from BASF Corporation

, 26 Davis Dr., Research Triangle Park, NC 27709 request ing, 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 Trichoderma asperelloides strain JM41R

.

Pursuant to section 408 (d)(2)(A)(i) of F FDCA, as amended, BASF Corporation has submitted the following summary of information, data, a nd arguments in support of

its pesticide petition. This summary was prepared by BASF Corporation , 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 an d not the position of the petitioner.

I. BASF Corporation Petition Summary

2F8102

A. Product Name s and Proposed Use Practices

Product Name s : Trichoderma asperelloides strain JM41R Technical (TGAI /MP ) and Tricho Plus (EP)

.

Proposed Use Practice s : Tr ichoderma asperelloides strain JM41R Technical is prop osed for manufacturing use only (i.e., for further formulation into registered end

- use pesticide products )

.

Tricho Plus, a formulated end

- use pesticide product, is a biological fungicide for use to cont rol

soil

- borne diseases such as Pythium

, Rhizoctonia

, Fusarium

, Sclerotina , and Phytophthora

. Tricho Plus is intended for use in greenhouses as soil drench or chemigation to soils and growing

media.



### B. Product Identity/Chemistry

1

. I dentity of the pesticide and corresponding residues

.

Active Ingredient: Tr ichoderma asperelloides strain JM41R (CAS No. Not applicable).2

Information regarding the name, identity and composition has been submitted to the EPA and can

be found in MRID No. 494690

- 01.

Trichod erma spp. are fungi that are present in nearly all soils and other diverse habitats. In soil, they frequently are the most prevalent culturable fungi. They are favored by the presence of high levels of plant roots, which they colonize readily. Some strains are highly rhizosphere competent, i.e., able to colonize and grow on roots as they develop . The most strongly rhizosphere

- competent strains can be added to soil or seeds by any method. Once they come into contact with roots, they

colonize the root surface or cortex, depending on the strain.

Mode of Action: Trichoderma asperelloides strain JM41R controls the growth of target diseases by competitive displacement and hyperparasitism.



### 2. Magnitude of residues at the time of harvest and method used to dete rmine the

residue

. Not applicable.

3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed

. An analytical method for residues is not applicable. It is expected that, when used as proposed, Trichoderma asperelloides strain JM41R would not result in residues that are of toxicological concern.



### C. Mammalian Toxicological Profile

Studies to evaluate the safety to mammals were conducted on the technical grade active ingredient (TGAI) and are su mmarized as follows:

1. Acute Oral Toxicity (OCSPP 870.1100) : Trichoderma asperelloides strain JM41R was not toxic in an acute oral study in female rats that received a dose of 5,000 mg/kg test article by gavage (MRID No 489476

- 03). There were no clinica l signs of toxicity and no mortality in any of the subjects during the study. The acute oral LD 50 for Trichoderma asperelloides strain JM41R was determined to be > 5,000 mg/kg bodyweight in female

rats , which is the EPA ’s Toxicity Category IV.

2. Acute Der mal Toxicity (OCSPP 870.1200) : Trichoderma asperelloides strain JM41R was not toxic in an acute dermal study in albino rats that received a single dose of 5,050 mg/kg test article moistened with 1.0 ml water applied to the skin (MRID No. 489476

- 04). The t reated area on each rat was covered with gauze and wrapped with a veterinary bandage for 24 hours. After 24 hours

, the wrappings were removed

, and the sites were gently washed. There were no clinical signs of toxicity or dermal irritation during the

observ ation period and no mortality during the study. The acute dermal LD 50 for

Trichoderma asperelloides strain JM41R wa s determined to be > 5,050 mg/kg

b odyweight , which is the EPA ’s Toxicity Category IV.

3. Acute Inhalation Toxicity (OCSPP 870.1300) : Trichod erma asperelloides strain JM41R was not toxic in an acute inhalation study in rats exposed to the undiluted test article at a concentration of 2.34 mg/L (MRID No. 489476

- 05). In this study, five male and five female albino rats were exposed to an aerosoliz ed fine powder of the test article at a concentration of 2.34 mg/L. The particle size data indicated that the mass median aerodynamic diameter ( MMAD ) of the test article was 6.3 μm. In

- life observations reported on day 0 included a decrease in activity and piloerection that resolved by day 1.3

There was no mortality during the study, and all subjects except one gained weight throughout the observation period. The acute inhalation LC 50 for Trichoderma asperelloides strain JM41R was determined to be >2.34 mg/L mg/kg b odyweight in male and female rats, which is the EPA ’s Toxicity Category IV.

4. Acute Pulmonary Toxic ity/Pathogenicity Study (OCSPP 885.3200) : A study was conducted to evaluate the pulmonary toxicity, infectivity and pathogenicity of

Trichoderma asperelloides strain JM41R at a single high dose exposure and an adequate

post

- exposure observation period (MRID No. 489476

- 02) . The animals were observed frequently on day of dosing for mortality and signs of pharmacologic and/or toxicologic

effects and o nce daily thereafter for 21 days. A control group (untreated) was conducted concurrently. Tissue and blood samples taken at interim sacrifices from the group receiving the active test substance were cultured to provide quantitative measurements of

the test microbe’s clearance pattern. There were no abnormal general health observations. A gross necropsy of all animals was performed and recorded. There were no observed abnormalities during necropsy. There was no test substance found at any time point of the

s tudy. The test substance was considered to be completely clear from test animals by Day 7, as quantification results from plated tissue and fluids yielded two consecutive counts that were below clearance threshold. With no plated organisms seen and no obse rved abnormalities during general health observations or at necropsy, there is no evidence for toxic or pathogenic effects caused by the test substance. Trichoderma asperelloides strain

JM41R was determined to be non

- toxic to rats when administered by trac heal injection in a single dose of 4.7 x 10 8 CFU/mL or 4.7 x 10 7 CFU/rat.

5. Acute Eye Irritation (OCSPP 870.2400) : A n acute eye irritation study using Trichoderma asperelloides strain JM41R was conducted on rabbits by instilling 100 mg of test article in the conjunctival sac of the right eye of each of three rabbits (MRID No. 489476

- 06)

. The left eye of each served as the untreated control. The degree of ocular irritation was characterized and recorded at 1, 24, 48 and 72 hours after treatment. After 2 4 hours, the treated eyes were rinsed with room temperature deionized water for one minute. Redness was observed in the treated eye of two rabbits 24 hours after exposure that resolved by 48 hours. This resulted in a maximum average eye irritation score of 6. Trichoderma asperelloides strain JM41R was identified as minimally irritating to the eyes and assigned

to the EPA’s Toxicity Category III.

6. Primary Dermal Irritation (OCSPP 870.2500) : A primary dermal irritation study using

Trichoderma asperello ides strain JM41R was conducted on rabbits by application of 500 mg of test article moistened with 0.5 ml of deionized water to clipped sites on the dorsal

skin of three rabbits (MRID No. 489476

- 07) . The contralateral dorsal skin of each rabbit

served as t he untreated control. The treated area on each rabbit was covered with gauze and loosely wrapped with a semipermeabl e membrane for 4 hours. After 4 hours

, the wrappings were removed and the sites were gently washe d to remove the test substance.

The test si tes were observed for erythema and edema or other signs of dermal irritation at 1, 24, 48 and 72 hours after removal of the wrappings. Very slight erythema was observed through the first 24 hours, but no edema was observed during the study. No other signs of irritation were reported during the study. This resulted in a primary irritation index of 0.3 out of a possible 8.0. Trichoderma asperelloides strain JM41R was identified as slightly irritating and assigned to the EPA’s Toxicity Category IV.

7. Hype rsensitivity Incidents (OCSPP 885.3400) : The petitioner has noted that no incidents of hypersensitivity or any other adverse effects have occurred through the research,4

development or testing of the active ingredient and its related end

- use product. Shoul d any incidents occur, they will be reported per FIFRA Section 6(a)(2).

Literature searches have demonstrated that there are no report s of human health hazards caused by Trichoderma asperelloides . It does not produce recognized toxins, enzymes, or virulen ce factors normally associated with mammalian invasiveness or toxicity.

T he results of toxicology testing show there is no risk to human health from the active ingredient.

Trichoderma asperelloides strain JM41R is not toxic, pathogenic, and/or infecti ve to mammals, is minimally irritating to the eyes of mammals, and is slightly irritating to the s kin of mammals.



### D

. Aggregate Exposure

1. Dietary exposure.

i

. F ood

. Dietary exposure from use of Trichoderma asperelloides strain JM41R, as proposed, is expected to be minimal because the end

- use pesticide product is intended for application to soil and growing media, not to growing crops

. The residues on food crops are anticipated to be insignificant because this pesticide is typically applied to soils by drip irrigation

systems. The intended use of Trichoderma asperelloides strain JM41R is as a biological fungicide applied to soils and growing med ia in greenhouses for the purposes of disease control.

The results of toxicity testing indicate there i s no risk to human health from Trichoderma asperelloides strain JM 41R. There are no reports of human health hazards caused by Trichoderma asperelloides . It does not produce recognized toxins , enzymes, or virulence factors normally ass ociated with mammalian invasiveness or toxicity. T he absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.



### i i

. D rinking water

. Similarly, exposure to humans from residues of Trichoderma

a sperelloides s train JM41R in consumed drinking water would be unlikely because the end

- use pesticide product is not applied to water, and the normal habitat of the microbe is soil and herbaceous tissue, not water. Potential exposure to surface water would be negligible and exposure to drinking water (well or ground water) would be impossible to measure. The intended use of Trichoderma asperello i d es strain JM41R is applications to soils and growing media in greenhouses for the purposes of disease control. The risk of the microo rganism passing through the soil to ground water is minimal to unlikely because the growing organism forms a cottony web that is stationary, and the spores are not of the type that are able to survive unfavorable conditions (water), i.e., no chlamydospores are formed. Additionally, the fungus would not tolerate the

conditions wate r is subjected to in a drinking

- water facility (including: chlorination, pH adjustments, high temperatures and/or anaerobic conditions).

The results of toxicity testing indic ate there is no risk to human health from Trichoderma

a sperello i d es strain JM41R. There are no reports of human health hazards caused by Trichoderma asperelloides

. It does not produce recognized toxins, enzymes, or virulence factors normally

associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.



### 2. Non

- dietary exposure

.

The potential for non

- dietary exposure to the general population, including infants and5

children, is unlikely as the proposed use sites are agricultural. The intended use of Trichoderma

a sperelloides strain JM41R is applications to soils a nd growing media in greenhouses for the purposes of disease control. Personal Protective Equipment (PPE) mi tigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural settings.

The results of toxicity testing indicate there is no risk to human health f rom Trichoderma

a sperelloides strain JM41R. There are no rep orts of human health hazards caused by

Trichoderma a sperelloides . It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory anima ls demonstrates the benign nature of this strain. Non

- dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.



### E . Cumulative Effects

It is not expected that, when used as proposed, Trichod erma a sperelloides strain JM41R would result in residues that are of toxicological concern. The intended use of Trichoderma

a sperelloides strain JM41R is applications to soils and growing media in greenhouses for the purposes of disease control. The results of toxicit y testing indicate there is no risk to human

health from Trichoderma a sperelloides strain JM41R. There are no reports of human health hazards caused by Trichoderma a sperelloides . It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.



### F . Safety Determination

1. U.S. population. Acute toxicity studies have shown that Trichoderma a sperelloides strain JM41R is not toxic, pathogenic, and/or infective to mammals, is minimally irritating to the eyes of mammals, and is slightly irritating to the s kin of mammals. The intended use of

Trichoderma a sperelloides strain JM41R is applications to soils and growing media in greenhouses for the purposes of disease control. The results of toxicity testing indicate there is no

risk to human health from Trichoderma a sperelloides strain JM41R. There are no reports of human health hazards caused by Trichoderma a sperelloides . I t does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. There is a reasonable certainty of no harm to the general U

. S

. population from exposure to this active ingredient.



### 2. Infants and children

. As mentioned above, it is not expected that, when used as proposed, Trichoderma a sperelloides strain JM41R would result in residues that are of toxicological concern. There is a reasonable certainty of no harm for infants and children from

exposure to Trichoderma a sperelloides strain JM41R from the proposed uses.



### G. Effects on the Immune and Endocrine Systems

To date

, there is no evidence to suggest that Trichoderma a sperelloides strain JM41R functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter.



### H. Existing Tolerances6

There are no existing EPA tolerances or tolerance exemption s for Trichoderma

a sperelloides strain JM41R.



### I . International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established

for Trichoderma a sperelloides strain JM41R.