### 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 address: BPPDFRNotices@epa.gov

BASF Corporation

2F8102

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

, 2 6 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 18 0 to establish an exemption from the requirement of a tolerance for the microbial pesticide

, Trichoderma fertile strain JM41R

.

Pursuant to sec tion 408(d)(2)(A)(i) of F FDCA, as amended, BASF Corporation has submitted the following summary of i nformation, 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 u sed 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. BASF Corporation Petition Summary

2F8102

A. Product Name s and Proposed Use Practices

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

.

Proposed Use Practice s : Trichoderma fertile 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 control

soil

- borne diseases such as Pythium

, Rhizoctonia

, Fusarium

, Sclero tina , 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. Identity of the pesticide and corresponding residues

.

Active Ingredient: Tr ichoderma fertile strain JM41R (CAS No. Not applicable). Information2

regarding the name, identity and composition has been submitted to the EPA and can be found in

MRID No. 489476

- 01.

Trichoderma 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 fertile 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 determine the

residue

. Not a pplicable

.

3. A statement of why an analytica l 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 fertile strain JM41R would not result in

residues that a re 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 summarized as follows:

1. Acute Oral Toxicity (OCSPP 870.1100) : Trichode rma fertile 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 clinical signs of toxicity and no mortality in any of the subjects during the study. The acute oral LD 50 for Trichoderma fertile strain

JM41R was d etermined to be > 5,000 mg/kg bod y weight in female rats , which is the

EPA ’ s Toxicity Category IV.

2. Acute Dermal Toxicity (OCSPP 870.1200) : Trichoderma fertile 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 treated area on each rat was covered with gauze and wrapped with a veterinary bandage

for 24 hours. After 24 hour s
, the wrappings were removed

, and the sites were gently

washed. There were no clinical signs of toxicity or dermal irritation during the observation period and no mortality during the study. The acute dermal LD 50 for Trichoderma fertile strain JM41R wa s determined to be > 5,050 mg/kg b odyweight

, whic h is the EPA ’ s Toxicity Category IV.

3. Acute Inhalation Toxicity (OCSPP 870.1300) : Trichoderma fertile 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 aerosolized fine powder of the test article at a concentration of 2.34 mg/L. The particle size data indicated that the MMAD of the test article was 6.3 μm. In

- life observations repo rted on day 0 included a decrease in activity and piloerection that resolved by day 1. There was no mortality during the study, and all3

subjects except one gained weight throughout the observation period. The acute

inhalation LC 50 for Trichoderma fertile strain JM41R was determined to be >2 .34 mg/L mg/kg b o dyweight 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

Trichoder ma fertile 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 once 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 pat tern. 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 study. 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 observed

abnormalities durin g general health observations or at necropsy, there is no evidence for toxic or pathogenic effects caused by the test substance. Trichoderma fertile strain

JM41R was determined to be non

- toxic to rats when administered by tracheal injection in a single do se 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 fertile 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 24 hours, the treated eyes were rinsed with room tem perature 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 fertile 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 fertile strain JM41R was conducted on r abbits 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 the untreated control. The treated area on each rabbit was c overed 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 sites 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 resul ted in a primary irritation index of 0.3 out of a possible 8.0. Trichoderma fertile strain JM41R was identified as slightly irritating and assigned to the EPA ’ s Toxicity Category IV.

7. Hypersensitivity Incidents (OCSPP 885.3400) : The petitioner has noted that no incident s of hypersensitivity or any other adverse effects have occurred through the research, development or testing of the active ingredient and its related end

- use product. Should4

any incidents occur, they will be reported per FIFRA Section 6(a)(2).

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

T he results of toxicolog y testing show there is no risk to human health from the active ingredient. Trichoderma fertile 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 eyes of mammals.



### D

. Aggregate Exposure

1. Dietary exposure.

i. Food. Di etary exposure from use of Trichoderma fertile strain JM41R, as proposed, is expected t o 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 irr igation systems. The

intended use of Trichoderma fertile strain JM41R is as a biological fungicide applied to soils and growing med ia in greenhouses for the purposes of disease con trol.

The results of toxicity testing indicate there is no risk to h uman health or the environment

from T richoderma fertile strain JM 41R. There are no reports of human health hazards caused by Trichoderma fertile . It does not produce rec ognized toxins , enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. T he absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.



### ii. Drinking water

. Similar ly, exposure to humans from residues of Trichoderma fertile strain 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 mea sure. The intended use of Trichoderma fertile

strain JM41R is applications to soils and growing media in greenhouses for the purposes of disease

control. The risk of the microorganism passing through the soil to ground water is minimal to unlikely because the growing organism forms a cottony web that is stat ionary, and the spores are not of the type that are able to surviv e 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 indicate there is no risk to human health from Trichoderma fertile strain JM41R. There are no reports of human health hazards caused by Trichoderma fertile

. It does not produce recognized toxins, enzymes, or virulence factors normally associate d 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, in cluding infants and children, is unlikely as the proposed use sites are agricultural. The intended use of Trichoderma5

fertile strain JM41R is applications to soils and growing media in greenhouses for the purposes of

disease control. Personal Protective Equipment (PPE) mitigates 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 fertile strain JM41R. There are no reports of human health hazards caused by Trichoderma fertile

. It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. The absence o f acute toxicity or pathogenicity in laboratory animals 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, Trichoderma fertile strain JM41R would result in residues that are of toxicological concern. The intended use of Trichoderma fertile strain

JM41R is applications to soils and growing media in greenhouses fo r the purposes of disease

control. The results of toxicity testing indicate there is no risk to human health from Trichoderma fertile strain JM41R. There are no reports of human health hazards caused by Trichoderma fertile

. 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 fertile 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 eyes of mammals. The intended use of Trichoderma fertile 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 fertile strain JM41R. There are no reports of human health hazards caused by Trichoderma fertile . 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. 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 fert ile 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 fertile strain JM41R from the proposed uses.



### G. Effects on the Immune and Endocr ine Systems

To date

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



### H. Existing Tolerances

There are no existing EPA tolerances or toleranc e exemption s for Trichoderma fertile6

strain JM41R.



### I

. International Tolerances

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

for Trichoderma fertile strain JM41R.