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 EPA has received a pesticide petition (2F8102) from BASF Corporation, 26 

Davis Dr., Research Triangle Park, NC 27709 requesting, 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 fertile strain JM41R.

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

has submitted the following summary of information, data, and arguments in support of 

its pesticide petition. This summary was prepared by BASF Corporation, 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. BASF Corporation Petition Summary

2F8102

A. Product Names and Proposed Use Practices

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

Proposed Use Practices: Trichoderma fertile strain JM41R Technical is proposed 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, 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. Identity of the pesticide and corresponding residues.

Active Ingredient: Trichoderma fertile strain JM41R (CAS No. Not applicable). Information 
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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 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 fertile 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 summarized as follows:

1. Acute Oral Toxicity (OCSPP 870.1100): Trichoderma 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 LD50 for Trichoderma fertile strain 

JM41R was determined to be >5,000 mg/kg bodyweight 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 hours, 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 LD50 for 

Trichoderma fertile strain JM41R was determined to be >5,050 mg/kg bodyweight, 

which 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 reported on day 0 included a decrease in activity 

and piloerection that resolved by day 1. There was no mortality during the study, and all 
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subjects except one gained weight throughout the observation period. The acute 

inhalation LC50 for Trichoderma fertile strain JM41R was determined to be >2.34 mg/L 

mg/kg bodyweight in male and female rats, which is the EPA’s Toxicity Category IV.

4. Acute Pulmonary Toxicity/Pathogenicity Study (OCSPP 885.3200): A study was 

conducted to evaluate the pulmonary toxicity, infectivity and pathogenicity of 

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

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 during 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 dose of 4.7 x 108CFU/mL or 4.7 x 107CFU/rat. 

5. Acute Eye Irritation (OCSPP 870.2400): An 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 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 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 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 the untreated control. The treated area on each rabbit was covered with gauze and 

loosely wrapped with a semipermeable membrane for 4 hours. After 4 hours, the 

wrappings were removed and the sites were gently washed 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 resulted 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 incidents 

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

Literature searches have demonstrated that 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 results of toxicology 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. Dietary exposure from use of Trichoderma fertile 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 fertile strain JM41R is as a biological fungicide applied 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 or the environment

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.

ii. Drinking water. Similarly, 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 measure. 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 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 water 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 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 and 

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

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 fertile 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 Endocrine 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 tolerance exemptions for Trichoderma fertile 
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strain JM41R.

I. International Tolerances

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

for Trichoderma fertile strain JM41R.