Petition for an exemption from the requirement of a tolerance 

for residues of products containing the active ingredient 

“Trichoderma asperelloides strain JM41R” in and on all food 

commodities

Originally submitted under the taxonomic name:

Trichoderma fertile strain JM41R 

on October 25, 2012.

Petition No.: 2F8102

Submitted by: BASF Corporation (EPA Co. No. 71840)

26 Davis Drive

Research Triangle Park, NC 27709 USA

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 1 of 55 
SECTION A Products and Proposed Use

Product Name: Trichoderma asperelloides strain JM41R Technical (TGAI)

Tricho Plus (EP)

Proposed Use Practice: Trichoderma asperelloides strain JM41R Technical, a Technical 

Grade Active Ingredient (TGAI) is proposed for manufacturing use 

only, for further formulation into registered end-use products.

Tricho Plus, a formulated end-use 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.

SECTION B Product identity/chemistry

Active Ingredient: Trichoderma asperelloides strain JM41R (CAS No. Not

applicable).

Information regarding the name, identity and composition has 

been submitted to EPA and can be found in MRID No. 494690-01.

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 asperelloides strain JM41R controls the growth of 

target diseases by competitive displacement and hyperparasitism. 

Magnitude of residues and

method to determine: 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.

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 2 of 55 
SECTION C 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 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 clinical signs of toxicity and no 

mortality in any of the subjects during the study. The acute oral LD50 for Trichoderma 

asperelloides strain JM41R Technical was identified as > 5,000 mg/kg, which is EPA 

Toxicity Category IV.

2. Acute Dermal 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 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 was 

determined to be >5,050 mg/kg bw, which is EPA Toxicity Category IV.

3. Acute Inhalation Toxicity (OCSPP 870.1300): Trichoderma 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 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 

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

inhalation LC50 was determined to be >2.34 mg/L mg/kg bw in male and female rats, 

which is EPA Toxicity Category IV.

4. Acute Pulmonary Toxicity/Pathogenicity Study in Rats (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 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 asperelloides strain JM41R, was determined to be 

non-toxic to rats when administered by tracheal injection in a single dose of 4.7 x 108

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 3 of 55 
CFU/mL or 4.7 x 107 CFU/rat. 

5. Primary Eye Irritation (OCSPP 870.2400): A primary 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 

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 for Trichoderma asperelloides strain JM41R Technical. The test substance 

was identified as minimally irritating to the eyes and assigned to Toxicity Category III. 

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

Trichoderma asperelloides 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 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. The test substance was identified as 

slightly irritating and assigned to Toxicity Category IV. 

7. Hypersensitivity Incidents (OCSPP 885.3400): The registrant 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 any incidents occur, they will be reported per FIFRA Section 6(a)(2).

Literature searches have demonstrated that there are no reports of ecological or human health 

hazards caused Trichoderma asperelloides. It does not produce recognized toxins, enzymes, or 

virulence factors normally associated with mammalian invasiveness or toxicity. 

The results of toxicity testing show there is no risk to human health from the active ingredient. 

Trichoderma asperelloides strain JM41R is not toxic, pathogenic, infective or irritating to 

mammals. 

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 4 of 55 
SECTION D Aggregate Exposure

1) Dietary Exposure:

Dietary exposure from use of Trichoderma asperelloides strain JM41R, as proposed, is 

expected to be minimal because the product is intended for application to soil and 

growing media, not to growing crops (see Product Label). The residues on food crops 

are anticipated to be 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 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 asperelloides strain JM41R. There are no reports of ecological or 

human health hazards caused Trichoderma asperelloides (See Attachment 1: Results of 

Pub Med search). 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) Drinking Water Exposure:

Similarly, exposure to humans from residues of Trichoderma asperelloides strain JM41R 

in consumed drinking water would be unlikely because the product is not applied to 

water, and the normal habitat of the microbe is soil and herbaceous tissue, not water 

(Chaverri, et al., 2003 - see Attachment 2). 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 asperelloides strain JM41R is 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), that is no 

chlamydospores are formed (Chaverri, et al., 2003 - see Attachment 2). 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 or the environment 

from Trichoderma asperelloides strain JM41R. There are no reports of ecological or 

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. 

3) 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 

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 5 of 55 
Trichoderma asperelloides strain JM41R is 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 lack of acute oral toxicity, infectivity, and pathogenicity support an exemption from 

the requirement of a tolerance for Trichoderma asperelloides strain JM41R. There are 

no reports of ecological or 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. Nondietary exposures would not be expected to pose any quantifiable risk due to a lack of 

residues of toxicological concern.

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 6 of 55 
SECTION E Cumulative Effects

It is not expected that, when used as proposed, Trichoderma asperelloides strain JM41R would 

result in residues that are of toxicological concern. The intended use of Trichoderma 

asperelloides strain JM41R is 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 asperelloides strain JM41R. There are no reports of ecological 

or 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. 

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 7 of 55 
SECTION F Safety Determination

1) General US Population:

Acute toxicity studies have shown that Trichoderma asperelloides strain JM41R is not 

toxic, pathogenic, infective or irritating to mammals. The intended use of Trichoderma 

asperelloides strain JM41R is 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 asperelloides strain JM41R. There 

are no reports of ecological or 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. There is a reasonable certainty of no harm to the general US population from 

exposure to this active ingredient.

2) Infants and Children:

As mentioned above, it is not expected that, when used as proposed, Trichoderma 

asperelloides 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 asperelloides strain JM41R from the proposed uses. 

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 8 of 55 
SECTION G – Effects on Immune and Endocrine Systems

To date there is no evidence to suggest that Trichoderma asperelloides strain JM41R functions

in a manner similar to any known hormone, or that it acts as an endocrine disrupter. 

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 9 of 55 
SECTION H – Existing Tolerances

There is no US EPA tolerance or tolerance exemption for Trichoderma asperelloides strain 

JM41R. 

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 10 of 55 
SECTION I – International Tolerances

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

Trichoderma asperelloides strain JM41R.

Petition to Establish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014

Page 11 of 55