Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 1 of 11 

## Petition for an exemption from the requirement of a tolerance for residues of products containing the active ingredient

“ Trichoderma fertile strain JM41R” in and on all food

commodities

Submitted by: Becker Underwood, Inc. (EPA Co. No. 71840) 801 Dayton Avenue Ames, IA 50010Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 2 of 11 

## SECTION A Products and Proposed Use

Product Name: Trichoderma fertile strain JM41R Technical (TGAI) Tricho Plus (EP)

Proposed Use Practice: Trichoderma fertile 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 and nurseries, as soil drench or chemigation to soils and growing media.



## SECTION B Product identity/chemistry

Active Ingredient: Trichoderma fertile 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. 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.

Magnitude of residues and

method to determine: 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.Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 3 of 11 

## 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 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 Technical was identified as > 5,000 mg/kg, which is EPA 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 t he 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 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 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 pulmonar y toxicity, infectivity and pathogenicity of

Trichoderma fertile strain JM41R at a single high dose exposure and an adequate postexposure observation period. The animals were observed frequently on day of dosing for mortality and signs of pharmacologic and/or toxi cologic 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 measurement s 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 ani mals 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 nontoxic to rats when administered by tracheal injection in a single dose of 4.7 x 10 8 CFU/mL orTrichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 4 of 11 4.7 x 10 7 CFU/rat.

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

rabbits. 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 ingredi ent 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 fertile . 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 fertile strain JM41R is not toxic, pathogenic, infective or irritating to mammals.Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 5 of 11 

## SECTION D Aggregate Exposure

1) Dietary Exposure:

Dietary exposure from use of Trichoderma fertile strain JM41R, as proposed, is minimal.

The intended use of Trichoderma fertile strain JM41R is as a biological fungicide to soils and growing media in greenhouses and nurseries 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 ecological or human health

hazards caused 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) Drinking Water Exposure:

Similarly, exposure to humans from residues of Trichoderma fertile strain JM41R in consumed drinking water would be unlikely. 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 to soils and growing media in greenhouses and nurseries for the purposes of disease control. The risk of the microorganism passing through the soil to ground water is minimal to unlikely. 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 fertile strain JM41R. There are no reports of ecological or 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.

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

Trichoderma fertile strain JM41R is to soils and growing media in greenhouses and nurseries 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 or the environment

from Trichoderma fertile strain JM41R. There are no reports of ecological or human health hazards caused by Trichoderma fertile . It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity. TheTrichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 6 of 11 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.

.Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 7 of 11 

## SECTION 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 to soils and growing media in greenhouses and nurseries 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 ecological or 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.Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 8 of 11 

## SECTION F Safety Determination

1) General US Population:

Acute toxicity studies have shown that Trichoderma fertile strain JM41R is not toxic, pathogenic, infective or irritating to mammals. The intended use of Trichoderma fertile strain JM41R is to soils and growing media in greenhouses and nurseries for the purposes of disease control. The results of toxicity te sting indicate there is no risk to human health or

the environment from Trichoderma fertile strain JM41R. There are no reports of ecological or 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 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 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.Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 9 of 11 

## SECTION G – Effects on 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.Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 10 of 11 

## SECTION H – Existing Tolerances

There is no US EPA tolerance or tolerance exemption for Trichoderma fertile strain JM41R.Trichoderma fertile strain JM41R Petition to Establish a Tolerance Exemption – October 5, 2012 Page 11 of 11 

## SECTION I – International Tolerances

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

Trichoderma fertile strain JM41R.