## Petition for an exempt ion 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 E stablish 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 product s

.

Tricho Plus, a formulated end

- use product, is a biological fungicide for use to control soil

- borne diseases such as Pythium, Rhizoctonia, Fusarium Scleroti na, and Phytophthora

. Tricho Plus

is intended for use in greenh ouses , 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. 4 94690

- 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 r hizosphere 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, d epending 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 E stablish 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 ra ts that received a dose of 5,000 mg/kg t est 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 ar ticle moistened with 1.0 ml wate r 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

ob servation 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

concentrati on 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 a ll 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 c onducted 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 grou p (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 abno rmal 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

co mpletely 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

observa tions or at necropsy, there is no evidence for toxic or pathogenic effect s 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 10 8

Petition to E stablish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014 Page 3 of 55CFU/mL or 4.7 x 10 7 CFU/rat.

5. Primary Eye Irritation ( OCSPP 870.2400) : A prima r y 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 h ours, 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 p rimary dermal irritation study usi ng
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

- 0 7 )

. 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 s ites 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 sig ns 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, develop ment 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).

L iterature searches have demonstrated that t here 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.

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## 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 pes ticide 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 greenh ouses for the purposes

of disease control.

The r esults 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

P ub 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

s train.

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 Trichoderm a asperelloides strain JM41R is to soils and growing media in greenh ouses 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 c onditions 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 E stablish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014 Page 5 of 55Trichoderma asperelloides strain JM41R is to soils and growing media in greenh ouses 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. Non

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

Petition to E stablish 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 greenh ouses 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 ar e 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 path ogenicity in laboratory animals demonstrates the benign nature of this strain.

Petition to E stablish 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 greenh ouses for the purposes of disease control. T he results of toxicity testing indic ate 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 E stablish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014 Page 8 of 55

## SECTION G

– Effects on Immune and E ndocrine S ystems

To date there is no evidence to suggest that Trichoderma asperelloides strain JM41R function s in a manner similar to any known hormone, or that it acts as an endocrine disrupter.

Petition to E stablish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014 Page 9 of 55

## SECTION H

– Existing Tolerances

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

JM41R

.

Petition to E stablish 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 E stablish a Tolerance Exemption Trichoderma asperelloides strain JM41R Dec.10, 2014 Page 11 of 55