BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Trichoderma asperelloides strain JM41R

(originally Trichoderma fertile strain JM41R)

Pesticide Chemical (PC) Code: 119000

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

May 20, 2015
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TABLE OF CONTENTS

I. EXECUTIVE SUMMARY .........................................................................................................................4

II. ACTIVE INGREDIENT OVERVIEW .....................................................................................................7

III. REGULATORY BACKGROUND ............................................................................................................7

A. Applications for Pesticide Product Registration............................................................................7

B. Food Tolerance Exemption .............................................................................................................7

IV. RISK ASSESSMENT..................................................................................................................................8

A. Product Analysis Assessment (40 CFR § 158.2120) ......................................................................8

B. Human Health Assessment (40 CFR § 158.2140)..........................................................................9

C. Environmental Assessment (40 CFR § 158.2150)........................................................................14

V. ENVIRONMENTAL JUSTICE...............................................................................................................16

VI. RISK MANAGEMENT DECISION........................................................................................................17

VII. ACTIONS REQUIRED OF THE REGISTRANT .................................................................................18

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ....................................................................19

IX. BIBLIOGRAPHY......................................................................................................................................20

A. Studies Submitted to Support the Trichoderma asperelloides strain JM41R 

 Pesticide Product Registrations....................................................................................................20

B. Environmental Protection Agency Risk Assessment Memoranda.............................................21

C. Other References............................................................................................................................21

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS ........................................................23

APPENDIX B. PESTICIDE PRODUCTS...........................................................................................................29
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs (OPP)

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch

Science Reviews

Shannon Borges Environmental Effects

Joel V. Gagliardi, Ph.D. Product Analysis and Human Health

John L. Kough, Ph.D. Product Analysis and Human Health

In-Soon You, Ph.D. Environmental Effects

Regulatory

ShaRon Carlisle Associate Chief

Jeannine Kausch Regulatory Action Leader

Kimberly Nesci Chief
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I. EXECUTIVE SUMMARY

Background

In October 2012, Becker Underwood, Inc. (now BASF Corporation) submitted registration applications

for a manufacturing-use pesticide product (MP) (Trichoderma fertile strain JM41R Technical, EPA File 

Symbol: 71840-RL) and an end-use pesticide product (EP) (Tricho Plus, EPA File Symbol: 71840-RU)

to the U.S. Environmental Protection Agency (EPA) under section 3 of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA). Concurrently with these applications, Becker Underwood, Inc. 

(now BASF Corporation) filed a petition for a tolerance exemption. At that time, the pesticide products

contained and the tolerance exemption involved the new active ingredient Trichoderma fertile strain 

JM41R. Subsequently, BASF Corporation provided additional data on the identity of the active 

ingredient in the pesticide products to the EPA. After reviewing these data, the EPA concluded that the 

correct identity of the active ingredient was Trichoderma asperelloides strain JM41R and not 

Trichoderma fertile strain JM41R. In conjunction with the active ingredient clarification, BASF 

Corporation adjusted the names of the pesticide products to Trichoderma asperelloides strain JM41R 

Technical (EPA File Symbol: 71840-RL) and TRICHO PLUSTM Biofungicide (EPA File Symbol: 71840-

RU) and updated its tolerance exemption petition.

Fungi of the genus Trichoderma are abundant in nature, especially in soil and close to plant roots 

(Druzhinina et al., 2006; Harman et al., 2004). Since 1989, several Trichoderma species (e.g., 

Trichoderma polysporum and Trichoderma viride) have been used in pesticide products—notably 

without reported incidents—to control various fungal plant pathogens such as Pythium species, 

Phytophthora species, Heterobasidion annosum, and Chondrostereum purpureum. In conjunction with 

the registration of some of these pesticide products, the EPA established the following tolerance 

exemptions:

(1) Gliocladium virens isolate GL-21 (now recognized as Trichoderma virens isolate GL-21) (40 

CFR 180.1100) – see the Federal Register of September 20, 1995 (60 FR 48657) and October 5, 

1995 (60 FR 52248).

(2) Trichoderma harzianum Rifai strain T-22 (40 CFR 180.1102) – see the Federal Register of April 

7, 1999 (64 FR 16856).

(3) Trichoderma harzianum strain T-39 (40 CFR 180.1201) – see the Federal Register of June 22, 

2000 (65 FR 38753).

(4) Trichoderma gamsii strain ICC 080 (40 CFR 180.1293) – see the Federal Register of February 

25, 2010 (75 FR 8504).

(5) Trichoderma asperellum strain ICC 012 (40 CFR 180.1294) – see the Federal Register of March 

3, 2010 (75 FR 9527).

(6) Trichoderma hamatum isolate 382 (40 CFR 180.1298) – see the Federal Register of July 23, 

2010 (75 FR 43072). 

(7) Trichoderma virens strain G-41 (40 CFR 180.1310) – see the Federal Register of February 1, 

2012 (77 FR 4903).

In 2003, a University of Pretoria student isolated Trichoderma asperelloides strain JM41R in South 

Africa. This particular fungus colonizes root surfaces close to inoculated plants, parasitizing and 

competitively displacing invasive fungi (e.g., Rhizoctonia species and Fusarium species) and 

mineralizing insoluble phosphate to create a form of this substance that is available to plants. In light of 

Trichoderma asperelloides strain JM41R’s fungicidal capabilities, BASF Corporation proposed to
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register a MP and an EP; both pesticide products contain Trichoderma asperelloides strain JM41R as an 

active ingredient, and the EP is to be applied to soil and growing media in commercial greenhouses to 

manage soilborne diseases caused by organisms such as Rhizoctonia species and Fusarium species.

The EPA’s scientists reviewed product analysis, toxicology, and nontarget organism data and 

information (40 CFR §§ 158.2120, 158.2140, and 158.2150, respectively) submitted to support the

registration of the Trichoderma asperelloides strain JM41R pesticide products. Overall, such data and 

information are adequate for risk assessment purposes, fulfill most of the current microbial pesticide

data requirements, and support registration of the pesticide products under FIFRA section 3(c)(5).

Product Analysis

BASF Corporation fulfilled most of the product analysis data requirements for Trichoderma 

asperelloides strain JM41R, including product chemistry and composition, analysis of samples, and 

physical and chemical characteristics, by submitting acceptable guideline studies. Although a one-year 

storage stability and corrosion characteristics study is outstanding, the EPA is requiring these data as 

terms of registration.

Toxicology

BASF Corporation submitted adequate mammalian toxicology information to support the Trichoderma 

asperelloides strain JM41R pesticide products. An acute toxicity/pathogenicity study showed that, at a 

single high dose, Trichoderma asperelloides strain JM41R is not toxic, infective, or pathogenic via the 

pulmonary route of exposure. The EPA waived acute oral toxicity/pathogenicity and acute injection 

toxicity/pathogenicity testing for this active ingredient, based on BASF Corporation’s scientific 

rationale. The rationale cited to the results of other toxicological data done with Trichoderma 

asperelloides strain JM41R, a literature search that yielded no human pathogenicity concerns, and data 

describing a lack of active ingredient growth at 35°C or above. Moreover, BASF Corporation reported 

that, to date, no hypersensitivity incidents have occurred during research, development, and testing of 

Trichoderma asperelloides strain JM41R. In light of the adequacy of the toxicological data, scientific 

rationale, and literature provided by BASF Corporation and the absence of hypersensitivity incidents, the 

EPA is not requiring testing at higher tiers (i.e., Tiers II and III).

Tolerance Exemption

The EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, 

including infants and children, from aggregate exposure to residues of Trichoderma asperelloides strain 

JM41R. The EPA does not expect dietary (food and drinking water) or other non-occupational risks 

from use of Trichoderma asperelloides strain JM41R as an active ingredient in the pesticide products.

Although exposure to Trichoderma asperelloides strain JM41R through consumed food and drinking 

water may be possible, the EPA anticipates these types of exposures to be negligible because, among 

other things, applications of the EP will be made to soil and growing media within commercial 

greenhouses, and typical food commodity processing procedures (e.g., peeling, washing, and/or 

additions of sugar, salt, and other preservatives) tend to remove microbes or render them nonviable (U.S. 

EPA, 1996). Furthermore, since applications of Trichoderma asperelloides strain JM41R are limited to

commercial greenhouses, increased exposures of the active ingredient to the general population in 

residential settings are not expected. Should Trichoderma asperelloides strain JM41R be present in food 

or drinking water or in residential settings, supporting toxicological information indicates that human 

exposure to this fungus would not result in adverse effects.
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Occupational Exposure

Despite the low toxicological profile of Trichoderma asperelloides strain JM41R, the EPA is requiring 

baseline protective clothing for individuals who, due to their occupation, may be exposed to the active 

ingredient for prolonged periods and/or multiple times. At a minimum, individuals working with

Trichoderma asperelloides strain JM41R to manage certain soilborne diseases are directed to wear a 

long-sleeved shirt, long pants, socks, shoes, protective eyewear, and a dust/mist filtering respirator 

meeting National Institute for Occupational Safety and Health (NIOSH) standards of at least N-95, R-95, 

or P-95. 

Nontarget Organisms

The EPA found that scientific rationale and a honey bee study submitted by BASF Corporation are 

sufficient to fulfill the nontarget organism data requirements and for risk assessment purposes. Further 

testing of nontarget organisms at higher tier levels (i.e., Tiers II, III, and IV) is not required. The EPA 

performed an environmental risk assessment based on information provided by BASF Corporation and 

has determined that unreasonable adverse effects to nontarget organisms are not expected from the 

proposed pesticidal uses of Trichoderma asperelloides strain JM41R. Moreover, the EPA made a “no 

effect” determination for direct and indirect effects to endangered and threatened species and their

habitats from the proposed uses of Trichoderma asperelloides strain JM41R, as labeled. 

Public Participation

On October 1, 2009, the EPA announced a policy to provide a more meaningful opportunity for the 

public to participate in major registration decisions before they occur. According to this policy, the EPA 

provides a public comment period prior to making a registration decision for the following types of 

applications: new active ingredients; first food uses; first outdoor uses; first residential uses; or any other 

registration actions for which the EPA believes there may be significant public interest.

 

Consistent with the policy of making registration actions more transparent, the proposed pesticide 

products containing Trichoderma asperelloides strain JM41R, a new active ingredient, and allowing for 

this active ingredient’s first food use were subject to a 15-day comment period. During this comment 

period, the EPA received no comments on its preliminary decision to register the Trichoderma 

asperelloides strain JM41R pesticide products. Therefore, the EPA maintains that, based upon the risk 

assessment and information submitted in support of Trichoderma asperelloides strain JM41R Technical 

and TRICHO PLUSTM Biofungicide, it is appropriate to issue these registrations. The basis for this 

decision can be found in the risk assessment for Trichoderma asperelloides strain JM41R, which is 

characterized throughout this Biopesticides Registration Action Document (BRAD). 
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II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Trichoderma asperelloides strain JM41R

Culture Deposit: Agricultural Research Service Culture Collection (also known as 

the Northern Regional Research Laboratory Collection) in Peoria, 

Illinois under Accession Number NRRL-50759

OPP Chemical Code: 119000

Type of Pesticide: Microbial Pesticide – Fungicide

See Appendix B for specific information (e.g.,

use site(s), application rate(s), method(s) of application, 

formulation type, and target pest(s)) regarding

the pesticide products containing this 

active ingredient.

III. REGULATORY BACKGROUND

A. Applications for Pesticide Product Registration

In October 2012, Becker Underwood, Inc. (now BASF Corporation) submitted applications to register a

MP (Trichoderma fertile strain JM41R Technical, EPA File Symbol: 71840-RL) and an EP (Tricho Plus,

EPA File Symbol: 71840-RU) under FIFRA section 3. On January 16, 2013 (78 FR 3422), the EPA

announced receipt of these applications to register pesticide products containing a new active ingredient 

and opened a 30-day public comment period pursuant to the provisions of FIFRA section 3(c)(4). The 

EPA received no comments on this publication. 

Subsequently, BASF Corporation provided additional data (i.e., deoxyribonucleic acid (DNA) sequence 

information based on newly published taxonomies) on the identity of the active ingredient in these 

pesticide products to the EPA. After reviewing these data, the EPA concluded that the correct identity of 

the active ingredient was Trichoderma asperelloides strain JM41R and not Trichoderma fertile strain 

JM41R. In order to give the public an opportunity to comment on this new information, the EPA

republished its receipt of these applications with an updated and accurate description in the Federal 

Register of January 21, 2015 (80 FR 2929). The EPA received no comments on this publication. 

B. Food Tolerance Exemption

Concurrent with its registration applications and under Federal Food, Drug, and Cosmetic Act (FFDCA) 

section 408(d), Becker Underwood, Inc. (now BASF Corporation) submitted a petition to establish an 

exemption from the requirement of a tolerance for Trichoderma fertile strain JM41R (PP 2F8102). In the 

Federal Register of February 21, 2014 (79 FR 9870), the EPA announced that BASF Corporation

proposed to establish an exemption from the requirement of a tolerance for residues of the fungicide

Trichoderma fertile strain JM41R in or on all food commodities and opened a 30-day comment period. 

The EPA received no comments on this publication. 
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Subsequently, BASF Corporation provided additional data (i.e., DNA sequence information based on 

newly published taxonomies) on the identity of the pesticide to the EPA. After reviewing these data, the 

EPA concluded that the correct identity of the pesticide was Trichoderma asperelloides strain JM41R 

and not Trichoderma fertile strain JM41R. In order to give the public an opportunity to comment on this 

new information, the EPA republished its receipt of this tolerance exemption petition filing with an 

updated and accurate description in the Federal Register of January 28, 2015 (80 FR 4525) and placed a 

revised petition from BASF Corporation into the docket. The EPA received no comments on this 

publication. 

On May 18, 2015, the EPA established an exemption from the requirement of a tolerance for residues of 

Trichoderma asperelloides strain JM41R in or on all food commodities when used in accordance with 

label directions and good agricultural practices (40 CFR § 180.1331; 80 FR 28201).

IV. RISK ASSESSMENT

In the Federal Registers of October 26, 2007 (72 FR 60988), and August 30, 2012 (77 FR 52610), the 

EPA issued Final Rules on the data requirements to support registration of microbial pesticides and 

updated the definition for microbial pesticides. The data and information evaluated for this BRAD were 

considered in light of these requirements.

The classifications that are found for each data submission are assigned by the EPA’s science reviewers 

and are an indication of the usefulness of the information contained in the documents for risk

assessment. A rating of “acceptable” indicates a study is scientifically sound and is useful for risk 

assessment. A “supplemental” rating indicates the data provide some information that can be useful for 

risk assessment. Studies may have certain aspects determined not to be scientifically acceptable 

(“supplemental: upgradeable”). If a study is rated as “supplemental: upgradeable,” the EPA always 

provides an indication of what is lacking or what can be provided to change the rating to “acceptable.” If 

there is simply a “supplemental” rating, the reviewer will often state that the study is not required by 40 

CFR Part 158. Both “acceptable” and “supplemental” studies may be used in the risk assessment process 

as appropriate. An “unacceptable” rating indicates that new data must be submitted.

For the acute toxicity data requirements, Toxicity Categories are assigned based on the hazard(s)

identified from studies and/or other information submitted to the EPA in support of a pesticide

registration. The active ingredient or particular product is classified into Toxicity Category I, II, III, or 

IV, where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the 

lowest toxicity (see section II.B. of U.S. EPA (2014)). 

A. Product Analysis Assessment (40 CFR § 158.2120)

With the exception of a one-year storage stability and corrosion characteristics study, which the EPA is 

requiring as terms of registration, BASF Corporation fulfilled all product analysis data requirements for 

Trichoderma asperelloides strain JM41R. Refer to Tables 1 and 2 in Appendix A for a summary of the

data requirements, including both generic and product-specific information. 
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B. Human Health Assessment (40 CFR § 158.2140)

1. Toxicity

BASF Corporation fulfilled all toxicology data requirements for Trichoderma asperelloides strain 

JM41R. Acceptable or supplemental Tier I mammalian toxicology studies and scientific rationale 

support registration of the Trichoderma asperelloides strain JM41R pesticide products. The EPA is not 

requiring Tier II and Tier III studies for Trichoderma asperelloides strain JM41R, based on the adequacy 

of the data and information provided by BASF Corporation for Tier I.

For a summary of the generic toxicology data requirements described in sections IV(B)(1)(a) and 

IV(B)(1)(b) of this document, as well as additional product-specific data submitted to support the 

individual registrations, refer to Tables 3 and 4 in Appendix A.

a. Acute Toxicity/Pathogenicity – Tier I

Acute Oral Toxicity/Pathogenicity (Harmonized Guideline 885.3050; Master Record Identification 

Number (MRID No.) 489476-09): Upon consideration of BASF Corporation’s scientific rationale that 

cited to results of other toxicological data and public literature, the EPA waived acute oral 

toxicity/pathogenicity testing for Trichoderma asperelloides strain JM41R. An acute oral toxicity study 

conducted on female rats (MRID No. 489476-03) demonstrated that Trichoderma asperelloides strain 

JM41R is not toxic, while an acute pulmonary toxicity/pathogenicity study conducted on rats (MRID 

No. 489476-02) showed that Trichoderma asperelloides strain JM41R is not toxic, pathogenic, or 

infective. Further, Trichoderma asperelloides strain JM41R does not grow at or above 35°C (normal 

human body temperature is 37°C). Finally, although a literature search yielded two reports of infections 

in humans from Trichoderma species, the fungi involved were Trichoderma longibranchiatum or 

Trichoderma harzianum and not Trichoderma asperelloides, and the infections were likely due to 

immune system dysfunction, invasive procedures involved with therapy for the overlying disease, and/or 

immunosuppressive drugs. The EPA believes these data and information, when taken together, indicate 

that this fungus would not be toxic, pathogenic, or infective through the oral route of exposure and that 

further testing is not necessary.

Acute Pulmonary Toxicity/Pathogenicity – Rat (Harmonized Guideline 885.3150; MRID No. 489476-

02): In an acute pulmonary toxicity and pathogenicity study, groups of approximately 7- to 8-week-old 

Sprague Dawley rats (15 per sex) were exposed by the intratracheal route to Trichoderma asperelloides

strain JM41R. The test substance label claimed viability and lack of laboratory confirmation of the test 

substance viability resulted in animals receiving a dose of 4.7 x 107 colony-forming units (CFU) per rat 

instead of the guideline dose of 108 CFU per rat. The animals were observed frequently on the day of 

dosing for mortality and signs of pharmacologic and/or toxic effects and once daily thereafter for 21 

days. A control group (untreated) was observed concurrently. Tissue and blood samples taken at interim

sacrifices from the group receiving the active test substance were cultured on days 0, 3, and 7. There 

were no abnormal general health observations. There were no observed abnormalities during necropsies 

through day 21. The test substance was confirmed dosed to all animal lungs at day 0 where counts of 

approximately 5 x 105 colony-forming units per gram (CFU/g) were noted in all animal lung tissues. The 

study author concluded that the test substance cleared from all tissues by day 7 and a value of 0 was 

reported for most tissue samples, though the limit of detection based on dilution and sample sizes was 

not described and the report should have instead listed a value less than the detection limit. Also, a single
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male at day 7 had a reported <100 CFU/g in the lungs, while all other animals had 0 CFU/g detected; 

thus, clearance was apparently not established by day 7, and further sampling did not occur at interim 

and terminal sacrifices on days 14 and 21.

Trichoderma asperelloides strain JM41R is not toxic, pathogenic, or infective when administered by 

intratracheal instillation in a single dose of 4.7 x 107 colony-forming units (CFU) per animal. The EPA 

rated this study supplemental because clearance was not definitively established and the 4.7 x 107 CFU 

per animal dose used was below the acceptable guideline dose of 108 CFU per animal. Even with these 

deficiencies, however, the EPA still concluded that Trichoderma asperelloides strain JM41R showed a 

general pattern of clearance from lung tissues and considered these data useful for risk assessment 

purposes. 

Acute Injection Toxicity/Pathogenicity (Harmonized Guideline 885.3200; MRID No. 489476-09): Upon 

consideration of BASF Corporation’s scientific rationale that cited to results of other toxicological data 

and public literature, the EPA waived acute injection toxicity/pathogenicity testing for Trichoderma 

asperelloides strain JM41R. An acute oral toxicity study conducted on female rats (MRID No. 489476-

03) and an acute inhalation toxicity study conducted on male and female rats (MRID No. 489476-05) 

demonstrated that Trichoderma asperelloides strain JM41R is not toxic, while an acute pulmonary 

toxicity/pathogenicity study conducted on rats (MRID No. 489476-02) showed that Trichoderma 

asperelloides strain JM41R is not toxic, pathogenic, or infective. Further, Trichoderma asperelloides 

strain JM41R does not grow at or above 35°C (normal human body temperature is 37°C). Finally, 

although a literature search yielded two reports of infections in humans from Trichoderma species, the 

fungi involved were Trichoderma longibranchiatum or Trichoderma harzianum and not Trichoderma 

asperelloides, and the infections were likely due to immune system dysfunction, invasive procedures 

involved with therapy for the overlying disease, and/or immunosuppressive drugs. The EPA believes 

these data and information, when taken together, indicate that this fungus would not be toxic, 

pathogenic, or infective through the injection route of exposure (when the skin is bypassed as a barrier)

and that further testing is not necessary.

Hypersensitivity Incidents (Harmonized Guideline 885.3400; MRID No. 489476-09): BASF Corporation 

reported that, to date, no hypersensitivity incidents, including immediate-type or delayed-type reactions 

of humans and domestic animals, have occurred during research, development, or testing of 

Trichoderma asperelloides strain JM41R. Any future hypersensitivity incidents must be reported to the 

EPA (refer to test note #3 of 40 CFR § 158.2140(d)).

Cell Culture (Harmonized Guideline 885.3500; MRID No. 489476-09): Not required because 

Trichoderma asperelloides strain JM41R is not a virus (refer to test note #4 of 40 CFR § 158.2140(d)).

b. Acute Toxicology and Subchronic Toxicity/Pathogenicity – Tier II;

 Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

 Infectivity/Pathogenicity Analysis – Tier III

The EPA is not requiring Tier II and Tier III studies for Trichoderma asperelloides strain JM41R, based 

on the adequacy of the data and information provided by BASF Corporation for Tier I.
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c. Endocrine Disruptors

As required by the Administrator under FFDCA section 408(p), the EPA has developed the Endocrine 

Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be 

used to test all pesticides in order to determine whether certain substances (including pesticide active and

other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally 

occurring estrogen, or other such endocrine effects as the Administrator may designate.” 

FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of 

the Estrogenic Substances Screening Program a biologic substance or other substance if a determination 

is made that the substance is not anticipated to produce any effect in humans similar to an effect 

produced by a naturally occurring estrogenic substance. 

Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 

67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 

chemicals identified for EDSP screening was published on June 14, 2013,1 and includes some pesticides 

scheduled for registration review and chemicals found in water. Trichoderma asperelloides strain 

JM41R is not among the group of pesticide active ingredients on the lists to be screened under the 

EDSP. 

The EPA believes that Trichoderma asperelloides strain JM41R, the active ingredient described in this 

document, is a substance that would not likely produce any effect in humans similar to an effect 

produced by a naturally occurring estrogenic substance. As such, pursuant to Section 408(p)(4), the EPA 

will determine in the future whether it can exempt Trichoderma asperelloides strain JM41R from the 

requirements of the Section 408(p) EDSP. In the event the EPA does determine to exempt this substance 

from the EDSP, an order will be issued. 

For further information on the status of the EDSP, the policies and procedures, the list of chemicals,

future lists, the test guidelines and the Tier 1 screening battery, please visit our website at 

http://www.epa.gov/endo/.

2. Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations

Section 408(c)(2)(A)(i) of FFDCA allows the EPA to establish an exemption from the requirement for a 

tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines that 

the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a 

reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, 

including all anticipated dietary exposures and all other exposures for which there is reliable 

information.” This includes exposure through drinking water and in residential settings but does not 

include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining 

in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors 

set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to 

exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance 

exemption, and to “ensure that there is a reasonable certainty that no harm will result to infants and 

children from aggregate exposure to the pesticide chemical residue . . . .” Additionally, FFDCA section 

408(b)(2)(D) requires that the EPA consider “available information concerning the cumulative effects of 

1 See http://www.gpo.gov/fdsys/pkg/FR-2013-06-14/pdf/2013-14232.pdf for the second list of chemicals.

 
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[a particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.”

The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide 

residues. First, the EPA determines the toxicity of the pesticide. Second, the EPA examines exposure to 

the pesticide through food, drinking water, and other exposures that occur as a result of pesticide use in 

residential settings.

Consistent with FFDCA section 408(b)(2)(D), the EPA reviewed the available scientific data and other 

relevant information on Trichoderma asperelloides strain JM41R, and considered its validity, 

completeness, and reliability, as well as the relationship of this information to human risk. The EPA also 

considered available information concerning the variability of the sensitivities of major identifiable 

subgroups of consumers, including infants and children.

Based on the acute toxicity/pathogenicity information discussed previously and presented in Table 3 in 

Appendix A, the data required for a FFDCA risk assessment for Trichoderma asperelloides strain 

JM41R have been fulfilled.

a. Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs the EPA to consider available information 

concerning exposures from the pesticide residue in food and all other non-occupational exposures, 

including drinking water from ground water or surface water and exposure through pesticide use in 

gardens, lawns, or buildings (residential and other indoor uses).

Food Exposure and Risk Characterization: Exposure to residues of Trichoderma species, fungi 

commonly found in agricultural settings (i.e., soils and plant roots) and on fresh produce (Druzhinina et 

al., 2006; Harman et al., 2004; U.S. EPA, 2015a and 2015b), in consumed food is possible. For optimal 

management of the target pests (i.e., soilborne diseases caused by organisms such as Rhizoctonia species 

and Fusarium species), Trichoderma asperelloides strain JM41R needs to be applied to soil and growing 

media in commercial greenhouses in a manner that facilitates the fungus’ movement into the root zones 

of plants. This requires that end users take certain actions, depending on the treatment type, that would 

inevitably minimize the amount of Trichoderma asperelloides strain JM41R residues on above-ground 

commodities. That is, although Trichoderma asperelloides strain JM41R can be applied to soil, pesticide 

applications made to the soil include enough water or are followed immediately by irrigation to properly 

incorporate Trichoderma asperelloides strain JM41R into the soil. As Trichoderma asperelloides strain 

JM41R colonizes the soil or growing media in close proximity to plant roots or the root surfaces of 

plants, it is possible that food commodities that develop underground (e.g., root and tuber vegetables) or 

adjacent to the soil/ground (e.g., cucumber) could be directly exposed to Trichoderma asperelloides

strain JM41R. Although residues from use of pesticides containing Trichoderma asperelloides strain 

JM41R may be present on certain food commodities, processing procedures (e.g., peeling and washing) 

may reduce such residues (U.S. EPA, 1996). Finally, since Trichoderma species can be endophytes (i.e., 

organisms that live within plants) (Chaverri et al., 2011), it is conceivable that Trichoderma 

asperelloides strain JM41R could be present within food commodities. Should Trichoderma 

asperelloides strain JM41R be present in or on food, supporting toxicological data and information 

indicate that no toxicity, pathogenicity, or infectivity is likely to occur with this type of exposure 

resulting from the use of this microbial pesticide when applied in accordance with label directions and 

good agricultural practices (see section IV(B)(1)(a) of this document and Table 3 in Appendix A).
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Drinking Water Exposure and Risk Characterization: Trichoderma asperelloides strain JM41R is to be 

applied to soil or growing media in commercial greenhouses and is not intended for use in drinking 

water. Once applied, the risk of Trichoderma asperelloides strain JM41R 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 the type (i.e., chlamydospores) that are able to survive unfavorable 

conditions such as water (Chaverri et al., 2003). If Trichoderma asperelloides strain JM41R were to be 

transferred to surface or ground waters, it likely would not survive the conditions water is subjected to in 

wastewater treatment systems and drinking facilities (e.g., pH adjustments and chlorination) (Centers for 

Disease Control and Prevention, 2015; U.S. EPA, 2004). Should Trichoderma asperelloides strain 

JM41R be present in drinking water, supporting toxicological data and information indicate that no 

toxicity, pathogenicity, or infectivity is likely to occur with this type of exposure resulting from the use

of this microbial pesticide when applied in accordance with label directions and good agricultural 

practices (see section IV(B)(1)(a) of this document and Table 3 in Appendix A).

Non-occupational, Residential Risk Characterization: Dermal or inhalation exposure to the general 

population due to use of Trichoderma asperelloides strain JM41R is not likely to occur, based on 

product labeling that limits the use site to commercial greenhouses. Even if additional non-occupational 

exposures were to occur (e.g., through eventual expansion of use sites), no adverse effects attributed to 

Trichoderma asperelloides strain JM41R are anticipated, particularly in light of testing that indicates 

that this fungus is not toxic (acute inhalation toxicity, acute dermal toxicity, and acute pulmonary 

toxicity/pathogenicity tests), is only mildly irritating (primary dermal irritation test), and is not 

pathogenic or infective (acute pulmonary toxicity/pathogenicity test) at high doses (see section 

IV(B)(1)(a) of this document and Table 3 in Appendix A).

b. Cumulative Effects from Substances with a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or 

revoke a tolerance, the EPA consider “available information concerning the cumulative effects of [a 

particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.”

Trichoderma asperelloides strain JM41R is not toxic via the oral, dermal, or inhalation routes of 

exposure. Thus, for the purposes of the tolerance action, the EPA has concluded that Trichoderma 

asperelloides strain JM41R does not have a common mechanism of toxicity with other substances. 

Following from this, therefore, the EPA concludes that there are no cumulative effects associated with 

Trichoderma asperelloides strain JM41R that need to be considered. 

For information regarding the EPA’s efforts to determine chemicals that have a common mechanism of 

toxicity and to evaluate the cumulative effects of such chemicals, see the EPA’s website at 

http://www.epa.gov/pesticides/cumulative.

c. Determination of Safety for the U.S. Population, Infants and Children

U.S. Population: For all of the reasons discussed previously, there is reasonable certainty that no harm 

will result to the U.S. population, including infants and children, from aggregate exposure to residues of 

Trichoderma asperelloides strain JM41R. This includes all anticipated dietary exposures and all other 

exposures for which there is reliable information.
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Infants and Children: FFDCA section 408(b)(2)(C) provides that the EPA shall apply an additional 

tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for 

prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless the 

EPA determines based on reliable data that a different margin of safety will be safe for infants and 

children. This additional margin of safety is commonly referred to as the Food Quality Protection Act 

Safety Factor. In applying this provision, the EPA either retains the default value of 10X or uses a 

different additional safety factor when reliable data available to the EPA support the choice of a different 

factor. Humans, including infants and children, have likely been exposed and continue to be exposed to 

Trichoderma asperelloides through soil and fresh produce, where it is commonly found, with no known 

or reported adverse effects. As discussed above, the EPA has concluded that Trichoderma asperelloides

strain JM41R is not toxic, pathogenic, or infective to mammals, including infants and children. Because 

there are no threshold levels of concern to infants, children, and adults when Trichoderma asperelloides

strain JM41R is used according to label directions and good agricultural practices, the EPA concludes 

that no additional margin of safety is necessary to protect infants and children.

3. Occupational Exposure and Risk Characterization

Worker exposure to Trichoderma asperelloides strain JM41R is not expected to pose any undue risk. 

Regardless, the EPA is requiring appropriate protective clothing and precautionary statements on the 

pesticide product label to mitigate any potential risks to pesticide handlers and applicators due to 

prolonged and/or multiple exposures. At a minimum, individuals working with Trichoderma 

asperelloides strain JM41R to manage certain soilborne diseases are directed to wear a long-sleeved 

shirt, long pants, socks, shoes, protective eyewear, and a dust/mist filtering respirator meeting NIOSH

standards of at least N-95, R-95, or P-95. 

4. Human Health Risk Characterization

The EPA considered human exposure to Trichoderma asperelloides strain JM41R in light of the 

standard for registration in FIFRA and the relevant safety factors in FFDCA. When the Trichoderma 

asperelloides strain JM41R pesticide products are applied/used in accordance with labeling approved by 

the EPA, the EPA has determined that no unreasonable adverse effects to human health are expected and 

that there is a reasonable certainty that no harm will result to the U.S. population, including infants and 

children.

C. Environmental Assessment (40 CFR § 158.2150)

1. Introduction

BASF Corporation submitted an application to register two pesticide products containing Trichoderma 

asperelloides strain JM41R as their active ingredient (a.i.). The two products include a MP, 

Trichoderma asperelloides strain JM41R Technical (EPA File Symbol: 71840-RL), and an EP, TRICHO 

PLUSTM Biofungicide (EPA File Symbol: 71840-RU). Trichoderma spp. are widely found in soil, and 

typically are understood to be saprotrophic, parasites of other fungi, and/or endophytes. Trichoderma 

asperelloides is an inhabitant of soil and used for biocontrol of plant diseases (Chaverri and Samuels, 

2013; Druzhinina et al., 2011). It can become established within the plant rhizosphere, where it may 

stimulate plant growth and defenses against disease (Druzhinina et al., 2011). 
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TRICHO PLUSTM Biofungicide is intended for use in greenhouses to control soilborne diseases caused 

by microorganisms such as Pythium, Rhizoctonia, Fusarium, Sclerotinia, and Phytophthora. 

Applications are to be soil directed and made through coarse spray, soil drench, or chemigation. The 

labeling directs the user to apply TRICHO PLUSTM Biofungicide at a rate of 0.8 fluid ounces per 10,000 

square feet and to reapply at 21- to 28-day intervals throughout the growing season. While the EP is for 

use in greenhouses and can be applied to the soil or growing media of all plants grown in greenhouses, 

the product labeling does not specify whether applications are restricted to enclosed greenhouses only.

2. Ecological Effects Data

BASF Corporation conducted a dietary exposure study on honey bee (Apis mellifera) and submitted 

rationale to address other data requirements for the FIFRA section 3 registration of products containing 

the new active ingredient. Details of the honey bee study and scientific rationale are discussed below. 

The information provided is sufficient to satisfy the nontarget organism data requirements for ecological 

risk assessment for the a.i., Trichoderma asperelloides strain JM41R. Further testing of nontarget 

organisms at higher tiers is not required. 

a. Scientific Rationale (Harmonized Guidelines 885.4050, 885.4100, 885.4150, 885.4200, 

885.4240, 885.4280, 885.4300, and 885.4340; MRID No. 489476-09)

Scientific rationale was provided to address the hazard of Trichoderma asperelloides strain JM41R to 

birds, wild mammals, freshwater and marine/estuarine fish and invertebrates, nontarget plants, and 

nontarget insects (MRID No. 489476-09). The rationale was written assuming that the active ingredient 

was Trichoderma fertile; however, BASF Corporation determined the current identity with better 

analysis. The rationale was based on knowledge of the natural occurrence of Trichoderma species, the 

low concentration of the a.i. in the EP, its limited application to soil of potted plants in greenhouses, and 

lack of evidence of adverse effects to nontargets. Except for information that was specific to 

Trichoderma fertile (e.g., optimum growth temperature for this species), the rationale was applicable to 

Trichoderma asperelloides. Additionally, a literature search was performed using “Trichoderma 

asperelloides” as the search term, and no reports of adverse effects to nontarget organisms were found. 

Based on the well-characterized nature of Trichoderma species of fungi, adverse effects to nontarget 

organisms are unlikely as a result of the proposed applications of the EP as labeled. The rationale was 

determined to be acceptable.

b. Honey Bee Toxicity/Pathogenicity (Harmonized Guideline 885.4380, MRID No. 493849-

01)

A 17-day oral toxicity and pathogenicity study was conducted with adult honey bees (Apis mellifera; 

MRID No. 493849-01). Bees were exposed to a sucrose solution containing the active or inactive test 

substance, a sucrose solution only (untreated control), or dimethoate at 100 parts per million (positive 

control). There were no significant differences in the active or inactive test substance groups for 

mortality or food consumption when compared to the control group bees. All the bees in the positive 

control dimethoate group were dead by day 4. The study ended on day 17 when mortality in the 

untreated control group exceeded 20%. Based on the results of this study, the test substance, 

Trichoderma asperelloides strain JM41R, was determined to be non-toxic to the honey bee when 

administered at 8.1 x 103 colony-forming units per milliliter (CFU/mL). The study was classified as 

supplemental because the level of exposure was below the expected environmental exposure 
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concentration, which was determined to be 1.2 x 105 CFU/mL based on the proposed TRICHO PLUSTM

Biofungicide labeling. It is possible that this study may be useful for applications of Trichoderma 

asperelloides strain JM41R at lower rates; however, this study is not useful to the current risk 

assessment, and risk was determined based on other information. 

3. Risk Characterization and Description

Exposure of nontarget organisms to Trichoderma asperelloides strain JM41R is expected to be minimal,

based on the proposed uses as labeled. Applications are to occur only in greenhouses, which will limit 

environmental exposure. The labeling does not specify that greenhouses in which TRICHO PLUSTM

Biofungicide will be used must be enclosed; therefore, it is possible that greenhouses may be open on the

sides at certain or at all times during the year. Some exposure to nontarget organisms that would enter 

the greenhouse may occur; however, applications are to be directed to soil or planting media in 

containers within the greenhouse. Therefore, the potential for any significant exposure to any nontarget 

organisms is expected to be very limited.

Information on bee hazard was inconclusive based on the submitted study; however, exposure to bees as 

a result of the labeled uses is expected to be very low. Applications are directed to media or soil within 

containers in greenhouses, so they are not made to foliage and will not result in exposure to bees 

intentionally introduced for pollination or incidentally visiting greenhouses. Native species of bees that 

live in soil are also unlikely to make use of the soil in the treated containers. Therefore, exposure to bees 

as a result of the proposed labeled uses are not expected.

As described above, adverse effects that might result from exposure are also unlikely. Trichoderma 

asperelloides is widespread within soil and is saprotrophic on plant matter (Chaverri and Samuels,

2013). Since it is associated with growth within the plant rhizosphere, its likely mode of action is 

stimulation of normal plant defenses (Druzhinina et al., 2011) and competition for resources (a common 

mode of action for Trichoderma spp.). Therefore, its effects are expected to be limited to plant disease 

causing microorganisms for which it is labeled.

Based on limited exposure and very low likelihood of adverse effects, risk to nontarget organisms 

resulting from the proposed labeled applications of Trichoderma asperelloides strain JM41R is expected 

to be minimal. 

4. Threatened and Endangered Species Assessment

The EPA has determined that adverse effects to nontarget organism are not expected as a result of the 

proposed applications of Trichoderma asperelloides strain JM41R. Therefore, the EPA makes a “no 

effect” determination for direct and indirect effects to endangered and threatened species and their 

habitats from the proposed uses of Trichoderma asperelloides strain JM41R, as labeled. 

V. ENVIRONMENTAL JUSTICE

The EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of all 

people regardless of race, color, national origin, or income—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. Fair treatment means 
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that no group of people, including racial, ethnic, or socioeconomic groups, should bear a 

disproportionate share of the negative environmental consequences resulting from industrial, municipal, 

and commercial operations or the execution of federal, state, local, and tribal environmental programs 

and policies. Meaningful involvement means that (1) potentially affected community residents have an 

appropriate opportunity to participate in decisions about a proposed activity that will affect their 

environment and/or health; (2) the public’s contribution can influence the regulatory agency’s decision; 

(3) the concerns of all participants involved will be considered in the decision-making process; and (4) 

the decision-makers seek out and facilitate the involvement of those potentially affected. The EPA has 

this goal for all communities and persons across the U.S. 

To help address potential environmental justice issues, during the 15-day public participation comment 

period, the EPA sought information on any groups or segments of the population who, as a result their 

location, cultural practices, or other factors, may have atypical, unusually high exposure to Trichoderma 

asperelloides strain JM41R, compared to the general population. The EPA received no public comments 

on this particular matter.

For additional information regarding environmental justice issues, please visit the EPA’s website at 

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. RISK MANAGEMENT DECISION

Section 3(c)(5) of FIFRA permits for the registration of a pesticide provided that all the following 

determinations are made:

(1) Its composition is such as to warrant the proposed claims for it;

(2) Its labeling and other material required to be submitted comply with the

 requirements of FIFRA;

(3) It will perform its intended function without unreasonable adverse effects on 

 the environment; AND

(4) When used in accordance with widespread and commonly recognized 

 practice, it will not generally cause unreasonable adverse effects on the 

 environment.

To satisfy criterion 1, the EPA understands that Trichoderma asperelloides strain JM41R is well known 

to have fungicidal capabilities. The EPA has no knowledge that would contradict the claims made on the

Trichoderma asperelloides strain JM41R Technical and TRICHO PLUSTM Biofungicide labels, and such 

pesticide products are not expected to cause unreasonable adverse effects on the environment when used 

according to their respective label instructions. Criterion 2 is satisfied by the current product labels, as 

well as the data and information presented in this document. It is believed that the Trichoderma 

asperelloides strain JM41R pesticide products will not cause any unreasonable adverse effects on the 

environment, and TRICHO PLUSTM Biofungicide (end-use pesticide product), in particular, is likely to 

manage certain soilborne diseases caused by organisms such as Pythium, Rhizoctonia, Fusarium, 

Sclerotinia, and Phytophthora as claimed, satisfying criterion 3. Criterion 4 is satisfied in that the 

Trichoderma asperelloides strain JM41R pesticide products are not expected to cause unreasonable 

adverse effects when used according to label instructions. Therefore, EPA believes Trichoderma 

asperelloides strain JM41R Technical and TRICHO PLUSTM Biofungicide, containing Trichoderma 
Trichoderma asperelloides strain JM41R Page 18 of 29

Biopesticides Registration Action Document

asperelloides strain JM41R as a new active ingredient, are eligible for registration under FIFRA section 

3(c)(5) for the labeled uses.

VII. ACTIONS REQUIRED OF THE REGISTRANT

A. Final Printed Labeling

Before releasing pesticide products containing Trichoderma asperelloides strain JM41R for shipment, 

the registrant must provide appropriate final printed labeling to the EPA.

B. Terms of Registration

As terms of the Trichoderma asperelloides strain JM41R Technical and TRICHO PLUSTM Biofungicide 

registrations, the registrant must submit the results of a one-year storage stability (Harmonized Guideline 

830.6317) and corrosion characteristics (Harmonized Guideline 830.6320) study for each pesticide 

product within 18 months of registration.

C. Reporting of Adverse Effects and Hypersensitivity Incidents

Notwithstanding the information stated in the previous sections, it should be clearly understood that 

certain specific data are required to be reported to the EPA as a requirement for maintaining the federal 

registration for a pesticide product. A brief summary of these types of data are described below.

Reports of all incidents of adverse effects to the environment must be submitted to the EPA under the 

provisions stated in FIFRA section 6(a)(2). Additionally, all incidents of hypersensitivity (including both 

suspected and confirmed incidents) must be reported to the EPA under the provisions of 40 CFR § 

158.2140(d).
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VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. active ingredient

BRAD Biopesticides Registration Action Document

CFR Code of Federal Regulations

CFU colony-forming units

CFU/g colony-forming units per gram

CFU/mL colony-forming units per milliliter

DNA deoxyribonucleic acid

EDSP Endocrine Disruptor Screening Program

EP end-use pesticide product

EPA United States Environmental Protection Agency 

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FR Federal Register

lb/cu ft pounds per cubic foot

LC50 median lethal concentration. A statistically derived concentration of a substance that can 

be expected to cause death in 50% of test animals. It is usually expressed as the weight of 

substance per weight or volume of water, air, or feed (e.g., mg/L, mg/kg, or ppm).

LD50 median lethal dose. A statistically derived single dose that can be expected to cause death 

in 50% of the test animals when administered by the route indicated (oral, dermal, or 

inhalation). It is expressed as a weight of substance per unit weight of animal (e.g., 

mg/kg).

mg/kg milligrams per kilogram

mg/L milligrams per liter

MP manufacturing-use pesticide product

MRID No. Master Record Identification Number

NIOSH National Institute for Occupational Safety and Health

NRRL Northern Regional Research Laboratory

OPP Office of Pesticide Programs

PC Code Pesticide Chemical Code

PP Pesticide Petition

ppm parts per million

TGAI technical grade of the active ingredient

U.S. United States
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IX. BIBLIOGRAPHY

A. Studies Submitted to Support the Trichoderma asperelloides strain JM41R Pesticide Product

Registrations

MRID No. Study Information

489476-01 Sargent G. 2012. Product Chemistry for Trichoderma fertile Strain JM41R Technical. 

Unpublished study prepared by Becker Underwood, Inc., 132 pages.

489476-02 Doig A. 2012. Trichoderma fertile Strain JM41R: Acute Pulmonary Toxicity and 

Pathogenicity Study in Rats. Project Number: 16704/12/OCR. Unpublished study 

prepared by Stillmeadow, Inc., 37 pages.

489476-03 Kuhn J. 2011. Trichoderma fertile Strain JM41R: Acute Oral Toxicity Study (UDP) in 

Rats – Final Report. Project Number: 15357/11/OCR. Unpublished study prepared by 

Stillmeadow, Inc., 11 pages.

489476-04 Kuhn J. 2011. Trichoderma fertile Strain JM41R: Acute Dermal Toxicity in Rats – Final 

Report. Project Number: 15358/11/OCR. Unpublished study prepared by Stillmeadow, 

Inc., 14 pages.

489476-05 Doig A. 2011. Trichoderma fertile Strain JM41R: Acute Inhalation Toxicity Study in Rats 

– Final Report. Project Number: 15359/11/OCR. Unpublished study prepared by 

Stillmeadow, Inc., 18 pages.

489476-06 Kuhn J. 2011. Trichoderma fertile Strain JM41R: Acute Eye Irritation Study in Rabbits –

Final Report. Project Number: 15360/11/OCR. Unpublished study prepared by

Stillmeadow, Inc., 17 pages.

489476-07 Kuhn J. 2011. Trichoderma fertile Strain JM41R: Acute Dermal Irritation Study in 

Rabbits – Final Report. Project Number: 15361/11/OCR. Unpublished study prepared by 

Stillmeadow, Inc., 11 pages.

489476-08 Younger C. 2012. Trichoderma fertile Strain JM41R: Honey Bee Testing (Apis mellifera), 

Non-target Insect Microbial Testing. Project Number: 16382/12/OCR. Unpublished study 

prepared by Stillmeadow, Inc., 14 pages.

489476-09 Mileson B. 2012. Response to Tier 1 Microbial Pesticide Data Requirements for 

Trichoderma fertile Strain JM41R Technical. Unpublished study prepared by Technology 

Sciences Group, Inc., 75 pages.

489477-01 Sargent G. 2012. Product Chemistry for Tricho Plus. Unpublished study prepared by 

Becker Underwood, Inc., 70 pages.
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Biopesticides Registration Action Document

MRID No. Study Information

489477-02 Mileson B. 2012. Response to Tier 1 Microbial Pesticide Data Requirements for Tricho 

Plus. Unpublished study prepared by Becker Underwood, Inc., 27 pages.

492477-01 Sargent G. 2013. Addendum to Volume 2: Product Chemistry for Tricho Plus (MRID No. 

489477-01). Unpublished study prepared by BASF Corporation, 74 pages.

492496-01 Sargent G. 2013. Volume 2: Product Chemistry for Trichoderma fertile Strain JM41R 

Technical – Final Report. Unpublished study prepared by BASF Corporation, 84 pages.

493849-01 Younger C. 2014. Trichoderma fertile Strain JM41R: Honey Bee Testing (Apis mellifera), 

Non-target Insect Microbial Testing. Project Number: 16382/12. Unpublished study 

prepared by Stillmeadow, Inc., 25 pages.

494690-01 Sargent G. 2014. Product Chemistry for Trichoderma asperelloides Strain JM41R 

Technical. Project Number: 2014/7002837. Unpublished study prepared by BASF 

Corporation, 168 pages.

494691-01 Sargent G. 2014. Product Chemistry for TrichoPlusTM Biofungicide. Project Number: 

2014/7002851. Unpublished study prepared by BASF Corporation, 87 pages.

B. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2015a. Trichoderma asperelloides strain JM41R. Memorandum from J.V. Gagliardi, Ph.D. 

through J.L. Kough, Ph.D. to J. Kausch, dated January 21, 2015.

U.S. EPA. 2015b. Environmental risk assessment of Trichoderma asperelloides strain JM41R for a 

FIFRA section 3 registration for use in greenhouses. Memorandum from S. Borges to J. Kausch, 

dated February 18, 2015.

C. Other References

Centers for Disease Control and Prevention. 2015. Drinking Water - Water Treatment. Available from 

http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.

Chaverri P, Samuels GJ. 2013. Evolution of habitat preference and nutrition mode in a cosmopolitan 

fungal genus with evidence of interkingdom host jumps and major shifts in ecology. Evolution 67: 

2823–2837. Available from 

https://psla.umd.edu/sites/default/files/_images/uploaded/Research/Chaverri_Lab/PDFs/evolution.p

df. 

Chaverri P, Gazis RO, Samuels GJ. 2011. Trichoderma amazonicum, a new endophytic species on 

Hevea brasiliensis and H. guianensis from the Amazon basin. Mycologia 103(1):139–151. Available 

from http://www.mycologia.org/content/103/1/139.full. 
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Chaverri P, Castlebury LA, Overton BE, Samuels GJ. 2003. Hypocrea/Trichoderma: species with 

conidiophore elongations and green conidia. Mycologia 95(6):1100–1140. Available from 

http://www.mycologia.org/content/95/6/1100.full.

Druzhinina IS, Seidl-Seiboth V, Herrera-Estrella A, Horwitz BA, Kenerley CM, Monte E, Mukherjee 

PK, Zeilinger S, Grigoriev IV, Kubicek CP. 2011. Trichoderma: the genomics of opportunistic 

success. Nature Reviews Microbiology 9:749–759.

Druzhinina IS, Kopchinskiy AG, Kubicek CP. 2006. The first 100 Trichoderma species characterized by 

molecular data. Mycoscience 47:55–64. Available from 

http://isth.info/library/pdf/61/isth_library_61.pdf.

Harman GE, Howell CR, Viterbo A, Chet I, Lorito M. 2004. Trichoderma species – opportunistic, 

avirulent plant symbionts. Nature Reviews Microbiology 2:43–56. Available from 

http://naldc.nal.usda.gov/download/25508/PDF.

U.S. EPA. 2014. Chapter 7 of the Label Review Manual (Precautionary Statements) (Revised July 

2014). Available from http://www2.epa.gov/sites/production/files/2014-

07/documents/chapter7_revised_final_0714.pdf.

U.S. EPA. 2004. Primer for Municipal Wastewater Treatment Systems. EPA 832-R-04-001. Available 

from http://www.epa.gov/npdes/pubs/primer.pdf. 

U.S. EPA. 1996. Microbial Pesticide Test Guidelines – Background for Residue Analysis of Microbial 

Pest Control Agents (OPPTS 885.2000) (Dated February 1996). Available from 

http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm. 
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APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 

(40 CFR PART 158 – SUBPART V)

TABLE 1. Product Analysis Data Requirements for Trichoderma asperelloides strain JM41R (Technical Grade of the Active Ingredient, TGAI), Trichoderma asperelloides

strain JM41R Technical (Manufacturing-use Pesticide Product, MP), and TRICHO PLUSTM Biofungicide (End-use Pesticide Product, EP) (40 CFR § 158.2120)

1

Harmonized 

Guideline 

Number 

Data Requirement

Results

MRID No.

TGAI MP EP

885.1100 Product Identity N/A

Submitted data fulfill the requirement 

for product identity. Trichoderma 

asperelloides strain JM41R Technical 

contains 100.0% by weight Trichoderma 

asperelloides strain JM41R (contains a 

minimum of 2.0 x 1010 colony-forming 

units (CFU) per gram).

Submitted data fulfill the 

requirement for product identity. 

TRICHO PLUSTM Biofungicide 

contains 5.5% by weight 

Trichoderma asperelloides strain 

JM41R (contains a minimum of 2.0 x 

109 colony-forming units (CFU) per 

gram).

494690-012

(replaces 489476-01 

and 492496-01)

494691-013

(replaces 489477-01 

and 492477-01)

885.1200 Manufacturing 

Process Submitted data fulfill the requirement for manufacturing process.

885.1250

Deposition of a 

Sample in a 

Nationally 

Recognized Culture 

Collection

Trichoderma asperelloides strain

JM41R is on deposit with the 

Agricultural Research Service 

Culture Collection (also known as 

the Northern Regional Research 

Laboratory Collection) in Peoria, 

Illinois under Accession Number 

NRRL 50759.

N/A

494690-01

(replaces 489476-01 

and 492496-01)

885.1300

Discussion of 

Formation of 

Unintentional 

Ingredients

Submitted data fulfill the requirement for discussion of formation of unintentional ingredients.

494690-012

(replaces 489476-01 

and 492496-01)

494691-013

(replaces 489477-01 

and 492477-01)

885.1400 Analysis of Samples Submitted data fulfill the requirement for analysis of samples.

885.1500 Certification of 

Limits N/A Limits listed on the confidential statements of formula are adequate/acceptable.

 1 In this case, the TGAI is equivalent to the MP. 2 Data package associated with the TGAI/MP. 3 Data package associated with the EP.
Trichoderma asperelloides strain JM41R Page 24 of 29

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TABLE 2. Physical and Chemical Characteristics for Trichoderma asperelloides strain JM41R (Technical Grade of the Active Ingredient, TGAI), Trichoderma asperelloides

strain JM41R Technical (Manufacturing-use Pesticide Product, MP), and TRICHO PLUSTM Biofungicide (End-use Pesticide Product, EP) (40 CFR § 158.2120)1

Harmonized 

Guideline 

Number

Data Requirement

Results

MRID No. TGAI MP EP

830.6302 Color Dark green

N/A

494690-01

(replaces 489476-01 

and 492496-01)

830.6303 Physical State Fine dry powder

830.6304 Odor Musty

830.6313

Stability to Normal and 

Elevated Temperatures, 

Metals and Metal Ions

Stable 60 days above 24°C

830.6317 Storage Stability

As terms of the Trichoderma asperelloides strain JM41R Technical and TRICHO PLUSTM Biofungicide 

registrations, the EPA is requiring BASF Corporation to submit the results of a one-year storage 

stability study for each product within 18 months of registration.

N/A

830.6319 Miscibility

N/A

Not required because the pesticide products are not emulsifiable liquids 

(refer to test note #3 of 40 CFR § 158.2120(d)).

494690-012

(replaces 489476-01 

and 492496-01)

494691-013

(replaces 489477-01 

and 492477-01)

830.6320 Corrosion Characteristics

As terms of the Trichoderma asperelloides strain JM41R Technical 

and TRICHO PLUSTM Biofungicide registrations, the EPA is 

requiring BASF Corporation to submit the results of a corrosion 

characteristics study for each product within 18 months of 

registration.

N/A

830.7000 pH 6.0

(1% aqueous solution) N/A 5.0 (1% aqueous solution)4

494690-012

(replaces 489476-01 

and 492496-01)

494691-013

(replaces 489477-01 

and 492477-01)

830.7100 Viscosity N/A Not required because the pesticide products are not liquids (refer to test 

note #5 of 40 CFR § 158.2120(d)).

830.7300

Density/Relative 

Density/Bulk Density 

(Specific Gravity)

16.2 lb/cu ft N/A 44 lb/cu ft

4

1 In this case, the TGAI is equivalent to the MP.

2 Data package associated with the TGAI/MP. 3 Data package associated with the EP.

4 According to 40 CFR § 158.2120, these data are only required for the TGAI. Since BASF Corporation included this information with its application for TRICHO PLUSTM 

 Biofungicide, it is summarized appropriately in this table.
Trichoderma asperelloides strain JM41R Page 25 of 29

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TABLE 3. Toxicology Data Requirements for Trichoderma asperelloides strain JM41R (Technical Grade of the Active Ingredient, TGAI) and Trichoderma asperelloides

strain JM41R Technical (Manufacturing-use Pesticide Product, MP) (40 CFR § 158.2140)1

Harmonized

Guideline 

Number

Data Requirement

Results

MRID No.

TGAI MP

Tier I

885.3050 Acute Oral 

Toxicity/Pathogenicity

Testing waived based on BASF Corporation’s scientific 

rationale, which cited to MRID No. 489476-03 (acute oral 

toxicity study conducted with the TGAI/MP) and MRID No. 

489476-02 (acute pulmonary toxicity/pathogenicity study 

conducted with the TGAI/MP); included a literature search 

that yielded no human pathogenicity concerns; and provided 

data describing no growth of Trichoderma asperelloides

strain JM41R at 35°C or above. 

Classification: Acceptable

N/A

489476-09

885.3150 Acute Pulmonary 

Toxicity/Pathogenicity

Not toxic, infective, or pathogenic to rats when administered 

by intratracheal instillation in a single dose of 4.7 x 107 CFU 

per animal. 

Classification: Supplemental because clearance was not 

established and the dose used was below the guideline of 

108 CFU per animal.

489476-02

885.3200 Acute Injection 

Toxicity/Pathogenicity

Testing waived based on BASF Corporation’s scientific 

rationale, which cited to MRID No. 489476-03 (acute oral 

toxicity study conducted with the TGAI/MP), MRID No. 

489476-05 (acute inhalation toxicity study conducted with the 

TGAI/MP) and MRID No. 489476-02 (acute pulmonary 

toxicity/pathogenicity study conducted with the TGAI/MP); 

included a literature search that yielded no human 

pathogenicity concerns; and provided data describing no 

growth of Trichoderma asperelloides strain JM41R at 35°C 

or above. 

Classification: Acceptable

489476-09

885.3400 Hypersensitivity

Incidents

BASF Corporation reported that, to date, no hypersensitivity incidents, including immediate-type or delayed-type 

reactions of humans and domestic animals, have occurred during research, development, and testing of the TGAI/MP. 

Any future hypersensitivity incidents must be reported to the EPA (refer to test note #3 of 40 CFR § 158.2140(d)). 

885.3500 Cell Culture

Not required because Trichoderma asperelloides strain 

JM41R is not a virus (refer to test note #4 of 40 CFR § 

158.2140(d)).

N/A
Trichoderma asperelloides strain JM41R Page 26 of 29

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TABLE 3. Toxicology Data Requirements for Trichoderma asperelloides strain JM41R (Technical Grade of the Active Ingredient, TGAI) and Trichoderma asperelloides

strain JM41R Technical (Manufacturing-use Pesticide Product, MP) (40 CFR § 158.2140)1

Harmonized

Guideline 

Number

Data Requirement

Results

MRID No.

TGAI MP

870.1100 Acute Oral Toxicity N/A

Oral LD50 (female rats) > 5,000 mg/kg

Classification: Acceptable

TOXICITY CATEGORY IV

489476-03

870.1200 Acute Dermal Toxicity

N/A

Dermal LD50 (male and female rats combined) > 5,050 

mg/kg

Classification: Acceptable

TOXICITY CATEGORY IV

489476-04

870.1300 Acute Inhalation Toxicity

Inhalation LC50 (male and female rats combined) > 2.34 

mg/L

Classification: Supplemental because the particle 

size (6.5 μm) was above the guideline standard.

TOXICITY CATEGORY IV

489476-05

870.2400 Acute Eye Irritation

Trichoderma asperelloides strain JM41R is mildly 

irritating to the eyes of rabbits. Conjunctival irritation 

(e.g., redness) was noted on all rabbits at 24 hours after 

test material instillation with resolution by 72 hours.

Classification: Acceptable

TOXICITY CATEGORY III

489476-06

870.2500 Primary Dermal Irritation

Trichoderma asperelloides strain JM41R is mildly 

irritating to the skin of rabbits. All animals were free of 

slight dermal erythema without edema by 48 hours.

Classification: Acceptable

TOXICITY CATEGORY IV

489476-07

Tiers II and III

Toxicological testing at higher tiers is not required for Trichoderma asperelloides strain JM41R. 

 1 In this case, the TGAI is equivalent to the MP.
Trichoderma asperelloides strain JM41R Page 27 of 29

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TABLE 4. Toxicology Data Requirements for TRICHO PLUSTM Biofungicide (End-use Pesticide Product, EP) (40 CFR § 158.2140)

Harmonized 

Guideline 

Number

Data Requirement Results MRID No.

885.3050 Acute Oral 

Toxicity/Pathogenicity

885.3150 N/A N/A Acute Pulmonary 

Toxicity/Pathogenicity

885.3200 Acute Injection 

Toxicity/Pathogenicity

885.3400 Hypersensitivity 

Incidents

BASF Corporation reported that, to date, no hypersensitivity incidents, including immediate-type or delayed-type reactions of 

humans and domestic animals, have occurred during research, development, and testing of the EP. Any future hypersensitivity 

incidents must be reported to the EPA (refer to test note #3 of 40 CFR § 158.2140(d)).

489476-09

885.3500 Cell Culture N/A N/A

870.1100 Acute Oral Toxicity

Testing waived based on BASF Corporation’s scientific rationale, which cited to the results of MRID No. 489476-03 (acute oral 

toxicity study conducted with the TGAI/MP, see Table 3), and because this formulation contains an inert ingredient that is not 

expected to be of toxicological concern (refer to test note #5 of 40 CFR § 158.2140(d)).

Classification: Acceptable

TOXICITY CATEGORY IV

489477-02

870.1200 Acute Dermal 

Toxicity

Testing waived based on BASF Corporation’s scientific rationale, which cited to the results of MRID No. 489476-04 (acute 

dermal toxicity study conducted with the TGAI/MP, see Table 3), and because this formulation contains an inert ingredient that is 

not expected to be of toxicological concern (refer to test note #5 of 40 CFR § 158.2140(d)).

Classification: Acceptable

TOXICITY CATEGORY IV

870.1300 Acute Inhalation 

Toxicity

Testing waived based on BASF Corporation’s scientific rationale, which cited to the results of MRID No. 489476-05 (acute 

inhalation toxicity study conducted with the TGAI/MP, see Table 3), and because this formulation contains an inert ingredient 

that is not expected to be of toxicological concern (refer to test note #5 of 40 CFR § 158.2140(d)).

Classification: Acceptable

TOXICITY CATEGORY IV

870.2400 Acute Eye Irritation

Testing waived based on BASF Corporation’s scientific rationale, which cited to the results of MRID No. 489476-06 (acute eye

irritation study conducted with the TGAI/MP, see Table 3), and because this formulation contains an inert ingredient that is not 

expected to be of toxicological concern (refer to test note #5 of 40 CFR § 158.2140(d)).

Classification: Acceptable

TOXICITY CATEGORY III

870.2500 Primary Dermal 

Irritation

Testing waived based on BASF Corporation’s scientific rationale, which cited to the results of MRID No. 489476-07 (primary 

dermal irritation study conducted with the TGAI/MP, see Table 3), and because this formulation contains an inert ingredient that 

is not expected to be of toxicological concern (refer to test note #5 of 40 CFR § 158.2140(d)).

Classification: Acceptable

TOXICITY CATEGORY IV
Trichoderma asperelloides strain JM41R Page 28 of 29

Biopesticides Registration Action Document

TABLE 5. Nontarget Organism Toxicity and Environmental Fate Data Requirements for Trichoderma asperelloides strain JM41R (Technical Grade of the Active Ingredient, 

TGAI) (40 CFR § 158.2150)

Harmonized Guideline 

Number Data Requirement Results MRID No.

Tier I

885.4050 Avian Oral Toxicity

Scientific rationale provides sufficient information to determine that 

toxicity/pathogenicity is not expected.

Classification: Acceptable

489476-09

885.4100 Avian Inhalation 

Toxicity/Pathogenicity

885.4150 Wild Mammal 

Toxicity/Pathogenicity

885.4200 Freshwater Fish 

Toxicity/Pathogenicity

885.4240 Freshwater Invertebrate 

Toxicity/Pathogenicity

885.4280 Estuarine/Marine Fish and 

Invertebrate Testing

885.4300 Nontarget Plant Testing

885.4340 Nontarget Insect Testing

885.4380 Honey Bee Testing

A 17-day toxicity/pathogenicity laboratory study showed that Trichoderma asperelloides

strain JM41R is not toxic or pathogenic to honey bees at 8.1 x 103 CFU/mL. 

Classification: Supplemental because the test was done at a rate below the estimated 

environmental concentration.

493849-01

(replaces 489476-08)

Tiers II, III, and IV

Environmental testing at higher tiers is not required for Trichoderma asperelloides strain JM41R.
Trichoderma asperelloides strain JM41R Page 29 of 29

Biopesticides Registration Action Document

APPENDIX B. PESTICIDE PRODUCTS

EPA 

Registration 

Number

Registration 

Name

Percentage 

Active 

Ingredient

Formulation 

Type Use Site(s) Method(s) of Application Application Rate(s) Target Pest

71840-14 TRICHO PLUSTM

Biofungicide 5.5%

End Use –

Wettable 

Powder

Soil or growing 

media used 

within

commercial

greenhouses

Coarse spray, soil 

drench, or common 

irrigation application 

systems

0.8 ounce of TRICHO 

PLUSTM Biofungicide per 

10,000 square feet of soil or 

growing media

Soilborne diseases caused by organisms such as 

Pythium, Rhizoctonia, Fusarium, Sclerotinia, and 

Phytophthora

71840-15

Trichoderma 

asperelloides

strain JM41R 

Technical

100.0% Technical N/A