Registration Decision for the New Active Ingredient 

Trichoderma asperelloides strain JM41R 

(originally Trichoderma fertile strain JM41R) 

Approved by: 

Date: 
1. Background

On October 10, 2012, the U.S. Environmental Protection Agency (EPA) received applications 

for registration that involve and a petition to establish a tolerance exemption for the new 

fungicide Trichoderma fertile strain JM41R from Becker Underwood, Inc. (now BASF 

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

ingredient associated with the aforementioned pesticide products and tolerance exemption 

petition 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.

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

roots. 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); (2) Trichoderma harzianum Rifai strain T-22 (40 CFR § 180.1102); (3) Trichoderma

harzianum strain T-39 (40 CFR § 180.1201); (4) Trichoderma gamsii strain ICC 080 (40 CFR § 

180.1293); (5) Trichoderma asperellum strain ICC 012 (40 CFR § 180.1294); (6) Trichoderma 

hamatum isolate 382 (40 CFR § 180.1298); and (7) Trichoderma virens strain G-41 (40 CFR §

180.1310). The EPA also completed registration review of certain Trichoderma species in 

September 2008 (search for “EPA-HQ-OPP-2006-0245” at www.regulations.gov).

Regarding Trichoderma asperelloides strain JM41R, 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 proposed to register a manufacturing-use pesticide product (MP) 

and an end-use pesticide product (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.

2. Evaluation

In evaluating a pesticide registration application, the EPA assesses a wide variety of studies to 

determine the likelihood of adverse effects (i.e., risk) from exposures associated with the

proposed use of the product. Risk assessments are developed to evaluate how the compound 

might affect a wide range of nontarget organisms, including humans and terrestrial and aquatic 

wildlife (plants and animals). Based on these assessments, the EPA evaluates and approves 

language for each pesticide label to ensure the directions for use and safety measures are 

appropriate to mitigate any potential risk. In this way, the pesticide’s label helps to communicate 

essential limitations and mitigations that are necessary for public safety. In fact, the pesticide law 

Page 2 of 7
has a provision that indicates it is a violation to use a pesticide in a way that conflicts with the 

label. 

2.1 Assessment of Risk to Human Health

In order to assess a microbial pesticide’s risk to human health, the EPA initially requires a wide 

range of studies, including Tier I acute toxicity/pathogenicity (oral, pulmonary, and injection) 

data, cell culture data, reports of hypersensitivity incidents, acute toxicity (oral, dermal, and 

inhalation) data, and irritation (dermal and eye) data. Tier II and III testing (e.g., subchronic 

toxicity/pathogenicity) is triggered only when there is indication, usually through lower tier 

testing, that a microbial pesticide has unusual toxicological characteristics, such as infectivity or 

being suspected as or known to be a carcinogen. For Trichoderma asperelloides strain JM41R, 

the database of studies required to support the assessment of risk to human health is complete.

The toxicity tests (acute oral, dermal, and inhalation toxicity) and irritation tests (acute eye and 

primary dermal irritation) that address potential routes of exposure to the active ingredient are all 

classified in Toxicity Category III or IV and reveal little to no toxicity or irritation attributed to 

Trichoderma asperelloides strain JM41R. Moreover, during a typical toxicity/pathogenicity test 

done with microbial pesticides, Trichoderma asperelloides strain JM41R did not show any signs 

of toxicity, pathogenicity, or infectivity 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’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 (normal human body temperature is 37°C). Regarding cell culture testing, in 

this case, the EPA did not require these data as Trichoderma asperelloides strain JM41R is a 

fungus and not a virus. Finally, BASF reported that, to date, no hypersensitivity incidents have 

occurred during research, development, and testing of this fungus. In light of the adequacy of the 

toxicological data, scientific rationale, and literature provided by BASF and the absence of 

hypersensitivity incidents, the EPA did not require toxicological testing at higher tiers.

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 proposed pesticide products. Although exposure to Trichoderma asperelloides

strain JM41R through consumed food and drinking water is possible, the EPA anticipates these 

types of exposures may be reduced because, among other things, applications of the EP will be 

made to soil and growing media within commercial greenhouses, and typical processing 

procedures (e.g., peeling and/or additions of sugar, salt, and other preservatives) could remove 

the microbe from commodities. 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 or on food, in drinking water, or in residential settings, 

Page 3 of 7
supporting toxicological information indicates that human exposure to this fungus would not 

result in adverse effects.

For more information on the human health risk assessment of Trichoderma asperelloides strain 

JM41R, please see the supporting documents contained in the associated regulatory dockets

(search for “EPA-HQ-OPP-2012-0962” and/or “EPA-HQ-OPP-2012-0963” at 

www.regulations.gov). 

2.2 Assessment of Ecological Risk 

In order to assess a microbial pesticide’s risk to the environment, the EPA initially requires a 

wide range of studies, including Tier I testing done on the following nontarget organisms: birds 

(oral and inhalation), wild mammals, freshwater fish and invertebrates, estuarine/marine fish and 

invertebrates, plants, insects, and honeybees. Higher tier testing (II, III, and IV) generally 

encompasses definitive hazard determinations and longer term greenhouse or field testing and is 

implemented only when unacceptable effects are seen at the Tier I screening level. For 

Trichoderma asperelloides strain JM41R, the database of studies required to support the 

assessment of risk to the environment is complete. 

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

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

limit environmental exposure. The EP labeling does not specify that greenhouses in which it will 

be used must be enclosed; therefore, 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 a 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.

Adverse effects that might result from exposure are also unlikely. Trichoderma asperelloides is 

widespread within soil and is saprotrophic on plant matter. Since it is associated with growth 

within the plant rhizosphere, its likely mode of action is stimulation of normal plant defenses and 

competition for resources (a common mode of action for Trichoderma species). 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 labeled applications of Trichoderma asperelloides strain JM41R is 

expected to be minimal. In addition, since the EPA has determined that adverse effects to 

nontarget organisms are not expected as a result of the applications of Trichoderma asperelloides

strain JM41R, it also makes a “no effect” determination for direct and indirect effects to 

Page 4 of 7
endangered and threatened species and their habitats from the uses of Trichoderma asperelloides

strain JM41R, as labeled. 

For more information on the environmental risk assessment of Trichoderma asperelloides strain 

JM41R, please see the supporting documents contained in the associated regulatory docket 

(search for “EPA-HQ-OPP-2012-0962” at www.regulations.gov). 

3. Alternatives

The use of this microbial fungicide could possibly reduce a certain amount of conventional 

fungicide used for soil treatment in commercial greenhouses. Growers may use Trichoderma 

asperelloides strain JM41R as an alternative to conventional fungicides (e.g., fenamidone) or in 

conjunction with other biopesticides in an integrated pest management program. Among other 

things, Trichoderma asperelloides strain JM41R will have an established exemption from the 

requirement of a tolerance (no limitations) for all food commodities, the EP has a 4-hour 

restricted-entry interval, and the EP is not classified as a restricted-use pesticide because of 

human toxicity or environmental concerns.

4. Benefits and Public Comments

Biopesticides are pesticides derived from such natural materials as animals, plants, bacteria, and 

certain minerals. Microbial pesticides, a class of biopesticides, consist of a microorganism (e.g., 

bacterium, fungus, virus, or protozoan) as the active ingredient and may have the following 

benefits: 

• Usually are inherently less harmful than conventional pesticides.

• Generally affect only the target pest and closely related organisms, in contrast to broadspectrum conventional pesticides that may affect many different organisms (e.g., birds, 

insects, and mammals).

• Often effective in very small quantities and often decompose quickly, thereby resulting in 

lower exposures and largely avoiding the pollution problems caused by conventional 

pesticides.

• Can greatly decrease the use of conventional pesticides while crop yields remain high, 

when used as a component of integrated pest management programs. 

• Can offer another tool for pest management in areas where pesticide resistance, niche 

markets, environmental concerns, and organic preference limit the use of conventional 

pesticides. 

Like other microbial pesticides, Trichoderma asperelloides strain JM41R aligns with the 

potential benefits above as it exhibits little to no toxicity or irritation, is not pathogenic or 

infective, seems to be specific to soilborne plant pathogens, and could fill particular needs in 

unique markets.

Page 5 of 7
Overall, the EPA has provided the public five separate opportunities to comment on the 

Trichoderma fertile/Trichoderma asperelloides strain JM41R registration and tolerance 

exemption actions.

In the Federal Register of January 16, 2013 (78 FR 3422), the EPA announced receipt of 

applications to register pesticide products containing a new active ingredient (Trichoderma 

fertile strain JM41R) and opened a 30-day public comment period. The EPA received no 

comments on this publication. Subsequent to this publication and after reviewing additional 

product identity data from BASF, 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. 

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

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. Subsequent to this 

publication and after reviewing additional product identity data from BASF, 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 into the docket. The EPA received no comments on this 

publication. 

Because BASF’s pesticide product applications involve a new active ingredient, as well as this 

active ingredient’s first food uses, the EPA opened a 15-day public comment period from April 

10, 2015, to April 25, 2015. The EPA took this action in accordance with a policy, first 

implemented in October 2009, designed to provide a more meaningful opportunity for the public 

to participate in major registration actions. During this comment period, the EPA received no 

comments. 

5. Regulatory Decision

The Trichoderma asperelloides strain JM41R database is comprised of 11 studies that cover at 

least 33 different data requirements and, with the exception of storage stability and corrosion

characteristics studies that will be required as terms of registration, is considered complete. The 

proposed uses of Trichoderma asperelloides strain JM41R are well supported by this database. 

In considering the assessed risk to human health and the environment, the EPA concludes that 

Trichoderma asperelloides strain JM41R meets the regulatory standard under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA). Therefore, the EPA is granting the 

unconditional registration of the Trichoderma asperelloides strain JM41R pesticide products 

under FIFRA section 3(c)(5). 

Page 6 of 7
Two pesticide products will be registered. “Trichoderma asperelloides strain JM41R Technical” 

is a MP, while “TRICHO PLUSTM Biofungicide” is an EP; Trichoderma asperelloides strain 

JM41R is the sole active ingredient in both pesticide products. In order to manage soilborne 

diseases caused by organisms such as Pythium, Rhizoctonia, Fusarium, Sclerotinia, and 

Phytophthora, the EP will be applied to soil and growing media used within commercial 

greenhouses. It can be applied as a coarse spray, by soil drench, or by common irrigation 

application systems at a rate of 0.8 ounce per 10,000 square feet of soil or growing media.

The risk assessments supporting this decision can be found in the associated regulatory dockets 

(search for “EPA-HQ-OPP-2012-0962” and/or “EPA-HQ-OPP-2012-0963” at 

www.regulations.gov). 

Page 7 of 7