Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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Petition for an exemption from the requirement of a tolerance 

for residues of products containing the active ingredient 

“Trichoderma virens strain G-41” in and on all food 

commodities

Submitted for: BioWorks, Inc. (EPA Co. No. 68539) 

 100 Rawson Road, Ste. 205 

 Victor, NY 14564 

Submitted by: Technology Sciences Group Inc. 

 1150 18th Street NW, Suite 1000 

 Washington, DC 20036 

 
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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SECTION A - SUMMARY OF PRODUCT CHEMISTRY 

 

Active Ingredient: Trichoderma virens strain G-41 

Trichoderma virens strain G-41 is a naturally-occurring mycoparasitic 

fungus in most countries of the world, and occurs in various soil 

types and decaying wood at very low densities. 

Mode of Action: Trichoderma virens strain G-41 inhibits or kills plant pathogenic fungi 

such as Pythium, Fusarium, Rhizoctonia, and Phytophthora. 

Trichoderma virens strain G-41 kills or inhobits the pathogenic fungi 

through several mechanisms including: 1) competition for food and 

space, 2) mycoparasitism via the production of enzymes and 

antibiotics, and 3) induction of plant defensive responses. 

Analytical Method: An analytical method for residues is not applicable. It is expected 

that, when used as proposed, Trichoderma virens strain G-41 would 

not result in residues that are of toxicological concern. 
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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SECTION B - PROPOSED USE PRACTICE 

G-41 Technical is intended for use in the formulated pesticide products (BW240 WP and BW240 G; 

0.61% ai) to be applied directly to soil as a fungicide to growing food, non-food and ornamental 

crops in fields, greenhouses, nurseries. 
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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SECTION C - TOXICOLOGICAL PROFILE

Acute Toxicity: Acute toxicity/pathogenicity studies conducted with the technical material, 

Trichoderma virens strain G-41, showed no adverse effects to human health by any route of 

exposure. In an acute injection toxicity/pathogenicity study, a single dose of Trichoderma virens

strain G-41 at 107 cfu administered by the intraperitoneal route was not toxic, infectious or 

pathogenic to rats based on microbial analysis of blood. 

In acute toxicity studies conducted with the formulated end-use product (BW240 WP; 0.61%) show 

low toxicity regardless of route of administration. The acute oral LD50 value for BW240 WP was 

>5000 mg/kg using female rats (Toxicity Category IV). The acute dermal LD50 was >5050 mg/kg 

bw and the acute inhalation LC50 was > 2.18 mg/L in male and female rats when administered 

BW240 WP (Toxicity Category IV). The formulated end-use product (BW240 WP; 0.61%) was a 

non-irritant to skin and was slightly irritating to the eyes (Toxicity Category IV and III, respectively). 

BW240 WP was classified as a dermal sensitzer. 

Waivers have been requested for all other Tier 1 biochemical pesticide data requirements including 

subchronic and developmental toxicity. Data waiver rationales are based on the facts that 

Trichoderma virens strain G-41 does not affect any organisms and does not grow or develop at 

temperatures above 35°C and therefore, is not pathogenic to mammals. Trichoderma virens strain 

G-41 is ubiquitous in nature and there is a lack of human exposure from intended uses. 

The results of toxicity testing, inert ingredients of low toxicity and the lack of residues on treated 

commodities show there is no risk to human health from Trichoderma virens strain G-41. Both 

dietary and non-dietary exposures would not be expected to pose any quantifiable risk due to a lack 

of residues of toxicological concern. 

 
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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SECTION D - AGGREGATE EXPOSURE 

1) Dietary Exposure:

 Dietary exposure from use of Trichoderma virens strain G-41, as proposed, is minimal. The 

intended use of Trichoderma virens strain G-41 is application to growing agricultural crops 

as a mycoinsecticide. It is a naturally occurring ingredient that is not able to grow or 

develop on vegetal tissue. 

 Acute toxicity studies have shown that Trichoderma virens strain G-41 is not toxic, not 

infective and is moderately irritating to mammals. It does not produce any metabolite of 

toxic concern during the fermentation process. Lastly, Trichoderma virens strain G-41 can’t 

live or persist in warm blooded mammals. 

 Residues of Trichoderma virens strain G-41 are not expected to occur since it degrades in 

sunlight and high temperatures. Any remaining residues are removed from common post 

harvest treatments including washing, packing, peeling, etc. 

 

 The results of toxicity testingand the lack of residues on treated commodities show there is 

no risk to human health Trichoderma virens strain G-41. Dietary exposures would not be 

expected to pose any quantifiable risk due to a lack of residues of toxicological concern. 

2) Drinking Water Exposure:

Similarly, exposure to humans from residues of Trichoderma virens strain G-41 in 

consumed drinking water would be unlikely. Potential exposure to surface water and 

drinking water would be negligible. The intended use of Trichoderma virens strain G-41 is 

application to growing agricultural crops and ornamentals. The ingredient is not applied 

directly to water. 

No residues of Trichoderma virens strain G-41 are expected to occur on food due to the fact 

that it degrades rapidly in sunlight and high temperatures and does not develop or persist 

on vegetal tissues. Any remaining residues are removed from common post harvest 

treatments including washing, packing, peeling, etc. 

 

 The results of toxicity testing, inert ingredients of low toxicity and the lack of residues on 

treated commodities show there is no risk to human health. Any remaining residues are 

removed from common post harvest treatments including washing, packing, peeling, etc. 

Drinking water exposures would not be expected to pose any quantifiable risk due to a lack 

of residues of toxicological concern. 

3) Non-Dietary Exposure:

 The potential for non-dietary exposure to the general population, including infants and 
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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children, is unlikely as the proposed use sites are agricultural and ornamental use. The 

intended use of Trichoderma virens strain G-41 is application to growing agricultural crops 

as a mycoinsecticide. 

 Acute toxicity studies have shown that Trichoderma virens strain G-41 is not toxic, not 

infective and is moderately irritating to mammals. It does not produce any metabolite of 

toxic concern during the fermentation process. Lastly, Trichoderma virens strain G-41 can’t 

live or persist in warm blooded mammals. 

 Residues of Trichoderma virens strain G-41 are not expected to occur since it degrades in 

sunlight and high temperatures. Any remaining residues are removed from common post 

harvest treatments including washing, packing, peeling, etc. 

 

 The results of toxicity testing, inert ingredients of low toxicity and the lack of residues on 

treated commodities show there is no risk to human health Trichoderma virens strain G-41. 

Dietary exposures would not be expected to pose any quantifiable risk due to a lack of 

residues of toxicological concern. 
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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SECTION E - CUMULATIVE EFFECTS 

It is not expected that, when used as proposed, Trichoderma virens strain G-41 would result in 

residues that are of toxicological concern. The intended use of Trichoderma virens strain G-41 is 

application to growing agricultural and ornamental crops as a mycoinsecticide for applied directly to 

soil. Trichoderma virens strain G-41 is a naturally occurring ingredient and is not considered 

persistent based on its characteristics, properties or known degradation pathways. 

Acute toxicity studies have shown that Trichoderma virens strain G-41 is not toxic, not infective and 

is moderately irritating to mammals. It does not produce any metabolite of toxic concern during the 

fermentation process. Lastly, Trichoderma virens strain G-41 can’t live or persist in warm blooded 

mammals.

Residues of Trichoderma virens strain G-41 are not expected to occur since it degrades in sunlight 

and high temperatures. Any remaining residues are removed from common post harvest 

treatments including washing, packing, peeling, etc. 

 

The results of toxicity testing, inert ingredients of low toxicity and the lack of residues on treated 

commodities show there is no risk to human health Trichoderma virens strain G-41. Dietary 

exposures would not be expected to pose any quantifiable risk due to a lack of residues of 

toxicological concern. 
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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SECTION F - SAFETY DETERMINATION 

1) General US Population: 

 The results of toxicity testing, inert ingredients of low toxicity and the lack of residues on 

treated commodities show there is no risk to human health from Trichoderma virens strain 

G-41. The intended use of Trichoderma virens strain G-41 is application to growing 

agricultural crops as a mycoinsecticide applied to soil Trichoderma virens strain G-41. 

Trichoderma virens strain G-41 is a naturally occurring ingredient and is not considered 

persistent based on its characteristics, properties or known degradation pathways. There is 

a reasonable certainty of no harm to the general US population from exposure to this active 

ingredient. 

2) Infants and Children:

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

strain G-41 would result in residues that are of toxicological concern. There is a reasonable 

certainty of no harm for infants and children from exposure to Trichoderma virens strain G41 from the proposed uses. 
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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SECTION G - EXISTING TOLERANCES 

US EPA Tolerance -

There is no US. EPA Tolerance for Trichoderma virens strain G-41. However a Tolerance 

Exemption was granted for Trichoderma harzianum Rifai strain KRL-AG2 and Gliocladium virens 

strain GL-2, which are related microorganisms. 

International -

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

virens strain G-41.
Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 

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SECTION H - INFORMATION ON ENDOCRINE EFFECTS 

To date there is no evidence to suggest that Trichoderma virens strain G-41 functions in a manner 

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