Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 Page 1 of 10 

## 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 18 th 

### Street NW, Suite 1000 Washington, DC 20036Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 Page 2 of 10 

## 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 Page 3 of 10 

## 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 Page 4 of 10 

## 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 10 7 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 Page 5 of 10 

## 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 andTrichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 Page 6 of 10 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 Page 7 of 10 

## 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 Page 8 of 10 

## 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 concer n. There is a reasonable certainty of no harm for infants and children from exposure to Trichoderma virensstrain G41 from the proposed uses.Trichoderma virens strain G-41 Petition to Establish a Tolerance Exemption – September 18, 2009 Page 9 of 10 

## 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 Page 10 of 10 

## 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.