Document ID: EPA-HQ-OPP-2021-0534-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2021-09-22T04:00Z

EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Biopesticides and Pollution Prevention Division contact:
Jeannine Kausch 703-347-8920

SUBMISSION: Email the completed template to: hollis.linda@epa.gov.

TEMPLATE:
Symborg, Inc.
Petition number: XXXXXX

	EPA has received a pesticide petition (XXXXXX) from Symborg, Inc. PO Box 12810 San Luis Obispo, CA 93406 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for microbial pesticide Trichoderma harzianum strain T78. Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Symborg, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Symborg, Inc. and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

I. Symborg, Inc. Petition Summary
   
   	XXXXXXX

A. Product Name and Proposed Use Practices

      TrichoSym Biological Fungicide (EP)

      Trichoderma harzianum T78 is an Active Ingredient AI proposed for use only in TrichoSym Biological Fungicide. It is not being proposed as a manufacturing use product. 
      
      TrichoSym Biological Fungicide, a formulated end-use product, is a preventative biofungicide for control of plant diseases, such as Sclerotinia, Pythium, Rhizoctonia, Fusarium, Macrophomina and Thielaviopsis.

B. Product Identity/Chemistry

     Identity of the pesticide and corresponding residues. Trichoderma harzianum strain T78 (CAS No. Not applicable): Trichoderma spp. are fungi that are present in nearly all soils and other diverse habitats. In soil, they frequently are the most prevalent culturable fungi.
     Magnitude of residues at the time of harvest and method used to determine the residue. It is expected that, when used as proposed, Trichoderma harzianum strain T78 would not result in residues that are of toxicological concern. 
      
     A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. An analytical method for residues is not applicable. It is expected that, when used as proposed, Trichoderma harzianum strain T78 would not result in residues that are of toxicological concern

C. Mammalian Toxicological Profile	Studies to evaluate the safety to mammals were conducted on the technical grade active ingredient (TGAI) and are summarized below.

 Acute Oral Toxicity/Pathogenicity (OCSPP 885.3050): Trichoderma harzianum T-78 showed no evidence of toxicity, infectivity or pathogenicity following a single oral dose of 2.25  -  3.56 x 10[8] cfu/animal to rats. Over the study period there was no evidence of any proliferation, infectivity or pathogenicity of the test item, Trichoderma harzianum T-78, within blood, organs or intestinal contents of treated rats and that rapid clearance of the test item was achieved with 8 days following oral dosing. There were no deaths of subjects during the study. (MRID: 510647-05)
      
 Acute Pulmonary Toxicity/Pathogenicity (OPPTS 885.3150): Trichoderma harzianum T-78 showed no evidence of toxicity, infectivity or pathogenicity following a single intratracheal dose of 6.68 x 107 cfu/animal to rats. No clinical signs of death were observed throughout the study following administration of the live or autoclaved test item. (MRID: 510647-06)

 Acute Intraperitoneal Toxicity/Pathogenicity (OPPTS 885.3200): Trichoderma harzianum T-78 showed no evidence of toxicity, infectivity or pathogenicity following a single intraperitoneal dose of 1.96 x 10[7]  -  3.55 x 10[7] cfu/animal to rats. No clinical signs of death were observed throughout the study following administration of the live or autoclaved test item. (MRID: 510647-07)

 Hypersensitivity Incidents (OCSPP 885.3400): The registrant has noted that no incidents of hypersensitivity or any other adverse effects have occurred through the research, development or testing of the active ingredient and its related end-use product. Should any incidents occur, they will be reported per FIFRA Section 6(a)(2).

The results of toxicity testing show there is no risk to human health from the active ingredient. Trichoderma harzianum strain T78is not toxic, pathogenic, or infective to mammals.

D. Aggregate Exposure

	1. Dietary exposure.

      i. Food. Dietary exposure from use of Trichoderma harzianum T78, as proposed, is expected to be minimal because the product is intended for application to soil, not to growing crops (see Product Label). The residues on food crops are anticipated to be to be insignificant because this pesticide is applied to soils by drip irrigation systems. The intended use of Trichoderma harzianum T78 is as a biological fungicide to soils for the purposes of disease control.
      
      The results of toxicity testing indicate there is no risk to human health or the environment from Trichoderma harzianum T78. Trichoderma spp. are common and widespread soil fungi that inhabit soil and root ecosystems that are generally recognized as beneficial to plant species. 
      
      The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

      
      ii. Drinking water. Exposure to humans from residues of Trichoderma harzianum T78 in consumed drinking water would be unlikely because the product is not applied to water. The normal habitat of the genus is soil and herbaceous tissue, not water (Chaverri et al. 2003). Potential exposure to surface water would be negligible and exposure to drinking water (well or groundwater) would be impossible to measure. The intended use of Trichoderma harzianum T78 is in soils for the purposes of disease control. The risk of the microorganism passing through the soil to groundwater is minimal to unlikely because the growing organism forms a cottony web that is stationary, and the spores are not of the type that are able to survive unfavorable conditions (water), that is no chlamydospores are formed (Chaverri et al. 2003). Additionally the fungus would not tolerate the conditions water is subjected to in a drinking -water facility (including: chlorination, pH adjustments, high temperatures and/or anaerobic
      conditions).
      
      The results of toxicity testing indicate there is no risk to human health or the environment from Trichoderma harzianum T78. The absence of acute toxicity or pathogenicity of Trichoderma harzianum T78 in laboratory animals demonstrates the benign nature of this strain.

      
      2. Non-dietary exposure. The potential for non-dietary exposure to the general population, including infants and children, is unlikely as the proposed use sites are agricultural. The intended use of Trichoderma harzianum T78 is to soils and for the purposes of disease control. Personal Protective Equipment (PPE) mitigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural settings.
      
      The lack of acute oral toxicity, infectivity, and pathogenicity support an exemption from the requirement of a tolerance for Trichoderma harzianum T78. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. Non-dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

      
E. Cumulative Effects

It is not expected that, when used as proposed, Trichoderma harzianum T78 would result in residues that are of toxicological concern. The intended use of Trichoderma harzianum T78 is to soils for the purposes of disease control. The results of toxicity testing indicate there is no risk to human health or the environment from Trichoderma harzianum T78. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

F. Safety Determination

      1. U.S. population. It is not expected that, when used as proposed, Trichoderma harzianum T78 would result in residues that are of toxicological concern. The intended use of Trichoderma harzianum T78 is to soils for the purposes of disease control. The results of toxicity testing indicate there is no risk to human health or the environment from Trichoderma harzianum T78. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. There is a reasonable certainty of no harm to the general US population from exposure to this ingredient. 

      
      2. Infants and children. As mentioned above, it is not expected that, when used as proposed, Trichoderma harzianum T78 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 harzianum T78 from the proposed uses.
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G. Effects on the Immune and Endocrine Systems

To date there is no evidence to suggest that Trichoderma harzianum T78 functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

H. Existing Tolerances

There is no US EPA tolerance or tolerance exemption for Trichoderma harzianum T78.

I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established for Trichoderma harzianum T78
.