**BIOPESTICIDES REGISTRATION ACTION DOCUMENT**



## Trichoderma asperellum strain T34 Pesticide Chemical (PC) Code: 119209

**U.S. Environmental Protection Agency Office of Pesticide Programs**  **Biopesticides a nd Pollution Prevention Division** 

October 14 , 2011Trichoderma asperellum , strain T34 Page 2 of 26

Biopesticides Registration Action Document **TABLE OF CONTENTS I.**  **EXECUTIVE SUMMARY ................................**  **................................ ................................**  **4 II.**  **ACTIVE INGREDIENT OV ERVIEW**  **................................ ................................**  **............. 5**  **III. REGULATORY BACKGROUN**  **D ................................**  **................................ .....................**  **5 A. Applications for Pesticide Registration**  **................................ ................................**  **................................ .**  **5 B. Food Tolerance Exem** **ption ................................**  **................................ ................................**  **..................... 5**  **IV. RISK ASSESSMENT**  **................................ ................................**  **................................ ..........**  **5 A. Product Analysis Assessm**  **ent (40 CFR § 158.2120) ................................**  **................................ ..............**  **6 B. Hum**  **an Health Assessm ent (40 CFR § 158.2140)**  **................................ ................................**  **.................. 6**  **C. Environm ental Assessm**  **ent (40 CFR § 158.2150)**  **................................ ................................**  **............... 10**  **V. ENVIRONMENTAL JU STICE**  **................................ ................................**  **.......................... 12**  **VI. RISK MANAGEMENT DECI**  **SION ................................**  **................................ ................**  **13 VII. ACTIONS REQUIR** **ED BY THE APPLICANT**  **................................ ............................**  **13 A. Final Printed Labeling**  **................................ ................................**  **................................ ..........................**  **13 B.**  **Term s of Registration**  **................................ ................................**  **................................ ............................**  **13 C.**  **Reporting of Adverse Effects and Hypersensitivity Incidents ................................**  **........................... 14**  **VIII. GLOSSARY OF A CRONYMS AND ABBREVIA**  **TIONS ................................**  **........... 15**  **IX. BIBLIOGRA PHY**  **................................ ................................**  **................................ ................**  **16 A. Studies Subm** **itted to Support Pesticide Product Registrations ................................**  **......................... 16**  **B. Environm ental Protection Agency Risk Assessm**  **ent M em**  **oranda ................................**  **..................... 20**  **APPENDIX A. MICROBI AL PESTICIDES DATA R** **EQUIREMENTS ............................**  **21 APPENDIX B. PESTICI**  **DE PRODUCT ................................**  **................................ .................**  **26**Trichoderma asperellum , strain T34 Page 3 of 26

Biopesticides Registration Action Document

**BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM**

**Office of Pesticide Programs (OPP)**  **Biopesticides and Pollution Prevention Division**

**Microbial Pesticides Branch Science Reviews**  John L. Kough, Ph.D. Ib rahim S. Barsoum, Ph.D
. Shannon Borg es Zigfridas Vaituzis Product Characterization and Human Health Assessment Product Characterization and Human Health Assessment Environmental Effects Assessment Environmental Effects Assessment **Regulations** Sheryl K. Reilly, Ph.D. Anna Gros s Matthew Thompson Chief, Microbial Pesticides Branch Regulatory

Action L eader Regulatory

Action L eader Michael Glikes Regulatory Action L eaderTrichoderma asperellum , strain T34 Page 4 of 26

Biopesticides Registration Action Document **I. EXECUTIVE SUMMAR**  Trichoderma asperellum strain T34 is a naturally occurring fungus that increases plant defenses against Fusarium oxysporum , a pathogenic , soil
- born fungus of significant economic importance in the United States . When Trichoderma asperellum strain T34 ( “ T34 ” ) , is preventative ly applied, it protects plants from this disease
- causing organism by initially colonizing the roots and building a physical barrier against pathogens. T34 induces the sy nthesis of defense proteins in the plant , which increases the plants’ resistance to inf ection by Fusarium oxysporum . T34 also has the ability to parasitize and kill the plant pathogen
. Biocontrol Technologies, S.L
. (“applicant”) has proposed to register an end
- use microbial pesticide product, T34 Biocontrol (EPA File Sy mbol 8 7301
- R), containing T34 as the active ingredient
. The proposed product is intended for use in greenhouse s to control Fusarium oxysporum on nonfood crops, specifically, carnations
. Environmental Protection Agency ( “ EPA ” or “Agency” ) scientists have reviewed product analysis, toxicology, and nontarget organism data (reference 40 Code of Federal Regulations (CFR) §§ 158.2120, 158.2140, and 158.2150, respectively ) , and other information submitted by the applicant to support the re gistratio n. The submitted data and informatio n fulfill the current data requirements and demonstrate that the proposed greenhouse use of T34 will not generally cause unreasonable adverse effects on the environment, in accordance with the requirements for pesticide registration under Section 3(c)(5) o f the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
. On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for the public to participate in major registration decisions before they occur. According to this policy, EPA intends to provide a public comment period prior to making a registration decision for, at minimum, the following ty pes of applications: new active ingredients; first food uses; first outdoor uses; first residential uses; or any other registration actions for which EPA believes there may

be significant public interest. Consistent with the policy of making registration actions more transparent, the proposed pe sticide produ cts containing T34 as a new active ingredient were subject to a 30
- day c omment period. The docket identification number , associated with these registration actions and accessed through either http://www.regulations. gov/ or http://www.epa.gov/pesticides/regulating/registration
- status.html , is EPA
- HQ
- OPP
- 2010
- 0 247
. The following documents were made available for comment in EPA
- HQ
- OPP
- 201 0
- 0058: (1) draft Trichoderma asperellum strain T34 Biopesticides Registration Action Document (BRAD) ; (2 ) environmental risk assessment for T34 ; and (3 ) draft product label for the end
- use product, T - 34 Biocontrol (EPA File Sy mbol 8 7301
- R). While a final decision on registration is contingent upon review and consideration of public comments, EPA presently believes that, based upon the risk assessment and information submitted in support of T - 34 Biocontrol , it is in the best interest of the public and th e environment to issue these registrations. The basis for this decision can be found in the risk assessment for T34 , which is characterized throughout this BRAD
.Trichoderma asperellum , strain T34 Page 5 of 26

Biopesticides Registration Action Document **II. ACTIVE**  **INGREDIENT OVERVIEW Biological Name:**  T richoderma asperellum strain T34 **Produ ct Name:**  T - 34 Biocontrol **Culture Deposit:** Spanish Collection of Ty pe Cultures, University

of Valencia in Valencia, Spain under CECT No. 20417
. **OPP Chemical Code:** 119209 **Type of Pesticide:** Microbial Pesticide

– Fungicide See Appendix B for specific information ( e.g., use sites, application rate s , methods of application, formulation ty pe s , and target pests) regarding the registered pesticide products containing this active ingredient. **III. REGULATORY BACKGROUND**  **A. Applications for Pesticide Registration** On December 31 , 2009 , Wagner Regulatory Associates, Inc. (address: P.O. Box 640 , 7460 Lancaster Pike, Suite #9, Hockessin, DE 19707
- 0640 ) on behalf of Biocontrol Technologies, S.L . (address: 08028 Barcelona, Spain, C/ Baldiri Reixac, 15
- 21) , submitted application s to register an end
- use product (EP) T34 BIOCONTROL (EPA Reg. No. 87301
- R) containing a new TGAI Trichoderma asperellum strain T34 ( “ T34 ” ) , under section 3(c)(5) of FIFRA. On November 24 , 2010 , EPA ann ounced receipt of these application s to register pesticide product s containing a new active ingredient ( 75 Federal Register (FR) 71697 ) and opened a 3 0
- day public comment period pursuant to the provisions of FIFRA section 3(c)(4). No comments were received following this publication
. **B. Food Tolerance Exemption**  No tolerance or exemption from the requirement of a tolerance is associated with or required for this regulatory

action as only nonfood uses are currently proposed for T34
. Accordingly, this action is outside the scope of the Food Quality Protection Act (FQPA)
. There are no CODEX maximum residue levels established for T34. **IV . RISK**  **A SSESSMENT**  Inthe Federal Register of October 26, 2007, EPA issued a Final Rule on the data requirements to support registration of microbial pesticides and updated the definition for microbial pesticides ( 72 FR 61002 ). The rule became effective on December 26, 2007. The data and information evaluated for this BRAD were considered in light of these requirements. The classifications for each data submission are assigned by EPA science reviewers , and are an indication of the usefulness of the information contained in the documents for riskTrichoderma asperellum , strain T34 Page 6 of 26

Biopesticides Registration Action Document assessment. A rating of “ACCEPTABLE” indicates the 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. The studies may have certain aspects determined not to be scientifically acceptable (“SUPPLEMENTAL: UPGRAD EABLE”). If a study is rated as “SUPPLEMENTAL: UPGRAD EABLE,” EPA always provides an indication of what is lacking or what can be provided to change the rating to “ACCEPTABLE.” I f there is simply a “SUPPLEMENTAL” rating, the reviewer will often state that the study

is not required by 40 C FR P art 158. Both “ACCEPTABLE” and “SUPP LEMENTAL” studies may be used in the risk assessment process as appropriate. An “UNACCEPTABLE” rating indicates that new data need to be submitted. For the acute toxicity

data requirements, Toxicity C ategories are assigned based on the hazard(s) identifi ed from studies and/or other information submitted to 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 Iindicates the highest toxicity and Toxicity Category IV indicates the lowest toxicity
. **A. Product Analysis Assessment**  **( 40 CFR**  **§ 158.2120 )**  A ll product analysis data requirements for T34 , have been **fulfilled** . Refer to Table 1 in Appendix A for a brief summary of the data requirements, including both generic and product
- specific information. **B. Hu**  **man Health Assessment (**  **40 CFR § 158.2140 )**  **1. Toxicity** All toxicology

data requirements for T3 4 , have been **fulfilled**
. Acceptable Tier I mammalian toxicology

data and information support registration of the T34 pesticide products
. Furthermore, Tier II and Tier III studies were not required for T34 , based on the lack of acute toxicity /pathogenicity

i n the Tier I

studies. For a comprehensive summary of the generic toxicology data requirements described in sections IV(B)(1)(a) and IV(B)(1)(b), as well as additional product
- specific data submitted to support the individual registrations, refer to Table 3 Appendix A
. **a. Acute Toxicity/Pathogenicity** 
**– Tier I**  Acute Oral Toxicity/Pathogenicity (Office of Chemical Safety and Pollution Prevention (OCSPP) Guideline 885.3050; Master Record Identification Number (MRID No.) 4806740 1 and 48067403

) : Inan acute oral toxicity study (MRID 4806740 1), groups of fasted, 8
- 12 week old HsdRccHan:32 WI ST rats (3/sex) were given a single oral dose of T34 (Batch No. 5170708 ;11.71% T
- 334, 1.8 x 10 9/g) , at a concentration of 0.1 g in 1.5 mL wat er per animal (~10 8 cfu/animal). The animals were observed up to 21 days with interim sacrifices on Days 3, 7, and 14. Two untreated males and 2 females were housed together with the treated animals as shelf controls , and two untreated animals were housed s eparately from the test groups as room controls
.Trichoderma asperellum , strain T34 Page 7 of 26

Biopesticides Registration Action Document There were no treatment related clinical signs, necropsy findings, or significant changes in body weight
. The clearance of T34 from the feces was established by day 19 , and no viable counts were noted from any organ of animals sacrificed on day 21. No viable counts were noted in the organ samples of untreated shelf control animals
. Based on the results of this study, T34 does not appear to be infective and/or pathogenic in HsdRccHan: 32 WI ST rats, when dos ed at 1.1 x 10 8 cfu/animal. T oxicity has been o bserved in the pancreas and adrenal glands o f treated animals at necropsy
. This study satisfies the requirement for an acute oral toxicity and pathogenicity

study, and is classified as ACCEPTABLE. Acute Pulmo nary Toxicity/Pathogenicity (OCSPP Guideline 885.3150; MRID No. 4794 6906 and 48067404

) : Inan acute pulmonary toxicity and pathogenicity study

(MRID No. 47946906), groups of 8
- 12 week old HsdRccHan: 44 WI ST rats (3 or 5 /sex) received intratracheal treatment with T34 (Batch No. 5170708 ; 11.71% T
- 334, 1.8 x 10 9/g)
. The animals were observed for up to 21 days. Five males and five females served as untreated controls. Following instillation of 0.2 mLtest substance, o ne male and one female died immediately and one male and two females died approximately 10 minutes thereafter. Thereafter , the instillation volume was decreased to 0.1mL . One female was found dead 2.5 hours after test material instillation but all other animals survived to scheduled sacrifice. No c linical sign s were observed in surviving animals. Body weight gain of the treated animals was slightly lower than that in the control group. Slight effects on lungs, pancreas, liver, thy mus, adrenal glands, and/or spleen in treated animals were noted at ne cropsy . No grossly observable pathological changes were found in control animals
. The test material showed slight toxic effects but did not proliferate in the treated animals following a single intratracheal instillation
. Nevertheless, the organism could b e detected in selected tissue samples, particularly

the lung, until day

21 of the study
. Based on these results, T34 appears to be slightly toxic but not infective and/or pathogenic in rats . The dose the animals received may be less than that suggested by guideline requirements
. The study report states the test material (1.8 x 10 9 cfu/g) was diluted 1:10 (~1.8 x 10 8 cfu/mL) and the animals received 0.1 mL (~1.8 x 10 7 cfu/animal)
. This study satisfies the acute pulmonary

toxicity and pathogenicity

guidel ine requirement and is classified as ACCEPTABLE . Acute Injection Toxicity/Pathogenicity (Intravenous)

– Rat (OCSPP Guideline 885.3200; MRID No. 4794 6903 and 48067406 ) : Inan acute intravenous injection toxicity and pathogenicity

study (MRID No. 47946903) , three male and three female young adult 8
- 12 week old HsdRccHan:10 WI ST rats were injected IP with T34 (Batch No. 5170708 ;11.71% T - 334, 1.8 x 10 9/g) , at a dose of 0.1 g/animal , at a dose volume of a 1 mL suspension
. The test material was suspended in wat er prior to use. Two males and two females not treated served as controls. Surviving animals were observed for up to 21 days. All treated animals died or were euthanized within 19
- 52 hours of test material injection.Trichoderma asperellum , strain T34 Page 8 of 26

Biopesticides Registration Action Document Before death , the animals had reduced spontaneous activity, apathy, sunken flanks and ruffled fur
. All control animals survived, gained weight, and had no clinical sy mptoms during the study . All decedents had an accumulation of fluid in the peritoneum and stomach, brightened fringes of the liv er, and slightly reddish and swollen pancreas. The control animals had no gross pathological changes at necropsy
. The test for enumeration of the test organisms in tissues and feces of treated animals were validated in MRID 48067406. Based on the result s of this study, T34 showed toxic characteristics in rats following a single intrapertioneal injection administration of 0.1 g/animal; however, infectivity and pathogenicity

were not addressed
. Oral and pulmonary studies have shown that the test organism does appear infective or to be a pathogen
. The Agency

requested f

urther testing of the spores vs. the filtrate to elucidate the mortality and pancreatic toxicity

observed in the acute toxicity /pathogenicity

studies . Specifically, further testing will determine if the presence of the toxins is the cause of the observed mortality and pancreatic toxicity

in the treated animals
. The applicant responded to the Agency request noting: The high mortality observed in the rats from the study

“Acute Injection Toxic ity /Pathogenicity

with Biocontrol Technologies, S.L ., T34 ” (dosed at 1 x 10 8 cfu/rat) was not due to the production of toxins by T34 , but rather to the high concentration of spores injected intrapertioneally to the rats
. This conclusion is based on:

1. New GLP studies conducted to find the test dose that causes moderate but non - lethal sy

mptoms in rats , and a n ew acute toxicity /pathogenicity study

with T34 (MRID 48348306, 48348307). 2. No toxins have been detected in T34 compared with other Trichoderma species that do produce toxins (MRID 48377002). Hypersensitivity Incidents (OCSPP Guideline 885.3400; MRID No. 47945023) : No hy persensitivity

incidents, including immediate
- ty pe or delayed
- ty

pe reactions of humans and domestic animals that occurred during research , development, or testing of T34 , were reported by

the applicant . Any

future hy persensitivity

incidents must be reported per OCSPP Guideline 885.3400. Cell Culture (OCSPP Guideline 885.3500) : This study is not required because T34 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**  Tier II and Tier III studies were not required for T34 , based on the lack of acute toxicity /pathogenicity

in the Tier I

studies.Trichoderma asperellum , strain T34 Page 9 of 26

Biopesticides Registration Action Document **c. Endocrine Disruptors**  As required under FFDCA section 408(p), EPA has developed the Endocrine Disrup tor Screening Program (EDSP) 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 effec ts as the Administrator may

designate.” The EDSP employs a two - tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thy roid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which , if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine
- related effects caused by the substance, and establish a quantitative relationship between the dose and the E, A, or T eff ect. Between October 2009 and February 2010, EPA issued test orders/data call
- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for h uman exposure through pathways such as food and water, residential activity, and certain post
- application agricultural scenarios. This list should not be construed as a list of known or likely endocrine disruptors. T34 is not among the group of 58 pestici de active ingredients on the initial list to be screened under the EDSP. Under FFDCA section 408(p), EPA must screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data call
- ins for all pesticide active ingredients. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/
. **2 . F**  **ood Quality Protection Act (FQPA) Considerations** Although no tolerance or exemption from the requirement of a tolerance is associated with or required for this regulatory action as only nonfood uses are currently proposed for T34 , the applicant submitted waiver requests for Residue Chemistry Guidelines OCSPP 885.2100, 885.2200, 885.2250, 885.2500, 885.2550, and 885.2600. The following points were made to support the waivers for Residue Chemistry requirements: (1) the proposed use pattern for T34 Biocontro l EP is limited to closed greenhouse systems on nonfood crops, specifically, carnations; (2) T34 occurs naturally in soil. It can grow only in soil, under specific conditions (high soil organic matter content, humidity, and temperatures <35 O C); (3) the T34 mode of action is to protect roots by inducing the plant’s own enzy me production to stimulate growth and biological control of plant disease; (4) T34 does not produce any

known toxins. No T2 toxin (trichodermin; harzianum A) was found in a sample of 0.25 g of the EP that was sonicated, extracted with ethyl acetate, and the supernatant evaluated by

mass spectroscopy, and (5) T34 is not hazardous to humans, based on acute oral, pulmonary, and intravenous toxicity studies conducted in rats. Rats treated withTrichoderma asperellum , strain T34 Page 10 of 26

Biopesticides Registration Action Document 5.5 x 10 5 to 10 8 units/animal had color changes in unspecified organs, but these effects were not sufficient to classify T34 as toxic
. Itwas determine d that the provided rationale was adequate to justify

a waiver for the requested Residue Chemistry Guidel ines. **3. Occupational Exposure and Risk Characterization** Handler exposure to T34 is not expected to pose any undue risk. Regardless, appropriate personal protective equipment and precautionary statements are required on pesticide product label s to mitigate any

potential risks to pesticide handlers due to prolonged or numerous exposure s . Handlers applying T34 end
- use products in commercial and agricultural settings must wear a long
- sleeved shirt, long pants, and shoes plus socks. Additional PPE, other than the standard described above, may be required on a product
- specific basis. **4. Human Health Risk Characterization** The Agency

considered human exposure to T34 in light of the standard for registration in FIFRA and the relevant safety factors in FFDCA. A determination has been made that T34 has no known potential to cause adverse human health effects or to produce a mammalian toxin, and that residues are not likely to be present in or on food when used in accordance with EPA
- approved labeling. **C. Envir**  **onmental Assessment (**  **40 CFR § 158.2150**  **)** The data and data waiver rationale, submitted by the applicant to support the pesticide products containing T34 , are sufficient to **fulfill** the Tier I 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 for the current uses and application methods. EPA has performed an environmental risk assessment based on the data and data waiver rationale provided by the applicant and has determined that the proposed use of T34 does not pose significant risk to nontarget organisms when used according to label directions. For a comprehensive summary of the generic data requirements described in sections IV ( C)(1) , refer to Table 4 in Appendix A
. **1. Ecological Exposure an**  **d Risk Characterization**
**a. Terrestrial**  **Animals and Plants** The proposed registration limits use to indoor environments within greenhouses and the proposed maximum application use rates result in concentrations that are not above measured concentration s of Trichoderma spp. naturally occurring in soil. Therefore, exposure in the terrestrial environment is expected to be negligible, if it occurs at all
. The applicant submitted data waiver rationale s to fulfill the requirement of acute oral and avian inh alation toxicity

/pathogenicity

studies
. Data from an optimum growth temperature study was also submitted, and showed that T34 does not grow at normal avian body temperatures . Based on this information, exposure of birds to T34 is not expected to result in adverse effects on birds and risk to birds resulting from the proposed use of T34 is notTrichoderma asperellum , strain T34 Page 11 of 26

Biopesticides Registration Action Document anticipated. Acute oral toxicity

/pathogenicity

testing indicated no significant adverse effects to laboratory rats dosed at 1.1 x 10 8 cfu/animal after 21 days (MRID 4 8067401)
. There is no reason that tests on laboratory

mammals are not representative of the potential hazard to wild mammals in this case; therefore, based on this information, adverse effects on wild mammals are not expected from exposure to T34
. Since th e proposed use is also expected to minimize exposure, risk to wild mammals resulting from the proposed registration of T34 is not anticipated. The applicant submitted information on the toxicity /pathogenicity

data for several insect species exposed to Tri choderma harzianum (the former classification of some strains of Trichoderma asperellum ) and Trichoderma gamsii . While these data cannot be used directly to determine the potential hazard of this particular strain of Trichoderma asperellum , they do provide some evidence of the lack of effects of Trichoderma spp. on insects . The Agency had previously

expressed concern over the potential hazard of Trichoderma harzianum, strain T39 (USEPA 2000), and several papers have shown adverse effects of this related fungus on nontarget insects, particularly coleopteran species (Cardoza et al. , 2006 ; Jassim et al. , 1990 ; Shakeri and Foster 2006)
. Nontarget insect testing has not been performed for T34 because nontarget insects’ exposure to this strain is not expected
. Future expansion of the uses of T34 may require nontarget insect toxicity /pathogenicity

testing
. As with other nontarget insects, the Agency had previously expressed concerns for potential effects on honey

bees for a related Trichoderma spp. , Trichoderma har zianum strain T39 (USEPA 2000); however, data were subsequently submitted to show that adverse effects are not expected from exposure to that strain. Trichoderma spp. are widely understood to present no potential adverse effects to honey bees, which is supported by data submitted by

the applicant showing lack of effects of honey bees and bumble bees (

Bombus terrestris ) following exposure to several Trichoderma spp . Therefore, BPPD conclude d that T34 will not pose risk to honey

bees as a result of the propos ed labeled uses. Studies on the toxicity

/pathogenicity

of T34 to terrestrial plants were not required because Trichoderma asperellum , and other Trichoderma spp., are not taxonomically related to any known plant pathogens
. Therefore, adverse effects to plants are not expected as a result of the proposed uses of T34
.

**b. Aquatic Animals and Plants**  The applicant presented extensive rationale to show that exposure of T34 in aquatic environments would be negligible, if it occurred at all, and would have no e ffects on fish or aquatic invertebrates if this biopesticide were to reach surface waters. Data from a study was submitted to show that at four months after the last application of T34 to potted plants, leachate from the pots contains 10 2 cfu/mLof T34 , wh ich is less than the amount of Trichoderma spp. found naturally in soil
. Therefore, spillage onto greenhouse soil and outdoor disposal of treated potting material would not increase the amount of Trichoderma spp. normally

found in soil or in runoff. Incidents such as these are expected to have negligible contribution to exposure. The applicant presented additional data from public literature to show that if T34 were to reach surface waters, it would be unable to proliferateTrichoderma asperellum , strain T34 Page 12 of 26

Biopesticides Registration Action Document and would be unlikely

to survive. Based on the information provided, exposure to aquatic environments is expected to be negligible and adverse effects in these environments are not expected. Therefore, BPPD concludes that the proposed use of T34 will not result in risk of adverse effects to fish and aquatic invertebrates in freshwater and marine environments. Studies on the toxicity

/pathogenicity

of T34 to aquatic plants were not required because Trichoderma asperellum and other Trichoderma spp. are not taxonomically related to any known plant pathogens and exposure in these environments is not expected
. Therefore, adverse effects to aquatic plants are not expected as a result of the proposed uses of T34
.

**c. Open Literature Information**  Li terature searches were performed to determine i f other effects have been reported that were not contained within the information provided by the applicant. Both the Science Citation In dex Expanded database (1970
- present) and the Environmental Information Search service (1964
- present) were searched using the terms “ Trichoderma asperellum , ” “ Trichoderma asperellum strain T34, ” and “ asperellum strain T34.” The Environmental Information Search service includes the Agricola; Biosis Previews; CAB Abstracts; Energy, Science, and Technology ; General Science Ab stracts; National Technical Information Service; and Waternet databases. None of the records found in any of the searches described here reported effects on any

non - target species. **2. Environmental Fate Data**  The information provided , for the current u ses and application methods is sufficient to satisfy the Tier I nontarget organism data requirements , and for conducting a nontarget organism risk asse ssment for T34 , f

urther testing at higher tier levels (i.e., Tiers II, III, and IV) is not required. **3 .**  **Threatened and Endangered**  **Species Assessment** Since EPA has determined that no effects are anticipated for any nontarget species exposed to T34 as a result of the proposed labeled applications, effects to threatened and endangered species and their desi gnated critical habitats also are not expected
. There fore, a “No Effect” determination wa s made for direct and indirect effects to listed species and their designated critical habitats resulting from the registered uses of T34
. **V. ENVIRONMENTAL JUSTICE**  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 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 theirTrichoderma asperellum , strain T34 Page 13 of 26

Biopesticides Registration Action Document 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 se ek out and facilitate the involvement of those potentially

affected. EPA has this goal for all communities and persons across the United States. To help address potential environmental justice issues, EPA seeks information on any groups or segments of th e population who, as a result their location, cultural practices, or other factors, may

have aty pical, unusually

high exposure to T34 compared to the general population. During the comment period, the Agency solicited comment s from the public on any subpop ulations that may have aty pical, unusually

high exposure compared to the general population. For additional information regarding environmental justice issues, please visit EPA’s web site at http://www.epa.gov/compliance/environmentaljustice/index.html
. **V I**  **. RISK MANAGEMENT DECISION**  Section 3(c)(5) of FIFRA provides for the registration of new active ingredients if it is determined that (A) its composition is such as to warrant the proposed claims for it; (B) its labeling and other materials required to be submitted comply with the requirements of FIFRA; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment. The four criteria of the e ligibility determination for pesticidal active ingredients were satisfied by

the science assessments supporting products containing T34
. Such products are not expected to cause unreasonable adverse effects and are likely to provide protection as claimed when used according to label instructions. Therefore, we have concluded that T34 is eligible for re gistration for the labeled uses
. **V I**  **I .**  **ACTIONS REQUIRED BY THE**  **APPLICANT A. Final Printed Labeling**  Before releasing pesticide products containing T34 for shipment, the applicant will be required to provide appropriate final printed labeling to EPA
. **B. Terms of Registration**  We propose the following as terms f or the T34 Biocontrol registration : the applicant must submit the following data upon completion : (1) A cute Injection Toxicity /Pathogenicity

– Rat (OCSPP Guideline 885. 3200 ) : Due to the results of a p revious IP toxicity study and the high potential of toxicity of the product, a new toxicity

/pathogenicity

study, using a lower concentration of the TGAI , was performed and has been accepted by the Agency
. Another IP injection study addressing concern relating to culture filtrates and killed cultures is in process andTrichoderma asperellum , strain T34 Page 14 of 26

Biopesticides Registration Action Document will be submitted to the UK and the EU
. US EPA also expects to receive this study upon completion. **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 EPA as a requirement for maintaining the federal registration for a pesticide product. A brief summary of these ty

pes of data are described below. Reports of all incidents of adverse effects to the environment must be submitted to EPA under the provisions stated in FIFRA section 6(a)(2). Additionally, all incidents of hy persensitivity

(including both suspected and confirmed incidents) must be reported to EPA under the provisions of 40 CFR § 158.2140(d).Trichoderma asperellum , strain T34 Page 15 of 26

Biopesticides Registration Action Document **VIII .**  **GLOSSARY OF ACRONYMS AND ABBREVIATIONS**  BPPD Biopesticides and Pollution Prevention Division BRAD Biopesticides Registration Action Document CFR Code of Federal Regulations cfu Colony
- forming unit(s) cfu/kg Colony
- forming units per kilogram cfu/mL Colony
- forming units per milliliter cP Centipoise EDSP Endocrine Disruptor Screening Program EP End
- use product EPA Environmental Protection Agency (the “Agency”) FFDCA Fed eral Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act FR Federal Register g/mL Gram per milliliter LC 50 Median lethal concentration. A statistically derived concentration of a subs tance that can be expected to cause death in 50% of test animals. Iti s usually e xpressed as the weight of substance per weight or volume of water, air, or feed (e.g., mg/L, mg/kg, or ppm). LD 50 Median lethal dose. A statistically d erived 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 Milli grams per liter MP Manufacturing
- use product MPCA Microbial Pesticide Control Agent MPCP Microbial Pesticide Control Product MRID No. Master Record Identification Number NI OSH National Institute for Occupational Safety and Health NRRL Northern Region al Research Laboratory OCSPP Office of Chemical Safety and Pollution Prevention (formerly OPPTS). OPP Office of Pesticide Programs PC Code Pesticide Chemical Code PP Pesticide Petition PPE Personal protective equipment ppm Parts per million TGAI Tec hnical grade of the active ingredientTrichoderma asperellum , strain T34 Page 16 of 26

Biopesticides Registration Action Document **I X**  **. BIBLIOGRAPHY** A. Studies Submitted to Support the T34 Pesticide Product Registrations 47946901 Schropp P. 2007
. Acute Dermal Irritation/Corrosion
. Project No. 070961
.

Unpublished study

prepared by

B iocontrol T echnologies , S.L ., 22 pages. 47946902 Schropp P. 2007
. Acute Oral Toxicity A cute Toxic Class Method
. Project No. 070963
. Unpublished study p repared by Biocontrol Technologies , S.L ., 21 pages. 47946903 Schropp P. 2007
. Acute In jection Toxicity

/Path ogenicity
. Project No. 070966
. Unpublished study

prepared by Biocontrol Technologies , S.L ., 23 pages. 47946904 Schropp P. 2007
. Test for Sensitization (Guinea Pig Maximasation Test)
.

Project No. 070965
. Unpublished study p repared by Biocontrol Technologi es , S.L ., 33 pages. 47946905 Schropp P. 2007
. Acute Eye Irritation/Corrosion
. Project No. 070962
.

Unpublished study

prepared by Biocontrol Technologies , S.L ., 26 pages. 47946906 Schropp P. 2007
. Acute Pulmonary T oxicity /Pathogenicity
. Project No. 07096 9
. Unpublished study p repared by Biocontrol Technologies , S.L ., 27 pages. 47946907 Schropp P. 2007
. Acute Dermal Toxicity
. Project No. 070964
. Unpublished

study prepared by Biocontrol Technologies , S.L ., 21 pages. 47946907 Schropp P. 2007
. Acute Oral T oxicity /Pathogenicity
. Project No. 070967
. Unpublished study

prepared by Biocontrol Technologies , S.L ., 42 pages. 47946908 Lo we, C. 2007
. Acute Inhalation Toxicity S tudy in Rats - Li mit Test . Unpublished study

prepared by Biocontrol Technologies , S.L ., 20 pages. 47946909 Biocontrol Technologies, S.L
. 2009
. Microbial Pesticides Residue Data

Requirements: Rationale and Request for Waivers of Certain Data . Unpublished study

prepared by Biocontrol Technologies , S.L ., 10 pages. 47946911 By

rd, C. 2009
. Produ ct Chemistry D ata Waivers
. Unpublished study p repared by Biocontrol Technologies , S.L ., 4 pages. 47946912 Trillas, Dr. I . 2009
. Molecular Classification
. Unpublished study prepared by Biocontrol Technologies , S.L ., 9 pages. 47946913 Trillas, Dr. I. 2 00 7 . Morphological Classification of the Biological Control

Agent
. Unpublished study p repared by Biocontrol Technologies , S.L ., 28 pages.Trichoderma asperellum , strain T34 Page 17 of 26

Biopesticides Registration Action Document 47946914 Trillas, Dr. I. 2 008
. Specific Detection
. Unpublished study p repared by Biocontrol Technologies , S.L ., 25 pag es. 47946915 Trillas, Dr. I. 2 008
. Specific PCR Fingerprinting
. Unpublished study p repared by Biocontrol Technologies , S.L ., 17 pages. 47946916 Biocontrol Technologies, S.L. 2008
. Id entity
. Unpublished study p repared by Biocontrol Technologies , S.L ., 2 8 pages. 47946917 Samuels, Dr. G, Segarra G. 2007
. Document on the Classification of

Trichoderma asperellum
. Unpublished study p repared by Biocontrol Technologies , S.L ., 8 pages. 47946918 Fy

tovita S. 2008
. Manufacturing Process . Unpublished study p repared by Biocontrol Technologies , S.L ., 35 pages. 47946919 Biocontrol Technologies, S.L
. 2008
. Protocol to Monitor the Levels of

Contaminating Microorganisms in the Formulated Microbial Pest Control Product
. Unpublished study p repared by Biocontrol Technol ogies, S.L ., 4 pages. 47946920 Fy

tovita S. 2008
. Method to Control Impurities, Study o f Contaminants in Broth, Study

o f Contaminants in Formulated Product, Quality C ontrol of Formulated Product
. Unpublished study p repared by Biocontrol Technologies , S.L
. , 16 pages. 47946921 Trillas, Dr. I. 2 007
. Id entification of Contaminant Microorganisms in the

Active Substance and the Formulated Microbial Pest Control Product
. Unpublished study

prepared by Biocontrol Technologies , S.L ., 6 pages. 47946923 Guerrero, M. 2007
. Determination of the Active Components of Different

Batches of the Microbial Pest Control Agent
. Unpublished study prepared by Biocontrol Technologies , S.L ., 5 pages. 47946924 Trillas, Dr. I. 2 008
. Storage Stability and Shelf Li fe of the MPCP at 36 o C, 37 o C, 38 o C, 39 o C, 40 o C, 45 o C, and 50 o C
. Unpublished study p repared by Biocontrol Technologies , S.L ., 15 pages. 47946925 Trillas, Dr. I . 2008
. Study of Storage Stability

and Shelf Life of MPCA from Different Batches at 4 o C and 25 o C
. Unpublished stu dy p repared by Biocontrol Technologies , S.L ., 16 pages. 47946926 Trillas, Dr. I. 2008
. Study of Storage Stability

and Shelf Life of MPCP from Different Batches at 4 o C and 25 o C
. Unpublished study p repared by Biocontrol Technologies , S.L ., 19 pages. 4794 6927 Cassals, Dr. I . 2007
. Study of pH
. Unpublished study prepared by Biocontrol Technologies , S.L ., 12 pages.Trichoderma asperellum , strain T34 Page 18 of 26

Biopesticides Registration Action Document 47964922 Guerrero, M. 2007
. Determination of the Active Components of Different

Batches of the Microbial Pest Control Product
. Unpublished study prepared by Biocontrol Technologies , S.L ., 6 pages. 48067402 Hoppner, Dr. C. 2007
. Determination of the microbial count of a powdery

formulation of conidia
. Project No. 071324
. Unpublished study p repared by Biocontrol Technologies , S.L ., 35 pages
. 48 067403 Hoppner, Dr. C. 2007
. Determination of the microbial count . Project No.

071405
. Unpublished study p repared by Biocontrol Technologies , S.L ., 44 pages . 48067404 Hoppner, Dr. C. 2007
. Determination of the microbial count . Project No.

071406
. Unpubl ished study p repared by Biocontrol Technologies , S.L ., 39 pages . 48067405 Hoppner, Dr. C. 2007
. Determination of the microbial count of a powdery

formulation of conidia
. Project No. 071325
. Unpublished study p repared by Biocontrol Technologies , S.L ., 35 pages . 48067406 Hoppner, Dr. C. 2007
. Validation of the determination of the microbial count

in tissue
- and feces samples
. Project No. 071327
. Unpublished study p repared by Biocontrol Technologies , S.L ., 37 pages
. 48348303 Biocontrol Technologies, S .L . 2011
. Discussion of Formation of Unintentional

In gredients, Microbiological Analysis Results
. Unpublished study prepared by Biocontrol Technologies , S.L ., 5 pages. 48348304 Trillas, Dr. I. 2011
. Study of Storage Stability

and Shelf Life of MPCP from Different Batches at 4 o C and 25 o C
. Unpublished study p repared by Biocontrol Technologies , S.L ., 24 pages. 48348305 Trillas, Dr. I. 2011
. Study of the Tap Density
. Unpublished study p repared by Biocontrol Technologies , S.L ., 7 pages. 48348306 Allingham, Dr. P. 2010
. Intrapertioneal Dose Range Finding Study i n Rats . Study No. 101684
. Unpublished study prepared by Biocontrol Technologies , S.L ., 22 pages. 48348307 Allingham, Dr. P. 2010
. Acute In jection Toxicity

/Pathogenicity

S tudy
. Unpublished study

prep ared by Biocontrol Technologies , S.L ., 112 pages. 48377001 Biocontrol Technologies, S.L
. 2011
. Response to the US EPA Deficiency

Letter of 17 th December 2010
. Unpublished study p repared by Biocontrol Technologies , S.L ., 17 pages. 48377002 Biocontrol Te chnologies, S.L
. 2011
. Production of Trichotecene
. Unpublished

study prepared by Biocontrol Technologies , S.L ., 39 pages.Trichoderma asperellum , strain T34 Page 19 of 26

Biopesticides Registration Action DocumentTrichoderma asperellum , strain T34 Page 20 of 26

Biopesticides Registration Action Document **B. Environmental Protection Agency Risk Assessment Memoranda** U.S. EPA. 20 1 0 a . Environmental Risk Assessment for a FIFRA Section 3 Registration for T34 for Control of Fungal Root Disease in Ornamental and Carnation Plants in Greenhouse [EPA File No. 87301
- R]; Decision # 425700, DP Barcode # 373656, Submission # 865549, Memorandum from S. Borges and Z. Vaituzis to A. Gross, dated Sept ember 22, 2010. U.S. EPA. 201 0 b. Review of Product Chemistry, Manufacturing Process, Acute Toxicity Studies, and Waiver Requests for Residue Chemistry S tudies, for Section 3 registration of a New End Use Product, T34 BIOCONTROL (EPA Reg. No. 87301
- R) cont aining a new TGAI Trichoderma asperellum , strain T34 , Memorandum from I . Barsoum and J. Kough to A. Gross, dated November 23, 2010 U.S. EPA. 2011. Review of the Applicant ’s Response to the Deficiencies Found by the Agency in its Review of Product Chemistr y, Manufacturing Process, and Acute Toxicity S tudies of the Product T - 34 Biocontrol containing the AI T34 (EPA Reg. No. 87301
- R), Memorandum from I . Barsoum and J. Kough to A. Gross, dated June 16, 2011
.Trichoderma asperellum , strain T34 Page 21 of 26

Biopesticides Registration Action Document **A PPENDIX**  **A. MICROBIAL PESTICIDES D**  **ATA REQUIREMENTS**

**(40 CFR PART 158** 
**– SUBPART**  **V )**  **TABLE 1. Product**  **Analysis Data Requirem**  **ents for**  **the Technical Grade of the Active Ingredient (TGAI)**  **T34 & End**  ****

**Use Product (EP) T34**  **Biocontrol, (EPA Reg. No. 87301 -**  **R) (40 CFR § 158.2**  **120 )**  **OCSPP G**  **uideline N**  **umb er**  **Data Requirem ent**  **Results MRID No.**  **TGAI /MPCA**  **E P**  **/MPCP** 885.1100 Product Identity Not applicable
. Submitt ed data fulfill the requirement for product identity. T34 Biocontrol contains 12.00 % active ingredient T34 , 8 8
. 0 0% other ingredients
. 4794611 27

885.1200 Manufacturing Process Submitted data fulfill the requirement for manufacturing process . 479461127 Not applicable Deposition of a Sample

in a Nationally Recognized Culture Collection T34 is deposited in the

Spanish Collection of Type Culture s , University of Valencia in Valencia Spain (CECT No. 20417). Not applicable
. 4794 6917

885.1300 Discussion of Formation

of Unintentional Ingredients Submitted data fulfill the requirement for discussion of

formation of unintentional ingredients
. 47946112 7 885.1400 Analysis of S amples Submitted data fulfill the requirement for analysis of samples. 479461127 8 85 .1 50 0 Certification of L imits Not applicable
. Limits listed o n the confidential statement of formula are a cceptable. 4794 61127 **Additional Studie s**  830.1800 Enforcement Analytical M ethod Not applicable
. Submitted data fulfill the requirement for an enforcement analytical method
. 479461127Trichoderma asperellum , strain T34 Page 22 of 26

Biopesticides Registration Action Document **TABLE 2**  **. Physical and Chem** **ical Characteristics for the Technical Grade of the Active Ingredient (**  **TGAI) T34**  **&**

**End -**  **Use Product (EP) T34**  **Biocontrol, (EPA Reg. No. 87301 -**  **R) (40 CFR § 158.2120)**  **OCSPP G**  **uideline N**  **umber Data Requirem**  **ent Results**  **MRID No. TGAI/MPCA**  **EP/MPCP** 830.6302 Color Colorless (transparent or translucent), green or brow n . Not appli cable
. 47946913 830.6303 Physical State Solid (Colony) Not applicable
. 47946913 830.6304 Odor Decaying wo od or forest
- like
. Not applicable
. 47946913 830.6313 Stability to Normal and

E levated Tem peratures, Metals, and Metal I ons Viability was maintained for 14 days at 36
- 40 O C, but viability decreased at 45 O C after 5 days, and all colonies died after 3 days at 50 O C. S tability to metals is not relevant as the product will not be packaged in metal containers (waiver requested)
. Not applicable
. 47946911 479 46924 47946925 47946926

830.6317 Storage Stability Stable at 4 O C for 2 years and at 25 O C for <5 months. 47946925
- 26 483483
- 04 830.6319 Miscibility Not applicable
. Not required because T34 Biocontrol is not an e mulsifiable liquid to be mixed with petroleum solvents (refer to test note #10 of 40 CFR § 158.2120(d)). Not applicable

830.6320 Corrosion

Characteristics Not applicable
. Data Waiver Request; EP has no oxidizing properties, inters are noncorrosive, and packaging not exposed to metal, metal ions or humidity. Not applicable

830.7000 pH 5.95 (1% suspension of TGAI in water) Not applicable
. 47946927 47946916 CSF 830.7100 Viscosity Not applicable
. Data not required, the material is a powder
. 47946911 830.7300 Density/Relative

Density/Bulk Density (Sp ecific Gravity) 200
- 600kg/m3 at 20 O C

per the MSDS CSF lists 200 kg/m3 at 20 O C Not applicable
. 47946911 47946918 CSFTrichoderma asperellum , strain T34 Page 23 of 26

Biopesticides Registration Action Document **T ABLE**  **3 .**  **Toxicology Data Requirem**  **ents for the**  **Technical Grade of the Active Ingredient (TGAI) T34**  **& End -**  **Use**

**Product (EP) T34**  **Biocontrol, (EPA Reg. No. 87301**  **- R)**  **(40 CFR § 158.2140) OCSPP**  **Guideline N**  **umber Data Requirem**  **ent Results**  **MRID N**  **o. TGAI/MPCA**  **EP/MPCP Tier I**  885.3050 Acute Oral

Toxicity/Pathogenicity T34 does not appear to be

toxic, infective, and/or pathogenic to rats w

hen dosed at 1.1 x 10 8 cfu/animal **Classification: Acceptable** Not applicable 48067401 48067403

885.3150 Acute Pulmonary

Toxicity/Pathogenicity T34 appears to be slightly

toxic but not infective and/or pathogenic in rats when dosed at 1.1 x 10 8 cfu/animal **Classificat ion: Acceptable**  Not applicable 47946906 48067404

885.3200 Acute Injection

Toxicity/Pathogenicity (Intravenous) T34 is associated with mild

to moderate signs of toxicity but no mortality when dosed with 4.2 x 10 7 cfu/animal **Classification: Acceptable** Not applicable 47946903 48067406 483483
- 07 885.3400 Hypersensitivity

Incidents No hypersensitivity incidents, including immediate
- type or

delayed
- type reactions of humans and domestic animals that occurred during research, development, or testing of the TGAI/MP , were reported by the applicant. Any future hypersensitivity incidents must be reported per OCSPP Guideline 885.3400. 885.3500 Cell Culture Not required because T34 i s not a virus (refer to test note #4 of 40 CFR § 158.2140(d)). Not applicable Not applicable 870.1100 Acute Oral Toxicity Not applicable Oral LD 50 female rats > 2 ,000 mg/kg bw
. **Classification: Acceptable TOXICITY**  **CATEGORY I** **II** 47946902

870.1200 Acute Dermal Toxicity Not applicable Dermal LD 50 combined (male and female) rabbits > 2,000 mg/kg bw
. **Classification: Acceptable TOXICITY**  **CATEGORY I** **II** 47946907

870.1300 Acute Inhalation

Toxicity Not applicable Inhalation LC 50 combined (male and female) rats > 2. 03 mg/L
. **Classification: Acceptable TOXICITY**  **CATEGORY I** **V** 47946908

870.2400 Acute Eye Irritation Not applicable T34 wa s mil dly irritating to the eyes of rabbits. **Classification: Acceptable TOXICITY**  **CATEGORY I** **II** 47946905

870.2500 Primary Dermal

Irritation Not applicable T34 wa s not to the skin of rabbits. **Classification: Acceptable TOXICI**  **TY CATEGORY**  **I V**  47946901

**Tiers II and III** Not required for T34, based on the lack of acute toxicity/pathogenicity in the Tier I studies. **Additional Studies**Trichoderma asperellum , strain T34 Page 24 of 26

Biopesticides Registration Action Document **T ABLE**  **3 .**  **Toxicology Data Requirem**  **ents for the**  **Technical Grade of the Active Ingredient (TGAI) T34**  **& End -**  **Use**

**Product (EP) T34**  **Biocontrol, (EPA Reg. No. 87301**  **- R)**  **(40 CFR § 158.2140) OCSPP**  **Guideline N**  **umber Data Requirem**  **ent Results**  **MRID N**  **o. TGAI/MPCA**  **EP/MPCP** 870.2600 Skin Sensitization T34 wa s a dermal sensitizer to guinea pigs
. **Classification: Accep**  **table** 4794 6904 Not applicable Production of Toxins If any trichodermin is produced by T34 , the amounts are smaller compared to known producer strains and no toxicity is expected
. **Classification: Supplem ental** 
**– Not a required study**  48377002Trichoderma asperellum , strain T34 Page 25 of 26

Biopesticides Registration Action Document
**TABLE 4**  **. Nontarget Organism** **Toxicity and Environm ental Fate Data Requirem**  **ents for the**  **Technical Grade of the Active Ingredient (TGAI)**  **T34 & End**  **- Use Product (EP)**  **T34 Biocontrol, (EPA Reg. No. 87301**  **- R)**  **(40 CFR § 158.2150) OCSPP Guideline**  **Num ber**  **Data Requirem ent**  **Res ults**  **MRID No. Tier**  **I** 885.4050 885.4200 885.4240 885.4280 885.4340 885.4380  Avian Oral

toxicity /pathogenicity  Freshwater fish toxicity/pathogenicity  Freshwater invertebrate toxicity/pathogenicity  Estuarine/marine fish and invertebrate testing  Nontarget in sect testing  Honey bee testing Data waiver rationale provides sufficient information to determine that toxicity/pathogenicity to avian wildlife, wild mammals, freshwater and marine/estuarine fish and invertebrates, nontarget insects and honey bees is not e xpected as a result of the proposed label
. **Classification: Acceptable** 47068102

885.4150 Wild Mammal

Toxicity/Pathogenicity Studies required by 40 CFR § 158.2140 are adequate and appropriate for assessment of hazards to wild mammals
. Acute oral toxicity/p athogenicity testing indicated no significant adverse effects to laboratory rats dosed at 1.1 x 10 8 cfu/animal after 21 days. **Classification: Acceptable for wild m**  **am ma**  **l risk assessment**  47945023

885.4100 885.4300  Avian Inhalation

Toxicity/Pathogenicity  Nontarget plant testing Not required
- active ingredient is not related to known avian or plant pathogens
. N/A **Tiers II, III, and IV** Not required for T34 , based on the current uses and application methods.Trichoderma asperellum , strain T34 Page 26 of 26

Biopesticides Registration Action Document **APPENDIX B. PESTICIDE PRODUCT EPA**  **File Sym bol**  **Registration Nam** **e Percentage** 

**Active Ingredient**  **Form ulation** 

**Type Use Site(s)**  **Method(s) of Application**  **Application**

**Rate Target Pest**  8 7301
- R T34

Biocontrol 1 2 .00% End Use
Powder Greenhouse

Carnations Standard

ground spray, root soak, or irrigation Maximum of

10g/L Fusarium

oxysporum