BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Trichoderma hamatum isolate 382 

U.S. Environmental Protection Agency 

 Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

Version #1 

June 1, 2010 
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Biopesticides Registration Action Document 

TABLE OF CONTENTS

I. BACKGROUND .................................................................................................................. 4

II. ACTIVE INGREDIENT OVERVIEW.............................................................................. 4

III. REGULATORY BACKGROUND..................................................................................... 5

A. Applications for Pesticide Registration.................................................................................... 5 

B. Food Tolerance Exemptions................................................................................................... 5 

IV. RISK ASSESSMENT .......................................................................................................... 5

A. Product Analysis Assessment (40 CFR § 158.2120) ................................................................... 6 

B. Human Health Assessment (40 CFR § 158.2140)....................................................................... 6 

C. Environmental Assessment (40 CFR § 158.2150)....................................................................... 9 

V. ENVIRONMENTAL JUSTICE ....................................................................................... 11

VI. RISK MANAGEMENT DECISION................................................................................ 11

VII. TERMS AND CONDITIONS OF THE REGISTRATION(S)...................................... 11

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................ 12

IX. BIBLIOGRAPHY.............................................................................................................. 13

A. Studies Submitted to Support the Trichoderma hamatum isolate 382 Pesticide Product ............... 13 

B. Environmental Protection Agency Risk Assessment Memoranda.............................................. 16 

C. Other References................................................................................................................ 17 

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS ............................ 18
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM 

Office of Pesticide Programs (OPP) 

Biopesticides and Pollution Prevention Division 

Microbial Pesticides Branch 

Science Reviews 

Ibrahim Barsoum, Ph.D. Product Analysis, Human Health 

John Kough, Ph.D. Product Analysis, Human Health 

Shannon Borges Environmental Effects 

Zigfridas Vaituzis, Ph.D. Environmental Effects 

Regulations 

Sheryl Reilly, Ph.D. Chief, Microbial Pesticides Branch 

Ann Sibold Regulatory Action Leader 
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I. BACKGROUND 

Trichoderma hamatum isolate 382 is a naturally occurring fungus that is found widely in soils, 

potting media, corn grits, and flour, as well as on root surfaces of various plants, decaying bark, 

rotting wood, fruits, and vegetables. It is intended for use in compost and soilless growing media 

to suppress soil borne plant pathogens, including Pythium species, Phytophthora species, 

Fusarium species, Rhizoctonia solani, Sclerotium rolfsii, and Thielaviopsis basicola. The mode 

of action for Trichoderma hamatum isolate 382 is primarily though colonization of compost or 

soilless growing media before disease-causing microorganisms, such as those mentioned 

previously, have an opportunity to do so. 

On October 1, 2009, the Environmental Protection Agency (EPA or the Agency) 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 new policy, the Agency intends to 

provide a public comment period prior to making a registration decision for, at minimum, the 

following types of applications: new active ingredients; first food uses; first outdoor uses; first 

residential uses; and any registration decisions for which the Agency believes there may be 

substantial public interest. 

Consistent with the new policy of making registration actions more transparent, Trichoderma 

hamatum isolate 382 is subject to a 30-day comment period as a “new active ingredient” whose 

registration would result in a “first outdoor use,” a “first food use,” and possibly a “first 

residential use.” While a final decision on registration is contingent upon review and 

consideration of public comments, the Agency presently believes that, based upon the 

preliminary risk assessment and information submitted in support of registration of Trichoderma 

hamatum isolate 382, it is in the best interest of the public and the environment to issue the 

registration for Trichoderma hamatum isolate 382. The basis for this preliminary decision can be 

found in the risk assessment for Trichoderma hamatum isolate 382, which is characterized 

throughout this Biopesticides Registration Action Document (BRAD) and the associated 

reference documents written by Agency scientists. 

II. ACTIVE INGREDIENT OVERVIEW 

Biological Name: Trichoderma hamatum isolate 382 

Culture Deposit: American Type Culture Collection in Manassas, 

 Virginia under Accession Number 20765 

 OPP Chemical Code: 119205 

 Type of Pesticide: Microbial Pesticide/Biofungicide

III. REGULATORY BACKGROUND
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A. Applications for Pesticide Registration 

On February 20, 2007, Interregional Research Project Number 4 (IR-4) of Rutgers University 

(address: 500 College Road, East, Suite 201W, Princeton, NJ 08540), acting as the authorized 

agent for Sellew and Associates, LLC (address: 84 Shadybrook Lane, Carlisle, MA 01741), 

submitted an application to register Trichoderma hamatum isolate 382 (EPA File Symbol 74205-

G) under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). On July 

22, 2009, the Agency announced receipt of this application to register a pesticide product 

containing a new active ingredient (74 Federal Register [FR] 36215) and opened a 30-day public 

comment period pursuant to the provisions of FIFRA section 3(c)(4). No comments were 

received following this publication. 

B. Food Tolerance Exemptions 

Concurrent with their registration application and under Federal Food, Drug, and Cosmetic Act 

(FFDCA) section 408(d), IR-4 (on behalf of Sellew and Associates, LLC) submitted a petition to 

establish an exemption from the requirement of a tolerance for Trichoderma hamatum isolate 

382 (Pesticide Petition [PP] 7E7188). In the Federal Register of July 22, 2009 (74 FR 36200), 

the Agency announced that IR-4 (on behalf of Sellew and Associates, LLC) proposed to 

establish an exemption from the requirement of a tolerance for residues of the microbial 

pesticide, Trichoderma hamatum isolate 382, in or on all food commodities and opened a 30-day 

comment period. 

One comment, which specifically stated that the aforementioned petition should be rejected 

without full testing for 20 years, was received in response to the notice of filing. The Agency 

notes that neither the data requirements nor the data guidelines require 20 years of testing; the 

applicant has fulfilled all applicable data requirements to support the petition by providing 

acceptable toxicology studies. For the proposed uses described on the pesticide product label 

(soilless potting media, compost and soil), the Agency has made a preliminary conclusion that 

there is a reasonable certainty that no harm will result to the United States population, including 

infants and children, from aggregate exposure to the residues of Trichoderma hamatum isolate 

382. 

IV. RISK ASSESSMENT 

On October 26, 2007, the Agency issued a Final Rule in the Federal Register 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 that are found for each data submission are assigned by Agency science 

reviewers and are an indication of the usefulness of the information contained in the documents 

for risk 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: UPGRADABLE”). If a 

study is rated as “SUPPLEMENTAL: UPGRADABLE,” the Agency always provides an 
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Biopesticides Registration Action Document 

indication of what is lacking or what can be provided to change the rating to “ACCEPTABLE.” 

If there is simply a “SUPPLEMENTAL” rating, the reviewer will often state that the study is not 

required by the current 40 Code of Federal Regulations (CFR) part 158. Both “ACCEPTABLE” 

and “SUPPLEMENTAL” 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 categories are assigned based on the 

hazard(s) identified from studies and/or other information submitted to the Agency 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 I indicates the highest toxicity and Toxicity 

Category IV indicates the lowest toxicity. 

A. Product Analysis Assessment (40 CFR § 158.2120) 

All product analysis data requirements for Trichoderma hamatum strain 382 have been satisfied. 

Refer to Tables 1 and 2 in Appendix A for a brief summary of these data requirements, including 

both generic and product-specific information. Additionally, the comprehensive Agency risk 

assessments that evaluate these data are available as “Supporting & Related Materials” within 

Docket Number EPA-HQ-OPP-2010-0489 at http://www.regulations.gov (U.S. EPA 2009, 

2010b). 

B. Human Health Assessment (40 CFR § 158.2140)

1. Toxicity 

All toxicology data requirements for Trichoderma hamatum strain 382 have been satisfied. 

Acceptable Tier I mammalian toxicology data/information support the registration of 

Trichoderma hamatum strain 382. Furthermore, Tier II and Tier III studies were not required for 

Trichoderma hamatum strain 382 based on the lack of acute toxicity/pathogenicity in the Tier I 

studies. Refer to Table 3 in Appendix A for a brief summary of these data requirements, 

including both generic and product-specific information. Additionally, the comprehensive 

Agency risk assessments that evaluate these data are available as “Supporting & Related 

Materials” within Docket Number EPA-HQ-OPP-2010-0489 at http://www.regulations.gov (U.S. 

EPA 2009, 2010b, 2010c). 

2. Endocrine Disruptors 

As required under FFDCA section 408(p), the Agency has developed the Endocrine Disruptor 

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 effects 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 thyroid (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 the 

Agency 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 effect. 
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Between October 2009 and February 2010, the Agency 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 human 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. 

Trichoderma hamatum strain 382 is not among the group of 58 pesticide active ingredients on 

the initial list to be screened under the EDSP. Under FFDCA section 408(p), the Agency must 

screen all pesticide chemicals. Accordingly, the Agency 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/. 

3. Food Quality Protection Act (FQPA) Considerations 

Section 408(c)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act allows the Agency to 

establish an exemption from the requirement for a tolerance (the legal limit for a pesticide 

chemical residue in or on a food) only if the Agency determines that the exemption is “safe.” 

Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty 

that no harm will result from aggregate exposure to the pesticide chemical residue, including all 

anticipated dietary exposures and all other exposures for which there is reliable information.” 

This includes exposure through drinking water and in residential settings, but does not include 

occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or 

maintaining in effect an exemption from the requirement of a tolerance, the Agency must take 

into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require the Agency to 

give special consideration to exposure of infants and children to the pesticide chemical residue in 

establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result 

to infants and children from aggregate exposure to the pesticide chemical residue....” 

Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider “available 

information concerning the cumulative effects of [a particular pesticide's] residues and other 

substances that have a common mechanism of toxicity.” 

The Agency performs a number of analyses to determine the risks from aggregate exposure to 

pesticide residues. First, the Agency determines the toxicity of pesticides. Second, the Agency 

examines exposure to the pesticide through food, drinking water, and through other exposures 

that occur as a result of pesticide use in residential settings. 

Consistent with section 408(b)(2)(D) of FFDCA, the Agency has reviewed the available 

scientific data and other relevant information, and considered its validity, completeness, and 

reliability and the relationship of this information to human risk. The Agency has also 

considered available information concerning the variability of the sensitivities of major 

identifiable subgroups of consumers, including infants and children. 

Based on the acute toxicity/pathogenicity data presented in Table 3 in Appendix A, the data 

required for a FQPA risk assessment for Trichoderma hamatum strain 382 have been satisfied. 
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a. Aggregate Exposures 

In examining aggregate exposure, section 408 of FFDCA directs the Agency to consider 

available information concerning exposures from the pesticide residue in food and all other 

nonoccupational exposures, including drinking water from ground water or surface water and 

exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor 

uses). 

Dietary Exposure and Risk Characterization: No harmful effects to humans are expected from 

eating treated food. Dietary exposure to the microbial pesticide is likely to occur, but the lack of 

acute oral toxicity, infectivity, and pathogenicity support the establishment of an exemption from 

the requirement of a tolerance for Trichoderma hamatum isolate 382. 

Dietary exposure to the microbial active ingredient is expected to be minimal. The label 

directions specify that product is to be mixed into potting soil or applied to soil and will not 

likely result in residues on crops.. Moreover, Trichoderma hamatum isolate 382 lives in soils and 

is unlikely to live on the plants because any spores that do end up on the plant due to application 

would decrease over time due to weathering, desiccation, and ultraviolet radiation, which can kill 

even quiescent forms of the fungus. In the remote likelihood that the applied fungus grew on the 

edible portions of a treated crop, the results of the oral toxicity testing demonstrated that no 

toxicity or pathogenicity in treated animals occurred, even when dosed with the fungus at high 

levels by the oral route of exposure. 

Drinking Water Risk Characterization: Drinking water exposure is expected to be negligible 

because the microbial fungicide will not be applied to water. Further, Trichoderma hamatum 

isolate 382 is a soil microorganism and would not proliferate in aquatic environments. Moreover, 

the Agency believes that Trichoderma hamatum isolate 382 within the soil will not likely 

percolate into water due both to the large size of the fungal spores and the fact that they adhere 

to soil particles. Even in the unlikely event that dietary exposure occurs through drinking water, 

the Agency concludes that there is a reasonable certainty that no harm will result because of the 

lack of acute oral toxicity/pathogenicity to mammals. 

Nonoccupational, Residential Risk Characterization: Trichoderma hamatum isolate 382 is a 

naturally occurring microorganism and is ubiquitous in the environment. Trichoderma hamatum 

isolate 382 will be applied to soiless potting media, compost and/or soil primarily in greenhouses 

and nurseries. Although some applications to soilless potting media, compost and/or soil may be 

in residential areas, non-dietary exposure would be expected to be below the Agency’s level of 

concern because of its low toxicity classification, and because the lab results indicate

Trichoderma hamatum isolate 382 is not pathogenic to mammals. 

b. Cumulative Effects from Substances with a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, 

or revoke a tolerance, the Agency consider “available information concerning the cumulative 

effects of [a particular pesticide’s] residues and other substances that have a common mechanism 

of toxicity.” 

The Agency has not found Trichoderma hamatum isolate 382 to share a common mechanism of 
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Biopesticides Registration Action Document 

toxicity with any other substances, and Trichoderma hamatum isolate 382 does not appear to 

produce a toxic metabolite as its mode of action against the target pest. For the purposes of this 

tolerance exemption action, therefore, the Agency has assumed that Trichoderma hamatum 

isolate 382 does not have a common mechanism of toxicity with other substances. For 

information regarding the Agency’s efforts to determine which chemicals have a common 

mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the 

Agency’s website at http://www.epa.gov/pesticides/cumulative. 

c. Determination of Safety for the U.S. Population, Infants, and Children 

FFDCA section 408(b)(2)(C) provides that the Agency shall assess the available information 

about consumption patterns among infants and children, special susceptibility of infants and 

children to pesticide chemical residues, and the cumulative effects on infants and children of the 

residues and other substances with a common mechanism of toxicity. In addition, FFDCA 

section 408(b)(2)(C) provides that the Agency shall apply an additional tenfold margin of safety 

for infants and children in the case of threshold effects to account for prenatal and postnatal 

toxicity and the completeness of the database unless the Agency determines that a different 

margin of safety will be safe for infants and children. Margins of exposure (safety), which are 

often referred to as uncertainty factors, are incorporated into Agency risk assessments either 

directly or through the use of a margin of exposure analysis, or by using uncertainty (safety) 

factors in calculating a dose level that poses no appreciable risk. 

Based on the acute toxicity and pathogenicity data summarized in Table 3 of Appendix, the 

Agency concludes that there is a reasonable certainty that no harm will result to the United 

States population, including infants and children, from aggregate exposure to the residues of 

Trichoderma hamatum isolate 382. This includes all anticipated dietary exposures and all other 

exposures for which there is reliable information. The Agency has arrived at this conclusion 

because the data available on Trichoderma hamatum isolate 382 do not demonstrate toxic, 

pathogenic, or infective potential to mammals. Thus, there are no threshold effects of concern 

and, as a result, the provision requiring an additional margin of safety does not apply. 

3. Occupational Exposure and Risk Characterization 

In light of the Tier I acute toxicity/pathogenicity studies, which did not show any toxicity or 

pathogenicity via the oral, pulmonary, or intraperitoneal injection routes of exposure, handler 

exposure to Trichoderma hamatum isolate 382 is not expected to pose any undue risk. 

Regardless, appropriate personal protective equipment and precautionary statements are required 

to be on the product label to mitigate any potential risks to pesticide handlers due to prolonged 

exposure. Handlers working with Trichoderma hamatum isolate 382 must wear a long-sleeved 

shirt, long pants, socks, shoes, waterproof gloves, and a dust/mist filtering respirator meeting 

National Institute for Occupational Safety and Health (NIOSH) standards of at least N-95, R-95, 

or P-95 when mixing, loading, or applying the product. 

C. Environmental Assessment (40 CFR § 158.2150) 

1. Nontarget Organism Toxicology 
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All nontarget toxicology data requirements for Trichoderma hamatum isolate 382 have been 

satisfied. Acceptable Tier I nontarget toxicology data/information support the registration of 

Trichoderma hamatum strain 382. Refer to Table 4 in Appendix A for a brief summary of these 

data requirements. Additionally, the comprehensive Agency risk assessment that evaluates these 

data is available as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP2010-0489 at http://www.regulations.gov (U.S. EPA 2010a). 

2. Environmental Fate and Ground Water Data 

As the information provided is sufficient to both satisfy the Tier I nontarget organism data 

requirements and for nontarget organism risk assessment for Trichoderma hamatum isolate 382, 

further testing at higher tier levels (i.e., Tiers II, III, and IV) is not required. 

3. Ecological Exposure and Risk Characterization

The Agency has performed an environmental risk assessment based on the literature citations 

and studies provided by the registrant and has determined that the proposed uses of Trichoderma 

hamatum isolate 382 do not pose a hazard to wildlife. Trichoderma hamatum isolate 382 is a 

naturally occurring strain of Trichoderma hamatum. This and other Trichoderma species are 

ubiquitous and occur widely in soils, including agricultural soils in concentrations ranging up 

to106 colony-forming units per gram (cfu/g) of dry soil. The concentrated technical product 

contains at least 1 x 107 cfu/g. Trichoderma hamatum isolate 382 and is intended for application 

to soilless potting media, compost and soil primarily in nurseries and greenhouses, for the 

production of ornamentals and vegetable plants. Due to the nature of the application method, 

exposure to terrestrial nontarget organisms is expected to be low. The use of Trichoderma 

hamatum isolate 382 as proposed is not expected to significantly increase the amount of 

Trichoderma hamatum or other Trichoderma species beyond levels that are already present in 

container media or in soils. Post application should not produce effects not already seen from the 

natural Trichoderma species concentration fluctuations. 

The applicant has submitted data waiver rationales to satisfy data requirements for nontarget 

organism risk assessment with the technical grade of the active ingredient (TGAI). Submitted 

data, data waiver rationales, and a search by the Agency of several literature databases provides 

sufficient information to determine that toxicity/pathogenicity to wild mammals, avian wildlife, 

freshwater and marine/estuarine vertebrates and invertebrates, honey bees, nontarget insects, and 

terrestrial and aquatic plants is not expected from the proposed label uses. As a result, a “No 

Effect” determination is also made for direct and indirect effects to listed species and their 

designated critical habitats resulting from the registered uses of Trichoderma hamatum isolate 

382, as labeled. 

 

The information provided is sufficient to both satisfy the Tier I nontarget organism data 

requirements and for nontarget organism risk assessment for the active ingredient. Further 

testing of nontarget organisms at higher tier levels is not required. 

4. Threatened and Endangered Species Assessment 

Since the Agency has determined that no effects are anticipated for any nontarget species 

exposed to Trichoderma hamatum isolate 382 as a result of the proposed labeled applications, 

effects to threatened and endangered species and their designated critical habitats are also not 
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expected. Therefore, a “No Effect” determination is made for direct and indirect effects to listed 

species and their designated critical habitats resulting from the registered uses of Trichoderma 

hamatum isolate 382, as labeled. 

V. ENVIRONMENTAL JUSTICE 

The Agency 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. To help address potential environmental justice issues, the Agency seeks information on 

any groups or segments of the population who, as a result their location, cultural practices, or 

other factors, may have atypical, unusually high exposure to Trichoderma hamatum isolate 382, 

compared to the general population. Please comment if you are aware of any subpopulations that 

may have atypical, unusually high exposure compared to the general population. 

For additional information regarding environmental justice issues, please visit the Agency’s web 

site at http://www.epa.gov/compliance/environmentaljustice/index.html. 

VI. RISK MANAGEMENT DECISION 

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient 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 Eligibility Determination for Pesticidal Active Ingredients are satisfied 

by the science assessments supporting the product containing Trichoderma hamatum isolate 382. 

This product is not expected to cause unreasonable adverse effects and is likely to provide 

protection as claimed when used according to label instructions. Therefore, the Agency believes 

that Trichoderma hamatum isolate 382 is eligible for registration for the labeled uses. 

VII. TERMS AND CONDITIONS OF THE REGISTRATION(S)

There are no terms and/or conditions associated with this registration. 

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 

BRAD Biopesticides Registration Action Document 

CFR Code of Federal Regulations 
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cfu colony-forming units 

cfu/g colony-forming units per gram 

°C degrees Celsius 

EDSP Endocrine Disruptor Screening Program 

EP end-use product 

EPA Environmental Protection Agency (the “Agency”) 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act 

FR Federal Register 

g/mL grams per milliliter 

IR-4 Interregional Research Project Number 4 

LLC limited liability company 

MRID No. Master Record Identification Number 

NIOSH National Institute for Occupational Safety and Health 

OCSPP Office of Chemical Safety and Pollution Prevention 

OPP Office of Pesticide Programs 

PP Pesticide Petition 

TGAI technical grade of the active ingredient 

IX. BIBLIOGRAPHY 

A. Studies Submitted to Support the Trichoderma hamatum isolate 382 Pesticide Product 

 Registration 
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43543801 Hoitink, H.; Stoneman, W.; Bowman, L.; et al. (1995) Trichoderma hamatum 

isolate 382--Product Identity and Disclosure of Ingredients, Manufacturing 

Process, and Discussion on the Formation of Unintentional Ingredients: Lab 

Project Number: 49B. Unpublished study prepared by Ohio State University, 

CHR. Hansen's Biosystems, and Earthgro. 55 pages. 

43543802 Stoneman, W.; Bowman, L.; Feldman, K. (1995) Trichoderma hamatum isolate 

382--Analysis of Samples, Certification of Ingredient Limits, Analytical Method 

for Certified Limits, and Physical and Chemical Properties: Lab Project Number: 

49B. Unpublished study prepared by CHR. Hansen's Biosystems and Earthgro. 

22 pages. 

43543803 Hoitink, H.; Hartman, C.; Biehn, W. (1995) Trichoderma hamatum isolate 382 

Safety Data in Support of Petition for Proposing a Temporary Exemption from the 

Requirements of a Tolerance for Thichoderma hematum (sic) for Use in 

Vegetable Bedding Plant Production: Lab Project Number: 49B. Unpublished 

study prepared by Ohio State University and IR-4. 157 pages. 

43543804 Hoitink, H. (1995) Trichoderma hamatum isolate 382: Hypersensitivity Incidents 

with Microbial Pest Control Agents: Statement of Finding No Hypersensitivity: 

Lab Project Number: 49B. Unpublished study prepared by Ohio State University. 

4 pages. 

43543805 Hoitink, H. (1995) Trichoderma hamatum isolate 382: Plant Studies: Request for 

Waiver of the Requirements for Testing: Lab Project Number: 49B. Unpublished 

study prepared by Ohio State University. 72 pages. 

43543806 Hoitink, H.; Hartman, C.; Biehn, W. (1995) Trichoderma hamatum isolate 382: 

Product Performance Data: Lab Project Number: 49B. Unpublished study 

prepared by Ohio State University and IR-4. 59 pages. 

44420001 Cascino, J.; O'Leary, M. (1997) Trichoderma hamatum isolate 382-Product 

Identify (sic) and Disclosure of Ingredients, Manufacturing Process and 

Discussion on the Formation of Unintentional Ingredients: Amendment: Lab 

Project Number: 49B. Unpublished study prepared by Sylvan Bioproducts and 

Earthgro. 29 pages. 

44420002 Stoneman, W.; Bowman, L.; O'Leary, M. et al. (1997) Trichoderma hamatum

isolate 382-Analysis of Samples, Certification of Ingredient Limits, Analytical 

Methods for Certified Limits Physical and Chemical Properties, Analysis of 5 

Production Batches: Amendment: Lab Project Number: 49B. Unpublished study 

prepared by CHR. Hansen Biosystems, Earthgro Inc., and Sylvan Bioproducts. 

24 pages. 

44420003 Shelton, L. (1996) Acute Oral Toxicity/Pathogenicity Study in Rats: TH382: Lab 

Project Number: M96AW33.6G41: 18.6G41. Unpublished study prepared by 

Microbiological Associates, Inc. 88 pages. 
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44420004 Shelton, L. (1997) Acute Intraperitoneal Toxicity Study in Rats: FB299 and 

TH382: Lab Project Number: M96AW33.6P31: 18.6P31. Unpublished study 

prepared by Microbiological Associates, Inc. 65 pages. 

44420005 O'Leary, M. (1997) Trichoderma hamatum strain 299 (sic)-Statement of Finding 

of No Adverse Effects to Users/Workers: Lab Project Number: 49B. Unpublished 

study prepared by Earthgro. 4 pages. 

44422004 Shelton, L. (1997) Acute Intraperitoneal Toxicity Study in Rats: FB299 and 

TH382: Lab Project Number: M96AW33.6P31: 18.6P31. Unpublished study 

prepared by Microbiological Associates, Inc. 65 pages. 

45583601 Cascino, J.; O'Leary, M. (2001) Trichoderma hamatum isolate 382--Analysis of 

Samples, Certification of Ingredient Limits, Analytical Methods for Certified 

Limits, Physical and Chemical Properties, Analysis of 5 Production Batches: Lab 

Project Number: 49B. Unpublished study prepared by Sylvan Bioproducts. 52 

pages. 

45583602 Hoitink, H.; Biehn, W.; Hartman, C. (1995) Trichoderma hamatum isolate 382 

Safety Data in Support of Petition Proposing a Temporary Exemption from the 

Requirement of a Tolerance for Trichoderma hamatum for Use in Vegetable 

Bedding Plant Production: Lab Project Number: 49B. Unpublished study 

prepared by Ohio State University. 57 pages. 

45583603 Shelton, L. (1996) Acute Oral Toxicity/Pathogenicity Study in Rats: TH382: Lab 

Project Number: M96AW33.6G41. Unpublished study prepared by 

Microbiological Associates, Inc. 88 pages. 

45583604 Biehn, W. (2001) Trichoderma hamatum isolate 382 Hypersensitivity Incidents 

with Microbial Pest Control Agents: Statement of Finding of No Hypersensitivity: 

Lab Project Number: 49B. Unpublished study prepared by Ohio State University, 

OARDC. 4 pages. 

45583605 Hoitink, H. (2001) Nontarget Plant Studies--Pathogenicity and Phytotoxicity 

Testing of Trichoderma hamatum isolate 382 on Conifers (1998-2000): Lab 

Project Number: 49B. Unpublished study prepared by Ohio State University, 

OARDC. 22 pages. 

45583606 Hoitink, H. (2001) Nontarget Plant Studies--Pathogenicity and Phytotoxicity 

Testing of Trichoderma hamatum isolate 382 on Corn (1998-2000): Lab Project 

Number: 49B. Unpublished study prepared by Ohio State University, OARDC. 

19 pages. 

45583607 Hoitink, H.; Hartman, C.; Biehn, W. (1995) Trichoderma hamatum isolate 382 

Product Performance Data: Lab Project Number: 49B. Unpublished study 

prepared by Ohio State University, OARDC. 59 pages. 
Trichoderma hamatum isolate 382 Page 15 of 22

Biopesticides Registration Action Document 

46010601 Hoitink, H.; Cascino, J.; O'Leary, M. (2002) Trichoderma hamatum isolate 382 – 

Product Identity and Disclosure of Ingredients, Manufacturing Process and 

Discussion on the Formation of Unintentional Ingredients. Project Number: 49B, 

IR/4/PR/NO/49B. Unpublished study prepared by Ohio State University, Sylvan 

Bioproducts, and Sellew & Associates LLC. 276 pages. 

46010602 O'Leary, A. (2000) Acute Pulmonary Toxicity/Pathogenicity Study in Rats with 

Trichoderma hamatum, Strain TH 382. Project Number: 011695/1. Unpublished 

study prepared by Ricerca Biosciences, LLC. 30 pages. 

46999701 O'Leary, A. (2000) Acute Pulmonary Toxicity/Pathogenicity Study in Rats with 

Trichoderma hamatum, Strain TH382. Project Number: 011695-1. Unpublished 

study prepared by Ricerca, Inc. 29 pages. 

47005702 Braverman, M. (2004) Trichoderma hamatum isolate 382: Rationale for Waivers. 

Project Number: 49B. Unpublished study prepared by Interregional Research 

Project No. 4. 46 pages. 

47005703 Braverman, M. (2004) Trichoderma hamatum isolate 382 Safety Information 

Rationale for Waivers. Project Number: 49B. Unpublished study prepared by 

Interregional Research Project No. 4. 27 pages. 

47015501 Hoitink, H.; Cascino, J.; O'Leary, M. (2004) Trichoderma hamatum isolate 382 

Product Identity and Disclosure of Ingredients, Manufacturing Process and 

Discussion on the Formation of Unintentional Ingredients. Project Number: 49B, 

20765. Unpublished study prepared by Ohio State University, Sellew & 

Associates LLC, and Ohio State University. 251 pages. 

47068102 Braverman, M. (2007) Trichoderma hamatum isolate 382 - Rationale for 

Waivers-Non Target and Environmental Effects. Project Number: 49B. 

Unpublished study prepared by Interregional Research Project No. 4. 126 pages. 

47598902 Baysal-Gurel, F.; Hoitink, H; Miller, S. (2008) Storage/Stability Characteristics 

 for the Dry Product Formulation of Trichoderma hamatum 382. Unpublished 

 study prepared by Ohio State University. 82 pages. 

47598903 Stoneman, W. (2008) Five Batch Analysis/Chemistry for the Dry Product 

Formulation of Trichoderma hamatum 382. Unpublished study prepared by Ohio 

State University and Sylvan Biosciences. 78 pages. 

47598904 Braverman, M. (2008) Trichoderma hamatum isolate 3982 - Safety Information 

- Rationale for Waivers. Project Number: 49B. Unpublished study prepared by 

Interregional Research Project No. 4. 59 pages. 

47598905 Durando, J. (2008) Trichoderma hamatum (TH382) - Primary Skin Irritation in 

 Rabbits: Final Report. Project Number: 24091. Unpublished study prepared by 

 Product Safety Laboratories. 21 pages. 
Trichoderma hamatum isolate 382 Page 16 of 22

Biopesticides Registration Action Document 

47598906 Durando, J. (2008) Trichoderma hamatum (TH382) - Primary Eye Irritation in 

 Rabbits. Project Number: 24090. Unpublished study prepared by 

 Product Safety Laboratories. 24 pages. 

47598907 Gingras, B. (2008) Sensitivity of Detection of Trichoderma hamatum TH382 for 

 Toxicity/Pathogenicity Testing in Rats. Project Number: 2193/SN1. Unpublished 

 study prepared by IIT Research Institute. 41 pages. 

47598908 Gingras, B. (2008) Toxicity/Pathogenicity Testing of Trichoderma hamatum 

TH382 Following Acute Intraperitoneal Challenge in Rats. Project Number: 

2193/SN2. Unpublished study prepared by IIT Research Institute. 89 pages. 

 

47613701 Diehle, D. (2008) Manufacturing Protocol and Standard Operating Procedures for 

Trichoderma hamatum 382. Unpublished study prepared by Sylvan Bioproducts 

Inc. 25 pages. 

47747601 Braverman, M. (2009) Trichoderma hamatum isolate 382 Safety Information – 

Rationale for Waivers. Project Number: IR/4/PR/NO/49B. Unpublished study 

prepared by Interregional Research Project No. 4. 5 pages. 

47980202 Braverman, M. (2010) Trichoderma hamatum isolate 382 - Primary Skin 

Irritation in Rabbits. Amendment Number 1 to MRID 47598905. Project Number: 

0049B. Unpublished study prepared by Interregional Research Project No. 4. 4 

pages. 

47980203 Braverman, M. (2010) Trichoderma hamatum isolate 382 - Primary Eye Irritation 

in Rabbits: Amendment Number 1 to MRID 47598906. Project Number: 0049B. 

Unpublished study prepared by Interregional Research Project No. 4. 4 pages. 

48050501 Stoneman, W. (2010) Manufacturing Process, Certified Limits and Physical and 

Chemical Properties of the TGAI/EP of Trichoderma hamatum 382: Amendment 

Number One to MRID 47613701 and 47598903. Unpublished study prepared by 

Sylvan Bioproducts, Inc. 4 pages. 

B. Environmental Protection Agency Risk Assessment Memoranda 

U.S. EPA. 2009. Review of Product Chemistry, Manufacturing Process, and Acute Toxicity 

studies of the end use product (EP) Floraguard (EPA Reg. No. 74205-G) containing the 

active ingredient (AI) Trichoderma hamatum isolate 382 (0.9%). Memorandum from 

 I. Barsoum, Ph.D. and J. Kough, Ph.D. to A. Sibold dated December 14, 2009. 

U.S. EPA. 2010a. Environmental Risk Assessment of Trichoderma hamatum isolate 382 (PC 

119205) for Use in Plant Growing Media; Decision No. 376203, DP Barcode No. 

368013, MRIDs 477476-01, 470681-02, 455836-05, 455836-06. Memorandum from S. 

Borges and Z. Vaituzis, Ph.D. to A. Sibold dated January 5, 2010. 

U.S. EPA. 2010b. Review of the Registrant’s Response to the Deficiencies Found by the Agency 

in its Review of Product Chemistry, Manufacturing Process, and Acute Toxicity Studies 
Trichoderma hamatum isolate 382 Page 17 of 22

Biopesticides Registration Action Document 

of the Product Trichoderma hamatum isolate 382 (EPA Reg. No. 74205-G). 

Memorandum from I. Barsoum, Ph.D. and J. Kough, Ph.D. to A. Sibold dated April 27, 

2010. 

U.S. EPA. 2010c. Review of Information to Support a Food Tolerance Determination for 

Trichoderma hamatum isolate 382 (ATCC# 20765), the Active Ingredient in Floraguard 

Related to Tolerance Petition (7E7188). Memorandum from J. Kough, Ph.D. to A. Sibold 

dated May 18, 2010. 

C. Other References 

Brewer, D. and A. Taylor. 1981. Trichoderma hamatum isolated from pasture soil. 

Mycopathologia 76:167–173. 

Leandro, L. F. S., T. Guzman, L. M. Ferguson, G. E. Fernandez, and F. J. Louws. 2007. 

Population dynamics of Trichoderma in fumigated and compost-amended soil and on 

strawberry roots. Applied Soil Ecology 35:237–246. 

Liu, B., D. Glenn, and K. Buckley. 2008. Trichoderma communities in soils from organic, 

sustainable, and conventional farms, and their relation with Southern blight of tomato. 

Soil Biology and Biochemistry 40:1124–1136. 

Prinzinger, R., A. Pressmar, and E. Schleucher. 1991. Body temperature in birds. Comparative 

Biochemistry and Physiology 99A(4):499–506. 

Appendix A. Microbial Pesticides Data Requirements (40 CFR Part 158 - Subpart V) 
Trichoderma hamatum isolate 382 Page 18 of 22

Biopesticides Registration Action Document 

*NOTE: Master Record Identification Numbers listed in the following tables are representative 

 of supporting data for the original registration of the product containing Trichoderma hamatum

 isolate 382. 

TABLE 1. Product Analysis Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Trichoderma 

hamatum isolate 382, and Its Associated End-Use Product (EP) (40 CFR § 158.2120) 

OCSPP Results

Guideline 

Number 

Data Requirement 

TGAI EP 

MRID No. 

885.1100 Product Identity Not applicable Submitted data satisfy the 

requirement for product 

identity. This product 

contains 0.9% w/w 

Trichoderma hamatum 

isolate 382 (not less than 1 x 

107

 cfu/g). 

885.1200 Manufacturing Process 

885.1300 Discussion of Formation 

of Unintentional 

Ingredients 

Submitted data satisfy the requirements for manufacturing 

process and discussion of formation of unintentional 

ingredients. 

47015501 

47598902 

47598903 

47598904 

47613701 

45583601 

Not applicable Deposition of a Sample 

in a Nationally 

Recognized Culture 

Collection 

Trichoderma hamatum

isolate 382 is on deposit with 

the American Type Culture 

Collection in Manassas, 

Virginia under Accession 

Number 20765. 

Not applicable 

47015501 

47598902 

47598903 

47598904 

47613701 

45583601 

885.1400 Analysis of Samples Submitted data satisfy the requirement for analysis of 

samples. 

45583601 

47598903

885.1500 Certification of Limits Not applicable 

Limits listed on the 

confidential statement of 

formula are 

adequate/acceptable. 

45583601

Additional Studies

830.1800 Enforcement Analytical 

Method 

Not applicable Acceptable 45583601
Trichoderma hamatum isolate 382 Page 19 of 22

Biopesticides Registration Action Document 

TABLE 2. Physical and Chemical Characteristics for the End-Use Product (EP), Trichoderma hamatum isolate 382 

(40 CFR § 158.2120)

OCSPP 

Guideline 

Number 

Data Requirement Results 

MRID 

Number 

830.6302 Color Light brown 47598903 

830.6303 Physical State Solid, dry powder 47598903 

830.6304 Odor Soil like 47598903 

830.6313 Stability to Normal and 

Elevated 

Temperatures, Metals, 

and Metal Ions 

Not required for an EP Not 

applicable 

830.6317 Storage Stability After 128 days of storage at 4o and 25o C, the viability of 

Trichoderma hamatum isolate 382 was 1.3 x 108

 cfu/g in the 

EP. 

47598902 

830.6319 Miscibility Not required because Trichoderma hamatum isolate 382 is 

not an emulsifiable form of microbial pesticide (refer to test 

note #2 of 40 CFR § 158.2120(d)). 

47598903 

830.6320 Corrosion 

Characteristics 

The EP is not corrosive by composition or chemical structure. 47598903 

830.7000 pH 7.2 CSF 

830.7100 Viscosity Not required because Trichoderma hamatum isolate 382 is 

not a liquid form of microbial pesticide (refer to test note #4 

of 40 CFR § 158.2120(d)). 

47598903 

830.7300 Density 0.197 grams per milliliter (g/mL) CSF 

Additional Studies

830.6315 Flammability Not flammable 47598903 

830.6314 Oxidation/Reduction; 

Chemical Incompatibility 

The oxidation/reduction potential of the EP is not relevant 

based on the fact that this is a granular material and that the 

EP is not a product of formulation of the active ingredient 

with the inert ingredients. The material is relatively dry (10% 

moisture) and shipped in bags in which the organism is 

grown, and the material will be added to the potting media or 

its components directly. The EP is a lower moisture 

concentration than the media formulation 

48050501 

830.6316 Explodability Product is not potentially explosive. 47598903 

830.6321 Dielectric Breakdown 

Voltage 

Product is not intended for use around electrical equipment. 47598903 
Trichoderma hamatum isolate 382 Page 20 of 22

Biopesticides Registration Action Document 

TABLE 3. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Trichoderma 

hamatum isolate 382, and Its Associated End-Use Product (EP) (40 CFR § 158.2140)

OCSPP Guideline Results 

Number 

Data Requirement

TGAI EP 

MRID 

Number 

Tier I

885.3050 Acute Oral 

Toxicity/Pathogenicity 

Not toxic, infective, and/or 

pathogenic to rats when dosed 

at 3.9 x 108

 colony-forming 

units (cfu) per animal. 

Classification: Acceptable

Not applicable 45583603 

885.3150 Acute Pulmonary 

Toxicity/Pathogenicity 

Not toxic, infective, and/or 

pathogenic to rats when dosed 

at 1.3 x 107

 cfu per animal. 

Classification: Acceptable 

Not applicable 46999701 

46010602

885.3200 Acute Injection 

Toxicity/Pathogenicity 

Not toxic, infective, and/or 

pathogenic to rats when dosed 

at 4.0 x 107

 cfu per animal. 

Classification: Acceptable

Not applicable 47598908 

885.3400 Hypersensitivity 

Incidents 

No hypersensitivity incidents, including immediate-type or 

delayed-type reactions of humans and domestic animals 

occurring during the testing or production of the TGAI and EP, 

were observed by the applicant. Any future hypersensitivity 

incidents must be reported per OCSPP Guideline 885.3400. 

Not 

applicable 

885.3500 Cell Culture 

Not required because 

Trichoderma hamatum isolate 

382 is not a virus (refer to test 

note #4 of 40 CFR § 

158.2140(d)). 

Not applicable Not 

applicable 

870.1100 Acute Oral Toxicity 

870.1200 Acute Dermal Toxicity 

870.1300 Acute Inhalation Toxicity 

Not applicable

Waived based on (1) 

Trichoderma hamatum

isolate 382’s ubiquitous 

presence in the 

environment; (2) the 

absence of incidents of 

hypersensitivity, allergies, 

or other adverse effects, 

despite varying uses of 

Trichoderma hamatum

isolate 382 since 1986; and 

(3) all inert ingredients in 

the end-use product 

formulation being exempt 

from the requirement of a 

tolerance. 

Classification: Acceptable

47598904 

870.2400 Acute Eye Irritation Not applicable

Trichoderma hamatum

isolate 382 was mildly 

irritating to the eye based on 

the highest maximum mean 

total score of 7.3, recorded 

1 hour after test material 

instillation. 

Classification: Acceptable 

TOXICITY CATEGORY 

III

47598906 
Trichoderma hamatum isolate 382 Page 21 of 22

Biopesticides Registration Action Document 

TABLE 3. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Trichoderma 

hamatum isolate 382, and Its Associated End-Use Product (EP) (40 CFR § 158.2140)

OCSPP Guideline Results 

Number 

Data Requirement

TGAI EP 

MRID 

Number 

870.2500 Primary Dermal Irritation Not applicable

Trichoderma hamatum

isolate 382 was slightly 

irritating to the skin. The 

Primary Irritation Index was 

0.3. 

Classification: Acceptable 

TOXICITY CATEGORY 

IV 

47598905 

Tiers II and III

Not required for Trichoderma hamatum isolate 382 based on the lack of acute toxicity/pathogenicity in the Tier I studies.

Additional Studies

Not applicable Sensitivity of Detection 

Intraperitoneal 

pathogenicity/toxicity testing 

could be performed using 

potato dextrose agar as a nonselective recovery medium 

for rat tissue other than the 

stomach, cecum, and 

intestinal tract, while potato 

dextrose agar with gentamicin 

may be used as the 

enumeration medium for 

determination of the presence 

of Trichoderma hamatum

isolate 382 in the cecum. 

Classification: Acceptable 

 

Not applicable 47598907 
Trichoderma hamatum isolate 382 Page 22 of 22

Biopesticides Registration Action Document 

TABLE 4. Nontarget Organism Toxicity and Environmental Fate Data Requirements for the Technical Grade of the 

Active Ingredient (TGAI), Trichoderma hamatum isolate 382 (40 CFR § 158.2150)

OCSPP Guideline 

Number 

Data Requirement Results MRID 

Number 

885.4050 Avian Oral Toxicity 

885.4200 Freshwater Fish 

Toxicity/Pathogenicity 

885.4240 Freshwater Invertebrate 

Toxicity/Pathogenicity 

885.4280 Estuarine/Marine Fish and 

Invertebrate Testing 

885.4300 Nontarget Plant Testing 

885.4340 Nontarget Insect Testing 

885.4380 Honey Bee Testing 

Data waiver rationales provide sufficient 

information to determine that 

toxicity/pathogenicity to avian wildlife, wild 

mammals, freshwater and marine/estuarine fish 

and invertebrates, honey bees, nontarget insects, 

and nontarget plants is not expected as a result 

of the proposed label uses. 

Classification: Acceptable 

47068102 

885.4100 Avian Inhalation 

Toxicity/Pathogenicity 

Data waiver rationales were submitted. 

However, this information was not required as 

the nature of the microbial pesticide does not 

indicate potential pathogenicity to birds or 

relatedness to any known bird pathogens (refer 

to test note #3 of 40 CFR § 158.2150(e)). 

47747601 

885.4150 Wild Mammal 

Toxicity/Pathogenicity 

Tests required by 40 CFR § 158.2140 are 

adequate and appropriate for assessment of 

hazards to wild mammals (refer to test note #4 of 

40 CFR § 158.2150(e)). Testing indicates no 

adverse effects to laboratory rats at 3.9 x 108 cfu 

per animal when dosed orally. Data waiver 

rationales also support the conclusion that 

adverse effects to wild mammals are not 

expected as a result of the proposed label uses. 

Classification: Acceptable for wild mammal 

risk assessment 

45583603 

47068102 

Tiers II, III, and IV

Not required for Trichoderma hamatum isolate 382 based on the acceptability of the waiver rationales provided for Tier I.