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BIOPESTICIDE REGISTRATION ACTION DOCUMENT 

Ulocladium oudemansii (U3 strain)

PC Code: 102111

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Last updated- October 16, 2009
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TABLE OF CONTENTS

I. EXECUTIVE SUMMARY 

II. ACTIVE INGREDIENT OVERVIEW

III. REGULATORY BACKGROUND

IV. RISK ASSESSMENT

A. PRODUCT ANALYSIS ASSESSMENT

1. Product Chemistry and Composition

2. Analysis and Certification of Limits

3. Physical and Chemical Characteristics

B. HUMAN HEALTH ASSESSMENT

1. Toxicological Hazard Assessment

2. Dietary Exposure and Risk Characterization

3. Drinking Water Exposure and Risk Characterization

4. Acute and Chronic Dietary Exposure and Risks for Sensitive

 Subpopulations, Particularly Infants and Children

5. Occupational, Residential, School, and Daycare Exposure and Risk Characterization

6. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation

7. Cumulative Effects

8. Risk Characterization

C. ENVIRONMENTAL ASSESSMENT

1. Summary of Non-Target Organism Testing and Waiver Rationales

2. Environmental Effects Conclusions

 3. Threatened and Endangered Species Assessment

V. ENVIRONMENTAL JUSTICE

VI. RISK MANAGEMENT AND REGISTRATION DECISIONS

A. DETERMINATION OF ELIGIBILITY

B. REGULATORY DECISION

C. LABELING

VII. ACTIONS REQUIRED BY THE REGISTRANT

A. REPORTING OF ADVERSE EFFECTS AND HYPERSENSITIVITY INCIDENTS

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

IX. BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

A. STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

B. EPA RISK ASSESSMENT MEMORANDA

APPENDIX A-MICROBIAL PESTICIDE DATA REQUIREMENTS

APPENDIX B- MANUFACTURING-USE AND END-USE PRODUCTS
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BIOPESTICIDE REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch

Science Reviews

 Shannon Borges Environmental Effects

 Carl Etsitty Product Analysis, Human Health

 Joel Gagliardi, Ph.D. Product Analysis, Human Health

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

 Zigfridas Vaituzis, Ph.D. Environmental Effects

Regulations

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

 Denise Greenway Regulatory Action Leader
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I. EXECUTIVE SUMMARY

The active ingredient, Ulocladium oudemansii (U3 strain), is a naturally occurring soil fungus 

existing as a saprophyte of dead and decaying plant matter. As a biofungicide, it is intended to 

protect fruit and vegetable crops, and ornamental plants from plant pathogenic diseases by 

competing for the same ecological niches (senescent plant material) and nutrients. EPA has 

determined that Ulocladium oudemansii (U3 strain) presents no issues of toxicological, 

ecological, or environmental concern. Accordingly, EPA is granting a time-limited registration 

for Ulocladium oudemansii (U3 strain) under Section 3(c)(5) of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA). 

Adequate mammalian toxicology data and other information were submitted to support the 

registration of Ulocladium oudemansii (U3 strain). Acceptable acute toxicity guideline studies 

were submitted, and data waivers were granted by the Agency to fulfill the remaining Tier I 

acute toxicity data requirements, based on the lack of toxicity and/or pathogenicity of 

Ulocladium oudemansii (U3 strain), because the manufacturing-use product is equivalent to the 

technical grade of the active ingredient, and/or the low potential for worker exposure attributed 

to appropriate precautionary statements and requirements for personal protective equipment on 

the label.

Based on studies evaluated by the Agency, the active ingredient demonstrates very low toxicity

potential by neither damaging live plant tissue nor being able to grow on human serum or blood 

at 170, 250or 370C. Thus, the application of Ulocladium oudemansii (U3 strain) as a fungicide 

on food crops, and ornamental plants is not expected to cause harm to exposed populations.

The toxicological data demonstrate that Ulocladium oudemansii (U3 strain) is not toxic, infective 

or pathogenic to mammals. No acute, sub-chronic, chronic, immune, endocrine, or non-dietary

exposure issues indicating that fungicidal use of the active ingredient could be expected to cause 

no harm to infants, children, and the general U.S. population were identified. Because of the low 

toxicity profile, an exemption from the requirement of a tolerance is being established in 40 CFR 

180 under Section 408 of the Federal Food, Drug, and Cosmetics Act (FFDCA). 

Dietary exposure via drinking water is not expected to pose harm to populations because the 

biofungicide is not known to grow or thrive in aquatic environments and is not expected to 

survive municipal treatment of drinking water. Further, the intended uses of this microbial 

fungicide do not pose a dietary risk to the U.S. population in general, and to infants and children 

in particular. Even if humans were exposed to Ulocladium oudemansii (U3 strain) by this route, 

the results of acute oral toxicity testing suggest no adverse effect via drinking water.
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The potential for aggregate, non-occupational exposure from agricultural applications is unlikely, 

because use sites identified for the subject active ingredient are not expected to be in close 

proximity to residential areas.

Data waiver rationales were submitted in response to data requirements for avian, freshwater fish 

and invertebrate, insect, and honey bee non-target organism testing requirements. The 

information provided is sufficient to satisfy the Tier I non-target organism data requirements for 

the technical product and proposed end-use products containing Ulocladium oudemansii (U3 

strain) as an active ingredient, and further testing of non-target organisms at higher tier 

levels is not required. Based on the rationales submitted, adverse effects to terrestrial animals 

and plants or freshwater and marine/estuarine fish, invertebrates, and plants are not expected as a 

result of exposure to fungicidal applications of Ulocladium oudemansii (U3 strain). 

Furthermore, BPPD made “No Effect” (NE) determinations for direct and indirect effects to 

listed threatened and endangered species and their habitat as a result of the proposed uses of 

Ulocladium oudemansii (U3 strain).

Fungicidal applications of Ulocladium oudemansii (U3 strain) will not pose unreasonable 

adverse risks to non-target organisms, including endangered species or to the environment. The 

Agency does not require labeling, or data for endangered species, for the proposed fungicidal 

uses of Ulocladium oudemansii (U3 strain).

The Biopesticides and Pollution Prevention Division (BPPD) reviewed data requirements for 

granting registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide 

Act (FIFRA). It was determined that the data/information submitted fulfilled current guideline 

requirements (refer to 40 CFR Subpart V § 158.2100).

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate on major registration decisions before they occur. According to this new 

policy, EPA 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 use, first 

outdoor use, and first residential use. 

Notwithstanding that the current action on Ulocladium oudemansii (U3 strain) qualifies as a 

“new active ingredient” under the new policy, EPA believes that it is in the best interests of the 

public and the environment to issue the registration for Ulocladium oudemansii (U3 strain) 

without delay. As discussed above, acute toxicity data for Ulocladium oudemansii (U3 strain) 

demonstrate that it is either toxicity category IV or III. Ulocladium oudemansii (U3 strain) does 

not demonstrate subchronic or developmental toxicity, and it is not mutagenic or genotoxic. 

EPA has no concerns for any non-target organisms exposed to Ulocladium oudemansii (U3 

strain) in accordance with approved label directions. EPA has not identified any toxic endpoints

for non-target mammals, birds, plants, aquatic, or soil organisms. Nor or there concerns for any 

threatened and endangered species. Thus, given that Ulocladium oudemansii (U3 strain) has 

very low toxicity and presents little if any risk to non-target organisms, EPA concludes that it is 
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in the best interests of the public and the environment to issue the registration for Ulocladium 

oudemansii (U3 strain) without delay. Consistent with the Agency’s new policy for making 

these registration actions more transparent, however, EPA is issuing this registration with an 

initial period of one-year and, concurrent with its issuance, providing a 30-day public comment 

period on both the time-limited registration and the final rule establishing a tolerance exemption 

for Ulocladium oudemansii (U3 strain). EPA is registering this product as a time-limited 

registration, with the understanding that public comments could bring to light new information or 

concerns that could inform EPA’s initial decision. Any subsequent action taken by EPA will be 

made in the context of information received during the public comment period. 

All data requirements are fulfilled and EPA has determined that a time-limited, 12-month 

unconditional registration for Ulocladium oudemansii (U3 strain) is warranted under Section 

3(c)(5) of FIFRA. If the Agency receives comments during the 30 day public comment period 

that inform EPA’s initial decision, EPA will address such new information and take appropriate 

action. 
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II. ACTIVE INGREDIENT OVERVIEW

 Biological Name: Ulocladium oudemansii (U3 strain)

Patent Number: http://www.patentstorm.us/patents/7407794/description.html

Culture Deposit: Held at National Measurement Institute as NM 99/06216 in Australia

Trade/Other Names: BOTRY-Zen®

OPP Chemical Code: 102111

Type of Pesticide: Microbial Pesticide/Biofungicide

III. REGULATORY BACKGROUND

EPA published in the Federal Register (FR) on October 29, 2008 (73 FR 64325) a notice 

announcing that Botry-Zen, Ltd., 21 Willis St., PO Box 5664, Dunedin, New Zealand, submitted 

applications to register pesticide products (EPA File Symbols 75747-R and 75747-E) containing 

a new active ingredient not included in any currently registered products. No comments were 

received following the publication of this notice

A pesticide petition (7F7269) seeking an exemption from the requirement of a tolerance for 

residues of the biofungicide, Ulocladium oudemansii (U3 Strain),when applied or used preharvest only, in/on all food commodities was filed by Botry-Zen, Ltd., and published in the FR 

on November 14, 2008 (73 FR 67512). One comment from an anonymous correspondent was

received following this publication. A final rule establishing the exemption from tolerance was 

signed October 20, 2009, in which the commenter’s concerns were addressed. The exemption 

from the requirement of a tolerance is codified under 40 CFR part 180. 

Before issuing any tolerance exemption, the Agency examines the potential effects of the 

pesticide on humans and the environment. For this particular microbial pesticide, EPA 

conducted a comprehensive assessment of Ulocladium oudemansii (U3 Strain), including a 

review of the acceptable studies and other supporting information addressing the potential effects 

of this pesticide. EPA’s review of these data and information indicated that the active ingredient 

is not toxic to test animals when administered via the oral, dermal, or intraperitoneal routes of 

exposure and is unlikely under the conditions of use to be a human health hazard by the 

pulmonary route because the large aggregated fungal spore material is not respirable. Also, 

there was no evidence that the active ingredient is a mutagen. In addition, the active ingredient 

was not infective or pathogenic to test animals when administered via the oral, dermal or 

intravenous routes. Moreover, growth temperature analysis has shown that Ulocladium 
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oudemansii (U3 strain) does not grow above 30oC, making infection of humans and other 

mammals having normal body temperatures above

37 oC unlikely. No reports of hypersensitivity have been recorded in personnel working with this 

organism. Based on these data, the Agency has concluded that there is a reasonable certainty 

that no harm will result from dietary exposure to residues of Ulocladium oudemansii (U3 Strain), 

when applied/used pre-harvest only in or on all food commodities (excluding applications made 

post-harvest or to processed commodities). Thus, under the standard in FFDCA section 

408(c)(2), an exemption from the requirement of a tolerance is appropriate.

The US representative for Botry-Zen, Ltd. is Technology Sciences Group, Inc., 1101 17th Street, 

N.W., Suite 500, Washington, D.C., 20036-4704, US. 

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 biochemical and microbial pesticides, and updated the 

definitions for biochemical and microbial pesticides (72 FR 61002). The rule became effective 

on December 26, 2007. The data and information evaluated for this Biopesticides Registration 

Action Document (BRAD) were considered in light of these requirements.

The classifications that are found 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 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 Environmental Protection Agency

always provides an 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 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 ASESSMENT

1. Product Chemistry and Composition
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Ulocladium oudemansii is a common soil fungus, existing as a saprophyte of dead and decaying 

plant matter. Rapid growth on plant-based media occurs at 18-20oC, first appearing olive-green 

then darker to a velvety charcoal black. Ulocladium oudemansii (U3 strain) rapidly declines in 

viability at 30oC, and spores begin losing viability after 48 hours at 25oC. This strain is reported 

to not damage live plant tissues or grow on human serum or blood at 17, 25 or 37oC. 

Ulocladium oudemansii Technical (100% w/w Ulocladium oudemansii (U3 strain)) is a technical 

grade of the active ingredient/manufacturing product (TGAI/MP) to be used to manufacture enduse products intended to control plant pathogenic diseases, such as Botrytis cinerea and 

Sclerotinia sclerotiorum, by competing for the same ecological niches and nutrients on 

degrading plant debris.

Master seed stock is stored (in 15% glycerol/water at -70oC) and maintained at the HortResearch 

Labs in New Zealand and at a culture collection (National Measurement Institute, as NM 

99/06216) in Australia.

2. Analysis and Certification of Limits

The submitted data satisfied the requirement for Analysis and Certification of Limits. Five 

batches tested by cultural methods showed a 98% viability of Ulocladium oudemansii, (U3 

Strain) with no appreciable contaminants. The certified limits for the active and inert ingredients 

fall within the ranges specified by OPPTS Guideline 8850.1500.

3. Physical and Chemical Characteristics

The Agency has determined that the submitted data adequately describe the physical and 

chemical characteristics, and the scientifically justified data waiver rationales are acceptable for 

color, physical state, odor, stability to normal and elevated temperatures, metals, and metal ions, 

corrosion characteristics, pH, viscosity, and density/relative density/bulk density (specific 

gravity).

B. HUMAN HEALTH ASSESSMENT

1. Toxicological Hazard Assessment

Acute toxicology studies have shown that Ulocladium oudemansii (U3 Strain) is not toxic, 

pathogenic, infective, or irritating to mammals. The intended use is on agricultural crops, and 

Ulocladium oudemansii (U3 Strain) has limited survivability once its carrier nutrient source is 

exhausted. The results of the toxicity testing indicate there is no risk to human health or the 

environment, and there are no reports of ecological or human health hazards caused by 

Ulocladium oudemansii (U3 Strain). It does not produce any recognized toxins, enzymes, or 

virulence factors normally associated with mammalian invasiveness or toxicity. There is a 
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reasonable certainty of no harm to the general U.S. population, including infants and children, 

from exposure to this active ingredient from the proposed uses. 

For a comprehensive guideline-by-guideline summary of the toxicology data requirements 

described in sections IV(B)(1)(a) and IV(B)(1)(b), refer to Table 2 in Appendix A.

a. Acute Toxicity/Pathogenicity – Tier I (40 CFR § 158.2140)

Acute Oral Toxicity and Pathogenicity – Rat [OPPTS Guideline 885.3050; Master Record 

Identification (MRID) Number (No.) 472465-03]: Ulocladium oudemansii Technical (purity

5.7x109cfu/g) does not appear to be toxic, infective, and/or pathogenic in rats, at a dose of 1 x 

108 CFU/animal in 0.9% sterile injectable saline. This study was rated “ACCEPTABLE” and 

Ulocladium oudemansii (U3 Strain) was classified as TOXICITY CATEGORY IV.

Acute Dermal Toxicity and Pathogenicity – Rat (OPPTS Guideline 885.3100; MRID No. 

472465-04): Botry-Zen® does not appear to be toxic, infective, and/or pathogenic in rats, when 

treated at 1 x 108cfu/animal. There were no treatment related clinical signs, dermal irritation, 

necropsy findings, or changes in body weight. No test organism was recovered from blood, 

brain, kidney, liver, cervical lymph nodes, or spleen of any animal. This study was rated 

“ACCEPTABLE” and Ulocladium oudemansii (U3 Strain) was classified as TOXICITY 

CATEGORY III.

Acute Pulmonary Toxicity and Pathogenicity – Rat (OPPTS Guideline 885.3150; MRID No. 

472465-05): Test material was a coarse suspension of particles in a liquid vehicle. Due to the 

rapid sedimentation of these particles, the suspension was unsuitable for aerosolization as 

supplied and efforts were made to reduce the larger particles using a homogenizer, using 

polyethylene glycol (PEG 400) to give a better suspension, and forcing the formulation through a 

38 μm sieve to obtain particle size suitable for the purposes of an inhalation study. A 

representative portion of the sample was dried at 65°C for 2 days. The milled powder was 

passed through a Marple Cascade Impactor in order to investigate the relative proportion of 

material below 10 μm. The results of three runs showed that the percentages of material < 10 

μm were 5.06, 2.98, and 3.44 with a mean of 3.83. The sponsor had provided the following data: 

Ulocladium oudemansii: Mycelium 3-6 micron diameter; conidiophores up to 250 x 5-8 micron; 

conidia dimensions are 18-34 micron x 11-17 micron with 1-3 transverse and 1 or more 

longitudinal or oblique septa. For rats, it is generally considered that a mass median 

aerodynamic diameter (MMAD) between 1-4 μm is required to ensure deposition throughout the 

respiratory tract. For humans, data on deposition are not so clear and it is generally considered 

that particles with an MMAD > 10 μm have a low probability of being inhaled and deposited in 

pulmonary region. Particles deposited in the naso-pharnygeal region are removed by coughing, 

sneezing, or physical wiping from the nasal regions. Particles deposited in the tracheobronchial 

region are removed by the mucocillary escalator system. As for the particles swallowed, an oral 

study would determine the hazard represented by the material. BOTRY-Zen®
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is considered unlikely to represent a significant hazard to humans by the inhalation route due to 

the large particle sizes of the fungal spores.

 

CLASSIFICATION: This study does not satisfy the guideline requirement for an acute 

pulmonary toxicity and pathogenicity study (OPPTS 885.3150; PMRA DATA CODE M4.2.3 

OECD IIIM 7.1.3) in rat. The study sponsor has submitted a formal waiver request for acute 

pulmonary toxicity and pathogenicity study.

Acute Injection Toxicity and Pathogenicity – Rat (OPPTS Guideline 885.3200; MRID No. 

472465-02): Ulocladium oudemansii Technical did not appear to be toxic, infective, and/or 

pathogenic in rats, when dosed at >107cfu/animal. This study was rated “ACCEPTABLE”

Skin Sensitization (OPPTS Guideline 870.2600; MRID No. 472465-08) Based upon the 

submitted data, Ulocladium oudemansii Technical, purity not less than 2x108cfu/g and a 

minimum spore viability of 90% does not appear to be a dermal sensitizer. This study was 

classified as “ACCEPTABLE.”

Cell Culture (OPPTS Guideline 885.3500; MRID 472465-17): Cell culture testing is required if 

the active ingredient Ulocladium oudemansii (U3 Strain) is a naturally-occurring fungus. Cell 

culture testing is therefore not required. 

Acute Oral Toxicity (OPPTS Guideline 870.1100; MRID No. 472482-02): Waiver request 

rationales offered by the registrant for acute oral toxicity/pathogenicity, for Ulocladium 

oudemansii Technical, is as follows: 1) The submitted studies MRIDs 47246502 to 09 did not 

show any pathogenicity in animals dosed/treated by oral gavage, dermal application, pulmonary

instillation, or intravenous injection; 2) Based on the laboratory data and the ubiquitous nature 

of Ulocladium oudemansii, the end-use product BOTRY-Zen® is non-toxic and non-pathogenic. 

None of the inerts are known to cause any adverse effects or toxicity. This waiver request was 

rated “ACCEPTABLE” and Ulocladium oudemansii (U3 Strain) was classified as TOXICITY 

CATEGORY IV.

Acute Dermal Toxicity (OPPTS Guideline 870.1200; MRID No . 472482-02): Waiver request 

rationales offered by the registrant for acute dermal toxicity for Ulocladium oudemansii

Technical is as follows: 1) The submitted studies MRIDs 47246502 to 09 did not show any

pathogenicity in animals dosed/treated by oral gavage, dermal application, pulmonary

instillation, or intravenous injection; 2) Based on the laboratory data and the ubiquitous nature 

of Ulocladium oudemansii, the end-use product BOTRY-Zen® is non-toxic and nonpathogenic. None of the inerts are known to cause any adverse effects or toxicity. This waiver 

request was rated “ACCEPTABLE” and Ulocladium oudemansii (U3 Strain) was classified as 

TOXICITY CATEGORY IV.
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Acute Inhalation Toxicity (OPPTS Guideline 870.1300; MRID No. 472482-02): Waiver request 

rationales offered by the registrant for acute inhalation toxicity for Ulocladium oudemansii

Technical is as follows: 1) The submitted studies MRIDs 47246502 to 09 did not show any

pathogenicity in animals dosed/treated by oral gavage, dermal application, pulmonary

instillation, or intravenous injection; 2) Based on the laboratory data and the ubiquitous nature 

of Ulocladium oudemansii, the end-use product BOTRY-Zen® is non-toxic and non-pathogenic. 

None of the inerts are known to cause any adverse effects or toxicity. This waiver request was 

rated “ACCEPTABLE” and Ulocladium oudemansii (U3 Strain) was classified as TOXICITY 

CATEGORY IV.

Acute Eye Irritation (OPPTS Guideline 870.2400; MRID No. 472482-02): Waiver request 

rationales offered by the registrant for acute eye irritation for Ulocladium oudemansii Technical 

is as follows: 1) The submitted studies MRIDs 47246502 to 09 did not show any pathogenicity 

in animals dosed/treated by oral gavage, dermal application, pulmonary instillation, or 

intravenous injection; 2) Based on the laboratory data and the ubiquitous nature of Ulocladium 

oudemansii, the end-use product BOTRY-Zen® is non-toxic and non-pathogenic. None of the 

inerts are known to cause any adverse effects or toxicity. This waiver request was rated 

“ACCEPTABLE” and Ulocladium oudemansii (U3 Strain) was classified as TOXICITY 

CATEGORY IV.

Primary Dermal Irritation (OPPTS Guideline 870.2500; MRID No. 472482-02): Waiver request 

rationales offered by the registrant for primary dermal irritation for Ulocladium oudemansii

Technical is as follows: 1) The submitted studies MRIDs 47246502 to 09 did not show any

pathogenicity in animals dosed/treated by oral gavage, dermal application, pulmonary

instillation, or intravenous injection; 2) Based on the laboratory data and the ubiquitous nature 

of Ulocladium oudemansii, the end-use product BOTRY-Zen® is non-toxic and nonpathogenic. None of the inerts are known to cause any adverse effects or toxicity. This waiver 

request was rated “ACCEPTABLE” and Ulocladium oudemansii (U3 Strain) was classified as 

TOXICITY CATEGORY IV.

b. Acute Toxicology and Subchronic Toxicity/Pathogenicity – Tier II; 

Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

Infectivity/Pathogenicity Analysis – Tier III (40 CFR § 158.2140)

Tier II and Tier III studies were not required for Ulocladium oudemansii (U3 Strain) based on 

the lack of acute toxicity/pathogenicity in the Tier I studies.

c. Effects on the Endocrine System

Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to develop 

a screening program to determine whether certain substances (including all pesticide active and 

other ingredients) “may have an effect in humans that is similar to an effect produced by a 

naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.” 
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Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory

Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of 

its program, androgen and thyroid hormone systems, in addition to the estrogen hormone system. 

The Environmental Protection Agency also adopted EDSTAC’s recommendation that the 

Program include evaluations of potential effects on wildlife.

Ulocladium oudemansii is a ubiquitous organism in the environment. The subject of this 

tolerance exemption, Ulocladium oudemansii (U3 Strain), is non-toxic to mammals. To date, 

there is no evidence to suggest that Ulocladium oudemansii (U3 Strain) affects the immune 

system, functions in a manner similar to any known hormone, or that it acts as an endocrine 

disruptor. Indeed, the submitted toxicity/pathogenicity studies in rodents indicate that, following 

several routes of exposure, the immune system is intact and able to process and clear the active 

ingredient. Therefore, it is unlikely that this organism will have estrogenic or endocrine effects.

2. Dietary Exposure and Risk Characterization

Ulocladium oudemansii, a common soil fungus, is ubiquitous in the environment and exists 

worldwide as a naturally occurring saprophyte, i.e., an organism that lives and feeds on dead and 

decaying plant matter. The subject of this tolerance exemption, Ulocladium oudemansii (U3

strain), was originally isolated from kiwifruit leaf litter. Spores of Ulocladium oudemansii (U3

strain), when deposited under the suitable environmental conditions on dead or decaying plant 

debris, will germinate and colonize the necrotic plant tissue. But if such decayed vegetative 

matter is not available, or becomes exhausted, the fungus cannot survive. Therefore, despite its 

presence in soils, dietary exposure from the proposed use of Ulocladium oudemansii (U3 strain) 

will be minimal on food due to its limited viability in the absence of a decayed plant material 

nutrient source. Also, there are no known mycotoxins associated with Ulocladium species, and 

the submitted toxicological studies indicate no risk to human health from dietary exposure to 

Ulocladium oudemansii (U3 strain). Furthermore, the fungus produces no recognized toxins, 

enzymes or virulence factors normally associated with mammalian invasiveness or toxicity. 

Additionally, growth temperature analysis has shown that Ulocladium oudemansii (U3 strain) 

does not grow above 30oC, making infection of humans and other mammals having normal body 

temperatures above 37 oC unlikely

Ulocladium oudemansii (U3 Strain) applied to food crops to control plant pathogens will not 

survive except on dead or decaying plant tissues. Food crops exhibiting such tissues are of poor 

quality, are not commonly consumed, and are not commercially marketed. Good quality food 

free of such decayed material will not support the fungus and so Ulocladium oudemansii (U3 

Strain) residues would not be expected. Due to the limited survivability of Ulocladium 

oudemansii (U3 Strain) once its decayed plant material nutrient source is exhausted, dietary

exposure to the naturally-occurring microbe from the proposed pre-harvest applications to food 

crops is unlikely. Even if oral exposure from ingestion of poor-quality treated crops should 

occur, the hazard posed to adults, infants and children from food-related exposures to

Ulocladium oudemansii (U3 Strain) will be minimal due to the demonstrated lack of acute oral 
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toxicity/pathogenicity associated with the microbial pesticide. Based on the evaluation of the 

submitted data, there are no dietary risks that exceed the Agency’s level of concern.

3. Drinking Water Exposure Risk Characterization

Exposure of humans to residues of Ulocladium oudemansii (U3 Strain) in consumed drinking 

water would be unlikely. Ulocladium oudemansii (U3 Strain) is not known to grow or thrive in 

aquatic environments. Potential exposure via surface water would be negligible and exposure via 

drinking water would be impossible to measure. Ulocladium oudemansii (U3 Strain) is intended 

for use on agricultural and horticultural crops, and has limited survival potential once its carrier 

nutrient source is exhausted. The risk of the microorganism passing through soil to groundwater 

is minimal to unlikely. Additionally, the fungus would not tolerate municipal drinking water 

treatment processes, such as chlorination, pH adjustment, high temperature and/or anaerobic 

conditions. More importantly, even if oral exposure to this ubiquitous microbe should occur 

through drinking water, due to its demonstrated lack of acute oral toxicity/pathogenicity, the 

Agency concludes that there is a reasonable certainty that no harm will result from such 

exposure.

4. Acute and Chronic Dietary Exposure and Risks for Sensitive Subpopulations,

Particularly Infants and Children

Based on the toxicity information discussed above, EPA 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 residues of Ulocladium oudemansii (U3 Strain). 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 Ulocladium oudemansii (U3 

Strain) demonstrate a lack of toxicity/pathogenicity potential. Ulocladium oudemansii (U3 

Strain) is not known to produce any recognized toxins, virulence factors or enzymes normally 

associated with mammalian invasiveness or toxicity. 

5. Occupational, Residential, School and Day Care Exposure and Risk 

Characterization

Due to its use as an agricultural product, outdoors and in greenhouses, significant additional 

human exposure to Ulocladium oudemansii (U3 Strain) is not expected in occupational, 

residential, school, or daycare areas.

a. Occupational Exposure and Risk Characterization

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

pathogenic effects to rats via oral, pulmonary, dermal, and intravenous routes of exposure (see 

section IV(B)(1)(a)), handler exposure to Ulocladium oudemansii (U3 Strain) is not expected to 

pose any undue risk. Regardless, requirements for the use of appropriate personal protective 
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equipment, and precautionary statements are required on the product label to mitigate any

potential risks to pesticide handlers due to prolonged exposure. Handlers working with 

Ulocladium oudemansii (U3 Strain) in manufacturing facilities must wear a long-sleeved shirt, 

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

standards of at least N-95, R-95, or P-95. 

b. Residential, School, and Daycare Exposure and Risk Characterization

According to the label, Ulocladium oudemansii (U3 Strain) is only to be used for agricultural 

areas, greenhouses and horticultural nurseries. No indoor residential, school, or daycare uses 

currently appear on the label; thus, human exposure to Ulocladium oudemansii (U3 Strain)

should not occur in these areas. 

6. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and 

Inhalation

Due to the inability of Ulocladium oudemansii (U3 Strain) to survive once its carrier nutrient 

source is exhausted, and the low to negligible toxicity and infectivity potential, non-occupational 

exposure through these uses is not likely to cause harm to the exposed population.

7. Cumulative Effects

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

modify, or revoke a tolerance, to consider “available information” concerning the cumulative 

effects of pesticide residues and “other substances that have a common mechanism of toxicity.” 

These considerations include the cumulative effects of such residues on infants and children. 

Because, there is no indication of mammalian toxicity from Ulocladium oudemansii (U3 Strain), 

the Agency concludes that Ulocladium oudemansii (U3 Strain) does not share a common 

mechanism of toxicity with other substances. Therefore, section 408(b)(2)(D)(v) does not apply.

8. Risk Characterization

The Agency considered human exposure to Ulocladium oudemansii (U3 Strain) in light of the 

standard for registration in FIFRA, as amended by the Food Quality Protection Act (FQPA) of 

1996. A determination has been made that no unreasonable adverse effects to the United States 

population in general, and to infants and children in particular, will result from Ulocladium 

oudemansii (U3 Strain), when used in accordance with the Agency’s accepted labeling.
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C. ENVIRONMENTAL ASSESSMENT

1. Summary of Non-target Organism Testing and Waiver Rationales

a. Avian Oral Toxicity/Pathogenicity (OPPTS Guideline 885.4050); Avian 

Inhalation Toxicity/Pathogenicity (OPPTS Guideline 885.4100)

Requests for waivers for these tests with avian species are based on the rationale that Ulocladium 

oudemansii is ubiquitous as a naturally occurring saprophyte found in soils worldwide, has a 

mode of action that are not consistent with those causing toxic or pathogenic effects in animals, 

and there is no literature documenting reports of animal pathogenicity or toxicity as a result of 

exposure to Ulocladium oudemansii (U3 Strain) (based on a search in the AGRICOLA, 

TOXLINE and NLM PubMed databases). Ulocladium spp. are typically associated with 

decaying plant material, and some are also associated with soil (Bokhary et al. 1995), and 

mycotoxins associated with this genus have not been found (Andersson et al. 1978, Nielsen et al. 

1999). The mode of action exhibited by Ulocladium oudemansii is antagonistic competition with 

plant pathogenic fungi for physical space, and thus it does not have a toxic mode of action (Kohl 

et al. 1997). The rationale presented is acceptable and satisfies the data requirement. Based on 

this information, adverse effects to birds resulting from exposure to Ulocladium oudemansii (U3 

Strain) are not anticipated. 

b. Wild Mammal Toxicity/Pathogenicity (OPPTS 885.4150)

Similar rationale as presented above for birds is given in the waiver request for the wild mammal 

toxicity/pathogenicity data requirement. In addition to that rationale, Ulocladium oudemansii

(U3 Strain) does not grow at normal mammalian body temperatures. Growth temperature range 

data for Ulocladium oudemansii (U3 Strain) shows that this strain does not grow at temperatures 

above 30°C and does not show mycelial growth of germ tube formation in human blood serum at 

25°C or 37°C. The rationale presented is acceptable and satisfies the data requirement. Based on

this information, adverse effects to wild mammals resulting from exposure to Ulocladium 

oudemansii (U3 Strain) are not anticipated. 

c. Freshwater Fish Toxicity/Pathogenicity (OPPTS Guideline 885. 4200; MRID 

No. 472465-10

In a 30-day toxicity/pathogenicity study, juvenile rainbow trout (Oncorhynchus mykiss) received 

an aqueous exposure to nominal concentrations of 9.4, 19, 38, 75, and 150 mg Ulocladium 

oudemansii Technical/L (corresponding to 7.9 x 106, 1.6 x 107, 3.2 x 107, 6.3 x 

107, and 1.3 x 108cfu/L, respectively) under static-renewal conditions. Accurate confirmation of 

the test material concentrations was not possible due to its hydrophobic nature and tendency to 

adhere to the surfaces of the test containers. The nominal 
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concentrations represented 11x, 22x, 44x, 86x, and 177x the estimated environmental 

concentration (EEC), of U. oudemansii in water expected from application of the product at the 

labeled rate. A dilution water control and an attenuated control were also included. The fish also 

received a daily oral exposure to the test material via its inclusion in commercial fish feed at a 

nominal concentration of 300 mg/kg of food (equivalent to 345x the EEC in water). There was 

no statistically significant difference in the mortality of any of the groups in the test, and there 

were no other compound-related toxic or pathogenic effects observed in examinations of fish at 

test termination. The 30-day LC50 was empirically estimated to be greater than the highest 

nominal concentration tested (>1.3 x 108cfu/L, >177x EEC). This test concentration is below 

the maximum hazard dosage recommendations in the OPPTS guideline. However, the difficulty 

of meeting this requirement due to the nature of the fungus preparations in water is recognized,

and so the test concentrations are acceptable. Based on the results, this study indicates that 

adverse effects to freshwater fish are not expected as a result of exposure to Ulocladium 

oudemansii. This study was rated “ACCEPTABLE.”

d. Freshwater Invertebrate Toxicity/Pathogenicity (OPPTS Guideline 885.4240;

MRID No. 472465-11)

In a 21-day static-renewal chronic toxicity/pathogenicity study (MRID 47246511), Daphnia 

magna neonates received an aqueous exposure to nominal concentrations of 9.4, 19, 38, 75, and 

150 mg Ulocladium oudemansii Technical/L (corresponding to 7.9 x 106, 1.6 x 107, 3.2 x 107, 

6.3 x 107, and 1.3 x 108cfu/L, respectively). Accurate confirmation of the test material 

concentrations was not possible due to its hydrophobic nature and tendency to adhere to the 

surfaces of the test containers. The nominal concentrations represent 11x, 22x, 44x, 86x, and 

177x the EEC, which is 7.35 x 105cfu/L (2.9 mg/L) based on a product application rate of 4 

lbs/acre. An untreated control (dilution water only) and an attenuated control were also included. 

At the conclusion of the test, cumulative survival was 50%, 60%, 70%, 85%, and 75% in the 

11x, 22x, 44x, 86x, and 177x EEC test groups, respectively. Survival in the untreated control 

was 100%, while survival in the attenuated control was 70%. There were no statistically

significant differences (p≤0.05) in cumulative mortality among any of the control or test groups. 

Since a similar level of mortality was observed in the attenuated control (assumed to be 

sufficiently killed), mortality on the Daphnia was apparently the result of other effects related to 

the presence of the test material and could have resulted from complications of maintaining the 

test substance in suspension at high concentrations. Based on the results, the EC50 value was 

therefore empirically estimated to be >1.3 x 108, or >177x the EEC. This test concentration is 

below the maximum hazard dosages recommended by the OPPTS guideline. However, the 

difficulty of meeting this requirement due to the nature of the fungus preparations in water is 

recognized and so the test concentrations are acceptable. Based on the results, the study

indicates that adverse effects related to pathogenicity or 

toxicity of Ulocladium oudemansii in freshwater invertebrates are not anticipated. This study

was classified as “ACCEPTABLE.”
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e. Estuarine/Marine Fish Testing and Estuarine/Marine Invertebrate Testing 

(OPPTS Guideline 885.4280)

Similar rationale as presented above for birds is also given in the waiver request for the 

estuarine/marine fish and invertebrate testing data requirement. Documented cases of toxicity or 

pathogenicity to aquatic species were not found in the literature search in the AGRICOLA, 

TOXLINE, and NLM PubMed databases. Furthermore, the end use product is not intended for 

direct application to water, and Ulocladium oudemansii (U3 Strain) is not expected to enter 

estuarine or marine environments in significant concentrations. This rationale is acceptable and 

satisfies the data requirement. Based on the information provided, adverse effects to 

estuarine/marine fish and invertebrates resulting from exposure to Ulocladium oudemansii (U3 

Strain) are not anticipated. 

f. Non-Target Plant Testing (OPPTS Guideline 885.4300; MRID No. 472465-16)

The phytotoxic effect of Botry-Zen® on tomato, lettuce, cabbage, parsley, rose, rhododendron, 

azalea, and apple was studied at nominal concentrations of 1x, 2x, and 10x the normal 

commercial concentration of Botry-Zen®. The plants were observed for 21 days following 

application of the test material. A separate test was also performed in which the presence of 

Ulocladium oudemansii (U3 Strain) was examined in grapes following a spray program with a 

commercial batch of Botry-Zen®. No Ulocladium oudemansii (U3 strain) was detected on the 

grapes post-harvest, but other fungi (Penicillium, Aspergillus, Alternaria spp.) were detected. 

The study is deficient in that it does not include a positive control as required by the guideline for 

microbial pesticides that are closely related to plant pathogens (though one was included in the 

residue study with grapes), and the sample sizes were very small. There were no test materialrelated phytopathogenic effects seen in any of the plants in the test at the 10x concentration (2.7 

x 107cfu/mL). This study contains several deficiencies. Although the study was not performed 

according to the OPPTS Microbial Test Guidelines, it does demonstrate a lack of adverse effect 

of Ulocladium oudemansii (U3 strain) in plants. In addition, there are no published reports of 

Ulocladium oudemansii causing phytopathological effects. Therefore, adverse effects to nontarget terrestrial plants are not anticipated from the proposed uses of Botry-Zen®. This study

was classified as “SUPPLEMENTARY.”

g. Non-Target Insect Testing (OPPTS Guideline 885.4340) 

In a 27-day dietary toxicity/pathogenicity study, green lacewing (Chrysoperla rufilabris) larvae 

were exposed to Ulocladium oudemansii Technical at nominal doses of 95,000 ppm, 47,900 

ppm, or 19,200 ppm of the test material (equivalent to 5.4 x 107, 2.7 x 107and 1.1 x 107cfu/mL, 

respectively) in accordance with OPPTS 885.4340 (MRID 472465-12). Test subjects were 

exposed via Mediterranean meal moth (Ephestia kuehniella) eggs sprayed with the test material 

suspended in water. Accurate confirmation of the test material concentrations was not possible 

due to spore settling in the dose suspensions. The nominal concentrations represented 11.3x, 

5.5x, and 2.2x the highest EP label recommended 
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concentration (based on the maximum application rate of 4 lbs/acre, mixed in the lowest 

reasonable spray volume of 25 gallons of water per acre). The test also included an untreated 

control, an adjuvant control (Tween 80, 0.3% v/v in sterile water), and a reference control 

(Dimilin 2L, 96 fl oz/A). Pre-emergence mortality in the test group exposed to the highest 

concentration was significantly higher than in the untreated control group, but was comparable to 

that of the adjuvant control group. Emergence of fully-formed adults in the groups exposed to the 

highest and lowest concentrations was significantly reduced compared to the untreated control 

group, but was comparable to that of the adjuvant control group. The adjuvant apparently

contributed to the differences between the test material groups and the untreated control group 

seen in this study, which has been observed in other studies with nontarget insects (MRID 

472465-13, 472465-14, and 472465-15). Based on comparable pre-emergence mortality and 

overall survival in the test material and adjuvant control groups, the test material did not produce 

any adverse effects on the test organisms. Therefore, the LC50 for the test material is determined 

to be >95,000 ppm. Thus, adverse effects in green lacewing resulting from exposure to the tested 

levels of Ulocladium oudemansii (U3 strain) are not expected. This study was rated 

“ACCEPTABLE.”

In a 24-day dietary toxicity study, adult ladybird beetles (Hippodamia convergens; MRID 

472465-13) were exposed to Ulocladium oudemansii Technical via a cotton wick soaked with 

the test material at nominal concentrations of 95,000 ppm, 47,900 ppm, or 19,200 ppm 

(equivalent to 5.4 x 107, 2.7 x 107, and 1.1 x 107cfu/mL, respectively). The nominal 

concentrations were calculated to represent 11.3x, 5.5, and 2.2x the highest EP label application 

rate in the lowest reasonable spray volume (4 lbs EP in 25 gallons of water). Accurate 

confirmation of the test material concentrations was not possible due to spore settling in the dose 

suspensions. The test also included an untreated control (30% sucrose solution only), an adjuvant 

control (Tween 80, 0.3% v/v in sucrose solution), and a positive control (Dimethoate, 50 ppm). 

Percent mortality in the nominal high, middle, and low U. oudemansii test groups was 59.65%, 

64.25%, and 67.96%, respectively. Mortality in the untreated control was 22.16% and in the 

adjuvant control was 59.05%. Mortality in all the U. oudemansii treatments was significantly

higher than in the untreated control, but did not differ significantly from the adjuvant control, 

indicating that the adjuvant contributed to the increased mortality. This effect has also been 

observed in U. oudemansii studies with the honeybee (MRID 472465-15), green lacewing 

(MRID 472465-12), and a parasitic wasp (MRID 472465-14). No adverse effects were observed 

at the highest nominal concentration tested if compared to the adjuvant control, and it is 

concluded that the mortality resulted from the adjuvant. Therefore, the LC50 for the test material 

is determined to be >95,900 ppm. Thus, adverse effects in ladybird beetle resulting from dietary

exposure to the tested levels of Ulocladium oudemansii are not expected. This study was rated 

“ACCEPTABLE.”

In a nontarget insect dietary toxicity/pathogenicity test with the parasitic wasp (MRID 472465-

14), Ulocladium oudemansii technical was administered for five days via a cotton wick soaked 
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with the test material at nominal concentrations of 95,900 ppm, 47,900 ppm, and 19,200 ppm 

(equivalent to 5.4 x 107, 2.7 x 107, and 1.1 x 107cfu/mL, respectively). The 

nominal test concentrations represented, respectively, 11.3x, 5.5x, and 2.2x the pesticide 

concentration expected to result from the EP label application rate in the lowest reasonable spray

volume (4 lbs EP in 25 gallons of water). Mortality in the test groups did not differ significantly 

from the untreated control (70% honey/sterile water solution) The LC50 of Ulocladium 

oudemansii technical for parasitic wasp was empirically determined to be greater than the 

highest test concentration of 95,900 ppm (>11.3x the maximum application rate of Ulocladium 

oudemansii EP). The results of this study demonstrate that exposure of the parasitic wasp, 

Aphytis melinus, to U. oudemansii at the concentrations tested is not expected to result in adverse 

effects. This study was rated “ACCEPTABLE.”

h. Honey Bee Testing (OPPTS Guideline 885.4380; MRID No. 472465-15)

In a honey bee dietary toxicity/pathogenicity test, larvae were treated with Ulocladium

oudemansii (U3 strain) technical at two test concentrations. The “low” concentration 

represented 19,200 ppm or 2.2x the expected max spore concentration if the end use product 

(EP) is prepared according to the label directions (4 lbs EP in 25 gallons of water). The “high” 

concentration represented 95,900 ppm or 11.3x the maximum expected concentration. Both test 

substance concentrations were combined with Tween 80 in a 30% sucrose solution for dosing of 

larvae in brood frames. Control solutions administered to honey bee larvae were a positive 

control (potassium arsenate), negative control (30% sucrose only) and an adjuvant control 

(Tween 80, 0.3% v/v in 30% sucrose solution). Overall, survival in the Ulocladium oudemansii

treatments did not differ significantly from the adjuvant control (ANOVA, p<0.05). These 

treatments and the adjuvant control also differed significantly from the untreated control. Thus, 

mortality observed in the Ulocladium oudemansii technical treatments appears to be an adverse 

effect of the adjuvant (Tween 80) and not the Ulocladium oudemansii technical. This was also 

documented in other studies with U. oudemansii and nontarget insects, including green lacewing 

(MRID 472465-12), ladybird beetle (MRID 472465-13) and a parasitic wasp (MRID 472465-

14). Therefore, the LC50 is determined to be greater than the highest concentration of 95,900

ppm. The results indicate that exposure to Ulocladium oudemansii at the tested concentrations is 

not expected to result in adverse effects to honeybees. This study was rated “ACCEPTABLE.”

2. Environmental Effects Conclusions

a. Terrestrial Animals and Plants 

Data waiver rationale provides sufficient information to conclude that adverse effects are not 

expected in birds and mammals as a result of exposure to Ulocladium oudemansii. Ulocladium 

oudemansii is ubiquitous as a naturally-occurring saprophyte found in soils worldwide, does not 
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have a toxic mode of action, and there is no literature documenting reports of animal 

pathogenicity or toxicity as a result of exposure to Ulocladium oudemansii. 

Additionally, Ulocladium oudemansii does not grow at normal mammalian body temperatures. 

Studies were submitted with three nontarget insect species, including the green lacewing 

(Chrysoperla rufilabris), ladybird beetle (Hippodamia convergens) and a parasitic wasp (Aphytis 

melinus). The parasitic wasp was used in place of the big-eyed bug due to limitations of the 

testing facility chosen to conduct these studies (rationale for use of this species was acceptable to

BPPD). A honeybee (Apis mellifera) study was also submitted. The effects of dietary exposure 

to these four insect species was tested at nominal concentrations that were up to 11.3x the 

concentration of the EP expected if prepared according to labeled rates (i.e., 4 lbs EP in 25 

gallons of water). Adverse effects were not observed in these species, and therefore the results 

of the studies indicate that adverse effects to nontarget insects and honey bees as a result of 

exposure to Ulocladium oudemansii are not anticipated.

A study with terrestrial nontarget plants (tomato, lettuce, cabbage, parsley, rose, rhododendron, 

azalea, and apple -scientific names not provided) demonstrated no adverse effects for 21 days 

following an application of the EP. An additional study on grapes demonstrated no post-harvest 

residues of Ulocladium spp. on grapes following a spray program of the EP. This study is 

classified as supplemental, but does provide data that demonstrate a lack of effects in nontarget 

plants. Ulocladium oudemansii is related to species that are known plant pathogens, but no 

reports of pathogenicity of Ulocladium oudemansii are documented. Therefore, based on this 

information adverse effects to terrestrial nontarget plants are not expected from applications of 

the EP.

b. Aquatic Animals and Plants 

Studies with a freshwater fish species (rainbow trout [Oncorhynchus mykiss]) and a freshwater 

invertebrate (Daphnia magna) indicate no adverse effects in these animals at concentrations up 

to 177x the EEEC of the EP in water. Data waiver rationale was provided to satisfy data 

requirements and support effects conclusions for marine and estuarine nontarget animals. 

Ulocladium oudemansii is ubiquitous as a naturally-occurring saprophyte found in soils 

worldwide, does not have a toxic mode of action, and there is no literature 

documenting reports of pathogenicity or toxicity to aquatic animals as a result of exposure to 

Ulocladium oudemansii. Based on the studies and rationale submitted, adverse effects to 

freshwater and marine/estuarine fish and invertebrates are not expected as a result of exposure to 

Ulocladium oudemansii. Furthermore, exposure in these environments is not expected to be 

significant, and the product is not intended for direct application to water. For this reason, 

aquatic plant testing is not necessary.
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Based on the data and waiver rationale submitted, adverse effects to terrestrial and aquatic 

nontarget organisms are not anticipated as a result of the application of Ulocladium oudemansii

as intended on the proposed EP label.

c. Threatened and Endangered Species Assessment

As discussed above, Ulocladium oudemansii presents no toxicological concerns to any living 

organisms. Ulocladium oudemansii only survives and thrives on dead and decaying plant matter. 

Given EPA’s determation that no effects are anticipated for any non-target species exposed to 

Ulocladium oudemansii (U3 strain) as a result of labeled applications, effects to listed species are 

also not expected. Therefore, a “No Effect” determination is made for direct and indirect effects 

to listed species resulting from the proposed use of Ulocladium oudemansii (U3 strain), as 

labeled. 

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, in 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 of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to Ulocladium oudemansii (U3 strain), compared to the 

general population. Please comment if you are aware of any sub-populations that may have 

atypical, unusually high exposure compared to the general population.

For a comprehensive guideline-by-guideline summary of the non-target toxicity data 

requirements, refer to Table 3 in Appendix A.

VI. RISK MANAGEMENT AND REGISTRATION DECISIONS

A. Determination of Eligibility

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 Eligibility Determination for Pesticidal Active Ingredients are satisfied by 

the science assessments supporting products containing Ulocladium oedemansii (U3 Strain). 
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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, Ulocladium 

oedemansii (U3 Strain) is eligible for registration for the labeled uses.

B. Regulatory Decision

As set forth above, EPA has determined that Ulocladium oedemansii (U3 Strain) presents no 

issues of toxicological, ecological, or environmental concern. Accordingly, EPA is granting a 

time-limited registration for Ulocladium oedemansii (U3 Strain) under Section 3(c)(5) of 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 

on major registration decisions before they occur. According to this new policy, EPA 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 use; first outdoor use; and first 

residential use. 

Notwithstanding that the current action on Ulocladium oedemansii (U3 Strain) qualifies as a 

“new active ingredient” under the new policy, EPA believes that it is in the best interests of the 

public and the environment to issue the registration for Ulocladium oedemansii (U3 Strain) 

without delay. As discussed above, acute toxicity data for Ulocladium oedemansii (U3 Strain) 

demonstrate that it is either toxicity category IV or III. Ulocladium oedemansii (U3 Strain) does 

not demonstrate subchronic or developmental toxicity, and it is not mutagenic or genotoxic. 

EPA has no concerns for any non-target organisms exposed to Ulocladium oedemansii (U3 

Strain) in accordance with approved label directions. EPA has not identified any toxic endpoints 

for non-target mammals, birds, plants, aquatic, or soil organisms. Nor or there concerns for any 

threatened and endangered species. Thus, given that Ulocladium oedemansii (U3 Strain) has 

very low toxicity and presents little if any risk to non-target organisms, EPA concludes that it is 

in the best interests of the public and the environment to issue the registration for Ulocladium 

oedemansii (U3 Strain) without delay. Consistent with the Agency’s new policy for making 

these registration actions more transparent, however, EPA is issuing this registration with an 

initial period of one-year and, concurrent with its issuance, providing a 30-day public comment 

period on both the time-limited registration and the final rule establishing a tolerance exemption 

for Ulocladium oedemansii (U3 Strain). EPA is registering this product as a time-limited 

registration, with the understanding that public comments could bring to light new information or 

concerns that could inform EPA’s initial decision. Any subsequent action taken by EPA, will be 

made in the context of information received during the public comment period. 

The data submitted fulfill the requirements of registration of Ulocladium oedemansii (U3 Strain) 

for pre-harvest use as a biofungicide in on food commodities and ornamental plants. Refer to 

Appendix B for product-specific information. 

1. Conditional/Unconditional Registration
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All data requirements are fulfilled and EPA has determined that a time-limited, 12-month 

unconditional registration for Ulocladium oedemansii (U3 Strain) is warranted under Section 

3(c)(5) of FIFRA. If the Agency receives comments during the 30 day public comment period 

that inform EPA’s initial decision, EPA will address such new information and take appropriate 

action. 

C. Labeling

Before releasing pesticide products containing Ulocladium oedemansii (U3 Strain) for shipment, 

the applicant is required to provide appropriate labels.

VII. ACTIONS REQUIRED BY THE REGISTRANT

The Agency evaluated the data submitted in connection with the initial registration of 

Ulocladium oedemansii (U3 Strain) and determined that these data fulfill current registration 

guideline requirements. No additional data are required to be submitted to the Agency at this 

time. Additional data may be required for new uses and/or changes to existing uses. 

Not withstanding the information stated in the previous paragraph, it should be clearly

understood that certain, specific, data are required to be reported to the Agency as a requirement 

for maintaining the Federal registration for a pesticide product. A brief summary of these types 

of data are listed below. 

A. Reporting of Adverse Effects and Hypersensitivity Incidents

Reports of all incidents of adverse effects to the environment must be submitted to the Agency

under the provisions stated in FIFRA, Section 6(a)(2).

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the Agency under the provisions of 40 CFR Part 158.2140 OPPTS Guideline 

reference number 885.3400.
Ulocladium oudemansii (U3 strain) Page 25 

Biopesticide Registration Action Document

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

CFR Code of Federal Regulations

cm3cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

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 gram

kg kilogram

L liter

LD50 median lethal dose. A statistically derived 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).

MRID No. Master Record Identification Number

mg milligram

mL milliliter

MP manufacturing-use product

MPCA microbial pest control agent

NE “No Effect”

NIOSH National Institute for Occupational Safety and Health

OPP Office of Pesticide Programs

OPPTS Office of Prevention, Pesticides, and Toxic Substances

PCR polymerase chain reaction 

PPE personal protective equipment

TGAI technical grade of the active ingredient
Ulocladium oudemansii (U3 strain) Page 26 

Biopesticide Registration Action Document

IX. BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION

A. Studies Submitted in Support of this Registration.

47246500

Botry-Zen Limited (2007) Submission of Product Chemistry and Toxicity Data in 

Support of the Application for Registration of Ulocladium oudemansii Technical and 

the Petition for Tolerance of Ulocladium oudemansii in/on All Agricultural 

Commodities. Transmittal of 17 Studies.

28-

Sep2007

47246501

Roberts, A. (2007) Product Chemistry for Ulocladium oudemansii Technical. Project 

Number: VP/BOT/001, VP/BOT/002, BZWG2. Unpublished study prepared by 

Technology Science Group, Inc. 145 p.

28-

Sep2007

47246502

Crutchfield, V. (2007) Ulocladium oudemansii Technical: Acute IP Injection 

Toxicity/Pathogenicity Study in Rats with Microbial Pest Control Agents (MPCA): 

Final Report. Project Number: 10073/06. Unpublished study prepared by 

Stillmeadow, Inc. 35 p.

28-

Sep2007

47246503

Dreher, D. (2002) Acute Oral Toxicity / Infectivity Study in the Rat (Ulocladium 

oudemansii Technical). Project Number: 1638/001. Unpublished study prepared by 

Safepharm Laboratories, Ltd. 30 p.

28-

Sep2007

47246504

Dreher, D. (2002) Acute Dermal Toxicity / Infectivity Study in the Rat (Ulocladium 

oudemansii Technical). Project Number: 1638/002. Unpublished study prepared by 

Safepharm Laboratories, Ltd. 31 p.

28-

Sep2007

47246505

Wesson, C. (2002) Acute Inhalation (Nose Only) Toxicity / Infectivity Study in the Rat 

(Ulocladium oudemansii Technical). Project Number: 1638/003. Unpublished study 

prepared by Safepharm Laboratories, Ltd. 17 p.

28-

Sep2007

47246506

Dreher, D. (2002) Acute Eye Irritation / Infectivity Study in the Rabbit (Ulocladium 

oudemansii Technical). Project Number: 1638/005. Unpublished study prepared by 

Safepharm Laboratories, Ltd. 23 p.

28-

Sep2007

47246507

Dreher, D. (2002) Acute Dermal Irritation Study in the Rabbit (Ulocladium oudemansii 

Technical). Project Number: 1638/004. Unpublished study prepared by Safepharm 

Laboratories, Ltd. 17 p.

28-

Sep2007

47246508

Dreher, D. (2002) Skin Sensitisation in the Guinea Pig - Magnusson and Kligman 

Maximisation Method (Ulocladium oudemansii Technical). Project Number: 

1638/008. Unpublished study prepared by Safepharm Laboratories, Ltd. 28 p.

28-

Sep2007

47246509

Thompson, P. (2002) Reverse Mutation Assay "Ames Test" Using Salmonella 

typhimurium (Ulocladium oudemansii Technical). Project Number: 1638/007. 

Unpublished study prepared by Safepharm Laboratories, Ltd. 25 p.

28-

Sep2007

47246510

Putt, A. (2007) Ulocladium oudemansii Technical - Toxicity, Infectivity and 

Pathogenicity to Rainbow Trout (Oncorhynchus mykiss) During a 30-Day StaticRenewal Test. Project Number: 13881/6100, 020606/OPPTS/RBT/STR/MCPA. 

Unpublished study prepared by Springborn Smithers Laboratories. 53 p.

28-

Sep2007

47246511 Putt, A. (2007) Ulocladium oudemansii Technical - Toxicity, Infectivity and 28-
Ulocladium oudemansii (U3 strain) Page 27 

Biopesticide Registration Action Document

Pathogenicity to Daphnids (Daphnia magna) During a 21-Day Static-Renewal Test. 

Project Number: 13881/6101, 020606/OPPTS/DAPHNID/STR/MPCA. Unpublished 

study prepared by Springborn Smithers Laboratories. 48 p.

Sep2007

47246512

Richards, K. (2007) Ulocladium oudemansii Technical: A Dietary Study with Green 

Lacewing Larvae (Chrysoperla rufilabris). Project Number: CAR/106/06, 10428/06. 

Unpublished study prepared by California Agricultural Research Inc. and 

Stillmeadow, Inc. 76 p.

28-

Sep2007

47246513

Richards, K. (2007) Ulocladium oudemansii Technical: A Dietary Toxicity Study with 

the Ladybird Beetle (Hippodamia convergens). Project Number: CAR/105/06, 

10410/06. Unpublished study prepared by California Agricultural Research Inc. and 

Stillmeadow, Inc. 58 p.

28-

Sep2007

47246514

Richards, K. (2007) Ulocladium oudemansii Technical: A Dietary Study with Parasitic 

Wasp (Aphytis melinus). Project Number: CAR/107/06, 10431/06. Unpublished study 

prepared by California Agricultural Research Inc. and Stillmeadow, Inc. 96 p.

28-

Sep2007

47246515

Richards, K. (2007) Evaluation of the Dietary Effect(s) of Ulocladium oudemansii 

Technical on Larval Honeybee Development. Project Number: CAR/111/06, 

10141/06. Unpublished study prepared by California Agricultural Research Inc. and 

Stillmeadow, Inc. 54 p.

28-

Sep2007

47246516

Burgess, I. (2001) Non-Target Plant Testing with Ulocladium oudemansii (U3 Strain). 

Project Number: VP/BOT/005, VP/BOT/006. Unpublished study prepared by BotryZen Limited. 18 p.

28-

Sep2007

47246517

Mileson, B. (2007) Response to Tier 1 Microbial Pesticide Data Requirements for 

Ulocladium oudemansii Technical. Unpublished study prepared by Technology 

Sciences Group. 47 p.

28-

Sep2007

47340701 Roberts, A. (2008) Supplemental Product Chemistry for Ulocladium oudemansii 

Technical. Unpublished study prepared by Technology Sciences Group, Inc. 14 p.

06-

Feb2008

47445501

Roberts, A. (2008) Supplemental Product Chemistry for Ulocladium oudemansii 

Technical. Project Number: SOP/BQA/001/1. Unpublished study prepared by 

Technology Sciences Group, Inc. 12 p.

13-

Jun2008

47638901

Mileson, B. (2008) Supplemental Product Chemistry for Ulocladium oudemansii 

Technical - Product Identity. Unpublished study prepared by Technology Sciences 

Group, Inc. 39 p.

08-

Jan2009

47638902

Roberts, A. (2009) Supplemental Product Chemistry for Ulocladium oudemansii 

Technical and BOTRY-Zen - Analysis of Samples and Manufacturing Process 

Description. Unpublished study prepared by Technology Sciences Group, Inc. 24 p.

08-

Jan2009

47639301 Roberts, A. (2008) Supplemental Product Chemistry for Ulocladium Oudemansii 

Technical. Unpublished study prepared by Botry-Zen Limited. 12 p.

22-

Sep2008

B. EPA Risk Assessment Memoranda
Ulocladium oudemansii (U3 strain) Page 28 

Biopesticide Registration Action Document

Borges, S. Amended: September 25, 2008 Environmental Risk Assessment of Ulocladium 

oudemansii (U3 Strain). Undated memorandum received via an email dated October 2, 2008.

Etsitty, C. and J. Gagliardi. BPPD Review of Pathogenicity and Toxicity Data Submitted by

BOTRY-ZEN Limited, for Registration of BOTRY-Zen® Containing Ulocladium oudemansii

(U3 Strain). Memorandum dated December 9, 2008.

Gagliardi, J. Review of Product Characterization Data for a Technical and an End-use Product; 

BOTRY-Zen® Containing Ulocladium oudemansii (U3 Strain). Memorandum dated January

27, 2009.

APPENDIX A – MICROBIAL PESTICIDE DATA REQUIREMENTS

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

 Manufacturing-Use Product (MP), Ulocladium oudemansii (U3 Strain) (40 CFR § 158.2120)

Data Requirement

(OPPTS Guideline)

Results MRID 

TGAI MP Number

Product Chemistry and Composition

Product Identity

(885.1100)

Ulocladium oudemansii, a soil saprophytic fungus, 

grows rapidly at 18-20oC first appearing olive-green 

then darker to a velvety charcoal black. The 

registrant has described characteristics on several 

different media and incubation conditions, some 

listed in Table 1, useful in characterizing the a.i. 

Spore production is high on oatmeal agar. 

“Conidiophores are abundant, erect or ascending, 

simple or branched, golden brown, smooth, septate, 

bearing solitary conidia at 1-5 uniportate 

geniculations. Conidia are initially narrowly 

obovoid, hyaline, smooth, becoming yellowish 

brown, and inconspicuously roughened; finally 

broadly obovoid or ellipsoidal, dark olivaceouscharcoal 21.6-30.8 by 10.8-16.9 microns with 3-5 

transverse and one or two longitudinal or oblique 

septa, base broadly conical to rounded, apex broadly 

rounded and often more conspicuously varicose 

(warted) than remainder of conidium. Conidia 

germinate readily on moist substrates producing one 

or more rapidly growing hyphae per conidium.”

473407-01

Manufacturing Process 

(885.1200)

Submitted data satisfy the requirements of manufacturing process 

for the TGAI/MP for the purposes of a conditional, time-limited 

FIFRA section 3(c)(7)(C) registration only. 

Deposition of a Sample in a 

Nationally Recognized 

Culture Collection

Ulocladium oudemansii is 

stored in 15% glycerol/water at 

-700C at the HortReseach Labs 

Not applicable Not applicable
Ulocladium oudemansii (U3 strain) Page 29 

Biopesticide Registration Action Document

Data Requirement

(OPPTS Guideline)

Results MRID 

TGAI MP Number

(Not applicable) in New Zealand and at the 

National Measurement Institute 

as NM 99/06216 in Australia

Discussion of Formation of 

Unintentional Ingredients 

(885.1300)

Submitted data satisfy the requirements of discussion of formation 

of unintentional ingredients for the TGAI/MP.

Classification: Acceptable

476389-01

476389-02

Analysis and Certified Limits

Analysis of Samples 

(885.1400)

Submitted data satisfy the requirements of manufacturing process 

for the TGAI/MP for the purposes of a conditional, time-limited 

FIFRA section 3(c)(7)(C) registration only.

Classification: Acceptable

476389-01

476389-02

Certification of Limits 

(885.1500)

Not applicable The certified limits for the active

and inert ingredients fall within

the OPPTS Guideline 830.1750

specified ranges.

Classification: Acceptable

Physical and Chemical Characteristics

Color

(830.6302)

Black Not applicable 472465-01

Physical State

(830.6303)

Solid Not applicable 472465

Odor

(830.6304)

Not stated Not applicable 472465

Stability to Normal and 

Elevated Temperatures, 

Metals, and Metal Ions 

(830.6313)

Used immediately to make EP 

in an integrated process

Not applicable 472465

Storage Stability

(830.6317)

Not required for TGAI [OPPTS 830.1000 (e)(2)]

Miscibility

(830.6319)

Not required for TGAI [OPPTS 

830.1000 (e)(2)]

Not applicable 472465

Corrosion Characteristics

(830.6320)

Not required for TGAI [OPPTS 

830.1000 (e)(2)]

Not applicable 472465

pH

(830.7000)

6.6 Not applicable 472465

Viscosity

(830.7100)

Not applicable, product is not a 

liquid [40 CFR 158.190 (b)(8)]

Not applicable 472465

Density/Relative Density/Bulk 

Density (Specific Gravity)

(830.7300)

0.7g/mL Not applicable 472465

TABLE 2. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/

 Manufacturing-Use Product (MP), Ulocladium oudemansii (U3 Strain) (40 CFR § 158.2140)
Ulocladium oudemansii (U3 strain) Page 30 

Biopesticide Registration Action Document

Data Requirement

(OPPTS Guideline)

Results MRID 

TGAI MP Number

Tier I

Acute Oral 

Toxicity/Pathogenicity

(885.3050)

Technical (purity 5.7x109cfu/g) 

does not appear to be toxic, 

infective, and/or pathogenic in 

rats, at a dose of 1 x 108

CFU/animal in 0.9% sterile 

injectable saline.

Classification: Acceptable

TOXICITY CATEGORY IV

Not applicable 472465-03

Acute Dermal 

Toxicity/Pathogenicity

(885.3100)

Botry-Zen® does not appear to 

be toxic, infective, and/or 

pathogenic in rats, when treated 

at 1 x 108cfu/animal.

Classification: Acceptable

TOXICITY CATEGORY III

Not applicable 472465-04

Acute Pulmonary 

Toxicity/Pathogenicity

(885.3150)

Waived based on the results of 

MRID Number 472482-02

Not applicable 472482-02

Acute Injection 

Toxicity/Pathogenicity

(885.3200)

Technical did not appear to be 

toxic, infective, and/or 

pathogenic in rats, when dosed 

at >107cfu/animal.

Classification: Acceptable

Not applicable 472465-02

Skin Sensitization

(870.2600)

Based upon the submitted data, Ulocladium oudemansii Technical, 

purity not less than 2x108cfu/g and a minimum spore viability of 

90% does not appear to be a dermal sensitizer. Any 

hypersensitivity incidents must be reported per OPPTS Guideline 

885.3400. 

Cell Culture

(885.3500)

Not required because 

Ulocladium oudemansii (U3 

Strain) is not a virus (refer to test 

note #4 of 40 CFR § 

158.2140(d)).

Not applicable 472465-17

Acute Oral Toxicity

(870.1100)

Not applicable Waived based on the results of 

MRID Number 472465-03 and 

because the MP is equivalent 

to the TGAI.

Classification: Acceptable

TOXICITY CATEGORY 

IV

472482-02

Acute Dermal Toxicity

(870.1200)

Not applicable Waived based on the results of

MRID Number 472465-04 and

because the MP is equivalent 

to the TGAI.

Classification: Acceptable

TOXICITY CATEGORY 

IV

472482-02

Acute Inhalation Toxicity Not applicable Waived based on the results of 472482-02
Ulocladium oudemansii (U3 strain) Page 31 

Biopesticide Registration Action Document

Data Requirement

(OPPTS Guideline)

Results MRID 

TGAI MP Number

(870.1300) MRID Number 472482-02 and

because the MP is equivalent 

to the TGAI.

Classification: Acceptable

TOXICITY CATEGORY 

IV

Acute Eye Irritation

(870.2400)

When dosed with Ulocladium 

oudemansii Technical, purity not 

less than 2x108cfu/g and a 

minimum spore viability of 90%

at 0.1 mL/animal, Ulocladium 

oudemansii Technical is nonirritating.

Classification: Acceptable

TOXICITY CATEGORY IV

Not Applicable 472465-06

Primary Dermal Irritation

(870.2500)

When dosed with Ulocladium 

oudemansii Technical, purity not 

less than 2x108cfu/g and a 

minimum spore viability of 90%

at 0.5 mL/animal, Botry-Zen® is 

non-irritating.

Classification: Acceptable

TOXICITY CATEGORY IV

Not Applicable 472465-07

Tiers II and III

Not required for Ulocladium oudemansii (U3 Strain) based on the lack of acute toxicity/pathogenicity in the Tier I 

studies.

 

TABLE 3. Non-Target Organisms and Environmental Fate Data Requirements for the Technical Grade of the 

 Active Ingredient (TGAI), Ulocladium oudemansii (U3 Strain) (40 CFR § 158.2150)

Data Requirement

(OPPTS Guideline)

Results MRID Number

Tier I

Avian Oral Toxicity

(885.4050)

Data waiver rationale provides sufficient 

information to satisfy this data requirement.

Classification: Acceptable

472465-17

Avian Inhalation 

Toxicity/Pathogenicity

(885.4100)

Data waiver rationale provides sufficient 

information to satisfy this data requirement.

Classification: Acceptable

472465-17

Wild Mammal 

Toxicity/Pathogenicity

(885.4150)

Data waiver rationale provides sufficient 

information to satisfy this data requirement.

Classification: Acceptable

472465-17

Freshwater Fish 

Toxicity/Pathogenicity

(885.4200)

Based on a 30-day toxicity study of rainbow

trout, receiving an aqueous exposure up to 1.3 

x 108cfu/L, it was determined that adverse 

effects to freshwater fish are not expected. 

Classification: Acceptable

472465-10

Freshwater Invertebrate Based on a 21-day static renewal chronic 472465-11
Ulocladium oudemansii (U3 strain) Page 32 

Biopesticide Registration Action Document

Data Requirement

(OPPTS Guideline)

Results MRID Number

Toxicity/Pathogenicity

(885.4240)

toxicity/pathogenicity study, receiving an 

aqueous exposure up to 1.3 x 108cfu/L, 

adverse effects in freshwater invertebrates are 

not anticipated. 

Classification: Acceptable

Estuarine/Marine Fish Testing

Estuarine and Marine 

Invertebrate Testing

(885.4280)

Data waiver rationale provides sufficient 

information to satisfy this data requirement.

Classification: Acceptable

472465-17

Non-Target Plant Testing

(885.4300)

Various vegetables were treated with 

concentrations 10x stronger than the end 

product. This test had several deficiencies, 

but due to no published reports of 

phytopthological effects no adverse effects to 

nontarget terrestrial plants are anticipated. 

Classification: Supplementary

472465-16

Non-Target Insect Testing

(885.4340)

A 27-day dietary toxicity/pathogenicity study 

exposed Green lacewings, ladybird beetles, 

and parasitic wasps to concentrations of 1.1 x 

107cfu/mL, determined that adverse effects 

are not expected

Classification: Acceptable

472465-12

472465-13

472465-14

Honey Bee Testing

(885.4380)

Honey bees larvae were treated with doses 

2.2x the expected maximum concentration of 

the end use product. The test indicated that 

no adverse effects is expected in honey bees.

Classification: Acceptable

472465-15

APPENDIX B – Ulocladium oudemansii (U3 Strain) MANUFACTURING-USE AND ENDUSE PRODUCTS

EPA 

Registration 

Number

Registration 

Name

Percentage 

Active 

Ingredient

Formulation 

Type

Use Site Method 

of 

Applicat

ion

Application 

Rate

Target Pests

75747-R Ulocladium 

oudemansii

(U3 Strain)

100.0% Technical N/A N/A N/A N/A

75747-E Ulocladium 

oudemansii

45.0% End Use 

Product

Agricultural, 

Horticultural

Spray 4 pounds/acre Botrytis cinerea and 

Sclerotinia sclerotiorum
Ulocladium oudemansii (U3 strain) Page 33 

Biopesticide Registration Action Document

(U3 Strain)