# - 1 -

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

L ast updated - October 16, 2009Ulocladium oudemansii (U3 strain) Page 2

Biopesticide Registration Action Document
TABLE OF CONTENTS I. EXECUTIVE SUMMARY II. ACTIVE INGREDIENT OVERVIEW III
. REGULATORY BACKGROUND IV
. RISK ASSESSMENT A. PRODUCT ANALYSIS ASSESSMENT 1. Pro duct Chemistry and Composition 2. Analysis and Certification of Limits 3. Physical and Chemical Characteristics B. HUMAN HEALTH ASSESSMENT 1. Toxicolog ical Hazard Assessment 2. Dietary Exposure and Risk Characterization 3. Drinking Water Exposure and Risk Characterization 4. Ac ute 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. Threaten ed and Endangered Species Assessment V. ENVIRONMENTAL JUSTICE VI
. RISK MANAGEMENT AND REGISTRATION DECISIONS A. D ETERMINATION OF ELIGIBILITY B. REGULATORY DECISION C. LABELING VII
. ACTIONS REQUIRED BY THE REGISTRANT A. REPORTING OF ADVERSE EFFECTS AND H YPERSENSITIVITY INCIDENTS VII I. GLOSSARY OF ACRONYMS AND ABBREVIATIONS I X. BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION A. STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION B. EPA RISK ASSESSMENT MEMORAND A APPENDIX A
- MICRO BIAL PESTICIDE DATA REQUIREMENTS APPENDIX B
- MANUFACTURING
- USE AND END
- USE PRODUCTSUlocladium oudemansii (U3 strain) Page 3

Biopesticide Registration Action Document

BIOPESTICIDE REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch Science Review s Shannon Borges Environmental Effects Carl Etsitty

Product Anal ys is, Human Health Joel Ga g liardi, Ph.D. Product Anal ys is , Human Health John L . Kough, Ph.D. Product Anal ys is, Human Health Zi gfridas Vaituzis, Ph.D. Environmental Effects Regulations Sheryl K. Reill y , Ph.D. Chief, Microbial Pesticides Branch Denise Gre e nway Regulatory Action LeaderUlocladium oudemansii (U3 strain) Page 4

Biopesticide Registration Action Document

I. EXECUTIVE SUMMARY The active ingredient, Ulocladium oudemansii ( U3 strain ) , is a naturall y occ urring soil fungus existing as a saproph yt e 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 b y competing for the same ecological niches (senesc ent 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 w ere submitted to support the registration of Ulocladium oudemansii (U3 strain) . Acceptable a cute toxicity guideline studies were submitted, and data waivers were granted b y 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. Ba sed 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 17 0 , 25 0 or 37 0 C
. Thus, the application of Ulocladium oudemansii (U3 strain) as a fungicide on f ood 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, s ub
- chronic, chronic, immune, endocrine, or non
- dietary exposure issues indicat ing that fungicida l 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 tox ic ity 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 be cause 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 su ggest no adverse effect via drinking water
.Ulocladium oudemansii (U3 strain) Page 5

Biopesticide Registration Action Document 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 requ irements 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 fo r the technical product and proposed end
- use products containing Ulocladium oudemansii (U3 strain) as an active ingredient, and f urther testing of non
- target organisms at higher tier levels is n ot 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 m ade “No Effect” (NE) determinations for direct and indirect ef fects 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 fung icid al 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 opportunit y 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 t ypes of applications: new active ingredients, first food use , first outdoor use , and first residential use. Notwithstanding that the current action on Ulocladi um 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 discus sed 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 genotox ic
. 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 an y 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 isUlocladium oudemansii (U3 strain) Page 6

Biopesticide Registration Action Document 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 p eriod of one
- ye ar 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 produc t 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 rec eives comments during the 30 day public comment period that inform EPA’s initial decision, EPA will address such new information and take appropriate action.Ulocladium oudemansii (U3 strain) Page 7

Biopesticide Registration Action Document
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 BA C KGROUND EPA published in the Federal Register (FR) on October 29 , 200 8 (73 FR 64325 ) a notice announcing that Botry
- Zen, Ltd. , 21 Willi s St., PO Box 5664, Dunedin, New Zealand , submitted application s to register pesticide product s (EPA File Sy mbols 75747
- R and 75747
- E) containing a new active ingredient not included in any currently registered products
. No comme nts 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 pre
harvest onl y, in/on all food commodities w as filed by Botry
- Zen, Ltd., and published in the FR on November 14 , 200 8 (73 FR 67512 ). One comment from an anon ym ous correspondent was received following this publication. A final rule establishing the exemption from tolerance was signed October 20, 20 09, in which the commenter’s concerns were addressed. The exemption from the requirement of a tolerance is codified under 40 C F R part 180
. Before issuing an y 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 anal ys is has shown that UlocladiumUlocladium oudemansii (U3 strain) Page 8

Biopesticide Registration Action Document oudemansii ( U3 s train) does not grow above 30oC, making infection of humans and other mammals having normal body temperatures above 37 oC unlikely . No reports of hy persensitivity

have been recorded in personnel working with this organism. Based on these data, the Agency has concluded that there is a reasonable certaint y that no harm will result from dietary exposure to resi dues of Ulocladium oudemansii (U3 Strain), when applied/used pre
- harvest onl y 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. T he US representative for Botry
- Zen, Ltd. i s Technology Sciences Group, Inc., 1 101 17 th Street, N.W., Suite 500, Washington, D.C., 20036
- 4704 , US
. IV . RISK ASSESSMENT On Octo ber 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 requireme nts. The classifications that are found for each data submission are assigned b y 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 “SUPPL EMENTAL” 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 (“SUP PL EMENTAL: UPGRADABLE”). If a study is rated as “SUPPLEMENTAL: UPGRADABLE,” the Environmental Protection Agency alway s provides an indication of what is lacking or what can be provided to change the rating to “ACCEPTABLE.” If there is simply a “SUPPLEMENTA L” rating, the reviewer will often state that the study

is not required by

the current 40 CFR Part 158. Both “ACCEPTABLE” and “SUPPL EMENTAL” 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 infor mation submitted to the Agency in support of a pesticide registration. The active ingredie nt or particular product is classified into Toxicity Category I , II, III, or IV, where Toxicity Category Iindicates the highest toxicity and Toxicity Category IV indicates the lowest toxicity
. A. PRODUCT ANALYSIS ASESSMENT 1. Product Chemistry and CompositionUlocladium oudemansii (U3 strain) Page 9

Biopesticide Registration Action Document
Ulocladium oudemansii is a common soil fungus, existing as a saproph yt e of dead and decaying plant matter. Rapid growth on plant
- based media occurs at 18
- 20 o C , first appearing ol ive
- green then darker to a velvet y charcoal black
. Ulocladium oudemansii ( U3 strain ) rapidly decline s in viability at 30 o C , and spores begin losing viabilit y after 48 hours at 25 o C
. This strain is reported to not damage live plant tissues or grow on huma n serum or blood at 17, 25 or 37 o C. 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 end
use products intended to control p lant 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% gl ycerol/water at
- 70 o C ) and maintained at the HortR esearch 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 Analy sis and Certification of L imits
. Five b atches tested b y cultural methods showed a 98% viability of Ulocladium oudemansii , (U3 Strain) with no appreciable contaminant s. The certified limits for the act ive and inert ingredients fall within the ranges specified by OPPTS Guideline 8 85 0.1 5 0 0 . 3. Physical and Chemical Characteristics The Agency

has determined that the s ubmitted data adequately describe the phy sical and chemical characteristics , and the scientificall y justified data waiver rationa les are acceptable for color, ph ys ical state, odor, stability to normal and elevated temperatures, metals, and metal ions, corrosion characteristics, pH, viscosity , and density /relative densit y/

bulk density

(specific gravity).
B. HUMAN HEALTH ASSESSM ENT 1. Toxicolog ical 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 b y Ulocladium oudemansii (U3 Strain) . It does not produce an y recognized toxins, enzy mes, or virulence factors normally associated with mammalian invasiveness or toxicity . There is aUlocladium oudemansii (U3 strain) Page 10

Biopesticide Registration Action Document reasonable certainty

of no harm to the general U.S. population, including in fants 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 Identificati on (MRID) Number (No.) 472465

- 03 ] : Ulocladium oudemansii Technical (purity 5.7x10 9 cfu/g) does not appear to be toxic, infective, and/or pathogenic in rats, at a dose of 1 x 10 8 CFU/animal in 0.9% sterile injectable saline
. This study was rated “ ACCEPTABL E” and Ulocladium oudemansii (U3 Strain) was classified as TOXICITY CATEGORY IV. Acute Dermal Toxicity and Pathogenicity

– Rat (OPPTS Gui deline 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 10 8 cfu/animal. There were no treatment related clinical signs, dermal irritation, necrops y findings, or changes in bod y weight. No test organism was recovered from blood, brain, kidney , liver, cervical ly mph nodes, or spleen of any animal. This study

was rated “ACCEPTABLE” and Ulocladium oudemansii (U3 Strain) was classified as TOXI CI TY CATEGORY I II
. Acute Pulmonary Toxicity and Pathogen icity

– Rat (OPPTS Guide line 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 poly eth yl ene 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 r epresentative portion of the sample was dried at 65°C for 2 day s. 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 percentag es 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 micr on with 1
- 3 transverse and 1 or more longitudinal or oblique septa. For rats, it is generally considered that a mass median aerod ynamic 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 generall y 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
- pharn ygeal region are removed by coughing, sneezing, or ph ys ical wiping from the nasal regions. Particles deposited in the tracheobronchial region are removed b y the mucocillary escalator sy stem. As for the particles swallowed, an oral study would determine the hazard represented by the material. BOTRY
- Zen ®Ulocladium oudemansii (U3 strain) Page 11

Biopesticide Registration Action Document is considered unlikel y 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 Guidel ine 885.3200; MRID No. 472465
- 02

) : Ulocladium oudemansii Technical did not appear to be toxic, infective, and/or pathogenic in rats, when dosed at >10 7 cfu/animal. T his study was rated “ACCEPTABL E” Skin Sensitization (OPPTS Guideline 870.2600; MRI D No. 472465
- 08

) Based upon the submitted data, Ulocladium oudemansii Technical, purity not less than 2x10 8 cfu/g and a minimum spore viability

of 90% does not appear to be a dermal sensitizer. This study was classified as “ACCEPTABLE.” Cell Culture (OPPT

S Guideline 885.3500 ; MRID 472465
- 17 ) : Cell culture testing is required if the active i n gredient Ulocladium oudemansii (U3 Strain) is a naturall y - occurring fungus. Cell culture testing is therefore not required. Acute Oral Toxicity (OPPTS Guideline 870.1 100; MRID No. 472482
- 02) : Waiver request rationale s offered b y the registrant for acute oral toxicity /pathogenicit y, for Ulocladium oudemansii Technical , is as follow s : 1) The submitted studies MRIDs 472 46502 to 09 did not show an y pathogenicit y i n 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 (O PPTS Guideline 870.1200; MRID No . 472482
- 0 2 ) : W aiver request ration ale s offered b y the registrant for acute dermal toxicity for Ulocladium oudemansii Technical is as follow s: 1) The submitted studies MRIDs 47246502 to 09 did not show any pathogenicity

in animals dosed/treated by oral gavage, derm al 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 I V
.Ulocladium oudemansii (U3 strain) Page 12

Biopesticide Registration Action Document Acute Inhalation Toxicity (OPPTS Guideline 870.1300; MRID No. 472482
- 02 ) : Waiver request rationale s offered b y the registrant for acute inhalation toxicity for Ulocladium oudemansii Technical is as follow s: 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 an y adverse effects or toxic ity . 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 rationale s offered b y the registrant for acute ey e irritation for Ulocladium oudemansii Technical is as follow s: 1) The submitted studies MRIDs 47246502 to 09 did not show any pathogenicit y 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 “A CCEPTABLE” and Ulocladium oudemansii (U3 Strain) was classified as TOXI CI TY CATEGORY IV. Primary Dermal Irritation (OPPTS Guideline 870.2500; MRID No. 472482
- 02 ) : Waiver request rationale s offered b y the registrant for primary dermal irritation for Ulocla dium oudemansii Technical is as follow s: 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 o udemansii (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.”Ulocladium oudemansii (U3 strain) Page 13

Biopesticide Registration Action Document Following the reco mmendations 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 thy roid hormone s ys tems, in addition to the estrogen hormone s ys te m. 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 sy stem, functions in a manner similar to any known hormone, or that it acts as an endocrine disr uptor. Indeed, the submitted toxicity /pathogenicity

studies in rodents indicate that, following several routes of exposure, the immune sy stem 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 naturall y occurring saproph yt e, i.e., an organism that lives and feeds on dead and decaying plant matter. The subject of this tolerance exemption, Ulocladium oudemansii ( U3 s train), was originall y isolated from kiwifruit leaf litter . Spores of Ulocladium oudemansii ( U3 s train), when deposited under the suitable environmental conditions on dead or decaying plant debris, will germinate and colonize the necrotic plant tissue. But if such decay ed vegetative matter is not available, or becomes exhausted, the fungus cannot survive. Therefore, despite its presence in s oils, dietary

exposure from the proposed use of Ulocladium oudemansii ( U3 s train) 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 m yc otoxins associated with Ulocladi um species, and the submitted toxicological studies indicate no risk to human health from dietary exposure to Ulocladium oudemansii ( U3 s train). Furthermore, the fungus produces no recognized toxins, enzy mes or virulence factors normally associated with m ammalian invasiveness or toxicity
. Additionally , growth temperature anal ys is has shown that Ulocladium oudemansii ( U3 s train) does not grow above 30oC, making infection of humans and other mammals having normal body temperatures above 37 oC unlikely Uloc ladium 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 commerciall y marketed. Good quality food free of such decay ed 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 decay ed 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 adul ts, infants and children from food
- related exposures to Ulocladium oudemansii (U3 Strain) will be minimal due to the demonstrated lack of acute oralUlocladium oudemansii (U3 strain) Page 14

Biopesticide Registration Action Document toxicity /pathogenicit y associated with the microbial pesticide. Based on the evaluation of the submitted d ata, 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 h as 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 Chi ldren Based on the toxicity

information discussed above , EPA concludes that there is a reasonable certaint y that no harm will result to the United States population, including infants and children, from aggregate exposure to residues of Ulocladium oudema nsii (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 lac k of toxicity /pathogenicity

potential. Ulocladium oudemansii (U3 Strain) is not known to produce an y recognized toxins, virulence factors or enzy mes normall y associated with mammalian invasiveness or toxicity. 5 . O ccupational , Residential, School and Day Care Exposure and Risk Characterization Due to its use as an agricultural product, outdoors and in greenhouses, s ignificant 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 /pathogenicit y s tudies, which did not show an y 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 an y undue risk. Regardless, requirements for the use of appropriate personal protectiveUlocladium oudemansii (U3 strain) Page 15

Biopesticide Registration Action Document equipment , and precautionary statements are required on the product label to mitigate any potential risks to pesticide handlers due to prolonged exposure. H andlers working with Ulocladium oudemansii (U3 Strain) in manufacturing facilities must wear a long
- sleeved s hirt, long pants, socks, shoes, waterproof gloves , and a dust/mist filtering respirator meeting NI OSH standards of at least N
- 95, R
- 95, or P
- 95
.

b . R esidential, School, and Daycare Exposure and Risk Characterization According to the label, Ulocladiu m oudemansii (U3 Strain) is only to be used for agricultural areas, greenhouses and horticultural nurseries . No indoor residential, school, or daycare uses currentl y appear on the label; thus, human exposure to Ulocladium oudemansii (U3 Strain) should no t 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 t ox icity 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 residue s 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. Ther efore, section 408(b)(2)(D)(v) does not apply
. 8 . Risk Characterization The Agen cy

considered human exposure to Ulocladium oudemansii (U3 Strain) in light of the standard for registration in FIFRA , as amended by the Food Qualit y 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.Ulocladium oudemansii (U3 strain) Page 16

Biopesticide Registration Action Document 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 saprophy te found in soils worldwide, has a mode of action that are not consistent with those causing tox ic 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 AGRI COLA, TOXLINE and NLM PubMed databases ). Ulocladium spp. are t ypicall y 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 acti on exhibited by Ulocladium oudemansii is antagonistic competition with plant pathogenic fungi for phy sical 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 i n the waiver request for the wild mammal toxicity /pathogenicit y 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 oudemansi i (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 / pathog enicity

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 10 6 , 1.6 x 10 7 , 3.2 x 10 7 , 6.3 x 10 7 , and 1.3 x 10 8 cfu/L , respectivel y) 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 nominalUlocladium oudemansii (U3 strain) Page 17

Biopesticide Registration Action Document concentrations rep resented 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 dail y 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 an y 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 L C 50 was empirically

estimated to be greater than the highest nominal concentration tested (>1.3 x 10 8 cfu/L , >177x EEC). This test concentration is below the maximum hazard dosage recommendations in the OPPTS guideline. However, the difficult y of meeting this requirement due to the nature of the fungus preparations in water is recognized , an d 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 Inverteb rate 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 10 6 , 1.6 x 10 7 , 3.2 x 10 7 , 6.3 x 10 7 , and 1.3 x 10 8 cfu/L , respectively). Accurate confirmation of the test material concentrations was not possible due to its hydrophobic nature and tend ency 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 10 5 cfu/L(2.9 mg/L) based on a product application rate of 4 lbs/acre. An untreated control (dilution water o nly) 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, respectivel y. Survival in the untreated control was 100%, while surv ival in the attenuated control was 70%. There were no statistically significant differences (p ≤0.05) in cumulative mortality among an y 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 apparentl y 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 EC 50 value was therefore empirically

estimated to be >1.3 x 10 8 , 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 inv ertebrates are not anticipated. This study was classified as “ACCEPTABLE.”Ulocladium oudemansii (U3 strain) Page 18

Biopesticide Registration Action Document

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 - 1 6) The phy totoxic 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 day s 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 oudemansi i (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 stud y with grapes), and the sample sizes were very small. There were no test material
related ph yt opathogenic effects seen in any of the plants in the test at the 10x conce ntration (2.7 x 10 7 cfu/mL ). This study contains several deficiencies . Although the stud y wa s 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 a ddition, there are no published reports of Ulocladium oudemansii causing ph yt opathological effects. Therefore, adverse effects to non
target terrestrial plants are not anticipated from the proposed uses of Botry
- Zen ®
. This study was classified as “SUPPLEM ENTARY.”

g. Non - Target Insect Testing (OPPTS Guideline 885.4340) In a 27
- day

dietary toxicity

/pathogenicit y stud y, g reen 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 10 7 , 2.7 x 10 7 and 1.1 x 10 7 cfu/mL , respectivel y) in accordance with OPPTS 885.4340 (MRID 472465
- 12 ) . Test subjects were exposed via Mediterranean meal moth ( Ephestia kuehniella ) eggs spray ed 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 recommendedUlocladium oudemansii (U3 strain) Page 19

Biopesticide Registration Action Document 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 o f 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 dif

ferences 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 overa ll survival in the test material and adjuvant control groups, the test material did not produce any adverse effects on the test organisms. Therefore, the LC 50 for the test material is determined to be >95,000 ppm. Thus, adverse effects in green lacewing r esulting 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 lad ybird beetles ( Hippodamia convergens ; MRID 472465
- 13) were exposed to Ulocla dium 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 10 7 , 2.7 x 10 7 , and 1.1 x 10 7 cfu/mL , respectivel y). The nominal concentrations were calculate d 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 mortalit y in the nominal high, middle, and low U. oudem ansii test groups was 59.65%, 64.25%, and 67.96%, respectivel y. 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 significantl y 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 L C 50 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 day s via a cotton wick soakedUlocladium oudemansii (U3 strain) Page 20

Biopesticide Registration Action Document with the test material at nominal concentrations of 95,900 ppm, 47,900 ppm, and 19,200 ppm (equivalent to 5.4 x 10 7 , 2.7 x 10 7 , and 1.1 x 10 7 cfu/mL , respectivel y). 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 significantl y from the untreated control (70% honey /sterile water solution) The LC 50 of Ulocladium oudemansii technical for parasitic wasp was empirically determined to be gr eater 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 t ested 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 /pathogenicit y test, larvae were treated with Ulocladium oudemansi i (U3 strain) technical at two test concentrations. The “low” concentration represented 19,200 ppm or 2.2 x 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). Th e “high” concentration represented 95,900 ppm or 11.3 x 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 ho ney bee larvae were a positive control (potassium arsenate), negative control (30% sucrose onl y) and an adjuvant control (Tween 80, 0.3% v/v in 30% sucrose solution). Overall, survival in the Ulocladium oudemansii treatments did not differ significantl y f rom the adjuvant control (ANOVA, p<0.05). These treatments and the adjuvant control also differed significantl y 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), lad ybird beetle (MRID 472465
- 13) and a parasitic wasp (MRID 4724 65
- 14). Therefore, the L C 50 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 honey bees. Thi s 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 saprophy te found in soils worldwide, does notUlocladium oudemansii (U3 strain) Page 21

Biopesticide Registration Action Document 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 ) , lady bird beetle (Hippodamia convergens ) and a parasitic wasp ( Aphytis melinus ). The parasitic wasp was used in place of the big
- ey ed bug due to limitations of the testing facility

chosen to conduct these studies (rationale for use of this species was acceptable to BPPD). A honey

bee ( 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 ar e 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 day s following an application of the EP. An addi tional 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 applic ations 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 EEE C 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 saprophy te 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
.Ulocladium oudemansii (U3 strain) Page 22

Biopesticide Registration Action Document 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 oudemans ii as intended on the proposed EP label.

c . Threatened and Endangered Species Assessment As discussed above, Ulocladium oudemansii presents no toxicological concerns to an y living organisms. Ulocladium oudemansii only survives and thrives on dead and de caying plant matter. Given EPA’s determation that no effects are anticipated for an y 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 Ef fect” 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 an d 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 aty pical, unusually

high exposure to Ulocladium oudemansii (U3 strain) , compared to the general populat ion. Please comment if you are aware of an y sub
- populations that may have aty pical, 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 b y the science assessments supporting products containing Ulocladium oedemansii (U3 Strain)
.Ulocladium oudemansii (U3 strain) Page 23

Biopesticide Registration Action Document Such products are not expected to cause unreasonable adverse e ffects, and are likel y 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 determi ned 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 Insec ticide, Fungicide, and Rodenticide Act (FIFRA). On October 1, 2009, EPA announced a new policy

to provide a more meaningful opportunit y for the public to participate on major registration decisions before they occur. According to this new policy , EPA int ends to provide a public comment period prior to making a registration decision for, at minimum, the following t ypes 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 an y 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 inte rests 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 registratio n with an initial period of one
- ye ar 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 regi stering 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 Append ix B for product
- specific information. 1. Conditional/Unconditional RegistrationUlocladium oudemansii (U3 strain) Page 24

Biopesticide Registration Action Document 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 . L abeling Before releasing pesticide p roducts containing Ulocladium oedemansii (U3 Strain) for shipment, the applicant is required to provide appropriate labels. V II . 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 p esticide product. A brief summary of these t ypes of data are listed below. A. R eporting of Adverse Effects and Hypersensitivity Incidents Reports of all incidents of adverse effects to the environment must be submitted to the Agency under the provis ions stated in FIFRA, Section 6(a)(2). Additionally , all incidents of hy persensitivity

(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 V I II . GLOSSARY OF ACRONYMS AND ABBREVIATIONS BPPD Biopesticides and Pollution Prevention Division BRAD Biopesticide Registration Action Document CFR Code of Federal Regulations
cm 3 cubic 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, Fungic ide, and Rodenticide Act FQPA Food Qualit y Protection Act FR Federal Register g gram kg kilogram L liter LD 50 median lethal dose. A statistically derived single dose that can be expected to cause death in 50% of the test animals when a dministered 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 MPC A microbial pest control agent NE “No Effect” NI OSH National Institute for Occupational Safet y and Health OPP Office of Pesticide Programs OPPTS Office of Prevention, Pesticides, and Toxic Substances PCR poly

merase chain reaction PPE personal protectiv e equipment TGAI technical grade of the active ingredientUlocladium oudemansii (U3 strain) Page 26

Biopesticide Registration Action Document
I X . BIBLIOGRAPHY STUDIES SUBMITTED IN SUPPORT OF THIS REGISTRATION A. Studies Submitted in Support of this Registration
.
47246500 Botr y- 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 - Sep 2007
47246501 Roberts, A. (2 007) Product Chemistry for Ulocladium oudemansii Technical. Project Number: VP/BOT/001, VP/BOT/002, BZW G2. Unpublished study prepared by Technology Science Group, Inc. 145 p. 28 - Sep 2007
47246502 Crutchfield, V. (2007) Ulocladium oudemansii Technical: Acu te IP Injection

Toxicity/Pathogenicity Study in Rats with Microbial Pest Control Agents (MPCA): Final Report. Project Number: 10073/06. Unpublished study prepared by Stillm eadow, Inc. 35 p. 28 - Sep 2007
47246503 Dreher, D. (2002) Acute Oral Toxicity / Infe ctivity Study in the Rat (Ulocladium

oudem ansii Technical). Project Number: 1638/001. Unpublished study prepared by Safepharm Laboratories, Ltd. 30 p. 28 - Sep 2007 47246504 Dreher, D. (2002) Acute Dermal Toxicity / Infectivity Study in the Rat (Ulocladium

oudem ansii Technical). Project Number: 1638/002. Unpublished study prepared by Safepharm Laboratories, Ltd. 31 p. 28 - Sep 2007 47246505 We sson, 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 - Sep 2007 47246506 Dreher, D. (2002) Acute Eye Irritation / Infectivity Study in the Rabbit (Ulocladium

oudem ansii Technical). Project Number: 1638/005. Unpubli shed study prepared by Safepharm Laboratories, Ltd. 23 p. 28 - Sep 2007 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 - Sep 2007 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 - Sep 2007 47246509 Thompson, P. (2002) Reverse Mutation Assay "Ames Test" Using Salmonella

ty phimurium (Ulocladium oudemansii Technical). Project Number: 1638/007. Unpublished study prepared by Safepharm Laboratories, Ltd. 25 p. 28 - Sep 2007
47246510 Putt, A. (2007) Ulocladium oudemansii Technical - Toxicity, Infectivity and

Pathogenicity to Rainbow Trout (Oncorhynchus m yk iss) During a 30 - Day Static Renewal Test. Project Number: 13881/6100, 020606/OPPTS/RBT/STR/MCPA. Unpublished study prepared by Spri ngborn Smithers Laboratories. 53 p. 28 - Sep 2007 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/DA PHNID/STR/MPCA. Unpublished study prepared by Springborn Smithers Laboratories. 48 p. Sep 2007

47246512 Richards, K. (2007) Ulocladium oudemansii Technical: A Dietar y Stud y with Green

Lacewing Larvae (Chrysoperla rufilabris). Project Number: CAR/106/0 6, 10428/06. Unpublished study prepared by California Agricultural Research Inc. and Stillm eadow, Inc. 76 p. 28 - Sep 2007
47246513 Richards, K. (2007) Ulocladium oudemansii Technical: A Dietar y T oxicity Study with

the Ladybird Beetle (Hippodamia convergens ). Project Number: CAR/105/06, 10410/06. Unpublished study prepared by California Agricultural Research Inc. and Stillm eadow, Inc. 58 p. 28 - Sep 2007
47246514 Richards, K. (2007) Ulocladium oudemansii Technical: A Dietar y Stud y with Parasitic

Wa sp (Aphytis me linus). Project Number: CAR/107/06, 10431/06. Unpublished study prepared by California Agricultural Research Inc. and Stillmeadow, Inc. 96 p. 28 - Sep 2007
47246515 Richards, K. (2007) Evaluation of the Dietary Effect(s) of Ulocladium oudemansii

Technica l on Larval Honeybee Development. Project Number: CAR/111/06, 10141/06. Unpublished study prepared by California Agricultural Research Inc. and Stillm eadow, Inc. 54 p. 28 - Sep 2007
47246516 Burgess, I. (2001) Non - Target Plant Testing with Ulocladium oudema nsii (U3 Strain).

Project Number: VP/BOT/005, VP/BOT/006. Unpublished study prepared by Botry Zen Limited. 18 p. 28 - Sep 2007 47246517 Mileson, B. (2007) Response to Tier 1 Microbial Pesticide Data Requirements for

Ulocladium oudemansii Technical. Unpublis hed study prepared by Technology Sciences Group. 47 p. 28 - Sep 2007 47340701 Roberts, A. (2008) Supplemental Product Chemistry for Ulocladium oudemansii Technical. Unpublished study prepared by Technology Sciences Group, Inc. 14 p. 06 - Feb 2008 47445501 Ro berts, 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 - Jun 2008 47638901 Mileson, B. (2008) Supplemental Product Chemistry for Ulocladium oudemansii

Technical - Product Identity. Unpublished study prepared by Technology Sciences Group, Inc. 39 p. 08 - Jan 2009 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 - Jan 2009 47639301 Roberts, A. (2008) Supplemental Product Chemistry for Ulocladium Oudemansii Technical. Unpublished study prepared b y Botr y- Zen Limited. 12 p. 22 - Sep 2008 B. EPA Risk Assessment MemorandaUlocladium oudemansii (U3 strain) Page 28

Biopesticide Registration Action Document Borges, S. Amended: September 25, 2008 Environmental Risk Assessment of Ulocladium oudemansii (U3 Strain). Undated m emorandum 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 Char acterization 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 Number TGAI M P Product Chemistry and Compositio n Product Identity (885.1100) Ulocladium oudemansii , a soil saprophytic fungus, grows rapidly at 18
- 20 o C 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 olivaceous
charcoal 21.6
- 30.8 by 10.8
- 16.9 microns with 3
- 5 trans verse 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 rapidl y 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. D eposition of a Sample in a Nationally Recognized Culture Collection Ulocladium oudemansii is stored in 15% glycerol/water at

- 70 0 C at the HortReseach Labs Not applicable Not applicableUlocladium oudemansii (U3 strain) Page 29

Biopesticide Registration Action Document Data Requirement (OPPTS Guideline) Results MRID Number TGAI M P (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 condition al, time
- limited FIFRA section 3 (c)(7)(C) registration only. Classification: Acce ptable 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 Charact eristics Color (830.6302) Black Not applicable 472465
- 01 Phy sical 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 immed iately 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 Characteris tics (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 Densi ty /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 Stra in) (40 CFR § 158.2140)Ulocladium oudemansii (U3 strain) Page 30

Biopesticide Registration Action Document Data Requirement (OPPTS Guideline) Results MRID Number TGAI M P Tier I Ac ute Oral Toxicity/Pathogenicity (885.3050) Technical ( purity 5.7x10 9 cfu/g)

does not appear to be toxic, infective, and/or pathogenic in rats, at a dose of 1 x 10 8 CFU/animal in 0.9% sterile injectable saline
. Classification: Acceptable TOXICITY CATEGORY IV Not applicable 472465
- 03

Ac ute Dermal Toxicity/Pathogenicity (885.3100) Botry
- Zen ® does not appear to

be toxic, infective, and/or pathogenic in rats, wh en treated at 1 x 10 8 cfu/animal. Classification: Acceptable TOXICITY CATEGORY I II Not applicable 472465
- 04

Ac ute Pulmonary Toxicity/Pathogenicity (885.3150) Waived based on the results of

MRID Number 472482
- 02 Not applicable 472482
- 02
Ac ute Injection To xicity/Pathogenicity (885.3200) Technical did not appear to be

toxic, infective, and/or pathogenic in rats, when dosed at >10 7 cfu/animal. Classification: Acceptable Not applicable 47 2465
- 02

Skin S ensiti zation (8 70
. 2600 ) Based upon the submitted data, Ulocladium oudemansii Technical,

purity not less than 2x10 8 cfu/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

Ac ute Oral Toxicity (870.1100) Not applicable Waived based on the results of MRID Number 47 2465
- 03 and because the MP is equivalent to the TGAI
. Classification: Acceptable TOXICITY CATEGORY IV 47 2482
- 02

Ac ute 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: Acce ptable TOXICITY CATEGORY IV 472482
- 02

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

Biopesticide Registration Action Document Data Requirement (OPPTS Guideline) Results MRID Number TGAI M P (870.1300) MRID Number 472482
- 02 and because the MP is equivalent to the TGAI. Classification: Acceptable TOXICITY CATEGORY IV Ac ute E ye Irritation (870.2400) When dosed with Ulocladium

oudemansii Technical, purity not less than 2x10 8 cfu/g and a minimum spore viability of 90% at 0.1 mL/animal, Ulocladium oudemansii Technical is non irritating. Classification: Acceptable TOXICITY CATEGO RY IV Not Applicable 472465
- 06

Primary Dermal Irritation (870.2500) When dosed with Ulocladium

oudemansii Technical, purity not less than 2x10 8 cfu/g and a minimum spore viability of 90% at 0.5 mL/animal, Botry
- Zen ® is non - irritating. Classification: Acce ptable TOXICITY CATEGORY IV Not Applicable 47 2465
- 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 w aiver ratio nale provides sufficient

information to satisfy this data requirement. Classification: Acceptable 472465
- 17 Avian Inhalation Toxicity/Pathogenicity (885.4100) Data w aiver rationale provides sufficient

information to satisfy this data requirement. Classifi cation: Acceptable 472465
- 17 Wild Mammal Toxicity/Pathogenicity (885.4150) Data w aiver rationale provides sufficient

information to satisfy this data requirement. Classification: Acceptable 472465
- 17 Freshwater Fish Toxicity/Pathogenicity (885.4200) Bas ed on a 30
- day toxicity study of rainbow

trout, receiving an aqueous exposure up to 1.3 x 10 8 cfu/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
- 11Ulocladium oudemansii (U3 strain) Page 32

Biopesticide Registration Action Document Data Requirement (OPPTS Guideline) Results MRID Number Toxicity/Pathog enicity (885.4240) toxicity/pathogenicity study, receiving an

aqueous exposure up to 1.3 x 10 8 cfu/L, adverse effects in freshwater invertebrates are not anticipated. Classification: Acceptable Estuarin e/Marine Fish Testing Estuarine and Marine Invertebrate Testing (885.4280) Data w aiver 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: Suppl em entary 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 10 7 cfu/mL, determined that adverse effects are not expected Cl assification: Acceptable 472465
- 12 472465
- 13 472465
- 14
Honey Bee Testing (885.4380) Honey bees larvae w ere 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 END USE PRODUCTS

EPA Registration Number Registration

Name Percentage

Active Ingredient Formulation

Type Use Site Method of Applicat i on 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 sclerotiorumUlocladium oudemansii (U3 strain) Page 33

Biopesticide Registration Action Document

(U3 Strain)