Aureobasidium pullulans strains DSM 14940 and 14941 Page 1 of 41

Biopesticides Registration Action Document

 

BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Aureobasidium pullulans strain DSM 14940 

and 

Aureobasidium pullulans strain DSM 14941

Pesticide Chemical (PC) Codes: 

046010 and 036010

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

January, 2012
Aureobasidium pullulans strains DSM 14940 and 14941 Page 2 of 41

Biopesticides Registration Action Document

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY...................................................................................................... 4

II. ACTIVE INGREDIENT OVERVIEW ................................................................................ 6

III. REGULATORY BACKGROUND................................................................................. 6

A. Applications for Pesticide Registration................................................................................................................6

B. Food Tolerance Exemption ...................................................................................................................................6

IV. RISK ASSESSMENT ...................................................................................................... 6

A. Product Analysis Assessment (40 CFR § 158.2120) .......................................................................................7

B. Human Health Assessment (40 CFR § 158.2140)................................................................................................8

C. Environmental Assessment (40 CFR § 158.2150)..............................................................................................14

V. ENVIRONMENTAL JUSTICE .......................................................................................... 17

VI. RISK MANAGEMENT DECISION ................................................................................. 17

VII. ACTIONS REQUIRED BY THE REGISTRANT ......................................................... 18

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS........................................... 19

A. Studies Submitted to Support the Aureobasidium pullulans strains DSM 14940 and 14941 Pesticide 

Product Registrations................................................................................................................................................20

B. Environmental Protection Agency Risk Assessment Memoranda...................................................................25

C. Other References .................................................................................................................................................25

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS............................ 28

APPENDIX B. PESTICIDE PRODUCTS............................................................................... 41
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Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs (OPP)

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch

Science Reviews

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

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

Shannon Borges Environmental Effects

Gail Tomimatsu, Ph.D. Environmental Effects

Regulations

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

Alan Reynolds Team Leader, Microbial Pesticides Branch

Susanne Cerrelli Regulatory Action Leader
Aureobasidium pullulans strains DSM 14940 and 14941 Page 4 of 41

Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY

Aureobasidium pullulans strains DSM 14940 and DSM 14941 are naturally occurring fungi, 

which were isolated from apple leaves and classified as Aureobasidium pullulans (A. pullulans) 

by the German Strain Collection for Microorganisms (DSMZ). These closely related fungi are 

neither mutant nor genetically modified strains.

Bioferm GmbH submitted applications to register two manufacturing-use pesticide products,

Aureobasidium pullulans strain DSM 14941Technical (EPA File Symbol 86174-E) and

Aureobasidium pullulans strain DSM 14940 Technical (EPA File Symbol 86174-R). The active 

ingredient is 80% w/w (minimum of 2 x 109cfu/g) in each of these technical products. Bioferm 

GmbH also submitted applications to register two end-use pesticide products:

• Botector (EPA File Symbol 86174-G), containing 40% w/w Aureobasidium pullulans

strain DSM 14940 (minimum of 5.3 x 108cfu/g) and 40% w/w Aureobasidium pullulans

strain DSM 14941 (minimum of 5.3 x 108

cfu/g), to protect pome fruits from storage 

diseases; grapes and strawberries from Botrytis; and stone fruit from Monilia; 

and 

• Blossom Protect (EPA File Symbol 86174-U), to protect pome fruits against fire blight, 

containing the active ingredients of 25.8% w/w Aureobasidium pullulans strain DSM 

14940 (minimum of 4.4 x 108

cfu/g) and 25.8% w/w Aureobasidium pullulans strain 

DSM 14941 (minimum of 4.4 x 108

cfu/g).

A. pullulans is a “yeast-like” saprophytic fungus found in the phyllosphere of many plants, and it 

also has been isolated from soil and aquatic environments (Chi et al. 2009, Cooke 1959, 

Slepecky and Starmer 2009). It is commonly isolated from healthy grape (Fleet 2002, 2003), 

apple (Granado et al. 2008), and other plants (Gao et al. 2005, Osono 2008, Slavikova et al. 

2007, Suryanarayanan et al. 2005, Webb and Mundt 1978). This fungus is generally recognized 

as an organism that derives its nourishment from non-living or decaying organic matter (saprobe)

and as a weak pathogen or parasite of certain plants (Kockova-Kratochvilova et al. 1980, Cooke 

1959). A. pullulans is an antagonist of several plant disease-causing organisms, and it is an

important producer of enzymes for biotechnological and industrial applications (Chi et al. 2009). 

The applicant, bioferm GmbH, submitted product analysis, toxicology, and non-target organism 

data and other information sufficient to satisfy the data requirements for an unconditional 

registration of Aureobasidium pullulans strains DSM 14940 and 14941 for the proposed 

pesticide uses. The data, cited literature, and other information submitted by the applicant were 

reviewed by Agency scientists from the Microbial Pesticides Branch (MPB) in the Biopesticides 

and Pollution Prevention Division (BPPD). 

The submitted acute oral, pulmonary and subcutaneous injection toxicity/pathogenicity studies in 

laboratory rats showed that, at a single high dose, A. pullulans strain DSM 14941 is not toxic, 

infective, and/or pathogenic. Since the product analysis data demonstrated that strain DSM

14941 is closely related to strain DSM 14940, the results of these studies were applicable to both 

strains. A second acute subcutaneous toxicity/pathogenicity study was submitted that was 

conducted with both A. pullulans strains (DSM 14940 and DSM 14941), and neither where 

shown to be toxic, infective, or pathogenic in laboratory rats. 
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Biopesticides Registration Action Document

Although A. pullulans infections in immune-compromised patients have been reported in 

published literature, the Agency’s scientists found that the organisms responsible for these

infections were not closely related to the A. pullulans strains (DSM 14941 and DSM 14940) 

proposed for registration as pesticides. Since neither of the strains can grow at temperatures

above 34oC, their potential pathogenicity in humans, with an average body temperature of 37 oC,

is virtually impossible. No dietary or non-dietary exposure issues were identified to indicate that 

the intended use of these active ingredients as pesticides would be harmful to infants, children, 

and the general U.S. population. 

The Agency’s scientists determined that adverse effects to non-target organisms (wild mammals, 

birds, non-target plants, non-target insects, honey bees, freshwater fish and invertebrates) are not 

anticipated as a result of the proposed pesticide uses of A. pullulans strains DSM 14940 and 

DSM 14941. A “No Effect” determination has been made for direct and indirect effects to listed 

species and their designated critical habitats resulting from the proposed uses of Aureobasidium 

pullulans strains DSM 14940 and DSM 14941, as labeled. 

If post-harvest use sites are proposed for these products in the future, additional product analysis 

data would be required.

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

for the public to participate in major registration decisions before they occur. According to this 

policy, EPA intends to provide a public comment period prior to making a registration decision 

for, at minimum, the following types of applications: new active ingredients; first food uses; 

first outdoor uses; first residential uses; or any other registration actions for which EPA believes 

there may be significant public interest. Consistent with this policy, the proposed pesticide 

products containing two new microbial pesticide active ingredients, A. pullulans strains DSM 

14941 and DSM 14940, were subject to a 30-day comment period. During this comment period, 

one comment was received indicating support of the proposed uses because strains of this 

species are commonly present in apple trees in the United States, and the biopesticide shows 

“significant promise for control of fire blight,” which “may help replace the use of antibiotic” 

for controlling this disease. 

The Agency’s risk assessments and conclusions that the standards for registration under FIFRA 

section 3(c)(5) have been met for the proposed active ingredients, Aureobasidium pullulans

strain DSM 14940 and Aureobasidium pullulans strain DSM 14941, are provided in this

Biopesticide Registration Action Document (BRAD).
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II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Aureobasidium pullulans strains DSM 14940 and 14941

Culture Deposit: German Strain Collection for Microorganisms (DSMZ) under the 

reference number DSM 14940 & DSM 14941

OPP Chemical Code: 046010 and 036010

Type of Pesticide: Microbial Pesticide – Fungicide

See Appendix B for specific information (e.g.,

use sites, application rates, methods of application, 

formulation types, and target pests) regarding

the registered pesticide products containing this 

active ingredient.

III. REGULATORY BACKGROUND

A. Applications for Pesticide Registration

On September 18, 2009, bioferm GmbH, (address: Konrad Lorenz Str. 20; A-3430; Tulin 

Austria) submitted applications to register two manufacturing use products, Aureobasidium 

pullulans strains DSM 14940 Technical (EPA File Symbol 86174-E) and Aureobasidium 

pullulans strains DSM 14941 Technical (EPA File Symbol 86174-R); and two end-use products, 

Blossom Protect (EPA File Symbol 86174-U) and Botector (EPA File Symbol 86174-G) under

FIFRA section 3. On March 10, 2010, EPA announced receipt of these applications to register 

pesticide products containing new active ingredients (75 Federal Register (FR) 11175) and 

opened a 30-day public comment period pursuant to the provisions of FIFRA section 3(c)(4). No 

comments were received following this publication.

B. Food Tolerance Exemption

Concurrent with its registration applications, and in accordance with the Federal Food, Drug, and 

Cosmetic Act (FFDCA) section 408(d), bioferm GmbH submitted a petition to establish an 

exemption from the requirement of a tolerance for Aureobasidium pullulans strains DSM 14940 

and DSM 14941 (Pesticide Petition (PP) 9F7623). On March 10, 2010 EPA announced (75 FR 

11171) that bioferm GmbH proposed to establish an exemption from the requirement of a 

tolerance for residues of the fungicides, Aureobasidium pullulans strains DSM 14940 and DSM 

14941, in or on all food commodities, and opened a 30-day comment period. No comments were 

received following this publication. 

IV. RISK ASSESSMENT

EPA issued a Final Rule (72 FR 61002) amending the data requirements to support registration 

of microbial pesticides and updated the definition of “microbial pesticides,” which became 

effective on December 26, 2007. The data and scientific risk assessments presented in this 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 7 of 41

Biopesticides Registration Action Document

BRAD were considered in light of these requirements.

Classification of Data Submissions

The classifications for each study or data submission are assigned by EPA science reviewers, and 

indicate the usefulness of the information for risk assessment. An “acceptable” rating indicates a

study conducted in accordance with an established Agency guideline is scientifically sound and 

useful for a risk assessment. A study may have certain aspects determined not to be scientifically 

acceptable, but with additional information, it may be upgraded to “acceptable.” This study is 

rated “supplemental: upgradeable,” and EPA provides information to the registration applicant 

concerning what must be provided to upgrade the study. A “supplemental” rating the data 

provide some information useful for risk assessment, or it may mean that the data were not 

required. 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.

Acute toxicity studies are assigned Toxicity Categories, based on the hazard(s) identified from 

studies and/or other information provided or cited by the registration applicant. The active 

ingredient and/or product is classified as Toxicity Category I, II, III, or IV, where Toxicity 

Category I is assigned for the highest level of toxicity, and Toxicity Category IV indicates the 

lowest. 

A. Product Analysis Assessment (40 CFR § 158.2120)

A. pullulans strains DSM 14940 and DSM 14941 were isolated from apple leaves and classified 

as Aureobasidium pullulans by the German Strain Collection for Microorganisms (DSMZ) by 

means of morphological characterization of the colonies on yeast medium (YM) agar plates. The 

two strains show similar colony characteristics on agar plates; they are identical on their 18S

ribosomal RNA gene region; and they are also identical on their Internal Transcribed Spacer 

(ITS) regions ITS1 and ITS4, which are commonly used for inter- and intra-species 

differentiation. Definitive differentiation can only be achieved by molecular biological methods 

focusing on the whole genome, either by conducting such analyses as RAPD PCR (Random 

Amplification of Polymorphic DNA Polymerase Chain Reaction) or by using recently developed 

strain-specific primer characteristics. xvFurther confirmation of these strains can be achieved via 

PCR. PCR reveals a specific band that distinguishes A. pullulans strains DSM 14940 and DSM 

14941 from other isolates of A. pullulans and from other yeast-like fungi. The subject strains are 

neither mutant strains nor genetically modified strains. [Pesticide Petition (PP) 9F7623]

A. pullulans can live in an environment offering very low levels of nutrients. A. pullulans can be 

found in environments with fluctuating water activities, such as leaf surfaces, bathrooms, food, 

and feeds; and highly osmotically stressed environments, such as hypersaline waters in salterns 

and rocks and monuments. Due to the production of large quantities of yeast-like propagules, this 

fungus disperses globally. [Pesticide Petition (PP) 9F7623]

All product analysis data requirements for A. pullulans strains DSM 14940 and 14941 have been 

fulfilled to support current use sites. Refer to Tables 1, 2, 3, 4, 5, 6 and 7 in Appendix A for a 

brief summary of the data requirements, including both generic and product-specific information. 
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B. Human Health Assessment (40 CFR § 158.2140)

1. Toxicity

All toxicology data requirements for A. pullulans strains DSM 14940 and 14941 have been 

fulfilled. Acceptable Tier I mammalian toxicology data and information support registration of

the A. pullulans strains DSM 14940 and 14941 pesticide products. Furthermore, Tier II and Tier 

III studies were not required for A. pullulans strains DSM 14940 and 14941 because of the lack 

of acute toxicity/pathogenicity in the Tier I studies.

For a comprehensive summary of the generic toxicology data requirements described in sections 

IV(B)(1)(a) and IV(B)(1)(b), as well as additional product-specific data submitted to support the 

individual registrations, refer to Table 8 in Appendix A.

a. Acute Toxicity/Pathogenicity – Tier I

Twenty-four rats were given a single dose of A. pullulans strain DSM 14941. Three animals of 

each sex were sacrificed on days 3, 7, and 14; the remaining animals were sacrificed at the end of 

the study (day 21). Body tissues were examined for A. pullulans. All samples of feces, blood, 

brain, lung, liver, kidney, spleen, stomach, and intestine were negative. The lymph nodes of one 

animal sacrificed on day 7 tested positive. Based on the results of this study, yeast isolate A.

pullulans DSM 14941 does not appear to be toxic, infective, and/or pathogenic in rats, when 

dosed at 4 x 108 cfu/animal.Acceptable.

Acute Oral Toxicity/Pathogenicity (Office of Chemical Safety and Pollution Prevention (OCSPP) 

Guideline 885.3050; Master Record Identification Number (MRID No.) 47899302):

Acute Pulmonary Toxicity/Pathogenicity (OCSPP Guideline 885.3150; MRID No. 47899303):

Male and female rats were given an intratracheal dose of A. pullulans strain DSM 14941 

Technical (4 x 108 cfu/g). Interim sacrifices were made 3 hours post-dose and on study days 3, 7, 

and 14; the remaining animals were sacrificed at the end of the study (day 21). There was no 

mortality, and, except on the day of dosing when the entire test material group showed reduced 

motor activity and dyspnea, all animals appeared normal throughout the study. Tissue samples 

were evaluated for A. pullulans after sacrifice. The following tissues were negative for A. 

pullulans at all time points: feces, brain, kidney, and intestine. Blood samples were negative 

except for one male on day 0; lung samples were negative except for two males and two females 

on day 0; liver samples were negative except for three males on day 0; spleen samples were 

negative except for two males on day 0; lymph node samples were negative except for one 

animal on day 7, and stomach samples were negative except for two males on day 0. Based on 

these results, A. pullulans DSMZ 14941 does not appear to be toxic, infective, and/or pathogenic 

in rat, when dosed at 0.8 x 108 cfu/animal. Acceptable.

Acute Injection Toxicity/Pathogenicity (OCSPP Guideline 885.3200; MRID No. 47871807 and 

47871808):

Male and female rats were injected with A. pullulans strain DSM 14940 (2.36 x 1010 cfu/g) and 

DSM 14941 (1.5 x 1010 cfu/g). Interim sacrifices were made on days 3, 7, and 14; the remaining 

animals were sacrificed at the end of the study (day 21). There were no deaths, and all animals 

appeared normal throughout the study except for edema or slight erythema at the injection site. 

Samples of the following tissues were negative for A. pullulans at all time points: feces, blood, 

brain, lung, liver, kidney, spleen, stomach, and intestine. Lymph node samples were negative 
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Biopesticides Registration Action Document

except for one animal sacrificed on day 7. A. pullulans strains DSMZ 14940 and DSMZ 14941

did not appear to be toxic. Acceptable.

In a second acute subcutaneous toxicity/pathogenicity study (MRID 47871808), male and female 

rats were injected with A. pullulans strain DSM 14941 (1.1 x 109 cfu/g). Interim sacrifices were 

made on days 1 and 7; the remaining animals were sacrificed at the end of the study (day 21).. 

There were no deaths, and all animals appeared normal throughout the study except for severe 

edema or slight erythema at the injection site. Samples of the following tissues were negative for 

A. pullulans at all time points: brain, lung, spleen, kidney, lymph nodes, blood and urine. The 

skin was positive for A. pullulans in three males and three females from the test material group 

on day 1 and in two females of the same group on day 7. The liver of one male from the test 

material group was positive on day 1. The cecum contents were positive in one male and one 

female from the test material group on day 1, and in two females from the same group on day 7.

A. pullulans DSM 14941 does not appear to be toxic, infective, and/or pathogenic in rats, when 

dosed at 1.6 x 107 cfu/animal. Acceptable.

Hypersensitivity Incidents (OCSPP Guideline 885.3400; MRID No. 47945023)

No hypersensitivity incidents, including immediate-type or delayed-type reactions of humans 

and domestic animals during research, development, or testing of A. pullulans strains DSM 

14940 and 14941 were reported by the applicant. Any future hypersensitivity incidents must be 

reported to EPA (refer to OCSPP Guideline 885.3400).

:

Cell Culture (OCSPP Guideline 885.3500)

This study was not required because Aureobasidium pullulans strains DSM 14940 and 14941 are 

not viruses (refer to test note #4 of 40 CFR § 158.2140(d)).

:

Acute Oral Toxicity

Six rats received a single 2000 mg/kg bw dose of Blossom Protect [22% (2 x 1010 cfu/g) A. 

pullulans strain DSM 14940, 22% (2 x 1010 cfu/g) A. pullulans strain DSM 14941, 25% sucrose, 

6% water]. There was no mortality, and all animals appeared normal throughout the study. The 

LD50 was >2000 mg/kg.

(OCSPP Guideline 870.1100; MRID No. 47869614):

Acceptable; Toxicity Category IV. 

Ten rats were dosed with 2000 mg/kg Blossom Protect (7 x 109 cfu/g each of DSM 14940 and 

DSM 14941). One male was humanely sacrificed on day 5 due to a ruptured abscess at the 

injection site; all other animals survived until study end on day 14. Necropsy revealed abscesses 

at all injection sites. The LD50 was >2000 mg/kg. Acceptable.

Acute Subcutaneous Toxicity (MRID 47869616):

In an acute dermal toxicity study, 10 rats were dosed with 2000 mg/kg Blossom Protect (7 x 10

9

cfu/g each of strains DSM 14940 and DSM 14941). One male and one female exhibited 

chromodacryorrhea, but this was not considered to be toxicologically significant. All animals 

appeared healthy at necropsy. The LD50 was >2000 mg/kg.

Acute Dermal Toxicity (OCSPP Guideline 870.1200; MRID 47869615):

Acceptable; Toxicity Category IV. 
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In an acute inhalation toxicity study, 10 rats were exposed (nose-only) to a 10% suspension of 

Blossom Protect (7 x 109 cfu/g A. pullulans strain DSM 14940 and 7 x 10

9

cfu/g A. pullulans

strain DSM 14941) at 5.17 mg/L. The MMAD was 4.2 μm. There were no deaths and all animals 

appeared healthy throughout the study. Necropsy was unremarkable. The LC50 was >5.17 mg/L. 

Acute Inhalation Toxicity (OCSPP Guideline 870.1300; MRID 47869617):

Acceptable; Toxicity Category IV. 

Three rabbits were dosed with 0.1 mL (60-62 g) of Blossom Protect (7 x 109 cfu/g A. pullulans

strain DSM 14940 and 7 x 109 cfu/g A. pullulans strain DSM 14941). One animal had a score of 

1 for conjunctival redness one hour after application. There were no other clinical signs, and all 

animals appeared normal at 24 hours. Blossom protect was considered to be virtually nonirritating.

Acute Eye Irritation (OCSPP Guideline 870.2400; MRID 47869618):

Acceptable; Toxicity Category IV.

Three rabbits were dosed with 0.5 g Blossom Protect (7 x 109 cfu/g A. pullulans strain DSM 

14940 and 7 x 109 cfu/g A. pullulans strain DSM 14941) moistened with 1.0 mL deionized 

water. All animals appeared normal throughout the study. Blossom Protect was considered 

virtually non-irritating. Acceptable; Toxicity Category IV. 

Primary Dermal Irritation (OCSPP Guideline 870.2500; MRID 47869619):

In vivo Micronucleus (MRID 47899304)

Mice received single oral gavage doses of A. pullulans strain DSM 14941 (2000 mg/kg) 

dissolved in water. There were no clinical signs. The animals were sacrificed 24 or 48 hours 

post-dosing, and the femoral bone marrow was immediately harvested. The ratio of 

polychromatic erythrocytes to total erythrocytes (mature and immature) was determined, and 

2000 immature erythrocytes/animal were scored for the incidence of micro nucleated immature 

erythrocytes. A. pullulans strain DSM 14941 did not produce a statistically significant increase in 

micro nucleated immature erythrocytes compared to the negative control animals. The response 

of the positive control animals (cyclophosphamide, IP injection, 10 mg/kg) was appropriate. 

Acceptable.

:

The effects of temperature on the reproduction of A. pullulans strains DSM 14940, DSM 14941, 

and CBS 626.85 in liquid culture or on agar plates were examined. All three strains grew well at 

30°C. At 33°C, the number of duplications of DSM 14940 and DSM 14941 was less than one, 

while the number of duplications for CBS 626.85 was approximately five. Neither DSM 14940 

nor DSM 14941 grew at 35 or 37°C. CBS 625.85 produced approximately two duplications at 

35°C and one at 37°C. Based on the lack of growth at temperatures of 35°C and above, strains 

DSM 14940 and DSM 14941 are non-pathogenic in humans. Acceptable.

Influence of Temperature on Reproduction (MRID 47871833):

Toxicity/Pathogenicity of Aureobasidium pullulans in Immunocompromised Patients

(MRID 4787181631):

Published literature describing various infections caused by Aureobasidium pullulans in 

immune-compromised patients were reviewed. None of the infections were caused by the two 

strains of A. pullulans (DSM 14941, 14940) submitted for registration. 
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b. Acute Toxicology and Subchronic Toxicity/Pathogenicity – Tier II;

 Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

 Infectivity/Pathogenicity Analysis – Tier III

Tier II and Tier III studies were not required for A. pullulans strains DSM 14940 and 14941

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

c. Endocrine Disruptors

As required under FFDCA section 408(p), EPA developed the Endocrine Disruptor Screening 

Program (EDSP) to determine whether certain substances (including pesticide active and other 

ingredients) may have an effect in humans or wildlife similar to an effect produced by a 

“naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” The EDSP employs a two-tiered approach to making the statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a quantitative relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first 

group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.

A. pullulans strains DSM 14940 and 14941 are not among the group of 58 pesticide active 

ingredients on the initial list to be screened under the EDSP. Under FFDCA section 408(p), EPA 

must screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP 

orders/data call-ins for all pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

2. Food Quality Protection Act (FQPA) Considerations

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement 

for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA 

determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to 

mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the 

pesticide chemical residue, including all anticipated dietary exposures and all other exposures for 

which there is reliable information.” This includes exposure through drinking water and in 

residential settings but does not include occupational exposure. Pursuant to section 408(c)(2)(B) 

of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a 

tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, 

which require EPA to give special consideration to exposure of infants and children to the 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 12 of 41

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pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable 

certainty that no harm will result to infants and children from aggregate exposure to the pesticide 

chemical residue....” Additionally, section 408(b)(2)(D) of FFDCA requires that EPA consider 

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

other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide 

residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the 

pesticide through food, drinking water, and through other exposures that occur as a result of 

pesticide use in residential settings.

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

and other relevant information, and considered its validity, completeness, and reliability and the 

relationship of this information to human risk. EPA has also considered available information 

concerning the variability of the sensitivities of major identifiable subgroups of consumers, 

including infants and children.

Based on the acute toxicity/pathogenicity data and information discussed previously and 

presented in Table 8 in Appendix A, the data required for a FQPA risk assessment for A.

pullulans strains DSM 14940 and 14941 have been fulfilled.

a. Aggregate Exposure

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

available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and 

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

uses).

Dietary Exposure and Risk Characterization: A. pullulans is likely to be commonly present on 

fresh produce. According to Webb and Mundt (1978) A. pullulans is “a major resident on most 

green plants.” In a study with several species of crop plants, they determined A. pullulans to be 

among the most abundant (71% - 85%) of all fungi present on plant surfaces. A. pullulans made 

up an average of 77.1% of the mold species isolated on green beans, and A. pullulans and other 

fungi occurred at high levels (up to 2.7 x 104 cfu/cm2

) on cucumbers and squash. Dietary 

exposure to A. pullulans strains DSM 14940 and 14941 is possible from ingestion of

strawberries, grapes, pome and stone fruits harvested from plants treated with pesticide 

containing these active ingredients. None of the studies indicated thattoxic or pathogenic effects 

will result if dietary exposure occurs. In addition, neither strain of A. pullulanscan grow at 

human body temperature (37°C), even if dietary exposure occurred, there is a reasonable 

certainty that no harm will result from exposure to such residues because of the lack of toxicity, 

infectivity, and or pathogenicity in the previously described toxicological studies (see section 

IV(B)(1)(a) and Table 8 in Appendix A).

Drinking Water Risk Characterization: Naturally occurring A. pullulans is widely distributed in 

many environmental habitats (e.g., in soil, water, leaves and other above ground plant parts, 

wood and many other plant materials, rocks monuments and limestone; Chi et al. 2009). Human 

exposure to residues of pesticides containing A. pullulans strains DSM 14940 and 14941 in

consumed drinking water is highly unlikely, however, since the proposed uses do not include 

direct application to aquatic environments, and neither strain is . A. pullulans strains DSM 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 13 of 41

Biopesticides Registration Action Document

14940 and 14941 known to inhabit aquatic environments. Should A. pullulans strains DSM 

14940 and 14941 be transferred to surface or ground water intended for human consumption, 

however, the fungi would not survive the conditions water is subjected to in a drinking water 

treatment facility, including high temperatures, chlorination, pH adjustments, and/or filtration.

Even if exposure should occur through consumed drinking water, there is a reasonable certainty 

that no harm will result from exposure to such residues, because of the lack of toxicity, 

infectivity, and/or pathogenicity in the previously described toxicological studies (see section 

IV(B)(1)(a) and Table 8 in Appendix A).

Non-occupational, Residential Risk Characterization: The use sites for these products include 

agricultural and residential gardens. Based on the data and other information submitted to satisfy 

data requirements for registration of the manufacturing-use and end-use pesticide products

containing the active ingredients A. pullulans strains DSM 14940 and 14941, no toxicity, 

infectivity, pathogenicity or other adverse effects from non-occupational exposure are expected 

(see section IV(B)(1)(a), above, and Table 8 in Appendix A).

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

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

or revoke a tolerance exemption, EPA consider “available information concerning the 

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

mechanism of toxicity.”

A. pullulans strains DSM 14940 and 14941 do not appear to produce toxic metabolites against 

target pests and do not share a common mechanism of toxicity with other substances. For the 

purposes of this tolerance action, therefore, EPA has assumed that A. pullulans strains DSM 

14940 and 14941 do not have a common mechanism of toxicity with other substances. For 

information regarding EPA’s efforts to determine which chemicals have a common mechanism 

of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at 

http://www.epa.gov/pesticides/cumulative.

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

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

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

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

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

408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for 

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

and the completeness of the database on toxicity and exposure unless EPA determines that a 

different margin of safety will be safe for infants and children. This additional margin of safety is 

commonly referred to as the FQPA Safety Factor. In applying this provision, EPA either retains 

the default value of 10X or uses a different additional safety factor when reliable data available 

to EPA support the choice of a different factor.

Based on the acute toxicity and pathogenicity data summarized in section IV(B)(1)(a) and Table 

5 in Appendix A, EPA concludes that there is a reasonable certainty that no harm will result to 

the U.S. population, including infants and children, from aggregate exposure to the residues of A.

pullulans strains DSM 14940 and 14941. This includes all anticipated dietary exposures and all 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 14 of 41

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other exposures for which there is reliable information. EPA has arrived at this conclusion 

because the data and information available on A. pullulans strains DSM 14940 and 14941 do not 

demonstrate toxic, pathogenic, and/or infective potential to mammals. There are no threshold 

effects of concern and, as a result, the provision requiring an additional margin of safety does not 

apply. 

3. Occupational Exposure and Risk Characterization

Handler exposure to A. pullulans strains DSM 14940 and 14941 is not expected to pose any 

undue risk. However, published literature was submitted concerning various infections caused by 

Aureobasidium pullulans in immune-compromised patients (MRID 47871816- 31). These 

infections were not caused by the two strains of A. pullulans (DSM 14941, 14940) submitted for 

registration. As a precautionary measure, the Agency is requiring that the label include specified 

personal protective equipment (PPE) to protect workers from repeated exposure to 

Aureobasidium pullulans strains DSM 14941 & DSM 14940. Appropriate personal protective 

equipment and precautionary statements are required on pesticide product labels to mitigate any 

potential risks to pesticide handlers due to prolonged or numerous exposures. Handlers applying 

A. pullulans strains DSM 14940 and 14941 end-use products in agricultural settings 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. Additional PPE, other than 

the standard described above, may be required on a product-specific basis.

4. Human Health Risk Characterization

EPA considered human exposure to A. pullulans strains DSM 14940 and 14941 in light of the 

standards for registration in FIFRA and the relevant safety factors in FFDCANo unreasonable 

adverse effects to the U.S. population in general, and to infants and children in particular, will 

result when A. pullulans strains DSM 14940 and 14941 pesticide products are used in 

accordance with EPA-approved labeling.

C. Environmental Assessment (40 CFR § 158.2150)

The Agency has performed an environmental risk assessment for the proposed uses of A.

pullulans strain DSM 14940 and 14941. 

The data and data waiver rationale, submitted by the applicant to support the pesticide products 

containing A. pullulans strains DSM 14940 and 14941 fulfill the Tier I non-target organism data 

requirements and are sufficient for risk assessment purposes. Further testing of non-target 

organisms at higher tier levels (i.e., Tiers II, III, and IV) is not required for the current uses and 

application methods. EPA performed an environmental risk assessment based on the data and 

data waiver rationale provided by the applicant and determined that the proposed use of A.

pullulans strains DSM 14940 and 14941 does not pose significant risk to non-target organisms 

when used according to label directions. 

For a comprehensive summary of the generic data requirements described in sections IV(C)(1), 

refer to Table 9 in Appendix A.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 15 of 41

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1. Ecological Exposure and Risk Characterization 

a. Terrestrial Animals and Plants

Birds (OCSPP Guideline 885.4050) and Mammals (OCSPP Guideline 885.4150); MRID 

47871811

The applicant submitted guideline studies and scientific rationale to satisfy data requirements for 

non-target organism risk assessment with the active ingredient. Submitted studies show that 

adverse effects to birds and mammals do not occur at maximum hazard doses (1.0 x 109

cfu/animal for birds and 4 x 108 cfu/animal for mammals) after 30 and 21 days of exposure, 

respectively. Additionally, information was submitted to show that A. pullulans strains DSM 

14940 and DSM 14941 do not grow at avian or mammalian body temperatures. 

:

A guideline study with honey bees showed no toxicity or pathogenicity after 22 days of exposure 

at 1.0 x 106 cfu/bee. Scientific rationale discussed additional evidence that A. pullulans is not 

toxic, pathogenic, or infective to other non-target insects. A. pullulans has been reported as part 

of the normal flora of insects (Pagnocca et al. 2008, Sacchi and Vaughan-Martini 2002, 2003)

and stingless bees (Rosa et al. 2003). It is commonly found in the environment, and it is not 

known as an entomopathogen. Therefore, A. pullulans strains DSM 14940 and DSM 14941 are

not expected to cause adverse effects in non-target insects and honey bees. 

Non-target Insects (OCSPP Guideline 885.4340) and Honey Bees (OCSPP Guideline 885.4380); 

MRID 48531003:

Non-target Plants (OCSPP Guideline 885.4300): Based on published literature, normal 

populations of A. pullulans on plants occur at up to 105 cfu/cm2 (e.g., see Osono 2008). The end 

use products (EPs) are applied at rates that are within the range of naturally occurring levels on 

plants. Spray drift analysis indicates that the amounts deposited at a point immediately adjacent 

to the treated area in terrestrial environments are several orders of magnitude lower. A spray 

buffer of 25 ft is required around aquatic areas, to limit concentrations of the active ingredients 

in aquatic environments to within the range of concentrations observed in nature (e.g., see 

Slavikova and Vadkertiova 1997). Therefore, the proposed applications of Aureobasidium 

pullulans strains DSM 14940 and DSM 14941 are not expected to result in concentrations in 

terrestrial or aquatic environments above those found in the environment. Data waiver rationale 

was submitted to fulfill the non-target plant data requirement. 

Aureobasidium pullulans is regarded as a weak plant pathogen (Deshpande et al. 1992, KockovaKratochvilova et al. 1980). Instances where disease is known to occur have required vectors 

(e.g., stigmatomycosis in pistachio) or where A. pullulans was intentionally applied at very high 

concentration (1016 cfu/mL) for weed biocontrol. A. pullulans also is reported as a naturally 

occurring epi- or endophyte from a wide range of plant species but does not cause any signs of

disease (Deshpande et al. 1992, see also Gao et al. 2005, Granado et al 2008, Osono 2008, 

Slavikova et al. 2007, Smith et al. 1989, Suryanarayanan et al. 2005, Webb and Mundt 1978). A. 

pullulans also is very common on the phylloplane of plants (Chi et al. 2009). BPPD performed a 

literature search in several databases and did not find any reports of Aureobasidium pullulans as 

a pathogen in plants. Based on the available data, BPPD concluded that A. pullulans strains 

DSM 14940 and DSM 14941 have low potential to cause toxicity or pathogenicity in plants. 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 16 of 41

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b. Aquatic Animals and Plants

Freshwater Fish (OCSPP Guideline 885.4200) and Freshwater Invertebrates (OCSPP Guideline 

885.4240); MRID 47871812: A freshwater fish study showed that A. pullulans strains DSM 

14940 and 14941 do not produce toxic effects at 100 mg/L (4.1 x 103 cfu/mL measured). 

Additional rationale and a spray drift analysis were sufficient to show that significant 

concentrations (i.e., above naturally occurring levels) will not reach aquatic environments when 

applied according to the proposed label. A 21-day Daphnia study showed that the active 

ingredients are not toxic or pathogenic to aquatic invertebrates at concentrations (approx. 2 – 24 

cfu/mL) that may occur in water as a result of the proposed applications (EC50 > 1.3 x 106

cfu/mL, NOEC = 1.3 x 106 cfu/mL). Based on this information, adverse effects are not expected 

to freshwater fish and invertebrates. Testing on marine/estuarine fish and invertebrate and 

aquatic plants was not required because significant concentrations are not expected to reach these 

organisms. 

Estuarine/Marine Fish and Invertebrates (OCSPP Guideline 885.4280): As determined above, 

the proposed applications are not expected to reach aquatic areas in significant amounts with the 

25 foot spray buffer requirement in place. Therefore, adverse effects to marine or estuarine fish 

and invertebrates are not expected to result from the proposed applications of A. pullulans strains

14940 and 14941. 

c. Open Literature Information

EPA performed literature searches to determine if other effects have been reported that were not 

contained within the information provided by the registrant. A search was performed using the 

Environmental Information Search service available to the Agency. This search tool 

simultaneously queries the Agricola, Biosis Previews, CAB Abstracts, Energy, Science, and 

Technology, General Science Abstracts, and National Technical Information Service databases 

within the years of 1926 – present. The Web of Knowledge database also was searched for all 

years available. Searches were performed with the term ‘Aureobasidium pullulans’ combined 

with each of the terms, ‘bird,’ ‘mammal,’ insect,’ ‘bee,’ ‘arthropod,’ ‘aquatic,’ ‘invertebrate,’ 

‘fish,’ ‘reptile,’ ‘amphibian,’ ‘plant,’ ‘algae,’ ‘freshwater,’ ‘marine,’ ‘estuarine,’ ‘soil,’ and 

‘pathogen. None of the records returned in these searches indicated potential adverse effects on 

non-target organisms.

2. Environmental Fate Data 

As the information provided, for the current uses and application methods, is sufficient to both

satisfy the Tier I non-target organism data requirements and for non-target organism risk 

assessment for A. pullulans strains DSM 14940 and DSM 14941, further testing at higher tier 

levels (i.e., Tiers II, III, and IV) is not required. 

3. Threatened and Endangered Species Assessment

The proposed applications of A. pullulans strains DSM 14940 and DSM 14941 are not expected 

to increase the amount of A. pullulans above levels that are found naturally in the environment. 

Additionally, several guideline studies and scientific rationale show that toxicity or pathogenicity 

is not expected with wild mammals, birds, non-target plants, non-target insects, honey bees, 

freshwater fish (toxicity only), and freshwater invertebrates. The information provided is 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 17 of 41

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sufficient to satisfy the Tier I non-target organism data requirements and for non-target organism 

risk assessment for the active ingredient. Further testing of non-target organisms at higher tier 

levels is not required. Based on the data, literature citations, and data waiver rationale provided 

by the applicant, BPPD has determined that adverse effects to non-target organisms are not 

anticipated as a result of the proposed uses of Aureobasidium pullulans strains DSM 14940 and 

DSM 14941. A “No Effect” determination is also made for direct and indirect effects to listed 

species and their designated critical habitats resulting from the proposed uses of Aureobasidium 

pullulans strains DSM 14940 and DSM 14941, 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—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. Fair 

treatment means that no group of people, including racial, ethnic, or socioeconomic groups, 

should bear a disproportionate share of the negative environmental consequences resulting from 

industrial, municipal, and commercial operations or the execution of federal, state, local, and 

tribal environmental programs and policies. Meaningful involvement means that (1) potentially 

affected community residents have an appropriate opportunity to participate in decisions about a 

proposed activity that will affect their environment and/or health; (2) the public’s contribution 

can influence the regulatory agency’s decision; (3) the concerns of all participants involved will 

be considered in the decision-making process; and (4) the decision-makers seek out and facilitate 

the involvement of those potentially affected. EPA has this goal for all communities and persons 

across the United States. 

EPA sought information on any groups or segments of the population who, as a result their 

location, cultural practices, or other factors, may have atypical, unusually high exposure to A.

pullulans strains DSM 14940 and DSM 14941, compared to the general population. No public 

comments were received on this particular matter.

For additional information regarding environmental justice issues, please visit EPA’s web site at 

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

VI. RISK MANAGEMENT DECISION

Section 3(c)(5) of FIFRA permits for the registration of a pesticide provided that all the 

following determinations are made:

(1) Its composition is such as to warrant the proposed claims for it;

(2) Its labeling and other material required to be submitted comply with the

 requirements of FIFRA;

(3) It will perform its intended function without unreasonable adverse effects on 

 the environment; AND

(4) When used in accordance with widespread and commonly recognized 

 practice, it will not generally cause unreasonable adverse effects on the 

 environment.

To satisfy criterion 1, the Aureobasidium pullulans strain DSM 14940 and Aureobasidium 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 18 of 41

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pullulans strain DSM 14941 pesticide products have well-known properties. EPA has no 

knowledge that would contradict the claims made on the Aureobasidium pullulans strain DSM 

14940 Technical, Aureobasidium pullulans strain DSM 14941 Technical, Botector, and Blossom 

Protect EP labels. These products are not expected to cause unreasonable adverse effects on the 

environment when used according to label instructions. Criterion 2 is satisfied by the current 

product labels, as well as the data and information presented in this document. It is believed that

the Aureobasidium pullulans strain DSM 14940 and Aureobasidium pullulans strain DSM 14941

will not cause any unreasonable adverse effects on the environment, and Botector, and Blossom 

Protect EPs (end-use products), in particular, are likely to protect against fungal pests as claimed, 

thereby satisfying criterion 3. Criterion 4 is satisfied in that the Aureobasidium pullulans strain

DSM 14940 and Aureobasidium pullulans strain DSM 14941 pesticide products are not expected 

to cause unreasonable adverse effects when used according to label instructions. Therefore, 

Aureobasidium pullulans strain DSM 14940 Technical, Aureobasidium pullulans strain DSM 

14941 Technical, Botector, and Blossom Protect (all containing Aureobasidium pullulans strain

DSM 14940 and/or Aureobasidium pullulans strain DSM 14941 as two new active ingredients)

are eligible for registration under FIFRA section 3(c)(5) for labeled uses. If the applicant

proposes uses that are more extensive in the future (e.g., post-harvest applications), EPA will 

likely require that additional data be submitted in conjunction with a registration amendment 

request.

VII. ACTIONS REQUIRED BY THE REGISTRANT

A. Final Printed Labeling

Before releasing pesticide products containing Aureobasidium pullulans strain DSM 14940 and 

Aureobasidium pullulans strain DSM 14941 for shipment, the registrant is required to provide 

appropriate final printed labeling to EPA.

B. Reporting of Adverse Effects and Hypersensitivity Incidents

Notwithstanding the information stated in the previous sections, it should be clearly understood 

that certain, specific data are required to be reported to EPA as a requirement for maintaining the 

federal registration for a pesticide product. A brief summary of these types of data are described 

below.

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

the provisions stated in FIFRA section 6(a)(2). Additionally, all incidents of hypersensitivity 

(including both suspected and confirmed incidents) must be reported to EPA under the 

provisions of 40 CFR § 158.2140(d).
Aureobasidium pullulans strains DSM 14940 and 14941 Page 19 of 41

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VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

ASAE American Society of Agricultural Engineers

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticides Registration Action Document

CFR Code of Federal Regulations

cfu colony-forming unit(s)

cfu/kg colony-forming units per kilogram

cfu/mL colony-forming units per milliliter

cP centipoise

DSMZ Deutsche Sammlung von Mikroorganismen und Zellkulturen (the German Strain 

Collection for Microorganisms)

EDSP Endocrine Disruptor Screening Program

EP end-use product

EPA Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g/mL gram per milliliter

LC50 median lethal concentration. A statistically derived concentration of a 

substance that can be expected to cause death in 50% of test animals. It is 

usually expressed as the weight of substance per weight or volume of water, 

air, or feed (e.g., mg/L, mg/kg, or ppm).

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).

mg/kg milligrams per kilogram

mg/L milligrams per liter

MP manufacturing-use product

MRID No. Master Record Identification Number

NIOSH National Institute for Occupational Safety and Health

NRRL Northern Regional Research Laboratory

OCSPP Office of Chemical Safety and Pollution Prevention

OPP Office of Pesticide Programs

PC Code Pesticide Chemical Code

PP Pesticide Petition

PPE personal protective equipment

ppm parts per million

TGAI technical grade of the active ingredient

ULV ultra low volume
Aureobasidium pullulans strains DSM 14940 and 14941 Page 20 of 41

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IX. BIBLIOGRAPHY

A. Studies Submitted to Support the Aureobasidium pullulans strains DSM 14940 and 14941 Pesticide Product

Registrations

MRID Citation Reference

47869500 Bio-Fern GmbH (2009) Submission of Product Chemistry and Toxicity Data in 

Support of the Application for Registration of Botector. Transmittal of 3 

Studies.

47869501 Smith, F. (2009) Botector: Product Identity and Composition, Description of 

Beginning Materials, Description of Formulation Process, Discussion of the 

Formation of Impurities, and Certified Limits. Unpublished study prepared by 

SciReg, Inc. 39 p.

47869502 Smith, F. (2009) Botector: Physical-Chemical Properties. Unpublished study 

prepared by SciReg, Inc. 7 p.

47869503 Smith, F. (2009) Botector: Acute Toxicity Summary. Unpublished study 

prepared by SciReg, Inc. 11 p.

47869600 Bio-Ferm GmbH (2009) Submission of Product Chemistry and Toxicity Data in 

Support of the Application for Registration of Blossom Protect. Transmittal of 

19 Studies.

47869601 Smith, F. (2009) Blossom Protect: Product Identity and Composition, 

Description of Beginning Materials, Description of Formulation Process, 

Discussion of the Formation of Impurities, and Certified Limits. Unpublished 

study prepared by SciReg, Inc. 33 p.

47869602 Smith, F. (2009) Blossom Protect: Physical-Chemical Properties. Unpublished 

study prepared by SciReg, Inc. 9 p.

47869603 Kiss, G. (2006) Determination of Flammability of Component B of Blossom 

Protect FB: Final Report. Project Number: 06/262/356AN. Unpublished study 

prepared by LAB International Research Centre Hungary, Ltd. 12 p.

47869604 Kiss, G. (2009) Determination of the pH - Values of Blossom Protect 

(Component B): Final Report. Project Number: 09/097/338AN. Unpublished 

study prepared by LAB International Research Centre Hungary, Ltd. 12 p.

47869605 Kiss, G. (2006) Determination of the Relative Self-Ignition Temperature of 

Component B of Blossom Protect FB: Final Report. Project Number: 

06/262/355AN. Unpublished study prepared by LAB International Research 

Centre Hungary, Ltd. 12 p.

47869606 Moller, M. (2007) Component B of Blossom Protect FB: Wettability: Final 

Report. Project Number: 20060875/03. Unpublished study prepared by Siemens 

Axiva GmbH & Co. KG. 10 p.

47869607 Moller, M. (2007) Component B of Blossom Protect FB: Persistent Foaming: 

Final Report. Project Number: 20060875/01. Unpublished study prepared by 

Siemens Axiva GmbH & Co. KG. 9 p.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 21 of 41

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47869608 Moller, M. (2007) Component B of Blossom Protect FB: Suspensibility: Final 

Report. Project Number: 20060875/02. Unpublished study prepared by Siemens 

Axiva GmbH & Co. KG. 10 p.

47869609 Moller, M. (2007) Component B of Blossom Protect FB: Dispersibility: Final 

Report. Project Number: 20060875/04. Unpublished study prepared by Siemens 

Axiva GmbH & Co. KG. 10 p.

47869610 Kiss, G. (2007) Wet Sieve Test of Component B of Blossom Protect FB: Final 

Report. Project Number: 06/262/342AN. Unpublished study prepared by LAB 

International Research Centre Hungary, Ltd. 12 p.

47869611 Kiss, G. (2006) Determination of the Particle Size Distribution of Component B 

of Blossom Protect FB: Final Report. Project Number: 06/262/363AN. 

Unpublished study prepared by LAB International Research Centre Hungary, 

Ltd. 14 p.

47869612 Moller, M. (2007) Component B of Blossom Protect FB: Dustiness of Granules: 

Final Report. Project Number: 20060875/05. Unpublished study prepared by 

Siemens Axiva GmbH & Co. KG. 10 p.

47869613 Smith, F. (2009) Blossom Protect: Acute Toxicity Summary. Unpublished study 

prepared by SciReg, Inc. 5 p.

47869614 Wolf, T. (2003) "BP2042": Acute Oral Toxicity Study with Rats (Acute Toxic 

Class Method). Project Number: ARC/UL/0608. Unpublished study prepared by 

Austrian Research Center (ARC). 18 p.

47869615 Bernat, E. (2003) "BP2042": Acute Dermal Toxicity Study with Rats. Project 

Number: ARC/UL/0614. Unpublished study prepared by Austrian Research 

Center (ARC). 20 p.

47869616 Wolf, T. (2003) "BP2042": Acute Subcutaneous Toxicity Study with Rats. 

Project Number: ARC/UL/0609. Unpublished study prepared by Austrian 

Research Center (ARC). 22 p.

47869617 Weniger, P. (2003) "BP2042": Acute Inhalation Toxicity in Rats. Project 

Number: OEFZS/UL/0638. Unpublished study prepared by Austrian Research 

Center (ARC). 30 p.

47869618 Wolf, T. (2003) "BP2042": Acute Eye Irriation/Corrosion Study with Rabbits. 

Project Number: ARC/UL/0611. Unpublished study prepared by Austrian 

Research Center (ARC). 16 p.

47869619 Wolf, T. (2003) "BP2042": Acute Dermal Irritation/Corrosion Study with 

Rabbits. Project Number: ARC/UL/0610. Unpublished study prepared by 

Austrian Research Center (ARC). 16 p.

47871700 Bio-Ferm GmbH (2009) Submission of Product Chemistry Data in Support of 

the Application for Registration of Aureobasidium pullulans Strains DSM 14940 

Technical. Transmittal of 3 Studies.

47871701 Smith, F. (2009) Aureobasidium pullulans Strain DSM 14940: Product Identity 

and Composition, Description of Beginning Materials, Description of 

Production Process, Discussion of the Formation of Impurities, and Certified 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 22 of 41

Biopesticides Registration Action Document

Limits. Unpublished study prepared by SciReg, Inc. 95 p.

47871702 Smith, F. (2009) Aureobasidium pullulans Strain DSM 14940: Analysis of 

Samples. Unpublished study prepared by SciReg, Inc. 10 p.

47871703 Smith, F. (2009) Aureobasidium pullulans Strain DSM 14940: Summary of 

Physical-Chemical Properties. Unpublished study prepared by SciReg, Inc. 11 p.

47871800 Bio-Fern GmbH (2009) Submission of Product Chemistry, Toxicity, Efficacy, 

and Exposure and Risk Data in Support of the Application for Registration of 

Aureobasidium pullulans Strain DSM 14941 Technical, and the Petition for 

Tolerance of Aureobasidium pullulans for Food Use. Transmittal of 26 Studies. 

47871802 Smith, F. (2009) Aureobasidium pullulans Strain DSM 14941: Analysis of 

Samples. Unpublished study prepared by SciReg, Inc. 10 p.

47871803 Smith, F. (2009) Aureobasidium pullulans Strain DSM 14941: Summary of 

Physical-Chemical Properties. Unpublished study prepared by SciReg, Inc. 11 p.

47871804 Smith, F. (2009) Storage Stability of Aureobasidium pullulans Strains DSM 

14940 and DSM 14941. Unpublished study prepared by SciReg, Inc. 8 p.

47871805 Smith, F. (2009) Summary of Tier 1 Data Requirements: (Aureobasidium 

pullulans Strain DSM 14941 Technical). Unpublished study prepared by 

SciReg, Inc. 13 p.

47871807 Muller, W. (2005) Determination of the Toxic/Infectious/Pathogen Behaviour of 

Two Strains of Aureobasidium pullulans (DSM 14940 and 14941) in the Rat 

after Subcutaneous Administration: Final Report. Project Number: 

KBL/2004/1474/RSC. Unpublished study prepared by Kesla Forschung & 

Service GmbH + Co. KG. 60 p.

47871808 Muller, W. (2006) Determination of the Toxic/Infectious/Pathogen Behaviour of 

Aureobasidium pullulans DSMZ 14941 in the Rat after Subcutaneous 

Administration: Final Report. Project Number: KBL/2006/1540/RSC. 

Unpublished study prepared by Kesla Forschung & Service GmbH + Co. KG. 

60 p.

47871811 Gaty, S. (2009) Avian Oral Pathogenicity and Toxicity Study of Aureobasidium 

pullulans DSM 14941 (CF40) on Japanese Quail (Coturnix coturnix japonica): 

Final Report. Project Number: 09/159/115FU. Unpublished study prepared by 

LAB Research, Ltd. 40 p.

47871812 Hernadi, D. (2007) Fish Acute Toxicity Study with Component B of Blossom 

Protect fb on Rainbow Trout (Oncorhynchus mykiss): Final Report. Project 

Number: 06/282/009H. Unpublished study prepared by LAB International 

Research Centre Hungary, Ltd. 23 p.

47871816 Redondo-Bellon, P.; Idoate, M. ; Rubio, M. ; et al. (1997) Chromoblastomycosis 

Produced by Aureobasidium pullulans in an Immunosuppressed Patient. 

Archives of Dermatology 133:663-664.

47871817 Tan, H. ; Wahlstrom, H. ; Zamora, J. ; et al. (1997) Aureobasidium pneumonia 

in a Post Liver Transplant Recipient: A Case Report. Hepato-Gastroenterology 

44:1215-1218.
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47871818 Clark, E.; Silver, S.; Hollick, G.; et al. (1995) Continuous Ambulatory 

Peritoneal Complicated by Aureobasidium pullulans Peritonitis. American 

Journal of Nephrology 15:353-355.

47871819 Caporale, N.; Calegari, L.; Perez, D.; et al. (1996) Peritoneal Catheter 

Colonization and Peritonitis with Aureobasidium pullulans. Peritoneal Dialysis 

International 16(1):97-98.

47871820 Matsumoto, T.; Padhye, A.; Ajello, L. (1987) Medical Significance of the SoCalled Black Yeasts. European Journal of Epidemiology 3(2):87-95.

47871821 Hoog, G. (1996) Risk Assessment of Fungi Reported from Humans and 

Animals. Mycoses 39:407-417.

47871822 Bolignano, G.; Criseo, G. (2003) Disseminated Nosocomial Fungal Infection by 

Aureobasidium pullulans Var. melanigenum: A Case Report. Journal of Clinical 

Microbiology 41(9):4483-4485.

47871823 Fostel, J.; Lartey, P. (2000) Emerging Novel Antifungal Agents. Drug 

Discovery Today 5(1):25-32.

47871824 Schrattenholz, A.; Flesch, P. (1993) Isolation, Structural and Toxicological 

Characterization of Three New Mycotoxins Produced by the Fungus 

Aureobasidium pullulans. Mycotoxin Research 9:13-21.

47871825 Sanchez, D.; Calla, M.; Martin-diaz, M.; et al. (2006) Subcutaneous Mycosis 

Produced by Aureobasidium pullulans in a Renal Transplant Recipient. Journal 

of European Academy of Dermatology and Venereology 20:229-230.

47871826 Koppang, H.; Olsen, I.; Stuge, U.; et al. (1990) Aureobasidium Infection of the 

Jaw. Journal of Oral Pathology and Medicine 20:191-195.

47871827 Hawkes, M.; Rennie, R.; Sand, C.; et al. (2005) Aureobasidium pullulans 

Infection: Fungemia in an Infant and a Review of Human Cases. Diagnostic 

Microbiology and Infectious Disease 51:209-213.

47871828 Taylor, P.; Esch, R.; Flagan, R.; et al. (2005) Identification and Possible Disease 

Mechanisms of an Under-Recognized Fungus, Aureobasidium pullulans. 

International Archives of Allergy and Immunology 139:45-52.

47871829 Salkin, I.; Martinez, J.; Kemna, M. (1986) Opportunistic Infection of the Spleen 

Caused by Aureobasidium pullulans. Journal of Clinical Microbiology 

23(5):828-831.

47871830 Kaczmarski, E.; Liu, J.; Tooth, J.; et al. (1986) Systemic Infection with 

Aureobasidium pullulans in a Leukaemic Patient. Journal of Infection 13:289-

291.

47871831 Buzina, W.; Braun, H.; Freudenschuss, K.; et al. (2003) Fungal Biodiversity - as 

Found in Nasal Mucus. Medical Mycology 41:149-161.

47871832 Perez, R.; Chacon, J.; Martin, J.; et al. (2009) Peritonitis by Aureobasidium

pullulans in Conditions Ambulatory Peritoneal Dialysis. Archives of 

Dermatoloy 133:1544-1545.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 24 of 41

Biopesticides Registration Action Document

47871833 Kunz, S. (2009) Influence of Temperature on the Reproduction on Different 

Strains of the Species Aureobasidium pullulans. Unpublished study prepared by

Bio-Protect GmbH. 11 p.

47899300 Bio-Ferm GmbH (2009) Submission of Product Chemistry Data in Support of 

the Application for Registration of Aureobasidium pullulans Strains DSM 14941 

Technical and the Petition for Tolerance of Aureobasidium pullulans (Strains 

DSM 14941 and DSM 14941). Transmittal of 7 Studies.

47899301 Smith, F. (2009) Aureobasidium pullulans strain DSM 14941: Product Identity 

and Composition, Description of Beginning Materials, Description of 

Production Process, Discussion of the Formation of Impurities, and Certified 

Limits. Unpublished study prepared by SciReg, Inc. 144 p.

47899302 Zeljenkova, D. (2006) Acute Oral Toxicity/Pathogenicity in Rats According to 

EPA Microbial Pesticide Test Guidelines: (Aureobasidium pullulans): Final 

Report. Project Number: E/318/2006. Unpublished study prepared by Slovak 

Medical University. 33 p.

47899303 Zeljenkova, D.; Kazar, J. (2007) Acute Pulmonary Toxicity/Pathogenicity in 

Rats According to EPA Microbial Pesticide Test Guidelines: (Aureobasidium 

pullans): Final Report. Project Number: E/400/2006. Unpublished study 

prepared by Slovak Medical University. 54 p.

47899304 Szabova, E. (2006) Mutagenicity - in Vivo Mammalian Erythrocyte 

Micronucleus Test: (Aureobasidium pullulans): Final Report. Project Number: 

319/06. Unpublished study prepared by Slovak Medical University. 24 p.

47899305 Fritz, J.; Pruckner, M. (2009) Extended Report: Toxicity Test with Water Fleas: 

(Blossom Protect, Produktkomponente B). Project Number: 

BIOFERM/DAPHNIA. Unpublished study prepared by University of Natural 

Resources and Applied Life Sciences, Vienna. 8 p.

47899306 Fritz, J.; Pruckner, M. (2009) Extended Report: Toxicity Test with Plants: 

(Blossom Protect). Project Number: BIOFERM/PLANTS. Unpublished study 

prepared by Univ. of Natural Resources and Applied Life Sciences, Vienna. 21 

p.

47899307 Donat, C. (2009) Statement on Toxicity of the Active Substance of Blossom 

Protect on Bees. Unpublished study prepared by Bio-ferm GmbH. 10 p.

48531000 Bio-Ferm GmbH (2011) Submission of Toxicity and Product Chemistry Data in 

Support of the Applications for Registration of Aureobasidium pullulans Strain 

DSM 14940 Technical, Aureobasidium pullulans Strain DSM 14941, Botector 

and Blossom Protect. Transmittal of 3 Studies.

48531002 Gaty, S. (2009) Reproduction Test with Blossom Protect (Component B) on 

Daphnia magna. Project Number: 09/097/124/DA. Unpublished study prepared 

by LAB International Research Centre Hungary, Ltd. 46 p.

48531003 Gaty, S. (2009) Oral Toxicity Test with Blossom Protect (Component B) and 

with Tank Solution on Honey Bees (Apis mellifera). Project Number: 

09/127/116MT. Unpublished study prepared by LAB International Research 

Centre Hungary, Ltd. 26 p.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 25 of 41

Biopesticides Registration Action Document

48531004 Smith, F. (2011) Blossom Protect: Certified Limits. Unpublished study prepared 

by SciReg, Inc. 7 p.

48547201 Donat, C. (2011) Storage Stability: Blossom Protect Component B at 20 

Degrees Celsius. Unpublished study prepared by Bio-Ferm GmbH. 15p.

B. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2011a. Environmental risk assessment for the FIFRA Section 3 registration of 

Aureobasidium pullulans strain DSM 14940 and strain DSM 14941 for control of diseases in 

pome fruits, stone fruits, grapes, and strawberries. Memorandum from S. Borges, to S. Cerrelli 

dated November 2, 2011.

U.S. EPA. 2011b. Review of Product Chemistry, Manufacturing Process, and Acute Toxicity 

Studies for section 3 registration of two end use products (EP) Botector (EPA Reg. No. 86174-

G) and Blossom Protect (EPA Reg. No. 86174-U) containing two new TGAI: Aureobasidium

pullulans strain DSM 14941 and Aureobasidium pullulans strain DSM 14940. Memorandum 

from I. S. Barsoum, Ph.D . and J. L. Kough, Ph.D., to S. Cerrelli dated May 1, 2011.

U.S. EPA. 2011c. Review of Product Chemistry, Manufacturing Process, and Acute Toxicity 

Studies for section 3 registration of two TGAI Aureobasidium pullulans strains DSM 14941 

(EPA Reg. No. 86174-R) and strain DSM 14940 (EPA Reg. No. 86174-E) Memorandum from:

I.S. Barsoum, , Ph.D. and J. L. Kough, Ph.D., to S. Cerrelli dated May 1, 2011.

U.S. EPA. 2011d. Review of the Registrant’s response to the deficiencies found by the Agency 

in its review of product chemistry, manufacturing process, and acute toxicity studies for the 

registration of two new EPs: Botector and Blossom Protect containing two new TGAIs 

Aureobasidium pullulans strains DSM 14940 & DSM 14941. Memorandum from: I. S. Barsoum,

Ph.D and J. L. Kough, Ph.D., to S. Cerrelli dated September 29, 2011.

C. Other References

Andrews, J.H., R.N. Spear, E.V. Nordheim. 2002. Population biology of Aureobasidium 

pullulans on apple leaf surfaces. Can. J. Microbiol. 48: 500-513.

Chi, Z., F. Wang, Z. Chi, L. Yue, G. Liu, T. Zhang. 2009. Bioproducts from Aureobasidium 

pullulans, a biotechnologically important yeast. Appl. Microbiol. Biotechnol., 82: 793-804.

Cooke, W.B. 1959. An ecological life history of Aureobasidium pullulans (De Bary) Arnaud. 

Mycopathologia, 12: 1-45.

Deshpande, M.S., V.B. Rale, and J.M. Lynch. 1992. Aureobasidium pullulans in applied 

microbiology: a status report. Enzyme Microbiol. Technol. 14: 514-527.

Eskalen, A., M. Kusek, L. Dani-ti, and S. Karada. 1999. Fungal diseases in pistachio trees in 

East-Mediterranean and Southeast Anatolian regions. 11. GREMPA Seminar on Pistachios 

and Almonds, Sanliurfa (Turkey), 1-4 Sept. 1999.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 26 of 41

Biopesticides Registration Action Document

Fleet, G.H. 2002. The yeast ecology of wine grapes. Pp. 1-17 in Biodiversity and Biotechnol. Of 

Wine Yeasts (Ciani, M., ed.). Research Signpost, Kerala, India.

Fleet, G.H. 2003. Yeast interactions and wine flavor. Int. J. Food Microbiol., 86: 11-22.

Gao, X.-X., H. Zhou, D.-Y. Xu, C.-H. Yu, Y.-Q. Chen, L.-H. Qu. 2005. High diversity of 

endophytic fungi from the pharmaceutical plant, Heterosmilax japonica Kunth revealed by 

cultivation-independent approach. FEMS Microbiol. Letters, 249: 255-266.

Granado, J., B. Thurig, E. Kieffer, L. Petrini, A. Fliessbach, L. Tamm, F.P. Weibel, G.S. Wyss. 

2008. Culturable fungi of stored ‘Golden Delicious’ apple fruits: a one-season comparison 

study of organic and integrated production systems in Switzerland. Microb. Ecol., 56: 720-

732.

Kockova-Kratochvilova, A., M. Cernakova, and E. Slavikova. 1980. Morphological changes 

during the life cycle of Aureobasidium pullulans (de Bary) Arnaud. Folia Microbiologica, 

25: 

Leibinger, W., B. Breuker, M. Hahn, and K. Mendgen. 1997. Control of postharvest pathogens 

and colonization of the apple surface by antagonistic microorganisms in the field. 

Phytopathology, 97: 1103-1110.

Osono, T. 2008. Endophytic and epiphytic phyllosphere fungi of Camellia japonica: seasonal 

and leaf age-dependent variations. Mycologia, 100: 387-391.

Pagnocca, F.C., A. Rodrigues, N.S. Nagamoto, M. Bacci, Jr. 2008. Yeasts and filamentous fungi 

carried by the gynes of leaf-cutting ants. Antonie van Leeuwenhoek, 94: 517-526.

Prashanthi, S.K. and S. Kulkarni. 2005. Aureobasidium pullulans, a potential mycoherbicide for 

biocontrol of eupatorium [Chromolaena odorata (L.) King and Robinson] weed. Current 

Science, 88: 18-21.

Rosa, C.A., M.-A. Lachance, J.O.C. Silva, A.C.P. Teixeira, M.M. Marini, Y. Antonini, R.P. 

Martins. Yeast communities associated with stingless bees. FEMS Yeast Res. 4: 271-275.

Slavikova, E., R. Vadkertiova, and D. Vranova. 2007. Yeasts colonizing the leaf surfaces. J. 

Basic Microbiol. 47: 344-350.

Slepecky, R.A. and W.T. Starmer. 2009. Phenotypic plasticity in fungi: a review with 

observations on Aureobasidium pullulans. Mycologia 101: 823-832.

Smith, C.S., T. Chand, R.F. Harris, J.H. Andrews. 1989. Colonization of a submersed aquatic 

plant, Eurasian water milfoil (Myriophyllum spicatum), by fungi under controlled conditions. 

Appl. and Environm. Microbiol. 55: 2326-2332.

Suryanarayanan, T.S., S.K. Wittlinger, and S.H. Faeth. 2005. Endophytic fungi associated with 

cacti in Arizona. Mycol. Res. 109: 635-639.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 27 of 41

Biopesticides Registration Action Document

Webb, T.A. and J.O. Mundt. 1978. Molds on vegetables at the time of harvest. Appl. Environ. 

Microbiol., 35: 655-658.

Woody, S.T., R.N. Spear, E.V. Nordheim, A.R. Ives, and J.H. Andrews. 2003. Single-leaf 

resolution of the temporal population dynamics of Aureobasidium pullulans on apple leaves. 

Appl. Environm. Microbiol., 69: 4892-4900.

Zacchi, L. and A. Vaughan-Martini. 2002. Yeasts associated with insects in agricultural areas of 

Perugia, Italy. Ann. Microbiol. 52: 237-244.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 28 of 41

Biopesticides Registration Action Document

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 

(40 CFR PART 158 – SUBPART V)

TABLE 1. Product Analysis Data Requirements for the Technical Grade of the Active Ingredient

(TGAI)/Manufacturing-Use Product (MP), Aureobasidium pullulans strain DSM 14940 Technical

(40 CFR § 158.2120)

OCSPP 

Guideline 

Number 

Data Requirement

Results

MRID No.

TGAI MP

885.1100 Product Identity Not applicable Submitted data fulfill the 

requirement for product 

identity.

47871701

885.1200 Manufacturing Process Submitted data fulfill the requirement for manufacturing 

process.

47871701

Not applicable Deposition of a Sample 

in a Nationally 

Recognized Culture 

Collection

Aureobasidium pullulans

strain DSM 14940 is on 

deposit with the Deutsche 

Sammlung von 

Mikroorganismen und 

Zellkulturen (DSMZ , the 

German Strain Collection for 

Microorganisms) under the 

reference number DSM 

14940 

Not applicable 47871701

885.1300 Discussion of Formation 

of Unintentional 

Ingredients

Submitted data fulfill the requirement for discussion of 

formation of unintentional ingredients for the current use 

sites. 

47871701

885.1400 Analysis of Samples Submitted data fulfill the requirement for analysis of samples. 47871702

885.1500 Certification of Limits Not applicable Limits listed on the 

confidential statement of 

formula are 

adequate/acceptable.

CSF dated 

July 7, 2011 

Additional Studies

830.1800 Enforcement Analytical 

Method

Not applicable Submitted data fulfill the 

requirement for an 

enforcement analytical 

method.

47869601
Aureobasidium pullulans strains DSM 14940 and 14941 Page 29 of 41

Biopesticides Registration Action Document

TABLE 2. Product Analysis Data Requirements for the Technical Grade of the Active Ingredient 

(TGAI)/Manufacturing-Use Product (MP), and Aureobasidium pullulans strain DSM 14941 Technical (40 CFR § 

158.2120)

OCSPP 

Guideline 

Number 

Data Requirement

Results

MRID No.

TGAI MP

885.1100 Product Identity Not applicable Submitted data fulfill the 

requirement for product 

identity. 

47899301

885.1200 Manufacturing Process Submitted data fulfill the requirement for manufacturing 

process.

47899301

Not applicable Deposition of a Sample 

in a Nationally 

Recognized Culture 

Collection

Aureobasidium pullulans

strain DSM 14941 is on 

deposit with the DSMZ (the 

German Strain Collection for 

Microorganisms) under the 

reference number DSM 

14941 

Not applicable 47871701

885.1300 Discussion of Formation 

of Unintentional 

Ingredients

Submitted data fulfill the requirement for discussion of 

formation of unintentional ingredients for the current use 

sites. .

47899301

885.1400 Analysis of Samples Submitted data fulfill the requirement for analysis of samples. 47871802

885.1500 Certification of Limits Not applicable Limits listed on the 

confidential statement of 

formula are 

adequate/acceptable.

CSF dated 

July 7, 2011

Additional Studies

830.1800 Enforcement Analytical 

Method

Not applicable Submitted data fulfill the 

requirement for an 

enforcement analytical 

method.

47869601
Aureobasidium pullulans strains DSM 14940 and 14941 Page 30 of 41

Biopesticides Registration Action Document

TABLE 3. Product Analysis Data Requirements for the End-Use Product (EP), Blossom Protect (40 CFR § 158.2120)

OCSPP Guideline Number Data Requirement Results MRID No.

885.1100 Product Identity Submitted data fulfill the requirement for 

product identity.

47869601

885.1200 Manufacturing Process Submitted data fulfill the requirement for 

manufacturing process.

47869601

Not applicable Deposition of a Sample in a 

Nationally Recognized 

Culture Collection

Not applicable Not applicable

885.1300 Discussion of Formation of 

Unintentional Ingredients

Submitted data fulfill the requirement for 

discussion of formation of unintentional 

ingredients for the current use sites. .

47869601

885.1400 Analysis of Samples Results of a five-batch preliminary 

analysis for the active ingredient in 

Blossom Protect were not submitted. Each 

of the active ingredients is being registered 

concurrently.

47869601

885.1500 Certification of Limits Limits listed on the confidential statement 

of formula are adequate/acceptable.

CSF dated

January 26, 2012

Additional Studies

830.1800 Enforcement Analytical 

Method

Submitted data fulfill the requirement for 

an enforcement analytical method.

47869601

TABLE 4. Product Analysis Data Requirements for the End-Use Product (EP), Botector (40 CFR § 158.2120)

OCSPP Guideline Number Data Requirement Results MRID No.

885.1100 Product Identity Submitted data fulfill the requirement for 

product identity. 

47869501

885.1200 Manufacturing Process Submitted data fulfill the requirement for 

manufacturing process.

47869501

Not applicable Deposition of a Sample in a 

Nationally Recognized 

Culture Collection

Not applicable Not applicable

885.1300 Discussion of Formation of 

Unintentional Ingredients

Submitted data fulfill the requirement for 

discussion of formation of unintentional 

ingredients for the current use sites. 

47869501

885.1400 Analysis of Samples Results of a five-batch preliminary 

analysis for the active ingredient in 

Botector were not submitted. Each of the 

active ingredients is being registered 

concurrently.

47869501

885.1500 Certification of Limits Limits listed on the confidential statement 

of formula are adequate/acceptable.

CSF dated

January 26, 2012

Additional Studies

830.1800 Enforcement Analytical 

Method

Submitted data fulfill the requirement for 

an enforcement analytical method.

47869501
Aureobasidium pullulans strains DSM 14940 and 14941 Page 31 of 41

Biopesticides Registration Action Document

TABLE 5. Physical and Chemical Characteristics for the Technical Grade of the Active Ingredient 

(TGAI)/Manufacturing-Use Product (MP), Aureobasidium pullulans strain DSM 14940 Technical (40 CFR § 

158.2120)

OCSPP 

Guideline 

Number 

Data Requirement

Results

MRID No.

TGAI MP

830.6302 Color Pale pink to pale brown Not applicable 47871703

830.6303 Physical State Powder Not applicable 47871703

830.6304 Odor Bread-like Not applicable 47871703

830.6313 Stability to Normal and 

Elevated

Temperatures, Metals,

and Metal Ions

Expected to be stable 

during application or 

when in contact with 

metals or metal ions

Not applicable 47871703

830.6317 Storage Stability The registrant is relying on the storage stability for Blossom Protect 

(EP) which was stable at 20°C for 12 months.

48547201

830.6319 Miscibility Not applicable Not required because A. pullulans

strain DSM 14940 is not an 

emulsifiable form of microbial 

pesticide (refer to test note #2 of 

40 CFR § 158.2120(d)).

Not 

applicable

830.6320 Corrosion 

Characteristics

Not applicable Blossom protect data cited are 

adequate to support this data 

requirement.

48547201

830.7000 pH 5.66-6.25 (1% solution 

in deionized water)

Not applicable 47871703

830.7100 Viscosity Not applicable Not applicable, the product is a 

solid.

47871703

830.7300 Density/Relative 

Density/Bulk Density 

(Specific Gravity)

0.69 g/mL Not applicable 47871703

TABLE 6. Physical and Chemical Characteristics for the End-Use Product (EP), Blossom Protect 

(40 CFR § 158.2120)

OCSPP Guideline Number Data Requirement Results MRID No.

830.6317 Storage Stability the product is considered to be stable for 

12 months at 20°C

48547201

830.6319 Miscibility Not applicable, the product is not an 

emulsifiable liquid.

47869602

830.6320 Corrosion Characteristics No damage of the packaging material 

was observed during 15 month storage 

stability study.

48547201

830.7100 Viscosity Not applicable, the product is a solid 47869602

830.7300* Density/Relative Density/Bulk 

Density (Specific Gravity)

0.60-0.69 g/mLb 47869602 and 

CSF dated 

July 7, 2011
Aureobasidium pullulans strains DSM 14940 and 14941 Page 32 of 41

Biopesticides Registration Action Document

TABLE 7. Physical and Chemical Characteristics for the End-Use Product (EP), Botector 

(40 CFR § 158.2120)

OCSPP Guideline Number Data Requirement Results MRID No.

830.6317 Storage Stability The registrant is relying on the storage 

stability forBlossom Protect (EP) which was

stable at 20°C for 12 months.

48547201

830.6319 Miscibility Not applicable, the product is not an 

emulsifiable liquid.

47869502

830.6320 Corrosion Characteristics Cited Data on Blossom Protect are

adequate to support this EP. No damage 

of the packaging material was observed

during this 15 month storage stability 

study.

48547201

830.7100 Viscosity Not applicable, the product is a solid 47869502

830.7300* Density/Relative Density/Bulk 

Density (Specific Gravity)

0.64 kg/L

0.60-0.69 g/mLb

47869502 and 

CSF
Aureobasidium pullulans strains DSM 14940 and 14941 Page 33 of 41

Biopesticides Registration Action Document

TABLE 8. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/Manufacturing-Use Product (MP), Aureobasidium pullulans

strain DSM 14940 and strain DSM 14941 Technicals and for the End-Use Products (EP), Botector and Blossom Protect (40 CFR § 158.2140)

OCSPP 

Guideline 

Number

Data 

Requirement

Results

DSM 14941 TGAI DSM 14940

TGAI

DSM 14941

&

DSM 14940

Technicals

(MPs)

Botector 

(EP)

Blossom Protect 

(EP)

MRID No.

Tier I

885.3050 Acute Oral 

Toxicity/

Pathogenicity

24 rats were administered a single dose of A. 

pullulans strain DSM 14941. Three animals /sex 

were sacrificed on days 3, 7, and 14; the remaining 

animals were sacrificed at test end on day 21. Body 

tissues were examined for A. pullulans. All samples 

of feces, blood, brain, lung, liver, kidney, spleen, 

stomach, and intestine were negative. The lymph 

nodes of one animal sacrificed on day 7 tested 

positive. Classification: Acceptable

A. pullulans

strain DSM 

14941 data

Cited1

Not 

applicable

Not 

applicable

Not applicable 47899302

885.3150 Acute 

Pulmonary 

Toxicity/

Pathogenicity

Male and female animals were dosed with A. 

pullulans strain DSM 14941 Technical (4 x 108

cfu/g). There was no mortality, and, except on the 

day of dosing when the entire test material group 

showed reduced motor activity and dyspnea, all 

animals appeared normal throughout the study. 

Tissue samples were evaluated for A. pullulans after 

sacrifice. The following tissues were negative for A. 

pullulans at all time points: feces, brain, kidney, and 

intestine. Blood samples were negative except for 

one male on day 0; lung samples were negative 

except for two males and two females on day 0; 

liver samples were negative except for three males 

on day 0; spleen samples were negative except for 

two males on day 0; lymph node samples were 

negative except for one animal on day 7, and 

stomach samples were negative except for two 

males on day 0.

A. pullulans

strain DSM 

14941 data 

Cited1

Not 

applicable

Not 

applicable

Not applicable 47899303
Aureobasidium pullulans strains DSM 14940 and 14941 Page 34 of 41

Biopesticides Registration Action Document

TABLE 8. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/Manufacturing-Use Product (MP), Aureobasidium pullulans

strain DSM 14940 and strain DSM 14941 Technicals and for the End-Use Products (EP), Botector and Blossom Protect (40 CFR § 158.2140)

OCSPP 

Guideline 

Number

Data 

Requirement

Results

DSM 14941 TGAI DSM 14940

TGAI

DSM 14941

&

DSM 14940

Technicals

(MPs)

Botector 

(EP)

Blossom Protect 

(EP)

MRID No.

Classification: Acceptable

885.3200 Acute Injection 

Toxicity/

Pathogenicity

Male and female rats were dosed subcutaneously with A. pullulans 

strain DSM 14940 (2.36 x 1010 cfu/g) and DSM 14941 (1.5 x 1010

cfu/g). Interim sacrifices were made on days 3, 7, and 14; the 

remaining animals were sacrificed at test end on day 21. There were 

no deaths, and all animals appeared normal throughout the study 

except for edema or slight erythema at the injection site. Samples of 

the following tissues were negative for A. pullulans at all time 

points: feces, blood, brain, lung, liver, kidney, spleen, stomach, and 

intestine. Lymph node samples were negative except for one animal 

sacrificed on day 7. Classification: Acceptable

Not 

applicable

Not 

applicable

Not applicable 47871807

Male and female rats were dosed subcutaneously 

with A. pullulans strain DSM 14941 (1.1 x 109

cfu/g). Interim sacrifices were made on days 1 and 

7; the remaining animals were sacrificed at test end 

on day 21. There were no deaths, and all animals 

appeared normal throughout the study except for 

severe edema or slight erythema at the injection 

site. Samples of the following tissues were negative 

for A. pullulans at all time points: brain, lung, 

spleen, kidney, lymph nodes, blood and urine. The 

skin was positive for A. pullulans in three males and 

three females from the test material group on day 1 

and in two females of the same group on day 7. The 

liver of one male from the test material group was 

positive on day 1. The cecum contents were positive 

in one male and one female from the test material 

group on day 1, and in two females from the same 

group on day 7. Classification: Acceptable

A. pullulans

strain DSM 

14941 Cited1

47871808

885.3400 Hypersensitivity No incidents of hypersensitivity associated with A. pullulans strains DSM 14940 or DSM 14941 have been reported by the 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 35 of 41

Biopesticides Registration Action Document

TABLE 8. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/Manufacturing-Use Product (MP), Aureobasidium pullulans

strain DSM 14940 and strain DSM 14941 Technicals and for the End-Use Products (EP), Botector and Blossom Protect (40 CFR § 158.2140)

OCSPP 

Guideline 

Number

Data 

Requirement

Results

DSM 14941 TGAI DSM 14940

TGAI

DSM 14941

&

DSM 14940

Technicals

(MPs)

Botector 

(EP)

Blossom Protect 

(EP)

MRID No.

Incidents applicant. Any future hypersensitivity incidents must be reported per OCSPP Guideline 885.3400.

885.3500 Cell Culture Not required because A. pullulans strain DSM 14940 and strain 

14941 are not viruses (refer to test note #4 of 40 CFR § 

158.2140(d)).Not applicable

Not 

applicable

Not 

applicable

Not applicable

870.1100 Acute Oral 

Toxicity

Not applicable Not 

applicable

Oral LD50 was 

>2000 mg/kg.

Classification: 

Acceptable

TOXICITY 

CATEGORY III

47869614

870.1200 Acute Dermal 

Toxicity

Not applicable Not 

applicable

The LD50 was 

>2000 mg/kg.

Classification: 

Acceptable

TOXICITY 

CATEGORY III

47869615

870.1300 Acute Inhalation 

Toxicity

Not applicable Not 

applicable

The LC50 was 

>5.17 mg/L.

Classification: 

Acceptable 

TOXICITY 

CATEGORY IV

47869617

870.2400 Acute Eye 

Irritation

Not applicable Not 

applicable

Three female rabbits 

were treated with 

0.1 mL test material. 

No corneal opacity, 

iritis, or positive 

conjunctival 

irritation was noted 

on any rabbit 

47869618
Aureobasidium pullulans strains DSM 14940 and 14941 Page 36 of 41

Biopesticides Registration Action Document

TABLE 8. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/Manufacturing-Use Product (MP), Aureobasidium pullulans

strain DSM 14940 and strain DSM 14941 Technicals and for the End-Use Products (EP), Botector and Blossom Protect (40 CFR § 158.2140)

OCSPP 

Guideline 

Number

Data 

Requirement

Results

DSM 14941 TGAI DSM 14940

TGAI

DSM 14941

&

DSM 14940

Technicals

(MPs)

Botector 

(EP)

Blossom Protect 

(EP)

MRID No.

throughout the 

study. Blossom 

Protect was not 

irritating to the eye.

Classification: 

Acceptable;

Toxicity 

TOXICITY 

CATEGORY IV

870.2500 Primary Dermal 

Irritation

Not applicable Not 

applicable

Three female rabbits 

were treated with 

0.5 g test material 

for 4 hours. No 

dermal irritation was 

noted on any rabbit.

Classification: 

Acceptable;

Toxicity 

TOXICITY 

CATEGORY IV

47869619

Additional Studies

Acute 

Subcutaneous 

Toxicity/

Pathogenicity

10 animals were 

dosed with 2000 

mg/kg Blossom 

Protect. One male 

was humanely 

sacrificed on day 5 

due to a ruptured 

abscess at the 

injection site; all 

47869616
Aureobasidium pullulans strains DSM 14940 and 14941 Page 37 of 41

Biopesticides Registration Action Document

TABLE 8. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/Manufacturing-Use Product (MP), Aureobasidium pullulans

strain DSM 14940 and strain DSM 14941 Technicals and for the End-Use Products (EP), Botector and Blossom Protect (40 CFR § 158.2140)

OCSPP 

Guideline 

Number

Data 

Requirement

Results

DSM 14941 TGAI DSM 14940

TGAI

DSM 14941

&

DSM 14940

Technicals

(MPs)

Botector 

(EP)

Blossom Protect 

(EP)

MRID No.

other animals 

survived until study 

end on day 14. 

Necropsy revealed 

abscesses at all 

injection sites.

The LD50 was 

>2000 mg/kg.

Classification: 

Acceptable

In vivo

Micronucleus

Groups of mice received a single oral gavages of 

2000 mg/kg A. pullulans strain DSM 14941 

dissolved in water. There were no in-life clinical 

signs. The animals were sacrificed 24 or 48 hours 

post-dosing and the femoral bone marrow was 

immediately harvested. The ratio of polychromatic 

erythrocytes to total erythrocytes (mature and 

immature) was determined, and 2000 immature 

erythrocytes/animal were scored for the incidence 

of micro nucleated immature erythrocytes. A. 

pullulans strain DSM 14941 did not produce a 

statistically significant increase in micro nucleated 

immature erythrocytes compared to the negative 

control animals. The response of the positive

control animals (cyclophosphamide, IP injection, 10 

mg/kg) was appropriate.

Classification: Acceptable

47899304

Influence of 

Temperature on 

Reproduction

The effect of temperature on the reproduction of Aureobasidium pullulans strains DSM 14940, DSM 14941, and CBS 

626.85 was examined. Strain CBS 626.85 was isolated from the peritoneal dialysis fluid of a human. In Liquid Culture

47871833

-

Neither DSM 14940 nor DSM 14941 was able to grow at 35 or 37°C. CBS 625.85 produced about two duplications at 
Aureobasidium pullulans strains DSM 14940 and 14941 Page 38 of 41

Biopesticides Registration Action Document

TABLE 8. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/Manufacturing-Use Product (MP), Aureobasidium pullulans

strain DSM 14940 and strain DSM 14941 Technicals and for the End-Use Products (EP), Botector and Blossom Protect (40 CFR § 158.2140)

OCSPP 

Guideline 

Number

Data 

Requirement

Results

DSM 14941 TGAI DSM 14940

TGAI

DSM 14941

&

DSM 14940

Technicals

(MPs)

Botector 

(EP)

Blossom Protect 

(EP)

MRID No.

35°C and about one duplication at 37°C. The pH of the media for the two DSM strains was unchanged, while the CBS 

625.85 medium pH fell from 6.3 to 5.0. On Agar Plates

Classification: Acceptable

– At 27°C, colonies of all three strains were visible after 48 hours. 

At 37°C, only CBS 626.85 produced colonies. Neither DSM 14940 nor DSM 14941 produced any colonies after five days 

at 37°C. Based on the lack of growth at temperatures of 35°C and above, strains DSM 14940 and DSM 14941 can be 

considered non-pathogenic in humans.

Toxicity/

Pathogenicity of 

Aureobasidium 

pullulans in 

Immunocompro

mised PatientsPublished 

Literature

The registrant has submitted reviews of various infections caused by Aureobasidium pullulans in immunocompromised 

patients. These infections were not caused by the two strains of A. pullulans (DSM 14941, 14940) submitted for 

registration. Also, these infections were successfully treated in the immunocompromised patients by antifungal drugs.

47871816 –

47871831

1 Data listed can be cited because microbial characteristics are very similar and no difference was noted between A. pullulans strain DSM 14940 

and A. pullulans strain DSM 14941 in their toxicity, irritation, or pathogenic potential to a variety of species.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 39 of 41

Biopesticides Registration Action Document

TABLE 9. Non-target Organism Toxicity and Environmental Fate Data Requirements for the Technical Grade of 

the Active Ingredient (TGAI), Aureobasidium pullulans strain DSM 14940 and strain DSM 14941. (40 CFR § 

158.2150)

OCSPP Guideline 

Number

Data Requirement Results MRID No.

Tier I

885.4050 Avian Oral Toxicity The LD50 for A. pullulans DSM 14941 (CF40) in 

Japanese quail was >2000 mg/kg bw (1.0 x 109

cfu/animal). BPPD determined that bridging to 

DSM 14940 was acceptable.

Classification: Acceptable

47871811

885.4100 Avian Inhalation 

Toxicity/Pathogenicity

Not required; A. pullulans is not known or shown 

to be an avian pathogen

N/A

885.4150 Wild Mammal 

Toxicity/Pathogenicity

Tests required by 40 CFR § 158.2140 are 

adequate and appropriate for assessing hazards of 

A. pullulans strains DSM 14940 and 14941 to 

wild mammals. An acute oral 

toxicity/pathogenicity study with laboratory rats 

indicates no adverse effects at 4 x 108 cfu/animal. 

Classification: Acceptable for wild mammal 

risk assessment

47899302

885.4200 Freshwater Fish 

Toxicity/Pathogenicity

The 96-hour LC50 was >100mg/L (estimated to 

be 3.2 x 105 cfu/mL nominal; measured conc.’s 

ranged up to 4.1 x 103 cfu/mL). The test was 

insufficient to determine pathogenicity

Classification: Supplemental

Additional rationale was given that A. pullulans

strains DSM 14940 and 14941 will not reach 

aquatic areas in significant concentration.

Classification: Acceptable rationale

47871812

No MRID

885.4240 Freshwater Invertebrate 

Toxicity/Pathogenicity

In a 48-hour static toxicity test with Daphna 

magna, control mortality was 28%, indicating 

possible study design problems. 

Classification: Unacceptable

A 21-day static-renewal study with Daphnia 

magna showed the mortality-based EC50 is >1.3 x 

106 cfu/mL and the reproduction-based NOEC is 

1.3 x 106 cfu/mL.

Classification: Acceptable 

47899305

48531002

885.4280 Estuarine/Marine Fish and 

Invertebrate Testing

Not required – significant concentrations are not 

expected to reach marine/estuarine environments 

as a result of the proposed uses.

N/A

885.4300 Non-target Plant Testing Wheat, soybean, and lettuce plants were exposed 

to A. pullulans strains DSM 14940 and DSM 

14941. The study is inadequate to determine if 

the test material may be pathogenic to non-target

plants.

Classification: Unacceptable

Additional rationale was provided that was 

sufficient for use in ecological risk assessment. 

Classification: Acceptable rationale

47899306

No MRID

885.4340 Non-target Insect Testing Not required – A. pullulans does not infect or 

create an epizootic condition in insects.

N/A
Aureobasidium pullulans strains DSM 14940 and 14941 Page 40 of 41

Biopesticides Registration Action Document

885.4380 Honey Bee Testing Descriptions of several field trials were 

submitted, but the provided information was 

insufficient to determine the hazard to honey 

bees.

Classification: Unacceptable

A 22-day toxicity/pathogenicity laboratory study 

with honey bees determined the LD50 to be 1.0 x 

106 cfu/bee.

Classification: Supplemental

Additional pathogenicity testing data for this 

guideline were waived based on scientific 

rationale and published literature that reports 

A. pullulans as part of the normal flora of insects 

and stingless bees and as commonly found in the 

environment. A. pullulans was not reported in 

publications as an entomopathogen. 

Classification: Acceptable rationale

47899307

48531003

(Pagnocca et al. 

2008, Sacchi 

and VaughanMartini 2002, 

2003) and 

(Rosa et al. 

2003)

Tiers II, III, and IV

Not required for A. pullulans strains DSM 14940 and DSM 14941 based on the current uses and application methods.
Aureobasidium pullulans strains DSM 14940 and 14941 Page 41 of 41

Biopesticides Registration Action Document

APPENDIX B. PESTICIDE PRODUCTS

EPA File 

Symbol

Registration 

Name

Percentage 

Active 

Ingredient

Formulation 

Type

Use Site(s) Method(s) 

of 

Application

Application 

Rate

Target Pest

86174-R Aureobasidium 

pullulans strain 

DSM 14940 

Technical 

80.00% Technical N/A N/A N/A N/A

86174-E Aureobasidium 

pullulans strain 

DSM 14941 

Technical

80.00% Technical N/A N/A N/A N/A

86174-G Botector 40% strain DSM 

14940

40% strain DSM 

14941

End-use 

Product

Pome and 

stone fruits

Strawberries

Grapes

Preharvest 

spray

As directed 

on label

Penicillium

Botrytis 

Monilia 

Nectria

Pezicula

86174-U Blossom Protect 25.8% strain 

DSM 14940

25.8% strain 

DSM 14941

End-use 

Product

Pome Fruits Spray 1.25 lbs/acre

As directed 

on label

Erwinia 

amylovora

(Fire Blight)