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Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Aureobasidium pullulans strains 

DSM 14940 and DSM 14941

Docket ID Number: EPA-HQ-OPP-2010-0099

Date: October 15, 2015

Section 408(c)(2)(A)(i) of FFDCA allows the U.S. Environmental Protection Agency (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 the 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 FFDCA section 408(c)(2)(B), in establishing or 

maintaining in effect an exemption from the requirement of a tolerance, the EPA must take into account the 

factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to 

exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance 

exemption, 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, FFDCA section

408(b)(2)(D) requires that the EPA consider “available information concerning the cumulative effects of [a 

particular pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.”

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

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

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

residential settings.

I. Summary of Petitioned-for Amendment of Tolerance Exemption

In the Federal Register of July 17, 2015 (80 FR 42462), the EPA issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 4F8342) 

by bio-ferm GmbH, Technologiezentrum Tulln, Technopark 1, Tulln, 3430, Austria. The petition requested 

that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for 

residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on all food commodities. 

That document referenced a summary of the petition prepared by the petitioner bio-ferm GmbH, which is 

available in Docket ID Number EPA-HQ-OPP-2010-0099 via http://www.regulations.gov.

II. Toxicological Profile

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

relevant information on Aureobasidium pullulans strains DSM 14940 and DSM 14941, and considered its 

validity, completeness, and reliability, as well as the relationship of this information to human risk. The 

EPA also considered available information concerning the variability of the sensitivities of major 

identifiable subgroups of consumers, including infants and children.

A. Overview of Aureobasidium pullulans strains DSM 14940 and DSM 14941

Aureobasidium pullulans is a ``yeast-like'' saprophytic fungus found in the phyllosphere of many plants, 

and it has been isolated from soil and aquatic environments (Refs. 1, 2, and 3). It is commonly isolated 

from healthy grape (Refs. 4 and 5) and apple (Ref. 6) plants, as well as other plants (Refs. 7, 8, 9, 10, and 

11). Although associated with disease in some plants, the fungus generally is recognized as a saprobe, since 
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it derives its nourishment from nonliving or decaying organic matter, and is only considered a weak 

pathogen or parasite of certain plants (Refs. 2 and 12). It is a known antagonist of several plant diseasecausing organisms, and is an important producer of enzymes for biotechnological and industrial 

applications (Ref. 1).

 Aureobasidium pullulans strains DSM 14940 and DSM 14941 were isolated from apple leaves and 

classified by the German Strain Collection for Microorganisms (DSMZ). Neither is a mutant nor 

genetically modified strain and they are not closely related to toxigenic human pathogens. As discussed in 

Pesticide Petitions (PP) 9F7623 and 4F8342), product analysis data demonstrate that Aureobasidium 

pullulans strain DSM 14941 is closely related to strain DSM 14940. The two strains share many similar 

genetic and morphological characteristics. Bioferm GmbH has registered two manufacturing-use pesticide 

products (MPs): ``Aureobasidium pullulans strain DSM 14941 Technical,'' and ``Aureobasidium pullulans

strain DSM 14940 Technical.'' The active ingredient is 80% w/w (minimum of x 109 colony forming 

units/grams (unit of measure for bacteria (cfu/g)) in each of the proposed technical products. Two end-use 

products containing equal parts of Aureobasidium pullulans strains DSM 14940 and DSM 14941 are 

currently registered by EPA. Blossom Protect is applied to pome fruit and walnuts only during the 

blossoming period to protect plants against bacterial fire blight and walnut blight, respectively. Botector is 

currently applied pre-harvest to grapes, pome fruit, stone fruit, and strawberries. Bio-ferm proposes to 

amend the Botector label to permit post-harvest uses, presently only to citrus, to protect these crops against 

fruit rot diseases caused by blue and green mold caused by Penicillium spp. and sour rot caused by 

Geotrichum spp. Post-harvest application rates are projected to be up to 1 pound of Botector per 60 gallons 

of water (as a 0.2% spray or dip).

B. Microbial Pesticide Toxicology Data Requirements

The Agency has determined that all mammalian toxicology data requirements submitted

to support the petition to exempt residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941

from the requirement of a tolerance have been fulfilled (Ref. 13) and that the submitted data ( MRID 

49717901) are acceptable to an expansion of the tolerance exemption to include post-harvest use sites (Ref. 

14). 

The product analysis data demonstrated that Aureobasidium pullulans strain DSM 14941 is closely related 

to strain DSM 14940. Because the strains are closely related, the Agency has determined that the findings

of the submitted acute toxicity/ pathogenicity studies conducted only with strain DSM 14941 supported 

both strains, and those studies show no evidence of toxicity, or pathogenicity at the doses tested. In 

addition, both strains were tested in an acute subcutaneous injection toxicity/ pathogenicity study in rats. 

The results of this study indicated that both strains were not toxic, infective, and/or pathogenic to the test 

animals. These findings were supported by the results of a study of the influence of temperature on the 

growth of the two Aureobasidium pullulans strains, which showed that growth of both strains does not 

occur at or above 35 °C. Since human body temperature is 37 °C, and based on the results from these 

studies as discussed in this unit the Agency concluded that neither strain would be toxic, infective and/or 

pathogenic in humans.

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

Guideline 885.3050; Master Record Identification Number (MRID) No. 47899302. Twenty-four rats

were administered a single dose of Aureobasidium pullulans strain DSM 14941. Three animals of each 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 Aureobasidium 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 for the presence of Aureobasidium pullulans DSM 14941. These findings show a pattern of

clearance with no Aureobasidium pullulans DSM 14941 detected by day 14. The results of this acceptable 
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study demonstrated that Aureobasidium pullulans DSM 14941 was not toxic, infective, and/or pathogenic 

in rats, when dosed at 4 × 108 cfu/animal.

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

and female animals were exposed intratracheally with Aureobasidium pullulans strain DSM 14941 

Technical (4 × 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 study end on 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 Aureobasidium pullulans 

after sacrifice. The following tissues were negative for Aureobasidium 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. These findings show a pattern of clearance with no Aureobasidium pullulans DSM 14941 detected by 

day 14. The results of this acceptable study demonstrated that Aureobasidium pullulans DSM 14941 was 

not toxic, infective, and/or pathogenic in rat, when dosed at 0.8 × 108 cfu/animal.

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

47871808). In an acute subcutaneous toxicity/pathogenicity study (MRID 47871807), male and female rats 

were injected with Aureobasidium pullulans strain DSM 14940 (2.36 × 1010 cfu/g) and DSM 14941 (1.5 × 

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

Aureobasidium 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. The study author 

suggested this was likely a post-mortem transmission. A pattern of clearance was observed in this study, 

with no Aureobasidium pullulans DSM 14941 or 14940 detected by day 14. The results of this acceptable

study demonstrated that Aureobasidium pullulans strains DSMZ 14940 and DSMZ 14941 were not toxic, 

infective, and/or pathogenic in rats, when dosed at 1.95 × 107 or 1.12 × 107cfu/animal, respectively. In a 

second acute subcutaneous toxicity/pathogenicity study (MRID 47871808), male and female rats were

injected with Aureobasidium pullulans strain DSM 14941 (1.1 × 109 cfu/g). Interim sacrifices were made 

on days 1and 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 Aureobasidium pullulans at all time points: Brain, 

lung, spleen, kidney, lymph nodes, blood and urine. The skin was positive for Aureobasidium 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. These findings show a pattern of clearance with no Aureobasidium pullulans 

DSM 14941 detected by day 21. The results of this acceptable study demonstrated that Aureobasidium 

pullulans DSM 14941 was not toxic, infective, and/or pathogenic in rats, when dosed at 1.6 × 107 

cfu/animal.

4. Acute Dermal Toxicity (OCSPP Guideline 870.1200; MRID 47869615).

In an acute dermal toxicity study, the shaved skin of 10 rats was dosed with 2,000 milligram/kilogram 

(mg/kg) Blossom Protect (7 × 109 cfu/g each of strains DSM 14940 and DSM 14941) for

24 hours. One male exhibited chromodacryorrhea from day 7 to day 14 and one female exhibited

chromodacryorrhea from day 1 to day 2 of the study, but this was not considered to be toxicologically 
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significant because this is a normal but rare response and it did not result in mortality. All animals appeared 

healthy at necropsy. The lethal dose (LD50) was >2,000 mg/kg. This study was rated acceptable, and the 

end use product (EP) is classified as toxicity category IV.

5. Primary Dermal Irritation (OCSPP Guideline 870.2500; MRID 47869619).

In a dermal irritation study, the shaved skin of 3 rabbits was dosed with 0.5 g Blossom Protect (7 × 109

cfu/g Aureobasidium pullulans strain DSM 14940 and 7 × 109 cfu/g Aureobasidium pullulans strain DSM 

14941) moistened with 1.0 milliliter (mL) deionized water for 4 hours. All animals appeared normal 

throughout the study; thus, Blossom Protect was considered to be non-irritating. This study was rated

acceptable, and the EP is classified as toxicity category IV.

6. Acute Oral Toxicity (OCSPP Guideline 870.1100; MRID No. 47869614.) In an acute oral toxicity

study, six animals received a single 2,000 mg/kg body weight (bw) dose of Blossom Protect 22% (2 × 1010 

cfu/g) Aureobasidium pullulans strain DSM 14940, 22% (2 × 1010 cfu/g) Aureobasidium pullulans strain 

DSM 14941, 25% sucrose, 6% water. There was no mortality, and all animals appeared normal throughout 

the study. The LD50 was >2,000 mg/kg. This study was rated acceptable, and the EP is classified as toxicity 

category III.

7. Acute Inhalation Toxicity (OCSPP Guideline 870.1300; MRID 47869617).

In an acute inhalation toxicity study, 10 animals were exposed nose-only to a 10% suspension of Blossom 

Protect (7 × 10 9 cfu/g A. pullulans strain DSM 14940 and 7 × 109 cfu/g A. pullulans strain DSM 14941) at 

5.17 milligrams per liter (mg/L). The Mass Medium Aerodynamic Diameter (MMAD) was 4.2 mm. There 

were no deaths and all animals appeared healthy throughout the study. Necropsy was unremarkable.

The lethal concentration (LC50) was >5.17 mg/L. This study was rated acceptable, and the EP is classified 

as toxicity category IV.

8. Acute Eye Irritation (OCSPP Guideline 870.2400; MRID 47869618). 

In an eye irritation study, three rabbits were dosed with 0.1 mL (60–62 grams (g) of Blossom Protect (7 × 

109 cfu/g A.pullulans strain DSM 14940 and 7 × 109 cfu/g A. pullulans strain DSM 14941). One animal had 

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

animals appeared normal at 24 hours. Blossom protect was considered to be virtually non-irritating.

This study was rated acceptable, and the EP is classified as toxicity category IV.

9. In vivo Micronucleus Assay (MRID 47899304). Twenty mice (two groups of five male and two groups 

of five female mice) received single 2,000 mg/kg Aureobasidium pullulans strain DSM 14941 dissolved in 

water by oral gavage. There were no clinical signs observed in any of the test animals, which were

sacrificed 24 or 48 hours after receiving the test material. The femoral bone marrow was immediately 

harvested, and the ratio of polychromatic erythrocytes to total erythrocytes (mature and immature) was 

determined, and 2,000 immature erythrocytes/animal were scored for the presence of micronucleated 

immature erythrocytes, a sign of potential toxicity or damage to genetic material in the cells.

Aureobasidium pullulans strain DSM 14941 did not produce a statistically significant increase in 

micronucleated immature erythrocytes compared to the untreated control animals. The response of the 

positive control animals (treated with a known toxic substance, cyclophosphamide, by intraperitoneal

injection, at 10 mg/kg) was appropriate for comparison and did produce a statistically significant increase 

in micronucleated immature erythrocytes compared to the untreated control animals. This study was rated

acceptable.

10. Influence of Temperature on Reproduction (MRID 47871833).

Aureobasidium pullulans strain CBS 626.85 was isolated from the peritoneal dialysis fluid of a human in 
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Australia. The effects of temperature on the reproduction or growth of Aureobasidium pullulans strains 

DSM 14940 and, DSM 14941, in liquid culture or on agar plates were examined and compared against this 

positive control, Aureobasidium pullulans strain CBS 626.85, to observe the ability of these strains to 

reproduce at human body temperature of 37 °C. All three strains grew well at 30 °C. At 33 °C, the

number of replications (per 48 hours) of the Aureobasidium pullulans strains DSM 14940 and, DSM 14941 

was less than one, while the number of duplications for strain CBS 626.85 was approximately five. Neither 

strain DSM 14940 or strain DSM 14941 was able to grow at 35 °C or 37 °C, while strain CBS 625.85 

replicated (approximately) twice at 35 °C and once at 37 °C. Based on the lack of growth of the DSM 

strains at 35 °C and above, and given human body temperature is 37 °C, Aureobasidium pullulan strains 

DSM 14940 and DSM 14941 are expected to be nonpathogenic in humans. This study was rated 

acceptable.

11. 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 Aureobasidium pullulans strains DSM 14940 and DSM 14941 were 

reported by the applicant. Any future hypersensitivity incidents must be reported per OCSPP Guideline

885.3400.

III. Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs the EPA to consider available information

concerning exposures from the pesticide residue in food and all other non-occupational 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).

Food Exposure: Should this microbial pesticide be present on food, the acute toxicity, infectivity, and 

pathogenicity data, as well as the data demonstrating the lack of growth at human body temperature 

submitted for Aureobasidium pullulans strains DSM 14940 and DSM 14941 demonstrated that no toxicity, 

infectivity, and/or pathogenicity is likely to occur with any exposure level resulting from application of 

these two pesticide active ingredients in accordance with good agricultural practices (see Unit II above). 

Aureobasidium pullulans strains DSM 14940 and DSM 14941sprayed pre-harvest still have residues 

detected post-harvest, and no pathogenic effects have been reported. Nor have pathogenic effects been 

reported when Aureobasidium pullulans strains DSM 14940 and DSM 14941are applied on stored fruits.

Drinking Water Exposure: Naturally occurring Aureobasidium pullulans is ubiquitous and has been 

isolated from all types of water (Ref. 15). Exposure of humans to residues of pesticides containing 

Aureobasidium pullulans strains DSM 14940 and DSM 14941 in consumed drinking water is possible but 

potential exposure through drinking water is reduced, given the proposed use patterns, use sites, and 

application methods for Aureobasidium pullulans strains DSM 14940 and DSM 14941, which do not 

include direct application to aquatic environments. In the event that Aureobasidium pullulans strains DSM 

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

the fungi would not survive the high temperatures, chlorination, pH adjustments, and/or filtration water is 

subjected to in a drinking water treatment facility. Even if oral exposure should occur through consumed 

drinking water, there is a reasonable certainty that no harm will result from exposure to such residues, 

based upon the lack of toxicity, infectivity, and/or pathogenicity, as well as the inability of these fungal 

strains to grow at human body temperature, demonstrated in the previously described toxicological studies 

(see Unit II)
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Other Non-occupational Exposure: The use sites for these products include residential garden sites and 

agricultural sites. Aureobasidium pullulans is naturally present in many habitats, and based on the data and 

other information submitted to satisfy data requirements for registration of the MPs and EPs containing the 

active ingredients Aureobasidium pullulans strains DSM 14940 and DSM 14941, no toxicity, infectivity, 

pathogenicity or other adverse effects from non-occupational exposure are expected, and none have been 

reported to EPA. (see Unit II)

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

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

a tolerance, the EPA consider “available information concerning the cumulative effects of [a particular 

pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.”

Aureobasidium pullulans strains DSM 14940 and DSM 14941 are not toxic via the oral, dermal, or 

inhalation routes of exposure. Thus, for the purposes of this tolerance action, the EPA has concluded that 

Aureobasidium pullulans strains DSM 14940 and DSM 14941do not have a common mechanism of 

toxicity with other substances. Following from this, therefore, the EPA concludes that there are no 

cumulative effects associated with Aureobasidium pullulans strains DSM 14940 and DSM 14941 that need 

to be considered.

For information regarding the EPA’s efforts to determine chemicals that have a common mechanism of 

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

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

V. 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 Unit II.B., 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 Aureobasidium pullulans strains DSM 14940 and DSM 14941. This 

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

EPA has arrived at this conclusion because the data and information available on Aureobasidium pullulans

strains DSM 14940 and DSM 14941 do not demonstrate toxic, pathogenic, and/or infective potential to 

mammals. Thus, there are no threshold effects of concern and, as a result, the Agency has concluded that an 

additional margin of safety for infants and children is unnecessary in this instance. Further, the need to 

consider consumption patterns, special susceptibility, and cumulative effects does not arise when dealing 

with pesticides with no demonstrated significant adverse effects.
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VI. Conclusions

The 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 residues of Aureobasidium pullulans strains 

DSM 14940 and DSM 14941. Therefore, an exemption from the requirement of a tolerance is established 

for residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on all food 

commodities when used in accordance with label directions and good agricultural practices.

VII. References

1. 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.

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

Mycopathologia, 12: 1-45.

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

Aureobasidium pullulans. Mycologia 101: 823-832.

4. 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.

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

6. 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.

7. 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.

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

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

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

Microbiol. 47: 344-350.

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

Arizona. Mycol. Res. 109: 635-639.

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

Microbiol., 35: 655-658.

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

life cycle of Aureobasidium pullulans (de Bary) Arnaud. Folia Microbiologica, 25.

13. U.S. EPA. January 2012 Biopesticides Registration Action Document of Aureobasidium pullulans

strains DSM 14940 and 14941.
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14. U.S. EPA. October 2015. Review of the Registrant’s response to a 75- day deficiency letter concerning 

a petition by the registrant to add Post Harvest use to its registered product Botector containing 

Aureobasidium pullulans strains DSM 14940 & DSM 14941. Memorandum from I.S. Barsoum, Ph.D., and 

J. L. Kough, Ph.D. to S. Cerrelli, dated October 6, 2015

15. Slavikova, E. and R. Vadkertiova. 1997. Seasonal occurrence of yeasts and yeast like organisms in the 

river Danube. Antonie van Leeuwenhoek 72: 77-80, 1997.