UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

SUBJECT: 

FROM: 

THROUGH: 

TO: 

C~T 0 6 7015 

OFFICE OF PREVENTION, 

PESTICIDES AND TOXIC 

SUBSTANCES 

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. 

Ibrahim S. Barsoum, Ph.D., Microbiologist .J 11~ · 

J)~!o Ju;tr 

Microbial Pesticides Branch, 

Biopesticides and Pollution Prevention Division 

John L. Kough, Ph.D., Senior Scientist 

Microbial Pesticides Branch, 

Biopesticides and Pollution Prevention 

Suzrume Cerrelli, Regulatory Action Leader 

Microbial Pesticides Branch, 

Biopesticides and Pollution Prevention Division (75 11 C) 

ACTION REQUESTED: To review the Registrant's response to the 75-day deficiency letter 

(dated July 15, 20 15) concerning a petition by the registrant to add Post Harvest use to its 

registered product Botector (EPA Reg. no. 86174-3) containing A ureobasidium pulfulans strains 

DSM 14940 & DSM 14941 

CONCLUSION: ACCEPTABLE 
DATA REVIEW RECORD 

Active Ingredients: 

Products Name: 

Company Name: 

lD No: 

Chemical Number: 

Submission N umber: 

DP Barcode: 

MRIDNo: 

BACKGROUND: 

Aureobasidium pullulans strains DSM 14940 & DSM 14941. 

Botector 

BIO-FERM GMBH 

86174-3 

0360 10, 046010 

97402 1 

429403 

497179-01 

The registrant has submitted a petition for Post-Harvest use to amend the register product 

Botector (EPA Reg. no. 86174-3). The Agency has identified concerns about potential effects of 

post-harvest applications on human health. These concerns are based on reports in the published 

literature of infections caused by Aureobasidium pullu/ans particularly in immune-compromised 

patients and was unabl e to amend the tolerance exemption for the product label as requested. To 

address these concerns the Agency has requested that the registrant submits additional scientific 

rationale that suppotis the safety of post-harvest application to individuals that may consume 

food products after post-harvest treatment. 

Registrant's response to refute harmful health effect of post-harvest use of Botector: 

1. A. pul/ulans is a cosmopolitan yeast-like fungus and ubiquitously distributed in 

different environments and it lacks of any kind of invasiveness into the human 

organism. The strains DSM 14940 and DSM 14941 are not able to grow at 37°C and did 

not cause any symptoms in toxicity or pathogenicity studi es in rats and rabbits. 

2. The species A. pullulans is furthennore classified in BSL-1 (Bio-safety level I) (de 

Hoag, 1996). In BSL-1 fungi are c lassi fied, which are not harmful. even ifthere are 

single reports on the involvement in human diseases. 

3. A. pullulans strains from case studies on human pathogenicity arc often not well 

classified on species level, must be abl e to grow at 37°C. which is a prerequisite to 

colonize the human organism, or are graded as contaminant and not as pathogen 

(Matsumoto et a!. 1987). 

4. In the relation to frequency, in whi ch humans get in contact to spores of the species A. 

pullu/ans. the reports on pathogenic ity are rare. The likelihood of a contact with the 

spores of A. pu/lu/ans in daily life is very high as the species is ubiquitous. 

5. Due to the fact that A. pulfulans is frequentl y found on vegetables (Webb and Mundt. 

1978) grapes (Fleet, 2003) and apples (Granado eta/., 2008) under natural conditions, 

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the post-harvest treatment with A. pullulans strains DSM 14940 and DSM 14941 give no 

additional risk to the consumer. 

Reviewers' Comments: The registrant has presented the following scientifi c evidence: 

I. The two strains of Aureobasidium pullulans DSM 14940 & 1494 1 do not grow at 37° C 

while other strains isolated from human infections do grow at this temperature. 

2. A. pullulans DSM 14940 & 14941 sprayed pre harvest have still residues detected postharvest, and no pathogenic effect has been reported. 

3. No pathogenic effect has been reported when A. pullulans DSM 14940 & 14941 are 

applied on stored fruits. 

Since Botector has shown to be non-toxic, non-pathogenic, and non-infective in experimental 

toxicity studies, it can be deduced that Botector can be used post-harvest, as long as it is used at 

the allowable rate of application to reduce excess exposure to the microorganism. 

NC ~ON: ACCEPTABLE 

REFERENCES: 

I. De Hoog. G.S .. Yurlova, N.A., 1994. Conidiogenesis, nutritional physiology and 

taxonomy of Aureobasidium and Hormonema. Antonie Van Leeuwenhoek 65, 41-54. 

2. Matsumoto. T.. Padhye, A.A., Ajello, L.. 1987. Medical significance ofthe socalled black yeasts. Eur. J. Epidemiology . 3, 87-95. 

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

Environ Microbial 35, 655-658. 

4. Fleet, G.H., 2003. Yeast interactions and wine tlavor.lnt. Food 

M icrobiol. 86, 11-22. 

s. Granado.J .. Thorig, B .. Kieffer, E., Petrini, L., Tamm, L.. We ibe l, F.P., 

Wyss, G.S .. 2008.Cu lturable Fungi of Stored Golden Delicious Apple 

Fru its: A One -Season Comparison Study ofOrgan ic and Integrated 

Production Systems in Switzerland Microbia l. Eco l. 56, 720-732. 

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