UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

JUN 14 2D1Z 

MEMORANDUM 

SUBJECT: 

TO: 

FROM: 

THROUGH: 

Section 18 Specific Emergency Exemption requested for 

Bacillus mycoides isolate J, active ingredient for BmJ WG. 

Debra Rate, PhD 

Registration Division 

RIMUERB/Section 18 Team (7505P) 

Susanne Cerrelli, M.S., Regulatory Action Leader 

Microbial Pesticides Branch, Biopesticides and 

Pollution Prevention Division (7511 P) 

John L. Kough, Ph.D., Senior Scientist ~ A.AA.. ~ • 

Microbial Pesticides Branch, Biopestici@nd \.../" 

Pollution Prevention Division (7511 P) 

ACTIONS REQUESTED: 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

(~ 

Review of an Emergency Exemption requested for Bacillus mycoides isolate J, and supporting 

evaluation records. 

Applicant: Montana Department of Agriculture 

Active Ingredient: Bacillus mycoides isolate J 

Product name: BmJ WG. 

Site: Potato 

Pest: Potato Virus Y 

EE#: 12-MT -01 

Chemical Number: 006516. 

Decision Number: 464680 

DP Barcode: 401704 

MRIDNos.: 

CONCLUSION: 

The Section 18 Specific Emergency Exemption requested for BmJ WG by Montana Department 

of Agriculture is supported by prior data and data waiver requests that were submitted by 

Montana Microbial Products for an Experimental Use permit ofBmJ WP (82761-EUP-2), and a 

Manufacturing Process Description received on June 12, 2012 that was prepared by Certis 

U.S.A., L. L. C. The supporting EPA reviews are listed on page 3. 

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BACKGROUND: 

The Bmj Wettable Granular formulation proposed for the emergency exemption differs from the 

Bmj Wettable Powder formulation that was evaluated previously for an Experimental Use permit 

(82761-EUP-2). However, the Bacillus mycoides isolate J culture used to manufacture the 

technical dry powder that is formulated into Bmj Wettable Granular is the same of that was 

deposited at the Microbial Genomics & Bioprocessing, National Center for Agricultural 

Utilization Research as NRRL B-30890. This Bacillus mycoides isolate J culture (NRRL B30890) culture was evaluated previously for two experimental use permits, 82761-EUP-1 and 

82761-EUP-2. The quality control that will be used to manufacture the technical to produce 

BmJ WG is that ofMRID 46632909 and this data was determined to be adequately addressed to 

support issuance of82761-EUP-1 and 82761-EUP-2. 

All inerts listed for the Bmj Wettable Granular are cleared 

for pre- and post harvest use in or on food and feed. 

The maximum rate of application for this section 18 does not exceed the maximum application 

rate provided on the 82761-EUP-2label that was approved on January 14, 2009, and the 

proposed use period for the Section 18 is 9 weeks in duration which is shorter than the 2 year 

EUP period thatwas previously granted for 82761-EUP-2. 

The maximum number of acres and total amount of pesticide to be used is greater than the 

acreage and amount of pesticide that were requested for the 82761-EUP-2 

The requested Section 18 is for treating seed potatoes. As discussed in the Federal register 

notice that announce the temporary exemption from a tolerance for the prior EUP, this Section 

18 for seed potatoes is not expected to result in increased dietary, occupational or other nondietary exposure to Bacillus mycoides isolate J from treated food products during the program. 

Bacillus mycoides in soils, on foliage and treated produce is not expected to significantly change 

from background levels already present in agriculture. This assumption holds during exposure 

analysis of the potatoes. No further human exposures to BmJ spores in meat or milk as a result of 

cattle feed with BmJ residue are expected. Due to the ubiquitous level of B. mycoides present in 

agricultural soils, there has been long term human exposure to B. mycoides in crops and to 

residual B. mycoides cells or spores in food crops. From persistence studies, BmJ residues 

decline by more than 1000 fold over a two week period on foliage. BmJ spores are hydrophilic 

and can also be removed by the routine washing employed in packing produce, lessening any 

potential exposures through food contact. In the acute pulmonary toxicity and pathogenicity 

study submitted "No test material-related clinical signs of toxicity, effects on body weight, or 

overt pathogencity were found" at a dose of 1.1 x 108 CPU/animal- a level far above any 

expected exposures through treated crops. Personnel who worked with BmJ, rnore than 20 

people over 8 years, have not reported any exposure effects in routine use of the experimental 

product. B. mycoid?s is not reported as a human pathogen, or as a cause of foodbome illness, 

food spoilage or plant d~seases. No toxicity, infectivity or pathogenicity of B. mycoides in 

humans w~ repo.rt~d in numerous searched citations. EPA registered pesticides containing 

Bacillus th~rirzgi~~Jsis have long been used in similar applications to food crops, B. mycoides is 

readily ~ifferent~able from other B. cereus group organisms in production batches (including B . • ;:f.>4~t:' • • ' 

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thuringiensis) and well defined quality control procedures keep contaminants from fermentation 

batches. In potatoes, spores applied to foliage will not directly contact tubers. Tubers are 

exposed to natural soil concentrations of Bacillus that exceed the quantity of Bacillus mycoides 

isolate J spores applied to potato foliage. Washing peeling and or cooking will remove or 

destroy any residual spores. 

Supporting EPA Reviews: 

U.S. EPA 2006. Memorandum from Zig Vaituzis, Ph.D. to Anne Ball. Ecological Risk 

Assessment for Bacillus mycoides Isolate J (006516), 82671-EUP-R from Montana Microbial 

Products for Control of Cercospora Leaf Spot in Sugar Beets. March 7, 2006 

U.S. EPA 2006. Memorandum from Carl Etsitty, M.S. and John Kough, Ph.D. to Anne Ball. 

BPPD Review of Product Chemistry and Toxicity/Pathogenicity Data submitted by Montana 

Microbial Products, for BmJ WP which contains Bacillus mycoides isolate J. March 15, 2006. 

U.S. EPA 2006. Memorandum from Carl Etsitty, M.S. and John Kough, Ph.D. to Anne Ball. 

BPPD Review of Supplemental Product Chemistry Data submitted by Montana Microbial 

Products, for BmJ WP which contains Bacillus mycoides isolate J. March 23,2006. 

U.S. EPA 2008. Memorandum from Joel Gagliardi, Ph.D. to Susanne Cerrelli. Review of an 

EUP Application, temporary tolerance exemption, data waiver requests and updated 

environmental risk assessment. December 23, 2008 

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