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 (7511P) ACTIONS REQUESTED: OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION

# (~

Review ofan Emergency Exemption requested for Bacillus mycoides 

### isolate J, and supporting evaluation records. Applicant: Montana Department ofAgriculture 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 ofAgriculture 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. 

### 1

### BACKGROUND: The Bmj Wettable Granular formulation proposed for the emergency exemption differs from the Bmj Wettable Powder formulation that was evaluated previously for an Experimenta l 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 ofthat 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 thatwill 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 ofapplication 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 ofacres and total amount ofpesticide to be used is greater thanthe acreage and amount ofpesticide 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 ofthe potatoes. No further human exposures to BmJ spores in meat or milkas a result of cattle feed with BmJ residue are expected. Due to theubiquitous 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 oftoxicity, 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 ofthe experimental product. 

### B. mycoid?s is not reported as a human pathogen, or as a cause offoodbome illness, food spoilage or plant**d~seases.** No toxicity, infectivity orpathogenicity 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:'**  • • ' 

### 2

### 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 ofBacillus that exceed the quantity ofBacillus mycoides 

### isolate J spores applied to potato foliage. Washing peeling and or cooking will remove or destroy any residual spores.

SupportingEPA 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 MontanaMicrobial Products for Control ofCercospora LeafSpot 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 ofProduct 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 ofSupplemental Product Chemistry Data submitted by MontanaMicrobial 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 ofan EUP Application, temporary tolerance exemption, data waiver requests and updated environmental risk assessment. December 23, 2008

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