# &EPA

Bacillus sphaericus EPA-HQ-OPP-2013-0116 Case 6052


### PreliminaryWork Plan and Summary Document Registration Review: Initial Docket March 2013



### Bacillus sphaericusstrain 2362serotype H5a5b strain ABTS 17 43 (PC codes 119801, 119803) 

### Bacillus sphaericus2362 serotype H5a5b strain AM614 (PC Code 119801, 119804)



### Approved by:

# :ft{z~~ Keith A. Matthews, Director Biopesticides and Pollution Prevention Division

## Date:~**~?~ ~/~** BacillussplwericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov

2BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov

TABLE

### OF CONTENTS



### A. Overview

......................................................................................................................5 B. Statutory and RegulatoryAuthority

..............................................................................6 C. Background and Regulatory Information

.....................................................................7 D. Anticipated Data Needs and RiskAssessments

........................................................ 10 E. Risk to Threatened and Endangered Species

........................................................... 19 F. Product Performance

.................................................................................................19 G. Endocrine Effects

.......................................................................................................19 H. Incidents

....................................................................................................................20 I. Timeline

.....................................................................................................................20 

### J. Guidance for Commenters

.........................................................................................21 K. Next Steps

.................................................................................................................22 II. FACT SUMMARY FOR CASE 6052

..................................................................................23 Ill. BIBLIOGRAPHY

.........................................................................................**~**

### ......................24 A. Studies Supporting Registration Review of Bacillus sphaericusstrainABTS 1743 (PC Codes 119801 , 119803)

............................................................................................24 B. Studies Supporting Registration Review of Bacillus sphaericusserotype H5a5b strain AM614 (PC code 119801, 119804)

...........................................................................28 C. Environmental Protection Agency RiskAssessment Memoranda

..............................29

3Bacillus sphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP

-2013-0116 www.regulations

.gov ACRONYMS AND ABBREVIATIONS 4SstarM FourStar Microbials, LLC (Company Number83362) 4SstarMP FourStar Microbial Products, LLC (Company Number85685) AM Advanced Microbiologicals, LLC. (Company Number84268) 

### B. sphaericus Bacillussphaericus BSIU 

### Bacillussphaericus International Units ABTS 1743 

### Bacillussphaericusstrain 2362 serotype H5a5b ABTS 1743 AM614 

### Bacillussphaericusstrain 2362 serotype H5a5b AM614 (also known as SPH88) BPPD EPA's Biopesticides and Pollution Prevention Division C

.F

.R

. Code of Federal Regulations cfu Colonyforming units DER Data Evaluation Record- refers to EPA's review ofcompany submissions of data or information DNA Deoxyribonucleic acid EDSP Endocrine DisrupterScreening Program EP End-use pesticide product EPA U.S. Environmental Protection Agency (the Agency) FFDCA Federal Food, Drug, and CosmeticAct FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act FR Federal Register FWP Final Work Plan gal Gallon g gram HR Hypersensitive response IDS Incident Data System kD Kilodalton kg Kilogram lb Pound memo memorandum mg Milligram MRID No. Master Record Identification Number:EPA'ssystem of recording and tracking studies submitted tothe Officeof Pesticide Programs

. MP Manufacturing-use Product MRL Maximum Residue Limit OPP EPA's Office of Pesticide Programs oz Ounce PC Code Pesticide chemical code: asix-digit numberassigned by OPP to identify pesticide chemicals. PWP PreliminaryWork Plan TGAI Technical grade ofthe active ingredient TMDL Total Maximum Daily Load 

## u
.

s
. United States VBS Valent BioSciences (Company Number73049)

4Bacillus sphaericus Case 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov 

### I. PRELIMINARYWORK PLAN 

### A. Overview The docketfor Bacillus sphaericus 

### (Case 6052) is now open, initiating the first public comment period for this registration review (docket number EPA-HQ-OPP-2013-0116). This case includes the following active ingredients: Bacillus sphaericus

### 2362 serotype H5a5bABTS 1743 (PC codes 119801, 119803) and Bacillus sphaericus

### 2362 serotype H5a5b strain AM614 (also known as SPH88) (PC Codes 119801, 119804). Bacillus sphaericus 

### are aerobic endosporeforming bacteria belonging to the family Bacilliaceae, 

### order Bacil/iales, 

### class Bacilli, 

### phylum Firmicutes, 

### and kingdom Eubacteria. 

### Entomopathogenic strains of B. sphaericus

### can be found worldwide in water, soil, and insects. Bacterial insecticide pesticide products containing these active ingredients are registered underthe Federal Insecticide, Fungicide and RodenticideAct (FIFRA) for use against selected species of mosquito larvae in aquatic habitats, including crop sites, where mosquitoes grow. These two active ingredients will be referred to asABTS 1743 orAM614 in this document pending confirmation ofthe consistency in nomenclature and labeling during this registration review. Bacillus sphaericus 

### strains are included in registered Manufacturing-Use and End-Use products (MPs and EPs, respectively). The current registrants are as follows: • Valent BioSciences (called VBS in this document)- MP and EPs- company number 73049; • Advanced Microbiologicals, LLC (called AM in this document)- MP and EPs- company number 84268; • B2E doing business as (dba) FourStar Microbials, LLC- EPs- company number 83362; and • FourStar Microbial Products, LLC

- EPs
- company number85685). This PreliminaryWork Plan (PWP) document explains what the Environmental Protection Agency's (EPA) Office of Pesticide Programs knows aboutthe registered pesticides containing the Bacillus sphaericus

### strains in this registration review case, highlighting anticipated data and assessment needs, identifying types of information that would be especially useful to EPA in conducting the review, and providing an anticipated timeline for completing the review ofthis Case 6052. The Registration Review process was designed to include a public participation componentto solicit inputfrom interested stakeholders. EPA intends, by sharing this information in the docket, to inform the public ofwhat it knows about the registered Bacillus sphaericus

### strains and whattypes of new data or other information would be helpful for EPAto receive as it moves toward a decision on Bacillus sphaericus. 

### EPA encourages all interested stakeholders to review the PWP and to provide comments and additional information that will help EPA's decision-making process for these microbial pesticides. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP about which EPA specifically seeks comments and information. Interested stakeholders could include the following: environmental nonprofit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; orthe public at large.

5BacillussphaericusCase 6052- PreliminaryWorkPlan EPA

-HQ-OPP-2013-0116 www.regulations.gov 

### The PWP begins by discussing the statutory and regulatory authority for Registration Review. Next, it provides background on Bacillus sphaericuscurrently registered pesticide products, use sites, and tolerance exemption information. Then, it lists the anticipated data needs and risk assessments and a projected Registration Review timeline for Bacillus sphaericus strains in Case 6052. Table 1 lists the currently registered B. sphaericus pesticides. Additional information about application rates and methods for these registered pesticides is available in the labels on EPA's website http://www.epa.gov/pesticides/ppls. Finally, the PWP describes guidance for commenters, explains the next steps EPA will be taking for this Registration Review, summarizes background information for this Registration Review, and lists supporting studies, risk assessment memoranda, and other documents. Further information aboutthis case, including background and supporting documents, is available at http://www.regulations.gov(under "SEARCH for: Rules, Comments, Adjudications or Supporting Documents," enterthe docket identification number, which is indicated above). 

### B. Statutory and Regulatory Authority The Food Quality ProtectionAct (FQPA) of 1996 mandated a Registration Review program. All pesticides distributed orsold in the United States (U.S.) must generally be registered by EPA, based on scientific data showing thattheywill not cause unreasonable risks to human health orthe environmentwhen used as directed on the product labeling. The Registration Review program is intended to make sure that, as the abilityto assess risk evolves and as policies and practices change, all registered pesticides continue to meetthe statutory standard of no unreasonable adverse effects to human health orthe environment. Changes in science, public policy, and pesticide use practices will occur overtime. Through the Registration Review program, EPA periodically reevaluates pesticides to make sure that, as change occurs, products in the marketplace can continue to be used safely

. Information on this program is provided on EPA's website. 1


### EPA is implementing the Registration Review program pursuantto Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRAstandard for registration

. The regulations governing Registration Review begin at 40 C.F.R. 

### § 155.40. EPAwill consider benefits information and data as required by FIFRA. The public phase of Registration Review begins when the initial docket is opened for each case. The docket is EPA's opportunityto state what it knows aboutthe pesticide and what additional risk analyses and data or information it believes are needed to make a Registration Review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, EPA will develop a Final Work Plan (FWP) and anticipated schedule for the Registration Review ofthe Bacillus sphaericusstrains 2362 serotype H5a5b ABTS 17 43 and AM614.

1See http://www.epa.gov/oppsrrdl/registration review!. 6BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov 

### C. Background and Regulatory Information i. Summary of the Active lngredients2 

### Baci/lus sphaericus 

### are aerobic endospore-forming bacteria belonging to the family Baci/liaceae, 

### order Bacilliales, 

### class Baci/li, 

### phylum Firmicutes, 

### and kingdom Eubacteria. 

### Both insecticidal and non-insecticidal entomopathogenic strains of B. sphaericus

### can be found worldwide in water, soil, and insects. Some B. sphaericus

### strains may contain parasporal inclusions, but may not be entomopathogenic. The Baci/lus sphaericus

### strains addressed in this document are identified as strain 2362 by cellular fatty acid analysis and included within the H5a5b serotype group by flagellar antigen analysis (MRID 40885301, U.S. EPA Memorandum dated 03/10/89 from W. Hazel toP. Hutton). Baci/lus sphaericus

### strain 2632 serotype H5a5b (now called ABTS 1743) was first isolated in 1981 from an adult blackfly (Simulium damnosum) 

### in Nigeria and subsequently obtained in the U.S. These strains can be uniquely identified bytheir antibiotic resistance profile and from the morphology of crystalline inclusions (toxin proteins) produced during sporulation. While they are both characterized as Baci/lus sphaericus

### 2362 serotype H5a5b, the two Bacillus sphaericus

### strains addressed in this document are differentiated as strains ABTS 1743 and AM614. AM provided a written certification from the lnstitut PasteurthatAM614 (also known as SPH88) is B. sphaericus

### serotype H5a5b, strain 2362 (Attachment 1 of MRID 47356801, U.S. EPA Memorandum 2008c from 

### I. Barsoum to M. Mendelsohn). AM also provided comparisons of the biochemical profiles ofAM614 to demonstrate its similarityto VBS'ABTS 1743 active ingredient. The similarities were demonstrated by using the following tests: 1) standardized identification system Baci/lus

### for microbes; 2) cellularfatty acid profile (FAME) analysis; and 3) Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE) analysis (U.S. EPA Memoranda 2008c, 2011e, 2011f, from 

### I. Barsoum to M. Mendelsohn). Strain ABTS 1743was assigned PC Code 119801 when it was first registered on August 21, 1991 to Abbott Labs, as an EP with limited use for mosquito control (EPA Reg. No. 275-77; Caswell No. 143447-72-7). It was transferred on April29, 2000, to VBS and is now called Vectolex CG Biological Larvicide (EPA Reg. No. 73049-20). VBS registered a technical product containing 11%ABTS 17 43 on September 27, 2004 (EPA Reg. No. 73049-65). Other amendments were made to update the registrations ofthree EP pesticide formulations containing the active ingredientABTS 1743 (see Table 1). EPA recoded ABTS 1743 as PC Code 119803 on March 15, 2012 to distinguish it from the other registered strain. On September 15, 2008, AM registered the other B. sphaericus

### 2362 serotype H5a5b strain AM614 as a manufacturing use product (EPA Reg. No. 84268-1) for formulating into EPs. At the time of the FIFRAsection 3(c)(7) registration, AM614 was called SPH88 and was also assigned PC code 119801

. During the registration review process, EPA anticipates requiring clarification ofthe nomenclature and consistency in labeling ofAM's B. sphaericus 

### pesticides. AM demonstrated similarityto ABTS 1743 as previously discussed. On March 15, 2012, EPA recoded AM614to PC Code 119804to distinguish it from VBS' active ingredient, but data

2 Information in this section extracted from U.S. EPA (1989a), U.S. EPA. (2008c) and labels. 7BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations

.gov 

### submissions and reviews between 2008 and 2012 may refertoAM614 products as PC code 119801. Products containing Bacillus sphaericus are microbial mosquito larvicides registered for use where mosquitoes live and lay eggs, e.g. storm water and drainage systems, marine and coastal areas, freshwater bodies such as lakes and streams, waterthat collects in discarded tires, manmade and natural bodies of water, dormant rice fields, and water in agricultural sites. Pesticides containing these registered Bacillus sphaericus strains are not registered for use in or on treated or finished drinkingwaterfor human consumption. Additional details ofthese use sites, application rates and types are in Table 1 below, and also can be found on the pesticide product labels; see: http://www.epa.gov/pesticides/ppls. 

### ii. 

### Bacillus sphaericus Products In 1991, EPA registered the first Bacillus sphaericus -containing pesticide productfor use to control mosquito larvae. There are currently ten FIFRA Section 3 registered B. sphaericus insecticide products3

, 

### two of these products are MPs. VBS and AM have each registered aMP to be used for formulating into EPs to control selected species of mosquito larvae in avariety of habitats, including crop sites. Some of the registered EPs also contain Bacillus thuringiensis. Registered pesticide products containing both these active ingredients are available as briquets, controlled release granular (CRG), granular, spray, wettable powder and water soluble pouch formulations for application both by ground and aerially

. See Table 1 below for additional information on the currently registered Bacillus sphaericus products. TABLE 1. Summary ofCurrently Registered Bacillussphaericus Products 

### EPA Application Registration Product Name 

### Rates Numberand 

### (% Active Ingredient, (range) Application UseSites** Date Registered FonnulationType) IU=BS Methods International Units* Bacillus sphaericus

### strain 2362 serotype H5a5b ABTS 1743 (PC Codes 1198012, 1198032 ) 

### 73049-65 1 Bacillussphaericus 

### N/A Manufacturing use For manufacturing use only. 

### 09/27/04 Slurry 

### 11% Mosquito habitats
- agricultural crop and non-crop sitesWastewater, Stormwater/ 

### 151U- 80 Drainage Systems, Marine/Coastal Areas, 

### 73049-20 Vectolex CG Biological lbs/acre Forground and Water Bodies, Rice, pastures/hay fields, 

### 08/21/1991 Larvicide 

### 7.5% granular aerial equipment orchards, citrus groves, irrigated crops
. Water soluble pouch for ponds, lagoons, water gardens, bird baths, fountains, flower pots and planters. VectolexWDG Wastewater, Stormwater/Drainage 

### 73049-57 Biological Larvicide 

### 76.81U -0.5 Forground and Systems, Marine/Coastal Areas, Water 

### 06/08/1999 (51.2%) (dried 

### 1.5 lbs/acre aerial equipment Bodies (natural and manmade), concentrate) granular- Agricultural crops (Dormant Rice Fields, fororganic 

### use Rice, pastures/hayfields, orchards, citrus

3 Section 3 productlabels canbeobtained from the PesticideProductLabel System (PPLS) website

(http:1/oaspub.epa.gov/pestlab/Jppls.homeor www.epa.gov/pesticides/ppls). 8Bacillus sphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov TABLE 1. Summary of Currently Registered Bacillussphaericus Products EPA Application Registration Product Name Rates Numberand 

### (% Active Ingredient, (range) Application UseSites** Date Registered IU=BS Methods Formulation Type) International Units* groves, irrigated crops. Rice fields, pastures/hayfields, orchards (including citrus groves, peaches, almonds, dates, and walnuts), asparagus fields, corn fields, cotton fields, alfalfafields, vineyards. Vectomax FG Forground and 73049-429 Biological Larvicide 541U-20 aerial equipment; Sitesthat contain fish, otheraquatic life 04/24/2006 2.7% B.sphaericus lbs/acre watersoluble and plants +4.5% Bti4 includes watersoluble pouch pouch Bacillussphaericusstrain AM614 (PC Codes 1198013, 1198043 ) Advanced Microbiologies LLC (84268) MP and EP 84268-1 1 AM61432 Primary 09/15/2008 Powder 100% N/A Manufacturing use For manufacturing use only. Powder Waste water, storm water/drainage 84268-2 AM61432 (50 G) 100 IU to Forground and systems, Marine coastal areas, natural and 09/15/2008 5% granular 5-20 lb/acre. aerial equipment man-made waterbodies, dormant rice fields. Ricefields, pastures 

### Ihayfields, orchards, citrus groves, irrigated crops, agricultural 84268-3 AM61432 WP 97.51U Forground and irrigation waters (0.5 to 1.5 lb/acre); 09/15/2008 65%
-wettable powder 0.5 to 1.5 aerial spraying Wastewater, storm water/drainage lb/acre systems, Marine coastal areas, natural and man-madewaterbodies, dormant rice fields. Bacillussphaericusstrain AM614 EPs (PC Codes 1198013, 1198043 ) FourStar Products (83362) and FourStar Microbial Products (85685) Areasthatcontain aquatic life, fish and plants, or used by or in contactwith humans, animals, horses, livestock, pets, birds orwildlife. Storm drains, catch basins, underground drainage systems, storm 83362-3 FourStar Briquets Briquet Briquet
- Apply by water retention areas, retention ponds, 05/06/2009 6% hand abandoned swimming pools, ornamental fountains, ponds, fish ponds, water gardens, animal drinking troughs, standing water, water holding receptacles, manmade and natural siteswhere mosquitoes grow. FourStarCRG 180 IU-to 20 Add granule or Mosquito habitats- Pre-hatch orpost85685-2 (Controlled Release lbs/acre; one pouch to hatch totemporaryand permanentwater 09/07/2011 Granule) ( 1 )teaspoon treatmentarea by sites priortoflooding; areaswhere aquatic +1% BtF
- Granule or - cup/50-2400 hand; ground or life, fish, plants, humans, animals, horses, Watersoluble pouch squarefoot aerial application. livestock, pets, birds orwildlife; freshwater
9Bacillussphaericus Case 6052- PreliminaryWorkPlan EPA

-HQ-OPP-2013-0116 www.regulations.gov TABLE 1. Summary ofCurrently Registered Bacillussphaericus Products 

### EPA Application Registration Product Name Rates Numberand {%

### Active Ingredient, {range) Application UseSites** Date Reglstttred FormulationType) IU=BS Methods International Units* water; 1-2 marshes, cattail marshes, woodland pools pouches/50 and meadows, grassyswales, floodplains, square ft- flood water, standing water, roadside double rate in ditches, canals, catch basins, storm drains, deep water, storm watercollection areasand dense surface impoundments, lakes, ponds, abandoned cover swimming pools, ornamental fountains, ponds, watergardens, waterholding receptacles, othernatural and manmade sites. Commercial and Residential Use [including WaterSoluble Pouches (WSP)] Any 85685-3 FourStar MBG 60 IU-Ibs/acre Ground, aerial locationwherewater accumulates and 10/25/2012 

### +3% Bti5 to 20 lbs/acre applications remains standing for periods oftime, excepttreated, finished drinkingwaterfor human consumption. Footnotes Table 1: 1Manufactunng Use Product. 28. sphaencusserotype H5a5b stra1n ABTS1743. 38. sphaencusserotype H5a5b strain AM614. 48. thuringiensis israelensis (Btt) H-14strain AM65-52 5 Bacillus thuringiensis israe/ensis (Btt) Strain BMP144. *The potency ofthe active ingredient is expressed as B.sphaericus International Units (BS IU) ratherthan cfu/g.

. **Fordetails of sites see use**s~es** on EPA's label site at www
.epa.gov/pesticides/pplse.g
..Waste tires -1 VectoLex Soluble Pouch for up to 50 square feet of treatment area. 

### iii. ToleranceActions An exemption from the requirement of a tolerance is established for residues ofthe microbial pesticides, 

### Bacillus sphaericuswhen used in oron all food crops [40 CFR 

### § 180.1202, 63 FR 48597, Sept. 11 , 1998]. Registered 

### Bacillus sphaericus pesticides can be applied to agricultural food crop areas where water is standing, such as dormant rice fields, etc. (see Table 1 and labels). In light of available toxicity and exposure data, EPA concluded that there was a reasonable certainty that no harm would result to the U.S. population, including infants and children, from aggregate exposure to residues of 

### Bacillus sphaericus (Final Rule to establish tolerance exemption, 63 FR 48597, Sept. 11, 1998). Since this tolerance exemption took effect after FQPA amended FIFRA in 1996, the exemption did not require reassessment. 

### D. Anticipated Data Needs and RiskAssessments Provided below are tables ofthe current data requirements for microbial pesticides as setforth in 40 C.F.R. part 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, toxicology, and nontarget organisms and environmental fate) and descriptions are included regarding howthe data requirements have been fulfilled orwhere data gaps (anticipated data needs) have been identified. Presently, there are data gaps and anticipated data needs for both registered strains of 

### Bacillus sphaericus, as follows:
10BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov 

### i. Fortechnical products for both ABTS 1743 and AM614, confirmatory data/information thatthe ProductAnalysis requirement has been satisfied for 'deposition of a sample in a nationally recognized culture collection' (40 CFR 158.2120) and meets currentAgency data requirements for registration of pesticides under FIFRA. 

### i. Product Chemistry (40 C.F.R. 

### § 158.2120) Tables 2 to 5 below provide summaries of product chemistry datathat support registration of 

### Bacillus sphaericus strain ABTS 1743 and AM614. The data continue to meet EPA's current data requirements for pesticide registration. 

### ABTS 1743 One EP (EPA Reg. No. 275-77) was registered to Abbott in 1991 and transferred to VBS as EPA Reg. No. 73049-20). VBS cited the previously submitted and reviewed EP data and provided additional data to register the MP (EPA Reg. No. 73049-65). All product chemistry requirements for registration of products containing ABTS 1743 have been met. Nevertheless, EPA anticipates requiring confirmation thatthe depositof active ingredient in a National or recognized culture collection is currently maintained to validate thatthe source ofthe active ingredient is still the same as was originally registered. TABLE 2. Summaryof ProductChemistry Datafor 

### Bacillussphaericusstrain ABTS 1743Technical

. EPA Reg. No. 73049-65 Harmonized Has Data MRID/Accession

Guideline Data Requirement Requirement Been Source NumberorOther

Number Addressed? How? Reference U.S. EPA (1989a )1 40028001 U.S. EPA (1989a)1 40885301 885.1100 Product Identity Yes Studies U.S. EPA (1991) 41586701 U.S. EPA (1991) 41604001 U.S. EPA (2001) 45233004 U.S. EPA (2004) 45681801 U.S. EPA (1991) 41586701 885.1200 Manufacturing Process Yes Study U.S. EPA (2001)2 45233004 U.S. EPA (2004)3 45681801 Deposition of aSample in a U.S. EPA (1989a)1 885.1250 Nationally Recognized Culture No Data gap; ATCC Collection confirmation needed 885.1300 Discussion of Formation of Yes Study U.S. EPA (1989a)1 40028001 Unintentional Ingredients U.S. EPA (1991)1 41586703 885.1400 Analysis of Samples Yes Study U.S. EPA (1991}_1 41586701 U.S. EPA (2001)2 45233004 885.1500 Certification of Limits Yes Study U.S. EPA (2001)2 45233004 CSF dated May26, 2000 140885301: U.S.EPA. 1989a. W. J. Hazel to P. Hutton, 03/10/89. 245233004: Memo: C. Ets1ttyto A. Reynolds 10/15/01. 345681801:Memo C. Etsittyto A. Reynolds 09/22/04.

IIBacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov
TABLE 3. Summary

### of Physical and Chemical Characteristics

### for Bacillussphaerlcusstrain ABTS 1743(VBS73049) EPA Reg. No. 73049-65 

### MRID/ Harmonized Has Data Accession Guideline Number Data Requirement Requirement Been Source Numberor Addressed? How? Other Reference 830.6302 Color Yes Study U.S. EPA 1989a1 40885301 830.6303 Physical State Yes Study U.S. EPA 40885301 (1989a)1 830.6304 Odor Yes Study U.S. EPA 40885301 (1989a)1 Stabilityto Normal and Elevated 830.6313 Temperatures, Metals and Metal Yes -Study U.S. EPA (1991) 41586702 Ions U

.S. EPA (1989) 40886601 40886602 830.6317 Storage Stability Yes Study U.S. EPA (1991) 41586702 U.S. EPA (2001)2 45233004 U.S. EPA (2004)3 45681801 830.6319 Miscibility Not required perOCSPP 830.1000(e)(2), the product is not an emulsifiable liquid 830.6320 Corrosion Characteristics Yes Study U.S. EPA (1991) 41586702 830.7000 pH Yes Study U.S. EPA (1989a) 40885301 830.7100 Viscosity Not applicabletotheTGAI test substance, as it is not aliquid

. 830.7300 Density/Relative Density/Bulk Yes Study U.S. EPA (1989a) 40885301 Density 140885301: U.S.EPA. 1989a. W

.J

.Hazel to P. Hutton, 03/10/89

. 245233004: Memo: C. Ets1ttyto A. Reynolds 10/15/01. 345681801 :Memo C. Etsittyto A. Reynolds 09/22/04.



### AM614 AM614 was registered in accordance with FIFRA Section 3(c)(7) on September 15, 2008 with conditions of registration asfollows: to confirm similarity toABTS 1743, to provide methods for determination of unintentional ingredients, and to submitdata/information regarding oxidationreduction, chemical incompatibility, storage stability, and corrosion characteristics of the active ingredient. AM provided the data/information required to meetthese conditions (MAID 47898202: DER I. Barsoum toM. Mendelsohn 02/10/11b; letter March 14,2011 from S. Reilly to A. Roberts, AM's consultant). The product characterization and physical and chemical properties data submitted to support the registration of products containing 

### B. sphaericus strainAM614 meetthe data requirements for microbial pesticide product analysis. As noted for the other active ingredient and for the same reason to ascertain the integrity ofthe master stock culture ofthe registered strain ofthis microbe, EPA anticipates requiring confirmation thatthe deposit in a nationally recognized culture collection is current (Guideline 885.1250). In addition, during the registration review 12BacillussphaericusCase 6052 -PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov 

### process, EPAwill clarify the relationship between AM614 and SPH88 and establish consistency in the nomenclature of the active ingredient in regulatory documents and labeling.

TABLE 4. Summaryof ProductChemistry Datafor Bacillussphaericusstrain AM614 (EPA Reg. No. 84268-1) Has Data litarmonized Requirement MRID/Accession

Guideline Data Requirement Been Source Numberor

Number Addressed? OtherReference How? U.S. EPA (2008c) 47157201 47356801 1 U.S. EPA (2008c) 47898200 885.1100 47898202 Product Identity Yes Studies !J.S. EPA (2011e) 47898404 Registrant U.S. EPA (2011f) response to deficiencies U.S. EPA (2008c) 47157201 885.1200 Manufacturing Process Yes Study U.S. EPA (2011a) 47356801 U.S. EPA (2011b) 47898202 Yes letterfrom Pasteur U.S. EPA2008c 885.1250 Deposition of aSample in aNationally lnstitut in cited Data Gap; 47356801 Recognized Culture Collection study- need confirmation to ascertain needed1 currentstatus. Discussion of Formation of Unintentional U.S. EPA (2008c) 47157201 885.1300 Yes Study 47356801 Ingredients U.S. EPA (2011e) 47898404 885.1400 Analysis of Samples Yes Study U.S. EPA (2008c) 47157201 47356801 885.1500 47157201 Certification of Limits Yes Study U.S. EPA (2008c) 47356801 CSF dated March 10, 2011 NotesTable 4: 147356801, U.S. EPA Memorandum 2008cfrom I. Barsoum to M. Mendelsohn
- letter in studystates it is in the Pasteur lnstitut- EPA requires confirmation that culture deposit is maintained currently.

13Bacillussphaericus Case 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov


### TABLE5. Summaryof Physical and Chemical Characteristicsfor 

### Bacillussphaericusstrain AM614 (EPA Reg. No. 84268-1) Has Data MRID/ Harmonized Requirement Accession

Guideline Data Requirement Been Source Numberor

Number Addressed? OtherReference How? 830.6302 Color Yes Study U.S. EPA (2008c) 47157201

830.6303 Physical State Yes Study U.S. EPA (2008c) 47157201

830.6304 Odor Yes Study U.S. EPA (2008c) 47157201

830.6313 Stabilityto Normal and Elevated Yes Study U.S. EPA (2008c) 47157201 Temperatures, Metals and Metal Ions U.S

. EPA (2011b) 47898202 U.S. EPA (2008c) 47157201 830.6317 Storage Stability Yes Study U.S. EPA(2011b) 47898202 U.S. EPA (2011e) 47898404 830.6319 Miscibility Not required perOCSPP 830.1OOO(e)(2), the product is not an emulsifiable liquid. 830.6320 Corrosion Characteristics Yes Study U.S. EPA (2011b) 47898202 U.S. EPA (2011e) 47898404 830.7000 pH Yes Study U.S. EPA (2008c) 47157201 830.7100 Viscosity Yes Study U.S. EPA (2008c) N/Asolid 830.7300 Density/Relative Density/Bulk Density Yes Study U.S. EPA (2008c) 47157201



### ii. Toxicology (40 C.F.R. 

### § 158.2140) These microbial active ingredients, 

### B. sphaericus strainsABTS 1743 and AM614, are nottoxic, infective or pathogenic on the basis of acute toxicologytests conducted with laboratory mammals oron data/information submitted to show equivalence of strain AM614 to strain ABTS 1743 (see summary of active ingredients where equivalence was shown to registered strain by 1) standardized identification system 

### Bacillusfor microbes; 2) cellularfatty acid profile (FAME) analysis; and 3) Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDSPAGE) analysis (U.S. EPA Memoranda 2008c, 2011e, 2011f, from 

### I. Barsoum to M. Mendelsohn). During registration review, the EPA anticipates reviewing current labels and ensuring that precautionary language is present to mitigate exposure and risk to the potential moderate eye irritation and dermal sensitization effects of some oftheformulations that include these active ingredients.

14BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov 

### a) Strain ABTS 1743 The toxicology data submitted to support the registration ofthe B. sphaericusserotype H5a5b strain ABTS 17 43 pesticide products satisfythe current microbial pesticide acute toxicology data requirements. The company's submissions for the data requirements for mammalian acute oral, dermal, and pulmonarytoxicity, primary dermal irritation, primary eye irritation and dermal sensitization are shown in Tables 6 and 7 below. EPA has reviewed these submissions and rationale to support requests to waive testing and has determined thatthey meet current requirements for pesticide registration. The MP and EPs are in Toxicity Category IVfor acute oral, dermal, pulmonary toxicity and primary eye irritation effects (U.S. EPA 1989a, U.S. EPA · 1989b, and U.S.EPA 1996e). Primary dermal irritation and dermal sensitization studies indicate that products may be potential dermal sensitizers (U.S. EPA 1989a, U.S. EPA 1996e).

TABLE6. SummaryofToxicology Datafor 

### BacillussphaericusstrainABTS 1743 (EPA Reg. No. 73049-65)
Harmonized Has Data Requirement MRID/Accession Guideline Number Data Requirement Been Addressed? Source NumberorOther How? Reference
885.3050 Acute Oral Toxicity/ Yes Studies1 U.S. EPA (1989a) 40329802 Pathogenicity U.S. EPA (1989b) 41103401 885.3150 Acute PulmonaryToxicity/ Yes Study1 U.S. EPA (1989a) 40329804 Pathogenicity U.S. EPA (1989bJ 41103402 Acute InjectionToxicity/ U.S. EPA (1989a) 40329805 885.3200 Pathogenicity Yes Study U.S. EPA (1989b Intravenous 41103403 40329809- inconclusive but anyfuture hypersensitivity incidents must 885.3400 Hypersensitivity lncidents2 be reported per40 CFR 158.2140 (see also OPPTS Guideline 885.3400). 885.3500 Cell Culture NotApplicable. 

### Bacillussphaericusis not avirus (refertotest note #4 of40 CFR § 158.2140(d):. 870.1100 Acute Oral Toxicity Yes Study U.S. EPA (1989a) 40329802 U.S. EPA (1989b) 41103401 870.1200 Acute Dermal Toxicity Yes Study U.S. EPA (1989b) 40329803 870.1300 Acute InhalationToxicity Yes Study U.S. EPA (1989b) 40329804 870.2400 Acute Eye Irritation Yes Study U.S. EPA (1989b) 40329808 870.2500 Primary Dermal Irritation Yes Study U.S. EPA (1989a) 40329807 U.S. EPA (1996e)3 439919013 1U.S. EPAJ. T. McClintockto P. Hutton 09/14/1989. 240329809, Inconclusive gu1nea p1g study submitted forth1s gUideline. au.S. EPA 1996e: from J. F. Heminway, 11/24/96-Toxcategory IV.

15BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov b) Strain AM614 The toxicology data submitted for the registration of B. sphaericusserotype H5a5b strain AM614 pesticide MP satisfy the current microbial pesticide toxicology data requirements for acute toxicity studies for pesticide registration (Table 7).



### TABLE7. SummaryofToxicology Datafor 

### BacillussphserlcusstrainAM614 (EPA Reg. No. 84268-1)
Harmonized Has Data Requirement MAID/Accession Guideline Number Data Requirement Been Addressed? Source NumberorOther How? Reference 885.3050 Acute Oral Toxicity/ Yes Study U.S. EPA (2008c) 47157203* Pathogenicity 885.3150 Acute Pulmonary Yes Study U.S. EPA (2008c) 47157205 Toxicity/Pathogenicity Acute InjectionToxicity/ 885.3200 Pathogenicity- Yes Study U.S. EPA (2008c) 47157203 Intravenous 885.3400 Hypersensitivity Incidents Anyfuture hypersensitivity incidents must be reported per40 CFR 158.2140 (see alsoOPPTS Guideline 885.3400). 885.3500 Cell Culture NotApplicable. 

### Bacillussphaericusis not avirus (refertotest note #4 of 40 CFR 

### § 158.2140(d)). 870.1100 Acute Oral Toxicity Yes Study U.S. EPA (2008c) 47157203* 870.1200 Acute Dermal Toxicity Yes Study U.S. EPA (2008c) 47157204 870.1300 Acute InhalationToxicity Yes Study U.S. EPA (2008c) 47157205 870.2400 Acute Eye Irritation Yes Study U.S. EPA (2008c) 47157206 870.2500 Primary Dermal Irritation Yes Study U.S. EPA (2008c) 47157207 870.2600 Dermal Sensitization Yes Study U.S. EPA (2008c) 47157208



### . . . • 0 

### . . ... *While study 1n1t1allyclass1f1ed as Supplemental att1me of reg1strat1on,th1s was based on the results ofs1m1lanty stud1es. The s1mllanty stud1es were submitted and found acceptable (47898202, and US. EPA2008c, 2011e, 2011f; also seeTable 4).


### iii. NontargetOrganisms and Environmental Fate (40 C.F.R. 

### § 158.2060) The nontarget organism and environmental fate data submitted for registration of pesticide products containing the active ingredients, B. sphaericusABTS 1743 satisfy the current microbial pesticide nontarget organism and environmental fate data requirements (40 CFR part 158.2150) for the currently labeled sites. See Tables 8 and 9 belowfor citations of studies and EPA reviews of these data. ABTS 1743 Between 1988 and 2001, EPA reviewed data/information submitted by VBS to establish thatthe active ingredient, ABTS 1743, was not toxic or pathogenic to birds, fish, freshwater and marine invertebrates, nontarget insects and honeybees. The original ecological effects review (written by Z. Vaituzis, dated August 4, 1988) for Bacillus sphaericus H5a5b strain 2362 ABTS 1743 provides an evaluation of the avian, freshwater fish, and honeybee toxicity data, and cited several data gaps. VBS subsequently submitted some data to satisfy the data requirements (see Table 8, for MRIDs and U.S. EPA 16BacillussphaericusCase 6052-PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov explanations and citations, including U.S. EPA (1996a-d). EPA also determined in some cases that data were no longer needed. The data gaps and actions to address them were: 1) A chronic feeding studyto evaluate possible risk to aquatic avian wildlife from repeated ingestion of B. sphaericusgranularformulations. • EPA determined that the chronic feeding study was no longer required because it was initially requested on the basis of the results of an avian injection study, which is no longer required, because the nature of the microbial pesticide does not indicate potential pathogenicity to birds (Table 8). 2) Mouse infectivity studies requested by human health effects data reviewers • Acute oral, acute inhalation, and acute intravenous toxicity/pathogenicity data with laboratory rats were subsequently submitted, the results of which concluded no toxicity, pathogenicity, or infectivity of Bacillus sphaericus H5a5b strain 2362 to rats. These data were determined to adequately address the infectivity concerns4

. 3) Testing of green alga Selenastrum capricornutumto fulfill the Tier I nontarget plant study requirements. 4) Because the current plant data requirements are conditional and only required if the microbial pesticide is taxonomically related to a known plant pathogen, which is not the case for B. sphaericus, EPA determined that this study is no longer required (Table 8: U.S. EPA 1996b and 2008b). 5) Estuarine and marine aquatic animal studies, since use is expected in areas with estuarine environments. • Studies with sheepshead minnow (MRID 41931301), mysid shrimp (MRID 41931302), and Eastern oyster (MRID 41931305) were submitted and were found to be acceptable U.S. EPA (1996a-c) 2• The data requirement has been met. 

### TABLE 8. SummaryofNontargetOrganisms Dataforthe 

### Bacillussphaerlcusstrain ABTS 1743 (EPA Reg. No.73049-65) Harmonized Has Data MRID/Accession

Guideline Data Requirement Requirement Been Source NumberorOther Number Addressed? How? Reference 885.4050 Avian Oral Toxicity Yes Study U.S. EPA (1988) 403298111, U.S. EPA (1988) 41931304 885.4100 Avian Inhalation The nature ofthe microbial pesticide does not indicate potential Toxicity/Pathogenicity pathogenicityto birds. 1 Wild Mammal Toxicity/ Not applicable. Notesting expected to be required. Results ofthe Tier 1 885.4150 Pathogenicity toxicitytests required by 40 CFR 

### §158.2140 (Table 6) are adequate and approJriate for assessment of hazards. Freshwater Fish Toxicity/ 403298131 885.4200 Yes Studies U.S. EPA (1988) 403298141 Pathogenicity 40193701 1 885.4240 Freshwater Invertebrate Yes Studies U.S. EPA (1988) 403298151 Toxicity/ Pathogenicity 40193701 1 EstuarineAnd Marine 41931301 885.4280 InvertebrateTesting Yes Studies U.S. EPA (1996a-c)2 41931302 41931305 Nontarget plant Yes Studyand U.S. EPA (1996d)2 41931303 (algae) 885.4300 ScientificWaiver Testing Rationale U.S. EPA (2008b) Nottaxonomically

4 Memorandum from J. McClintock (OPP/HED) to P. Hutton (OPP/RD) dated September28, 1989b and Table 2: MAID 45681801: Memo from C. Etsittyto A. Reynolds dated 09/22/04 for acceptable mouse infectivitytesting. 17BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations

.gov 

### TABLE 8. Summaryof NontargetOrganisms Dataforthe 

### Bacillussphaericusstrain ABTS 1743 (EPA Reg. No. 73049-65) Harmonized Has Data MRID/Accession

Guideline Data Requirement Regulrement Been Source NumberorOther

Number Addressed? How? Reference related to aknown

plant pathogen

. 885.4340 Nontarget insecttesting Yes Scientific U.S. EPA (1988) 40391401 1 Waiver Rationale 41604001 885.4380 Honey beetesting Yes Scientific U.S. EPA (1988) 403298161 Waiver Rationale

.. 1VBS c1ted own datafrom registered 73049-20 and submitted add1t1onal data. DER 08/28/1988 from Z

.Va1tuz1s toP. Hutton and2U.S. EPA 1996a-d: from Horne, D. dated 08/19/96 a-d. Active ingredients are veryspecificfor mosquitoes as shown by host range specificity and product performance tests for both active ingredients (U.S. EPA 1999, 2006, 2008a, 2008e, 2011g, 2012)

. 

### AM614 AM submitted a request to bridge data by claiming that it is similartoABTS 17 43

. Between 2008 and 2011, AM provided data to demonstrate similarity ofAM614 to the earlier registered active ingredientABTS 1743 (Memoranda 

### I. Barsoum toM. Mendelsohn, U.S.EPA2008c, 02/10/2011 ). This led to bridging of data for avian oral toxicity pathogenicity, freshwaterfish, estuarine/marine fish and invertebrate non-target organisms and honey bee testing, which were submitted to supportthe original registration ofthe ABTS 1743 strain. AM also provided a studywith 

### Daphnia magna and scientific rationale to waive the data requirements for freshwater invertebrate and nontarget insecttesting, respectively (see ecotoxicology summary Table 9). Data to determine effects on nontarget plants were not required on the basis that AM614 is not known as a plant pathogen (U.S

. 

### EPA 2008b).


### TABLE 9. Summaryof NontargetOrganisms Datafor 

### Bacillussphaericusstrain AM614 (EPA Reg. No. 84268-1) Harmonized Has Data Requirement MRID/Accession

Guideline Data Requirement Been Addressed? Source NumberorOther

Number How? Reference Yes. Datawaiver Previouslysubmitted 885.4050 Avian OralToxicity rationale inMAID U.S. EPA data are adequate to 471572021 (2008b) fulfill data requirement by bridging. 885.4100 Avian inhalation The nature ofthe microbial pesticide does not indicate potential toxicity/pathogenicity pathogenicityto birds. 1 Wild mammal toxicity/ Not applicable .Notesting expected to be required. Results oftheTier 1 885.4150 pathogenicity toxicitytests required by40 CFR 

### § 158

.2140 (Table 7) are adequate and appropriate forassessment of hazards

. Yes. Datawaiver 47157202. Previously 885.4200 Freshwaterfish toxicity/ rationale in MAID U.S. EPA (2008b) submitted data are pathogenicity 471572021 adequatetofulfill data requirement by bridging. 885.4240 Freshwater invertebrate Yes Study U.S. EPA (2008b) 47157209 toxicity/pathogenicity

18Bacillus sphaericus Case 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov
TABLE 9. Summaryof NontargetOrganisms Datafor 

### Bacillussphaericusstrain AM614 (EPA Reg. No. 84268-1) Harmonized Has Data Requirement MRID/Accession

Guideline Data Requirement Been Addressed? Source NumberorOther

Number How? Reference Yes. Datawaiver Previouslysubmitted 885.4280 Estuarine and marine rationale in MRID U.S. EPA (2008b) data are adequateto invertebrate testing fulfill data requirement 471572021 by bridging. B. sphaericusis not 885.4300 Nontarget plant Yes. Known insect U.S. EPA (2008b) taxonomically related to Testing pathogen aknown plant pathogen. 885.4340 Nontarget insecttesting Yes. Datawaiver Previouslysubmitted rationale in MRID U.S. EPA (2008b) data are adequateto 885.4380 Honey beetesting 471572021 fulfill data requirements by bridging



### .. 1U.S.EPA. 2008c, 2011 e, 2011f-s1m1lanty shown to ABTS 1743. Request 1n MRID47157202to wa1vetest1ng relied on demonstration of similarityto ABTS 1743 (see product chemistryTable 4) and citation to previouslysubmitted data. 2U.S. EPA2008b: Memorandum from S. Borges to M. Mendelsohn. dated 09/02/08. 

### E. RisktoThreatened and Endangered Species EPA has prepared risk assessments that support a complete endangered species determination for the registered Bacillus sphaericus

### strains ABTS 1743 and AM614 (U.S. EPA, Z. Vaituzis to P. Hutton, 08/04/1988; S. Borges toM. Mendelsohn U.S. EPAIBPPD DER dated 09/02/2008). During Registration Review, EPA plans to conduct an ecological risk assessment to reassess whether use of the registered Bacillus sphaericus

### strains will have "no effect" or "may affect" federally listed threatened or endangered species (listed species) and/ortheir designated critical habitat. When an assessment concludes that a pesticide's use "may affect" a listed species and/or its designated critical habitat, EPAwill consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate. 

### F. Product Performance Product Performance data submitted for Bacillus sphaericus

### ABTS 1743 and AM614 demonstrate that the range of efficacyfor EPs tested in acceptable studies range from 85 to 100%. (U.S. EPA 1999, 2006, 2008a, 2008e, 2011g, 2012). 

### G. Endocrine Effects As required by theAdministrator underthe Federal Food, Drug, and CosmeticAct (FFDCA) section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be used to test all pesticides in order to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans orwildlife similarto an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." FFDCA section 408(p)(4) authorizes the Administrator, by order, to exemptfrom the requirements of the Estrogenic Substances Screening Program a biologic substance or other 19Bacillussphaericus Case 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov 

### substance if a determination is made that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance. Between October 2009 and February 2010, EPA issued test orders/data call-ins forthe first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. The 

### Bacillus sphaericusstrainsABTS 1743 and AM614 are not among the group of58 pesticide active ingredients on the initial list to be screened underthe EDSP. EPA, as part ofthis PreliminaryWork Plan, believes thatthe 

### Bacillus sphaericusstrainsABTS 1743 and AM614, the active ingredients involved in this Registration Review case, likely are substances thatwould not produce any effect in humans similarto an effect produced by a naturally occurring estrogenic substance. As such, pursuantto Section 408(p)(4), EPA will determine in the future whether it can exemptthe 

### Bacillus sphaericusstrainsABTS 1743 and AM614 from the requirements of the Section 408(p) EDSP. In the event EPA does determine to exemptthese substances from the EDSP, an orderwill be issued. Forfurther information on the status ofthe EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website at 

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

### H. Incidents There were no incidents for 

### Bacillus sphaericus pesticides in the Environmental Incident Information System (EllS) database up to the last update in August 2011. In accordance with section 6(a)(2), VBS reported two incidents overthe two decades of use ofABTS 1743. One was a human minor (HD) in 1991 and the otherwas a moderate domestic animal report in 2003. As of March 2013, these were reported as line items in a quarterly aggregate report of incidents in OPP's Incident Data System (IDS); no detailed information was included in the main individual study reports that are part of OPP's IDS. 

### I. Timeline The projected timeline for case 6052
- 

### Bacillus sphaericus
- Registration Review follows.



### Activities Estimated MonthNear Opening the Docket Open Docket and 60-Day Public Comment Period for 

### Bacillus March 27, 2013 

### sphaericus

Close Public Comment Period May 27, 2013 

### Case Development Issue Final Work Plan September2013 Issue Data Call-in January2015 Data Submission January 2016 Open 30-Day Public Comment Period for Draft RiskAssessments October2016 Close Public Comment Period November 2016 

### Registration Review Decision
20BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov


### Activities Estimated MonthNear Open 60-Day Public Comment Period for Proposed Registration March 2018 Review Decision Close Public Comment Period May 2018 Final Decision September2018 *Estimated Total (years) 4.5

.. * Th1s schedule IS subjectto rev1s1on should unforeseen 1ssues anse dunng the reg1strat1on rev1ew process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be issued atthat time. That Final Work Plan will identify any newly anticipated data needs and set forth a new timeline. 

### J. Guidancefor Commenters The public is invited to comment on EPA's Preliminary Work Plan and rationale. The areas below highlighttopics of special interest to EPAwhere comments, information, submissions, or reference to sources of additional information could be of particular use. EPAwill consider all comments, as well as any additional information ordata provided in a timely manner, priorto issuing a Final Work Plan for this case. 

### i. 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, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, EPA seeks information on any groups or segments of the population who, as a result of their location, cultural practices, orotherfactors, may have atypical, unusually high exposure to these registered pesticides containing Bacillus sphaericus strains, compared to the general population. 

### Please comment if you are aware of any subpopulations that may have atypical, unusually high exposure compared to the general population. 

### ii. Water Quality The Bacillus sphaericusstrains in registered pesticide products are not identified as a cause of impairmentfor anywater bodies listed as impaired under section 303(d) of the Clean Water Act. 2 

### In addition, no Total Maximum Daily Loads (TMDLs) have been developed for these Bacillus sphaericusstrains: ABTS 1743 and AM614.3 

### More information on impaired water bodies and TMDLs can be found at EPA's website.5 

### EPA invites submission of water quality data for these pesticides. To the extent possible, data should conform to the quality standards in AppendixA of the Office ofPesticide Program's (OPP) Standard Operating Procedure: Inclusion ofImpaired WaterBodyand Other Water QualityData in OPP's Registration ReviewRiskAssessmentandManagementProcess 4 

### to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

2 Based on information provided at http:/lwww.epa.gov/owowltmdl/. 3 Based on information provided at http://iaspub.epa.gov/tmdl waterslO/text search.tmdl search form

. 5 See http:/lwww.epa.gov/owowltmdll. 4 This document can be found at http://www.epa.gov/oppsrrdllregistration review/water quality sop.htm

. 21BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov



### iii. Trade Irritants Through the Registration Review process, EPA intendsto solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. EPAwill work to harmonize tolerance and international Maximum Residue Limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lackof MRLs ordisparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature ofthe concern. An exemption from the requirement of a tolerance has been established in the U.S. for Bacillus sphaericus in 40 CFR 180.1202. Moreover, there are no known MRLs for Bacillus sphaericus strains: ABTS 1743 and AM614. EPAdoes not anticipate that current uses of Bacillus sphaericusstrains: ABTS 1743 and AM614 will pose concerns as trade irritants. 

### iv. Additional Information Stakeholders are also specifically asked to provide information and data that will assist EPA in refining the risk assessments. EPA is interested in obtaining the following information regarding the Bacillus sphaericusstrains, ABTS 1743 and AM614:**~** 

### Confirmation on the following label information:

- Sites ofapplication

- Formulations -Application methods andequipment

- Maximum application rates

- Frequencyofapplication, application intervals, andmaximum numberof

applications -Geographic limitations on use**~** 

### Use or potential use distribution (e.g., acreage and geographical distribution of relevant use sites);**~** 

### Median and goth 

### percentile reported use rates (lbs active ingredient/1 ,000 square feet) from usage data- national, state, and county;**~Application** 

### timing (date of first application and application intervals)- national, state, and county;**~** 

### Usage/use information for nonagricultural uses;**~Typical** 

### application interval (days);**~** 

### State or local use restrictions;**~** 

### Monitoring data. K. NextSteps Afterthe 60-day comment period closes, EPA will review and respond to any comments received in a timely manner and then issue a Final Work Plan for case 6052: Bacillus sphaericus.

22BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov 

### II. FACT SUMMARY FOR CASE 6052 TABLE 11. Background Informationfor Bacillussphaericus

### Registration Review PubliclyAvailable Additional RiskAssessmenf. 3 

### Active Ingredient First CurrentlyRegistered EPA Scienceand Needed?(Yes orNo) (PC Code) Registered Pesticide Products' Regulatory Product Human Ecological Documents Chemistry HeaHh Bacillus 1991 1MP( 73049-57) registered Registration Notices 

### sphaericusstrain 2001 and Labels on



### 2362 serotype 3end-use products www.epa.gov/pesticides/ 

### H5a5b ABTS1743 (73049-20, 73049-57, 73049- ppls 

### (PC Codes 429) Citations in No No Yes 

### 119801, 119803) Bibliographyand references to EPA reviews in this document. Bacillus 1991 1MP (84268-1) and 2EPs 3 Registration Notices 

### sphaericusstrain (84268-2, 84268-3). and Labels on



### 2362 serotype www.epa.gov/pesticides/ 

### H5a5b AM614 Three additional EPs3 ppls



### (PC Codes (83362-3, 85685-2, 85685-3) Citations in No No Yes 

### 119801, 119804) contain AM614. Bibliographyand references to EPA reviews in this document.

0 0 1SeeTable 1foradd1t1onal1nformat1on (e.g., use s1tes) on the currently registered products. Labels forthese products can befound 1n the Pesticide Product Label System ( www.epa.gov/pesticides/ppls)

. 2SeeAnticipated Data Needs and RiskAssessments. 3Product registrations is an ongoing process and subjectto reviews as data/information are submitted.

23BacillussplwericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations

.gov 

### Ill. BIBLIOGRAPHY A. Studies Supporting Registration Review of 

### Bacillus sphaericusstrainABTS 1743 (PC Codes119801, 119803)

MRID 32514

148466 148467

148468

148469

148470
148471
156631
156632
156633
156634
40028000
40028001
40028002
40028003
40193700
40193701
40329800 Bibliography: Bacillussphaer/cus2362 serotype H5a5b ABTS 1743 (PC code119801, 119804) Citation Reference Goldberg, L.J.; Margalit, J. (1977) A bacterial spore demonstrating rapid larvicidal activity against Anopheles sergentii, Uranotaenia unguiculata, Culex univitattus, Aedes aegypti, and Culexpipiens. Mosquito News 37(3):355-358. (Also In unpublished submission received Apr 15, 1980 under 43382-3; submitted by Biochem Products, S.A., Brussels, Belgium; CDL: 242360-J). Biochem Products S.C.S. (1985) BSP 1: Chemical and Physical Properties. Unpublished study.1 p. Biochem Products S.C.S. (1985) Toxicity Data or Reference to Available Data on the Toxicity of the Pesticide (Bacillus sphaericus) Including Data on the Toxicityto Fish and Wildlife. Unpublished study. 5 p. De Barjac, H.; Larget, 1.; Cosmao, V.; et al. (19??) lnnocuite de Bacillus sphaericus, Souche 1593, pour les Mammiferes: WHONBC/79.731. Unpublished study prepared byWorld Health Organization

. 20 p. World Health Organization, Div. of Vector Biology and Control (1980) Data Sheet on the Biological Control Agent: Bacillus sphaericus, Strain 1593: HONBC/80.777: VBC/BCDS/80.10. Unpublished study. 15 p. Shadduck, J. (1983) Some considerations on the safety evaluation of nonviral microbial pesticides. Bulletin ofthe World Health Organization 61 (1):117-128. Biochem Products S.C.S. (1985) Effectiveness Data Which Indicate Thatthe Product (B.S.P. 1) Is Useful for the Purposes Proposed. Unpublished compilation. 28 p. Abbott Laboratories (1986) Chemical and Physical Properties: [Bacillus sphaericus-Biological Mosquito Larvicide]

. Unpublished study

.4 p. Shadduck, J.; Singer, S.; Lause, S. (1980) Lack of mammalian pathogenicity of entomocidal isolates of Bacillus sphaericus. Entomological Society of America 9(4):403-407. Shadduck, J. (1985) Mammalian Safety of Bacillus sphaericus: BCV/CSP/WP.25. Unpublished review of studies prepared byWorld Health Organization. 6 p. Mulla, M. (1985) Safety of Bacillus sphaericusto Beneficial Macro- invertebrates: BCV/CSP/WP.24. Unpublished study prepared byWorld Health Organization. 6 p. Abbott Laboratories (1986) Product Chemistry of Bacillus sphaericus H-5a5b Granules. Compilation of 3 studies. Devissetty, B. (1986) Product Identity and Composition of[

...] Bacillus sphaericus H-5a5b Granules. Unpublished compilation prepared by Abbott Laboratories

. 39 p. Devisetty, B. (1986) Analysis and Certifications of Product Ingredients of Bacillus sphaericus H5a5b Granules. Unpublished study prepared byAbbott Laboratories. 15 p. Devisetty, B. (1986) Physical/Chemical Properties of[

...] Bacillus sphaericus H-5a5b Granules. Unpublished study prepared byAbbott Laboratories. 11 p. Abbott Laboratories (1987) Submission of Toxicity Data in Support of Application for Registration of Bacillus sphaericus H-5a5b. Transmittal of 1 study. Foster, R. (1987) Supplementary Information on the Toxicity of Bacillus sphaericus H-5a5b to Nontarget Aquatic Organisms. Unpublished study prepared byAbbott Laboratories. 8 p. Abbott Laboratories (1987) Submission ofToxicity Data To Supportthe Registration of Bacillus
24BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov

MRID

40329801
40329802
40329803
40329804

40329805

40329806

40329807
40329808
40329809

40329810
40329811

40329812

40329813

40329814

40329815

40329816
40391400 Bibliography: Bacillus sphaericus2362 serotype H5a5bABTS 1743 (PC code119801, 119804) Citation Reference sphaericus H-5a5b Granules. Transmittal of 16 studies. Cozzi, E. (1986) An Overview of the Toxicity and Pathogenicity of Bacillus sphaericus H-5a5b to Mammals: Document No.4. Unpublished compilation prepared by Abbott Laboratories. 53 p. Henck,J. (1986) Bacillus sphaericus: Acute Oral LD50 in Rats: Document No.5: TRL Study No. 024-025. Unpublished study pre- pared byToxicity Research Laboratories, Ltd. 25 p. Henck,J. (1986) Bacillus sphaericus: Acute Dermal Toxicity Study: Document No. 7: TRL Study No. 024-026. Unpublished study pre- pared byToxicity Research Laboratories, Ltd. 27 p. Newton, P. (1986) Four HourAcute Dust Aerosol Inhalation Toxicity Study in Rats of Bacillus sphaericus: Document No.9: ABC Study No. 420-2507. Unpublished study prepared by American Biogenics Corp. 24 p. Henck, J. (1986) Intravenous Toxicity/Infectivity Studywith Bacillus sphaericus in NewlyWeaned Mice: Document No. 11: TRL Study No. 024-029. Unpublished study prepared byToxicity Research Laboratories, Ltd. 32 p. Henck, J. (1986) Intravenous Toxicity/Infectivity Studywith Bacillus sphaericus in NewlyWeaned Hamsters: Document No. 12: TRL Study No. 024-028. Unpublished study prepared byToxicity Research Laboratories, Ltd. 24 p. Henck, J. (1986) Bacillus sphaericus: Primary Dermal Irritation Study: Document No. 13: TRL Study No. 024-023. Unpublished study prepared byToxicity Research Laboratories, Ltd. 28 p. Henck, J. (1986) Bacillus sphaericus: Primary Eye Irritation Study: Document No. 14: TRL Study No. 024-024. Unpublished study pre- pared byToxicity Research Laboratories, Ltd. 33 p. Henck, J. (1986) Hypersensitivity Study of Bacillus sphaericus in Albino Guinea Pigs: Document No. 15: TRL Study No. 024-027. Unpublished study prepared byToxicity Research Laboratories, Ltd. 48 p. Cozzi, E. (1986) An Overview of the Toxicity and Pathogenicity of Bacillus sphaericusto Non-target Organisms: Document No. 16. Unpublished study prepared byAbbott Laboratories. 8 p. Henck, J. (1986) Bacillus sphaericus: Avian Single Dose Oral Toxicity Study in Mallard Ducks: Document No. 17: TRL Study No. 024-030. Unpublished study prepared byToxicity Research Laboratories, Ltd. 17 p. Henck,J. (1986) Bacillus sphaericus: Avian Injection PathogenicityTest in Mallard Ducks: Document No. 18: TRL Study No. 024-031. Unpublished study prepared byToxicity Research Laboratories, Ltd. 25 p. Surprenant, D. (1986) Bacillus sphaericus: Acute Toxicity of ABG

- 6184to Bluegill (Lepomis machrochirus): Document No. 19: Study No. 2439.0786.6100.100. Unpublished study prepared by Spring- born Bionomics, Inc. 22 p. Surprenant, D. (1987) Bacillus sphaericus: Acute Toxicity of ABG- 6184 to Rainbow Trout (Salmo gardnen) (sic): Document No. 20: Study No. 2439.0786.6100.103. Unpublished study prepared by Springborn Bionomics, Inc. 21 p. Surprenant, D. (1986) Bacillus sphaericus: Acute Toxicity of ABG- 6184 to Daphnids (Daphnia magna): Document No. 21: Study No. 2439.0786.6100.110. Unpublished study prepared by Springborn Bionomics, Inc. 22 p. Vandenberg, J. (1986) Safety of Bacillus sphaericusfor Caged Adult Honey Bees: Document No. 24. Unpublished study prepared by USDA-ARS Beneficial Insects Laboratory. 12 p. Abbott Laboratories (1987) Submission of Toxicity DataTo Supportthe Application for the Registration of Bacillus sphaericus Serotype H-5a5b Biological Larvicide. Transmittal of 1 study. 25Bacillussphaericus Case 6052- Preliminary Work Plan EPA-HQ-OPP-2013-0116 www.regulations.gov

MRID 40391401

40429500
40429501
40885300
40885301
40885302
40886600
40886601
40886602
41103400
41103401

41103402

41103403

41586701

41586702
41586703
41604000
41604001

41931300 Bibliography: Bacillus sphaericus2362 serotype H5a5b ABTS 1743 (PC code119801, 119804) Citation Reference Surprenant, D. (1986) Bacillus sphaericus: Acute Toxicity of ABG- 6184 to Mayfly Larva (Hexagenia sp.): Study No. 2439.0786.6100. 711. Unpublished study prepared by Springborn Bionomics, Inc. 22 p. Abbott Laboratories (1987) Submission of Supplementary Information in Response to Preliminary Review Comments on B. sphaericus H-5a 5b Granules. Transmittal of 1 study. Jovanovich, A.; Cozzi, E. (1987) Application to Register B. sphaericus H-5a5b Granules for Control of Mosquito Larvae. Unpublished compilation prepared byTechnology Services Group, Inc. 74 p. Abbott Laboratories (1988) Submission of Chemistry Data in Support of Vectolex G Powder; Granular Biological Mosquito Larvicide Containing Bacillus sphaericus. Transmittal of 2 studies. Rowell, R. (1988) Vectolex G: Product Chemistry. Unpublished compilation prepared by Abbott Laboratories. 25 p. Melin, B.; Coddens, M. (1988) Vectolex G: Product Chemistry. Unpublished compilation prepared by Abbott Laboratories. 23 p. Abbott Laboratories (1988) Submission of DataTo Support Registration of VectolexTech Powder: Product Chemistry Data. Transmittal of 2 studies. Smith, R.; Cooper, R. (1988) Vectolex Technical: Product Chemistry: 10/88-01. Unpublished study prepared by Abbott Laboratories. 240 p. Melin, B.; Coddens, M. (1988) Vectolex Technical: Product Chemistry: 10/88-02. Unpublished study prepared byAbbott Laboratories. 23 p. Abbott Laboratories (1989) Submission of Toxicity Data in Support of Bacillus sphaericus Registration Standard. Transmittal of 3 studies. David, R. (1989) Acute Oral Toxicity/Pathogenicity Study of Bacillus sphaericusTechnical Powder in Rats: Final Report: Project No. G-7161.222. Unpublished study prepared by Microbiological Associates Inc. 21 p. David, R. (1989) Acute PulmonaryToxicity/Pathogenicity Study of Bacillus sphaericusTechnical Powder in Rats: Project No.G-7161. 225. Unpublished study prepared by Microbiological Associates Inc. 21 p. David, R. (1989) Acute Intravenous Toxicity/Pathogenicity Study of Bacillus sphaericusTechnical Powder in Rats: Project No. G-7161 224. Unpublished study prepared by Microbiological Associates Inc. 21 p. Eliezer, E. (1989) Product Chemistry Based on Bacillus sphaericus, (ABTS-1743) as the Active Ingredient: Lab Project Number: BSP 7/90-02. Unpublished study prepared by Abbott Laboratories. 42p. Jaronski, S. (1990) Physical Stability Study of Technical Grade Bacillus sphaericus: Lab Project Number: 910-8903. Unpublished study prepared by Abbott Laboratories. 26 p. Smith, R. (1990) Product Identityand Disclosure of Ingredients: Bacillus sphaericus: Lab Project Number: BSP 7/90-04. Unpublished study prepared by Abbott Laboratories. 10 p. Abbott Laboratories (1990) Submission of Toxicity/Pathogenicity Data in Support of Bacillus sphaericus Registration. Transmittal of 1study. Jaronski, S. (1990) Host Spectrum Studyof Technical Grade Bacillus sphaericus: Lepidoptera, Orthoptera, and Coleoptera: Lab Project Number: 910-8908. Unpublished study prepared byAbbott Laboratories. 20 p. Abbott Laboratories (1991) Submission of Data To Support Registration of Vectolex, Biological 26BacillussphaericusCase 6052- Preliminary Work Plan EPA-HQ-OPP-2013-0116 www.regulations.gov

MRID

41931301

41931302

41931303

41931304

41931305

43016200
43016201

43016202

43991900
43991901

44216500
44216501
44572310
44631700
44631701

45233000 Bibliography: Bacillussphaericus2362 serotype H5a5bABTS 1743 (PC code119801, 119804) Citation Reference Mosquito Larvicide: Toxicology Studies. Transmittal of 5 studies. Bowman, J. (1989) Acute Toxicity of Bacillus sphaericusTechnical Material to Sheepshead Minnow (Cyprinodon variegatus) in a Static Renewal System: Lab Project Number: 37730. Unpublished study prepared byAnalytical Biochemistry Labs., Inc. 93 p. Forbis, A. (1990) Acute Toxicity of Bacillus sphaericusto Mysidopsis bahia: Final Report: Lab Project Number: 38126. Unpublished study prepared by Analytical Bio-chemistry Laboratories, Inc. 98 p. Forbis, A. (1989) Acute Toxicity of Bacillus sphaericusto Se/enastrum capricornutum Printz: Final Report: Lab Project No: 37657. Unpublished study prepared by Analytical Bio-chemistry Laboratories, Inc. 80 p. Grimes, J. (1989) Bacillus sphaericusTechnical Powder: An Avian Dietary Pathogenicity and Toxicity Study in the Mallard: Lab Project Number: 161-111. Unpublished study prepared by Wildlife International Ltd. 41 p. Dionne, E. (1990) Bacillus sphaericusTechnical Material--Acute Toxicityto Eastern Oysters (Crassostrea virginica) Under Flow- through Conditions: Final Report: Lab Project No: 89-06-3017; 2439.0289.6102.504. Unpublished study prepared by Springborn Laboratories, Inc. 45 p. Abbott Labs. (1993) Submission of Product Chemistry Data for ABG-3097 in Support of Registration. Transmittal of 2 Studies. Rojas, F. (1993) Addendum to Report Titled Physical and Chemical Properties Characterization of ABG-3097 Technical Grade Active Ingredient and End-use Material--MAID No. 42704701: Lab Project Number: 81-2389-62. Unpublished study prepared by Abbott Labs., Chemical & Agricultural Products Div. 59 p. Mathieu, G. (1993) Storage Stability and Corrosion Characteristics of ABG-3097 Technical Grade Active Ingredient and End-use Material: Final Report: Project No. 69-2002-62. Prepared by Abbott Labs. 23 p. Abbott Laboratories (1996) Submission of Toxicology Data in Support of the Amended Registration of Vectolex CG Biological Larvicide. Transmittal of 1 Study. Kuhn, J. (1996) Primary Dermal Irritation Study in Rabbits: VectoLex Technical Powder: Final Report: Lab Project Number: 2709-96: S9-FF81-5.A12. Unpublished study prepared by Stillmeadow, Inc. 16 p. Abbott Laboratories (1997) Submission of Efficacy Data in Support of the Registration for Vectolex CG Biological Larvicide. Transmittal of 1 Study. Melin, B. (1997) Field/Laboratory Performance Evaluations of Bacillus sphaericus: Lab Project Number: BS EF-1. Unpublished study prepared by Abbott Laboratories. 120 p. Melin, B. (1998) Field Evaluations of VectolexWDG, ABG-6491: Lab Project Number: AB019: BS WDG EF-1. Unpublished study prepared by Benzon Research. 58 p. Abbott Laboratories (1998) Submission of Efficacy Data in Support of the Registration of Vectolex CG Biological Larvicide. Transmittal of 1 Study. Melin, B. (1997) Efficacy of Vectolex CG and Vectolex WDG against Larvae of Coquilletidia perturbans in a Cattail Marsh in Capemay, NJ: Lab Project Number: AB012. Unpublished study prepared by Benzon Research. 8 p. Valent Biosciences (2000) Submission of Product Chemistry Data in Support of the Application for the Registration of Bacillus thuringiensis subsp. aizawaiSlurry, Bacillussubsp. israe/ensis Slurry, Bacillus subsp. kurstakiSlurry, Bacillussubsp. tenebrionis Slurry and Bacillus subsp. sphaericus
27Bacillus sphaericus Case 6052- Preliminary Work Plan EPA-HQ-OPP-2013-0116 www.regulations.gov

MRID

45233004

45681800
45681801

46511000
46511001
46724405
46724406

46724407 Bibliography: Bacillus sphaericus2362 serotype H5a5b ABTS 1743 (PC code119801, 119804) Citation Reference Slurry and Myrothecium verrucaria Slurry

. Transmittal of2 Studies. Rowell, R. (2000) Slurry Manufacturing Process for Vectolex Products (Bacillus sphaericus) at Abbott Laboratories: Lab Project Number: BSSLMAN-V28R. Unpublished study prepared by Abbott Laboratories. 27 p. Valent BioSciences Corp. (2002) Submission of Product Chemistry Data in Support of the Application for Registration of Bacillus sphaericus Slurry. Transmittal of 1 Study. Rowell, R. (2002) Slurry Manufacturing Process for Vectolex Products (Bacillus sphaericus) at Abbott Laboratories: Lab Project Number: 60012 MAN 5/21/02: SCP.V.78339. Unpublished study prepared byAbbott Laboratories. 274 p. {OPPTS 885.1200} Valent Biosciences Corporation (2005) Submission of Product Chemistry Data in Support of the Amended Registration of VectoLex CG Biological Larvicide Granules. Transmittal of 1 Study. Woolley, A.; Mullee, D. (2005) Determination of Dust Content and Friability and Attrition: ABG6185. Project Number: 1438/002. Unpublished study prepared by Safepharm Laboratories Ltd. 9 p. Durando, J. (2005) Dermal Sensitization Study in Guinea Pigs (Buehler Method): VBC-60034. Project Number: 17961, P328. Unpublished study prepared by Product Safety Laboratories. 28 p
. DeChant, P. (2005) Field Efficacy Datafor VBC-60035. Project Number: VBC/12/09/05/1, 2002PDECH026, 2004PPDECH024. Unpublished study prepared by Valent Biosciences Corporation. 10 p. Smith, W. (2005) Discussion of Requirements for Biochemical Pesticide Toxicity Data: V60035 CG. Project Number: D/928NBC/60035. Unpublished study prepared byValent Biosciences Corporation. 36 p.

B. Studies Supporting Registration Review of Bacillus sphaericus serotype H5a5b strain AM614 (PC code 119801, 119804)

MRID Bibliography: Bacillus sphaericus2362 serotype H5a5b AM614 (PC code119801, 119804) Citation Reference 84268-1- Advanced Microbiologies, LLC 47157200 Advanced Microbiologies, LLC (2007) Submission of Product Chemistry, Efficacy, and Toxicity Data in Support of the Application for Registration of AM61432 Primary Powder. Transmittal of 10 Studies. 47157201
47157202
47157203

47157204 Roberts, A. (2007) Product Chemistryfor AM61432 Primary Powder. Unpublished study prepared byTechnology Sciences Group, Inc. 119 p. Mileson, B. (2007) Response to Tier 1 Microbial Pesticide Data Requirements forAM61432 Primary Powder. Unpublished study prepared byTechnology Sciences Group, Inc. 66 p. Moore, G. (2005) Acute Oral Toxicity Up and Down Procedure in Rats: Bacillus sphaericus Strain 2362. Project Number: 17860, P320/UDP

. Unpublished study prepared by Product Safety Laboratories. 15 p. Moore, G. (2005) Acute Dermal Toxicity Study in Rats- Limit Test: Bacillus sphaericus Strain 2362. Project Number: 17861, P322. Unpublished study prepared by Product Safety Laboratories. 15 p
. 28BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov

MRID 47157205

47157206
47157207
47157208

47157209

47157210
47356800

47356801

47898200
47898201
47898202
48391600
48391601
48405900

48405901 Bibliography: Bacillus sphaericus2362 serotype H5a5b AM614 (PC code119801, 119804) Citation Reference Moore, G. (2005) Acute Inhalation Toxicity Study in Rats- Limit Test: Bacillus sphaericus Strain 2362. Project Number: 17862, P330. Unpublished study prepared by Product Safety Laboratories. 23 p. Moore, G. (2005) Primary Eye Irritation Study in Rabbits: Bacillus sphaericus Strain 2362. Project Number: 17863, P324. Unpublished study prepared by Product Safety Laboratories. 15 p. Moore, G. (2005) Primary Skin Irritation Study in Rabbits: Bacillus sphaericus Strain 2362. Project Number: 17864, P326. Unpublished study prepared by Product Safety Laboratories. 15 p. Moore, G. (2005) Dermal Sensitization Study in Guinea Pigs (Buehler Method): Bacillus sphaericus Strain 2362. Project Number: 17865, P328. Unpublished study prepared by Product Safety Laboratories. 24 p. Hicks, S. (2007) Bacillus sphaericus Strain 2362: Tier I Static Renewal 21-DayToxicityTest with Daphnia magna. Project Number: 50395. Unpublished study prepared byABC Laboratories, Inc. 55 p. Becnel, J. (2007} Bacillus sphaericus Strain 2362: Field and Lab MortalityTests. Unpublished study prepared by USDA, ARS, Center for Medical Agricultural and Veterinary Entomology. 20 p. Advanced Microbiologies, LLC (2008) Submission of Product Chemistry and Efficacy Data in Support of the Applications for Registration of AM61432 Primary Powder, AM61432 (50 G) and AM61432 WP. Transmittal of 3 Studies. Roberts, A. (2008} Supplemental Product Chemistryfor AM61432 Primary Powder. Project Number: 07584D/GB/2002/10. Unpublished study prepared byTechnology Science Group, Inc. 36 p. Advanced Microbiologies, LLC. (2009} Submission of Product Chemistry Data in Support of the Registration of AM61432 Primary Powder. Transmittal of 2 Studies. Federici, B. (2009) Supplemental Product IdentityforAM61432 Primary Powder: Final Report. Unpublished study prepared by University of California, Riverside. 71 p. Roberts, A. (2009} Supplemental Product Chemistryfor AM61432 Primary Powder: Final Report. Unpublished study prepared byTechnology Sciences Group, Inc. 20 p. Advanced Microbiologies, LLC (2011) Submission of Product Chemistry Data in Support of the Registration of AM61432 Primary Powder. Transmittal of 1 Study. Roberts, A. (2011) Supplemental Product Chemistryfor AM61432 Primary Powder. Unpublished study prepared byAdvanced Microbiologies, LLC. 28 p. Advanced Microbiologies, LLC (2011) Submission of Product Chemistry Data in Support of the Registration of AM61432 Primary Powder. Transmittal of 1 Study. Roberts, A. (2011) Supplemental Product Chemistryfor AM61432 Primary Powder. Unpublished study prepared byTechnology Science Group, Inc. 28 p.

C. Environmental Protection Agency Risk Assessment Memoranda U.S. EPA. 1988. EEB Review: Ecological effects Bacillus sphaericus H5a5b granules mosquito larvicides. Memorandum from Z. Vaituzis to P. Hutton dated August 4, 1988. U.S. EPA. 1989a. SACB Review: Bacillus sphaericus mosquito larvicide. Abbott Laboratories' registration application for Vectolex technical and granular products. Memorandum from W. J. Hazel toP. Hutton dated March 22, 1989. 29BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov U.S. EPA. 1989b. SACB review of Toxicity Studies submitted by Abbott Laboratories to support registration of Bacillus sphaericus H5a5b granules. Memorandum from J. T. McClintocktoP. Hutton dated September 14, 1989. U.S. EPA. 1991. SACB Review of Additional Product Identity Information Submitted byAbbottfor Bacillus sphaericus (VectolexTGAI and Vectolex G). [EPA ID No. 275-TT; Record No. 381936; MRID Nos. 41586701, 02, and 03; Caswell No. 066A; HED Project No. 0-2053) U.S. EPA. 1996a. Horne, D. Acute Toxicity of Bacillus sphaericusTechnical Material to Sheepshead Minnow (Cyprinodon variegatus) in a Static Renewal System (Guideline 72-1/885.4280) Data Evaluation Record dated August 19, 1996. MAID41931301. U.S. EPA. 1996b. Horne, D

.Acute Toxicity ofTechnical Material Bacillus sphaericus to Mysidopsis bahia (Guideline 72-3/885 .4280). Data Evaluation Record dated August 19, 1996. MRID 41931302. U.S. EPA. 1996c. Horne, D. Acute Toxicity of Bacillus sphaericusto Selanastrum capricornutum Printz- static Algal Bioassay. (Guideline 122-2/850.5400). Data Evaluation Record dated August 19, 1996. MRID 41931303. U.S. EPA. 1996d. Horne, D. Acute Toxicity of Bacillus sphaericusTechnical Material to crassostrea virginica (Eastern Oyster)- Shell Deposition Bioassay (Guideline 154A-21/885.4280)Data Evaluation Record dated August 19, 1996. MRID 41931305. U

.S. EPA. 1996e. BPPD Review of Primary Dermal Irritation StudyforTechnical B.sphaericus. J. F. Heminway dated November 24, 1996. U.S. EPA. 1999b. BPPD Review of Field and laboratory efficacy studies to support product labeling claims to control mosquitoes- Vectolex WDG. Memorandum from Robyn Rose toW. Nelson dated January7, 1999. U.S. EPA. 2001: BPPD Review of Data Submitted byValent BioSciences Corporation, for Registration and Review of Manufacturing (Use Product) Production Process to Vectolex Products (Bacillus sphaericus) at Abbott Laboratories. Memorandum from C. Etsitty to A. Reynolds dated October 15, 2001. U.S. EPA. 2004. BP1 D Review of Data Submitted by Valent BioSciences Corporation, for Registration and Review of Manufacturing (Use Product)Production Processto Vectolex Products (Bacillus sphaericus) at Abbott Laboratories. Memorandum from C. Etsitty to A. Reynolds dated September22, 2004. U.S. EPA. 2006. BPPD Review of Product Identity, Manufacturing Process, Formation of Unintentional Ingredients, Analysis of Samples, Certification of Limits, Physical & Chemical Characteristics, and Five batch analyses, Efficacy, Storage Stability, Acute Oral Toxicity, Dermal Sensitization and Primary Eye Irritation Studies of the End Use Product: V60035 CG Biological Larvicide to determine its eligibilityfor registration. Memorandum from I. Barsoum to A. Reynolds dated April 10, 2006. U.S. EPA. 2008a. BPPD Review of Product Performance Datato Support Registration of the New Products AM61432 (50G) (EPA File Symboi84268-E) and AM61432 WP (EPA File Symbol 84268-G) Containing Bacillus sphaericus, Serotype H5a5b, strain 2362 (PC Code 119801); Submitted by Advanced Microbiologies, LLC for AM61432 WP. Memorandum from S. BorgestoM. Mendelsohn dated August 29, 2008. U.S. EPA. 2008b. Ecological Risk Assessment forthe Active Ingredient Bacillus sphaericus H5a5b strain 2362 to Support Registration of the New Product AM6 1432 Primary Powder (EPA File Symbol 84268-R); Submitted byAdvanced Microbiologies, LLC. Memorandum from S. Borges toM. Mendelsohn dated September 02, 2008. U.S. EPA. 2008c. Product Chemistry, Manufacturing Process and Acute toxicities studies for AM61432 Primary Powder (EPA Reg. No. 84268-R). Memorandum from I. Barsoum toM. Mendelsohn dated September 09, 2008. 47157201, 47356801 (Pchem) 47157203 to 08- 03 oral, 04dermal, 05 inhalation, 06 eye, 07 skin irritation, 08 dermal sensitization- Pasteur deposit. U.S. EPA. 2008d. BPPD Ecological Risk Assessment for the Active Ingredient Bacillus sphaericus HSaSb strain 2362 to Support Registration of the New Product AM61432 Primary Powder. Memorandum from S. Borges toM. Mendelsohn dated October29, 2008.

30BacillussphaericusCase 6052- PreliminaryWorkPlan EPA-HQ-OPP-2013-0116 www.regulations.gov U.S. EPA. 2008e. BPPD Review of Product Performance Datato Support Registration of the New Product FourStar Briquets (EPA File Symbol 83362-G) Containing Bacillus sphaericus, Serotype H5a5b, strain 2362 (PC Code 119801) and Bacillus thuringiensis subspecies israe/ensis Strain BMP 144 (PC Code 006520); Submitted by B2E Microbials, LLC; MAID 47373303. Memorandum from S. Borges toM. Mendelsohn dated October 29, 2008. U.S. EPA. 2011a. BPPD review: Product Identity, Manufacturing Process, Analysis of Samples for Advanced Microbiologies' Product Registration (EPA Reg. No. 84268-1). Memorandum by I. Barsoum toM. Mendelsohn Word file dated February 10, 2011. U.S. EPA. 2011 b. BPPD review: Product Chemistry Supplemental to Product Identity, Manufacturing Process, Physical and Chemical Characteristics for Advanced Microbiologies' Product Registration (EPA Reg. No. 84268-1) MAID 47898202. Memorandum by I. Barsoum toM. Mendelsohn Word file dated February 10, 2011. U.S. EPA. 2011c. BPPD review: Product Identity, Analysis of Samples, Physical and Chemical Characteristics, Storage Stability MAID 47898301 for Advanced Microbiologies' Product Registration (EPA Reg. No. 84268-1). Memorandum by I. Barsoum toM. Mendelsohn Word file dated February 10, 2011. U.S. EPA. 2011d. BPPD review: Acute Dermal Toxicity- rat for Advanced Microbiologies' Product Registration. Memorandum by I. Barsoum to M. Mendelsohn Word file dated February 10, 2011. U.S. EPA. 2011e. BPPD review: Review of Product Chemistry, Manufacturing Process data, and Acute Toxicities studies ofthe new product AM61432 Primary Powder (EPA Reg. No. 84268-R) containing the active ingredient Bacillus sphaericusstrain 2362- summary all 84628-1. Memorandum from I. Barsoum toM. Mendelsohn Word file dated February28, 2011. U.S. EPA. 2011f. Review of the registrant's response to the data deficiencies found bythe Agency in its review of product chemistry, manufacturing process of the new product AM61432 Primary Powder containing the active ingredient Bacillus sphaericusstrain 2362 to demonstrate similarityto ABTS 1743. Memorandum from I. Barsoum to M. Mendelsohn dated March 03, 2011. U.S. EPA. 2011g. BPPD review: Product Chemistry and Efficacy Review for FourStar CRG. Memorandum from K. Martin to S. Johnson dated September 07, 2011. U.S. EPA. 2012. BPPD review: FourStar® MBG containing Bacillus thuringiensis subspecies BMP 144 and Bacillus sphaericus2362, Serotype H5a5b, strain AM614. Memorandum from J. Gagliardi to S. Bacchus dated October 03, 2012.

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