# Bacillus thuringiensis

Revised Preliminary Work Plan and Summary Document

Registration Review: Initial Docket

September 2014

Case 0247

Bacillus thuringiensis subsp. galleriae strain SDS-502

- PC Code 006399

Bacillus thuringiensis subsp. israel ens is

- PC Code 006401

Bacillus thuringiensis subsp. kurstaki- PC Code 006402

Bacillus thuringiensis subsp. kurstaki strain BMP 123

- PC Code 006407

Bacillus thuringiensis subsp. kurstaki strain EG2371

- PC Code 006423

Bacillus thuringiensis subsp. kurstaki strain EG2348

- PC Code 006424

Bacillus thuringiensis subsp. aizawai strain GC-91

- PC Code 006426

Bacillus thuringiensis subsp. kurstaki strain EG7841

- PC Code 006453

Bacillus thuringiensis subsp. kurstaki strain EG7826

- PC Code 006459

Bacillus thuringiensis subsp. israe/ensis strain EG2215

- PC Code 006476

Bacillus thuringiensis subsp. aizawai strain NB200

- PC Code 006494

Bacillus thuringiensis subsp. kurstaki strain SA-12 -PC Code 006518

Bacillus thuringiensis subsp. kurstaki strain SA-11 -PC Code 006519

Bacillus thuringiensis subsp. israelensis strain BMP 144- PC Code 006520

Bacillus thuringiensis subsp. kurstaki strain ABTS-351 -PC Code 006522

Bacillus thuringiensis subsp. aizawai strain ABTS-1857- PC Code 006523

Bacillus thuringiensis subsp. tenebrionis strain NB-176- PC Code 006524

Bacillus thuringiensis subsp. israe/ensis strain SUM-6218 -PC Code 006642

Bacillus thuringiensis subsp. kurstaki strain VBTS-2546- PC Code 006699

Bacillus thuringiensis subsp. israe/ensis strain AM 65-52- PC Code 069162

Bacillus thuringiensis subsp. israe/ensis strain SA3A- PC Code 069210



### Robert McNally, Director 

# i-61

Biopesticides and**~-** 

### · Pollution Prevention Division

Date:Bacillus thuringiensis EPA

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### 2 

## T ABLE 

## O F 

## C ONTENTS

I. Overview



### ................................ ................................ ................................ ................................ ......... 4

II. Statutory and Regulatory Authority



### ................................ ................................ ................................ 5

III. Background and Regulatory Information



### ................................ ................................ ........................ 6

a. Brief History

................................ ................................ ................................ ................................ ............ 6

b. Taxonomy

................................ ................................ ................................ ................................ ................ 6

c. Biology

................................ ................................ ................................ ................................ ...................... 8

d. General Manufacturing Process and the EPA’s Risk Mitigation Measures

................................ ..... 9

e. Registered Pesticide Products

................................ ................................ ................................ ................ 9
f. Use Profile

................................ ................................ ................................ ................................ .............. 10

g. Exemption from the Requirement of a Tolerance

................................ ................................ ............. 10

IV. Anticipated Data Needs and Risk Assessments



### ................................ ................................ ............... 11

V. Risk to Threatened and Endangered Species



### ................................ ................................ ................. 12

VII. Endocrine Effects



### ................................ ................................ ................................ ........................... 13

VIII. Incidents



### ................................ ................................ ................................ ................................ ........ 13

IX. Summary of Anticipated Data Needs



### ................................ ................................ ............................. 14

X. Timeline



### ................................ ................................ ................................ ................................ ......... 19

XI. Guidance for Commenters



### ................................ ................................ ................................ ............. 20

a. Environmental Justice

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

b. Water Quality

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

c. Trade Irr itants

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

d. Additional Information

................................ ................................ ................................ ......................... 21

XII. Next Steps



### ................................ ................................ ................................ ................................ ...... 21

APPENDIX I

– History of the B

. thuringiensis Tolerance Exemption



### ................................ ........................ 23

APPENDIX II

– Pesticide Products Containing B

. thuringiensis



### ................................ ................................ 27

APPENDIX III

– Representative B

. thuringiensis Technical Products



### ................................ ....................... 32

APPENDIX IV

– Product Analysis Data Requirements (40 CFR § 158.2120)



### ................................ ............ 34

APPENDIX V

– Human H ealth Toxicity Data Requirements (40 CFR § 158.2140)



### ................................ ... 53

APPENDIX VI

– Nontarget Organism Data Requirements (40 CFR § 158.2150)



### ................................ ...... 59

APPENDIX VII

– Summary of Incidents Involving B

. thuringiensis



### ................................ .......................... 71

APPENDIX VIII

– Bibliography



### ................................ ................................ ................................ ............... 72Bacillus thuringiensis EPA

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### 3 

## ACRONYMS AND ABBREVIATIONS

B

. thuringiensis Bacillus thuringiensis

BPPD The EPA’s Biopesticides and Pollution Prevention Division

Bta Bacillus thuringiensis subspecies aizawai
Btg Bacillus thuringiensis subspecies galleriae

Bti Bacillus thuringiensis subspecies israelensis

Btk Bacillus thuringiensis subspecies kurstaki

Btt Bacillus thuringiensis subspecies tenebrionis

CFR Code of Federal Regulations

DCI Data C all

- I n Notice

EDSP Endocrine Disruptor Screening Program

EFED The EPA’s Environmental Fate and Effects Division

EIIS Ecological Incident Information System

EP End

- use pesticide product

EPA U.S. Environmental Protection Agency (Agency)
EPA Reg. No. EPA Registration Number

FAO Food and Agriculture Organization of the United Nations

FDA U.S. Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

FWP Final Work Plan

HPLC High

- performance liquid chromatography

IDS Incident Data System

IR

- 4 Interregional Research Project No. 4

MP Manufacturing

- use pesticide product

MRID No. Master Record Identification Number : The EPA ’ s system of recording and tracking studies submitted to the

Office of Pesticide Programs.

MRL Maximum R esidue Limit

NIH National Institutes of Health

OPP The EPA’s Office of Pesticide Programs

PC Code Pesti cide chemical c ode: a six

- digit number assigned by OPP to identify pesticide chemicals.

PWP Preliminary Work Plan

RED Reregistration Eligibility Document

TEP Typical end

- use pesticide pro duct

TGAI Technical grade of the active ingredient

TMDL Total Maximum Daily Load

U.S. United States

USFWS United States Fish and Wildlife Service
24(c) Special Local Needs registration (FIFRA section 24(c))Bacillus thuringiensis EPA

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### 4 REVISED PRELIMINARY WORK PLAN AND SUMMARY DOCUMENT

I. Overview

On September 30, 2011, the U.S. Environmental Protection Agency (EPA or Agency ) initiated the registration review for Bacillus thuringiensis , a case currently comprised of 21 active ingredients. 1 

### This
action included o pening a public docket (docket number EPA

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- 0705) and taking comments on a Preliminary Work Plan (PWP) posted in the docket ( 76 FR 60822 )

. 2 

### At that time, the EPA stated that, due to the complexity of this case, it was still looking through records to determine whether there were data gaps and what types of risk assessments, if any, needed to be completed during
the course of registration revi ew . Although the EPA originally stated it would convey this information in the Final Work Plan (FWP), in the interest of allowing the public the opportunity to review and provide input on the additional information gathered since 2011, the Agency is instea d revising th e 2011 PWP and presenting this revised PWP for comment. Some noticeable differences between this revised PWP
and the 2011 PWP are as follows: (1) a complete listing of microbial pesticide data requirements and
how these have been met for each active ingredient, (2) a complete listing of documents (e.g., data packages and the EPA’s memoranda) that are associated with the active ingredients, and (3) information

on new Bacillus thuringiensis active ingredients registered within the past three years. In light of the information described in the preceding sentence and presented below , the EPA is opening t he docket for Bacillus thuringiensis (case 0247 ) again , initiati ng the second public comment period for this registration review case

.

Bacillus thuringiensis is an active ingredient in re gistered pesticide products that are applied to field

- , greenhouse

- , and water

- grown crops; outdoor and greenhouse

- grown ornamental and nursery crops; seed; forested areas; food and nonfood storage contai ners, buildings, and transport vehicles; and /or standing water to control insects of the orders Coleoptera, Lepidoptera, or Diptera. This revised PWP explains what the EPA’s Office of Pesticide Programs knows about Bacillus thuringiensis , highlights its

an ticipated data and assessment needs, identifies types of information that would be especially useful in conducting the review, and provides an anticipated timeline for completing the registration review process for Bacillus thuringiensis

.

The registration review process was designed to include a public participation component and by sharing this information in the docket, the EPA intends to inform the public of what it knows about Bacillus thuringiensis and what types of new data or other infor mation would be helpful to receive as it moves
toward a decision on Bacillus thuringiensis . The EPA encourages all interested stakeholders to review
the revised PWP and to provide comments and additional information that will help the EPA’s decision

making process for this microbia l pesticide. Interested stakeholders could include the following: environmental nonprofit or interest groups; pesticide manufacturers; agricultural labor or commodity

1 There are 21 active ingredients in this case; however, as part of this registration review, the EPA is integrating four pesticide products containing two of these active ingredients ( Bacillus thuringiensis subspecies israelensis

, PC Code 006401; Bacillus thuringiensis subspecies kurstaki , PC Code 006402) into other PC Codes with ingredients that bear the appropriate strain designation ( 40 CFR § 158.2100(c)(2) ) and that are still subject to this registration review. This will result in the case ultimately comprising 19 active ingredients. Please see Section III (b) of this document for additional

information.

2 During the 60

- day public comment period, the EPA received no comments on the 2011 PWP.Bacillus thuringiensis EPA

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### 5 groups; commercial, institutional, residential, and other users of pesticides; or the public at large. In addition to general areas on which persons may wish to comment, there are some areas identified in the
revised PWP about which the EPA specifically seeks comments and information.

The revised PWP begins by descri bing the statutory and regulatory authorities for r egistration r eview

. Next, it provides background on Bacillus thuringiensis , which includes a description of this active ingredient’s history, taxonomy, biology, registered pesticide products, use profile, tolerance exemption,
and general manufacturing process

. Then , it discusses anticipate d data needs and risk assessments, endangered and threatened species , endocrine effects, incidents, and a projected r egistration r eview timeline for this case. Finally, the revised PWP provides guidance for commenters, explains the next steps the EPA will be taking, and p resents additional information (e.g., references to studies, risk assessments, and other documents available for the r eg istration r eview of Bacillus thuringiensis ) in the Appendices.

Further information about this case, including background and supporting documents, is available at http://www.regulations.gov (u nder “ SEARCH for: Rules, Comments, Adjudications or Supporting Documents, ” enter the docket identification number, w hich is indicated above)

.

II. Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a R egistration R eview program

. All pesticides distributed or sold in the United States (U.S.) must generally be registered by the EPA , based on scientific data showing that they will not cause unreaso nable risks to human health or the environment when used as directed on the product labeling. The R egistration R eview program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human
health or the environment . Changes in science, public policy, and pesticide use practices will occur over time. Through the R egistration R eview program, the EPA periodically reevaluates pesticides to make
sure that

, as change occurs, products in the marketplace can continue to be used safely. Informatio n on this program is provided on the EPA’s website

. 3



### The EPA is implementing the R egistration R eview program pursuant to 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 FIFRA standard for registration. The regulations governing

R egistration R eview begin at 40 CFR § 155.40. The EPA will consider benefits information and data as required by FIFRA. The public phase of R egistration R eview begins when the initial docket is opened
for each case. The docket is the EPA ’s opportunity to st ate what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a r egistration r eview
decision. After reviewing and responding to comments and data received in the docket durin g this
comment pe riod, the EPA wil l develop a F inal W ork P lan (FWP) and anticipated schedule for the

r egistration r eview of Bacillus thuringiensis

.

3 See http://www2.epa.gov/pesticide

- reevaluation

.Bacillus thuringiensis EPA

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### 6 III. Background and Regulatory Information

a. Brief History

Bacillus thuringiensis was first isolated in Japan (1901) by Ishiwata during his study of a bacterial
disease of silkworms. In 1911, Berliner, a German scientist, isolated the bacterium from infected flour
moths that were collected at a mill in the province of Thuringia . In 1915, he described the bacterium and

n amed it Bacillus thuringiensis Berliner (Sanchis

, 201 1 )

.

Agronomists first tried using Bacillus thuringiensis for insect control in the late 1920 s against the gypsy moth in the northeastern United States and the European corn borer in Hungary. In 1938, France produced the first commercial Bacillus thuringiensis prod uct; it was known as Sporéine (Sanchis , 2011 )

. In 1960, the U.S. Food and Drug Admin istration (FDA) established an exemption from the requirement of tolerance for residues of viable spores of the microorganism Bacillus thuringiensis Berliner (25 FR 3207, April 14, 1960) and, in 1961, Bacillus thuringiensis was first registered in the U.S. for use as an
insecticide

. Currently, there are 137 pesticide products that contain Bacillus thuringiensis as an active ingredient, and the associated exemption fr om the requirement of tolerance for “Viable spores of the microorganism Bacillus thuringiensis Berliner ” can be found at 40 CFR § 180.1011

.

Prior to this r egistration r eview

, the EPA conducted a thorough review of Bacillus thuringiensis as part
of the r eregistration p rogram . The 1988 amendments to FIFRA authorized the EPA to conduct a comprehensive review of pesticides first registered before November 1, 1984, to ensure that they met current scientific and regulator y standards. In 1988, the EPA published “Guidance for the Reregistration of Pesticide Products Containing Bacillus thuringiensis as the Active Ingredient,” which is commonly

known as the Bacillus thuringiensis Registration Standard (U.S. EPA

, 1988)

. Th at d ocument provided

an assessment of what the EPA knew about Bacillus thuringiensis in 1988 and what data were needed to bring the science database up to date. A D ata C all

- I n Notice (DCI) was issued in conjunction with th at document; it required submission to the EPA of additional product analysis, human health

, and environmental toxicity data. After reviewing the additional data, the EPA issued the Reregistration Eligibility Decision (RED) for Bacillus thuringiensis (U.S. EPA

, 1998a). In th at document , the EPA described its human health and ecological risk assessment findings. The RED also discussed the risk mitigation measures that needed to be implemented during p roduct r eregistration

. The EPA completed

p roduct re registration for all products containing Bacillus thuringiensis as an active ingredient on November 26, 2008

.

b. Taxonomy

The taxonomic lineage for Bacillus thuringiensis is (NIH, 201 4 ) :

K INGDOM 

### : Eub acteria

P HYLUM 

### : F irmicutes

C LASS 

### : B acilli

O RDER 

### : B acillales

F AMILY 

### : B acillaceae

G ENUS 

### : Bacillus

S PECIES GROUP 

### : Bacillus cereus group S PECIES 

### : thuringien sisBacillus thuringiensis EPA

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### 7 The EPA has registered pesticide products containing microbial active ingredients belonging to one of
the five subspecies of Bacillus thuringiensis listed below : 3



### ∙ Bacillus thuringiensis subspecies israelensis ( Bti)

∙ Bacillus thuringiensis subspecies kurstaki (Bt k)

∙ Bacillus thuringiensis subspecies aizawai (Bta)

∙ Bacillus thuringiensis subspecies tenebrionis (Btt)

∙ Bacillus thuringiensis subspecies galleriae (Btg)

Each subspecies, in turn

, has one or more strains. Provided in Table 1 is a summary of the strains (listed by subspecies) along with the number of products registered under each subspecies. 4 

### In the table, there

are notes for B acillus thuringiensis subspecies israelensis (PC Code 006401) and B acillus thuringiensis subspecies kurstaki ( PC Code 006402) that state, “ To be reclassified under . . . ” At one time

, all strains of a particular subspecies were classified under a single PC Code (i.e., all strai ns of one subspecies were one active ingredient). During r eregistration , the EPA started differentiating among the strains, assigning

to each strain its own PC Code. The pesticide products containing the active ingredients mentioned
above are a few (four total) that have not yet been reclassified.

Table 1

. Bacillus thuringiensis Subspecies and Strains

S TRAIN PC
C ODE N O

. P RODUCTS N OTES

MP EP 24( C )

B. thuringiensis subspecies israelensis

B. thuringiensis subspecies israelensis 006401

-- 2

-- To be re classified under PC Code

069162

B. thuringiensis subspecies israelensis strain EG2215 006476 1

-- -- B. thuringiensis subspecies israelensis strai n BMP 144 006520 1 1 8

-- B. thuringiensis subspecies israelensis strai n SUM

6218 006642 1

B. thuringiensis subspecies israelensis AM 65

- 52 069162 3 14 1

B. thuringiensis subspecies israelensis strain SA3A 069210 2 3

--

T OTAL : 8 3 7 1

B. thuringiensis subspecies kurstaki

B. thuringiensis subspecies kurstaki 006402

-- 2

-- To be reclassified under PC Code

006518 or PC Code 006519. 5

B. thuringiensis subspecies kurstaki strain BMP123 006407 1 4

-- B. thuringiensis subspecies kurstaki strain EG2371 006423 1 1

-- B. thuringiensis subspecies kurstaki strain EG2348 006424 1 3

-- B. thuringiensis subspecies kurstaki strain EG7841 006453

-- 2

-- B. thuringiensis subspecies kurstaki strain EG7826 006459 1 1

--

3 Four of five of the subspecies were subject to r eregistration based on their initial registration dates (U.S. EPA, 1998a).

4 See Appendix II for a comprehensive list of registered Bacillus thuringiensis pesticide products.

5 The EPA will w ork with the registrant for these products as the Agency determines which PC Code is appropriate.Bacillus thuringiensis EPA

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### 8 S TRAIN PC
C ODE N O

. P RODUCTS N OTES

MP EP 24( C )

B. thuringiensis subspecies kurstaki stra in SA

- 12 006518 2 14

--

B. thuringiensis subspecies kurstaki strain SA

- 11 006519 1 4

--

B. thuringiensis subspecies kurstaki strain ABTS

- 351 006522 5 29 3

B. thuringiensis subspecies kurstaki strain V BTS

- 2546 006699 2 2

--

T OTAL : 14 6 2 3

B. thuringiensis subspecies aizawai

B. thuringiensis subspecies aizawai strain GC

- 91 006426 1 2

-- B. thuringiensis subspecies aizawai strain NB200 006494 1

-- -- B. thuringiensis subspecies aizawai strain ABTS

- 1857 006523 3 3

--
T OTAL : 5 5 0

B. thuringiensis subspecies tenebrionis

B. thuringiensis subspecies tenebrionis strain NB

- 176 006524 2 1

--
T OTAL : 2 1 0

B. thuringiensis subspecies galleriae

B. thuringiensis subspecies galleriae strain SDS

- 502 00 6399 1 2

--
T OTAL : 1 2 0



### c. Biology

Members of the genus Bacillus are gram

- positive, aerobic (or facultative anaerobic), endospore

- forming bacteria; this ability to form spores allows such bacteria to survive in soil (Todar, 2012 ). During spore formation, many Bacillus thuringiensis strains produce highly specific crystalline proteins (i.e., Cry proteins) that are toxic to certain invertebrates, especially species of insect larvae belonging to the insect orders Coleoptera (beetles), Diptera (flies) and Lepidoptera (butterflies and moths) (Bravo

, 2007). The toxicity of the crystalline bodies is strain

- specific, that is, not all Bacillus thuringiensis strains are toxic

to all insects.

Bacill us thuringiensis belongs to the g roup Bacillus cereus . It is geno typically and phenotypically related to two species

—

Bacillus cereus and Bacillus anthracis

— that may adversely affect human health (Vilas

- Bôas et al

., 2007). B acillus cereus causes two forms of foodborne illness via production of

enterotoxins. B acillus anthracis causes anthrax, which is primarily a disease of domesticated and wild animals; humans may become infected when brought into contact with diseased animals. During the fermentation process for Bacillus thuringiensis

, B acillus cereus and B acillus anthracis are potential

contaminants. In the next section, the EPA provides a summary of how it mitigates risk from the

formation of these and other undesirable toxins.Bacillus thuringiensis EPA

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### 9 d. General Manufacturing Process and the EPA’s Risk Mitigation Measures

In general, m icrobial pesticides are made by fermentation, where a starter culture is added to a broth of nutrients so that the bacteria can grow. The result is a slurry, which contains unused broth, fermentation solids, spores, and insecticidal toxins. This slurry can then be dried down to a solid by centrifugatio n and drying in air or an oven (Taborsky, 1992)

. For some microbial products

, the slurry is consi dered the manufacturing

- use pesticide product (MP). For others, the MP is the dry form, where the excess
moisture has been removed. After fermentation but before drying, inert ingredients

, such as wetting
agents , may be added. Some end

- use pesticide products (EP) are made without an intermediate MP, as
the EP is made from start to finish in a single “ integrated process. ”

A concern with Bacillus thuringiensis manufacturing , which utilizes a fermentation process, in particular is the potential for the p resence of undesirable contaminants or toxins. The three categories of

undesirable toxins that the EPA is concerned about are as follows: (1) β

- exotoxin, which is naturally produced by certain strains of Bacillus thuringiensis ; (2) exotoxins due to the p resence of Bacillus

cereus or Bacillus anthracis in the fermentation broth; and (3) heat

- labile exotoxins that may form during the fermentation process

. In approving pesticide products containing Bacillus thuringiensis active ingredients, the EPA requires that manufacturers produce spore preparations by pure culture fermentation processes with adequate quality control measures and that they test each lot of spore preparation by subcutaneous injection into laboratory mice . T hese specifications are meant to m ake sure that each batch is free from undesirable toxins. Further, the EPA requires manufacturers to produce preparations that are free from β

- exotoxin when tested wit h the fly larvae toxicity test

. Some registrants have addressed this requirement by either demonstrat ing that their strains are incapable of producing β

exotoxin or developing an analytical method that they use to screen for β

- exotoxin

. Lastly, each new manufacturing process for Bacillus thuringiensis must be standardized and certified b y a Daphnia

magna test to address heat

- labile exotoxins (U.S. EPA, 1998a)

. Taken together, the EPA believes these requirements adequately mitigate potential risks unique to the general Bacillus thuringiensis manufacturing process.

e. Registered Pesticide Products

Currently, there are 137 registered pesticide products containing one of five subspecies of Bacillus thuringiensis as an active ingredient (see Appendix II ).Bacillus thuringiensis EPA

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### 10 f. Use Profile

Provided below is a summary of Bacillus thuringiensis ’ current use pattern; it is essentially the same as
what it was back in 1998 , when the EPA last performed a comprehensive assessment of this active ingredient

.

P ESTICIDE T YPE : Insecticide

U SE S ITES : Field

- , greenhouse

- , and water

- grown 6 crops

(preharvest and postharvest use)

Outdoor

- and greenhouse

- grown ornamental and nursery crops

Seed treatment (food and nonfood seeds)

Forestry Food and nonfood storage containers, buildings, and transport vehicles
Standing water (e.g., certain crop fields, flooded fields, irrigation ditches, livestock watering containers, ornamental ponds, p astures, snowmelt, rights

- of

- way , wetlands, lakes, tires, and sewage lagoons)

R EGISTERED FOR U SE A GAINST T HESE P ESTS : Coleoptera (beetles, bugs, weevils)

Diptera (flies, gnats, midges, mosquitoes) Lepidoptera (borers, butterflies, casebearers, cutworm, leaf f olders, leaf perforator, leafrollers, leafworms, loopers, moths, orange dog, skippers) 7

F ORMULATION T YPES : Aqueous suspe nsion

Emulsifiable concentrate
Emulsifiable suspension
Dry flowable, dust Water dispersible granule
Wettable powder
Water soluble pouch Bait

Granule
Slurry

A PPLICATION M ETHODS : Aerial (fixed wing and rotary aircraft)

Low

- and ultra

- low volume application (aqueous or oil spray) Tank mix
Hand sprayer

B ASIC M ANUFACTURERS : Summit Chemical Company ( EPA Company Number: 6218 )

Becker Microbial Products, Inc. ( EPA Company Number: 62637)

Ce rtis USA, LLC (EPA Company Number: 70051)

Valent Bio S cience s Corporation (EPA Company Number: 73049)
Phyllom BioProducts Corporation (EPA Company Number: 88347)



### g. Exemption from the Requirement of a Toleran c e 8



### The current exemption from the requirement of tolerance for Bacillus thuringiensis reads as follows :

§ 180.1011 Viable spores of the microorganism Bacillus thuringiensis Berliner; exemption from the requirement of a tolerance.

(a) For the purposes of this section the microbial insecticide for which exemption from the requirement of a tolerance is being established shall have the following specifications:

(1) The microorganism shall be an authentic strain of Bacillus thuringiensis Berliner conforming t o the morphological and biochemical characteristics of Bacillus thuringiensis as described in Bergey’s Manual of Determinative Bacteriology, Eighth Edition.

6 Water

- grown crops include cranberry bogs and rice fields.

7 Bacillus thuringiensis pesticide products are registered for use against mature insects and insects in one of their life stages (e.g., 3 rd instar, egg, larval, and pupal).

8 See Appendix I for details regarding the evolution of the Bacillus thuringiensis tolerance exemption.Bacillus thuringiensis EPA

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### 11 (2) Spore preparations of Bacillus thuringiensis Ber liner shall be produced by pure culture fermen tation procedures with adequate control measures during production to detect any changes from the characteristics of the parent st rain or contamination by other microorganisms.

(3) Each lot of spore preparation, prior to the addition of other materials, s hall be tested by subcutaneous injection of at least 1 million spores into each of five laboratory test mice weighing 17 grams to 23 grams. Such test shall show no evidence of infection or injury in the test animals when observed for 7 days following injection.

(4) S pore preparations shall be free of the Bacillus thuringiensis β

- exotoxin when tested with the fly larvae toxicity test (“Microbial Control of Insects and Mites,” R.P.M. Bond et al ., p. 280 ff., 1971). This specification can be satisfied ei ther by determining that each master seed lot brought into production is a Bacillus thuringiensis strain which does not produce β

- exotoxin under standard manufacturing conditions or by periodically determining that β

- exotoxin synthesized during spore produ ction is eliminated by the subsequent spore

- harvesting procedure.

(b) Exemption from the requirement of a tolerance is established for residues of the microbial

insecticide Bacillus thuringiensis Berliner, as specified in paragraph (a) of this section, in or on honey and honeycomb and all other raw agricultural commodities when it is applied either to growing crops, or when it is applied after harvest in accordance wi th good agricultural practices.

The EPA is concerned about ß

- exotoxin, an undesirable heat

- stable toxin secreted by certain Bacillus thuringiensis strains. To address this, in 1973, the EPA amended the tolerance exemption to include a toxicity test to determine the presence of ß

- exotoxin to e nsure that Bacillus thuringiensis products are
free of this toxin (38 FR 19045, July 17, 1973) ; the amendment was codified as paragraph (a)(4) (see directly above)

.

Exce pt for the paragraph ( a ) (4) addition and minor changes to paragraphs (a) and (b) (e.g., addition of food commodities) , this tolerance exemption has not been updated since 1960. During the r egistration

r eview of Bacillus thuringiensis

, the EPA will evaluate whether this tolerance exemption needs to be
amended , on the Agency’s own initiative under section 408(e) of the Fed eral Food, Drug, and Cosmetic Act (FFDCA), to take into account advances in microbial analytic techniques and microbiology in general. Since the current tolerance exemption is broad (i.e., it only considers Bacillus thuringiensis at the genus and species l evel), the EPA also intends to in vestigate whether it should be amended to consider lower taxonomic levels such as subspecies and strain. This approach would be consistent with how the EPA presently treats other microbial pesticidal active ingredients that require the establishment of a tolerance exemption and would also directly align with how the EPA considers microbial active ingredients during the pesticide product registration process ( 40 CFR § 158.2100(c)(2) )

.

IV. Anticipated Data Needs and Risk Assessment s

To assess the science database for this complex registration review case, the EPA chose a represent ative pesticide product , generally a MP , for each Bacillus thuringiensis strain ; Appendix III shows the se representative pesticide products . Provided in Appen dix IV

, Appendix V , and Appendix VI are tables of the current data requirements for microbial pesticides as set forth in 40 CFR part 158, subpart V. These
tables are arrayed by scientific discipline (i.e., product analysis, toxicology, and nontarget organisms ) and descriptions are included regarding how the data requirements have been fulfilled or where data gaps (anticipated data needs) have been identified.Bacillus thuringiensis EPA

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### 12 P res ently

, most of the Bacillus thuringiensis strains have data gaps. Despite a comprehensive search of
documents from the Federal Records Center and EPA

- internal archives while preparing this document, the EPA found that many science reviews and other importa nt documentation needed to complete the database were missing from its records

. Therefore, while developing the FWP, the EPA will examine
those data packages that it could not find reviews to support in order to ascertain whether to require
much of the data presented in Section IX

. I n the interim, those data areas are identified as “data gaps” or “anticipated data needs” for purposes of this revised PWP . Those anticipated data needs, which are being further considered by the EPA between now and the F WP ’s issuance, are specifically identified as such. In the FWP, the EPA will discuss its findings and will finalize its conclusions regarding the need for
additional data and risk assessments.

V. Risk to Threatened and Endangered Species

The EPA consulted with the U.S. Fish and Wildlife Service (USFWS) in 1986 regarding the potential hazards to endangered and threatened species from the use of pesticide formulations containing Bacillus thuringiensis subspecies kurstaki

. In a December 18, 1986, B iological O pinion (Case No. 1

- 1

- 86

- F

- 95) that was subsequently revised on January 12, 1987 , the USFWS determined that certain uses of Bacillus thuringiensis subspecies kurstaki would jeopardize the continued existence of some but terfly species 9 

### and provided, pursuant to the Endangered Species Act, the following “ reasonable and prudent
alternatives” to the EPA:

Anti

- lepidopteran delta endotoxin, or any formulations thereof, should not be aerially applied within 1⁄4 mile of any hab itats of endangered or threatened Lepidoptera. No manual application should be made within 300 feet of any threatened or endangered Lepidoptera.

As a result of th is consultation, the EPA began requiring registrants of Bacillus thuringiensis end

- use pesticide products to place the following language on their labels in the “Environmental Hazards”
section during product reregistration :

This product must not be applied aerially within 1⁄4 mile of any habitats of threatened or endangered Lepid optera. No manual application can be made within 300 feet of any threatened or endangered Lepidoptera. 10



### The EPA has not prepared a risk assessment that supports a complete endangered species determination
for Bacillus thuringiensis and has concerns about whether the current label language fully addresses
risks as pesticide applicators likely do not know where listed species occur on the landscape . Therefore,
d uring r egistration r eview

, the EPA plans on conducting an ecological risk assessment t o determine
whether use of Bacillus thuringiensis will have “no effect” or “may affect” federally listed threatened or

9 These butterfly species included the following: Kern primrose sphinx moth, Lange’s metalmark butterfly, Smith’s blue butterfly, El Segundo blue butterfly, Oregon silverspot butterfly, Mission blue butterfly, San Bruno elfin butterfly, Lotis

blue butte rfly, and Schaus swallowtail butterfly.

10 There may be some slight variation to this text, depending upon the uses of the product and the strain of Bacillus thuringiensis . For example, some Bacillus thuringiensis pesticide products are only applied by gr ound equipment and may be active against both lepidopteran and coleopteran pests. In these situations, the label language is adjusted to read as follows: “No manual application can be made within 300 feet of any threatened or endangered Lepidoptera or

C oleoptera.”Bacillus thuringiensis EPA

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### 13 endangered species (listed species) and/ or thei r designated critical habitat. When an assessment concludes that a pesticide’s use “may affect” a listed species and/ or its designated critical habitat, the

EPA will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

VII. Endocrine Effects

As required by the Administrator under FFDCA section 408(p), the 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) m ay have an effect in humans or wildlife similar to 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 exempt from t he requirements of the Estrogenic Substances Screening Program a biologic substance or other 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 e strogenic substance.

Between October 2009 and February 2010, the EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of

chemicals identified for EDSP screening was published on June 14, 2013, 11 

### and includes some pesticides scheduled for registration review and chemicals found in water. Bacillus thuringiensis is not among the group of pesticide active ingredients on the list s to be screened under the EDSP.

The EPA believes tha t Bacillus thuringiensis is a substance that would not likely produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance. As such, pu rsuant to Section 408(p)(4), the EPA will determine in the future whether it can exempt Bacillus thuringiensis from the requirements of the Section 408(p) EDSP. In the event the EPA does determine to exempt this

substance from the EDSP, an order will be issued.

For further information on the status of the EDSP, the policies and procedures, the list of chemicals, future lists, the test guidelines and the Tier 1 screening ba ttery, please visit our website at http://www.epa.gov/endo/

.

VIII. Incidents

From January 1, 1992

, through September 10, 2014, searches of the Office of Pesticide Programs’
Incident Data System (ID S ) conducted on October 21, 2010, and September 10, 2014, show 61 human or domestic animal reports of adverse effects following exposu re to pesticide product s containing Bacillus thuringiensis . Forty

- three are human cases . Although most of these were categorized as minor in nature (e.g., skin irritation due to being accidentally sprayed with pesticide), several were significant.
Some of the significant human incidents also involved other pesticides or chemicals. Eighteen cases involved domestic animals. In a few of the cases

, the animals died or had to be euthanized. In others

, they experienced mild to moderate effects. For example, in on e case a Great Dane had diarrhea for two days. On September 15, 2014, the EPA conducted a search of the Ecological Incident Information System (EIIS) (version 2.1.1) from the time period of January 1966 to September 2014 and found six

11 See http://www.regulations.gov/#!documentDetail;D=EPA

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- 0074 for the second list of chemicals.Bacillus thuringiensis EPA

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### 14 reports of adverse fi eld effects to nontarget plants as a result of exposure to Bacillus thuringiensis

. T he
reports involved effects to orchard, almond, tobacco, and grape crops

. For more information on the IDS
and EIIS reports , se e Appendix VII

. T he EPA will consider any incident data or comments submitted to this docket in response to this revised PWP

.

I X. Summary of Anticipated Data Needs

Table 2 summarizes the anticipated data needs for Bacillus thuringiensis

.

Table 2 . Anticipated Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized

Guideline Number Study Title Test

Material Estimated

Timeframe

(Months from Receipt of DCI)

Bacillus thuringiensis subspecies israelensis strain EG2215 (PC Code 006476)

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

885.1200 Manufacturing Process TGAI & MP 8 months

885.1250 Deposition of a Sample in a Nationally Recognized Culture Collection TGAI 8 months

885.1300 Discussion of Formation of Unintentional Ingredients TGAI & MP 8 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies israelensis strain BMP 144 (PC Code 0 06520 )

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3050 Acute Oral Toxicity/Pathogenicity TGAI 12 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

Bacillus thuringiensis subspecies israelensis strain AM 65

- 52 (PC Code 069162)Bacillus thuringiensis EPA

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### 15 Table 2 . Anticipated Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized

Guideline Number Study Title Test

Material Estimated

Timeframe

(Months from Receipt of DCI)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3050 Acute Oral Toxicity/Pathogenicity TGAI 12 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

885.4340 Nontarget Insect Testing TGAI 12 months

Bacillus thuringiensis subspecies israelensis strain SA3A (PC Code 069210)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 monthsBacillus thuringiensis EPA

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### 16 Table 2 . Anticipated Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized

Guideline Number Study Title Test

Material Estimated

Timeframe

(Months from Receipt of DCI)

885.4050 Avian Oral Toxicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

885.4200 Freshwater Fish Toxicity/Pathogenicity TGAI or TEP 12 months

885.4280 Estuarine and Marine Fish/Invertebrate Testing TGAI 12 months

885.4340 Nontarget Insect Testing TGAI 12 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain BMP 123 (PC Code 006407 )

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3050 Acute Oral Toxicity/Pathogenicity TGAI 12 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain EG2371 (PC Code 006423)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

885.4340 Nontarget Insect Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain EG2348 (PC Code 006424)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

Bacillus thuringiensis subspecies kurstaki strain EG7841 (PC Code 006453)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 monthsBacillus thuringiensis EPA

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### 17 Table 2 . Anticipated Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized

Guideline Number Study Title Test

Material Estimated

Timeframe

(Months from Receipt of DCI)

Bacillus thuringiensis subspecies kurstaki strain EG7826 (PC Code 006459)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

885.4340 Nontarget Insect Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain SA

- 12 (PC Code 006518)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4050 Avian Oral Toxicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

885.4200 Freshwater Fish Toxicity/Pathogenicity TGAI or TEP 12 months

885.4240 Freshwater Invertebrate Toxicity/Pathogenicity TGAI or TEP 12 months

885.4340 Nontarget Insect Testing TGAI 12 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain SA

- 11 (PC Code 006519)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3050 Acute Oral Toxicity/Pathogenicity TGAI 12 months

885.3150 Acute Pulmonary Toxicity/Pathogenicity TGAI 12 monthsBacillus thuringiensis EPA

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### 18 Table 2 . Anticipated Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized

Guideline Number Study Title Test

Material Estimated

Timeframe

(Months from Receipt of DCI)

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4050 Avian Oral Toxicity TGAI 12 months

885.4150 Wild Mammal Toxicity/Pathogenicity TGAI 12 months

885.4200 Freshwater Fish Toxicity/Pathogenicity TGAI or TEP 12 months

885.4240 Freshwater Invertebrate Toxicity/Pathogenicity TGAI or TEP 12 months

885.4340 Nontarget Insect Testing TGAI 12 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies kurstaki strain ABTS

- 351 (PC Code 006522)

830.6302 Color TGAI 8 months

830.6303 Physical State TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

830.7000 pH TGAI 8 months

830.7300 Density/Relative Density/Bulk Density (Specific Gravity) TGAI 8 months

885.1100 Product Identity MP 8 months

885.1400 Analysis of Samples TGAI & MP 8 months

885.3200 Acute Injection Toxicity/Pathogenicity TGAI 12 months

885.4240 Freshwater Invertebrate Toxicity/Pathogenicity TGAI or TEP 12 months

885.4380 Honey Bee Testing TGAI 12 months

Bacillus thuringiensis subspecies aizawai strain NB200 (PC Code 006494)

830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions TGAI 8 months

830.6317 Storage Stability TGAI & MP 16 months

Bacillus thuringiensis subspecies aizawai strain ABTS

- 1857 (PC Code 006523)

830.6317 Storage Stability TGAI & MP 16 months

Bacillus thuringiensis subspecies tenebrionis strain NB

- 176 (PC Code 006524)Bacillus thuringiensis EPA

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### 19 Table 2 . Anticipated Data Needs for the Registration Review of Bacillus thuringiensis

Harmonized

Guideline Number Study Title Test

Material Estimated

Timeframe

(Months from Receipt of DCI)

830.6313 Stability to Normal and Elevated Temperatures, Metals

, and Metal Ions TGAI 8 months

TGAI = technical grade of the active ingredient , M P = manufacturing

- use pesticide product , TEP = typical end

- use pesticide product



### X. Timeline

Below is the projected timeline for Registration Review C ase 0247: Bacillus thuringiensis

.

Activities Estimated Month/Year

Opening the Docket Open Docket and 60

- Day Public Comment Period for Bacillus thuringiensis September 2011

Close Public Comment Period November 2011

Open Docket and 60

- Day Public Comment Period for Bacillus thuringiensis

(2 nd 

### Time for Revised PWP ) September 2014

Close Public Comment Period November 2014

Case Development

Issue Final Work Plan December 2015

Issue Data Call

- in December 2016

Data Submission April 2018

Open 30

- Day Public Comment Period for Draft Risk Assessments October 2019

Close Public Comment Period November 2019

Registration Review Decision
Open 60

- Day Public Comment Period for Proposed Registration Review
Decision March 2020

Close Public Comment Period May 2020

Final Decision June 2020

*Estimated Total (years)

~ 9

* This schedule is subject to revision should unforeseen issues arise during the r egistration r eview process. In the event an issue arises, such as the failure to conclude that an EDSP exemption is warranted , an amended Final Work Plan will be issued at that time. That Final Work Plan will identify any newly anticipated data needs and set forth a new timeline.Bacillus thuringiensis EPA

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### 20 XI. Guidance for Commenters

The public is invited to comment on the EPA ’s revised PWP and rationale. The areas below highlight topics of special interest to the EPA where comments, information and data , or reference to sources of additional information could be of particular use. The EPA will consider all comments

, as well as any additional information or data provided in a timely manner

, prior to issuing a FWP for this case.

a. Environmental Justice

The 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 policie s. To help address potential environmental justice issues, the EPA seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical, unusually high exposure to the

pes ticidal use of Bacillus thuringiensis , 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.

b. Water Quality

Bacillus thuringiensis is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 12 

### In addition, no Total Maximum Daily Loads (TMDL) have been developed fo r Bacillus thuringiensis

. 13 

### More information on impaired water bodies and

TMDL s c an be found at the EPA ’s website. 14 

### The EPA invites submission of water q uality data for this pesticide

. To the extent possible, data should conform to the quality standards in Appendix A of the Office of Pesticide Program’s (OPP) Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Ass essment and Management

Process 15 

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

c. Trade Irritants

Through the r egistration r eview process, the EPA intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The EPA will work to harmonize
tolerance and internatio nal Maximum Residue Limits (MRL ) and , if necessary, may modify toleranc e levels to do so

. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of MRL s or disparities between U.S. tolerances and MRLs in key export markets

, providing as much specificity as poss ible regarding the nature of the concern.

Bacillus thuringiensis is covered under an existing exemption from the requirem ent of a tolerance

. Moreover, there are n o known MRLs for Bacillus thuringiensis . Therefore, the EPA does not anticipate
that current uses of Bacillus thuringiensis will pose concerns as trade irritants.

12 Based on information provided at http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/index.cfm

.

13 Based on information provided at http://iaspub.epa.gov/tmdl_waters10/text_search.tmdl_search_form

.

14 See http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/index.cfm

.

15 T his document can be found at http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm

.Bacillus thuringiensis EPA

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### 21 d. Additional Information

Stakeholders are also specifically asked to provide information and data that will assist the EPA in refining the risk assessments

. The EPA is interested in obtaining the following information regarding Bacillus thuringiensis :

 Any data, information, and/or scientific rationale that could be used to fill data gaps

 Confirmation on the following label information:

- Sites of application

- Formulations

- Application methods and equipment

- Maximum application rates

- Frequency of application, application intervals, and maximum number of applications

- Geographic limitations on use

 Use or potential use distribution (e.g., acreage and geogra phical distribution of relevant use sites)

 Median and 90 th 

### percentile reported use rates ( pounds 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 use s

 Typical application interval (days)

 State or local use restrictions

 Monitoring data

XII. Next Steps

After the 60

- day comment period closes, the EPA will review and respond to any comments received in a timely manner and then issue a F inal W ork P lan for case 0247 : Bacillus thuringiensis

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### 22 

## APPENDICES

N OTE 

### : Because of the complexity of this r egistration r eview c ase, the subh eadings of Appendices I I

– V I ( these Appendices are arranged by subspecies) are color coded as follows:

 Bacillus thuringiensis subspecies israelensis

– pale yellow

 Bacillus thuringiensis subspecies kurstaki

– p ale blue

 Bacillus thuringiensis subspecies aizawai

– purple /rose

 Bacillus thuringiensis subspecies tenebrionis

– pale green

 Bacillus thuringiensis subspecies galleriae

– orange

LIST OF APPENDICES

APPENDIX I History of the B

. thuringiensis Tolerance Exemption

APPENDIX I I Pesticide Products Containing B

. t huringiensis

APPENDIX II I Representative B

. t huringiensis Technical Product s

APPENDIX IV Product Analysis Data Requirements (40 CFR § 158.2120) (How They Have

Been Met)

APPENDIX V Human Health Toxicity Data Requirements (40 CFR § 158.2140) (How They

Have Been Met )

APPENDIX V I Nontarget Organism Data Requirements (40 CFR § 158.2150) (How They Have

Been Met )

APPENDIX VI I Summary of Incidents Involving Exposure to B

. thuringiensis

APPENDIX VIII BibliographyBacillus thuringiensis EPA

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### 23 APPENDIX I

– History of the B

. thuringiensis Tolerance Exemption

Provided below is the original tolerance exemption (by the FDA) followed by it s subsequent amendments
and the reasons for the amendments.

FR Citation
and Publication

Date Tolerance Expression in the Code of Federal Regulations Tolerance Action Explanation

25 FR 3207 April 14, 1960 21 CFR § 120.176 Exemption from the requirement of a tolerance for

residues of viable spores of the microorganism Bacillus thuringiensis
Berliner.

(a) For the purposes of this section the microbial pesticide for which exemption from the requirement of a tolerance is being established shall have the following specifications:

(1) The microorganism shall be an authentic strain of Bacillus thuringiensis Berliner conforming to the morphological and biochemical characteristics of Bacillus thuringiensis as described in Bergey ’ s Manual of Determinative Bacteriology, Seventh Edition.

(2) Spore preparations of Bacillus thuringiensis Berliner shall be produced by pure culture fermentation procedures with adequate control measures during production to detect any changes from the characteristics of the parent strain or contamination by other microorganisms.

(3) Each lot of spore preparation, prior to the addition of other materials, shall be tested by subcutaneous injection of at least 1 million spores into eac h of five laboratory test mice weighing 17 grams to 23 grams. Such test shall show no evidence of infection or injury in the test animals when observed for 7 days following injection.

(b) Exemption from the requirement of a tolerance is established for res idues of the microbial pesticide Bacillus thuringiensis Berliner as specified in paragraph (a) of this section in or on the following raw agricultural commodities: Alfalfa, apples, artichokes, beans, broccoli, cabbage, cauliflower, celery, cottonseed, lett uce, potatoes, spinach. Original t olerance e xemption

26 FR 8071 August 29, 1961 21 CFR § 120.176 Exemption from the requirement of a tolerance for

residues of viable spores of the microorganism Bacillus thuringiensis

Berliner.

(a) * * *

(b) Exemption from the requirement of a tolerance is established for residues of the microbial pesticide Bacillus thuringiensis Berliner as specified in paragraph (a) of this section in or on the following raw agricultural commodities: Alfalfa, apples, art ichokes, beans, broccoli, cabbage, cauliflower, celery, cottonseed, lettuce, melons, potatoes, spinach , tomatoes

. THE FDA amended the tolerance exemption to add melons and tomatoes to the commodity list in paragraph (b).

27 FR 8071 August 14, 1962 21 CFR § 120.176 Exemption from the requirement of a tolerance for

residues of viable spores of the microorganism Bacillus thuringiensis

Berliner.

(a) For the purposes of this section the microbial insecticide for which exemption from the requirement of a tolerance is being established shall have the following specifications:

* * *

(b) Exemption from the requirement of a tolerance is established for residues

of the microbial insecticide Bacillus thuringiensis Berliner

, as specified in paragraph (a) of t his section

, in or on the following raw agricultural commodities: Alfalfa, apples, artichokes, bananas, beans, broccoli, cabbage, cauliflower, celery, cottonseed, lettuce, melons, potatoes, spinach , tomatoes

. THE FDA amended the tolerance exemption to chan ge “microbial pesticide” to “microbial insecticide” (in paragraphs (a) and (b)) and to add bananas to the commodity list in paragraph (b).Bacillus thuringiensis EPA

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### 24 FR Citation
and Publication

Date Tolerance Expression in the Code of Federal Regulations Tolerance Action Explanation

27 FR 12110 December 6,

1992 21 CFR § 120. 1011 V iable spores of the microorganism Bacillus

thuringiensis Berliner; exemption from the requirement of a tolerance.

(a) For the purposes of this section the microbial insecticide for which exemption from the requirement of a tolerance is being established shall have the following specifications:

(1) The microorga nism shall be an authentic strain of Bacillus thuringiensis Berliner conforming to the morphological and biochemical characteristics of Bacillus thuringiensis as described in Bergey’ s Manual of Determinative Bacteriology, Seventh Edition.

(2) Spore prepara tions of Bacillus thuringiensis Berliner shall be produced by pure culture fermentation procedures with adequate control measures during production to detect any changes from the characteristics of the parent strain or contamination by other microorganisms

. (3) Each lot of spore preparation, prior to the addition of other materials, shall be tested by subcutaneous injection of at least 1 million spores into each of five laboratory test mice weighing 17 grams to 23 grams. Such test shall show

no evidence of infection or injury in the test animals when observed for 7 days following injection.

(b) Exemption from the requirement of a tolerance is established for residues

of the microbial insecticide Bacillus thuringiensis Berliner

, as specified in paragraph (a) of this section

, in or on the following raw agricultural commodities: Alfalfa, apples, artichokes, bananas, beans, broccoli, cabbage, cauliflower, celery, cottonseed, lettuce, melons, potatoes, spinach , tomatoes

. The FDA revi sed 21 CFR Part 120 for editorial and codification purposes

.

31 FR 7376 May 21, 1966 21 CFR § 120. 1011 V iable spores of the microorganism Bacillus

thuringiensis Berliner; exemption from the requirement of a tolerance.

(a) * * *

(b) Exemption from the requirement of a tolerance is established for residues

of the microbial insecticide Bacillus thuringiensis Berliner

, as specified in paragraph (a) of this section

, in or on the following raw agricultural commodities: Alfalfa, apples, artichokes, bananas, beans, broccoli, cabbage, cauliflower, celery, collards, cottonseed, grapes, kale, lettuce, melons, mustard greens, potatoes, spinach , strawberries, sweet corn, tomatoes, turnip

greens

. The FDA amended the tolerance exemption to add c ollards, grapes, kale, mustard greens, strawberries, sweet corn, and turnip greens to the commodity list in paragraph (b).

34 FR 6655 April 18, 1969 21 CFR § 120. 1011 V iable spores of the microorganism Bacillus

thuringiensis Berliner; exemption from the requirement of a tolerance.

(a) * * *

(b) Exemption from the requirement of a tolerance is established for residues

of the microbial insecticide Bacillus thuringiensis Berliner

, as specified in paragraph (a) of this sectio n , in or on the following raw agricultural commodities: Alfalfa, apples, artichokes, bananas, beans, broccoli, cabbage, cauliflower, celery, collards, cottonseed, cucumbers, eggplants, grapes, kale, lettuce, melons, mustard greens, oranges, potatoes, spinach , strawberries, sweet corn, tomatoes, and turnip greens

. THE FDA amended the tolerance exemption to add cucumbers, eggplants, and oranges to the commodity list in paragraph (b).Bacillus thuringiensis EPA

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### 25 FR Citation
and Publication

Date Tolerance Expression in the Code of Federal Regulations Tolerance Action Explanation

36 FR 22572 November 25,

1971 40 CFR § 120. 1011 V iable spores of the microorganism Bacillus

thuringiensis Berliner; exemption from the requirement of a tolerance.

(a) For the purposes of this section the microbial insecticide for which exemption from the requirement of a tolerance is being established shall have the following specifications:

(1) The microorganism shall be an authentic strain of Bacillus thuringiensis Berliner conforming to the morphological and biochemical cha racteristics of Bacillus thuringiensis as described in Bergey’ s Manual of Determinative Bacteriology, Seventh Edition.

(2) Spore preparations of Bacillus thuringiensis Berliner shall be produced by pure culture fermentation procedures with adequate control measures during production to detect any changes from the characteristics of the parent strain or contamination by other microorganisms.

(3) Each lot of spore preparation, prior to the addition of other materials, shall be tested by subcutaneous injection of at least 1 million spores into each of five laboratory test mice weighing 17 grams to 23 grams. Such test shall show no evidence of infection or injury in the test animals when observed for 7 days following injection.

(b) Exemption from the requirement of a tolerance is established for residues

of the microbial insecticide Bacillus thuringiensis Berliner

, as specified in paragraph (a) of this section

, in or on the following raw agricultural commodities: Alfalfa, apples, artichokes, bananas, beans, brocc oli, cabbage, cauliflower, celery, collards, cottonseed, cucumbers, eggplants, grapes, kale, lettuce, melons, mustard greens, oranges, potatoes, spinach , strawberries, sweet corn, tomatoes, and turnip greens

. Bacillus thuringiensis tolerance exemption move d from 21 CFR to 40

CFR after the establishment of the

EPA.

38 FR 1 9045 July 17, 1973 40 CFR § 180.1011 V iable spores of the microorganism Bacillus

thuringiensis Berliner; exemption from the requirement of a tolerance.

(a) * * *

( 4 ) Spore preparations shall be free of the Bacillus thuringiensis β

- exotoxin when tested with the fly larvae toxicity test (“Microbial Control of Insects and Mites,” R.P.M. Bond et al., p. 280 ff., 1971). This specification can be satisfied either by determ ining that each master seed lot brought into production is a Bacillus thuringiensis strain which does not produce β

exotoxin under standard manufacturing conditions or by periodically determining that β

- exotoxin synthesized during spore production is elimi nated by the subsequent spore

- harvesting procedure.

(b) * * * The EPA amen ded the tolerance exemption to include a toxicity test to determine the presence of β

- exotoxin

to e nsure that

Bacillus thuringiensis p roducts are free

of this toxin.

42 FR 28540 June 3, 1977 40 CFR § 180.1011 Viable spores of the microorganism Bacillus

thuringiensis Berliner; exemption from the requirement of a tolerance.

(a) * * *

(b) Exemption from the requirement of a tolerance is established for residues

of the microbial insecticide Bacillus thuringiensis

, Berliner, as specified in paragraph (a) of this section, in or on all raw agricultural commodities when it

is applied either to g rowing crops or when it is applied after harvest in accordance with good agricultural practice. The EPA, at the request of Interregional Research Project No. 4 (IR

- 4 ), amended the tolerance exemption to exempt residues of

“ Bacillus thuringiensis

, Berliner from the requirement of tolerance in or on all raw agricultural commodities when

the pesticide is applied to growing

crops.”Bacillus thuringiensis EPA

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### 26 FR Citation
and Publication

Date Tolerance Expression in the Code of Federal Regulations Tolerance Action Explanation

45 FR 43721 June 30, 1980 40 CFR § 180.1011 Viable spores of the microorganism Bacillus

thuringiensis Berliner, exemption from the requirement of a tolerance

. (a) * * *

( 1 ) The microorganism shall be an authentic strain of Bacillus thuringiensis Berliner conforming to the morphological and biochemical characteristics of Bacillus thuringiensis as described in Bergey’s Manual of Determinative Bacteriology, Eighth Edition.

(b) * * * The EPA amended the tolerance exemption to update the Bergey’s Manual reference (7 th edition to 8 th

edition).

45 FR 56347 August 25, 1980 40 CFR § 180.1011 Viable spores of the microorganism Bacillus

thuringiensis Berliner, exemption from the requirement of a tolerance.

(a) * * *

(b) Exemption from the requirement of a tolerance is established for residues

of the microbial insecticide Bacillus thuringiensis Berliner, as s pecified in paragraph (a) of this section, in or on beeswax and honey and all other raw agricultural commodities when it is applied either to growing crops, or when it is applied after harvest in accordance with good agricultural practices. The EPA, a t the re quest of IR

- 4, amended the tolerance exemption to exempt residues of “ Bacillus thuringiensis Berliner in or on the raw agricultural commodities beeswax and

honey.”

74 FR 26533 June 3, 2009 40 CFR § 180.1011 Viable spores of the microorganism Bacillus

thuringiensis Berliner; exemption from the requirement of a tolerance.

(a) * * *

(b) Exemption from the requirement of a tolerance is established for residues

of the microbial insecticide Bacillus thuringiensis Berliner, as specified in paragraph (a) of this section, in or on honey and honeycomb and all other raw agricultural commodities when it is applied either to growing crops, or when it is applied after harvest in accordance with good agricultural practices. The Office of Pesticide Programs

develo ped a standard commodity vocabulary database

, entitled Food and Feed Commodity Vocabulary

. The EPA updated the tolerance e xemption from requirement of tolerance was updated to comport with this new

database.Bacillus thuringiensis EPA

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### 27 APPENDIX I I

– Pesticide Products Containing B

. thuringiensis

Provided below is the current list of pesticide products containing Bacillus thuringiensis as an active ingredie nt; they include FIFRA section 3 and 24(c) registrations. Highlighted (yellow) e ntries denote

ma nufacturing

- use pesticide products (MP)

.

PC C ODE &

A CTIVE I NGREDIENT EPA

R EG

. N O

. P RODUCT N AME %
A.I. N OTES

Bacillus thuringiensis subspecies israelensis

006401

B. thuringiensis subspecies

israelensis 4

- 455 Bonide Mosquito Beater WSP 1.7 To be reclassified under P C C ode

069162

70051

- 102 Bti Granule Larvicide 2.86 To be reclassified under PC C ode

006520

006476

B. thuringiensis subspecies
israelensis
strain EG2215 73049

- 405 Bti Technical Powder Bioinsecticide 100 MP

006520

B. thuringiensis subspecies

israelensis

strain BMP 144 432

- 1515 BES0531 10

769

- 992 Allpro Sustain BCG 5.71

6218

- 47 Summit B.T.I. Briquets 10.31

6218

- 73 Summit Mosquito Bits 2.86

62637

- 1 BMP 144 (2X) 8

62637

- 2 BMP 144 (3X) 12

62637

- 3 BMP 144 (200 G) 2.86

62637

- 7 BMP 144 Primary Powder 100 MP

62637

- 11 BMP 144 DF 17.15

62637

- 12 BMP 144 DFX 25.7 0

62637

- 13 BMP 144 (400 G) 5.71

62637

- 14 BMP 144DF 3000 43

62637

- 15 BMP 144 Primary Powder OSF 100

83362

- 2 Meridian

- 02 7

83362

- 3 FourStar Briquets 1 a

85685

- 1 Four Star SBG 2.15

85685

- 2 FourStar CRG 1 a

85685

- 3 FourStar MBG 3 a

85685

- 4 FourStar Bti CRG 10

006642

B. thuringiensis subspecies

israelensis
strain SUM

- 6218 6218

- 83 Bti MP 100 MPBacillus thuringiensis EPA

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### 28 PC C ODE &

A CTIVE I NGREDIENT EPA

R EG

. N O

. P RODUCT N AME %
A.I. N OTES

069162

B. thuringiensis subspecies

israelensis
strain AM 65

- 52 8329

- 39 Bti Granules 5

9688

- 212 Chemsico Insect Granules ML 4.95

73049

- 10 Vectobac G Biological Larvicide Granules 2.8 0

73049

- 11 Vectobac

- AS 6.38

73049

- 13 Vectobac Technical Powder 99 MP

73049

- 18 Vectobac 12 AS

– II Biological Larvicide 11.6 1

73049

- 19 Vectobac GR 4.95

73049

- 38 Vectobac 12AS Biological Larvicide 11.6 1

73049

- 56 Vectobac WDG Biological Larvicide 37.4

73049

- 61 Bacillus thuringiensis subsp. israelensis Slurry (for Vectobac

Technical Powder and DF Formulations) 14 MP

73049

- 355 Vectobac Biological Larvicide Primary Powder 99

73049

- 429 Vectomax FG 4.5 a

73049

- 447 Vectobac DT Biological Larvicide (VBC

- 60046) 37.4

73049

- 451 VBC

- 60092 (Bactimos Briquette) 10.3

73049

- 452 Bactimos PT 12.3

73049

- 477 Bacillus thuringiensis subsp. i sraelensis Slurry (for Liquid Vectobac Formulations) 14 MP

73049

- 486 Vectobac GR 2.8 0

DE090002 Vectobac WDG Biological Larvicide 37.4 Parent registration is EPA Reg. No.
73049

- 56

069210
B. thuringiensis subspecies

israelensis
strain SA3A 73049

- 403 Teknar G 1.70

73049

- 404 Teknar HP

- D 1.6

73049

- 408 Teknar Technical Concentrate 100 MP

73049

- 428 Teknar Slurry 12 MP

73049

- 435 Teknar HP Biological Larvicide Aqueous Suspension 5.6

a Contains Bacillus sphaericus as a second active ingredient ( EPA Reg. No. 83362

- 3, 6%; EPA Reg. No. 85685

- 2, 9%; EPA Reg. No. 85685

- 3, 3 %; and EPA Reg.

No. 73049

- 429, 2.7%).

Bacillus thuringiensis subspecies kurstaki

006402

B. thuringiensis subspecies
kurstaki 73049

- 406 Thuricide 76 LV 14.4 To be reclassified under PC Code

006518 or PC Code 006519

73049

- 413 Thuricide 48LV Forestry 19 To be reclassified under PC Code

006518 or PC Code 006519

006407

B. thuringiensis subspecies

kurstaki

strain BMP 123 62637

- 5 BMP 123 (2X WP) 4 0

62637

- 6 BMP 123 (48 LC) 1 2

62637

- 8 BMP 123 (10G) 2

62637

- 9 BMP 123 Primary Powder 100 MP

62637

- 10 BMP 123 (64 ES) 22

006423

B. thuringiensis subspecies

kurstaki
strain EG2371 70051

- 79 Cutlass 4 0

70051

- 84 Cutlass Technical Powder 1 00 MP

006424

B. thuringiensis subspecies

kurstaki strain EG2348 7 0051

- 78 Condor 24.5

70051

- 80 Condor WP 43

70051

- 83 Condor Technical Powder 100 MP

70051

- 85 Condor XL 45Bacillus thuringiensis EPA

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### 29 PC C ODE &

A CTIVE I NGREDIENT EPA

R EG

. N O

. P RODUCT N AME %
A.I. N OTES

006453

B. thuringiensis subspecies

kurstaki strain EG7841 70051

- 86 Crymax 40 Integrated process

70051

- 90 Crymax WP 40

006459

B. thuringiensis subspecies
kurstaki strain EG7826 70051

- 87 Lepinox 100 MP

70051

- 89 Lepinox WDG 40

006518

B. thuringiensis subspecies
kurstaki
strain SA

- 12 4

- 226 Bonide Bacillus thuringiensis (Bt) Moth Larvae ( Caterpillar)
Control 15

4

- 487 Bonide Bacillus t huringiensis “ O ” 98.35

829

- 202 SA

- 50 Brand Thuricide HPC 15

2724

- 688 Security Bt Dust Biological Insecticide 0.049

9688

- 294 Chem s i co HPC

- O Concentrate 98.35

70051

- 52 Thuricide HPC 15

70051

- 53 Thuricide HP WP 70

70051

- 57 Thuricide 48 LV 19

70051

- 65 Thuricide HPC for Home and Gardens 15

70051

- 68 Thuricide Technical Concentrate 100 MP

70051

- 69 San 420 I WG 85

70051

- 70 SAN 420 I Technical Concentrate 100 MP

70051

- 103 Btk32 85

70051

- 106 Thuricide HPC

- O for Home a nd Gardens 98.35

70051

- 113 Thuricide HPC

- O RTU 9.83

73327

- 9 Green Light Bt Worm Killer 15

006519

B. thuringiensis subspecies

kurstaki
strain SA

- 11 7 0051

- 60 Javelin 17.8

70051

- 61 Javelin WP 80

70051

- 66 Javelin WG 85

70051

- 67 Javelin Technical Concentrate 100 MP

70051

- 98 Javelin WG 2 85Bacillus thuringiensis EPA

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### 30 PC C ODE &

A CTIVE I NGREDIENT EPA

R EG

. N O

. P RODUCT N AME %
A.I. N OTES

006522

B. thuringiensis subspecies

kurstaki
strain ABTS

- 351 4

- 251 Bonide Dipel 150 Dust f or Vegetables 0.47

4

- 252 Dipel WP Home & Garden Insecticide 6.4

4

- 336 Dipel 10G Sweet Corn Granules 2.3

4

- 405 Dipel Bio Garden Spray 6.4

829

- 196 SA

- 50 Brand Dipel Dust 0.41

2935

- 398 Bt 320 Dust 0.582

2935

- 399 Bt 320 Sulfur 25 Dust 0.582 a

7001

- 7775 Brit z Bt 25 Sulfur Dust 1.16 a

7001

- 7779 Britz Bt Dust 1.94

7401

- 290 Ferti

- Lome Dipel Dust Biological Insecticide 0.064

34704

- 722 Bt Sulfur 15

- 50 Dust 0.72 a

36488

- 25 Ringer Vegetable Insect Attack 0.4365

42697

- 23 Safer B.T. Caterpillar Killer Concentrate 12.74

73049

- 5 Dipel (Worm Killer) Wettable Powder Biological Insecticide 23.7

73049

- 8 Dipel 2 X Biological Insecticide Wettable Powder 58.2

73049

- 12 Dipel Biological Insecticide Technical Powder 91 MP

73049

- 14 Dipel 10G Biological Insecticide Granules 2.3

73049

- 17 Dipel ES 23.7

73049

- 27 ABG

- 6345 Technical Powder 84 MP

73049

- 30 Dipel ES

- NT Biological Insecticide

Emulsifiable Suspension 21

73049

- 33 Dipel SG Plus Biological Insecticide Sand Granule 2.5

73049

- 34 Dipel WDG Biological Insecticide 63.5

73049

- 35 Foray 48F Biological Insecticide Flowable Concentrate 17.6

73049

- 39 Dipel DF Dry Flowable Biological Insecticide 54

73049

- 46 Foray 48BC 17.19

73049

- 49 Foray 76B 18.44

73049

- 50 Biobit HP WP II Biological Insecticide 34.11

73049

- 54 Biobit HP Biological Insecticide Wettable Powder 58.2

73049

- 62 Bacillus thuringiensis subsp. kurstaki Slurry (for Dipel Technical and DF Formulations) 22 MP

73049

- 427 Foray 48B 12.65

73049

- 471 Foray WG 76.2

73049

- 476 Bacillus thuringiensis subsp. kurstaki Slurry (for Foray Products) 22 MP

73049

- 485 Bacillus t huringiensis subsp

. kurstaki Slurry (for Liquid Formulations except Foray 48B/SI) 22 MP

73327

- 10 Green Light Dipel Dust 0.49

CA100012 Dipel DF Dry Flowable Biological Insecticide 54 Parent r egistration is EPA Reg. No.

73049

- 39

ND010004 Dipel ES 23.7 Parent registration is EPA Reg. No.
73049

- 17

TX020001 Dipel ES 23.7 Parent registration is EPA Reg. No.

73049

- 17

006699

B. thuringiensis subspecies

kurstaki

strain V BTS

- 2546 73049

- 478 VBC

- 60219 Biological Insecticide Slurry 16 MP

73049

- 479 VBC

- 60225 Biological Insecticide Technical Grade Active Ingredient Powder 98 MP

73049

- 480 VBC

- 60236 Biological Insecticide Dry Flowable 67

73049

- 481 Foray 2WG Biological Insecticide (Water Dispersible Granules) 67

a C ontain s sulfur as a second active ingredient ( EPA Reg. No. 2935

- 399 , 25%; EPA Reg. No. 7001

- 7775, 25%; and EPA Reg. No. 34704

- 722, 50%).Bacillus thuringiensis EPA

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### 31 PC C ODE &

A CTIVE I NGREDIENT EPA

R EG

. N O

. P RODUCT N AME %
A.I. N OTES

Bacillus thuringiensis subspecies aizawai

006426

B. thuringiensis subspecies
aizawai
strain GC

- 91 70051

- 47 Agree WG 50

70051

- 48 Technical CGA

- 237218 100 MP

70051

- 99 Agree 50 WP 50

006494

B. thuringiensis subspecies
aizawai
strain NB200 73049

- 68 Florbac Slurry Biological Larvicide 18 MP

006523

B. thuringiensis subspecies
aizawai
strain ABTS

- 1857 73049

- 23 Xentari Biological Insecticide Water Dispersible Granule 48.1

73049

- 24 Xentari Biological Insecticide Technical Powder 89 MP

73049

- 28 ABG

- 6346 Biological Insecticide 83 MP

73049

- 31 Xentari A S Biological Insecticide 10.8

73049

- 40 Xentari Biological Insecticide Dry Flowable 54

73049

- 63 Bacillus thuringiensis subsp. aizawai Slurry 18 MP

Bacillus thuringiensis subspecies tenebrionis

006524

B. thuringiensis subspecies
tenebrionis

strain NB

- 176 73049

- 47 Novodor Technical 92.6 MP

73049

- 48 Novodor Biological Insecticide Flowable Concentrate 10

73049

- 64 Bacillus thuringiensis subsp. tenebrionis Slurry 17 MP

WA040029 Novodor Biological Insecticide Flowable Concentrate 10 Parent registration is EPA Reg. No.
73049

- 48

00 6399

B. thuringiensis subspecies galleriae strain SDS

- 502 88347

- 1 Phyllom SDS

- 502 MP 90 MP

88347

- 2 grubGONE! G 9

88347

- 3 Phyllom beetleGONE! Biological Insecticide 76.5 Bacillus thuringiensis subspecies galleriaeBacillus thuringiensis EPA

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### 32 APPENDIX II I

– Representative B

. t huringiensis Technical Product s

S TRAIN AND PC C ODE EPA R EG

. N O

. P RODUCT N AME % A CTIVE
I NGREDIENT F IRST

R EGISTERED REREGISTERED a

Bacillus thuringiensis subspecies israelensis

B. thuringiensis subspecies israelensis strain EG2215 (PC Code 006476) 73049

- 405 Bti Technical Powder

Bioinsecticide 100 Sep tember 30, 1998 N/A

B. thuringiensis subspecies israelensis strain BMP 144 ( PC Code 006520) 62637

- 7 BMP 144 Primary Powder 100 Oct ober 2, 1992 Nov ember 21, 2005

B

. thuringiensis subspecies israelensis strain SUM

- 6218 (PC Code 006642) 6218

- 83 Bti MP 100 May 13, 2013 N/A

B. thuringiensis subspecies israelensis strain AM 65

- 52 (PC Code 069162) 73049

- 13 Vectobac Technical Powder 99 Mar ch 12, 1984 Feb ruary 23, 2006

B. thuringiensis subspecies israelensis strain SA3A (PC Code 069210) 73049

- 408 Teknar Technical Concentrate 100 May 6, 2003 N / A

Bacillus thuringiensis subspecies kurstaki

B. thuringiensis subspecies kurstaki strain BMP 123 (PC Code 006407) 62637

- 9 BMP 123 Primary Powder 100 May 14, 1997 Nov ember 21, 2005

B. thuringiensis subspecies kurstaki strain EG2371 (PC Code 006423) 70051

- 84 Cutlass Technical Powder 100 May 25, 1995 Sep tember 30, 2005

B. thuringiensis subspecies kurstaki strain EG2348 (PC Code 006424) 70051

- 83 Condor Technical Powder 100 May 25, 1995 Sep tember 30, 2005

B. thuringiensis subspecies kurstaki strain EG7841 (PC Code 006453) 70051

- 86 Crymax 40 Feb ruary 15, 1996 May 22, 2006

B. thuringiensis subspecies kurstaki strain EG7 826 (PC Code 006459) 70051

- 87 Lepinox 100 Dec ember 16, 1996 Sep tember 30, 2005

B

. thuringiensis subspecies kurstaki strain SA

- 12 ( PC Code 006518) 70051

- 68 Thuricide Technical Concentrate 100 Nov ember 12, 1992 Nov ember 17, 2005

B

. thuringiensis subspecies kurstaki strain SA

- 11 (PC Code 006519) 70051

- 67 Javelin Technical Concentrate 100 Jun e 15, 1993 Nov ember 17, 2005

B. thuringiensis subspecies kurstaki strain ABTS

- 351 (PC Code 006522) 73049

- 12 Dipel Biological Insecticide

Technical Powder 91 Mar ch 12, 1984 Jan uary 27, 2006

B. thuringiensis subspecies kurstaki strain VBTS

- 2546 (PC Code 006699) 73049

- 479 VBC

- 60225 Biological Insecticide Technical Grade Active Ingredient

Powder 98 September 27, 2012 N/ABacillus thuringiensis EPA

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### 33 S TRAIN AND PC C ODE EPA R EG

. N O

. P RODUCT N AME % A CTIVE
I NGREDIENT F IRST

R EGISTERED REREGISTERED a

Bacillus thuringiensis subspecies aizawai

B. thuringiensis subspecies aizawai strain GC

- 91 (PC Code 006426) 70051

- 48 Technical CGA

- 237218 100 Aug ust 8, 1992 Sep tember 28, 2005

B. thuringiensis subspecies aizawai strain NB200 (PC Code 006494) 73049

- 68 Florbac Slurry Biological Larvicide 18 June 10, 2005 N / A

B. thuringiensis subspecies aizawai strain ABTS

- 1857 ( PC Code 006523) 73049

- 24 Xentari Biological Insecticide
Technical Powder 89 Aug ust 20, 1992 Feb ruary 28, 2006

Bacillus thuringiensis subspecies tenebrionis

B. thuringiensis subspecies tenebrionis strain NB

- 176 (PC Code 006524) 73049

- 47 Novodor Technical 92.6 May 8, 1992 Jan uary 27, 2006

Bacillus thuringiensis subspecies galleriae

B. thuringiensis subspecies galleriae strain SDS

- 502 (PC Code 006399 ) 88347

- 1 Phyllom SDS

- 502 MP 90 June 6, 2013 N/A

a Reregistration applied to pesticides first registered prior to November 1, 1984 (U.S. EPA, 2011).Bacillus thuringiensis EPA

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### 34 APPENDIX IV

– Product Analysis Data Requirements (40 CFR § 158.2120) (How They Have Been Met )

D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Bacillus thuringiensis subspecies israelensis

Active Ingredient: B. thuringiensis subspecies israelensis strain EG2215 (PC Code 006476) Representative Product: Bti Technical Powder Bioinsecticide (EPA Reg. No. 73049

- 405)

Product identity (885.1100) MRID No s

. 443916

- 01, 443916

- 02, 444238

- 01 , and 449910

- 02 ( U.S. EPA

, 1998b, 1998 c , 1998d

, 1999b, and 2000 )

Manufacturing process (885.1200) MRID No s

. 408988

- 01 and 449910

- 01; Av é (1998) ( U.S. EPA

, 1989c, 1998b, 1998c

, 1998d , and 2000 ) a

Deposition of a sample in a nationally recognized culture collection (885.1250) ONR

- 60A (World Health Organization Collaborating Centre for Entomopathogenic

Bacillus , Institut Pasteur, Paris, France) or HD567 (H. Dulmage USDA Collection)

MRID No. 444238

- 01 ( U.S. EPA

, 1998c and 1998d ) b

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin

. The registrant demonstrated that this strain will not produce ß

- exotoxin.

MRID No. 444238

- 01 (U.S. EPA

, 1998b)

. a

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011 (a) (3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID No. 443916

- 03 ( U.S. EPA, 1998c and 1998d)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 408988

- 01 ( U.S. EPA, 1989c, 1998c

, and 1998d) c

a Since the cited manufacturing process and discussion of formation of unintentional ingredients is largely from 1988, the regi strant will need to submit a revised manufacturing process and discussion of formation of unintentional ingredients that conforms to Section V(A)(1) of U.S. EPA (1998a). The EPA considers this to be a data gap.

b The registrant will need to clarify where it maintains a sample of the active ingredient that it uses in its manufacturing

- use pesticide product. The EPA considers this to be a data gap.

c All physical and chemical characteristics data appear to be fulfilled, except for storage stability (830.6317) and pH (830.70 00). The EPA considers storage stability and pH to be data gaps.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 35 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies israelensis strain BMP 144 (PC Code 006520) Representative Product: BMP 144 Primary Powder ( EPA Reg. No. 62637

- 7)

Product identity (885.1100) MRID No s

. 412220

- 01 , 412703

- 01, and 419151

- 01 (U.S. EPA, 1990f)

Manufacturing process (885.1200) MRID Nos. 447932

- 03, 463185

- 01, 464708

- 00, 464708

- 01, and 466755

- 01; Roberts (2005) (U.S. EPA, 2002g, 2004j, 2005g, 2005h, and 2005i)

Deposition of a sample in a nationally recognized culture collection (885.1250) IPS 82 ( Institut Pasteur in Paris, France )

MRID Nos. 41 9151

- 01 and 463185

- 01

(U.S. EPA, 2004j)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that it is highly unlikely that this strain will produce ß

- exotoxin. MRID Nos. 464708

- 00, 464708

- 01, and 466755

- 01; Roberts (2005) (U.S. EPA, 2005g, 2005h, and 2005i).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID No. 419151

- 01 a

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 419151

- 01 a

a There are no review s in the EPA’s files for MRID No. 419151

- 01 (analysis of samples and physical and chemical characteristics). Therefore, this data package will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional analysis of samples and/or physical and chemical characteristics information for this Bti strain from this registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 36 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies israelensis strain SUM

- 6218 (PC Code 006642) Representative Product: Bti MP (EPA Reg. No. 6218

- 83)

Product identity (885.1100) MRID Nos. 486826

- 01 and 486826

- 02 (U.S. EPA, 2012c , 2012d, 2013a , and 2013e )

Manufacturing process (885.1200) MRID Nos. 486286

- 03

, 490320

- 01 , 490321

- 01, and 490540

- 01 (U.S. EPA, 2012c , 2012d, 2013a

, 2013e , and 2013f )

Deposition of a sample in a nationally recognized culture collection (885.1250) ATCC BAA

- 2453 (American Type Culture Collection in Manassas, Virginia)

MRID No. 486826

- 04 (U.S. EPA, 2012c, 2012d, 2013a , and 2013e )

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin

. The registrant uses a fly larvae toxicity test assay to detect ß

- exotoxin in production batches. MRID No. 486826

- 05 (U.S. EPA, 2012c)

.

Other toxins or contaminants

. MRID No s

. 486826

- 05 and 489542

- 02 (U.S. EPA, 2012c, 2012d, and 2013e)

. The tolerance exemption (40 CFR 180. 1011(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID No. 486826

- 06 (U.S. EPA, 2012c and 2013a)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID Nos. 486826

- 08, 493669

- 01 , and 494592

- 01 (U.S. EPA, 2012c and 2013a) a

a The registrant submitted MRID Nos. 493669

- 01 and 494592

- 01 (storage stability) in response to terms of the 2013 registration for Bti MP. The EPA is currently reviewing these data to ascertain their acceptability.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 37 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies israelensis strain AM 65

- 52 (PC Code 069162) Representative Product: Vectobac Technical Powder (EPA Reg. No. 73049

- 13)

Product identity (885.1100) MRID Nos. 414390

- 01, 443171

- 02, and 465246

- 01 (U.S. EPA, 1 998g and 2005f) a

Manufacturing process (885.1200) MRID Nos. 443171

- 01, 447916

- 02, 452330

- 02, 457152

- 01, 465246

- 01, 465246

- 02,

465246

- 03, and 465246

- 04; Herrero (2005a) and Mero (2006b)

(U.S. EPA, 2001, 2004i, and 2005f)

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 1276 (American Type Culture Collection in Manassas, Virginia)

MRID Nos. 414390

- 01 and 465246

- 01

(U.S. EPA, 2005f)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant uses HPLC to detect ß

- exotoxin in production batches.

MRID No. 465246

- 02; Herrero (2005a) and Mero (2006b) (U.S. EPA, 2005f).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID Nos. 414390

- 02 and 418800

- 01 (U.S. EPA, 1992g) a

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 414390

- 02 a

a There are no review s in the EPA’s files f or MRID Nos. 414390

- 01 (product identity) and 414390

- 02 (analysis of samples and physical and chemical characteristics). Therefore, these data packages will be reviewed between now and the issuance of the

FWP to ascertain whether the EPA requires additional product identity, analysis of samples, and/or physical and chemical characteristics information for this Bti strain from the registrant. For now, the EPA considers this to be a data gap, subjec t to change in the FWP.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 38 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies israelensis strain SA3A (PC Code 069210) Representative Product: Teknar Technical Concentrate ( EPA Reg. No. 73049

- 4 0 8)

Product identity (885.1100) MRID Nos. 414415

- 03, 414415

- 06, 414415

- 09, 414415

- 12, 414415

- 15, 414415

- 19,

414415

- 22, 414415

- 25, and 466687

- 01

(U.S. EPA, 2005j) a

Manufacturing process (885.1200) MRID No s . 448074

- 01, 461861

- 01, 466687

- 01 , 466687

- 02, and 466687

- 03; Smith (2006) (U.S. EPA, 2005j)

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 1320 (American Type Culture Collection in Manassas, Virginia)

MRID No. 461861

- 01 (U.S. EPA, 2005j)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant uses a fly larvae toxicity test assay to detect ß

- exotoxin in production batches. MRID No. 466687

- 02; Smith (2006) (U.S. EPA, 2005j).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that e ach lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) **DATA GAP**

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 414415

- 31 a

a There are no review s in the EPA’s files for the product identity or physical and chemical characteristics data package s . Therefore, these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional product identity and/or physical and chemical characteristics information for this Bti strain from the registrant. For now, the EPA considers this to be a data gap, su bject to change in the FWP.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 39 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Bacillus thuringiensis subspecies kurstaki

Active Ingredient: B. thuringiensis subspecies kurstaki strain BMP 123 (PC Code 006407) Representative Product: BMP 123 Primary Powder (EPA Reg. No. 62637

- 9)

Product identity (885.1100) MRID Nos. 418250

- 01 , 418266

- 08, 418266

- 09, and 463185

- 01; Dively (1994) (U.S. EPA, 1992j and 2004j) a

Manufacturing process (885.1200) MRID Nos. 447932

- 03, 463185

- 01, 464708

- 00, 464708

- 01, and 466755

- 01; Roberts (2005) (U.S. EPA, 2002g, 2004j, 2005g, 2005h, and 2005i)

Deposition of a sample in a nationally recognized culture collecti on (885.1250) NRRL HD

- 263 (Agricultural Research Service Culture Collection (also known as the Northern Regional Research Laboratory Collection) in Peoria, Illinois)

MRID Nos. 418250

- 01 and 463185

- 01; Dively (1994)

(U.S. EPA, 2004j)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that it is highly unlikely that this strain will produce ß

- exotoxin. MRID Nos. 464708

- 00, 464708

- 01, and 466755

- 01; Roberts (2005) (U.S. EPA, 2005g, 2005h, and 2005i)

.

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.140 0) MRID No. 418250

- 01; Dively (1994) a

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 419151

- 01; Dively (1994) a

a There are no review s in the EPA’s files for MRID Nos. 418250

- 01 (product identity and analysis of samples) and 419151

- 01 (physical and chemical characteristics). Therefore, these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional product identity, analysis of samples, and/or physical and chemical characteristics information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subjec t to change in the FWP.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 40 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG2371 (PC Code 006423) Representative Product: Cutlass Technical Powder (EPA Reg. No. 70051

- 84)

Product identity (885.1100) MRID Nos. 409509

- 01, 411503

- 02, 415396

- 01, and 415399

- 01 (U.S. EPA, 1989a, 1989b

, and 1990d)

Manufacturing process (885.1200) MRID Nos. 447915

- 01, 462977

- 01, and 466493

- 01; Chen and Dively (2004e) and Dively (2005) (U.S. EPA, 2002f, 2004h, and 2005b)

Deposition of a sample in a nationally recognized culture collection (885.1250) NRRL B

- 18209 (Agricultural Research Service Culture Collection (also known as the Northern Regional Research Laboratory Collection) in Peoria, Illinois)

MRID No. 409509

- 01 (U.S. EPA, 1989b)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that this strain is incapable of producing ß

exotoxin. MRID No. 466493

- 01; Dively (2005) (U.S. EPA, 2005b).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID No. 416371

- 01 and 447915

- 01 (U.S. EPA, 1991d and 2002f)

Color (830.6302) Physical state (830.6303)

Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID Nos. 409509

- 01, 416372

- 01, and 447915

- 01 (U.S. EPA, 1989b , 1991e, and 2002f) a

a All physical and chemical characteristics data appear to be fulfilled, except for stability to normal and elevated temperatures, metals, and metal ions (830.6313). The EPA considers stability to normal and elevated temperatures, metal s, and metal ions to be a data gap.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 41 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG2348 (PC Code 006424) Representative Product: Condor Technical Powder (EPA Reg. No. 70051

- 83)

Product identity (885.1100) MRID Nos. 408988

- 01, 411503

- 01, 415396

- 01, and 415399

- 01 (U.S. EPA, 1989a, 1989c and 1990d)

Manufacturing process (885.1200) MRID Nos. 447915

- 03, 462170

- 01, and 466493

- 01; Chen and Dively (2004d) and Dively (2005) (U.S. EPA, 2002e, 2004g, and 2005b)

Deposition of a sample in a nationally recognized culture collection (885.1250) NRRL B

- 18208 (Agricultural Research Service Culture Collection (also known as the Northern Regional Research Laboratory Collection) in Peoria, Illinois)

MRID No. 408988

- 01 (U.S. EPA, 1989c)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that this strain is incapable of producing ß

exotoxin. MRID No. 466493

- 01; Dively (2005) (U.S. EPA, 2005b).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID Nos. 416371

- 01 and 447915

- 03 (U.S. EPA, 1991d and 2002e)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID Nos. 408988

- 01, 416372

- 01, and 447915

- 03 (U.S. EPA, 1989c , 1991e, and 2002e) a

a All physical and chemical characteristics data appear to be fulfilled, except for stability to normal and elevated temperatur es, metals, and metal ions (830.6313). The EPA considers stability to normal and elevated temperatures, metals, and metal ions to be a data gap.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 42 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG7841 (PC Code 006453) Representative Product: Crymax (EPA Reg. No. 70051

- 86)

Product identity (885.1100) MRID Nos. 436080

- 01, 436080

- 02, 436080

- 03, and 443279

- 01 (U.S. EPA, 1995a and 1998h )

Manufacturing process (885.1200) MRID Nos. 447915

- 07, 461862

- 01, and 466493

- 01; Chen and Dively (2004c) and Dively (2005) (U.S. EPA, 2002d, 2004f, and 2005b)

Deposition of a sample in a nationally recognized culture collection (885.1250) NRRL B

- 21250 (Agricultural Research Service Culture Collection (also known as the Northern Regi onal Research Laboratory Collection) in Peoria, Illinois)

MRID No. 436080

- 01 (U.S. EPA, 1995a)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that this strain is incapable of producing ß

exotoxin. MRID No. 466493

- 01; Dively (2005) (U.S. EPA, 2005b).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID Nos. 436080

- 06, 436080

- 07, and 447915

- 07 (U.S. EPA, 1995a and 2002d)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 436080

- 08 and 447915

- 07 (U.S. EPA, 1995a and 2002d) a

a All physical and chemical characteristics data appear to be fulfilled, except for stability to normal and elevated temperatur es, metals, and metal ions (830.6313). The EPA considers stability to normal and elevated temperatures, metals, and metal ions to be a data gap.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 43 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG7826 (PC Code 006459) Representative Product: Lepinox (EPA Reg. No. 70051

- 87)

Product identity (885.1100) MRID Nos. 438293

- 01, 438293

- 02, 438293

- 03, 442792

- 01, 443214

- 01, 443798

- 01, and 443798

- 02 (U.S. EPA, 1996a, 1997a, and 1998e)

Manufacturing process (885.1200) MRID Nos. 447915

- 09, 462231

- 01, and 466493

- 01; Chen and Dively (2004a) and Dively (2005) (U.S. EPA, 2002b, 2004a, and 2005b)

Deposition of a sample in a nationally recognized culture collection (885.1250) NRRL B

- 21249 (Agricultural Research Service Culture Collection (also known as the Northern Regional Research Laboratory Collection) in Peoria, Illinois)

MRID No. 438293

- 01 (U.S. EPA, 1996a)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that this strain is incapable of producing ß

exotoxin. MRID No. 466493

- 01; Dively (2005) (U.S. EPA, 2005b).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID No. 447915

- 09 (U.S. EPA, 2002b)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 447915

- 09 (U.S. EPA, 2002b) a

a All physical and chemical characteristics data appear to be fulfilled, except for stability to normal and elevated temperatur es, metals, and metal ions (830.6313). The EPA considers stability to normal and elevated temperatures, metals, and metal ions to be a data gap.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 44 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain SA

- 12 (PC Code 006518) Representative Product: Thuricide Technical Concentrate (EPA Reg. No. 70051

- 68)

Product identity (885.1100) MRID No s

. 414416

- 0 1, 414416

- 08, 414416

- 10, 414416

- 16, 414416

- 20, 414416

- 24,

414416

- 28, and 414416

- 33 a

Manufacturing process (885.1200) MRID No s

. 448074

- 01, 461417

- 01, and 466493

- 01 ; Chen and Dively (2004f) and (200 3a ) and Dively (2005) (U.S. EPA, 2002h

, 2004k

, and 2005b )

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 1323 (American Type Culture Collection in Manassas, Virginia)

MRID No. 461417

- 01 (U.S. EPA, 2 004k )

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that this strain is incapable of producing ß

exotoxin. MRID No. 466493

- 01; Dively (2005) (U.S. EPA, 2005b).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that ea ch lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) **DATA GAP**

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 414416

- 41 a

a There are no review s in the EPA’s files for the product identity or physical and chemical characteristics data packages. Therefore, these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional product identity and/or phys ical and chemical characteristics information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 45 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain SA

- 11 (PC Code 006519) Representative Product: Javelin Technical Concentrate ( EPA Reg. No. 70051

- 67)

Product identity (885.1100) MRID Nos. 414416

- 04, 414416

- 06, 414416

- 12, 414416

- 14, 414416

- 18, 414416

- 19,

414416

- 22, 414416

- 27, and 414416

- 30

(U.S. EPA, 1990g)

Manufacturing process (885.1200) MRID Nos. 448074

- 01, 461411

- 01, and 466493

- 01; Chen and Dively (2004g) and (2003b) and Dively (2005) (U.S. EPA, 2002i , 2004l, and 2005b)

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 1322 (American Type Culture Collection in Manassas, Virginia)

MRID No. 461411

- 01 (U.S. EPA, 2004l)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that this strain is incapable of producing ß

exotoxin. MRID No. 466493

- 01; Dively (2005) (U.S. EPA, 2005b).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore prepa ration be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) ** DATA GAP **

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 414416

- 36 (U.S. EPA, 1990g) a

a All physical and chemical characteristics data appear to be fulfilled, except for stability to normal and elevated temperatur es, metals, and metal ions (830.6313) and storage stability (830.6317). The EPA considers stability to normal and elevated temperatures, metals, and metal ions and storage stability to be data gaps.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 46 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain ABTS

- 351 (PC Code 006522) Representative Product: Dipel Biological Insecticide Technical Powder (EPA Reg. No. 73049

- 12)

Product identity (885.1100) MRID Nos. 415161

- 01, 440355

- 01, and 466425

- 01 (U.S. EPA, 1996d and 2005e ) a

Manufacturing process (885.1200) MRID Nos. 440072

- 01, 447916

- 03, 452330

- 03, 457153

- 01, 466425

- 01, and

466425

- 02; Herrero (2005a) (U.S. EPA, 1996d, 2001, 2004e, and 2005e)

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 1275 (American Type Culture Collection in Manassas, Virginia)

MRID No. 466 425

- 01 (U.S. EPA, 2005e)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant uses a fly larvae toxicity test assay to detect ß

- exotoxin in production batches. MRID No. 466425

- 02; Herrero (2005a) (U.S. EPA, 2005e).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID No s . 415161

- 02 and 418838

- 01 a

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 415161

- 02 and 418838

- 01 a

a There are no review s in the EPA’s files for MRID Nos. 415161

- 01 (product identity), 415161

- 02 (analysis of samples and physical and chemical characteristics), and 418838

- 01 (analysis of samples and physical and chemical characteristics). Therefore, these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional product identity, analysis of samples, and/or physical and chemical characteristics information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 47 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain VBTS

- 2546 (PC Code 006699) Representative Product: VBC

- 60225 Biological Insecticide Technical Grade Active Ingredient Powder (EPA Reg.

No. 73049

- 479)

Product identity (885.1100) MRID Nos. 485592

- 01 and 485592

- 05 (U.S. EPA, 2012 a )

Manufacturing process (885.1200) MRID No s

. 485592

- 02 and 485592

- 05 (U.S. EPA, 2012 a )

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 6283 (American Type Culture Collection in Manassas, Virginia)

MRID No. 485592

- 05 (U.S. EPA, 2012 a )

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant uses a fly larvae toxicity test assay to detect ß

- exotoxin in production batches. MRID No. 485592

- 02 (U.S. EPA, 2012 a ).

Other toxins or contaminants

. MRID No. 485592

- 05 (U.S. EPA, 2012 a ). The

tolerance exem

ption (40 CFR § 180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or

infection must be noted.

Analysis of samples (885.1400) MRID No. 486774

- 02 (U.S. EPA, 2012 a )

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 485592

- 06, 485592

- 07 , and 486774

- 02 (U.S. EPA, 2012 a )Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 48 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Bacillus thuringiensis subspecies aizawai

Active Ingredient: B. thuringiensis subspecies aizawai strain GC

- 91 (PC Code 006426) Representative Product: Technical CGA

- 237218 (EPA Reg. No. 70051

- 48)

Product identity (885.1100) MRID Nos. 419943

- 02 and 419943

- 03 (U.S. EPA, 1992f and 1998a )

Manufacturing process (885.1200) MRID Nos. 448074

- 01, 461416

- 01, and 466493

- 01; Chen and Dively (2004b) and Dively (2005) (U.S. EPA, 2002c, 2004d, and 2005b)

Deposition of a sample in a nationally recognized culture collection (885.1250) NCTC 11821 (National Collection of Type Cultures, PHLS Central Public Health Laboratory in London, England)

MRID No. 461416

- 01 (U.S. EPA, 2004d)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant demonstrated that this strain is incapable of producing ß

exotoxin. MRID No. 466493

- 01; Dively (2005) (U.S. EPA, 2005b).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID Nos. 419943

- 04, 419943

- 05

, and 423132

- 01 (U.S. EPA, 1992f)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID Nos. 420065

- 01, 424530

- 01, and 430587

- 01 (U.S. EPA, 1992f and 1996c)Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 49 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies aizawai strain NB200 (PC Code 006494) Representative Product: Florbac Slurry Biological Larvicide (EPA Reg. No. 73049

- 68)

Product identity (885.1100) MRID Nos. 454220

- 01, 464235

- 01, and 464235

- 03 (U.S. EPA, 2002a and 2005a)

Manufacturing process (885.1200) MRID Nos. 454220

- 01, 464235

- 00, 464235

- 01, 464235

- 02, and 464235

- 04; Herrero (2005b) and Herrero (2005c) (U.S. EPA, 2002a and 2005a)

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 5416 (American Type Culture Collection in Manassas, Virginia)

MRID No. 464235

- 01 (U.S. EPA, 2005a)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant uses HPLC and a fly larvae toxicity test assay to detect ß

exotoxin in production batches. MRID Nos. 464235

- 01 and 464235

- 02; Herrero (2005b) and Herrero (2005c) (U.S. EPA, 2005a).

Other toxins or contaminants . Thee tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID No. 453756

- 02 (U.S. EPA, 2002a)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 453756

- 01 (U.S. EPA, 2002a) a

a All physical and chemical characteristics data appear to be fulfilled, except for stability to nor mal and elevated temperatures, metals, and metal ions (830.6313) and storage stability (830.6317). The EPA considers stability to normal and elevated temperatures, metals, and metal ions and storage stability to be data gaps.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 50 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies aizawai strain ABTS

- 1857 (PC Code 006523) Representative Product: Xentari Biological Insecticide Technical Powder (EPA Reg. No. 73049

- 24)

Product identity (885.1100) MRID Nos. 417225

- 01, 41722 5

- 03, 417225

- 04, 417225

- 05, 4172 25

- 06, 4172 25

- 07,
and 466382

- 01 (U.S. EPA, 1991b, 1998a, and 2005d)

Manufacturing process (885.1200) MRID Nos. 447916

- 01, 452330

- 01, 457151

- 01, 466382

- 01, and 466382

- 02; Herrero (2005a) (U.S. EPA, 2001, 2004c, and 2005d)

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 1372 (American Type Culture Collection in Manassas, Virginia)

MRID No. 466382

- 01 (U.S. EPA, 2005d)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant uses a fly larvae toxicity test assay to detect ß

- exotoxin in production batches. MRID No. 466382

- 02; Herrero (2005a) (U.S. EPA, 2005d).

Other toxins or con taminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID Nos. 417225

- 09, 417225

- 11, 417225

- 12, and 421133

- 01 (U.S. EPA, 1991b and 1992d)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID Nos. 417225

- 14, 417225

- 16, and 421400

- 01 (U.S. EPA, 1991b and 1992d) a

a All physical and chemical characteristics data appear to be fulfilled, except for storage stability (830.6317). The EPA considers storage stability to be a data gap.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 51 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Bacillus thuringiensis subspecies tenebrionis

Active Ingredient: B. thuringiensis subspecies tenebrionis strain NB

- 176 (PC Code 006524) Representative Product: Novodor Technical (EPA Reg. No. 73049

- 47)

Product identity (885.1100) MRID Nos. 414127

- 01 , 418075

- 01, and 465198

- 01 (U.S. EPA, 1990a , 1991a, and 2005c)

Manufacturing process (885.1200) MRID Nos. 447916

- 04, 452330

- 05, 457154

- 01, 465198

- 01, and 465198

- 02; Herrero (2005a) and Mero (2006a) (U.S. EPA, 2001, 2004b, and 2005c)

Deposition of a sample in a nationally recognized culture collection (885.1250) SD

- 5428 (American Type Culture Collection in Manassas, Virginia)

MRID No. 465198

- 01 (U.S. EPA, 2005c)

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant uses a HPLC assay to detect ß

- exotoxin in production
batches. MRID No. 465198

- 02; Herrero (2005a) and Mero (2006a) (U.S. EPA, 2005c).

Other toxins or contaminants . The tolerance exemption (40 CFR §

180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of toxicity or infection must be noted.

Analysis of samples (885.1400) MRID Nos. 4141 27

- 02 and 424041

- 01 (U.S. EPA, 1990a and 1992b)

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID No. 414127

- 03 (U.S. EPA, 1990c) a

a All physical and chemical characteristics data appear to be fulfilled, except for stability to normal and elevated temperatur es, metals, and metal ions (830.6313). The EPA considers stability to normal and elevated temperatures, metals, and metal ions to be a data gap.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 52 Bacillus thuringiensis subspecies galleriae

Active Ingredient: B. thuringiensis subspecies galleriae strain SDS

- 502 (PC Code 006399) Representative Product: Phyllom SDS

- 502 MP (EPA Reg. No. 88347

- 1)

Product identity (885.1100) MRID No. 485532

- 01 ; Rose (2013a) and Rose (2013b) (U.S. EPA, 2012b, 2013b , and 2013c )

Manufacturing process (885.1200) MRID No s . 485532

- 02, 490940

- 02, and 490940

- 03 ; Rose (2013b) (U.S. EPA, 2012b, 2013b , and 2013c )

Deposition of a sample in a nationally recognized culture collection (885.1250) FERM BP

- 7667 (Japan International Patent Organism Depository, National Institute of Technology and Evaluation in Tsukuba

- shi, Japan)

MRID N o. 485532

- 01; Rose (2013a) and Rose (2013b) ( U.S. EPA, 2012b, 2 0 1 3b , and 2013c )

Discussion of formation of unintentional ingredients (885.1300) ß

- exotoxin . The registrant uses a fly larvae toxicity test assay to detect ß

- exotoxin in production batches. MRID Nos. 485532

- 03 and 490940

- 01; Rose (2013b) (U.S. EPA, 2012b, 2013b

, and 2013c ).

Other toxins or contaminants

. MRID Nos. 485532

- 03, 490940

- 02, and 490940

- 03 ; Rose (2013b) (U.S. EPA, 2012b, 2013b , and 2013c ). The tolerance exemption (40 CFR § 180. 1011(a)(3)) requires that each lot of spore preparation be tested on mice via subcutaneous injection; any evidence of to xicity or infection must be noted.

Analysis of samples (885.1400) MRID Nos. 485532

- 04 and 490940

- 04 (U.S. EPA, 2012b, 2013b , and 2013c )

Color (830.6302) Physical state (830.6303) Odor (830.6304) Stability to normal and elevated temperatures, metals, and metal ions (830.6313) Storage stability (830.6317) pH (830.7000) Density/relative density/bulk density (830.7300) MRID Nos. 487168

- 01, 492913

- 01, 494011

- 01, 494011

- 02 , and 494632

- 01 ; Rose (2013b) (U.S. EPA, 2013b) a

a The registrant submitted MRID Nos. 492913

- 01, 494011

- 01, 494011

- 02, and 494632

- 01 (storage stability and pH data ) in response to terms of the 2013 registration for Phyllom SDS

- 502 MP . The EPA is currently reviewing these data to ascertain their acceptability.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 53 APPENDIX V

– Human Health Toxicity Data Requirements (40 CFR § 158.2140) (How They Have Been Met )

D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Bacillus thuringiensis subspecies israelensis

Active Ingredient: B. thuringiensis subspecies israelensis strain EG2215 (PC Code 006476) Representative Product: Bti Technical Powder Bioinsecticide (EPA Reg. No. 73049

- 405)

Acute oral toxicity/pathogenicity (885.3050) CITE ALL ( U.S. EPA

, 1998b, 1998 c , and 1998d )

Acute pulmonary toxicity/ pathogenicity (885.3150) CITE ALL ( U.S. EPA

, 1998b, 1998 c , and 1998d )

Acute injection toxicity /

pathogenicity ( intravenous or intraperitoneal) (885.3200) CITE ALL (U.S. EPA, 1998b, 1998c, and 1998d)

Intraperitoneal safety test in mice (no guideline number) MRID No. 449910

- 02 (U.S. EPA, 1999b and 2000)

Active Ingredient: B. thuringiensis subspecies israelensis strain BMP 144 (PC Code 006520) Representative Product: BMP 144 Primary Powder ( EPA Reg. No. 62637

- 7)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 412220

- 02 (U.S. EPA, 1990e) a

Acute pulmonary toxicity/ pathogenicity (885.3150) MRID No. 412220

- 04 (U.S. EPA, 1990e) a
Acute injection toxicity/ pathogenicity (intravenous or intraperitoneal) (885.3200) **DATA GAP**

Intraperitoneal safety test in mice (no guideline number) MRID No. 412703

- 01 (U.S. EPA, 1990f)

a The EPA has found that these studies may not have looked at toxicity, pathogenicity, and infectivity through the oral and inhalation routes of exposure. Therefore, these data package s will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional acute toxicity/pathogenicity information for this Bti strain from the registran t. For now, the EPA considers this to be a data gap, subject to change in the FWP.

Active Ingredient: B. thuringiensis subspecies israelensis strain SUM

- 6218 (PC Code 006642) Representative Product: Bti MP (EPA Reg. No. 6218

- 83 )

Acute oral toxicity/pathogenicity (885.3050) MRID No. 486826

- 10 (U.S. EPA, 2012c and 2013a)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 486826

- 11 (U.S. EPA, 2012c and 2013 a )

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 486826

- 12

, 489542

- 03, and 489542

- 04 (U.S. EPA, 2012c , 2012d, 2013 a , and 2013e )Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 54 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies israelensis strain AM 65

- 52 (PC Code 069162) Representative Product: Vectobac Technical Powder ( EPA Reg. No. 73049

- 13)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 414390

- 03 a

Acute pul monary toxicity/ pathogenicity (885.3150) MRID No. 414874

- 01 a

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 414390

- 04 a

a There are no review s in the EPA’s files for MRID Nos. 414390

- 03, 414874

- 01, and 414390

- 04. Therefore, these data packages

will be reviewed between now and the issuance of the FWP to ascertain whether th e EPA requires additional acute toxicity/pathogenicity information for this Bti strain fr om the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.

Active Ingredient: B. thuringiensis subspecies israelensis strain SA3A (PC Code 069210) Representative Product: Teknar Technical Concentrate ( EPA Reg. No. 73049

- 408)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 142733 (U.S. EPA

, 1986 and 1998a )

Acute pulmonary toxicity/ pathogenicity (885.3150) MRID No. 142735 a

Acute inject ion toxicity/pathogenicity (intravenous or intraperitoneal) (885.3200) **DATA GAP**

Intraperitoneal safety test in mice (no guideline number) MRID No. 414415

- 06 (U.S. EPA, 1998a)

a There are no review s in the EPA’s files for MRID No. 142735 (acute pulmonary toxicity/pathogenicity). Therefore, this data package will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional acute pulmonary toxicity/pathogenicity information for this Bti strain from the registrant. For now, the EPA considers this to be a data

gap, subject to change in the FWP.

Bacillus thuringiensis subspecies kurstaki

Active Ingredient: B. thuringiensis subspecies kurstaki strain BMP 123 (PC Code 006407) Representative Product: BMP 123 Primary Powder ( EPA Reg. No. 62637

- 9)

Acute oral toxicity/pathogenicity (885.3050) MRID Nos. 415426

- 04, 418991

- 05, and 418266

- 02 (U.S. EPA, 1992h and 1992i ) a

Acute pulmonary toxicity/ pathogenicity (885.3150) MRID No s

. 415426

- 07, 417511

- 06, and 418266

- 04 (U.S. EPA, 1992h and 1992i) a
Acute injection toxicity/ pathogenicity (intravenous) (885.3200) MRID No s

. 415500

- 01 and 417511

- 07 (U.S. EPA, 1992h) a

Intraperitoneal safety test in mice (no guideline number) MRID Nos. 418266

- 08 and 418266

- 09 (U.S. EPA, 1992j)

a There are no review s in the EPA’s files for MRID Nos. 415426

- 04, 415426

- 07, and 415500

- 01

, and the EPA has classified MRID

Nos. 417511

- 05, 417511

- 06, and 417511

- 07 as unacceptable. Regarding MRID Nos. 418266

- 02 and 418266

- 04, these studies may not have looked at toxicity, pathogenicity, and infectivity. As a result, all of these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional acute toxicity/pathoge nicity information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 55 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG2371 (PC Code 006423) Representative Product: Cutlass Technical Powder ( EPA Reg. No. 70051

- 84)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 411503

- 04 (U.S. EPA, 1989a)

Acute pulmonary toxicity/ pathogenicity (885.3150) MRID Nos. 408988

- 04 and 411503

- 05 (Bridged from Btk strain EG2348: U.S. EPA 1989a, 1989b, and

1989 c)

Acute injection toxicity/ pathogenicity (intravenous ) (885.3200) MRID No. 408988

- 05 ( Bridged from Btk strain EG2348: U.S. EPA, 1989b and 1989c)

Acute injection toxicity/pathogenicity test in mice (intraperitoneal) (no guideline number) MRID No. 411503

- 02 (U.S. EPA, 1989a)

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG2348 (PC Code 006424) Representative Product: Condor Technical Powder (EPA Reg. No. 70051

- 83)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 411503

- 04 (Bridged from Btk strain EG2371: U.S. EPA 1989a and 1989b)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID Nos. 408988

- 04 and 411503

- 05 (U.S. EPA, 1989a and 1989c)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 408988

- 05 (U.S. EPA, 1989c)

Acute injection toxicity/pathogenicity test in mice (intraperitoneal) (no guideline number) MRID No. 411503

- 01 (U.S. EPA, 1989a)

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG7841 (PC Code 006453) Representative Product: Crymax (EPA Reg. No. 70051

- 86)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 436080

- 10 (U.S. EPA, 1995a)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 436080

- 13 (U.S. EPA, 1995a)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 436080

- 14 (U.S. EPA, 1995a)

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG7826 (PC Code 006459) Representative Product: Lepinox (EPA Reg. No. 70051

- 87)

Acute oral toxicity/pathogenicity (885.3050) MRID Nos. 438293

- 10 and 438293

- 11 (U.S. EPA, 1996a and 1996b)

Acute pulmonary toxicity/pathogenicity (885.3150) MRIDs 438293

- 10 and 438293

- 13 (U.S. EPA, 1996a and 1996b)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRIDs 438293

- 10 and 438293

- 14 (U.S. EPA, 1996a and 1996b)Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 56 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain SA

- 12 (PC Code 006518) Representative Product: Thuricide Technical Concentrate (EPA Reg. No. 70051

- 68)

Acute oral toxicity/pathogenicity (885.3050) MRID Nos. 96527, 109492, and 429358

- 03 (U.S. EPA, 1994h and 1998a)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID Nos. 96529 and 109494 (U.S. EPA, 1986 and 1998a)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 429544

- 03 (U.S. EPA, 1994h) a
Acute injection toxicity test in mice (intraperitoneal) (no guideline number) MRID No. 414416

- 10

a The EPA classified this study as supplemental as a pattern of clearance was not established in the spleens and mesenteric lym ph nodes of the test animals. Therefore, this data package will be reviewed between now and the is suance of the FWP to ascertain whether the EPA requires additional acute injection toxicity/pathogenicity information for this Btk strain from the registran t. For now, the EPA considers this t o be a data gap , subject to change in the FWP.

Active Ingredient: B. thuringiensis subspecies kurstaki strain SA

- 11 (PC Code 006519) Representative Product: Javelin Technical Concentrate (EPA Reg. No. 70051

- 67)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 429085

- 01 a

Acute pulmonary toxicity/pathogenicity (885.3150) Accession Nos. 007390 and 127354; MRID Nos. 96529 and 109494 (U.S. EPA, 1986 and 1998a) b

Acute injection toxicity/pathogenicity (intraperitoneal or intravenous) (885.3200) **DATA GAP**

Acute injection toxicity test in mice (intraperitoneal) (no guideline number) MRID No. 414416

- 12 (U.S. EPA, 1990g and 1998a)

a There are no review s in the EPA’s files for MRID No. 429085

- 01 (acute oral toxicity/pathogenicity ). Therefore, this data package will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional acute oral toxicity/pathogenicity information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.

b There are no review s in the EPA’s files for Accession Nos. 007390 and 127354. Further, these studies may not have looked at toxicity, pathogenicity, and infectivity and may not have been conducted using Btk strain SA

- 11 as the test substance. Regarding MRID Nos. 96529 and 109494, although these particular studies are acceptable acute pulmona ry toxicity/pathogenicity tests, the active ingredient tested is not Btk strain SA

- 11. As a result, all of these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional acute pulmonary t oxicity/pathogenicity information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.Bacillus thuringiensis EPA

- HQ

- OPP

- 2011

- 0705 www.regulations.gov



### 57 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain ABTS

- 351 (PC Code 006522) Representative Product: Dipel Biological Insecticide Technical Powder (EPA Reg. No. 73049

- 12)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 414434

- 01 (U.S. EPA, 1994f)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 414434

- 02 (U.S. EPA, 1994f)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 414875

- 01 a

a There are no review s in the EPA’s files for MRID No. 414875

- 01 (acute injection toxicity/pathogenicity). Therefore, this data package will be reviewed between now and the issuance of the FWP to ascertain whether th e EPA requires additional acute injection toxicity/pathogenicity information for this Btk strain from the registrant. For now, the EPA considers this to be a data

gap, su bject to change in the FWP.

Active Ingredient: B. thuringiensis subspecies kurstaki strain VBTS

- 2546 (PC Code 006699) Representative Product: VBC

- 60225 Biological Insecticide Technical Grade Active Ingredient Powder (EPA Reg.

No. 73049

- 479)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 485592

- 08 (U.S. EPA, 2012a)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 485592

- 10 (U.S. EPA, 2012a)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 485592

- 11 (U.S. EPA, 2012a)

Bacillus thuringiensis subspecies aizawai

Active Ingredient: B. thuringiensis subspecies aizawai strain GC

- 91 (PC Code 006426) Representative Product: Technical CGA

- 237218 (EPA Reg. No. 70051

- 48)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 420065

- 02 (U.S. EPA, 1992f and 1998a)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 420065

- 03 (U.S. EPA, 1992f and 1998a)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 420065

- 04 (U.S. EPA, 1992f)

Acute injection toxicity/pathogenicity test in mice (intraperitoneal) (no guideline number) MRID No. 419943

- 03 (U.S. EPA, 1992f and 1998a)

Active Ingredient: B. thuringiensis subspecies aizawai strain NB200 (PC Code 006494) Representative Product: Florbac Slurry Biological Larvicide (EPA Reg. No. 73049

- 68)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 453756

- 04 (U.S. EPA, 2002a)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 453756

- 03 (U.S. EPA, 2002a)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID Nos. 453756

- 06 and 464235

- 00 (U.S. EPA, 2002a and 2005a)Bacillus thuringiensis EPA

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### 58 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies aizawai strain ABTS

- 1857 (PC Code 006523) Representative Product: Xentari Biological Insecticide Technical Powder (EPA Reg. No. 73049

- 24)

Acute oral toxicity/pathogenicity (885.3050) MRID Nos. 418089

- 03 and 428511

- 01 (U.S. EPA, 1991b and 1993a)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 419748

- 01 (U.S. EPA, 1991c)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 418089

- 02 (U.S. EPA, 1991b)

Intraperitoneal and subcutaneous injection tests in mice (no guideline number) MRID No. 417225

- 07 (U.S. EPA, 1991b and 1998a)

Bacillus thuringiensis subspecies tenebrionis

Active Ingredient: B. thuringiensis subspecies tenebrionis strain NB

- 176 (PC Code 006524) Representative Product: Novodor Technical (EPA Reg. No. 73049

- 47)

Acute oral toxicity/pathogenicity (885.3050) MRID No. 414400

- 01 (Bridged from Btt strain NB125: U.S. EPA, 1990a and 1991a)

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 414400

- 02 (Bridged from Btt strain NB125: U.S. EPA, 1990a and 1991a)

Acute injection toxicity/pathogenicity (intravenous) (885.3200) MRID No. 414400

- 03 (Bridged from Btt strain NB125: U.S. EPA, 1990a and 1991a)

Bacillus thuringiensis subspecies galleriae

Active Ingredient: B. thuringiensis subspecies galleriae strain SDS

- 502 (PC Code 006399 ) Representative Product: Phyllom SDS

- 502 MP ( EPA Reg. No. 88347

- 1 )

Acute oral toxicity/pathogenicity (885.3050) MRID Nos. 485532

- 08, 485532

- 11, and 489401

- 08 (U.S. EPA, 2012b and 2013b)

Acute pulmonary toxicity/ pathogenicity (885.3150) MRID Nos. 485532

- 09, 485532

- 11, 489401

- 08 , and 489731

- 01 (U.S. EPA, 2012b and 2013b)

Acute injection toxicity/pathogenicity (intraperitoneal) (885.3200) MRID Nos. 485532

- 10, 485532

- 11, and 489401

- 08 (U.S. EPA, 2012b and 2013b)Bacillus thuringiensis EPA

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### 59 APPENDIX V I

– Nontarget Organism Data Requirements (40 CFR § 158.2150) (How They Have Been Met )

D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Bacillus thuringiensis subspecies israelensis

Active Ingredient: B. thuringiensis subspecies israelensis strain EG2215 (PC Code 006476) Representative Product: Bti Technical Powder Bioinsecticide (EPA Reg. No. 73049

- 405)

Avian oral toxicity (885.4050) MRID No s

. 414390

- 05 and 414390

- 06 (B ridged from Bti strain AM 65

- 52: U.S. EPA

, 1998a and 1998c)

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

Freshwater fish toxicity/ pathogenicity (885.4200) MRID Nos. 414390

- 07 and 414390

- 08 (B ridged fro m Bti strain AM 65

- 52: U.S. EPA

, 1998a and 1998c)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 449910

- 01 (U.S. EPA, 2000)

Estuarine and marine fish/invertebrate testing (885.4280) MRID No s

. 415404

- 01 and 415404

- 02 (B ri dged from Bti strain AM 65

- 52: U.S. EPA

, 1998a and 1998c)

Nontarget plant testing (885.4300) Waived

– A ctive ingredient is not a known plant pathogen

. ( U.S. EPA , 1998c)

Nontarget insect testing (885.4340) MRID No s

. 418427

- 08, 418427

- 09, and 418427

- 10 (B ridged from Bti strain NB31 : U.S. EPA

, 1992l, 1992m, 1992n,

1998a

, and 1998c)

Honey bee testing (885.4380) MRID No. 418427

- 11 (B ridged from Bti strain NB31: U.S. EPA

, 1992o, 1998a

, and 1998c) b

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b The EPA classified this honey bee study as supplemental as it was conducted for 5 days instead of 30 days. Therefore, this data package will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional honey bee information for this Bti strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.

Active Ingredient: B. thuringiensis subspecies israelensis strain BMP 144 (PC Code 006520) Representative Product: BMP 144 Primary Powder ( EPA Reg. No. 62637

- 7)

Avian oral toxicity (885.4050) CITE ALL (U.S. EPA, 1992k)

Wild mammal toxicity/pathogenicity (885.4150) CITE ALL (U.S. EPA, 1992k)

Freshwater fish toxicity/ pathogenicity (885.4200) CITE ALL (U.S. EPA, 1992k)

Freshwater invertebrate toxicity/ pathogenicity (885.4240) CITE ALL (U.S. EPA, 1992k)

Estuarine and marine fish/invertebrate testing (885.4280) CITE ALL (U.S. EPA, 1992k)

Nontarget plant testing (885.4300) CITE ALL (U.S. EPA, 1992k)

Nontarget insect testing (885.4340) CITE ALL (U.S. EPA, 1992k)

Honey bee testing (885.4380) CITE ALL (U.S. EPA, 1992k)Bacillus thuringiensis EPA

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### 60 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies israelensis strain SUM

- 6218 (PC Code 006642) Representative Product: Bti MP (EPA Reg. No. 6218

- 83)

Avian oral toxicity (885.4050) MRID No. 486826

- 20 ( U.S. EPA, 2013 a and 2013g )

Wild mammal toxicity/pathogenicity (885.4150) MRID No. 486826

- 22 (U.S. EPA, 2013 a and 2013g )

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 486826

- 23 (U.S. EPA, 2013 a and 2013g )

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No s . 486826

- 24 and 489542

- 01 (U.S. EPA, 2012e, 2013 a , and 2013g )

Estuarine and marine fish/invertebrate testing (885.4280) MRID No. 486826

- 25 (U.S. EPA, 2013 a and 2013g )

Nontarget plant testing (885.4300) MRID No. 486826

- 26 (U.S. EPA, 2013 a and 2013g )

Nontarget insect testing (885.4340) MRID No. 486826

- 27 (U.S. EPA, 2013 a and 2013g )

Honey bee testing (885.4380) MRID No. 486826

- 28 (U.S. EPA, 2013 a and 2013g )

Active Ingredient: B. thuringiensis israelensis strain AM 65

- 52 (PC Code 069162) Representative Product: Vectobac Technical Powder ( EPA Reg. No. 73049

- 13)

Avian oral toxicity (885.4050) MRID No s . 414390

- 05 and 414390

- 06 (U.S. EPA, 1998a and 1998c)

Wild mammal toxicity/pathogenicity (885.4150) **DATA GAP**

Freshwater fish toxic ity/

pathogenicity (885.4200) MRID No s . 414390

- 07 and 414390

- 08 (U.S. EPA, 1998a and 1998c)

Fr eshwater invertebrate toxicity/ pathogenicity (885.4240) MRID No. 414390

- 09 , 465246

- 03, and 465246

- 04 (U.S. EPA, 1998a, 1998c , and 2005f )

Estuarine and marine fish/invertebrate testing (885.4280) MRID No s

. 414390

- 10, 415404

- 01, and 415404

- 02 (U.S. EPA, 1998a and 1998c)

Nontarget plant testing (885.4300) Waived

– Scientific literature indicates no known detrimental effects

of Bacillus thuringiensis on plant life. (U.S. EPA, 1998a)

Nontarget insect testing (885.4340) **DATA GAP**

Honey bee testing (885.4380) MRID No. 414390

- 11 ( U.S. EPA, 1998c)Bacillus thuringiensis EPA

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### 61 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies israelensis strain SA3A (PC Code 069210) Representative Product: Teknar Technical Concentrate ( EPA Reg. No. 73049

- 408)

Avian oral toxicity (885.4050) Accession Nos. 090261, 092441, 092442, and 127354 a
Wild mammal toxicity/pathogenicity (885.4150) Accession No. 092441 a
Freshwater fish toxicity/ pathogenicity (885.4200) Accession No. 127354 a

Freshwate r invertebrate toxicity/ pathogenicity (885.4240) MRID No. 466687

- 03 (U.S. EPA, 2005j)

Estuarine and marine fish/invertebrate testing (885.4280) **DATA GAP**

Nontarget plant testing (885.4300) Waived

– Scientific literature indicates no known detrimental effects

of Bacillus thuringiensis on plant life. (U.S. EPA, 1998a)

Nontarget insect testing (885.4340) Accession No. 090189 ; MRID No. 414415

- 16 a

Honey bee testing (885.4380) Accession No. 127355 a

a There are no review s in the EPA’s files for these Accession Nos. or MRID Nos. Therefore, these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional nontarget o rganism information for this Bti strain from the registrant. For now, the EPA considers this to b e a data gap , subject to change in the FWP.

Bacillus thuringiensis subspecies kurstaki

Active Ingredient: B. thuringiensis subspecies kurstaki strain BMP 123 (PC Code 006407) Representative Product: BMP 123 Primary Powder ( EPA Reg. No. 62637

- 9)

Avian oral toxicity (885.4050) Waived

- B ased on the lack of expected harmful effects against avian species. (U.S. EPA, 1995c)

Wild mammal toxicity/pathogenicity (885.4150) **DATA GAP**

Freshwater fish toxicity/ pathogenicity (885.4200) MRID No. 408988

- 08 (B ridged from Btk strain EG2348 : U.S. EPA, 1996f and 1997f )

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No s

. 434917

- 01, 438988

- 01, and 440882

- 01 (U.S. EPA, 1995c and 1996f )

Estuarine and marine fish/invertebrate testing (885.4280) Not requir ed

– Products with this active ingredient are not intended for direct application into estuarine or marine environments and are not expected to enter these environments in significant concentrations

. a

Nontarget plant testing (885.4300) Waived

– Bacillus thuringiensis is not known to have negative effects on plants. ( U.S. EPA, 1993b)

Nontarget insect testing (885.4340) Waived

– B ased on this active ingredient’s lack of exotoxin production

. (U.S. EPA, 1993b and 1993c)

Honey bee testing (885.4380) MRID No. 434917

- 02 (U.S. EPA, 1995c and 1998a )

a See 40 CFR § 158.2150(d) and test note #6 in 40 CFR § 158.2150(e).Bacillus thuringiensis EPA

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### 62 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG2371 (PC Code 006423) Representative Product: Cutlass Technical Powder ( EPA Reg. No. 70051

- 84)

Avian oral toxicity (885.4050) MRID No s . 404677

- 01 and 408988

- 07 (B ridged from Btk strain EG2348: U.S. EPA, 1989d and 1997d )

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

(U.S. EPA, 1989d)

Freshwater fish toxicity/ pathogenicity (885.4200) MRID No. 408988

- 08 (Bridged from Btk strain EG2348: U.S. EPA , 1989d )

Fr eshwater invertebrate toxicity/ pathogenicity (885.4240) MRID No. 408988

- 09 (Bridged from Bt k strain EG2348: U.S. EPA , 1989d )

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Product with this active ingredient is not intended for direct application into estuarine or marine environments and is not expected to enter these environments in significant concentrations

. b

(U.S. EPA, 1989d)

Nontarget plant testing (885.4300) MRID No s

. 404677

- 05, 404677

- 07, 408988

- 10, and 408988

- 11 (Bridged from Bt k strain EG2348: U.S. EPA, 1989d )

Nontarget insect testing (885.4340) MRID No s

. 405084

- 02, 405084

- 03, 405084

- 04, and 416389

- 01 (U.S. EPA, 1989d) c

Honey bee testing (885.4380) MRID No. 404677

- 14 (Bridged from Btk strain EG2348 : U.S. EPA, 1989d )

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b See 40 CFR § 158.2150(d) and test note #6 in 40 CFR § 158.2150(e).

c There are no review s in the EPA’s files for MRID No. 416389

- 01 (nontarget insect testing). There fore, this data package will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires addi tional nontarget insect testing

information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG2348 (PC Code 006424) Representative Product: Condor Technical Powder ( EPA Reg. No. 70051

- 83)

Avian oral toxicity (885.4050) MRID Nos. 404677

- 01 and 408988

- 07 (U.S. EPA, 1989e and 1997d )

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

(U.S. EPA, 1989e)

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 408988

- 08 (U.S. EPA, 1989e)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 408988

- 09 (U.S. EPA, 1989e)

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Products with this active ingredient are not intended for direct application into estuarine or marine environments and are not expected to enter these environments in significant concentrations

. b

(U.S. EPA, 1989e)

Nontarget plant testing (885.4300) MRID No s

. 404677

- 05, 404677

- 07, 408988

- 10, and 408988

- 11 (U.S. EPA, 1989e)

Nontarget insect testing (885.4340) MRID No s

. 404677

- 09, 404677

- 11, and 404677

- 13 (U.S. EPA, 1989e)

Honey bee testing (885.4380) MRID No. 404677

- 14 (U.S. EPA, 1989e)

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b See 40 CFR § 158.2150(d) and test note #6 in 40 CFR § 158.2150(e).Bacillus thuringiensis EPA

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### 63 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG7841 (PC Code 006453) Representative Product: Crymax (EPA Reg. No. 70051

- 86)

Avian oral toxicity (885.4050) MRID Nos. 404677

- 01, 408988

- 07, 436080

- 17 and 436601

- 01 ( Some Data Bridged from Btk strain EG2348: U.S. EPA, 1989e,

1996e, and 1997d)

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

(U.S. EPA, 1996e)

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 436080

- 18 ( U.S. EPA, 1996e)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 436080

- 19; Olson (1996b) (U.S. EPA, 1996e and 1997e)

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Product with this active ingredient is not intended for direct application into estuarine or marine environments and is not expected to enter these environments in significant concentrations

. b

Nontarget plant testing (885.4300) Waived

– Scientific literature indicates no known detrimental effects

of Bacillus thuringiensis on plant life. (U.S. EPA, 1998a)

Nontarget insect testing (885.4340) MRID No. 436080

- 20 (U.S. EPA, 1996e and 1997e)

Honey bee testing (885.4380) MRID No. 436080

- 21 (U.S. EPA, 1996e and 1997e)

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b See 40 CFR § 158.2150(d) and test note #6 i n 40 CFR § 158.2150(e).Bacillus thuringiensis EPA

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### 64 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain EG7826 (PC Code 006459) Representative Product: Lepinox (EPA Reg. No. 70051

- 87)

Avian oral toxicity (885.4050) Waived

– Based on this active ingredient’s known lack of toxicity to

birds. (U.S. EPA, 1996a and 1996b)

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

Freshwater fish toxicity/ pathogenicity (885.4200) Waived

– Based on this active ingredient’s known lack of toxicity to

fish. (U.S. EPA, 1996a and 1996b)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 43 8293

- 17 and Olson (1996a) (U.S. EPA, 1996a and 1996b)

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Product with this active ingredient is not intended for direct application into estuarine or marine environments and is not expected to enter these environments in significant concentrations

. b

Nontarget plant testing (885.4300) Waived

– Based on this active ingredient’s known lack of toxicity to plants. (U.S. EPA, 1996a and 1996b)

Nontarget insect testing (885.4340) Waived

– Based on the lack of exposure to nontarget insects. (U.S. EPA, 1996a) c

Honey bee testing (885.4380) MRID No. 438293

- 18 (U.S. EPA, 1996a and 1996b)

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b See 40 CFR § 158.2150(d) and test note #6 in 40 CFR § 158.2150(e).

c In 1996, the EPA granted a waiver for nontarget insect testing for this active ingredient based upon a lack of exposure. The current
end

- use pesticide product label ( Lepinox WDG, EPA Reg. No. 70051

- 89 ) that contains this active ingredient, however, allows for a broad range of application methods (e.g., aerial applications) to many different crops. Given the current end

- use pesticide product

label and the potential for nontarget insects to be exposed to this active ingredient, the EPA considers this to be a data gap and anticipates requiring more data/information to support the expanded uses on the label.

Active Ingredient: B. thuringiensis subspecies kurstaki strain SA

- 12 (PC Code 006518) Representative Product: Thuricide Technical Concentrate ( EPA Reg. No. 70051

- 68)

Avian oral toxicity (885.4050) Accession Nos. 0 90261, 092441, 0 92442

, 127354 a

Wild mammal toxicity/pathogenicity (885.4150) Accession No. 092441 a

Freshwater fish toxicity/ pathogenicity (885.4200) Accession No. 127354 a

Freshwater invertebrate toxicity/pathogenicity (885.4240) Accession No. 127354; MRID No. 96533 a

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Product s with this active ingredient are not intended for direct application into estuari ne or marine environments and are not expected to enter these environments in significant concentrations

. b

Nontarget plant testing (885.4300) Waived

– Scientific literature indicates no known detrimental effects

of Bacillus thuringiensis on plant life. (U.S. EPA, 1998a)

Nontarget insect testing (885.4340) Accession No s . 090189 and 127355 a

Honey bee testing (885.4380) Accession No. 127355 a

a There are no review s in the EPA’s files for these Accession Nos. or MRID Nos. Therefore, these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional nontarge t organism information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.

b See 40 CFR § 158.2150(d) and test n ote #6 in 40 CFR § 158.2150(e).Bacillus thuringiensis EPA

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### 65 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain SA

- 11 (PC Code 006519) Representative Product: Javelin Technical Concentrate (EPA Reg. No. 70051

- 67)

Avian oral toxicity (885.4050) Accession Nos. 090261, 092441, 092442, 127354 a

Wild mammal toxicity/pathogenicity (885.4150) Accession No. 092441 a

Freshwater fish toxicity/ pathogenicity (885.4200) Accession No. 127354 a

Fr eshwater invertebrate toxicity/ pathogenicity (885.4240) Accession No. 127354; MRID No. 96533 a

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Product s with th is active ingredient are not intended for direct application into estuarine or marine environments and are not expected to enter these environments in significant concentrations

. b

Nontarget plant testing (885.4300) Waived

– Scientific literature indicates no known detrimental effects

of Bacillus thuringiensis on plant life. (U.S. EPA, 1998a)

Nontarget insect testing (885.4340) Accession Nos. 090189 and 127355 a

Honey bee testing (885.4380) Accession No. 127355 a

a There are no review s in the EPA’s files for these Accession Nos. or MRID Nos. Therefore, these data packages will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional nontarge t organism information for this

Btk st rain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.

b See 40 CFR § 158.2150(d) and test n ote #6 in 40 CFR § 158.2150(e).Bacillus thuringiensis EPA

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### 66 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain ABTS

- 351 (PC Code 006522) Representative Product: Dipel Biological Insecticide Technical Powder (EPA Reg. No. 73049

- 12)

Avian oral toxicity (885.4050) MRID Nos. 414434

- 03, 414434

- 04, 416539

- 05, 416539

- 06, 416570

- 07, and 416570

- 08 (Some Data Bridged from Btk strain NB

- 75: U.S. EPA, 1994e, 1994g, 1996d, and 1998a)

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

Freshwater fish toxicity/pathogenicity (885.4200) MRID Nos. 414434

- 05, 414434

- 06, 416539

- 07, and 416570

- 09 (Some Data Bridged from Btk strain NB

- 75: U.S. EPA, 1994e, 1994g, 1996d, and 1998a)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID Nos. 414434

- 07, 416539

- 08, 416570

- 10, and 4352 2 9

- 01 (Some Data Bridged from Btk strain NB

- 75: U.S. EPA, 1994e, 1994g, 1996d, and 1998a) b

Estuarine and marine fish/invertebrate testing (885.4280) MRID Nos. 414434

- 08, 415408

- 01, and 415408

- 02 (U.S. EPA, 1994e and 1998a)

Nontarget plant testing (885.4300) Waived

– Scientific literature indicates no known detrimental effects

of Bacillus thuringiensis on plant life. (U.S. EPA, 1994e and 1998a)

Nontarget insect testing (885.4340) MRID Nos. 414434

- 09, 414434

- 10, 414434

- 11, 416539

- 09, 416539

- 10, 416539

- 11, 416570

- 11, 416570

- 12, and 416570

- 13 (Some Data Bridged from Btk strain NB

- 75: U.S. EPA, 1994e, 1994g, 1996d, and 1998a)

Honey bee testing (885.4380) MRID Nos. 414434

- 12, 416539

- 12, and 416570

- 14 (Some Data Bridged from Btk strain NB

- 75: U.S. EPA, 1994e, 1994g, and 1996d) c

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b There are no review s in the EPA’s files for MRID No. 435229

- 01 (freshwater invertebrate toxicity/ pathogenicity). Therefore, this data package will be reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional freshwater invertebrate toxicity/pathogenicity information for this Btk strain from the registrant. For now, the EPA considers this to be a data gap, subject to change in the FWP.

c The EPA classified all three honey bee studies as invalid. Therefore, the EPA considers this to be a data gap.Bacillus thuringiensis EPA

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### 67 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies kurstaki strain VBTS

- 2546 (PC Code 006699) Representative Product: VBC

- 60225 Biological Insecticide Technical Grade Active Ingredient Powder (EPA Reg. No.

73049

- 479)

Avian oral toxicity (885.4050) MRID No. 485592

- 18 (U.S. EPA, 2012 a )

Wild mammal toxicity/pathogenicity (885.4150) MRID No. 485592

- 37 (U.S. EPA, 2012 a )

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 485592

- 19 (U.S. EPA, 2012 a )

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 485592

- 20 (U.S. EPA, 2012 a )

Estuarine and marine fish/invertebrate testing (885.4280) MRID No. 485592

- 38 (U.S. EPA, 2012 a )

Nontarget plant testing (885.4300) MRID No. 485592

- 39 (U.S. EPA, 2012 a )

Nontarget insect testing (885.4340) MRID Nos. 485592

- 21, 485592

- 22, and 485592

- 23 (U.S. EPA, 2012 a )

Honey bee testing (885.4380) MRID No. 485592

- 24 (U.S. EPA, 2012 a )

Bacillus thuringiensis subspecies aizawai

Active Ingredient: B. thuringiensis subspecies aizawai strain GC

- 91 (PC Code 006426) Representative Product: Technical CGA

- 237218 (EPA Reg. No. 70051

- 48)

Avian oral toxicity (885.4050) MRID Nos. 419943

- 13 and 419943

- 14 (U.S. EPA, 1992e and 1998a)

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

(U.S. EPA, 1992e)

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 419943

- 15 (U.S. EPA, 1992e and 1998a)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID Nos. 4199 43

- 16, 432066

- 01, and 443582

- 01 (U.S. EPA, 1992e, 1994d, 1998a, and 1999 a )

Estuarine and marine fish/invertebrate testing (885.4280) MRID Nos. 4199 43

- 17 and 419943

- 18 (U.S. EPA, 1992e and 1998a)

Nontarget plant testing (885.4300) Waived

– Scientific literatur e indicates no known detrimental effects

of Bacillus thuringiensis on plant life. (U.S. EPA, 1998a)

Nontarget insect testing (885.4340) MRID Nos. 419943

- 19, 419943

- 20, and 419943

- 21 (U.S. EPA, 1992e and 1998a)

Honey bee testing (885.4380) MRID Nos. 419943

- 22, 434030

- 01, and 434030

- 02; Peters (1995) and Peters (1996) (U.S. EPA, 1992e, 1995b, and 1997c)

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).Bacillus thuringiensis EPA

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### 68 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies aizawai strain NB200 (PC Code 006494) Representative Product: Florbac Slurry Biological Larvicide (EPA Reg. No. 73049

- 68)

Avian oral toxicity (885.4050) MRID Nos. 453756

- 09 and 453756

- 10 (U.S. EPA, 2003)

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies will be adequate and appropriate for wild mammal hazard assessment that will be completed should end

- use pesticide products be proposed for registration. a

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 453756

- 11 (U.S. EPA, 2003)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 453756

- 12 (U.S. EPA, 2003)

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Only product w ith this active ingredient (i.e., a manufacturing

- use pesticide product) is not intended for direct application into estuarine or marine environments. b

Nontarget plant testing (885.4300) Not required

– Bacillus thuringiensis is not taxonomically related to a known plant pathogen. c

Nontarget insect testing (885.4340) MRID Nos. 453756

- 13, 453756

- 14, and 453756

- 15 (U.S. EPA, 2003)

Honey bee testing (885.4380) MRID No. 453756

- 16 (U.S. EPA, 2003)

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b See 40 CFR § 158.2150(d) and test note #6 in 40 CFR § 158.2150(e).

c See 40 CFR § 158.2150(d) and test n ote #7 in 40 CFR § 158.2150(e).Bacillus thuringiensis EPA

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### 69 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Active Ingredient: B. thuringiensis subspecies aizawai strain ABTS

- 1857 (PC Code 006523) Representative Product: Xentari Biological Insecticide Technical Powder (EPA Reg. No. 73049

- 24)

Avian oral toxicity (885.4050) MRID Nos. 419748

- 04 and 419748

- 05 (U.S. EPA, 1992c and 1 998a)

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

(U.S. EPA, 1992c)

Freshwater fish toxicity/pathogenicity (885.4200) MRID Nos. 419748

- 03, 429099

- 01, and 438288

- 01 (U.S. EPA, 1992c, 1994a, and 1997b)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID Nos. 419748

- 02, 428191

- 01, and 437576

- 01 (U.S. EPA, 1992c, 1994b, 1997b, and 1998a)

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Products with this active ingredient are not intended for direct application into estuarine or marine environments. b

(U.S. EPA, 1992c).

Nontarget plant testing (885.4300) Waived

– Scientific literature indicates no known detrimental effects

of Bacillus thuringiensis on plant life. (U.S. EPA, 1998a)

Nontarget insect testing (885.4340) MRID Nos. 419748

- 06, 419748

- 07, 419748

- 09, 422453

- 01, 422863

- 01, 422955

- 01, 423289

- 01, 423289

- 02, and 429421

- 01 (U.S. EPA, 1992c, 1994c, and 1998a)

Honey bee testing (885.4380) MRID No. 419748

- 08 (U.S. EPA, 1992c and 1998a)

Simulated or actual field tests (insect pollinators) (850.3040) MRID No. 443761

- 01 (U.S. EPA, 1998f)

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b See 40 CFR § 158.2150(d) and test note #6 in 40 CFR § 158.2150(e).Bacillus thuringiensis EPA

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### 70 D ATA R EQUIREMENT (G UIDELINE ) H OW I T H AS B EEN A DDRESSED

Bacillus thuringiensis subspecies tenebrionis

Active Ingredient: B. thuringiensis subspecies tenebrionis strain NB

- 176 (PC Code 006524) Representative Product: Novodor Technical (EPA Reg. No. 73049

- 47)

Avian oral toxicity (885.4050) MRID Nos. 414127

- 08 and 414127

- 09 ( Bridged from Btt strain NB125: U.S. EPA, 1990b and 1992a)

Wild mammal toxicity/pathogenicity (885.4150) Not required

– 40 CFR § 158.2140 (toxicology) studies are adequate and appropriate for wild mammal hazard assessment. a

(U.S. EPA, 1990b)

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 414400

- 04 ( Bridg ed from Btt strain NB125: U.S. EPA, 1990b and 1992a)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 414400

- 05 ( Bridged from Btt strain NB125: U.S. EPA, 1990b and 1992a)

Estuarine and marine fish/invertebrate testing (885.4280) Not required

– Products with this active ingredient are not intended for direct application into estuarine or marine environments and are not expected to enter these environments in significant concentrations

. b

(U.S. EPA, 1990b)

Nontarget plant testing (885 .4300) Waived

– This active ingredient does not resemble any known plant pathogens. (U.S. EPA, 1990b)

Nontarget insect testing (885.4340) MRID Nos. 414127

- 11, 414127

- 12, and 414127

- 13 ( Bridged from Btt strain NB125: U.S. EPA, 1990b and 1992a)

Honey bee testing (885.4380) MRID Nos. 414127

- 14 and 414127

- 15 ( Bridged from Btt strain NB125: U.S. EPA, 1990b and 1992a)

a See 40 CFR § 158.2150(d) and test note #4 in 40 CFR § 158.2150(e).

b See 40 CFR § 158.2150(d) and test n ote #6 in 40 CFR § 158.2150(e).

Bacillus thuringiensis subspecies galleriae

Active Ingredient: B. thuringiensis subspecies galleriae strain SDS

- 502 (PC Code 006399) Representative Product: Phyllom SDS

- 502 MP (EPA Reg. No. 88347

- 1)

Avian oral toxicity (885.4050) MRID Nos. 485532

- 19 and 489401

- 07; Rose (2013b) (U.S. EPA, 2013b and 2013d )

Wild mammal toxicity/pathogenicity (885.4150) MRID Nos. 485532

- 08, 485532

- 11, 485532

- 21, and 489401

- 08 (U.S. EPA, 2013b and 2013d )

Freshwater fish toxicity/ pathogenicity (885.4200) MRID No. 485532

- 22 (U.S. EPA, 2013b and 2013d )

Fr eshwater invertebrate toxicity/ pathogenicity (885.4240) MRID Nos. 485532

- 04, 485532

- 23, and 489401

- 07; Rose (2013b) (U.S. EPA, 2013b and 2013d )

Estuarine and marine fish/invertebrate testing (885.4280) MRID No. 485532

- 24 (U.S. EPA, 2013b and 2013d )

Nontarget plant testing (885.4300) MRID No. 485532

- 25 (U.S. EPA, 2013b and 2013d )

Nontarget insect testing (885.4340) MRID Nos. 485532

- 04, 485532

- 26, 485532

- 27, 485532

- 28, 485532

- 29, 487168

- 03, and 489401

- 07; Rose (2013b) (U.S. EPA, 2013b and 2013d )

Honey bee testing (885.4380) MRID No. 48553 2

- 30 (U.S. EPA, 2013b and 2013d )Bacillus thuringiensis EPA

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### 71 APPENDIX VII

– Summary of Incidents Involving B

. thuringiensis

Provided in the following table is a summary, arrayed by subspecies, of incidents compiled in the EPA ’s Incident Data System database between 1992 and 201 4 and the EPA’s Ecological Incident Information System between 1966 and 2014 . Where information was av ailable, discussion regarding the nature of the incident is given.

T OTAL
N UMBER OF
I NCIDENTS : N O

.

H UMAN N O

. D OMESTIC

A NIMAL NO

. NONTARGET

ORGANISM D ISCUSSION

Bacillus thuringiensis subspecies israelensis

13 4=H

- D 3=D

- C

6=D

- D Human Cases
Allergic reaction was reported among farmworkers who were exposed to Bacillus thuringiensis ; they exhibited a significant increase in positive skin tests to spore extracts.

Bacillus thuringiensis subspecies kurstaki

49 3=H

- B

1=H

- C

30=H

- D 2=D

- A

1=D

- C

4=D

- D

2=DCDE 6 Human Cases
A number of the cases involved individuals being sprayed accidentally. In one incident of aerial application, a female experienced an allergic reaction (burning, itching eyes, red skin rash). In another incident, a female was sprayed while horseback riding ; she experienced eye and lymph node problems, skin irritation, and headache. A man reported being sprayed in the face by a helicopter; he later fell from the roof. Sunbathers who were sprayed by a helicopter developed laryngitis. In a case where the Fores t Service sprayed an 800

- acre housing area, residents developed watery eyes and breathing problems.

Other cases involved incidental exposure after the pesticide was applied. In an incident where a house was treated for two days, the resident had an alle rgic reaction, most likely due to an inert ingredient. Symptoms included difficulty breathing and plugged ears. A 78

- year

- old man developed full

- body edema one hour after pecan trees were sprayed; a rash appeared five days

later. Another case involved fiv e passengers and two cargo handlers of an airplane who became ill with nausea and dizziness; treated bananas were in the cargo. Another case involved a man who ate tomatoes sprayed with Bacillus thuringiensis , who vomited 18 hours later, collapsed, seized, and went into a coma.

Several cases involved suicide attempts.

Lastly, one case involved a woman who was hospitalized, underwent surgery, and will require organ transplantation as medically neces sary. This serious report listed 107 other pesticides (e.g., conventional pesticides) or chemicals along with Bacillus thuringiensis

.

Domestic Animal Cases
In a case of aerial spraying, a Great Dane developed diarrhea for two days.

Nontarget Org anism Cases

Six reports involved orchard, almond, tobacco, or grape crops.

Bacillus thuringiensis subspecies aizawai

4 2=H

- B

2=H

- D Human Cases
California farmworkers experienced allergic reaction after exposure to Bacillus thuringiensis ; they showed significant positive skin tests to spore extracts.

One case involved a woman who was hospitalized, underwent surgery, and will require organ transplantation as medically necessary. This serious report listed 10 7 other pesticides (e.g., conventional pesticides) or chemicals along with Bacillus thuringiensis

.

Bacillus thuringiensis subspecies tenebrionis

1 1= H

- D

**See 40 CFR §159.184(c)(5) for an explanation of the severity category designations listed above.Bacillus thuringiensis EPA

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### 72 APPENDIX VI I I

– B ibliography

A. Studies Supporting Registration Review of Bacillus thuringiensis

MRID No. Study Description

96527 Lankas GR, Hogan GK, Fasanella J. 1981. A Single Oral Dose

Toxicity/Infectivity Study of Thuricide 32 B in Rats: Project No. 80

- 2523; Report No. T

- 1

- 2/23/81. (Unpublished study received Mar 8, 1982 under

11273

- 2; prepared by Biodynamics, Inc., submitted by Sandoz, Inc. Crop Protection, San Diego, Calif.; CDL:246967

- A)

96529 Ben

- Dyke R, Hogan GK, Hoffman CA. 1981. An Acute Inhalation Toxicity and

Infectivity Study of Thuricide 32

- B in the Rat: Project No. 80

- 7472; Report No.

T

- 3

- 3/16/81. (Unpu blished study received Mar 8, 1982 under 11273

- 2; prepared by Bio dy namics, I nc., submitted by Sandoz, Inc. Crop Protection, San Diego, Calif.; CDL:246967

- C)

96533 World Health Organization. 1980. Data Sheet on the Biological Control

Agent~ Bacillus thuringiensis ~ Serotype H

- 14 (de Barjac 1978): WHO/VBC/79.750. (Unpublished study; CDL:246969

- B)

109492 Lankas G, McCormack R, Hogan G. 1981

. Single Oral Dose

Toxicity/Infectivity Study of Thuricide 32B in the Rat: Project No. 80

- 2523; Report No . T

- 1

- 2/23/81. Final rept. (Un published study received Aug 9, 1982
under 11273

- 2; p repared in cooperation with Bio dynamics, Inc., submitted by Sandoz, I nc. Crop Protection, San Diego, CA; CDL:248007

- E)

109494 Dyke R, McCormack R, Hogan G. 1981. Acute Inhalation Toxicity/In fectivity

Study of Thuricide 32B in the Rat: Project No. 80

- 7472; Report No. T

- 3

- 3/16/81. Final rept. (Unpublished study received Aug 9, 1982 under 11273

- 2;

p repared in cooperation with Bio dynamics, Inc. and Gibraltar Biological Laboratories, Inc., submitted by Sandoz, Inc. Crop Protection, San Diego, CA;

CDL:248007

- G)

142733 Stoll R. 1984. Acute Oral LD50 Tox icity/Infectivity Study o f Tek nar in the Rat:

Project No. T

- 1866. Unpublished study prepared by Sandoz, Inc. 25 p ages

.

142735 Terrill J. 1983. An Acute Inhalation Toxicity/Infectivity Study in the Rat on

Teknar

- 4 Hour Exposure: Final Report: Project No. 83

- 7652. Un published

st udy prepared by Bio dynamics, Inc. 40 p ages

.Bacillus thuringiensis EPA

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### 73 MRID No. Study Description

404677

- 01 Beavers J, Jaber M. 1986. Bacillus Thuringiensi s (LX186

- 02): An Avian

Single

- dose Toxicity and Pathogenicity Study in the Mallard: Project No. 190

- 119. Unpublished study prepared by Wildlife International Ltd. 20 pages.

404677

- 05 Jones G. 1987. Bacillus thuringiensis (LX186

- 05): A Vegetative Vigor Study

with Nine Species of Plants: SAR Test No. SAR

- 86

- 01

- 17

- CS

- MULTI. Unpublished study prepared by Southern Agricultural Research, Inc. 13 pages.

404677

- 07 Mayo J. 1987. Toxicity of LX186

- 05 to the Freshwater Green Algae

Selenastrum capricornutum : Study No. 10934

- 1286

- 6107

- 550. Unpublished study prepared by Springborn Bionomics, Inc. 26 pages.

404677

- 09 Hoxter K, Dingledine J, Jaber M. 1987. Bacillus thuringiensis (LX186

- 04): An

Acute Contact Toxicity Study with the Par asitic Hymenoptera ( Brachymeria
intermedia ): Project No. 190

- 129. Unpublished study prepared by Wildlife International Ltd. 14 pages.

404677

- 11 Hoxter K, Dingledine J, Jaber M. 1987. Bacillus thuringiensis (LX186

- 04): An

Acute Contact Toxicity Study with Ladybird Beetles: Project No. 190

- 130. Unpublished study prepared by Wildlife International Ltd. 15 pages.

404677

- 13 Hinken C, Jaber M. 1987. Bacillus thuringiensis (LX186

- 04): An Acute

Contact Toxicity Study with the Green Lacewing Larvae: Project No. 190

- 132. Unpublished study prepared by Wildlife International Ltd. 14 pages.

404677

- 14 Kirkland R. 1988. Toxicity of EG2001, EG2101, EG2157, EG2348, EG2349,

EG2397, and EG2424 to the Honey Bee, Apis mellifera L.: Laboratory Project

ID: LR87

- 42. Unpublished study prepared by Pan

- Agricultural Laboratories, Inc. 34 pages.

405084

- 02 Kirkland R. 1988. Toxicity of EG2001, EG2101, EG2157, EG2348, EG2349,

EG2371, and EG2424 to Chrysopa carnea : (Chrysopidae: Neuropte ra): Laboratory Project ID: LR87

- 43. Unpublished study prepared by Pan

Agricultural Laboratories, Inc. 26 pages.

405084

- 03 Hoxter K, Jaber M. 1988. Bacillus thuringiensis Strains EG2397; EG2349;

EG2001; EG2424; EG2371: An Acute Contact Toxicity Study wit h the Parasitic Hymenoptera: ( Brachymeria intermedia ): Wildlife International Ltd. Project

No.: 235

- 119A. Unpublished study prepared by Wildlife International Ltd. 14

pages.Bacillus thuringiensis EPA

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### 74 MRID No. Study Description

405084

- 04 Hoxter K, Jaber M. 1988. Bacillus thuringiensis Strains EG2424, EG2371

,

EG2397, EG2165 and EG239: An Acute Contact Toxicity Study with Ladybird Beetles: Wildlife International Ltd. Project No.: 235

- 118. Unpublished study prepared by Wildlife International Ltd. 14 pages.

408988

- 01 Currier T, Gawron

- Burke C, Silver R. 1988. Product Chemistry and

Manufacturing Process for Condor OF Insecticide: Ecogen Report No. 0022. Unpublished study prepared by Ecogen, Inc. 73 pages.

408988

- 04 David R. 1988. Acute Pulmonary Toxicity/Pathogenicity Study of Condor OF

Insecticide in Rats: MBA Study No. G

- 7095.225. Unpublished study prepared by Microbiological Associates, Inc. 18 pages.

408988

- 05 David R. 1988. Acute Intravenous Toxicity/Pathogenicity Study of Condor OF

Insecticide in Rats: MBA Study No. G

- 7095.224. Unpublished study prepa red by Ecogen, Inc. 18 pages.

408988

- 07 Beavers J, Clauss B, Jaber M. 1988. Bacillus thuringiensis Strain EG2348: An

Avian Acute Oral LD 50 

### Pathogenicity Study in the Bobwhite: Wildlife International Ltd. Project No.: 235

- 120. Unpublished study prepared b y Wildlife International Ltd. 19 pages.

408988

- 08 Swigert J. 1988. A 30

- day Static Renewal Toxicity and Pathogenicity

Evaluation on the Effects of Bacillus thuringiensis Strain EG2348 to Rainbow Trout ( Salmo gairdneri ): Final Report #37054. Unpublished s tudy prepared by Analytical Bio

- Chemistry Laboratories, Inc. 220 pages.

408988

- 09 Forbis A. 1988. A 21

- day Static Renewal Toxicity and Pathogenicity Evaluation

on the Effects of Bacillus thuringiensis Strain EG2348 to Daphnia magna : Final Report #37055. Unpublished study prepared by Analytical Bio

- Chemistry Laboratories, Inc. 159 pages.

408988

- 10 Canez V. 1988. Nontarget Phytotoxicity Test: Vegetative Vigor: Tier 2: Condor

OF: Laboratory Project ID: LR88

- 52. Unpublished study prepared by Pan

Agricultural Labs, Inc. 132 pages.

408988

- 11 Canez V. 1988. Nontarget Phytotoxicity Test Seed Germination/Seedling

Emergence: Tier 1: Laboratory Project ID: LR88

- 53. Unpublished study prepared by Pan

- Agricultural Labs, Inc. 141 pages.

409509

- 01 Cur

rier T, Gawron

- Burke C, Silver R. 1988. Product Chemistry and Manufacturing Process for Cutlass Wettable Powder Insecticide: Ecogen Report No. 0026. Unpublished study prepared by Ecogen, Inc. 80 pages.Bacillus thuringiensis EPA

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### 75 MRID No. Study Description

411503

- 01 Sherwood R. 1989. Acute Intraperitoneal Toxicity/Pathogenicity Testing of

Condor Technical Powder, a Microbial Pesticide: IITRI Project No. L08239. Unpublished study prepared by IIT Research Institute. 18 p ages

.

411503

- 02 Sherwood R. 1989. Acute Intraperitoneal Toxicity/Pathogenicity Testing o f

Cutlass Technical Powder, a Microbial Pesticide: IITRI Project No. L08239. Unpublished study prepared by IIT Research Institute. 20 pages.

411503

- 04 David R. 1989. Acute Oral Toxicity/Pathogenicity Study of Cutlass of

Insecticide in Rats: MBA Study No. G

- 7155.222. Unpublished study prepared by Microbiological Associates, Inc. 20 pages.

411503

- 05 David R. 1989. Supplement to Acute Pulmonary Toxicity/Pathogenicity Study

of Condor OF Insecticide in Rats: MBA Study No. G

- 7095.225. Unpublished study prepar ed by Microbiological Associates, Inc. 5 pages.

412220

- 01 Couch T. 1989. Product Chemistry: BMP 144 (2X), (3X). Unpublished study

prepared by Becker Microbial Products, Inc. 22 pages.

412220

- 02 Robbins G. 1988. Acute Oral Toxicity Study in Rats: Bacill us thuringiensis var.

israelensis (BMP 144): Study No. A1917. Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc. 20 pages.

412220

- 04 Robbins G. 1989. Acute Inhalation Toxicity Study in Rats: Bacillus

thuringiensis var. israelensis (BMP 14 4): Study No. C1917. Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc. 32 pages.

412703

- 01 Robbins G. 1989. Intraperitoneal Safety Test in Mice: BMP 144 (2X) (3X):

Study No. S2032. Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc. 18 pages.

414127

- 01 Jensen B, Rugh S, Overholt J. 1990. Product Analysis Data: Product Identity

and Manufacturing Information in Support of Registration of Novodor Technical. Unpublished study prepared by Novo

- Nordisk A/S in cooperation with Novo Laboratories, Inc. 120 pages.

414127

- 02 Jensen B, Rugh S, Overholt J. 1990. Product Analysis Data: Sample Analysis in

Support of Registration of Novodor Technical. Unpublished study prepared by

Novo

- Nordisk A/S in cooperation with Novo Laborato ries, Inc. 33 pages.

414127

- 03 Jensen B, Rugh S, Overholt J. 1990. Product Chemistry Data: Physical and

Chemical Properties in Support of Registration of Novodor Technical. Unpublished study prepared by Novo

- Nordisk A/S in cooperation with Novo Laboratories, Inc. 11 pages.Bacillus thuringiensis EPA

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### 76 MRID No. Study Description

414127

- 08 Beavers J. 1989. SP

- 408 Technical Powder: An Avian Oral Pathogenicity and

Toxicity Study in the Bobwhite in Support of Registration of Novodor Technical: Lab Project I.D. 254

- 102. Unpublished study prepared by Wildl ife International Ltd. 26 pages.

414127

- 09 Beavers J. 1989. SP

- 408 Technical Powder: An Avian Oral Pathogenicity and

Toxicity Study in the Mallard in Support of Registration of Novodor Technical: Lab Project I.D.: 254

- 103. Unpublished study prepared by Wildlife International Ltd. 26 pages.

414127

- 11 Hoxter K. 1989. SP 408 Technical Powder: A Dietary Pathogenicity and

Toxicity Study with the Green Lacewing Larvae in Support of Registration of Novodor Technical: Lab Project I.D.: 254

- 105A. Unpublished st udy prepared by Wildlife International Ltd. 22 pages.

414127

- 12 Hoxter K. 1989. SP 408 Technical Powder: A Dietary Pathogenicity and

Toxicity Study with the Ladybird Beetles in Support of Registration of Novodor Technical: Lab Project I.D.: 254

- 106. Unpu blished study prepared by Wildlife International Ltd. 24 pages.

414127

- 13 Hoxter K. 1989. SP 408 Technical Powder: A Dietary Pathogenicity and

Toxicity Study with the Parasitic Hymenopteran Brachymeria intermedia in Support of Registration of Novodor Tec hnical: Lab Project Number: 254

- 107. Unpublished study prepared by Wildlife International Ltd. 26 pages.

414127

- 14 Hoxter K. 1988. SP 408 Technical Powder: An Acute Contact Toxicity Study

with the Honey Bee in Support of Registration of Novodor Technical : Lab Project I.D.: 254

- 101. Unpublished study prepared by Wildlife International Ltd. 17 pages.

414127

- 15 Hoxter K. 1990. SP 408 Technical Powder: A Dietary Pathogenicity and

Toxicity Study with the Honey Bee in Support of Registration of Novodor Technical: Lab Project I.D.: 254

- 119. Unpublished study prepared by Wildlife International Ltd. 22 pages.

414390

- 01 Smith R, Cooper R. 1990. Vectobac Technical Powder ... Product Chemistry

Based on Bacillus thuringiensis , subspecies israelensis Strain AM 65

- 52 (ATCC

- SD

- 1276) as the Active Ingredient: Lab Project Nos. Abbott Lab

- VTP

02: 910

- 8906. Unpublished study prepared by Abbott Laboratories. 174 pages.

414390

- 02 Coddens M. 1990. Vectobac Technical Powder ... Product Chemistry Based on

Bacillus thuri ngiensis , subspecies israelensis , Strain AM 65

- 52 (ATCC

- SD

1276) as the Active Ingredient: Lab Project Nos. Abbott Lab

- VTP

- 03; 910

- 8902. Unpublished study prepared by Abbott Laboratories. 186 pages.Bacillus thuringiensis EPA

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### 77 MRID No. Study Description

414390

- 03 David R. 1990. Acute Oral Toxicity/Pathogenic ity Study of Vectobac Technical

Material ( Bacillus thuringiensis var. israelensis ) in Rats: Final Report: Lab Study No. G

- 7264.222. Unpublished study prepared by Microbiological Associates, Inc. 61 pages.

414390

- 04 David R. 1990. Acute Intravenous Toxici ty/Pathogenicity Study of Vectobac

Technical Material ( Bacillus thuringiensis var. israelensis ) in Rats: Final Report: Lab Study No. G

- 7264.224. Unpublished study prepared by Microbiological Associates, Inc. 58 pages.

414390

- 05 Lattin A, Grimes J, Hoxter K. 1990. Vectobac Technical Material ( Bacillus

thuringiensis var. israelensis ): An Avian Oral Toxicity and Pathogenicity Study in the Mallard: Project No. 161

- 115. Unpublished study prepared by Wildlife International Ltd. 24 pages.

414390

- 06 Lattin A, H oxter K, Smith G. 1990. Vectobac Technical Material ( Bacillus

thuringiensis var. israelensis ): An Avian Oral Toxicity and Pathogenicity Study in the Bobwhite: Project No. 161

- 114. Unpublished study prepared by Wildlife International Ltd. 29 pages.

414390

- 07 Christensen K. 1990. Vectobac Technical Material ( Bacillus thuringiensis var.

israelensis )

— Infectivity and Pathogenicity to Bluegill Sunfish ( Lepomis macrochirus) During a 30

- day Static Renewal Test: Final Report: SLI Report

90

- 2

- 3228; SLI Study 2439.0 889.6104.158. Unpublished study prepared by Springborn Laboratories, Inc. 55 pages.

414390

- 08 Christensen K. 1990. Vectobac Technical Material ( Bacillus thuringiensis var.

israelensis )

— Infectivity and Pathogenicity to Rainbow Trout ( Oncorhynchus mykiss ) During a 32

- day Static Renewal Test: Final Report: SLI Report 90

- 2

- 3242; SLI Study 2439.0889.103.157. Unpublished study prepared by Springborn Laboratories, Inc. 55 pages.

414390

- 09 Ward T, Boeri R. 1990. Chronic Toxicity of Vectobac Technical Material

( Bacillus thuringiensis var. israelensis ) to the Daphnid, Daphnia magna : Lab Study No. 9022

- A; Method No. IPM

- 2. Unpublished study prepared by EnviroSystems Div., Resource Analysts, Inc. 46 pages.

414390

- 10 Chandler G. 1990. Chronic Toxicity of Bacillus thuringiensis var. israelensis

Technical Material to the Benthic Harpacticoid Copepod, Amphiascus minutus under Static Conditions: Report No. USC

- SPH

- 2

- 90: Abbott Lab

- VTP

- 12. Unpublished study prepared by Univ. of South Carolina, School of Public
Health an d the Belle W. Baruch Institute for Marine Biology and Coastal Research. 43 pages.Bacillus thuringiensis EPA

- HQ

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- 2011

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### 78 MRID No. Study Description

414390

- 11 Atkins E. 1990. Bee Adult Toxicity Feeding Test/Chronic Evaluating the

Comparative Chronic Stomach Poison Toxicity of Bacillus thuringiensis subsp.
israelensis B ti) to Honey Bee Worker Adults, Apis mellifera L: Report No. Bti
BATFT/C 90

- 833

- F/C; Abbott Lab

- VTP

- 13. Unpublished study prepared by Univ. of California, Dept. of Entomology. 27 pages.

414400

- 01 Bak J. 1989. SP 408 Acute Oral Toxicity/Pathogenicity Stud y in Rats: Novodor

Technical: Lab Project Number: 12488. Unpublished study prepared by Novo

Nordisk A/S, Enzyme Toxicology Laboratory. 39 pages.

414400

- 02 Stavnsbjerg M. 1989. SP 408 Acute Pulmonary Toxicity/Pathogenicity Study in

Rats: Novodor Technical : Lab Project No: 13388. Unpublished study prepared by Novo

- Nordisk A/S, Enzyme Toxicology Laboratory. 39 pages.

414400

- 03 De Boer A. 1989. SP 408 Acute Intravenous Toxicity/Pathogenicity Study in

Rats: Novodor Technical: Lab Project Number: 13588. Unpub lished study prepared by Novo

- Nordisk A/S, Enzyme Toxicology Laboratory. 47 pages.

414400

- 04 Bogers M. 1988. 28

- Day Toxicity Study of the Microbial Pest Control Agent

SP408 in Rainbow Trout: Novodor Technical: Lab Project Number:
RCC/NOTOX/1237/FPB/0. Unpublished study prepared by RCC Notox B. V. 29 pages.

414400

- 05 Bogers M. 1988. 21

- Day Toxicity Study of the Microbial Pest Control Agent SP

408 in Daphnia magna : Novodor Technical: Lab Project Number: RCC/NOTOX/1237/DR7/0. Unpublished study prepared b y RCC Notox B. V. 22 p ages

.

414415

- 03 Smith R, Regan K. 1990. Bioch emical and Morphological Charac teristics of

Bacillus thuringiensis subsp. israelensis Strain SA3A with a Discussion of Strain History Included: Final Report: Final Report No.: 90/02/02A. Unpublished study prepared by Sandoz Crop Protection Corp. 63 p ages

.

414415

- 06 Schindler J. 1990. Single Intraperitoneal Administration of Bacillus

thur ingiensis Strain SA

- 3A in Mice: SRI Project Number LSC

- 8491: SRI Study

No. 8491

- M04

- 89. Unpublished study prepared by SRI International. 16 p ages

.

414415

- 09 Chen C, Macuga R. 1990. Plasmid Profile of Bacillus thuringien sis subsp.

i sraelensis , Strain SA3A : Final Report: Final Report No. 90/02/03D. Unpublished study prepared by Sandoz Crop Protec tion Corp. 40 p ages

.

414415

- 12 Chen C, Macuga R. 1990. Flagella Antigen Serotyping of Bacillus thuringiensis

subsp. i sraelensis , Strain SA3A: Final Report: Final Report No. 90/02/12D. Unpublished study prepared by Sandoz Crop Protection Corp. 23 p ages

.Bacillus thuringiensis EPA

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### 79 MRID No. Study Description

414415

- 15 Smith R, Regan K. 1989. Antibiotic Sensitivity Patterns for Bacillus

thuringiensis subsp. i

sraelensis Strain SA3A: Final Report: Final Report No.
89/12/1 2E. Unpublished study prepared by Sandoz Crop Protection Corp. 38

p ages

.

414415

- 16 Cerf D. 1990

. Susceptibility of F our Orders of Insects (Lepidop tera, Diptera,

Coleoptera, and Orthoptera) to Technical Grade Active Ingredients (TGAI's), Manufacturing

. . . and tenebrionis in SA10): Final Report: Final Report No. 90/03/12. Unpublished study prepared by Sandoz Crop Protection Corp. 40

p ages

.

414415

- 19 Chen C, Macuga R. 1990. Description of Endotoxin Proteins Produced by

Bacillus thuringiensis subsp. israelensis , Strain SA3A: Final Report: Final Report No. 90/02/21F. Unpublished study prepared by Sandoz Crop Protection Corp. 27 p ages

.

414415

- 22 Chen C, Macuga R, Cerf D. 1990. Insecticidal Toxins Produced by Bacillus

thuringiensis subsp. i

sraelensis , S train SA3A. I. Effect of Autoclaving: Final Report: Final Report No. 90/01/31D. Unpublished study prepared by Sandoz Crop Protection Corp. 19 p ages

.

414415

- 25 Chen C, Cerf D, Sjolander A. 1990. Insecticidal Toxins Produced by Bacillus

thuringiensis subsp. i

sraelensis , Strain SA3A. II. Concentration of beta

Exotoxin: Final Report: Final Report No. 90/02/07D. Unpublished study prepared by Sandoz Crop Protection Corp. 36 p ages

.

414415

- 31 Fowler J. 1989. Physical Properties of SA

- 3A Technical Grade Ac tive

Ingredient (TGAI): Final Report: Final Report No. 89/11/ 30C. Unpublished study prepared by Sandoz Crop Protection Corp. 32 p ages

.

41441 6

- 01 Smith R, Regan K. 1990. Biochemical and Morphological Characteristics of

Bacillus thuringiensis subsp. kurst aki Strain SA12 with a Discussion of Strain History Included: Lab Project Number 90/02/02F. Unpublished study prepared by Sandoz Crop Protection Corp. 63 pages.

414416

- 04 Smith R, Regan K. 1990. Biochemical and Morphological Characteristics of

Bacillus Thuringiensis subsp. kurstaki Strain SA11001C98

- 1

- 1 with a Discussion of Strain History Included: Final Report: Project Number: 90/02/02E. Unpublished study prepared by Sandoz Crop Protection Corp. 63

pages.Bacillus thuringiensis EPA

- HQ

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### 80 MRID No. Study Description

414416

- 06 Chen C, Macuga R, Cerf D. 1990. Inse cticidal Toxins Produced by Bacillus

thuringiensis subsp. kurstaki Strain SA11001C98

- 1

- 1. I. Effect of Autoclaving: Final Report: Lab Project Number: 90/01/31A. Unpublished study prepared by Sandoz Crop Protection Corp. 19 pages.

414416

- 08 Chen C, Macuga R, Cerf D. 1990. Insecticidal Toxins Produced by Bacillus

thuringiensis subsp. kurstaki Strain SA12. I. Effect of Autoclaving: Lab Project Number: 90/01/31B. Unpublished study prepared by Sandoz Crop Protection Corp. 19 pages.

414416

- 10 Sc hindler J. 1990. Single Intraperitoneal Administration of Bacillus

thuringiensis Strain SA

- 12 in Mice: Lab Project Number: 8491

- M07

- 89: LSC

8491. Unpublished study prepared by SRI International. 17 pages.

414416

- 12 Schindler J. 1990. Single Intraperitone al Administration of Bacillus

thuringiensis Strain SA

- 11 in Mice: Lab Project Number: 8491

- M06

- 89: LSC

8491. Unpublished study prepared by SRI International. 15 pages.

414416

- 14 Chen C, Macuga R. 1990. Plasmid Profile of Bacillus thuringiensis subsp.

kur staki Strain SA11001C98

- 1

- 1: Lab Project Number: 90/0203A. Unpublished study prepared by Sandoz Crop Protection Corp. 40 pages.

414416

- 16 Chen C, Macuga R. 1990. Plasmid Profile of Bacillus thuringiensis subsp.

kurstaki Strain SA12: Lab Project Number: 9 0/02/03B. Unpublished study prepared by Sandoz Crop Protection Corp. 40 pages.

414416

- 18 Chen C, Macuga R. 1990. Flagella Antigen Serotyping of Bacillus thuringiensis

subsp. kurstaki Strain SA11001C98

- 1

- 1: Lab Project Number: 90/02/12A. Unpublished study prepared by Sandoz Crop Protection Corp. 23 pages.

414416

- 19 Chen C, Macuga R. 1990. Flagella Antigen Serotyping of Bacillus thuringiensis

subsp. kurstaki Strain SA11001C98

- 1

- 1: Lab Project Number: 90/02/12A. Unpublished study prepared by Sandoz Crop Protection Corp. 23 pages.

414416

- 20 Chen C, Macuga R. 1990. Flagella Antigen Serotyping of Bacillus thuringiensis

subsp. kurstaki Strain SA12: Lab Project Number: 90/02/12B. Unpublish ed study prepared by Sandoz Crop Protection Corp. 23 pages.

414416

- 22 Smith R, Regan K. 1989. Antibiotic Sensitivity Patterns for Bacillus

thuringiensis subsp. kurstaki Strain SA11001C98

- 1

- 1: Lab Project Number: 89/12/12. Unpublished study prepared by Sa ndoz Crop Protection Corp. 28

pages.Bacillus thuringiensis EPA

- HQ

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### 81 MRID No. Study Description

414416

- 24 Smith R, Regan K. 1989. Antibiotic Sensitivity Patterns for Bacillus

thuringiensis subsp. kurstaki Strain SA12: Lab Project Number: 89/12/12F. Unpublished study prepared by Sandoz Crop Protection Corp. 28 p a ges

.

414416

- 27 Chen C, Macuga R. 1990. Description of Endotoxin Proteins Produced by

Bacillus thuringiensis subsp. kurstaki Strain

- 1

- 1: Lab Project Number: 90/02/21. Unpublished study prepared by Sandoz Crop Protection Corp. 30

p ages

.

414416

- 28 Chen C, Macuga R. 1990. Description of Endotoxin Proteins Produced by

Bacillus thuringiensis subsp. kurstaki Strain SA12: Project Number: 900221B. Unpublished study prepared by Sandoz Crop Protection Corp. 30 p ages

.

414416

- 30 Chen C, Cerf D, Sjolander A. 1990 . Insecticidal Toxins Produced by Bacillus

thuringiensis subsp. kurstaki Strain SA11001C98

- 1

- 1. II. Concentrated of Beta

exotoxin: Lab Project Number: 90/02/07A. Unpublished study prepared by Sandoz Crop Protection Corp. 36 pages.

414416

- 33 Chen C, Cerf D, Sjolander A. 1990. Insecticidal Toxins Produced by Bacillus

thuringiensis subsp. kurstaki Strain SA12. II. Concentration of Beta

- exotoxin: Lab Project Number: 90/02/07B. Unpublished study prepared by Sandoz Crop Protection Corp. 36 pages.

414416

- 36 Fowler J. 1989. Physical Properties of SA

- 11 Spray Dried Technical

Concentrate (SDTC): Lab Project Number: 89/11/30M. Unpublished study prepared by Sandoz Crop Protection Corp. 29 pages.

414416

- 41 Fowler J. 1989. Physical Properties of SA

- 12 Technical Gr ade Active

Ingredient: Final Report: Lab Project Number: 89/11/30H. Unpublished study prepared by Sandoz Crop Protection Corp. 32 pages.

414434

- 01 David R. 1990. Acute Oral Toxicity/Pathogenicity Study of Dipel Technical

Material ( Bacillus thuringiensis var. kurstaki ) in Rats: Lab Project Number: G

7239.222. Unpublished study prepared by Microbiological Associates, Inc. 54

pages.

414434

- 02 David R. 1990. Acute Pulmonary Toxicity/Pathogenicity Study of Dipel

Technical Material ( Bacillus thuringiensis var

. kurstaki ) in Rats: Lab Project
Number: G

- 7239.001. Unpublished study prepared by Microbiological Associates, Inc. 66 pages.Bacillus thuringiensis EPA

- HQ

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### 82 MRID No. Study Description

414434

- 03 Lattin A, Hoxter K, Driscoll C. 1990. Dipel Technical Material ( Bacillus

thuringiensis var. kurstaki ): An Avian Oral T oxicity and Pathogenicity Study in the Mallard: Lab Project No: 161

- 113. Unpublished study prepared by Wildlife International Ltd. 28 pages.

414434

- 04 Lattin A, Grimes J, Hoxter K. 1990. Dipel Technical Material ( Bacillus

thuringiensis var. kurstaki ): An Avian Oral Toxicity and Pathogenicity Study in the Bobwhite: Lab Project Number: 161

- 112. Unpublished study prepared by Wildlife International Ltd. 25 pages.

414434

- 05 Christensen K. 1990. Dipel Technical Material ( Bacillus thuringiensis var.

kurstaki )

— Infectivity and Pathogenicity to Bluegill Sunfish ( Lepomis
macrochirus ) During a 32

- day Static Renewal Test: Lab Project Number: 2439. 0889.6108.158. Unpublished study prepared by Springborn Laboratories, Inc. 53 pages.

414434

- 06 Christensen K. 1990. Dip el Technical Material ( Bacillus thuringiensis var.

kurstaki )

— Infectivity and Pathogenicity to Rainbow Trout ( Oncorhynchus mykiss ) During a 32

- day Static Renewal Test: Lab Project Number: 2469.0889.6107.157; 90

- 2

- 3219. Unpublished study prepared by Springbo rn Laboratories, Inc. 57 pages.

414434

- 07 Young B. 1990. 21

- day Prolonged Static Renewal Toxicity of Dipel Technical

to Daphnia magna : Lab Project Number: 38417. Unpublished study prepared by Analytical Bio

- chemistry Laboratories, Inc. 123 pages.

41443 4

- 08 Chandler G. 1990. Chronic Toxicity of Bacillus thuringiensis var. kurstaki

Technical Material to the Benthic Harpacticoid Copepod, Amphiascus minutus

, under Static Condition: Toxicity Test Report: Lab Project Number: USC

- SPH

1

- 90. Unpublished study pr epared by Univ. of South Carolina, School of Public Health. 43 pages.

414434

- 09 Beevers M. 1990. Effects of Bacillus thuringiensis subp. kurstaki on the Insect

Egg Parasitoid, Trichogramma pretiosum : Final Report: Lab Project Number:
CAR/103

- 90. Unpublished study prepared by California Agricultural Research, Inc. 41 pages.

414434

- 10 Nelson R. 1990. The Effect of the Microbial Pest Control Agent Bacillus

thuringiensis subsp. kurstaki on the Predatory mite Metaseiulus occidentalis (Nesbit) and their Host Prey the Two

- spotted Spider Mite Tetranychus urticae (Koch): Lab Project No: 90.020: Protocol No. I

- PSI

- NTO

- PM

- 90. Unpublished study prepared by Plant Sciences, Inc. 39 pages.Bacillus thuringiensis EPA

- HQ

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### 83 MRID No. Study Description

414434

- 11 O’Leary P. 1990. Effect of Bacillus thuring iensis subsp. kurstaki on the

Common Green Lacewing, Chrysoperla carnea (Stephens): Lab Project
Number: LR90

- 406. Unpublished study prepared by Pan

- Agricultural Laboratories. 41 pages.

414434

- 12 Atkins E. 1990. Bee Adult Toxicity Feeding Test/Chronic Eva luating the

Comparative Chronic Stomach Poison Toxicity of Bacillus thuringiensis subsp.
kurstaki (Btk) to Honey Bee Worker Adults: Dipel Technical Material: Lab Project No: BTK/BATFT/C/90

- 832

- F. Unpublished study prepared by Univ. of California, Dept. of Entomology. 27 pages.

414874

- 01 David R. 1990. Acute Pulmonary Toxicity/Pathogenicity Study of Vectobac

Technical Material ( Bacillus thuringiensis var. israelensis ) in Rats: Lab Project
Number: G

- 7264.225. Unpublished study prepared by Microbiological

As sociates, Inc. 3 pages.

414875

- 01 David R. 1990. Acute Intravenous Toxicity/Pathogenicity Study of Dipel

Technical Material ( Bacillus thuringiensis var. kurstaki ) in Rats: MBA Study

No.: G

- 7239.224.001. Unpublished study prepared by Microbiological Associates, Inc. 54 pages.

415161

- 01 Smith R, Cooper R. 1990. Dipel Technical Powder: Product Chemistry Based

on Bacillus thuringiensis , subspecies kurstaki ... as the Active Ingredient: Lab Project Number: TP

- 02. Unpublished study prepared by Abbott Lab oratories. 72 pages.

415161

- 02 Coddens M. 1990. Dipel Technical Powder: Product Chemistry Based on

Bacillus thuringiensis , subspecies kurstaki ... as the Active Ingredient: Lab Project Number: TP

- 03. Unpublished study prepared by Abbott Laboratories.

59 pages.

415396

- 01 Barbera P. 1990. NCCLS Standard Disk Susceptibility Test of Bacillus

thuringiensis Strains: Amended Final Report: IITRI Project No.: L08245; Study

No.: EC

- 02. Unpublished study prepared by IIT Research Institute, Life
Sciences Research. 20 pages.

415399

- 01 Barbera P. 1990. Biochemical and Morphological Characterization of Bacillus

thuringiensis Strains: Lab Project Number: L08245 EC

- 01. Unpublished study prepared by IIT Research Institute. 17 pages.Bacillus thuringiensis EPA

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### 84 MRID No. Study Description

415404

- 01 Christensen K. 1990. Vectobac Technical Material ( Bacillus thuringiensi s var.

israelensis )

— Infectivity and Pathogenicity to Sheepshead Minnow ( Cyprinodon variegatus ) During a 30

- day Static Renewal Test: Lab Project Number: Report No. 90

- 4

- 3288; Study No. 2439.889.6105.160. Unp ublished study prepared by Springborn Laboratories, Inc. 57 pages.

415404

- 02 Christensen K. 1990. Vectobac Technical Material ( Bacillus thuringiensis var.

israelensis )

— Infectivity and Pathogenicity to Grass Shrimp ( Palaemonetes vulgaris ) During a 31

- day Static Renewal Test: Lab Project Number: Report

No. 90

- 5

- 3339; Study No. 2439.0889.6106.161. Unpublished study prepared by Springborn Laboratories, Inc. 50 pages.

415408

- 01 Christensen K. 1990. Dipel Technical Material (Bacillus thuringiensis var.

kursta ki )

— Infectivity and Pathogenicity to Sheepshead Minnow ( Cyprinodon variegatus ) During a 30

- day Static Renewal Test: Lab Project Number: 90

- 5

- 3317: 2439.0889.6110.160. Unpublished study prepared by Springborn Laboratories, Inc. 57 pages.

415408

- 02 Christe nsen K. 1990. Dipel Technical Material ( Bacillus thuringiensis var.

kurstaki )

— Infectivity and Pathogenicity to Grass Shrimp ( Palaemonetes vulgaris ) During a 30

- day Static Renewal Test: Lab Project Number: 90

- 5

- 3337: 2439.0889.6109.161. Unpublished study pr epared by Springborn Laboratories, Inc. 50 pages.

415426

- 04 Gelin M, Killeen J. 1990. Acute Oral Toxicity/Pathogenicity Study in Rats with

Microbial Pest Control Agent (MPCA) Bacillus thuringiensis

, kurstaki (SPRA

119

- 28

- IC): Lab Project Number: 90

- 0015. Unpublished study prepared by Ricerca, Inc., Dept. of Toxicology and Animal Metabolism. 100 pages.

415426

- 07 Gelin M, Killeen J. 1990. Acute Pulmonary Toxicity/Pathogenicity Study in

Rats with Microbial Pest Control Agent (MPCA) Bacillus thuringiensis

, kurstaki (SPRA

- 119

- 28

- IC): Lab Project No. 90

- 0017. Unpublished study prepared by Ricerca, Inc. 102 pages.

415 500

- 01 Gelin M, Killeen J. 1990. Acute Intravenous Toxicity/Pathogenicity Study in

Rats with Microbial Pest Control Agent (MCPA) Bacillus thuringiensis

, kurstaki (SPRA

- 119

- 28

- IC): Lab Project Number: 3537

- 90

- 0016

- TX

- 001: 90

- 0016. Unpublished study prepared by Ricerca, Inc. 127 pages.

416371

- 01 Dicker H. 1990. Condor, Cutlass and Foil: Viable Spore Count and Total Count

of Five Production Batches: Lab Project Number: 90

- 03. Unpublished study prepared by Ecogen, Inc. 5 pages.Bacillus thuringiensis EPA

- HQ

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### 85 MRID No. Study Description

416372

- 01 Cuffari G, Johnson T, Groat R. 1990. One Year Storage Stability of Condor,

Cutlass and Foil Technical Powders: Lab Project Number: 90

- 02. Unpublished study prepared by Ecogen, Inc. 11 pages.

416389

- 01 Winter P, Hoxter K, Smith G. 1990. Cutlass: A Dietary Pathogenicity and

Toxicity Study with the Parasitic Hymenopteran Uga menoni : Lab Project Number: 235/124B. Unpublished study prepared by Wildlife International Ltd. 16 pages.

416539

- 05 Lattin A, Hoxter K, Jaber M. 1990. Avian Oral Pathogenicity and Toxicity

Study in Bobwhite: Biobit Wettable Powder (Batch PPQ 2843): Lab Project
Number: 254

- 114. Unpublished study prepared by Wildlife International Ltd. 27 pages.

416539

- 06 Lattin A, Hoxter K, Jabber M. 1990. An Avian Oral Pathogenicity and Toxicity

Study in the Mallar d: Biobit Wettable Powder (Batch PPQ 2843): Lab Project
Number: 254

- 113. Unpublished study prepared by Wildlife International Ltd. 27 pages.

416539

- 07 Christensen K. 1990. Infectivity and Pathogenicity to Rainbow Trout

( Oncorhynchus mykiss ) During a 31

- d ay Static Renewal Test: Biobit Wettable Powder: Lab Project Number: 12262.1289.6100.157: 90

- 8

- 3412. Unpublished study prepared by Springborn Labs, Inc. 54 pages.

416539

- 08 Christensen K. 1990. Chronic Toxicity to Daphnids ( Daphnia magna ) under
Static Ren ewal Conditions: Biobit Wettable Powder: Lab Project Number:

12262.1289.6101.130: 90

- 8

- 3446. Unpublished study prepared by Springborn Labs, Inc. 62 pages.

416539

- 09 Hoxter K, Thompson M, Jaber M. 1990. A Dietary Pathogenicity and Toxicity

Study with the Green Lacewing Larvae (BTK Tox Batch NB 75, Batch PPQ 2843): Biobit Wettable Powder: Lab Project Number: 254

- 117. Unpublished study prepared by Wildlife International Ltd. 20 pages.

416539

- 10 Hoxter K, Thompson M, Jaber M. 1990. A Dietary Pathogenicity and Toxicity

Study with Ladybird Beetles (BTK Toxbatch NB75, Batch PPQ 2843): Biobit Wettable Powder: Lab Project Number: 254

- 116. Unpublished study prepared by Wildlife International Ltd. 23 pages.

416539

- 11 Thompson M, Hoxter K, Smith G. 1990. A Dietar y Pathogenicity and Toxicity

Study with the Parasitic Hymenopteran Pediob i us foveolatus (BTK Toxbatch NB 75, Batch No. PPQ 2843): Biobit Wettable Powder: Lab Project Number:

254

- 115A. Unpublished study prepared by Wildlife International Ltd. 24 pages.Bacillus thuringiensis EPA

- HQ

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### 86 MRID No. Study Description

41 6539

- 12 Hoxter K, Thompson M, Jaber M. 1990. A Dietary Pathogenicity and Toxicity

Study with the Honeybee (BTK Toxbatch NB 75, Batch PPQ 2843): Biobit Wettable Powder: Lab Project Number: 254

- 118. Unpublished study prepared by Wildlife International Ltd. 2 2 pages.

416570

- 07 Lattin A, Hoxter K, Jaber M. 1990. BTK Toxbatch NB75 Batch No. PPQ 2843:

An Avian Oral Pathogenicity and Toxicity Study in Bobwhite in Support of Registration of Biobit Flowable Concentrate: Lab Project Number: 254/114. Unpublished stu dy prepared by Wildlife International Ltd. 27 pages.

416570

- 08 Lattin A, Hoxter K, Jaber M. 1990. BTK Toxbatch NB75 Batch No. PPQ 2843:

An Avian Oral Pathogenicity and Toxicity Study in the Mallard in Support of Registration of Biobit Flowable Concentrat e: Lab Project Number: 254/113. Unpublished study prepared by Wildlife International Ltd. 27 pages.

416570

- 09 Christensen K. 1990. Bacillus thuringiensis var. kurstaki Infectivity and

Pathogenicity to Rainbow Trout ( Oncorhynchus mykiss ) During a 31

- day Static Renewal Test in Support of Reregistration of Biobit Flowable Concentrate: Lab Project Number: 90/8/3412. Unpublished study prepared by Springborn Laboratories, Inc. 54 pages.

416570

- 10 Christensen K. 1990. Bacillus thur in giensis var. kurstaki Chro nic Toxicity to

Daphnids (

Daphnia magna ) Under Static Renewal Conditions in Support of Reregistration of Biobit Flowable Concentrate: Lab Project Number: 90/8/3446. Unpublished study prepared by Springborn Laboratories, Inc. 62 pages.

416570

- 11 Hoxter K, Thompson M, Jaber M. 1990. BTK Toxbatch NB 75 Batch No. PPQ

2843: A Dietary Pathogenicity and Toxicity Study with the Green Lacewing Larvae in Support of Registration of Biobit Flowable Concentrate: Lab Project Number: 254/117. Unpublished study prepared by Wildlife International Ltd. 20 pages.

416570

- 12 Hoxter K, Thompson M, Jaber M. 1990. BTK Toxbatch NB75 Batch No. PPQ

2843: A Dietary Pathogenicity and Toxicity Study with Ladybird Beetles in Support of Registration of Biobit Flowable Concentrate: Lab Project Number: 254/116. Unpublished study prepared by Wildlife International Ltd. 23 pages.

416570

- 13 Thompson M, Hoxter K, Smith G. 1990. BTK Toxbatch NB75 Batch No. PPQ

2843: A Dietary Pathogenicity and Toxici ty Study with the Parasitic Hym enopteran P ediob i us foveolatus in Support of Registration of Biobit Flowable Concentrate: Lab Project Number: 254/115A. Unpublished study prepared by Wildlife International Ltd. 24 pages.Bacillus thuringiensis EPA

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### 87 MRID No. Study Description

416570

- 14 Hoxter K, Thompson M, Jaber M. 1990. BTK Toxbatch NB 75 Batch No. PPQ

2843: A Dietary Pathogenicity and Toxicity Study with the Honey Bee in Support of Registration of Biobit Flowable Concentrate: Lab Project Number: 254/118. Unpublished study prepared by Wildlife International Ltd. 22 pages.

417225

- 01 Cooper R, Schwar tz R, Primus H. 1990. Product Chemistry of ABG

- 6305

Technical Powder: Lab Project Number: 451/TP1. Unpublished study prepared by Abbott Laboratories. 148 pages.

417225

- 03 Smith R. 1990. Microbiological Characterization of ABG

- 6305 Product Strain:

Lab Pro ject Number: 1859

- 91Y. Unpublished study prepared by Abbott Laboratories. 35 pages.

417225

- 04 Jaronski S. 1990. Host Spectrum Study of ABG

- 6305 Technical Powder:

C o leoptera: Lab Project Number: 910

- 9006. Unpublished study prepared by Ratech Services. 7 p ages.

417225

- 05 Jaronski S. 1990. Host Spectrum Study of ABG

- 6305 Technical Powder:

Orthoptera: Lab Project Number: 910

- 9002. Unpublished study prepared by Abbott Laboratories. 8 pages.

417225

- 06 Jaronski S. 1990. Host Spectrum Study of ABG

- 6305 Technical Powder:

Diptera: Lab Project Number: 910

- 9003. Unpublished study prepared by Abbott Laboratories. 8 pages.

417225

- 07 Ferry E. 1990. Intraperitoneal and Subcutaneous Injection Tests with ABG

6305 Technical Powder: Lab Project Number: 85K

- 11/90. Unpublished study prepared by Abbott Laboratories. 6 pages.

417225

- 09 Copeland A. 1990. Bacillus thuringiensis Water Dispersible Granules (ABG

6305) Bioburden: Analysis of Samples: Lab Project Number: 40156

- 40160. Unpublished study prepared by Abbott Lab oratories. 6 pages.

417225

- 11 Short M. 1990. Quantitation of Active Ingredient ABG

- 6305 Technical Powder

Analysis of Samples: Lab Project Number: 46

- 255

- 62. Unpublished study prepared by Abbott Laboratories. 18 pages.

417225

- 12 Martinat P. 1990. Analys is of Lepidopteran Biopotency of ABG

- 6305 Technical

Powder: Analysis of Samples: Lab Project Number: 910

- 9004. Unpublished study prepared by Abbott Laboratories. 17 pages.

417225

- 14 Yuan J. 1990. Physical and Chemical Property Characterization of ABG

- 6305

Technical Powder: Lab Project Number: 45

- 252

- 62. Unpublished study prepared by Abbott Laboratories. 10 pages.Bacillus thuringiensis EPA

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### 88 MRID No. Study Description

417225

- 16 Jaronski S. 1990. ABG

- 6305 Technical Powder: Physical and Chemical

Properties: TGAI Stability: Lab Project No: 910

- GLP

- 9001. Unpublished study prepared by Abbott Laboratories. 33 pages.

417511

- 05 Holbert M. 1990. Acute Oral Toxicity/Pathogenicity Study in Rats with a

Microbial Pest Control Agent (MCPA) Consisting of Viable Microbes and Non

Viable Organisms: Lab Project Number: 6891

- 90. Unpublished study prepared by Stillmeadow, Inc. 19 pages.

417511

- 06 Holbert M. 1990. Acute Pulmonary Toxicity/Pathogenicity Study in Rats with a

Microbial Pest Control Agent (MPCA) Consisting of Viable Microbes and Non

Viable Organisms: Lab Pro ject Number: 6893

- 90. Unpublished study prepared by Stillmeadow, Inc. 19 pages.

417511

- 07 Holbert M. 1990. Acute Intravenous Toxicity/Pathogenicity Study in Rats with

a Microbial Pest Control Agent (MCPA) Consisting of Viable Microbes and

Non

- Viable Orga nisms: Lab Project Number: 6892

- 90. Unpublished study prepared by Stillmeadow, Inc. 19 pages.

418075

- 01 Sorensen E, Rugh S, Overholt J. 1991. Product Analysis Data: Product Identity

and Manufacturing Information in Support of Registration of Novodor Flowable Concentrate. Unpublished study prepared by Novo Nordisk A/S & Novo Nordisk Bioindustrials, Inc. 210 pages.

418089

- 02 Carter J. 1991. Acute Intravenous Toxicity and Infectivity/Pathogenicity to Rats

of ABG

- 6305: Lab Project Number: 901291D/ABT 143

- 1/AC. Unpublished study prepared by Huntingdon Research Center Ltd. 38 pages.

418089

- 03 Gelin M. 1991. Acute Oral Toxicity and Clearance Study in Rats with ABG

6314: Lab Project Number: 90

- 0470. Unpublished study prepared by Ricerca, Inc. 34 pages.

418250

- 01 Couch T. 1989. BMP 123 (2X WP): Product Chemistry. Unpublished study

prepared by Becker Microbial Products, Inc. 63 pages.

418266

- 02 Robbins G. 1988. BMP Technical Powder: Acute Oral Toxicity in Rats: Lab

Project Number: A1824. Unpublished stu dy prepared by Cosmopolitan Safety Evaluation, Inc. 19 pages.

418266

- 04 Robbins G. 1988. BMP Technical Powder: Acute Inhalation Toxicity Study in

Rats: Lab Project Number: C1824. Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc. 35 pages.Bacillus thuringiensis EPA

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### 89 MRID No. Study Description

418266

- 08 Robbins G. 1991. BMP Technical Powder: Intraperitoneal Safety Test in Mice:

Lab Project Number: S3101. Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc. 16 pages.

418266

- 09 Robbins G. 1991. BMP Technical Powder: Intrap eritoneal Safety Test in Mice:

Lab Project Number: S3102. Unpublished study prepared by Cosmopolitan Safety Evaluation, Inc. 17 pages.

418427

- 08 Winter P, Hoxter K, Smith G. 1991. Bacillus thuringiensis var. israelensis :

Strain NB31, Tox Batch PPQ 3044: A Dietary Pathogenicity and Toxicity Study with Green Lacewing Larvae: Lab Project Number: 254

- 123. Unpublished study prepared by Wildlife International Ltd. 22 pages.

418427

- 09 Winter P, Hoxter K, Smith G. 1991. Bacillus thuringiensis var. israelensis :

Strain NB31, Tox Batch PPQ 3044: A Dietary Pathogenicity and Toxicity Study with the Parasitic Hymenopteran Uga menoni : Lab Project Number: 254

- 121. Unpublished study prepared by Wildlife International Ltd. 22 pages.

418427

- 10 Winter P, Hoxter K, Smith G. 1990. Bacillus thuringiensis var. israelensis :

Strain NB31, Tox Batch PPQ 3044: A Dietary Pathogenicity and Toxicity Study with Ladybird Beetles: Lab Project Number: 254

- 122. Unpublished study prepared by Wildlife International Ltd. 19 pages.

418427

- 11 Hoxter K, Smith G. 1991. Bacillus thuringiensis var. israelensis : Strain NB31,

Tox Batch PPQ 3044: A Dietary Pathogenicity and Toxicity Study with the Honey Bee: Lab Project Number: 254

- 120. Unpublished study prepared by
Wildlif e International Ltd. 20 pages.

418800

- 01 Isaacson J. 1991. Analysis of Beta

- exotoxin (thuringiensis) Content of Five

Lots of VectoBac TP by Housefly Bioassay: Lab Project Number: 910/9011. Unpublished study prepared by Abbott Laboratories. 12 pages.

41 8838

- 01 Isaacson J. 1991. Analysis of Beta

- exotoxin (thuringiensin) Content of Five

Lots of DiPel TP by Housefly Bioassay: Lab Project Number: 910

- 9010. Unpublished study prepared by Abbott Labs. 12 pages.

419151

- 01 Couch T. 1989. Product Chemistry Data: BMP 144 Primary Powder.

Unpublished study prepared by Becker Microbial Products, Inc. 36 pages.

419748

- 01 Carter J. 1991. Acute Pulmonary Toxicity and Infectivity/Pathogenicity to Rats

of Bacillus thuringiensi s: ABG

- 6305: Lab Project Number: 901292D/ABT 143

- 2/AC. Unpublished study prepared by Huntington Research Centre Ltd. 40

pages.Bacillus thuringiensis EPA

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### 90 MRID No. Study Description

419748

- 02 Boeri R. 1991. Chronic Toxicity of ABG

- 6305 to Daphnid: Daphnia magna :

Lab Project Number: 90162

- A. Unpublished study prepared by Resource Analysts, Inc. 47 page s.

419748

- 03 Boeri R. 1991. Acute Toxicity of ABG

- 6305 to the Rainbow Trout

( Oncorhynchus mykiss ): Lab Project Number: 9107

- A. Unpublished study prepared by Resource Analysts, Inc. 26 pages.

419748

- 04 Beavers J. 1991. ABG

- 6305: An Avian Oral Pathogenic ity and Toxicity in the

Bobwhite: Lab Project Number: 161

- 117. Unpublished study prepared by Wildlife International Ltd. 21 pages.

419748

- 05 Beavers J. 1991. ABG

- 6305: An Avian Oral Pathogenicity and Toxicity in the

Bobwhite: Lab Project Number: 161

- 118. Unpublished study prepared by Wildlife International Ltd. 20 pages.

419748

- 06 Nelson R. 1991. The Effect of Bacillus thuringiensis , ABG

- 6305 Technical

Powder, on the Common Green Lacewing, Chrysoperla carnea (Stephens): Lab Project Number: 91.043. Unpublished study prepared by Plant Sciences, Inc. 30

pages.

419748

- 07 Kirkland R. 1991. Effect of Bacillus thuringiensis , ABG

- 6305 Technical

Powder, on the Insect Egg Parasitoid ( Trichogramma pretiosum Riley): La b Project Number: 104L

- 91. Unpublished study prepared by California Agricultural Research, Inc. 53 pages.

419748

- 08 Kirkland R. 1991. The Effect of Bacillus thuringiensis , ABG

- 6305 Technical

Powder, on the Honeybee ( Apis mellifera L.): Lab Project Number: CAR 196

- 90. Unpublished study prepared by California Agricultural Research, Inc. 52

pages.

419748

- 09 Nelson R. 1991. The Effect of Bacillus thuringiensis , ABG

- 6305 Technical

Powder, on the Predatory Mite Metaseilus occidentalis (Nesbit) and Their Host Prey the Two

- spotted Spider Mite Tetranychus urticae (Koch): Lab Project Number: 91.042. Unpublished study prepared by Plant Sciences, Inc. 38 pages.

419943

- 02 Verma M. 1991. Product Chemistry: Technical CGA

- 237218: Lab Project

Nu mber: PC

- 91

- 005. Unpublished study prepared by Ciba

- Geigy Corp. 72

pages.

419943

- 03 Vlachos D. 1991. Acute Intraperitoneal Toxicity/Pathogenicity Screening

Studies of Technical CGA

- 237218 in Mice: Lab Project Number: 7961

- 91:

7963

- 91: 7965

- 91. Unpublished study prepared by Stillmeadow, Inc. 103 pages.Bacillus thuringiensis EPA

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### 91 MRID No. Study Description

419943

- 04 Vlachos D. 1991. Human Pathogen Screening Studies of Technical CGA

237218: Lab Project Number: 8231

- 91: 8232

- 91: 8233

- 91. Unpublished study prepared by Stillmeadow, Inc. 57 pages.

419 943

- 05 Verma M. 1991. Product Chemistry: Technical CGA

- 237218: Lab Project

Number: PC

- 91

- 005. Unpublished study prepared by Ciba

- Geigy Corp. 43

pages.

419943

- 13 Lattin A. 1990. CGA

- 237218 Technical (GC

- 91): An Avian Oral Pathogenicity

and Toxicity Study in the Bobwhite: Lab Project Number 108

- 308. Unpublished study prepared by Wildlife International Ltd. 21 pages.

419943

- 14 Lattin A. 1990. CGA

- 237218 Technical (GC

- 91): An Avian Oral Pathogenicity

and Toxicity Study in the Mallard: Lab Project Number 108

- 309. Unpublished study prepared by Wildlife International Ltd. 22 pages.

419943

- 15 Christensen K. 1991. CGA

- 237218 Technical Material: Infectivity and

Pathogenicity to Rainbow Trout ( Oncorhyncus mykiss ) During a 32

- day Static Renewal Test: Lab Project Number: 90

- 6

- 3363. Unpublished study prepared by Springborn Labs, Inc. 52 pages.

419943

- 16 Christensen K. 1991. CGA

- 237218: Chronic Toxicity to Daphnids ( Daphnia

magna ) Under Static Renewal Conditions: Lab Project Number: 90

- 7

- 3385. Unpublished study pre pared by Springborn Labs, Inc. 90 pages.

419943

- 17 Christensen K. 1991. CGA

- 237218: Infectivity and Pathogenicity to

Sheepshead Minnow ( Cyprinodon variegatus ) During a 30

- day Static Renewal Test: Lab Project Number: 90

- 8

- 3439. Unpublished study prepared by Springborn Labs, Inc. 50 pages.

419943

- 18 Christensen K. 1991. CGA

- 237218 Technical Material: Infectivity and

Pathogenicity to Grass Shrimp ( Palaemonetes vulgaris ) During a 30

- day Static Renewal Test: Lab Project Number: 90

- 6

- 3445. Unpublished study p repared by Springborn Labs, Inc. 48 pages.

419943

- 19 Winter P. 1991. CGA

- 237218: A Dietary Pathogenicity and Toxicity Study with

the Parasitic Hymenopteran Uga menoni : Lab Project Number: 108

- 311A. Unpublished study prepared by Wildlife International Ltd . 21 pages.

419943

- 20 Thompson M. 1991. CGA

- 237218: A Dietary and Toxicity Study with Ladybird

Beetles: Lab Project Number: 108

- 313. Unpublished study prepared by Wildlife International Ltd. 18 pages.Bacillus thuringiensis EPA

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### 92 MRID No. Study Description

419943

- 21 Thompson M. 1991. CGA

- 237218: A Dietary and Toxicity Study with the

Green Lacewing Larvae: Lab Project Number: 108

- 312. Unpublished study prepared by Wildlife International Ltd. 18 pages.

419943

- 22 Winter P. 1991. CGA

- 237218: A Dietary Pathogenicity and Toxicity Study with

the Honey Bee: Lab P roject Number: 108

- 310A. Unpublished study prepared by Wildlife International Ltd. 18 pages.

420065

- 01 Verma M. 1991. Technical CGA

- 237218: Product Chemistry: Lab Project

Number: PC

- 91

- 005. Unpublished study prepared by Ciba

- Geigy Corp. 11

pages.

42006 5

- 02 Hossack D. 1990. Acute Oral Toxicity and Infectivity/Pathogenicity Study of

CGA

- 237218 (

Bacillus thuringiensis var. aizawai ) in Rats: Lab Project
Number: CBG 517

- 1. Unpublished study prepared by Huntingdon Research Centre, Ltd. 35 pages.

420065

- 03 Hossack D. 1990. Acute Pulmonary Toxicity and Infectivity/Pathogenicity

Study of CGA

- 237218 ( Bacillus thuringiensis var. aizawai ) in Rats: Lab Project Number: CBG 517

- 2. Unpublished study prepared by Huntingdon Research Centre, Ltd. 40 pages.

420065

- 04 H ossack D. 1990. Acute Intravenous Toxicity and Infectivity/Pathogenicity

Study of CGA

- 237218 ( Bacillus thuringiensis var. aizawai ) in Rats: Lab Project Number: CBG 517

- 3. Unpublished study prepared by Huntingdon Research Centre, Ltd. 40 pages.

421133

- 01 Jaronski S. 1991. Analysis of Diamondback Moth Biopotency of Centari

Technical Powder: Lab Project Number: 91M

- 91

- 002. Unpublished study prepared by Abbott Labs. 19 pages.

421400

- 01 Jaronski S. 1991. TGAI Physical Stability Study of Bacillus thuringiensi s

subsp. aizawai : Final Report: Lab Project Number: 91M

- 91

- 004. Unpublished study prepared by Abbott Labs. 29 pages.

422453

- 01 Nelson R. 1991. The Effects of Bacillus thuringiensis , ABG

- 6305 Technical

Powder, on the Common Green Lacewing, Chrysoperla car na (Stephens): Lab Project Number: 91.043. Unpublished study prepared by Plant Sciences, Inc. 30

pages.

422863

- 01 Nelson R. 1991. Raw Data Addendum to MRID Number 41974809: Trial

Notes: Bacillus thuringiensis , ABG

- 6305 Technical Powder: Lab Project Number: 91.042. Unpublished study prepared by Plant Sciences, Inc. 5 pages.Bacillus thuringiensis EPA

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### 93 MRID No. Study Description

422955

- 01 Nelson R. 1991. Raw Data Addendum to MRID Number 41974806: The Effect

of Bacillus thuringiensis , ABG

- 6305 Technical Powder on the Common Green Lacewing, Chrysoperla car nea (Stephens): Lab Project Number: 91.043. Unpublished study prepared by Plant Sciences, Inc. 9 pages.

423132

- 01 Verma M. 1992. Technical CGA

- 237218: Product Chemistry: An Addendum:

Lab Project Number: PC

- 92

- 011. Unpublished study prepared by Ciba

- Geigy Corp. 9 pages.

423289

- 01 Vargas R. 1991. Baseline Toxicity of Thuringiensis to Immature and Mature

Stages of TSM: Report No. 1: Lab Project Number: 01.08.91. Unpublished study prepared by Lincoln University, Plant Protection Res. Unit. 8 pages.

423289

- 02 Vargas R. 1991. Baseline Toxicity of Thuringiensis to Immature and Mature

Stages of TSM: Report No. 2: Lab Project Number: 10.12.91. Unpublished study prepared by Lincoln University, Plant Protection Res. Unit. 9 pages.

424041

- 01 Sterndorff H, Overholt J. 1992. BT Protein Quantification by Cobas FARA

Immunoturbidimetry: Supplementary Study in Support of the Registration of Foray 76B, Novodor Flowable Concentrate, and Novodor Technical: Lab Project Number: NOVO/PIA/VOL1. Unpublished study prepare d by Novo Nordisk A/S. 29 pages.

424530

- 01 Verma M. 1992. Product Chemistry: Technical CGA

- 237218: Lab Project

Number: PC

- 92

- 028. Unpublished study prepared by CIBA

- GEIGY Corp. 5

pages.

428191

- 01 Ward T, Kowalski P, Boeri R. 1993. Acute Toxicity of Com ponents of ABG

6305 to the Daphnid, Daphnia magna

— Addendum to MRID No. 41974802: Lab Project Number: 123

- AB. Unpublished study prepared by T. R. Wilbury Labs, Inc. 101 pages.

428511

- 01 Gelin M. 1993. Acute Oral Toxicity and Pathogenicity to Rats of ABG

- 6 346:

Lab Project Number: 92

- 0502: 5523

- 92

- 0502

- TX

- 001. Unpublished study prepared by Ricerca, Inc. 59 pages.

429085

- 01 Allan S. 1992. Acute Oral Toxicity to the Rat: SAN 415 I WG 391 PA

Formulation (SA

- 11): Lab Project Number: 920066D/SNC 149/AC. Unpubli shed study prepared by Huntingdon Research Centre Ltd. 19 pages.Bacillus thuringiensis EPA

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### 94 MRID No. Study Description

429099

- 01 Collins M. 1993. Xentari Technical Powder (ABG

- 6305)

- Infectivity and

Pathogenicity to Rainbow Trout ( Oncorhynchus mykiss ) During a 20

- day Static Renewal Test: Final Report: Lab Project Number: 93

- 6

- 4837: 2439.0493.6115.103. Unpublished study prepared by Springborn Labs, Inc. 83

pages.

429358

- 03 Allan S. 1992. SAN 420 I WG 390 PA Formulation (SA

- 12): Acute Oral

Toxicity to the Rat: Lab Project Number: DP 300775: 920067D/SNC 149/ AC. Unpublished study prepared by Huntingdon Research Centre Ltd. 19 pages.

429421

- 01 Palmer S, Beavers J. 1993. Xentari Technical Powder (ABG

- 6305): A Dietary

Pathogenicity and Toxicity Study with the Ladybird Beetle ( Hippodamia

convergens ): Final Repor t: Lab Project Number: 161

- 126A. Unpublished study prepared by Wildlife International Ltd. 36 pages.

429544

- 03 Hossack D, Carter J, Baker M. 1992. Acute Intravenous Toxicity and

Infectivity/Pathogenicity to Rats of SAN 420 I technical (SA 12): Final Repo rt: Lab Project Number: 91673D/SNC 135/AC. Unpublished study prepared by Huntingdon Research Centre Ltd. 36 pages.

430587

- 01 Stubbs D. 1993. Technical CGA

- 237218: Product Chemistry: Lab Project

Number: PC

- 93

- 018: PPD

- 93

- 017: E325. Unpublished study prepa red by

CIBA

- GEIGY Corp. and RICERCA, Inc. 53 pages.

432066

- 01 Collins M. 1993. Infectivity and Pathogenicity to Daphnids ( Daphnia magna )

During a 21

- day Static Renewal Test: CGA

- 237218: Lab Project Number: 93

- 10

- 4968. Unpublished study prepared by Springborn Labs, Inc. 104 pages.

434030

- 01 Parrish J, Yeager B. 1994. Honey Bee Toxicity Feeding Test/Chronic

- CGA

237218: Lab Project Number: HB419. Unpublished study prepared by BioWest, Inc. 47 pages.

434030

- 02 Balcomb R. 1994. Honey Bee Exposure a nd Risk Assessment for Agree

Insecticide. Unpublished study prepared by Ciba

- Geigy Corp. 14 pages.

434917

- 01 Bowman J, Gledhill D. 1994. Chronic Toxicity of BMP 123 Primary Powder to

Daphnia magna Under Static Renewal Test Conditions: Final Report: Lab

P roject Number: 41479: 41479R. Unpublished study prepared by ABC Labs, Inc. 277 pages.

434917

- 02 March K, Rhodes J. 1994. Honey Bee Chronic Toxicity Study with the

Microbial Pest Control Agent (MPCA) BMP 123 Primary Powder: Final Report: Lab Project Numbe r: 42117: 42117R. Unpublished study prepared by ABC Labs, Inc. 343 pages.Bacillus thuringiensis EPA

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### 95 MRID No. Study Description

435229

- 01 Collins M. 1995. Comparative Toxicity Test Exposing Daphnids ( Daphnia

magna ) to DiPel Technical Powder Produced by Two Different Processes: Lab Project Number: 94

- 11

- 5567: 2439.1194.6124.110. Unpublished study prepared by Springborn Labs, Inc. 75 pages.

436080

- 01 Baum J. 1995. Product Identity: EG7841 Bioinsecticide: Lab Project Number:

7841/RD/01. Unpublished study prepared by Ecogen, Inc. 33 pages.

436080

- 0 2 Barbera P. 1994. NCCLS Standardized Disk Susceptibility Test of Bacillus

thuringiensis var. kurstaki strain EG7841: Final Report: Lab Project Number: L08374. Unpublished study prepared by IIT Research Institute. 18 pages.

436080

- 03 Barbera P. 1994. Bio chemical and Morphological Characterization of Bacillus

thuringiensis var. kurstaki strain EG7841: Final Report: Lab Project Number: L08374. Unpublished study prepared by IIT Research Institute. 15 pages.

436080

- 06 Gao M. 1995. Bacillus thuringiensis EG7 841: Toxin Protein Analysis of Water

Dispersible Granular Formulations by SDS

- Page: Lab Project Number: QCPRO031095. Unpublished study prepared by Ecogen, Inc. 7 pages.

436080

- 07 Wimpfheimer L. 1995. Bacillus thuringiensis EG7841: Determination of

Efficacy of Water Dispersible Granule Formulations Against Trichoplusia ni in Artificial Diet Bioassay: Lab Project Number: QCBIO032895. Unpublished study prepared by Ecogen, Inc. 8 pages.

436080

- 08 Arnold K. 1995. EG7841 Bioinsecticide: Physical and Chemical Properties:

Lab Project Number: 7841/FORM/01. Unpublished study prepared by Ecogen, Inc. 5 pages.

436080

- 10 Carter J, Liggett M. 1994. Acute Oral Toxicity and Infectivity/Pathogenicity to

Rats of EG7841: Final Report : Lab Project Number: ECO/6/942538. Unpublished study prepared by Huntingdon Research Centre Ltd. 56 pages.

436080

- 13 Carter J, Liggett M. 1995. Acute Pulmonary Toxicity and

Infectivity/Pathogenicity to Rats of EG7841: Final Report: Lab Project
Number: E CO/8/943020. Unpublished study prepared by Huntingdon Research Centre Ltd. 68 pages.

436080

- 14 Carter J, Liggett M. 1994. Acute Intravenous Toxicity and

Infectivity/Pathogenicity to Rats of EG7841: Final Report: Lab Project Number: ECO/7/942539. Unpublis hed study prepared by Huntingdon Research Centre Ltd. 59 pages.Bacillus thuringiensis EPA

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### 96 MRID No. Study Description

436080

- 17 Cameron D. 1995. Oral Pathogenicity in Bobwhite Quail: EG7841: Lab Project

Number: ECO/9/943059. Unpublished study prepared by Huntingdon Research Centre Ltd. 21 pages.

436080

- 18 Collins M. 1995. EG7841

— Infectivity and Pathogenicity to Rainbow Trout

( Oncorhynchus mykiss ) During a 30

- day Static Renewal Test: Amended Final Report: Lab Project Number: 94/9/5454: 11675/0394/6119/260. Unpublished study prepared by Springborn Labs, Inc. 120 pages.

436080

- 19 Collins M. 1995. EG 7841

— Infectivity and Pathogenicity to Daphnids

( Daphnia magna ) During a 21

- day Static Renewal Test: Amended Final Report: Lab Project Number: 94/8/5420: 11675/0394/6121/264. Unpublished study prepared by Springbo rn Labs, Inc. 89 pages.

436080

- 20 Palmer S, Beavers J. 1995. EG 7841 Technical: A Dietary Pathogenicity and

Toxicity Study with the Ladybird Beetle ( Hippodamia convergens ): Final Report: Lab Project Number: 235/137. Unpublished study prepared by Wildlife International Ltd. 19 pages.

436080

- 21 Palmer S, Beavers J. 1995. EG 7841 Technical: A Dietary Pathogenicity and

Toxicity Study with the Honey Bee ( Apis mellifera ): Final Report: Lab Project Number: 235/136E. Unpublished study prepared by Wildlife Inter national Ltd. 18 pages.

436601

- 01 Rodgers M. 1995. Oral Pathogenicity in Mallard Duck: EG 7841: Lab Project

Number: ECO 10/942727: ECO 10. Unpublished study prepared by Huntingdon Research Centre, Ltd. 21 pages.

437576

- 01 Collins M. 1995. ABG

- 6305

— Toxicity to Water Fleas ( Daphnia magna ) Under

Static Renewal Conditions: Lab Project Number: 95

- 5

- 5855. Unpublished study prepared by Springborn Labs, Inc. 91 pages.

438288

- 01 Collins M. 1995. Xentari Technical Powder (ABG

- 6305)

— Toxicity to Rain bow

Trout ( Oncorhynchus mykiss ) During a 30

- day Static Renewal Test: Final Report: Lab Project Number: 95

- 7

- 5977. Unpublished study prepared by Springborn Labs, Inc. 62 pages.

438293

- 01 Baum J. 1995. EG7826 Bioinsecticide Product Chemistry: Lab Project N umber:

7826

- RD

- 01. Unpublished study prepared by Ecogen, Inc. 31 pages.

438293

- 02 Barbera P. 1995. NCCLS Standardized Disk Susceptibility Test of Bacillus

thuringiensis Strain EG7826: Final Report: Lab Project Number: L08574: 6: L08574SN6. Unpublished s tudy prepared by IIT Research Institute. 18 pages.Bacillus thuringiensis EPA

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### 97 MRID No. Study Description

438293

- 03 Barbera P. 1995. Biochemical and Morphological Characterization of Bacillus

thuringiensis Strain EG7826: Final Report: Lab Project Number: L08574: 5. Unpublished study prepared by IIT Research Institute. 16 pages.

438293

- 10 Barbera P. 1995. Sensitivity of Detection of Bacillus thuringiensis Strain EG

7826 for Toxicity/Pathogenicity Testing in Rats: Final Report: Lab Project Number: L08574: 1: L08574SN1. Unpublished study prepared by IIT Research Institute. 29 pages.

438293

- 11 Barbera P. 1995. Toxicity/Pathogenicity Testing of Bacillus thuringiensis Strain

EG 7826 Following Acute Oral Chall enge in Rats: Final Report: Lab Project Number: L08574: 2: L08574SN2. Unpublished study prepared by IIT Research Institute. 108 pages.

438293

- 13 Barbera P. 1995. Toxicity/Pathogenicity Testing of Bacillus thuringiensis Strain

EG 7826 Following Acute Intratracheal Challenge in Rats: Final Report: Lab Project Number: L08574: 3: L08574SN3. Unpublished study prepared by IIT Research Institute. 202 pages.

438293

- 14 Barbera P. 1995. Toxicity/Pathogenicity Testing of Bacillu s thuringiensis Strain

EG 7826 Following Acute Intravenous Challenge in Rats: Draft Final Report: Lab Project Number: L08574: 4: L08574SN4. Unpublished study prepared by IIT Research Institute. 111 pages.

438293

- 17 Collins M. 1995. EG 7826

— Toxicity and Pathogenicity to Daphnids ( Daphnia

magna ) During a 21

- day Static Renewal Test: Final Report: Lab Project
Number: 11675.0395.6125.110: 95

- 7

- 5982. Unpublished study prepared by Springborn Labs, Inc. 120 pages.

438293

- 18 March K, Sebaugh J. 1995. Honey Bee Toxicity/Pathogenicity Study with the

Microbial Pest Control Agent (MCPA) EG 7826 Technical: Final Report: Lab Project Number: 42695: ABC 42695. Unpublished study prepared by ABC Labs, Inc. 376 pages.

438988

- 01 Bowman J. 1995. Chronic Toxicity of BMP 123 Primary Powder to Daphnia

magna Under Static Renewal Test Conditions: Final Report: Lab Project Number: 42863. Unpublished study prepared by ABC Labs, Inc. 35 pages.

440072

- 01 Birkhold D. 1996. Comparison of Abbott and Novo Manufacturing Processes

for B acillus thuringiensis spp. kurstaki Technical Grade Active Ingredient: Lab Project Number: JDP

- BTK

- 1. Unpublished study prepared by Abbott Laboratories. 12 pages.Bacillus thuringiensis EPA

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### 98 MRID No. Study Description

440355

- 01 Smith R. 1996. Diagnostic Comparison of DiPel and Biobit Production Strains:

Lab Project Number: JDP

- BTK

- 2. Unpublished study prepared by Abbott Labs. 19 pages.

440882

- 01 Bowman J. 1995. Chronic Toxicity of BMP 123 Primary Powder to Daphnia

magna Under Static Renewal Test Conditions: Final Report: Lab Project Number: 42863R: 42863. Unpublished study prepared by ABC Labs, Inc. 22

pages.

442792

- 01 Baum J. 1997. Product Identity: Lepinox Bioinsecticide: Lab Project Number:

7826

- 11097

- RD

- 9701. Unpub lished study prepared by Ecogen, Inc. 30 pages.

443171

- 01 Birkhold D. 1997. Comparison of Abbott and Novo Manufacturing Processes

for Bacillus thuringiensis spp. israelensis Technical Grade Active Ingredient: Lab Project Number: MHA

- BTI

- 1. Unpublished st udy prepared by Abbott Laboratories. 11 pages.

443171

- 02 Smith R, Benson T. 1997. Diagnostic Comparison of Vectobac and Bactimos

Production Strains: Lab Project Number: MHA

- BTI

- 2. Unpublished study prepared by Abbott Laboratories. 22 pages.

443214

- 01 A

ve D. 1997. Bioassay Studies: Lepinox Bioinsecticide ( Bacillus thuringiensis subspecies kurstaki EG7826 Construct 11097): Lab Project Number: ECO

INS.97001. Unpublished study prepared by Ecogen, Inc. 5 pages.

443279

- 01 Baum J. 1997. Bacillus thuringiensis subspecies kurstaki EG7841 Construct

11831: Product Chemistry: Lab Project Number: 7841

- 11831

- RD

- 9701. Unpublished study prepared by Ecogen, Inc. 28 pages.

443582

- 01 Collins M. 1997. CGA

- 237218

— Acute Toxicity to Daphnids, Daphnia magna

, Und er Static

- Renewal Conditions: Lab Project Number: 97

- 1

- 6842: 360

- 96: 1781.1296.6546.264. Unpublished study prepared by Springborn Laboratories, Inc. 60 pages.

443761

- 01 Rhodes J, Downing J. 1997. Toxicological Effect of XenTari WDG (ABG

6314) on a Colony of Honey Bees: Lab Project Number: 43052: ABC 43052. Unpublished study prepared by ABC Labs, Inc. 210 pages.

443798

- 01 Ecogen, Inc. 1997. Bioassay Studies: Bacillus thuringiensis subspecies kurstaki

EG7826 Construct 11724: Lepinox Bioinsecticide: Lab Pr oject Number: ECO

INS.96001. Unpublished study. 5 pages.Bacillus thuringiensis EPA

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### 99 MRID No. Study Description

443798

- 02 Baum J. 1997. Southern Blot Analyses: Bacillus thuringiensis subspecies

kurstaki EG7826 Construct 11097: Lepinox Bioinsecticide: Lab Project
Number: 7826

- 11097

- RD

- 9702. Unpublished study prepared by Ecogen, Inc. 9

pages.

443916

- 01 Harrington K. 1997. NCCLS Standardized Disk Susceptibility Test of Bacillus

thuringiensis strain EG2215: Final Report: Lab Project Number: L08687. Unpublished study prepared by IIT Research Institute. 17 pages.

443916

- 02 Harrington K. 1997. Biochemical and Morphological Characteristics of

Bacillus thuringiensis strain EG2215: Final Report: Lab Project Number: L08687. Unpublished study prepared by IIT Research Institute. 15 pages.

443916

- 03 Gao M. 1997. Bacillus thuringiensis israelensis EG2215 Toxin Protein Analysis

of Technical Grade Active Ingredient Powders by SDS

- PAGE: Lab Project Number: QCPRO063097. Unpublished study prepared by Ecogen, Inc. 6 pages.

444238

- 01 Baum J. 1997. BTI Technical Powder: Bacillus thuringiensis subspecies

israelensis strain EG2215: Product Identity: Lab Project Number: ECOBTI

9701. Unpublished study prepared by Ecogen, Inc. 11 pages.

447915

- 01 Dicker H, Hudson A. 1999. Cutlass Technical Powder Bioinsecticide:

Manufacturing Process: Discussion of the Forma tion of Unintentional Ingredients: Analysis of Sample

— QC: Certification of Limits: Lab Project
Number: PROD

- CUTLASSTECH

- 199. Unpublished study prepared by Ecogen, Inc. 23 pages.

447915

- 03 Dicker H, Hudson A. 1999. Condor Technical Powder Bioinsecticide:

Manufacturing Process: Discussion of the Formation of Unintentional Ingredients: Analysis of Sample

— QC: Certification of Limits: Lab Project
Number: PROD

- CONDORTECH

- 199. Unpublished study prepared by Ecogen, Inc. 24 pages.

447915

- 09 Dicker H, Hudson A. 1 999. Lepinox Insecticide: Manufacturing Process:

Discussion of the Formation of Unintentional Ingredients: Analysis of Sample

QC: Certification of Limits: Lab Project Number: PROD

- LEPINOXTECH

199. Unpublished study prepared by Ecogen, Inc. 24 pages.

447 916

- 01 Birkhold D. 1999. Fermentation Manufacturing Process for Bacillus

thuringiensis spp. aizawai at Abbott Laboratories: Lab Project Number:

BTAMAN

- 28R. Unpublished study prepared by Abbott Laboratories. 13 pages.Bacillus thuringiensis EPA

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### 100 MRID No. Study Description

447916

- 02 Birkhold D. 1999. Fermentat ion Manufacturing Process for Bacillus

thuringiensis spp. israelensis at Abbott Laboratories: Lab Project Number:

BTIMAN

- 28R. Unpublished study prepared by Abbott Laboratories. 13 pages.

447916

- 03 Birkhold D. 1999. Fermentation Manufacturing Process for Bacillus

thuringiensis spp. kurstaki at Abbott Laboratories: Lab Project Number:

BTKMAN

- 28R. Unpublished study prepared by Abbott Laboratories. 13 pages.

447916

- 04 Birkhold D. 1999. Fermentation Manufacturing Process for Bacillus

thuringiensis spp. tenebrionis at Abbott Laboratories: Lab Project Number:

BTTMAN

- 28R. Unpublished study prepared by Abbott Laboratories. 13 pages.

447915

- 07 Dicker H, Hudson A. 1999. CRYMAX Bioinsecticide: Manufacturing Process:

Discussion of the Formation of Unintentiona l Ingredients: Analysis of Sample

— QC: Certification of Limits: Lab Project Number: PROD

CRYMAXWDG

- 199. Unpublished study prepared by Ecogen, Inc. 26 pages.

447932

- 03 Couch T. 1999. Manufacturing Process of Bacillus thuringiensis israelensis and

kurstaki

. Unpublished study prepared by Becker Microbial Products, Inc. 83

pages.

448074

- 01 Eyal J. 1999. Manufacturing Process Description for Bacillus thuringiensis :

Lab Project Number: 011990

- A. Unpublished study prepared by Thermo Trilogy Corp. 270 pages.

4 49910

- 01 Putt A. 1999. Bti Technical Powder Bioinsecticide

— Toxicity to Water Fleas

( Daphnia magna ) Under Static

- Renewal Conditions: Lab Project Number: 11675.6129. Unpublished study prepared by Springborn Laboratories, Inc. 62

pages.

449910

- 02 Kuhn J. 1999. Acute Intraperitoneal Toxicity Study in Mice: Bti Technical

Powder: Final Report: Lab Project Number: 4721

- 98. Unpublished study prepared by Stillmeadow, Inc. 20 pages.

452330

- 01 Rowell R. 2000. Slurry Manufacturing Process for Xentari Pro ducts ( Bacillus

thuringiensis subsp. aizawai ) at Abbott Laboratories: Lab Project Number:

BTASLMAN

- V28R. Unpublished study prepared by Abbott Laboratories. 27

pages.

452330

- 02 Rowell R. 2000. Slurry Manufacturing Process for Vectobac Products ( Bacillus

t huringiensis subsp. israelensis ) at Abbott Laboratories: Lab Project Number:

BTISLMAN

- V

- 28R. Unpublished study prepared by Abbott Laboratories. 27

pages.Bacillus thuringiensis EPA

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### 101 MRID No. Study Description

452330

- 03 Rowell R. 2000. Slurry Manufacturing Process for Dipel/Foray Products

( Bacillus thuringiensis subsp. kurstaki ) at Abbott Laboratories: Lab Project
Number: BTKSLMAN

- V28R. Unpublished study prepared by Abbott Laboratories. 27 pages.

452330

- 05 Rowell R. 2000. Slurry Manufacturing Process for Novodor Products ( Bacillus

thuringiensis sub sp. tenebrionis ) at Abbott Laboratories: Lab Project Number:

BTTSLMAN

- V28R. Unpublished study prepared by Abbott Laboratories. 27

pages.

453756

- 01 Wang Y. 2001. Physical and Chemical Properties of VBC

- 60008: Lab Project

Number: 48010

- 01

- 01. Unpublished s tudy prepared by Valent BioSciences Corp. 25 pages.

453756

- 02 Nair A. 1996. HPLC Assay for (Beta)

- Exotoxin in Florbac Strain NB200

Technical Powder: Lab Project Number: 96

- 25

- 399. Unpublished study prepared by Valent BioSciences Corp. 12 pages.

453756

- 03 Noer A. 1995. Florbac Tech Batch BEB 0035 Intratracheal

Toxicity/Pathogenicity Study in Rats: Lab Project Number: 932227. Unpublished study prepared by Novo Nordisk A/S. 85 pages.

453756

- 04 Harde T. 1994. Bacillus thuringiensis subsp. aizawai Acute Oral

Toxicity/Pathogenicity Study in Rats Dosed Florbac Tech: Lab Project Number: 932225. Unpublished study prepared by Novo Nordisk A/S. 42 pages.

453756

- 06 Harde T. 1995. Bacillus thuringiensis subsp . aizawai Acute Intravenous

Toxicity/Pathogeni city Study in Rats Dosed Florbac Tech: Lab Project Number: 932228. Unpublished study prepared by Novo Nordisk A/S. 41 pages.

453756

- 09 Campbell S, Grimes J, Beavers J. 1995. Florbac Tech: An Avian Oral

Pathogenicity and Toxicity Study in the Northern Bob white: Lab Project
Number: 254

- 130. Unpublished study prepared by Wildlife International Ltd. 41 pages.

453756

- 10 Campbell S, Grimes J, Beavers J. 1995. Florbac Tech: An Avian Oral

Pathogenicity and Toxicity Study in the Mallard: Lab Project Number: 254

- 131. Unpublished study prepared by Wildlife International Ltd. 42 pages.

453756

- 11 Memmert U. 1994. Chronic Toxicity and Pathogenicity of Florbac Tech: To

Rainbow Trout ( Oncorhynchus mykiss ): In a Prolonged Semistatic Test (30 Days): Lab Project Number : RCC 427612: 932015. Unpublished study prepared by RCC Umweltchemie GmbH & Co. KG. 40 pages.Bacillus thuringiensis EPA

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### 102 MRID No. Study Description

453756

- 12 Memmert U. 1994. Influence of Florbac Tech: On Survival and Reproduction

of Daphnia magna in a Prolonged Semistatic Test (22 Days): Lab Project Number: RCC 427623: 932016. Unpublished study prepared by RCC Umweltchemie GmbH & Co. KG. 32 pages.

453756

- 13 Palmer S, Beavers J. 1995. Florbac Tech: A Dietary Pathogenicity and Toxicity

Study with Parasitic Hymenoptera ( Nasonia vitripennis ): Lab Project Number:

254

- 135. Unpublished study prepared by Wildlife International Ltd. 28 pages.

453756

- 14 Palmer S, Beavers J. 1995. Florbac Tech: A Dietary Pathogenicity and Toxicity

Study with the Ladybird Beetle ( Hippodamia convergens ): Lab Project
Number: 254

- 134A. Unpublished study prepared by Wildlife International Ltd. 31 pages.

453756

- 15 Palmer S, Beavers J. 1995. Florbac Tech: A Dietary Pathogenicity and Toxicity

Study with the Green Lacewing Larv ae ( Chrysopa carnea ): Lab Project
Number: 254

- 133. Unpublished study prepared by Wildlife International Ltd. 29 pages.

453756

- 16 Palmer S, Beavers J. 1995. Florbac Tech: A Dietary Pathogenicity and Toxicity

Study with the Honey Bee ( Apis mellifera ): Lab Project Number: 254

- 132B. Unpublished study prepared by Wildlife International Ltd. 30 pages.

454220

- 01 Rowell R. 2001. Product Chemistry of Florbac Slurry: Lab Project Number:

FLORSLUR.VBC. Unpublished study prepared by Abbott Laboratories. 114

pages.

457151

- 01 Rowell R, Benson T. 2002. Slurry Manufacturing Process for XenTari Products

( Bacillus thuringiensis subsp. aizawai ) at Abbott Laboratories: Lab Project Number: 60007 MAN 7/2/02. Unpublished study prepared by Abbott
Laboratories and Valent BioS ciences Corporation. 313 pages.

457152

- 01 Rowell R, Benson T. 2002. Slurry Manufacturing Process for Vectobac

Products ( Bacillus thuringiensis subsp. israelensis ) at Abbott Laboratories: Lab Project Number: 60010 MAN 7/2/02. Unpublished study prepared by Abbott Laboratories and Valent BioSciences Corporation. 313 pages.

457153

- 01 Rowell R, Benson T. 2002. Slurry Manufacturing Process for Dipel and For a y

Products ( Bacillus thuringiensis subsp. kurstaki ) at Abbott Laboratories: Lab Project Number: 60005 M AN 7/2/02. Unpublished study prepared by Abbott Laboratories and Valent Biosciences Corporation. 313 pages.Bacillus thuringiensis EPA

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### 103 MRID No. Study Description

457154

- 01 Rowell R, Benson T. 2000. Slurry Manufacturing Process for Novodor Products

( Bacillus thuringiensis subsp. tenebrionis ) at Abbott Labora tories: Lab Project Number: 60009 MAN 7/2/02. Unpublished study prepared by Abbott Laboratories. 311 pages.

461411

- 01 Chen C, Hargrove J. 2003. Amended Manufacturing Process Description for

Bacillus thuringiensis : Javelin Technical Concentrate. Unpublished study prepared by Certis USA, LLC. 21 pages.

461416

- 01 Chen C, Hargrove J. 2003. Amended Manufacturing Process Description for

Bacillus thuringiensis : Technical CGA

- 237218 (Agree). Unpublished study prepared by Certis USA, LLC. 20 pages.

461417

- 01 Chen C, Hargrove J. 2003. Amended Manufacturing Process Description for

Bacillus thuringiensis : Thuricide Technical Concentrate. Unpublished study prepared by Certis USA, LLC. 20 pages.

461861

- 01 Chen C, Hargrove J. 2003. Amended Manufacturing Process Description for

Bacillus thuringiensis : Teknar Technical Concentrate. Unpublished study prepared by Certis USA. 19 pages.

461862

- 01 Hargrove J, Iqbal M, Chen C. 2003. Amended Manufacturing Process

Description for Bacillus thuringiensis : CryMax TG AI. Project Number: QC83006, QC84010, QC83008. Unpublished study prepared by Certis USA, LLC. 67 pages.

462170

- 01 Hargrove J, Iqbal M, Chen C. 2003. Amended Manufacturing Process

Description for Bacillus thuringiensis : Condor TGAI. Unpublished study prepared by Certis USA, LLC. 19 pages.

462231

- 01 Hargrove J, Iqbal M, Chen C. 2003. Amended Manufacturing Process

Description for Bacillus thuringiensis : Lepinox Technical. Unpublished study prepared by Certis USA, LLC. 76 pages.

462977

- 01 Chen C, Davi s D, Cunningham M. 2003. Amended Manufacturing Process

Description for Bacillus thuringiensis . Project Number: FC88001, 83006, QC84010. Unpublished study prepared by Certis USA, LLC. 90 pages.

463185

- 01 Roberts A. 2004. Updated Manufacturing Process for Becker Microbial

Products, Inc. Bacillus thuringiensis Products. Project Number: BRP/10/1, BPI/F/90/V06, LO/23. Unpublished study prepared by Technology Sciences Group, Inc. 95 pages.Bacillus thuringiensis EPA

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### 104 MRID No. Study Description

464235

- 00 Valent Biosciences Corp. 2004. Submission of Product Chemist ry Data in

Support of the Application for Registration of Florbac Slurry. Transmittal of 4
Studies.

464235

- 01 Rowell R. 2004. Method of Production and Quality Control for Florbac

Products ( Bacillus thuringiensis subsp. aizawai ). Project Number: VBC11/04/3. Unpublished study prepared by Abbott Laboratories. 105 pages.

464235

- 02 Nair A. 2004. High Performance Liquid Chromatography Assay for Type I and

Type II (Beta)

- Exotoxin and their Dephosphorylated Variants in Florbac Slurry (NB200). Project N umber: VBC/LG/C/04/10/0005. Unpublished study prepared by Valent Biosciences Corp. 19 pages.

464235

- 03 Nair A, Benson T, Nikolai T. 1996. Differences Between Xentari and Florbac

Production Strains. Project Number: VBC12/04/1. Unpublished study prepared
b y Abbott Laboratories. 18 pages.

464235

- 04 Pedersen K, Ronholt A. 1994. Report on the Fermentation, Recovery and

Characterization of Florbac HPWP, batch 082

- 31

- 1

- Bacillus thuringiensis var. aizawai , strain, AL 7011. Project Number: VBC12/04/2, PP/9401677

. Unpublished study prepared by Novo Nordisk A/S. 14 pages.

464708

- 00 Becker Microbial Products, Inc. 2005. Submission of Product Chemistry Data

in Support of the Registrations of BMP 144 Primary Powder and BMP 123 Primary Powder. Transmittal of 1 Study.

464708

- 01 Benzon G. 2004. Bioassay for Presence of Exotoxin in B.t.i. and B.t.k.

Fermentation Broths Produced by Becker Microbial Products, Inc. Project Number: BE04065. Unpublished study prepared by Benzon Research. 8 pages.

465198

- 01 Rowell R. 2005. Method of Production and Quality Control for Novodor

Products ( Bacillus thuringiensis subsp. tenebrionis ). Project Number: VBC/04/05/1. Unpublished study prepared by Abbott Laboratories. 106 pages.

465198

- 02 Nair A. 2005. High Performance Liquid Chromat ography Assay for Type I and

Type II B

- Exotoxin and their Dephosphorylated Variants in Novodor Slurry. Project Number: VBC/LG/C/03/02/0005. Unpublished study prepared by Valent BioSciences Corporation. 19 pages.

465246

- 01 Rowell R. 2005. Method of Produc tion and Quality Control for VectoBac

Products ( Bacillus thuringiensis subsp. israelensis ). Project Number: VBC/03/05/1. Unpublished study prepared by Abbott Laboratories. 207 pages.Bacillus thuringiensis EPA

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### 105 MRID No. Study Description

465246

- 02 Nair A. 2005. High Performance Liquid Chromatography Assay fo r Type I and

Type II B

- Exotoxin and their Dephosphorylated Variants in VectoBac Slurry. Project Number: VBC/LG/C/01/02/0005. Unpublished study prepared by Valent BioSciences Corporation. 18 pages.

465246

- 03 Cafarella M. 1999. ABG

- 6164/TP

- SDLW, ABG

- 6513/Slurry

- SDLW and ABG

6512/Slurry

- HFPC

- Toxicity to Water Fleas ( Daphnia magna ) Under Static

Renewal Conditions. Project Number: 2439/6138. Unpublished study prepared by Abbott Laboratories and Springborn Laboratories, Inc. 72 pages.

465246

- 04 Pu tt A. 1999. VectoBac TP (ABG

- 6164S)

- Toxicity to Water Fleas ( Daphnia

magna ) Under Static

- Renewal Conditions. Project Number: 2439/6137. Unpublished study prepared by Abbott Laboratories and Springborn Laboratories, Inc. 42 pages.

466382

- 01 Rowell R. 20 05. Method of Production and Quality Control for XenTari

Products ( Bacillus thuringiensis subsp. aizawai ). Project Number: VBC/08/15/1. Unpublished study prepared by Abbott Laboratories. 110 pages.

466382

- 02 Benzon G. 2005. Bioassays for Presence of Beta

- exotoxin in Samples of

Xentari Technical Slurry Using House Fly Larvae: Final Report. Project Number: VB05016B. Unpublished study prepared by Benzon Research. 10

pages.

466425

- 01 Rowell R. 2005. Method of Production and Quality Control for DiPel/Foray

Products ( Bacillus thuringiensis subsp. kurstaki ). Project Number: VBC/09/02/1. Unpublished study prepared by Valent BioSciences Corporation. 154 pages.

466425

- 02 Benzon G. 2005. Bioassays for Presence of Beta

- exotoxin in Samples of DiPel

Technical Slurry Using House Fly Larvae: Final Report. Project Number: VB05016. Unpublished study prepared by Benzon Research. 10 pages.

466493

- 01 Chen C. 2004. Ability of Certis’ Bacillus thuringiensis Production Cultures to

Produce Beta

- exotoxin. Unpublished stu dy prepared by Certis USA, LLC and Benzon Research. 16 pages.

466687

- 01 Rowell R. 2005. Method of Production and Quality Control for Teknar Products

( Bacillus thuringiensis subsp. israelensis ). Project Number: VBC/09/07/1. Unpublished study prepared by A bbott Laboratories. 155 pages.

466687

- 02 Benzon G. 2005. Bioassay for Presence of Beta

- exotoxin in a Sample of Teknar

Technical Slurry Using House Fly Larvae. Project Number: VB05024. Unpublished study prepared by Benzon Research. 10 pages.Bacillus thuringiensis EPA

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### 106 MRID No. Study Description

466687

- 03 S erben K. 2005. 21

- D Survival of Daphnia magna Exposed to VBC

- 60070.

Project Number: 2/11/0951, TOX0564. Unpublished study prepared by Vizon SciTec, Inc. 70 pages.

466755

- 01 Couch T. 2005. Bioassay for Presence of Beta Exotoxin in a Bacillus

thuringiensis Subspecies thuringiensis (HD

- 2) Fermentation Broth. Project Number: BE05068. Unpublished study prepared by Benzon Research. 7 pages.

485532

- 01 Libs J, Rose R. 2010. Phyllom SDS

- 502 MP, Product Identity and

Characterization. Unpublished study prepared by Phyllom, LLC. 10 pages.

485532

- 02 Rose R, Libs J. 2010. Phyllom SDS

- 502 MP, Manufacturing Process.

Unpublished study prepared by Phyllom, LLC. 6 pages.

485532

- 03 Libs J, Rose R. 2010. Phyllom SDS

- 502 MP, Discussion of Formation of

Unintentional Ingred ients. Unpublished study prepared by Phyllom, LLC. 6

pages.

485532

- 04 Libs J, Rose R. 2010. Phyllom SDS

- 502 MP, Analysis of Sample s . Unpublished

study prepared by Phyllom, LLC. 14 pages.

485532

- 08 Munley S. 2011. Bacillus thuringiensis subsp. galleriae , Strain SDS

- 502: Acute

Oral Toxicity/Pathogenicity Study in Rats. Project Number: DUPONT/20580 16248 1013. Unpublished study prepared by E.I. du Pont de Nemours and Company, and Phyllom, LLC. 51 pages.

485532

- 09 Munley S. 2011. Bacillus thuringiensis subsp. galleriae , Strain SDS

- 502: Acute

Pulmonary Toxicity/Pathogenicity Study in Rats. Project Number: DUPONT/20579 16248 1014. Unpublished study prepared by E.I. du Pont de Nemours and Company, and Phyllom, LLC. 56 pages.

485532

- 10 Munley S. 2011. Bacill us thuringiensis subsp. galleriae , Strain SDS

- 502: Acute

Intraperitoneal Injection Toxicity/Pathogenicity Study in Rats. Project Number: DUPONT/20581 16248 1015. Unpublished study prepared by Phyllom, LLC, and E.I. du Pont de Nemours and Company. 49 pages.

485532

- 11 Libs J, Rose R. 2008. Phyllom SDS

- 502 MP, Spore Clearance. Unpublished

study prepared by Phyllom, LLC. 27 pages.

485532

- 19 Borchert J. 2006. Avian Oral Limit Toxicity Test with Bacillus thuringiensis

subsp. galleriae Strain SDS

- 502 in Mallar d Ducks ( Anas platyrhynchos ): Final Report. Project Number: 06001. Unpublished study prepared by Genesis Laboratories, Inc. 58 pages.Bacillus thuringiensis EPA

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### 107 MRID No. Study Description

485532

- 21 Libs J, Rose R. 2010. Phyllom SDS

- 502 MP, Wild Mammal

Toxicity/Pathogenicity (Waiver Request). Unpublished study prepared by Phyllom, LLC. 3 pages.

485532

- 22 Libs J, Rose R. 2010. Phyllom SDS

- 502 MP, Freshwater Fish

Toxicity/Pathogenicity (Waiver Request). Unpublished study prepared by Phyllom, LLC. 3 pages.

485532

- 23 Hartwell T. 2009. Bacillus thuringiensi s subsp. galleriae Strain SDS

- 502:

Microbial Pest Control Agent (MPCA) Freshwater Aquatic Invertebrate Test
with Daphnia magna : Final Report. Project Number: 13048/09. Unpublished study prepared by Stillmeadow, Inc. 27 pages.

485532

- 24 Libs J, Rose R. 2011. Phyllom SDS

- 502 MP, Estuarine/Marine Fish Testing and

Estuarine/Marine Invertebrate Testing (Waiver Request). Unpublished study prepared by Phyllom, LLC. 3 pages.

485532

- 25 Libs J, Rose R. 2011. Phyllom SDS

- 502 MP, Nontarget Plant Testing (Waiver

R equest). Unpublished study prepared by Phyllom, LLC. 3 pages.

485532

- 26 Porch J, Krueger H. 2011. Bacillus thuringiensis subsp. galleriae Strain SDS

502 TGAI: A Dietary Pathogenicity and Toxicity Study with the Ladybird Beetle ( Hippodamia convergens ): Final Report. Project Number: 702/101. Unpublished study prepared by Wildlife International, Ltd. 31 pages.

485532

- 27 Asano S, Yamashita C, Iizuka T. 2003. A Strain of Bacillus thuringiensis subsp.

galleriae Containing a Novel Cry8 Gene Highly Toxic to A nomala cuprea (Coleoptera: Scarabaeidae). Biological Control 28:191

– 196.

485532

- 28 Rose R, Libs J. 2010. Phyllom SDS

- 502 MP, Bacillus thuringiensis subsp.

galleriae , Strain SDS

- 502, Toxicity to the Colorado Potato Beetle, Leptinotarsa
decemlineata , Coleo ptera: Chrysomelidae, Acute Nontarget Insect Testing, Tier I. Project Number: PHY/SDS502/GRUB. Unpublished study prepared by University of Maryland. 5 pages.

485532

- 29 Libs J. 2010. Phyllom SDS

- 502 MP, Bacillus thuringiensis subsp. galleriae

,

Strain SDS

- 502, Toxicity to the Spotted Cucumber Beetle/Southern Corn Rootworm, Diabrotica undecimpunctata howardi , Coleoptera: Chrysomelidae, Acute Nontarget Insect Testing, Tier I. Unpublished study prepared by Phyllom, LLC. 4 pages.Bacillus thuringiensis EPA

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### 108 MRID No. Study Description

485532

- 30 Richards R. 2006. E valuation of Dietary Effects(s) of SDS

- 502 Cry8Da on

Larval Honeybee Development ( Apis mellifera L.). Project Number: CAR/152/05. Unpublished study prepared by California Agricultural Research, Inc. 37 pages.

485592

- 01 Benson T. 2011. Microbial Characterization of Bacillus thuringiensis subsp.

kurstaki , Strain VBTS

- 2546. Project Number: VBTS/2546/2011/1. Unpublished study prepared by Valent BioSciences Corporation. 62 pages.

485592

- 02 Benzon G. 2010. Bioassay for Prese nce of Beta

- exotoxin in VBC

- 60225 using

House Fly Larvae: Final Report. Project Number: VB10022. Unpublished study prepared by Benzon Research, Inc. 11 pages.

485592

- 05 Devisetty B, Rowell R. 2011. Method of Production and Quality Control for

VBC

- 60225 (

Bacillus thuringiensis subsp. kurstaki , Strain VBTS

- 2546, Technical Powder). Project Number: VBC/60225/MP/2. Unpublished study prepared by Valent Biosciences Corporation and Abbott Laboratories. 41 pages.

485592

- 06 Bujor D. 2011. VBC

- 60225: Stability to Normal and Elevated Temperatures,

Metals and Metal Ions: Request for No further Testing. Project Number: VBTS/2546/R/3. Unpublished study prepared by Valent BioSciences Corporation. 10 pages.

485592

- 07 Comb A. 2011. VBC

- 60225: Physico

- Chemical Properties . Project Number:

ZAB0151. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 32

pages.

485592

- 08 Bujor D. 2011. VBC

- 60225: Acute Oral Toxicity/Pathogenicity: Request for No

Further Testing. Project Number: VBTS/2546/R/1. Unpublished study prepared by Valent BioSciences Corporation. 5 pages.

485592

- 10 Gingras B. 2011. Toxicity/Pathogenicity Testing of VBC

- 60225 Following

Acute Intratracheal Challenge in Rats: Final Report. Project Number: 2297/SN2. Unpublished study prepared by IIT Researc h Institute. 76 pages.

485592

- 11 Gingras B. 2011. Toxicity/Pathogenicity Testing of VBC

- 60225 Following

Acute Intravenous Challenge in Rats: Final Report. Project Number: 2297/SN1. Unpublished study prepared by IIT Research Institute. 80 pages.

485592

- 18 Hubbard P, Beavers J. 2011. Bacillus thuringiensis , subsp. kurstaki , (Btk),

Strain VBTS

- 2546: An Avian Oral Pathogenicity and Toxicity Study in the Northern Bobwhite. Project Number: 529/124. Unpublished study prepared by Wildlife International, Ltd. 52 pages.Bacillus thuringiensis EPA

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### 109 MRID No. Study Description

485592

- 19 Bujor D. 2011. VBC

- 60225: Freshwater Fish Toxicity/Pathogenicity: Request

for No Further Testing. Project Number: VBTS/2546/R/2. Unpublished study prepared by Valent BioSciences Corporation. 6 pages.

485592

- 20 Gallagher S, Krueger H. 2011. Bacillus thuringiensis , subsp. kurstaki , (Btk),

Strain VBTS

- 2546: A 21

- day Life Cycle Toxicity and Pathogenicity Test with the Cladoceran (

Daphnia magna ): Final Report. Project Number: 592A/120. Unpublished study prepared by W ildlife International, Ltd. 77 pages.

485592

- 21 Herrero M, Bujor D. 2011. VBC

- 60225: Nontarget Insect Testing: Request for

No Further Testing. Project Number: VBTS/2546/R/4. Unpublished study prepared by Valent BioSciences Corporation. 25 pages.

485592

- 22 Warmers C. 2005. DiPel Technical Powder: Acute Toxicity to the Aphid

Parasitoid. Aphidius rhopalosiphi De Stefani Perez (Hymenoptera, Braconidae) in the Laboratory (Limit Test): Final Report. Project Number: 20051212/01/NLAP. Unpublished study pr epared by GAB Biotechnologie Gmbh. 30 pages.

485592

- 23 Warmers C. 2005. DiPel Technical Powder: Toxicity to the Predatory Mite,

Typhlodromus pyri Scheuten (Acari, Phytoseiidae) in the Laboratory (Limit Test): Final Report. Project Number: 20051212/01

- NLT p. Unpublished study prepared by GAB Biotechnologie Gmbh. 29 pages.

485592

- 24 Verge E. 2010. VBC

- 60225

- Acute Oral and Contact Toxicity to the Honeybee

Apis mellifera L. in the Laboratory: Draft Report. Project Number: VBC/60225
S10/00883 S10/00883/L1/B LEU. Unpublished study prepared by Eurofins

- GAB GmbH. 28 pages.

485592

- 37 Bujor D. 2011. VBC

- 60225: Wild Mammal Toxicity/Pathogenicity: Request for

No Further Testing. Project Number: VBTS/2546/W/2. Unpublished study prepared by Valent BioSciences Corporation. 5 pages.

485592

- 38 Bujor D. 2011. VBC

- 60225: Estuarine/Marine Fish and Invertebrate Testing:

Waiver Request. Project Number: VBTS/2546/W/3. Unpublished study prepared by Valent BioSciences Corporation. 4 pages.

485592

- 39 Herrero M, Bujor D . 2011. VBC

- 60225: Nontarget Plant Testing. Project

Number: VBTS/2546/W/4. Unpublished study prepared by Valent BioSciences Corporation. 4 pages.

486774

- 02 Bujor D. 2011. VBC

- 60225: Product Analysis and Physical and Chemical

Properties: Waiver Request. P roject Number: VBC/60225/W/1. Unpublished study prepared by Valent BioSciences Corporation. 13 pages.Bacillus thuringiensis EPA

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### 110 MRID No. Study Description

486826

- 01 Borovsky D. 2010. Product Identity for Summit’s Bacillus thuringiensis subsp.

israelensis (Bti) MP. Unpublished study prepared by University o f Florida

IFAS. 16 pages.

486826

- 02 Benzon G, Finkenbinder C. 2011. Product Identity (Bioassay

Analysis/Identity/Characterization) of Summit’s Bacillus thuringiensis subsp.
israelensis (Bti) MP. Unpublished study prepared by Benzon Research. 16

pages.

486826

- 03 Rose R. 2011. Manufacturing Process for Summit’s Bacillus thuringiensis

subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 6 pages.

486826

- 04 Rose R. 2011. Deposition of a Sample in a Nationally Recognized Culture

Co llection of Summit’s Bacillus thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3 pages.

486826

- 05 Rose R. 2011. Discussion of Formation of Unintentional Ingredients for

Summit’s Bacillus thuringiensis subsp. is raelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3 pages.

486826

- 06 Benzon G, Finkenbinder C. 2011. Analysis of Summit’s Bacillus thuringiensis

subsp. israelensi s (Bti) MP. Unpublished study prepared by Benzon Research. 21 pages.

486826

- 08 Rose R. 2011. Physical and Chemical Properties for Summit’s Bacillus

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 12 pages.

486826

- 10 Rose R. 2011. Acute Oral Toxicity/Pathogenicity (TGAI) for Summit’s Bacillus

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3 pages.

486826

- 11 Rose R. 2011. Acute Pulmonary Toxicity/Pathogenicity for Summit’s Bacillus

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3 pages.

486826

- 12 Monds K. 2011 Bacillus thuringiensis subsp./var. israelensis Strain SUM

- 6218,

Primary Powder/MUP/TGAI: Acute Injection Toxicity/Infe ctivity Study in Rats: Final Report. Project Number: 14546/10. Unpublished study prepared by Stillmeadow, Inc. 29 pages.Bacillus thuringiensis EPA

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### 111 MRID No. Study Description

486826

- 20 Rose R. 2011. Avian Oral Toxicity for Summit’s Bacillus thuringiensis subsp.

israelensis (Bti) MP. Unpublished study prepar ed by Summit Chemical Co. 4

pages.

486826

- 22 Rose R. 2011. Wild Mammal Toxicity/Pathogenicity for Summit’s Bacillus

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 4 pages.

486826

- 23 Rose R. 2011. Freshwater Fish Toxicity/Pathogenicity for Summit’s Bacillus

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3 pages.

486826

- 24 Brunner S. 2011. Bacillus thuringiensis subsp./var. israelensis , St rain: Sum

6218, Primary Powder/MUP/TGAI: MPCA Freshwater Aquatic Invertebrate
Test with Daphnia magna : Final Report. Project Number: 14472/10. Unpublished study prepared by Stillmeadow, Inc. 33 pages.

486826

- 25 Rose R. 2011. Estuarine and Marine Fish and Invertebrate Testing for Summit’s

Bacillus thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3 pages.

486826

- 26 Rose R. 2011. Nontarget Plant Testing for Summit’s Bacillus thuringiensi s

subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3 pages.

486826

- 27 Rose R. 2011. Nontarget Insect Testing for Summit’s Bacillus thuringiensis

subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3 pages.

486826

- 28 Rose R. 2011. Honeybee Testing for Summit’s Bacillus thuringiensis subsp.

israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3

pages.

487168

- 01 Libs J. 2012. Physical and Chemical Properties for Phyllom SDS

- 502 MP,

Bacillus thuringiensis subsp. galleriae . Unpublished study prepared by Phyllom, LLC. 15 pages.

487168

- 03 Bauer L, Londono D. 2012. Acute Nontarget Insect Testing, Tier 1: Parasitic

Hymenoptera Wasps: Tetrastichus planipennisi

, Oobius agrili

, Spathius agrili

, and Atanycolus cappaerti . Unpublished study prepared by U.S. Forest Service. 9 pages.Bacillus thuringiensis EPA

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### 112 MRID No. Study Description

489401

- 07 Rose R. 2012. Product

- Specific Data for the End

- Use Pesticide Product,

Phyllom grubGONE! Granular (G), and the Manufacturing

- Use Pesticide Product, Phyllom SDS

- 50 2 MP. Unpublished study prepared by Phyllom, LLC. 8 pages.

489401

- 08 Libs J. 2012. Phyllom Bacillus thuringiensis subsp./var. galleriae , Strain SDS

502, Primary Powder TGAI/MUP/MP Rationale/Clearance Demonstration of Lack of, or No Infectivity in Studies Conducted for Registration of Phyllom

SDS

- 502 MP. Unpublished study prepared by Phyllom, LLC. 9 pages.

489542

- 01 Rodrigue N. 2010. Analytical Report: Semiannual Tap, Fresh, & Salt Water.

Unpublished study prepared by Test America, Inc. 60 pages.

48954 2

- 02 Doig A. 2012. Each Lot of Spore Preparation, Prior to the Addition of Other

Materials, Shall be Tested by Subcutaneous Injection of at Least 1 Million Spores Into Each of Five Laboratory Test Mice for Summit’s Bacillus thuringiensis subsp. israelensis (Bti) MP. Project Number: 16557/12. Unpublished study prepared by Stillmeadow, Inc. 4 pages.

489542

- 03 Monds K. 2012. Bacillus thuringiensis subsp./var. israelensis Strain SUM

6218, Primary Powder/MUP/TGAI: Amended Final Report. Project Number:
14546/10 . Unpublished study prepared by Stillmeadow, Inc. 34 pages.

489542

- 04 Thomas J, Barrow S. 2011. Pre

- and Post

- Toxicity CFU Analysis. Project

Number: 14577/10. Unpublished study prepared by Stillmeadow, Inc. 3 pages.

489731

- 01 Doig A. 2012. Acute Inhalation Toxicity in Rats: Bacillus thuringiensis serovar

galleriae SDS

- 502 (BTG SDS

- 502) TGAI Powder. Project Number: 16757/12. Unpublished study prepared by Stillmeadow, Inc. 17 pages.

490320

- 01 Rose R. 2011. Manufacturing Process for Summit’s Bacillus thuringiensis

subsp. israelensis (Bti) MP. Unpublished study prepared by Robert Rose. 6

pages.

490321

- 01 Koester D. 2012. Spore Preparations of Bacillus thuringiensis (Berliner) Shall

be Produced by Pure Culture Fermentation

- for Summit’s Bacillus thuringiensis subsp./var/ israelensis (Bti), Strain SUM6218, MP. Project Number: R2012/365. Unpublished study prepared by The MicroStarLab, Ltd. 6

pages.Bacillus thuringiensis EPA

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### 113 MRID No. Study Description

490540

- 01 Koester D. 2013. Spore Preparations o f Bacillus thuringiensis (Berliner) Shall

be Produced by Pure Culture Fermentation

- for Summit’s Bacillus thuringiensis subsp./var/ israelensis (Bti), Strain SUM

- 6218, MP. Project Number: R2012/365/4. Unpublished study prepared by MicroStarLab, Ltd. 7

pag es.

490940

- 01 Benzon G, Finkenbin d er C. 2013. Phyllom Bacillus thuringiensis subsp.

galleriae , Strain SDS

- 502 MP (TGAI) Primary Powder beta

- Exotoxin Bioassay

on Musca domestica (House Fly Larvae), Diptera: Muscidae. Project Number: PH13001, PH13002. Unpu blished study prepared by Benzon Research. 14

pages.

490940

- 02 Libs J. 2013. Phyllom Manufacturing Process Quality Control Supplement to

MRID No. 485532

- 02 for Phyllom’s Bacillus thuringiensis subsp. galleriae

, Strain SDS

- 502, MP (TGAI). Unpublished study prepared by Phyllom, LLC. 5

pages.

490940

- 03 Doig A. 2013. Phyllom, LLC Bacillus thuringiensis subsp. galleriae , Strain

SDS

- 502, MP (TGAI) Primary Powder MPCA Subcutaneous Injection Safety Test in Mice. Project Number: 17193/13. Unpublished study p repared by Stillmeadow, Inc. 16 pages.

490940

- 04 Matthews T. 2013. Phyllom Bacillus thuringiensis subsp. galleriae , Strain SDS

502, MP (TGAI) Primary Powder Colony Forming Units (CFU) and Culture Purity Quality Control (QC) Analyses. Project Number: PHY/6/13/1. Unpublished study prepared by San Diego State University. 12 pages.

492913

- 01 Matthews T. 2013. Phyllom Bacillus thuringiensis subsp. galleriae , Strain SDS

502, MP (TGAI) Primary Powder pH of Water Solutions or Suspensions. Project Number: PH Y/6/13/4. Unpublished study prepared by Bio, Tech, and Beyond. 5 pages.

493669

- 01 Rose R, Finkenbinder C, Capano J. 2014. Storage Stability of Summit’s Bti MP

Interim Study Report. Project Number: SU13004, SU14002. Unpublished study prepared by Benzon Re search. 9 pages.

494011

- 01 Matthews T. 2014. Storage Stability of Cry8Da Protein Active Ingredient from

Phyllom Bacillus thuringiensis subsp. galleriae , Strain SDS

- 502, MP (TGAI) Primary Powder. Project Number: PHY/14/1. Unpublished study prepared by

San Diego State University and Bio, Tech, and Beyond. 16 pages.Bacillus thuringiensis EPA

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### 114 MRID No. Study Description

494011

- 02 Libs J. 2014. Analysis of Corrosion and Stability of Phyllom Bacillus

thuringiensis subsp. galleriae , Strain SDS

- 502, MP (TGAI) Primary Powder Packing Material. Project Number: PHY/14 /3. Unpublished study prepared by Phyllom BioProducts Corporation. 6 pages.

494592

- 01 Rose R, Finkenbinder C, Capano J. 2014. Storage Stability of Summit’s Bti

MP: Final Report. Project Number: SU13004, SU14002, SU14007. Unpublished study prepared by Ben zon Research, Inc. 10 pages.

494632

- 01 Matthews T. 2014. Addendum to Storage Stability of Cry8Da Protein Active

Ingredient From Phyllom Bacillus thuringiensis subsp. galleriae , Strain SDS

502, MP (TGAI) Primary Powder. Project Number: PHY/14/1. Unpublish ed study prepared by San Diego State University and Bio, Tech, and Beyond. 11pages.

B. U.S. Environmental Protection Agency Risk Assessment and Other Memoranda

U.S. EPA. 2013c. Bacillus thuringiensis subsp. galleriae strain SDS

- 502. Memorandum from J.V. Gagliardi, Ph.D. through J.L. Kough, Ph.D. to J. Kausch, dated April 30, 2013.

U.S. EPA. 2013d. Environmental Risk Assessment for the FIFRA Section 3 Registration of Bacillus thuringiensis subsp. galleriae strain SDS

- 502 (EPA File Symbols 88347

- R, 88347

- E, and 88347

- G). Memorandum from G. Tomimatsu, Ph.D. through S. Borges to J. Kausch, dated May 14, 2013.

U.S. EPA. 2013e. Review of the Registrant’s Response to the Deficiencies Found by the Agency in Its
Review of Pro duct Chemistry and Manufacturing Process for the Registration of the TGAI Bt

. israelensis strain SUM

- 6218. Memorandum from I.S. Barsoum, Ph.D. through J.L. Kough, Ph.D. to D. Greenway, dated January 23, 2013.

U.S. EPA. 2013f. Review of the Registrant’s Response to the Deficiencies Found by the Agency in Its Review of Product Chemistry, Manufacturing Process for the Registration of the TGAI Bt

. israelensis strain SUM

- 6218. Memorandum from I.S. Barsoum, Ph.D. thr ough J.L. Kough, Ph.D. to D. Greenway, dated March 12, 2013.

U.S. EPA. 2013g. Environmental Risk Assessment for the FIFRA Section 3 Registration of Bacillus thuringiensis subsp. israelensis strain SUM

- 6218. Memorandum from S. Borges to D. Greenway,
dated April 17, 2013.

U.S. EPA. 2012b. Bacillus thuringiensis serotype galleria strain SDS

- 502. Memorandum from J.V. Gagliardi, Ph.D. through J.L. Kough, Ph.D. to J. Kausch, dated December 18, 2012.

U.S. EPA. 2012c. Review of Product Chemistry, Acute Injection Tox/Path Study, and Waiver Request for Toxicity Data Requirements for Section 3 Registration of the TGAI: Bacillus thuringiensisBacillus thuringiensis EPA

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### 115 israelensis strain SUM

- 6218. Memorandum from I.S. Barsoum, Ph.D. through J.L. Kough, Ph.D to D. Greenway, dated July 10, 2012.

U.S. EPA. 2012d. Review of the Registrant’s Response to the Deficiencies Found by the Agency in Its Review of Product Chemistry, Manufacturing Process, and Acute Toxicity Studies for the Regist ration of the TGAI Bt

. israelensis strain SUM

- 6218. Memorandum from I.S. Barsoum, Ph.D. through J.L. Kough, Ph.D. to D. Greenway, dated November 13, 2012.

U.S. EPA. 2012e. Review of the Registrant’s Response to the Deficiencies Found by the Agency in Its Review of the Freshwater Aquatic Invertebrate Test with Daphnia magna . Memorandum from A. Waggoner to D. Greenway, dated December 10, 2012.

U.S. EPA. 2005 a . Review of Resubmitted Studies on the Manufacturing Process, Quality Control, and β
Exotoxin Tes ting for Florbac Products (EPA Reg. No. 73049

- AI) . Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated May 5, 2005.

U.S. EPA. 2005c. Review of Res ubmitted Studies on the Manufacturing Process, Quality Control, and β Exotoxin Testing for Novodor Products (EPA Reg. No. 73049

- AU) in Response to Deficiencies Noted by the Agency in a Memorandum Sent to the Registrant on 9/16/2004. Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated October 14, 2005.

U.S. EPA. 2005d. Review of Resubmitted Studies on the Manufacturing Process, Quality Control, and β Exotoxin Bioassay Testing for XenTari Products (EPA Reg. No. 73049

- AG) in Response to Deficiencies Noted by the Agency in a Memorandum Sent to t he Registrant on 9/16/2004. Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated November 16, 2005.

U.S. EPA. 2005e. Review of Resubmitted Studies on the Manufacturing Process, Quality Control, and β Exotoxin Bioassay Test ing for Dipel/Foray Products (EPA Reg. No. 73049

- AE) in Response to Deficiencies Noted by the Agency in a Memorandum Sent to the Registrant on 9/16/2004. Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated November 16, 200 5.

U.S. EPA. 2005f. Review of Resubmitted Studies on the Manufacturing Process, Quality Control, and β Exotoxin Testing for VectoBac Products (EPA Reg. No. 73049

- AR) in Response to Deficiencies Noted by the Agency in a Memorandum Sent to the Registrant on 9/16/2004. Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated October 14, 2005.

U.S. EPA. 2005j. Review of Submitted Studies on the Manufacturing Process, Quality Control, β Exotoxin Bioassay Testing, and a 21 Days Dap hnia Survival Study, in Support of the Application for Registration of Teknar Products (EPA Reg. No. 73049

- UEI). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to P. Moe, dated December 1, 2005.

U.S. EPA. 2004 a . Registration of Lepinox Bioinsecticide (EPA Reg. No. 70051

- 87). Memorandum from I.S. Barsoum, Ph.D. through W.S. Schneider, Ph.D., dated September 9, 2014.Bacillus thuringiensis EPA

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### 116 U.S. EPA. 2004b. Review of the Manufacturing Process for Novodor (EPA Reg. No. 73049

- AU). Memorandum from I.S. Barsoum, Ph .D. through W. Schneider, Ph.D. to A. Reynolds, dated September 16, 2004.

U.S. EPA. 2004c. Review of the Manufacturing Process for XenTari (EPA Reg. No. 73049

- AG). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated August 25, 2004.

U.S. EPA. 2004d. Registration of GCA

- 237218 Technical Powder (EPA Reg. No. 70051

- 48). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated September 9, 2004.

U.S. EPA. 2004e. Review of the Manufacturing P rocess for Dipel & Foray (EPA Reg. No. 73049

- AE). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated September 16, 2004.

U.S. EPA. 2004f. Registration of Crymax Bioinsecticide (EPA Reg. No. 70051

- 86). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated August 3, 2004.

U.S. EPA. 2004g. Registration of Condor Technical Powder (EPA Reg. No. 70051

- 83). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated S eptember 9, 2004.

U.S. EPA. 2004h. Registration of Cutlass Bioinsecticide (EPA Reg. No. 70051

- 84). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated September 9, 2004.

U.S. EPA. 2004i. Review of the Manufacturing Proce ss for Vectobac (EPA Reg. No. 73049

- AR). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated September 16, 2004.

U.S. EPA. 2004j. Review of Bacillus thuringiensis subspecies kurstaki , strain HD

- 263, BMP 123 Primary Powder (EPA Reg. No. 62637

- 9) and Bacillus thuringiensis subspecies israelensis , serotype H14, BMP 144 Primary Powder (EPA Reg. No. 62637

- 7). Memorandum from A. Fellman through W. Schneider, Ph.D. to A. Reynolds, dated September 30, 2004.

U.S. EPA. 2004k. Regis tration of Thuricide Technical Concentrate (EPA Reg. No. 70051

- 68). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated September 9, 2004.

U.S. EPA. 2004l. Registration of Javelin Technical Concentrate (EPA Reg. No. 70051

- 67). Memorandum from I.S. Barsoum, Ph.D. through W. Schneider, Ph.D. to A. Reynolds, dated September 9, 2004.

U.S. EPA. 2003. Review of Ecological Studies Including Avian Oral Toxicity (Mallard Duck and Bobwhite Quail), Aquatic Toxicity (Rainbow Trout) , Aquatic Invertebrate Toxicity ( Daphnia

magna ), and Non

- Target Insect Toxicity (Parasitic Hymenoptera, Lady Beetle, Green Lacewing and Honey Bee) Testing for Florbac Slurry Biological Larvicide. Memorandum from R. Rose through Z. Vaituzis, Ph.D. to A. Reynolds, dated October 30, 2003.Bacillus thuringiensis EPA

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### 117 U.S. EPA. 200 2 a . BPPD Review of Data Submitted by Valent Biosciences Corporation to Support Registration of Florbac Slurry Biological Larvicide. Memorandum from M.T. Watson, Ph.D. and C. Etsitty through J.L. Kough, Ph.D. to A. Reynolds, dated April 10, 2002.

U.S. EPA. 2002b. Registration of Lepinox Insecticide (EPA Reg. No. 70051

- 87). Memorandum from I.S. Barsoum, Ph.D. through R. Sjoblad, Ph.D. to A. Reynolds, dated October 29, 2002.

U.S. EPA. 2002c. Registration of Agree Technical Powder (EPA Reg. No. 70051

- 48). Mem orandum from I.S. Barsoum, Ph.D. through R. Sjoblad, Ph.D. to A. Reynolds, dated November 27, 2002.

U.S. EPA. 2002d. Registration of Crymax Bioinsecticide (EPA Reg. No. 70051

- 86). Memorandum from I.S. Barsoum, Ph.D. through R. Sjoblad, Ph.D. to A. Reynolds, dated October 29, 2002.

U.S. EPA. 2002e. Registration of Condor Technical Powder Bioinsecticide (EPA Reg. No. 70051

- 83). Memorandum from I.S. Barsoum, Ph.D. through R. Sjo blad, Ph.D. to A. Reynolds, dated October 29, 2002.

U.S. EPA. 2002f. Reg istration of Cutlass Technical Powder Bioinsecticide (EPA Reg. No. 70051

- 84). Memorandum from I.S. Barsoum, Ph.D. through R. Sjoblad, Ph.D. to A. Reynolds, dated October 29, 2002.

U.S. EPA. 2002g. Registration of BMP 144 [& BMP 123] Primary Powder Bioinse cticide (EPA Reg.

No. 62637

- 7 [& 62637

- 9]). Memorandum from I.S. Barsoum, Ph.D. through R. Sjoblad, Ph.D. to A. Reynolds, dated August 3, 2002.

U.S. EPA. 2002h. Registration of Thuricide Technical Concentrate (EPA Reg. No. 70051

- 68).
Memorandum from I.S . Barsoum, Ph.D. through R. Sjoblad, Ph.D. to A. Reynolds, dated November 26, 2002.

U.S. EPA. 2002i. Registration of Javelin Technical Concentrate (EPA Reg. No. 70051

- 67). Memorandum from I.S. Barsoum, Ph.D. through R. Sjoblad, Ph.D. to A. Reynolds, dated November 27, 2002.

U.S. EPA. 2001. BPPD Review of Data Submitted by Valent BioSciences Corporation, for Registration and Review of Manufacturing Use Product Production Process for Xentari Products ( Bacillus thuringiensis spp. aizawai ); Vectobac Products ( Bacillus thuringiensis spp. israelensis ); Dipel/Foray Products ( Bacillus thuringiensis spp. kurstaki ); and Novodor Products ( Bacillus thuringiensis subsp.
tenebrionis ) at Abbott Laboratories. Memorandum from C. Etsitty through J. Kough, Ph.D. to A. Reyno lds, dated October 15, 2001.

U.S. EPA. 2000. BPPD Review of Conditional Data Submitted by Ecogen, Inc., for Full Registration of Bacillus thuringiensis subsp. israelensis strain EG2215 Technical Powder. Memorandum from C. Etsitty through J. Kough, Ph.D. t o A. Reynolds, dated April 17, 2000.

U.S. EPA. 1999 a

. Review of Special Daphnia magna Study to Determine the Cause of Non

- Target Toxicity in Laboratory Studies Involving Bacillus thuringiensis subspecies aizawai Strain GC

- 91Bacillus thuringiensis EPA

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### 118 (Agree). Memorandum from M.L. Mendelsohn through Z. Vaituzis, Ph.D. and W. Schneider, Ph.D. to S. Matten, Ph.D., dated July 29, 1999.

U.S. EPA. 1998b

. Concurrence M emorandum R egarding the Product Identity and Toxicology Risk
Assessment for E cogen BTI Technical Powder Bioinsecticide (55638

- UR). Memorandum from A

. Reynolds through P. Hutton to C. Schaffer , dated August 4, 1998

.

U.S. EPA. 1998d. BPPD Review of Data Submitted by Ecogen Incorporated in Support of Registration
of BTI Technical Pow der Bioinsecticide and the Applicability of the Bt Tolerance Exemption for this Strain ( Bacillus thuringiensis subspecies israelensis strain EG2215). Memorandum from R.I. Rose through C. Schaffer and P.O. Hutton to A. Reynolds, dated April 1, 1998.

U.S. E PA. 1998g. Technical Review of Product Characterization/Identity for Two Strains of Bacillus thuringiensis subp. Israelensis (PC Code: 6401) to Support Abbott’s Request to Interchange Powders. Memorandum from G.S. Tomimatsu, Ph.D. through J.L. Kough, Ph.D. to M. Mendelsohn, dated May 29, 1998.

U.S. EPA. 1998h. Review of Product Chemistry for CRYMAX ® 

### Bioinsecticide Utilizing Bacillus thuringiensis subsp. kurstaki EG7841 Construct 11831 (EPA Reg. No. 55638

- 34) as a Registration Amendment. Memorandum from J.L. Kough, Ph.D. through P.O. Hutton to M. Mendelsohn, dated April 30, 1998.

U.S. EPA. 1997 a . Review of Product Chemistry and Waiver Requests for Use of Construct 11097 of Bacillus thuringiensis subspecies kurstaki EG7826 to Produce Lepinox TM 

### Bioinsecticide. Memorandum from J.L. Kough, Ph.D. through P.O. Hutton to M. Mendelsohn, dated July 18, 1997.

U.S. EPA. 1997b. Freshwate r Aquatic Organism Risk Assessment and Revision of Predatory Wasp Environmental Hazards Statement for XenTari ( Bacillus thuringiensis subspecies aizawai ). Memorandum from M.L. Mendelsohn through Z. Vaituzis, Ph.D. to P.O. Hutton, dated November 21, 1997.

U.S. EPA. 1997c. Data from Ciba in Support of Removal of the Honey Bee Warning Statement on Their

B

. t

. aizawai Product, Agree Biological Insecticide (EPA Reg. No. 100

- 733). Memorandum from J.F. Heminway through R.D. Sjoblad, Ph.D. to M. Mendelsohn, dated January 21, 1997.

U.S. EPA. 1997e. Modifications to the 2/13/96 Ecological Effects Risk Assessment for Bacillu s thuringiensis subspecies kurstaki Strain EG7841. Memorandum from M.L. Mendelsohn through Z. Vaituzis, Ph.D. and R.D. Sjoblad, Ph.D. to T. Chin, Ph.D., dated February 5, 1997.

U.S. EPA. 1997f. Revised Freshwater Aquatic Organism Risk Assessment for Bacil lus thuringiensis subspecies kurstaki BMP 123. Memorandum from M.L. Mendelsohn through Z. Vaituzis, Ph.D. to R. Kumar and P.O. Hutton, dated May 8, 1997.

U.S. EPA, 1996a. BPPD Review of Data Submitted by Ecogen, Inc., for the Registration of Crystar

Tec hnical, Crystar G and Crystar WDG Bioinsecticide. Memorandum from C. Schaffer through R. Sjoblad, Ph.D. to R. Kumar, dated August 1, 1996.Bacillus thuringiensis EPA

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### 119 U.S. EPA. 1996c. BPPD Review of Storage Stability Studies Submitted by Novo Nordisk A/S, and
Ciba

- Geigy Corporation in Support of the Registration of Foray 76B, Technical CGA

- 237218, and Agree. Memorandum from C. Schaffer through R. Sjoblad, Ph.D. to M. Mendelsohn, dated December 4, 1996.

U.S. EPA. 1996d. BPPD Review of Data Submitted by Abbott Laboratories Comparing t he Product Identity and Manufacturing Process of Bt Products Previously Manufactured by Novo Nordisk A/S
to Abbott Laboratories Bt Products ( Bacillus thuringiensis var. kurstaki

, Bacillus thuringiensis var. aizawai ) . Memorandum from C. Schaffer through R. Sjoblad, Ph.D. to L. Hollis, dated December 11, 1996.

U.S. EPA. 1996e. Ecological Effects Risk Assessment of Bacillus thuringiensis subspecies kurstaki Strain EG7841 for Lepidopteran Insect Control. Memorandum from M.L. Mendelsohn through R.I. Rose, Ph.D. to P.O. Hutton and R.D. Sjoblad, Ph.D., dated February 13, 1996.

U.S. EPA. 1996f. Freshwater Aquatic Organism Risk Assessment for Bacillus thuringiensis subspecies
kurstaki BMP 123. Memorandum from M.L. Mendelsohn through G.S. Tomimatsu, Ph.D. and R.D.

S joblad, Ph.D. to P.O. Hutton, dated October 31, 1996.

U.S. EPA. 1995 a . BPPD Review of Data Submitted by Ecogen for Registration of Crymax Bioinsecticide; and the Applicability of the Bt Tolerance Exemption for This Strain. Memora ndum
from C. Schaffer thro ugh R. Sjoblad, Ph.D. to M. Mendelsohn, dated October 25, 1995.

U.S. EPA. 1995c. Becker Request for Waivers from Avian Oral (154A

- 16) and Freshwater Fish (154A

19) Data Requirements for BMP 123. Memorandum from C.C. Beegle, Ph.D. and R.I. Rose, Ph.D.

to M . L. Mendelsohn, dated July 10, 1995.

U.S. EPA. 1994f. SAB Review of a Request to Review Toxicology Data Submitted by Abbott Laboratories for Support of the Reregistration of Dipel Technical. Memorandum from C. Schaffer through R. Sjoblad, Ph.D. to L. Schnaubelt /R. Richards , dated March 8, 1994.

U.S. EPA. 1994h. SAB Review of Toxicology and Product Identity Studies Submitted by Sandoz Agro, Inc. for Support of the Registration of SAN 420 I WG Biological Insecticide and Technical
Concentrate. Memorandum from C. Schaffer through R. Sjoblad, Ph.D. to P. Hutton, dated September 20, 1994.

U.S. EPA. 1993 a . SAB Review of a Change in Manufacturing Process and Acute Toxicity Studies from Abbott Laboratories for Support of the Registration of ABG

- 6346. Memorandu m from C. Schaffer through R. Sjoblad, Ph.D. to P. Hutton/M. Mendelsohn, dated November 23, 1993.

U.S. EPA. 1993b. Resubmission of Application for Registration of Bacillus thuringiensis subsp.
kurstaki , Isolate HD

- 263. Memorandum from A.F. Maciorowski to P. Hutton and L. Dye, dated May 24, 1993.

U.S. EPA. 1993c. Consideration of Conditional Registrations for the New Active Ingredient, Bacillus thuringiensis subspecies kurstaki (B.t.k.) HD

- 263, Trade Name BMP 123. Decision Memorandum
from L.E. Cullen to D. D. Campt, dated July 28, 1993.Bacillus thuringiensis EPA

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### 120 U.S. EPA. 1992 a . Review of a Submission from Novo Nordisk to Bridge Data Between Bacillus thuringiensis var. tenebrionis (Btt) strain NB176 and NB125 (Novodor). Memorandum from D. Urban to M. Mendelsohn, dated April 13, 1992.

U.S. EPA. 1992b. SAB Review of a Request from Novo Nordisk A/S for Support of the Registration of Foray 76B. Memorandum from C. Schaffer through R. S joblad, Ph.D. to L. Dye /P. Hutton , dated October 27, 1992.

U.S. EPA. 1992d. Bacillus thuringiensis var. aizawai , ABG

- 6305 (CenTari) Technical Powder and Wettable Dispersible Granule (WDG): Review of Data to Support Registration. Memorandum from R. Briggs, Ph.D. through R. Engler, Ph.D. to M. Mendels ohn/P. Hutton, dated April 17, 199 2.

U.S. EPA. 1992f. SACB Review of Data Submitted by Ciba

- Geigy Corporation in Regard to Completeness of the Database for Agree Technical CGA

- 237218 and the End Use Product; an d the Applicability of the Bt Tolerance Exemption for this Strain . Memorandum from C. Schaffer through R. Engler, Ph.D. to P. Hutton/M. Mendelsohn, dated April 15, 1992.

U.S. EPA. 1992g. SACB Review of Beta

- Exotoxin Data Submitted by Abbott Laboratories o f Vectobac Technical Powder (

Bacillus thuringiensis var. israelensis ). Memorandum from C. Schaffer through R. Engler, Ph.D. to L. Schnaubelt/R. Richards, dated March 11, 1992.

U.S. EPA. 1992h. SACB Review of Data Submitted by Delta Biological Products to Support the Reregistration of Delta BT ( Bacillus thuringiensis var. kurstaki ). Memorandum from C. Schaffer through R. Engler, Ph.D. to L. Schnaubelt/R. Richards, dated March 5, 1992.

U.S. EPA. 1992i. EPA File Symbol/EPA Reg. No.: 62637

- A. Memorandum from L.D. Markarian through T.C. Ellwanger to P. Hutton, dated August 12, 1992.

U.S. EPA. 1992j. SACB Review of Data Submitted by Becker Microbial Products Inc. ( Bacillus thuringiensis var. kurstaki ). Memorandum from C. Schaffer through R. Engler, Ph.D. to P. Hutton/M. Mendelsohn, dated February 24, 1992.

U.S. EPA. 1991 a . SACB Review of Request from Novo

- Nordisk A/S for Waiver of Certain Product Identity and End

- use Product Toxicology Data for B

. thuringiensis var. tenebrionis . Memorandum from R.D. Sjoblad, Ph.D. through R. Engler , Ph.D. to M. Mendelsohn/P. Hutton, dated September 24, 1991.

U.S. EPA. 1991b. Review of Toxicology and Product Analysis Data in Support of Seven Experimental User Permit (EUP) Applications of Bacillus thuringiensis ( Berliner ) var. aizawai . Memorandum from R. Briggs, Ph.D. through R. Engler, Ph.D. to M. Mendelsohn/P. Hutton, dated April 24, 1991.

U.S. EPA. 1991c. Review of Acute Pulmonary Toxicity/Pathogenicity Data and Addendum to Manufacturing Process in Support of an EUP/Registration of Bacillus thuringiensis var. aizawai

, ABG

- 6305 Technical Powder. Memorandum from R. Briggs, Ph.D. through R. En gler, Ph.D. to M. Mendelsohn/P. Hutton, dated November 12, 1991.Bacillus thuringiensis EPA

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### 121 U.S. EPA. 1991d. SACB Review of Data Submitted by Ecogen Inc. on Viable Spore Count and Total
Count of Five Production Batches of Condor ® 

### , Cutlass ® 

### , and Foil ® 

### . Memorandum from R.D. Sjoblad, Ph.D. through R. Engler, Ph.D. to M. Mendelsohn/P. Hutton, dated January 17, 1991.

U.S. EPA. 1991e. SACB Review of One

- year Storage Stability Study for Condor ® 

### , Cutlass ® 

### , and Foil ® 

### Technical Powders and Formulated Products. Memorandum from R.D. Sjoblad, P h.D. through R. Engler, Ph.D. to M. Mendelsohn/P. Hutton, dated January 17, 1991.

U.S. EPA. 1990a. Review of Toxicology Data and Waiver Request in Support of Registration of
Novodor

TM 

### Technical. Memorandum from F. Chow through R. Engler , Ph.D. and R.D. Sj oblad, Ph.D.

to P. Hutton/M. Mendelsohn, dated August 20, 1990.

U.S. EPA. 1990 b . New Chemical Registration of Novodor TM 

### Biological Insecticide for Coleopteran Larva Control. Memorandum from Z. Vaituzis, Ph.D. through R.W. Matheny and J.W. Akerman to P.

H utton, dated November 2, 199 0.

U.S. EPA. 1990c. Product Chemistry Review of Novodor TM 

### Technical (EPA File No. 58998

- RL). Memorandum from A. Smith through D. Stubbs to P. Hutton, dated July 5, 1990.

U.S. EPA. 1990d. SACB Review of Biochemical/Morphological Data and Antibiotic Sensitivity Profiles for the Active Bacterial Ingredients of Foil, Cutlass, and Condor. Memorandum from R.D. Sjoblad, Ph.D. through R. Engler, Ph.D. to M. Mendelsohn, dated Octob er 11, 1990.

U.S. EPA. 1990e. EPA Reg. No./File Symbol 62673

- R (BMP 144). Memorandum from M.L. Waller to P. Hutton, dated February 2, 1990.

U.S. EPA. 1990f. SACB Review of Product Chemistry and Intraperitoneal Injection Data for BMP 144 (2X) and BMP 144 (3X), Products Containing Bacillus thuringiensis var. israelensis as the Active Ingredient. Memorandum from R.D. Sjoblad, Ph.D. through R. Engler, Ph.D. to M. Mendelsohn, dated March 7, 1990.

U.S. EPA. 1990g. SACB Review of Information Supplied by Sandoz Crop Protection Corporation to Support a Small

- scale Field Test of Bacillus thuringiensis var. kurstaki Engineered to Produce a
Delta

- endotoxin with a Single Amino Acid Substitution. Memorandum from R.D. Sjoblad, Ph.D. through R. Engler, Ph.D. to M. Mende lsohn/P. Hutton, dated June 21, 1990.

U.S. EPA. 1989a. SACB Consideration of Mammalian Toxicology Data Submitted by Ecogen, Inc., to Support the Registration of Cutlass WP Insecticide, Cutlass OF Insecticide, and also of Condor OF
Insecticide. Memorandum from R.D. Sjoblad, Ph.D. through R. Engler, Ph.D. to M. Mendelsohn/P. Hutton, dated August 16, 1989.

U.S. EPA. 1989b. Bacillus thuringiensis transconjugant strain EG2371 (Cutlass WP Bioinsecticide). Memorandum from W.J. Hazel, Ph.D. and R.D. Sjoblad, Ph.D. through R. Engler, Ph.D. to P. Hutton/M. Mendelsohn, dated May 12, 1989.

U.S. EPA. 1989c. SACB Consideration of Product Analysis/Residue C hemistry and Mammalian Toxicology Data Submitted by Ecogen, Inc., to Support the Registration of Condor ® 

### OF InsecticideBacillus thuringiensis EPA

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### 122 for Forestry Use. Memorandum from R.D. Sjoblad, Ph.D. and W.J. Hazel, Ph.D. through R. Engler

, Ph.D. to M. Mendelsohn/P. Hutton, dated M ay 16, 1989.

U.S. EPA. 1986

. Bacillus thuringiensis Registration Standard. Memorandum from A. Castillo through R. Engler, Ph.D. to W.S. Woodrow, Ph.D., dated April 22, 1986.

C. Other References

Av é DA. 1998. May 12, 1998, Letter from D.A. Ave (Principal Research Scientist for Ecogen, Inc.) to J. Andersen (EPA) (re: Response to the EPA’s April 21, 1998, Letter).

Bravo A. 2007. Mode of action of Bacillus thuringiensis Cry and Cyt toxins and their potential for insect
control. Toxicon 49(4):423

– 4 35.

Chen C

- Y, Dively CA. 2004 a . Response to Manufacturing Process Data Review by EPA (Lepinox ® 

### Bioinsecticide, EPA Reg. No. 70051

- 87) (Dated December 15, 2004)

.

Chen C

- Y, Dively CA. 2004b. Response to Manufacturing Process Data Review by EPA (CGA

- 237218 Technical Concentrate, EPA Reg. No. 70051

- 48) (Dated December 15, 2004).

Chen C

- Y, Dively CA. 2004c. Response to Manufacturing Process Data Review by EPA (Cryma x ® 

### , EPA Reg. No. 70051

- 86) (Dated December 15, 2004).

Chen C

- Y, Dively CA. 2004d. Response to Manufacturing Process Data Review by EPA (Condor ® 

### Technical Concentrate, EPA Reg. No. 70051

- 83) (Dated December 15, 2004).

Chen C

- Y, Dively CA. 2004e. Response to Manufacturing Process Data Review by EPA (Cutlass ® 

### Technical Concentrate, EPA Reg. No. 70051

- 84) (Dated December 15, 2004).

Chen C

- Y, Dively CA. 2004f. Response to Manufacturing Process Data Review by EPA (Thuricide ® 

### Technical Concentrate, EPA Reg. No. 70051

- 68) (Dated December 15, 2004).

Chen C

- Y, Dively CA. 2004g. Response to Manufacturing Process Data Review by EPA (Javelin ® 

### Technical Concentrate, EPA Reg. No. 70051

- 67) (Dated December 15, 2004).

Chen C

- Y, Dively CA. 2003a . Response to Manufacturing Process Data Review by EPA (Agency Letter Dated December 12, 2002

– Thuricide ® 

### Technical Concentrate, EPA Reg. No. 70051

- 68) ) (Dated March 31, 2003 ).

Chen C

- Y, Dively CA. 2003b. Response to Manufacturing Process Data Review by EPA (Agency Letter Dated December 12, 2002

– Javelin ® 

### Technical Concentrate, EPA Reg. No. 70051

- 67) (Dated March 31, 2003).

Dively C. 2005. August 1, 2005, Email from C. Dively (Certis USA) to A. Reynolds (EPA) (re: Answers to Questions on the R eport on the Inability of Certis Bt Cultures to Produce B eta

- Exotoxin).

Dively CA. 1994. March 16, 1994, Letter from C.A. Dively (Authorized Representative of Becker Microbial Products, Inc.) to P.O. Hutton (EPA) (re: BMP 123 Primary Powder Registratio nBacillus thuringiensis EPA

- HQ

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- 2011

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### 123 Application).

Herrero M. 2005 a

. December 22, 2005, Email from M. Herrero (Valent BioSciences Corporation) to A. Reynolds (EPA) (re: Bt Re

- registration: 2 Small Items from t he Teleconference)

.

Herrero M. 2005b. May 16, 2005, Letter from M. Herrero (Regulatory Affairs Manager for Valent BioSciences Corporation) to A. Reynolds (EPA) (re: Response to the EPA’s May 9, 2005, Letter).

Herrero M. 2005c. May 18, 2005, Letter from M. Herrero (Regulato ry Affairs Manager for Valent BioSciences Corporation) to A. Reynolds (EPA) (re: Response to the EPA’s May 9, 2005, Letter).

Mero H. 2006 a . January 26, 2006, Email from H. Mero (Valent BioSciences Corporation) to A. Reynolds (EPA) (re: Novodor Strain Question).

Mero H. 2006b. February 17, 2006, Email from H. Mero (Valent BioSciences Corporation) to A. Reynolds (EPA) (re: Vectobac HPLC Question).

National Institutes of Health (NIH). 201 4

. Taxonomy Browser. Available from http://www.ncbi.nlm.nih.gov/Taxonomy/Browser/wwwtax.cgi

.

Olson DL. 1996 a . September 3, 1996, Letter from D.L. Olson (Director of Regulatory Affairs for Ecogen, Inc.) to R. Kumar (EPA) (re: Spore Count in the Sterile Filtrate Used in the Crystar Daphnia Study).

Olson DL. 1996b. May 20, 1996, Letter from D.L. Olson (Director of Regulatory Affairs for Ecogen, Inc.) to J. Andersen (EPA) (re: Label Changes, Including Adding Watercress).

Peters GT. 1996. September 16, 1996, Letter from G.T. Peters, Ph.D. (Senior Regulatory Manager for
Ciba

- Geigy Corporation) to M. Mendelsohn (EPA) (re: Submission of Additional Data Regarding Honey Bee Toxicity Te sts with Agree ® 

### Biological Insecticide (EPA Reg. No. 100

- 733)).

Peters GT. 1995. August 29, 1995, Letter from G.T. Peters, Ph.D. (Senior Regulatory Manager for Ciba

Geigy Corporation) to P. Hutton (EPA) (re: Response to the Review of a Honey Bee Toxicit y and Pathogenicity Test Conducted for Agree Biological Insecticide, EPA Reg. No. 100

- 733).

Roberts AP. 2005. July 11, 2005, Letter from Amy Plato Roberts (Regulatory Consultant for Becker Microbial Products, Inc.) to A. Reynolds (EPA) (re: Becker Mic robial Products, Inc., EPA Company

No. 62637

– EPA Science Review (Dated June 1, 2005) of Supplemental Data to Support Reregistration of Bacillus thuringiensis ).

Rose RI. 2013a. January 11, 2013, Letter from R.I. Rose, Ph.D., Authorized Agent for Phyllom, LLC, to the EPA (re: Culture Collection Certificate from the Japan International Patent Organism Depository, National Institute of Technology and Evaluation; Additional Product Identity

Information on Bacillus thuringiensis subspecies galleriae strain SDS

- 502; and Revised Experimental Use Permit Description Forms).

Rose RI. 2013b. March 30, 2013, Letter from R.I. Rose, Ph.D., Authorized Agent for Phyllom, LLC, toBacillus thuringiensis EPA

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- 2011

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### 124 the EPA (re: Response to the Meeting Minutes/Action Items from the February 28, 2013 Meeting between Phyllom

, LLC, and the EPA and the Deficiencies Described in a March 30, 2013, 90

- day Preliminary Technical Screening Letter from the EPA).

Sanchis V. 20 11 . From m icrobial s prays to i nsect

- resistant t ransgenic p lants: h istory of the b iopesticide Bacillus thuringiensis . A review. Agron omy for Sustainable Development 31:217

– 231.

Smith W. 2006. January 18, 2006, Email from W. Smith (Valent BioSciences Corporation) to P. Moe (EPA) (re: Teknar Slurry).

Taborsky V. 1992. Small

- Scale Processing of Microbial Pesticides. FAO Agricultural Services Bulletin No. 96. Food and Agriculture Organization of the United Nations. Rome. Available from www.fao.org/docrep/t0533E/t0533E00.htm

.

Todar K. 2012. Todar’s Online Textbook of Bacteriology. University of Wisconsin. Available fro m www.textbookofbacteriology.net

.

U.S. EPA. 2013 a

. Bacillus thuringiensis subspecies israelensis strain SUM

- 6218 (PC Code 006 6 42) Biopesticides Registration Action Document (Dated May 9, 2013 ) (available as a “Supporting
Document” within docket ID number EPA

- HQ

- OPP

- 201 2

- 0 485 at http://www.regulations.gov .)

U.S. EPA. 2013b. Bacillus thuringiensis subspecies galleriae strain SDS

- 502 (PC Code 006399) Biopesticides Registration Action Document (Dated July 24, 2013) (available as a “Supporting
Document” within docket ID number EPA

- HQ

- OPP

- 2011

- 0862 at http://www.regulations.gov .)

U.S. EPA. 2012 a . Draft Bacil lus thuringiensis subspecies kurstaki strain VBTS

- 2546 (PC Code 006699) Biopesticides Registration Action Document (Dated September 4, 2012 ) (available as a “Supporting
Document” within docket ID number EPA

- HQ

- OPP

- 201 1

- 0 769 at http://www.regulations.gov .)

U.S. EPA. 2011

. Pesticide Reregistration Facts. Available from http://www.epa.gov/pesticides/reregistration/reregistration_facts.htm

.

U.S. EPA. 2005b. Email from W. Schneider , Ph.D. (EPA) to A. Reynolds (EPA) (re: Review of Certis’ Answers to Questions on the Report on the Inability of Certis Bt Cultures to Produce Beta

- Exotoxin) (Dated August 4, 2005).

U.S. EPA. 2005g. Review of Becker’s Beta

- exotoxin Study 12/20/2004 #464708

- 01. Prepared by W.R. Schneider, Ph.D. (Dated June 1, 2005).

U.S. EPA. 2005h. Review of 7

- 11

- 05 Letter from A.P. Roberts (Regulatory Con sultant for Becker Microbial Products, Inc.) to A. Reynolds (EPA) ( re: Becker Microbial Products ) . Prepared by W.R. Schneider, Ph.D. (Dated August 3, 2005).

U.S. EPA. 2005i. Review of Bioassay for Presence of Beta

- exotoxin in a Bacillus thuringiensis subspecies thuringiensis (HD

- 2) Fermentation Broth (MRID No. 466755

- 01). Prepared by W.R. Schneider, Ph.D. (Dated November 16, 2005).Bacillus thuringiensis EPA

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### 125 U.S. EPA. 1999b. Data Evaluation Report for Acute Injection Toxicity Test in Mice (MRID No. 449910

- 02). Prepared by C. Etsitty and J.L. Kough, Ph.D. (Dated April 7, 1999).

U.S. EPA. 1998a. Reregistration Eligibility Decision (RED)

– Bacillus thuringiensis (Dated March 1998). Available from http://www.epa.gov/ oppsrrd1/REDs/0247.pdf

.

U.S. EPA. 1998c. Bacillus thuringiensis subspecies israelensis strain EG2215 (PC Code 006476) Registration Eligibility Decision (Dated September 30, 1998).

U.S. EPA. 1998e. April 21, 1998, Letter from J.L. Andersen, Ph.D. (EPA) to D. Ave (Director of Regulatory Affairs for Ecogen, Inc.) (re: Acceptability of MRID Nos. 443798

- 01 and 443798

- 02).

U.S. EPA. 1998f. Data Evaluation Report for Simulated or Actual Field Testing for Insect Pollinators (MRID No. 443761

- 01). Prepared by Z. Vaituzis, Ph.D., P.G. Forsyth, Ph.D., S.S. Talmage, Ph.D., and R.H. Ross (Dated May 29, 1998).

U.S. EPA. 1997d. Data Evaluation Report for an Avian Acute Oral LD 50 

### Pathogenici ty Study in the Bobwhite (MRID No 408988

- 07). Prepared by Z. Vaituzis, Ph.D. (Dated August 29, 1997).

U.S. EPA. 1996b. Bacillus thuringiensis subspecies kurstaki strain EG7826 Pesticide Fact Sheet (Dated November 1996).

U.S. EPA. 1995b. Data Evaluation Report for Honey Bee Toxicity/Pathogenicity Tests (MRID Nos.

434030

- 01 and 434030

- 02). Prepared by C.C. Beegle, Ph.D. and R.I. Rose, Ph.D. (Dated April 26, 1995).

U.S. EPA. 1994 a

. EPA/OPP/EFED Biologicals Review of XenTari Technical Powder ( Bacillus thuringiensis subsp. aizawai ) (Fish) . Review from C. Beegle, Ph.D., R.I. Rose, Ph.D., and E.M. Leovey, Ph.D. to P. Hutton and M. Mendelsohn (Dated July 20, 1994).

U.S. EPA. 1994b. EPA/OPP/EFED Biologicals Review of XenT ari Technical Powder ( Bacillus thuringiensis subsp. aizawai ) (Aquatic Invertebrate). Review from C. Beegle, Ph.D., R.I. Rose, Ph.D., and E.M. Leovey, Ph.D. to P. Hutton and M. Mendelsohn (Dated July 20, 1994).

U.S. EPA. 1994c. EPA/OPP/EFED Biologicals Review of XenTari Technical Powder ( Bacillus thuringiensis subsp. aizawai ) (Nontarget Insect). Review from C. Beegle, Ph.D., R.I. Rose, Ph.D., and E.M. Leovey, Ph.D. to P. Hutton and M. Mendelsohn (Dated July 5, 1994).

U.S. EPA. 1994d. EPA/OPP/EFED Biolo gicals Review of Agree Technical Powder (CGA

- 237218) ( Bacillus thuringiensis subsp. aizawai ) (Aquatic Invertebrate). Review from C. Beegle, Ph.D., R.I. Rose, Ph.D., and E.M. Leovey, Ph.D. to P. Hutton and M. Mendelsohn (Dated August 25, 1994).

U.S. EPA. 1 994e. EPA/OPP/EFED Biologicals Review of Dipel Technical Powder ( Bacillus thuringiensis subsp. kurstaki ) (Generic Data Submission). Review from C. Beegle, Ph.D., R.I. Rose, Ph.D., and E.M. Leovey, Ph.D. to L. Schnaubelt and R. Richards (Dated October 5, 1994).Bacillus thuringiensis EPA

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### 126 U.S. EPA. 1994g. EPA/OPP/EFED Biologicals Review of Biobit Technical Powder ( Bacillus thuringiensis subsp. kurstaki ) (Core Data). Review from C. Beegle, Ph.D., R.I. Rose, Ph.D., and E.M. Leovey, Ph.D. to L. Schnaubelt and R. R ichards (Dated September 15, 1994).

U.S. EPA. 1992c. Ecological Effects Branch Review of CenTari

– Bacillus thuringiensis Berliner subsp.

aizawai (ABG

- 6305) strain ABTS

- 1857. Review from C.C. Beegle, Ph.D., L.W. Touart, and D.J.
Urban to M. Mendelsohn/P. Hut ton (Dated July 30, 1992).

U.S. EPA. 1992e. Ecological Effects Branch Review of Agree TM 

### ( Bacillus thuringiensis subsp. aizawai ). Review from C.C. Beegle, Ph.D., L.W. Touart, and D.J. Urban to P. Hutton (Dated August 10, 1992).

U.S. EPA. 1992k. Note to P. Hutton (re: Status of BMP 144 (3X)) (Dated August 7, 1992).

U.S. EPA. 1992l. Data Evaluation Record for Dietary Pathogenicity and Toxicity Test with the Green Lacewing (MRID No. 418427

- 08). Prepared by Prepared by M.A. Mossler, P. Kosalwat, Ph.D., an d H.T. Craven. (Dated July 23, 1992).

U.S. EPA. 1992m. Data Evaluation Record for Dietary Pathogenicity and Toxicity Test with Uga

menoni (MRID No. 418427

- 09). Prepared by Prepared by M.A. Mossler, P. Kosalwat, Ph.D., and H.T. Craven. (Dated July 23, 1992).

U.S. EPA. 1992n. Data Evaluation Record for Dietary Pathogenicity and Toxicity Test with the Ladybird Beetle (MRID No. 418427

- 10). Prepared by Prepared by M.A. Mossler, P. Kosalwat, Ph.D., and H.T. Craven. (Dated July 23, 1992).

U.S. EPA. 1992o. Data Evaluation Record for Dietary Pathogenicity and Toxicity Test with the Honey Bee (MRID No. 418427

- 11). Prepared by Prepared by M.A. Mossler, P. Kosalwat, Ph.D., and H.T. Craven. (Dated July 23, 1992).

U.S. EPA. 1989d. Ecological Effects Branch Review and Update of EPA File Symbol 55638

- I. Review from Z. Vaituzis, Ph.D., R. Matheny, and J.W. Akerman to P. Hutton (Dated August 11, 1989).

U.S. EPA. 1989e. Ecological Effects Branch Review of Condor TM 

### (Transconjugant B.t.). Review from Z. Vaituzis, Ph.D., R. Matheny, and J.W. Akerman to P. Hutton (Dated April 26, 1989).

U.S. EPA. 1988. Guidance for the Reregistration of Pesticide Products Containing Bacillus thuringiensis as the Active Ingredient. U.S. Environmental Protection Agency. Office of Pesticides and Toxic
Substances. December 1998. 540/RS

- 89

- 023. Available online from the National Service Center for
Environmental Publications

.

Vilas

- B ôas GT, Peruca APS, Arantes OMN. 2007. Biology and taxonomy of Bacillus cereus

, Bacillus
anthracis , and Bacillus thuringiensis

. Canadian Journal of Microbiology 53:673

– 687.