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: 
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TABLE OF CONTENTS

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 Irritants ......................................................................................................................................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 Health 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 ............................................................................................................... 72
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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 Call-In 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 Residue Limit

NIH National Institutes of Health

OPP The EPA’s Office of Pesticide Programs

PC Code Pesticide chemical code: a six-digit number assigned by OPP to identify pesticide chemicals.

PWP Preliminary Work Plan

RED Reregistration Eligibility Document

TEP Typical end-use pesticide product

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))
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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 opening a public docket (docket number EPA-HQ-OPP-2011-0705) 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 review. 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 instead revising the 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 the docket for 

Bacillus thuringiensis (case 0247) again, initiating the second public comment period for this 

registration review case.

Bacillus thuringiensis is an active ingredient in registered 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 containers, 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 

anticipated 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 information 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 decisionmaking process for this microbial 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.
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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 describing the statutory and regulatory authorities for registration review. 

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 anticipated data needs and risk assessments,

endangered and threatened species, endocrine effects, incidents, and a projected registration review 

timeline for this case. Finally, the revised PWP provides guidance for commenters, explains the next 

steps the EPA will be taking, and presents additional information (e.g., references to studies, risk 

assessments, and other documents available for the registration review of Bacillus thuringiensis) in the 

Appendices. 

Further information about this case, including background and supporting documents, is available at

http://www.regulations.gov (under “SEARCH for: Rules, Comments, Adjudications or Supporting 

Documents,” enter the docket identification number, which is indicated above).

II. Statutory and Regulatory Authority

The Food Quality Protection Act (FQPA) of 1996 mandated a Registration Review 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 unreasonable risks to human health or the 

environment when used as directed on the product labeling. The Registration Review 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 Registration Review program, the EPA periodically reevaluates pesticides to make 

sure that, as change occurs, products in the marketplace can continue to be used safely. Information on 

this program is provided on the EPA’s website.

3

The EPA is implementing the Registration Review 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 

Registration Review begin at 40 CFR § 155.40. The EPA will consider benefits information and data as 

required by FIFRA. The public phase of Registration Review begins when the initial docket is opened 

for each case. The docket is the EPA’s opportunity to state what it knows about the pesticide and what 

additional risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during this 

comment period, the EPA will develop a Final Work Plan (FWP) and anticipated schedule for the 

registration review of Bacillus thuringiensis.

 

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

named it Bacillus thuringiensis Berliner (Sanchis, 2011).

Agronomists first tried using Bacillus thuringiensis for insect control in the late 1920s 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 product; it was known as Sporéine (Sanchis, 2011). 

In 1960, the U.S. Food and Drug Administration (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 from the requirement of tolerance for “Viable spores of the 

microorganism Bacillus thuringiensis Berliner” can be found at 40 CFR § 180.1011.

Prior to this registration review, the EPA conducted a thorough review of Bacillus thuringiensis as part 

of the reregistration program. 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 regulatory 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). That document 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 Data Call-In Notice (DCI) was issued in conjunction with that

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 that 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 product reregistration. The EPA completed 

product reregistration for all products containing Bacillus thuringiensis as an active ingredient on 

November 26, 2008.

b. Taxonomy

The taxonomic lineage for Bacillus thuringiensis is (NIH, 2014): 

KINGDOM: Eubacteria

PHYLUM: Firmicutes

CLASS: Bacilli

ORDER: Bacillales

FAMILY: Bacillaceae

GENUS: Bacillus

SPECIES GROUP: Bacillus cereus group

SPECIES: thuringiensis
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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 (Btk) 

∙ 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.4In the table, there 

are notes for Bacillus thuringiensis subspecies israelensis (PC Code 006401) and Bacillus 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 strains of one subspecies were 

one active ingredient). During reregistration, 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

STRAIN

PC

CODE

NO. PRODUCTS

NOTES

MP EP 24(C)

B. thuringiensis subspecies israelensis

B. thuringiensis subspecies israelensis 006401 -- 2 -- To be reclassified under PC Code 

069162

B. thuringiensis subspecies israelensis strain EG2215 006476 1 -- --

B. thuringiensis subspecies israelensis strain BMP 144 006520 1 18 --

B. thuringiensis subspecies israelensis strain SUM6218006642 1

B. thuringiensis subspecies israelensis AM 65-52 069162 3 14 1

B. thuringiensis subspecies israelensis strain SA3A 069210 2 3 --

TOTAL:

8 37 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 reregistration 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 work with the registrant for these products as the Agency determines which PC Code is appropriate.
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STRAIN

PC

CODE

NO. PRODUCTS

NOTES

MP EP 24(C)

B. thuringiensis subspecies kurstaki strain 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 VBTS-2546 006699 2 2 --

TOTAL: 14 62 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 --

TOTAL: 5 5 0

B. thuringiensis subspecies tenebrionis

B. thuringiensis subspecies tenebrionis strain NB-176 006524 2 1 --

TOTAL: 2 1 0

B. thuringiensis subspecies galleriae

B. thuringiensis subspecies galleriae strain SDS-502 006399 1 2 --

TOTAL: 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. 

Bacillus thuringiensis belongs to the group Bacillus cereus. It is genotypically and phenotypically 

related to two species—Bacillus cereus and Bacillus anthracis—that may adversely affect human health 

(Vilas-Bôas et al., 2007). Bacillus cereus causes two forms of foodborne illness via production of 

enterotoxins. Bacillus 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, Bacillus cereus and Bacillus 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.
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d. General Manufacturing Process and the EPA’s Risk Mitigation Measures

In general, microbial 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 centrifugation and 

drying in air or an oven (Taborsky, 1992). For some microbial products, the slurry is considered 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 presence 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 presence 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. These specifications are meant to make 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 with the fly larvae toxicity test. Some registrants 

have addressed this requirement by either demonstrating that their strains are incapable of producing βexotoxin 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 by 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).
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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. 

PESTICIDE TYPE: Insecticide

USE SITES: Field-, greenhouse-, and water-grown6crops 

(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, pastures, snowmelt, rights-of-way, wetlands, lakes, 

tires, and sewage lagoons) 

REGISTERED FOR 

USE AGAINST 

THESE PESTS:

Coleoptera (beetles, bugs, weevils)

Diptera (flies, gnats, midges, mosquitoes)

Lepidoptera (borers, butterflies, casebearers, cutworm, leaf 

folders, leaf perforator, leafrollers, leafworms, loopers, 

moths, orange dog, skippers)7

FORMULATION 

TYPES:

Aqueous suspension

Emulsifiable concentrate

Emulsifiable suspension

Dry flowable, dust

Water dispersible granule

Wettable powder

Water soluble pouch

Bait

Granule

Slurry

APPLICATION 

METHODS:

Aerial (fixed wing and rotary aircraft)

Low- and ultra-low volume application

(aqueous or oil spray)

Tank mix

Hand sprayer

BASIC 

MANUFACTURERS:

Summit Chemical Company (EPA Company Number: 6218)

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

Certis USA, LLC (EPA Company Number: 70051)

Valent BioSciences Corporation (EPA Company Number: 73049)

Phyllom BioProducts Corporation (EPA Company Number: 88347)

g. Exemption from the Requirement of a Tolerance

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 to 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., 3rd instar, egg, larval, and pupal).

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

(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 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 

production 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 with 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 ensure 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).

Except 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 registration 

review 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 Federal 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 level), the EPA also intends to investigate 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 Assessments

To assess the science database for this complex registration review case, the EPA chose a representative 

pesticide product, generally a MP, for each Bacillus thuringiensis strain; Appendix III shows these

representative pesticide products. Provided in Appendix 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.
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Presently, 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 important 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. In 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 FWP’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, Biological Opinion (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 butterfly species9

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 habitats of endangered or threatened Lepidoptera. No 

manual application should be made within 300 feet of any threatened or endangered 

Lepidoptera.

As a result of this 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 Lepidoptera. 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, 

during registration review, the EPA plans on conducting an ecological risk assessment to 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 butterfly, 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 ground 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 

Coleoptera.” 
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endangered species (listed species) and/or their 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) may 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 the 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 estrogenic 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 lists to be screened under the EDSP.

The EPA believes that 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, pursuant 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 battery, 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 (IDS) conducted on October 21, 2010, and September 10, 2014, show 61 human 

or domestic animal reports of adverse effects following exposure to pesticide products 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 one 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-HQ-OPPT-2009-0477-0074 for the second list of chemicals.
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reports of adverse field effects to nontarget plants as a result of exposure to Bacillus thuringiensis. The 

reports involved effects to orchard, almond, tobacco, and grape crops. For more information on the IDS 

and EIIS reports, see Appendix VII. The EPA will consider any incident data or comments submitted to 

this docket in response to this revised PWP. 

IX. 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 006520)

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)
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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 months
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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 months
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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 months
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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)
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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, MP = manufacturing-use pesticide product, TEP = typical end-use pesticide 

product

X. Timeline

Below is the projected timeline for Registration Review Case 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 

(2nd 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 registration review 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. 
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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 policies. 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 

pesticidal 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 for Bacillus thuringiensis.

13 More information on impaired water bodies and 

TMDLs can be found at the EPA’s website.14 The EPA invites submission of water quality 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 Assessment and Management 

Process15 to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

c. Trade Irritants

Through the registration review 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 international Maximum Residue Limits (MRL) and, if necessary, may modify tolerance 

levels to do so. Growers and other stakeholders are asked to comment on any trade irritant issues 

resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, 

providing as much specificity as possible regarding the nature of the concern. 

Bacillus thuringiensis is covered under an existing exemption from the requirement of a tolerance. 

Moreover, there are no 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 This document can be found at http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm.
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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 geographical distribution of relevant use 

sites)

 Median and 90th 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 uses

 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 Final Work Plan for case 0247: Bacillus thuringiensis. 
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APPENDICES

NOTE: Because of the complexity of this registration review case, the subheadings of Appendices II–VI

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

 Bacillus thuringiensis subspecies israelensis – pale yellow

 Bacillus thuringiensis subspecies kurstaki – pale 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 II Pesticide Products Containing B. thuringiensis

APPENDIX III Representative B. thuringiensis Technical Products

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 VI Nontarget Organism Data Requirements (40 CFR § 158.2150) (How They Have 

Been Met)

APPENDIX VII Summary of Incidents Involving Exposure to B. thuringiensis

APPENDIX VIII Bibliography
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APPENDIX I – History of the B. thuringiensis Tolerance Exemption

Provided below is the original tolerance exemption (by the FDA) followed by its 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 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 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, lettuce, potatoes, spinach.

Original tolerance exemption

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, artichokes, 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 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 amended the tolerance 

exemption to change “microbial 

pesticide” to “microbial insecticide” 

(in paragraphs (a) and (b)) and to add 

bananas to the commodity list in 

paragraph (b). 
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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 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 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 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 revised 21 CFR Part 120 for 

editorial and codification purposes.

31 FR 7376

May 21, 1966

21 CFR § 120.1011 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 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 collards, 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 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 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).
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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 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 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 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, collards, cottonseed, cucumbers, eggplants, grapes, kale, 

lettuce, melons, mustard greens, oranges, potatoes, spinach, strawberries, 

sweet corn, tomatoes, and turnip greens.

Bacillus thuringiensis tolerance 

exemption moved from 21 CFR to 40 

CFR after the establishment of the 

EPA.

38 FR 19045

July 17, 1973

40 CFR § 180.1011 Viable 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 determining that each master seed lot brought into 

production is a Bacillus thuringiensis strain which does not produce βexotoxin under standard manufacturing conditions or by periodically 

determining that β-exotoxin synthesized during spore production is eliminated 

by the subsequent spore-harvesting procedure.

(b) * * *

The EPA amended the tolerance 

exemption to include a toxicity test to 

determine the presence of β-exotoxin 

to ensure that

Bacillus thuringiensis products 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 growing 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.”
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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 (7th edition to 8th

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 specified 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, at the request 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 

developed a standard commodity 

vocabulary database, entitled Food and 

Feed Commodity Vocabulary. The 

EPA updated the tolerance exemption 

from requirement of tolerance was 

updated to comport with this new 

database.
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APPENDIX II – Pesticide Products Containing B. thuringiensis

Provided below is the current list of pesticide products containing Bacillus thuringiensis as an active 

ingredient; they include FIFRA section 3 and 24(c) registrations. Highlighted (yellow) entries denote 

manufacturing-use pesticide products (MP). 

PC CODE &

ACTIVE INGREDIENT

EPA

REG. NO.

PRODUCT NAME

%

A.I. NOTES

Bacillus thuringiensis subspecies israelensis

006401

B. thuringiensis subspecies 

israelensis

4-455 Bonide Mosquito Beater WSP 1.7 To be reclassified under PC Code 

069162

70051-102 Bti Granule Larvicide 2.86 To be reclassified under PC Code 

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 25.70

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 FourStar 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 MP
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PC CODE &

ACTIVE INGREDIENT

EPA

REG. NO.

PRODUCT NAME

%

A.I. NOTES

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 2.80

73049-11 Vectobac - AS 6.38

73049-13 Vectobac Technical Powder 99 MP

73049-18 Vectobac 12AS – II Biological Larvicide 11.61

73049-19 Vectobac GR 4.95

73049-38 Vectobac 12AS Biological Larvicide 11.61

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 4.5a

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. israelensis Slurry (for Liquid 

Vectobac Formulations) 14 MP

73049-486 Vectobac GR 2.80

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

 aContains 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) 40

62637-6 BMP 123 (48 LC) 12

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 40

70051-84 Cutlass Technical Powder 100 MP

006424

B. thuringiensis subspecies 

kurstaki strain EG2348

70051-78 Condor 24.5

70051-80 Condor WP 43

70051-83 Condor Technical Powder 100 MP

70051-85 Condor XL 45
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PC CODE &

ACTIVE INGREDIENT

EPA

REG. NO.

PRODUCT NAME

%

A.I. NOTES

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 thuringiensis “O” 98.35

829-202 SA-50 Brand Thuricide HPC 15

2724-688 Security Bt Dust Biological Insecticide 0.049

9688-294 Chemsico HPC-O Concentrate 98.35

70051-52 Thuricide HPC 15

70051-53 Thuricide HPWP 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 and 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

70051-60 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 85
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PC CODE &

ACTIVE INGREDIENT

EPA

REG. NO.

PRODUCT NAME

%

A.I. NOTES

006522

B. thuringiensis subspecies 

kurstaki 

strain ABTS-351

4-251 Bonide Dipel 150 Dust for 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 0.582a

7001-7775 Britz Bt 25 Sulfur Dust 1.16a

7001-7779 Britz Bt Dust 1.94

7401-290 Ferti-Lome Dipel Dust Biological Insecticide 0.064

34704-722 Bt Sulfur 15-50 Dust 0.72a

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 2X 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 thuringiensis 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 registration 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 VBTS-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

aContains 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%).
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PC CODE &

ACTIVE INGREDIENT

EPA

REG. NO.

PRODUCT NAME

%

A.I. NOTES

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 AS 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

006399

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 galleriae
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APPENDIX III – Representative B. thuringiensis Technical Products

STRAIN AND PC CODE

EPA REG.

NO.

PRODUCT NAME

% ACTIVE

INGREDIENT

FIRST

REGISTERED

REREGISTEREDa

Bacillus thuringiensis subspecies israelensis

B. thuringiensis subspecies israelensis strain EG2215 

(PC Code 006476) 73049-405 Bti Technical Powder Bioinsecticide 100 September 30, 1998 N/A

B. thuringiensis subspecies israelensis strain BMP 144

(PC Code 006520) 62637-7 BMP 144 Primary Powder 100 October 2, 1992 November 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 March 12, 1984 February 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 November 21, 2005

B. thuringiensis subspecies kurstaki strain EG2371 

(PC Code 006423) 70051-84 Cutlass Technical Powder 100 May 25, 1995 September 30, 2005

B. thuringiensis subspecies kurstaki strain EG2348 

(PC Code 006424) 70051-83 Condor Technical Powder 100 May 25, 1995 September 30, 2005

B. thuringiensis subspecies kurstaki strain EG7841

(PC Code 006453) 70051-86 Crymax 40 February 15, 1996 May 22, 2006

B. thuringiensis subspecies kurstaki strain EG7826 

(PC Code 006459) 70051-87 Lepinox 100 December 16, 1996 September 30, 2005

B. thuringiensis subspecies kurstaki strain SA-12 

(PC Code 006518) 70051-68 Thuricide Technical Concentrate 100 November 12, 1992 November 17, 2005

B. thuringiensis subspecies kurstaki strain SA-11

(PC Code 006519) 70051-67 Javelin Technical Concentrate 100 June 15, 1993 November 17, 2005

B. thuringiensis subspecies kurstaki strain ABTS-351

(PC Code 006522) 73049-12 Dipel Biological Insecticide Technical Powder 91 March 12, 1984 January 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/A
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STRAIN AND PC CODE

EPA REG.

NO.

PRODUCT NAME

% ACTIVE

INGREDIENT

FIRST

REGISTERED

REREGISTEREDa

Bacillus thuringiensis subspecies aizawai

B. thuringiensis subspecies aizawai strain GC-91 

(PC Code 006426) 70051-48 Technical CGA-237218 100 August 8, 1992 September 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 InsecticideTechnical Powder 89 August 20, 1992 February 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 January 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).
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APPENDIX IV – Product Analysis Data Requirements (40 CFR § 158.2120)

(How They Have Been Met)

DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 Nos. 443916-01, 443916-02, 444238-01, and 449910-02

(U.S. EPA, 1998b, 1998c, 1998d, 1999b, and 2000)

Manufacturing process (885.1200) MRID Nos. 408988-01 and 449910-01; Avé (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 registrant 

 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 (830.7000).

 The EPA considers storage stability and pH to be data gaps.
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 Nos. 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. 419151-01 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. 419151-01a

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. 419151-01a

a There are no reviews 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. 
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 Nos. 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.
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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, 1998g 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. 414390-02a

a There are no reviews in the EPA’s files for 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, subject to 

 change in the FWP. 
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

Active Ingredient: B. thuringiensis subspecies israelensis strain SA3A (PC Code 069210)

Representative Product: Teknar Technical Concentrate (EPA Reg. No. 73049-408) 

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 Nos. 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 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) **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. 414415-31a

a There are no reviews 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 physical and chemical characteristics 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 EPA-HQ-OPP-2011-0705

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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 collection (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 (885.1400) 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 reviews 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, subject to 

 change in the FWP. 
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 ßexotoxin. 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, metals, and metal ions to 

 be a data gap.
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 ßexotoxin. 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 temperatures, 

 metals, and metal ions (830.6313). The EPA considers stability to normal and elevated temperatures, metals, and metal ions to be 

 a data gap.
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 Regional 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 ßexotoxin. 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 temperatures, 

 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

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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 ßexotoxin. 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 temperatures, 

 metals, and metal ions (830.6313). The EPA considers stability to normal and elevated temperatures, metals, and metal ions to be 

 a data gap.
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 Nos. 414416-01, 414416-08, 414416-10, 414416-16, 414416-20, 414416-24, 

414416-28, and 414416-33a

Manufacturing process (885.1200)

MRID Nos. 448074-01, 461417-01, and 466493-01; Chen and Dively (2004f) and 

(2003a) 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, 2004k)

Discussion of formation of unintentional 

ingredients (885.1300)

ß-exotoxin. The registrant demonstrated that this strain is incapable of producing ßexotoxin. 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) **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. 414416-41a

a There are no reviews 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 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

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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 ßexotoxin. 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) **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 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

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46

DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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. 466425-01 

(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 Nos. 415161-02 and 418838-01a

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 418838-01a

a There are no reviews 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

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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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, 2012a)

Manufacturing process (885.1200) MRID Nos. 485592-02 and 485592-05 

(U.S. EPA, 2012a)

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, 2012a)

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, 2012a).

Other toxins or contaminants. MRID No. 485592-05 (U.S. EPA, 2012a). 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. 486774-02 

(U.S. EPA, 2012a)

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, 2012a)
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 ßexotoxin. 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)
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 ßexotoxin 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 normal 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.
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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, 417225-03, 417225-04, 417225-05, 417225-06, 417225-07, 

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 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. 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.
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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. 414127-02 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 temperatures, 

 metals, and metal ions (830.6313). The EPA considers stability to normal and elevated temperatures, metals, and metal ions to be 

 a data gap.
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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 Nos. 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 No. 485532-01; Rose (2013a) and Rose (2013b)

(U.S. EPA, 2012b, 2013b, 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 toxicity 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.
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APPENDIX V – Human Health Toxicity Data Requirements (40 CFR § 158.2140)

(How They Have Been Met)

DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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, 1998c, and 1998d)

Acute pulmonary toxicity/pathogenicity (885.3150) CITE ALL 

(U.S. EPA, 1998b, 1998c, 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 packages 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 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 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 2013a)

Acute injection toxicity/pathogenicity (intravenous) 

(885.3200)

MRID No. 486826-12, 489542-03, and 489542-04

(U.S. EPA, 2012c, 2012d, 2013a, and 2013e)
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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. 414390-03a

Acute pulmonary toxicity/pathogenicity (885.3150) MRID No. 414874-01a

Acute injection toxicity/pathogenicity (intravenous) 

(885.3200) MRID No. 414390-04a

a There are no reviews 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 the EPA requires additional acute 

 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. 

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. 142735a

Acute injection 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 reviews 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 Nos. 415426-07, 417511-06, and 418266-04

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

Acute injection toxicity/pathogenicity (intravenous) 

(885.3200)

MRID Nos. 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 reviews 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/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. 
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 

1989c)

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)
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 lymph

 nodes of the test animals. Therefore, this data package will be reviewed between now and the issuance of the FWP to ascertain 

 whether the 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, 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. 429085-01a

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 reviews 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 reviews 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 pulmonary 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 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. 
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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. 414875-01a

a There are no reviews 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 the 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, subject 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)
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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)
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APPENDIX VI – Nontarget Organism Data Requirements (40 CFR § 158.2150)

(How They Have Been Met)

DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 Nos. 414390-05 and 414390-06 

(Bridged 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 

(Bridged from 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 Nos. 415404-01 and 415404-02 

(Bridged from Bti strain AM 65-52: U.S. EPA, 1998a and 1998c)

Nontarget plant testing (885.4300) Waived – Active ingredient is not a known plant pathogen.

(U.S. EPA, 1998c)

Nontarget insect testing (885.4340)

MRID Nos. 418427-08, 418427-09, and 418427-10 

(Bridged from Bti strain NB31: U.S. EPA, 1992l, 1992m, 1992n, 

1998a, and 1998c)

Honey bee testing (885.4380) MRID No. 418427-11 

(Bridged 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)
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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, 2013a and 2013g)

Wild mammal toxicity/pathogenicity (885.4150) MRID No. 486826-22

(U.S. EPA, 2013a and 2013g)

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 486826-23 

(U.S. EPA, 2013a and 2013g)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID Nos. 486826-24 and 489542-01

(U.S. EPA, 2012e, 2013a, and 2013g)

Estuarine and marine fish/invertebrate testing (885.4280) MRID No. 486826-25

(U.S. EPA, 2013a and 2013g)

Nontarget plant testing (885.4300) MRID No. 486826-26

(U.S. EPA, 2013a and 2013g)

Nontarget insect testing (885.4340) MRID No. 486826-27

(U.S. EPA, 2013a and 2013g)

Honey bee testing (885.4380) MRID No. 486826-28

(U.S. EPA, 2013a 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 Nos. 414390-05 and 414390-06

(U.S. EPA, 1998a and 1998c)

Wild mammal toxicity/pathogenicity (885.4150) **DATA GAP**

Freshwater fish toxicity/pathogenicity (885.4200) MRID Nos. 414390-07 and 414390-08

(U.S. EPA, 1998a and 1998c)

Freshwater 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 Nos. 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)
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 127354a

Wild mammal toxicity/pathogenicity (885.4150) Accession No. 092441a

Freshwater fish toxicity/pathogenicity (885.4200) Accession No. 127354a

Freshwater 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. 414415-16a

Honey bee testing (885.4380) Accession No. 127355a

a There are no reviews 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 organism 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)

Avian oral toxicity (885.4050)

Waived - Based 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 

(Bridged from Btk strain EG2348: U.S. EPA, 1996f and 1997f)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID Nos. 434917-01, 438988-01, and 440882-01

(U.S. EPA, 1995c and 1996f)

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.

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 – Based 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).
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 Nos. 404677-01 and 408988-07 

(Bridged 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)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 408988-09 

(Bridged from Btk 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 Nos. 404677-05, 404677-07, 408988-10, and 408988-11 

(Bridged from Btk strain EG2348: U.S. EPA, 1989d)

Nontarget insect testing (885.4340) MRID Nos. 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 reviews in the EPA’s files for MRID No. 416389-01 (nontarget insect testing). Therefore, this data package will be 

 reviewed between now and the issuance of the FWP to ascertain whether the EPA requires additional 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 Nos. 404677-05, 404677-07, 408988-10, and 408988-11

(U.S. EPA, 1989e)

Nontarget insect testing (885.4340) MRID Nos. 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).
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 in 40 CFR § 158.2150(e).
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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. 438293-17 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. 090261, 092441, 092442, 127354a

Wild mammal toxicity/pathogenicity (885.4150) Accession No. 092441a

Freshwater fish toxicity/pathogenicity (885.4200) Accession No. 127354a

Freshwater invertebrate toxicity/pathogenicity (885.4240) Accession No. 127354; MRID No. 96533a

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

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 127355a

Honey bee testing (885.4380) Accession No. 127355a

a There are no reviews 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 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 note #6 in 40 CFR § 158.2150(e).
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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, 127354a

Wild mammal toxicity/pathogenicity (885.4150) Accession No. 092441a

Freshwater fish toxicity/pathogenicity (885.4200) Accession No. 127354a

Freshwater invertebrate toxicity/pathogenicity (885.4240) Accession No. 127354; MRID No. 96533a

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

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 127355a

Honey bee testing (885.4380) Accession No. 127355a

a There are no reviews 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 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 note #6 in 40 CFR § 158.2150(e).
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 435229-01

(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 reviews 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. 
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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, 2012a)

Wild mammal toxicity/pathogenicity (885.4150) MRID No. 485592-37

(U.S. EPA, 2012a)

Freshwater fish toxicity/pathogenicity (885.4200) MRID No. 485592-19 

(U.S. EPA, 2012a)

Freshwater invertebrate toxicity/pathogenicity (885.4240) MRID No. 485592-20

(U.S. EPA, 2012a)

Estuarine and marine fish/invertebrate testing (885.4280) MRID No. 485592-38

(U.S. EPA, 2012a)

Nontarget plant testing (885.4300) MRID No. 485592-39

(U.S. EPA, 2012a)

Nontarget insect testing (885.4340) MRID Nos. 485592-21, 485592-22, and 485592-23

(U.S. EPA, 2012a)

Honey bee testing (885.4380) MRID No. 485592-24

(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)

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. 419943-16, 432066-01, and 443582-01

(U.S. EPA, 1992e, 1994d, 1998a, and 1999a)

Estuarine and marine fish/invertebrate testing (885.4280) MRID Nos. 419943-17 and 419943-18

(U.S. EPA, 1992e and 1998a)

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. 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).
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 with 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 note #7 in 40 CFR § 158.2150(e).
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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 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, 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).
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DATA REQUIREMENT (GUIDELINE) HOW IT HAS BEEN ADDRESSED

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

(Bridged 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 note #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)

Freshwater 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. 485532-30

(U.S. EPA, 2013b and 2013d)
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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 2014 and the EPA’s Ecological Incident Information 

System between 1966 and 2014. Where information was available, discussion regarding the nature of 

the incident is given. 

TOTAL 

NUMBER OF 

INCIDENTS:

 NO. 

 HUMAN

NO. DOMESTIC 

ANIMAL

NO. NONTARGET 

ORGANISM

DISCUSSION

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 Forest 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 allergic 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 five 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 necessary. 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 Organism 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 107 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.
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APPENDIX VIII – Bibliography

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. (Unpublished study received Mar 8, 1982 under 11273-2; prepared 

by Biodynamics, Inc., 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. (Unpublished study received Aug 9, 1982 

under 11273-2; prepared in cooperation with Biodynamics, Inc., submitted by 

Sandoz, Inc. Crop Protection, San Diego, CA; CDL:248007-E)

109494 Dyke R, McCormack R, Hogan G. 1981. Acute Inhalation Toxicity/Infectivity 

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; 

prepared in cooperation with Biodynamics, 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 Toxicity/Infectivity Study of Teknar in the Rat: 

Project No. T-1866. Unpublished study prepared by Sandoz, Inc. 25 pages.

142735 Terrill J. 1983. An Acute Inhalation Toxicity/Infectivity Study in the Rat on 

Teknar - 4 Hour Exposure: Final Report: Project No. 83-7652. Unpublished 

study prepared by Biodynamics, Inc. 40 pages.
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MRID No. Study Description

404677-01 Beavers J, Jaber M. 1986. Bacillus Thuringiensis (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 Parasitic 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: Neuroptera): 

Laboratory Project ID: LR87-43. Unpublished study prepared by PanAgricultural Laboratories, Inc. 26 pages.

405084-03 Hoxter K, Jaber M. 1988. Bacillus thuringiensis Strains EG2397; EG2349; 

EG2001; EG2424; EG2371: An Acute Contact Toxicity Study with the Parasitic 

Hymenoptera: (Brachymeria intermedia): Wildlife International Ltd. Project 

No.: 235-119A. Unpublished study prepared by Wildlife International Ltd. 14 

pages.
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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 prepared 

by Ecogen, Inc. 18 pages.

408988-07 Beavers J, Clauss B, Jaber M. 1988. Bacillus thuringiensis Strain EG2348: An 

Avian Acute Oral LD50 Pathogenicity Study in the Bobwhite: Wildlife 

International Ltd. Project No.: 235-120. Unpublished study prepared by 

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 study 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 PanAgricultural 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 Currier 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.
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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 pages.

411503-02 Sherwood R. 1989. Acute Intraperitoneal Toxicity/Pathogenicity Testing of 

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 prepared 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: Bacillus 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 144): 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 Laboratories, 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.
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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 Wildlife 

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 study 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. Unpublished 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 Technical: 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-VTP02: 910-8906. Unpublished study prepared by Abbott Laboratories. 174 pages.

414390-02 Coddens M. 1990. Vectobac Technical Powder ... Product Chemistry Based on 

Bacillus thuringiensis, subspecies israelensis, Strain AM 65-52 (ATCC-SD1276) as the Active Ingredient: Lab Project Nos. Abbott Lab-VTP-03; 910-

8902. Unpublished study prepared by Abbott Laboratories. 186 pages.
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MRID No. Study Description

414390-03 David R. 1990. Acute Oral Toxicity/Pathogenicity 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 Toxicity/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, Hoxter 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 2439.0889.6104.158. 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 and the Belle W. Baruch Institute for Marine Biology and Coastal 

Research. 43 pages.
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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 Bti) 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 Study in Rats: Novodor 

Technical: Lab Project Number: 12488. Unpublished study prepared by NovoNordisk 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. Unpublished 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 by RCC Notox B. V. 

22 pages.

414415-03 Smith R, Regan K. 1990. Biochemical and Morphological Characteristics 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 pages.

414415-06 Schindler J. 1990. Single Intraperitoneal Administration of Bacillus 

thuringiensis Strain SA-3A in Mice: SRI Project Number LSC-8491: SRI Study 

No. 8491-M04-89. Unpublished study prepared by SRI International. 16 pages.

414415-09 Chen C, Macuga R. 1990. Plasmid Profile of Bacillus thuringiensis subsp. 

israelensis, Strain SA3A: Final Report: Final Report No. 90/02/03D. 

Unpublished study prepared by Sandoz Crop Protection Corp. 40 pages.

414415-12 Chen C, Macuga R. 1990. Flagella Antigen Serotyping of Bacillus thuringiensis

subsp. israelensis, Strain SA3A: Final Report: Final Report No. 90/02/12D. 

Unpublished study prepared by Sandoz Crop Protection Corp. 23 pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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MRID No. Study Description

414415-15 Smith R, Regan K. 1989. Antibiotic Sensitivity Patterns for Bacillus 

thuringiensis subsp. israelensis Strain SA3A: Final Report: Final Report No. 

89/12/12E. Unpublished study prepared by Sandoz Crop Protection Corp. 38 

pages.

414415-16 Cerf D. 1990. Susceptibility of Four Orders of Insects (Lepidoptera, 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 

pages.

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 pages.

414415-22 Chen C, Macuga R, Cerf D. 1990. Insecticidal Toxins Produced by Bacillus 

thuringiensis subsp. israelensis, Strain SA3A. I. Effect of Autoclaving: Final 

Report: Final Report No. 90/01/31D. Unpublished study prepared by Sandoz 

Crop Protection Corp. 19 pages.

414415-25 Chen C, Cerf D, Sjolander A. 1990. Insecticidal Toxins Produced by Bacillus 

thuringiensis subsp. israelensis, Strain SA3A. II. Concentration of betaExotoxin: Final Report: Final Report No. 90/02/07D. Unpublished study 

prepared by Sandoz Crop Protection Corp. 36 pages.

414415-31 Fowler J. 1989. Physical Properties of SA-3A Technical Grade Active 

Ingredient (TGAI): Final Report: Final Report No. 89/11/ 30C. Unpublished 

study prepared by Sandoz Crop Protection Corp. 32 pages.

414416-01 Smith R, Regan K. 1990. Biochemical and Morphological Characteristics of 

Bacillus thuringiensis subsp. kurstaki 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.
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MRID No. Study Description

414416-06 Chen C, Macuga R, Cerf D. 1990. Insecticidal 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 Schindler J. 1990. Single Intraperitoneal Administration of Bacillus 

thuringiensis Strain SA-12 in Mice: Lab Project Number: 8491-M07-89: LSC8491. Unpublished study prepared by SRI International. 17 pages.

414416-12 Schindler J. 1990. Single Intraperitoneal Administration of Bacillus 

thuringiensis Strain SA-11 in Mice: Lab Project Number: 8491-M06-89: LSC8491. Unpublished study prepared by SRI International. 15 pages.

414416-14 Chen C, Macuga R. 1990. Plasmid Profile of Bacillus thuringiensis subsp. 

kurstaki 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: 90/02/03B. 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. Unpublished 

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 Sandoz Crop Protection Corp. 28 

pages.
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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 pages.

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 

pages.

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 pages.

414416-30 Chen C, Cerf D, Sjolander A. 1990. Insecticidal Toxins Produced by Bacillus 

thuringiensis subsp. kurstaki Strain SA11001C98-1-1. II. Concentrated of Betaexotoxin: 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 Grade 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: G7239.222. 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.
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MRID No. Study Description

414434-03 Lattin A, Hoxter K, Driscoll C. 1990. Dipel Technical Material (Bacillus 

thuringiensis var. kurstaki): An Avian Oral Toxicity 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. Dipel 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 Springborn 

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.

414434-08 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-SPH1-90. Unpublished study prepared 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-OPP-2011-0705

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MRID No. Study Description

414434-11 O’Leary P. 1990. Effect of Bacillus thuringiensis 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 Evaluating 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 

Associates, 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 Laboratories. 

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.
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84

MRID No. Study Description

415404-01 Christensen K. 1990. Vectobac Technical Material (Bacillus thuringiensis 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. Unpublished 

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. 

kurstaki)—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 Christensen 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 prepared 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 (SPRA119-28-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.

415500-01 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.
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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 Mallard: 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-day 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 Renewal 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 Dietary Pathogenicity and Toxicity 

Study with the Parasitic Hymenopteran Pediobius 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.
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MRID No. Study Description

416539-12 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. 22 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 study 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 Concentrate: 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 thuringiensis var. kurstaki Chronic 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 Toxicity Study with the Parasitic 

Hymenopteran Pediobius 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-HQ-OPP-2011-0705

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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, Schwartz 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 Project Number: 1859-91Y. Unpublished study prepared by Abbott 

Laboratories. 35 pages.

417225-04 Jaronski S. 1990. Host Spectrum Study of ABG-6305 Technical Powder: 

Coleoptera: Lab Project Number: 910-9006. Unpublished study prepared by 

Ratech Services. 7 pages.

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 ABG6305 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 (ABG6305) Bioburden: Analysis of Samples: Lab Project Number: 40156-40160. 

Unpublished study prepared by Abbott Laboratories. 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. Analysis 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.
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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 NonViable 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 NonViable Organisms: Lab Project 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 Organisms: 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 ABG6314: 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 study 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.
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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: Intraperitoneal 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 

Wildlife 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.

418838-01 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 thuringiensis: ABG-6305: Lab Project Number: 901292D/ABT 143-

2/AC. Unpublished study prepared by Huntington Research Centre Ltd. 40 

pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

www.regulations.gov

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 pages.

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 Pathogenicity 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): Lab 

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 

Number: 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-HQ-OPP-2011-0705

www.regulations.gov

91

MRID No. Study Description

419943-04 Vlachos D. 1991. Human Pathogen Screening Studies of Technical CGA237218: Lab Project Number: 8231-91: 8232-91: 8233-91. Unpublished study 

prepared by Stillmeadow, Inc. 57 pages.

419943-05 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 prepared 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 prepared 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-HQ-OPP-2011-0705

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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 Project 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.

420065-02 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 Hossack 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 thuringiensis

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 carna (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-HQ-OPP-2011-0705

www.regulations.gov

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 carnea (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 prepared 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 Components of ABG6305 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-6346: 

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. 

Unpublished study prepared by Huntingdon Research Centre Ltd. 19 pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

www.regulations.gov

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 Report: 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 Report: 

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 prepared 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 - CGA237218: Lab Project Number: HB419. Unpublished study prepared by BioWest, 

Inc. 47 pages.

434030-02 Balcomb R. 1994. Honey Bee Exposure and 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 

Project 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 Number: 42117: 42117R. Unpublished study prepared by 

ABC Labs, Inc. 343 pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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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.

436080-02 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. Biochemical 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 EG7841: 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: ECO/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. Unpublished study prepared by Huntingdon Research 

Centre Ltd. 59 pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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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 Springborn 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 International 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 Rainbow 

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 Number: 

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 study prepared by IIT Research Institute. 18 pages. 
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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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 Challenge 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 Bacillus 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 Bacillus thuringiensis spp. kurstaki Technical Grade Active Ingredient: Lab 

Project Number: JDP-BTK-1. Unpublished study prepared by Abbott 

Laboratories. 12 pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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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. Unpublished 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 study 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 Ave D. 1997. Bioassay Studies: Lepinox Bioinsecticide (Bacillus thuringiensis

subspecies kurstaki EG7826 Construct 11097): Lab Project Number: ECOINS.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, 

Under 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 (ABG6314) 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 Project Number: ECOINS.96001. Unpublished study. 5 pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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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: ECOBTI9701. Unpublished study prepared by Ecogen, Inc. 11 pages.

447915-01 Dicker H, Hudson A. 1999. Cutlass Technical Powder Bioinsecticide: 

Manufacturing Process: Discussion of the Formation 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. 1999. Lepinox Insecticide: Manufacturing Process: 

Discussion of the Formation of Unintentional Ingredients: Analysis of SampleQC: Certification of Limits: Lab Project Number: PROD-LEPINOXTECH199. Unpublished study prepared by Ecogen, Inc. 24 pages. 

447916-01 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-HQ-OPP-2011-0705

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100

MRID No. Study Description

447916-02 Birkhold D. 1999. Fermentation 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 Unintentional Ingredients: Analysis of 

Sample—QC: Certification of Limits: Lab Project Number: PRODCRYMAXWDG-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.

449910-01 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 Products (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 

thuringiensis subsp. israelensis) at Abbott Laboratories: Lab Project Number: 

BTISLMAN-V-28R. Unpublished study prepared by Abbott Laboratories. 27 

pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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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 subsp. 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 study 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/Pathogenicity 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 Bobwhite: 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-HQ-OPP-2011-0705

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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 Larvae (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 BioSciences 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 Foray 

Products (Bacillus thuringiensis subsp. kurstaki) at Abbott Laboratories: Lab 

Project Number: 60005 MAN 7/2/02. Unpublished study prepared by Abbott 

Laboratories and Valent Biosciences Corporation. 313 pages.
Bacillus thuringiensis EPA-HQ-OPP-2011-0705

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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 Laboratories: 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 TGAI. 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, Davis 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-HQ-OPP-2011-0705

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104

MRID No. Study Description

464235-00 Valent Biosciences Corp. 2004. Submission of Product Chemistry 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 Number: 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 

by 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 Chromatography 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 Production 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-HQ-OPP-2011-0705

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105

MRID No. Study Description

465246-02 Nair A. 2005. High Performance Liquid Chromatography Assay for 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 ABG6512/Slurry-HFPC - Toxicity to Water Fleas (Daphnia magna) Under StaticRenewal Conditions. Project Number: 2439/6138. Unpublished study prepared 

by Abbott Laboratories and Springborn Laboratories, Inc. 72 pages.

465246-04 Putt 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. 2005. 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 study 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 Abbott 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.
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106

MRID No. Study Description

466687-03 Serben 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 Ingredients. Unpublished study prepared by Phyllom, LLC. 6 

pages.

485532-04 Libs J, Rose R. 2010. Phyllom SDS-502 MP, Analysis of Samples. 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. Bacillus 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 Mallard Ducks (Anas platyrhynchos): Final 

Report. Project Number: 06001. Unpublished study prepared by Genesis 

Laboratories, Inc. 58 pages.
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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 thuringiensis 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 

Request). Unpublished study prepared by Phyllom, LLC. 3 pages.

485532-26 Porch J, Krueger H. 2011. Bacillus thuringiensis subsp. galleriae Strain SDS502 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 Anomala 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, Coleoptera: 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.
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MRID No. Study Description

485532-30 Richards R. 2006. Evaluation 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 Presence 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 Research 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.
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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 Wildlife 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 prepared 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-NLTp. 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/BLEU. 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. Project Number: VBC/60225/W/1. Unpublished 

study prepared by Valent BioSciences Corporation. 13 pages.
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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 of FloridaIFAS. 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 

Collection 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. israelensis (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. israelensis (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/Infectivity Study in 

Rats: Final Report. Project Number: 14546/10. Unpublished study prepared by 

Stillmeadow, Inc. 29 pages.
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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 prepared 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, Strain: Sum6218, 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 thuringiensis 

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.
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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-502 MP. Unpublished study prepared by Phyllom, LLC. 

8 pages.

489401-08 Libs J. 2012. Phyllom Bacillus thuringiensis subsp./var. galleriae, Strain SDS502, 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.

489542-02 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 SUM6218, 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.
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MRID No. Study Description

490540-01 Koester D. 2013. Spore Preparations of 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 

pages.

490940-01 Benzon G, Finkenbinder 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. Unpublished 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 prepared by 

Stillmeadow, Inc. 16 pages.

490940-04 Matthews T. 2013. Phyllom Bacillus thuringiensis subsp. galleriae, Strain SDS502, 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 SDS502, MP (TGAI) Primary Powder pH of Water Solutions or Suspensions. 

Project Number: PHY/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 Research. 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-HQ-OPP-2011-0705

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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 Benzon 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 SDS502, MP (TGAI) Primary Powder. Project Number: PHY/14/1. Unpublished 

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 Product 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. through 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 thuringiensis 
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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 

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 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. 2005a. Review of Resubmitted Studies on the Manufacturing Process, Quality Control, and β 

Exotoxin Testing 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 Resubmitted 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 the 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 Testing 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, 2005.

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 Daphnia 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. 2004a. 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.
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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 Process 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 September 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 Process 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. Registration 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. 
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U.S. EPA. 2002a. 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). Memorandum 

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. Sjoblad, Ph.D. to A. Reynolds, dated October 

29, 2002. 

U.S. EPA. 2002f. Registration 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 Bioinsecticide (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. 

Reynolds, 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. to A. Reynolds, dated April 17, 2000.

U.S. EPA. 1999a. Review of Special Daphnia magna Study to Determine the Cause of Non-Target 

Toxicity in Laboratory Studies Involving Bacillus thuringiensis subspecies aizawai Strain GC-91 
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(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 Memorandum Regarding the Product Identity and Toxicology Risk 

Assessment for Ecogen 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 Powder 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. EPA. 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. 1997a. Review of Product Chemistry and Waiver Requests for Use of Construct 11097 of 

Bacillus thuringiensis subspecies kurstaki EG7826 to Produce LepinoxTM Bioinsecticide. 

Memorandum from J.L. Kough, Ph.D. through P.O. Hutton to M. Mendelsohn, dated July 18, 1997.

U.S. EPA. 1997b. Freshwater 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 Bacillus 

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 Bacillus 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 

Technical, Crystar G and Crystar WDG Bioinsecticide. Memorandum from C. Schaffer through R. 

Sjoblad, Ph.D. to R. Kumar, dated August 1, 1996.
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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 the 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. 

Sjoblad, Ph.D. to P.O. Hutton, dated October 31, 1996.

U.S. EPA. 1995a. BPPD Review of Data Submitted by Ecogen for Registration of Crymax 

Bioinsecticide; and the Applicability of the Bt Tolerance Exemption for This Strain. Memorandum 

from C. Schaffer through 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 (154A19) 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. 1993a. SAB Review of a Change in Manufacturing Process and Acute Toxicity Studies from 

Abbott Laboratories for Support of the Registration of ABG-6346. Memorandum 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.
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U.S. EPA. 1992a. 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. Sjoblad, 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. Mendelsohn/P. Hutton, dated April 17, 1992.

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; and 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 of 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. 1991a. 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. Engler, Ph.D. to M. 

Mendelsohn/P. Hutton, dated November 12, 1991.
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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, Ph.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 

NovodorTM Technical. Memorandum from F. Chow through R. Engler, Ph.D. and R.D. Sjoblad, Ph.D. 

to P. Hutton/M. Mendelsohn, dated August 20, 1990.

U.S. EPA. 1990b. New Chemical Registration of NovodorTM Biological Insecticide for Coleopteran 

Larva Control. Memorandum from Z. Vaituzis, Ph.D. through R.W. Matheny and J.W. Akerman to P. 

Hutton, dated November 2, 1990.

U.S. EPA. 1990c. Product Chemistry Review of NovodorTM 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 October 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. Mendelsohn/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 Chemistry and Mammalian 

Toxicology Data Submitted by Ecogen, Inc., to Support the Registration of Condor® OF Insecticide 
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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 May 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.

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