2

 
3

TABLE OF CONTENTS

ACRONYMS.............................................................................................................................. 4

A. Introduction .......................................................................................................................... 6

B. Background Information ....................................................................................................... 6

1. Use Profile ..................................................................................................................... 7

2. Exemption from the Requirement of Tolerance .............................................................. 7

3. Other Regulatory Considerations .................................................................................. 8

4. General Manufacturing Process for Microbial Pesticides............................................. 10

5. Biologic Considerations ............................................................................................... 10

C. Anticipated Data Needs and Risk Concerns ....................................................................... 11

1. Data for Risk Assessment............................................................................................. 11

2. Efficacy and Label Claims ........................................................................................... 12

3. Endocrine Effects ........................................................................................................ 12

4. Incidents ...................................................................................................................... 13

D. Timeline .............................................................................................................................. 13

E. Guidance for Commenters ................................................................................................. 14

F. Environmental Justice ......................................................................................................... 14

G. Water Quality ..................................................................................................................... 14

H. Trade Irritants ..................................................................................................................... 14

I. Next Steps ........................................................................................................................... 14

REFERENCES ........................................................................................................................ 15

APPENDIX I: Pesticide Products Containing B. thuringiensis as an Active Ingredient .. App I-1

APPENDIX II: Summary of Incidents Involving Exposure to B. thuringiensis ................ App II-1

APPENDIX III: History of the Tolerance Exemption for B. thuringiensis ........................ App III-1

 
4

ACRONYMS 

Acronym Extension 

a.i. Active ingredient 

ATTC American Type Tissue Collection 

B. anthracis Bacillus anthracis 

B. cereus Bacillus cereus

B. thuringiensis Bacillus thuringiensis 

CFR Code of Federal Regulations 

DCI Data Call-in 

EDSP Endocrine Disruptor Screening Program 

EP End-use product 

EPA U.S. Environmental Protection Agency or, the Agency 

EPA Reg. No. EPA Registration Number: a two-part number assigned 

by EPA to identify each pesticide product registration. 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act of 1996 

FR Federal Register 

FWP Final Work Plan 

IDS Incident Data System 

MP Manufacturing-use product 

MPCA Microbial pesticide control agent 

MRL Maximum residue limits 

NPIC National Pesticides Information Center 

OPP EPA’s Office of Pesticide Programs 

OPPIN Office of Pesticide Programs Information Network 

PC Code Pesticide Chemical Code: a six-digit number 

assigned by OPP to identify pesticide chemicals. 

RED Reregistration Eligibility Determination (RED) 

TMDL Total maximum daily loads 
5

BACILLUS THURINGIENSIS REGISTRATION REVIEW TEAM

Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

Microbial Pesticides Branch 

SCIENCE ASSESSMENT

Kathleen Martin; MSES, MPA 

Alan Reynolds; MS 

 

RISK MANAGEMENT

Sheryl Reilly, Ph.D., Chief, Microbial Pesticides Branch 

 

 

OFFICE OF GENERAL COUNSEL

Philip Ross, Esq. 

 
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PRELIMINARY WORK PLAN 

 A. Introduction

 The Food Quality Protection Act (FQPA) of 1996 mandated the continuous review of existing 

pesticides. All pesticides distributed or sold in the United States must generally be registered by the 

U.S. Environmental Protection Agency (EPA or the Agency), 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. Changes in science, public policy, and 

pesticide use practices will occur over time. Through the Registration Review program, the Agency 

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 at: 

www.epa.gov/oppsrrd1/registration_review/. 

 The Agency 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 Agency 

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 Agency’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 Agency will develop and 

commit to a Final Work Plan (FWP) and schedule for this registration review. 

 This Registration Review Summary Document includes the Preliminary Work Plan and provides 

an initial evaluation of the microbial pest control agent (MPCA) Bacillus thuringiensis. Further 

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

regulations.gov; under “Keyword” enter the docket number, which is EPA-HQ-OPP-2011-0705. 

 B. Background Information 

 Bacillus thuringiensis is a naturally occurring organism commonly found in soil. It forms 

parasporal crystalline bodies, which are toxic for 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 

B. thuringiensis strains are toxic to all insects. 

B. thuringiensis was first discovered in Japan (1901), by Ishiwata during his study of a bacterial 

disease of silkworms. Later, in 1915, a German scientist named Berliner found a similar bacillus killing 

the larvae of flour moths; he published a description of the bacterium and its properties, naming it 

B. thuringiensis1

. In the 1930’s, French researchers recognized its potential for use in agriculture and 

developed a product known as Sporeine. (Federici 2005) In 1960, the U.S. Food and Drug 

Administration 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); this exemption was 

republished after EPA was established (36 FR 22572; November 25, 1971). Subsequently, the 

tolerance exemption has been amended.2

 In 1961, B. thuringiensis was registered as a pesticide. 

Today there are more than 100 registered pesticide products containing B. thuringiensis as an active 

ingredient. Provided below, under “Regulatory Considerations,” are details regarding regulatory actions 

and the tolerance exemption. Appendix I provides a list of all currently registered products containing 

B. thuringiensis as an active ingredient. 

 

1

The species name “thuringiensis” is derived from Thuringia, the region in Germany in which the disease occurred (Federici 2005). 2

See Appendix III for details regarding the amendments. 
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1. Use Profile

PESTICIDE TYPE: Insecticide 

USE SITES: Field-, greenhouse-, and water-grown3

 crops (pre- and postharvest use) 

Food and nonfood storage containers, buildings, and transport vehicles 

Outdoor and greenhouse-grown ornamentals and nursery crops 

Seed treatment (food and nonfood seeds) 

Standing water (e.g., certain crop fields, flooded fields, irrigation ditches, 

livestock watering containers, ornamental ponds, pastures, snowmelt) 

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) 

NOTE: B. thuringiensis products are registered for use against mature 

insects and insects in one of their various life stages (e.g., 3rd 

instar, egg, larval, pupal). 

FORMULATION 

TYPES:

aqueous suspension, bait, dry flowable, dust, emulsifiable concentrate, 

emulsifiable suspension, granule, slurry, technical powder, water 

dispersible granule, water soluble pouch, wettable powder 

APPLICATION 

METHODS: 

Aerial (fixed wing and rotary aircraft), low- and ultra-low volume 

application (aqueous or oil spray), tank mix, hand sprayer 

BASIC 

MANUFACTURERS: 

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

Certis USA, LLC (Company Number: 70051) 

Valent Biosciences Corporation (Company Number: 73049) 

 2. Exemption from the Requirement of Tolerance

 The current version of the exemption 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. 

 (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

Water-grown crops include cranberry bogs and rice fields. 
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 (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. 

[36 FR 22540, Nov. 25, 1971, as amended at 38 FR 19045, July 17, 1973; 42 FR 28540, 

June 3,1977; 45 FR 43721, June 30, 1980; 45 FR 56347, Aug. 25, 1980; 74 FR 26533, 

June 3, 2009] 

3. Other Regulatory Considerations

 Reregistration. The 1988 amendments to FIFRA authorized the Agency to conduct a 

comprehensive pesticide reregistration program—a complete reassessment of the human 

health and environmental effects of pesticides first registered before November 1, 1984— 

to make decisions about these pesticides' future sale, distribution, and use.4

 The results of the 

reassessments were later summarized in Reregistration Eligibility Decision (RED) documents. 

A Registration Standard for B. thuringiensis was published in 1988 (U.S. EPA 1988) and the 

RED for the reregistration review of B. thuringiensis was issued in 1998 (U.S. EPA 1998). The 

RED concluded that B. thuringiensis products were eligible for reregistration; it pointed out that 

B. thuringiensis may produce undesirable toxins (see “Biologic Considerations,” below, for a 

discussion on the undesirable toxins). The RED also stated the following: “To mitigate risks of 

potential toxicity to the public and/or non target species from these toxins, the Agency is 

requiring continuation of the production batch quality control testing that originally appeared in 

the tolerance exemption and is requiring the reevaluation and standar[d]ization of the 

manufacturing process for each registered technical grade of the active ingredient” (U.S. EPA 

1998). This RED element is also addressed in the tolerance exemption and in 40 CFR 158. 

 Registered Products. Pesticide products containing B. thuringiensis as an active 

ingredient are of one of four subspecies: 

 B. thuringiensis subspecies israelensis; 

· B. thuringiensis subspecies kurstaki; 

· B. thuringiensis subspecies aizawai; or 

· B. thuringiensis subspecies tenebrionis. 

Each subspecies, in turn, has one or more strains of B. thuringiensis . Table 1 is a summary of 

Appendix I—it shows the subspecies and their strains but only provides how many active 

pesticide products are in each strain. Three of the entries (PC Codes 006401, 006402, and 

006405) show end-use products (EPs) or FIFRA section 24(c) registrations but no analogous 

manufacturing-use product (MP). PC Codes 006401, 006402, and 006405 are the generic 

PC Codes for B. thuringiensis subspecies israelenis, kurstaki, and tenebrionis, respectively. 

 

4

www.epa.gov/oppsrrd1/reregistration/reregistration_facts.htm. 
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At one time all B. thuringiensis israelensis, kurstaki, and tenebrionis registrations, regardless of 

strain, were listed in the Agency’s Office of Pesticide Programs Information Network (OPPIN) 

database under the generic PC Code. Later, the Agency began assigning individual PC Codes 

for each strain. During the course of registration review, EPA will correct this administrative 

artifact by assigning the strain-specific PC Codes to these products. Another curiosity is with 

B. thuringiensis kurstaki strain EG7841 Lepidopteran active toxin, PC Code 006453—there is a 

single entry for two products, and the number of EPs versus MPs is not differentiated. The 

reason for this is that these two products are made by an integrated process, where the EP is 

made from start to finish in a single stream—a separate MP is not formed. This is a common 

practice with some microbial pesticides. More information on the manufacturing process is 

provided below, under “General Manufacturing Process of Microbial Pesticides.” 

Table 1. Bacillus Thuringiensis Subspecies and Strains 

STRAIN PC

CODE

NO. ACTIVE PRODUCTS NOTES

MP EP 24(C) 

B. thuringiensis subspecies israelensis

B. thuringiensis israelensis 006401 -- 4 1 

During this registration review, EPA will reclassify 

these five products—PC Code 006401 is the generic 

category for B. thuringiensis israelensis; these five 

products should be coded by their particular strains. 

B. thuringiensis israelensis 

strain EG2215 006476 1 -- -- 

B. thuringiensis israelensis 

strain BMP 144 solids, 

spores and insecticidal 

toxins 

006520 1 14 -- 

B. thuringiensis israelensis 

AM 65-52 069162 3 13 1 Two of the MPs are solids; one is a slurry. 

B. thuringiensis israelensis 

strain SA3A 069210 2 3 -- One MP is a solid and the other is a slurry. 

B. thuringiensis subspecies kurstaki

B. thuringiensis kurstaki 006402 -- 3 2 

During this registration review, EPA will reclassify 

these five products—PC Code 006402 is the generic 

category for B. thuringiensis kurstaki; these five 

products should be coded by their particular strains. 

B. thuringiensis kurstaki

strain BMP123 006407 1 4 -- 

B. thuringiensis kurstaki

strain EG2371 006423 1 1 -- 

B. thuringiensis kurstaki

strain EG2348 006424 1 3 -- 

B. thuringiensis kurstaki

strain EG7841 Lepidopteran 

active toxin 

006453 2 -- Integrated Process (i.e., there is no technical or MP) 

B. thuringiensis kurstaki

strain EG7826 Lepidopteran 

active toxin 

006459 1 1 -- 

B. thuringiensis kurstaki

strain SA-12 solids, spores, 

and insecticidal toxins, 

ATCC # SD-1323 

006518 2 12 -- Both the MPs are solids. 
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STRAIN PC

CODE

NO. ACTIVE PRODUCTS NOTES

MP EP 24(C) 

B. thuringiensis kurstaki

strain SA-11 solids, spores 

and insecticidal toxins, 

ATCC # SD-1322 

006519 1 4 -- 

B. thuringiensis kurstaki 

strain ABTS-351 006522 4 29 1 Two of the MPs are solids and two are slurries. 

 B. thuringiensis subspecies aizawai

B. thuringiensis aizawai

strain GC-91 006426 1 2 -- 

B. thuringiensis aizawai

strain NB200 006494 1 -- -- 

B. thuringiensis aizawai 

strain ABTS 1857 006523 3 3 -- Two of the MPs are solids; one is a slurry. 

B. thuringiensis subspecies tenebrionis

B. thuringiensis tenebrionis 006405 -- -- 1 

B. thuringiensis tenebrionis

strain NB-176 006524 1 2 -- 

 4. General Manufacturing Process for Microbial Pesticides (Taborsky 1992) 

Microbial pesticides are made by fermentation, where a starter culture is added to a 

broth of nutrients so that the bacteria can grow. The end 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. For some microbial products the 

slurry is considered to be the manufacturing-use 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 products are made without 

an intermediate MP, as the end-use product (EP) is made from start to finish in a single 

‘integrated process.’ Crymax (EPA Reg. No. 70051-86) and Crymax WP (EPA Reg. 

No. 70051-90) are two B. thuringiensis-containing products that are made this way. See 

Appendix I for the complete list of the B. thuringiensis-containing products. 

 5. Biologic Considerations 

 The scientific classification for B. thuringiensis is (NIH 2011): 

KINGDOM: Bacteria 

PHYLUM: Firmicutes 

 CLASS: Bacilli 

ORDER: Bacillales 

FAMILY: Bacillaceae

GENUS: Bacillus

SPECIES GROUP: Bacillus cereus 

SPECIES: thuringiens

 
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 Members of the genus Bacillus are gram-positive, aerobic (or facultative anaerobic), 

endospore-forming bacteria. It is this ability to form spores that allows these bacteria to survive 

in soil. (Todar 2011). B. thuringiensis is one of three species of the Bacillus cereus group (the 

others being B. cereus and Bacillus anthracis) that have an impact on human activity 

(Vilas-Bôas 2007). B. cereus and B. anthracis are human pathogens. B. cereus causes two 

forms of foodborne illness via production of exotoxins. The emetic form, which is characterized 

by nausea and vomiting, is caused by emetic toxin and the more severe diarrheal form, which 

manifests as abdominal cramps and diarrhea, is caused by nonhemolytic enterotoxin and/or 

hemolytic enterotoxin. B.anthracis causes anthrax, which is primarily a disease of domesticated 

and wild animals; humans may become infected when brought into contact with diseased 

animals. In the United States, the incidence of naturally-acquired human anthrax is extremely 

rare (one to two cases of cutaneous disease per year) (Todar 2011). 

B. thuringiensis is geno- and phenotypically related to B. cereus and B.anthracis. It is 

genetically indistinguishable from B. cereus, except for the ability of B. thuringiensis to produce 

parasporal crystalline bodies, which are toxic for certain invertebrates, especially species of 

insect larvae belonging to the insect orders Coleoptera, Diptera and Lepidoptera. The crystals 

are predominantly comprised of one or more proteins (Cry and Cyt toxins), which are also called 

δ-endotoxins. They have various shapes (e.g., bipyramidal, cuboidal, flat rhomboid, spherical) 

depending on their protein composition. Correlation between crystal morphology, protein 

composition, and bioactivity against target insects has been established. 

(Bravo 2007; IPCS 1999) 

 C. Anticipated Data Needs and Risk Concerns

 1. Data for Risk Assessment

B. thuringiensis is a complex registration review case—not only are there a great 

number of strains, each with its own data set for the three scientific disciplines (i.e., product 

analysis, toxicology, and nontarget organisms and environmental fate), as set forth in 40 CFR 

158, subpart V, but the Agency’s internal system for tracking data and data reviews has 

changed over time. EPA uses PC Codes5

 to track and file data submitted to support registration 

and the Agency’s data reviews. At one time, the same PC Code was used for all strains of a 

particular subspecies; for example, all strains of B. thuringiensis israelensis were coded under 

PC Code 006401. In 1989, EPA started assigning individual PC Codes for each new strain. 

Some of the data and reviews are still coded under the old system, which has presented 

challenges thus far in the registration review of B. thuringiensis. 

 EPA has completed a preliminary review of the B. thuringiensis database and has 

identified some data gaps. For example, the Product Analysis requirement for ‘deposition of a 

sample in a nationally recognized culture collection’ (40 CFR 158.2120) has not been satisfied 

for a number of strains. This can be expected, as many of the B. thuringiensis-containing 

products were registered before the October 26, 2007 Final Rule; this rule, among other things, 

revised the microbial data requirements to include the aforementioned data requirement for 

culture collection deposition (72 FR 60988; October 26, 2007). As the Agency develops its 

FWP for this case, it will also complete a comprehensive evaluation of its entire record for 

B. thuringiensis. To date, EPA has only reviewed the information available in its electronic 

databases. The Agency is now in the process of examining the paper files for B. thuringiensis, 

which includes product jackets housed in the Federal Record Center. In the FWP, a full 

accounting of how each data requirement has (or has not) been met will be provided. Also in 

the FWP, EPA will discuss its findings and will finalize its conclusions regarding the need for 

additional data for risk assessment. 

 

5

A PC Code (Pesticide Chemical Code) is a six-digit number assigned by OPP to identify and track 

pesticide chemicals, inert ingredients, and other chemicals in its internal databases. 
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 In addition to the comprehensive review of its entire record for B. thuringiensis, EPA 

plans to complete the following during the registration review of B. thuringiensis: 

· Review the tolerance exemption to determine if it needs to be updated or amended to 

take into account advances in microbial analytic techniques and microbiology in 

general. Also, the current exemption is broad, it only considers B. thuringiensis at the 

genus and species level; EPA intends to investigate whether the exemption should be 

expanded to consider lower taxonomic levels such as subspecies and strain. 

· Reassess B. thuringiensis’ hazard to threatened and endangered species, and review 

current ecological risk mitigation measures. 

· Review the science data sets for each strain of the technical products to make sure 

 that they are current with complete bibliographies. 

2. Efficacy and Label Claims 

 The Agency requires and reviews efficacy data for microbial pesticides making labeling 

claims to control public health pests. Public health pests are either: (1) pest microorganisms 

infectious to man in any area of the inanimate environment; or (2) vertebrates or invertebrates 

(including but not limited mosquitoes and ticks) that may directly or indirectly transmit diseases 

to humans (40 CFR 158.2160). Because B. thuringiensis is registered for use against 

mosquitoes, efficacy data are required. As part of its comprehensive review of the entire 

B. thuringiensis record, the Agency will ensure that all efficacy data requirements have been 

met. If efficacy data gaps are identified, EPA will discuss them in the FWP. 

 3. Endocrine Effects 

 As required by the Administrator under the Federal Food, Drug, and Cosmetic Act 

(FFDCA) section 408(p), EPA has developed the Endocrine Disruptor Screening Program 

(EDSP) and has begun to implement the screening program that is to be used to test all 

pesticides 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 anticipated not to produce any effect 

in humans similar to an effect produced by a naturally occurring estrogenic substance. 

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

first group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert 

ingredients. B. thuringiensis is not among the group of 58 pesticide active ingredients on the 

initial list to be screened under the EDSP. 

 The Agency, as part of this preliminary work plan, believes that B. thuringiensis , the 

active ingredient involved in this registration review case, likely is a substance that would not 

produce any effect in humans similar to an effect produced by a naturally occurring estrogenic 

substance. As such, pursuant to Section 408(p)(4), EPA will determine in the future whether it 

can exempt B. thuringiensis from the requirements of the Section 408(p) EDSP. In the event 

the Agency 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 

67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our 

website: www.epa.gov/endo/. 
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 4. Incidents 

 The National Pesticides Information Center (NPIC) database reported no incidents 

associated with products containing B. thuringiensis . The Office of Pesticide Programs’ (OPP) 

Incident Data System (IDS) shows 40 human or domestic animal reports of adverse effects 

following exposure to a pesticide product containing B. thuringiensis. Twenty-nine are human 

cases that are considered to be minor; many involved being sprayed accidentally during aerial 

application and a few were attempted suicides. Eleven 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. For more 

information on the incidents, see Appendix III. The Agency will consider any incident data or 

comments submitted to this docket in response to this preliminary work plan. 

 D. Timeline 

 The projected timeline for case 0247—The Bacillus thuringiensis Registration Review— is 

shown in Table 2. Please note that 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 acquire an 

EDSP exemption, an amended FWP will be issued. As also discussed earlier, the FWP will identify any 

newly anticipated data needs and set forth a new timeline if necessary. 

 Table 2. Projected Timeline for the Registration Review of Case 0247

ACTIVITY ESTIMATED

MONTH AND YEAR

 Phase 1: Open the Public Docket

Open Comment Period for Docket September 30, 2011 

Close Comment Period November 30, 2011 

 Phase 2: Case Development

Develop Final Work Plan May 2012 

Issue DCI May 2013 

Data Submission May 2015 

Open Public Comment Period for Preliminary Risk Assessments November 2016 

Close Public Comment Period December 2016 

 Phase 3: Registration Review Decision

Open Comment Period for Proposed Registration Review Decision June 2018 

Close Comment Period August 2018 

Final Decision and Begin Post-Decision Followup 2018 

Estimated Total (years) 7 

 
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 E. Guidance for Commenters

 The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency will 

consider all comments as well as any additional information or data provided in a timely manner prior to 

issuing an FWP for the case. 

 F. Environmental Justice

 EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of 

all people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency 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 B. 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. 

 G. Water Quality

B. 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.6

 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for B. thuringiensis.

7

 More information on impaired water bodies and 

TMDLs can be found at: www.epa.gov/owow/tmdl/. The Agency invites submission of water quality 

data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix 

A of OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality 

Data in OPP’s Registration Review Risk Assessment and Management Process8

 to ensure they can be 

used quantitatively or qualitatively in pesticide risk assessments. 

 H. Trade Irritants 

 Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and other 

stakeholders are asked to comment on any trade irritant issues resulting from lack of Maximum 

Residue Limits (MRLs) or disparities between United States tolerances and MRLs in key export 

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

 Residues of B. thuringiensis are exempt from the requirement of tolerance and there are no 

known MRLs (FAO and WHO 2010). Therefore, the Agency does not anticipate that current uses of 

B. thuringiensis will pose concerns as trade irritants. 

I. Next Steps

 After the 60-day comment period closes, the Agency will review and respond to any comments 

received in a timely manner and then issue an FWP for Bacillus thuringiensis case 0247. 

 

 

6

Based on information provided at: http://www.epa.gov/owow/tmdl/. 7

Based on information provided at: http://iaspub.epa.gov/tmdl_waters10/text_search.tmdl_search_form. 8

This document can be found at: http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm.
Bacillus thuringiensis Case 0247 EPA-HQ-OPP-2011-0705 

 regulations.gov 

15

REFERENCES 

Bergey. 2009. Bergey’s Manual of Systematic Bacteriology, Volume 3; 2nd Ed. Springer. New York. 

Bravo, A. 2007. Mode of action of Bacillus thuringiensis Cry and Cyt toxins and their potential for 

insect control. Toxicon. March 15; 49(4):423–435. 

FAO and WHO. 2010. Codex Alimentarius. United Nations Food and Agriculture Organization & 

World Health Organization. Information retrieved on June 9, 2011. 

www.codexalimentarius.net/mrls/pestdes/jsp/pest_q-e.jsp 

Federici, BA. 2005. Insecticidal bacteria: An overwhelming success for invertebrate pathology. 

Journal of Invertebrate Pathology 89 (2005) 30–38. 

IPCS. 1999. Environmental Health Criteria 217: Bacillus thuringiensis. International Programme on 

Chemical Safety. United Nations Environment Programme and World Health Organization. Geneva. 

www.inchem.org/pages/ehc.html 

NIH 2011. Taxonomy Browser. U.S. Department of Health and Human Services. National Institutes of 

Health. National Library of Medicine. National Center for Biotechnology Information. Information 

retrieved on September 15, 2011. www.ncbi.nlm.nih.gov/Taxonomy/Browser/wwwtax.cgi 

Taborsky, V. 1992. Small-Scale Processing of Microbial Pesticides. FAO Agricultural Services 

Bulletin No. 96. Food and Agriculture Organization of the United Nations. Rome. 

www.fao.org/docrep/t0533E/t0533E00.htm. 

Todar, Kenneth. 2011. Todar’s Online Textbook of Bacteriology. University of Wisconsin. Information 

retrieved on September 15, 2011. www.textbookofbacteriology.net 

U.S. EPA. 1988. Guidance for the Reregistration of Pesticide Products Containing Bacillus 

thuringiensis as the Active Ingredient. U.S. Environmental Protection Agency. Office of Pesticides and 

Toxic Substances. December 1988. 540/RS-89-023. 

U.S. EPA. 1998. Reregistration Eligibility Decision (RED): Bacillus thuringiensis. U.S. Environmental 

Protection Agency. Office of Prevention, Pesticides, and Toxic Substances. March 1998. EPA738-R98-004. 

Vilas-Bôas, G.T., et. al. 2007. Biology and taxonomy of Bacillus cereus, Bacillus anthracis, and 

Bacillus thuringiensis. Can. J. Microbiol. 53:673-687. 
APP I-1

APPENDIX I: PESTICIDE PRODUCTS CONTAINING 

BACILLUS THURINGIENSIS AS AN ACTIVE INGREDIENT (A.I.) 

 Provided below are the currently registered pesticide products containing Bacillus thuringiensis 

as an active ingredient; they include section (3) and 24(c) registrations. Highlighted entries denote 

manufacturing-use products (MP). 

SUBSPECIES, STRAIN

AND PC CODE

EPA

REG. NO. NAME % A.I. NOTES

Bacillus thuringiensis subspecies israelensis

006401 

B. thuringiensis 

israelensis

4-455 Bonide Mosquito Beater WSP 1.7 

6218-73 Summit Mosquito Bits 2.86 

70051-102 Bti Granule Larvicide 2.86 

81045-1 Healthy Outdoors Brand Sustained 

Release Mosquito Larvicide 15 

AZ960003 Vectobac G Biological Larvicide Granules 0.2 Parent sec(3) 

registration is 73049-10

006476 

B. thuringiensis israelensis strain 

EG2215 

73049-405 Bti Technical Powder Bioinsecticide 100 MP 

006520 

B. thuringiensis israelensis

strain BMP 144 

solids, spores and 

insecticidal toxins 

62637-7 BMP 144 Primary Powder 100 MP 

432-1515 BES0531 10 

769-992 Allpro Sustain BCG 5.71 

6218-47 Summit B.T.I. Briquets 10.31 

62637-1 BMP 144 (2x) 8 

62637-2 BMP 144 (3x) 12 

62637-3 BMP 144 (200 G) 2.86 

62637-11 BMP 144 DF 17.15 

62637-12 BMP 144 DFX 25.7 

62637-13 BMP 144 (400 G) 5.71 

62637-14 BMP 144DF 3000 43 

83362-2 Meridian-02 7 

83362-3 FourstarTM Briquets 1a 

85685-1 FourstarTM SBG 2.15 

85685-2 FourstarTM CRG 1a 

069162 

B. thuringiensis israelensis 

strain AM 65-52 

73049-13 Vectobac Technical Powder 99 MP 

73049-355 Vectobac Biological Larvicide Primary Powder 99 MP 

73049-61 Bacillus Thuringiensis subspecies Israelensis Slurry 14 MP 

8329-39 Bti Granules 0.25 

9688-212 Chemsico Insect Granules Ml 4.95 

73049-10 Vectobac G Biological Larvicide Granules 2.8 

73049-11 Vectobac- AS 6.38 

73049-18 Vectobac-12 AS-II 11.6 

73049-19 Vectobac GR 4.95 

73049-38 Vectobac 12AS Biological Larvicide 11.6 

73049-56 Vectobac WDG Biological Larvicide 37.4 

73049-429 V60035 CG 4.5a 

73049-447 Vectobac DT Biological Larvicide (VBC-60046) 37.4 

73049-451 VBC-60092 (Bactimos Briquette) 10.3 

73049-452 Vectobac Pellet Biological Larvicide 12.3 

73049-477 Bacillus thuringiensis subspecies Israelensis Slurry 14.0 

DE090002 Vectobac WDG 37.4 Parent sec(3) 

registration is 73049-56

069210 

B. thuringiensis israelensis

strain SA3A 

73049-408 Teknar Technical Concentrate 100 MP 

73049-428 Teknar Slurry 22 MP 

73049-403 Teknar G 1.7 
APP I-2

SUBSPECIES, STRAIN

AND PC CODE

EPA

REG. NO. NAME % A.I. NOTES

73049-404 Teknar HP-D 1.6 

73049-435 Teknar HP Biological Larvicide Aqueous Suspension 5.6 a

Contains Bacillus sphaericus as a second active ingredient (83362-3, 6%; 85685-2, 9%; and 73049-429, 2.7%). 

Bacillus thuringiensis subspecies kurstaki

006402 

B. thuringiensis kurstaki

73049-406 Thuricide 76 LV 14.4 

73049-413 Thuricide 48LV Forestry 19 

85827-3 Green Light Bt Worm Killer 15 

ND010004 Dipel ES 23.7 Parent section (3) 

TX020001 Dipel ES 23.7 registration is 73049-17

006407 

B. thuringiensis kurstaki 

strain BMP123 

62637-9 BMP 123 Primary Powder 100 MP 

62637-5 BMP 123 (2X WP) 40 

62637-6 BMP 123 (48 LC) 2.15 

62637-8 BMP 123 (10G) 2 

62637-10 BMP 123 (64ES) 22 

006423 

B. thuringiensis kurstaki 

strain EG2371

70051-84 Cutlass Technical Powder 100 MP 

70051-79 Cutlass 40 

006424 

B. thuringiensis 

kurstaki strain EG2348 

70051-83 Condor Technical Powder 100 MP 

70051-78 Condor 24.5 

70051-80 Condor WP 43 

70051-85 Condor XL 45 

006453 

B. thuringiensis kurstaki strain 

EG7841Lepidopteran active toxin 

70051-86 Crymax 40 

Integrated processa

70051-90 Crymax WP 40 

006459 

B. thuringiensis kurstaki strain 

EG7826 Lepidopteran active toxin 

70051-87 Lepinox 100 MP 

70051-89 Lepinox WDG 40 

006518 

B. thuringiensis kurstaki 

strain SA-12 

solids, spores, 

and insecticidal toxins, 

ATCC # SD-1323 

70051-68 Thuricide Technical Concentrate 100 MP 

70051-70 San 420 I® Technical Concentrate 100 MP 

4-226 Bonide Bacillus thuringiensis (Bt) 

Moth Larvae (Caterpillar) 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 Chemisco HPC-O Concentrate 98.35 

70051-52 Thuricide HPC 15 

70051-53 Thuricide HP WP 70 

70051-57 Thuricide 48 LV 19 

70051-65 Thuricide HPC 15 

70051-69 San 420 I WG 85 

70051-103 Btk32 85 

70051-106 Thuricide HPC-O For Home 

And Gardens 98.35 

006519 

B. thuringiensis kurstaki 

strain SA-11 solids, spores and 

insecticidal toxins, 

ATCC # SD-1322 

70051-67 Javelin Technical Concentrate 100 MP 

70051-60 Javelin 17.8 

70051-61 Javelin WP 80 

70051-66 Javelin WG 85 

70051-98 Javelin WG 2 85 

006522 

B. thuringiensis kurstaki 

strain ABTS-351 

73049-12 Dipel Technical Powder 91 MP 

73049-27 ABG-6345 Technical Powder 84 MP 

73049-62 Bacillus thuringiensis subspecies Kurstaki Slurry 22 MP 

73049-476 Bacillus thuringiensis subspecies Kurstaki Slurry (for 

Foray Products) 22 MP 

4-251 Bonide Dipel 150 Dust For Vegetables 0.47 

4-252 Dipel WP Home & Garden Insecticide 6.4 
APP I-3

SUBSPECIES, STRAIN

AND PC CODE

EPA

REG. NO. NAME % A.I. NOTES

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 Wilbur-Ellis Bt 320 Dust 0.582 

2935-399 Bt 320 Sulfur 25 Dust 0.582a 

7401-290 Ferti-Lome Dipel Dust Biological Insecticide 0.064 

10951-10 Britz Bt 25 Sulfur Dust 1.16 

10951-17 Britz Bt Dust 1.94 

34704-722 Bt Sulfur 15-50 Dust 0.72 

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 58.2 

73049-14 Dipel 10G Biological Insecticide Granules 2.3 

73049-17 Dipel ES 23.7 

73049-30 Dipel ES-NT Biological Insecticide 

Emulsifiable Suspension 25 

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 76 B 18.44 

73049-50 Biobit HP WP II Biological Insecticide 34.11 

73049-54 Biobit HP Biological Insecticide Wettable Powder 58.2 

73049-427 Foray 48B 57.5 

73049-471 Foray WG 76.2 

85827-4 Green Light Dipel Dust 0.49 

CA100012 Dipel DF Biological Insecticide 54 Parent section (3) 

registration is 73049-39 a

These products contain sulfur as a second active ingredient (2935-399 and 10951-10 at 25% and 34704-722 at 50%). 

Bacillus thuringiensis subspecies aizawai

006426 

B. thuringiensis aizawai

strain GC-91 

70051-48 Technical CGA-237218 100 MP 

70051-47 Agree 50 

70051-99 Jackpot WP 50 

006494 

B. thuringiensis aizawai 

strain NB200 

73049-68 Florbac Slurry Biological Larvicide 18 MP 

006523 

B. thuringiensis aizawai 

strain ABTS 1857 

73049-24 Xentari Biological Insecticide Technical Powder 89 MP 

73049-28 ABG-6346 Biological Insecticide 83 MP 

73049-63 Bacillus thuringiensis subspecies 

Aizawai Slurry 18 MP 

73049-23 Xentari Biological Insecticide Water Dispersible Granule 48.1 

73049-31 Xentari As Biological Insecticide 10.8 

73049-40 Xentari Biological Insecticide Dry Flowable 54 

Bacillus thuringiensis subspecies tenebrionis

006405 

B. thuringiensis tenebrionis WA040029 Novodor Biological Insecticide Flowable Concentrate 10 Parent section (3) 

registration is 73049-48

006524 

B. thuringiensis tenebrionis 

strain NB-176 

73049-47 Novodor Technical 92.6 MP 

73049-64 Novodor Flowable Concentrate 10 

73049-48 Bacillus thuringiensis subspecies Tenebrionis Slurry 17 
APP II-1 

APPENDIX II: SUMMARY OF INCIDENTS INVOLVING EXPOSURE TO BACILLUS THURINGIENSIS

 Provided in the following table is a summary, arrayed by subspecies, of incidents compiled in 

the Agency’s Incident Data System database between 1992 and 2010. Where information was 

available, discussion regarding the nature of the incident is given. 

TOTAL 

NUMBER OF 

INCIDENTS:

DISCUSSION

NO. HUMAN

NO. DOMESTIC 

ANIMAL

Bacillus thuringiensis subspecies israelensis

11 3=H-Da 3=D-Cb

5=D-Dc

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

 

26 23=H-D 2=D-Ad

2=D-Dc

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 difficultly 

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. 

Several cases involved suicide attempts. 

Animal

In a case of aerial spraying, a Great Dane developed diarrhea for two days. 

 

Bacillus thuringiensis subspecies aizawai

 2 H-D Human Cases

California farmworkers experienced allergic reaction after exposure to Bacillus 

thuringiensis; they showed significant positive skin tests to spore extracts. 

 

Bacillus thuringiensis subspecies tenebrionis

 1 H-D a

H-D is considered to be a minor human incident. An incident is classified as H-D if “If the person alleged or exhibited some symptoms, but they 

were minimally traumatic. The symptoms resolved rapidly and usually involve skin, eye or respiratory irritation” 40 CFR 159.184(c)(5). 

b

D-C is a moderate domestic animal incident. An incident is classified as D-C if “ the domestic animal exhibited or was alleged to have exhibited 

symptoms which are more pronounced, more prolonged or of a more systemic nature than minor symptoms. Usually some form of treatment would 

have been indicated to treat the animal. Symptoms were not life threatening and the animal has returned to its pre-exposure state of health with no 

additional residual disability” 40 CFR 159.184(c)(5). 

c

D-D is a minor domestic animal incident. An incident is classified as D-D if “the domestic animal was alleged to have exhibited symptoms, but they 

were minimally bothersome. The symptoms resolved rapidly and usually involve skin, eye or respirator irritation” 40 CFR 159.184(c)(5). 

d

D-A is a domestic animal death. This code is used if the If the domestic animal died or was euthanized” 40 CFR 159.184(c)(5).
APP III-1 

APPENDIX III: HISTORY OF THE TOLERANCE EXEMPTION FOR BACILLUS THURINGIENSIS

 Provided below is the original tolerance exemption (by the Food and Drug Administration) followed by 

it’s subsequent amendments and the reasons for the amendments. 

25 FR 3207 

April 14, 1960 

§ 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 

 

38 FR 9045 

July 17, 1973 

§ 180.1011 Exemption from the requirement of a tolerance for 

residues of viable spores of the Bacillus thuringiensis

Berliner; exemption from the requirement of a tolerance. 

(a) * * * 

 (b) 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. 

EPA amended the exemption “to 

include a toxicity test to determine the 

presence of β-exotoxin to insure that 

B. thuringiensis products are free of 

this toxin.” 

 

42 FR 28540 

June 3, 1977 

§ 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. 

At the request of IR-4 (Interregional 

Research Project No. 4), the Agency 

amended § 180.1011 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.” 
APP III-2 

 

45 FR 43721 

June 30, 1980 

§ 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. 

EPA made an amendment to update 

the Bergey reference from the Seventh 

edition to the Eighth edition. 

 

45 FR 56347 

Aug. 25, 1980 

§ 180.1011 Viable spores of the microorganism Bacillus 

thuringiensis Berliner, exemption from the requirement of a 

tolerance. 

* * * * * 

(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. 

At the request of IR-4 (Interregional 

Research Project No. 4), the Agency 

amended § 180.1011 to exempt 

residues of “Bacillus thuringiensis 

Berliner in or on the raw agricultural 

commodities beeswax and honey.” 

 

74 FR 26533 

June 3, 2009 

§ 180.1011 Viable spores of the microorganism Bacillus

thuringiensis Berliner; exemption from the requirement of a 

tolerance. 

* * * * * 

 (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 

exemption from requirement of 

tolerance was updated to comport with 

this new database.