BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Bacillus thuringiensis subsp. israelensis strain SUM-6218

Pesticide Chemical (PC) Code: 006642

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

May 9, 2013
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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TABLE OF CONTENTS

I. EXECUTIVE SUMMARY...........................................................................................................................4

II. ACTIVE INGREDIENT OVERVIEW .......................................................................................................5

III. REGULATORY BACKGROUND ..............................................................................................................5

A. Applications for Pesticide Registration ..........................................................................................5

B. Food Tolerance Exemption..............................................................................................................5

IV. RISK ASSESSMENT..................................................................................................................................6

A. Product Analysis Assessment (40 CFR § 158.2120).......................................................................6

B. Human Health Risk Assessment (40 CFR § 158.2140)..................................................................7

C. Environmental Assessment (40 CFR § 158.2150)........................................................................10

V. ENVIRONMENTAL JUSTICE.................................................................................................................13

VI. RISK MANAGEMENT DECISION .........................................................................................................14

VII. ACTIONS REQUIRED OF THE REGISTRANT...................................................................................15

A. Final Printed Labeling ...................................................................................................................15

B. Terms of Registration.....................................................................................................................15

C. Reporting of Adverse Effects and Hypersensitivity Incidents....................................................15

VIII. BIBLIOGRAPHY .......................................................................................................................................16

A. Studies Submitted to Support the Registration of Pesticide Product Containing 

Bacillus thuringiensis subsp. israelensis strain SUM-6218.....................................................................................16

B. Environmental Protection Agency Risk Assessment Memoranda .............................................18

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS ...........................................................20

APPENDIX B. PESTICIDE PRODUCT................................................................................................................24
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch (MPB)

Science Review

Ibrahim Barsoum, Ph.D. Product Analysis and Human Health

Shannon Borges, M.S. Nontarget Effects

Regulatory Review

Shannon Borges, M.S. Team Leader, MPB

Denise Greenway Regulatory Action Leader, MPB

Kimberly Nesci, M.S. Chief, MPB
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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I. EXECUTIVE SUMMARY

Background: In December 2011, Summit Chemical Company submitted an application for a 

new manufacturing-use pesticide product containing the active ingredient Bacillus thuringiensis

subsp. israelensis strain SUM-6218, at 100.00% concentration in powder form (EPA File 

Symbol 6218-IG), to the United States Environmental Protection Agency (EPA) under section 3 

of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Description of the Active Ingredient: L.H. Goldberg and J. Margalit originally isolated 

Bacillus thuringiensis subsp. israelensis (Bti) in Israel in 1977. Bacillus thuringiensis subsp. 

israelensis strain SUM-6218 has a cream-like color and is a gram-positive, motile bacillus 

containing ellipsoid spores that readily stain with Coomassie Brilliant Blue. Cells grown on LB 

agar in the presence of 100 μg/mL penicillin show that the strain is penicillin resistant. Cells 

grown on modified egg yolk agar under anaerobic conditions develop white opaque zones of 

precipitation, indicating that they synthesize lecithinase. The delta endotoxins are insecticidal.

Assessing Risks to Human Health: Data derived from appropriate tests give no indication that 

the living microorganism is toxic or pathogenic to humans. No harmful health effects to humans 

are expected from the use of Bacillus thuringiensis subsp. israelensis strain SUM-6218 as a 

pesticide.

Assessing Risks to the Environment: Pesticide products containing Bacillus thuringiensis

subsp. israelensis strain SUM-6218 are not likely to pose a risk to the environment or to any 

nontarget organisms. 

Public Participation: On October 1, 2009, the U.S. Environmental Protection Agency (EPA, or 

Agency) announced a policy to provide a more meaningful opportunity for the public to 

participate in major registration decisions before they occur. According to this policy, EPA 

provides a public comment period prior to making a registration decision for the following types 

of applications: new active ingredients; first food uses; first outdoor uses; first residential uses; 

or any other registration actions for which EPA believes there may be significant public interest. 

Consistent with the policy of making registration decisions more transparent, EPA’s registration 

decision on a pesticide product containing the new active ingredient, Bacillus thuringiensis

subsp. israelensis strain SUM-6218, is subject to a concurrent 15-day comment period. While a 

final decision on registration is usually contingent upon review and consideration of public 

comments, the Agency believes that, based upon the risk assessment and information submitted 

in support of registration of Bacillus thuringiensis subsp. israelensis strain SUM-6218, it is in the 

best interest of the public and the environment to issue the registration for Bacillus thuringiensis

subsp. israelensis strain SUM-6218 without delay. The basis for this decision can be found in the 

risk assessment for Bacillus thuringiensis subsp. israelensis strain SUM-6218, which is 

characterized throughout this Biopesticides Registration Action Document (BRAD) and the 

associated referenced documents. Although considered a new active ingredient by regulation, 

because the data and information supporting this new strain of Bacillus thuringiensis subsp. 

israelensis have established that it is substantially similar to previously registered Bacillus 

thuringiensis subsp. israelensis strains, the actual purpose for allowing pre-decisional public 

comments on new active ingredients is not served here. The following documents are being 
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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made available for comment in the docket, identification number EPA-HQ-OPP-2012-0485, and 

accessed through either http://www.regulations.gov or 

http://www.epa.gov/pesticides/regulating/registration-status.html: (1) Bacillus thuringiensis

subsp. israelensis strain SUM-6218 Biopesticides Registration Action Document (BRAD); (2) 

label for the manufacturing-use pesticide product, Summit® Bti MP (EPA Registration Number 

6218-83). 

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/.

II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Bacillus thuringiensis subsp. israelensis strain SUM-6218

Culture Collection: Deposited at the American Type Culture Collection (ATCC) in

Manassas, Virginia under ATCC BAA-2453.

OPP Chemical Code: 006642

Type of Pesticide: Microbial Pesticide – Insecticide

See Appendix B for specific information (i.e., use sites, application 

rates, methods of application, formulation types, and target pests) 

regarding the pesticide product containing this active ingredient.

III. REGULATORY BACKGROUND

A. Applications for Pesticide Registration 

On December 6, 2011, an application for registration was submitted on behalf of Summit 

Chemical Company, 235 South Kresson Street, Baltimore, MD 21224-2616 for the 

manufacturing-use pesticide product, Summit® Bti MP (EPA File Symbol 6218-IG), containing 

the new microbial active ingredient Bacillus thuringiensis subsp. israelensis strain SUM-6218. 

In the Federal Register of August 14, 2012 (77 FR 48520), EPA announced receipt of this

application for registration of a pesticide product containing a new active ingredient for 

manufacturing use only. No comments were received following publication of this notice. For 

more information, see the following docket at http://www.regulations.gov/: EPA-HQ-OPP-2012-

0485.

B. Food Tolerance Exemption

An exemption from the requirement of a tolerance is established for viable spores of the 

microorganism Bacillus thuringiensis Berliner 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, provided the specifications set forth in the 

exemption are met (40 CFR 180.1011). The specifications are listed below:
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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(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) 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.

Bacillus thuringiensis subsp. israelensis strain SUM-6218 meets the criteria of 40 CFR 

180.1011.

IV. RISK ASSESSMENT

A. Product Analysis Assessment (40 CFR § 158.2120)

Microbial pesticide product analysis data requirements1include product chemistry and 

composition, analysis and certified limits, and physical and chemical characteristics data. 

Product chemistry and composition data include information about the identity of the active 

ingredient, the manufacturing process, deposition of a sample of the microbial active ingredient

in a nationally recognized culture collection, and discussion of the potential for formation of 

unintentional ingredients. Analysis and certified limits data include information on analysis of 

samples and certification of limits. Physical and chemical characteristics data describe basic 

characteristics of the registered pesticide products, including color, physical state, odor, stability, 

miscibility, pH, corrosion characteristics, viscosity and density.

Bacillus thuringiensis subsp. israelensis strain SUM-6218 contained in Summit® Bti MP is a 

gram-positive, motile bacillus containing ellipsoid spores that readily stain with Coomassie 

 

1

For information on microbial data requirements, refer to http://www.epa.gov/fedrgstr/EPAPEST/2007/October/Day-26/p20828.htm.
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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Brilliant Blue. Cells grown on LB agar in the presence of 100 μg/mL penicillin show that the 

strain is penicillin resistant. Cells grown on modified egg yolk agar under anaerobic conditions 

develop white opaque zones of precipitation, indicating that they synthesize lecithinase. The 

delta endotoxins are insecticidal. A sample of Bacillus thuringiensis subsp. israelensis strain 

SUM-6218 is deposited at the American Type Culture Collection (ATCC) in Manassas, Virginia 

under ATCC BAA-2453.

A new, unique PC code 006642 has been assigned to Bacillus thuringiensis subsp. israelensis

strain SUM-6218, as it is a new active ingredient. 

Refer to Table 1 in Appendix A for a summary of product chemistry and composition, analysis 

and certified limits data. Refer to Table 2 in Appendix A for a summary of physical and chemical 

characteristics data.

All product analysis data requirements required for registration of Bacillus thuringiensis subsp. 

israelensis strain SUM-6218 have been fulfilled.

B. Human Health Risk Assessment (40 CFR 158.2140)

1. Toxicity

All toxicology data requirements for Bacillus thuringiensis subsp. israelensis strain SUM-6218

have been fulfilled. Acceptable Tier I mammalian toxicology data and information support the 

registration of the pesticide product. Tier II and Tier III studies were not required. The results of 

the submitted studies are summarized below; for more information, refer to Table 3 in Appendix 

A.

a. Acute Toxicity/Pathogenicity – Tier I 

In lieu of certain toxicology testing of Bacillus thuringiensis subsp. israelensis strain SUM-6218, 

the applicant provided acceptable scientific justifications/rationales to address the following data 

requirements, as described in more detail below. EPA generally agrees with the rationales

provided (U.S. EPA 2012c).

Acute Oral Toxicity/Pathogenicity – Rat (Harmonized Guideline 885.3050; Master Record 

Identification Number (MRID No). 48682610

Acute Pulmonary Toxicity/Pathogenicity – Rat (Harmonized Guideline 885.3150; MRID No. 

48682611)

Cell Culture (Harmonized Guideline 885.3500; MRID No. 48682614): This study is not required 

because Bacillus thuringiensis, subsp. israelensis strain SUM-6218 is not a virus (refer to test 

note #4 of 40 CFR § 158.2140(d)).

Acute Oral Toxicity – Rat (Harmonized Guideline 870.1100; MRID No. 48682615)

Acute Dermal Toxicity – Rat (Harmonized Guideline 870.1200; MRID No. 48682616)
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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Acute Inhalation Toxicity – Rat (Harmonized Guideline 870.1300; MRID No. 48682617)

Primary Eye Irritation – Rabbit (Harmonized Guideline 870.2400; MRID No. 48682618)

Primary Dermal Irritation – Rabbit (Harmonized Guideline 870.2500; MRID No. 48682619)

Hypersensitivity Incidents (Harmonized Guideline 885.3400; MRID No. 48682613): EPA 

regulations require that hypersensitivity incidents, including immediate-type and delayed-type 

reactions of humans and domestic animals, that occur during the testing or production of the 

technical grade of the active ingredient, or manufacturing-use product, or end-use product, or are 

otherwise known to the applicant, be reported if they occur (refer to test note #3 of 40 CFR § 

158.2140(d)). The applicant knows of no reports of hypersensitivity from Bacillus thuringiensis

subsp. israelensis strain SUM-6218. 

In lieu of testing Bacillus thuringiensis subsp. israelensis strain SUM-6218, the applicant 

provided the following rationales to address the data requirements listed above:

1. Summit Chemical Company’s Bacillus thuringiensis subsp. israelensis strain SUM-6218 

product is a manufacturing-use product intended for formulation into end-use products that are 

not meant to be applied to agricultural food, feed, or livestock, with the possible exception that 

livestock may drink water treated with Bti end-use products intended for mosquito larvae control. 

Bti end-use products may be used to control pest Diptera larvae that infest mushroom culture.

2. The manufacturing-use product consists of 100.00% Bacillus thuringiensis subsp. israelensis, 

and does not contain any inert ingredients likely to pose any significant human health risks.

3. The applicant claims that these studies are only required for registration of a microbial 

pesticide when the following conditions apply: The potential to cause adverse human health 

effects or the product characterization indicates the microbial pesticide has a significant potential 

to produce a mammalian toxin. While this is not exactly accurate per 40 CFR 158 subpart U, 

EPA agrees that in the case of Bacillus thuringiensis subsp. israelensis strain SUM-6218, there is 

very little potential for this active ingredient to cause adverse health effects. As described in the 

1998 EPA Reregistration Eligibility Decision (RED) for Bacillus thuringiensis, (U.S. EPA 1998; 

hereafter referred to as the “Bt RED”) toxicity testing conducted with other registered strains of 

Bti indicated no significant adverse effects to human health. 

4. Toxicity/pathogenicity studies involving Bacillus thuringiensis-based pesticides have 

demonstrated no known mammalian health effects. The sum total of all toxicology data 

submitted to the Agency, complete with the lack of any reports of significant human health 

hazards of the various Bacillus thuringiensis strains, allow the conclusion that all toxicity studies 

may be waived as long as product identity and manufacturing process testing data indicate no 

mammalian toxicity associated with the strains. 

Summit Chemical Company submitted the following toxicology study in support of Bacillus 

thuringiensis subsp. israelensis strain SUM-6218.
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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Acute Injection Toxicity/Pathogenicity (Intravenous) – Rat (Harmonized Guideline 885.3200;

MRID No. 48682612, 48954203): All animals survived, gained weight, and appeared normal 

during the study. No observable abnormalities were noted in any animal at necropsy. Kidney

weight of both males and females was significantly decreased relative to untreated controls in 

Bacillus thuringiensis subsp. israelensis strain SUM-6218-treated animals, and brain and liver 

weight were significantly decreased in treated males. No test organism was detected in the brain 

tissue of the treated animals in group 3, and the test organism was cleared from the blood and 

kidneys by day 7. Test organism counts were near zero in the lungs from days 7 through 21. The 

test organism was not cleared from the liver, spleen, mesenteric lymph nodes, or caecum 

contents within the 21 days of the study. The caecum count peaked at day 7 (4.5 x 103) and 

decreased thereafter. The CFU count in the liver increased between days 3 and 7 and remained 

fairly steady thereafter. Test organism counts in the spleen declined through day 7 but increased 

thereafter, reaching 6.3 x 102cfu/mL by day 21, while test organism counts in the mesenteric 

lymph nodes declined to 0 cfu/mL by day 14 and then increased to 2.4 x 102cfu/mL by day 21.

Acceptable clearance trends were demonstrated for all respective tissues. Bacillus thuringiensis

subsp. israelensis strain SUM-6218does not appear to be toxic, infective or pathogenic in rats 

when dosed intravenously at 3.4 x 107cfu/animal. These data were found acceptable.

b. Acute Toxicology and Subchronic Toxicity/Pathogenicity – Tier II;

Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

Infectivity/Pathogenicity Analysis – Tier III

Tier II and Tier III studies were not required for Bacillus thuringiensis subsp. israelensis strain

SUM-6218, based on the lack of acute toxicity/pathogenicity in the Tier I studies.

 c. Endocrine Disruptors

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 Endocrine 

Disruptor 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 contain 58 

pesticide active ingredients and nine inert ingredients. Bacillus thuringiensis subsp. israelensis

strain SUM-6218 is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP.

The Agency believes that Bacillus thuringiensis subsp. israelensis strain SUM-6218 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, and pursuant to Section 408(p)(4), EPA will 

determine in the future whether it can exempt Bacillus thuringiensis subsp. israelensis strain 
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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SUM-6218 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: 

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

2. Occupational Exposure and Risk Characterization

The available data (e.g., lack of toxicity noted for oral, dermal, and inhalation routes of exposure 

to Bacillus thuringiensis subsp. israelensis strain SUM-6218 do not demonstrate toxic potential 

to persons occupationally exposed to this microbial pest control agent. Standard personal 

protective equipment (PPE) on the label (mixer and handler use of an N-95 equivalent respirator)

further mitigates unintentional exposures to formulators.

3. Human Health Risk Characterization

EPA considered human exposure to Bacillus thuringiensis subsp. israelensis strain SUM-6218 in 

light of the standard for registration in FIFRA. A determination has been made that no 

unreasonable adverse effects to the U.S. population in general, and to infants and children in 

particular, will result when the Bacillus thuringiensis subsp. israelensis strain SUM-6218

manufacturing-use pesticide product is used to formulate end-use pesticide products in 

accordance with EPA-accepted labeling.

C. Environmental Assessment (40 CFR § 158.2150)

1. Ecological Hazards

In the Bt RED, EPA concluded that risks to nontarget organisms exposed to Bacillus 

thuringiensis (including Bti) are unlikely as long as the presence of heat labile exotoxins or betaexotoxins is minimized. In addition to information submitted to show that beta-exotoxins will not 

be produced (U.S. EPA. 2012c), Summit Chemical Company provided EPA with an acceptable 

21-day study on Daphnia (MRID 48682624, with supplemental information in MRIDs 48954200 

and 48954201) to show that Bacillus thuringiensis subsp. israelensis strain SUM-6218 does not 

produce heat-labile exotoxins. This study is summarized below and more fully described in the 

attached DER, and provides a satisfactory basis to make similar conclusions about Bacillus 

thuringiensis subsp. israelensis strain SUM-6218 that have been made for other Bti based 

pesticides. 

Summit Chemical Company also showed that Bacillus thuringiensis subsp. israelensis strain 

SUM-6218 is substantially similar to the Bti originally isolated by Goldberg and Margalit and 

registered with EPA. Therefore, bridging to previously submitted data and extending conclusions 

on nontarget organisms from the Bt RED to Bacillus thuringiensis subsp. israelensis strain SUM6218 are both possible. This was the applicant’s approach to addressing the data requirements. In 

addition to citing EPA’s conclusions, Summit Chemical Company cited specific data and other 

information to show that adverse effects on nontarget organisms are not expected as a result of 
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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the registration of Bacillus thuringiensis subsp. israelensis strain SUM-6218. The data and 

rationales submitted to support the nontarget risk assessment are described below.

The data and other information presented are sufficient to fulfill the relevant microbial pesticide 

data requirements for Bacillus thuringiensis subsp. israelensis strain SUM-6218 and for risk 

assessment purposes. Further testing of nontarget organisms at higher tier levels (i.e., Tiers II, 

III, and IV) is not required. EPA performed an environmental risk assessment, and has 

determined that adverse effects to nontarget organisms are not anticipated from the pesticidal 

uses of Bacillus thuringiensis subsp. israelensis strain SUM-6218. Moreover, EPA has made a 

“No Effect” determination for direct and indirect effects to listed species and their designated 

critical habitats resulting from the registration of Bacillus thuringiensis subsp. israelensis strain 

SUM-6218 in a manufacturing use product.

For a summary of the generic data requirements described in sections IV(C)(1), refer to Table 4

in Appendix A.

a. Terrestrial Animals and Plants

Avian Oral and Avian Inhalation Toxicity (Harmonized Guidelines 885.4050 and 885.4100) 

(MRID Nos. 48682620 and 48682621): Results of previously submitted studies show that Bti

was practically nontoxic to birds at 3.1 g/kg/day and 5 ml/kg/day to Northern bobwhite (Colinus 

virginianus) and mallard (Anas platyrhynchos) in avian oral studies (MRIDs 41842702, 

41439006, and 41842703). Based on the available information, adverse effects to birds are not 

expected from exposure to Bacillus thuringiensis subsp. israelensis strain SUM-6218.

Wild Mammals Toxicity/Pathogenicity(Harmonized Guideline 885.4150) (MRID No. 48682622):

Summit Chemical Company cited mammalian toxicity/pathogenicity data submitted previously 

to support registrations of Bti, including Accession Nos./MRIDs 142733, 41046704, 42006502, 

43186101, 40951102, 96520, 96527, 96533, 109492, and 246968. Details of the findings of these 

studies are presented in the Bt RED. EPA also concluded in the Bt RED that 

infectivity/pathogenicity studies with Bacillus thuringiensis have demonstrated no known 

mammalian health effects. Additionally, Summit Chemical Company submitted an Acute 

Injection Toxicity/Pathogenicity study and additional rationales to satisfy toxicology data 

requirements to support the human health risk assessment (U.S. EPA. 2012c.), and EPA has no 

reason to believe that studies with laboratory animals would not be representative of potential 

effects on wild mammals. Therefore, based on the rationales, studies cited, and the study

submitted, EPA does not expect that exposure to Bacillus thuringiensis subsp. israelensis strain

SUM-6218 will result in adverse effects to wild mammals. 

Nontarget Insect and Honey Bee Testing (Harmonized Guidelines 885.4340 and 885.4380) 

(MRID Nos.48682627 and 48682628): Summit Chemical Company provided rationales as well 

as data citations to fulfill these data requirements. Summit referenced EPA’s conclusions for 

nontarget insects and honey bees in the Bt RED, and noted that insect testing was not required 

(except for honey bee) because Bt functions by a toxic mode of action and does not cause 

epizootics in the field. Additionally, they cite previously submitted data on Bti. Under Guideline 

885.4340, studies showed that Bacillus thuringiensis subsp. israelensis has a 16-day LC50 > 1.5 x 
Bacillus thuringiensis subsp. israelensis strain SUM-6218

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10 and 16-day NOEL = 2.5 x 10

4

cfu/g for the green lacewing; 30-day LC50 > 7.9 x 107cfu/g diet 

for parasitic hymenoptera; 9-day LC50 > 1.8 x 108cfu/g diet for a predaceous coleopteran; and 5-

day LC50 > 7.0 x 107cfu/g diet for honey bees (MRID 41842708, 41842709, 41842710, and 

41842711). 

While certain subspecies of Bt have shown adverse effects on honey bees, previously submitted 

tests with Bti on honey bees demonstrated minimal toxicity, according to the Bt RED. 

Additionally, studies submitted under Guideline 885.4380 showed that Bacillus thuringiensis

subsp. israelensis has a 5-day LC50 > 7.0 x 107cfu/g diet for honey bees (MRID 41842711).

Based on the data and other information submitted and cited, EPA does not anticipate that 

exposure to Bacillus thuringiensis subsp. israelensis strain SUM-6218 will result in adverse 

effects to honey bees and other nontarget insects.

Nontarget Plant Testing (Harmonized Guideline 885.4300); (MRID No. 48682626): EPA 

requires nontarget plant testing only when the active ingredient is taxonomically related to 

known plant pathogens. Bti is not a plant pathogen and is not related to known plant pathogens, 

so testing on nontarget plants is not required. EPA does not anticipate adverse effects to 

nontarget plants as a result of exposure to Bacillus thuringiensis subsp. israelensis strain SUM6218.

b. Aquatic Animals and Plants

Freshwater Fish Toxicity/Pathogenicity (Harmonized Guideline 885.4200) (MRID No. 

48682623): Summit Chemical Company cited previously submitted data in addition to 

rationales citing previous conclusions on the currently registered Bti. Studies submitted in 

accordance with Guideline 885.4200 (Freshwater Fish Toxicity) showed that Bti have aqueous 

LC50s of > 8.7 x 109cfu/L and 1.4 x 1010 cfu/L and oral LC50s of > 1.7 x 1010 cfu/g food and > 

5.3 x 109cfu/g food in rainbow trout. Studies with bluegill sunfish determined aqueous LC50s of

> 8.9 x 109cfu/L and LC50 > 1.6 x 1010 cfu/L and oral LC50s of > 1.3 x 1010 cfu/g food and > 4.3 

x 109cfu/g food (MRIDs 41439008, 41980105, 41439007, 41842704). Based on this 

information, EPA concludes that adverse effects to freshwater fish are unlikely to result from 

exposure to Bacillus thuringiensis subsp. israelensis strain SUM-6218.

Freshwater Invertebrate Toxicity/Pathogenicity (Harmonized Guideline 885.4240) (MRID No. 

48682624, 48954201): Summit Chemical Company submitted a 21-day study with Daphnia 

magna to demonstrate the effects of Bacillus thuringiensis subsp. israelensis strain SUM-6218 

on freshwater invertebrates. The LC50 was determined to be > 1.0 x 103cfu/mL. It is noted also 

that no effects on survival were observed at the two highest concentrations tested (1.0 x 105and 

1.0 x 106cfu/mL). The NOEC and LOEC based on reproduction are 1.0 x 106and > 1.0 x 106

cfu/mL, respectively. The NOEC and LOEC based on mass of surviving adults are 1.0 x 103and 

1.0 x 104cfu/mL, respectively; however, the study reviewer noted that the effect observed was 

an increase in body weight, which is not considered deleterious in this case. The study is 

sufficient to demonstrate that Bacillus thuringiensis subsp. israelensis strain SUM-6218 does not 

cause detrimental effects to freshwater invertebrates and also does not product heat labile 

exotoxins.
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Estuarine/Marine Fish and Invertebrate Testing (Harmonized Guideline 885.4280), (MRID No. 

48682625): Summit Chemical Company cited data submitted previously on estuarine/marine 

fish and invertebrates. Studies submitted according to Guideline 885.4280 showed that Bacillus

thuringiensis subsp. israelensis has NOELs of > 2.0 x 1010 cfu/g and NOEL > 4.2 x 109cfu/g 

food for grass shrimp; an oral NOEL > 2.0 x 1010 cfu/g food and oral and aqueous LC50s of > 2 x 

1010 cfu/g food and LC50 >7.2 x 109cfu/L, respectively, for sheepshead minnow; and a NOEL = 

50 mg/kg sediment for a marine copepod (MRIDs 41540402, 41842706, 41540401, 41842707, 

and 41439010). This information is sufficient to conclude that adverse effects to 

estuarine/marine fish and invertebrates resulting from exposure to Bacillus thuringiensis subsp. 

israelensis strain SUM-6218 are unlikely.

2. Environmental Fate Assessment Data

Environmental fate and groundwater data requirements (Tier II testing) were not triggered 

because there were no significant adverse effects to nontarget organisms in the Tier I toxicity

studies cited or submitted, and because acceptable rationales address certain nontarget organism 

data requirements not fulfilled by testing (as discussed in C.1. above and summarized in Table 4, 

Appendix A). Additionally, the product is only registered for manufacturing use, which limits 

environmental exposure. 

3. Ecological Exposure and Risk Characterization

Since the product is registered for manufacturing use only, exposure to nontarget organisms is 

not anticipated. Based on this expected lack of exposure and the data/information discussed 

above, EPA concludes that risks to nontarget organisms are minimal as a result of registering 

Bacillus thuringiensis subsp. israelensis strain SUM-6218.

Additional consideration for nontarget exposure and a risk assessment may be necessary if an 

end use product containing Bacillus thuringiensis subsp. israelensis strain SUM-6218 is 

proposed for registration. 

4. Endangered Species Assessment

Since EPA has determined that no effects are anticipated for nontarget species exposed to

Bacillus thuringiensis subsp. israelensis strain SUM-6218 as a result of its labeled use, effects to 

federally listed threatened and endangered species and their designated critical habitats are also 

not expected. Therefore, a “No Effect” determination is made for direct and indirect effects to 

federally listed threatened and endangered species and their designated critical habitats for the 

use of Bacillus thuringiensis subsp. israelensis strain SUM-6218, as labeled. 

V. 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—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. Fair 
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 14 of 24

treatment means that no group of people, including racial, ethnic, or socioeconomic groups, 

should bear a disproportionate share of the negative environmental consequences resulting from 

industrial, municipal, and commercial operations or the execution of federal, state, local, and 

tribal environmental programs and policies. Meaningful involvement means that (1) potentially

affected community residents have an appropriate opportunity to participate in decisions about a 

proposed activity that will affect their environment and/or health; (2) the public’s contribution 

can influence the regulatory agency’s decision; (3) the concerns of all participants involved will 

be considered in the decision-making process; and (4) the decision-makers seek out and facilitate 

the involvement of those potentially affected. EPA has this goal for all communities and persons 

across the U.S. 

To help address potential environmental justice issues, EPA seeks information on any groups or 

segments of the population who, as a result their location, cultural practices, or other factors, 

may have atypical, unusually high exposure to Bacillus thuringiensis subsp. israelensis strain 

SUM-6218, 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. 

For additional information regarding environmental justice issues, please visit EPA’s web site at 

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. RISK MANAGEMENT DECISION

Section 3(c)(5) of FIFRA provides for the registration of a pesticide provided that all the 

following determinations are made: (1) its composition is such as to warrant the claims for it; (2) 

its labeling and other materials required to be submitted comply with the requirements of FIFRA; 

(3) it will perform its intended function without unreasonable adverse effects on the 

environment; and (4) when used in accordance with widespread and commonly recognized 

practice, it will not generally cause unreasonable adverse effects on the environment. 

To satisfy criterion (1), the composition of the Bacillus thuringiensis subsp. israelensis strain 

SUM-6218 pesticide product has well-known properties. EPA has no knowledge that would 

contradict the claims made on the label for the manufacturing-use pesticide product, Summit® 

Bti MP, and the pesticide product is not expected to cause unreasonable adverse effects on the 

environment when used according to the label instructions. Criterion (2) is satisfied by the 

current product label, as well as the data and information presented in this document. EPA 

believes that the Bacillus thuringiensis subsp. israelensis strain SUM-6218 pesticide 

manufacturing-use product, if used to formulate registered microbial end-use pesticide products,

will not cause any unreasonable adverse effects on the environment, and such end-use products 

are likely to control pests, satisfying criterion (3). Criterion (4) is satisfied in that the Bacillus 

thuringiensis subsp. israelensis strain SUM-6218 manufacturing–use pesticide product is not 

expected to cause unreasonable adverse effects when used according to label instructions. 

Therefore, Summit® Bti MP, containing Bacillus thuringiensis subsp. israelensis strain SUM6218 as a new active ingredient, is eligible for registration under FIFRA section 3(c)(5) for the 

labeled uses.
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 15 of 24

VII. ACTIONS REQUIRED OF THE REGISTRANT

A. Final Printed Labeling 

Before releasing the pesticide product containing Bacillus thuringiensis subsp. israelensis strain 

SUM-6218 for shipment, the registrant is required to provide appropriate final printed labeling to 

EPA.

B. Terms of Registration

As a term of the registration, the applicant must submit the results of storage stability testing 

(Harmonized Guideline 830.6317) within one year of registration.

C. Reporting of Adverse Effects and Hypersensitivity Incidents

Notwithstanding the information stated in the previous sections, it should be clearly understood 

that certain specific data are required to be reported to EPA as a requirement for maintaining the 

federal registration for a pesticide product. A brief summary of these types of data are listed 

below. 

Reports of all incidents of adverse effects to the environment must be submitted to EPA 

under the provisions stated in FIFRA section 6(a)(2). Additionally, all incidents of 

hypersensitivity (including both suspected and confirmed incidents) must be reported to 

EPA under the provisions of 40 CFR § 158.2140(d).
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 16 of 24

VIII. BIBLIOGRAPHY

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/.

A. Studies Submitted to Support the Registration of Pesticide Product Containing Bacillus 

thuringiensis subsp. israelensis strain SUM-6218.

MRID Citation Date

48682600

Summit Chemical Company (2011) Submission of Product Chemistry, Toxicity and 

Exposure and Risk Data in Support of the Application for Registration of Bacillus 

thuringiensis subsp. israelensis (Bti) TGAI/MUP/MP/PP. Transmittal of 29 Studies.

08-Dec-2011

48682601 Borovsky, D. (2010) Product Identity for Summit's Bacillus thuringiensis subsp. israelensis 

(Bti) MP. Unpublished study prepared by University of Florida-IFAS. 16p. 08-Dec-2011

48682602

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. 16p.

08-Dec-2011

48682603 Rose, R. (2011) Manufacturing Process for Summit's Bacillus thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 6p. 08-Dec-2011

48682604

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. 3p.

08-Dec-2011

48682605

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. 3p.

08-Dec-2011

48682606 Benzon, G.; Finkenbinder, C. (2011) Analysis of Summit's Bacillus thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Benzon Research. 21p. 08-Dec-2011

48682607 Rose, R. (2011) Certification of Limits for Summit's Bacillus thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 2p. 08-Dec-2011

48682608 Rose, R. (2011) Physical and Chemical Properties for Summit's Bacillus thuringiensis 

subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 12p. 08-Dec-2011

48682609

Rose, R. (2011) Residue Data for Tolerance Exemption for Summit's Bacillus 

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit 

Chemical Co. 4p.

08-Dec-2011

48682610

Rose, R. (2011) Acute Oral Toxicity/Pathogenicity (TGAI) for Summit's Bacillus 

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit 

Chemical Co. 3p.

08-Dec-2011

48682611

Rose, R. (2011) Acute Pulmonary Toxicity/Pathogenicity for Summit's Bacillus 

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit 

Chemical Co. 3p.

08-Dec-2011

48682612

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. 29p.

08-Dec-2011

48682613 Rose, R. (2011) Hypersensitivity Incidents for Summit's Bacillus thuringiensis subsp. 08-Dec-2011
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 17 of 24

israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 2p.

48682614 Rose, R. (2011) Cell Culture for Summit's Bacillus thuringiensis subsp. israelensis (Bti) 

MP. Unpublished study prepared by Summit Chemical Co. 2p. 08-Dec-2011

48682615 Rose, R. (2011) Acute Oral Toxicity for Summit's Bacillus thuringiensis subsp. israelensis 

(Bti) MP. Unpublished study prepared by Summit Chemical Co. 3p. 08-Dec-2011

48682616 Rose, R. (2011) Acute Dermal Toxicity for Summit's Bacillus Thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 4p. 08-Dec-2011

48682617 Rose, R. (2011) Acute Inhalation Toxicity for Summit's Bacillus thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3p. 08-Dec-2011

48682618 Rose, R. (2011) Acute Eye Irritation for Summit's Bacillus thuringiensis subsp. israelensis 

(Bti) MP. Unpublished study prepared by Summit Chemical Co. 3p. 08-Dec-2011

48682619 Rose, R. (2011) Primary/Acute Dermal Irritation for Summit's Bacillus thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3p. 08-Dec-2011

48682620 Rose, R. (2011) Avian Oral Toxicity for Summit's Bacillus thuringiensis subsp. israelensis 

(Bti) MP. Unpublished study prepared by Summit Chemical Co. 4p. 08-Dec-2011

48682621 Rose, R. (2011) Avian Inhalation Toxicity/Pathogenicity for Summit's Bacillus thuringiensis 

subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 4p. 08-Dec-2011

48682622 Rose, R. (2011) Wild Mammal Toxicity/Pathogenicity for Summit's Bacillus thuringiensis 

subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 4p. 08-Dec-2011

48682623 Rose, R. (2011) Freshwater Fish Toxicity/Pathogenicity for Summit's Bacillus thuringiensis 

subsp. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3p. 08-Dec-2011

48682624

Brunner, S. (2011) Bacillus thuringiensis subsp./var. israelensis, Strain: Sum-6218, 

Primary Powder/MUP/TGAI: MPCA Freshwater Aquatic Invertebrate Test with Daphnia 

magna: Final Report. Project Number: 14472/10. Unpublished study prepared by 

Stillmeadow, Inc. 33p.

08-Dec-2011

48682625

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. 3p.

08-Dec-2011

48682626 Rose, R. (2011) Nontarget Plant Testing for Summit's Bacillus thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Summit CHemical Co. 3p. 08-Dec-2011

48682627 Rose, R. (2011) Nontarget Insect Testing for Summit's Bacillus thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 3p. 08-Dec-2011

48682628 Rose, R. (2011) Honeybee Testing for Summit's Bacillus thuringiensis subsp. israelensis 

(Bti) MP. Unpublished study prepared by Summit Chemical Co. 3p. 08-Dec-2011

48682629

Rose, R. (2011) Threatened and Endangered Species Analysis for Summit's Bacillus 

thuringiensis subsp. israelensis (Bti) MP. Unpublished study prepared by Summit 

Chemical Co. 4p.

08-Dec-2011

48954200 Summit Chemical Company (2012) Submission of Toxicity Data in Support of the 

Application for Registration of Summit Bti MP. Transmittal of 4 Studies. 28-Sep-2012

48954201 Rodrigue, N. (2010) Analytical Report: Semiannual Tap, Fresh, & Salt Water. Unpublished 

study prepared by Test America, Inc. 60p. 28-Sep-2012
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 18 of 24

48954202

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. 4p.

28-Sep-2012

48954203

Monds, K. (2012) Bacillus thuringiensis subsp./var. israelensis Strain SUM-6218, Primary

Poweder/MUP/TGAI: Amended Final Report. Project Number: 14546/10. Unpublished 

study prepared by Stillmeadow, Inc. 34p.

28-Sep-2012

48954204 Thomas, J.; Barrow, S. (2011) Pre- and Post-Toxicity CFU Analysis. Project Number: 

14577/10. Unpublished study prepared by Stillmeadow, Inc. 3p. 28-Sep-2012

49032000 Summit Chemical Company (2012) Submission of Product Chemistry Data in Support of 

the Application for Registration of Bti MP. Transmittal of 1 Study. 21-Dec-2012

49032001 Rose, R. (2011) Manufacturing Process for Summit's Bacillus thuringiensis subsp. 

israelensis (Bti) MP. Unpublished study prepared by Robert Rose. 6p. 21-Dec-2012

49032100 Summit Chemical Company (2012) Submission of Product Chemistry Data in Support of 

the Application for Registration of Bti MP. Transmittal of 1 Study. 03-Jan-2013

49032101

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. 6p.

03-Jan-2013

49054000 Summit Chemical Co. (2013) Submission of Efficacy Data in Support of the Application for 

Registration of Bti MP. Transmittal of 1 Study. 06-Feb-2013

49054001

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. 7p.

06-Feb-2013

B. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2013a. 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. 2012e. 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 to D. Greenway dated March

12, 2013.

U.S. EPA. 2012a. 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 study... 

Memorandum from A. Waggoner to D. Greenway dated December 10, 2012. 
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 19 of 24

U.S. EPA. 2012b. 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 

to D. Greenway dated November 13, 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 israelensis strain SUM-6218. Memorandum from I. S. Barsoum to D. 

Greenway dated July 10, 2012. 

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

Office of Prevention, Pesticides, and Toxic Substances, Washington, DC. EPA 738-R-98-

004. 
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 20 of 24

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS (40 CFR PART 158 – SUBPART V)

TABLE 1. Product Analysis Data Requirements for Bacillus thuringiensis subsp. israelensis strain SUM-6218 (40 CFR § 158.2120)

Harmonized 

Guideline 

Number

Data Requirement Results Summary MRID No.

885.1100 Product Identity Submitted data fulfill the requirement for product identity. Summit® Bti MP contains 100.00% by weight 

Bacillus thuringiensis subsp. israelensis strain SUM-6218

48682601

48682603

48682606

48682607

48682608

49054001

885.1200 Manufacturing Process Submitted data fulfill the requirement for manufacturing process.

885.1300

Discussion of Formation 

of Unintentional 

Ingredients

Submitted data fulfill the requirement for discussion of formation of unintentional ingredients.

N/A

Deposition of a Sample 

in a Nationally 

Recognized Culture 

Collection

A sample of Bacillus thuringiensis subsp. israelensis strain SUM-6218is on deposit with the American Type 

Culture Collection under Accession Number ATCC BAA-2453

885.1400 Analysis of Samples As a term of Summit® Bti MP manufacturing-use product registration, EPA is requiring submission of a 

storage stability study within one year of registration.

885.1500 Certification of Limits Limits are adequate/acceptable.
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 21 of 24

TABLE 2. Physical and Chemical Characteristics for Bacillus thuringiensis subsp. israelensis strain SUM-6218 (40 CFR § 158.2120)

Guideline Reference No./Property Description of Results

830.6302 Color Light brown, beige, or tan

830.6303 Physical State Flour-like powder

830.6304 Odor Mild, earthy, slightly yeast-like

830.6313 Stability The product is coagulated or deactivated at elevated temperatures. The product will not be exposed to elevated 

temperatures, metals, or metal ions during storage and intended use. It is stored in PE-lined fiberboard drums.

830.6314 Oxidation/Reduction: 

Chemical Incompatibility

Not applicable, the product does not contain oxidizing or reducing ingredients.

830.6315 Flammability Not applicable, the product is a powder.

830.6316 Explodability Not applicable, the product does not contain explosive ingredients.

830.6317 Storage Stability No physical or chemical change observed when stored under warehouse conditions for at least two years. The 

registrant has manufactured mosquito dunks and briquets using another brand of Bti MP stored as long with no 

change in potency of those products.

830.6319 Miscibility Not applicable, the product is not to be diluted with nonpolar solvents.

830.6320 Corrosion Characteristics Non-corrosive to metals, glass, or various plastics such as polyethylene or polyvinyl alcohol.

830.6321 Dielectric Breakdown Voltage Not applicable, the product is not for use around electrical equipment.

830.7000 pH Not applicable, the product is a solid.

830.7100 Viscosity Not applicable, the product is a solid.

830.7200 Melting Range Not applicable, the product is composed of spores and fermentation media.

830.7220 Boiling Range Not applicable, the product is a solid.

830.7300 Density/Relative Density/Bulk 

Density

0.4 to 0.56 depending on degree of compaction or settling

25-35 lb/ft3

830.7370 Dissociation Constant in Water Not applicable, the product forms a fine-particulate suspension in water that settles out over time and easily 

redistributes in the water column when mildly agitated.

830.7550 Partition Coefficient Not applicable, the product is a solid.

830.7840 Water Solubility Not applicable, the product forms a fine-particulate suspension in water that settles out over time and easily 

redistributes in the water column when mildly agitated.

830.7950 Vapor Pressure Not applicable, the product is not volatile.

aData from MRID 48682608
Bacillus thuringiensis subsp. israelensis strain SUM-6218

Biopesticides Registration Action Document 

Page 22 of 24

 

TABLE 3. Tier I Toxicology Data Requirements for Bacillus thuringiensis subsp. israelensis strain SUM-6218 (40 CFR § 158.2140)

Harmonized 

Guideline 

Number

Data Requirement Results Summary and Classification MRID No.

885.3050 Acute Oral Toxicity/

Pathogenicity Waived 48682610

885.3150 Acute Pulmonary Toxicity/

Pathogenicity Waived 48682611

885.3200 Acute Injection Toxicity/

Pathogenicity (Intravenous)

Summit® Bti MP does not appear to be toxic or pathogenic in rats when dosed 

intravenously at 3.4 x 107cfu/animal.

Classification: Acceptable

Spore Preparation (Supplemental)

Amended Final Report (Supplemental)

Pre/Post-toxicity CFU analysis (Acceptable)

48682612

48954202 

48954203

48954204

885.3400 Hypersensitivity Incidents

EPA regulations require that hypersensitivity incidents, including immediate-type 

and delayed-type reactions of humans and domestic animals, that occur during the 

testing or production of the technical grade of the active ingredient, or 

manufacturing-use product, or end-use product, or are otherwise known to the 

applicant, be reported if they occur (refer to test note #3 of 40 CFR § 

158.2140(d)). There are no reports of hypersensitivity from Bacillus thuringiensis, 

subsp. israelensis strain SUM-6218 known to the applicant. 

48682613

885.3500 Cell Culture Not required because Bacillus thuringiensis subsp. israelensis strain SUM-6218 is 

not a virus (refer to test note #4 of 40 CFR § 158.2140(d)).

48682614

870.1100 Acute Oral Toxicity Waived

TOXICITY CATEGORY III

48682615

870.1200 Acute Dermal Toxicity Waived

TOXICITY CATEGORY III

48682616

870.1300 Acute Inhalation Toxicity Waived

TOXICITY CATEGORY III

48682617

870.2400 Acute Eye Irritation Waived

TOXICITY CATEGORY III

48682618

870.2500 Primary Dermal Irritation Waived

TOXICITY CATEGORY III

48682619

1 According to 40 CFR § 158.2120, these data are only required for the technical grade of the active ingredient. 
Table 4. Non-target Organism Toxicity Requirements for Bacillus thuringiensis subsp. israelensis strain SUM-6218 (40 CFR 158.2150)

Harmonized 

Guideline

Number

Data Requirement Results Summary and Classification MRID No.

885.4050 Avian oral 

toxicity/pathogenicity

Rationales and studies cited are sufficient to satisfy the data requirement. Cited MRIDs: 41842702, 41439006, and 

41842703

Classification: Acceptable

48682620

885.4100 Avian inhalation 

toxicity/pathogenicity

Rationales and studies cited are sufficient to satisfy the data requirement. Cited MRIDs: 41842702, 41439006, and 

41842703

Classification: Acceptable

48682621

885.4150 Wild mammal 

toxicity/pathogenicity

Rationales and studies cited are sufficient to satisfy the data requirement. Cited Accession Nos./MRIDs: 142733, 

41046704, 42006502, 43186101, 40951102, 96520, 96527, 96533, 109492, and 246968

Classification: Acceptable

48682622

885.4200 Freshwater fish 

toxicity/pathogenicity

Rationales and studies cited are sufficient to satisfy the data requirement. Cited MRIDs: 41439008, 41980105, 

41439007, and 41842704

Classification: Acceptable

48682623

885.4240 Freshwater invertebrate 

toxicity/pathogenicity

A 21-day study shows that the EC50 to Daphnia magna based on mortality/immobility is > 1.0 x 103 CFU/mL, the 

NOEC based on reproduction was 1.0 x 106 CFU/mL, and the NOEC based on body weight was 1.0 x 103

CFU/mL (though, effect was weight gain not loss). Study is sufficient to show that heat labile exotoxins are not 

produced.

Classification: Acceptable

A semiannual analytical reporting of tap, fresh and salt water.

Classification: Supplemental

48682624

48954201

885.4280 Estuarine/marine fish 

and invertebrate testing

Rationales and studies cited are sufficient to satisfy the data requirement. Cited MRIDs: 41540402, 41842706, 

41540401, 41842707, and 41439010

Classification: Acceptable

48682625

885.4300 Nontarget plant testing Rationales submitted was sufficient to determine that adverse effects are not expected in plants as a result of 

exposure to Bti SUM-6218.

Classification: Acceptable 

48682626

885.4340 Nontarget insect testing Rationales and studies cited are sufficient to satisfy the data requirement. Cited MRIDs: 41842708, 41842709, 

41842710, and 41842711

Classification: Acceptable

48682627

885.4380 Honey bee testing Rationales and studies cited are sufficient to satisfy the data requirement. Cited MRID: 41842711

Classification: Acceptable

48682628

Non-guideline Endangered Species 

Assessment

A summary of information was provided. These data are not required.

Classification: Supplemental

48682629
APPENDIX B. PESTICIDE PRODUCT

EPA 

Registration 

Number

Product Name

Percentage 

Active 

Ingredient

Formulation Type Use Site(s) Method(s) of 

Application

Application 

Rate Target Pest(s)

6218-83 Summit® Bti MP 100.00%

Manufacturing-Use 

Product (powder)

For 

manufacturing 

use only

N/A N/A N/A