**BIOPESTICIDES REGISTRATION ACTION DOCUMENT**



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

Pesticide Chemical (PC) Code: 006 6 4 2

**U.S. Environmental Protection Agency Office of Pesticide Programs**  **Biopesticides and Pollution Prevention Division**

May 9 , 201 3Bacillus thuringiensis subsp. israelensis strain SUM - 6218

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**TABLE OF CONTENTS I.**  **EXECUTIVE SUMMARY ................................**  **................................ ................................**  **........................... 4**  **II. ACTIVE INGREDIENT OV** **ERVIEW ................................**  **................................ ................................**  **....... 5**  **III. REGULATORY BACKGROUN** **D ................................**  **................................ ................................**  **.............. 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. Hum**  **an Health Risk Assessment (40 CFR §**  **158.2140) ................................**  **................................ ..**  **7 C. Environmental Assessment (40 CFR §**  **158.2150) ................................**  **................................ ........**  **10 V.**  **ENVIRONMENTAL JUSTIC E**  **................................ ................................**  **................................ .................**  **13 VI.**  **RISK MANAGEMENT DECI SION**  **................................ ................................**  **................................ .........**  **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 P esticide Product Containing**  **Bacillus thuringiensis subsp**  **. israelensis**  **strain SUM**  **- 6218**  **................................ ................................**  **..................... 16** 

**B. Environm ental Protection Agency Risk Assessment Mem** **oranda ................................**  **............. 18**  **APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS ................................**  **........................... 20**  **APPENDIX B. PESTICI DE PRODUCT**  **................................ ................................**  **................................ ................**  **24**Bacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 3 of 24

**BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM**

**Office of Pesticide Programs Biopesticides**  **and Pollution Prevention Division Microbial**  **Pesticides Branch (MPB)** 

**Science Review** Ib rahim Barsoum , Ph.D. Product Anal ys is 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, MPBBacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 4 of 24 **I. EXECUTIVE SUMMARY**  **Background:** InDecember 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 Sy mbol 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. israelensi s strain SUM - 6218 has a cream - like color and is a gram -positive , motile bacillus containing ellipsoid spore s that readil y stain with Coomassie Brilliant B lue. Cells grown on LB agar in the presence of 100 μg/mLpenicillin 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 s ynthesize lecithinase . The delta endotoxins are insecticidal. **Assessing Risks to Human Health:**  Data derived from a ppropriate tests give no indication that the living microorganism is toxic or pathogenic to humans . N o harmful health effects to humans are expected from the use of Bacillus thuringiensis subsp. israelensis strain SUM - 62 18 as a pesticide. **Assessing Risks to the Environment:** P esticide products containing Bacillus thuringiensis subsp. israelensis strain SUM - 6218 are not likel y 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 provide s a public comment period prior to making a registration decision for the following typ es 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 Baci llus 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 i s substantial ly similar to previously registered Bacillus thuringiensis subsp. israelensis strains , the actual purpose f or allowing pre - decisional public comments on new active ingredients is not served here . The following documents are beingBacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 5 of 24 made available for comment in the docket, identification number EPA - HQ - OPP - 201 2 - 0 485 , 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 Ty pe Culture Collection (ATCC) in Manassas, Virginia under ATCC BAA - 2453 . **OPP Chemical Code:** 006 6 4 2 **Type of Pesticide:** Microbial Pesticide

– Insecticide See Appendix B for specific information ( i.e ., use sites, application rates, methods of application, formulation ty pes, 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 -us e pesticide product, Summit® Bti MP (EPA File Sy mbol 6218 - IG), containing the new microbial active ingredient Bacillus thuringiensis subsp. israelensis strain SUM - 6218 . In the Federal Register of August 1 4 , 201 2 ( 77 FR 48520 ), EPA announced receipt of this application for registration of a pesticide product containing a new active ingredient for manufacturing use onl y . No comments were received following publication of this notice . For more information, see the following docket at http://www.regulations.gov/ : EPA - HQ - OPP - 201 2 - 0 485 . **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

Biopesticides Registration Action Document Page 6 of 24 (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 b y 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 b y 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 specif ication can be satisfied either b y 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 sy nthesized 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 anal ys is data requirements **1** include product chemistry and composition, analysis and certified limits, and physical and chemical characteristics data. Product chemistry

and composition data inc lude 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 anal ys is of samples and certification of limits. Physical and chemical characteristics data describe basic characteristics of the registered pesticide products, including color, phys ical 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 C oomassie 1 For information on microbial data requirements, refer to http://www.epa.gov/fedrgstr/EPA
PEST/2007/October/Day
- 26/p20828.htm .Bacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 7 of 24 B rilliant B lue. Cells grown on LB agar in the presence of 100 μg/mLpenicillin 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 s ynthesize lecithinase. The delta endotoxins are insecticidal. A sample of Bacillus thuringiensis subsp. israelensis strain SUM - 6218 is deposited at the American T yp e Culture Collection (ATCC) in Manassas, Virginia under ATCC BAA - 2453 . A new, unique PC code 006 6 4 2 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, analysi s and certified limits data . Refer to Table 2 in Appendix A for a summary of physical and chemical characteristics data . All product anal ys is 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. Toxic** **ity** 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 /P**  **athogenicity**
**– Tier I**  In lieu of certain toxicology testing of Bacillus thuringiensis subsp. israelensis strain SUM - 6218 , the applicant provided acceptable scientific justification s/rationale s to address the following data requirement s , as described in more detail below . EPA generall y agrees with the rationale s 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

Biopesticides Registration Action Document Page 8 of 24 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 hy persensitivity

incidents, including immediate - ty pe and delayed- ty

pe 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 hyp ersensitivity from Bacillus thuringiensis subsp. israelensis strain SUM - 6218 . In lieu of testing Bacillus thuringiensis subsp. israelensis strain SUM - 6218 , the applicant provided the following rationale s to address the data requirement s 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 the se studies are only required for registration of a microbial pesticide when the following conditions appl y: 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 -b ased 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 strain s . 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

Biopesticides Registration Action Document Page 9 of 24 Acute Injection T

oxicity/ Pathogenicity (Intravenous)

**–** Rat ( Harmonized Guideline 885.3200; MRID No. 48 68261 2, 48954203 ) : All animals survived, gained weight, and appeared normal during the study . No observable abnormalities were no ted in any animal at necrops y. 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 org anism 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 10 3 ) and decrease d thereafter. The CFU count in the liver increased between days 3 and 7 and remained fairl y steady thereafter. T est organism counts in the spleen declined through day 7 but increased thereafter, reaching 6.3 x 10 2 cfu/mLby day 21, while test organism counts in the mesenteric ly mph nodes declined to 0 cfu/mLby day 14 and then increased to 2.4 x 10 2 cfu/mLby day 21. Acceptable clearance trends were demonstrated for all respective tissues. Bacillus thuringiensis subsp. israelensis strain SUM - 6218 does not a ppear to be toxic , infective or pathogenic in rats when dosed intravenously at 3.4 x 10 7 cfu/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 b y 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 pesti cides 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 “naturall y 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 anticip ated not to produce any effect in humans similar to an effect produced b y a naturall y 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 pestic ide 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 th uringiensis 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 strainBacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 10 of 24 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 chemi cals, 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 i s 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 unlikel y 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. 2012 c), 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- l abile exotoxins. This study is summarized below and more fully described in the attached DER, and provides a satisfactory basis to make similar conclusions about B acillus thuringiensis subsp. israelensis strain SUM - 6218 that have been made for other Bti ba sed 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 SUM 6218 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 ofBacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 11 of 24 the registration of Bacillus thuringiensis subsp. israelensis strain SUM - 6218 . The data and rationale s 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 . 48 682620 and 48 682621 ): Results of previously

submitted studies show that Bti was practicall y 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(H armonized Guideline 885.4150) (MRID No. 48 682622 ): Summit Chemical Company cited mammalian toxicity /pathogenicity data submitted previously to support registrations of Bti , including Accession Nos./MRIDs 142733, 41046704, 42006502, 43186101, 40951102, 9652 0, 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 rationale s to satisfy toxicology

data requirements to support the human health risk assessment (U.S. EPA. 2012 c. ), 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 rationale s , 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 48 682628 ) : Summit Chemical Company provided rationale s 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 L C 50 > 1.5 xBacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 12 of 24 10 and 16 - day

NOEL = 2.5 x 1 0 4 cfu/g for the green lacewing; 30 - day L C 50 > 7.9 x 10 7 cfu/g diet for parasitic hy

menoptera; 9 - day

L C 50 > 1.8 x 10 8 cfu/g diet for a predaceous coleopteran; and 5 - day L C 50 > 7.0 x 10 7 cfu/g diet for honey bees (MRID 41842708, 41842709, 41842710, and 4184 2711). 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 LC 50 > 7.0 x 10 7 cfu/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. 48 682626 ) : EPA requires nontarget plant testing onl y 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 SUM 6218 . **b. Aquatic Animals and Plants** Freshwater Fish Toxicity/Pathogenicity (Harmonized Guideline 885.4200) (MRID No. 48 682623 ) : Summit Chemical Company cited previously

submitted data in addition to rationale s citing previous conclusions on the currently registered Bti . Studies submitted in accordance with Guideline 885.4200 (Freshwater Fish Toxicity ) showed that B ti have aqueous LC 50 s of > 8.7 x 10 9 cfu/L and 1.4 x 10 10 cfu/Land oral LC 50 s of > 1.7 x 10 10 cfu/g food and > 5.3 x 10 9 cfu/g food in rainbow trout . Studies with bluegill sunfish determined aqueous LC 50 s of > 8.9 x 10 9 cfu/L and LC 50 > 1.6 x 10 10 cfu/L and oral LC 50 s of > 1.3 x 10 10 cfu/g food and > 4.3 x 10 9 cfu/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 (Harmoni zed Guideline 885.4240) (MRID No . 48 682624, 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 LC 50 was determined to be > 1.0 x 10 3 cfu/mL . It is noted also that no effects on survival were observed at the two highest concentrations tested (1.0 x 10 5 and 1.0 x 10 6 cfu/mL). The NOEC and LOEC based on reproduction are 1.0 x 10 6 and > 1.0 x 10 6 cfu/mL , respectivel y. The NOEC and LOEC based on mass of surviving adults are 1.0 x 10 3 and 1.0 x 10 4 cfu/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.Bacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 13 of 24 Estuarine/Marine Fish and Invertebrate Tes ting (Harmonized Guideline 885.4280), (MRID No. 48 682625 ): 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 10 10 cfu/g and NOEL > 4.2 x 10 9 cfu/g food for grass shrimp; an oral NOEL > 2.0 x 10 10 cfu/g food and oral and aqueous LC 50 s of > 2 x 10 10 cfu/g food and LC 50 >7.2 x 10 9 cfu/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 unlikel y. **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 rationale s 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 federal ly 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 f ederally 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. FairBacillus 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 se ek 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 populati on 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 . **V I**  **. RISK MANAGEMENT DECISION** Section 3(c)(5) of FIFRA provides for the registration of a pes ticide 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 ha s 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 likel y to control pests , satisfying criterion ( 3 ) . Criterion (4 ) is satisfied in that the Bacillus thuringiensis subsp. israelensis strain SUM - 6218 manufacturing

– use pesticide product i s not expected to cause unreasonable adverse effects when used according to label instructions. Therefore, Summit® Bti MP , containing Bacillus thuringiensis subsp. israelensis strain SUM 6218 as a new active ingredient, is eligib le 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 **V I**  **I .**  **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 f ederal 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 s ection 6(a)(2). Additionally, all incidents of hy persensitivity

(including both suspected and confirmed incidents) must be reported to EPA under the provisions of 40 CFR § 158.2 140 (d).Bacillus thuringiensis subsp. israelensis strain SUM - 6218

Biopesticides Registration Action Document Page 16 of 24 **VIII. BIBLIOGRAPHY**  For definitions of scientific ter ms, 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 Borovsk y, 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 P rocess 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 th uringiensis 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 486826 07 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. israelen sis 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 - 2011Bacillus 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) Wi ld 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,

Prim ary Powder/MUP/TGAI: MPCA Freshwater Aquatic Invertebrate Test with Daphnia ma gna: Final Report. Project Number: 14472/10. Unpublished study prepared by Stillm eadow, Inc. 33p. 08 - Dec - 2011
48682625 Rose, R. (2011) Estuari ne 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 thuringie nsis 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 Chem ical 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 S pecies 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 Regist ration of Summit Bti MP. Transmittal of 4 Studies. 28 - Sep - 2012 48954201 Rodrigue, N. (2010) Analytical Report: Semiannual Tap, Fresh, & Salt W ater. Unpublished

study prepared by Test America, Inc. 60p. 28 - Sep - 2012Bacillus 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. Unpublis hed 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 st udy prepared by MicroStarLab, Ltd. 7p. 06 - Feb - 2013 **B. Environmental Protection Agency Risk Assessment**  **Memoranda** U.S. EPA . 201 3 a . 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 1 7 , 201 3 . U.S. EPA. 2012 e. 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. 2012 a . 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, 20 12.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. 2012 c . 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) Harm** **onized 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 - 6218 is on deposit with the American T ype

Culture Collection under Accession Number AT CC 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. isra**  **e lensis**  **strain SUM**  **- 6218**  **(40 CFR § 158.2120) Guideline**  **Reference No./Property D**  **escription 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. 8 30.6319 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 48682608Bacillus 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)**  **Harm onized**  **Guideline Number**  **Data Requirement Results Summary**  **and Classification MRID No.**  885.3050 Ac ute Oral Toxicity/

Pathogenicity Waived 48682610 885.3150 Ac ute Pulmonary Toxicity/

Pathogenicity Waived 48 682611

885.3200 Ac ute Injection Toxicity/

Pathogenicity (Intravenous) Summit® Bti MP does not appear to be toxic or pathogenic in rats when dosed intravenously at 3.4 x 10 7 cfu/animal . Classification: Acceptable Spore Preparation (Supplemental) Amended Final Report (Supplemental) Pre/Post-toxicity CFU analysis (Acceptable ) 48 682612 48954202 48954203 48954204

885.3400 Hy

persensitivity Incidents EPA regulations require that hypersensitivity incidents, including immediate -ty pe 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 p roduct, 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 know n 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)). 48 682614 870.1100 Ac ute Oral Toxicity Waived TOXICITY CATEGORY I II 48 682615 870.1200 Ac ute Dermal Toxicity Waived TOXICITY CATEGORY I II 48 682616 870.1300 Ac ute Inhalation Toxicity Waived TOXICITY CATEGORY I II 48 682617 870.2400 Ac ute Eye Irritation Waived TOXICITY CATEGORY III 48 682618 870.2500 Primary Dermal Irritation Waived TOXICITY CATEGORY III 48 682619 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 158.2**  **150) Harm** **onized Guideline**  **Number Data Requirement**  **Results Summary and Classification MRID No.**  885.4050 Avian oral

toxicity/pathogenicity Rationale s 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 Rationale s 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 Rationale s 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 Rationale s and studies cited are suf ficient 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 EC 50 to Daphnia magna based on mortality/immobility is > 1.0 x 10 3 CFU/mL, the NOEC based on reproduction was 1.0 x 10 6 CFU/mL, and the NOEC based on body weight was 1.0 x 10 3 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 Rationale s 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 Rationale s 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 Rationale s 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 Rationale s 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 1 00 .00 % Manufacturing -Use Product (powder) For manufacturing use only N/A N/A N/A