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           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

                                       
                                       
                               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

                                       
                                       
                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					



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 ug/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 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(R) 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(R) 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:

   (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 requirements include 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(R) Bti MP 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 ug/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)   

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.

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 102 cfu/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 102 cfu/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 107 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 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 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 beta-exotoxins 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 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 of 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 10 and 16-day NOEL = 2.5 x 10[4] cfu/g for the green lacewing; 30-day LC50 > 7.9 x 10[7] cfu/g diet for parasitic hymenoptera; 9-day LC50 > 1.8 x 10[8] cfu/g diet for a predaceous coleopteran; and 5-day LC50 > 7.0 x 10[7] cfu/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 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. 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 SUM-6218. 

		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 10[9] cfu/L and 1.4 x 10[10] cfu/L and oral LC50s 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 LC50s of > 8.9 x 10[9] cfu/L and LC50 > 1.6 x 10[10] cfu/L and oral LC50s 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 (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 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, respectively. 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.

 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 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 LC50s of > 2 x 10[10] cfu/g food and LC50 >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 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 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(R) 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(R) Bti MP, containing Bacillus thuringiensis subsp. israelensis strain SUM-6218 as a new active ingredient, is eligible for registration under FIFRA section 3(c)(5) for the labeled uses.

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).

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. israelensis (Bti) MP. Unpublished study prepared by Summit Chemical Co. 2p.
                                  08-Dec-2011
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
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.  
 
 
 
 
 
 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.   
 
 
 
 
                                       
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(R) 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(R) 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.
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
                                       
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/ft[3]

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.
	[a]Data from MRID 48682608

  
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(R) Bti MP does not appear to be toxic or pathogenic in rats when dosed intravenously at 3.4 x 107 cfu/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 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
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(R) Bti MP
                                    100.00%
Manufacturing-Use Product (powder)
For manufacturing use only
                                      N/A
                                      N/A
                                      N/A

