BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Killed, nonviable Streptomyces acidiscabies strain RL-110T 

Pesticide Chemical (PC) Code: 016328 

 

U.S. Environmental Protection Agency 

 Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

DRAFT – March 12, 2012 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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TABLE OF CONTENTS 

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

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

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

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

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

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

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

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

 C. Environmental Assessment (40 CFR § 158.2150) ........................................................................ 14

V. ENVIRONMENTAL JUSTICE ................................................................................................................. 19

VI. RISK MANAGEMENT DECISION.......................................................................................................... 20

VII. ACTIONS REQUIRED OF THE REGISTRANT ................................................................................... 21

 A. Final Printed Labeling ................................................................................................................... 21

 B. Terms of Registration ..................................................................................................................... 21

 C. Reporting of Adverse Effects and Hypersensitivity Incidents .................................................... 21

VIII. BIBLIOGRAPHY ....................................................................................................................................... 21

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

 Killed, Nonviable Streptomyces acidiscabies strain RL-110T ........................................................ 21

 B. Environmental Protection Agency Risk Assessment Memoranda ............................................. 24

 C. Other References ............................................................................................................................ 24

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS ............................................................ 25

APPENDIX B. PESTICIDE PRODUCTS .............................................................................................................. 32
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM 

Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

Microbial Pesticides Branch (MPB) 

Science Review

Joel V. Gagliardi, Ph.D. Product Analysis, Human Health, 

Environmental Effects 

John L. Kough, Ph.D. Product Analysis, Human Health, 

Environmental Effects 

Regulatory Review

Ann Sibold Regulatory Action Leader 

Alan Reynolds Team Leader, Microbial Pesticide 

 Branch (MPB) 

Sheryl Reilly, Ph.D. Chief, MPB 
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I. EXECUTIVE SUMMARY 

Description of the Active Ingredient: Streptomyces acidiscabies strain RL-110T is a naturally 

occurring bacterium that lives on dead organic matter (e.g., leaf litter). The killed, nonviable 

form of this microorganism is proposed for use as a pre- and post-emergent herbicide applied 

pre-plant, at-plant, and post-plant to control annual grasses, broadleaf and sedge weeds in 

landscape turf and ornamentals, residential lawns, and agricultural crops. 

Assessing Risks to Human Health: Appropriate tests found no evidence that the live 

microorganism is toxic or pathogenic to humans, the microorganism is unable to grow at 

mammalian body temperatures, and the active ingredient contained in the proposed pesticide 

product is a killed, nonviable Streptomyces acidiscabies strain RL-110T

, so no harmful health 

effects to humans are expected from its use as a pesticide. 

Assessing Risks to the Environment: Pesticide products containing killed, nonviable

Streptomyces acidiscabies strain RL-110T 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 actions more transparent, the proposed pesticide 

products (i.e., MBI-005 TGAI and MBI-005 EP) containing a new active ingredient, killed, 

nonviable Streptomyces acidiscabies strain RL-110T

, are subject to a 30-day comment period. In 

addition to containing a new active ingredient, the registration of these pesticide products would 

result in the first outdoor, residential and food uses for killed, nonviable Streptomyces acidiscabies

strain RL-110T

. The following documents are available for comment in the docket, identification 

number EPA-HQ-OPP-2010-0079, and accessed through either http://www.regulations.gov or 

http://www.epa.gov/pesticides/regulating/registration-status.html: (1) draft killed, nonviable 

Streptomyces acidiscabies strain RL-110T

 Biopesticides Registration Action Document (BRAD); 

(2) draft label for the manufacturing-use pesticide product, MBI-005 TGAI (EPA File Symbol 

84059-RR); and (3) draft label for the end-use pesticide product, MBI-005 EP (EPA File Symbol 

84059-RE). While a final decision on registration is contingent upon review and consideration of 

public comments, EPA presently believes that, based upon the data and other information 

submitted in support of the proposed registrations, it is appropriate to issue these registrations 

under Section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The 

basis for this preliminary decision is characterized throughout this BRAD. 

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

Biological Name: Killed, nonviable Streptomyces acidiscabies strain RL-110T

Culture Collection: American Type Culture Collection (ATCC) in Manassas, Virginia 

 under ATCC 49003 

 

OPP Chemical Code: 016328 

Type of Pesticide: Microbial Pesticide – Herbicide 

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

application rates, methods of application, formulation types, and 

target pests) regarding the proposed pesticide products containing 

this active ingredient. 

III. REGULATORY BACKGROUND 

A. Applications for Pesticide Registration 

On December 29, 2009, Marrone Bio Innovations (2121 Second Street, Suite B-107, Davis, CA 

95618) submitted an application for registration of the manufacturing-use pesticide product, 

MBI-005 TGAI (EPA File Symbol 84059-RR), containing the new microbial active ingredient, 

killed, nonviable Streptomyces acidiscabies strain RL-110T

. In the Federal Register (FR) of 

March 10, 2010 (75 FR 11175), EPA announced receipt of this application for a pesticide 

product containing a new active ingredient. Subsequent to the submission of the manufacturinguse pesticide product, on June 25, 2010, Marrone Bio Innovations submitted an application for 

registration of the end-use pesticide product, MBI-005 EP (EPA File Symbol 84059-RE), as a 

pre- and post-emergent herbicide on food crops, turf, and for landscape and grounds 

maintenance. In the Federal Register of November 24, 2010 (75 FR 71697), EPA announced 

receipt of an application for a pesticide product containing a new active ingredient. No 

comments were received following these publications. On March 9, 2012, EPA announced 

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

for use on agricultural crops, residential lawns and landscape turf and ornamentals. For more 

information, see the following docket at http://www.regulations.gov/: EPA-HQ-OPP-2010-0079. 

B. Food Tolerance Exemption 

On December 29, 2009, Marrone Bio Innovations also submitted a petition that requested an 

exemption from the requirement of a tolerance for killed, nonviable Streptomyces acidiscabies

strain RL-110T

. EPA announced notice of this petition in the Federal Register of March 10, 2010 

(75 FR 11171). No comments were received following this publication. For more information, 

see the following docket at http://www.regulations.gov/: EPA-HQ-OPP-2009-0078. 
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IV. RISK ASSESSMENT1

A. Product Analysis Assessment (40 CFR § 158.2120) 

Microbial pesticide product analysis data requirements1

 include product chemistry and 

composition, analysis and certified limits, and physical and chemical characteristics1

 data. 

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

ingredient, the manufacturing process, deposition of a sample in a nationally recognized culture 

collection, and discussion of 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. 

Streptomyces spp. are commonly found in agricultural settings (i.e., soils and decaying plant 

material) and are present on fresh produce of all kinds with no known adverse effects (Faucher et 

al. 1992; Lambert et al. 1989; Loria et al. 2008; Loria et al. 2006; Wanner 2009). The Manual 

of Clinical Microbiology (9th edition) states that the primary ecological niche for aerobic 

actinomycetes, such as Streptomyces acidiscabies strain RL-110T, is likely decaying plant 

material. The Manual of Clinical Microbiology (9th edition) further states that infections caused 

by Streptomyces spp. are infrequent and limited to species unrelated to acidiscabies and does not 

identify Streptomyces acidiscabies as clinically significant. 

The active ingredient (a.i.) is identified as killed, nonviable Streptomyces acidiscabies strain RL110T

 (ATCC 49003) cells and spent fermentation media. This a.i. was initially isolated from 

scab-infected potatoes collected in Maine and New York. 

The herbicidal mode of action is exposure to and uptake of thaxtomin A, which is produced by 

the plant pathogen, Streptomyces acidiscabies strain RL-110T. The herbicidal mode of action for 

thaxtomin A is based on disruption of cell wall synthesis, with inhibition of cellulose 

biosynthesis being the main effect (Fett et al. 1992). 

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 killed, nonviable Streptomyces 

acidiscabies strain RL-110T

 have been fulfilled.

 

1

 For information on microbial data requirements, refer to http://www.epa.gov/fedrgstr/EPAPEST/2007/October/Day-26/p20828.htm. 
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B. Human Health Risk Assessment (40 CFR 158.2140)

1. Toxicity

All toxicology data requirements for killed, nonviable Streptomyces acidiscabies strain RL-110T

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

registration of the proposed pesticide products. 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 

Acute Oral Toxicity/Pathogenicity – Rat (Harmonized Guideline 885.3050) and Acute 

Pulmonary Toxicity/Pathogenicity – Rat (Harmonized Guideline 885.3150); Master Record 

Identification Number (MRID No). 47946817): The applicant provided the following rationale to 

support data waivers for acute toxicity/pathogenicity and acute pulmonary toxicity/pathogenicity 

testing: (1) the acute oral and acute inhalation toxicity studies described below demonstrated that 

killed, nonviable Streptomyces acidiscabies strain RL-110T is practically nontoxic to rats; (2) the 

acute injection toxicity toxicity/pathogenicity study (described below) demonstrated that live 

Streptomyces acidiscabies strain RL-110T is not toxic, infective and/or pathogenic to rats; (3) a 

literature search found that this microorganism is not known to be infective to mammals; and (4) 

Streptomyces acidiscabies strain RL-110T is naturally occurring in soil in the U.S. 

EPA waived the required data given that Streptomyces acidiscabies strain RL-110T

 is killed, 

pathogenicity and/or infectivity in mammals is not expected, and it would be unnecessary to 

conduct additional studies to evaluate toxicity. 

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

MRID No. 47946808): Thirty young adult Sprague-Dawley rats (15/sex) were injected with live 

MOI 005 Streptomyces acidiscabies at a dose of 9.0 x 106 colony-forming units (CFUs) per 

animal and observed for signs of toxicity and pathogenicity up to 21 days. Ten animals (5/sex) 

were treated with autoclaved MOI 005 Streptomyces acidiscabies as controls, and ten animals 

(5/sex) were not treated. All animals survived, gained weight and appeared normal during the 

study. No observable abnormalities were noted in any animal at necropsy. There were no 

significant variations among organ weights. The test organism was not detected in the blood, 

brain, lungs, spleen, liver, kidneys, mesenteric lymph nodes and cecum contents of treated 

animals. The test organism was not evaluated in the tissues/organs of animals treated with 

autoclaved test material or from the untreated control group. Live Streptomyces acidiscabies

strain RL-110 T was not toxic, infective, and/or pathogenic to rats when dosed intravenously at 

9.0 x 106 CFU per animal. This study was rated acceptable. 

Hypersensitivity Incidents (Harmonized Guideline 885.3400): Hypersensitivity incidents, 

including immediate-type and delayed-type reactions of humans and domestic animals, that 

occur during the testing of the technical grade of the active ingredient or manufacturing-use 

product, or are otherwise known to the applicant, must be reported if they occur (refer to test 

note #3 of 40 CFR § 158.2140(d)). 
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Cell Culture (Harmonized Guideline 885.3500): This study is not required because killed, 

nonviable Streptomyces acidiscabies strain RL-110T 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. 47946802): Three fasted 

female Sprague-Dawley rats were given a single oral gavage dose of MOI 005 (containing 

killed, nonviable Streptomyces acidiscabies strain RL-110T) at a concentration of 5,000 

milligrams per kilogram (mg/kg) body weight. The animals were observed for 14 days. All 

animals survived and appeared normal throughout the study. One animal lost weight during the 

second week; all other animals gained weight throughout the study. No observable abnormalities 

were found at necropsy. The weight loss in one animal was determined to not be significant, 

since the acute injection toxicity/pathogenicity study (MRID 47946808) conducted with the live 

microbe showed live Streptomyces acidiscabies strain RL-110T

 was not toxic, infective or 

pathogenic to rats. The acute median lethal dose (LD50) for female rats was greater than 5,000 

mg/kg. This study was rated acceptable, and MOI 005 was classified as Toxicity Category IV. 

Acute Dermal Toxicity – Rat (Harmonized Guideline 870.1200; MRID No. 47946803): Ten 

young adult Sprague-Dawley rats (5/sex) were dermally exposed to 5,050 mg/kg of MOI 005 

(containing killed, nonviable Streptomyces acidiscabies strain RL-110T) for 24 hours on a 

clipped dorsal surface comprising approximately 10% of the body surface area. Following 

exposure, the animals were observed for 14 days. All animals survived, gained weight, appeared 

normal and had no signs of dermal irritation throughout the study. No observable abnormalities 

were found in any animal at necropsy. The acute LD50 for combined (male and female) rats was 

greater than 5,050 mg/kg. This study was rated acceptable, and MOI 005 was classified as 

Toxicity Category IV. 

Acute Inhalation Toxicity – Rat (Harmonized Guideline 870.1300; MRID No. 47946804): Ten 

young adult Sprague-Dawley rats (5/sex) were exposed nose-only to MOI 005 aerosol 

(containing killed, nonviable Streptomyces acidiscabies strain RL-110T) for 4 hours at a 

concentration of 2.21 milligrams per liter (mg/L). The animals were observed for 14 days. All 

animals survived the study. Decreased activity was noted from all animals upon removal from 

the chamber through day 1 with recovery by day 2. Piloerection was noted on all animals upon 

removal from the chamber with recovery by day 1. All animals gained weight during the first 

week, and five males and four females lost weight during the second week. One female gained 

weight throughout the study. Red lungs were noted in the female that gained weight throughout 

the study. All other animals were emaciated and had swollen and pink lungs at necropsy. The 

acute median lethal concentration for combined (male and female) rats was greater than 2.21 

mg/L. This study was rated acceptable, and MOI 005 was classified as Toxicity Category IV. 

 

Acute Eye Irritation – Rabbit (Harmonized Guideline 870.2400; MRID No. 47946805): Three (1 

male, 2 female) New Zealand White rabbits were exposed to 0.1 milliliters (mL) of killed, 

nonviable Streptomyces acidiscabies strain RL-110T instilled into the conjunctival sac of the 

right eye and were observed at 1, 24, 48, and 72 hours. Irritation was scored by the method of 

Draize and classified by the system of Kay and Calandra. No corneal opacity or iritis was noted 

throughout the study. Positive conjunctival irritation was noted in one rabbit at one hour after 
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test material instillation with resolution by 24 hours. The maximum average score was 2.7 at one 

hour after test material instillation. This study was rated acceptable, and MOI 005 was minimally 

irritating to the eye and classified as Toxicity Category IV. 

Primary Dermal Irritation – Rabbit (Harmonized Guideline 870.2500; MRID No. 47946806): In 

a primary dermal irritation study, one male and two female New Zealand White rabbits were 

dermally exposed to 0.5 mL of undiluted MOI 005 (containing killed, nonviable Streptomyces 

acidiscabies strain RL-110T) for 4 hours on an approximately 2.5 square centimeter (cm2) area of 

the body surface. The animals were observed at 1, 24, 48, and 72 hours after patch removal. 

Irritation was scored by the method of Draize. No dermal irritation was noted on any animal 

during the study. The primary irritation index was 0.0. This study was rated acceptable, and MOI 

005 was not dermally irritating and classified as Toxicity Category IV. 

Skin Sensitization – Guinea Pig (Harmonized Guideline 870.2600; MRID No. 47946807): Thirty 

four young adult Hartley guinea pigs (17/sex) were tested using the Buehler Method. After three 

weekly consecutive inductions, no test or naive control animals showed any dermal reaction after 

challenge. This study was rated acceptable, and MOI 005 was found to be not a dermal 

sensitizer. 

 c. Endocrine Disruptors 

As required under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA 

has developed the Endocrine Disruptor Screening Program (EDSP) 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.” The EDSP employs a two-tiered approach to 

making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays 

to identify the potential of a chemical substance to interact with the estrogen, androgen, or 

thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found 

to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage 

of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on 

the available data. Tier 2 testing is designed to identify any adverse endocrine-related effects 

caused by the substance, and establish a quantitative relationship between the dose and the E, A, 

or T effect. 

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

group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors. 

Killed, nonviable Streptomyces acidiscabies strain RL-110T

 is not among the group of 58 

pesticide active ingredients on the initial list to be screened under the EDSP. Under FFDCA 

section 408(p), EPA must screen all pesticide chemicals. Accordingly, EPA anticipates issuing 

future EDSP orders/data call-ins for all pesticide active ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

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

2. Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement 

for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA 

determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to 

mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the 

pesticide chemical residue, including all anticipated dietary exposures and all other exposures for 

which there is reliable information.” This includes exposure through drinking water and in 

residential settings but does not include occupational exposure. Pursuant to section 408(c)(2)(B) 

of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a 

tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, 

which require EPA to give special consideration to exposure of infants and children to the 

pesticide chemical residue in establishing a tolerance exemption and to “ensure that there is a 

reasonable certainty that no harm will result to infants and children from aggregate exposure to 

the pesticide chemical residue....” Additionally, section 408(b)(2)(D) of FFDCA requires that 

EPA consider “available information concerning the cumulative effects of [a particular 

pesticide’s] . . . residues and other substances that have a common mechanism of toxicity.” 

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide 

residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the 

pesticide through food, drinking water, and through other exposures that occur as a result of 

pesticide use in residential settings. 

Consistent with section 408(b)(2)(D) of FFDCA, EPA reviewed the available scientific data and 

other relevant information, and considered its validity, completeness, and reliability and the 

relationship of this information to human risk. EPA also considered available information 

concerning the variability of the sensitivities of major identifiable subgroups of consumers, 

including infants and children. 

Based on the acute toxicity/pathogenicity data and information discussed previously and 

presented in Table 3 in Appendix A, the data required for a FFDCA risk assessment for killed, 

nonviable Streptomyces acidiscabies strain RL-110T

 have been fulfilled. 

 a. Aggregate Exposure 

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available 

information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and

exposure through pesticide use in gardens, residential and other lawns and landscapes, or 

buildings (residential and other indoor uses). 

Food Exposure and Risk Characterization: Killed, nonviable Streptomyces acidiscabies strain 

RL-110T will be applied as a herbicide to agricultural crops pre-plant, at-plant and post-plant, 
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and may be applied up to the day of harvest; exposure to this active ingredient through food is 

possible, but is expected to be minimal for the following reasons: (1) the proposed pesticide 

products will be diluted prior to application; (2) pre-plant applications will occur 1-60 days or 

more before planting; (3) at-plant applications will be broadcast and incorporated into the soil 

mechanically or by rainfall or sprinkler irrigation; (4) post-plant applications for trees will be 

made as a broadcast or banded application to soil surface below established trees or between 

tree rows and incorporated into the soil by rainfall, irrigation or mechanical incorporation; (5) 

post plant lay-by and split application will be applied between rows and incorporated into the 

soil; (6) application to rice fields is followed by flooding or partially draining and re-flooding the 

fields; and (7) rainfall and sprinkler irrigation will further wash residues of the pesticide from the 

treated crops. 

Following application, the killed, non-viable Streptomyces acidiscabies strain RL-110T

 will 

naturally degrade due to consumption by other biological organisms, including bacteria and 

fungi (Doumbou et al. 1998). 

In the unlikely event that any residues of the pesticide remain in or on consumed food, no 

adverse effects would be expected, based on the lack of toxicity and pathogenicity demonstrated 

in the submitted studies (refer to section IV.B.1.a. of this BRAD). 

 

Drinking Water Exposure and Risk Characterization: Exposure to residues of killed, nonviable 

Streptomyces acidiscabies strain RL-110T

 in consumed drinking water is unlikely, since the 

majority of the proposed use patterns (ground and aerial) include measures to incorporate the 

herbicide into the soil with measures to incorporate the herbicide into the soil; however, 

residues may appear at low levels in ground and surface water from these uses due to runoff or 

drainage from treated fields, or by spray drift 

The proposed use in rice provides the greatest potential for residues of killed, nonviable 

Streptomyces acidiscabies strain RL-110T

 to appear in ground and surface water, since 

application to rice fields is followed by flooding or partially draining and re-flooding the fields. 

The ground and surface water exposure will be minimized by dilution of the product prior to 

application, by flooding or re-flooding the fields following application and by natural 

degradation of the active ingredient by microbial activity (Doumbou et al. 1998). Furthermore 

since application of the product is concentrated in upper soil strata, movement through the soils 

would likely filter out any remaining product. 

The proposed directions for applications to established turf in landscapes provide for dilution of 

the product prior to application, but do not include measures to incorporate the product. Since 

established turf constitutes significant ground cover, this, in itself, would be expected to reduce 

the potential runoff of the pesticide into surface water and percolation to ground water. 

The proposed directions for applications to ornamentals in landscapes specify dilution prior to 

application and incorporation by irrigation or raking into the soil. These measures, along with 

natural degradation and incorporation of the product into upper soil strata, will reduce the 

potential for runoff into surface or ground water. 
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If residues of Streptomyces acidiscabies strain RL-110T are transferred to surface or ground 

waters (e.g., though spray drift or runoff) that are intended for eventual human consumption, and 

subjected to sanitation (e.g., chlorination, pH adjustments, filtration, high temperatures) in 

drinking water treatment plants, the residues would likely be removed from the finished drinking 

water. 

In the unlikely event that any residues of the pesticide occur in drinking water, no adverse effects 

would be expected, based on the lack of toxicity and pathogenicity demonstrated in the 

submitted studies (refer to section IV.B.1.a. of this BRAD). 

Non-occupational, Residential Exposure and Risk Characterization: Given the natural 

occurrence of Streptomyces acidiscabies in soil (Faucher et al. 1992; Loria et al. 2006), nonoccupational and residential exposure may already be occurring. Application of killed, 

nonviable Streptomyces acidiscabies strain RL-110T to established turf in residential and 

landscape settings will result in exposure via the dermal and inhalation routes. Any such 

exposures are expected to be minimal since the concentration of killed, nonviable Streptomyces

acidiscabies strain RL-110T

 is diluted prior to application and the a.i. is not expected to persist, 

as described above. In the unlikely event that the proposed uses of the pesticide result in 

residential, non-occupational exposure, no adverse effects would be expected, based on the lack 

of toxicity and pathogenicity demonstrated in the submitted studies (refer to section IV.B.1.a. of 

this BRAD). 

 b. Cumulative Effects from Substances with a Common Mechanism of Toxicity. 

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, 

or revoke a tolerance exemption, EPA consider “available information concerning the 

cumulative effects of [a particular pesticide’s] . . . residues and other substances that have a 

common mechanism of toxicity.” 

EPA has found killed, nonviable Streptomyces acidiscabies strain RL-110T does not appear to 

produce a toxic metabolite similar to that found in other substances or produced by other 

microorganisms. For the purposes of the associated tolerance action, EPA has assumed that 

killed, nonviable Streptomyces acidiscabies strain RL-110T

 does not have a common mechanism 

of toxicity with other substances, and thus, section 408(b)(2)(D)(v) does not apply. For 

information regarding EPA’s efforts to identify chemicals that may have a common mechanism 

of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s website at 

http://www.epa.gov/pesticides/cumulative. 
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 c. Determination of Safety for the U.S. Population, Infants and Children 

 

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or 

tolerance exemption for a pesticide chemical residue, EPA shall assess the available information 

about consumption patterns among infants and children, special susceptibility of infants and 

children to pesticide chemical residues, and the cumulative effects on infants and children of the 

residues and other substances with a common mechanism of toxicity. In addition, FFDCA 

section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of 

exposure (safety) for infants and children in the case of threshold effects to account for prenatal 

and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA 

determines that a different margin of exposure (safety) will be safe for infants and children. This 

additional margin of exposure (safety) is commonly referred to as the Food Quality Protection 

Act Safety Factor. In applying this provision, EPA either retains the default value of 10X or uses 

a different additional safety factor when reliable data available to EPA support the choice of a 

different factor. 

Based on its analyses of the submitted toxicity data (refer to section IV.B.1.a. and Table 3 in 

Appendix A), EPA concludes that there are no threshold effects of concern to infants, children, 

or adults when killed, nonviable Streptomyces acidiscabies strain RL-110T

 is used as labeled in 

accordance with good agricultural practices. As a result, EPA also concludes that no additional 

margin of exposure (safety) is necessary to protect infants and children and that not adding any 

additional margin of exposure (safety) will be safe for infants and children. 

Moreover, based on the same data and EPA analysis as presented directly above, the Agency is 

able to conclude that there is a reasonable certainty that no harm will result to the U.S. 

population, including infants and children, from aggregate exposure to the residues of killed, 

nonviable Streptomyces acidiscabies strain RL-110T when it is used as labeled and in accordance 

with good agricultural practices as an herbicide. Such exposure includes all anticipated dietary 

exposures and all other exposures for which there is reliable information. EPA arrived at this 

conclusion because, considered collectively, the data available on killed, nonviable Streptomyces 

acidiscabies strain RL-110T

 do not demonstrate toxic potential to mammals, including infants 

and children. 

3. Occupational Exposure and Risk Characterization

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

to killed, nonviable pesticide available on Streptomyces acidiscabies strain RL-110T

) do not 

demonstrate toxic potential to persons occupationally exposed to this microbial pest control 

agent. Standard personal protective equipment (PPE) on the label, including an N95 equivalent 

respirator, long-sleeve shirt, long pants, shoes, socks and waterproof gloves, further mitigates 

unintentional exposures to applicators. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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4. Human Health Risk Characterization 

EPA considered human exposure to killed, nonviable Streptomyces acidiscabies strain RL-110T

in light of the standard for registration in FIFRA and the relevant safety factors in FFDCA. 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 killed, nonviable Streptomyces 

acidiscabies strain RL-110T

 pesticide products are used in accordance with EPA-approved 

labeling. 

C. Environmental Assessment (40 CFR § 158.2150) 

1. Ecological Hazards 

Data and other information (e.g., scientific literature) submitted by the applicant to support 

requests to waive nontarget organism testing for killed, nonviable Streptomyces acidiscabies

strain RL-110T are sufficient to fulfill the relevant microbial pesticide data requirements 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 based on data 

and other information provided by the applicant, and has determined that adverse effects to 

nontarget organisms are not anticipated from the proposed pesticidal uses of killed, nonviable 

Streptomyces acidiscabies strain RL-110T

. Moreover, EPA has made a “No Effect” 

determination for direct and indirect effects to listed species and their designated critical habitats 

resulting from these same proposed pesticidal uses. 

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 Toxicity (Harmonized Guideline 885.4050) (MRID Nos. 47946811): Fourteen-dayold mallard ducks (Anas platyrhynchos) were dosed with the test material containing killed, 

nonviable Streptomyces acidiscabies strain RL-110T

 (63 milligrams of active ingredient per 

kilogram of body weight (mg a.i. per kg bw)) once daily for 5 days and observed for an 

additional 25 days. A sterile filtrate control group and a negative control group were included in 

the test. One bird in the test material group was euthanized on day 23 due to low body weight 

and poor general condition, attributed to a feeder malfunction and pen mate aggression. There 

was no mortality in the other 2 groups. There were no treatment related signs of toxicity in any 

of the birds during the study. Gross necropsy of the survivors revealed no treatment-related 

differences between the test material group or the sterile filtrate control group compared to the 

negative control group. There was no evidence of test material multiplication (plaques, foci) in 

any bird. The No Observed Effect Level (NOEL) was determined to be greater than 63 mg a.i. 

per kg bw per day for five days. This study was acceptable. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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Avian Inhalation Toxicity Pathogenicity (Harmonized Guideline 885.4100) (MRID Nos. 

47946817): The applicant provided the following rationale to support a data waiver for Avian 

Inhalation Toxicity Pathogenicity testing: (1) killed, nonviable Streptomyces acidiscabies strain 

RL-110T

 was not toxic or pathogenic in an avian oral toxicity study; (2) the a.i. in MBI-005 

TGAI is a naturally occurring bacterium commonly found in soils and water; and (3) 

a literature search yielded no reports of adverse effects in avian species. 

EPA considers the toxicity component of the acute avian inhalation toxicity/pathogenicity data 

requirement to be fulfilled by the acute avian oral toxicity study (MRID No. 47946811). Given 

that the a.i. is killed, pathogenicity and/or infectivity in birds are not expected. It would be 

inappropriate and unnecessary to conduct further testing to evaluate these endpoints. Thus, EPA 

waived the pathogenicity component of the acute oral toxicity/pathogenicity data requirement. 

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

47946817): The applicant provided the following rationale to support a data waiver for Wild 

Mammals Toxicity/Pathogenicity testing: (1) killed, nonviable Streptomyces acidiscabies strain 

RL-110T

 was not toxic in acute exposure studies in rats; (2) Streptomyces acidiscabies strain RL110T

 was not pathogenic in an intravenous injection study in rats; (3) Streptomyces acidiscabies

strain RL-110T is a naturally occurring bacterium commonly found in soils; and (4) a literature 

search yielded no reports of adverse effects in humans or other mammals. 

EPA considers the toxicity component of the acute oral toxicity/pathogenicity data requirement 

to be fulfilled by the acute oral, dermal and inhalation toxicity studies in rats (MRIDs 47946802, 

47946803, 47946804). Given that the a.i. is killed, pathogenicity and/or infectivity in mammals 

are not expected. It would be inappropriate and unnecessary to conduct additional testing to 

evaluate these endpoints. Thus, EPA waived testing for the pathogenicity component of the acute 

oral and inhalation toxicity/pathogenicity data requirements. 

Nontarget Insects (Harmonized Guideline 885.4340) (MRID Nos. 47946814, 47946815 and 

48104505): Two studies were conducted to determine the toxic effects of killed, nonviable 

Streptomyces acidiscabies strain RL-110T

 to adult ladybird beetles (Hippodamia convergens) 

and green lacewing (Chrysoperla rufilabris) larvae. In the adult ladybird study, killed, nonviable 

Streptomyces acidiscabies strain RL-110T

 was administered in diet at nominal concentrations of 

510, 5,100, or 51,000 parts per million (ppm). The test included a negative control group. The 

test was terminated on day 17, when mortality in the untreated control group exceeded 20%. 

Cumulative mortality in the 510 ppm, 5,100 ppm, and 51,000 ppm test material groups was 24%, 

25%, and 32%, respectively, compared to 21% in the untreated control group. Surviving beetles 

in all groups were normal in appearance and behavior throughout the test. The no observed effect 

level (NOEL) for 17 day diet exposure was 51,000 ppm. This study was acceptable. 

In the green lacewing (Chrysoperla rufilabris) larvae study, the larvae were provided killed, 

nonviable Streptomyces acidiscabies strain RL-110T

 in nominal concentrations of 510, 5,100, or 

51,000 ppm in a moth egg diet. The test included a negative control group fed moth egg diet 

treated with reverse osmosis water only. The test was terminated when mortality in the negative 

control group exceeded 20% on day 10. Mortality in the 510 ppm, 5,100 ppm, and 51,000 ppm 

test material groups was 30%, 30%, and 33%, respectively, compared to 22% in the untreated 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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control. No pupation occurred in any group, and there were no signs of toxicity. The NOEL for 

10 day diet exposure was 51,000 ppm. This study was acceptable. 

A third nontarget insect lab study was conducted with the end-use product MOI-005 EP 

(containing 17% killed nonviable Streptomyces acidiscabies strain RL-110T

 and spent 

fermentation media) to determine the toxicity of this product to the parasitic wasp (Aphidius 

matricariae), dusty miller plants (Centaurea cineraria) were artificially infested with green 

peach aphids (Myzus persicae) and sprayed with the test material at 10X the field application 

rate. The test included an inactivated test material group, a test material sterile filtrate group, and 

an untreated control. The treated plants and aphids were infested with parasitic wasps for 24 

hours and observed for 22 days afterward. Beginning on day 8, plant leaves with mummies 

(parasitized aphids) were removed, placed in Petri dishes, and monitored for adult wasp 

emergence. At test end, emergence of adult wasps in the test material, inactivated test material, 

and sterile filtrate groups was 182%, 147%, and 100%, respectively, compared to 162% in the 

untreated control. Emergence exceeded 100% due to uncounted parasitized, but not yet 

mummified, aphids on the leaves that mummified after being placed in the Petri dishes. The test 

material did not appear to be toxic to the parasitic wasp when applied to plant hosts at 10X the 

field application rate. The EC50 was greater than 11.04 mg/L; the NOEL was greater than 11.04 

mg/L. This study was acceptable. 

Honey Bees (Harmonized Guideline 885.4380) (MRID No. 47946816): To determine the effects 

of killed nonviable Streptomyces acidiscabies strain RL-110T

 in the diet to adult honeybees (Apis 

mellifera), bees were provided a nominal test material concentration of 500 μg per mL in 30% 

sucrose solution for 20 days. A positive control and untreated control were included in the test. 

All bees appeared normal during the test. At test end, mortality in the test material group was 

16.5%, compared to 30.0% in the untreated control group. Response of the positive control 

group was appropriate. There were no adverse effects of Streptomyces acidiscabies strain RL110T

 on adult honeybees under the conditions of this study. The NOEL was 500 μg per mL in 

30% sucrose solution for 20 days. This study was acceptable. 

Nontarget Plants (Harmonized Guideline 885.4300); (MRID No.47990702): Bioassays were 

conducted to determine the effects of the end-use product MOI-005 EP containing 17% killed 

nonviable Streptomyces acidiscabies strain RL-110T

 and spent fermentation media on nontarget 

crops. Potted plants were sprayed with the test material at 2X, 1X, or 0.5X the field application 

rate. MBI-005 EP was phytotoxic to all dicots tested, even at the 0.5X rate. Phytotoxicity was 

mild to moderate on broccoli, tomato, and pea; moderate on lettuce and bean; and moderate to 

severe on soybean and cucumber. For monocots, no signs of phytotoxicity occurred on 

bluegrass, bentgrass, or rice. At the highest application rate, very mild symptoms were noted on 

chive, wheat, and barley; and mild symptoms on sorghum, corn and onion. The product was 

determined to be phytotoxic at less than or equal to half the field application rate for dicots and 

greater than or equal to the application rate for monocots. The study was acceptable. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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 b. Aquatic Animals and Plants 

Freshwater Fish (Harmonized Guideline 885.4200) (MRID No. 47946812). A 30-day staticrenewal laboratory study was conducted to determine the toxic effects of killed nonviable 

Streptomyces acidiscabies strain RL-110T

 bluegill sunfish (Lepomis macrochirus). The fish were 

exposed to nominal aqueous test material concentrations of 1.1, 11, or 28 mg dry cell mass/L of 

dilution water, equivalent to 1, 10, and 25 times the expected environmental concentration 

(EEC), respectively. Additionally, the fish were exposed to a nominal dietary concentration of 

110 mg/Kg (100 times the EEC). The test included a sterile filtrate control and a negative 

control. There was no mortality in any group, and no signs of toxicity (lesions, necroses, tumors) 

were observed internally or externally in any fish. The 30-day LC50 (concentration at which 50% 

of the test animals are killed) and NOEL was greater than 28 mg/L (equivalent to 25 times the 

estimated concentration of killed nonviable Streptomyces acidiscabies strain RL-110T in the 

environment following application according to the product label). The study was acceptable. 

Freshwater Invertebrates (Harmonized Guideline 885.4240) (MRID Nos. 47946813, 48104504).

A 21-day static-renewal laboratory study was conducted to determine the effects of killed 

nonviable Streptomyces acidiscabies strain RL-110T

 on survival and reproduction of the 

freshwater invertebrate Daphnia magna. Neonates were exposed to nominal concentrations of 

killed nonviable Streptomyces acidiscabies strain RL-110T at 1.1, 11, or 28 mg dry cell mass/L 

of dilution water (equivalent to 1, 10, and 25 times the expected environmental concentration 

(EEC), respectively). The test included a sterile filtrate control and a negative control of dilution 

water only. Survival in the 1.1, 11, and 28 mg/L groups was 95%, 65%, and 80%, respectively, 

compared to 90% in the negative control group. Survival in the sterile filtrate group was 55%, 

possibly due to bacterial contamination of the fermentation broth. Daphnids in the 11 and 28 mg 

dry cell mass/L groups were observed to be small and pale in color compared to the negative 

control group. No adverse effects were seen in the 1.1 mg/L group. The mean cumulative 

number of offspring per female in the 1.1, 11, and 28 mg/L groups was 151, 80, and 28, 

respectively, compared to 130 in the negative control group and 118 in the sterile filtrate group. 

The 21-day EC50 for survival (the concentration, or “effective concentration,” of the test 

substance at which the survival of the test group is 50%) is greater than 28 mg dry cell mass/L of 

dilution water (25 times the EEC) and NOEL was greater than 1.1 mg dry cell mass/L (1 times 

the EEC). The study was acceptable. 

In a 21-day static-renewal laboratory study conducted to determine the effect of the end-use 

product MBI-005 EP containing 17% killed nonviable Streptomyces acidiscabies strain RL-110T

in spent fermentation media on survival and growth of the freshwater invertebrate, Hyalella 

azteca, third instars were exposed to nominal test material concentrations of 11.04, 110.4, or 

1,104.0 mg/L of water, chosen to represent 10, 100, and 1000 times the expected environmental 

concentration (EEC), respectively. The test included a negative control of dilution water only 

and a sterile filtrate control at 1,104 mg/L. Mean survival in the 11.04, 110.4, and 1,104 mg/L 

groups was 97.5%, 95%, and 97.5%, respectively, compared to 100% in the negative control. 

Mean survival in the sterile filtrate group was 92.5%, which was significantly lower than the 

negative control group. The mean survival rates of the control and test material groups were not 

significantly different. The EC50 for survival was greater than 1,104 mg/L. The mean weight of 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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the surviving organisms in the 11.04, 110.4, and 1,104 mg/L groups was 0.133, 0.129, and 0.065 

mg, respectively, compared to 0.130 mg in the negative control group. Mean weight of survivors 

in the sterile filtrate group was 0.080 mg. The NOEL for growth was 1,057.3 mg/L. The EC50 for 

survival was greater than1,104 mg/L or 1000 times the expected environmental concentration; 

The NOEL for growth was less than or equal to 1,057.3 mg/L. The study was acceptable. 

Estuarine/Marine Fish and Invertebrates (Harmonized Guideline 885.4280), (MRID No. 

47946817): The applicant provided the following rationale to support a data waiver for 

Estuarine/Marine Fish and Invertebrates Toxicity/Pathogenicity testing: (1) killed, nonviable 

Streptomyces acidiscabies strain RL-110T is not intended for direct application to estuarine or 

marine environments, nor is it expected to enter those environments in significant 

concentrations; (2) toxicity and pathogenicity of Streptomyces acidiscabies strain RL-110T

 have 

been evaluated in freshwater fish and invertebrates and the NOEL was greater than 25 times the 

estimated environmental concentration for fish and aquatic invertebrates; (3) Streptomyces 

acidiscabies strain RL-110T is ubiquitous as a naturally-occurring bacterium found in soils; and 

(4) a literature search yielded no reports of adverse effects in aquatic species. 

EPA considers the toxicity component of the estuarine/marine fish and invertebrates data 

requirement to be fulfilled by the freshwater fish toxicity/pathogenicity study (MRID 47946812) 

and the two studies with freshwater invertebrates (MRID Nos. 47946813 and 48104504). These 

studies showed no toxic effects to fish or survival or reproductive effects on freshwater 

invertebrates. Streptomyces acidiscabies strain RL-110T

 is killed and nonviable, and 

pathogenicity and/or infectivity in estuarine and marine organisms are not expected. It would be 

inappropriate and unnecessary to conduct testing with this active ingredient to evaluate these 

endpoints. Thus, EPA waived testing for the freshwater fish toxicity/pathogenicity and 

invertebrate testing requirements. 

Nontarget Plants (Harmonized Guideline 885.4300); (MRID No.47990702): Bioassays were 

conducted to determine the effects of the end-use product MOI-005 EP containing 17% killed 

nonviable Streptomyces acidiscabies strain RL-110T in spent fermentation media on nontarget 

aquatic plants. In the aquatic plant tests, MBI-005 EP was incorporated into the growth medium 

in a series of dilution concentrations ranging from the field application rate to 85 times lower 

than the field application rate for duckweed (Lemna minor) and from the field application rate to 

700 times lower than the application rate for the green alga Pseudokirchneriella subcapitata. 

After seven days of incubation, even the most diluted test material treatments were toxic to 

duckweed and P. subcapitata. The product is determined to be phytotoxic at less than or equal to 

one half the application rate for aquatic plants. The study was acceptable. 

2. Environmental Fate Data 

The need for environmental fate and groundwater data was not triggered because results of the 

acute toxicity studies did not trigger any additional Tier I studies. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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3. Ecological Exposure and Risk Characterization

As noted in Unit IV.C.1., Streptomyces acidiscabies strain RL-110T

 does not pose a hazard to 

nontarget animals as it is highly selective to plants. 

For nontarget plants, the risk characterization is focused on thaxtomin A. The degradation 

potential of thaxtomin A was analyzed in one study that showed common soil fungi and bacteria 

readily degrade thaxtomin A and can utilize this substance as a sole carbon source for growth. 

“Three bacterial isolates and two fungal isolates grew in thaxtomin A-containing media. Growth 

of these organisms resulted in decreases in the optical densities at 400 nm of culture supernatants 

and in 10% reductions in the thaxtomin A concentration. The fungal isolates were identified as a 

Penicillium sp. isolate and a Trichoderma sp. isolate. One bacterial isolate was associated with 

the species Ralstonia pickettii, and the two other bacterial isolates were identified as 

Streptomyces sp. strains” (Doumbou et al. 1998). 

In addition to the degradation of thaxtomin A, instructions on the end use product label for MBI05 provide specific directions to apply the product as a pre-, at- or post-emergent application 

along with instructions on application, timing and incorporation and a precautionary statement 

not to apply to surface water. 

Streptomyces acidiscabies strain RL-110T

 does not pose a hazard to nontarget organisms when 

applied according to label directions, as it is highly selective to plants, requires direct application 

to target plants for efficacy, and is expected to degrade in the environment following application. 

Pesticide products containing killed, nonviable Streptomyces acidiscabies strain RL110T are not 

likely to pose a risk to the environment or to any non-target organisms when applied according 

to the proposed label directions. 

4. Endangered Species Assessment 

Streptomyces acidiscabies strain RL-110T is highly selective to plants, and requires pre- atand/or post-plant application according to label directions for efficacy. Further, it is expected to 

degrade in the environment when applied in accordance with the proposed product label. EPA 

has determined Streptomyces acidiscabies strain RL-110T will have "No Effect" on any currently 

listed threatened or endangered species or on any designated critical habitat. 

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 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

Biopesticides Registration Action Document 

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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 killed, nonviable Streptomyces acidiscabies strain 

RL-110T, 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 proposed 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 killed, nonviable Streptomyces acidiscabies strain RL-110T pesticide 

products have well-known properties. EPA has no knowledge that would contradict the claims 

made on the MBI-005 TGAI and MBI-005 EP labels, and such pesticide products are not 

expected to cause unreasonable adverse effects on the environment when used according to their 

respective label instructions. Criterion 2 is satisfied by the current product labels, as well as the 

data and information presented in this document. It is believed that the killed, nonviable 

Streptomyces acidiscabies strain RL-110T pesticide products will not cause any unreasonable 

adverse effects on the environment, and MBI-005 EP (end-use pesticide product), in particular, 

is likely to control labeled annual grass, broadleaf and sedge weeds as claimed, satisfying 

criterion 3. Criterion 4 is satisfied in that the killed, nonviable Streptomyces acidiscabies strain 

RL-110T pesticide products are not expected to cause unreasonable adverse effects when used 

according to label instructions. Therefore, MBI-005 TGAI and MBI-005 EP, containing killed, 

nonviable Streptomyces acidiscabies strain RL-110T as a new active ingredient, are eligible for 

registration under FIFRA section 3(c)(5) for the labeled uses. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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VII. ACTIONS REQUIRED OF THE REGISTRANT 

A. Final Printed Labeling 

Before releasing pesticide products containing killed, nonviable Streptomyces acidiscabies strain 

RL-110T for shipment, the registrant is required to provide appropriate final printed labeling to 

EPA. 

B. Terms of Registration 

As terms of the MBI-005 TGAI and MBI-005 EP registrations, Marrone Bio Innovations must 

submit the results of storage stability (Harmonized Guideline 830.6317) and corrosion 

characteristics (Harmonized Guideline 830.6320) studies within one year of registration and 

verification of OMRI certification. 

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 Products Containing Killed, 

Nonviable Streptomyces acidiscabies strain RL-110T

MRID No. Citation

47946801 Koivunen, M. 2009. Product Chemistry for MBI-005 TGAI. Unpublished study prepared 

by Marrone Bio Innovations. 280 p. 

47946802 Kuhn, J. 2009. MOI 005: Acute Oral Toxicity Study (UDP) in Rats: Final Report. Project 

Number: 12679/09. Unpublished study prepared by Stillmeadow, Inc. 11 p. 

47946803 Kuhn, J. 2009. MOI 005: Acute Dermal Toxicity Study in Rats: Final Report. Project 

Number: 13042/09. Unpublished study prepared by Stillmeadow, Inc. 11 p. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

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MRID No. Citation

47946804 Younger, C. 2009. MOI 005: Acute Inhalation Toxicity Study in Rats: Final Report. Project 

Number: 13043/09. Unpublished study prepared by Stillmeadow, Inc. 17 p. 

47946805 Kuhn, J. 2009. MOI 005: Acute Eye Irritation Study in Rabbits: Final Report. Project 

Number: 13044/09. Unpublished study prepared by Stillmeadow, Inc. 16 p. 

47946806 Kuhn, J. 2009. MOI 005: Acute Dermal Irritation Study in Rabbits: Final Report. Project 

Number: 13045/09. Unpublished study prepared by Stillmeadow, Inc. 11 p. 

47946807 Kuhn, J. 2009. MOI 005: Skin Sensitization Study in Guinea Pigs: Final Report. Project 

Number: 13046/09. Unpublished study prepared by Stillmeadow, Inc. 17 p. 

47946808 

Monds, K. 2009. MOI 005 Streptomyces acidiscabies: Acute Injection Toxicity/Infectivity 

Study (in Rats): Final Report. Project Number: 13054/09. Unpublished study prepared by 

Stillmeadow, Inc. 19 p. 

47946809 

Monds, K. 2009. MOI 005: Acute Injection Toxicity/Pathogenicity Pilot Study in Mice: 

Final Report. Project Number: 13095/09. Unpublished study prepared by Stillmeadow, Inc. 

8 p. 

47946810 Monds, K. 2009. MOI 005: Subcutaneous Mouse Safety Study: Final Report. Project 

Number: 13096/09. Unpublished study prepared by Stillmeadow, Inc. 8 p. 

47946811 

Hubbard, P.; Beavers, J. 2009. MBI-005: An Avian Oral Pathogenicity and Toxicity Study 

in the Mallard. Project Number: 664/102. Unpublished study prepared by Wildlife 

International, Ltd. 50 p. 

47946812 

Sayers, L. 2009. MBI 005: 30 Day Bluegill Sunfish (Lepomis macrochirus) Static-Renewal 

Toxicity, Infectivity and Pathogenicity Test. Project Number: 071409/OPPTS885/BG/STR, 

13909/6103. Unpublished study prepared by Springborn Smithers Laboratories. 46 p. 

47946813 

Sayers, L. 2009. MBI 005: 21 Day Daphnid (Daphnia magna) Static Renewal Toxicity, 

Infectivity and Pathogenicity Test. Project Number: 13909/6104, 

071409/OPPTS/DAPHNID/STR/MPCA. Unpublished study prepared by Springborn 

Smithers Laboratories. 45 p. 

47946814 

Porch, J.; Krueger, H. 2009. MBI 005: A Dietary Pathogenicity and Toxicity Study with the 

Ladybird Beetle (Hippodamia convergens): Final Report. Project Number: 664/104, 

664/072109/LBBLCP/SUB664. Unpublished study prepared by Wildlife International, Ltd. 

30 p. 

47946815 

Porch, J.; Krueger, H. 2009. MBI 005: A Dietary Pathogenicity and Toxicity Study with 

Green Lacewing Larvae (Chrysoperla rufilabras): Final Report. Project Number: 664/105, 

664/072109/GLWLCP/SUB664. Unpublished study prepared by Wildlife International, 

Ltd. 45 p. 
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MRID No. Citation

47946816 

Richards, K. 2009. Evaluation of the Dietary Effect(s) of MBI 005 on Adult Honey Bees 

(Apis mellifera L.). Project Number: CAR/139/09. Unpublished study prepared by 

California Agricultural Research, Inc. 68 p. 

47946817 Pitts, K. 2009. Response to Tier 1 Microbial Pesticide Data Requirements for MBI-005 

TGAI. Unpublished study prepared by Marrone Bio Innovations. 29 p. 

47946818 Pitts, K. 2009. Endangered Species Evaluation for MBI-005. Unpublished study prepared 

by Marrone Bio Innovations. 80 p. 

47946819 Cordova-Kreylos, A. 2009. MBI-005: Literature Review: Scab-Causing Streptomyces. 

Unpublished study prepared by Marrone Bio Innovations. 294 p. 

47990702 Morgan, C.; Koivunen, M. 2010. MBI-005 - Nontarget Plants. Project Number: 1503/33. 

Unpublished study prepared by Marrone Bio Innovations, Inc. 63 p. 

48104501 Koivunen, M. 2010. Secondary Metabolites of MBI-005 (Streptomyces acidiscabies). 

Unpublished study prepared by Marrone Bio Innovations. 128 p. 

48104502 

Pitts, K. 2010. One Month Interim Report for Storage Stability and Corrosion 

Characteristics of MBI-005 TGAI. Unpublished study prepared by Marrone Bio 

Innovations. 46 p. 

48104503 

Koivunen, M. 2010. Manufacturing Process for MBI-005 TGAI: Heat Devitalization 

Process: Supplemental to MRID 47946801. Unpublished study prepared by Marrone Bio 

Innovations. 15 p. 

48104504 

Hartwell, T. 2010. MOI 005: Microbial Pest Control Agent (MCPA) Freshwater Aquatic 

Invertebrate Test with Hyalella azteca: Final Report. Project Number: 13841/10. 

Unpublished study prepared by Stillmeadow, Inc. 17 p. 

48104505 Younger, C. 2010. MBI 005: Parasitic Wasp Non-Target Insect Microbial Testing. Project 

Number: 13483/09. Unpublished study prepared by Stillmeadow, Inc. 14 p. 

48140901 Koivunen, M. 2010. Product Chemistry for MBI-005 EP. Unpublished study prepared by 

Marrone Bio Innovations. 190 p. 

48140902 Pitts, K. 2010. Response to Tier 1 Microbial Pesticide Data Requirements for MBI-005 EP. 

Unpublished study prepared by Marrone Bio Innovations. 88 p. 

48582301 Tan, E. 2011. Amended Manufacturing Process for MBI-005 TGAI. Unpublished study 

prepared by Marrone Bio Innovations. 52p. 

48582302 Tan, E. 2011. Heat Inactivation of MBI-005 TGAI (Streptomyces acidiscabies strain RL110). Unpublished study prepared by Marrone Bio Innovations. 25p. 

48582401 Tan, E. 2011. Amended Manufacturing Process for MBI-005 EP. Unpublished study 

prepared by Marrone Bio Innovations. 59p. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

Biopesticides Registration Action Document 

Page 24 of 32

B. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2011a. Streptomyces acidiscabies strain RL-110T (ATCC 49003) producing 

thaxtomin A. MOI-401. Memorandum from J.V. Gagliardi, Ph.D. and J.L. Kough, Ph.D. to 

A. Sibold dated Nov. 15, 2011. 

U.S. EPA. 2011b. Streptomyces acidiscabies strain RL-110T (ATCC 49003) producing 

thaxtomin A. MOI-401. Memorandum from J.V. Gagliardi, Ph.D. and J.L. Kough, Ph.D. to 

A. Sibold dated Jan. 25, 2012. 

C. Other References 

Bischoff, V., S.J. Cookson, S. Wu and W.R. Scheible. 2009. Thaxtomin A affects CESA- 

 complex density, expression of cell wall genes, cell wall composition, and causes ectopic 

 lignification in Arabidopsis thaliana seedlings. Journal of Experimental Botany 60(3):955- 

 65. 

Doumbou, C.L., V. Akimov and C. Beaulieu. 1998. Selection and characterization of 

 microorganisms utilizing thaxtomin A, a phytotoxin produced by Streptomyces scabies. 

Applied and Environmental Microbiology 64(11):4313-4316. 

Faucher, E., T. Savard, and C. Beaulieu. 1992. Characterization of Actinomycetes Isolated from 

Common Scab Lesions on Potato-Tubers. Canadian Journal of Plant Pathology-Revue 

Canadienne De Phytopathologie. 14: 197-202. 

Fett W.F., et al. 1992. Cutinase production by Streptomyces spp.. Curr. Microbiol. 25:165-171. 

Lambert, D.H., and R. Loria. 1989. Streptomyces-Acidiscabies SP-NOV. International Journal 

of Systematic Bacteriology 39:393-396. 

Loria, R., D.R. D. Bignell, S. Moll, J.C. Huguet-Tapia, M.V. Joshi, E.G. Johnson, R.F. Seipke, 

and D.M. Gibson. 2008. Thaxtomin biosynthesis: The Path to Plant Pathogenicity in the Genus 

Streptomyces. Antonie Van Leeuwenhoek International Journal of General and Molecular 

Microbiology 94:3-10. 

Loria, R., J. Kers, and M. Joshi. 2006. Evolution of Plant Pathogenicity in Streptomyces. Annual 

Review of Phytopathology 44:469-487. 

Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry and M.A. Pfaller, editors. 2007. Manual 

of Clinical Biology. Vol.1. 9th Ed. Washington (DC): ASM Press. 

Wanner, L.A. 2009. A Patchwork of Streptomyces Species Isolated from Potato Common Scab 

Lesions in North America. American Journal of Potato Research 86:247-264. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

Biopesticides Registration Action Document 

Page 25 of 32

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 

(40 CFR PART 158 – SUBPART V) 

TABLE 1. Product Analysis Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Killed, Nonviable 

Streptomyces acidiscabies strain RL-110T, and Its Associated End-Use Pesticide Product (EP), MBI-005 EP (40 CFR § 158.2120) 

Harmonized 

Guideline 

Number 

Data Requirement 

Results

MRID No. 

TGAI EP 

885.1100 Product Identity 

Submitted data fulfill the 

requirement for product identity. 

MBI-005 TGAI contains 100% 

by weight killed, nonviable 

Streptomyces acidiscabies strain 

RL-110T cells and spent 

fermentation media. 

Submitted data fulfill the 

requirement for product 

identity. MBI-005 EP contains

17% killed, nonviable 

Streptomyces acidiscabies 

strain RL-110T cells and spent 

fermentation media. 

47946801 

48140901 

48104503 

48582301 

48582302 

48582401 

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 Streptomyces 

acidiscabies strain RL-110T is 

on deposit with the American 

Type Culture Collection under 

Accession Number ATCC 

49003. 

N/A 

885.1400 Analysis of Samples Submitted data fulfill the requirement for analysis of samples. 

885.1500 Certification of Limits Limits are adequate/acceptable. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

Biopesticides Registration Action Document 

Page 26 of 32

TABLE 2. Physical and Chemical Characteristics for the Technical Grade of the Active Ingredient (TGAI), Killed, Nonviable 

Streptomyces acidiscabies strain RL-110T, and Its Associated End-Use Pesticide Product (EP), MBI-005 EP (40 CFR § 158.2120)

Harmonized 

Guideline Number Data Requirement 

Results 

MRID No. 

TGAI EP 

830.63021 Color Amber Black 

47946801 

48104502 

48140901 

830.63031 Physical State Liquid 

830.63041 Odor Grass-like Rancid, Sweet 

830.63131 

Stability to Normal and 

Elevated 

Temperatures, Metals, 

and Metal Ions 

Expected to be stable when 

stored at 25°C. N/A 

830.6317 Storage Stability 

Expected to be stable for one 

year when stored per label 

directions. As a term of the 

MBI-005 TGAI registration, 

EPA is requiring submission of 

a storage stability study within 

one year of registration. 

Expected to be stable for two 

years when stored per label 

directions. As a term of the 

MBI-005 EP registration, EPA 

is requiring submission of a 

storage stability study within 

one year of registration. 

830.6319 Miscibility 

Not required because MBI-005 

TGAI is not an emulsifiable 

liquid form of a microbial 

pesticide (refer to test note #2 of 

40 CFR § 158.2120(d)). 

Miscible with water. 

830.6320 Corrosion 

Characteristics 

Not expected to be corrosive to packaging materials. As terms of the 

MBI-005 TGAI and MBI-005 EP registrations, EPA is requiring 

submission of corrosion characteristics studies within one year of 

registration.

830.70001 pH 7.4 6.6 

830.7100 Viscosity 4.96 cP 63.8 cP 

830.73001 

Density/Relative 

Density/Bulk Density 

(Specific Gravity) 

0.999 g/mL 1.02 g/mL 

 1 According to 40 CFR § 158.2120, these data are only required for the technical grade of the active ingredient. Since Marrone Bio 

 Innovations included this information with its application for MBI-005 EP, it is summarized appropriately in this table. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

Biopesticides Registration Action Document 

Page 27 of 32

TABLE 3. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Killed, Nonviable Streptomyces 

acidiscabies strain RL-110T

, and Its Associated End-Use Product (EP), MBI-005 EP (40 CFR § 158.2140)

Harmonized 

Guideline Number 

Data 

Requirement

Results 

MRID No.

TGAI EP 

Tier I

885.3050 

Acute Oral 

Toxicity/ 

Pathogenicity 

Toxicity component of the acute oral 

toxicity/pathogenicity data 

requirement fulfilled by MRID No. 

479468-02. Given that Streptomyces 

acidiscabies strain RL-110T

 is killed 

and nonviable, pathogenicity and/or 

infectivity in mammals is not expected. 

It would be inappropriate and 

unnecessary to conduct testing with 

this active ingredient to evaluate these 

endpoints. Thus, EPA waived testing 

for the pathogenicity component of the 

acute oral toxicity/pathogenicity data 

requirement. 

Classification: Acceptable

N/A 47946817 

885.3150 

Acute Pulmonary 

Toxicity/ 

Pathogenicity 

Toxicity component of the acute 

pulmonary toxicity/pathogenicity data 

requirement fulfilled by MRID No. 

479468-04. Given that Streptomyces 

acidiscabies strain RL-110T

 is killed 

and nonviable, pathogenicity and/or 

infectivity in mammals is not expected. 

It would be inappropriate and 

unnecessary to conduct testing with 

this active ingredient to evaluate these 

endpoints. Thus, EPA waived testing 

for the pathogenicity component of the 

acute pulmonary toxicity/pathogenicity 

data requirement. 

Classification: Acceptable 

N/A 47946817

885.3200 

Acute Injection 

Toxicity/ 

Pathogenicity 

(Intravenous) 

Not toxic, infective, or pathogenic (live 

Streptomyces acidiscabies strain RL-110T

) 

when administered intravenously at 9.0 x 

106

 CFU per animal. 

Classification: Acceptable 

N/A 47946808 

885.3400 Hypersensitivity 

Incidents 

Hypersensitivity incidents, including immediate-type and delayed-type reactions 

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

TGAI, MP or EP, or are otherwise known to the applicant, must be reported if 

they occur (refer to test note #3 of 40 CFR § 158.2140(d)). 

N/A 

885.3500 Cell Culture 

Not required because killed, nonviable 

Streptomyces acidiscabies strain RL-110T

is not a virus (refer to test note #4 of 40 

CFR § 158.2140(d)). 

N/A N/A 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

Biopesticides Registration Action Document 

Page 28 of 32

TABLE 3. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Killed, Nonviable Streptomyces 

acidiscabies strain RL-110T

, and Its Associated End-Use Product (EP), MBI-005 EP (40 CFR § 158.2140)

Harmonized 

Guideline Number 

Data 

Requirement

Results 

MRID No.

TGAI EP 

870.1100 Acute Oral 

Toxicity 

Oral LD50 female rats > 5,000 mg/kg 

Classification: Acceptable

TOXICITY CATEGORY IV 

Waived based on the results of 

MRID No. 479468-02 and because 

MBI-005 EP contains inert 

ingredients that are not expected to 

be of toxicological concern (refer to 

test note #5 of 40 CFR § 

158.2140(d)). 

Classification: Acceptable

Toxicity Category III 

47946802 

48140902 

870.1200 Acute Dermal 

Toxicity 

Dermal LD50 combined (male and female) 

rats > 5,050 mg/kg 

Classification: Acceptable

TOXICITY CATEGORY IV

Waived based on the results of 

MRID No. 479468-03 and because 

MBI-005 EP contains inert 

ingredients that are not expected to 

be of toxicological concern (refer to 

test note #5 of 40 CFR § 

158.2140(d)). 

Classification: Acceptable

Toxicity Category III

47946803 

48140902 

870.1300 Acute Inhalation 

Toxicity 

Inhalation LC50 combined (male and female

rats > 2.12 mg/L 

Classification: Acceptable

TOXICITY CATEGORY IV

Waived based on the results of 

MRID No. 479468-04 and because 

MBI-005 EP contains inert 

ingredients that are not expected to 

be of toxicological concern (refer to 

test note #5 of 40 CFR § 

158.2140(d)). 

Classification: Acceptable

Toxicity Category III

47946804 

48140902 

870.2400 Acute Eye 

Irritation 

MOI 005 was minimally irritating to the 

eyes of rabbits. 

Classification: Acceptable 

TOXICITY CATEGORY IV 

Waived based on the results of 

MRID No. 479468-05 and because 

MBI-005 EP contains inert 

ingredients that are not expected to 

be of toxicological concern (refer to 

test note #5 of 40 CFR § 

158.2140(d)). 

Classification: Acceptable

Toxicity Category III

47946805 

48140902 

870.2500 Primary Dermal 

Irritation 

MOI 005 was not irritating to the skin of 

rabbits. 

Classification: Acceptable 

TOXICITY CATEGORY IV 

Waived based on the results of 

MRID No. 479468-06 and because 

MBI-005 EP contains inert 

ingredients that are not expected to 

be of toxicological concern (refer to 

test note #5 of 40 CFR § 

158.2140(d)). 

Classification: Acceptable

Toxicity Category III

47946806 

48140902 

870.2600 Skin Sensitization Not a dermal sensitizer

Classification: Acceptable N/A 47946807 

Tiers II and III

Not required for killed, nonviable Streptomyces acidiscabies strain RL-110T, based on the lack of acute toxicity in the Tier I studies.
Table 4. Non-target Organism Toxicity Requirements for Streptomyces acidiscabies strain RL-110 T (40 CFR 158.2060 

Requirement (OPPTS Guideline No.) 

MRID Toxicity and Classification 

Avian oral toxicity  (885.4050) 

47946811 An indoor study was conducted to determine the acute toxicity of killed, nonviable Streptomyces acidiscab

(Anas platyrhynchos). Fourteen-day-old birds were dosed with the test material (63 mg a.i./Kg body weigh

observed for an additional 25 days. There were no treatment related signs of toxicity in any of the birds durthan 63 mg a.i./Kg body weight/day for five days. Classification: Acceptable. 

Avian inhalation toxicity/ pathogenicity (885.4100) 

47946817 “Data required when the nature of the microbial pesticide and/or its toxins indicates potential pathogenicity 

testnote 3). Marrone Bio Innovations submitted a request for a waiver of the conditional data requirement based on the 

Streptomyces acidiscabies strain RL-110T was not toxic or pathogenic in an avian oral toxicity study (2) the 

TGAI is ubiquitous as a naturally occurring bacterium found in soils and water and 3) A literature search yi

in avian species. Classification: The waiver rationale is acceptable. 

Wild mammal toxicity/ pathogenicity (885.4150) 

47946817 This study is “Required on a case-by-case basis if results of tests required by §158.2140 are inadequate or i

hazards to wild mammals” (40 CFR 158.2150, testnote 4). Marrone Bio Innovations submitted a request for a waiver of the conditional data requirement based on the 

Streptomyces acidiscabies strain RL-110T was not toxic in acute exposure studies in rats, (2) Streptomyces 

not pathogenic in an intravenous injection study in rats, (3) the active ingredient in MBI-005 TGAI is ubiqubacterium found in soils; and 4) a literature search yielded no reports of adverse effects in humans or other Classification: The waiver rationale is acceptable. Effects on wild mammals are expected to be minimal as on both the viable and non-viable active ingredient with no effects. 
Freshwater fish 

toxicity/ pathogenicity (885.4200) 

47946812 A 30-day static-renewal laboratory study was conducted to determine the toxic effects of killed, nonviable 

RL-110T to bluegill sunfish (Lepomis macrochirus). There was no mortality in any group, and no signs of t

were observed internally or externally in any fish. 30-day LC50 and NOEL was greater than28 mg/L (25 timenvironmental concentration (EEC)). Classification: Acceptable 

Freshwater invertebrate testing  (885.4240) 

47946813 A 21-day static-renewal laboratory study was conducted to determine the effects of killed, nonviable Strep

110T on survival and reproduction of Daphnia magna. The 21-day EC50 is greater than 28 mg dry cell mass

greater than 1.1 mg dry cell mass/L (equivalent to the EEC). Classification: Acceptable 

48104504. A 21-day static-renewal laboratory study was conducted to determine the effect of the end use product MB

the freshwater invertebrate, Hyalella azteca. The NOEL for growth was 1,057.3 mg/L. The EC50 for surviv

NOEL for growth was less than or equal to 1,057.3 mg/L. Classification: Acceptable 

Estuarine/Marine fish testing Estuarine/Marine invertebrate testing (885.4280) 

47946817 This study is “Required if the product is intended for direct application into the estuarine or marine environ

environment in significant concentrations because of expected use or mobility pattern.” (40 CFR 158.2150, 

Marrone Bio Innovations submitted a request for a waiver of the conditional data requirement based on the 

product MBI-005 EP is not intended for direct application to estuarine or marine environments; 2) killed, 

acidiscabies strain RL-110T toxicity and pathogenicity have been evaluated in freshwater fish and invertebr

ubiquitous as a naturally-occurring bacterium found in soils, and 4) a literature search yielded no reports of 

Classification: The waiver rationale is acceptable. Effects to estuarine and marine organisms are expected ttesting occurred on the non-viable TGAI and EP products. 

Nontarget Plant Testing (885.4300) 

47990702 Bioassays were conducted to determine the effects of the end use product MBI-005 EP on nontarget crop an

phytotoxic to all dicots tested, even at the 0.5X rate. Phytotoxicity was mild to moderate on broccoli, tomat

bean; and moderate to severe on soybean and cucumber. For monocots no phytotoxicity was seen on bluegr

highest application rate, very mild symptoms were seen on chive, wheat, and barley; and mild symptoms on 

aquatic plant tests, MBI-005 EP was incorporated in the growth medium in a series of dilution concentratio

application rate to 85 times lower than the field application rate for duckweed (Lemna minor) and from the 

lower than the application rate for the green alga Pseudokirchneriella subcapitata. After seven days of incu

material treatments were toxic to duckweed and P. subcapitata. Classification: Acceptable – The product is phytotoxic at less than or equal to half the field application rate the application rate for monocots; less than or equal to one half the application rate for aquatic plants. 
Killed, nonviable Streptomyces acidiscabies strain RL-110T 

Biopesticides Registration Action Document Nontarget Insect Testing (885.4340) 

47946814 A laboratory study was conducted to determine the effects of killed nonviable Streptomyces acidiscabies s

beetles (Hippodamia convergens). Surviving beetles in all groups were normal in appearance and behavior 

Classification: Acceptable – The NOEL for 17 day diet exposure was 51,000 ppm. 

47946815 A laboratory study was conducted to determine the toxic effects of killed nonviable Streptomyces acidisca

lacewing (Chrysoperla rufilabris) larvae. There were no signs of toxicity. 

Classification: Acceptable – The NOEL for 10 day diet exposure was 51,000 ppm. 

48104505 A laboratory study was conducted to determine the toxic effects of the end use product containing 17% kil

acidiscabies strain RL-110T and spent fermentation media on the parasitic wasp. The test material did not a

wasp when applied to plant hosts at 10X the field application rate. Classification: Acceptable. The NOEL was greater than 11.04 mg/L. 

Honeybee Testing (885.4380) 

47946816 A laboratory study was conducted to determine the effects of MBI-005 TGAI in the diet to adult honeybees 

adverse effects of MBI-005 on adult honeybees under the conditions of this study. Classification: Acceptable – The NOEL was 500 μg/mL in 30% sucrose solution for 20 days. 
APPENDIX B. PESTICIDE PRODUCTS 

EPA File Symbol Registration Name Percentage Active 

Ingredient 

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

Application 

Applica

84059-RR MBI-005 TGAI 100.00% Technical N/A N/A N/A 84059-RE MBI-005 EP 17% End Use – Liquid Listed agricultural 

crops, turf and ornamentals in landscapes, residential lawns 

Aerial and Ground Application, Broadcast, Pre- plant surface application, incorporated, Pre-plant incorporated, At-plant, incorporated, and Layby, soil directed. 

Up to 12 per 1000