BIOPESTICIDES REGISTRATION ACTION DOCUMENT 

 

Pasteuria usgae 

Pesticide Chemical (PC) Code: 006545 

U.S. Environmental Protection Agency 

Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

Last Updated – November 9, 2010 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Table of Contents 

I. EXECUTIVE SUMMARY 4 

II. ACTIVE INGREDIENT OVERVIEW 7 

III. REGULATORY BACKGROUND 7 

 A. Applications for Pesticide Registration 7 

 B. Request for an Experimental Use Permit 8 

 C. Food Tolerance Exemptions 8 

IV. RISK ASSESSMENT 9 

 A. Product Analysis Assessment 10 

 1. Product Chemistry and Composition 10 

 2. Analysis of Samples 11 

 3. Physical and Chemical Characteristics 11 

 B. Human Health Assessment 12 

 1. Toxicology 12 

 2. Food Quality Protection Act Considerations______________________ 14 

 3. Occupational Exposure and Risk Characterization 17 

 4. Human Health Risk Characterization 17 

 C. Environmental Assessment 17 

 1. Summary of Nontarget Organism Waiver Rationales 18 

 2. Environmental Effects Conclusions 20 

 3. Threatened and Endangered Species Assessment 21 

V. ENVIRONMENTAL JUSTICE 21 

VI. PUBLIC INTEREST FINDING 22 

VII. RISK MANAGEMENT AND REGISTRATION DECISIONS 23 

A. Determination of Eligibility 23 

1. Pasteuria usgae – BL1 23 

2. EconemTM and Pasteuria usgae – Liquid Formulation 23 

B. Registration Review 24 

C. Regulatory Decisions 24 

1. Pasteuria usgae – BL1 24 

2. EconemTM 25 

3. Pasteuria usgae – Liquid Formulation 25 

D. Labeling 26 

VIII. ACTIONS REQUIRED BY THE REGISTRANT 26 

A. Final Printed Labeling 26 

B. Terms and Conditions of the Pasteuria usgae Pesticide Products 26 

1. Pasteuria usgae – BL1 26 

2. EconemTM 28 

3. Pasteuria usgae – Liquid Formulation 29 

C. Reporting of Adverse Effects and Hypersensitivity Incidents 29 

IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 30 

X. BIBLIOGRAPHY 31 

A. Studies Submitted to Support the Pasteuria usgae Pesticide Product 

 Registrations 31 

B. Environmental Protection Agency Risk Assessment Memoranda 36 

C. Other References 36 

APPENDIX A 38 

APPENDIX B 48 

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Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM 

Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

Microbial Pesticides Branch 

Science Reviews 

Stuart Schüssel Product Analysis, Human Health 

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

Shannon Borges Environmental Effects 

Zigfridas Vaituzis, Ph.D. Environmental Effects 

Regulations 

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

Jeannine Kausch Regulatory Action Leader 

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Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

I. EXECUTIVE SUMMARY 

Pasteuria species are gram-positive, mycelial, endospore-forming bacteria that are 

endoparasitic to nematodes and water fleas. The microbial active ingredient, Pasteuria 

usgae, is host-specific to the sting nematode (Belonolaimus longicaudatus), which can be 

damaging to a wide variety of crops such as turf and strawberry. The active agent of 

Pasteuria usgae is an endospore that attaches to and infects the host nematode during all 

life stages (except eggs). These endospores are formed inside the host, released into the 

soil when the infected nematode decomposes, and considered nonmotile and stable in the 

soil environment for several years. 

Environmental Protection Agency (EPA or the Agency) scientists reviewed product 

analysis, toxicology, and nontarget organism/environmental fate data and other 

information (40 Code of Federal Regulations (CFR) §§ 158.2120, 158.2140, and 

158.2150, respectively), which were submitted to support the registration of three 

Pasteuria usgae pesticide products. It was determined that the data and other information 

adequately satisfy current data requirements for the purposes of particular time-limited, 

conditional registrations under section 3(c)(7) of the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) for a manufacturing-use product (Pasteuria usgae – BL1, EPA 

Registration Number 85004-1) and two end-use products (EconemTM, EPA Registration 

Number 85004-2; Pasteuria usgae – Liquid Formulation, EPA Registration Number 

85004-3). All pesticide products containing Pasteuria usgae are presumed to be in the 

public interest as they could serve as partial replacements for conventional nematicides of 

continuing concern to the Agency (e.g., methyl bromide (ozone-depleting substance) and 

1,3-dichloropropene (probable human carcinogen)). 

For the purposes of conditional, time-limited registrations, product analysis data 

requirements for Pasteuria usgae (to include product chemistry and composition, 

analysis of samples, and physical and chemical characteristics) were satisfied by 

acceptable guideline studies. Additional product analysis data that the Agency required 

by specific dates include the following: 

 A written description of quality control measures taken during the manufacturing 

process to screen for Pasteuria species that parasitize saprophytic nematodes. 

This information was submitted by the registrant in a timely manner and is being 

reviewed for acceptability. 

 A new five-batch analysis with all batches from production level. 

 Results from an ongoing twelve-month storage stability study. This information 

was submitted by the registrant in a timely manner and is being reviewed for 

acceptability. 

Lastly, documentation indicating official recognition of Pasteuria usgae as a species by 

the Judicial Commission of the International Committee for Systematic Bacteriology 

must be submitted to the Agency when it becomes available. 

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Biopesticides Registration Action Document (BRAD) November 2010 

Adequate mammalian toxicology data and other information were submitted to support 

all of the Pasteuria usgae pesticide products. The Tier I microbial pesticide toxicological 

studies showed that, at a single high dose, Pasteuria usgae was not toxic and/or 

pathogenic via any examined route of exposure (i.e., oral, dermal, pulmonary, and 

injection). Since microbial enumeration was not performed in some of these tests because 

Pasteuria usgae would not grow on agar media, the infectivity was uncertain. However, 

because Pasteuria usgae spores are highly specific to the sting nematode, infectivity is 

unlikely to be a concern. Moreover, no hypersensitivity incidents, occurring during the 

testing or production of Pasteuria usgae, were observed by the registrant. Given the 

results of the Tier I toxicological studies and the absence of hypersensitivity incidents, 

testing at higher tiers was not required. 

The Agency concluded that there is a reasonable certainty that no harm will result to the 

United States population, including infants and children, from aggregate exposure to the 

residues of Pasteuria usgae. No dietary risks are expected from use of Pasteuria usgae as 

an active ingredient in pesticide products. Significant dietary exposure (through food and 

drinking water) is not expected given the established use patterns, use sites, and 

application methods for the pesticide products, as well as standard practices for 

postharvest handling of food commodities (e.g., washing and cooking). In the unlikely 

event oral exposure should occur through food or drinking water, such exposure to 

Pasteuria usgae is expected to be several orders of magnitude lower than the dose used in 

the acute oral toxicity/pathogenicity test, during which no toxic or pathogenic effects 

were observed in rats. Finally, nonoccupational exposure is considered unlikely for 

Pasteuria usgae as all currently approved uses occur in distinctly agricultural or 

commercial settings. 

Despite the low toxicological profile of Pasteuria usgae, baseline personal protective 

equipment (PPE) is required for handlers that may be exposed to the active ingredient, 

due to their occupation, for prolonged periods. Handlers working with Pasteuria usgae in 

manufacturing facilities or in occupational and agricultural settings are directed to wear a 

long-sleeved shirt, long pants, socks, shoes, waterproof gloves, and a dust/mist filtering 

respirator meeting National Institute for Occupational Safety and Health (NIOSH) 

standards of at least N-95, R-95, or P-95. The Agency may require additional PPE, other 

than the standard described above, on a product-specific basis. For example, protective 

eyewear is required for EconemTM, the registered granular Pasteuria usgae formulation. 

 

Data waiver rationales were submitted in response to data requirements for avian, 

freshwater fish and invertebrate, insect, and honey bee nontarget organism testing. The 

information provided was sufficient to satisfy the Tier I nontarget organism data 

requirements for the pesticide products containing Pasteuria usgae as an active 

ingredient. Further testing of nontarget organisms at higher tier levels is not required. 

Based on the rationales submitted, adverse effects to terrestrial animals and plants or 

freshwater and marine/estuarine fish, invertebrates, and plants are not expected because 

of exposure to labeled applications of Pasteuria usgae. Furthermore, the Agency has 

made “No Effect” (NE) determinations for direct and indirect effects to listed species and 

their habitat as a result of the current uses of Pasteuria usgae. 

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Biopesticides Registration Action Document (BRAD) November 2010 

On October 1, 2009, the 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, the Agency intends to provide a public comment period prior to 

making a registration decision for, at minimum, the following types of applications: new 

active ingredients; first food uses; first outdoor uses; first residential uses; and any 

registration decisions for which the Agency believes there may be substantial public 

interest. 

Consistent with the policy of making registration actions more transparent, the end-use 

product containing Pasteuria usgae as an active ingredient (Pasteuria usgae – Liquid 

Formulation, EPA Registration Number 85004-3) was subject to a 30-day comment 

period because the associated label allows for application to strawberry, which was 

considered a “first food use” for this currently registered active ingredient. During this 

comment period, no comments were received on the Agency’s preliminary decision to 

register. Therefore, the Agency maintained that, based upon the risk assessment and 

information submitted in support of registration of Pasteuria usgae – Liquid Formulation, 

it was in the best interest of the public and the environment to issue the registration for 

this pesticide product with a first food use. The basis for this decision can be found in the 

risk assessment for Pasteuria usgae, which is characterized throughout this BRAD. 

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Biopesticides Registration Action Document (BRAD) November 2010 

II. ACTIVE INGREDIENT OVERVIEW 

 Biological Name: Pasteuria usgae

Culture Deposit: American Type Culture Collection in Manassas, 

 Virginia under Accession Number SD-5835 

Office of Pesticide 

Programs (OPP) 

Chemical Code: 006545 

Type of Pesticide: Microbial Pesticide – Nematicide 

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

use sites, application rates, methods of application, 

formulation types, and target pests) regarding 

the registered pesticide products containing this 

active ingredient. 

III. REGULATORY BACKGROUND 

A. Applications for Pesticide Registration 

On May 5, 2008, MacIntosh and Associates, Incorporated (address: 1203 Hartford 

Avenue, Saint Paul, Minnesota 55116-1622), acting as the authorized agent for Pasteuria 

Bioscience, Incorporated (address: 12085 Research Drive, Suite 185, Alachua, Florida 

32615), submitted an application to register Pasteuria usgae – BL1 (EPA File Symbol 

85004-R) under FIFRA section 3. On August 13, 2008, the Agency announced receipt of 

this application to register a pesticide product containing a new active ingredient (73 

Federal Register (FR) 47166) and opened a 60-day public comment period pursuant to 

the provisions of FIFRA section 3(c)(4). No comments were received following this 

publication. 

Pursuant to FIFRA section 3(c)(7)(C), a conditional, time-limited registration was issued 

for the manufacturing-use product, Pasteuria usgae – BL1, on June 2, 2009 (EPA 

Registration Number 85004-1). The Agency announced the approval to conditionally 

register Pasteuria usgae – BL1, containing a new active ingredient, in the Federal 

Register of July 1, 2009 (74 FR 31426).

While the Agency was assessing the data submitted in connection with Pasteuria usgae – 

BL1, MacIntosh and Associates, Incorporated (on behalf of Pasteuria Bioscience, 

Incorporated) submitted two additional applications for associated end-use products 

(EconemTM, EPA File Symbol 85004-E; Pasteuria usgae – Liquid Formulation, EPA File 

Symbol 85004-G). Pursuant to FIFRA section 3(c)(7)(A), a conditional, time-limited 

registration was issued for EconemTM, a granular end-use product applied to turf to 

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Biopesticides Registration Action Document (BRAD) November 2010 

control sting nematode, on September 3, 2009 (EPA Registration Number 85004-2). The 

other end-use product was associated with a “new use” as one of the use patterns (i.e., 

application to strawberry) required the establishment of an exemption from the 

requirement of a tolerance under section 408 of the Federal Food, Drug, and Cosmetic 

Act (FFDCA) (40 CFR § 152.3). Pursuant to the provisions of FIFRA section 3(c)(4), on 

March 5, 2010, the Agency announced receipt of the application from MacIntosh and 

Associates, Incorporated (on behalf of Pasteuria Bioscience, Incorporated) requesting to 

register a new use (75 FR 10259). No comments were received following this 

publication. Pursuant to FIFRA section 3(c)(7)(A), a conditional, time-limited 

registration was issued for Pasteuria usgae – Liquid Formulation, a liquid end-use 

product applied to turf and strawberry to control sting nematode, on June 16, 2010 (EPA 

Registration Number 85004-3). 

B. Request for an Experimental Use Permit 

On January 14, 2009, receipt of an experimental use permit application was announced in 

the Federal Register (74 FR 2070), and a 30-day public comment period was opened. No 

comments were received following this publication. After the associated temporary 

exemption from the requirement for a tolerance was established for Pasteuria usgae (see 

section III(C)), the experimental use permit was issued on August 12, 2009 (EPA 

Experimental Use Permit Number 85004-EUP-1). This experimental use permit allowed 

the use of 59,675 pounds of formulated product (3,272.5 pounds of nematicidal active 

ingredient, Pasteuria usgae) on 385 acres of strawberry and turf to evaluate control of the 

sting nematode under various methods of application. The program was authorized only 

in the States of Alabama, Florida, Georgia, Mississippi, and North Carolina and was 

effective from August 12, 2009 to August 31, 2010. Issuance of this experimental use 

permit was announced in the Federal Register of August 27, 2009 (74 FR 43696). 

C. Food Tolerance Exemptions 

Concurrent with their experimental use permit application and under FFDCA section 

408(d), MacIntosh and Associates, Incorporated (on behalf of Pasteuria Bioscience, 

Incorporated) submitted a petition to establish a temporary exemption from the 

requirement of a tolerance for Pasteuria usgae (Pesticide Petition (PP) 8G7471). In the 

Federal Register of January 8, 2009 (74 FR 808), the Agency announced that MacIntosh 

and Associates, Incorporated (on behalf of Pasteuria Bioscience, Incorporated) proposed 

to establish a temporary exemption from the requirement of a tolerance for residues of the 

microbial nematicide, Pasteuria usgae, in or on strawberries and opened a 30-day public 

comment period. No comments were received following this publication. 

On August 5, 2009, the Agency established a temporary exemption from the requirement 

of a tolerance for Pasteuria usgae when applied/used as a nematicide on strawberries in 

accordance with the terms of Experimental Use Permit 85004-EUP-1 (40 CFR § 

180.1290; 74 FR 38970). This temporary exemption from the requirement of a tolerance 

would have expired and been revoked on December 31, 2010 but was replaced by a 

permanent tolerance exemption (see explanation in the next paragraph). 

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Biopesticides Registration Action Document (BRAD) November 2010 

In addition to the petition associated with the temporary exemption that was submitted 

with the experimental use permit, MacIntosh and Associates, Incorporated (on behalf of 

Pasteuria Bioscience, Incorporated) also submitted a separate petition, along with their 

application for registration for Pasteuria usgae – Liquid Formulation (EPA File Symbol 

85004-G), to establish a permanent exemption from the requirement of a tolerance for 

Pasteuria usgae (PP 9F7539). In the Federal Register of April 8, 2009 (74 FR 15969), the 

Agency announced that MacIntosh and Associates, Incorporated (on behalf of Pasteuria 

Bioscience, Incorporated) proposed to establish a permanent exemption from the 

requirement of a tolerance for residues of the microbial nematicide, Pasteuria usgae, in 

or on all food commodities and opened a 30-day public comment period. No substantive 

comments were received following this publication. On June 30, 2010, the Agency 

established a permanent exemption from the requirement of a tolerance for residues of 

Pasteuria usgae in or on all food commodities when applied preharvest and used as a 

nematicide in accordance with good agricultural practices (40 CFR § 180.1290; 75 FR 

37734). This exemption revised the temporary exemption established previously in 

conjunction with EPA Experimental Use Permit Number 85004-EUP-1. 

IV. RISK ASSESSMENT 

On October 26, 2007, the Agency issued a Final Rule in the Federal Register on the data 

requirements to support registration of biochemical and microbial pesticides and updated 

the definitions for biochemical and microbial pesticides (72 FR 60988). The rule became 

effective on December 26, 2007. The data and information evaluated for this 

Biopesticides Registration Action Document (BRAD) were considered in light of these 

requirements. 

The classifications that are found for each data submission are assigned by Agency 

science reviewers and are an indication of the usefulness of the information contained in 

the documents for risk assessment. A rating of “ACCEPTABLE” indicates the study is 

scientifically sound and is useful for risk assessment. A “SUPPLEMENTAL” rating 

indicates the data provide some information that can be useful for risk assessment. The 

studies may have certain aspects determined not to be scientifically acceptable 

(“SUPPLEMENTAL: UPGRADABLE”). If a study is rated as “SUPPLEMENTAL: 

UPGRADABLE,” the Agency always provides an indication of what is lacking or what 

can be provided to change the rating to “ACCEPTABLE.” If there is simply a 

“SUPPLEMENTAL” rating, the reviewer will often state that the study is not required by 

the current 40 CFR part 158. Both “ACCEPTABLE” and “SUPPLEMENTAL” studies 

may be used in the risk assessment process as appropriate. An “UNACCEPTABLE” 

rating indicates that new data need to be submitted. 

For the acute toxicity data requirements, toxicity categories are assigned based on the 

hazard(s) identified from studies and/or information submitted to the Agency. The active 

ingredient or particular product is classified into Toxicity Category I, II, III, or IV, where 

Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the 

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Biopesticides Registration Action Document (BRAD) November 2010 

lowest toxicity. 

A. Product Analysis Assessment (40 CFR § 158.2120) 

For purposes of conditional, time-limited registrations, all product analysis data 

requirements were satisfied by acceptable guideline studies. The Agency required 

additional product analysis data on Pasteuria usgae by specific dates. 

For a comprehensive guideline-by-guideline summary of the generic product analysis 

data requirements described in sections IV(A)(1), IV(A)(2), and IV(A)(3), as well as 

additional product-specific data submitted to support individual registrations, refer to 

Tables 1 and 2 in Appendix A. 

 1. Product Chemistry and Composition (Office of Chemical Safety and 

 Pollution Prevention (OCSPP) Guidelines 885.1100, 885.1200, 

 and 885.1300) 

Pasteuria species are gram-positive, mycelial, endospore-forming bacteria that are 

endoparasitic to nematodes and water fleas. The endospores of Pasteuria species can be 

identified and counted microscopically, but it is difficult to distinguish between species 

unless high magnification electron microscopy is used so that size and shape of the spores 

can be visualized and measured. Molecular techniques, such as polymerase chain reaction 

(PCR) methods, have been reported for Pasteuria penetrans but have not been developed 

for the other species. Therefore, host specificity assay, requiring the establishment of 

nematode cultures and a bioassay, is the most direct and reliable technique for species 

identification. 

Pasteuria usgae, a recently discovered strain, is host-specific to the sting nematode 

(Belonolaimus longicaudatus), which can be damaging to a variety of crops such as turf 

and strawberry. Currently, full recognition of Pasteuria usgae as a species is still pending 

with the Judicial Commission of the International Committee for Systematic 

Bacteriology. Once Pasteuria usgae is recognized and removed from the category 

Candidatus, documentation indicating official recognition must be provided to the 

Agency. 

The active agent of Pasteuria usgae is an endospore that attaches to and infects the host 

nematode during all life stages (except eggs). Increased moisture, neutral pH, 

temperatures above 10°C, and sandy soil seem to provide the best environments for spore 

attachment to the host. In laboratory studies, Pasteuria species were able to attach to 

nematodes after exposure to high temperatures and wide ranges of pH; however, at 

extremes, the number of attached spores per nematode was reduced and, in some cases, 

no infection occurred after attachment. After attachment of the endospore, a germ tube 

penetrates the nematode cuticle and mycelial microcolonies are formed in the 

pseudocoelom, leading to eventual death of the host. The endospores are formed inside 

the host, released into the soil when the infected nematode decomposes, and considered 

nonmotile and stable in the soil environment for several years. 

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Biopesticides Registration Action Document (BRAD) November 2010 

Submitted data also adequately described the production process and potential microbial 

contaminants, and these requirements were satisfied for the purposes of conditional, timelimited registrations. The original manufacturing process did not describe quality control 

measures taken to confirm that Pasteuria usgae was the only Pasteuria species present in 

the master stock. A follow-up explanation, which demonstrated that batches are screened 

for the presence of other microbes and screened against sting nematodes to confirm the 

presence of Pasteuria usgae, still did not provide sufficient information to indicate that 

screening for other Pasteuria species is conducted during the manufacturing process. 

Other Pasteuria species, specifically those that parasitize saprophytic (non-plant 

pathogenic) nematodes, must be screened for during the manufacturing process. Pasteuria 

Bioscience, Incorporated was required to integrate quality control measures that screen 

for Pasteuria species that parasitize saprophytic nematodes, either immediately after 

freezing or after making seed stock, into their current manufacturing process and provide 

a written description of these measures to the Agency on or before October 1, 2009. This 

information was submitted by Pasteuria Bioscience, Incorporated in a timely manner 

(Master Record Identification Number (MRID No.) 478853-01) and is being reviewed for 

acceptability. 

 2. Analysis of Samples (OCSPP Guideline 885.1400) 

Results of a preliminary five-batch analysis were provided and the requirement for 

analysis of samples was satisfied for purposes of conditional, time-limited registrations. 

The preliminary analysis of samples provided to the Agency revealed a wide range of 

concentrations, with many replicates containing 1–2 orders of magnitude fewer Pasteuria 

usgae spores than the minimum specified on the Confidential Statement of Formula 

(CSF) and product label (i.e., 1 x 106 spores per milliliter). A follow-up explanation, 

attempting to address this variability, mentioned several factors that contributed to this 

inconsistency and discussed how the concentration of spores could be adjusted during the 

manufacturing process, if necessary. Despite this additional information, a new five-batch 

analysis, with all batches from production level, must be submitted to the Agency on or 

before May 1, 2011.

 

 3. Physical and Chemical Characteristics (OCSPP Guidelines 830.6302, 

 830.6303, 830.6304, 830.6313, 830.6317, 830.7000, and 830.7300) 

Submitted data adequately described the physical and chemical characteristics of 

Pasteuria usgae; however, a twelve-month storage stability study was cited as ongoing 

with the original application. Therefore, the requirements for color, physical state, odor, 

stability to normal and elevated temperatures, metals, and metal ions, pH, and 

density/relative density/bulk density (specific gravity) were satisfied. Pasteuria 

Bioscience, Incorporated was required to submit the final storage stability study to the 

Agency on or before June 1, 2010. This information was submitted by Pasteuria 

Bioscience, Incorporated in a timely manner (MRID No. 479672-01) and is being 

reviewed for acceptability. 

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Biopesticides Registration Action Document (BRAD) November 2010 

B. Human Health Assessment 

 1. Toxicology 

Adequate mammalian toxicology data and other information are available to support the 

registration of Pasteuria usgae pesticide products, including the most recent end-use 

product (Pasteuria usgae – Liquid Formulation, EPA Registration Number 85004-3) 

registered for use on strawberry and turf. All Tier I toxicology data requirements were 

satisfied by guideline studies. Furthermore, Tier II and Tier III studies were not required 

for Pasteuria usgae based on the lack of acute toxicity/pathogenicity in the Tier I studies. 

For a comprehensive guideline-by-guideline summary of the generic toxicology data 

requirements described in sections IV(B)(1)(a) and IV(B)(1)(b), as well as additional 

product-specific data submitted to support individual registrations, refer to Tables 3 and 4 

in Appendix A. 

a. Acute Toxicity/Pathogenicity – Tier I (40 CFR § 158.2140) 

Acute Oral Toxicity and Pathogenicity – Rat (OCSPP Guideline 885.3050; MRID No.

474267-09): There were no treatment-related clinical signs or necropsy findings in rats 

receiving a single oral dose of 1 x 108 Pasteuria usgae spores. Three males in the 

microbial pest control agent (MPCA)-treated group gained weight through day 14 but lost 

weight by day 21. All other animals gained weight prior to scheduled sacrifice. Pasteuria 

usgae did not appear to be toxic and/or pathogenic in rats when dosed at 1 x 108 

spores/animal. Since microbial enumeration was not performed because the test material 

would not grow on agar media, the infectivity was uncertain. However, because the 

spores are highly specific to the sting nematode, infectivity is unlikely to be a concern. 

This study was rated “ACCEPTABLE,” and Pasteuria usgae was classified as 

TOXICITY CATEGORY IV. 

Acute Dermal Toxicity – Rat (OCSPP Guideline 885.3100; MRID No. 474267-12): 

There were no treatment-related significant adverse effects seen in the dosed rats. Two 

males and one female had very slight erythema on day 1 with clearance by day 4. One 

male lost weight slightly during the second week and one male and two females lost 

weight during the first week, but all gained weight by the end of the study. All other 

animals gained weight throughout the study. Based on the results of this study, Pasteuria 

usgae did not appear to be toxic in rats when treated with 2,000 milligrams/kilogram 

(mg/kg) at 108 spores/milliliter (mL). The acute dermal median lethal dose (LD50) was 

greater than 2,000 mg/kg for 108 spores/mL in male and female rats. This study was rated 

“ACCEPTABLE,” and Pasteuria usgae was classified as TOXICITY CATEGORY IV. 

 

Acute Pulmonary Toxicity and Pathogenicity – Rat (OCSPP Guideline 885.3150; MRID 

No. 474267-10): In an acute pulmonary toxicity and pathogenicity assessment, there 

were no test substance-related significant adverse effects seen in rats receiving a single 

dose of approximately 1–3 x 108 spores of Pasteuria usgae. One dosed female exhibited 

pale lungs. Additionally, one untreated control female lost weight by day 21 and another 

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Biopesticides Registration Action Document (BRAD) November 2010 

untreated control female lost weight by day 14 but gained weight by day 21. One MPCAtreated male did not gain weight by day 7 but gained weight thereafter. All other animals 

gained weight throughout the study. Based on these results, Pasteuria usgae did not 

appear to be toxic and/or pathogenic in rats when dosed at approximately 1–3 x 108 

spores/animal. Since microbial enumeration was not performed because the test material 

would not grow on agar media, the infectivity was uncertain. However, because the 

spores are highly specific to the sting nematode, infectivity is unlikely to be a concern. 

This study was rated “ACCEPTABLE,” and Pasteuria usgae was classified as 

TOXICITY CATEGORY IV. 

 

Acute Injection Toxicity and Pathogenicity – Rat (OCSPP Guideline 885.3200; MRID 

No. 474267-11): There were no treatment-related significant adverse effects seen in rats 

receiving a single intravenous dose of 108 Pasteuria usgae spores. One treated female lost 

weight by day 7 but gained weight prior to sacrifice on day 14. All other animals gained 

weight throughout the study. All animals survived and appeared normal during the study. 

No abnormalities were observed in any animal at necropsy or in harvested organs. No 

significant variations in organ weight were found between different groups or sexes. The 

acute intravenous LD50 of Pasteuria usgae was greater than 1 x 108 spores/animal in male 

and female rats. Pasteuria usgae did not appear to be toxic and/or pathogenic in rats 

when dosed at 108 spores/animal. Since microbial enumeration was not performed 

because the test material would not grow on agar media, the infectivity was uncertain. 

However, because the spores are highly specific to the sting nematode, infectivity is 

unlikely to be a concern. This study was rated “ACCEPTABLE.” 

Hypersensitivity Incidents (OCSPP Guideline 885.3400; MRID No. 474350-02): No 

hypersensitivity incidents, including immediate-type or delayed-type reactions of humans 

and domestic animals occurring during the testing or production of Pasteuria usgae, were 

observed by Pasteuria Bioscience, Incorporated. Any future hypersensitivity incidents 

must be reported to the Agency. 

Cell Culture (OCSPP Guideline 885.3500): This study was not required because 

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

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

 Reproductive Fertility Effects, Carcinogenicity, Immunotoxicity, and 

 Infectivity/Pathogenicity Analysis – Tier III (40 CFR § 158.2140) 

Tier II and Tier III studies were not required for Pasteuria usgae based on the lack of 

acute toxicity/pathogenicity in the Tier I studies.

c. Endocrine Disruptors 

As required under FFDCA section 408(p), the Agency 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 

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Biopesticides Registration Action Document (BRAD) November 2010 

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 the Agency 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, the Agency 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 postapplication agricultural scenarios. This list should not be construed as a list of known or 

likely endocrine disruptors. 

Pasteuria usgae 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), the Agency must 

screen all pesticide chemicals. Accordingly, the Agency 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 chemicals, the test guidelines and the Tier 1 screening battery, please visit our 

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

2. Food Quality Protection Act (FQPA) Considerations 

Section 408(c)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act allows the Agency 

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 the Agency 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, the Agency must take into account the 

factors set forth in section 408(b)(2)(C) of FFDCA, which require the Agency to give 

special consideration to exposure of infants and children to the pesticide chemical residue 

in establishing a tolerance 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 the Agency 

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

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

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Biopesticides Registration Action Document (BRAD) November 2010 

The Agency performs a number of analyses to determine the risks from aggregate 

exposure to pesticide residues. First, the Agency determines the toxicity of pesticides. 

Second, the Agency 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, the Agency 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. The Agency has 

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 discussed previously and presented in 

Table 3 in Appendix A, the data required for a FQPA risk assessment for Pasteuria usgae

have been satisfied. 

a. Aggregate Exposures 

In examining aggregate exposure, section 408 of FFDCA directs the Agency 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, lawns, or buildings (residential and 

other indoor uses). 

Dietary Exposure and Risk Characterization: Dietary exposure to the naturally occurring 

soil bacterium, Pasteuria usgae, although a possibility, is anticipated to be negligible. For 

optimal control of sting nematode, Pasteuria usgae is applied in a manner that facilitates 

movement of spores into the root zone of the affected crop. This requires that end users 

take two particular actions that would inevitably minimize the amount of Pasteuria usgae

residues on aboveground food commodities—soil-directed applications and irrigation 

with a specified amount of water following any such applications. For food commodities 

that develop underground, exposure to Pasteuria usgae residues is a more likely scenario, 

although standard postharvest practices of washing, cooking, or processing would reduce 

such residues. In general, any actual dietary exposure is expected to be several orders of 

magnitude lower than the dose used in the acute oral toxicity/pathogenicity test 

referenced in section IV(B)(1)(a), during which no toxic or pathogenic effects were 

observed in rats. Moreover, since Pasteuria usgae is host-specific, no toxicity or 

pathogenicity in humans is likely to occur. The Agency concludes that there is a 

reasonable certainty that no harm will result from the aggregate exposure to the residues 

of Pasteuria usgae in food. 

Drinking Water Risk Characterization: Exposure of humans to residues of Pasteuria 

usgae in consumed drinking water is unlikely. The currently approved use patterns, use 

sites, and application methods for Pasteuria usgae do not include direct application to 

aquatic environments. Furthermore, given that Pasteuria usgae spores attach specifically 

to the sting nematode, which is a plant-parasitic nematode that thrives only in sandy soil 

environments and is dependent upon plant roots to sustain life, future proposals to add 

aquatic use sites to pesticide products containing this bacterium are not expected. Even if 

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Biopesticides Registration Action Document (BRAD) November 2010 

oral exposure should occur through consumed drinking water, the Agency concludes that 

there is a reasonable certainty that no harm will result from the exposure to the residues 

of Pasteuria usgae in all the anticipated drinking water exposures because of the lack of 

acute oral toxicity/pathogenicity to mammals and the host-specific nature of the 

bacterium, as stated previously. 

Nonoccupational, Residential Risk Characterization: Nonoccupational exposure is 

considered unlikely for Pasteuria usgae as all currently approved uses occur in distinctly 

agricultural or commercial settings. 

The only other nonoccupational exposure is that which would normally be encountered as 

part of the natural environment (i.e., not as a result of pesticide use). As expected, since 

Pasteuria usgae is an obligate endoparasite of the sting nematode, there have been no 

reports of adverse effects from human exposure to this bacterium that naturally occurs in 

sandy soils, particularly those of the southeastern and midwestern United States. 

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, the Agency consider “available information concerning the 

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

common mechanism of toxicity.” 

The Agency has not found Pasteuria usgae to share a common mechanism of toxicity 

with any other substances, and Pasteuria usgae does not appear to produce a toxic 

metabolite as its mode of action against the target pest. For the purposes of this tolerance 

action, therefore, the Agency has assumed that Pasteuria usgae does not have a common 

mechanism of toxicity with other substances. For information regarding the Agency’s 

efforts to determine which chemicals have a common mechanism of toxicity and to 

evaluate the cumulative effects of such chemicals, see the Agency’s website at 

http://www.epa.gov/pesticides/cumulative. 

c. Determination of Safety for U.S. Population, Infants, and Children 

FFDCA section 408(b)(2)(C) provides that the Agency 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 the 

Agency shall apply an additional tenfold margin of safety for infants and children in the 

case of threshold effects to account for prenatal and postnatal toxicity and the 

completeness of the database unless the Agency determines that a different margin of 

safety will be safe for infants and children. Margins of exposure (safety), which are often 

referred to as uncertainty factors, are incorporated into Agency risk assessments either 

directly or through the use of a margin of exposure analysis, or by using uncertainty 

(safety) factors in calculating a dose level that poses no appreciable risk. 

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Biopesticides Registration Action Document (BRAD) November 2010 

Based on the acute toxicity and pathogenicity data discussed in section IV(B)(1)(a), the 

Agency concludes that there is a reasonable certainty that no harm will result to the 

United States population, including infants and children, from aggregate exposure to the 

residues of Pasteuria usgae. This includes all anticipated dietary exposures and all other 

exposures for which there is reliable information. The Agency has arrived at this 

conclusion because the data available on Pasteuria usgae do not demonstrate toxic, 

pathogenic, or infective potential to mammals. Thus, there are no threshold effects of 

concern and, as a result, the provision requiring an additional margin of safety does not 

apply. 

 3. Occupational Exposure and Risk Characterization 

In light of the Tier I acute toxicity/pathogenicity studies, which did not show any toxic 

and/or pathogenic effects to rats via oral, pulmonary, dermal, and intravenous routes of 

exposure (see section IV(B)(1)(a)), handler exposure to Pasteuria usgae is not expected 

to pose any undue risk. Regardless, appropriate personal protective equipment and 

precautionary statements are required on the product label to mitigate any potential risks 

to pesticide handlers due to prolonged exposure. Handlers working with Pasteuria usgae

in manufacturing facilities and applying the end-use products in commercial and 

agricultural settings must wear a long-sleeved shirt, long pants, socks, shoes, waterproof 

gloves, and a dust/mist filtering respirator meeting NIOSH standards of at least N-95, R95, or P-95. Additional PPE, other than the standard described above, may be required on 

a product-specific basis (e.g., protective eyewear for EconemTM, the registered granular 

Pasteuria usgae formulation). 

4. Human Health Risk Characterization 

The Agency considered human exposure to Pasteuria usgae in light of the standard for 

registration and safety factors in FIFRA and FFDCA, as amended by the FQPA. A 

determination has been made that no unreasonable adverse effects to the United States 

population in general, and to infants and children in particular, will result from the use of 

Pasteuria usgae when used in accordance with EPA-approved labeling. 

C. Environmental Assessment 

Exposure of nontarget organisms is possible with application of end-use products 

containing Pasteuria usgae to turf and strawberry. Pasteuria Bioscience, Incorporated 

submitted data waiver rationales containing information cited in published literature to 

satisfy data requirements for nontarget organism testing with the technical grade of the 

active ingredient (TGAI). The following is a review of the rationales submitted to support 

the registration of the manufacturing-use product and end-use products, as well as 

resulting conclusions regarding environmental risks based on the submitted waiver 

justifications. 

For a comprehensive guideline-by-guideline summary of the nontarget toxicity data 

requirements, refer to Table 5 in Appendix A. 

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Biopesticides Registration Action Document (BRAD) November 2010 

1. Summary of Nontarget Organism Waiver Rationales (40 CFR § 

 158.2150) 

Data waiver rationales were submitted in response to data requirements for avian, 

freshwater fish and invertebrate, insect, and honey bee nontarget organism testing 

requirements. Justification for these waivers is described in sections IV(C)(1)(a), 

IV(C)(1)(c), and IV(C)(1)(f). Some data requirements were not required based on the test 

notes described in 40 CFR § 158.2150(e), and explanations are provided in sections 

IV(C)(1)(b), IV(C)(1)(d), and IV(C)(1)(e). Overall, the information provided was 

sufficient to satisfy the Tier I nontarget organism data requirements for the 

manufacturing-use product and end-use products. Further testing of nontarget organisms 

at higher tier levels was not required. 

a. Avian Oral Toxicity/Pathogenicity (OCSPP Guideline 885.4050)

The request to waive avian oral toxicity/pathogenicity testing was based on the rationale 

that exposure of birds to Pasteuria usgae as a result of its applications will be minimal, 

and that no records are available in which toxicity or pathogenicity of Pasteuria usgae or 

other Pasteuria species to birds is reported. Pasteuria species are ubiquitous in soil 

environments where plant-parasitic nematodes exist (Chen and Dickson 1998; Hewlett et 

al. 1994), and their population dynamics are strongly linked to parasite-prey interactions 

with their nematode hosts (Ciancio and Queneherve 2000; Darban et al. 2005). Pasteuria 

usgae is very specific to its host (Bekal et al. 2001; Giblin-Davis et al. 2001, 2003). 

Extensive literature searches were performed within Agricola and PubMed databases, as 

well as several relevant journals, and no information was found relating exposure to 

naturally occurring Pasteuria usgae or other Pasteuria species to toxic or pathogenic 

effects in birds. The searches also did not result in finding any reports of genotoxic, 

carcinogenic, allergenic, mutagenic, or teratogenic effects. 

An argument could be made that the absence of a record of toxicity/pathogenicity to birds 

is not evidence that such effects could not occur. However, since Pasteuria usgae is a 

naturally occurring and ubiquitous bacterium, there would likely have been reports in 

these databases if it was toxic or pathogenic to birds. Based on this information, adverse 

effects to avian wildlife resulting from exposure to Pasteuria usgae are not anticipated. 

Therefore, the rationale presented was acceptable and fulfilled the data requirement for 

avian oral toxicity/pathogenicity testing. 

b. Avian Inhalation Toxicity/Pathogenicity (OCSPP Guideline 885.4100) 

These data were not required as the nature of the microbial pesticide does not indicate 

potential pathogenicity to birds or relatedness to any known bird pathogens (refer to test 

note #3 of 40 CFR § 158.2150(e)).

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Biopesticides Registration Action Document (BRAD) November 2010 

c. Freshwater Fish Toxicity/Pathogenicity (OCSPP Guideline 885. 4200) and 

 Freshwater Invertebrate Toxicity/Pathogenicity (OCSPP Guideline 

 885.4240)

The requests to waive the data requirements for freshwater fish toxicity/pathogenicity and 

freshwater invertebrate toxicity/pathogenicity were combined. The rationale was similar 

to that for birds described above, wherein exposure is expected to be limited and there are 

no reports of toxicity or pathogenicity of Pasteuria usgae to freshwater fish or 

invertebrates. Additionally, Pasteuria usgae and other Pasteuria species do not produce 

crystalline insect toxins like bacteria that are toxic to insects (e.g., Bacillus thuringiensis). 

Pasteuria ramosa is a closely related species to Pasteuria usgae that is known to 

parasitize Daphnia magna and other Daphnia species. However, Pasteuria ramosa does 

not infect nematode hosts typical to other Pasteuria species (Ebert et al. 1996). 

Furthermore, neither Pasteuria usgae nor Pasteuria ramosa are included in published 

fish pathogen listings. Pasteuria usgae is unique in the ultrastructural characteristics of 

its spores, and this contributes to its specificity (Ebert et al. 1996; Giblin-Davis et al. 

2001). 

Based on this information, adverse effects to freshwater fish or invertebrates resulting 

from labeled applications of Pasteuria usgae are not expected. The request to waive the 

data requirements for freshwater fish and invertebrate toxicity/pathogenicity testing was 

acceptable. 

d. Estuarine/Marine Fish Testing and Estuarine/Marine Invertebrate 

 Testing (OCSPP Guideline 885.4280) 

These data were not required because Pasteuria usgae will not be applied to water and is 

not expected to enter marine/estuarine environments in amounts that are significantly 

higher than naturally occurring concentrations (refer to test note #6 of 40 CFR § 

158.2150(e)). 

 e. Nontarget Plant Testing (OCSPP Guideline 885.4300) 

These data were not required because Pasteuria usgae is not related to known plant 

pathogens, and adverse effects to plants are not expected (refer to test note #7 of 40 CFR 

§ 158.2150(e)). 

f. Nontarget Insect Testing (OCSPP Guideline 885.4340) and Honey Bee 

 Testing (OCSPP Guideline 885.4380)

The requests to waive the data requirements for nontarget insect testing and honey bee 

testing were combined. The rationale was similar to that given for other nontarget taxa 

above, wherein exposure to nontarget insects and honey bees is expected to be limited, 

and neither Pasteuria usgae nor other Pasteuria species are included in published insect 

or honey bee pathogen listings. Pasteuria usgae and other Pasteuria species do not 

produce crystalline insect toxins as seen in other bacteria that are known to be toxic to 

insects. 

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Biopesticides Registration Action Document (BRAD) November 2010 

Based on this information, adverse effects to nontarget insects or honey bees resulting 

from labeled applications of Pasteuria usgae are not expected, and the request to waiver 

these data requirements were acceptable. 

 

2. Environmental Effects Conclusions

a. Terrestrial Animals and Plants 

Data waiver rationales provided sufficient information to conclude that adverse effects 

are not expected in birds, nontarget insects, and honey bees as a result of exposure to 

Pasteuria usgae (MRID No. 474267-13). These rationales addressed exposure via 

applications of granules containing Pasteuria usgae to turf; however, the rationales 

presented are also applicable to liquid applications to turf and strawberry. Pasteuria 

species are ubiquitous in soils worldwide, and Pasteuria usgae is highly host-specific to 

the plant-parasitic sting nematode (Belonolaimus longicaudatus). None of the uses are 

expected to increase the concentrations of Pasteuria usgae in the soil above naturally 

occurring levels. Soil applications of granules to turf are expected to limit exposure in the 

environment. While liquid applications would result in exposure on foliar surfaces of turf 

and strawberry plants, no reports of terrestrial animal toxicity or pathogenicity from 

exposure to Pasteuria usgae exist in the available scientific literature. 

An acute oral toxicity and pathogenicity study with laboratory rats (MRID No. 474267-

09) is available with which to determine the potential effects of Pasteuria usgae on wild 

mammals. Laboratory rats were dosed with 108

 spores/mL and were observed for 21 

days. No signs of toxic or pathogenic effects were observed throughout the test or at 

necropsy. This study demonstrated that toxicity/pathogenicity to wild mammals is not 

expected from labeled applications of Pasteuria usgae. 

Nontarget plant testing was not required because Pasteuria usgae is not related to any 

known plant pathogen. Adverse effects on plants are not expected to result from labeled 

applications of Pasteuria usgae. 

Based on the above rationales, adverse effects are not expected to occur to terrestrial 

animals or plants as a result of labeled applications of Pasteuria usgae. The request to 

waive these data requirements was acceptable. 

b. Aquatic Animals and Plants 

Data waiver rationales were submitted to fulfill data requirements for and support effects 

conclusions for freshwater aquatic organisms (MRID No. 474267-13). These rationales 

addressed exposure via applications of granules containing Pasteuria usgae to turf; 

however, the rationales presented are also applicable to liquid applications to turf and 

strawberry. The rationales provided sufficient information to conclude that adverse 

effects are not expected in freshwater fish or freshwater invertebrates as a result of 

exposure to Pasteuria usgae. The rationales were similar to those presented for terrestrial 

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Biopesticides Registration Action Document (BRAD) November 2010 

organisms in that Pasteuria species are ubiquitous in soils worldwide, and Pasteuria 

usgae is highly host-specific to the plant-parasitic sting nematode (Belonolaimus 

longicaudatus). Soil applications in turf only are expected to limit exposure in the aquatic 

environment, and runoff from both soil and liquid applications is not expected to increase 

the concentrations of Pasteuria usgae in freshwater environments above naturally 

occurring levels. There is no available literature documenting reports of pathogenicity or 

toxicity to freshwater fish or invertebrates as a result of exposure to Pasteuria usgae. 

Pasteuria ramosa is a closely related species to Pasteuria usgae that does parasitize 

Daphnia magna and other Daphnia species. However, Pasteuria ramosa does not infect 

nematode hosts typical to other Pasteuria species, and Pasteuria usgae is very hostspecific and is not known to parasitize aquatic invertebrates. 

Because the use of Pasteuria usgae is limited to applications to turf and strawberry and is 

not intended for application directly to water, exposure is not expected to be significant in 

aquatic environments, including marine or estuarine systems. Therefore, testing with 

marine/estuarine animals and testing with aquatic plants was not necessary. 

Based on the rationales submitted, adverse effects to freshwater and marine/estuarine 

fish, invertebrates, and plants are not expected as a result of exposure to labeled 

applications of Pasteuria usgae. The request to waive these data requirements was 

acceptable. 

3. Threatened and Endangered Species Assessment 

There are no listed endangered or threatened species related to the target pest. Since it is 

concluded that effects are not anticipated for nontarget species exposed to Pasteuria 

usgae as a result of labeled applications, direct and indirect effects to listed species or 

their habitat are also not expected. Therefore, the Agency made “No Effect” (NE) 

determinations for direct and indirect effects to listed species and their habitat as a result 

of the uses of Pasteuria usgae. 

V. ENVIRONMENTAL JUSTICE 

The Agency 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 

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Biopesticides Registration Action Document (BRAD) November 2010 

and facilitate the involvement of those potentially affected. The Agency has this goal for 

all communities and persons across the United States. 

At this time, the Agency does not believe the use of Pasteuria usgae pesticide products 

will cause harm or a disproportionate impact on at-risk communities. 

For additional information regarding environmental justice issues, please visit the 

Agency’s web site at http://www.epa.gov/compliance/environmentaljustice/index.html. 

VI. PUBLIC INTEREST FINDING 

The Agency determines whether conditional registration of a pesticide is in the public 

interest in accordance with the criteria set forth in the Federal Register of March 5, 1986 

(58 FR 7268). There is a presumption that registration of a pesticide is in the public 

interest if (1) the use is for a minor crop, (2) the use is a replacement for another pesticide 

that is of continuing concern to the Agency, (3) the use is one for which an emergency 

exemption under FIFRA section 18 has been granted (i.e., the basis for the exemption 

was lack of a registered alternative product), or (4) the use is against a pest of public 

health significance. Pasteuria usgae pesticide products could serve as partial 

replacements for conventional nematicides of continuing concern to the Agency (e.g., 

methyl bromide (ozone-depleting substance) and 1,3-dichloropropene (probable human 

carcinogen)). Based on this information, registration of Pasteuria usgae pesticide 

products are presumed to be in the public interest.

 

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Biopesticides Registration Action Document (BRAD) November 2010 

VII. RISK MANAGEMENT AND REGISTRATION DECISIONS 

A. Determination of Eligibility 

 1. Pasteuria usgae – BL1 (EPA Registration Number 85004-1) 

Section 3(c)(7)(C) of the Federal Insecticide, Fungicide, and Rodenticide Act provides 

for the conditional registration of a pesticide containing an active ingredient not 

contained in any currently registered pesticide for a period reasonably sufficient for the 

generation and submission of required data if the following are determined: 

(1) Use of the pesticide during a defined period will not cause any 

 unreasonable adverse effect on the environment; 

(2) Use of the pesticide is in the public interest; AND 

(3) For data that are lacking, a reasonable period of time sufficient for 

 generation of that data has not elapsed since the Agency first imposed the data 

 requirements. 

As discussed in this document, use of products containing Pasteuria usgae is not likely to 

result in any unreasonable adverse effects on the environment, fulfilling criterion 1. 

Furthermore, as mentioned in section VI, the registration of Pasteuria usgae – BL1 is 

presumed to be in the public interest because it will be used to create end-use products 

that could serve as partial replacements for particular conventional nematicides of 

continuing concern to the Agency; thus, criterion 2 has been satisfied. To satisfy criterion 

3, insufficient time has elapsed since the initial imposition of the data requirements 

outlined in section VIII(B)(1). 

2. EconemTM (EPA Registration Number 85004-2) and Pasteuria usgae – 

 Liquid Formulation (EPA Registration Number 85004-3) 

Section 3(c)(7)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act provides 

for the conditional registration of a pesticide if the following are determined: 

(1) The pesticide and proposed use are identical or substantially similar to any 

 currently registered pesticide and use thereof, or differ only in ways that 

 would not significantly increase the risk of unreasonable adverse effects on 

 the environment AND 

(2) Approving the registration in the manner proposed by the applicant would not 

 significantly increase the risk of any unreasonable adverse effect on the 

 environment. 

Although these end-use pesticide products are not substantially similar to the 

manufacturing-use product, Pasteuria usgae – BL1 (EPA Registration Number 85004-1), 

use of these products to control sting nematode in commercial and agricultural settings is 

not likely to result in any unreasonable adverse on the environment, a conclusion that is 

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Biopesticides Registration Action Document (BRAD) November 2010 

supported by the information presented throughout this document. Thus, criterion 1, and 

by default, criterion 2 have both been satisfied. 

 

B. Registration Review 

The Federal Insecticide, Fungicide, and Rodenticide Act, as amended by the FQPA of 

1996, mandated the continuous review of existing pesticides. All pesticides distributed 

and sold in the United States must generally be registered by the Agency, based on 

scientific data showing that they will not cause unreasonable risks to human health, 

workers, or the environment when used as directed in product labeling. The registration 

review program is intended to make sure that, as the ability to assess risk evolves and as 

policies and practices change, all registered pesticides continue to meet the statutory 

standard of no unreasonable adverse effects to human health or the environment. Changes 

in science, public policy, and pesticide use practices will occur over time. Through the 

registration review program, the Agency periodically reevaluates pesticides to make sure 

that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided at http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency has implemented the registration review program pursuant to FIFRA section 

3(g) and will review each registered pesticide every 15 years to determine whether it 

continues to meet the FIFRA standard for registration. A registration review decision is 

the Agency’s determination whether a pesticide meets, or does not meet, the standard for 

registration in the Federal Insecticide, Fungicide, and Rodenticide Act. Pasteuria usgae 

will be included in the schedule for registration review at the end of the Fiscal Year when 

schedules are updated. 

C. Regulatory Decisions 

 1. Pasteuria usgae – BL1 (EPA Registration Number 85004-1) 

Based on the data submitted and under FIFRA section 3(c)(7)(C), the Agency granted a 

conditional, time-limited registration for the manufacturing-use product, Pasteuria usgae

– BL1, containing Pasteuria usgae as a new active ingredient. Although the data were 

satisfactory, they were not sufficient to support an unconditional registration under 

FIFRA section 3(c)(5). Additional data, discussed in section VIII(B)(1), are necessary for 

a finding of registrability under FIFRA section 3(c)(5) and are still considered terms or 

conditions for the purposes of this registration. 

Handler exposure to Pasteuria usgae is not expected to pose any undue risk given the 

Tier I acute toxicological studies, which showed that Pasteuria usgae is not toxic and/or 

pathogenic. Regardless, appropriate personal protective equipment and precautionary 

statements are required on the product label to mitigate any potential risks to pesticide 

handlers due to prolonged exposure. Handlers working with Pasteuria usgae in 

manufacturing facilities must, at a minimum, wear a long-sleeved shirt, long pants, socks, 

shoes, waterproof gloves, and a dust/mist filtering respirator meeting NIOSH standards of 

at least N-95, R-95, or P-95. 

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Biopesticides Registration Action Document (BRAD) November 2010 

2. EconemTM (EPA Registration Number 85004-2) 

Based on the data submitted and under FIFRA section 3(c)(7)(A), the Agency granted a 

conditional, time-limited registration for the end-use product, EconemTM. Although the 

data were satisfactory to make the determinations required by this section of FIFRA, they 

were not sufficient to support an unconditional registration under FIFRA section 3(c)(5). 

Additional data, discussed in section VIII(B)(2), are necessary for a finding of 

registrability under FIFRA section 3(c)(5) and remain as terms or conditions for the 

purposes of this registration. Furthermore, the registrant must submit/cite all data 

required to support Pasteuria usgae – BL1 (as outlined in its associated registration 

notice) as this particular manufacturing-use product serves as EconemTM’s source of 

active ingredient. 

Handler exposure to Pasteuria usgae is not expected to pose any undue risk given the 

Tier I acute toxicological studies, which showed that Pasteuria usgae is not toxic and/or 

pathogenic. Regardless, appropriate personal protective equipment and precautionary 

statements are required on the product label to mitigate any potential risks to pesticide 

handlers due to prolonged exposure. Handlers working with Pasteuria usgae in 

commercial and agricultural settings must, at a minimum, wear a long-sleeved shirt, long 

pants, socks, shoes, waterproof gloves, and a dust/mist filtering respirator meeting 

NIOSH standards of at least N-95, R-95, or P-95. In addition, because the productspecific data eye irritation data indicated that EconemTM most appropriately fit in 

Toxicity Category III, all handlers must also wear protective eyewear. 

3. Pasteuria usgae – Liquid Formulation (EPA Registration Number 85004-3) 

 

On October 1, 2009, the 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, the Agency intends to provide a public comment period prior to 

making a registration decision for, at minimum, the following types of applications: new 

active ingredients; first food uses; first outdoor uses; first residential uses; and any 

registration decisions for which the Agency believes there may be substantial public 

interest. 

The Agency concluded that the data submitted fulfill the requirements of registration for 

the end-use product, Pasteuria usgae – Liquid Formulation, which contains Pasteuria 

usgae as a nematicidal active ingredient and is labeled for this currently registered active 

ingredient’s first food use. Acute toxicological data for Pasteuria usgae demonstrated 

that it is not toxic and/or pathogenic via any examined route of exposure (i.e., oral, 

dermal, pulmonary, and injection). Moreover, because Pasteuria usgae spores are highly 

specific to the sting nematode, infectivity is unlikely to be a concern. Product-specific 

data and other information placed this end-use product in either Toxicity Category III or 

IV. Finally, the Agency has no concerns for any nontarget organisms (to include 

threatened and endangered species) exposed to Pasteuria usgae in accordance with its 

currently approved uses as no toxic endpoints have been identified for mammals, birds, 

25 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

plants, insects, honey bees, or aquatic organisms. Given the nontoxic character of 

Pasteuria usgae and its associated end-use product, Pasteuria usgae – Liquid 

Formulation, but also taking into consideration that certain data are still outstanding for 

this pesticide product’s source of active ingredient (i.e., Pasteuria usgae – BL1, EPA 

Registration 85004-1), the Agency supported Pasteuria usgae – Liquid Formulation’s 

registration under Section 3(c)(7)(A) of the Federal Insecticide, Fungicide, and 

Rodenticide Act. Although the data were satisfactory to make the determinations required 

by this section of FIFRA, they were not sufficient to support an unconditional registration 

under FIFRA section 3(c)(5). Additional data, discussed in section VIII(B)(3), are 

necessary for a finding of registrability under FIFRA section 3(c)(5) and remain as terms 

or conditions for the purposes of this registration. 

D. Labeling 

The labels for the registered pesticide products containing the active ingredient, Pasteuria 

usgae, are available at http://oaspub.epa.gov/pestlabl/ppls.home. 

VIII. ACTIONS REQUIRED BY THE REGISTRANT 

A. Final Printed Labeling 

Before releasing pesticide products containing Pasteuria usgae for shipment, the 

registrant is required to provide appropriate final printed labeling to the Agency. 

B. Terms and Conditions of the Pasteuria usgae Pesticide Products 

 1. Pasteuria usgae – BL1 (EPA Registration Number 85004-1) 

The Agency evaluated the data submitted in connection with the initial registration of the 

manufacturing-use product, Pasteuria usgae – BL1, containing Pasteuria usgae as a new 

active ingredient. Although it was determined that these data fulfilled current 

requirements for a conditional, time-limited FIFRA section 3(c)(7)(C) registration, the 

Agency required Pasteuria Bioscience, Incorporated to submit the following additional 

data and/or information in the time frames listed: 

Study Type Required Data/Information Due Date 

Analysis of Samples 

(OCSPP Guideline 

885.1400) 

The preliminary analysis of samples provided to the Agency revealed a 

wide range of concentrations, with many replicates containing 1–2 orders 

of magnitude fewer Pasteuria usgae spores than the minimum specified 

on the Confidential Statement of Formula and product label (i.e., 1 x 106 

spores per milliliter). A follow-up explanation, attempting to address this 

variability, mentioned several factors that contributed to this 

inconsistency and discussed how the concentration of spores could be 

adjusted during the manufacturing process, if necessary. Despite this 

additional information, a new five-batch analysis, with all batches from 

production level, must be submitted to the Agency. 

May 1, 2011 

26 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Study Type Required Data/Information Due Date 

Manufacturing Process 

(OCSPP Guideline 

885.1200) 

The original manufacturing process did not describe quality control 

measures taken to confirm that Pasteuria usgae was the only Pasteuria 

species present in the master stock. A follow-up explanation, which 

demonstrated that batches are screened for the presence of other microbes 

and screened against sting nematodes to confirm the presence of 

Pasteuria usgae, still did not provide sufficient information to indicate 

that screening for other Pasteuria species is conducted during the 

manufacturing process. Other Pasteuria species, specifically those that 

parasitize saprophytic (non-plant pathogenic) nematodes, must be 

screened for during the manufacturing process. Pasteuria Bioscience, 

Incorporated must integrate quality control measures that screen for 

Pasteuria species that parasitize saprophytic nematodes, either 

immediately after freezing or after making seed stock, into their current 

manufacturing process and provide a written description of these 

measures to the Agency. 

This information was submitted by Pasteuria Bioscience, 

Incorporated (MRID No. 478853-01) in a timely manner and is 

currently being reviewed for acceptability. 

October 1, 2009 

Product Identity (OCSPP 

Guideline 885.1100) 

Currently, full recognition of Pasteuria usgae as a species is still pending 

with the Judicial Commission of the International Committee for 

Systematic Bacteriology. Once Pasteuria usgae has been recognized and 

removed from the category Candidatus, documentation indicating official 

recognition must be provided to the Agency. 

As soon as the 

specified 

information becomes 

available 

Storage Stability (OCSPP 

Guideline 830.6317) 

The storage stability study for the technical grade of the active ingredient 

(TGAI)/manufacturing-use product (MP) has been cited as ongoing. 

When the study has been completed and the results have been compiled, 

these data must be submitted to the Agency. Within the discussion of 

these results, the test substance must be described to ensure that this data 

requirement has been fulfilled for both the TGAI and the MP (i.e., 

reference that the TGAI is equivalent to the MP for Pasteuria usgae – 

BL1). 

This information was submitted by Pasteuria Bioscience, 

Incorporated (MRID No. 479672-01) in a timely manner and is 

currently being reviewed for acceptability.

June 1, 2010 

 

 

27 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

2. EconemTM (EPA Registration Number 85004-2)

The Agency evaluated the data submitted in connection with the initial registration of the 

end-use product, EconemTM, containing Pasteuria usgae. Although it was determined 

that these data fulfill current requirements for a conditional, time-limited FIFRA section 

3(c)(7)(A) registration, the Agency required Pasteuria Bioscience, Incorporated to both 

submit/cite all data required to support Pasteuria usgae – BL1 (as outlined in its 

associated registration notice) and submit the following additional data and/or 

information in the time frames listed: 

Study Type Required Data/Information Due Date 

Analysis of Samples 

(OCSPP Guideline 

885.1400) 

The preliminary analysis of samples provided to the Agency revealed a 

wide range of concentrations of Pasteuria usgae spores. A new fivebatch analysis, with all batches from production level, must be submitted 

to the Agency. 

August 1, 2011 

Storage Stability (OCSPP 

Guideline 830.6317) 

The storage stability study for this end-use product has been cited as 

ongoing. When the study has been completed and the results have been 

compiled, these data must be submitted to the Agency. 

This information was submitted by Pasteuria Bioscience, 

Incorporated (MRID No. 480262-01) in a timely manner and is 

currently being reviewed for acceptability.

September 1, 2010 

Corrosion Characteristics 

(OCSPP Guideline 

830.6320) 

The corrosion characteristics study for this end-use product has been 

cited as ongoing. When the study has been completed and the results 

have been compiled, these data must be submitted to the Agency. 

This information was submitted by Pasteuria Bioscience, 

Incorporated (MRID No. 480262-02) in a timely manner and is 

currently being reviewed for acceptability.

September 1, 2010 

 

28 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

3. Pasteuria usgae – Liquid Formulation (EPA Registration Number 85004-3) 

The Agency evaluated the data submitted in connection with the initial registration of the 

end-use product, Pasteuria usgae – Liquid Formulation, containing Pasteuria usgae. 

Although it was determined that these data fulfill current requirements for a conditional, 

time-limited FIFRA section 3(c)(7)(A) registration, the Agency required Pasteuria 

Bioscience, Incorporated to both submit/cite all data required to support Pasteuria usgae

– BL1 (as outlined in its associated registration notice) and submit the following 

additional data and/or information in the time frames listed: 

Study Type Required Data/Information Due Date 

Storage Stability (OCSPP 

Guideline 830.6317) 

The storage stability study for this end-use product has been cited as 

ongoing. When the study has been completed and the results have been 

compiled, these data must be submitted to the Agency. 

June 18, 2011 

Corrosion Characteristics 

(OCSPP Guideline 

830.6320) 

The corrosion characteristics study for this end-use product has been 

cited as ongoing. When the study has been completed and the results 

have been compiled, these data must be submitted to the Agency. 

June 18, 2011 

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 the Agency as a 

requirement for maintaining the federal registration for a pesticide product. A brief 

summary of these types of data are described below. 

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

Agency 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 the Agency under the provisions of 40 CFR § 158.2140(d). 

29 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 

BRAD Biopesticides Registration Action Document 

CFR Code of Federal Regulations 

CSF Confidential Statement of Formula 

cSt CentiStokes 

°C degrees Celsius 

EDSP Endocrine Disruptor Screening Program 

EPA Environmental Protection Agency (the “Agency”) 

FFDCA Federal Food, Drug, and Cosmetic Act 

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act 

FQPA Food Quality Protection Act 

FR Federal Register 

g/cm3 grams per cubic centimeter 

LD50 median lethal dose. A statistically derived single dose that can be expected 

 to cause death in 50% of the test animals when administered by the route 

 indicated (oral, dermal, or inhalation). It is expressed as a weight of 

 substance per unit weight of animal (e.g., mg/kg). 

mg/kg milligrams per kilogram 

mL milliliter 

MP manufacturing-use product 

MPCA microbial pest control agent 

MRID No. Master Record Identification Number 

NE “No Effect” 

NIOSH National Institute for Occupational Safety and Health 

OCSPP Office of Chemical Safety and Pollution Prevention 

OPP Office of Pesticide Programs 

PC Code Pesticide Chemical Code 

PCR polymerase chain reaction 

PP Pesticide Petition 

PPE personal protective equipment 

TGAI technical grade of the active ingredient 

30 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

X. BIBLIOGRAPHY 

A. Studies Submitted to Support the Pasteuria usgae Pesticide Product 

 Registrations 

474267-01 MacIntosh S, Smith K. 2008. Product Identity: Pasteuria usgae Spores- 

 Liquid Suspension. Project Number: PBI-2008-001. Unpublished report 

 prepared by Pasteuria Bioscience, Incorporated and MacIntosh & 

 Associates, Incorporated, 17 pages. 

474267-02 Smith K. 2008. Manufacturing Process for Pasteuria usgae – Liquid 

 Suspension. Project Number: PBI-2008-003. Unpublished report prepared 

 by Pasteuria Bioscience, Incorporated, 17 pages. 

474267-03 MacIntosh S. 2008. Discussion of Formation of Unintentional Ingredients 

 (Pasteuria usgae). Project Number: RES-32244301-0, 11467-07. 

 Unpublished report prepared by Pasteuria Bioscience, Incorporated, 

 17 pages. 

474267-04 Smith K. 2008. Analysis of Samples/Enforcement Methods for Pasteuria 

 usgae Spores – Liquid Suspension. Unpublished report prepared by 

 Pasteuria Bioscience, Incorporated, 77 pages. 

474267-05 Smith K. 2008. Certification of Limits for Pasteuria usgae – Liquid 

 Suspension. Project Number: PBI-2008-004. Unpublished report prepared 

 by Pasteuria Bioscience, Incorporated, 13 pages. 

474267-06 Kaminsky M. 2008. Pasteuria usgae Spores – Liquid Suspension (TGAI): 

 Final Report. Project Number: 11565-08. Unpublished report prepared by 

 Stillmeadow, Incorporated, 17 pages. 

474267-07 Smith K. 2008. Product Stability to Elevated Temperatures (Pasteuria 

 usgae). Project Number: PBI-2008-005. Unpublished report prepared by 

 Pasteuria Bioscience, Incorporated, 8 pages. 

474267-08 Smith K. 2008. Interim Report: Storage Stability (Pasteuria usgae). 

 Project Number: PBI-2008-006. Unpublished report prepared by Pasteuria 

 Bioscience, Incorporated, 8 pages. 

474267-09 Crutchfield V. 2008. Acute Oral Toxicity/Pathogenicity Study in Rats 

 (MPCA): Pasteuria usgae Spores – Liquid Suspension: Final Report. 

 Project Number: 11463-07. Unpublished report prepared by Stillmeadow, 

 Incorporated, 15 pages. 

31 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

474267-10 Crutchfield V. 2008 Acute Pulmonary Toxicity/Pathogenicity Study in 

 Rats (MPCA): Pasteuria usgae Spores – Liquid Suspension: Final Report. 

 Project Number: 11465-07. Unpublished report prepared by Stillmeadow, 

 Incorporated, 15 pages. 

474267-11 Crutchfield V. 2008. Acute Injection Toxicity/Pathogenicity Study in Rats 

 (MPCA): Pasteuria usgae Spores – Liquid Suspension: Final Report. 

 Project Number: 11466-07. Unpublished report prepared by Stillmeadow, 

 Incorporated, 12 pages. 

474267-12 Crutchfield V. 2008. Acute Dermal Toxicity/Pathogenicity Study in Rats 

 (MPCA): Pasteuria usgae Spores – Liquid Suspension: Final Report. 

 Project Number: 11464-07. Unpublished report prepared by Stillmeadow, 

 Incorporated, 12 pages. 

474267-13 MacIntosh S, Smith K, Hewlett T. 2008. Request for Waivers from the 

 Requirement to Conduct Guideline Studies: Avian Oral Toxicity, 

 Freshwater Fish Toxicity/Pathogenicity, Freshwater Invertebrate Toxicity/ 

 Pathogenicity, Non-Target Insect Testing, and Honey Bee Testing 

 (Pasteuria usgae). Project Number: PBI-2008-002. Unpublished report 

 prepared by Pasteuria Bioscience, Incorporated, 29 pages. 

474267-14 Pasteuria Bioscience, Incorporated. 2008. Copies of Publications 

 (Pasteuria usgae). Unpublished report prepared by Pasteuria Bioscience, 

 Incorporated, 334 pages. 

474350-01 MacIntosh S. 2008. Request for Waivers from the Requirement to 

 Conduct Physical and Chemical Characteristics Guideline Studies: 

 Corrosion Characteristics – 830.6320 and Viscosity – 830.1700. Project 

 Number: PBI-2008-008. Unpublished report prepared by MacIntosh & 

 Associates, Incorporated, 43 pages. 

474350-02 MacIntosh S. 2008. Hypersensitivity Incidents – 885.3400. Project 

 Number: PBI-2008-009. Unpublished report prepared by MacIntosh & 

 Associates, Incorporated, 7 pages. 

474350-03 MacIntosh S. 2008. Request for Waivers from the Requirement to 

 Conduct Toxicology Guideline Studies: Acute Eye Irritation – 870.2400 

 and Primary Dermal Irritation – 870.2500. Project Number: 

 PBI-2008-007. Unpublished report prepared by Pasteuria Bioscience, 

 Incorporated, 8 pages. 

32 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

474979-01 MacIntosh S. 2008. Request for Waivers from the Requirement to 

 Conduct Toxicology Guideline Studies: Acute Oral Toxicity – 870.1100, 

 Acute Dermal Toxicity – 870.1200, and Acute Inhalation Toxicity – 

 870.1300. Project Number: PBI-2008-012. Unpublished report prepared 

 by MacIntosh & Associates, Incorporated, 9 pages. 

475218-01 MacIntosh S, Smith K. 2008. Product Identity and Manufacturing Process: 

 Pasteuria usgae – Dry Granule. Project Number: PBI-2008-011. 

 Unpublished report prepared by Pasteuria Bioscience, Incorporated and 

 MacIntosh & Associates, Incorporated, 9 pages. 

475218-02 MacIntosh S. 2008. Discussion of Formation of Unintentional Ingredients. 

 Unpublished report prepared by MacIntosh & Associates, Incorporated, 

 9 pages. 

475218-04 Smith K. 2008. Certification of Limits for Pasteuria usgae – Clay 

 Granule. Project Number: PBI-2008-013. Unpublished report prepared by 

 MacIntosh & Associates, Incorporated, 8 pages. 

475218-05 Smith K. 2008. Interim Report (2): Storage Stability – Pasteuria usgae. 

 Project Number: PBI-2008-014. Unpublished report prepared by Pasteuria 

 Bioscience, Incorporated, 8 pages. 

475218-06 MacIntosh S. 2008. Interim Report: Corrosion Characteristics for 

 Pasteuria usgae Spores – Clay Granule (EP). Project Number: 12008-08. 

 Unpublished report prepared by Pasteuria Bioscience, Incorporated, 

 10 pages. 

475218-07 MacIntosh S. 2008. Hypersensitivity Incidents: Pasteuria usgae. Project 

 Number: PBI-2008-010. Unpublished report prepared by MacIntosh & 

 Associates, Incorporated, 7 pages. 

475218-08 Kuhn J. 2008. Acute Eye Irritation Study in Rabbits: Pasteuria usgae 

 Spores – Clay Granule (End-Use Product): Final Report. Project Number: 

 12011-08. Unpublished report prepared by Stillmeadow, Incorporated, 

 16 pages. 

475218-09 Kuhn J. 2008. Acute Dermal Irritation Study in Rabbits: Pasteuria usgae 

 Spores – Clay Granule (End-Use Product): Final Report. Project Number: 

 12012-08. Unpublished report prepared by Stillmeadow, Incorporated, 

 11 pages. 

33 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

475218-10 MacIntosh S. 2008. Request for Waivers from the Requirement to 

 Conduct Toxicology Guideline Studies: Acute Oral Toxicity, Acute 

 Dermal Toxicity, and Acute Inhalation Toxicity for Pasteuria usgae 

 Spores – Clay Granule (EP). Project Number: PBI-2008-015. Unpublished 

 report prepared by MacIntosh & Associates, Incorporated, 9 pages. 

475375-01 Smith K. 2008. Analysis of Samples/Enforcement Methods for Pasteuria

 usgae Spores – Clay Granule. Unpublished report prepared by Pasteuria 

 Bioscience, 20 pages. 

475963-01 MacIntosh S, Smith K. 2008. Product Identity and Manufacturing Process: 

 Pasteuria usgae – Liquid Formulation. Project Number: PBI-2008-017. 

 Unpublished report prepared by Pasteuria Bioscience, Incorporated and 

 MacIntosh & Associates, Incorporated, 17 pages. 

475963-03 Smith K. 2008. Analysis of Samples/Enforcement Methods for Pasteuria 

 usgae – Liquid Formulation. Unpublished report prepared by Pasteuria 

 Bioscience, Incorporated, 28 pages. 

475963-04 Smith K. 2008. Certification of Limits for Pasteuria usgae – Liquid 

 Formulation. Project Number: PBI-2008-020. Unpublished report 

 prepared by Pasteuria Bioscience, Incorporated, 8 pages. 

475963-05 MacIntosh S. 2008. Request for Waivers from the Requirement to 

 Conduct Physical and Chemical Characterization Guideline Studies: 

 Storage Stability – 830.6317, Corrosion Characteristics – 830.6320, and 

 Viscosity – 830.7100 for Pasteuria usgae – Liquid Formulation (EP). 

 Project Number: PBI-2008-021. Unpublished report prepared by 

 MacIntosh & Associates, Incorporated, 9 pages. 

475963-06 MacIntosh S. 2008. Hypersensitivity Incidents – 885.3400 for Pasteuria 

 usgae – Liquid Formulation. Project Number: PBI-2008-018. Unpublished 

 report prepared by MacIntosh & Associates, Incorporated, 7 pages. 

475963-07 MacIntosh S. 2008. Request for Waivers from the Requirement to 

 Conduct Toxicology Guideline Studies: Acute Oral Toxicity – 870.1100, 

 Acute Dermal Toxicity – 870.1200, and Acute Inhalation Toxicity – 

 870.1300 for Pasteuria usgae – Liquid Formulation (EP). Project Number: 

 PBI-2008-019. Unpublished report prepared by MacIntosh & Associates, 

 Incorporated, 9 pages. 

34 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

475963-08 MacIntosh S. 2008. Request for Waivers from the Requirement to 

 Conduct Toxicology Guideline Studies: Acute Eye Irritation Study – 

 870.2400 and Primary Dermal Irritation Study – 870.2500 for Pasteuria 

 usgae – Liquid Formulation (EP). Project Number: PBI-2008-021. 

 Unpublished report prepared by MacIntosh & Associates, Incorporated, 

 8 pages. 

476054-01 MacIntosh S. 2008. Discussion of Formation of Unintentional Ingredients: 

 Pasteuria usgae – Liquid Formulation. Unpublished report prepared by 

 MacIntosh & Associates, Incorporated, 8 pages. 

476504-01 Harder J. 2009. Safety Study of Pasteuria usgae Liquid Formulation (EP) 

 in Mice. Project Number: 2229-001. Unpublished report prepared by IIT 

 Research Institute, 32 pages. 

476504-02 Kaminsky M. 2008. Pasteuria usgae Liquid Formulation: Product 

 Chemistry – Final Report. Project Number: 12492-08. Unpublished report 

 prepared by Stillmeadow, Incorporated, 10 pages. 

476504-03 Smith K. 2009. Storage Stability: Interim Report – Pasteuria usgae – 

 Liquid Formulation. Project Number: PBI-2009-001. Unpublished report 

 prepared by Pasteuria Bioscience, Incorporated, 9 pages. 

476504-04 MacIntosh S. 2009. Interim Report: Corrosion Characteristics for 

 Pasteuria usgae – Liquid Formulation (EP). Project Number: 12432-08. 

 Unpublished report prepared by MacIntosh & Associates, Incorporated, 

 10 pages. 

476504-05 Harder J. 2009. Acute Eye Irritation Study of Pasteuria usgae Liquid 

 Formulation (EP) in Rabbits. Project Number: 2229-001. Unpublished 

 report prepared by IIT Research Institute, 27 pages. 

476504-06 Harder J. 2009. Acute Dermal Irritation Study of Pasteuria usgae Liquid 

 Formulation (EP) in Rabbits. Project Number: 2229-001. Unpublished 

 report prepared by IIT Research Institute, 25 pages. 

478853-01 Smith K. 2009. SOP for Manufacturing Quality Control of Pasteuria 

 usgae – Liquid Suspension. Project Number: PBI-01-2009. Unpublished 

 report prepared by Pasteuria Bioscience, Incorporated, 6 pages. 

479672-01 Smith K. 2009. Storage Stability for Pasteuria usgae – Liquid Suspension 

 (TGAI/MP): Final Report. Project Number: PBI-2008-006. Unpublished 

 report prepared by Pasteuria Bioscience, Incorporated, 8 pages. 

35 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

480262-01 Smith K. 2010. Storage Stability for Pasteuria usgae – Clay Granule (EP): 

 Final Report. Project Number: PBI-2008-003. Unpublished 

 report prepared by Pasteuria Bioscience, Incorporated, 8 pages. 

480262-02 Kaminsky M. 2009. Pasteuria usgae Spores – Clay Granule (EP): 

 Corrosion Characteristics: Final Report. Project Number: 12008-08. 

 Unpublished report prepared by Stillmeadow, Incorporated, 12 pages. 

B. Environmental Protection Agency Risk Assessment Memoranda 

U.S. EPA. 2009a. Environmental Risk Assessment of Pasteuria usgae 

 (PC 006545) for Section 3 Registrations of the Technical Product 

 (Pasteuria usgae Spores – Liquid Suspension; EPA File Symbol 85004-R) 

 and End-Use Products (Pasteuria usgae Spores – Clay Granule, EPA File 

 Symbol 85004-E; Pasteuria usgae – Liquid Formulation, EPA File Symbol 

 85004-G), for Control of Sting Nematodes in Turf and Strawberries. 

 Memorandum from S. Borges and Z. Vaituzis, Ph.D. to J. Kausch dated 

 April 8, 2009. 

U.S. EPA. 2009b. Review of Product Chemistry and Human Health Studies 

 for Pasteuria usgae (AF254387) – Liquid Suspension to Support the Registration 

 of Technical Grade Active Ingredient (EPA Reg. No. 85004-R). Memorandum 

 from S. Schüssel and J.L. Kough, Ph.D. to J. Kausch dated April 9, 2009. 

U.S. EPA. 2009c. Review of Product Chemistry and Human Health Studies for Pasteuria 

 usgae – Liquid Formulation and Clay Granule to Support Request for 

 Experimental Use Permits (EPA Reg. No. 85004-EUP-1) – Pasteuria Biosciences. 

 Memorandum from S. Schüssel and J.L. Kough, Ph.D. to J. Kausch dated 

 August 5, 2009. 

U.S. EPA. 2009d. Review of Product Chemistry and Human Health Studies for Pasteuria 

 usgae – Clay Granule (EPA Reg. No. 85004-E) – Pasteuria Biosciences. 

 Memorandum from S. Schüssel and J.L. Kough, Ph.D. to J. Kausch dated 

 August 27, 2009. 

U.S. EPA. 2010. Review of Additional Product Chemistry and Human Health Data for 

 Tolerance Petition for Pasteuria usgae – Liquid Formulation (EPA Reg. No. 

 85004-G) – Pasteuria Biosciences. Memorandum from S. Schüssel and 

 J.L. Kough, Ph.D. to J. Kausch dated February 25, 2010. 

C. Other References 

Bekal S, Borneman J, Springer MS, Giblin-Davis RM, Becker JO. 2001. Phenotypic and 

 molecular analysis of a Pasteuria strain parasitic to the sting nematode. 

 Journal of Nematology 33:110–115. 

36 
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Biopesticides Registration Action Document (BRAD) November 2010 

Chen ZX, Dickson DW. 1998. Review of Pasteuria penetrans: biology, ecology, and 

 biological control potential. Journal of Nematology 30:313–340. 

Ciancio A, Queneherve P. 2000. Populations dynamics of Meloidogyne incognita and 

 infestation levels by Pasteuria penetrans in a naturally infested field in 

 Martinique. Nematropica 30:77–86. 

Darban DA, Pathan MA, Bhatti AG, Maitelo SA. 2005. The effect of different initial 

 densities of nematode (Meloidogyne javanica) on the build-up of Pasteuria 

 penetrans population. Journal of Zhejiang University 6B:113–118. 

Ebert D, Rainey P, Embley TM, Scholz D. 1996. Development, life cycle, ultrastructure, 

 and phylogenetic position of Pasteuria ramosa Metchnikoff 1888: rediscovery of 

 an obligate endoparasite of Daphnia magna Straus. Philosophical Transactions 

 of the Royal Society of London Series B 351:1689–1701. 

Giblin-Davis RM, Williams DS, Wergin WP, Dickson DW, Hewlett TE, Bekal S, Becker 

 JO. 2001. Ultrastructure and development of Pasteuria sp. (S-1 strain), an 

 obligate endoparasite of Belonolaimus longicaudatus (Nemata: Tyenchida). 

 Journal of Nematology 33:227–238. 

Giblin-Davis RM, Williams DS, Bekal S, Dickson DW, Brito JA, Becker JO, Preston JF. 

 2003. ‘Candidatus Pasteuria usgae’ sp. Nov., an obligate endoparasite of the 

 phytoparasitic nematode, Belonolaimus longicaudatus. International Journal of 

 Systematic and Evolutionary Microbiology 53:197–200. 

 

Hewlett TE, Cox R, Dickson DW, Dunn RA. 1994. Occurrence of Pasteuria spp. in 

 Florida. Journal of Nematology 26:616–619. 

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Biopesticides Registration Action Document (BRAD) November 2010 

APPENDIX A – MICROBIAL PESTICIDE DATA REQUIREMENTS 

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

 Manufacturing-Use Product (MP), Pasteuria usgae – BL1 (40 CFR § 158.2120)

Data Requirement Results 

 (OCSPP Guideline) TGAI MP 

MRID 

Number 

Product Chemistry and Composition 

Product Identity 

 (885.1100) 

Not applicable 

Pasteuria usgae is host-specific to 

the sting nematode (Belonolaimus 

longicaudatus), which can be 

damaging to a variety of crops 

such as turf and strawberry. The 

active agent of Pasteuria usgae is 

an endospore that attaches to and 

infects the host nematode during 

all life stages (except eggs). The 

endospores formed inside the host 

are released into the soil when the 

infected nematode decomposes. 

The spores are nonmotile and 

stable in the soil environment for 

several years. 

Classification: Acceptable. 

Currently, full recognition of 

Pasteuria usgae as a species is 

still pending with the Judicial 

Commission of the International 

Committee for Systematic 

Bacteriology. Once Pasteuria 

usgae has been recognized and 

removed from the category 

Candidatus, documentation 

indicating official recognition 

must be provided to the Agency. 

474267-01 

Manufacturing Process 

(885.1200) 

Submitted data satisfied the requirement of manufacturing process 

for the TGAI/MP for the purposes of a conditional, time-limited 

FIFRA section 3(c)(7)(C) registration. 

Classification: Supplemental: Upgradeable. Pasteuria 

Bioscience, Incorporated was required to integrate quality 

control measures that screen for Pasteuria species that 

parasitize saprophytic nematodes, either immediately after 

freezing or after making seed stock, into their current 

manufacturing process and provide a written description of 

these measures to the Agency on or before October 1, 2009. 

This information has been provided to the Agency (MRID No. 

478853-01) and is being reviewed for acceptability. 

474267-02 

Deposition of a Sample in a 

Nationally Recognized 

Culture Collection 

(Not applicable) 

Pasteuria usgae is on 

deposit with the American 

Type Culture Collection in 

Manassas, Virginia under 

Accession Number SD5835. 

Not applicable Not applicable 

38 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement Results 

 (OCSPP Guideline) TGAI MP 

MRID 

Number 

Discussion of Formation of 

Unintentional Ingredients 

(885.1300) 

Submitted data satisfied the requirement of discussion of 

formation of unintentional ingredients for the TGAI/MP. 

Classification: Acceptable 

474267-03 

Analysis and Certified Limits 

Analysis of Samples 

(885.1400) 

Submitted data satisfied the requirement of analysis of samples for 

the TGAI/MP for the purposes of a conditional, time-limited 

FIFRA section 3(c)(7)(C) registration. 

Classification: Unacceptable. A new five-batch analysis, with 

all batches from production level, must be submitted to the 

Agency on or before May 1, 2011. 

474267-04 

Certification of Limits 

(885.1500) 

Not applicable 

The certified limits for the 

active and inert ingredients fell 

within the OCSPP Guideline 

830.1750 specified ranges. 

Classification: Acceptable 

474267-05 

Physical and Chemical Characteristics 

Color 

(830.6302) 

Clear to very faint yellowbrown or cloudy at 24°C (5 

batches) 

Not applicable 474267-06 

Physical State 

(830.6303) 

Liquid at 20°C Not applicable 474267-06 

Odor 

(830.6304) 

No odor Not applicable 474267-06 

Stability to Normal and 

Elevated Temperatures, 

Metals, and Metal Ions 

(830.6313) 

Stable after exposure to 

54°C for 14 days.

Not applicable 474267-07 

Storage Stability 

(830.6317) 

Preliminary results indicated that after 1 month of storage at 4°C, 

the TGAI/MP had a 5% loss of attachment and a 15% loss of 

infectivity. 

Pasteuria Bioscience, Incorporated was required to submit the 

final storage stability study to the Agency on or before June 1, 

2010. This information has been provided to the Agency 

(MRID No. 479672-01) and is being reviewed for acceptability.

474267-08 

Miscibility 

(830.6319) 

Not applicable 

Not required because Pasteuria 

usgae – BL1 is not an emulsifiable 

form of microbial pesticide (refer 

to test note #2 of 40 CFR § 

158.2120(d)). 

Not applicable 

Corrosion Characteristics 

(830.6320) 

Not applicable 

Waived because Pasteuria usgae – 

BL1 will be packaged for very 

short time periods in plastic as it 

moves from the manufacturing 

facility to the formulation facility 

for end-use products. There will be 

no long-term exposure to the 

packaging. 

Classification: Acceptable 

474350-01 

pH 

(830.7000) 

6.80–6.96 (5 batches)* 

6–7.3** 

Not applicable 474267-06* 

CSF** 

39 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement Results 

 (OCSPP Guideline) TGAI MP 

MRID 

Number 

Viscosity 

(830.7100) 

Not applicable 

Waived because Pasteuria usgae – 

BL1 is not viscous and will not be 

applied as a product. There will be 

no environmental exposure. 

Classification: Acceptable 

474350-01 

Density/Relative Density/Bulk 

Density (Specific Gravity) 

(830.7300) 

Specific gravity = 1.006–

1.008 gram/cubic centimeter 

(g/cm3

) (5 batches)* 

Specific gravity = 1.0 

g/cm3

** 

Not applicable 474267-06* 

CSF** 

TABLE 2. Product Analysis Data Requirements for the End-Use Products, EconemTM and Pasteuria usgae – 

 Liquid Formulation (40 CFR § 158.2120) 

Data Requirement Results 

 (OCSPP Guideline) EconemTM* Pasteuria usgae – Liquid 

Formulation** 

MRID 

Number 

Product Chemistry and Composition 

Product Identity 

 (885.1100) 

EconemTM is an end-use 

product and a natural 

biological control for use on 

turf against sting nematodes. It 

contains 0.0020% Pasteuria 

usgae (at least 1 x 104

 spores 

per gram or 4.5 x 106

 spores 

per pound). 

Classification: Acceptable

Pasteuria usgae – Liquid 

Formulation is proposed as an 

end-use product, which will be 

used to control sting nematodes 

in turf and strawberry. It 

contains 0.0033% Pasteuria 

usgae (at least 1.3 x 107

 spores 

per gram or 5.8 x 109

 spores per 

pound). Currently, Pasteuria 

usgae has an exemption from the 

requirement of a tolerance for all 

food commodities (40 CFR § 

180.1290), while all inert 

ingredients in this formulation 

are cleared for food use under 40 

CFR part 180, subpart D 

(“Exemptions from 

Tolerances”). 

Classification: Acceptable 

 

 475218-01* 

 475963-01** 

Manufacturing Process 

(885.1200) 

Submitted data satisfied the 

requirement of manufacturing 

process for this end-use 

product. 

Classification: Acceptable 

Submitted data satisfied the 

requirement of manufacturing 

process for this end-use product. 

Classification: Acceptable 

 475218-01* 

 475963-01** 

Deposition of a Sample in a 

Nationally Recognized 

Culture Collection 

(Not applicable) 

Not applicable Not applicable 

40 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement Results 

 (OCSPP Guideline) EconemTM* Pasteuria usgae – Liquid 

Formulation** 

MRID 

Number 

Discussion of Formation of 

Unintentional Ingredients 

(885.1300) 

Submitted data satisfied the 

requirement of discussion of 

formation of unintentional 

ingredients for this end-use 

product. 

Classification: Acceptable 

Submitted data satisfied the 

requirement of discussion of 

formation of unintentional 

ingredients for this end-use 

product. 

Classification: Acceptable 

 475218-02* 

 475963-01** 

Analysis and Certified Limits 

Analysis of Samples 

(885.1400) 

Submitted data satisfied the 

requirement of analysis of 

samples for this end-use 

product for the purposes of a 

conditional, time-limited 

FIFRA section 3(c)(7)(A) 

registration only. 

Classification: 

Supplemental: Upgradeable. 

A new five-batch analysis, 

with all batches from 

production level, must be 

submitted to the Agency on 

or before August 1, 2011. 

Submitted data satisfied the 

requirement of analysis of 

samples for this end-use product. 

Classification: Acceptable 

 475375-01* 

 475963-03** 

Certification of Limits 

(885.1500) 

The certified limits for the 

active and inert ingredients 

fell within the OCSPP 

Guideline 830.1750 specified 

ranges. 

Classification: Acceptable 

The certified limits for the active 

and inert ingredients fell within 

the OCSPP Guideline 830.1750 

specified ranges. 

 Classification: Acceptable 

 475218-04* 

 475963-04** 

Physical and Chemical Characteristics 

Color 

(830.6302) 

Not applicable Not applicable 

Physical State 

(830.6303) 

Not applicable Not applicable 

Odor 

(830.6304) 

Not applicable Not applicable 

Stability to Normal and 

Elevated Temperatures, 

Metals, and Metal Ions 

(830.6313) 

Not applicable Not applicable 

Storage Stability 

(830.6317) 

Pasteuria Bioscience, 

Incorporated was required 

to submit the final storage 

stability study to the Agency 

on or before September 1, 

2010. This information has 

been provided to the Agency 

(MRID No. 480262-01) and 

is being reviewed for 

acceptability.

A twelve-month storage 

stability study is ongoing, and 

results must be submitted to 

the Agency upon completion 

(on or before June 18, 2011). 475218-05* 

 476504-03** 

41 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement Results 

 (OCSPP Guideline) EconemTM* Pasteuria usgae – Liquid 

Formulation** 

MRID 

Number 

Miscibility 

(830.6319) 

Not required because 

EconemTM is not an 

emulsifiable form of microbial 

pesticide (refer to test note #2 

of 40 CFR § 158.2120(d)). 

Not required because Pasteuria 

usgae – Liquid Formulation is 

not an emulsifiable form of 

microbial pesticide (refer to test 

note #2 of 40 CFR § 

158.2120(d)). 

Not applicable 

Corrosion Characteristics 

(830.6320) 

The test material was stored at 

20oC. Evaluation of the 

container pieces, regarding 

evidence of corrosion or other 

changes, occurred at months 0, 

3, 6, 9, and 12. 

Pasteuria Bioscience, 

Incorporated was required 

to submit the final corrosion 

characteristics study on or 

before September 1, 2010. 

This information has been 

provided to the Agency 

(MRID No. 480262-02) and 

is being reviewed for 

acceptability. 

A twelve-month corrosion 

characteristics study is 

ongoing, and results must be 

submitted to the Agency upon 

completion (on or before June 

18, 2011). 

 475218-06* 

 476504-04** 

pH 

(830.7000) 

Not applicable Not applicable 

Viscosity 

(830.7100) 

Not required because 

EconemTM is not a liquid form 

of microbial pesticide (refer to 

test note #4 of 40 CFR § 

158.2120(d)). 

15239.66 CentiStokes (cSt) at 

20oC and 2591.34 cSt at 40oC 476504-02** 

Density/Relative Density/Bulk 

Density (Specific Gravity) 

(830.7300) 

Not applicable Not applicable 

TABLE 3. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI)/ 

 Manufacturing-Use Product (MP), Pasteuria usgae – BL1 (40 CFR § 158.2140) 

Data Requirement Results 

(OCSPP Guideline) TGAI MP 

MRID 

Number 

Tier I 

Acute Oral 

Toxicity/Pathogenicity 

(885.3050) 

Not toxic and/or pathogenic to 

rats by oral dose of 1 x 108 

spores/animal. Since microbial 

enumeration was not performed 

because the test material would 

not grow on agar media, the 

infectivity was uncertain. 

However, because the spores are 

highly specific to the sting 

nematode, infectivity is unlikely 

to be a concern. 

Classification: Acceptable 

TOXICITY CATEGORY IV 

Not applicable 474267-09 

42 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement Results 

(OCSPP Guideline) TGAI MP 

MRID 

Number 

Acute Dermal Toxicity 

(885.3100) 

Not toxic to rats when treated 

with 2,000 mg/kg at 108 

spores/mL. The acute dermal 

LD50 was greater than 2,000 

mg/kg for 108

 spores/mL. 

Classification: Acceptable 

TOXICITY CATEGORY IV 

Not applicable 474267-12 

Acute Pulmonary 

Toxicity/Pathogenicity 

(885.3150) 

Not toxic and/or pathogenic to 

rats by pulmonary dose of 1–3 x 

108 spores/animal. Since 

microbial enumeration was not 

performed because the test 

material would not grow on agar 

media, the infectivity was 

uncertain. However, because the 

spores are highly specific to the 

sting nematode, infectivity is 

unlikely to be a concern. 

Classification: Acceptable 

TOXICITY CATEGORY IV 

Not applicable 474267-10 

Acute Injection 

Toxicity/Pathogenicity 

(885.3200) 

Not toxic and/or pathogenic to 

rats by intravenous dose of 1x 

108 spores/animal. Since 

microbial enumeration was not 

performed because the test 

material would not grow on agar 

media, the infectivity was 

uncertain. However, because the 

spores are highly specific to the 

sting nematode, infectivity is 

unlikely to be a concern. 

Classification: Acceptable 

Not applicable 474267-11 

Hypersensitivity Incidents 

(885.3400) 

No hypersensitivity incidents, including immediate-type or 

delayed-type reactions of humans and domestic animals occurring 

during the testing or production of the TGAI/MP, were observed 

by the registrant. Any future hypersensitivity incidents must be 

reported to the Agency. 

474350-02 

Cell Culture 

(885.3500) 

Not required because Pasteuria 

usgae is not a virus (refer to test 

note #4 of 40 CFR § 

158.2140(d)). 

Not applicable Not applicable 

Acute Oral Toxicity 

(870.1100) 

Not applicable Waived based on the results of 

MRID Number 474267-09 and 

because the MP is equivalent 

to the TGAI. 

Classification: Acceptable 

TOXICITY CATEGORY 

IV 

474979-01 

43 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement Results 

(OCSPP Guideline) TGAI MP 

MRID 

Number 

Acute Dermal Toxicity 

(870.1200) 

Not applicable Waived based on the results of 

MRID Number 474267-12 and 

because the MP is equivalent 

to the TGAI. 

Classification: Acceptable 

TOXICITY CATEGORY 

IV 

474979-01 

Acute Inhalation Toxicity 

(870.1300) 

Not applicable Waived based on the results of 

MRID Number 474267-10 and 

because the MP is equivalent 

to the TGAI. 

Classification: Acceptable 

TOXICITY CATEGORY 

IV 

474979-01 

Acute Eye Irritation 

(870.2400) 

Not applicable Waived based on Pasteuria 

usgae’s lack of toxicity in the 

other toxicology studies and 

precautionary statements that 

mitigate potential for worker 

exposure. 

Classification: Acceptable 

TOXICITY CATEGORY 

III 

474350-03 

Primary Dermal Irritation 

(870.2500) 

Not applicable Waived based on the results of 

MRID Number 474267-12 and 

precautionary 

statements/personal protective 

equipment that mitigate 

potential for worker exposure. 

Classification: Acceptable 

TOXICITY CATEGORY 

III 

474350-03 

Tiers II and III 

Not required for Pasteuria usgae based on the lack of acute toxicity/pathogenicity in the Tier I studies. 

 

TABLE 4. Toxicology Data Requirements for the End-Use Products, EconemTM and Pasteuria usgae – Liquid 

 Formulation (40 CFR § 158.2140) 

Data Requirement Results 

(OCSPP Guideline) EconemTM* Pasteuria usgae – Liquid 

Formulation** 

MRID 

Number 

Tier I 

Acute Oral 

Toxicity/Pathogenicity 

(885.3050) 

Not applicable Not applicable 

Acute Dermal Toxicity 

(885.3100) 

Not applicable Not applicable 

Acute Pulmonary 

Toxicity/Pathogenicity 

(885.3150) 

Not applicable Not applicable 

Acute Injection 

Toxicity/Pathogenicity 

(885.3200) 

Not applicable Not applicable 

44 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement Results 

(OCSPP Guideline) EconemTM* Pasteuria usgae – Liquid 

Formulation** 

MRID 

Number 

Hypersensitivity Incidents 

(885.3400) 

No hypersensitivity incidents, including immediate-type or 

delayed-type reactions of humans and domestic animals occurring 

during the testing or production of these end-use products, were 

observed by the registrant. Any future hypersensitivity incidents 

must be reported to the Agency. 

 475218-07* 

 475963-06** 

Cell Culture 

(885.3500) 

Not applicable Not applicable 

Acute Oral Toxicity 

(870.1100) 

Waived based on the results of 

MRID Number 474267-09 and 

because this formulation 

contains inert ingredients, which 

are not of toxicological concern 

and are cleared for food use. 

Classification: Acceptable 

TOXICITY CATEGORY IV

Waived based on the results of 

MRID Number 474267-09 and 

because this formulation 

contains inert ingredients, 

which are not of toxicological 

concern and are cleared for 

food use. 

Classification: Acceptable 

TOXICITY CATEGORY 

IV 

 475218-10* 

 475963-07** 

Acute Dermal Toxicity 

(870.1200) 

Waived based on the results of 

MRID Number 474267-12 and 

because this formulation 

contains inert ingredients, which 

are not of toxicological concern 

and are cleared for food use. 

Classification: Acceptable 

TOXICITY CATEGORY III 

Waived based on the results of 

MRID Number 474267-12 and 

because this formulation 

contains inert ingredients, 

which are not of toxicological 

concern and are cleared for 

food use. 

Classification: Acceptable 

TOXICITY CATEGORY 

III 

 475218-10* 

 475963-07** 

Acute Inhalation Toxicity 

(870.1300) 

Waived based on the results of 

MRID Number 474267-10 and 

because this formulation 

contains inert ingredients, which 

are not of toxicological concern 

and are cleared for food use. 

Classification: Acceptable 

TOXICITY CATEGORY III 

Waived based on the results of 

MRID Number 474267-10 and 

because this formulation 

contains inert ingredients, 

which are not of toxicological 

concern and are cleared for 

food use. 

Classification: Acceptable 

TOXICITY CATEGORY 

III 

 475218-10* 

 475963-07** 

Acute Eye Irritation 

(870.2400) 

EconemTM was moderately 

irritating to the eye based on the 

highest maximum mean total 

score of 37.0, recorded 1 hour 

after test material instillation. 

Classification: Acceptable 

TOXICITY CATEGORY III 

Pasteuria usgae – Liquid 

Formulation was not irritating 

to the eye based on the highest 

maximum mean total score of 

0.0. 

Classification: Acceptable 

TOXICITY CATEGORY 

IV 

 475218-08* 

 476504-05** 

Primary Dermal Irritation 

(870.2500) 

EconemTM was slightly irritating 

to the skin. The Primary 

Irritation Index was 0.1. 

Classification: Acceptable 

TOXICITY CATEGORY IV 

Pasteuria usgae – Liquid 

Formulation was not a dermal 

irritant. The Primary Irritation 

Index was 0.0. 

Classification: Acceptable 

TOXICITY CATEGORY 

IV 

 475218-09* 

 476504-06** 

45 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement Results 

(OCSPP Guideline) EconemTM* Pasteuria usgae – Liquid 

Formulation** 

MRID 

Number 

Tiers II and III 

Not required for Pasteuria usgae based on the lack of acute toxicity/pathogenicity in the Tier I studies. 

Additional Studies

Subcutaneous Injection 

Toxicity 

(Not applicable) 

Not applicable None of the five lots of 

Pasteuria usgae – Liquid 

Formulation induced mortality 

or clinical signs of toxicity in 

mice when injected 

subcutaneously at a 

concentration of 1.0 x 106

spores per animal. 

Classification: Acceptable 

476504-01** 

TABLE 5. Nontarget Organism and Environmental Fate Data Requirements for the Technical Grade of the 

 Active Ingredient (TGAI), Pasteuria usgae (40 CFR § 158.2150) 

Data Requirement 

(OCSPP Guideline)

Results Toxicity 

Category/Description 

MRID 

Number 

Tier I 

Avian Oral Toxicity 

(885.4050) 

Data waiver rationale provided 

sufficient information to determine that 

toxicity/pathogenicity to avian wildlife 

is not expected. 

Classification: Acceptable 

Not applicable 474267-13 

Avian Inhalation 

Toxicity/Pathogenicity 

(885.4100) 

Not required as the nature of the 

microbial pesticide does not indicate 

potential pathogenicity to birds or 

relatedness to any known bird 

pathogens (refer to test note #3 of 40 

CFR § 158.2150(e)). 

Not applicable Not applicable 

Wild Mammal 

Toxicity/Pathogenicity 

(885.4150) 

Tests required by 40 CFR § 158.2140 

were adequate and appropriate for 

assessment of hazards to wild 

mammals (refer to test note #4 of 40 

CFR § 158.2150(e)). 

Classification: Acceptable for wild 

mammal risk assessment 

Testing indicated no 

adverse effects to 

laboratory rats at 1 x 

108 spores/mL when 

dosed orally. 

474267-09 

Freshwater Fish 

Toxicity/Pathogenicity 

(885.4200) 

Pasteuria usgae will not be applied 

directly to water and is not expected to 

enter freshwater environments in 

amounts that are significantly higher 

than naturally occurring concentrations. 

Data waiver rationale provided 

sufficient information to determine that 

toxicity/pathogenicity or substantial 

exposure to freshwater fish is not 

expected. 

Classification: Acceptable 

Not applicable 474267-13 

46 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

Data Requirement 

(OCSPP Guideline)

Results Toxicity 

Category/Description 

MRID 

Number 

Freshwater Invertebrate 

Toxicity/Pathogenicity 

(885.4240) 

Pasteuria usgae will not be applied 

directly to water and is not expected to 

enter freshwater environments in 

amounts that are significantly higher 

than naturally occurring concentrations. 

Data waiver rationale provided 

sufficient information to determine that 

toxicity/pathogenicity or substantial 

exposure to freshwater invertebrates is 

not expected. 

Classification: Acceptable

Not applicable 474267-13 

Estuarine/Marine Fish and 

Invertebrate Testing 

(885.4280) 

Not required because Pasteuria usgae 

will not be applied to water and is not 

expected to enter marine/estuarine 

environments in amounts that are 

significantly higher than naturally 

occurring concentrations (refer to test 

note #6 of 40 CFR § 158.2150(e)). 

Not applicable Not applicable 

Nontarget Plant Testing 

(885.4300) 

Not required because Pasteuria usgae

is not related to known plant pathogens, 

and adverse effects to plants are not 

expected (refer to test note #7 of 40 

CFR § 158.2150(e)). 

Not applicable Not applicable 

Nontarget Insect Testing 

(885.4340) 

Data waiver rationale provided 

sufficient information to determine that 

toxicity/pathogenicity to nontarget 

insects is not expected. 

Classification: Acceptable 

Not applicable 474267-13 

Honey Bee Testing 

(885.4380) 

Data waiver rationale provided 

sufficient information to determine that 

toxicity/pathogenicity to honey bees is 

not expected. 

Classification: Acceptable 

Not applicable 474267-13 

Tiers II, III, and IV 

Not required for Pasteuria usgae based on the acceptability of the waiver rationales provided for Tier I. 

47 
Pasteuria usgae 

Biopesticides Registration Action Document (BRAD) November 2010 

48 

APPENDIX B – PASTEURIA USGAE MANUFACTURING-USE AND END-USE 

PRODUCTS 

EPA 

Registration 

Number 

Registration 

Name 

Percentage 

Active 

Ingredient 

Formulation 

Type 

Use Site(s) Method(s) of 

Application 

Application 

Rate 

Target 

Pest 

85004-1 Pasteuria 

usgae – BL1 

0.01% Technical N/A N/A N/A N/A 

85004-2 EconemTM 0.0020% End Use – 

Granular 

Turf Standard 

ground 

application 

equipment 

(e.g., drop 

spreader) 

2–10 pounds 

of product per 

1,000 square 

feet of turf 

Sting 

nematode 

85004-3 Pasteuria 

usgae – 

Liquid 

Formulation 

0.0033% End Use – 

Liquid 

Turf and 

Strawberry 

Standard 

ground spray 

application 

equipment or 

chemigation 

0.1–5 gallons 

of product per 

100 square 

feet of turf or 

strawberry 

bed 

Sting 

nematode