BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3

Pesticide Chemical (PC) Code: 016456

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

DRAFT – May 8, 2012
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Biopesticides Registration Action Document

TABLE OF CONTENTS

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

II. ACTIVE INGREDIENT OVERVIEW........................................................................................................6

III. REGULATORY BACKGROUND ..............................................................................................................7

A. Applications for Pesticide Product Registration ............................................................................7

B. Food Tolerance Exemption ..............................................................................................................7

IV. RISK ASSESSMENT....................................................................................................................................7

A. Product Analysis Assessment (40 CFR § 158.2120) .......................................................................8

B. Human Health Assessment (40 CFR § 158.2140)...........................................................................8

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

V. ENVIRONMENTAL JUSTICE.................................................................................................................17

VI. RISK MANAGEMENT DECISION..........................................................................................................18

VII. ACTIONS REQUIRED OF THE REGISTRANT....................................................................................18

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ......................................................................20

IX. BIBLIOGRAPHY .......................................................................................................................................21

A. Studies Submitted to Support the Pasteuria spp. 

 (Rotylenchulus reniformis nemtaode) – Pr3 Pesticide Product Registrations...........................21

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

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

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS............................................................27

APPENDIX B. PESTICIDE PRODUCTS..............................................................................................................35
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Biopesticides Registration Action Document

BIOPESTICIDES REGISTRATION ACTION DOCUMENT TEAM

Office of Pesticide Programs (OPP)

Biopesticides and Pollution Prevention Division

Microbial Pesticides Branch

Science Reviews

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

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

Shannon Borges Environmental Effects

Regulations

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

Jeannine Kausch Regulatory Action Leader
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Biopesticides Registration Action Document

I. EXECUTIVE SUMMARY

In July and August 2010, Pasteuria Bioscience, Inc. submitted applications for a manufacturinguse pesticide product, NAVIVA Tech (EPA File Symbol 85004-U), and two end-use pesticide 

products, NAVIVA ST (EPA File Symbol 85004-L) and NAVIVA LF (EPA File Symbol 85004-

I), to the United States Environmental Protection Agency (EPA) under section 3 of the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA). Concurrently with these applications, 

Pasteuria Bioscience, Inc. filed a petition for a tolerance exemption for residues of Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3, the new active ingredient contained in all three 

proposed pesticide products. 

Background

Pasteuria, a genus of bacteria, includes several species that have shown potential in controlling 

plant-parasitic nematodes that attack and cause significant damage to many valuable agricultural 

crops (see, e.g., the Federal Register of December 28, 1994 (59 Federal Register (FR) 66740), 

June 30, 2010 (75 FR 37734), and February 15, 2012 (77 FR 8736) for Final Rules that 

established tolerance exemptions for residues of the nematicides, Pasteuria penetrans (40 Code 

of Federal Regulations (CFR) 180.1135), Pasteuria usgae (40 CFR 180.1290), and Pasteuria 

nishizawae – Pn1 (40 CFR 180.1311), respectively). These gram-positive, mycelial, endosporeforming bacteria are obligate parasites (i.e., organisms that depend on particular hosts to 

complete their own life cycle) of nematodes and water fleas.1 Pasteuria species are ubiquitous in 

most environments and are found in nematodes in at least 80 countries on 5 continents, as well as 

on islands in the Atlantic, Pacific, and Indian Oceans (Chen and Dickson 1998; Ciancio et al. 

1994; Sturhan 1988). Higher population densities often occur in areas where there is an ample 

supply of nematode hosts (e.g., where crops susceptible to nematodes are cultivated) (Centitas 

and Dickson 2004; Noel 2008; Tain et al. 2007). Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 was specifically isolated from soil samples collected in the southeastern United 

States (U.S.). 

Endospores of Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 attach to Rotylenchulus 

spp. at all life stages, except eggs. After an endospore attaches to the cuticle of a nematode host, 

a germ tube penetrates the cuticle, and growth and sporogenesis begin in the pseudocoelom of the

nematode. The nematode is eventually filled with cells, mycelial hyphae, and sporangia, which 

leads to its death. In light of the demonstrated nematicidal capabilities and host specificity of 

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3, Pasteuria Bioscience, Inc. has 

proposed to register pesticide products intended for use on several food and nonfood crops, 

primarily as seed or soil treatments, to control the reniform nematode (Rotylenchulus reniformis).

EPA scientists reviewed product analysis, toxicology, and nontarget organism data and 

information (40 CFR §§ 158.2120, 158.2140, and 158.2150, respectively) submitted to support 

the registration of the three proposed Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 

pesticide products. Overall, such data and information are adequate for risk assessment purposes, 

fulfill the current microbial pesticide data requirements, and support registration of the proposed 

products under FIFRA section 3(c)(5).

 1 Pasteuria ramosa is the only Pasteuria species that is known to parasitize water fleas; it is not an active 

ingredient in any pesticides.
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For the purposes of FIFRA section 3(c)(5) registration, the product analysis data requirements for 

Pasteuria nishizawae – Pn1, including product chemistry and composition, analysis of samples, 

and physical and chemical characteristics, were fulfilled by acceptable guideline studies.

Product Analysis

Adequate mammalian toxicology data and information were submitted to support the Pasteuria

spp. (Rotylenchulus reniformis nematode) – Pr3 pesticide products. Acute oral, pulmonary, and 

injection toxicity/pathogenicity studies showed that, at a single high dose, Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3 is not toxic and/or pathogenic via these routes of 

exposure. Moreover, the applicant reported that no hypersensitivity incidents occurred during 

research, development, or testing of Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3. 

In light of the results of the acute toxicity/pathogenicity data and the absence of hypersensitivity 

incidents, testing at higher tiers (i.e., Tiers II and III) was not required.

Toxicology

EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, 

including infants and children, from aggregate exposure to residues of Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3. No dietary risks are expected from use of Pasteuria

spp. (Rotylenchulus reniformis nematode) – Pr3 as an active ingredient in pesticide products. 

Significant exposure to Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 through food 

and drinking water is not anticipated due to: (1) the proposed application methods of the end-use 

pesticide products (soil directed, soil incorporated, and/or seed directed; no aquatic applications);

(2) the filtering effect of many particulate soil types; and (3) the conditions (e.g., filtration and 

pH adjustments) water is subjected to in wastewater treatment systems and drinking water 

facilities. Should Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 be present on food 

or in drinking water, its specificity for Rotylenchulus spp. and supporting acute oral toxicity and 

pathogenicity data indicate that human exposure to this bacterium would not result in 

unreasonable adverse effects.

Tolerance Exemption

Despite the low toxicological profile of Pasteuria spp. (Rotylenchulus reniformis nematode) –

Pr3, baseline personal protective equipment (PPE) is required for handlers that may be exposed 

to the active ingredient, due to their occupation, for prolonged periods or numerous times. 

Handlers working with Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 in agricultural 

settings are directed to wear a long-sleeved shirt, long pants, socks, shoes, 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. For future products, EPA may require additional PPE

(e.g., protective eyewear), other than the standard described above, on a product-specific basis. 

Occupational Exposure

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

requests to waive nontarget organism testing for Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 are sufficient to fulfill the relevant microbial pesticide data requirements and for 

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

II, III, and IV) is not required. EPA performed an environmental risk assessment based on data 

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

organisms are not anticipated from the proposed pesticidal uses of Pasteuria spp. (Rotylenchulus 

Nontarget Organisms
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Biopesticides Registration Action Document

reniformis nematode) – Pr3. Moreover, EPA made a “No Effect” determination for direct and 

indirect effects to listed species and their designated critical habitats resulting from these same 

proposed pesticidal uses. 

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate in major registration decisions before they occur. According to this 

policy, EPA 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; or any other registration actions for which EPA believes there 

may be significant public interest.

Public Participation

 

Consistent with the policy of making registration actions more transparent, the proposed 

pesticide products containing Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3, a new 

active ingredient, are subject to a 30-day comment period. In addition to containing a new active 

ingredient, the registration of these pesticide products would result in the first outdoor and food 

uses for Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3. The docket identification 

number, associated with these registration actions and accessed through either 

http://www.regulations.gov or http://www.epa.gov/pesticides/regulating/registration-status.html, 

is EPA-HQ-OPP-2010-0808. The following documents are available for comment in EPA-HQOPP-2010-0808: (1) draft Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 

Biopesticides Registration Action Document (BRAD); (2) environmental risk assessment for 

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3; (3) draft label for the manufacturinguse pesticide product, NAVIVA Tech (EPA File Symbol 85004-U); (4) draft label for the enduse pesticide product, NAVIVA ST (EPA File Symbol 85004-L); and (5) draft label for the enduse pesticide product, NAVIVA LF (EPA File Symbol 85004-I). While a final decision on 

registration is contingent upon review and consideration of public comments, EPA presently 

believes that, based upon the risk assessment and information submitted in support of NAVIVA 

Tech, NAVIVA ST, and NAVIVA LF, it is appropriate to issue these registrations. The basis for 

this preliminary decision can be found in the risk assessment for Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3, which is characterized throughout this BRAD. 

II. ACTIVE INGREDIENT OVERVIEW

Biological Name: Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3

Culture Deposit: American Type Culture Collection in Manassas, Virginia 

under Accession Number SD-5834

OPP Chemical Code: 016456

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 proposed pesticide products containing this

active ingredient.
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III. REGULATORY BACKGROUND

A. Applications for Pesticide Product Registration

In July and August 2010, MacIntosh and Associates, Inc. (address: 1203 Hartford Avenue; Saint 

Paul, Minnesota 55116-1622), on behalf of Pasteuria Bioscience, Inc. (address: 12085 Research 

Drive, Suite 185; Alachua, Florida 32615), submitted applications to register a manufacturinguse pesticide product, NAVIVA Tech (EPA File Symbol 85004-U), and two end-use pesticide 

products, NAVIVA ST (EPA File Symbol 85004-L) and NAVIVA LF (EPA File Symbol 85004-

I), under FIFRA section 3. On November 24, 2010 (75 FR 71697) and February 2, 2011 (76 FR 

5805), EPA announced receipt of these applications to register pesticide products containing a 

new active ingredient and opened a 30-day public comment period pursuant to the provisions of 

FIFRA section 3(c)(4). No comments were received following these publications. 

B. Food Tolerance Exemption

Concurrent with its registration applications and under Federal Food, Drug, and Cosmetic Act 

(FFDCA) section 408(d), MacIntosh and Associates, Inc., on behalf of Pasteuria Bioscience, Inc.,

submitted a petition to establish an exemption from the requirement of a tolerance for Pasteuria

reniformis – Pr3 (now Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3)(Pesticide 

Petition (PP) 0F7745). In the Federal Register of February 4, 2011 (76 FR 6465), EPA

announced that Pasteuria Bioscience, Inc. proposed to establish an exemption from the 

requirement of a tolerance for residues of the microbial pesticide, Pasteuria reniformis – Pr3, in 

or on all raw agricultural crops and opened a 30-day comment period. Two comments were 

received following this publication and are addressed in the preamble to the final rule. 

IV. RISK ASSESSMENT

In the Federal Register of October 26, 2007, EPA issued a Final Rule on the data requirements to 

support registration of microbial pesticides and updated the definition for microbial pesticides 

(72 FR 61002). The rule became effective on December 26, 2007. The data and information 

evaluated for this BRAD were considered in light of these requirements.

The classifications that are found for each data submission are assigned by EPA 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: upgradeable”). If a study is rated as “supplemental: 

upgradeable,” EPA 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 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 must be submitted.
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For the acute toxicity data requirements, Toxicity Categories are assigned based on the 

hazard(s) identified from studies and/or other information submitted to EPA in support of a 

pesticide registration. 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 lowest toxicity (see 40 CFR § 156.62). 

A. Product Analysis Assessment (40 CFR § 158.2120)

For purposes of registration under FIFRA section 3(c)(5), all product analysis data requirements 

for Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 have been fulfilled. Refer to 

Tables 1, 2, 3, and 4 in Appendix A for a summary of the data requirements, including both 

generic and product-specific information.

B. Human Health Assessment (40 CFR § 158.2140)

1. Toxicity

All toxicology data requirements for Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 

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

registration of the Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 pesticide products. 

Furthermore, Tier II and Tier III studies were not required for Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3, based on the lack of acute toxicity/pathogenicity in the Tier I 

studies.

For a summary of the generic toxicology data requirements described in sections IV(B)(1)(a) and 

IV(B)(1)(b) (see pages 8–10), as well as additional product-specific data submitted to support the 

individual registrations, refer to Tables 5 and 6 in Appendix A.

a. Acute Toxicity/Pathogenicity – Tier I

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

Identification Number (MRID No.) 481460-09): Groups of fasted, 45- to 48-day-old CD® rats (3 

per sex per group) were given a single oral dose of Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 at approximately 1.5 x 109 spores per animal. The animals were observed for a 

period of up to 21 days, with interim scheduled sacrifices on Days 7 and 14. Three males and 

three females were treated with autoclaved Pasteuria spp. (Rotylenchulus reniformis nematode) –

Pr3 as controls, three males and three females were untreated shelf controls, and another three 

males and three females were untreated naïve controls. Based on the results of this study, 

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 does not appear to be toxic and/or 

pathogenic in rats when dosed at approximately 1.5 x 109 spores per animal. Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3 showed no clinical signs or major tissue 

abnormalities and no evidence of toxicity or pathogenicity to rats following a single oral 

administration of 1.5 x 109 spores per rat. Although clearance and infectivity were not measured, 

EPA believes these endpoints are not a concern given Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3’s well-established host specificity for Rotylenchulus spp. nematodes. This study 

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

481460-10): Groups of fasted, 45- to 48-day-old CD® rats (3 per sex per group) were exposed by 

the intratracheal route to Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 at a dose of 

approximately 1.5 x 108 spores per animal. The animals were then observed for up to 21 days. 

Three males and three females were treated with autoclaved Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3 as controls, while three males and three females were not treated and 

served as naïve controls. Based on the results of this study, Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3 does not appear to be toxic and/or pathogenic in rats when dosed at 

approximately 1.5 x 108 spores per animal. Pasteuria spp. (Rotylenchulus reniformis nematode) 

– Pr3 showed no clinical signs or major active ingredient-related tissue abnormalities and no 

evidence of toxicity or pathogenicity to rats following a single intratracheal instillation of 1.5 x 

108 spores per rat. Although clearance and infectivity were not measured, EPA believes these 

endpoints are not a concern given Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3’s 

well-established host specificity for Rotylenchulus spp. nematodes. This study was rated 

supplemental.

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

MRID No. 481460-11): Groups of fasted, 45- to 48-day-old CD® rats (3 per sex per group) were 

exposed by the intravenous route to Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 at 

a dose of approximately 1 x 107 spores per animal. The animals were then observed for up to 21 

days. Three males and three females were treated with autoclaved Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3 as controls, while three males and three females were not treated and 

served as naïve controls. Based on the results of this study, Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3 does not appear to be toxic and/or pathogenic in rats when dosed at 

approximately 1 x 107 spores per animal. Pasteuria spp. (Rotylenchulus reniformis nematode) –

Pr3 showed no active ingredient-related clinical signs or major tissue abnormalities and no 

evidence of toxicity or pathogenicity to rats following a single intravenous injection of 1 x 107

spores per rat. Although clearance and infectivity were not measured, EPA believes these 

endpoints are not a concern given Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3’s 

well-established host specificity for Rotylenchulus spp. nematodes. This study was rated 

supplemental.

Hypersensitivity Incidents (Harmonized Guideline 885.3400; MRID No. 481460-12): The 

applicant reported that no hypersensitivity incidents, including immediate-type or delayed-type 

reactions of humans and domestic animals, occurred during research, development, or testing of 

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3. Any future hypersensitivity incidents 

must be reported to EPA (refer to test note #3 of 40 CFR § 158.2140(d)).

Cell Culture (Harmonized Guideline 885.3500): This study is not required because Pasteuria

spp. (Rotylenchulus reniformis nematode) – Pr3 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

Tier II and Tier III studies were not required for Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3, based on the lack of acute toxicity/pathogenicity in the Tier I studies.
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c. Endocrine Disruptors

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a 

“naturally occurring estrogen, or other such endocrine effects as the Administrator may 

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a quantitative relationship between the dose and the E, A, or T effect.

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

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

of chemicals was selected based on the potential for human exposure through pathways such as 

food and water, residential activity, and certain post-application agricultural scenarios. This list 

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

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 is not among the group of 58 pesticide 

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

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

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

For further information on the status of the EDSP, the policies and procedures, the list of 67 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”
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EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide 

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

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

pesticide use in residential settings.

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

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

relationship of this information to human risk. EPA 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 and information discussed previously and 

presented in Tables 5 and 6 in Appendix A, the data required for a FFDCA risk assessment for 

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 have been fulfilled.

a. Aggregate Exposure

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

available information concerning exposures from the pesticide residue in food and all other 

nonoccupational exposures, including drinking water from ground water or surface water and 

exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Food Exposure and Risk Characterization: Dietary exposure to Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3, a naturally occurring soil bacterium, is anticipated to be negligible. 

For optimal control of the target pest, reniform nematode (Rotylenchulus reniformis), Pasteuria

spp. (Rotylenchulus reniformis nematode) – Pr3 is applied in a manner that facilitates spore 

movement into or spore placement near the root zone of potentially affected plants. This requires 

that end users take certain actions, depending on the treatment type, that would inevitably 

minimize the amount of Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 residues on 

aboveground food commodities. That is, although Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 can be applied to soil, plants, or seeds, some seeds are incorporated into the soil

immediately after treatment (at-planting, hopper box, planter box, or slurry box seed treatments)

and pesticide applications made to plants or the soil are always followed by irrigation to 

incorporate Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 into the soil. In instances 

where food commodities develop underground or where treated seed is diverted for food or feed 

purposes or to process into oil, exposure to Pasteuria spp. (Rotylenchulus reniformis nematode) 

– Pr3 residues is a more likely scenario. Should this microbial pesticide be present on food, its 

target pest specificity and available data indicate no toxicity and/or pathogenicity is likely to 

occur with any dietary exposure to Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3

that results from pesticide applications made in accordance with good agricultural practices (see 

section IV(B)(1)(a) on pages 8–9 and Tables 5 and 6 in Appendix A).

Drinking Water Exposure and Risk Characterization: Exposure to residues of Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3 in consumed drinking water is unlikely. The 

proposed use patterns for Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 are soil 

directed and/or soil incorporated, thereby limiting contact with surface water by drift and runoff. 

Furthermore, ground water is not expected to have significant exposure to Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3 since, like other microorganisms, this microbial 
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pesticide would likely be filtered out by the particulate nature of many soil types (Aislabie et al. 

2001; DeFelice et al. 1993; Pang et al. 2008). If Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 were to be transferred to surface or ground waters that are intended for eventual 

human consumption (e.g., through spray drift or runoff) and directed to wastewater treatment 

systems or drinking water facilities, it likely would not survive the conditions water is subjected 

to in such systems or facilities, including chlorination, pH adjustments, filtration, and/or 

occasionally high temperatures (Centers for Disease Control and Prevention 2009; U.S. EPA 

2004). In the remote likelihood that Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 is 

present in drinking water (e.g., water not subject to treatment systems or facilities), its target pest 

specificity and available data indicate no toxicity and/or pathogenicity is likely to occur with any

drinking water exposure to Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 that results 

from pesticide applications made in accordance with good agricultural practices (see section 

IV(B)(1)(a) on pages 8–9 and Tables 5 and 6 in Appendix A).

Non-occupational, Residential Risk Characterization: Given Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3’s natural occurrence in soil, non-occupational exposure to the 

bacterium is likely already occurring. Additional exposure to Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3, due to pesticidal applications, is not expected because the proposed 

pesticide end-use products are intended for use in distinct agricultural settings. Even if additional 

non-occupational exposures were to occur (e.g., eventual expansion of use sites), such exposures 

would not exceed EPA’s level of concern, particularly in light of Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3’s specificity for Rotylenchulus spp. nematodes and available data 

that demonstrated Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 is not toxic (acute 

dermal toxicity and acute pulmonary toxicity/pathogenicity), non-irritating (primary dermal 

irritation), and not pathogenic (acute pulmonary toxicity/pathogenicity) (see section IV(B)(1)(a)

on pages 8–9 and Tables 5 and 6 in Appendix A).

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

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

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

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

mechanism of toxicity.”

EPA has not found Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 to share a common 

mechanism of toxicity with other substances, and Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 does not appear to produce a toxic metabolite against the target pest. For the 

purposes of the tolerance action, therefore, EPA has assumed that Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3 does not have a common mechanism of toxicity with other 

substances. Thus, section 408(b)(2)(D)(v) of the FFDCA does not apply. For information 

regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity 

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

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

c. Determination of Safety for the United States Population, Infants and Children

In considering the establishment of a tolerance or tolerance exemption for a pesticide chemical 

residue, FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information 
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 13 of 35

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

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

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

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

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

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

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

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

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

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

different factor.

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

(see pages 8–9) and Tables 5 and 6 in Appendix A, as well as Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3’s host specificity for Rotylenchulus spp. nematodes, EPA concludes 

that there are no threshold effects of concern to infants, children, or adults when Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3 is used as labeled in accordance with good 

agricultural practices. As a result, EPA concludes that no additional margin of exposure (safety) 

is necessary to protect infants and children and that not adding any additional margin of exposure 

(safety) will be safe for infants and children.

Moreover, based on the same data/information and EPA analysis as presented directly above, the 

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

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

of Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 when it is used—as labeled and in 

accordance with good agricultural practices—as a nematicide. Such exposure includes all 

anticipated dietary exposures and all other exposures for which there is reliable information. EPA 

has arrived at this conclusion because, considered collectively, the data and information available 

on Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 do not demonstrate toxic and/ 

pathogenic potential to mammals, including infants and children. 

3. Occupational Exposure and Risk Characterization

Handler exposure to Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 is not expected to 

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

statements are required on pesticide product labels to mitigate any potential risks to pesticide 

handlers due to prolonged or numerous exposures. Handlers applying Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3 end-use pesticide products in agricultural settings 

must wear a long-sleeved shirt, long pants, socks, shoes, and a dust/mist filtering respirator 

meeting NIOSH standards of at least N-95, R-95, or P-95. For future products, additional PPE

(e.g., protective eyewear), other than the standard described above, may be required on a productspecific basis.

4. Human Health Risk Characterization

EPA considered human exposure to Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 in 

light of the standard for registration in FIFRA and the relevant safety factors in FFDCA. A 

determination has been made that no unreasonable adverse effects to the United States
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 14 of 35

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population in general, and to infants and children in particular, will result when Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3 pesticide products are used in accordance with EPAapproved labeling.

C. Environmental Assessment (40 CFR § 158.2150)

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

requests to waive nontarget organism testing for Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 are sufficient to fulfill the relevant microbial pesticide data requirements and for 

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

II, III, and IV) is not required. EPA performed an environmental risk assessment based on data 

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

organisms are not anticipated from the proposed pesticidal uses of Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3. Moreover, EPA has made a “No Effect” determination for direct and 

indirect effects to listed species and their designated critical habitats resulting from these same 

proposed pesticidal uses. 

For a summary of the generic data requirements described in sections IV(C)(1) (see pages 14–

17), refer to Table 7 in Appendix A.

1. Ecological Exposure and Risk Characterization 

a. Terrestrial Animals and Plants

Birds (Harmonized Guideline 885.4050), Wild Mammals (Harmonized Guideline 885.4150), 

Nontarget Plants (Harmonized Guideline 885.4300), Nontarget Insects (Harmonized Guideline 

885.4340), and Honey Bees (Harmonized Guideline 885.4380) (MRID No. 481460-17): The 

proposed end-use pesticide products are for use on several crops, including food and ornamental 

crops. The liquid formulation end-use pesticide product may be applied by soil-directed spray or 

chemigation, including both soil-directed and foliage-directed (e.g., overhead sprinkler) 

chemigation. Applications are to be followed with a sufficient amount of water to move the 

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 spores into the root zone. Therefore, 

both formulations will primarily deposit Pasteuria spp. (Rotylenchulus reniformis nematode) –

Pr3 into the soil. While this type of application reduces the potential for exposure to many 

nontarget species, exposure to nontarget species consuming, contacting, or living in the soil will 

not necessarily be eliminated.

Data and other information submitted by Pasteuria Bioscience, Inc. to support its waiver requests

provides sufficient information to conclude that adverse effects are not expected in birds, 

nontarget insects, and honey bees as a result of exposure to Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3. Pasteuria spp. are widespread in their distribution throughout the 

world (Chen and Dickson 1998; Ciancio et al. 1994; Sayre and Starr 1985; Sturhan 1988). They 

are known only as parasites of plant-parasitic nematodes, with the exception of Pasteuria ramosa 

that is known only to parasitize Daphnia spp. (Atibalentja et al. 2004; Chen and Dickson 1998;

Sayre et al. 1991). Therefore, Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 is not 

expected to be toxic or pathogenic to birds, nontarget insects, or honey bees if they are exposed 

as a result of the proposed pesticidal applications.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 15 of 35

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An acute oral toxicity/pathogenicity study with laboratory rats (MRID No. 481460-09) and an 

acute oral toxicity study (MRID No. 481460-13) are available to evaluate the potential effects of 

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 on wild mammals. The acute oral 

toxicity/pathogenicity study is summarized in section IV(B)(1)(a) on page 8. No signs of toxic or 

pathogenic effects were observed in that study. The study was determined to be supplemental 

because clearance and infectivity were not observed. The acute oral toxicity study showed no 

evidence of toxicity in rats dosed with 5,000 milligrams per kilogram bodyweight, and this study 

was determined to be acceptable. These studies show that toxicity/pathogenicity of Pasteuria

spp. (Rotylenchulus reniformis nematode) – Pr3 to laboratory rats is not expected. There is no 

reason that the test animals in these studies would not be adequate models with which to 

determine potential effects to wild mammals, so adverse effects to wild mammals are not 

expected as a result of the proposed pesticidal applications of Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3.

Nontarget plant testing is not required because Pasteuria species are not related to any known 

plant pathogen. Adverse effects on plants are not expected to result from the proposed pesticidal 

applications of Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3.

Additionally, there are no reports of toxicity or pathogenicity of Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3 to nontarget terrestrial animals or plants. To support its data waiver 

rationale, the applicant performed a search within the Agricola and PubMed databases, along 

with several biological journals (i.e., Journal of Bacteriology, Applied and Environmental 

Microbiology, FEMS Microbiology Ecology, Soil Biology and Biochemistry) for the period of 

1980–2010. The search was conducted using “Pasteuria” as the search word, and returned no 

reports of acute toxicity data on birds, freshwater fish, freshwater invertebrates, nontarget insects, 

and honey bees. The Biopesticides and Pollution Prevention Division also conducted a search

within the Environmental Information Database that is available to EPA. This database 

simultaneously searches the Agricola, Biosis Previews, CAB Abstracts, Energy Science and 

Technology, General Science Abstracts, and the National Technical Information Service 

literature search databases. The search was performed with the term “Pasteuria” coupled with 

each of the search terms of “bird,” “mammal,” “invertebrate,” “arthropod,” “insect,” “honey 

bee,” “plant pathogen,” and “phytopathogen” for all of the years available (1926–present). No 

unanticipated reports of adverse effects of Pasteuria species in nontarget organisms were found 

in any of these searches.2 Any reports of effects to nontarget organisms related to Pasteuria

species that are found in the future may trigger the need for testing; however, given the 

specificity of these bacteria for their hosts as is currently understood, such reports are not 

expected.

Based on the information above and available data, adverse effects are not expected to occur to 

terrestrial animals or plants as a result of the proposed pesticidal applications of Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3.

 2 Pasteuria ramosa is already recognized as parasitizing water fleas and is not considered an 

“unanticipated” report.
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b. Aquatic Animals and Plants

Freshwater Fish (Harmonized Guideline 885.4200), Freshwater Invertebrates (Harmonized 

Guideline 885.4240), Estuarine/Marine Fish and Invertebrates (Harmonized Guideline 

885.4280), and Nontarget Plants (Harmonized Guideline 885.4300) (MRID No. 481460-17):

Since the proposed applications are intended to deposit Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 in the soil, some runoff of the active ingredient to freshwater and 

marine/estuarine environments is expected. Applications of the liquid formulation and seed 

treatment, however, are intended primarily to put Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 in the root zone of the treated plants, so these amounts are not likely to be 

significant. Pasteuria species are naturally found in soil, so some natural presence of Pasteuria

spp. (Rotylenchulus reniformis nematode) – Pr3 in surface waters is expected. To date, no 

information is available on the size of naturally occurring populations of Pasteuria species. 

Scientific rationale was submitted to fulfill data requirements for and support effects conclusions 

for freshwater aquatic organisms. The rationale provides sufficient information to conclude that 

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

exposure to Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3. The rationale was similar 

to that presented for terrestrial organisms in that Pasteuria species are found in soils worldwide. 

Pasteuria ramosa is a closely related species that parasitizes Daphnia magna and other Daphnia

species (Ebert et al. 1996); however, it is widely understood that all other known Pasteuria

species are obligate parasites of soil-dwelling nematodes (Atibalentja et al. 2004; Chen and 

Dickson 1998; Sayre et al. 1991). 

There are no available reports in the literature documenting pathogenicity or toxicity to 

freshwater fish or invertebrates as a result of exposure to Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3. A search, similar to the one described for terrestrial animals and 

plants, was performed for aquatic animals and plants. In addition to the search terms used for 

terrestrial animals and plants, the terms “fish,” “aquatic,” “freshwater,” “estuarine,” and “marine” 

were also searched. No unanticipated reports of adverse effects of Pasteuria species in nontarget 

organisms were found in any of these searches.3 As noted above, reports of adverse effects that 

may be found in the future may trigger the need for testing; however, none are anticipated due to 

the specificity of Pasteuria species for their nematode hosts.

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

invertebrates, and plants are not expected as a result of exposure to proposed pesticidal 

applications of Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3. 

2. Environmental Fate Data 

As the data and information provided are sufficient to fulfill the Tier I nontarget organism data 

requirements and allow for nontarget organism risk assessment for Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3, further testing at higher tier levels (i.e., Tiers II, III, and IV) is not 

required. 

 3 Pasteuria ramosa is already recognized as parasitizing water fleas and is not considered an 

“unanticipated” report.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 17 of 35

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3. Threatened and Endangered Species Assessment

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

Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 as a result of the proposed 

applications, effects to federally listed threatened and endangered species and their designated 

critical habitats are also not expected. Therefore, a “No Effect” determination is made for direct 

and indirect effects to listed species and their designated critical habitats resulting from the 

proposed pesticidal uses of Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3, as 

labeled.

V. ENVIRONMENTAL JUSTICE

EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of 

all people regardless of race, color, national origin, or income—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. Fair treatment 

means that no group of people, including racial, ethnic, or socioeconomic groups, should bear a 

disproportionate share of the negative environmental consequences resulting from industrial, 

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

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

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

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

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

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

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

across the United States. 

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

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

have atypical, unusually high exposure to Pasteuria spp. (Rotylenchulus reniformis nematode) –

Pr3, compared to the general population. Please comment if you are aware of any subpopulations 

that may have atypical, unusually high exposure compared to the general population.

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

http://www.epa.gov/compliance/environmentaljustice/index.html.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 18 of 35

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VI. RISK MANAGEMENT DECISION

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

following determinations are made:

(1) Its composition is such as to warrant the proposed claims for it;

(2) Its labeling and other material required to be submitted comply with the

 requirements of FIFRA;

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

 the environment; AND

(4) When used in accordance with widespread and commonly recognized 

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

 environment.

To satisfy criterion 1, the Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 pesticide 

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

made on the NAVIVA Tech, NAVIVA ST, and NAVIVA LF labels, and such pesticide products 

are not expected to cause unreasonable adverse effects on the environment when used according 

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

as the data and information presented in this document. It is believed that the Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3 pesticide products will not cause any unreasonable 

adverse effects on the environment, and NAVIVA ST and NAVIVA LF (end-use pesticide 

products), in particular, are likely to provide protection against reniform nematode as claimed, 

satisfying criterion 3. Criterion 4 is satisfied in that the Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 pesticide products are not expected to cause unreasonable adverse effects when 

used according to label instructions. Therefore, NAVIVA Tech, NAVIVA ST, and NAVIVA LF,

containing Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 as a new active ingredient, 

are eligible for registration under FIFRA section 3(c)(5) for the labeled uses. 

VII. ACTIONS REQUIRED OF THE REGISTRANT

A. Final Printed Labeling

Before releasing pesticide products containing Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 for shipment, the registrant is required to provide appropriate final printed 

labeling to EPA.

B. Terms of Registration

As terms of the NAVIVA Tech, NAVIVA ST, and NAVIVA LF registrations, Pasteuria 

Bioscience, Inc. must submit additional information (confirmatory) on the discussion of 

unintentional ingredients (Harmonized Guideline 885.1300) within six months of registration.

Additionally, as a term of the NAVIVA LF registration, Pasteuria Bioscience, Inc. must submit 

an analysis of samples (Harmonized Guideline 885.1400) for four additional batches.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 19 of 35

Biopesticides Registration Action Document

C. Reporting of Adverse Effects and Hypersensitivity Incidents

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

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

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

below.

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

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

(including both suspected and confirmed incidents) must be reported to EPA under the 

provisions of 40 CFR § 158.2140(d).
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 20 of 35

Biopesticides Registration Action Document

VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

BRAD Biopesticides Registration Action Document

CFR Code of Federal Regulations

cSt centistokes

EDSP Endocrine Disruptor Screening Program

EP end-use pesticide product

EPA United States Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FR Federal Register

g/mL grams per milliliter

lb/gal pounds per gallon

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

MP manufacturing-use pesticide product

MRID No. Master Record Identification Number

NIOSH National Institute for Occupational Safety and Health

OPP Office of Pesticide Programs

PC Code Pesticide Chemical Code

PP Pesticide Petition

PPE personal protective equipment

TGAI technical grade of the active ingredient

U.S. United States
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 21 of 35

Biopesticides Registration Action Document

IX. BIBLIOGRAPHY

A. Studies Submitted to Support the Pasteuria spp. (Rotylenchulus reniformis nematode) –

 Pr3 Pesticide Product Registrations

MRID No. Study Information

481460-01 MacIntosh S, Smith K. 2010. Product Identity: Pasteuria reniformis – PR3. 

Project Number: PBI/2010/008. Unpublished study prepared by MacIntosh & 

Associates, Inc. and Pasteuria Bioscience, Inc., 51 pages.

481460-02 Smith K. 2010. Manufacturing Process for Pasteuria reniformis – PR3. Project 

Number: PBI/2010/009. Unpublished study prepared by Pasteuria Bioscience, 

Inc., 36 pages.

481460-03 MacIntosh S. 2010. Discussion of the Formation of Unintentional Ingredients: 

Pasteuria reniformis – PR3. Project Number: 14059/10. Unpublished study 

prepared by MacIntosh & Associates, Inc., 29 pages.

481460-04 Smith K. 2010. Analysis of Samples/Enforcement Methods for Pasteuria 

reniformis – PR3. Unpublished study prepared by Pasteuria Bioscience, Inc., 69

pages.

481460-05 Smith K. 2010. Certification of Limits for Pasteuria reniformis – PR3. Project 

Number: PBI/2010/010. Unpublished study prepared by Pasteuria Bioscience, 

Inc., 8 pages.

481460-06 Kaminsky M. 2010. Pasteuria reniformis – PR3 Product Chemistry: Final Report. 

Project Number: 13888/10. Unpublished study prepared by Stillmeadow, Inc., 16 

pages.

481460-07 Smith K. 2010. Product Stability to Elevated Temperatures: Pasteuria reniformis

– PR3. Project Number: PBI/115/53. Unpublished study prepared by Pasteuria 

Bioscience, Inc., 8 pages.

481460-08 Smith K. 2010. Storage Stability & Corrosion Characteristics for Pasteuria 

reniformis – PR3. Project Number: 13884/10, PBI/2010/001. Unpublished study 

prepared by Pasteuria Bioscience, Inc., 16 pages.

481460-09 Gingras B. 2010. Toxicity/Pathogenicity Testing of Pasteuria reniformis – PR3

Following Acute Oral Challenge in Rats (Final Report). Project Number: 

2262/SN1, 2262. Unpublished study prepared by IIT Research Institute, 59 pages.

481460-10 Gingras B. 2010. Toxicity/Pathogenicity Testing of Pasteuria reniformis – PR3

Following Acute Intratracheal Challenge in Rats (Final Report). Project Number: 

2262/SN2, 2262. Unpublished study prepared by IIT Research Institute, 55 pages.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 22 of 35

Biopesticides Registration Action Document

MRID No. Study Information

481460-11 Gingras B. 2010. Toxicity/Pathogenicity Testing of Pasteuria reniformis – PR3

Following Acute Injection Challenge in Rats. Project Number: 2262/SN3, 2262. 

Unpublished study prepared by IIT Research Institute, 57 pages.

481460-12 MacIntosh S. 2010. Hypersensitivity Incidents: Pasteuria reniformis – PR3. 

Project Number: PBI/2010/013. Unpublished study prepared by MacIntosh & 

Associates, Inc., 6 pages.

481460-13 Sullivan D. 2010. Acute Oral Toxicity Study of Pasteuria reniformis – PR3 in 

Rats. Project Number: 2262, 2262/SN7. Unpublished study prepared by IIT 

Research Institute, 28 pages.

481460-14 Sullivan D. 2010. Acute Dermal Toxicity Study of Pasteuria reniformis – PR3 in 

Rabbits. Project Number: 2262, 2262/SN8. Unpublished study prepared by IIT 

Research Institute, 30 pages.

481460-15 Sullivan D. 2010. Acute Eye Irritation Study of Pasteuria reniformis – PR3 in 

Rabbits. Project Number: 2262, 2262/SN9. Unpublished study prepared by IIT 

Research Institute, 25 pages.

481460-16 Sullivan D. 2010. Acute Dermal Irritation Study of Pasteuria reniformis – PR3 in 

Rabbits. Project Number: 2262, 2262/SN10. Unpublished study prepared by IIT 

Research Institute, 25 pages.

481460-17 MacIntosh S, Smith K, Hewlett T. 2010. Request for Waiver from the 

Requirement to Conduct Guideline Studies (Avian Oral Toxicity, Freshwater Fish 

Toxicity/Pathogenicity, Freshwater Invertebrate Toxicity/Pathogenicity, NonTarget Insect Testing, and Honey Bee Testing) for Pasteuria reniformis – PR3. 

Project Number: PBI/2010/012. Unpublished study prepared by Pasteuria 

Bioscience, Inc., 29 pages.

482061-01 MacIntosh S, Smith K. 2010. Product Identity and Manufacturing Process: 

Pasteuria reniformis – PR3 (Liquid Formulation; End Product). Project Number: 

PBI/2010/015. Unpublished study prepared by Pasteuria Bioscience, Inc. and 

MacIntosh & Associates, Inc., 17 pages.

482061-02 MacIntosh S. 2010. Discussion of Formation of Unintentional Ingredients: 

Pasteuria reniformis – PR3 (Liquid Formulation; End Product). Unpublished 

study prepared by MacIntosh & Associates, Inc., 6 pages.

482061-03 Smith K. 2010. Analysis of Samples/Enforcement Methods for Pasteuria 

reniformis – PR3 (Liquid Formulation; End Product). Unpublished study prepared 

by Pasteuria Bioscience, Inc., 20 pages.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 23 of 35

Biopesticides Registration Action Document

MRID No. Study Information

482061-04 Smith K. 2010. Certification of Limits for Pasteuria reniformis – PR3 (Liquid 

Formulation; End Product). Project Number: PBI/2010/017. Unpublished study 

prepared by Pasteuria Bioscience, Inc., 8 pages.

482061-05 Kaminsky M. 2010. Pasteuria reniformis – Liquid Formulation: Product 

Chemistry – Final Report. Project Number: 14078/10. Unpublished study 

prepared by Stillmeadow, Inc., 9 pages.

482061-06 Smith K. 2010. Storage Stability: Interim Report Pasteuria reniformis – PR3

(Liquid Formulation; End Product). Project Number: PBI/2010/018. Unpublished 

study prepared by Pasteuria Bioscience, Inc., 8 pages.

482061-07 Smith K. 2010. Corrosion Characteristics for Pasteuria reniformis – PR3 (Liquid 

Formulation; End Product). Project Number: 13884/10. Unpublished study 

prepared by Stillmeadow, Inc., 11 pages.

482061-08 MacIntosh S. 2010. Hypersensitivity Incidents: Pasteuria reniformis – PR3

(Liquid Formulation; End Product). Project Number: PBI/2010/019. Unpublished 

study prepared by MacIntosh & Associates, Inc., 6 pages.

482061-09 Sullivan D. 2010. Acute Oral Toxicity Study of Pasteuria reniformis – PR3 (End 

Product) in Rats. Project Number: 2262/SN15. Unpublished study prepared by IIT 

Research Institute, 28 pages.

482061-10 Sullivan D. 2010. Acute Dermal Toxicity Study of Pasteuria reniformis – PR3

(End Product) in Rabbits. Project Number: 2262/SN16, 2262, 16. Unpublished 

study prepared by IIT Research Institute, 28 pages.

482061-11 Sullivan D. 2010. Acute Eye Irritation Study of Pasteuria reniformis – PR3 (End 

Product) in Rabbits. Project Number: 2262, 17, 2262/SN17. Unpublished study 

prepared by IIT Research Institute, 22 pages.

482061-12 Sullivan D. 2010. Acute Dermal Irritation Study of Pasteuria reniformis – PR3

(End Product) in Rabbits. Project Number: 2262, 18, 2262/SN17. Unpublished 

study prepared by IIT Research Institute, 22 pages.

482744-01 Kaminsky M. 2010. Pasteuria reniformis – Pr3 and Pasteuria reniformis – Seed 

Treatment: Product Chemistry – Final Report. Project Number: 14450/10. 

Unpublished study prepared by Stillmeadow, Inc., 10 pages.

482744-03 MacIntosh S. 2010. Request for Waivers from the Requirement to Conduct 

Toxicology Guideline Study: Acute Inhalation Toxicity for Pasteuria reniformis

– Pr3 & Pasteuria reniformis – Seed Treatment. Project Number: PBI/2010/025. 

Unpublished study prepared by MacIntosh & Associates, Inc., 7 pages.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 24 of 35

Biopesticides Registration Action Document

MRID No. Study Information

482744-04 MacIntosh S. 2010. Request for Waivers from the Requirement to Conduct 

Toxicology Guideline Study: Acute Inhalation Toxicity for Pasteuria reniformis

– Liquid Formulation. Project Number: PBI/2010/026. Unpublished study 

prepared by MacIntosh & Associates, Inc., 7 pages.

485990-01 MacIntosh S, Smith K. 2011. Product Identity – Pasteuria spp. (Rotylenchulus

reniformis nematode)(Supplement to MRID No. 481460-01). Unpublished study 

prepared by Pasteuria Bioscience, Inc. and MacIntosh & Associates, Inc., 20 

pages.

486056-01 Smith K. 2011. Storage Stability Pasteuria spp. (Rotylenchulus reniformis): 

Supplement to MRID No. 481460-08 – Final Report. Project Number: 

PBI/2010/001. Unpublished study prepared by Pasteuria Bioscience, Inc., 8 pages.

486056-02 Kaminsky M. 2011. Pasteuria reniformis – PR3 Corrosion Characteristics: Final 

Report. Project Number: 13889/10. Unpublished study prepared by Stillmeadow,

Inc., 10 pages.

486057-01 Smith K. 2011. Storage Stability Pasteuria spp. (Rotylenchulus 

reniformis)(Liquid Formulation; EP): Supplement to MRID No. 482061-06 –

Final Report. Project Number: PBI/2010/018. Unpublished study prepared by 

Pasteuria Bioscience, Inc., 8 pages.

486057-02 Kaminsky M. 2011. Pasteuria reniformis – Liquid Formulation Corrosion 

Characteristics: Final Report. Project Number: 13884/10. Unpublished study 

prepared by Stillmeadow, Inc., 11 pages.

B. Environmental Protection Agency Risk Assessment Memoranda

U.S. EPA. 2011a. Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3. Memorandum from

J.V. Gagliardi, Ph.D. and J.L. Kough, Ph.D. to J. Kausch dated March 2, 2012.

U.S. EPA. 2011b. Environmental Risk Assessment of Pasteuria spp. (Rotylenchulus reniformis

nematode) – Pr3 (PC 016456) for a Section 3 Registration of the Technical Product (EPA 

File Symbol 85004-U) and Two End Use Products (EPA File Symbols 85004-L and 

85004-I) for Control of the Reniform Nematode. Memorandum from S. Borges to J. 

Kausch dated March 26, 2012.

C. Other References

Aislabie J, Smith JJ, Fraser R, McLeod M. 2001. Leaching of bacterial indicators of faecal 

contamination through four New Zealand soils. Australian Journal of Soil Research

39:1397–1406.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 25 of 35

Biopesticides Registration Action Document

Atibalentja N, Jakstys BP, Noel GR. 2004. Life cycle, ultrastructure, and host specificity of the 

North American isolate of Pasteuria that parasitizes the soybean cyst nematode, 

Heterodera glycines. Journal of Nematology 36:171–180.

Centers for Disease Control and Prevention. 2009. Drinking Water - Water Treatment. Available 

from http://www.cdc.gov/healthywater/drinking/public/water_treatment.html.

Cetintas R, Dickson DW. 2004. Persistence and suppressiveness of Pasteuria penetrans to 

Meloidogyne arenaria Race 1. Journal of Nematology 36:540–549.

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

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

Ciancio A, Bonsignore R, Vovlas N, Lamberti F. 1994. Host records and spore morphometrics of 

Pasteuria penetrans group parasites of nematodes. Journal of Invertebrate Pathology 

63:260–267.

DeFelice K, Wollenhaupt N, Buchholz D. 1993. Aquifers and Soil Filter Effect. Available from 

http://extension.missouri.edu/p/WQ24.

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.

Noel GR. 2008. IPM of soybean cyst nematode in the USA. In: Integrated Management and 

Biocontrol of Vegetable and Grain Crops Nematodes. Eds. A. Cianio and K.G. Mukerji. 

Springer. Pages 119–126. 

Pang L, McLeod M, Aislabie J, Šimůnek J, Close M, Hector R. 2008. Modeling transport of 

microbes in ten undisturbed soils under effluent irrigation. Vadose Zone Journal 7:97–

111.

Sayre RM, Wergin WP, Schmidt JM, Starr MP. 1991. Pasteuria nishizawae sp. nov., a mycelial

and endospore-forming bacterium parasitic on cyst nematodes of genera Heterodera and 

Globodera. Research in Microbiology 14:551–564.

Sayre RM, Starr MP. 1985. Pasteuria penetrans (ex Thorne, 1940) nom. rev., comb. n., sp. n., a 

mycelial and endospore-forming bacterium parasitic in plant-parasitic nematodes. 

Proceedings of the Helminthological Society of Washington 52:149–165.

Sturhan D. 1988. New host and geographical records of nematode-parasitic bacteria of the 

Pasteuria penetrans group. Nematologica 34:350–356.

Tain B, Yang J, Zhang K-Q. 2007. Bacteria used in the biological control of plant-parasitic 

nematodes: populations, mechanisms of action, and future prospects. FEMS 

Microbiology Ecology 61:197–213.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 26 of 35

Biopesticides Registration Action Document

U.S. EPA. 2004. Primer for Municipal Wastewater Treatment Systems. EPA 832-R-04-001. 

Available from http://www.epa.gov/npdes/pubs/primer.pdf.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 27 of 35

Biopesticides Registration Action Document

APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 

(40 CFR PART 158 – SUBPART V)

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

(Rotylenchulus reniformis nematode) – Pr3, and the Manufacturing-Use Pesticide Product (MP), NAVIVA Tech

(40 CFR § 158.2120)

Harmonized 

Guideline 

Number 

Data Requirement

Results

MRID No. Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3 NAVIVA Tech

885.1100 Product Identity N/A

Submitted data fulfill the requirement

for product identity. NAVIVA Tech 

contains 99.88% by weight Pasteuria

spp. (Rotylenchulus reniformis

nematode) – Pr3 (contains at least 1 x 

108 spores per gram).

481460-01

485990-01

885.1200 Manufacturing 

Process Submitted data fulfill the requirement for manufacturing process. 481460-02

N/A

Deposition of a 

Sample in a 

Nationally 

Recognized Culture 

Collection

Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3 is on 

deposit with the American Type 

Culture Collection in Manassas, 

Virginia under Accession Number 

SD-5834.

N/A 481460-01

485990-01

885.1300

Discussion of 

Formation of 

Unintentional 

Ingredients

Submitted data fulfill the requirement for discussion of formation of 

unintentional ingredients for purposes of FIFRA section 3(c)(5) registration.

As a term of the NAVIVA Tech registration, EPA is requiring additional 

information (confirmatory) on this data requirement.

481460-03

885.1400 Analysis of Samples Submitted data fulfill the requirement for analysis of samples. 481460-04

885.1500 Certification of 

Limits

N/A

Limits listed on the confidential 

statement of formula are 

adequate/acceptable.

481460-05
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 28 of 35

Biopesticides Registration Action Document

TABLE 2. Product Analysis Data Requirements for the End-Use Pesticide Product (EPs), NAVIVA ST and NAVIVA LF

(40 CFR § 158.2120)

Harmonized

Guideline 

Number

Data Requirement Results MRID No.

NAVIVA ST* NAVIVA LF**

885.1100 Product Identity

Submitted data fulfill the 

requirement for product 

identity. NAVIVA ST

contains 99.88% by weight 

Pasteuria spp. 

(Rotylenchulus reniformis

nematode) – Pr3 (contains at 

least 1 x 108 spores per 

gram). 

Submitted data fulfill the 

requirement for product 

identity. NAVIVA LF contains 

33.29% by weight Pasteuria 

spp. (Rotylenchulus reniformis

nematode) – Pr3 (contains at 

least 1.3 x 107 spores per gram).

481460-01*

485990-01*

482061-01**

885.1200 Manufacturing Process Submitted data fulfill the requirement for manufacturing 

process.

481460-02*

482061-01**

N/A

Deposition of a Sample in a 

Nationally Recognized 

Culture Collection

N/A N/A

885.1300 Discussion of Formation of 

Unintentional Ingredients

Submitted data fulfill the requirement for discussion of 

formation of unintentional ingredients for purposes of FIFRA 

section 3(c)(5) registration. As a terms of the NAVIVA ST and

NAVIVA LF registrations, EPA is requiring additional 

information (confirmatory) on this data requirement.

481460-03*

482061-02**

885.1400 Analysis of Samples

Submitted data fulfill the 

requirement for analysis of 

samples.

Submitted data fulfill the 

requirement for analysis of 

samples for purposes of 

FIFRA section 3(c)(5) 

registration. As a term of the 

NAVIVA LF registration, 

EPA is requiring submission 

of analysis of samples for 

four additional batches.

481460-04*

482061-03**

885.1500 Certification of Limits Limits listed on the confidential statement of formula are 

adequate/acceptable.

481460-05*

482061-04**
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 29 of 35

Biopesticides Registration Action Document

TABLE 3. Physical and Chemical Characteristics for the Technical Grade of the Active Ingredient (TGAI), Pasteuria spp. 

(Rotylenchulus reniformis nematode) – Pr3, and the Manufacturing-Use Pesticide Product (MP), NAVIVA Tech

(40 CFR § 158.2120)

Harmonized 

Guideline Number

Data Requirement Results MRID No.

Pasteuria spp. 

(Rotylenchulus reniformis

nematode) – Pr3

NAVIVA Tech

830.63021

Color Caramel brown, light beige, brownish-yellow, brown

481460-06 830.63031 Physical State Liquid

830.63041 Odor Like wet dog or dog food

830.63131

Stability to Normal and 

Elevated

Temperatures, Metals,

and Metal Ions

After 14 days at 54°C, viability was reduced by 25%. 481460-07

830.6317 Storage Stability Stable at least 12 months when stored at 4°C. 481460-08

486056-01

830.6319 Miscibility N/A

Not required because

NAVIVA Tech is not an 

emulsifiable liquid form of a 

microbial pesticide (refer to 

test note #2 of 40 CFR § 

158.2120(d)).

N/A

830.6320 Corrosion 

Characteristics N/A Stable at least one year at 20°C in packaging.

481460-08

486056-02

830.70001 pH 5.03–5.14 481460-06

830.7100 Viscosity N/A 1.48 cSt (20°C)

1.02 cSt (40°C) 482744-01

830.73001

Density/Relative 

Density/Bulk Density 

(Specific Gravity)

1.04 g/mL 481460-06

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

 Bioscience, Inc. included this information with its application for NAVIVA Tech, it is summarized appropriately in this table.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 30 of 35

Biopesticides Registration Action Document

TABLE 4. Physical and Chemical Characteristics for the End-Use Pesticide Products (EPs), NAVIVA ST and NAVIVA LF 

(40 CFR § 158.2120)

Harmonized

Guideline Number

Data Requirement Results MRID No.

NAVIVA ST* NAVIVA LF**

830.63021 Color

Caramel brown, light 

beige, brownish-yellow, 

brown

N/A 481460-06

830.63031 Physical State Liquid 481460-06*

482061-05**

830.63041 Odor Like wet dog or dog food N/A 481460-06

830.63131

Stability to Normal and 

Elevated Temperatures, 

Metals, and Metal Ions

After 14 days at 54°C, 

viability was reduced by 

25%.

N/A 481460-07

830.6317 Storage Stability Stable at least 12 months when stored at 4°C.

481460-08*

486056-01*

482061-06**

486057-01**

830.6319 Miscibility

Not required because the end-use pesticide products, 

NAVIVA ST and NAVIVA LF, are not emulsifiable 

liquid forms of microbial pesticides (refer to test note #2 

of 40 CFR § 158.2120(d)).

N/A

830.6320 Corrosion Characteristics Stable at least one year at 

20°C in packaging.

Stable at least one year at 

4°C in packaging.

481460-08*

486056-02*

482061-07**

486057-02**

830.7000 pH 5.03–5.141 3.5–4.52 481460-06*

830.7100 Viscosity 1.48 cSt (20°C)

1.02 cSt (40°C)

363.88 cSt (20°C)

253.62 cSt (40°C)

482744-01*

482061-05**

830.7300

Density/Relative 

Density/Bulk Density 

(Specific Gravity)

1.04 g/mL1 8.5 lb/gal2 481460-06*

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

 Bioscience, Inc. included this information with its applications for NAVIVA ST and/or NAVIVA LF, it is summarized 

 appropriately in this table.

2 Obtained from the confidential statement of formula for the end-use pesticide product.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 31 of 35

Biopesticides Registration Action Document

TABLE 5. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3, and the Manufacturing-Use Pesticide Product (MP), NAVIVA Tech (40 CFR § 158.2140)

Harmonized

Guideline 

Number

Data Requirement Results MRID No.

Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3

NAVIVA Tech

Tier I

885.3050 Acute Oral 

Toxicity/Pathogenicity

Not toxic and/or pathogenic to rats 

when administered by oral gavage in a 

single dose of 1.5 x 109 spores per 

animal. Although clearance and 

infectivity were not measured, EPA 

believes these endpoints are not a 

concern given Pasteuria spp. 

(Rotylenchulus reniformis nematode) –

Pr3’s well-established host specificity 

for Rotylenchulus spp. nematodes. 

Classification: Supplemental

N/A 481460-09

885.3150 Acute Pulmonary 

Toxicity/Pathogenicity

Not toxic and/or pathogenic to rats 

when administered by intratracheal 

instillation in a single dose of 1.5 x 108

spores per animal. Although clearance 

and infectivity were not measured, EPA 

believes these endpoints are not a 

concern given Pasteuria spp. 

(Rotylenchulus reniformis nematode) –

Pr3’s well-established host specificity 

for Rotylenchulus spp. nematodes. 

Classification: Supplemental

N/A 481460-10

885.3200

Acute Injection 

Toxicity/Pathogenicity 

(Intravenous)

Not toxic and/or pathogenic to rats

when administered intravenously in a 

single dose of 1.0 x 107 spores per 

animal. Although clearance and 

infectivity were not measured, EPA 

believes these endpoints are not a 

concern given Pasteuria spp. 

(Rotylenchulus reniformis nematode) –

Pr3’s well-established host specificity 

for Rotylenchulus spp. nematodes.

Classification: Supplemental

N/A 481460-11

885.3400 Hypersensitivity

Incidents

The applicant reported that no hypersensitivity incidents, including 

immediate-type or delayed-type reactions of humans and domestic animals, 

occurred during research, development, or testing of the TGAI or MP. Any 

future hypersensitivity incidents must be reported to EPA (refer to test note 

#3 of 40 CFR § 158.2140(d)). 

481460-12

885.3500 Cell Culture

Not required because Pasteuria spp. 

(Rotylenchulus reniformis nematode) –

Pr3 is not a virus (refer to test note #4 

of 40 CFR § 158.2140(d)).

N/A N/A

870.1100 Acute Oral Toxicity N/A

Oral LD50 combined (male and 

female rats) > 5,000 mg/kg

Classification: Acceptable

TOXICITY CATEGORY IV

481460-13

870.1200 Acute Dermal Toxicity N/A

Dermal LD50 combined (male and 

female rabbits) > 2,000 mg/kg

Classification: Acceptable

TOXICITY CATEGORY III

481460-14
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 32 of 35

Biopesticides Registration Action Document

TABLE 5. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3, and the Manufacturing-Use Pesticide Product (MP), NAVIVA Tech (40 CFR § 158.2140)

Harmonized

Guideline 

Number

Data Requirement Results MRID No.

Pasteuria spp. (Rotylenchulus 

reniformis nematode) – Pr3

NAVIVA Tech

870.1300 Acute Inhalation 

Toxicity N/A

Waived based on the results of 

MRID No. 481460-10 and 

because this formulation contains 

inert ingredients that are not 

expected to be of toxicological 

concern (refer to test note #5 of 

40 CFR § 158.2140(d)).

Classification: Acceptable

TOXICITY CATEGORY III

482744-03

870.2400 Acute Eye Irritation N/A

NAVIVA Tech was practically 

non-irritating to the eyes of 

rabbits.

Classification: Acceptable

TOXICITY CATEGORY III

481460-15

870.2500 Primary Dermal 

Irritation N/A

NAVIVA Tech was essentially 

non-irritating to the skin of 

rabbits.

Classification: Acceptable

TOXICITY CATEGORY IV

481460-16

Tiers II and III

Not required for Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3, based on the lack of acute toxicity/pathogenicity in the Tier I 

studies.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 33 of 35

Biopesticides Registration Action Document

TABLE 6. Toxicology Data Requirements for the End-Use Pesticide Products (EPs), NAVIVA ST and NAVIVA LF

(40 CFR § 158.2140)

Harmonized

Guideline 

Number

Data Requirement Results MRID No.

NAVIVA ST* NAVIVA LF**

885.3050 Acute Oral 

Toxicity/Pathogenicity N/A N/A

885.3150 Acute Pulmonary 

Toxicity/Pathogenicity N/A N/A

885.3200 Acute Injection 

Toxicity/Pathogenicity N/A N/A

885.3400 Hypersensitivity 

Incidents

The applicant reported than no hypersensitivity incidents, including 

immediate-type or delayed-type reactions of humans and domestic animals, 

occurred during research, development, or testing of the EPs. Any future 

hypersensitivity incidents must be reported to EPA (refer to test note #3 of 

40 CFR § 158.2140(d)).

481460-12*

482061-08**

885.3500 Cell Culture N/A N/A

870.1100 Acute Oral Toxicity

Oral LD50 combined (male and female rats) > 5,000 mg/kg

Classification: Acceptable

TOXICITY CATEGORY IV

481460-13*

482061-09**

870.1200 Acute Dermal 

Toxicity

Dermal LD50 combined (male and female rabbits) > 2,000 mg/kg

Classification: Acceptable

TOXICITY CATEGORY III

481460-14*

482061-10**

870.1300 Acute Inhalation 

Toxicity

Waived based on the results of MRID No. 481460-10 and because this 

formulation contains inert ingredients that are not expected to be of 

toxicological concern (refer to test note #5 of 40 CFR § 158.2140(d)).

Classification: Acceptable

TOXICITY CATEGORY III

482744-03*

482744-04**

870.2400 Acute Eye Irritation

NAVIVA ST was practically nonirritating to the eyes of rabbits.

Classification: Acceptable

TOXICITY CATEGORY III

NAVIVA LF was essentially nonirritating to the eyes of rabbits.

Classification: Acceptable

TOXICITY CATEGORY IV

481460-15*

482061-11**

870.2500 Primary Dermal 

Irritation

The EP test substances were essentially non-irritating to the skin of rabbits.

Classification: Acceptable

TOXICITY CATEGORY IV

481460-16*

482061-12**
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 34 of 35

Biopesticides Registration Action Document

TABLE 7. Nontarget Organism Toxicity and Environmental Fate Data Requirements for the Technical Grade of the Active 

Ingredient (TGAI), Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 (40 CFR § 158.2150)

Harmonized Guideline 

Number

Data Requirement Results MRID No.

Tier I

885.4050 Avian Oral Toxicity

Data and other information provide sufficient 

information to determine that 

toxicity/pathogenicity to avian wildlife is not 

expected as a result of the proposed pesticidal

uses.

Classification: Acceptable

481460-17

885.4100 Avian Inhalation 

Toxicity/Pathogenicity

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)).

N/A

885.4150 Wild Mammal 

Toxicity/Pathogenicity

Tests required by 40 CFR § 158.2140 are 

adequate and appropriate for assessment of 

hazards to wild mammals. Studies submitted with 

laboratory rats indicate no adverse effects due to 

oral exposure.

Classification: Acceptable for wild mammal 

risk assessment

N/A

885.4200 Freshwater Fish 

Toxicity/Pathogenicity

Data and other information provide sufficient 

information to determine that 

toxicity/pathogenicity to freshwater fish and 

invertebrates is not expected as a result of the 

proposed pesticidal uses.

Classification: Acceptable

481460-17

885.4240 Freshwater Invertebrate 

Toxicity/Pathogenicity

885.4280 Estuarine/Marine Fish and 

Invertebrate Testing

Not required as the microbial pesticide will not be 

applied directly to water and is not expected to 

enter marine/estuarine environments in amounts 

that would result in significant concentrations 

(refer to test note #6 of 40 CFR § 158.2150(e)).

N/A

885.4300 Nontarget Plant Testing

Not required as the microbial pesticide is not 

taxonomically related to any known plant 

pathogens (refer to test note #7 of 40 CFR § 

158.2150(e)).

N/A

885.4340 Nontarget Insect Testing

Data and other information provide sufficient 

information to determine that 

toxicity/pathogenicity to honey bees and

nontarget insects is not expected as a result of the 

proposed pesticidal uses.

Classification: Acceptable

481460-17

885.4380 Honey Bee Testing

Tiers II, III, and IV

Not required for Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3, based on the acceptability of the data and other information

provided for Tier I.
Pasteuria spp. (Rotylenchulus reniformis nematode) – Pr3 Page 35 of 35

Biopesticides Registration Action Document

APPENDIX B. PESTICIDE PRODUCTS

EPA File 

Symbol

Registration 

Name

Percentage 

Active 

Ingredient

Formulation 

Type

Use Site(s) Method(s) of 

Application

Application Rate(s) Target Pest

85004-U NAVIVA

Tech 99.88% Technical N/A N/A N/A N/A

85004-L NAVIVA 

ST 99.88%

End Use –

Liquid

Various 

food and 

nonfood 

crops

Seed Treatment 

(Preplant or Commercial)

0.25–25 milligrams of 

NAVIVA ST per 100 

pounds of seed

Reniform nematode

(Rotylenchulus 

reniformis)

85004-I NAVIVA 

LF 33.29%

Ground application 

equipment or 

chemigation

0.13–6.4 fluid ounces 

of NAVIVA LF per 100 

square feet of crop area