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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
July 26, 2012
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Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 Page 2 of 33
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 17
VII. ACTIONS REQUIRED OF THE REGISTRANT 18
VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 19
IX. BIBLIOGRAPHY 20
A. Studies Submitted to Support the Pasteuria spp.
(Rotylenchulus reniformis nemtaode) - Pr3 Pesticide Product Registrations 20
B. Environmental Protection Agency Risk Assessment Memoranda 23
C. Other References 23
APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 26
APPENDIX B. PESTICIDE PRODUCTS 33
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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
John L. Kough, Ph.D.
Shannon Borges
Regulations
Product Analysis, Human Health
Product Analysis, Human Health
Environmental Effects
Sheryl K. Reilly, Ph.D.
Jeannine Kausch
Chief, Microbial Pesticides Branch
Regulatory Action Leader
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I. EXECUTIVE SUMMARY
Background
In July and August 2010, Pasteuria Bioscience, Inc. submitted applications for a manufacturing-
use 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.
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 377341 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 - Pnl (40 CFR 180.1311), respectively). These gram-positive, mycelial, endospore-
forming 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 etal.
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. 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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Product Analysis
For the purposes of FIFRA section 3(c)(5) registration, the product analysis data requirements for
Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3, including product chemistry and
composition, analysis of samples, and physical and chemical characteristics, were fulfilled by
acceptable guideline studies.
Toxicology
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.
Tolerance Exemption
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.
Occupational Exposure
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, waterproof gloves, 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.
Nontarget Organisms
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, HI, and IV) is not required. EPA performed an environmental risk assessment based on data
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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 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.
Public Participation
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.
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, and allowing for this active ingredient's first outdoor and food uses were
subject to a 30-day comment period. During this comment period, no comments were received
on EPA's preliminary decision to register the Pasteuria spp. {Rotylenchulus reniformis
nematode) - Pr3 pesticide products, NAVIVA Tech, NAVIVA ST, and NAVIVA LF. Therefore,
EPA maintained that, based upon the risk assessment and information submitted in support of
registration of such pesticide products, it was appropriate to issue the NAVIVA Tech, NAVIVA
ST, and NAVIVA LF registrations under FIFRA section 3(c)(5). The basis for this decision can
be found in the risk assessment for Pasteuria spp. {Rotylenchulus reniformis nematode) - Pr3,
which is characterized throughout this Biopesticides Registration Action Document (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 registered 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 manufacturing-
use 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.
On July 9, 2012, EPA established an exemption from the requirement of a tolerance for residues
of Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 in or on all food commodities when
applied as a nematicide and used in accordance with label directions and good agricultural
practices (40 CFR § 180.1316; 77 FR 40271).
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
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"supplemental" studies may be used in the risk assessment process as appropriate. An
"unacceptable" rating indicates that new data must be submitted.
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, n, HI, 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 HI 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)(l)(a) and
IV(B)(l)(b) (see pages 8-9), 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/Pathosenicity - 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 naive 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. This study was rated supplemental.
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Biopesticides Registration Action Document
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 naive 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. This study was rated supplemental.
Acute In jection 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 naive 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. 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 HI studies were not required for Pasteuria spp. (Rotylenchulus reniformis
nematode) - Pr3, based on the lack of acute toxicity/pathogenicity in the Tier I studies.
c. Endocrine Disruptors
As required by the Administrator under FFDCA section 408(p), EPA has developed the
Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screening
program that is to be used to test all pesticides in order to determine whether certain substances
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(including pesticide active and other ingredients) may have an effect in humans or wildlife
similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects
as the Administrator may designate."
FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the
requirements of the Estrogenic Substances Screening Program a biologic substance or other
substance if a determination is made that the substance is not anticipated to produce any effect in
humans similar to an effect produced by a naturally occurring estrogenic substance.
Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group
of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. 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.
Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 is likely a substance that would not
produce any effect in humans similar to an effect produced by a naturally occurring estrogenic
substance. As such, pursuant to FFDCA section 408(p)(4), EPA will determine in the future
whether it can exempt Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 from the
requirements of the Section 408(p) EDSP. In the event EPA does determine to exempt this
substance from the EDSP, an order will be issued.
For further information on the status of the EDSP, the policies and procedures, the list of 67
chemicals, future lists, the test guidelines, and the Tier 1 screening battery, please visit our
website: http://www.epa.gov/endo/.
2. Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement
for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA
determines that the exemption is "safe." Section 408(c)(2)(A)(ii) of FFDCA defines "safe" to
mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures and all other exposures for
which there is reliable information." This includes exposure through drinking water and in
residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B)
of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a
tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA,
which require EPA to give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance exemption, and to "ensure that there is a
reasonable certainty that no harm will result to infants and children from aggregate exposure to
the pesticide chemical residue..." Additionally, section 408(b)(2)(D) of FFDCA requires that
EPA consider "available information concerning the cumulative effects of [a particular
pesticide's] . . . residues and other substances that have a common mechanism of toxicity."
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide
residues. First, EPA determines the toxicity of 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.
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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 non-
occupational 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. Regardless of the situation, however, should residues of
Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 result in or on food when used as a
pesticide in accordance with label directions and good agricultural practices, its lack of toxicity
and pathogenicity (as demonstrated in available data) indicate that no adverse effects are likely to
occur with respect to any exposures to such residues (see section IV(B)(l)(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 possible but not likely.
The proposed use patterns for Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 are soil
directed, soil incorporated, and/or seed directed, 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, given that this microbial pesticide
would likely be filtered out by the particulate nature of many soil types as are other
microorganisms (Aislabie etal. 2001; DeFelice etal. 1993; Pang etal. 2008). If Pasteuria spp.
(Rotylenchulus reniformis nematode) - Pr3 were to be transferred to surface or ground waters
(e.g., through spray drift or runoff) that are intended for eventual human consumption and
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directed to wastewater treatment systems or drinking water facilities, it may not survive some of
the conditions water is subjected to in such systems or facilities, including chlorination, pH
adjustments, and filtration (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 certain conditions in treatment systems or facilities),
its lack of toxicity and pathogenicity demonstrated by the available data indicate that no toxicity,
pathogenicity, and/or infectivity is likely to occur with respect to any exposures to residues of
Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 in drinking water that might result
from pesticide applications made in accordance with label directions and good agricultural
practices (see section IV(B)(l)(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 almost certainly is already occurring. Additional non-occupational exposure to
Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 due to pesticidal applications is not
expected because all proposed pesticide end-use products are labeled for use in distinct
agricultural settings. Even if additional non-occupational exposures were to occur (e.g., eventual
expansion of use sites), the lack of toxicity, pathogenicity, and irritation demonstrated in the
available data indicate that no adverse effects are likely to occur with respect to any exposures to
such residues that might result from pesticide applications made in accordance with label
directions and good agricultural practices (see section IV(B)(l)(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."
No mechanism of toxicity in mammals has been identified for Pasteuria spp. (Rotylenchulus
reniformis nematode) - Pr3, 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. For information
regarding EPA's efforts to determine chemicals that have a common mechanism of toxicity and
to evaluate the cumulative effects of such chemicals, see EPA's website at
http://www. epa. sov/pesticides/cumulative.
c. Determination of Safety for the United States Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or
tolerance exemption for a pesticide chemical residue, EPA shall assess the available information
about consumption patterns among infants and children, special susceptibility of infants and
children to pesticide chemical residues, and the cumulative effects on infants and children of the
residues and other substances with a common mechanism of toxicity. In addition, FFDCA
section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of
exposure (safety) for infants and children in the case of threshold effects to account for prenatal
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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 or no safety factor when reliable data are available to support a different
additional or no safety factor.
Based on the acute toxicity and pathogenicity data/information discussed in section IV(B)(l)(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 tor 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.
Moreover, based on the same data and EPA analysis as presented directly above, the Agency is
able to conclude that there is a reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposure to the residues of 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, pathogenic, and/or
infective 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, waterproof gloves, 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 product-specific 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 U.S. 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 EPA-approved
labeling.
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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, HI, 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),
Nontarset Plants (Harmonized Guideline 885.4300), Nontarset 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 etal. 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 etal. 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.
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)(l)(a) on page 8. No signs of toxic or
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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.
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), andNontarset 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
2 Pasteuria ramosa is already recognized as parasitizing water fleas and is not considered an
"unanticipated" report.
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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 el 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; Sayreetal. 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, IE, and IV) is not
required.
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
3 Pasteuria ramosa is already recognized as parasitizing water fleas and is not considered an
"unanticipated" report.
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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, during the 30-day public participation
comment period, EPA sought 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. No public comments were received on this particular matter.
For additional information regarding environmental justice issues, please visit EPA's web site at
http://www. epa. sov/compliance/environmentaliustice/index. html.
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
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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.
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).
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VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS
BRAD
CFR
cSt
EDSP
EP
EPA
FFDCA
FIFRA
FR
g/mL
lb/gal
LD50
mg/kg
MP
MRIDNo.
NIOSH
OPP
PC Code
PP
PPE
TGAI
U.S.
Biopesticides Registration Action Document
Code of Federal Regulations
centi stokes
Endocrine Disruptor Screening Program
end-use pesticide product
United States Environmental Protection Agency (the "Agency")
Federal Food, Drug, and Cosmetic Act
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Register
grams per milliliter
pounds per gallon
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).
milligrams per kilogram
manufacturing-use pesticide product
Master Record Identification Number
National Institute for Occupational Safety and Health
Office of Pesticide Programs
Pesticide Chemical Code
Pesticide Petition
personal protective equipment
technical grade of the active ingredient
United States
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IX. BIBLIOGRAPHY
A. Studies Submitted to Support the Pasteuria spp. (Rotylenchulus reniformis nematode) -
Pr3 Pesticide Product Registrations
MRIDNo.
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.
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MRIDNo.
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: PB1/2010/013. 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, Non-
Target 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:
PB 1/2010/015. 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.
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MRIDNo.
Study Information
482061-04 Smith K. 2010. Certification of Limits for Pasteuria reniformis - PR3 (Liquid
Formulation; End Product). Project Number: PB1/2010/017. 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.
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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)(iA(^d\6i 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. 201 la. 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. 201 lb. 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
85004-1) 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.
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Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3
Biopesticides Registration Action Document
Page 24 of 3 3
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 morphometries 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/W024.
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. Mukeiji.
Springer. Pages 119-126.
Pang L, McLeod M, Aislabie J, Simunek 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 14:5 51 -5 64.
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.
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Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 Page 25 of 33
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.
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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
MRU) 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
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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
MRU) 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
33.2900% 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**
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Page 28 of 33
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
MRU) 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.
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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
MRU) 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.
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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
MRU) No.
Pasteuria spp. (Rotylenchulus
reniformis nematode) - Pr3
NAVIVA Tech
Tier I
885.3050
Acute Oral
T oxicity/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.
Classification: Supplemental
N/A
481460-09
885.3150
Acute Pulmonary
T oxicity/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.
Classification: Supplemental
N/A
481460-10
885.3200
Acute Injection
T oxicity/Pathogenicity
(Intravenous)
Not toxic and/or pathogenic to rats
when administered intravenously in a
single dose of 1.0 x 107 spores per
animal.
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
870.1300
Acute Inhalation
Toxicity
N/A
Waived based on the results of
MRIDNo. 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
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Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3
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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
Pasteuria spp. (Rotylenchulus
reniformis nematode) - Pr3
NAVIVA Tech
MRU) No.
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.
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 non-
irritating to the eyes of rabbits.
Classification: Acceptable
TOXICITY CATEGORY III
NAVIVA LF was essentially non-
irritating 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**
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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
MRU) 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
T oxicity/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
T oxicity/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
T oxicity/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
T oxicity/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.
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Page 33 of 33
APPENDIX B. PESTICIDE PRODUCTS
EPA
Registration
Number
Registration
Name
Percentage
Active
Ingredient
Formulatio
11 Type
Use Site(s)
Method(s) of
Application
Application Rate(s)
Target Pest
85004-4
NAVIVA
Tech
99.88%
Technical
N/A
N/A
N/A
N/A
85004-5
NAVIVA
ST
99.88%
Various
Seed Treatment
(Preplant or
Commercial)
2.4-243 fluid ounces of
NAVIVA ST per 100
pounds of seed
Reniform nematode
(.Rotylenchulus
reniformis)
85004-8
NAVIVA
LF
33.2900%
End Use -
Liquid
food and
nonfood
crops
Ground application
equipment or
chemigation
0.13-6.4 fluid ounces
of NAVIVA LF per 100
square feet of crop area
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