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BIOPESTICIDES REGISTRATION ACTION DOCUMENT
Pasteuria nishizawae - Pnl
Pesticide Chemical (PC) Code: 016455
U.S. Environmental Protection Agency
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division
February 28, 2012
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Biopesticides Registration Action Document
TABLE OF CONTENTS
I. EXECUTIVE SUMMARY 4
II. ACTIVE INGREDIENT OVERVIEW 6
III. REGULATORY BACKGROUND 6
A. Applications for Pesticide Product Registration 6
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) 13
V. ENVIRONMENTAL JUSTICE 16
VI. RISK MANAGEMENT DECISION 17
VII. ACTIONS REQUIRED OF THE REGISTRANT 17
VIII. GLOSSARY OF ACRONYMS AND ABBREVIATIONS 19
IX. BIBLIOGRAPHY 20
A. Studies Submitted to Support the Pasteuria nishizawae - Pnl Pesticide
Product Registrations 20
B. Environmental Protection Agency Risk Assessment Memoranda 24
C. Other References 24
APPENDIX A. MICROBIAL PESTICIDES DATA REQUIREMENTS 26
APPENDIX B. PESTICIDE PRODUCTS 34
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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
Gail Tomimatsu, Ph.D.
Product Analysis, Human Health
Product Analysis, Human Health
Environmental Effects
Environmental Effects
Regulations
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, Soyacyst Tech (EPA File Symbol 85004-A), and two end-use pesticide
products, Soyacyst Tech+ (EPA File Symbol 85004-T) and Soyacyst LF (EPA File Symbol
85004-0), 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 nishizawae - Pnl, 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) and
June 30, 2010 (75 FR 37734) for Final Rules that established tolerance exemptions for residues
of the nematicides, Pasteuria penetrans (40 Code of Federal Regulations (CFR) 180.1135) and
Pasteuria usgae (40 CFR 180.1290), 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. 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
nishizawae - Pnl was specifically isolated from an Illinois soybean field in the mid-2000s.
Although endospores of Pasteuria nishizawae have been observed to attach to the cuticle of three
nematodes of the genus Heterodera and one nematode of the genus Globodera, it is known only
to infect and complete its life cycle within the female soybean cyst nematode {Heterodera
glycines). In the following manner, Pasteuria nishizawae - Pnl exerts a pesticidal effect on the
soybean cyst nematode through parasitism that ultimately results in the death of infected females:
(1) Endospores attach to the cuticle of a juvenile soybean cyst nematode female.
(2) Once a soybean cyst nematode female invades soybean roots, Pasteuria
nishizawae - Pnl produces a germ tube that penetrates the body of the nematode.
(3) Primary and secondary microcolonies of Pasteuria nishizawae - Pnl develop and
proliferate within the body of the nematode, causing its death.
In light of the demonstrated nematicidal capabilities and host specificity of Pasteuria nishizawae
- Pnl, Pasteuria Bioscience, Inc. proposed to register several pesticide products that could be
applied to soybean or its seed to control the soybean cyst nematode.
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 nishizawae - Pnl pesticide products. Overall,
1 Pasteuria ramosa is the only Pasteuria species that is known to parasitize water fleas.
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such data and information are adequate for risk assessment purposes, fulfill the current microbial
pesticide data requirements, and allow for registration under FIFRA section 3(c)(5).
Product Analysis
The product analysis data requirements for Pasteuria nishizawae - Pnl, 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
nishizawae - Pnl pesticide products. Acute oral, pulmonary, and injection toxicity/pathogenicity
studies showed that, at a single high dose, Pasteuria nishizawae - Pnl 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 nishizawae - Pnl. 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 nishizawae -
Pnl. No dietary risks are expected from use of Pasteuria nishizawae - Pnl as an active
ingredient in pesticide products. Significant exposure to Pasteuria nishizawae - Pnl 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 nishizawae - Pnl be present on food or in drinking water, its
specificity for the soybean cyst nematode and supporting acute oral toxicity and pathogenicity
data indicate that human exposure to this bacterium is not likely to be a concern.
Occupational Exposure
Despite the low toxicological profile of Pasteuria nishizawae - Pnl, 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
nishizawae - Pnl 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. 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 nishizawae - Pnl 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 nishizawae - Pnl. Moreover, EPA
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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 nishizawae - Pnl, 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 nishizawae - Pnl pesticide products, Soyacyst Tech, Soyacyst Tech+, and
Soyacyst 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
Soyacyst Tech, Soyacyst Tech+, and Soyacyst LF registrations under FIFRA section 3(c)(5). The
basis for this decision can be found in the risk assessment for Pasteuria nishizawae - Pnl, which
is characterized throughout this Biopesticides Registration Action Document (BRAD).
II. ACTIVE INGREDIENT OVERVIEW
Biological Name:
Pasteuria nishizawae - Pnl
Culture Deposit:
American Type Culture Collection in Manassas, Virginia
under Accession Number SD-5833
OPP Chemical Code:
016455
Type of Pesticide:
Microbial Pesticide - Nematicide
See Appendix B for specific information (e.g.,
use sites, application rates, methods of application,
formulation types, and target pests) regarding
the registered pesticide products containing this
active ingredient.
III. REGULATORY BACKGROUND
A. Applications for Pesticide 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-
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use pesticide product, Soyacyst Tech (EPA File Symbol 85004-A), and two end-use pesticide
products, Soyacyst Tech+ (EPA File Symbol 85004-T) and Soyacyst LF (EPA File Symbol
85004-0), 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), Pasteuria Bioscience, Inc. submitted a petition to establish an
exemption from the requirement of a tolerance for Pasteuria nishizawae - Pnl (Pesticide Petition
(PP) 0F7749). 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 nishizawae - Pnl, 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 February 15, 2012, EPA established an exemption from the requirement of a tolerance for
residues of Pasteuria nishizawae - Pnl in or on all food commodities when applied as a
nematicide and used in accordance with good agricultural practices (40 CFR § 180.1311; 77 FR
8736).
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.
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).
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A. Product Analysis Assessment (40 CFR § 158.2120)
All product analysis data requirements for Pasteuria nishizawae - Pnl 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 nishizawae - Pnl have been fulfilled. Acceptable
Tier I mammalian toxicology data and information support registration of the Pasteuria
nishizawae - Pnl pesticide products. Furthermore, Tier II and Tier HI studies were not required
tor Pasteuria nishizawae - Pnl, 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), 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.) 481517-09): Groups of rats were treated with live test
substance at 1.6 x 109 spores/rat, were treated with killed (autoclaved) test substance, or were in
1 of 2 untreated control groups. No adverse clinical signs were observed in any test animals. At
necropsy, no treatment-related gross observations were noted. Organ weights primarily did not
differ, though in male rats treated with live test substance, brain weights on days 7, 14, and 21
and spleen weight on day 21 were slightly but significantly decreased. In female rats from the
same group, the only statistically significant difference was heavier stomach/small intestine
weight on day 7. No evidence of pathogenicity or toxicity was found from oral administration of
Pasteuria nishizawae - Pnl to rats. Although clearance and infectivity were not measured, EPA
believes these endpoints are not a concern given Pasteuria nishizawae - Pnl's well-established
host specificity for the soybean cyst nematode. This study was rated supplemental.
Acute Pulmonary Toxicity/Pathosenicity - Rat (Harmonized Guideline 885.3150; MRID No.
481517-10): Groups of rats were treated with live test substance at 1.6 x 108 spores/rat, were
treated with killed (autoclaved) test substance, or were untreated controls. No adverse clinical
signs were observed in any test animals. At necropsy, no treatment-related gross observations
were noted. Organ weights primarily did not differ, though in male rats treated with live test
substance, brain weights on days 7, 14, and 21 and liver weight on day 21 were slightly but
significantly decreased. In female rats from the same group, there were no statistically significant
differences in organ weights. No evidence of pathogenicity or toxicity was found from
pulmonary administration of Pasteuria nishizawae - Pnl to rats. Although clearance and
infectivity were not measured, EPA believes these endpoints are not a concern given Pasteuria
nishizawae - Pnl's well-established host specificity for the soybean cyst nematode. This study
was rated supplemental.
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Acute In jection Toxicity/Pathogenicity (Intravenous) Rat (Harmonized Guideline 885.3200;
MRID No. 481517-11) : Groups of rats were treated with live test substance at 1.0 x 109
spores/rat, were treated with killed (autoclaved) test substance, or were untreated controls. No
adverse clinical signs were observed in any test animals. At necropsy, no treatment-related gross
observations were noted. Organ weights primarily did not differ, though in males rats treated
with live test substance, spleen weights on days 14 and 21 and liver weight on day 21 were
slightly but significantly decreased. In female rats from the same group, there were no
statistically significant differences in organ weights. No evidence of pathogenicity or toxicity was
found from intravenous administration of Pasteuria nishizawae - Pnl to rats. Although clearance
and infectivity were not measured, EPA believes these endpoints are not a concern given
Pasteuria nishizawae - Pnl's well-established host specificity for the soybean cyst nematode.
This study was rated supplemental.
Hypersensitivity Incidents (Harmonized Guideline 885.3400; MRID No. 481517-12): 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 nishizawae - Pnl. 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
nishizawae - Pnl 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 nishizawae - Pnl, based on the lack of
acute toxicity/pathogenicity in the Tier I studies.
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
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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 nishizawae - Pnl 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."
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide
residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the
pesticide through food, drinking water, and through other exposures that occur as a result of
pesticide use in residential settings.
Consistent with section 408(b)(2)(D) of FFDCA, EPA 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 nishizawae - Pnl have been fulfilled.
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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 nishizawae - Pnl, a
naturally occurring soil bacterium (Atibalentja et al. 2004; Noel et al. 2005; Sayre et al. 1991), is
anticipated to be negligible. For optimal control of the target pest, soybean cyst nematode
(Heterodera glycines), Pasteuria nishizawae - Pnl 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 nishizawae - Pnl residues on above-ground food
commodities. That is, although Pasteuria nishizawae - Pnl 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 nishizawae - Pnl 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 nishizawae - Pnl residues is a
more likely scenario. Regardless of the situation, should Pasteuria nishizawae - Pnl be present
on food, its specificity for the soybean cyst nematode and available data indicate no toxicity,
pathogenicity, and/or infectivity is likely to occur with any dietary exposure that results from
pesticide applications made in accordance with good agricultural practices (see section
IV(B)(l)(a) and Tables 5 and 6 in Appendix A).
Drinking Water Exposure and Risk Characterization: Exposure to residues of Pasteuria
nishizawae - Pnl in consumed drinking water is possible but not likely. The proposed use
patterns for Pasteuria nishizawae - Pnl 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 nishizawae - Pnl since, like other
microorganisms, this microbial 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
nishizawae - Pnl were to be transferred to surface or ground waters (e.g., through spray drift or
runoff) that are intended for eventual human consumption and 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
nishizawae - Pnl is present in drinking water (e.g., water not subject to treatment systems or
facilities), its specificity for the soybean cyst nematode and available data indicate no toxicity,
pathogenicity, and/or infectivity is likely to occur with any drinking water exposure that results
from pesticide applications made in accordance with good agricultural practices (see section
IV(B)(l)(a) and Tables 5 and 6 in Appendix A).
Non-occupational, Residential Risk Characterization: Given I'asteuria nishizawae'% natural
occurrence in soil (Atibalentja et al. 2004; Noel et al. 2005; Sayre et al. 1991), non-occupational
exposure to the bacterium is likely already occurring. Additional exposure to Pasteuria
nishizawae - Pnl due to pesticidal applications is not expected because all proposed pesticide
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end-use products are labeled for use in distinct agricultural settings. Even if non-occupational
exposures were to occur (e.g., eventual expansion of use sites), such exposures would not exceed
EPA's level of concern in light of Pasteuria nishizawae - Pnl's specificity for the soybean cyst
nematode and test results that indicated Pasteuria nishizawae - Pnl is not toxic (acute dermal
toxicity and acute pulmonary toxicity/pathogenicity), is essentially non-irritating (primary dermal
irritation), and is not pathogenic (acute pulmonary toxicity/pathogenicity) (see section
IV(B)(l)(a) 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 nishizawae - Pnl, and
Pasteuria nishizawae - Pnl does not appear to produce a toxic metabolite against the target pest.
For the purposes of the tolerance action, EPA has assumed that Pasteuria nishizawae - Pnl does
not have a common mechanism of toxicity with other substances. Therefore, section
408(b)(2)(D)(v) of 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 U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or
tolerance exemption for a pesticide chemical residue, EPA shall assess the available information
about consumption patterns among infants and children, special susceptibility of infants and
children to pesticide chemical residues, and the cumulative effects on infants and children of the
residues and other substances with a common mechanism of toxicity. In addition, FFDCA
section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of
exposure (safety) for infants and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA
determines that a different margin of exposure (safety) will be safe for infants and children. This
additional margin of exposure (safety) is commonly referred to as the Food Quality Protection
Act Safety Factor. In applying this provision, EPA either retains the default value of 10X or uses
a different additional safety factor when reliable data available to EPA support the choice of a
different factor.
Based on the acute toxicity and pathogenicity data discussed in section IV(B)(l)(a) and Tables 5
and 6 in Appendix A. as well as Pasteuria nishizawae - Pnl's host specificity for the soybean
cyst nematode, EPA concludes that there are no threshold effects of concern to infants, children,
or adults when Pasteuria nishizawae - Pnl 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 and EPA analysis as presented directly above, the Agency is
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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
nishizawae - Pnl 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 nishizawae - Pnl 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 nishizawae - Pnl 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 nishizawae - Pnl 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.
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 nishizawae - Pnl 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 nishizawae - Pnl pesticide products are used in
accordance with EPA-approved 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 nishizawae - Pnl 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, IE, 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 nishizawae - Pnl. 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.
For a summary of the generic data requirements described in sections IV(C)(1), refer to Table 7
in Appendix A.
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Biopesticides Registration Action Document
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. 481517-17): The
proposed end-use pesticide products are for use on soybeans. 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 nishizawae - Pnl spores into
the root zone. Therefore, both formulations will primarily deposit Pasteuria nishizawae - Pnl
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 nishizawae - Pnl.
Pasteuria spp. are widespread in their distribution throughout the world. 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). Pasteuria nishizawae is considered to be an obligate parasite of Heterodera glycines and
is known only to infect and complete its life cycle within females of Heterodera glycines (Noel et
al. 2005; Sayre et al. 1991). Therefore, Pasteuria nishizawae - Pnl 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. 481517-09) and an
acute oral toxicity study (MRID No. 481517-13) are available to evaluate the potential effects of
Pasteuria nishizawae - Pnl on wild mammals. In the acute oral toxicity/pathogenicity study,
laboratory rats were dosed with approximately 1.6 x 109 spores/animal and were observed for 21
days. No signs of toxic or pathogenic effects were found as a result of the exposure. This 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 nishizawae - Pnl 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 nishizawae - Pnl.
Nontarget plant testing is not required because Pasteuria nishizawae is not related to any known
plant pathogen. Adverse effects on plants are not expected to result from the proposed pesticidal
applications of Pasteuria nishizawae - Pnl.
Additionally, there are no reports of toxicity or pathogenicity of Pasteuria nishizawae to
nontarget terrestrial animals or plants. To support its data waiver rationale, the applicant
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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," and "plant" for
all of the years available (1926-present). The search was also performed with the search term
"Pasteuria nishizawae." No unanticipated reports of adverse effects of Pasteuria nishizawae or
other Pasteuria species in nontarget organisms were found in any of these searches.2 Any reports
of effects to nontarget organisms related to Pasteuria nishizawae that are found in the future may
trigger the need for testing; however, given the specificity of Pasteuria spp. 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
nishizawae - Pnl.
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 Nontarset Plants (Harmonized Guideline 885.4300) (MRID No. 481517-17):
Since the proposed applications are intended to deposit Pasteuria nishizawae - Pnl 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 nishizawae - Pnl in the root zone of the treated plants, so these
amounts are not likely to be significant. Pasteuria nishizawae and other Pasteuria spp. are
naturally found in soil, so some natural presence of Pasteuria nishizawae in surface waters is
expected. To date, no information is available on the size of naturally occurring populations of
Pasteuria nishizawae.
Data waiver 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 nishizawae - Pnl. The rationale was similar to that presented for
terrestrial organisms in that Pasteuria spp. are found in soils worldwide, and Pasteuria
nishizawae is known only to parasitize females of Heterodera glycines. Pasteuria ramosa is a
closely related species that parasitizes Daphnia magna and other Daphnia spp. (Ebert et al.
1996); however, it is widely understood that all other known Pasteuria spp. are obligate parasites
of soil-dwelling nematodes (Atibalentja et al. 2004; Chen and Dickson 1998; Sayre et al. 1991).
2 Pasteuria ramosa is already recognized as parasitizing water fleas and is not considered an "unanticipated" report.
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There are no available reports in the literature documenting pathogenicity or toxicity to
freshwater fish or invertebrates as a result of exposure to Pasteuria nishizawae. 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 reports of adverse
effects of Pasteuria nishizawae - Pnl in aquatic nontarget organisms were found in any of these
searches. 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 spp. 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 nishizawae - Pnl.
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 nishizawae - Pnl,
further testing at higher tier levels (i.e., Tiers II, HI, 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 nishizawae - Pnl as a result of the proposed applications, effects to 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 nishizawae - Pnl, 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
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result their location, cultural practices, or other factors, may have atypical, unusually high
exposure to Pasteuria nishizawae - Pnl, 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. gov/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 nishizawae - Pnl pesticide products have well-known
properties. EPA has no knowledge that would contradict the claims made on the Soyacyst Tech,
Soyacyst Tech+, and Soyacyst 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 nishizawae - Pnl
pesticide products will not cause any unreasonable adverse effects on the environment, and
Soyacyst Tech+ and Soyacyst LF (end-use pesticide products), in particular, are likely to provide
protection against soybean cyst nematode as claimed, satisfying criterion 3. Criterion 4 is
satisfied in that the Pasteuria nishizawae - Pnl pesticide products are not expected to cause
unreasonable adverse effects when used according to label instructions. Therefore, Soyacyst
Tech, Soyacyst Tech+, and Soyacyst LF, containing Pasteuria nishizawae - Pnl 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 nishizawae - Pnl for shipment, the
registrant is required to provide appropriate final printed labeling to EPA.
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B. Terms of Registration
No additional data are being required as terms of registration.
C. Reporting of Adverse Effects and Hypersensitivity Incidents
Notwithstanding the information stated in the previous sections, it should be clearly understood
that certain specific data are required to be reported to EPA as a requirement for maintaining the
federal registration for a pesticide product. A brief summary of these types of data are 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.
w/w
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
weight to weight
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IX. BIBLIOGRAPHY
A. Studies Submitted to Support the Pasteuria nishizawae - Pnl Pesticide Product
Registrations
MRIDNo.
Study Information
481517-01 Macintosh S, Smith K. 2010. Product Identity: Pasteuria nishizawae - Pnl.
Project Number: PBI/2010/001. Unpublished study prepared by Macintosh &
Associates, Inc. and Pasteuria Bioscience, Inc., 90 pages.
481517-02 Smith K. 2010. Manufacturing Process for Pasteuria nishizawae - Pnl. Project
Number: PBI/2010/002. Unpublished study prepared by Pasteuria Bioscience,
Inc., 36 pages.
481517-03 Macintosh S. 2010. Discussion of Formation of Unintentional Ingredients:
Pasteuria nishizawae - Pnl. Project Number: 14060/10. Unpublished study
prepared by Macintosh & Associates, Inc., 29 pages.
481517-04 Smith K. 2010. Analysis of Samples/Enforcement Methods for Pasteuria
nishizawae - Pnl. Unpublished study prepared by Pasteuria Bioscience, Inc., 62
pages.
481517-05 Smith K. 2010. Certification of Limits for Pasteuria nishizawae - Pnl. Project
Number: PBI/2010/004. Unpublished study prepared by Pasteuria Bioscience,
Inc., 8 pages.
481517-06 Kaminsky M. 2010. Pasteuria nishizawae - Pnl Product Chemistry: Final Report.
Project Number: 13885/10. Unpublished study prepared by Stillmeadow, Inc., 16
pages.
481517-07 Smith K. 2010. Product Stability to Elevated Temperatures: Pasteuria nishizawae
- Pnl. Project Number: 115/54. PBI/2010/005. Unpublished study prepared by
Pasteuria Bioscience, Inc., 8 pages.
481517-08 Smith K. 2010. Storage Stability & Corrosion Characteristics for Pasteuria
nishizawae. Project Number: 13886/10, PBI/2010/002. Unpublished study
prepared by Pasteuria Bioscience, Inc., 16 pages.
481517-09 Gingras B. 2010. Toxicity/Pathogenicity Testing of Pasteuria nishizawae - Pnl
Following Acute Oral Challenge in Rats. Project Number: 2262/SN4.
Unpublished study prepared by IIT Research Institute, 58 pages.
481517-10 Gingras B. 2010. Toxicity/Pathogenicity Testing of Pasteuria nishizawae - Pnl
Following Acute Intratracheal Challenge in Rats - Final Report. Project Number:
2262/SN5. Unpublished study prepared by IIT Research Institute, 53 pages.
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MRIDNo.
Study Information
481517-11 Gingras B. 2010. Toxicity/Pathogenicity Testing of Pasteuria nishizawae - Pnl
Following Acute Injection Challenge in Rats. Project Number: 2262/SN6.
Unpublished study prepared by IIT Research Institute, 56 pages.
481517-12 Macintosh S. 2010. Hypersensitivity Incidents: Pasteuria nishizawae - Pnl.
Project Number: PBI/2010/007. Unpublished study prepared by Macintosh &
Associates, Inc., 7 pages.
481517-13 Sullivan D. 2010. Acute Oral Toxicity Study of Pasteuria nishizawae - Pnl in
Rats. Project Number: 2262/SN11. Unpublished study prepared by IIT Research
Institute, 28 pages.
481517-14 Sullivan D. 2010. Acute Dermal Toxicity Study of Pasteuria nishizawae - Pnl in
Rabbits. Proj ect Number: 2262/SN12. Unpublished study prepared by IIT
Research Institute, 30 pages.
481517-15 Sullivan D. 2010. Acute Eye Irritation Study of Pasteuria nishizawae-Pnl in
Rabbits. Proj ect Number: 2262/SN13. Unpublished study prepared by IIT
Research Institute, 25 pages.
481517-16 Sullivan D. 2010. Acute Dermal Irritation Study of Pasteuria nishizawae - Pnl in
Rabbits. Proj ect Number: 2262/SN14. Unpublished study prepared by IIT
Research Institute, 24 pages.
481517-17 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 nishizawae - Pnl.
Project Number: PBI/2010/014. Unpublished study prepared by Macintosh &
Associates, Inc., 29 pages.
482103-01 Macintosh S, Smith K. 2010. Product Identity and Manufacturing Process:
Pasteuria nishizawae - Pnl (Liquid Formulation; End Product). Project Number:
PBI/2010/020. Unpublished study prepared by Pasteuria Bioscience, Inc. and
Macintosh & Associates, Inc., 17 pages.
482103-02 Macintosh S. 2010. Discussion of Formation of Unintentional Ingredients:
Pasteuria nishizawae - Pnl (Liquid Formulation; End Product). Unpublished
study prepared by Macintosh & Associates, Inc., 6 pages.
482103-03
Smith K. 2010. Analysis of Samples/Enforcement Methods for Pasteuria
nishizawae - Pnl (Liquid Formulation; End Product). Unpublished study prepared
by Pasteuria Bioscience, Inc., 20 pages.
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MRIDNo.
Study Information
482103-04 Smith K. 2010. Certification of Limits for Pasteuria nishizawae - Pnl (Liquid
Formulation; End Product). Project Number: PBI/2010/022. Unpublished study
prepared by Pasteuria Bioscience, Inc., 8 pages.
482103-05 Kaminsky M. 2010. Pasteuria nishizawae - Liquid Formulation: Product
Chemistry - Final Report. Project Number: 14070/10. Unpublished study
prepared by Stillmeadow, Inc., 8 pages.
482103-06 Smith K. 2010. Storage Stability: Interim Report Pasteuria nishizawae - Pnl
(Liquid Formulation; End Product). Project Number: PBI/2010/023. Unpublished
study prepared by Pasteuria Bioscience, Inc., 8 pages.
482103-07 Smith K. 2010. Corrosion Characteristics for Pasteuria nishizawae - Pnl (Liquid
Formulation; End Product). Project Number: PBI/2010/024. Unpublished study
prepared by Pasteuria Bioscience, Inc., 11 pages.
482103-08 Macintosh S. 2010. Hypersensitivity Incidents: Pasteuria nishizawae - Pnl
(Liquid Formulation; End Product). Project Number: PBI/2010/024. Unpublished
study prepared by Macintosh & Associates, Inc., 11 pages.
482103-09 Sullivan D. 2010. Acute Oral Toxicity Study of Pasteuria nishizawae - Pnl (End
Product) in Rats. Project Number: 2262/SN15. Unpublished study prepared by IIT
Research Institute, 28 pages.
482103-10 Sullivan D. 2010. Acute Dermal Toxicity Study of Pasteuria nishizawae - Pnl
(End Product) in Rabbits. Project Number: 2262/SN20. Unpublished study
prepared by IIT Research Institute, 28 pages.
482103-11 Sullivan D. 2010. Acute Eye Irritation Study of Pasteuria nishizawae - Pnl (End
Product) in Rabbits. Project Number: 2262/SN21. Unpublished study prepared by
IIT Research Institute, 22 pages.
482103-12 Sullivan D. 2010. Acute Dermal Irritation Study of Pasteuria nishizawae - Pnl
(End Product) in Rabbits. Project Number: 2262/SN22. Unpublished study
prepared by IIT Research Institute, 22 pages.
482744-02 Kaminsky M. 2010. Pasteuria nishizawae - Pnl and Pasteuria nishizawae - Seed
Treatment: Product Chemistry - Final Report. Project Number: 14451/10.
Unpublished study prepared by Stillmeadow, Inc., 10 pages.
482744-05 Macintosh S. 2010. Request for Waivers from the Requirement to Conduct
Toxicology Guideline Study: Acute Inhalation Toxicity for Pasteuria nishizawae
- Pnl & Pasteuria nishizawae - Seed Treatment. Project Number: PBI/2010/027.
Unpublished study prepared by Macintosh & Associates, Inc., 7 pages.
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MRIDNo.
Study Information
482744-06 Macintosh S. 2010. Request for Waivers from the Requirement to Conduct
Toxicology Guideline Study: Acute Inhalation Toxicity for Pasteuria nishizawae
- Liquid Formulation. Project Number: PBI/2010/028. Unpublished study
prepared by Macintosh & Associates, Inc., 7 pages.
485915-01 Macintosh S, Smith K. 2011. Product Identity: Pasteuria nishizawae - Pnl.
Unpublished study prepared by Pasteuria Bioscience, Inc., 6 pages.
485915-02 Smith K. 2011. Manufacturing Process for Pasteuria nishizawae-Pnl:
Supplement to MRID No. 481517-02. Unpublished study prepared by Pasteuria
Bioscience, Inc., 7 pages.
485915-03 Macintosh S. 2011. Discussion of Formation of Unintentional Ingredients -
Pasteuria nishizawae - Pnl: Supplement to MRID No. 481517-03. Unpublished
study prepared by Macintosh & Associates, Inc., 10 pages.
485915-04 Smith K. 2011. Analysis of Samples/Enforcement Methods for Pasteuria
nishizawae - Pnl: Supplement to MRID No. 481517-04. Unpublished study
prepared by Pasteuria Bioscience, Inc., 14 pages.
485915-05 Smith K. 2011. Storage Stability: Pasteuria nishizawae - Pnl - Final Report.
Project Number: PBI/2010/002. Unpublished study prepared by Pasteuria
Bioscience, Inc., 13 pages.
485915-06 KaminskyM. 2011. Pasteuria nishizawae-Vnl \ Corrosion Characteristics-
Final Report. Project Number: 13886/10. Unpublished study prepared by
Stillmeadow, Inc., 10 pages.
486052-01 Smith K. 2011. Storage Stability Pasteuria nishizawae - Liquid Formulation:
Supplement to MRID No. 482103-06 - Final Report. Project Number:
PBI/2010/023. Unpublished study prepared by Pasteuria Bioscience, Inc., 8 pages.
486052-02 Kaminsky M. 2011. Corrosion Characteristics Pasteuria nishizawae - Liquid
Formulation: Final Report. Project Number: 13887/10. Unpublished study
prepared by Stillmeadow, Inc., 11 pages.
486461-01 Smith K. 2011. New Sources of Inert Ingredients Pasteuria nishizawae - Pn 1
(TGAI/MP) and Pasteuria nishizawae - Seed Treatment (EP). Unpublished study
prepared by Pasteuria Bioscience, Inc., 51 pages.
486461 -02 Smith K. 2011. New Sources of Inert Ingredients Pasteuria nishizawae - Pn 1
(Liquid Formulations; EP) and Pasteuria nishizawae - Stabilized Seed Treatment
(EP). Unpublished study prepared by Pasteuria Bioscience, Inc., 101 pages.
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B. Environmental Protection Agency Risk Assessment Memoranda
U.S. EPA. 2011a. Pasteuria nishizawae strain Pnl. Memorandum from J.V. Gagliardi, Ph.D. and
J.L. Kough, Ph.D. to J. Kausch dated August 16, 2011.
U.S. EPA. 201 lb. Environmental Risk Assessment of Pasteuria nishizawae Pnl (PC 016455) for
a Section 3 Registration of the Technical Product (EPA File Symbol 85004-A) and Two
End Use Products (EPA File Symbols 85004-T and 85004-0) for Control of the Soybean
Cyst Nematode in Soybeans. Memorandum from S. Borges and G. Tomimatsu, Ph.D. to
J. Kausch dated September 15, 2011.
U.S. EPA. 201 lc. Pasteuria nishizawae strain Pnl from Pasteuria Bioscience, Inc. Memorandum
from J.V. Gagliardi, Ph.D. and J.L. Kough, Ph.D. to J. Kausch dated December 20, 2011.
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.
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.sov/healthywater/drinkins/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.
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Pasteuria nishizawae - Pnl
Biopesticides Registration Action Document
Page 25 of 34
Noel GR, Atibalentja N, Domier LL. 2005. Emended description of Pasteuria nishizawae.
International Journal of Systematic and Evolutionary Microbiology 55:1681-1685.
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.
U.S. EPA. 2004. Primer for Municipal Wastewater Treatment Systems. EPA 832-R-04-001.
Available from http://www. epa.sov/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 nishizawae -
Pnl, and the Manufacturing-Use Pesticide Product (MP), Soyacyst Tech (40 CFR § 158.2120)
Harmonized
Guideline
Number
Data Requirement
Results
MRU) No.
Pasteuria nishizawae - Pnl
Soyacyst Tech
885.1100
Product Identity
N/A
Submitted data fulfill the requirement
for product identity. Soyacyst Tech
contains 99.88% by weight Pasteuria
nishizawae - Pnl (contains at least 1 x
108 spores per gram).
481517-01
485915-01
486461-01
885.1200
Manufacturing
Process
Submitted data fulfill the requirement for manufacturing process.
481517-02
485915-02
N/A
Deposition of a
Sample in a
Nationally
Recognized Culture
Collection
Pasteuria nishizawae - Pnl is on
deposit with the American Type
Culture Collection in Manassas,
Virginia under Accession Number
SD-5833.
N/A
481517-01
485915-01
885.1300
Discussion of
Formation of
Unintentional
Ingredients
Submitted data fulfill the requirement for discussion of formation of
unintentional ingredients.
481517-03
485915-03
885.1400
Analysis of Samples
Submitted data fulfill the requirement for analysis of samples.
481517-04
485915-04
885.1500
Certification of
Limits
N/A
Limits listed on the confidential
statement of formula are
adequate/acceptable.
481517-05
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TABLE 2. Product Analysis Data Requirements for the End-Use Pesticide Product (EPs), Soyacyst Tech+ and Soyacyst LF
(40 CFR § 158.2120)
Harmonized
Guideline
Number
Data Requirement
Results
MRU) No.
Soyacyst Tech+*
Soyacyst LF**
885.1100
Product Identity
Submitted data fulfill the
requirement for product
identity. Soyacyst Tech+
contains 99.88% by weight
Pasteuria nishizawae - Pnl
(contains at least 1 x 108
spores per gram).
Submitted data fulfill the
requirement for product
identity. Soyacyst LF contains
33.29% by weight Pasteuria
nishizawae - Pnl (contains at
least 1.3 x 107 spores per gram).
481517-01*
485915-01*
486461-01*
482103-01**
486461-02**
885.1200
Manufacturing Process
Submitted data fulfill the requirement for manufacturing
process.
481517-02*
485915-02*
482103-01**
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.
481517-03*
485915-03*
482103-02**
885.1400
Analysis of Samples
Submitted data fulfill the requirement for analysis of samples.
481517-04*
485915-04*
482103-03**
885.1500
Certification of Limits
Limits listed on the confidential statement of formula are
adequate/acceptable.
481517-05*
482103-04**
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TABLE 3. Physical and Chemical Characteristics for the Technical Grade of the Active Ingredient (TGAI), Pasteuria nishizawae -
Pnl, and the Manufacturing-Use Pesticide Product (MP), Soyacyst Tech (40 CFR § 158.2120)
Harmonized
Guideline Number
Data Requirement
Results
MRU) No.
Pasteuria nishizawae - Pnl
Soyacyst Tech
830.63021
Color
Light brown/caramel brown
481517-06
830.63031
Physical State
Liquid
830.63041
Odor
Faint odor/similar to dog food
830.63131
Stability to Normal and
Elevated
Temperatures, Metals,
and Metal Ions
Stable up to 14 days at 54°C without loss of viability
481517-07
830.6317
Storage Stability
Stable for one year when stored at 4°C
481517-08
485915-05
830.6319
Miscibility
N/A
Not required because
Soyacyst 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
Not corrosive to packaging
materials in a one-year study.
481517-08
485915-06
830.70001
PH
4.69-5.21 (1% w/w)
481517-06
830.7100
Viscosity
N/A
1.570 cSt(20°C)
1.046 cSt(40°C)
482744-02
830.73001
Density/Relative
Density/Bulk Density
(Specific Gravity)
1.04 g/mL (or 1.04 g/cm3)
481517-06
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 Soyacyst 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), Soyacyst Tech+ and Soyacyst LF
(40 CFR § 158.2120)
Harmonized
Guideline Number
Data Requirement
Results
MRU) No.
Soyacyst Tech+*
Soyacyst LF**
830.63021
Color
Light brown/caramel
brown
N/A
481517-06
830.63031
Physical State
Liquid
N/A
481517-06
830.63041
Odor
Faint odor/similar to dog
food
N/A
481517-06
830.63131
Stability to Normal and
Elevated Temperatures,
Metals, and Metal Ions
Stable up to 14 days at
54°C without loss of
viability
N/A
481517-07
830.6317
Storage Stability
Stable for one year when stored at 4°C
481517-08*
485915-05*
482103-06**
486052-01**
830.6319
Miscibility
Not required because the end-use pesticide products,
Soyacyst Tech+ and Soyacyst 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
Not corrosive to packaging materials in a one-year study.
481517-08*
485915-06*
482103-07**
486052-02**
830.7000
pH
4.69-5.21 (l%w/w)'
3.5-4.52
481517-06*
830.7100
Viscosity
1.570 cSt (20°C)
1.046 cSt (40°C)
318.2 cSt(20°C)
255.15 cSt (40°C)
482744-02*
482103-05**
830.7300
Density/Relative
Density/Bulk Density
(Specific Gravity)
1.04 g/mL (or 1.04 g/cm3)1
8.5 lb/gal2
481517-06*
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 Soyacyst Tech+, 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 nishizawae - Pnl, and
the Manufacturing-Use Pesticide Product (MP), Soyacyst Tech (40 CFR § 158.2140)
Harmonized
Guideline
Number
Data Requirement
Results
MRU) No.
Pasteuria nishizawae - Pnl
Soyacyst 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 1.6 x 109 spores per
animal. Although clearance and
infectivity were not measured, EPA
believes these endpoints are not a
concern given Pasteuria nishizawae -
Pnl's well-established host specificity
for the soybean cyst nematode.
Classification: Supplemental
N/A
481517-09
885.3150
Acute Pulmonary
T oxicity/Pathogenicity
Not toxic and/or pathogenic to rats
when administered by intratracheal
instillation in a single dose of 1.6 x 108
spores per animal. Although clearance
and infectivity were not measured, EPA
believes these endpoints are not a
concern given Pasteuria nishizawae -
Pnl's well-established host specificity
for the soybean cyst nematode.
Classification: Supplemental
N/A
481517-10
885.3200
Acute Injection
T oxicity/Pathogenicity
(Intraperitoneal)
Not toxic and/or pathogenic to rats
when administered intravenously in a
single dose of 1.0 x 109 spores per
animal. Although clearance and
infectivity were not measured, EPA
believes these endpoints are not a
concern given Pasteuria nishizawae -
Pnl's well-established host specificity
for the soybean cyst nematode.
Classification: Supplemental
N/A
481517-11
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)).
481517-12
885.3500
Cell Culture
Not required because Pasteuria
nishizawae - Pnl 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
481517-13
870.1200
Acute Dermal Toxicity
N/A
Dermal LD50 combined (male and
female rabbits) > 2,000 mg/kg
Classification: Acceptable
TOXICITY CATEGORY IV
481517-14
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TABLE 5. Toxicology Data Requirements for the Technical Grade of the Active Ingredient (TGAI), Pasteuria nishizawae - Pnl, and
the Manufacturing-Use Pesticide Product (MP), Soyacyst Tech (40 CFR § 158.2140)
Harmonized
Guideline
Number
Data Requirement
Results
MRU) No.
Pasteuria nishizawae - Pnl
Soyacyst Tech
870.1300
Acute Inhalation
Toxicity
N/A
Waived based on the results of
MRIDNo. 481517-10 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
482744-05
870.2400
Acute Eye Irritation
N/A
Soyacyst Tech was essentially
non-irritating to the eyes of
rabbits.
Classification: Acceptable
TOXICITY CATEGORY IV
481517-15
870.2500
Primary Dermal
Irritation
N/A
Soyacyst Tech was essentially
non-irritating to the skin of
rabbits.
Classification: Acceptable
TOXICITY CATEGORY IV
481517-16
Tiers II and III
Not required for Pasteuria nishizawae - Pnl 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), Soyacyst Tech+ and Soyacyst LF
(40 CFR § 158.2140)
Harmonized
Guideline
Number
Data Requirement
Results
MRU) No.
Soyacyst Tech+*
Soyacyst 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)).
481517-12*
482103-08**
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
481517-13*
482103-09**
870.1200
Acute Dermal
Toxicity
Dermal LD50 combined (male and female rabbits) > 2,000 mg/kg
Classification: Acceptable
TOXICITY CATEGORY IV
481517-14*
482103-10**
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TABLE 6. Toxicology Data Requirements for the End-Use Pesticide Products (EPs), Soyacyst Tech+ and Soyacyst LF
(40 CFR § 158.2140)
Harmonized
Guideline
Number
Data Requirement
Results
MRID No.
Soyacyst Tech+*
Soyacyst LF**
870.1300
Acute Inhalation
Toxicity
Waived based on the results of MRID No. 481517-10 and because these
formulations contain 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
482744-05*
482744-06**
870.2400
Acute Eye Irritation
The EP test substances were essentially non-irritating to the eyes of rabbits.
Classification: Acceptable
TOXICITY CATEGORY IV
481517-15*
482103-11**
870.2500
Primary Dermal
Irritation
The EP test substances were essentially non-irritating to the skin of rabbits.
Classification: Acceptable
TOXICITY CATEGORY IV
481517-16*
482103-12**
TABLE 7. Nontarget Organism Toxicity and Environmental Fate Data Requirements for the Technical Grade of the Active
Ingredient (TGAI), Pasteuria nishizawae - Pnl (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
481517-17
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
481517-17
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
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TABLE 7. Nontarget Organism Toxicity and Environmental Fate Data Requirements for the Technical Grade of the Active
Ingredient (TGAI), Pasteuria nishizawae - Pnl (40 CFR § 158.2150)
Harmonized Guideline
Number
Data Requirement
Results
MRU) No.
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
481517-17
885.4380
Honey Bee Testing
Tiers II, III, and IV
Not required for Pasteuria nishizawae - Pnl based on the acceptability of the data and other information provided for Tier I.
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APPENDIX B. PESTICIDE PRODUCTS
EPA
Registration
Number
Registration
Name
Percentage
Active
Ingredient
Formulation
Type
Use
Site(s)
Method(s) of
Application
Application Rate(s)
Target Pest
85004-6
Soyacyst
Tech
99.88%
Technical
N/A
N/A
N/A
N/A
85004-7
Soyacyst
Tech+
99.88%
End Use -
Liquid
Soybean
Seed Treatment
(Preplant or Commercial)
2-5 fluid ounces of
Soyacyst Tech+ per 100
pounds of soybean seed
Soybean cyst
nematode
(Heterodera glycines)
85004-9
Soyacyst LF
33.29%
End Use -
Liquid
Soybean
Seed Treatment
(Preplant or Commercial)
2-5 fluid ounces of
Soyacyst LF per 100
pounds of soybean seed
Soybean cyst
nematode
(.Heterodera glycines)
Ground application
equipment or
chemigation
1.3-64 fluid ounces of
Soyacyst LF per 1,000
square feet of soybean
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