vvEPA
United States
Environmental Protection
Agency
April 22 2008
BIOPESTICIDES REGISTRATION ACTION DOCUMENT
Bacillus firmus 1-1582
(PC Code 029072)
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Biopesticide Registration Action Document for
Bacillus firmus 1-1582
PC Code 029072
Prepared by Shanaz Bacchus
U.S. Environmental Protection Agency
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division
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Biopesticides Registration Action Document Final draft Biopesticides and Pollution Prevention Division
TABLE OF CONTENTS
Bacillus firmus 1-1582
(PC Code 029072)
Page
I. EXECUTIVE SUMMARY/FACT SHEET 5
II. OVERVIEW 8
A. Product Overview 8
B. Use Profile 8
C. Estimated Usage 9
D. Data Requirements 9
E. Regulatory History 9
III. RISK ASSESSMENT 11
A. Physical and Chemical Properties Assessment 11
1. Product Identity and Mode of Action 11
2. Physical And Chemical Properties Assessment 12
B. Human Health Assessment 14
1. Toxicology Assessment 14
2. FQPA Considerations 20
3. Occupational and Residential Exposure and Risk Characterization 22
C. Environmental Assessment 23
1. Ecological Effects Hazard Assessment 23
2. Environmental Assessment 28
3. Endangered Species 28
IV. RISK MANAGEMENT AND REGISTRATION DECISION 29
A. Determination of Eligibility 29
B. Regulatory Position 30
C. Labeling 31
V. ACTIONS REQUIRED BY REGISTRANTS 32
VI. APPENDICES 33
APPENDIX A-Citations 33
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List of Tables Page
Table 1: Product identity and manufacturing process for Bacillus firmus 1-1582 12
Table 2. Physical and Chemical Properties for the TGAI Bacillus firmus
and the EPa Chancellor™
13
Table 3: Acute mammalian toxicology data requirements
for Bacillus firmus 1-1582 - TGAI 15
Table 4. Microbial pesticides nontarget organism data requirements for Bacillus firmus
Strain 1-1582 24
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BIOPESTICIDE REGISTRATION ACTION DOCUMENT TEAM
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division
Microbial Pesticides Branch
Health Effects
John Kough Biologist
Carl Etsitty Microbiologist
Ecological Effects
Gail Tomimatsu Plant Pathologist
Zigfridas Vaituzis Microbiologist
Regulations
Sheryl Reilly Chief, Microbial Pesticides Branch
Shanaz Bacchus Chemist, Regulatory Action Leader
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EPA-HQ-OPP-2007-0159 Bacillus firmus isolate 1582 April 22, 2008
Biopesticides Registration Action Document Final draft Biopesticides and Pollution Prevention Division
I. EXECUTIVE SUMMARY/FACT SHEET
Active Ingredient and Proposed Use
The active ingredient, Bacillus firmus isolate 1582 (B. firmus 1-1582), is a naturally
occurring, soil bacterium which possesses nematicidal activity. It is intended to protect roots
from nematode infestation, when applied directly to the soil, foliar treatment to turf, and as seed
treatments. For these uses, B. firmus 1-1582 is classified as a biological nematode suppressant.
The proposed uses include agricultural and residential outdoor and greenhouse applications to
fruit, vegetable, and field crops, including non-food crops such as turf and ornamentals. The
isolate has been deposited with the Collection Nationale de Cultures de Microorganismes
(CNCM), Institute Pasteur, France, on May 29, 1995 under Accession Number CNCMI-1582.
The Agency's Biopesticides and Pollution Prevention Division (BPPD) reviewed the
database submitted to support the registration of'Bacillusfirmus 1-1582, and determined that the
active ingredient meets the standards for pesticide registration and food use under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by the Food Quality
Protection Act (FQPA) of 1996. Details of the Agency's evaluations of Bacillus firmus 1-1582
are included in this Biopesticides Registration Action Document (BRAD).
Toxicology, Human Exposure and Risks
Toxicology Assessment
Data from toxicological and pathogenicity studies, and related information from the
scientific literature, submitted to the Agency in support of the pesticidal uses for B. firmus 1-1582
placed the active ingredient in Toxicity Category IV for the acute oral, dermal, intravenous and
pulmonary routes of exposure in laboratory mammals (refer to the Human Health Assessment in
Chapter II.B). Microbial clearance from all tissues analyzed in these studies was observed.
These data demonstrate that B. firmus 1-1582 is not toxic, infectious or pathogenic to laboratory
animals under the study conditions. Based on these data and the anticipated low exposure to
humans and the environment from the soil, turf, and seed treatment applications, the Agency
granted a request to waive the requirements for primary eye irritation and immune response data.
However, Personal Protective Equipment (PPE) is required to mitigate potential eye exposure to
agricultural workers and other pesticide handlers. There were no endpoints that triggered Tier II
or Tier III data requirements for B. firmus 1-1582. At such time as additional uses are proposed,
the Agency may require additional data to support those uses.
Food Tolerances
Concurrent with the registration of this active ingredient as a pesticide, the Agency is
establishing an exemption from the requirement for a tolerance for residues of B. firmus 1-1582
in or on all food and animal feed commodities, as required under Section 408 of the Federal
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Food, Drug, and Cosmetics Act (FFDCA). This exemption will apply only to those situations
when the pesticide is applied directly to the soil and as a seed treatment. The final rule
establishing the exemption will be published in the Federal Register, and appear in part 180 of
Title 40 of the Code of Federal Regulations.
FQPA Considerations
The Agency has assessed the toxicology database for B. firmus 1-1582 in light of the
safety factors listed in FQPA, and has concluded with reasonable certainty that the proposed uses
of this microbial insecticide do not pose a dietary risk to the US population in general, and to
infants and children in particular (refer to Chapter III.B.3 of this BRAD). Since the microbe is
not expected to survive municipal treatment of drinking water, dietary exposure via drinking
water is also not expected to pose risks to these populations from the pesticidal uses of this active
ingredient (refer to Chapter III.B.5 of this BRAD).
Occupational and Residential Exposure and Risk
The potential for aggregate, non-occupational exposure from agricultural applications is
unlikely since it will be applied directly to the soil, turf, or as a seed treatment. However, the
potential exists for human exposure to B. firmus 1-1582 as a result residential and greenhouse
uses. Chapter III.B.3 of this BRAD addresses the potential occupational exposure to Bacillus
firmus 1-1582. Should accidental exposure occur, the microbe is not expected to pose any harm
to workers and pesticide handlers due to its low toxicity and lack of infectivity and pathogenicity
to mammalian species. As required by the Worker Protection Standards (WPS), appropriate
Personal Protective Equipment (PPE) are required and a Restricted Entry Interval (REI) has been
established for agricultural applications to mitigate potential exposure and risks to agricultural
workers and pesticide applicators. The homeowner should wear protective eye equipment when
using any products containing the active ingredient as a pesticide. However, since B. firmus I-
1582 is not toxic, infective or pathogenic to humans and other mammals if exposure were to
occur to homeowners and other non-agricultural pesticide applicators, the risk concerns would be
negligible to non-existent.
Ecological and Environmental Exposure and Risks
The data from three acceptable studies for toxicity to non-target avian (oral route of
exposure), aquatic invertebrate and honeybees were submitted in support of the pesticidal uses of
B. firmus 1-1582. Requests to waive non-target avian (inhalation route of exposure), wild
mammals, terrestrial and aquatic plants, insects, and estuarine and marine invertebrates, were
submitted with acceptable, scientifically based rationale for waiving these required Tier I studies.
The submitted studies, acceptable waivers, and information from publicly available, scientific
literature were reviewed by BPPD scientists, who determined that the use of B. firmus strain I-
1582 as a biological nematode suppressant will not pose incremental risks to non-target
organisms or to the environment.
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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 - in the
development, implementation, and enforcement of environmental laws, regulations, and policies.
At this time EPA does not believe that the proposed use of'Bacillusfirmus 1-1582 as a pesticide
will cause harm or a disproportionate impact on at-risk communities. For additional information
regarding environmental justice issues, please visit EPA's website at:
http://www.epa.gov/compliance/environmentaljustice/index.html.
Endangered Species Considerations
Bacillus firmus 1-1582 is a bacterium intended to suppress nematodes and to protect roots
of plants. The target plant pests are nematodes and there are no Federally-listed endangered
nematode species. Plant-parasitic nematodes are not capable of infecting animal hosts. Bacillus
firmus 1-1582 does not pose a risk to Federally-listed plant species of concern. Based on
information submitted and publicly available literature, the Agency concluded that treatment of
agricultural or residential plants or soils with Bacillus firmus 1-1582 will have no direct or
indirect effect on endangered or threatened fauna or flora. As a result, the Agency has
determined that the proposed uses of Bacillus firmus 1-1582 will have "No Effect" (NE) on
endangered or threatened terrestrial or aquatic species as listed by the U.S. Fish and Wildlife
Service (USFWS) and the National Marine Fisheries Services (NMFS). The Agency does not
require labeling or additional data for endangered species for the proposed uses of Bacillus
firmus 1-1582 as a pesticide.
Data Gaps and Requirements/Labeling
The Agency has evaluated all submissions for Bacillus firmus 1-1582 for the proposed
pesticidal uses and has concluded that they are sufficient to support the data requirements for
microbial pesticide registration. If in the future more different use patterns are sought (e.g.,
foliar treatment of other agricultural, terrestrial, or aquatic sites), or if other methods of
application are proposed, additional data may be required. Hypersensitivity incidents must be
immediately reported to the EPA, as required under FIFRA Section 6(a)(2), 40 CFR Part
158.690(c), and OPPTS data requirement 885.3400, so that the Agency may take appropriate
regulatory action to mitigate any potential risk.
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II. OVERVIEW
A. Product Overview
Biological Name:
Patent Number:
Culture Deposit:
Bacillus firmus 1-1582
US Patent 6406690; Inventors: Peleg; Itzhak (Maccabim,
IL), Feldman; Katherina (Jerusalem, IL) Assignee:Minrav
Industries Ltd. (Jerusalem, IL)
Collection Nationale de Cultures de Microorganismes
(CNCM), Institute Pasteur, France, on May 29, 1995 under
Accession Number CNCMI-1582.
Trade/Other Names:
Chancellor
OPP Chemical Code:
Basic Manufacturer:
B. Use Profile
Type of Pesticide:
Use Sites:
029072
AgroGreen, Biological Division
Minrav Infrastructures (1993) Ltd.
3 Habossem Str, P.O. Box 153
Ashdod 77101, Israel.
Current US representative:
SciReg, Inc.
12733 Director's Loop
Woodbridge, VA 22192, USA.
Nematode suppressant
(1) for vegetables, fruits, cotton, herbs, spices, and tree
nuts, the product will be incorporated into soil via
drenching, placement in the furrow, or drip irrigation;
(2) for container-grown seedlings, trees and shrubs, field
ornamentals and bulbs, and greenhouse ornamentals, the
product will be applied by drench or drip irrigation;
(3) for bare root seedlings, the product will be applied as a
root dip;
(4) for seeds, the product will be applied as a coating prior
to planting; and
(5) for turf, as a foliar spray or fertigation treatment. Other
use sites and applications include: compost and other soil-
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less mixes treatments and residential outdoor terrestrial
uses, for application(s) via a watering can, pressure sprayer,
or hose-end sprayer. Soil and seed treatments to
agricultural and home and residential outdoor and
greenhouse applications to fruit, vegetable, and field crops,
as well as non-food crops such as turf, and ornamentals.
Target Pests: Plant-parasitic nematodes
Formulation Types: Liquid formulation containing 0.66% w/w Bacillus firmus
(Bf) strain 1-1582 (a minimum of 4 x 108 cfu/g)
Method of For use at labeled rates by drip irrigation, application to
Application /Rate: soil, foliar application to turf; seed treatments
C. Estimated Usage
This is the new pesticidal active ingredient, so usage has not been reported.
D. Data Requirements
The data and related information concerning the toxicity of B. firmus 1-1582, submitted
under Section 3(c)(5) of FIFRA in support of an unconditional pesticide registration, have been
reviewed by BPPD. All of the Tier I data requirements for this microbial pesticide have been
adequately addressed.
E. Regulatory History
1. Experimental Use Permit and Temporary Tolerance Exemption
No Experimental Use Permit (EUP) or temporary tolerance exemption is associated with
this active ingredient.
2. Registration and Exemption from Tolerance
On March 7, 2007, the Agency published a notice in the Federal Register (72 FR 10210-
10211) announcing that RegWest Company, LLC (RegWest), 30856 Rocky Road, Greeley, CO
80631-9375, USA, submitted an application to register a pesticide on behalf of AgroGreen
Biological Division, Minrav Infrastructures (1993) Ltd., 3 Habossem Str, P.O. Box 153, Ashdod
77101, Israel. The EP is proposed to contain 0.66 percent of the active ingredient, Bacillus
firmus 1-1582. On behalf of the applicant, RegWest also filed a petition to establish an
exemption from the requirement of a tolerance for residues of Bacillus firmus 1-1582 in or on all
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food /animal feed commodities as published in the FR on March 21, 2007 (72 FR 13277-13279).
However, RegWest no longer represents AgroGreen, whose current US representative as of
March, 2008 is SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192, USA.
Data supporting both the pesticide application and the petition for the exemption
from tolerance were reviewed and found to meet the safety standards for pesticide
registration and food/feed use under FIFRA and FFDCA, as amended by FQPA 1996.
Consequently, the Agency will publish a final rule in the Federal Register to establish an
exemption from the requirement of a tolerance on all food/feed commodities for Bacillus
firmus 1-1582 when applied to soil or as a seed treatment to suppress plant-parasitic soil
nematodes.
3. Registration Review
The Food Quality Protection Act of 1996 mandated the continuous review of existing,
registered pesticides. All pesticides distributed or sold in the United States must generally be
registered by EPA, based on scientific data showing that they will not cause unreasonable risks
to human health, workers, or the environment when used as directed on product labeling. The
scientific database for every active ingredient and pesticide product is reviewed every 15 years,
as new scientific methods are continuously being developed. This new active ingredient will be
assigned a case number at the end of this 2008 Fiscal Year, and will be subject to registration
review, along with any registered products containing the active ingredient, at an appropriately
scheduled time in the 15 year cycle.
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III. RISK ASSESSMENT
On October 26, 2007, the Agency issued a Final Rule in the Federal Register (FR) on the
data requirements to support registration of biochemical and microbial pesticides and updated
definitions for both biochemical and microbial pesticides (72 FR 61002). This rule became
effective on December 26, 2007. The data from studies conducted in laboratory animals and
related information evaluated for the registration of B. firmus 1-1582 were considered in light of
these recently published microbial pesticide data requirements.
The studies submitted to the Agency were issued Master Record Identification numbers
(MRIDs) and reviewed by BPPD. The following summaries of the product identity and
manufacturing process for B. firmus 1-1582 are based on BPPD's reviews, or Data Evaluation
Records (DERs), dated March 05, 2008.
A. Physical and Chemical Properties Assessment
1. Product Identity and Mode of Action (MRID #s in Table 1; OPPTS 885.1100,
885.1200, 885.1300, 885.1400, 885.1500,151-10)
The taxonomy of the active ingredient is as follows: superkingdom, Bacteria; class,
Bacilli; family, Bacillaceae; phylum, firmicutes; order, Bacillales; and genus, Bacillus; species,
firmus. Bacterial spores of Bacillus firmus isolate 1-1582 definitive species identification was
performed by molecular analysis 16S rRNA sequence and DNA hybridization by DSM
laboratories. CNCM at Institute Pasteur assigned the accession number 1-1582 to the isolate
(strain). Bfhas been isolated chiefly from soil; pigmented strains are isolated mostly from salt
marshes. The species is genetically heterogeneous and several DNA homology groups have
been described. The spores are ellipsoid and there is no swelling of the sporangium.
The maximum temperature for growth is 40-45°C and the minimum temperature is 5-
10°C. The position of Bf spores in the cell is excentral, sporangium is not widened, and the
spores are oval in shape with a smooth surface. BJ1-1582 has species-unique biochemical
activities and has some anomalies from the species norm. These activities make it possible to
develop a methodology for precise identification of the BfI-1582 isolate. The definitive test for
the characterization, isolation, and identification of BfI-1582 are presented in detail in MRID
46933001.
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Table 1: Product identity and manufacturing process for Bacillus firmus 1-1582
TGAI
Data
Requirement
885.1100*
151-20**
885.1200
151-21
885.1300
151-22
885.1400
151-23
885.1500
151-25
830.1800
151-25
Test
Product identity
Manufacturing process
Discussion of
formation of
unintentional
ingredients
Analysis of samples
Certification of limits
Enforcement analytical
method
Classification
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
MRID#
46933006
47024801
47024804
47024803
46933004
EP
Classification
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
Acceptable
MRID#
46933001
46933006
46933002
46933003
47024802
46933005
46933004
46933003
47024802
46933005
*OPPTS 800 series Microbial pesticide test guidelines
**Microbial pesticide test guidelines identified in the code of federal regulations (40 CFR).
Analytical enforcement methods exist to maintain Quality Assurance and Quality
Control (QA/QC) of the pesticide products containing Bacillus firmus 1-1582. Fungal,
bacterial or any other contamination of toxicological concern must meet Agency
requirements for safety to allow use of the pesticide. All batches containing unintentional
ingredients of toxicological concern must be destroyed. No further data are required for
product identity at this time for the labeled uses of this Bacillus firmus 1-1582 pesticide
product. Additional product chemistry data may be required for requested amendments on a
case-by-case basis.
2. Physical and Chemical Properties Assessment (MRIDs 46933006 (EP) and 47024805
(TGAI); OPPTS 830.6302, 830.6303, 830.7000, 830.7300, 830.6320, 830.6317,151-17)
Reviews of data from MRID #s 46933006, 47187201 (EP) and 47024805 (TGAI)
regarding the Physical and Chemical properties of the pesticides are reported in Table 2 (BPPD
DER March 05, 2008).
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TABLE 2. Physical and Chemical Properties for the TGAI Bacillus firmus
and the EPa Chancellor™
Data
Requirement
830.6302
830.6303
830.6304
830.6313
830.6314
830.6317
830.6320
830.7000
830.7050
830.7100
830.7300
830.7520
Test
Color
Physical State
Odor
Stability
Oxidation/Reduction:
Chemical
Incompatibility
Storage Stability
Corrosion
Characteristics
PH
UV/Visible
absorption
Viscosity
Specific
Gravity /Bulk Density
Particle
Size/Distribution
Description of results
EP
Dark brown, almost black at 22°C
Liquid at 20°C
Slight odor of fertilizer or used cooking
oil at 22°C
Mean concentration unchanged after 3
monthsb.
Compatible with water, carbon dioxide,
powdered elemental iron (reducing
agent), gasoline, with a range of -1 .6 to
+0.4°C, except sodium hypochlorite
oxidizer with a temperature change of
+5.4°C.
Mean concentration unchanged after 3
monthsb. MRID 47187201
No evidence of corrosionb
MRID 47 187201
6.57 (1% w/v in distilled water);
8 as per CSF
Not required for EP.
The viscosity of Bf spores could not be
determined as the spores clogged the
viscometer, stopping the flow. The test
was rerun after removing the spores.
The viscosity of the carrier fluid was
2.18 cSt at 20°C and 1.59 cSt at 40°C.
1.11(20°C/20°C);
9.25 Ib/gal as per CSF
Not applicable
TGAI
Brown
Powder
Yeast extract-
like
Not addressed
Not required
for TGAI
Not addressed
Not required
for TGAI
8.65 (1%
suspension)
Not addressed
Not required
for TGAI
Density: 0.55-
0.65 g/mL
2.3 % weight
> 125|i
Methods
ASTMD1539-89
Visual inspection
Olfactory inspection
Federal Register Vol.
44, No. 53, p. 16267
Counts of diluted
stored EP - must
submit protocol and
description of method
Must submit protocol
and description of
method
ERASTME 70-90;
Fisher Accumet AB 1 5
pH meter using a
pH/ATC combination
electrode with
Ag/AgCl reference;
TGAI: Orion research
pH meter
Cannon-Fenske
viscometer
EP: Using Hubbard-
Carmick specific
gravity bottle
TGAI: By weighing a
graduated cylinder
filled with the test
substance
TGAI: Using a pre-
weighed standard
testing sieve (Gilson
Co.)
"Data from MRID 46933006 (EP) and 47024805 (TGAI). "Data from MRID 47187201 (EP)
Data requirements (40 CFR Part §158.740(a)) for UV/Visible absorption corrosion
characteristics, melting point, boiling point, solubility, vapor pressure, dissociation constant,
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octanol/water partition coefficient, stability, oxidizing or reducing potential, flammability/flash
point, explodability, viscosity, miscibility, and dielectric breakdown voltage were not required
for the TGAI due to the microbial nature of the pesticide.
Except for the need for reports noted regarding protocols and methods used to arrive at
results of storage stability and corrosion effects, all Physical and Chemical Properties data are
acceptable. The EP appears to be stable for three months MRID 47187201. In order to establish
an expiration date that is longer than three months, additional storage stability data will be
required.
B. Human Health Assessment
Submitted mammalian toxicology studies are sufficient to support the proposed
registration of Bacillus firmus 1-1582.
1. Toxicological Hazard Assessment
Tier I studies- TGAI
Agency review of the toxicity studies (BPPD DER 03/05/2008) classified the acute
oral, acute pulmonary and acute intravenous toxicity pathogenicity tests as acceptable for
supporting an unconditional registration of the active ingredient as a pesticide. The active
ingredient is considered Toxicity Category IV, and is not infectious or pathogenic to
laboratory rats by the oral, dermal, pulmonary and intravenous routes of exposure. A
request to waive the data requirements for the primary dermal irritation and primary eye
irritation was granted, based on the low toxicity/lack of infectivity and pathogenicity of the
active ingredient. However, appropriate Personal Protective Equipment (PPE) to mitigate
any potential risks to the pesticide will be needed if the use could result in skin and/or eye
exposure to agricultural workers and other pesticide handlers. The data are summarized in
TableS.
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Table 3: Tier I - Acute mammalian toxicology data requirements
for Bacillus firmus 1-1582 - TGAI
Data
Requirement
*885.3050
**152-30
885.3100
152-31
885.3150
152-32
885.3400
152-32
885.3200
152-33
870.2500
152-34
870.2400
152-35
885.3500
Test
Acute oral
toxicity
Acute dermal
toxicity
Acute
pulmonary
toxicity/
pathogenicity
Acute
inhalation
toxicity
Acute
Intravenous
injection
toxicity/
pathogenicity
Primary
dermal
irritation
Acute eye
irritation
Cell culture
Toxicity
Category &
Classification
IV
Acceptable
IV
Acceptable
IV
Acceptable
N/A
Not toxic or
pathogenic
Acceptable
N/A
Acceptable
DW rationale
N/A
Acceptable
DW rationale
N/A - test not
required
Test
Material
Bacillus
firmus
spores at
1010cfu/gby
oral gavage
5050 mg/kg
body weight
1010 cfu/g
by
intratracheal
instillation
N/A
Greater than
107
cfu/animal.
N/A
N/A
N/A
Results Summary
Clearance from the blood by
day 7 and from all other
organs by day 14. No signs of
treatment-related toxicity. Not
toxic, infective or pathogenic.
LD50 greater than 5050
mg/kg. Very slight to well
defined erythema on day 1
with clearance by day 4 in
treated rabbits.
Clearance from the blood,
kidneys, and liver by day 7
and from all other organs by
day 14.
Not required for non-volatile
pesticide. Acceptable
pulmonary test, not infective
or pathogenic; low application
rates; low inhalation exposure
Clearance from cecum and
liver by day 14 and from
brain, blood, kidneys, lymph
nodes, and spleen established
by day 21.
Rationale: acceptable acute
dermal test with Toxicity
Category IV; low exposure
from application methods;
appropriate PPE.
Rationale: acceptable acute
dermal test with Toxicity
Category IV; low exposure
from application methods.
Confirmatory test required.
Not required: active ingredient
is not a virus.
MRID#
46933007
46933008
46933009
46933009
and inerts
46933010
N/A
N/A
N/A
Tier III data requirements
870.2500
152-38
Immune
response
Tier III
TGAI
N/A
Acceptable
DW rationale
N/A
Based on acceptable toxicity
tests, immune systems cleared
microbe. Immune response
test is not required.
46933007
46933008
46933009
46933010
*OPPTS 800 series Microbial pesticide test guidelines
**Microbial pesticide test guidelines identified in the code of federal regulations (40 CFR).
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a. Acute Oral Toxicity and Pathogenicity (MRID 46933007; OPPTS 885.3050, 40
CFR ref. # 152-30)
Nineteen male and 19 female Sprague-Dawley rats were each treated by a single oral
gavage dose of 0.1 mL per animal (>108 cfu/animal) of Bacillus firmus 1-1582 spores. The
presented data showed no clinical signs and no weight loss related to test substance in rats.
Bacillus firmus I-1582was detected in brain, blood, cecum content, kidneys, lungs, lymph nodes,
and spleen of the treated animals with clearance from the blood by day 7 and from all other
organs by day 14. Necropsy was not conducted. Based on the presented/submitted data,
Bacillus firmus 1-1582 does not appear to be toxic, infective, and/or pathogenic in rats, when
dosed orally at > 108 cfu/animal. This study was classified as ACCEPTABLE and the pesticide
considered Toxicity Category IV for acute oral effects. No further data are required at this time
for this data requirement for the proposed uses.
b. Acute Dermal Toxicity (MRID 46933008; OPPTS 870.1200, CFR ref. # 152-31)
Five male and five female New Zealand White rabbits were each treated with 5050
mg/kg body weight Bacillus firmus 1-1582 spore suspension applied to the clipped dorsal trunk
in an area of approximately 10% of the body surface in a dermal occlusion test according to
standard laboratory procedures. Animals were observed for dermal irritation 60 minutes after
patch removal. The test animals were observed for mortality and clinical signs of toxicity at least
three times on the day of treatment and once daily thereafter for 14 days. The rabbits were
euthanized on day 14 and necropsies were performed.
With the exception of one female that lost weight during the first week, all animals had
normal body weight gain. All rabbits appeared normal during the study and all survived the
study. Very slight to well defined erythema was observed on day 1 with clearance by day 4. No
observable abnormalities were noted at necropsy. The dermal LD50 for males, females, and
combined was greater than 5050 mg/kg. Thus, Bacillus firmus 1-1582 is not toxic, infective, or
pathogenic via the dermal route of exposure, and the active ingredient is placed in Toxicity
Category IV for acute dermal effects. No further acute dermal toxicity data are required at this
time for the proposed uses.
c. Acute Pulmonary Toxicity/Pathogenicity (MRID 46933009; OPPTS 885.3150,
40CFR ref. # 152-32)
Thirty male and 30 female Sprague-Dawley rats received 0.1 mL per animal (>108
cfu/animal) Bacillus firmus 1-1582 by intratracheal instillation. The presented data show no
adverse abnormal clinical signs in rats. No test organisms were detected in any sample from the
control rats. All six animals sacrificed on day 3 had significant cfus (686 to 30731 cfu/g) in their
lungs. The test organism was detected in brain, blood, cecum content, kidneys, lungs, lymph
nodes, and spleen of the treated animals. Clearance was observed from the blood, kidneys, and
liver by day 7 and from all other organs by day 14. Necropsy studies were not conducted. Based
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on the presented/submitted data, the test organisms were not toxic, infective and/or pathogenic to
rats and the active ingredient was placed in Toxicity Category IV for acute pulmonary effects.
No further data are required at this time for this data requirement for the proposed uses.
d. Acute Intravenous Injection Toxicity/Pathogenicity (MRID 46933010; OPPTS
885.3200, CFR ref. # 152-33)
Twenty six male and 26 female Sprague-Dawley rats each received a dose of 0.1 mL per
animal (>107 cfu/animal), by injection into the tail vein. The presented data showed no
observable clinical signs in treated rats. No test organisms were recovered in any samples from
the control rats. The test organism was detected in the blood, kidneys, liver, lungs, lymph nodes,
and spleen of the treated rats. Clearance from the brain, blood, kidneys, lymph nodes, and
spleen was established by day 21 after dosing. Clearance from the cecum and liver was
established by day 14 after dosing. Necropsy studies showed no abnormal findings. Bacillus
firmus spores did not appear to be toxic, infective, and/or pathogenic in rats, when dosed at >107
cfu/animal. The submission is classified as acceptable.
e. Hypersensitivity Incidents OPPTS 885.3400)
The applicant did not report any adverse hypersensitivity incidents regarding this active
ingredient, Bacillus firmus 1-1582. Reports of incidents of adverse effects to humans or domestic
animals are required under FIFRA, Section 6(a)(2) and incidents of hypersensitivity under 40
CFR Part 158.690(c), and OPPTS data requirement 885.3400).
f. Cell Culture (OPPTS 885.3500)
Since Bacillus firmus 1-1582 is not a virus, this study is not required.
Tier I studies - End-Use Product - Waiver Requests
The following tests are generally required for Manufacturing (MP) or End-Use Products
(EP) containing the Microbial Pesticide Control agents (MPCAs).
870.1100 Acute oral toxicity
870.1200 Acute dermal toxicity
870.1300 Acute inhalation toxicity
870.2400 Acute eye irritation
870.2500 Primary dermal irritation
For the EP containing Bacillus firmus 1-1582, the applicant requested that these tests be waived
based on the following rationales:
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• The submitted studies conducted with the TGAI, (MRIDs 46933007, 46933008,
46933009, and 46933010 discussed in III.B.l and Table 3 above), did not show
pathogenicity to animals treated by oral gavage, dermal application, pulmonary
instillation, or intravenous injection.
• The active ingredient, Bacillus firmus strain 1-1582, is a naturally occurring
microorganism.
• No reports of adverse effects of Bacillus firmus or its metabolites to humans or mammals
were found in literature searches.
• The proposed drip irrigation and soil application uses of the proposed End-use Product
are not expected to result in increased exposure or adverse effects to humans or
mammals.
• The bacteria count falls to ineffective levels in the environment within 90 days of
treatment.
An acute inhalation toxicity study is not required for this non-volatile EP. The Agency,
nevertheless, considered the following:
• Lack of acute toxicity, infectivity, and pathogenicity in the pulmonary study (TUB. 1,
Table 3);
• The nature of the inert ingredients;
• The requirements for Personal Protective Equipment;
• The potential low exposure associated with the proposed drip irrigation and soil
application methods.
These led to the conclusion that acute inhalation effects are not likely to cause harm to
workers or to the non-occupationally exposed population. (OPPTS 870.1300; MRTD
46933009)
Tier II and Tier III studies
Waiver Requests for Tier II and Tier III data (OPPTS 885.3550; MRIDs 46933011;
47024806)
In the following discussion, the Agency evaluated rationales in support of the waivers for
these data requirements in the light of the new December 2007 microbial pesticide data
requirements (72 FR 61002). To address all data requirements during the submission of the
application, the applicant requested that the Agency waive the requirement for submission of
data to support the following Tier II and Tier III studies for the TGAI: Immune Response (152-
38), Immune Response (152-46); Reproductive/Fertility Effects (Virulence Enhancement) (152-
48), Reproductive/Fertility Effects (Mammalian Mutagenicity)(l 52-49). These data waiver
requests, though supported by the rationales submitted, are not required because the Agency
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concluded that there are no toxicological end points in the Tier I data which trigger the
requirement for Tier II or Tier III toxicological data.
g. Immune Response- Waiver Granted or Agency Assessment (OPPTS Old 880.3800,
New Tier III OPPTS 870.7800, CFR ref. # 152-38)
The following rationale supports the request to waive this Tier III data requirement. As expected
from a non-pathogenic microorganism, the submitted toxicity/pathogenicity studies in the rodent
(required for microbial pesticides) indicate that following several routes of exposure (III.B.l;
Table 3), the immune system is still intact and able to process and clear the active ingredient.
Therefore, no adverse effects to immune systems are known or expected. The Agency has also
evaluated the Tier I data submitted and concluded that there are no toxicological end points
which trigger the requirement for Tier II or Tier III toxicological data.
h. Subchronic, Chronic Toxicity and Oncogenicity
In terms of the new 2007 microbial pesticide Tier II and Tier III data requirements are:
(a) Tier II tests for acute toxicology (OPPTS 885.3550) and subchronic
toxicity/pathogenicity (OPPTS 885.3600); and
(b) Tier III tests for reproductive fertility effects (OPPTS 885.3650), carcinogenicity
(OPPTS 870.4200), immunotoxicity (OPPTS 870.7800) and
infectivity/pathogenicity analysis (OPPTS 885.3000).
The applicant had submitted requests to waive Tier II and Tier III data. However, those
requests, even though reviewed and found acceptable, are not necessary. Based on the data lack
of toxicity endpoints of concern in the data generated to satisfy Tier I data requirements, the
Agency does not require Tier II and Tier III test data for the proposed uses.
i. Effects on the Endocrine System
EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including all pesticide active and
other ingredients) "may have an effect in humans that is similar to an effect produced by a
naturally-occurring estrogen, or other such endocrine effects as the Administrator may
designate." Following the recommendations of its Endocrine Disrupter Screening and Testing
Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including,
as part of the program, androgen and thyroid hormone systems, in addition to the estrogen
hormone system. EPA also adopted EDSTAC's recommendation that it include evaluations of
potential effects in wildlife.
The Agency has no knowledge of Bacillus firmus 1-1582 being an endocrine disrupter,
nor if this microbe is related to any class of known endocrine disrupters. Consequently,
endocrine-related concerns did not impact the Agency's safety finding for these Bacillus firmus
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1-1582 strains. Additional data specifically on the endocrine effects of this microbial pesticide
are not required at this time. When the appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disrupter Screening Program (EDSP) have been
developed and implemented, Bacillus firmus 1-1582 may be subject to additional screening
and/or testing to better characterize effects related to endocrine disruption.
2. FQPA Considerations
Dietary Exposure and Risk Assessment
a. Food Clearances/Tolerances
An exemption from the requirement of a tolerance for residues of'Bacillus firmus I-
1582 is being established for soil applications and seed treatments concomitant with the
unconditional registration of the pesticide. Data supporting the exemption from tolerance
were reviewed and found to meet the safety standards of the Food Quality Protection Act
(FQPA) of 1996 and current FIFRA pesticide registration data requirements. The exemption
applies when Bacillus firmus 1-1582 is applied as a nematode suppressant at approved label
rates and on sites as described on the approved label.
b. Dietary Exposure and Risk Characterization
Dietary exposure to B. firmus 1-1582 as a result of pesticide treatment is highly unlikely,
but could occur. However, the lack of acute oral toxicity/pathogenicity observed in laboratory
animals supports the exemption from the requirement of a tolerance for this active ingredient.
The pesticide is intended to be applied to the soil or to be used as seed treatments, mainly for
control of nematodes and to protect the roots of agricultural crops. Thus, dietary exposure by
direct contact with food is not expected. The acute oral study described in Unit III indicates that
the active ingredient is not toxic, infective or pathogenic when administered to mammals (rats)
via the oral route of exposure. Other toxicology studies indicated that the microbe cleared all
organs within the time allotted for the studies.
There is no post-harvest treatment of food commodities with Bacillus firmus 1-1582.
Thus, detectable residues of Bacillus firmus 1-1582 are not expected in or on food commodities
or animal feed as a result of the proposed use of this active ingredient. Moreover, washing,
peeling and processing of any treated food or feed commodities before consumption would
further mitigate dietary exposure to the microorganism.
c. Drinking Water Risk Characterization
Bacillus firmus 1-1582 is a natural soil organism. Percolation through soil and municipal
treatment of drinking water would reduce the potential exposure to Bacillus firmus 1-1582
through drinking water from its use as a pesticide. However, even if negligible oral exposure
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should occur through drinking water, the Agency concludes that such exposure would present no
risk due to the lack of acute oral mammalian toxicity.
d. Acute and Chronic Dietary Exposure and Risks for Sensitive Subpopulations
Particularly Infants and Children
There is a reasonable certainty that no harm to the U.S. population, including infants and
children, will result from aggregate exposure to residues of'Bacillus firmus 1-1582 due to its use
as a pesticide. This includes all anticipated dietary exposures and all other exposures for which
there is reliable information. Bacillus firmus 1-1582 is not toxic, pathogenic, or infectious to
laboratory mammals.
e. Determination of Safety for U.S. Population, Infants and Children
See Chapter III.B. above for acute toxicological evaluations ofBacillus firmus 1-1582.
The FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold 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.
Margins of exposure, which often are referred to as uncertainty factors, are incorporated into
EPA's risk assessment either directly or through the use of a margin of exposure analysis or by
using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk.
Actual exposures to adults and children through diet are expected to be several orders of
magnitude less than the doses used in the toxicity and pathogenicity tests referenced in Chapter
III above. Thus, the Agency has determined that an additional margin of safety for infants and
children is unnecessary.
f. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and
Inhalation
In considering aggregate exposure, section 408 of FFDCA directs EPA to examine the
available information concerning human exposures to the active ingredient from non-
occupational oral, dermal, and inhalation exposures, including drinking water from ground water
or surface water from its use in gardens or buildings or on lawns (residential and other indoor
uses).
(i). Oral exposure would occur primarily from eating treated food commodities.
However, negligible risk is expected, because Bacillus firmus 1-1582 demonstrated no
pathogenicity or toxicity potential at the maximum doses tested. Based on the acute oral toxicity
study, the pesticide is classified as Toxicity Category IV for oral exposure (see Chapter III.B.2
above).
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(ii). Dermal exposure. As discussed in III.B, Bacillus firmus 1-1582 is not toxic, infective,
or pathogenic via the dermal route of exposure, and the active ingredient is placed in Toxicity
Category IV for acute dermal effects. The pesticide is proposed for use as soil and seed
treatments to agricultural crops. For these exposure scenarios, non-occupational dermal
exposure is not expected. The potential for non-occupational exposure exists for residential and
home and garden use. However, low application rates, soil applications and the low toxicity
potential of the active ingredient indicate that non-occupational exposure through these uses is
not likely to cause harm to the exposed population if the pesticide is used as labeled.
(Hi). Inhalation exposure. A similar rationale supports the Agency's conclusion that non-
occupational inhalation exposure is not likely to cause harm to the exposed population if the
pesticide is used as labeled. The active ingredient is placed in Toxicity Category IV on the basis
of the acute pulmonary study (see III.B.).
g. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to consider the cumulative
effect of exposure to Bacillus firmus 1-1582 and to other substances that have a common
mechanism of toxicity. These considerations include the possible cumulative effects of such
residues on infants and children. Bacillus firmus 1-1582 is not toxic or pathogenic to mammals
via several routes of exposure (Chapter III.B). There is no other Bacillus firmus strain registered.
Consequently, no cumulative effects from the residues of this product with other related
microbial pesticides are anticipated (see Chapter III.B. 1 above).
Other Considerations
3. Occupational and Non-occupational Residential Risk Characterization
a. Non-occupational Residential, School and Day Care Exposure, and Risk
Characterization
Bacillus firmus 1-1582 will be applied to agricultural and greenhouse sites, turf and other
approved sites as previously discussed in this BRAD (see Chapter II). Although some
applications may be made near residential areas, no harm would be expected to result from
exposure to Bacillus firmus 1-1582 due to its low toxicity classification (see Chapter III.B. 1
above). The Agency expects non-occupational dermal and inhalation exposure to pose no harm
if the pesticide is used as labeled. The pesticide is intended to be mainly used commercially for
seed and soil treatments of agricultural crops. Other homeowner and residential uses are also for
soil applications outdoors at very low rates. No indoor residential, school, or daycare uses are
currently permitted for this active ingredient. Even if there is non-occupational residential,
school or day care exposure from the proposed uses of Bacillus firmus 1-1582, the risk posed by
this low toxicity microbe is likely to be minimal.
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b. Occupational Exposure and Risk
Potential worker and pesticide handler exposure to Bacillus firmus 1-1582 is not expected
to pose any harm to workers. The primary routes of exposure for mixer/loaders and applicators
would be dermal and/or inhalation exposure. The acute dermal and pulmonary
toxicity/pathogenicity studies submitted in support of the registration demonstrated that Bacillus
firmus 1-1582 is not toxic or infective and is non-pathogenic to mammals (Chapter III.B. 1
above). As such, the risks anticipated for occupational exposure are considered minimal to non-
existent. Appropriate Personal Protective Equipment (PPE) and Restricted Entry Intervals (REI)
are required to mitigate any potential risks to workers and pesticide handlers. PPE for workers
and handlers consists of long-sleeved shirt, long pants, shoes, socks, goggles, waterproof gloves,
and a dust/mist filtering respirator with NIOSH prefix N-95, P-95 or R-95. To perform post-
application activities, early entry workers must wear coveralls in addition to the PPE described
above.
C. Environmental Assessment
1. Ecological Effects Hazard Assessment
Below is a summary of the ecological effects database evaluated in support of this action
(Table 4). A determination of reasonable certainty that no incremental adverse effects to wild
mammals, avian species, insects including beneficial insects, freshwater fish, aquatic
invertebrates, estuarine and marine animals or to plant species will result from labeled
applications to agricultural crops or horticultural plants. The proposed use sites and respective
applications include: (1) for vegetables, fruits, cotton, herbs, spices, and tree nuts, the product
will be incorporated into soil via drenching, placement in the furrow, or drip irrigation; (2) for
container-grown seedlings, trees and shrubs, field ornamentals and bulbs, and greenhouse
ornamentals, the product will be applied by drench or drip irrigation; (3) for bare root seedlings,
the product will be applied as a root dip; (4) for seeds, the product will be applied as a coating
prior to planting; and (5) for turf, as a foliar spray or fertigation treatment. Other use sites and
applications include: compost and other soil-less mixes treatments and residential outdoor
terrestrial uses, for application(s) via a watering can, pressure sprayer, or hose-end sprayer.
The database consists of submitted data and acceptable waiver requests supported by
scientific rationale that support the conclusion that there are no incremental risks to nontarget
organisms as a result of intended uses of B. firmus strain 1-1582 as a biological nematode
suppressant. Table 4 summarizes the results of the data and information reviewed in support of
the ecological effects of Bacillus firmus Strain 1-1582.
Table 4. Tier I - Microbial pesticides nontarget organism data requirements for Bacillus
firmus Strain 1-1582.
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Data
Requirement
154-16*
885.4050**
154-17
885.4100
154-18
885.4150
154-19
885.4200
54-20 1
885.4240
154-21
885.4280
154-22
885.4300
154-23*
885.4340**
154-24
885.4380
Test
Avian oral
Avian injection
Wild mammal
Freshwater fish
Freshwater
aquatic invertebrate
Estuarine and marine
animal
Nontarget plant
Nontarget insect testing
Honey bee testing
Classification
Acceptable study.
Acceptable Waiver Rationale
Acceptable Waiver Rationale
Acceptable Waiver Rationale
Acceptable study.
Acceptable Waiver Rationale
Acceptable Waiver Rationale
Acceptable Waiver Rationale
Acceptable study.
MRID Nos.
46933012
46933013
46933013
46933013
46933014
46933015
46933015
46933015
46933016
Tier II ecological effects data requirements
155A-10
885.5200
155A-11
885.5300
155A-12
885.5400
Expression in a terrestrial
Environment
Expression in a freshwater
Environment
Expression in a marine or
estuarine environment
Acceptable Waiver Rationale
Acceptable Waiver Rationale
Acceptable Waiver Rationale
46933017
46933017
46933017
*Microbial Pesticide Guidelines Reference No. (40CFR 158.740)
**OPPTS Microbial Pesticide Test Guidelines - 885 series.
a. Avian Oral - (MRID 46933012; CFR ref. # 154-16; OPPTS 885.4050
Fourteen-day-old northern bobwhite (Colinus virginianus) received a daily oral gavage of
Bacillus firmus at a dose of 2.5 x 108 spores/kg of body weight for five days. Additional groups
of bobwhite were given a heat-attenuated B. firmus control or a reverse-osmosis water negative
control. The birds were then observed for an additional 26 days. No treatment-related mortality
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or clinical signs of toxicity were seen in any group. Gross necropsy showed no evidence of
pathogenicity in birds receiving B. firmus. Body weight and feed consumption were comparable
among all groups. The no-observed-effect dosage of B. firmus administered to northern bobwhite
in this study was approximately 2.5 x 108 spores/kg body weight/day for five days. The study
was acceptable and the results indicate that no avian hazard is expected from proposed uses of B.
firmus 1-1582 as a biological nematode suppressant.
b. Avian Injection- Waiver Request Granted (MRID 46933013 ; 40 CFR ref. # 154-
17; OPPTS 885.4100)
c. Wild Mammal- Waiver Request Granted (MRID 46933013; 40 CFR ref. # 154-18;
OPPTS 885.4150)
d. Freshwater Fish Waiver Request Granted (MRID 46933013; 40 CFR ref. # 154-19;
OPPTS 885.4200) (MRIDs 46933007, 46933008, 46933009, 46933010 and 46933013)
Waiver Rationale for data requirements annotated above as b. through d.
Bacillus firmus Strain 1-1582 is a naturally occurring strain of Bacillus firmus and is a
gram-positive, nonpathogenic bacterium that is ubiquitous in nature and considered harmless. It
has been isolated from ocean water (Siefert et al., 2000) and soils (Aslim et al., 2002) where it has
been found at concentrations greater than 10^ to lOfygram dry weight of sandy loam (Vardavakis,
1993). It occurs on the roots of rice (Datta and Banik, 1997), soybeans, and locust beans (Sarkar
et al., 2002). B. firmus has also been found in bee gut and pollen (Cano et al., 1994; Inglis et al.,
1993).
The applicant's literature search of the Agricola, Toxline, Biological Abstracts, Life
Sciences 1990-1998, PubMed, and OCLC databases found no evidence of pathogenicity or other
adverse effects produced by B. firmus to these fauna. The organism does not appear on any
authoritative list of pathogens. There have been no reports of interaction of B. firmus with birds,
wild mammals, or freshwater fish, and it has been found to be non-pathogenic in laboratory
mammal testing (MRIDs 46933007, 46933008, 46933009, and 46933010). Furthermore, natural
populations of B. firmus or its metabolites have not been associated with adverse effects in avian,
wild mammal, or freshwater fish species.
Metabolites in culture filtrates of B. firmus include citric, lactic, acetic, oxalic and
propionic acids at concentrations of 10 to 30 |ig/mL. Phenol and/>-hydroxyl benzoic acid are
produced at concentrations of 0.1 to 30 |ig/mL (Zlotnikov et al., 2001). These compounds are
produced in healthy plants growing under normal conditions. There is no known production of
genotoxic, carcinogenic, allergenic, mutagenic, or toxic metabolites or antibiotics.
Use of the Chancellor™ end use product containing B. firmus 1-1582 is not expected to
significantly increase the environmental exposure of birds, wild mammals, or freshwater fish to B.
firmus. The bacterial counts in treated soil fell to background levels 90 days after treatment. The
direct and targeted nature of EP applications minimizes exposures to birds, wild mammals, and
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freshwater fish. Since application of Chancellor™ is not expected to produce B. firmus counts
above those already found in healthy, productive soils, runoff from treated areas is not expected to
produce any effects not seen from natural populations of B. firmus.
e. Freshwater Aquatic Invertebrate-(MRID 46933014; 40 CFR ref. # 154-20; OPPTS
885.4240
In a 21-day static renewal limit test, Daphnia magna were exposed to a target
concentration of 1 x 10^ cfu/mL Bacillus firmus in water. An untreated control group was
exposed to water only. At test end, there were no statistically significant differences in the
length, weight, percent survival, or number of neonates produced in the control and test material
groups. The study is Acceptable and the results indicate that no aquatic invertebrate hazard is
expected from proposed uses of B. firmus 1-1582 as a biological nematode suppressant.
f. Estuarine/Marine Organisms- Waiver Request Granted (MRID 46933015; 40 CFR
ref. # 154-21; OPPTS 885.4280)
g. Nontarget Plant - Waiver Request Granted (MRID 46933015; 40 CFR ref. # 154-
22; OPPTS 885.4300)
h. Nontarget Insects- Waiver Request Granted (MRID 6933015; 40 CFR ref. # 154-
23; OPPTS 885.4340)
Waiver Rationale for data requirements annotated above asf. through h.
Bacillus firmus is a gram-positive, nonpathogenic bacterium that is ubiquitous in nature
and considered harmless. It has been isolated from ocean water (Siefert et al., 2000) and soils
(Aslim et al., 2002) where it has been found at concentrations greater than 10^ to 10^
bacteria/gram dry weight of sandy loam (Vardavakis, 1993).
The applicant conducted a literature search of several databases, including Agricola,
Toxline, Biological Abstracts, Life Sciences 1990-1998, PubMed for adverse effects produced
by B. firmus. The organism does not appear on any authoritative list of pathogens. There have
been no reports of interaction of B. firmus with estuarine and marine animals. The interaction of
B. firmus with plants has been reported to be beneficial and/or symbiotic. It occurs on the roots
of rice (Datta and Banik, 1997), soybeans, and locust beans (Sarkar et al., 2002). B. firmus has
not been named as, or is not suspected to be a plant pathogen. No adverse effects on plants,
including non-target plants, were seen in efficacy trials using the Chancellor™ end use product
on vegetables, fruits, and turf. In those trials, the quality and yield of plants treated with
Chancellor™ were equivalent to or greater than those treated with conventional chemicals.
The interaction of B. firmus with insects has been reported to be harmless and non-
pathogenic, with the exception of one report from India which indicated B. firmus pathogenicity
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to a lepidopteran tree pest (Varma and Mohamed All, 1986). B. firmus has also been found in bee
gut and pollen (Cano et al., 1994; Inglis et al., 1993).
Applications of Chancellor™ which contains 0.66% Bacillus firmus 1-1582 are not
expected to produce B. firmus counts above those already found in healthy, productive soils.
Moreover the bacterial counts in treated soil fell to background levels 90 days after treatment
(Markov, 2006). Runoff from treated areas is not expected to produce any effects not seen from
natural populations of B. firmus.
Metabolites in culture filtrates of B. firmus include citric, lactic, acetic, oxalic and
propionic acids at concentrations of 10 to 30 |ig/mL. Phenol and p-hydroxyl benzoic acid are
produced at concentrations of 0.1 to 30 |ig/mL (Zlotnikov, et al., 2001). These compounds are
produced in healthy plants growing under normal conditions. There is no known production of
genotoxic, carcinogenic, allergenic, mutagenic, or toxic metabolites or antibiotics. No natural
populations of B. firmus or its metabolites have been associated with adverse effects in estuarine
and marine animals, nontarget plants or nontarget insects.
The above rationale is acceptable to justify waiving Tier I estuarine and marine animal,
nontarget plant and nontarget insect guideline testing and indicate that no risks are expected to
these non-target populations, and to the majority of insect populations from the intended
nematode suppressant uses of B. firmus 1-1582. In the unlikely event that some non-target
organisms are affected during the commercial application of this product, such incidents should
be immediately reported to the EPA as required under FIFRA Section 6(a)(2) so that the Agency
may take appropriate action. This EP is intended for outdoor terrestrial applications as a seed
dressing, a pre-plant soil or soak, irrigation, or overhead spray or root drench, or as directed
targeted applications to foliage for residential home-owner sites.
i. Honeybees- (MRID 4633016; 40 CFR ref. # 154-24; OPPTS 885.4380)
In a laboratory bioassay, adult honeybees (Apis mettiferd) were fed a 30%sucrose
solution diet containing 1x10^ spores of Bacillus firmuslmL for 24 days. The study also
included a 30% sucrose solution-only assay control and a potassium arsenate reference control.
At test end, there was no statistically significant difference in the mean mortality of bees in the
untreated and test material groups. The potassium arsenate positive control produced 100%
mortality on day 1. The no-observed-effect concentration for B. firmus in this study was
determined to be at least 1x10^ spores/mL of diet.
The results of the scientifically valid study are consistent with current OPPTS 885.4380;
and indicate no honeybee hazard is expected from proposed uses of B. firmus 1-1582 (CNCM).
The study is Acceptable to fulfill the data requirement with the assumption that the test B. firmus
strain is substantially equivalent to B. firmus 1-1582 (CNCM).
Tier II ecological effects data requirements
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The applicant provided rationales for waiving Tier II ecological effects data
requirements. However, there were no endpoints in evaluations of Tier I ecotoxicological effects
data which trigger Tier II data requirements. The Agency had already evaluated the data waiver
requests and found that the rationales further supported the requests to not require Tier II
ecological and environmental effects data. See BRAD Chapters III.C. 1. b-d and f-h above for
waiver justifications (MRTD 46933017).
2. Environmental Fate, Ecological Exposure, and Environmental Expression Risk
Characterization.
The Tier I ecological data (as summarized in Chapter III.C.I above) and waiver rationale
support a conclusion that no incremental risks to nontarget organisms or to the environment are
expected as a result of intended uses of Bacillus firmus Strain 1-1582 (Chancellor™). These data
and information support labeled terrestrial uses in agricultural, horticultural and residential
environments. Accordingly, OPPTS Tier II, III and IV testing for ecological effects or
environmental expression is not required.
3. Endangered Species Assessment
Bacillus firmus 1-1582 is a bacterium intended to suppress nematodes and to protect roots
of plants. The target plant pests are plant-parasitic nematodes and there are no Federally-listed
endangered nematode species. Plant-parasitic nematodes are not capable of infecting animal
hosts. Bacillus firmus 1-1582 is a naturally-occurring strain of Bacillus firmus whose level in the
environment will fall to background environmental levels within 90 days of treatment. Based on
information submitted and publicly available literature, the Agency concluded that treatment of
agricultural or residential plants or soils with Bacillus firmus 1-1582 will have no direct or
indirect effect on endangered or threatened fauna or flora (BPPD Review -December 10, 2007).
As a result, the Agency has determined that the proposed uses of Bacillus firmus 1-1582
will have "No Effect" (NE) on endangered or threatened terrestrial or aquatic species as listed by
the U.S. Fish and Wildlife Service (USFWS) and the National Marine Fisheries Services
(NMFS). The Agency does not require labeling or additional data for endangered species for the
proposed uses of Bacillus firmus 1-1582 as a pesticide
4. State Water Quality Concerns (CWA 303D)
The Agency has determined that dietary exposure to Bacillus firmus 1-1582 via drinking
water meets the FQPA 1996 safety standard. Moreover, the pesticide active ingredient is not
likely to percolate through the soil or survive municipal treatment of drinking water.
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Bacillus firmus 1-1582 is not listed as the cause of impairment for any water bodies under
section 303(d) of the Clean Water Act, based on information provided at:
http://oa.spub.epa.gov/tmdl/waters list.impairments'! p_impid=3.
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IV. RISK MANAGEMENT AND REGISTRATION DECISIONS
A. 1. Determination of Eligibility
Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is
determined that: a) its composition is such as to warrant the proposed claims for it; b) its labeling
and other materials required to be submitted comply with the requirements of FIFRA; c) it will
perform its intended function without unreasonable adverse effects on the environment; and d)
when used in accordance with widespread and commonly recognized practice, it will not
generally cause unreasonable adverse effects on the environment.
To satisfy Criterion "A" above, Bacillus firmus 1-1582 has well known properties. The
Agency has no knowledge that would contradict the claims made on the label of this product and
the active ingredient is not expected to cause unreasonable adverse effects when used according
to label instructions. Criterion "B" is satisfied by the current label and by the data presented in
this document. It is believed that this pesticide active ingredient will not cause any unreasonable
adverse effects, and is likely to provide protection as claimed, satisfying Criterion "C". Criterion
"D" is satisfied in Bacillus firmus 1-1582 is not expected to cause unreasonable adverse effects
when used according to label instructions. Therefore, Bacillus firmus 1-1582 is eligible for
registration under FIFRA Section 3(c)(5) for the labeled uses provided the protocols and
methods for the storage stability tests are submitted within one year of registration. Additional
data may be required if the registrant proposes more extensive foliar terrestrial and aquatic
applications as registration amendments.
2. Registration Review
The Food Quality Protection Act of 1996 mandated the continuous review of existing
pesticides. The new registration review program is intended to make sure that, as the ability to
assess risk evolves and as policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects. Changes in science, public
policy, and pesticide use practices will occur over time. Through the new registration review
program, the Agency periodically reevaluates pesticides to make sure that as change occurs,
products in the marketplace can be used safely.
The Agency has begun to implement the new Registration Review program pursuant to
FIFRA Section 3(g) and intends to review each registered pesticide approximately every 15
years to determine whether it continues to meet the FIFRA standard for registration. A
registration review decision is the Agency's determination whether a pesticide meets, or does not
meet, the standard for registration in FIFRA. This new active ingredient will be included in the
schedule for registration review at the end of the Fiscal Year when schedules are updated.
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B. Regulatory Position
1. Unconditional Registration
The data requirements are fulfilled for the currently registered sites as of April, 2008.
Consequently, BPPD recommends registration under FIFRA Section 3(c)(5) of the EP,
Chancellor™, that contains Bacillus firmus 1-1582 as the active ingredient, provided the
protocols and methods for the storage stability and corrosivity tests are submitted within one year
of thi s regi strati on.
Eligible sites
Sites eligible for registration under FIFRA Section 3(c)(5) are listed in the approved draft
label and are listed in Chapter II of this BRAD. Upon registration pesticide labels can be seen on
the Agency's label database http://oaspub.epa.gov/pestlabl/ppls.home. The company number is
82608.
Ineligible sites
Sites not included on the proposed EP label are not eligible for registration under FIFRA
Section 3(c)(5). In order to register application methods which are likely to increase
environmental exposure over the currently registered sites on the label, registrants should consult
with the Agency about data requirements. These applications can be submitted as amendments
to currently registered pesticide products, or as new product registrations.
2. Tolerances for Food Uses and /or Exemption
The toxicology database meets the safety standards of FQPA 1996 as long as the
pesticide is used as labeled. The final rule granting the exemption from tolerance for residues of
Bacillus firmus 1-1582 on all food commodities will be published in 40 CFR, part 180.
3. CODEX Harmonization
There are no Codex harmonization considerations since there is no Codex Maximum
Residue Limits set for food use of this active ingredient.
4. Risk Mitigation
There is minimal or negligible potential risk to non-target organisms (mammals, plants
and wildlife), and to ground and surface water contamination through the proposed use of
products containing Bacillus firmus 1-1582 as discussed in this document. No mitigation
measures are required at this time for dietary risk, including risk due to exposure via drinking
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water. Appropriate PPE and REIs are required for pesticide handlers to mitigate worker exposure
for labeled uses (see Labeling, immediately below). The product label will also bear
environmental hazards text to mitigate any potential risk as determined by reviewed data and use
sites.
C. Labeling
The labels and labeling of all products must comply with EPA's current regulations and
requirements as specified in 40 CFR Part 156.10 and other applicable notices, such as, and
including the WPS labeling. Bacillus firmus 1-1582 products with commercial use sites are
subject to the Worker Protection Standard. Because of the low toxicity of'Bacillus firmus 1-1582,
the Restricted Entry Interval (REI) for greenhouse foliar applications within the scope of WPS is
4 hours. Precautionary statements and personal protective equipment (PPE), as specified below,
are required based on the acute toxicity categories of this organism.
Handlers (including mixer/loaders and applicators) applying this product must wear long-
sleeved shirt, long pants, goggles, shoes plus socks, and a dust/mist filtering respirator meeting
NIOSH standards of at least N-95, R-95, orP-95 (DHHS 1987 and 2004). Post application
agricultural workers and early-entry workers must wear coveralls in addition to the PPE above
when entering treated areas during the REI period of four hours.
The label for registered EP containing the active ingredient Bacillus firmus 1-1582 will be
available at http://oaspub.epa.gov/pestlabl/ppls.home. The PC code for this active ingredient is
029072. The relevant company number is 82608.
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V. ACTIONS REQUIRED BY REGISTRANTS
The applicant must submit reports of the protocols and methods used to arrive at the
conclusions regarding storage stability within one year of registration of the EP. As required for
all pesticides, hypersensitivity incidents must be reported under FIFRA Section 6(a)(2) 40 CFR
Part 158.690(c), and OPPTS data requirement 885.3400, so that the Agency may take
appropriate regulatory action.
If more extensive use patterns are sought for foliar treatment of other agricultural
terrestrial or aquatic sites or crops, or if other methods of application are requested, additional
information and data will be required on a case-by-case basis.
Before releasing pesticide products containing Bacillus firmus 1-1582 for shipment, the
applicant is required to provide appropriate labels and meet other EPA requirements. Release of
the microbe into the environment and its transport across state lines is the purview of the United
States Department of Agriculture (USDA) and other relevant government agencies.
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Biopesticides Registration Action Document Final draft Biopesticides and Pollution Prevention Division
VI. APPPENDICES
APPENDIX A. Studies Submitted in Support of this Registration
Bibliography
Study Information For
Product Registration - Section 3
82608-R- Bacillus firmus isolate 1582
MRID
46933000
46933001
46933002
Citation
AgroGreen, Biological Div, Minrav Infrastructures (1993) Ltd (2006)
Submission of Product Chemistry, Toxicity and Environmental Fate Data
in Support of the Application for Registration of Chancellor. Transmittal of
17 Studies.
Davis, K. (2006) Product Identity of Canceller. Project Number:
PCD/885/1100. Unpublished study prepared by Regwest. 119 p.
Davis, K. (2006) Manufacturing Process of Chancellor. Project Number:
PCD/885/1200. Unpublished study prepared by Regwest. 13 p.
Davis, K. (2006) Dicussion of Formation of Unintentional Ingredients of
46933003 Chancellor. Project Number: PCD/885/1300. Unpublished study prepared
by Regwest. 8 p.
46933004
Davis, K. (2006) Certification of Limits of Chancellor. Project Number:
PCD/885/1500. Unpublished study prepared by Regwest. 5 p.
Receipt
Date
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
Crutchfield, V. (2006) Preliminary Analysis of a Microbial Pest Control „
46933005 Agent (MPCA) Bacillus firmus Spores (Suspension): Chancellor. Project ^
Number: 7871/03. Unpublished study prepared by Stillmeadow, Inc. 13 p.
Sikod, B. (2006) Product Chemistry: End-Use Product Characterizations
46933006 Bacillus firmus Spores (Suspension): Chancellor. Project Number:
7969/03. Unpublished study prepared by Stillmeadow, Inc. 15 p.
12-Sep-
2006
46933007
Kuhn, J. (2006) Acute Oral Toxicity/Pathogenicity Study in Rats with a
Microbial Pest Control Agent (MPCA) Bacillus firmus Spores: Chancellor. 12-Sep-
Project Number: 7788/04. Unpublished study prepared by Stillmeadow, 2006
Inc. 23 p.
46933008 Kuhn, J. (2006) Acute Dermal Toxicity Study in Rabbits with a Microbial 12-Sep-
34
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EPA-HQ-OPP-2007-0159 Bacillus firmus isolate 1582 April 22, 2008
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MRID
46933009
46933010
46933011
46933012
Citation
Pest Control Agent (MFCA) Bacillus firmus Spores (Suspension):
Chancellor. Project Number: 7789/03. Unpublished study prepared by
Stillmeadow, Inc. 13 p.
Kuhn, J. (2006) Acute Pulmonary Toxicity/Pathogenicity Study in Rats
with a Microbial Pest Control Agent (MPCA) Bacillus firmus Spores:
Chancellor. Project Number: 7790/03. Unpublished study prepared by
Stillmeadow, Inc. 25 p.
Kuhn, J. (2006) Acute Intravenous Toxicity/Pathogenicity Study in Rats
with a Microbial Pest Control Agent (MPCA) Bacillus firmus Spores:
Chancellor. Project Number: 7791/03. Unpublished study prepared by
Stillmeadow, Inc. 23 p.
Davis, K. (2006) Group C: Toxicology Data Waiver Request Justification:
Chancellor. Project Number:
GROUP/C/TOXICOLOGY/DATA/WAIVERS. Unpublished study
prepared by Regwest. 87 p.
Gallagher, S.; Beavers, J. (2006) An Avian Oral Pathogenicity and
Toxicity Study in the Northern Bobwhite Bacillus firmus Spores:
Chancellor. Project Number: 572/101. Unpublished study prepared by
Wildlife International, Ltd. 34 p.
Receipt
Date
2006
Davis, K. (2006) Group D: Non-Target Organism and Environmental
Expression Data Waiver Request Justifications: Chancellor. Project
46933013 Number: GROUP/D/NON/TARGET/D AT A/WAIVERS/VOLUME/1.
Unpublished study prepared by Regwest, University of Houston and
Syracuse University. 93 p.
Rodrigue, N. (2006) Chronic Toxicity to the Freshwater Invertebrate Water
46933014 Flea Bacillus firmus Spores: Chancellor. Project Number: 7792/03.
Unpublished study prepared by Stillmeadow, Inc. 17 p.
Davis, K. (2006) Group D: Non-Target Organism and Environmental
Expression Data Waiver Request Justifications. Project Number:
46933015 GROUP/D/NON/TARGET/DATA/WAIVERS/VOLUME/2. Unpublished
study prepared by Regwest, University of Houston and Syracuse
University. 111 p.
46933016
Richards, K. (2006) Evaluation of the Dietary Effect(s) of Bacillus firmus
a.i. on Adult Honey Bees (Apis mellifera L.). Project Number:
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
12-Sep-
2006
35
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MRID Citation
CAR/101/04, 7896/03. Unpublished study prepared by California
Agricultural Research Inc. 83 p.
Davis, K. (2006) Group E: Environmental Expression Data Waiver
Request Justifications: Chancellor. Project Number:
46933017 GROUP/E/ENVIRONMENTAL/EXPRESSION/DATA/WAIVERS.
Unpublished study prepared by Regwest, University of Houston and
Syracuse University. 93 p.
AgroGreen, Biological Division of Minrav Infrastructures (2007)
47024800 Submission of Product Chemistry and Toxicity Data in Support of the
Application for Registration of Chancellor. Transmittal of 7 Studies.
Davis, K. (2007) Discussion of Formation of Unintentional Ingredients of
47024801 Bacillus firmus TGAI: Chancellor. Project Number: PCD/885/1300.
Unpublished study prepared by Regwest. 13 p.
Davis, K. (2007) Discussion of Formation of Unintentional Ingredients of
47024802 Chancellor . Project Number: PCD/885/1300/EP. Unpublished study
prepared by Regwest. 8 p.
Receipt
Date
47024803
47024804
47024805
Davis, K. (2007) Analysis of Samples of Bacillus firmus TGAI:
Chancellor. Project Number: PCD/885/1400/TGAI. Unpublished study
prepared by AgroGreen, Biological Div, Minrav Infrastructures (1993)
Ltd. 9 p.
Crutchfield, V. (2007) Amended Final Report: Preliminary Analysis of a
Microbial Pest Control Agent (MPCA): Bacillus firmus spores
(suspension): Chancellor. Project Number: 7871/03. Unpublished study
prepared by Stillmeadow, Inc. 13 p.
Davis, K. (2007) Physical and Chemical Properties of Bacillus firmus
TGAI: Chancellor. Project Number: PCD/151/26/TGAI. Unpublished
study prepared by AgroGreen, Biological Div, Minrav Infrastructures
(1993) Ltd. 6 p.
Davis, K. (2007) Group C: Toxicology Tier I and II Data Technical Grade
47024806 Active Ingredient Product Waiver Request Justification: Chancellor.
Unpublished study prepared by Regwest. 87 p.
Davis, K. (2007) Group C: Toxicology Tier I and II Data End-Use Product
47024807 Waiver Request Justification: Chancellor. Unpublished study prepared by
Regwest. 87 p.
36
12-Sep-
2006
05-Jan-
2007
05-Jan-
2007
05-Jan-
2007
05-Jan-
2007
05-Jan-
2007
05-Jan-
2007
05-Jan-
2007
05-Jan-
2007
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Biopesticides Registration Action Document Final draft Biopesticides and Pollution Prevention Division
MRID
Citation
Receipt
Date
070™ Agrogreen (2007) Submission of Product Chemistry Data in Support of the 25-Jul-
Application for Registration of Chancellor. Transmittal of 2 Studies. 2007
47187201
Crutchfield, V. (2007) Storage Stability and Corrosion Characteristics with
a Microbial Pest Control Agent (MPCA): Interim Report: Chancellor. 25-Jul-
Project Number: 10601/06. Unpublished study prepared by Stillmeadow, 2007
Inc. 9 p.
Crutchfield, V. (2007) MPCA Contaminant Verification and Mouse Safety
47187202 Study: SON Technical (Bacillus firmus): Final Report. Project Number:
10844/07. Unpublished study prepared by Stillmeadow, Inc. 15 p.
Total Rows: 29
25-Jul-
2007
MRID
Citation Reference
47024800
47024801
47024802
47024803
47024805
47024806
AgroGreen, Biological Division of Minrav Infrastructures (2007) Submission of
Product Chemistry and Toxicity Data in Support of the Application for
Registration of Chancellor. Transmittal of 7 Studies.
Davis, K. (2007) Discussion of Formation of Unintentional Ingredients of
Bacillus firmus TGAI: Chancellor. Project Number: PCD/885/1300.
Unpublished study prepared by Regwest. 13 p.
Davis, K. (2007) Discussion of Formation of Unintentional Ingredients of
Chancellor . Project Number: PCD/885/1300/EP. Unpublished study prepared
by Regwest. 8 p.
Davis, K. (2007) Analysis of Samples of Bacillus firmus TGAI: Chancellor.
Project Number: PCD/885/1400/TGAI. Unpublished study prepared by
AgroGreen, Biological Div, Minrav Infrastructures (1993) Ltd. 9 p.
Davis, K. (2007) Physical and Chemical Properties of Bacillus firmus TGAI:
Chancellor. Project Number: PCD/151/26/TGAI. Unpublished study prepared
by AgroGreen, Biological Div, Minrav Infrastructures (1993) Ltd. 6 p.
Davis, K. (2007) Group C: Toxicology Tier I and II Data Technical Grade
Active Ingredient Product Waiver Request Justification: Chancellor.
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Unpublished study prepared by Regwest. 87 p.
47024807 Davis, K. (2007) Group C: Toxicology Tier I and II Data End-Use Product
Waiver Request Justification: Chancellor. Unpublished study prepared by
Regwest. 87 p.
Check - where are the rest of the studies in OPPIN?
Data Evaluation Records (DERs)
Etsitty, Carl and Kough, John. USEPA/OPP/BPPD. Memorandum to Shanaz Bacchus,
USEPA/OPP/BPPD. DER dated March 05, 2008.
Tomimatsu, Gail and Vaituzis, Zigfridas. USEPA/OPP/BPPD. Memorandum to Shanaz
Bacchus, USEPA/OPP/BPPD. DER dated December 10, 2007.
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