United States Prevention, Pesticides EPA 738-R-06-007
Environmental Protection and Toxic Substances 2006
Agency (7508C) OPP-2005-0495
Reregistration
Eligibility Decision for
Imazapyr
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Reregistration Eligibility Decision (RED) Document for
Imazapyr
ListC
Case Number 3078
Approved by: Date:
Debra Edwards, Ph. D.
Director
Special Review and Reregistration Division
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Table of Contents
Imazapyr Reregistration Eligibility Decision Team iii
Glossary of Terms and Abbreviations iv
Abstract 1
I. Introduction 2
II. Chemical Overview 3
A. Chemical Background 3
B. Imazapyr Acid and Salt Nomenclature 4
C. Use Sites 4
D. Formulations 4
E. Methods of Application 5
F. Use rates 5
G. Annual usage 5
H. Technical Registrant 5
III. Summary of Risk Assessment 5
A. Human Health Risk Assessment 6
1. Hazard Profile 6
2. Dietary Risk (Food) 9
a. Acute Dietary Risk (Food) 10
b. Chronic Dietary Risk (Food) 10
3. Cancer Dietary Risk (Food) 10
4. Drinking Water Dietary Exposure 11
5. Chronic Risk from Food and Drinking Water 12
6. Residential Risk 12
a. Residential Handler Summary 13
b. Residential Post-application Summary 13
c. Combined Post-application Residential Summary 13
d. Recreational Uses 14
7. Aggregate Risk 14
8. Occupational Risk 14
a. Occupational Handler Summary 15
b. Post-application Occupational Risk 15
9. Incident Reports 16
B. Ecological Risk Assessment 16
1. Environmental Fate and Transport 17
2. Ecological Risk Assessment 17
a. Plant Toxicity 19
b. Terrestrial Plant Risk 19
c. Aquatic Plant Risk 22
3. Incident Reports 23
4. Endangered Species Risk 23
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 24
A. Determination of Reregistration Eligibility 24
B. Public Comments and Responses 25
C. Regulatory Position 26
1. Food Quality Protection Act Findings 26
a. "Risk Cup" Determination 26
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b. Endocrine Disrupter Effects 27
c. Cumulative Risks 27
2. Tolerance Summary 27
a. Tolerances Currently Listed and Tolerance Reassessment 29
D. Regulatory Rationale 30
1. Human Health Risk Management 30
a. Occupational Risk Mitigation 30
2. Environmental Risk Management 31
a. Non-target Terrestrial Plant Risk Mitigation 31
b. Non-target Aquatic Plant Risk Mitigation 32
3. Significance of Imazapyr Use 33
4. Other Labeling Requirements 33
5. Threatened and Endangered Species Considerations 33
a. The Endangered Species Program 33
b. General Risk Mitigation 34
V. What Registrants Need to Do 34
A. Manufacturing Use Products 34
1. Additional Generic Data Requirements 34
2. Labeling for Technical and Manufacturing Use Products 35
B. End-Use Products 35
1. Additional Product-Specific Data Requirements 35
2. Labeling for End-Use Products 36
a. Label Changes Summary Table 36
VI. Appendices 43
Appendix A. IMAZAPYR USE PATTERNS ELIGIBLE FOR
REREGISTRATION 44
Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES
USED TO MAKE THE REREGISTRATION DECISION 47
Appendix C. Technical Support Documents 57
Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE REREGISTRATION DECISION (BIBLIOGRAPHY) 58
Appendix E. GENERIC DATA CALL-IN 89
Appendix F. PRODUCT SPECIFIC DATA CALL-IN 90
Appendix G. EPA'S BATCHING OF IMAZAPYR PRODUCTS FOR
MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR
REREGISTRATION 91
Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN NOTICE
95
Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS 96
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Imazapyr Reregistration Eligibility Decision Team
Special Review and Reregistration Division
Sherrie L. Kinard
Eric Olson
Robert McNally
Health Effects Division
David Anderson
Yvonne Barnes
Sherrie L. Kinard
Charles (Billy) Smith
Christina Jarvis
William Hazel
Environmental Fate and Effects Division
Pamela Hurley
Stephan Carey
Lucy Shanaman
Biological and Economic Analysis Division
Bill Phillips
TJ Wyatt
Registration Division
Jim Tompkins
in
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Glossary of Terms and Abbreviations
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
BCF Bioconcentration Factor
CFR Code of Federal Regulations
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formulation
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DNT Developmental Neurotoxicity
EC Emulsifiable Concentrate Formulation
ED WC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
GLN Guideline Number
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that
can be expected to cause death in 50% of test animals. It is usually expressed as the
weight of a substance per weight or volume of water, air, or feed, e.g., mg/1, mg/kg, or
ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
LOC Level of Concern
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligram Per Liter
MOE Margin of Exposure
MRID Master Record Identification Number. EPA 's system for recording and tracking studies
submitted.
MUP Manufacturing-Use Product
NOAEL No Observed Adverse Effect Level
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides, and Toxic Substances
PAD Population Adjusted Dose
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRZM/EXAMS Tier II Surface Water Computer Model
RAC Raw Agriculture Commodity
iv
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RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
SCI-GROW Tier I Ground Water Computer Model
SAP Science Advisory Panel
SF Safety Factor
SLC Single Layer Clothing
TGAI Technical Grade Active Ingredient
USD A United States Department of Agriculture
USGS United States Geological Survey
UF Uncertainty Factor
UV Ultraviolet
WPS Worker Protection Standard
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Abstract
This document presents the Environmental Protection Agency's (hereafter
referred to as EPA or the Agency) decision regarding the reregistration eligibility of the
registered uses of imazapyr. The Agency has determined that imazapyr-containing
products are eligible for reregistration, provided that the risk mitigation measures
identified in this document are adopted and label amendments are made to reflect these
measures. Imazapyr is a systemic, non-selective herbicide used for the pre- and post-
emergence control of a broad range of terrestrial and aquatic weeds. There are currently
twenty-four tolerances established in 40 CFR §180.500 for residues of the herbicide
imazapyr, applied as the acid or ammonium salt which were reassessed in 2003 when
new food uses were established. The Agency has conducted human health and
environmental fate and ecological effect risk assessments for imazapyr and reassessed all
the existing tolerances. The risk conclusions of these assessments are summarized below.
In the human health risk assessment, dietary risks (food and drinking
water) are below the Agency's level of concern. Residential handler dermal and
inhalation risks for all scenarios are below the Agency's level of concern, as are
residential post-application exposures (including incidental oral exposure to toddlers and
oral and dermal exposure from swimming activities in treated lake water). Aggregate
risks (food, drinking water, and residential exposure) are also below the Agency's level
of concern.
There is a potential for exposure to workers through handling and applying
imazapyr as well as exposure to post-application residues. For workers, short- and
intermediate-term risks from mixing, loading, and applying imazapyr do not exceed the
Agency's level of concern at either baseline clothing, or with the addition of gloves.
There are no dermal post-application risks to workers, and inhalation post-application
risks are considered negligible; however, the Agency has determined that imazapyr is a
Toxicity Category I primary eye irritant. The restricted entry interval (REI) on current
imazapyr labels is 12 hours. Under the Worker Protection Standard (WPS; 40 CFR Part
170), a 48-hour REI is required for Category I eye irritants. The WPS also requires that
coveralls, shoes and socks, chemical resistant gloves, and protective eyewear be used for
early entry.
There are no risks of concern to terrestrial birds, mammals, and bees, or to aquatic
invertebrates and fish. However, there are ecological risks of concern associated with the
use of imazapyr for non-target terrestrial plants and aquatic vascular plants, and potential
risks to federally listed threatened and endangered species ("listed species") which
include aquatic vascular plants, terrestrial and semi-aquatic monocots and dicots that
cannot be precluded at this time. Imazapyr use at the labeled rates on non-crop areas
when applied as a spray or as a granular to forestry areas present risks to non-target plants
located adjacent to treated areas. Imazapyr use at the labeled rates on Clearfield™ corn,
which is resistant to imidazolinone herbicides, also present risks of concern to non-target
plants located adjacent to treated areas.
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Because imazapyr is an herbicide and may therefore harm non-target plants
exposed via drift, the Agency is requiring strict use restrictions to be placed on the labels
for all imazapyr products to help minimize spray drift. The Agency has determined that
the specific drift language amendments specified in this RED will substantially reduce,
though may not completely eliminate, the risks of imazapyr use to non-target plants.
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
in 1988 to accelerate the reregistration of products with active ingredients registered prior
to November 1, 1984, and amended again by the Food Quality Protection Act of 1996
(FQPA) and the Pesticide Registration Improvement Act of 2003 (PRIA) to set time
frames for the issuance of Reregistration Eligibility Decisions. FIFRA calls for the
development and submission of data to support the reregistration of an active ingredient,
as well as a review of all data submitted to the U.S. Environmental Protection Agency.
Reregistration involves a thorough review of the scientific database underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of a pesticide, to determine the need for
additional data on health and environmental effects, and to determine whether or not the
pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed
into law. This Act amended FIFRA and the Federal Food Drug and Cosmetic Act
(FFDCA) to require reassessment of all existing tolerances for pesticides in food. FQPA
also requires the Agency to review all tolerances in effect on August 2, 1996, by August
3, 2006. When the Agency reassessed the imazapyr tolerances in 2003, the Agency
considered, among other things, aggregate risks from non-occupational sources of
pesticide exposure, whether there is increased susceptibility among infants and children,
and the cumulative effects of pesticides that have a common mechanism of toxicity.
When the Agency determines that aggregate risks are not of concern and concludes that
there is a reasonable certainty of no harm from aggregate exposure, the tolerances are
considered reassessed. The Agency decided that, for those chemicals that have tolerances
and are undergoing reregistration, tolerance reassessment will be accomplished through
the reregistration process.
As mentioned above, FQPA requires the Agency to consider available
information concerning the cumulative effects of a particular pesticide's residues and
"other substances that have a common mechanism of toxicity" when considering whether
to establish, modify, or revoke a tolerance. Unlike other pesticides for which the Agency
has followed a cumulative risk approach based on a common mechanism of toxicity, the
Agency has not made a common mechanism of toxicity finding for imazapyr with any
other substances. Therefore, for the purposes of tolerance reassessment, which was
completed in 2003, the Agency did not assume that imazapyr shared a common
mechanism of toxicity with any other compound. In the future, if additional information
suggests imazapyr shares a common mechanism of toxicity with other compounds,
additional testing may be required and a cumulative assessment may be necessary. For
information regarding the Agency's efforts to determine which chemicals have a
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common mechanism of toxicity and to evaluate the cumulative effects of such chemicals,
see the policy statements released by the Agency's Office of Pesticide Programs
concerning common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
http ://EP A. gov/pesticides/cumulative/.
This document presents a summary of the Agency's revised human health and
ecological risk assessments, its progress toward tolerance reassessment, and the
reregistration eligibility decision for imazapyr. The document consists of six sections.
Section I contains the regulatory framework for reregistration and tolerance reassessment.
Section II provides a profile of the use and usage of the chemical. Section III gives an
overview of the revised human health and ecological risk assessments based on data,
public comments, and other information received in response to the preliminary risk
assessments. Section IV presents the Agency's reregistration eligibility and risk
management decisions. Section V summarizes label changes necessary to implement the
risk mitigation measures outlined in Section IV. Section VI provides information on how
to access related documents and contains the appendices that list related information and
supporting documents. The preliminary and revised risk assessments for imazapyr are
available in the Public Docket, under docket number OPP-2005-0495 and on EPA's web
page, http://www.regulations.gov.
II. Chemical Overview
Imazapyr is part of the imidazolinone chemical class. Imazapyr is a systemic,
non-selective, pre- and post-emergent herbicide used for the control of a broad range of
terrestrial and aquatic weeds, and controls plant growth by preventing the synthesis of
branched-chain amino acids. Imazapyr is applied either as an acid or as the
isopropylamine salt.
A. Chemical Background
Imazapyr technical was first registered in 1985; however, a non-crop end use
product had been previously registered in July 1984. The first food use on corn was
registered in April 1997. In 2003, the aquatic and grassland uses were registered which
resulted in the establishment of additional tolerances. Currently there are 24 tolerances
listed in 40 CFR § 180.500 for residues of the herbicide imazapyr, applied as the acid or
isopropylamine salt, which were reassessed in 2003.
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B. Imazapyr Acid and Salt Nomenclature:
Imazapyr, acid
Structure
Molecular Formula
IUPAC Name
CAS Number
PC Code
OH
/\
Ci3Hi5N3O3
[2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-nicotinic acid]
81334-34-1
128821
Imazapyr, salt
Molecular Formula
IUPAC Name
CAS Number
PC Code
CoHisNsOsCsHgN
2-Propanamine, 2-(4,5-dihydro-4-methyl-4-(l-methylethyl)-5-
oxo-l//-imidazol-2-yl]-3-pyridinecarboxylate
81334-34-1
128821
C. Use Sites:
Imazapyr is used for pre- and post-emergence control of a broad range of
weeds, including terrestrial annual and perennial grasses, broad-leaved
herbs, woody species, and riparian and emergent aquatic species.
Agricultural uses of imazapyr include field corn and grass. Tolerances are
established for imazapyr residues in field corn and its forage and stover,
and in grass forage and hay. Tolerances are also established for secondary
residues of imazapyr in milk, meat, fish, and shellfish.
Imazapyr is also registered for use on a variety of commercial and
residential use sites, including forestry sites, rights-of-way, fence rows,
hedge rows, drainage systems, outdoor industrial areas, outdoor buildings
and structures, domestic dwellings, paved areas, driveways, patios,
parking areas, walkways, various water bodies (including ponds, lakes,
streams, swamps, wetlands, stagnant water, and urban areas).
Imazapyr may also be used as a spot treatment in recreation areas, athletic
fields, and golf course roughs.
D. Formulations:
Imazapyr is formulated as a liquid, a wettable powder (in water soluble
bags only), and a granular.
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E. Methods of Application:
Aquatic applications of imazapyr can be made as a liquid. Application
methods include aerial and application to water via boat. Aqueous
imazapyr formulations may be mixed with surfactants or oils for
application. Applications to smaller areas may be made with handheld
equipment, including backpack sprayers, sprinkling cans, and handgun
sprayers.
Terrestrial applications of imazapyr consist of ground and aerial spray, as
well as granular broadcast applications. Granular formulations may also
be mixed with fertilizers, surfactants or oils for application. Applications
to smaller areas may be made with handheld equipment, including low-
pressure handwand sprayers, high-pressure/volume handwand sprayers,
push-type granular spreaders, backpack granular spreaders, sprinkling
cans, and handgun sprayers. Aqueous imazapyr formulations may be
mixed with surfactants or oils for application as well as mixed with other
herbicides and fertilizers.
F. Use rates:
Application rates of imazapyr range from 0.014 pounds acid equivalent
per acre (Ibs a.e./acre) on corn to 1.5 Ibs a.e./acre on non-crop areas and
aquatic sites.
G. Annual usage:
• For terrestrial agricultural uses of imazapyr, the use on corn is
approximately 20,000 Ibs/year, and the use on pastures and rangeland is
approximately 2,000 Ibs/year. The average percent crop treated is less
than one percent for both uses.
H. Technical Registrant:
BASF Corporation.
III. Summary of Risk Assessment
The following is a summary of the Agency's revised human health effects and
ecological risk assessment for imazapyr, as presented fully in the documents, Imazapyr:
HED Chapter of the Reregistration Eligibility Decision Document, dated December 8,
2005, and Screening Level Ecological Risk Assessment for the Reregistration Eligibility
Decision Document for Imazapyr, dated December 9, 2005. The purpose of this
summary is to assist the reader by identifying key features and findings of these risks
assessments, and to help the reader better understand the conclusions reached in the
assessments.
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The human health and ecological risk assessment documents and supporting
information listed in Appendix C were used to reach the regulatory decisions for
imazapyr. While the risk assessments and related addenda are not included in this
document, they are available in the Public Docket, under docket number OPP-2005-0495
and on the internet at http://www.regulations.gov. Hard copies of these documents may
be found in the OPP public docket under this same docket number.
A. Human Health Risk Assessment
The Agency has conducted a human health assessment for imazapyr for the
purposes of making a reregistration decision. The Agency evaluated toxicological and
chemistry studies submitted for imazapyr and determined that the data are adequate to
support a reregistration decision. In addition, the Agency has conducted dietary, drinking
water, residential, aggregate, and worker assessments to determine the potential risks
associated with the use of imazapyr. More in-depth details of the health effects of
imazapyr are provided in the human health risk assessment.
For a complete discussion, see Section 6.0 of Imazapyr: HED Chapter of the
Reregistration Eligibility Decision Document., dated December 8, 2005.
1. Hazard Profile
The toxicological database for imazapyr is complete. Imazapyr has low acute
toxicity via the oral (Toxicity Category IV) and dermal (Toxicity Category III) routes of
exposure. Imazapyr has been placed in acute Toxicity Category II for the inhalation route
of exposure. It is not irritating to the skin, and is negative for dermal sensitization;
however, imazapyr results in irreversible eye damage (Toxicity Category I) as seen in
Table 1. Normally, an acute hazard value is chosen from acute (non-lethal), subchronic,
or developmental toxicity studies from which there is reasonable evidence that a single
exposure can lead to a potential effect. The available data suggest that a single exposure
to imazapyr does not result in an effect of concern for risk assessment purposes.
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Table 1. Acute Toxicity Data for Imazapyr
Guideline Number
Study Type
870. 1 100 Acute Oral Toxicity
870.1200 Acute Dermal Toxicity
870. 1300 Acute Inhalation Toxicity
870.2400 Acute Eye Irritation
870.2500 Acute Dermal Irritation
870.2600 Skin Sensitization
MRID Numbers
41551002
93048016
41551003
93048017
00132032
93048018
41551001
93048019
41551004
93048020
00131607
93048021
Toxicity Category
IV
III
II
I
Tested with 99.3%
technical fine
powder
IV
Negative
Most of the toxicity studies with imazapyr showed no effects to minimal effects,
even at the HDT (highest dose tested). There is no evidence of acute or chronic
neurotoxicity resulting from exposure to imazapyr. No developmental toxicity was
observed in rabbits or rats up to the HDT; however, maternal toxicity, based on
salivation, was observed in rats at the mid-dose (300 mg/kg/day). Neither the rat nor the
rabbit study showed an increased susceptibility of the fetus to imazapyr administered pre-
natally or post-natally. In addition, a 2-generation reproduction rat study did not show
increased susceptibility to offspring at doses up to the HDT. There were no compound-
related effects in a one-year dietary toxicity study in beagle dogs up to the HDT.
Imazapyr was classified by the Agency in October 1995 as a "Group E" chemical, with
no evidence of carcinogenicity in at least 2 adequate studies in the rat and mouse. This
decision was reaffirmed on May 22, 2003 by a subcommittee of the Cancer Assessment
Review Committee (CARC). Imazapyr is negative for mutagenic potential and a
quantitative cancer risk assessment is not required.
The Agency selected NOAELs and endpoints for risk assessment purposes in
February 2003. A 1-year dog feeding study with a NOAEL of 250 mg/kg/day was
selected for calculating the chronic RfD because it was the lowest NOAEL in the
imazapyr database. Actually, the 250 mg/kg/day dose in the dog study was both the
NOAEL and the highest dose tested for that study. Because there were no adverse effects
seen in the dog study or in any of the imazapyr toxicity studies, EPA relied on a structural
analog, the pesticide imazapic (Cadre®), to choose an endpoint. Imazapic causes skeletal
muscle effects in dogs at 5000 ppm (137 mg/kg/day in males and 180 mg/kg/day in
females). Despite imazapyr's structural similarity to imazapic, as well as its similarity to
the pesticides, imazethapyr and imazamethabenz-methyl (Assert®), the available data do
not support the conclusion that these pesticides share a common mechanism of toxicity
such that combined exposure to them would result in cumulative effects. First, as noted,
the toxicity data for imazapyr show no adverse effects, including no skeletal muscle
effects. Second, the toxic endpoints for the three structurally similar pesticides are quite
varied: imazapic (skeletal muscle effects); imazethapyr (an increased incidence of
clinical signs during gestation, ulcerations in the mucosal layer of the stomach and gall
bladder, increased abortions, maternal deaths, decrements in body weight gain) and
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imazamethabenz-methyl (transient decreased body weight, mild liver effects, slight
increase in a common kidney lesion). Accordingly, for the purposes of this RED, EPA
has not assumed that imazapyr has a common mechanism of toxicity.
Non-cancer risk estimates are expressed as a margin of exposure (MOE) that is a
ratio of the dose from a toxicological study selected for risk assessment, typically a
NOAEL, to the predicted exposure. Estimated MOEs are compared to a level of concern
that reflects the dose selected for risk assessment and uncertainty factors (UFs) applied to
that dose. The standard UF is 100X and includes a 10X for interspecies extrapolation (to
account for differences between laboratory animals and humans) and a 10X for
intraspecies variation (to account for differences between humans). Additional
uncertainty or safety factors may also be applied. In the case of imazapyr, the Agency's
level of concern is an MOE of 100 which includes a factor of 10X for interspecies
extrapolation and 10X for intraspecies variation. The Special FQPA Safety Factor has
been reduced to IX because there are no residual exposure uncertainties, no increased
sensitivity to infants and children, and the toxicity database is essentially complete.
Table 2 shows the endpoints selected to assess risks for imazapyr.
Table 2. Summary of Toxicological Doses and Endpoints for Imazapyr Used in the
Human Health Risk Assessment
Exposure Scenario
Dose Used in Risk
Assessment, UF
Special FQPA SF and
Level of Concern
(LOC) for Risk
Assessment
Study and Toxicological
Effects and MRID No.
Acute Dietary
(Females 13-50
years of age and
General population
including infants and
children)
An acute dietary endpoint was not selected based on the absence of an appropriate
endpoint attributable to a single dose.
Chronic Dietary
(All populations)
NOAEL= 250
mg/kg/day
UF=100
Chronic RfD =
2.5 mg/kg/day
FQPA SF = Ix
cPAD = chronic RfD
FQPA SF
= 2.5 mg/kg/day
1-Year Dog [feeding] Study
No LOAEL was demonstrated
with imazapyr at doses up to
250 mg/kg/day (HOT; MRID
41039502). [HIARC assumed
this dose as an endpoint for RA
for imazapyr, based on skeletal
muscle effects seen in dogs
with structural analog
imazapic.]
Short and
Intermediate
Term Incidental Oral
(1-30 days and 1-6
months)
NOAEL= 250
mg/kg/day
Residential LOC for
MOE =100)
1-Year Dog [feeding] Study
No LOAEL was demonstrated
with imazapyr at doses up to
250 mg/kg/day (HOT; MRID
41039502). [HIARC assumed
this dose as an endpoint for RA
for imazapyr, based on skeletal
muscle effects seen in dogs
with structural analog
imazapic.]
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Short and
Intermediate
and Long-Term
Dermal (1 to 30
days, 1 to 6 months,
>6 months)
Short- and
Intermediate and
Long-Term
Inhalation (1 to 30
days, 1 to 6 months,
>6 months )
Cancer
NOAEL= 250
mg/kg/day
(dermal absorption
rate = 100 %)
NOAEL= 250
mg/kg/day
(inhalation absorption
rate = 100%)
Occupational
LOC for MOE = 100
(Residential LOC for
MOE = 100)
Occupational
LOC for MOE = 100
(Residential LOC for
MOE = 100)
1-Year Dog [feeding] Study
No LOAEL was demonstrated
with imazapyr at doses up to
250 mg/kg/day (HOT; MRID
41039502). [HIARC assumed
this dose as an endpoint for RA
for imazapyr, based on skeletal
muscle effects seen in dogs
with structural analog
imazapic.]
1-Year Dog [feeding] Study
No LOAEL was demonstrated
with imazapyr at doses up to
250 mg/kg/day (HOT; MRID
41039502). [HIARC assumed
this dose as an endpoint for RA
for imazapyr, based on skeletal
muscle effects seen in dogs
with structural analog
imazapic.]
Classified as Group E. No evidence of carcinogenicity; risk assessment not
required.
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL
= lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic),RfD = reference dose,
MOE = margin of exposure, LOC = level of concern.
2. Dietary Risk (Food)
Dietary risk assessment incorporates both exposure to and toxicity of a given
pesticide. Dietary risk is expressed as a percentage of a level of concern. The level of
concern is the dose predicted to result in no unreasonable adverse health effects to any
human population subgroup, including sensitive members of such population subgroups.
This level of concern is referred to as the population-adjusted dose (PAD), which reflects
the reference dose (RfD), acute or chronic, adjusted to account for the FQPA safety
factor.
Estimated risks that are less than 100% of the PAD are below EPA's level of
concern. The acute PAD (aPAD) is the highest predicted dose to which a person could
be exposed on any given day with no adverse health effects expected. The chronic PAD
(cPAD) is the highest predicted dose to which a person could be exposed over the course
of a lifetime with no adverse health effects expected. For imazapyr, a chronic RfD of
0.25 mg/kg/day is used in estimating the dietary risk. The RfD includes a lOx for
interspecies extrapolation and a lOx for intraspecies variation. Because the Special
FQPA Safety Factor has been reduced to IX, the PAD is equivalent to the RfD. The
imazapyr dietary risk assessment uses was performed using the Dietary Exposure
Evaluation Model (DEEM™).
For a complete discussion, see Section 6.0 of Imazapyr: HED Chapter of the
Reregistmtion Eligibility Decision Document, dated December 8, 2005.
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a. Acute Dietary Risk (Food))
As noted above, an acute dietary exposure assessment was not necessary because
no toxic effects resulting from acute exposures were seen in the imazapyr acute toxicity
database. The Agency does not expect acute risks resulting from dietary exposure.
b. Chronic Dietary Risk (Food)
For the chronic dietary exposure assessment, an estimate of the residue level in
each food or food-form on the food commodity residue list is multiplied by the average
daily consumption estimate for that food/food-form. The resulting residue consumption
estimate is summed with the residue consumption estimates for all other food/food forms
on the commodity residue list to arrive at the total average estimated exposure. Exposure
is expressed in mg/kg body weight/day and risk is expressed as a percent of the chronic
PAD (cPAD).
Food items may be exposed to residues of imazapyr in three ways: via direct
application, via irrigation water previously treated with imazapyr, or via livestock
ingestion of treated commodities resulting in secondary residues. To assess risks
resulting from residues on food, a screening level assessment was performed using the
Dietary Exposure Evaluation Model (DEEM™).
The results of the DEEM™ analysis show that all population subgroups' dietary
exposure to imazapyr residues in food comprises less than 0.1% of the cPAD. These
results are based on tolerance level residues, 100% crop treated, and default processing
factors, all of which are considered to be conservative estimates of potential chronic
dietary risk. Table 3 shows exposure levels for the general population and children one
to two years old, the most highly exposed population subgroup.
For a complete discussion of the health effects to imazapyr, please see Imazapyr:
Chronic Dietary Exposure Assessment for the Reregistration Eligibility Decision, dated
March 26, 2003.
Table 3. Summary of Food Chronic Dietary Exposure and Risk from Imazapyr
Population Subgroup
General U.S. Population
Children 1-2 years old
Dietary Exposure
mg/kg/day
0.000340
0.000828
% cPAD
0.1
O.I
3. Cancer Dietary Risk (Food)
A cancer dietary exposure assessment is not required because imazapyr is
classified as a Group E chemical, "not likely to be carcinogenic."
10
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4. Drinking Water Dietary Exposure
Drinking water exposure to pesticides can occur through groundwater and surface
water contamination. The Agency considers both acute (one day) and chronic (lifetime)
drinking water risks and uses either modeling or actual monitoring data, if available, to
estimate those risks. For imazapyr, non-cancer chronic concentration in drinking water
was estimated. A cancer concentration in drinking water was not estimated because
imazapyr is considered "not likely to be carcinogenic in humans."
To estimate drinking water concentrations resulting from the use of imazapyr,
screening level models were used. Non-crop uses with high and low application rates,
and corn uses were modeled to represent the labeled imazapyr uses (1.5, 0.9, and 0.014
Ibs. a.i./acre, respectively). The highest labeled rate for imazapyr is 1.5 Ibs. a.i./acre.
The Agency has determined that the residue of concern for imazapyr in drinking
water is parent only. Environmental fate data suggest that imazapyr is mobile and
persistent. Except for photolysis in water, imazapyr was stable under the conditions and
duration of the submitted fate studies. In the photolysis study, imazapyr degraded with
half-lives of approximately 3 to 5 days.
To predict concentrations of imazapyr that may be present in surface water as a
result of the terrestrial uses, Tier I FQPA Index Reservoir Screening Tool (FIRST)
exposure modeling was performed. The modeled estimates of drinking water
concentrations (EDWCs) of imazapyr in surface water for chronic durations range from
0.34 to 79jig/L. These values were established by modeling imazapyr use on corn and
non-crop uses with high and low application rates.
To predict concentrations of imazapyr in ground water as a result of terrestrial
uses, Tier I Screening Concentration in Ground Water (SCI-GROW) exposure modeling
was performed. The modeled concentrations of imazapyr in ground water are not
expected to exceed 36|ig/L. This value was established by modeling imazapyr non-crop
uses at the highest maximum application (1.5 Ibs a.i./A).
Exposure to imazapyr from drinking water resulting from aquatic applications is
also possible. The EDWC's for both surface and ground water from direct application to
surface water are both 61 |ig/L. This does not take into account the current imazapyr
label requirement of a one-half mile setback from drinking water intakes because the
Agency does not currently have an approved methodology for calculating EDWCs in
water bodies where pesticides are applied with a setback distance from drinking water
intakes. As a result, the EDWC is more conservative than had setback distances been
considered. Direct applications to water were modeled assuming uniform application
over an entire reservoir at the maximum labeled rate.
For a complete discussion, see Section 6.2 of the Imazapyr: HED Chapter of the
Reregistration Eligibility Decision Document, dated December 8, 2005.
11
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5. Chronic Risk from Food and Drinking Water
To assess chronic risk from food plus drinking water, exposure estimates from
chronic dietary (food) and chronic drinking water assessments were combined in the
DEEM™ modeling program. The modeled EDWC of imazapyr in surface water of
79|ig/L was used in the chronic dietary (food plus water) assessment. This value was
established by modeling imazapyr non-crop uses at the highest maximum application.
The combined chronic exposure for the general U.S. population and all population
subgroups is <0.1% of the cPAD. The most highly exposed population subgroup is
infants <1 year old (Table 4). These values are below the Agency's level of concern.
Table 4. Summary of Food and Water Dietary Exposure and Risk
Population Subgroup
General U.S. Population
All Infants <1 year old
Dietary Exposure
mg/kg/day
0.002005
0.005732
% cPAD
(Food + Water)
0.1
0.1
6. Residential Risk
Residential exposure to a pesticide can occur while mixing, loading, or applying
(handling) a pesticide, or after entering areas where the pesticide had previously been
applied. Residential non-cancer risk estimates are expressed as a margin of exposure
(MOE), which is a ratio of the dose from a toxicological study selected for risk
assessment, typically a NOAEL, to the predicted exposure. Estimated MOEs are
compared to a level of concern that reflects the dose selected for risk assessment and UFs
applied to that dose. The standard UF is 100X and includes a 10X for interspecies
extrapolation (to account for differences between laboratory animals and humans) and a
10X for intraspecies variation (to account for differences between humans). Additional
uncertainty or safety factors may also be applied. In the case of imazapyr, the Agency's
level of concern for inhalation, dermal, and incidental oral is an MOE of 100 that
includes a factor of 10X for interspecies extrapolation and 10X for intraspecies variation.
The Special FQPA Safety Factor has been reduced to IX because there are no residual
exposure uncertainties, no increased sensitivity to infants and children, and the toxicity
database is essentially complete.
Short-term exposures were assessed for residential handlers and residential post-
application exposures based on use and exposure patterns of registered imazapyr
products. Based on the current use pattern for imazapyr and the fact that endpoints are
the same across all durations of exposure, the Agency does not expect that intermediate
or long-term residential exposures will be higher than those for short-term exposures.
Inhalation, dermal, and incidental ingestion were considered to be the routes of exposure
for persons exposed to imazapyr. The maximum labeled rates were used for the non-
cancer residential handler and non-cancer residential post-application risk assessments.
For a complete discussion, see Section 6.3 of the Imazapyr: HED Chapter of the
Reregistration Eligibility Decision Document., dated December 8, 2005.
12
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a. Residential Handler Summary
Residential handler assessments are based on the assumptions that individuals
complete all tasks associated with the use of imazapyr (mixing, loading, and application),
up to 1,000 square feet are treated, and individuals are wearing shorts, short-sleeved
shirts, socks, and shoes. The residential handler exposure scenarios consider dermal and
inhalation exposure to adult pesticide handlers. The two residential handler scenarios
were assessed: 1) mixing/loading/applying emulsifiable concentrates with low-pressure
handwand, and 2) mixing/loading/applying emulsifiable concentrates with hose-end
sprayer. The risks for these scenarios are below the Agency's level of concern with
MOEs well above the target MOE of 100, at 25,000 and 85,000, respectively.
b. Residential Post-application Summary
Residential post-application exposure scenarios are also considered to be short-term and
consider exposures to individuals that occur as a result of an area previously treated with
imazapyr. The residential post-application assessment considers dermal exposure to
children and adults, as well as incidental oral ingestion exposures to toddlers. A series of
assumptions and exposure factors served as the basis for completing the residential
postapplication risk assessments. The assumptions and factors used in the risk
calculations are consistent with current Agency policy for completing residential
exposure assessments (i.e., Standard Operating Procedures for Residential Exposure
Assessment). The scenarios included in the residential post-application exposure
assessment were: (1) adult dermal exposure/residential turf (high contact activities); (2)
toddler dermal exposure/residential turf (high contact activities); (3) toddler oral
exposure/hand-to-mouth activity on turf; (4) toddler oral exposure/object-to-mouth
activity on turf; (5) toddler oral exposure/incidental soil ingestion; and (6) toddler oral
exposure/incidental ingestion of granules. Post-application residential risks to adults and
toddlers are below the Agency's level of concern for all scenarios assessed with MOEs of
720 and 430, respectively, on the day of application.
c. Combined Post-application Residential Summary
Additionally, combined residential risks resulting from the combining of separate
post-application exposure scenarios, when it is likely they can occur simultaneously, do
not exceed the Agency's level of concern with MOEs greater than 100 on the day of
application. These combined post-application exposure scenarios for toddlers are:
dermal, hand-to-mouth, object-to-mouth, and incidental soil ingestion. The combined
non-dietary MOE for toddlers using the turf spray scenario is 410.
13
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d. Recreational Uses
Imazapyr may be applied by broadcast application to aquatic freshwater sites to
control floating or emergent aquatic vegetation. Adults and children may be exposed
when swimming in treated water bodies following application of imazapyr. The potential
for postapplication incidental ingestion and dermal exposure to adults, children, and
toddlers as a result of swimming in treated waters immediately following application has
also been assessed. Post-application risks to adults, children, and toddlers swimming in
treated waters following application of imazapyr are below the Agency's level of concern
with MOEs ranging from 68,000 to 1,000,000.
7. Aggregate Risk
Aggregate risk combines exposure from food, drinking water, and, if applicable,
residential exposure. For imazapyr, the following aggregate risk assessments were
conducted: short-term aggregate (food + drinking water + short-term residential) and
long-term aggregate risk assessment (food + drinking water only). Based on the current
use patterns of imazapyr, the Agency does not expect exposure durations that would
result in intermediate- or long-term residential exposures; therefore long-term aggregate
risk assessment consists of exposure from food and drinking water only. A cancer
aggregate risk assessment is not required because imazapyr is classified as a Group E
chemical, "not likely to be carcinogenic".
For adult short-term aggregate exposure, the Agency aggregated chronic food and
drinking water exposures with residential handler and post-application exposures. The
adult residential exposure scenarios resulting from application and post-application
activities on turf were used. For short-term aggregate exposure to children, the Agency
aggregated chronic food and drinking water exposures for toddlers (1-2 years of age) and
combined these with post-application dermal and incidental oral exposures (combined
hand-to-mouth, object-to-mouth, and soil ingestion) from activity on turf. The estimated
MOEs are above 100, with values of 410 for children and 720 for adults. Therefore,
short-term aggregate risks are below the Agency's level of concern.
Because the Agency does not expect chronic residential exposure, long-term
aggregate risks are equal to chronic dietary risks (food plus water). As described above
in Section 5, these risks are below the Agency's level of concern.
For a complete discussion, see Section 7.0 of the Imazapyr: HED Chapter of the
Reregistration Eligibility Decision Document, dated December 8, 2005.
8. Occupational Risk
Workers can be exposed to a pesticide while mixing, loading, or applying a
pesticide, and when entering a treated site. Non-cancer worker risk estimates are
expressed as a margin of exposure (MOE) that is a ratio of the dose from a toxicological
study selected for risk assessment, typically a NOAEL, to the predicted exposure.
Estimated MOEs are compared to a level of concern that reflects the dose selected for
risk assessment and uncertainty factors (UFs) applied to that dose. The standard UF is
14
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100X and includes a 10X for interspecies extrapolation (to account for differences
between laboratory animals and humans) and a 10X for intraspecies variation (to account
for differences between humans). Additional uncertainty or safety factors may also be
applied. In the case of imazapyr, the NOAEL is 250 mg/kg/day taken from the 1-year
dog feeding study and an MOE of 100 is considered protective for worker risks.
The Agency initially calculates the handler risks using the least protective
measures. This is called the baseline assessment, and assumes normal work clothing and
no personal protective equipment (PPE). If there is a risk concern at this level, the
Agency considers the use of protective measures (e.g., personal protective equipment and
engineering controls) to lower the risk. PPE can include an additional layer of clothing,
chemical-resistant gloves, and a respirator. Common examples of engineering controls
include: enclosed tractor cabs, closed loading systems, and water-soluble packaging.
For a complete discussion, see the Occupational and Residential Exposure
Assessment and Recommendations for the Reregistration Eligibility Decision Document
for Imazapyr, dated August 31, 2005.
a. Occupational Handler Summary
The Agency has determined that workers may be exposed to imazapyr while
mixing, loading, and applying, as well as flagging for aerial applications. In the absence
of chemical-specific monitoring data for imazapyr, exposure analyses were performed
using surrogate data from the Pesticide Handlers Exposure Database (PHED) and the
Outdoor Residential Exposure Task Force (ORETF). For information on the scenarios
that use ORETF data, please see the Occupational and Residential Exposure Assessment
and Recommendations for the Reregistration Eligibility Decision Document for
Imazapyr, dated August 31, 2005. The MOEs for occupational exposures were
calculated for short-term and intermediate-term exposures because these durations of
exposures are likely based on current labels. Long-term handler exposures are not
expected to occur for imazapyr.
For all scenarios, short- and intermediate-term risks do not exceed the Agency's
level of concern (i.e., the MOEs are greater than 100) at either baseline PPE (long-
sleeved shirt, long pants, no gloves, and no respirator), or with the addition of gloves.
MOEs ranged from 10 to 1,100,000. Scenarios that require the addition of chemical
resistant gloves include mixing and loading liquid formulations for aerial applications to
aquatic sites, terrestrial non-crop sites, forestry sites, and areas grazed or cut for hay. The
addition of chemical resistant gloves are also required for workers that are mixing,
loading, and applying liquid and granular formulations via handwands, backpack
spreaders and sprayers, and handgun sprayers for non-crop and aquatic uses. MOEs for
these scenarios with the addition of chemical resistant gloves ranged from 460 to 22,000.
b. Post-application Occupational Summary
The Agency has determined that individuals may be exposed to imazapyr by
working in areas that have previously been treated. Both short-term and intermediate-
term occupational postapplication dermal exposure may occur. Inhalation exposures are
15
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expected to be negligible in outdoor postapplication scenarios because imazapyr has a
low vapor pressure and due to the dilution with ambient air expected after outdoor
application. As such, inhalation postapplication exposures are not considered in this
assessment.
All risks calculated for short-term and intermediate-term dermal postapplication
exposure to workers resulting from scouting, hand weeding, irrigation, detasseling, and
hand-harvesting are below the Agency's level of concern (MOEs range from 4,100 to
700,000) on day zero approximately 12 hours following application. Although the MOEs
are greater than 100 for post-application workers, the restricted-entry level (REI) must be
set at 48-hour REI because imazapyr has high acute toxicity (Category I for eye
irritation).
9. Incident Reports
Approximately 20 incidents involving human exposure to imazapyr have been
reported. However, none were listed under the "definite," "probable," or "possible"
certainty categories. In general, medical care was less frequently used in all cases
compared to other pesticide-related incidents, and not a single case required
hospitalization or treatment in a critical care unit. The most common symptom reported
was eye irritation, which was four times more prevalent than any other symptom.
Additional health effects included: dermal irritation, throat irritation, nausea, and
coughing or choking.
For a complete discussion, see the Review of Imazapyr Incident Reports, dated
February 23, 2006.
B. Ecological Risk Assessment
The Agency has conducted an environmental assessment for imazapyr for the
purposes of making a reregistration decision. The Agency evaluated environmental fate
and ecological studies submitted for imazapyr and determined that the data are adequate
to support a reregistration decision. More in-depth details of the environmental fate and
persistence of imazapyr are provided in the environmental risk assessment.
For a complete discussion, see the Screening Level Ecological Risk Assessment
for the Reregistration Eligibility Decision Document for Imazapyr, dated December 9,
2005.
16
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1. Environmental Fate and Transport
The herbicide imazapyr is an anionic, organic acid that is non-volatile and is both
persistent and mobile in soil. Commercial formulations contain either imazapyr acid or
the imazapyr isopropylamine salt, both of which are dissolved in a water solution.
Imazapyr is mainly in anionic form at typical environmental pH levels, and the behavior
of the acid and salt forms are expected to be similar. Laboratory studies show imazapyr
is essentially stable to hydrolysis, aerobic and anaerobic soil degradation, as well as
aerobic and anaerobic aquatic metabolism. Field dissipation study observations are
consistent with imazapyr's intrinsic ability to persist in soils and move via runoff to
surface water and to leach to groundwater.
Upon direct application, or indirect release into surface water, photolysis is the
only identified mechanism for imazapyr degradation in the environment. The half-life of
imazapyr is approximately 3 to 5 days in surface water. The major identified metabolites
were pyridine hydroxy-dicarboxylic acid, pyridine dicarboxylic acid, and nicotinic acid.
Under laboratory aerobic aquatic conditions, the aerobic aquatic metabolism half-lives
for hydroxy-dicarboxylic acid and pyridine dicarboxylic acid were in the range of 3 to 8
days in two different sediment/water systems. Metabolites hydroxy-dicarboxylic acid
and pyridine dicarboxylic acid are expected to be more polar, thus more rapidly excreted
than imazapyr, and no more toxic than the parent compound. Additionally, pyridine
hydroxy-dicarboxylic acid is considered to be less stable than the parent compound.
Nicotinic acid is a possible neurotoxin at high dose levels, but there is no concern for low
exposures. Nicotinic acid (also called Niacin and referred to as Vitamin B3) is
considered an essential nutrient. Imazapyr is not expected to bioaccumulate in aquatic
organisms because it exists as an anion at typical environmental pHs.
2. Ecological Risk Assessment
To estimate potential ecological risk, the Agency integrates the results of
exposure and ecotoxicity studies using the risk quotient method. Risk quotients (RQs)
are a screening level measure for potential risk and are calculated by dividing exposure
estimates by ecotoxicity values, both acute and chronic, for various wildlife species. RQs
are then compared to levels of concern (LOCs).
Table 5 lists the LOCs used in the risk assessment. Generally, the higher the RQ,
the greater the potential risk. Risk characterization provides further information on the
likelihood of adverse effects occurring by considering the fate of the chemical in the
environment, communities and species potentially at risk, their spatial and temporal
distributions, and the nature of the effects observed in studies.
17
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Table 5. Levels of Concern for Ecological Risk
If RQ > LOC value given below...
Terrestrial
Organisms
0.5
0.1
1
Aquatic
Organisms
0.5
0.05
1
Plants
1
1
N/A
Then EPA presumes...
Risk Presumption
Acute Risk- there is potential for acute risk; regulatory action
may be warranted
Acute Endangered Species- regulatory action may be warranted;
further analysis is needed
Chronic Risk-there is potential for chronic risk; regulatory action
may be warranted
The Agency has determined that there are no risks of concern to terrestrial birds,
mammals, and bees, or to aquatic invertebrates and fish. For terrestrial organisms,
available acute and chronic toxicity data indicate that imazapyr acid and salt are
practically non-toxic to birds, mammals, and honeybees. Acute risks to both mammals
and birds were not calculated because LCso/LD5o (Median Lethal Concentration/Median
Lethal Dose) values were greater than highest concentration tested. Chronic LOC's were
also not exceeded for these organisms. In addition, imazapyr shows low toxicity to bees.
Therefore, there is minimal risk to birds, mammals, and honeybees.
For aquatic organisms, available acute and chronic toxicity data indicate that
imazapyr acid and salt are practically non-toxic to fish, invertebrates, and non-vascular
aquatic plants. Acute risks to fish and aquatic invertebrates were not calculated because
LCso values were greater than the highest concentration tested. Chronic LOC's were also
not exceeded for these organisms. In addition, no LOC's were exceeded for aquatic non-
vascular plants. Therefore, there is minimal risk to fish, aquatic invertebrates, and
aquatic non-vascular plants. However, there is an uncertainty for estuarine/marine fish
and invertebrates, since no toxicity data were available to observe the prolonged effects
of imazapyr to estuarine/marine fish and invertebrates. These organisms were assumed
to have similar sensitivity as freshwater fish and invertebrates.
The Agency has determined that there are ecological risks of concern associated
with the use of imazapyr for non-target terrestrial plants and aquatic vascular plants, and
potential risks to endangered species (aquatic vascular plants, terrestrial and semi-aquatic
monocots and dicots). Because the ecological risks of concern for imazapyr are only to
non-target plants, the remainder of this Ecological Risk Assessment section of the RED
document will address risks to non-target plants.
18
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a. Plant Toxicity
Terrestrial plant toxicity studies with monocots and dicots indicate that seedling
emergence and vegetative vigor are severely impacted by exposure to imazapyr acid and
to the isopropylamine salt of imazapyr. Seedling emergence, based on "fresh weight",
was adversely impacted in monocots (wheat) at an £€25 (Effect Concentration) of 0.0046
Ib a.e./acre and in dicots (sugar beet) with an £€25 of 0.0024 Ib a.e./acre (Table 6).
Vegetative vigor in monocots, based on "fresh weight", was adversely impacted by both
imazapyr acid and the isopropylamine salt of imazapyr at an £€25 of 0.012 Ib a.e./acre in
wheat. In vegetative vigor studies with dicots (cucumber), imazapyr acid was more toxic
than the isopropylamine salt of imazapyr with an £€25 of 0.0009 Ibs a.e./acre. Non-lethal
effects included stunting, chlorosis, and necrosis.
Table 6.Summary of Selected Endpoints for Imazapyr Terrestrial Toxicity Studies
Plant Species
Effect
Endpoint (Ibs a.e./acre)
EC 25
EC 05/NOAEC
MRID
Terrestrial Monocots
Wheat
Emergence
Vegetative Vigor
0.0046
0.012
0.00099
0.0039
40811801
43889101
Terrestrial Dicots
Sugar Beet
Cucumber
Emergence
Vegetative Vigor
0.0024
0.0009
0.00017
0.000064
40811801
40811801
For aquatic plants, available toxicity studies indicate that imazapyr acid and the
isopropylamine salt are highly toxic and expected to exert detrimental effects to aquatic
vascular plants. The ECso for the aquatic vascular plant (duckweed) is 0.018 mg a.e./L
(NOAEC 0.011 mg a.e./L), based on inhibition of plant growth and reduction of frond
count (Table 7).
Table 7. Summary of Selected Endpoints for Imazapyr Aquatic Toxicity Studies
Plant Species
Aquatic Vascular
Aquatic Nonvascular
Effect
Inhibition of plant growth
Inhibition of plant growth
Endpoint (mg a.e./L)
EC 50
0.018
11.5
NOAEC
0.011
7.6
MRID
43889102
43889102
b. Terrestrial Plant Risk
Table 8 presents the RQs for terrestrial plants for three imazapyr uses and both
ground and aerial spray applications. For the terrestrial non-crop use of imazapyr and the
application rates of 0.9 and 1.5 Ibs a.e./acre, RQ LOCs exceeded for all non-endangered
and endangered monocots and dicots located adjacent to treated areas, in semi-aquatic
areas, and as a result of runoff and spray drift with the exception of non-endangered
monocots receiving spray drift alone from ground applications at 0.9 Ib a.e./acre. RQs
were higher for aerial applications when compared to ground applications, as expected
given the assumption that 5% of aerial sprays and 1% of ground sprays drift to non-target
areas.
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For Clearfield™ corn and the label application rate of 0.014 Ibs a.e./acre, LOCs
were exceeded for non-endangered monocots and dicots located in semi-aquatic areas
(based on "channelized runoff ratio) when exposed to imazapyr via ground or aerial
spray application. LOCs were not exceeded for non-endangered monocots and dicots
inhabiting dry areas (based on "sheet runoff ratio) via ground or aerial application, or
from spray drift alone. With the exception of monocots receiving drift alone, the
endangered species LOCs were exceeded for terrestrial plants located adjacent to treated
areas, in semi-aquatic areas and as a result of spray drift alone from aerial application on
cornfields. For ground application, the endangered species LOCs were exceeded for both
monocots and dicots located in semi-aquatic areas. However, the endangered species
LOCs were not exceeded for monocots inhabiting dry areas or exposed to spray drift
alone. Exposure to dicots from spray drift alone exceeds the endangered species LOG
but is not expected to exceed the non-endangered species LOG.
Table S.Terrestrial Plant Risk Quotient Summary for Terrestrial Spray Uses
Scenario
Non-endangered RQs
Adjacent to
treated sites
Semi-
aquatic
areas
Drift
Endangered RQs
Adjacent to
treated sites
Semi-
aquatic
areas
Drift
Terrestrial non-crop high application rate (1.5 Ibs a.e./acre
Ground spray application
Monocot
Dicot
Aerial spray a]
Monocot
Dicot
20**
38**
166**
319**
1.3**
17**
91*
529*
773*
4500*
3.9*
234*
jplication
26**
50**
H4**
219**
6.3**
83**
121*
706*
530*
3090*
19*
1170*
Terrestrial non-crop low application rate (0.9 Ibs a.e./acre)
Ground spray application
Monocot
Dicot
12**
23**
100**
191**
0.75
10**
55*
318*
464*
2700*
2.3*
141*
Aerial spray application
Monocot
Dicot
16**
30**
68**
131**
3.8**
50**
73*
424*
318*
1850*
124*
703*
Clearfield™ Corn (0.014 Ibs a.e./acre)
Ground spray application
Monocot
Dicot
0.18
0.35
1.6**
3.0**
0.01
0.16
0.85
4.9*
7.2*
42*
0.04
2.2*
Aerial spray application
Monocot
Dicot
0.24
0.47
1.1**
2.0**
0.06
0.78
1.1*
6.6*
5.0*
29*
0.18
11*
* indicates an exceedance of the Endangered Species LOG (LOC=1).
** indicates an exceedance of the Acute Risk LOG (LOC=1).
20
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For the aquatic non-crop use of imazapyr at the maximum application rate of 1.5
Ibs a.e./acre, LOCs were exceeded for non-endangered and endangered monocots and
dicots located adjacent to or on the edge of lakes and ponds as a result of flooding semi-
aquatic areas and spray drift from a direct application to surface water (Table 9). RQs
were higher for plants adjacent to or on the edge of lakes and ponds versus those exposed
via drift.
Table 9. Terrestrial Plant Risk Quotient Summary for Aquatic Spray Uses
Scenario
Non-endangered RQs
Water overflows to
flood a terrestrial
site
Incoming tide
pushes water to
flood a terrestrial
site
Endangered RQs
Water overflows to
flood a terrestrial
site
Incoming tide
pushes water to
flood a terrestrial
site
Aquatic non-crop high application rate (1.5 Ibs a.e./acre)
Ground spray application
Monocot
Dicot
163**
313**
24*
46*
758**
4412**
111*
647*
* indicates an exceedance of the Endangered Species LOG (LOC=1).
** indicates an exceedance of the plant LOG (LOC=1).
For the granular uses of imazapyr at the maximum application rates of 1.5 Ibs
a.e./acre and 0.5 Ibs a.e./acre, LOCs were exceeded for both non-endangered and
endangered monocots and dicots located adjacent to treated areas, in semi-aquatic areas
and as a result of runoff from application on non-crop areas (Table 10). Currently, EFED
does not perform chronic risk assessments for terrestrial plants.
Table 10. Terrestrial Plant Risk Quotient Summary for Granular Uses
Scenario
Non-endangered RQs
Adjacent to
treated sites
Semi-aquatic areas
Endangered RQs
Adjacent to
treated sites
Semi-aquatic areas
Terrestrial non-crop high application rate (1.5 Ibs a.e./acre)
Monocot
Dicot
16**
31**
163**
313**
76*
441*
758*
4410*
Terrestrial non-crop low application rate (0.5 Ibs a.e./acre)
Monocot
Dicot
5 4**
10**
54**
104**
25*
147*
253*
1471*
* indicates an exceedance of the Endangered Species LOG (LOC=1).
** indicates an exceedance of the Acute Risk LOG (LOC=1).
For a complete discussion, see the Screening Level Ecological Risk Assessment
for the Reregistration Eligibility Decision Document for Imazapyr, dated December 9,
2005.
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c. Aquatic Plant Risk
For imazapyr, there are exceedances of the endangered and non-endangered
LOCs for vascular plants for runoff/drift from ground and aerial spray and granular
applications at high and low rates for terrestrial use sites (Table 11). However, there
were no exceedances of non-vascular aquatic plant LOCs for these scenarios. There were
no exceedances of aquatic plants LOCs for the Clearfield™ corn application scenario.
Table 11. Aquatic Plant Risk Quotient Summary for Terrestrial Uses
Scenario
Non-endangered RQs
Non-Vascular
Vascular
Endangered RQs
Vascular
Non-Crop (high application rate, 1.5 Ibs a.e./acre)
Ground Application
Aerial Application
<0.01
0.01
4.5**
4.7**
7.4*
7.6*
Non-Crop (low application rate, 0.9 Ibs a.e./acre)
Ground Application
Aerial Application
<0.01
0.01
2.5**
2.8**
4.1*
4.6*
Forestry Granular (high application rate, 1.5 Ibs a.e./acre
Broadcast
O.01
4.3**
7.0*
Forestry Granular (low application rate, 0.5 Ibs a.e./acre
Broadcast
O.01
1.4**
2.3*
Clearfield™ Corn (0.014 Ibs a.e./acre)
Ground Application
Aerial Application
O.01
O.01
0.04
0.04
0.07
0.07
* indicates an exceedance of Endangered Species LOG (LOC=1).
** indicates an exceedance of plant LOG (LOC=1).
The imazapyr direct application to water scenario for aquatic uses indicated
exceedance of the non-endangered LOCs for vascular plants inhabiting various water
depths (Table 12). Likewise, endangered vascular plant LOCs were exceeded for the
direct application to waters at all three depths considered. There were no LOG
exceedances for non-vascular aquatic plants.
Table 12. Aquatic Plant Risk Quotient Summary for Aquatic Use
Scenario
Direct Application
to Water (1.5 Ibs
a.e./acre)
Water Depth
Ifoot
3 feet
2 meters
Non-endangered
Non-Vascular
0.048
0.016
<0.01
Vascular
31**
10**
4 7**
Endangered
Vascular
50*
17*
7.6*
* indicates an exceedance of Endangered Species LOG (LOC=1).
** indicates an exceedance of Acute Risk LOG (LOC=1).
For a complete discussion, see the Screening Level Ecological Risk Assessment for the
Reregistration Eligibility Decision Document for Imazapyr, dated December 9, 2005.
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3. Incident Reports
The Environmental Incident Information System (EIIS) database has records of
12 incidents related to the use of imazapyr (April 2005). Incidents reported include
impacts to terrestrial and aquatic plants and possibly birds and fish. There are several
reports of spray drift affecting plants on adjacent property and one report of agricultural
runoff to a pond resulting in a possible fish kill from imazapyr. In this report, it could not
be definitively determined that the fish kill was due to exposure to imazapyr. Another
report concerning mortality in birds and fish was based on an incident using a mixture of
herbicides, one of which was imazapyr. Because a mixture was used, it could not be
definitively determined that the mortalities were due to exposure to imazapyr. One
incident was a mixed herbicidal spray, including imazapyr, that resulted in a bird,
terrestrial and aquatic plant, and fish kill. Another incident involved a goldfish kill from
suspected runoff following aerial application of imazapyr. However, the cause of the kill
could not be determined. Nine other incidents involving plants have also been reported.
4. Endangered Species Risk.
As discussed previously, imazapyr acid and the imazapyr isopropylamine salt are
used in both aquatic and terrestrial environments. The screening level risk assessment for
endangered species indicates that imazapyr RQs exceed the endangered species LOCs for
the specified use scenario in the following taxonomic groups:
• non-target aquatic vascular plants for non-crop uses (both high and low
application rates) and for direct application to water (RQs are listed in
Tables 11 and 12).
• non-target terrestrial plants - monocots and dicots adjacent to treated
areas, semi-aquatic areas, and subject to drift for non-crop uses at both
high and low application rates by ground and aerial spray and granular
applications; monocots and dicots adjacent to semi-aquatic areas for
Clearfield™ corn use by ground spray application; dicots adjacent to
treated sites for Clearfield™ corn use by ground spray application; and
monocots and dicots adjacent to treated areas and semi-aquatic areas for
Clearfield™ corn use by aerial spray application; and for dicots, drift from
Clearfield™ corn use by ground and aerial spray application (RQs are
listed in Tables 8, 9, and 10).
Registered uses of imazapyr acid and the imazapyr isopropylamine salt will have
no direct effect on endangered or threatened fish, aquatic invertebrates, non-vascular
aquatic plants (algae), birds or mammals. However, there is a potential concern for
indirect effects to listed species with either broad or narrow dependencies on impacted
plant species/populations/communities for habitat, feeding or cover requirements.
Risks to endangered species identified in the Environmental Fate and Ecological
Risk Assessment for Imazapyr are based solely on the Agency's screening level
assessment and do not constitute "may effect" findings under the Endangered Species
Act. Rather, this assessment serves as a screen to determine the need for any species-
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specific assessments that will evaluate whether exposure may be at levels that could
cause harm to specific listed species and their critical habitat. That assessment refines the
screening-level assessment to take into account the geographic area of pesticide use in
relation to the listed species, the habits and habitat requirements of the listed species, etc.
If the Agency's specific assessments result in the need to modify use of the pesticide in
specific geographic areas, those changes to the pesticide's registration will take effect
through the process described in the Agency's Federal Register Notice (54 FR 27984)
regarding implementation of the Endangered Species Protection Program.
For a complete discussion, see the Screening Level Ecological Risk Assessment
for the Reregistration Eligibility Decision Document for Imazapyr., dated December 9,
2005.
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) calls for the Agency to determine, after submission of relevant data concerning
an active ingredient, whether pesticides containing the active ingredient are eligible for
reregistration. The Agency has previously identified and required the submission of the
generic (i.e., active ingredient specific) data required to support reregistration of products
containing imazapyr.
The Agency has completed its assessment of the dietary, residential, occupational,
and ecological risks associated with the use of pesticides containing the active ingredient
imazapyr. Based on a review of these data and public comments on the Agency's
assessments for the active ingredient imazapyr, the Agency has sufficient information on
the human health and ecological effects of imazapyr to make decisions as part of the
reregistration process under FIFRA, as amended by the Food Quality Protection Act
(FQPA). Note that the Agency reassessed the imazapyr tolerances in 2003. The Agency
has determined that currently registered uses of imazapyr will not pose unreasonable risks
or adverse effects to humans or the environment if the risk mitigation measures and label
changes outlined in the RED are implemented; therefore, products containing imazapyr
are eligible for reregistration. These products containing imazapyr are eligible for
reregistration provided that: (i) required product-specific data are submitted; (ii) the risk
mitigation measures outlined in the document are adopted; and, (iii) label amendments
are made to reflect these measures. Products that contain active ingredients in addition to
imazapyr will be reregistered when all of their other active ingredients also are
reregistered. Label changes are described in Section V of this document. Appendix B
identifies the generic data that the Agency reviewed as part of its determination of
reregistration eligibility of imazapyr and lists the submitted studies that the Agency found
acceptable.
The Agency has determined that specific drift language amendments proposed in
this RED will substantially reduce, though may not eliminate, the risks to non-target
plants.
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Based on its evaluation of imazapyr, the Agency has determined that imazapyr
products, unless labeled and used as specified in this document, would present risks
inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the
risk mitigation measures identified in this document, the Agency may take regulatory
action to address the risk concerns from the use of imazapyr. If all changes outlined in
this document are incorporated into the product labels, then all current risks for imazapyr
will be adequately mitigated for the purposes of this determination under FIFRA. Once a
comprehensive endangered species assessment is completed, further changes to these
registrations may be necessary.
B. Public Comments and Responses
Through the Agency's public participation process, the Agency worked with
stakeholders and the public to reach the regulatory decisions for imazapyr. During the
public comment period on the risk assessments, which closed on February 21, 2006, the
Agency received comments from the BASF Corporation, the Nebraska Department of
Agriculture, and the California Indian Basketweavers Association (CIBA). For responses
to public comments from the BASF Corporation and the Nebraska Department of
Agriculture please refer to the EFED Responses to Imazapyr Phase 3 Comments, dated
March 29, 2006 and is located in the public docket, http://www.regulations.gov, OPP-
2005-0495. Response to comments from CIBA is as follows:
As stated above, the CIBA submitted a public comment dated 2/21/06 to Docket
ID Number EPA-OPP-2005-0495 in response to the Imazapyr: HED Chapter of the
Reregistration Eligibility Decision Document, dated December 8, 2005. This group is
concerned about long-term use of pesticides such as imazapyr in forests and on rangeland
and their possible effects on wildlife, native plants, life cycles and contamination of
basket-making materials, water, and traditional foods. CIBA stated, "Currently, no
pesticide residue tolerance has been established for traditional foods eaten and gathered
by Native Americans, and the health and risk assessment is not protective for Native
American uses of plants growing on public lands where high volumes of imazapyr and
other herbicide uses occur. CIBA cited a study conducted by C. Ando, et al. at the
California Department of Pesticide Regulation (CDPR) claiming that, following forest
treatments, the researchers found that residues of "herbicides" in certain forest plants used
by Indians greatly exceed tolerances currently established for the same chemicals in
certain fruits, berries, herbs, and grains."
Many of CIBA's statements seem to be addressing general concerns associated
with various pesticide uses on rangeland and in forests. The published study supporting
the group's claims only addressed the use of glyphosate, hexazinone, and triclopyr in
California forests and residues of these three pesticides in four native species used by
local Indians. Maximum residues of these three herbicides in the four sampled native
plants were found at 19-241 ppm on the day of treatment; half-lives varied from 1 week
to 19 weeks. However, none of the tested pesticides are chemically similar to imazapyr.
There are several details about imazapyr that, taken together, should minimize CIBA's
concerns for imazapyr risks, specifically: Imazapyr tolerances at 40 CFR 180.500 have
been established at 100 ppm in grass forage and 30 ppm in grass hay. These tolerances
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reflect spot treatment of weed species in pasture and rangeland at 0.75 Ib a.i./A, but
<10% of any given acre may be treated. Therefore, the likelihood of imazapyr use on
plants traditionally used by Native Americans, unless targeted as a weed, is unlikely. If
spot-treated as a weed, the plant is likely to be exhibiting symptoms of phytotoxicity.
Applications in forests are also typically directed, spot treatments although broadcast
treatments may be applied at <1.5 Ib a.i./A. The preharvest interval is 7 days. The
Agency has usage information indicating that <2.5% of all U.S. pasture and rangeland is
treated with imazapyr.
As described in the 12/8/05 HED Chapter of the RED, there are no acute risks
associated with imazapyr because a single dose of the chemical does not induce adverse
effects. Aggregate chronic/long-term risk is <0.1% of the chronic Population Adjusted
Dose (cPAD), i.e., a negligible risk. Short-term aggregate risks (MOEs of 410 in
children and 720 in adults) are well below the Agency's level of concern (i.e., the MOEs
estimated for pesticide exposures are greater than 100).
In other words, additional human exposures to imazapyr in excess of those
expected from consumption of default, high volume foods could still occur in
subpopulations before the Agency's levels of concern (100% of the cPAD and an MOE of
100 for short-term) would be approached. Note that greater emphasis is being placed by
the Agency on determining consumption and exposure patterns of U.S. subpopulations,
such as Native Americans, that have thus far not been sufficiently represented in USD A's
Continuing Survey of Food Intakes by Individuals (CSFII), 1994-1996 and 1998 to
permit more refined dietary exposure assessments to be conducted for these groups.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
Imazapyr tolerances were reassessed in 2003 when new food uses were
established. However, part of reregistration under FIFRA, the Agency assessed the risks
associated with imazapyr. The Agency has concluded that aggregate exposure to
imazapyr through food, drinking water, and residential sources is within its own "risk
cup" and that human health risks from these combined exposures are within acceptable
levels. The Agency has determined that the human health risks from these combined
exposures are within acceptable levels. In other words, the Agency has concluded that
the tolerances for imazapyr meet FQPA safety standards. In reaching this determination,
the Agency has considered the available information on the special sensitivity of infants
and children, as well as aggregate exposure from food, drinking water, and residential
uses. The FQPA safety factor has not been retained for imazapyr because acceptable
developmental and reproduction studies have been submitted and reviewed and there is
low concern and no residual uncertainties for pre- and post-natal toxicity. In addition, the
dietary and residential assessments are not expected to underestimate exposure.
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b. Endocrine Disrupter Effects
The Agency is required under 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 endocrine effects as the Administrator may
designate." Following recommendations of its Endocrine Disrupter Screening and
Testing Advisory Committee (EDSTAC), the Agency determined that there was a
scientific basis for including, as part of the program, the androgen and thyroid hormone
systems, in addition to the estrogen hormone system. The Agency also adopted
EDSTAC's recommendation to include evaluations of potential effects in wildlife. For
pesticides, the Agency will use FIFRA and, to the extent that effects in wildlife may help
determine whether a substance may have an effect in humans, FFDCA authority to
require the wildlife evaluations. As the science develops and resources allow, screening
for additional hormone systems may be added to the Endocrine Disrupter Screening
Program (EDSP).
In the available toxicity studies on imazapyr, there was no evidence of endocrine
disruption. When the appropriate screening and/or testing protocols being considered
under the EDSP have been developed, imazapyr may be subject to additional screening
and/or testing to better characterize effects related to endocrine disruption.
c. Cumulative Risks
Risks summarized in this document are those that result only from the use of
imazapyr. Unlike other pesticides for which the Agency has followed a cumulative risk
approach based on a common mechanism of toxicity, the Agency has not made a
common mechanism of toxicity finding for imazapyr and any other substances.
Therefore, for the purposes of reregistration, the Agency has not assumed that imazapyr
shares a common mechanism of toxicity with other compounds.
2. Tolerance Summary
Imazapyr tolerances were reassessed in 2003 when new food uses were
established. This document does not result in any additional tolerances being reassessed.
The following information is provided for informational purposes only. A tolerance
summary is presented below in Table 13. The Agency has determined that the residue of
concern for tolerance expression in plants, livestock, fish, and water is imazapyr per se.
Existing tolerances are established in 40 CFR §180.500 for residues of the
herbicide imazapyr, [2-[4,5-dihydro-4-methyl-4-(l-methylethyl)-5-oxo-lH-imidazol-2-
yl]-3-pyridinecarboxylic acid], applied as the acid or ammonium salt, in/on corn, grass,
milk, meat, poultry, eggs, fish, and shellfish. Adequate data are available to reassess the
existing tolerance levels for imazapyr.
The submitted magnitude of the residue data for corn, grass, milk, meat, poultry,
and eggs are fulfilled and are adequate for the purposes of reregistration; however,
acceptable supporting storage stability data on corn forage and fodder and clarification of
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the identity and quantity of spray additives utilized in the grass field trials remain
outstanding. The submitted processing data on corn are acceptable, and the results of
these studies show that imazapyr does not appreciably concentrate in the processed
commodities of field corn. The submitted confined rotational crop data are adequate for
the purposes of reregistration, and limited field rotational crop data and rotational crop
tolerances are not required at this time.
Imazapyr is registered for use on aquatic areas and the treated water from these
sites may be diverted to irrigate food or feed crops. No data depicting imazapyr residue
levels in irrigated crops have been submitted and at present, no label restriction prohibits
use of imazapyr treated waters for irrigated crops. Data on irrigated crops or label
restrictions that prohibit the irrigation of crops with imazapyr treated water for 120 days
following application and/or demonstrates non-detectable residue levels of imazapyr in
irrigation water by laboratory analysis prior to use are required for reregistration.
Two methods are currently listed in the Pesticide Analytical Manual (PAM) Vol.
II for enforcing tolerances of imazapyr in/on corn commodities. Method M 2468 is a gas
chromatograph/ mass spectrometry (GC/MS) method with a limit of quantitation (LOQ)
of 0.01 ppm for imazapyr in/on corn grain, forage and fodder, and Method M 2657 is a
capillary electrophoresis (CE) method with UV detection that has a LOQ of 0.05 ppm for
imazapyr in/on corn grain, forage and fodder.
A series of CE/UV Methods are currently listed as enforcement methods for
determining imazapyr in/on grass forage and hay (Method M 3023), in livestock tissues
(Method M 3184), in milk and milk fat (Methods M 3075 and M 3223), and in fish and
shellfish tissues (Method M 3066). These methods are similar to the enforcement method
M 2657, and each of these methods also includes directions for a confirmatory analysis
using LC/MS.
Each of the above methods has undergone a successful independent laboratory
validation (ILV) trial. Adequate radiovalidation data were also submitted for CE/UV
methods M 3066, M 3075, and M 3184, demonstrating the efficiency of these methods in
extracting residues from aged samples.
The Food and Drug Administration (FDA) multiresidue methods do not exhibit
sufficient sensitivity to other imidazolinone herbicides, and thus there is no reasonable
expectation that these methods would prove to be useful for determining residues of
imazapyr.
Currently there are no Codex, Canadian or Mexican tolerances for residues of
imazapyr in/on corn, grass, fish, shellfish, or livestock commodities. Thus, international
harmonization of tolerances is not an issue at this time.
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a. Tolerances Currently Listed and Tolerance Reassessment
Table 13. Tolerance Table
Commodity
Corn, field, forage
Corn, field, grain
Corn, field, stover
Grass, forage
Grass, hay
Fish
Shellfish
Fat of cattle
Kidney of cattle
Meat byproducts, excluding
kidney, of cattle
Meat of cattle
Fat of sheep
Kidney of sheep
Meat byproducts, excluding
kidney of sheep
Meat of sheep
Fat of goats
Kidney of goats
Meat byproducts, excluding
kidney, of goats
Meat of goats
Fat of horses
Kidney of horses
Meat byproducts, excluding
kidney, of horses
Meat, of horses
Milk
Current Tolerance
(ppm)
0.05
0.05
0.05
100
30
1.0
0.1
0.05
0.20
0.05
0.05
0.05
0.20
0.05
0.05
0.05
0.20
0.05
0.05
0.05
0.20
0.05
0.05
0.01
Reassessed
Tolerance (ppm)
0.05
0.05
0.05
100.0
30.0
1.0
0.10
0.05
0.20
0.05
0.05
0.05
0.20
0.05
0.05
0.05
0.20
0.05
0.05
0.05
0.20
0.05
0.05
0.01
Comments
(Correct commodity definition)
The available residue data support
the reassessed tolerances.
The available residue data support
the reassessed tolerances.
The available residue data support
the reassessed tolerances.
The available residue data support
the reassessed tolerances.
The available residue data support
the reassessed tolerances.
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D. Regulatory Rationale
The Agency has determined that imazapyr is eligible for reregistration provided
the risk mitigation measures outlined in this document are adopted, and label
amendments are made to reflect these measures. This decision considers the risk
assessments conducted by the Agency and the significance of the use of imazapyr.
The following is a summary of the rationale for managing risks associated with
the use of imazapyr. Where labeling revisions are warranted, specific language is set
forth in the summary tables in Section V of this document.
1. Human Health Risk Management
In the human health risk assessment, dietary risks (food and drinking water),
residential handler dermal and inhalation risks, residential oral and dermal post-
application risks, and aggregate risks do not exceed the Agency's level of concern.
Therefore, no risk mitigation measures are required to address these exposure scenarios.
a. Occupational Risk Mitigation
As discussed in Section III.A.T.a, short- and intermediate-term dermal and
inhalation risks to occupational handlers who may be exposed to imazapyr during
mixer/loader/applicator activities are below the Agency's level of concern at either the
baseline level of personal protective equipment or with the addition of gloves. To protect
workers mixing and loading liquid formulations for aerial applications to aquatic sites,
terrestrial non-crop sites, forestry sites, and areas grazed or cut for hay, these handlers are
required to wear chemical resistant gloves. To protect workers mixing, loading, and
applying liquid and granular formulations via handwands, backpack spreaders and
sprayers, and handgun sprayers for non-crop and aquatic uses, those handlers are required
to wear chemical-resistant gloves. As a condition of reregistration, imazapyr formulation
into wettable powder end use products is not allowed unless they are packaged in water soluble
bags. Label language will include the following measures:
• Liquids: Chemical-resistant gloves are required for all mixers and loaders of
liquid formulations and for applicators using hand-held equipment.
• Granulars: Chemical-resistant gloves are required for all mixers and loaders of
granular formulations and applicators using hand-held equipment.
• Dry Flowables and Wettable Powders (water soluble bags): Chemical-resistant
gloves are required for all mixers and loaders of dry flowable and water soluble
bag formulations and applicators using hand-held equipment.
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For all agricultural postapplication exposure scenarios, postapplication
occupational risks are below HED's level of concern (i.e., the MOEs are greater than
100) on day 0 - approximately 12 hours following application. However, the Agency has
determined that imazapyr is a Toxicity Category I primary eye irritant and under the
Worker Protection Standard (WPS; 40 CFR Part 170), a 48-hour REI is required. Also
under the WPS, early entry requires that coveralls, shoes and socks, chemical resistant
gloves, and protective eyewear be used.
2. Environmental Risk Management
To address risks to non-target aquatic and terrestrial plants, additional directions
for use and use restrictions will be added to product labels to reduce potential risks.
Specific language and restrictions are discussed below.
a. Non-target Terrestrial Plant Risk Mitigation
As mentioned earlier, screening-level risk quotients (RQs) for non-target
terrestrial plants resulting from the terrestrial and aquatic spray uses range from 0.01 to
319 for non-target terrestrial plants and from 0.04 to 4,500 for endangered terrestrial
plants. Likewise, RQs for non-endangered terrestrial plants from the granular use range
from 5.4 to 313 for non-target terrestrial plants and from 25 to 4,410 for endangered
non-target terrestrial plants. For aquatic uses of imazapyr, the RQs for non-endangered
terrestrial plants ranged from 24 to 313 and 111 to 4,412 for endangered terrestrial
plants. Direct exposure scenarios were not calculated, but RQs for plants and
endangered plants would be significantly higher than those estimated from exposure via
spray drift and/or runoff.
Because imazapyr is an herbicide and may therefore harm non-target plants
exposed via drift, to be eligible for reregistration labels must require that imazapyr be
applied in a manner that minimizes spray drift. Strict use restrictions to minimize spray
drift will be placed on the labels for all imazapyr products. This language will include:
• For aerial applications, applicators are required to use a Coarse or coarser droplet
size (AS ABE S572) or, if specifically using a spinning atomizer nozzle,
applicators are required to use a volume mean diameter (VMD) of 385 microns or
greater for release heights below 10 feet; Applicators are required to use a Very
Coarse or coarser droplet size or, if specifically using a spinning atomizer nozzle,
applicators are required to use a VMD of 475 microns or greater for release
heights above 10 feet; applicators must consider the effects of nozzle orientation
and flight speed when determining droplet size;
• For aerial applications, applicators are required to use upwind swath
displacement;
• For aerial applications, the boom length must not exceed 60% of the wingspan or
90% of the rotor blade diameter, to reduce spray drift;
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• For aerial applications, applications with wind speeds less than 3 mph and with
wind speeds greater than 10 mph are prohibited;
• For groundboom applications, applicators are required to use a nozzle height
below 4 feet above the ground or plant canopy and Coarse or coarser droplet size
(ASABE S572) or, if specifically using a spinning atomizer nozzle, applicators
are required to use a volume mean diameter (VMD) of 385 microns or greater;
• For groundboom applications, applications with wind speeds greater than 10 mph
are prohibited;
• Applications into temperature inversions are prohibited.
The Agency has determined that specific drift language amendments proposed in
this RED will substantially reduce, though may not completely eliminate, the risks to
non-target plants.
b. Non-target Aquatic Plant Risk Mitigation
Screening-level risk quotients (RQs) for both the aquatic and terrestrial uses of
imazapyr were calculated. The RQs for non-endangered aquatic plants from the aquatic
use range from <0.01 for non-vascular aquatic plants to 31 for vascular aquatic plants
and from 7.6 to 50 for endangered vascular aquatic plants. The non-target endangered
and non-endangered aquatic plant RQs resulting from the terrestrial uses range from
<0.01 for non-vascular plants to 4.7 for vascular aquatic plants and from 0.07 to 7.6 for
endangered vascular aquatic plants. The Agency has determined that the specific drift
requirements listed above will substantially reduce the risks to non-target aquatic plants
from terrestrial uses of imazapyr.
For non-target plant risks resulting from the aquatic use of imazapyr, there is
currently the statement, "Do not apply to bodies of water or portions of bodies of water
where emergent and/or floating weeds do not exist" on labels that allow application to
water bodies. The Agency believes that this statement also substantially reduces the
risks to non-target aquatic plants (including endangered plants) from this use. However,
the Agency feels that this language should be placed in a more prominent location on the
label. Therefore, the Agency is requiring the statement be placed in the General Use
Precautions and Restrictions section of the label. Putting this use requirement in this
section will make it clearer that this is a use restriction when applying to bodies of water.
Currently, this statement is in the General Information section of the label.
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3. Significance of Imazapyr Use
The application of imazapyr for aquatic and semi-aquatic weed control is
predominantly conducted to control nuisance and nonnative weed species; most often
species such as Purple Loosestrife (Lythrum salicaria L.). When these species begin to
invade shoreline areas of lakes, streams, or canals, their establishment is rapid and often
results in their out-competing indigenous species, which then leads to a monoculture.
Since imazapyr has no effect on submerged aquatic vegetation (SAV), it can be used in
these margin, or shoreline, areas to control weeds without the risk of damaging desirable
SAV.
4. Other Labeling Requirements
In order to be eligible for reregistration, imazapyr use and safety
information will be included in the labeling of all end-use products containing imazapyr.
Imazapyr is classified as a Toxicity Category I primary eye irritant; therefore, the WPS
requires a REI of 48 hours. Also under the WPS, early entry requires that coveralls,
shoes and socks, chemical resistant gloves, and protective eyewear be used.
For the specific labeling statements and a list of outstanding data, refer to Section V of
this RED document.
5. Threatened and Endangered Species Considerations
a. The Endangered Species Program
The Agency has developed the Endangered Species Protection Program to
identify pesticides whose use may cause adverse impacts on threatened and endangered
species, and to implement mitigation measures that address these impacts. The
Endangered Species Act requires federal agencies to ensure that their actions are not
likely to jeopardize listed species or adversely modify designated critical habitat. To
analyze the potential of registered pesticide uses that may affect any particular species,
the Agency uses basic toxicity and exposure data developed for the REDs and then
considers ecological parameters, pesticide use information, geographic relationship
between specific pesticide uses and species locations, and biological requirements and
behavioral aspects of the particular species. When conducted, this species-specific
analysis will also consider the risk mitigation measures that are being implemented as a
result of this RED.
Following this future species-specific analysis, a determination that there is a
likelihood of potential effects to a listed species may result in limitations on use of the
pesticide, other measures to mitigate any potential effects, or consultations with the Fish
and Wildlife Service and/or the National Marine Fisheries as appropriate. If the Agency
determines use of imazapyr "may effect" listed species or their designated critical habitat,
the Agency will employ the provisions in the Services regulations (50 CFR Part 402).
Until the species-specific analysis is completed, the risk mitigation measures being
implemented through this RED will reduce the likelihood that endangered and threatened
species may be exposed to imazapyr at levels of concern. The Agency is not requiring
33
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specific imazapyr label language at the present time relative to threatened and endangered
species. If, in the future, specific measures are necessary for the protection of listed
species, the Agency will implement them through the Endangered Species Program.
b. General Risk Mitigation
Imazapyr end-use products (EUPs) may also contain other registered pesticides.
Although the Agency is not proposing any mitigation measures for products containing
imazapyr specific to federally listed threatened and endangered species, the Agency
needs to address potential risks from other end-use products. Therefore, the Agency
requires that users adopt all threatened and endangered species risk mitigation measures
for all active ingredients in the product. If a product contains multiple active ingredients
with conflicting threatened and endangered species risk mitigation measures, the more
stringent measure(s) must be adopted.
V. What Registrants Need to Do
The Agency has determined that imazapyr is eligible for reregistration provided
that the risk mitigation measures identified in this document are adopted and label
amendments are made to reflect these measures; however, additional data are required to
confirm this decision. In the near future, the Agency intends to issue Data Call-In
Notices (DCIs) requiring product specific data and generic (technical grade) data.
Generally, registrants will have 90 days from receipt of a DCI to complete and submit
response forms or request time extension and/or waiver requests with a full written
justification. For product specific data, the registrant will have 8 months to submit data
and amend labels. For generic data, due dates can vary depending on the specific studies
being required. Below are tables of additional generic data that the Agency intends to
require for imazapyr to be eligible for reregistration.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregistration of imazapyr has been reviewed
and determined to be substantially complete. However, the following additional data
requirements have been identified by the Agency as confirmatory and are included in the
generic DCI for this RED.
34
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Table 14. Confirmatory Data Requirements for Reregistration
New Guideline
Number
123-l(a)
123-Kb)
171-4e
171-4f, g, h,
165-5
171-4k
Old Guideline
Number
850.4225
850.4250
860.1380
860.1400
860.1500
Study/Requirements
Seedling Emergence- Tier II using Imazapyr isopropylamine salt
PLUS the adjuvant/surfactant/wetting agent as required on the label
Vegetative Vigor- Tier II using Imazapyr isopropylamine salt
PLUS the adjuvant/surfactant/wetting agent as required on the label
Storage stability data for corn or grass
Magnitude of residues in fish
Identity and quantity of spray additives used in all of the grass field
trials
Imazapyr is registered for use on aquatic areas and the treated water from these
sites may be diverted to irrigate food or feed crops. No data depicting imazapyr residue
levels in irrigated crops have been submitted and presently no label restriction prohibits
use of imazapyr treated waters for irrigated crops. Data on irrigated crops or label
restrictions that prohibit the irrigation of crops with imazapyr treated water for 120 days
following application and/or demonstrates non-detectable residue levels of imazapyr in
irrigation water by laboratory analysis prior to use are required to confirm this for
reregistration decision.
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing use products
(MP) labeling should be revised to comply with all current EPA regulations, PR Notices
and applicable policies. In order to be eligible for reregistration, amend all product labels
to incorporate the risk mitigation measures outlined in Section IV. The technical and MP
labeling should also bear the labeling statements contained in Table 15, Label Changes
Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g) (2) (B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticides after a determination of eligibility has been made.
The registrant must review previous data submissions to ensure they meet current EPA
acceptance criteria and if not, commit to conduct new studies. If a registrant believes that
previously submitted data meet current testing standards, then the study MRID numbers
should be cited according to the instructions in the Requirement Status and Registrations
Response Form provided for each product.
A product-specific data call-in, outlining specific data requirements will be i
iear fiiture
in the near future.
issued
35
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2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV
above. Specific language to incorporate these changes is specified in the Label Changes
Summary Table below.
a. Label Changes Summary Table
In order to be eligible for reregistration, registrants must amend all product labels
to incorporate the risk mitigation measures outlined in Section IV. The following table
describes how language on the labels should be amended.
36
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Table 15: Summary of Labeling Changes for Imazapyr
Description
Amended Labeling Language
Placement on Label
For all Manufacturing Use
Products
"Only for formulation into an herbicide for the following uses:
liquid, wettable powder (in water soluble bags only), and granular."
"Not for formulation into wettable powder end use products unless
they are packaged in water soluble bags."
Directions for Use
One of these statements may
be added to a label to allow
reformulation of the product
for a specific use or all
additional uses supported by
a formulator or user group
"This product may be used to formulate products for specific use(s)
not listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support
of suchuse(s)."
"This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
Directions for Use
Environmental Hazards
"This product is toxic to plants. Drift and run-off may be hazardous
to plants in water adjacent to treated areas. Do not apply to water
except as specified on the label. Treatment of aquatic weeds may
result in oxygen depletion or loss due to decomposition of dead
plants. Do not treat more than one half the surface area of the water
in a single operation and wait at least 10 to 14 days between
treatments. Begin treatment along the shore and proceed outward in
bands to allow aquatic organisms to move into untreated areas. Do
not contaminate water when disposing of equipment, washwater, or
rinsate. See Directions for Use for additional precautions and
requirements."
Precautionary Statements
37
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End Use Products for Occupational Use (WPS and non-WPS)
PPE Requirements
Established by the RED1
For All Formulations
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are"
(registrant inserts correct chemical-resistant material). "If you want
more options, follow the instructions for category" [registrant inserts
A,B,C,D,E,F,G, or H] "on an EPA chemical-resistance category
selection chart.
"Mixers, loaders, applicators, and other handlers must wear:
> Long-sleeve shirt and long pants,
> Shoes plus socks,
> Chemical resistant gloves for all mixers and loaders, plus
applicators using handheld equipment."
Precautionary Restrictions
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions for washables exist, use detergent and hot water.
Keep and wash PPE separately from other laundry.
Discard clothing and other absorbent materials that have been
drenched or heavily contaminated with this product's concentrate. Do
not reuse them."
Immediately following the PPE requirements
Engineering controls for
Products Applied Aerially as
Sprays
"Pilots must use an enclosed cockpit that meet the requirements listed
in the Worker Protection Standard (WPS) for agricultural pesticides
[40 CFR 170.240(d)(6)]."
Immediately following the User Safety
Requirements
38
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User Safety
Recommendations
"User Safety Recommendations
Users should wash hands with plenty of soap and water before eating,
drinking, chewing gum, using tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets
inside. Then wash thoroughly and put on clean clothing.
Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing. As soon as possible,
wash thoroughly and change into clean clothing."
Immediately following Engineering Controls
(Must be placed in a box.)
Environmental Hazards
"This product is toxic to plants. Drift and run-off may be hazardous
to plants in water adjacent to treated areas. Do not apply to water
except as specified on the label. Treatment of aquatic weeds may
result in oxygen depletion or loss due to decomposition of dead
plants. Do not treat more than one half the surface area of the water
in a single operation and wait at least 10 to 14 days between
treatments. Begin treatment along the shore and proceed outward in
bands to allow aquatic organisms to move into untreated areas. Do
not contaminate water when disposing of equipment, washwater, or
rinsate. See Directions for Use for additional precautions and
requirements."
Precautionary Statements immediately
following the User Safety Recommendations
Restricted-Entry Interval for
products with directions for
use within scope of the
Worker Protection Standard
for Agricultural Pesticides
(WPS)
"Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 48 hours."
Directions for Use, In Agricultural Use
Requirements Box
39
-------
Entry Restrictions for
Products with Directions for
Use not Within the Scope of
WPS
For products applied as Sprays: "Do not enter or allow others to
enter treated areas until sprays have dried"
For products applied as Dry: "Do not enter or allow others to enter
treated areas until dusts have settled."
Early Entry Personal
Protective Equipment for
products with directions for
use within the scope of the
WPS
"PPE required for early entry to treated areas that is permitted under
the Worker Protection Standard and that involves contact with
anything that has been treated, such as plants, soil, or water, is:
* coveralls
* shoes plus socks
* chemical-resistant gloves made of any waterproof material
* protective eyewear"
Direction for Use, In Agricultural Use
Requirements box, immediately following
theREI
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application."
General Application
Restrictions
Place in the Direction for Use directly above
the Agricultural Use Box.
Spray Drift
Spray drift requirements
Aerial Applications:
(1) Applicators are required to use a Coarse or coarser droplet size
(ASABE S572) or, if specifically using a spinning atomizer nozzle,
applicators are required to use a volume mean diameter (VMD) of
385 microns or greater for release heights below 10 feet; Applicators
are required to use a Very Coarse or coarser droplet size or, if
specifically using a spinning atomizer nozzle, applicators are required
to use a VMD of 475 microns or greater for release heights above 10
feet; Applicators must consider the effects of nozzle orientation and
flight speed when determining droplet size.
Directions for Use
40
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(2) Applicators are required to use upwind swath displacement.
(3) The boom length must not exceed 60% of the wingspan or 90% of
the rotor blade diameter to reduce spray drift.
(4) Applications with wind speeds less than 3 mph and with wind
speeds greater than 10 mph are prohibited.
(5) Applications into temperature inversions are prohibited.
Ground Boom Applications:
(1) Applicators are required to use a nozzle height below 4 feet above
the ground or plant canopy and Coarse or coarser droplet size
(ASABE S572) or, if specifically using a spinning atomizer nozzle,
applicators are required to use a volume mean diameter (VMD) of
385 microns or greater.
(2) Applications with wind speeds greater than 10 mph are
prohibited.
(3) Applications into temperature inversions are prohibited.
The use of treated waters on irrigated crops within 120 days of
treatment is prohibited.
41
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End Use Products Primarily Intended for Residential Use
Environmental Hazard
Statements
"This product is toxic to plants. Drift and run-off may be hazardous
to plants in water adjacent to treated areas. Do not apply to water
except as specified on the label. Treatment of aquatic weeds may
result in oxygen depletion or loss due to decomposition of dead
plants. Do not treat more than one half the surface area of the water
in a single operation and wait at least 10 to 14 days between
treatments. Begin treatment along the shore and proceed outward in
bands to allow aquatic organisms to move into untreated areas. Do
not contaminate water when disposing of equipment, washwater, or
rinsate. See Directions for Use for additional precautions and
requirements."
Precautionary Statements immediately
following the User Safety Recommendations
Entry Restrictions for
products applied as a spray
For products applied as Sprays: "Do not enter or allow others to
enter treated areas until sprays have dried"
For products applied as Dry: "Do not enter or allow others to enter
treated areas until dusts have settled."
Directions for use under General Precautions
and Restrictions
General Application
Restrictions
"Do not apply this product in a way that will contact any person, pet,
either directly or through drift. Keep people and pets out of the area
during application."
Directions for Use under General Precautions
and Restrictions
1 PPE that is established on the basis of Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
2 If the product contains oil or bears instructions that will allow application with an oil-containing material, the "N" designation must be dropped.
42
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VI. Appendices
43
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Appendix A. IMAZAPYR USE PATTERNS ELIGIBLE FOR REREGISTRATION
Site
Application Type
Application Timing
Application Equipment
Noncropland Areas
Pre-emergence
aerial, tractor-drawn
spreader
Noncropland Areas
Pre-emergence
aerial, tractor-drawn
spreader
Noncropland Areas
Pre-emergence
aerial, tractor-drawn
spreader
Noncropland Areas
Pre-emergence
aerial, tractor-drawn
spreader
Noncropland Areas
Pre-emergence
aerial, tractor-drawn
spreader
Noncropland Areas
Pre-emergence
Aerial, groundboom,
low-pressure handwand,
right-of-way sprayer,
backpack
[EPA Reg.
Nn 1
0.5%
granular
[228-307]
0 5%
granular
[228-308]
0.5%
granular
[241-295]
5.0%
granular
[241-308]
0.5%
granular
[241-344]
7.78%
dispersable
granules
[241-372]
Max. Single
Application
Rate
(Ib ae/A)
1.5
1.5
1.5
1.5
1.5
1.5 initial
application
0.5
reapplication
Max. #
Apps./season
1 (herbaceous)
1-2 per 10
years (brush)
1-2 per 10
years (brush)
1 (herbaceous)
1-2 per 10
years (brush)
1 (herbaceous)
1-2 per 10
years (brush)
1 (herbaceous)
1-2 per 10
years (brush)
1.5 Ib ae/A in
a 12 month
period
Minimum
Retreatment
Interval
(Days)
N/S
N/S
N/S
N/S
N/S
N/S
Use Limitations
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses. Do not appy where runoff or irrigation water may flow onto
agricultural land. Do not use on lawns, walks, driveways tennis cours, or
similar areas. Do not use in California.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses. Do not appy where runoff or irrigation water may flow onto
agricultural land. Do not use on lawns, walks, driveways tennis cours, or
similar areas. Do not use in California.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses. Do not appy where runoff or irrigation water may flow onto
agricultural land. Do not use on lawns, walks, driveways tennis cours, or
similar areas. Do not use in California.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses. Do not appy where runoff or irrigation water may flow onto
agricultural land. Do not use on lawns, walks, driveways tennis cours, or
similar areas. Do not use in California.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses. Do not appy where runoff or irrigation water may flow onto
agricultural land. Do not use on lawns, walks, driveways tennis cours, or
similar areas. Do not use in California.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses. Do not use on lawns, walks, driveways tennis cours, or similar
areas. Do not use in California.
44
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Site
Application Type
Application Timing
Application Equipment
Clearfield Corn
Hybrids
Post-emergence
Backpack, low-pressure,
handgun, airblast, aerial
Clearfield Corn
Hybrids
Post-emergence
Backpack, low-pressure,
handgun, airblast, aerial
Trees
Post-emergence
Aerial, groundboom,
handgun, rights-of-way
sprayer
Clearfield Corn
Hybrids
Post-emergence
Aerial, groundboom,
low-pressure handwand,
right-of-way sprayer,
backpack
Trees
Post-emergence
Aerial, groundboom,
handgun, rights-of-way
sprayer
Noncropland Areas
Pre-emergence
Aerial, groundboom,
low-pressure handwand,
right-of-way sprayer,
backpack
Noncropland Areas
Pre-emergence
aerial, tractor-drawn
spreader
Formulation
[EPA Reg.
No.]
17.5%
dispersable
granules
[241-377]
4.0%
dispersable
granules
[241-384]
75% soluble
granules
[241-387]
5.05% liquid
[241-400]
75.0%
soluble
granules
[241-402]
0.15% liquid
[2217-802]
0.5%
granules
[13283-19]
Max. Single
Application
Rate
(Ib ae/A)
0.014
0.014
1.5
0.014
1.25
0.014
1.5
Max. #
Apps./season
1
1
1 (herbaceous)
1-2 per 10
years (brush)
1
1 (herbaceous)
1-2 per 10
years (brush)
1
1 (herbaceous)
1-2 per 10
years (brush)
Minimum
Retreatment
Interval
(Days)
N/S
N/S
N/S
N/S
N/S
N/S
N/S
Use Limitations
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not apply through any
type of irrigation system. Do not use in California. New York - Not for sale or
use on Long Island
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not apply through any
type of irrigation system. Do not use in California. New York - Not for sale or
use on Long Island
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses. Do not use on lawns, walks, driveways tennis cours, or similar
areas. Do not use in California.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not mix or load within 50
feet of any wells, sink holes, perennial or intermittent streams and rivers, and
natural or impounded reservoirs. Not for use in California or New York.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not use on Christmas trees. Do not treat irrigation ditches, or water
used for crop irrigation or for domestic uses.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not apply through any
irrigation system.
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses.
45
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Noncropland Areas
Pre-emergence
aerial, tractor-drawn
spreader
Noncropland Areas
Pre-emergence
aerial, tractor-drawn
spreader
Grass Pasture and
Rangeland
Post-emergence
Spot treatment ground
equipment
Aquatic Areas or Draw
Down Area
Post-emergence
Aerial, boat
0.5%
granules
[34913-22]
5% granules
[34913-24]
2 Ib ae/gal
EC
[241-346]
2 Ib ae/gal
EC
[241-346]
1.5
1.5
0.75
1.5
1 (herbaceous)
1-2 per 10
years (brush)
1 (herbaceous)
1-2 per 10
years (brush)
1 per 5 years
N/S
N/S
N/S
7-day PHI2
N/S
Do not apply directly to water, or to areas where surface water is present, or to
intertidal areas below the mean high water mark. Do not use on food or feed
crops. Do not treat irrigation ditches, or water used for crop irrigation or for
domestic uses. Do not use on lawns, walks, driveways tennis cours, or similar
areas. Do not use in California.
Do not use on food or feed crops. Do not apply on ditches used to transport
irrigation water. Do not apply where runoff or irrigation water may flow onto
agricultural land. Do not use on lawns, walks, driveways, tennis courts, or
similar areas.
Applications may not exceed more than 1/10 of a given acre, therefore the
maximum rate per acre is 0.075 Ib ae/A. Do not cut forage for hay for 7 days
after application. Rotational crops: 12 months after application, a successful
field bioassay must be completed. If no crop injury is evident in the bioassay,
then the intended rotational crop may be planted the following year. Post-
emergence applications require the addition of a spray adjuvant (nonionic
surfactant or methylated seed oils or vegetable oil concentrates).
Do not apply to marine or estuarine areas. Do not apply within !/2 mile
(standing water) or within l/i mile upstreat (flowing water) of an active
irrigation or potable water intake. For application within 1A mile of a water
intake, the water intake must be turned off for a minimum of 48 hours after the
application. Allow 1 hour after treatment before refilling draw down area.
Apply in a minimum of value of 5 gal/A.
1. N/S—not specified
2. PHI—post-harvest interval
46
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Appendix B. TABLE OF GENERIC DATA REQUIREMENTS AND STUDIES USED
TO MAKE THE REREGISTRATION DECISION
GUIDE TO APPENDIX B
Appendix B contains listing of data requirements which support the reregistration for active
ingredients within Case #3078 (Imazapyr) covered by this RED. It contains generic data
requirements that apply to Imazapyr in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR part 158. The reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidance, which are available from the National
technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column list the identify number of each study. This normally is the Master Record
Identification (MIRD) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
47
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New Guideline
Number
Old Guideline
Number
Requirement
Use Pattern
Bibliographic Citation(s)
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
61-1
61-2(a)
61-2(b)
158.165
61-2(b)
62-1
62-2
62-3
63-2
63-3
Product Identity and
Composition
Start. Mat. & Mfg. Process
Description of Production
Process
Description of Formulation
Process
Discussion of Formation of
Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
43423700, 43423701
43423700
43423700
43423700
43423701-03
43423702
46274402
44102801
00145872
00145872
48
-------
830 6304
830.6313
830 7000
830.7050
830 7200
830.7220
830 7300
830 7370
830.7550
830 7560
830.7570
830 7840
830 7860
63-4
63-13
63-12
N/A
63-5
63-6
63-7
63-10
63-11
63-11
63-11
63-8
63-8
Odor
Stability - temp and ions
pH
UV/Visible absorption
Melting point/melting range
Boiling point/range
Density
Dissociation Constants in Water
Partition Coefficient, shake flask
method
Partition Coefficient generator
column method
Partition Coefficient, estimation
by liquid chromatography
Water Solubility column elution
method; shake flask method
Water Solubility generator
column method
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
ABCE F
G,J,K
00145872
00145872
00145872
Data Gap
00145872
N/A
00145872
00145872
00145872,00133555
See 830 7550
See 830.7550
See 830 7860
00145872
49
-------
830.7950
63-9
Vapor Pressure
ABCE F
G,J,K
00145782
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.2300
850.1075
850.1075
850.1075
850.1010
850.1045
850.1025
850.1035
71-l(a)
71-2(a)
71-2(b)
71-4(a)
71-4(b)
72-l(a)
72-l(b)
72-l(c)
72-2(a)
72-3 (a)
72-3(b)
72-3(c)
Avian Oral LD50 Quail/Duck
Avian Dietary LC50 Quail
Avian Dietary LC50 Duck
Avian Reproduction Quail
Avian Reproduction Duck
Freshwater Fish LC50 Bluegill
(warm water)
Freshwater Fish LC50 Channel
Catfish
Freshwater Fish LC50 Rainbow
trout (cold water)
Freshwater Invertebrate LC50
Daphnia magna
Estuarine/Marine Fish LC50
Estuarine/Marine Mollusk EC50
Estuarine/Marine Shrimp EC50
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
00131633,00131634
00131635, 0013552, 00133553
00131636,00131551
45119714,43831401
43831402
00133549
00131631
45119713
00131632,01133550
41315801
41315802, 45119709, 45119710
41315803
50
-------
850.1400
850.1400
850.1350
850.1500
850.171
850.4225
850.4400
850.4250
850.4450
850.3020
72-4(a)
72-4(a)
72-4(b)
72-5
72-6
122-1
122-2
123-1
124-2
141-1
Fish Early Life-Stage Rainbow
Trout (freshwater)
Fish Early Life- Stage Fathead
Minnow (estuarine/marine)
Aquatic Invertebrate Life-Cycle
(freshwater)
Freshwater Fish Full Life-Cycle
Aquatic Organism
Accumulation
Seed Germ. /Seedling
Emergence (Tier 2)
Aquatic Plant Growth (Tier 2)
Vegetative Vigor (Tier 2)
Aquatic Field
Honey Bee Acute Contact LD50
ABCE F
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
41315804
45119711
41315805
45119712
00147120
40003 7 11, Data Gap
43889102,40811802
43889101, 4081 1801, 4081 1802Data Gap
40811802, 00131628, 00131629, 00131637, 00133554, 00147114
00131637
TOXICOLOGY
870.1100
870.1200
870.1300
81-1
81-2
81-3
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-
Rabbit/Rat
Acute Inhalation Toxicity-Rat
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
41551002,93048016
41551003,93048017
00132032,93048018
51
-------
870 2400
870 2500
870.2600
8703100
870.3200
870.3700a
870 3700b
870.3800
8704100a
870.4100b
870.4200a
870 4200b
870.4300
81-4
81-5
81-6
82-1 (a)
82-2
83 -3 (a)
83 -3 (b)
83-4
83-1
83-1
83-2
83-2
83-5
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
21 -Day Dermal - Rabbit/Rat
Developmental Toxicity
(Teratogenicity) - rat
Developmental Toxicity
(Teratogenicity) - rabbit
2-Generation Reproduction - Rat
Chronic Toxicity - Rat
Chronic Toxicity - Dog
Carcinogenicity - Rat
Carcinogenicity - Mouse
Combined
Chronic/Carcinogenicity
ABCE F
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
41551001 93048019 Accession* 252004
41551004 93048020
00131607,93048021
42774401
00131609,93048022
00131611,93048023
00131613 93048024
41039505
N/A- see 870 4300
41039502
N/A; see 870.4300
41038505 42774401
41039503
52
-------
870.5100
870.5300
870.5375
870.5450
870.5500
870.7485
870.7600
84-2
84-2
84-2
84-2
84-2
85-1
85-3
Bacterial Reverse Mutation
(Ames Assay)
In vitro Mammalian Cell Gene
Mutation
In vitro Mammalian
Chromosome Aberration (CHO)
Rodent Dominant Lethal
Unscheduled DNA Synthesis
Metabolism and
Pharmacokinetics - Rat
Dermal Absorption - Rat
ABCE F
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
N/A
00131615,93048025
00151641,93048028
00151640,93048026
00151638
00151639,93048027
43861501
N/A
ENVIRONMENTAL FATE
835.2120
835.2240
835.4100
835.4200
835.4400
835.4300
161-1
161-2
162-1
162-2
162-3
162-4
Hydrolysis
Photodegradation - Water
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
00132359, 00131617, 00131639, 00133557
00131617
00131619, 41002301, 00131618, 00133557, 45119701
00131619,41023201,45119701
40003712
41002301,45119702
53
-------
835 1240
835 6100
835.6200
835 6500
N/A
N/A
835 7100
840 1100
840.2100
163-1
164-1
164-2
164-5
165-4
165-5
166-1
201-1
202-1
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
Aquatic Field Dissipation
Long Term Soil Dissipation
Accumulation in Fish
Accumulation - Aquatic Non-
target
Ground Water Monitoring
Spray Droplet Size Spectrum
Spray Drift Field Deposition
ABCE F
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
00131620 00131620 00133557 43423703 45119705
00131621 4219210142192102 45119705 45119706 00131622
00131623, 00131624, 0013357, 00147119
41891501, 45119707, 45119708
45119706
00147120
45119722
44746701 44746702 44746703 44865101 44865102 44975001
45035201, 45139101, 45139102, 45212601, 45212602, 45335301,
45335302, 45410001, 45410002, 45498201, 45212602, 45335301,
45335302, 45410001, 45410002, 45498201, 45498202, 45663801,
45663802, 45677401
41516301
41516301
54
-------
RESIDUE CHEMISTRY
860.1300
860.1300
860.1340
860.1340
860.1340
860.1360
860.1380
860.1400
860.1480
860.1500
860.1520
171-4(a)
171-4(b)
171-4(c)
171-4(d)
171-4(d)
171-4(m)
171-4(e)
171-4(h)
171-40
171-4(k)
171-4(1)
Nature of Residue in Plants
Nature of Residue in Livestock
Residue Analytical Method -
plant
Residue Analytical Method -
livestock
Residue Analytical Method -
Water/fish
Multiple Residue Methods
Storage Stability Data
Fish, water, & irrigated crops
Milk, Meat, Poultry, & Eggs
Cropfield Residue (Grass,
Forage, & Hay)
Processed Food/Feed
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
ABCE F
G,J,K
N/A
A,B,C,E, F,
G,J,K
A,B,C,G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
N/A
45119715
45119716
45119718
45119718
Data Gap
N/A
45 11 97 19, Data Gap
45 1 19709, 45 1 19722, 45 19707, Data Gap
45119721
45 11 9720, Data Gap
N/A
55
-------
860 1650
860 1 850
860.1900
171-13
165-1
165-2
Submittal of Analytical
Reference Standards
Confined rotational crops
Field rotational crops
ABCE F
G,J,K
ABCE F
G,J,K
A,B,C,E, F,
G,J,K
Submitted to EPA National Pesticide Standards Repository
45119717
45119717
HED concludes that there are no outstanding residue chemistry data requirements that would preclude the reassessment of tolerance
levels for reregistration purposes, provided that:
• the registrant submits an acceptable fish metabolism study,
• the registrant submits adequate corn or grass storage stability information,
• the registrant specifies the identity and quantity of spray additives used in all of the grass field trials,
• the analytical enforcement method is determined to be adequate, and
• labels are revised to prohibit use of treated waters on irrigated crops for 120 days after treatment or residue data is provided for irrigated crops.
A few data gaps were identified for imazapyr in a few different use areas that include:
• applying sprayers to aquatic sites via helicopters (PHED data for fixed wind aerial spray applications were used as a reasonable surrogate); and
• mixing/loading/applying liquids to trees via injection equipment (no surrogate data are available at this time).
For all agricultural postapplication exposure scenarios, data gaps exist such as a lack of imazapyr specific postapplication studies.
56
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP Regulatory
Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard
(South Building), 2777 S. Crystal Drive, Arlington, VA. It is open Monday through Friday,
excluding legal holidays, from 8:30 a.m. to 4:00 p.m.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded
or viewed via the Internet at the following site:
http ://docket. epa. gov/edkpub/index.j sp
These documents include:
1. Federal Register Notice: Imazapyr Reregistration Eligibility Decision; Notice of Availability
2. Reader's Guide to the Imazapyr EDOCKET OPP-2005-495
3. Imazapyr Reregistration Eligibility Decision
4. Imazapyr: Chronic Dietary Exposure Assessment for the Section 3 Registration Action on
Grasses and Aquatic Sites, PC Code: 128821, DP Barcode D288806 (March 26, 2003).
5. Imazapyr: Revised Health Effects Division (HED) Chapter of the Reregistration Eligibility
Document (RED), PC Code: 128821, CAS Reg 81334-34-1, Case #3078, DP Barcode D324106
(December 8, 2005).
6. Imazapyr: Occupational and Residential Exposure Assessment for the Reregistration
Eligibility Decision Document, PC Code: 128821, DP Barcode D320582, (August 31, 2005).
7. Response to Error Only Comments on the EFED Ecological Risk Assessment Supporting the
RED for the Herbicide, Imazapyr, PC Code: 128821, DP Barcodes: 324101, 324103, (December
9, 2005).
8. Imazapyr: Summary of Product Chemistry Data for Reregistration Eligibility Decision (RED)
Document, PC Code: 128821, DP Barcode: D320579 (August 29, 2005).
9. Level I Screening Ecological Risk Assessment for the Reregistration of Imazapyr, CAS
Number: 81334-34-1.
57
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Appendix D. CITATIONS CONSIDERED TO BE PART OF THE DATA BASE
SUPPORTING THE REREGISTRATION DECISION (BIBLIOGRAPHY)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies in
support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study." In the case
of published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they
were submitted. The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID" number. This number is unique to
the citation, and should be used whenever a specific reference is required. It is not related
to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases,
entries added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (1999),
the Agency was unable to determine or estimate the date of the document.
58
-------
c. Title. In some cases, it has been necessary for the Agency bibliographers to create
or enhance a document title. Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following
elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted
to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number
follows the symbol "CDL," which stands for "Company Data Library." This
accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
59
-------
Bibliography
MRID
131607
131609
131611
131612
131613
131614
131615
131616
Citation Reference
Ledoux, T. (1983) Evaluation of the Sensitization Potential of AC 243,997 in Guinea Pigs: T.P.S. Study No. 186A-201-
231-83; Spon- sor Study No. 981-83-129. (Unpublished study received Oct 6, 1983 under 241-273; prepared by
Toxicology Pathology Services, Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL: 251503-A)
Larson, D.; Kelly, W. (1983) Twenty-one Day Dermal Toxicity Study with AC 243,997 in Rabbits: T.P.S. Study No.
186B-301-230-83; Sponsor ID. No. 981-83-127. (Unpublished study received Oct 6, 1983 under 241-273; prepared by
Toxicology Pathology Services, Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL: 251503-C)
Salamon, C.; Enloe, P.; Mayhew, D.; et al. (1983) Teratology Study in Albino Rats with AC 243,997: Toxigenics' Study
450-1222. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Toxigenics, Inc., submitted by American
Cyanamid Co., Prince- ton, NJ; CDL:251504-A)
Salamon, C.; Enloe, P.; Taylor, G.; et al. (1983) Teratology Pilot Study in Albino Rats with AC 243,997: Toxigenics'
Study 450- 1221. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Toxigenics, Inc., submitted by
American Cyanamid Co., Princeton, NJ; CDL:251504-B)
Salamon, C.; Enloe, P.; Becker, S.; et al. (1983) Teratology Study in Albino Rabbits with AC 243,997: Toxigenics' Study
450-1224. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Toxigenics, Inc., submitted by American
Cyanamid Co., Prince- ton, NJ; CDL:251504-C)
Salamon, C.; Enloe, P.; Becker, S.; et al. (1983) Teratology Pilot Study in Albino Rabbits with AC 243,997: Toxigenics'
Study 450- 1223. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Toxigenics, Inc., submitted by
American Cyanamid Co., Princeton, NJ; CDL:251504-D)
Allen, J.; Fine, B.; Johnson, E.; et al. (1983) Bacterial/Microsome Reverse Mutation (Ames) Test on CL 243,997: Project
No. 0493; GTOX 5:1-23. Final rept. (Unpublished study received Oct 6, 1983 under 241-273; submitted by American
Cyanamid Co., Princeton, NJ; CDL:251504-E)
Mallipudi, N.; Stout, S.; Stanley-Millner, P.; et al. (1983) Herbi- cide AC 243,997: The Absorption, Excretion, Tissue
Residues and Metabolism of Carboxyl Carbon-14 Labeled AC 243,997 ... in the Rat: Report No. PD-M Volume 20-13:1-
83. (Unpublished study re- ceived Oct 6, 1983 under 241-273; submitted by American Cyanamid Co., Princeton, NJ;
CDL:251504-F)
60
-------
131617
131618
131619
131620
131621
131622
131623
131624
131625
Mallipudi, M.; Knoll, B.; Bullock, M.; et al. (1983) Arsenal Herbi- cide (AC 243,997): Photolysis of Carbon-14 Labeled
AC 243,997 ?Nicotinic Acid, 2-(4-Isopropyl-4-methyl-5-oxo-2-imidazolin-2- yl)- in Aqueous Media: Report No. PD-M
Volume 20-20. (Unpub- lished study received Oct 6, 1983 under 241-273; submitted by American Cyanamid Co.,
Princeton, NJ; CDL:251505-B)
Mallipudi, M.; DaCunha, A.; Stanley-Millner, P.; et al. (1983) Arsenal Herbicide (AC 243,997): Aerobic Soil Metabolism
of Car- boxyl Carbon-14 Labeled AC 243,997 ... in Sandy Loam Soil: Report No. PDM Volume 20-17. (Unpublished
study received Oct 6, 1983 under 241-273; submitted by American Cyanamid Co., Prince- ton, NJ; CDL:251505-C)
Mallipudi, N.; Knoll, B.; Stout, S.; et al. (1983) Arsenal Herbi- cide (AC 243,997): Anaerobic Soil Metabolism of
Carboxyl Carbon- 14 Labeled AC 243,997 ... in Sandy Loam Soil: Report No. PD-M Volume 20-15. (Unpublished study
received Oct 6, 1983 under 241-273; submitted by American Cyanamid Co., Princeton, NJ; CDL: 251505-D)
Mallipudi, M.; Hewel, D.; Knoll, B.; et al. (1983) Arsenal Herbi- cide (AC 243,997): Adsorption and Desorption
Coefficients for Soils: Report No. PD-M Volume 20-18. (Unpublished study re- ceived Oct 6, 1983 under 241-273;
submitted by American Cyanamid Co., Princeton, NJ; CDL:251505-E)
Mallipudi, M.; Knoll, B.; Stanley-Miller, P. (1983) Arsenal Herbi- cide (AC 243,997): Field Dissipation of Carboxyl
Carbon-14 La- beled AC 243,997 ...: Report No. PD-M Volume 20-19. (Unpub- lished study received Oct 6, 1983 under
241-273; submitted by American Cyanamid Co., Princeton, NJ; CDL:251505-F)
Picard, G.; Tafuro, A.; Elenewski, C.; et al. (1982) CL 243,997: Residues of CL 243,997 in Soil (Post; NY, 1981) (C-
2026): Report No. C-2030. (Unpublished study received Oct 6, 1983 under 241- 273; submitted by American Cyanamid
Co., Princeton, NJ; CDL: 251505-G)
Elenewski, C.; Tafuro, A.; Cornelius, A. (1983) CL 243,997: Resi- dues of CL 243,997 in Soil (Post; MO, 1981) (C-
2026): Report No. C-2029.1. (Unpublished study received Oct 6, 1983 under 241-273; submitted by American Cyanamid
Co., Princeton, NJ; CDL: 251505-H)
Picard, G.; Orwick, P. (1981) CL 243,997: Residues of CL 243,997 in Soil (PRE; NJ 1980) (C-1819): Report No. C-
1880. (Unpublished study received Oct 6, 1983 under 241-273; submitted by American Cyanamid Co., Princeton, NJ;
CDL:251505-1)
Picard, G; Orwick, P.; Robert, W. (1981) CL 243,997: Residues of CL 243,997 in Soil (PRE; MI, 1980)(C-1819): Report
No. C-1878. (Unpublished study received Oct 6, 1983 under 241-273; submitted by American Cyanamid Co., Princeton,
NJ;CDL:251505-J)
61
-------
131626
131627
131628
131629
131630
131631
131632
131633
131634
Picard, G. (1981) CL 243,997: Validation of GC Method M-1131 for the Determination of CL 243,997 Residues in Soil:
Report No. C- 1819. (Unpublished study received Oct 6, 1983 under 241-273; submitted by American Cyanamid Co.,
Princeton, NJ; CDL:251505-K)
Picard, G; Elenewski, C. (1982) CL 243,997: Validation of GC Method M-1205 for the Determination of CL 243,997
Residues in Soil: Report No. C-2026. (Unpublished study received Oct 6, 1983 under 241-273; submitted by American
Cyanamid Co., Prince- ton, NJ; CDL:251505-L)
American Cyanamid Co. (1983) Summary: Fish and Wildlife Data: AC 243,997. (Compilation; unpublished study
received Oct 6, 1983 under 241-273; CDL:251506-A)
Kintner, D.; Forbis, A. (1983) Acute Toxicity of AC 243,997 to Rainbow Trout (Salmo gairdneri): Static Bioassay Report
#30095. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Analytical Bio-Chemistry Laboratories,
Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL:251506-B)
Kintner, D.; Forbis, A. (1983) Acute Toxicity of AC 243,997 to Bluegill Sunfish (Lepomis macrochirus): Static Bioassay
Report #30096. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Analytical Bio-Chemistry
Laboratories, Inc., submit- ted by American Cyanamid Co., Princeton, NJ; CDL:251506-C)
Forbis, A.; Kintner, D. (1983) Acute Toxicity of AC 243,997 to Channel Catfish (Ictalurus punctatus): Static Bioassay
Report 30097. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Analytical Bio-Chemistry
Laboratories, Inc., submit- ted by American Cyanamid Co., Princeton, NJ; CDL:251506-D)
Kintner, D.; Forbis, A. (1983) Acute Toxicity of AC 243,997 to Daphnia magna: Static Acute Bioassay Report #30098.
(Unpub- lished study received Oct 6, 1983 under 241-273; prepared by Analytical Bio-Chemistry Laboratories, Inc.,
submitted by Ameri- can Cyanamid Co., Princeton, NJ; CDL:251506-E)
Fletcher, D. (1983) Report to ...: Acute Oral Toxicity Study with AC 243,997 in Bobwhite Quail: BLAL No. 83 QD 20;
AC No. 981-83- 116. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Bio-Life Assoc., Ltd.,
submitted by American Cyana- mid Co., Princeton, NJ; CDL:251506-F)
Fletcher, D. (1983) Report to ...: Acute Oral Toxicity Study with AC 243,997 in Mallard Ducks: BLAL No. 83 DD 16;
AC No. 981-83- 115. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Bio-Life Assoc., Ltd.,
submitted by American Cyana- mid Co., Princeton, NJ; CDL:251506-G)
62
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131635
131636
131637
131638
131639
132028
132029
132030
132031
132032
Fletcher, D. (1983) Report to ...: 8-Day Dietary LC50 Study with AC 243,997 in Bobwhite Quail: BLAL No. 83 QC 23;
AC No. 981-83-114. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Bio-Life Assoc., Ltd.,
submitted by American Cyanamid Co., Princeton, NJ; CDL:251506-H)
Fletcher, D. (1983) Report to ...: 8-Day Dietary LC50 Study with AC 243,997 in Mallard Ducklings: BLAL No. 83 DC
23; AC No. 981-83- 113. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Bio-Life Assoc., Ltd.,
submitted by American Cyana- mid Co., Princeton, NJ; CDL:251506-1)
Atkins, E. (1983) Letter sent to T. Peoples dated Apr 16, 1983 ?Honeybee toxicity study with AC 243,997|. (Unpublished
study received Oct 6, 1983 under 241-273; prepared by Univ. of Cali- forma—Riverside, Dept. of Entomology, submitted
by American Cyanamid Co., Princeton, NJ; CDL:251506-J)
Atlas, R. (1983) Assessment of the Effects of the Herbicide AC 243,997 on Soil Microorganisms. (Unpublished study
received Oct 6, 1983 under 241-273; prepared by Univ. of Louisville, Dept. of Biology, submitted by American
Cyanamid Co., Princeton, NJ; CDL: 251506-K)
Reichert, B.; Stanley-Millner, P. (1983) Herbicide AC 243,997: De- termination of the Partition Coefficient in n-
Octanol/Water: Report No. PD-M Volume 20-10. (Unpublished study received Oct 6, 1983 under 241-273; submitted by
American Cyanamid Co., Princeton, NJ; CDL:251506-L)
American Cyanamid Co. (1983) Product Chemistry: (AC 243,997 and Arsenal Herbicide). (Compilation; unpublished
study received Oct 6, 1983 under 241-273; CDL:251500-A)
American Cyanamid Co. (19??) Summary: Toxicology Data: (AC 243,997). (Unpublished study received Oct 6, 1983
under 241- 273; CDL:251502-A)
Fischer, J. (1983) Toxicity Data Report: (2-(4-Isopropyl-4-methyl- 5-oxo-2-imidazolin-2-yl) Nicotinic Acid: Rats and
Rabbits): Report No. A83-24. (Unpublished study received Oct 6, 1983 under 241-273; submitted by American
Cyanamid Co., Princeton, NJ; CDL:251502-B)
Fischer, J. (1983) Toxicity Data Report: (Isopropylamine Salt of 2- (4-isopropyl-4-methyl-5-oxo-2-imadazolin-2-yl)
Nicotinic Acid: Rats and Rabbits): Report No. A83-30. (Unpublished study re- ceived Oct 6, 1983 under 241-273;
submitted by American Cyanamid Co., Princeton, NJ; CDL:251502-C)
Voss, K.; Houghtaling, B.; Becci, P. (1983) Acute Inhalation Toxi- city of AC 243,997 in Sprague-Dawley Rats: FDRL
Study No. 7624. (Unpublished study received Oct 6, 1983 under 241-273; prepared by Food & Drug Research
Laboratories, Inc., submitted by Ameri- can Cyanamid Co., Princeton, NJ; CDL:251502-D)
63
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132359
133546
133547
133549
133550
133551
133552
133553
133554
133555
Hussain, M.; Mallipudi, M. (1982) CL 243,997 Herbicide: The Hydrol- ysis of Carbon-14 Labeled CL 243,997: Report
No. PD-M 19-8. (Unpublished study received Oct 6, 1983 under 241-273; submitted by American Cyanamid Co.,
Princeton, NJ; CDL:251505-A)
American Cyanamid Co. (1983) Toxicology Data: (AC243,997 & Others). (Unpublished study received Dec 15, 1983
under 24l-EX-101; CDL: 252004-A)
Ledoux, T. (1983) Evaluation of the Sensitization Potential of AC 243,997 in Guinea Pigs: T.P.S. Study No. 186A-201-
231-83; Spon- sor Study No. 981-83-129. (Unpublished study received Dec 15, 1983 under 241-EX-101; prepared by
Toxicology Pathology Ser- vices, Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL:252004-F)
Kintner, D.; Forbis, A. (1983) Acute Toxicity of AC 243,997 to Bluegill Sunfish (Lepomis macrochirus): Static Bioassay
Report #30096. (Unpublished study received Dec 15, 1983 under 241-EX- 101; prepared by Analytical Bio-Chemistry
Laboratories, Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL:252004-I)
Kintner, D.; Forbis, A. (1983) Acute Toxicity of AC 243,997 to Daphnia magna: Static Bioassay Report #30098.
(Unpublished study received Dec 15, 1983 under 241-EX-101; prepared by An- alytical Bio-Chemistry Laboratories, Inc.,
submitted by American Cyanamid Co., Princeton, NJ; CDL:252004-K)
Fletcher, D. (1983) Report to ...: Acute Oral Toxicity Study with AC 243,997 in Mallard Ducks: AC No. 981-83-115;
BLAL No. 83 DD 16. (Unpublished study received Dec 15, 1983 under 241-EX-101; prepared by Bio-Life Assoc., Ltd.,
submitted by American Cyan- amid Co., Princeton, NJ; CDL:252004-L)
Fletcher, D. (1983) Report to ...: 8-Day Dietary LC50 Study with AC 243,997 in Bobwhite Quail: BLAL No. 83 QC 23;
AC No. 981-83- 114. (Unpublished study received Dec 15, 1983 under 241-EX-101; prepared by Bio-Life Assoc., Ltd.,
submitted by American Cyan- amid Co., Princeton, NJ; CDL:252004-M)
Fletcher, D. (1983) Report to ...: 8-Day Dietary LC50 Study with AC 243,997 in Mallard Ducklings: BLAL No. 83 DC
23; AC No. 981- 83-113. (Unpublished study received Dec 15, 1983 under 241-EX- 101; prepared by Bio-Life Assoc.,
Ltd., submitted by American Cyanamid Co., Princeton, NJ; CDL:252004-N)
Atkins, E.; Kellum (1983) Bee Adult Toxicity Dusting Test Summary: Test No. 389. (Unpublished study received Dec
15, 1983 under 241-EX-101; prepared by Univ. of California—Riverside, Dept. of Entomology, submitted by American
Cyanamid Co., Princeton, NJ; CDL:252004-O)
Reichert, B.; Stanley-Miller, P. (1983) Herbicide AC 243,997: De- termination of the Partition Coefficient in n-
Octanol/Water: Report No. PD-M Volume 20-10. (Unpublished study received Dec 15, 1983 under 241-EX-101;
submitted by American Cyanamid Co., Princeton, NJ; CDL:252004-P)
64
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133556
133557
145872
147049
147114
147118
147119
147120
147121
151637
151638
151639
American Cyanamid Co. (1983) Product Chemistry: (AC 243,997 and Others). (Compilation; unpublished study received
Dec 15, 1983 under 241-EX-101; CDL:252005-A)
American Cyanamid Co. (1983) Residue and Environmental Fate:(Arsen- al Herbicide (AC 243,997 & Others).
(Compilation; unpublished study received Dec 15, 1983 under 241-EX-101; CDL:252006-A)
American Cyanamid Co. (19??) Product Chemistry — Technical Materi- al [Arsenal Herbicide]. Unpublished
compilation. 163 p.
Fischer, J. (1984) Summary of Experimental Results: (Acute Toxicity: Arsenal Technical): Report No. A84-52.
Unpublished study prepared by American Cyanamid Co. 5 p.
American Cyanamid Co. (1985?) Summary: Fish and Wildlife—Addition- al Data for Full Registration of Arsenal
Herbicide for Noncrop Uses. Unpublished study. 2 p.
American Cyanamid Co. (1985?) Summary: Environmental Fate—Addi- tional Data for Full Registration of Arsenal
Herbicide for Non- crop Uses. Unpublished study. 4 p.
Mallipudi, N. (1985) Arsenal Herbicide, AC 243,997: Weed and Soil Metabolism in a Field Plot: Report No. PD-M
Volume 22-23: 1-89. Unpublished study prepared by American Cyanamid Co. 89 p.
McAllister, W.; Bunch, B.; Burnett, J. (1985) Bioconcentration and Depuration of [Radiolabeled Carbon]-AC 243, 997 by
Bluegill Sun- fish ... under Flow-through Conditions: ABC Final Report #32819. Unpublished study prepared by
Analytical Bio-Chemistry Laborato- ries, Inc. 259 p.
American Cyanamid Co. (1985) Product Chemistry: Additional Data for Full Registration of Arsenal Herbicide for
Noncrop Uses. Unpub- lished compilation. 105 p.
American Cyanamid Co. (1985?) Toxicology: Summary and Sample Iden- tification and Purity: [Mutagenicity].
Unpublished study. 8 p.
Enloe, P.; Pfiffner, A.; Salamon, C. (1985) Dominant Lethal Assay in Male Rats with AC 243,997: Toxigenics' Study
450-1284: [In- eludes Pilot Study No. 450-1283 by Toxigenics, Inc.]. Unpub- lished study prepared by Toxigenics, Inc.
212 p.
Sernau, R. (1984) Unscheduled DNA Synthesis Rat Hepatocyte Assay: Compound AC 243,997: Final Report: Project
No. 362-170. Unpub- lished study prepared by Hazleton Laboratories America, Inc. 18 p.
65
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151640
151641
163194
163195
163196
163197
40070900
40070901
40387200
40387201
40387202
40403700
40403701
Cortina, T. (1984) In vitro Chromosomal Aberrations in Chinese Ham- ster Ovary Cells with AC-243,997: Final Report:
362-169. Unpub- lished study prepared by Hazleton Laboratories America, Inc. 34 p.
Johnson, E.; Allen, J. (1984) Mutagenicity Testing of AC 243,997 in the in vitro CHO/HGPRT Mutation Assay: Project
No. 0493. Unpub- lished study prepared by American Cyanamid Co. 39 p.
American Cyanamid Co. (1986) Chopper Herbicide: Product Chemistry. Unpublished compilation. 45 p.
Fischer, J. (1986) Toxicity Data Report: [Summary of Experimental Results]: Chopper C/A Formulation: Report No.
A86-31. Unpub- lished summaries prepared by American Cyanamid Co. 5 p.
Hershman, R. (1986) Acute Inhalation Toxicity - Rats: Chopper Herbicide: Project No. 86-5095A. Unpublished study
prepared by Biosearch Inc. 24 p.
Sahota, P. (1986) Dermal Sensitization Study with Chopper Herbicide in Guinea Pigs: DRC 4901. Unpublished study
prepared by Dawson Research Corp. 25 p.
American Cyanamid Co. (1987) Registration for Contain Herbicide: Acute Toxicology. Compilation of 1 Study.
Fisher, J. (1986) Contain Acute Toxicology of Herbicide: Laboratory Report No.: A 86-28. Unpublished compilation
prepared by Ameri- can Cyanamid Co. 10 p.
American Cyanamid Co. (1987) Submission of Chemistry Data to Sup- port the Registration for Arsenal 5-G Herbicide
for Noncrop and Forestry Usage. Transmittal of 2 studies.
Beardmore, R. (1987) Product Identity and Disclosure of Ingredien- ts: Arsenal 5-G. Unpublished study prepared by
American Cyana- mid Co. 15 p.
Beardmore, R. (1987) Physical Chemical Properties of Arsenal 5-G. Unpublished study prepared by American Cyanamid
Co. 4 p.
American Cyanamid Co. (1987) Submission of Residue Data Petition for Exemption from a Food Additive Tolerance for
Imazapyr in or on Palm Oil. Transmittal of 3 studies.
Mallipudi, N. (1987) Imazapyr Herbicide (AC 243, 997): Metabolism of Carbon-14 Imazapyr [Nicotinic acid, 2-(4-
isopropyl-4-methyl- 5-oxo-2-yl-] in Oil Palm: Laboratory Report No. PD-M Volume 23- 38. Unpublished study prepared
by American Cyanamid Co. 54 p.
66
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40403702
40403703
40421600
40421601
40672700
40672701
40763400
40763401
40763402
40811800
40811801
40811802
41002300
Potts, C. (1987) Arsenal Herbicide (CL 243,997/IPAS-AS): Residues of CL 243,997 in Palm Oil Fruit...: Laboratory
Report No.: C- 2461. Unpublished study prepared by American Cyanamid Co. 12 p.
Potts, C. (1987) Arsenal Herbicide (CL 252,925): GC Method for the Determination of CL 243,997 Residues in Oil Palm
Fruit: Labora- tory Report No. C-2422. Unpublished study prepared by American Cyanamid Co. 13 p.
American Cyanamid Co. (1987) Submission of Residue Data To Support the Application for the Registration of
Imazapyr. Transmittal of 1 study.
Mangels, G. (1987) Imazapyr Herbicide (AC 243,997): Metabolism of Carbon-14 Imazapyr ?Nicotinic Acid, 2-(4-
isopropyl-4-methyl-5- oxo-2-yl)- in Sugarcane: Laboratory Report No. PD-M Volume 24-19. Unpublished study
prepared by American Cyanamid Co. 27 p.
American Cyanamid Co. (1988) Product Chemistry Data submitted for Arsenal Herbicide 0.5G Registration: ?Minor
Amendments). Trans- mittal of 1 study.
Garber, M. (1988) Amendments to the Disclosure of Ingredients ... and Certification of Limits: Arsenal Herbicide 0.5G.
Unpub- lished study prepared by American Cyanamid Co. 7 p.
American Cyanamid Co. (1988) Submission of Product Chemistry and Toxicity Data to Support the Registration for
Event. Transmit- tal of 2 studies.
American Cyanamid Co. (1988) Product Identity and Disclosure of Ingredients: Event. Unpublished study. 21 p.
Lowe, C. (1988) Acute Oral, Acute Dermal, Eye Irritation, and Skin Irritation Studies with Event Formulation: Rept. No.
A87-3. Unpublished study prepared by American Cyanamid Co. 8 p.
American Cyanamid Co. (1988) Submission of Environmental Data in Support of Partial Fulfillment of the Unconditional
Registration of Imazapyr in Forestry. Transmittal of 2 studies.
American Cyanamid Co. (1988) The Effect of Arsenal on Non-target Terrestrial Plants: Tier II. Unpublished compilation.
172 p.
Hughes, J. (1987) The Effect of Arsenal on Non-target Aquatic Plants: Tier II: Laboratory Project ID: 0214-67-1100-
1,2,3,4. Unpublished compilation prepared by Malcolm Pirnie, Inc. 180 p.
American Cyanamid Co. (1989) Submission of Data To Support Regi- stration of Imazapyr: Environmental Fate Study.
Transmittal of 1 study.
67
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41002301
41023200
41023201
41039500
41039501
41039502
41039503
41039504
41039505
41315800
41315801
41315802
American Cyanamid Co. (1988) Imazapyr (AC243,997): Aerobic Aquatic Degradation: Report No. PD-M Volume 25-51.
Unpublished study. 33 p.
American Cyanamid Co. (1989) Submission of Data To Support Regi- stration of Arsenal Herbicide: Soil Metabolism
Data. Transmit- tal of 1 study.
Tollackson, L. (1988) Aerobic Soil Metabolism of ?carbon 13|-?car- bon 14|-AC 243,997 in Sandy Loam Soil at 1.5 ppm
Concentration at 25 degrees C: Report No. 34927. Unpublished study prepared by ABC Laboratories, Inc. 561 p.
America Cyanamid Co. (1989) Submission of Data To Support Registra- tion of Imazapyr (Arsenal Technical):
Toxicology Data. Trans- mittal of 5 studies.
Harris, J. (1989) Imazapyr Toxicology Summary. Unpublished study prepared by American Cyanamid Co. 9 p.
Shellenberger, T. (1987) One Year Dietary Toxicity Study in Pure- bred Beagle Dogs with AC 243,997: Report No.
86002. Unpublished study prepared by Tegeris Laboratories, Inc. 685 p.
Daly, I. (1988) A Chronic Dietary Toxicity and Oncogenicity Study with AC 243,997 in Rats: Report No. 84-2862.
Unpublished study prepared by Bio/dynamics Inc. 3597 p.
Auletta, C. (1988) A Chronic Dietary Toxicity and Oncogenicity Study with AC 243,997 in Mice: Report No. 86-3074.
Unpublished study prepared by Bio/dynamics Inc. 2795 p.
Robinson, K. (1987) A 2-Generation (2-Litter) Reproduction Study of AC 243,997 Administered in the Diet of the Rat:
Report No. 82408. Unpublished study prepared by Bio-Research Laboratories Ltd. 1194 p.
American Cyanamid Co. (1989) Submission of studies in support of reregistration for Arsenal (Imazapyr): Aquatic
organism toxi- city. Transmittal of 5 studies.
Manning, C. (1989) Acute Toxicity of AC 243,997 to Atlantic Silversides (Menidia menidia): Final Report: Lab Report
No. 87384-0300-2130; AC 243,997/MM; Protocol 971-87-153. Unpub- lished study prepared by Environmental Science
and Engineering, Inc. (ESE). 33 p.
Ward, C. (1989) Acute Toxicity on New Shell Growth of the Eastern Oyster (Crassostrea virginica): Final Report: Lab
Report No. 87384-0400-2130; AC 243,997/OYS; Protocol 971-87-151. Unpublished study prepared by Environmental
Science and Engineering, Inc. (ESE). 36 p.
68
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41315803
41315804
41315805
41353400
41353401
41353402
41353403
41353404
41353405
41353406
41353407
41353408
Manning, G. (1989) Acute Toxicity of AC 243,997 to Pink Shrimp (Penaeus duoraram): Final Report: Lab Report No.
87384-0200- 2130; AC 243,997/PS; Protocol 971-87-152. Unpublished study prepared by Environmental Science and
Engineering, Inc. (ESE). 33 p.
Manning, C. (1989) Chronic Toxicity Estimate of AC 243,997 to Rainbow Trout (Salmo gairdneri) under Flow through
Conditions: Final Report: Lab Report No. 87384-0600-2130; AC 243,997/RT; Protocol 971-87-155. Unpublished study
prepared by Environ- mental Science and Engineering, Inc. (ESE). 45 p.
Manning, C. (1989) Chronic Effect of AC 243,997 to the Water Flea (Daphnia magna) in a 21-day Flow-through
Exposure: Final Report: Lab Report No. 87384-0500-2130; AC 243,997/DM; Protocol 020F. Unpublished study prepared
by Environmental Science and Engineering, Inc. (ESE). 44 p.
American Cyanamid Co. (1990) Submission of Chemistry and Toxicity Data in Support of Chopper RTU Herbicide
Registration. Trans- mittal of 9 studies.
American Cyanamid Co. (1989) Product Identity and Disclosure Ingredients: ?Imazapyr|. Unpublished study. 15 p.
Banick, W. (1989) Certification of Limits and Analytical Method: ?Imazapyr . Unpublished study prepared by American
Cyanamid Co. 22 p.
Peevey, R. (1989) Physical and Chemical Properties of Chopper RTU Herbicide. Unpublished study prepared by
American Cyanamid Co. 8 p.
Fischer, J. (1989) Oral LD50 Study in Albino Rats with AC 243,997 6% RTU Formulation: Lab Project Number: T-0186:
Report No. A89- 205. Unpublished study prepared by American Cyanamid Co. 14 p.
Fischer, J. (1989) Dermal LD50 Study in Albino Rabbits with AC 243,997 6% RTU Formulation: Lab Project Number:
T-0187: Report No. A89-203. Unpublished study prepared by American Cyanamid Co 14 p.
Fischer, J. (1989) Eye Irritation Study in Albino Rabbits with AC 243,997 6% RTU Formulation: Lab Project Number: T-
0182: Report No. A89-200. Unpublished study prepared by American Cyanamid Co. 15 p.
Fischer, J. (1989) Skin Irritation Study in Albino Rabbits with AC 243,997 6% RTU Formulation: Lab Project Number:
T-0184: Report No. A89-201. Unpublished study prepared by American Cyanamid Co. 15 p.
Werley, M. (1987) Final Report on a Single Point Inhalation Expo- sure to Chopper RTU-6 in Adult Sprague-Dawley
Rats of Both Sexes: Lab Project Number: MB 87-8931 E. Unpublished study prepared by MB Research Laboratories, Inc.
55 p.
69
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41353409
41516300
41516301
41664700
41664701
41891500
41891501
42062400
42062401
42087300
42087301
42165400
42165401
American Cyanamid Co. (1988) Dermal Sensitization in Guinea Pigs: Lab Project Number: MB 87-8931 F. Unpublished
study prepared by MB Research Laboratories, Inc. 13 p.
American Cyanamid Co. (1990) Submission of Efficacy Study to Sup- port the Registration of Imazapyr. Transmittal of 1
study.
Iverson, R. (1990) Discussion and Summary of Reference Articles on Helicopter Spray Drift. Unpublished study prepared
by American Cyanamid Co. 41 p.
American Cyanamid Co. (1990) Submission of Product Chemistry Data to Support the Reregistration of ARSENAL.
Transmittal of 1 Study.
Cortes, D. (1990) Phase 3 Summary of MRID #145872: Imazapyr-Phy- sical and Chemical Characteristics Solubility in
Water and in Solvents: Lab Project Number: PD/M/27/36. Unpublished study prepared by American Cyanamid Co. 56 p.
American Cyanamid Co. (1991) Submission of environmental fate data to support an application for nonfood use of
Arsenal herbicide. Transmittal of 1 study.
American Cyanamid Co. (1991) Aquatic Dissipation Studies and Rela- ted Data ?Arsenal Herbicide): Lab Project
Number: CY 41. 328 p. Unpublished study. 328 p.
American Cyanamid Co. (1991) Submission of toxicity data to support the registration standard for Imazapyr (Arsenal).
Transmittal of 1 study.
Daly, I; Harris, J.; Koeferl, M. (1991) A Chronic Dietary Toxicity and Oncogenicity Study with AC 243, 997 in Rats
(Historical Con- trol Data): Supplement to MRID 41039503: Lab Project Number: 84-2862. Unpublished study prepared
by Bio/Dynamics Inc. 139 p.
American Cyanamid Co. (1991) Submission of product chemistry data to support the reregistration standard for Imazapyr.
Transmittal of 1 study.
Cortes, D. (1991) Imazapyr Storage Stability and Corrosion Characteristics. Unpublished study prepared by American
Cyanamid Co. 27 p.
American Cyanamid Co. (1992) Submission of product chemistry and toxicity data in support of registration of Arsenal
(R)/Diuron Granule. Transmittal of 9 studies.
Little, D. (1991) Product Identity and Disclosure of Ingred- ients, Arsenal/Diuron Granule. Unpublished study prepared
by American Cyanamid Co. 15 p.
70
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42165403
42165404
42165405
42165406
42165407
42165408
42165409
42774401
43423700
43423701
43423702
Wu, H. (1991) Analysis and Certification of Limits, Arsenal/ Diuron Granules. Unpublished study prepared by American
Cyanamid Co. 48 p.
Kimler, J. (1991) Physical and Chemical Characterisitics, Arsenal/Diuron Granule. Unpublished study prepared by
American Cyananmid Co. 42 p.
Lowe, C. (1991) Oral LD50 Study in Albino Rats with AC 243, 997/AC 58,901 (0.5%/2%) Granular Formulation: Lab
Project Number: STUDY T-0363. Unpublished study prepared by American Cyanamid Co. 14 p.
Lowe, C. (1991) Dermal LD50 Study in Albino Rabbits with AC 243, 997/AC 58,901 (0.5%/2%) Granular Formulation:
Lab Project Number: STUDY T-0366. Unpublished study prepared by American Cyanamid Co. 14 p.
Hershman, R. (1991) Acute Inhalation Toxicity Study with Imazapyr/Diuron in Rats: Lab Project Number: 91-7249A.
Unpublished study prepared by Biosearch Inc. 45 p.
Lowe, C. (1991) Eye Irritation Study in Albino Rabbits with AC 243,997/AC 58,901 (0.5%/2%) Granular Formulation:
Lab Project Number: STUDY T-0350. Unpublished study prepared by American Cyanamid Co. 15 p.
Lowe, C. (1991) Skin Irritation Study in Albino Rabbits with AC 243,997/AC 58,901 (0.5%/2%) Granular Formulation:
Lab Project Number: STUDY T-0352. Unpublished study prepared by American Cyanamid Co. 14 p.
Lowe, C. (1991) Skin Sensitization Study in Albino Guinea Pigs with AC 243,997/AC 58,901 (0.5%/2%) Granular
Formulation: Lab Project Number: STUDY T-0415. Unpublished study prepared by American Cyanamid Co. 27 p.
Hess, F. (1992) Additional Data on Chronic Toxicology Studies (Rodent), New Subchronic Rodent Study, and Rationale
Supporting the Acceptability of the Chronic Rodent Study: (including AC 243,997: A 13-week Dietary Toxicity Study in
the Albino Rat: Am. Cyanamid Lab report AX-92-3). Unpublished study prepared by American Cyanamid Co. 547 p.
American Cyanamid Co. (1994) Submission of Product Chemistry and Environmental Fate Data in Support of Arsenal
Reregistration. Transmittal of 3 Studies.
Cortes, D.; Chiarello, G. (1994) Product Identity, Description of Beginning Materials and Manufacturing Process, and
Theoretical Discussion of Impurities of ARSENAL Herbicide Technical: Lab Project Number: APBR 386: CHDV-30-
4.1. Unpublished study prepared by American Cyanamid Co. 56 p.
Danishevsky, V.; Cortes, D. (1994) Preliminary Analysis, Certification of Ingredient Limits, and Analytical Method for
ARSENAL Herbicide Technical: Lab Project Number: APBR 362: APBR 386. Unpublished study prepared by American
Cyanamid Co. 200 p.
71
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43578000
43578001
43578002
43578003
43578004
43578005
43578006
43578007
43578008
43578009
43831400
Mangels, G. (1994) AC 243,997 Adsorption/Desorption: Lab Project Number: ENV 94-022. Unpublished study prepared
by American Cyanamid Co. 41 p.
American Cyanamid Co. (1995) Submission of Product Chemistry and Toxicity Data in Support of the Application for
Registration of Arsenal/Diuron 70 DG Herbicide. Transmittal of 9 Studies.
Wixson, M. (1995) Product Identification and Disclosure of Ingredients, Description of Beginning Materials and
Manufacturing Process, Discussion of Formation of Impurities: Arsenal/Diuron 70 DG Herbicide. Unpublished study
prepared by American Cyanamid Co. 15 p.
Owtscharuk, P.; Banick, W. (1995) Certification of Limits and Analytical Methods: Arsenal/Diuron 70 DG Herbicide:
Lab Project Numbers: C-4109: 94FAI-0493-02. Unpublished study prepared by American Cyanamid Co. 49 p.
Arendt, V. (1994) Physical and Chemical Characteristics: Arsenal/Diuron 70 DG Herbicide: Lab Project Numbers: F-
1291: 94PIF-0493-06. Unpublished study prepared by American Cyanamid Co. 18 p.
Lowe, C. (1994) Oral LD50 in Albino Rats with AC 243,997/AC 58,901: 70 DG Formulation: Lab Project Numbers: T-
0702: A94-239. Unpublished study prepared by American Cyanamid Co. 16 p.
Lowe, C. (1994) Dermal LD50 in Albino Rats with AC 243,997/AC 58,901: 70 DG Formulation: Lab Project Numbers:
T-0703: A94-240. Unpublished study prepared by American Cyanamid Co. 15 p.
Hoffman, G. (1995) Acute Inhalation Study with AC 243,997/AC 58,901: 70 DG Formulation in Rats: Lab Project
Numbers: 94-5178: 971-94-101: TAN 94-044. Unpublished study prepared by Pharmco LSR. 109 p.
Boczon, L. (1994) Eye Irritation Study in Albino Rats (sic) with AC 243,997/AC 58,901: 70 DG Formulation: Lab
Project Numbers: T-0700: A94-246: P94-1044. Unpublished study prepared by American Cyanamid Co. 15 p.
Boczon, L. (1994) Skin Irritation Study in Albino Rabbits with AC 243,997/AC 58,901: 70 DG Formulation: Lab Project
Numbers: T-0701: A94-243: P94-1045. Unpublished study prepared by American Cyanamid Co. 16 p.
Boczon, L. (1994) Dermal Sensitization Study in Albino Guinea Pigs with AC 243,997/AC 58,901: 70 DG Formulation
Using the Buehler Closed Patch Method: Lab Project Numbers: T-0707: A94-249: P94-1056. Unpublished study
prepared by American Cyanamid Co. 27 p.
American Cyanamid Co. (1995) Submission of Hazard to Wildlife Data in Support of the Reregistration of Arsenal
Herbicide. Transmittal of 2 Studies.
72
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43861500
43861501
43861502
43861503
43861504
43861505
43861506
43861507
Fletcher, D.; Pedersen, C.; Solatycki, A.; et al. (1995) Toxicity and Reproduction Study: AC 243,997 Technical:
Bobwhite Quail (Colinus virginianus): Revised Final Report: Lab Project Number: 991-86-124: 86 QR 16: OREP 856.01.
Unpublished study prepared by Bio-Life Associates, Inc. 379 p.
Fletcher, D.; Pedersen, C.; Solatycki, A.; et al. (1995) Toxicity and Reproduction Study: Mallard Duck (Anas
platyrhynchos): AC 243,997 Technical: Revised Final Report: Lab Project Number: 991-86-123: 86 DR 15: OREP
856.01. Unpublished study prepared by Bio-Life Associates, Inc. 398 p.
American Cyanamid Co. (1995) Submission of Product Chemistry, Toxicology, Metabolism and Residue Chemistry Data
in Support of the Registration of AC 513,996 Herbicide and the Petition for Tolerance for Imazapyr on Field Corn.
Transmittal of 18 Studies.
Mallipudi, N.; Wu, D. (1994) CL 243,997: Rat Metabolism Study: Lab Project Number: RPT0074: MET 94-009:
XBL90045. Unpublished study prepared by Xenobiotic Labs, Inc. and Hazleton Wisconsin, Inc. 520 p.
Zulalian, J. (1995) Imazapyr (CL 243,997): Metabolism of Carbon-14 Labeled CL 243,997 Using Radishes, Soybeans,
Lettuce and Winter Wheat as Rotational Crops: Lab Project Number: MET 95-003: M93P997NC2: 0462. Unpublished
study prepared by American Cyanamid Co. 216 p.
Zulalian, J. (1995) CL 243,997: Metabolism of Carbon-14 Labeled CL 243,997 in Imidazolinone-Resistant Corn Under
Field Conditions: Lab Project Number: MET 95-002: M93P997NC1: 0462. Unpublished study prepared by American
Agricultural Services, Inc. 347 p.
Zdybak, J. (1992) CL 243,997: Carbon-14 Labeled CL 243,997- Derived Residues in Blood, Milk and Edible Tissues of
Lactating Goats: Lab Project Number: PD-M 29-34: RPT0025: 89020. Unpublished study prepared by Xenobiotic Labs,
Inc. and Biological Test Center. 126 p.
Tsalta, C. (1995) CL 243,997: Metabolic Fate of (carbon 14)-CL 243,997 in Tissues and Eggs of the Laying Hen: Lab
Project Number: MET 95-007: M94A997PT1. Unpublished study prepared by American Cyanamid Co. 170 p.
Frazier, T.; Krueger, R. (1995) Product Identification and Disclosure of Ingredients, Decription of Beginning Materials
and Manufacturing Process, Discussion of Formation of Impurities: (AC 513,996 Herbicide). Unpublished study prepared
by American Cyanamid Co. 15 p.
Fletcher, J. (1995) CL 243,997: Independent Laboratory Validation of GC/MS Method M 2468 for the Determination of
CL 243,997 Residues in Corn Grain, Forage and Fodder: Lab Project Number: RES 95-080: M-2468: AR94PT02.
Unpublished study prepared by Centre Analytical Labs, Inc. 68 p.
73
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43861509
43861510
43861511
43861512
43861513
43861514
43861515
43861516
43861517
43861518
44027100
Piznik, M. (1995) Certification of Limits and Analytical Methods: (AC 513,996): Lab Project Number: F-1325: 95FAI-
0193-01. Unpublished study prepared by American Cyanamid Co. 48 p.
Ong, J. (1995) Imazethapyr/Imazapyr 70 DG Herbicide: Physical and Chemical Characteristics: Lab Project Number: F-
1341: 95PIF-0193-09. Unpublished study prepared by American Cyanamid Co. 22 p.
Lowe, C. (1995) Oral LD50 Study in Albino Rats with AC 263,4997AC 243,997 70DG Formulation: Lab Project
Number: T-0805: A95-151. Unpublished study prepared by American Cyanamid Co. 18 p.
Lowe, C. (1995) Dermal LD50 Study in Albino Rats with AC 263,4997AC 243,997 70DG Formulation: Lab Project
Number: T-0806: A95-152. Unpublished study prepared by American Cyanamid Co. 18 p.
Hoffman, G. (1995) Acute Inhalation Toxicity Study with AC 263,4997AC 243,997 70DG in Rats: Lab Project Number:
94-5221. Unpublished study prepared by Pharmaco LSR. 90 p.
Boczon, L. (1995) Eye Irritation Study in Albino Rabbits with AC 263,499/AC 243,997 70 DG Formulation: Lab Project
Number: T-0792: A95-127. Unpublished study prepared by American Cyanamid Co. 17 p.
Boczon, L. (1995) Skin Irritation Study in Albino Rabbits with AC 263,499/AC 243, 997 70 DG Formulation: Lab
Project Number: T-0790: A95-128. Unpublished study prepared by American Cyanamid Co. 15 p.
Boczon, L. (1995) Dermal Sensitization Study in Albino Guinea Pigs with AC 263,499/AC 243,997 70 DG Formulation
Using the Buehler Closed Patch Method: Lab Project Number: A95-111. 01: T-0796. Unpublished study prepared by
American Cyanamid Co. 30 p.
Fletcher, J.; Khunachak, A. (1995) CL 243,997: Extractability and Accountability of CL 243,997 Residues in Corn Grain
and Plant: Lab Project Number: RES 95-081: AR95PT01. Unpublished study prepared by American Cyanamid Co. 34 p.
Fletcher, J.; Zheng, S. (1995) CL 243,997: Freezer Storage Stability of Residues of CL 243,997 in Corn Commodities
(Grain, Forage, and Fodder): Lab Project Number: RES 95-163: AR94PT01: 007-35. Unpublished study prepared by
Centre Analytical Labs, Inc. 52 p.
Mahl, T. (1995) CL 243,997 (Imazapyr): Crop Residue Study with AC 243,997 on Field Corn: Lab Project Nos.: RES 95-
083; RES 95-085; RES 95-086. Unpublished study prepared by Agsearch Co.; Centre Analytical Labs, Inc.; and Agvise
Labs. 1702 p.
American Cyanamid Co. (1996) Submission of Toxicology Data in Support of the Application for Registration of AC
513,996. Transmittal of 1 Study.
74
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44034501
44034502
44034503
44034504
44034505
44034506
44034507
44034508
44034509
44081900
Boczon, L.; Fischer, J. (1995) Eye Irritation Study in Albino Rabbits with AC 263,4997AC 243,997 70 DG Formulation:
Addendum to MRID 43861513: Lab Project Number: T-0792: A95-127. Unpublished study prepared by American
Cyanamid Co. 4 p.
American Cyanamid Co. (1996) Submission of Product Chemistry and Toxicity Data in Support of the Registration
Application for AC 513,995 Herbicide. Transmittal of 9 Studies.
Frazier, T. (1996) Product Identification and Disclosure of Ingredients, Description of Beginning Materials and
Manufacturing Process, Discussion of Formation of Impurities: AC 513,995 Herbicide. Unpublished study prepared by
American Cyanamid Co. 17 p.
Owtscharuk, P. (1996) Certification of Limits and Analytical Methods: AC 513,995 Herbicide: Lab Project Number:
F1353. Unpublished study prepared by American Cyanamid Co. 63 p.
Ong, J. (1996) Imazethapyr/Imazapyr/Dicamba DG Herbicide: Physical and Chemical Characteristics: Lab Project
Number: F-1357: 0193: 95PIF-0193-13. Unpublished study prepared by American Cyanamid Co. 21 p.
Lowe, C. (1996) Oral LD50 Study in Albino Rats with CL 263,499/CL 243,997/CL 350,410 DG Formulation: Lab
Project Number: T-0865: A95-220. Unpublished study prepared by American Cyanamid Co. 26 p.
Lowe, C. (1996) Dermal LD50 Study in Albino Rats with CL 263,499/CL 243,997/CL 350,410 DG Formulation: Lab
Project Number: T-0864: A95-219. Unpublished study prepared by American Cyanamid Co. 20 p.
Hoffman, G. (1996) Acute Inhalation Toxicity Study with CL 263,499/CL 243,997/CL 350,410 DG in Rats: Lab Project
Number: 95/5248: TAN/95/034: 971/95/114. Unpublished study prepared by Huntingdon Life Sciences. 80 p.
Boczon, L. (1996) Eye Irritation Study in Albino Rabbits with CL 263,499/CL 243,997/CL 350,410 DG Formulation:
Lab Project Number: T/0860: A95/200. Unpublished study prepared by American Cyanamid Co. 17 p.
Boczon, L. (1996) Skin Irritation Study in Albino Rabbits with CL 263,499/CL 243,997/CL 350,410 DG Formulation:
Lab Project Number: T/0861: A95/199. Unpublished study prepared by American Cyanamid Co. 16 p.
Glaza, S. (1996) Dermal Sensitization Study with CL 263,499/CL 243,997/CL 350,410 DG in Guinea Pigs: Lab Project
Number: CHW/50802096: 971/95/141: 50802096. Unpublished study prepared by Corning Hazleton Inc. 64 p.
American Cyanamid Co. (1996) Submission of Residue Data in Support of the Application for Registration of AC
513,996 Herbicide and the Petition for Tolerance of Imazapyr on Corn. Transmittal of 1 Study.
75
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44087700
44087701
44087702
44087703
44087704
44087705
44087706
44087707
44087708
44087709
44102800
Fletcher, 1; Zheng, S.; Zulalian, J. et al. (1996) CL 243,997: Freezer Stability of Residues of CL 243,997 in Corn
Commodities (Grain, Forage and Fodder): Addendum: Lab Project Number: RES 95-163: MET 95-002.01: AR94PT01.
Unpublished study prepared by Centre Analytical Labs., Inc. 8 p.
American Cyanamid Co. (1996) Submission of Product Chemistry and Toxicity Data in Support of the Application for
Registration of Arsenal 75 SG Herbicide. Transmittal of 9 Studies.
Birk, J. (1995) Arsenal 75 SG Herbicide: Product Identity and Composition. Unpublished study prepared by American
Cyanamid Co. 15 p.
Piznik, M. (1996) Arsenal 75 SG Herbicide: Certification of Limits and Analytical Methods: (Amended Report): Lab
Project Number: F-1299: M-1504.02: 94-FAI-0493-08. Unpublished study prepared by American Cyanamid Co. 53 p.
Arendt, V.; Comisky, S. (1995) Arsenal 75 SG Herbicide: Physical and Chemical Characteristics: Lab Project Number: F-
1296: 94PIF-0493-14: 0493. Unpublished study prepared by American Cyanamid Co. 18 p.
Lowe, C.; Bradley, D. (1996) Oral LD50 Study in Albino Rats with AC 243,997 75 SG Formulation: (Arsenal 75 SG):
Lab Project Number: A95-88.01: T-0763. Unpublished study prepared by American Cyanamid Co. 19 p.
Lowe, C. (1995) Dermal LD50 Study in Albino Rats with AC 243,997 75 SG Formulation: (Arsenal 75 SG): Lab Project
Number: T-0769: A95-91. Unpublished study prepared by American Cyanamid Co. 18 p.
Hoffman, G. (1995) Acute Inhalation Study with AC 243,997 75 SG in Rats: (Arsenal 75 SG): Lab Project Number: 94-
5211: 971-94-124: TAN 95-005. Unpublished study prepared by Pharmaco LSR, Inc. 116 p.
Boczon, L. (1995) Eye Irritation Study in Albino Rabbits with AC 243,997 75 SG Formulation: (Arsenal 75 SG): Lab
Project Number: A95-81: T-0766. Unpublished study prepared by American Cyanamid Co. 15 p.
Boczon, L. (1995) Skin Irritation Study in Albino Rabbits with AC 243,997 75 SG Formulation: (Arsenal 75 SG): Lab
Project Number: T-0767: A95-80. Unpublished study prepared by American Cyanamid Co. 15 p.
Boczon, L. (1995) Dermal Sensitization Study in Albino Guinea Pigs with AC 243,997 75 SG Formulation (Arsenal 75
SG) Using the Buehler Closed Patched Method: Lab Project Number: T-0775: A95-93. Unpublished study prepared by
American Cyanamid Co. 27 p.
American Cyanamid Co. (1996) Submission of Residue Data in Support of the Registration and Petition for AC 513996
Herbicide (Imazapyr) Use in Corn. Transmittal of 1 Study.
76
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44272201
44341400
44341401
44626700
44626701
44630800
44630801
44642900
44642901
44735300
Fletcher, J. (1996) CL 243,997: Independent Laboratory Validation of CE Method M 2657 for the Determination of CL
243,997 Residues in Corn Grain, Forage and Fodder: Lab Project Number: AR96PT01: RES96-074: 007-85. Unpublished
study prepared by Centre Analytical Labs., Inc. 69 p.
American Cyanamid Co. (1997) Submission of Residue Data in Support of the Registration of Lightning Herbicide and
Tolerance Petition for Imazapyr in/on Corn. Transmittal of 1 Study.
Fletcher, J.; Picard, J. (1997) CL 243,997: Freezer Stability of Residues of CL 243,997 in Corn Commodities (Grain,
Forage and Fodder): Final Report: Lab Project Number: RES 97-016: AR94PT01: P94-1068. Unpublished study prepared
by Centre Analytical Labs., Inc. 56 p.
American Cyanamid Co. (1997) Submission of Product Chemistry Data in Support of the Reregistration of Imazapyr
Containing Product Arsenal Railroad Herbicide. Transmittal of 1 Study.
Chiarello, G. (1995) Arsenal Technical (AC 243997) Grade Active Ingredient-Thermal Stability to Metals at Elevated
Temperatures and Stability when Exposed to Artificial Sunlight: (Final Report): Lab Project Number: P 141: 94-PROC-
0196-6: P 139. Unpublished study prepared by American Cyanamid Co. 44 p.
American Cyanamid Company (1998) Submission of Product Chemistry Data in Support of the Registration of Lightning
Herbicide. Transmittal of 1 Study.
Steller, W. (1998) Discussion of the Formation of Impurities of Lightning Herbicide. Unpublished study prepared by
American Cyanamid Company. 7 p. (OPPTS 830.1670}
American Cyanamid Company (1998) Submission of Product Chemistry Data in Support of the Registration of Arsenal
75 SG Herbicide. Transmittal of 1 Study.
Steller, W. (1998) Discussion of the Formation of Impurities of Arsenal 75 SG Herbicide. Unpublished study prepared by
American Cyanamid Company. 7 p. {OPPTS 830.1670}
American Cyanamid Company (1998) Submission of Product Chemistry Data in Support of the Registration of Sahara
DG Herbicide. Transmittal of 1 Study.
Steller, W. (1998) Discussion of the Formation of Impurities of Sahara DG Herbicide. Unpublished study prepared by
American Cyanamid Company. 7 p. {OPPTS 830.1670}
American Cyanamid Company (1999) Submission of Toxicity Data in Support of the Reregistration of Arsenal Herbicide
Technical. Transmittal of 1 Study.
77
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44746701
44746702
44746703
44761300
44761301
44761302
44761303
44761304
Lowe, C. (1999) Oral LD50 Study in Albino Rats with AC 243997: Lab Project Number: A98-90: T-1076. Unpublished
study prepared by American Cyanamid Company. 17 p. (OPPTS 870.1100}
American Cyanamid Company (1999) Submission of Environmental Fate Data in Support of the Registration of
Lightning Herbicide. Transmittal of 3 Studies.
Stout, S.; Folmar, K. (1999) CL 263499 (Imazethapyr): Independent Laboratory Validation of LC/MS Determinative
Method M 3119 for Residues of CL 263499 in Water: Lab Project Number: RES 98-081. Unpublished study prepared by
Centre Analytical Laboratories, Inc. 60 p.
Mangels, G.; Brandt, J.; Carver, L. (1999) Site Characterization and Instrumentation Report: A Small-Scale Prospective
Ground-Water Monitoring Study for Imazethapyr on Corn in the Midwestern United States: Lab Project Number: EEA
98-03: EXA 99-003. Unpublished study prepared by Centre Analytical Laboratories, Inc. and Agvise Laboratories, Inc.
138 p.
Mangels, G.; Erbe, M.; Carver, L. (1999) Site Characterization and Instrumentation Report: A Small-Scale Prospective
Ground-Water Monitoring Study for Imazethapyr on Corn in the Southeastern United States: Lab Project Number: EEA
98-04: EXA 99-002. Unpublished study prepared by Centre Analytical Laboratories, Inc. and Agvise Laboratories, Inc.
142 p.
American Cyanamid Company (1999) Submission of Product Chemistry and Toxicity Data in Support of the Application
for Registration of Liquid Lightning Herbicide. Transmittal of 9 Studies.
White, R. (1998) Product Identification and Disclosure of Ingredients, Description of Beginning Materials and
Manufacturing Process, Discussion of Formation of Impurities: Liquid Lightning Herbicide. Unpublished study prepared
by American Cyanamid Company. 15 p.
Zeng, M. (1998) Certification of Limits and Analytical Methods: Liquid Lightning Herbicide: Lab Project Number: F-
1404. Unpublished study prepared by American Cyanamid Company. 54 p.
Johnson, J.; Kovacs, G.; Sweetapple, G. (1998) Liquid Lightning Herbicide: Physical and Chemical Characteristics: Lab
Project Number: F-1407: 1857-98-0120-AS-001. Unpublished study prepared by American Cyanamid Company and
Analytical Services. 5 p.
Lowe, C. (1998) Oral LD50 Study in Albino Rats with AC 2634997AC 243997 1.8 AS: Liquid Lightning Herbicide: Lab
Project Number: A98-60. Unpublished study prepared by American Cyanamid Company. 20 p.
78
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44761306
44761307
44761308
44761309
44865100
44865101
44865102
44865103
44975000
44975001
Lowe, C.; Bradley, D. (1998) Dermal LD50 Study in Albino Rats with AC 2634997AC 243997 1.8 AS: Liquid Lightning
Herbicide: Lab Project Number: A98-73. Unpublished study prepared by American Cyanamid Company. 20 p.
Hoffman, G. (1998) Acute Inhalation Toxicology Study with AC 2634997AC 243997 1.8 AS in Rats: Liquid Lightning
Herbicide: Lab Project Number: 98-5352. Unpublished study prepared by Huntington Life Sciences. 63 p.
Boczon, L. (1998) Primary Eye Irritation Study in Albino Rats with AC 2634997AC 243997 1.8 AS: Liquid Lightning
Herbicide: Lab Project Number: A98-55: T-1063. Unpublished study prepared by American Cyanamid Company. 19 p.
Boczon, L. (1998) Primary Dermal Irritation Study in Albino Rats with AC 2634997AC 243997 1.8 AS: Liquid Lightning
Herbicide: Lab Project Number: A98-59: T-1064. Unpublished study prepared by American Cyanamid Company. 18 p.
Blanset, D. (1998) Dermal Sensitization Study with AC 2634997AC 243997 1.8 AS in Guinea Pigs-Buehler Method
(Nine Inductions): Liquid Lightning Herbicide: Lab Project Number: 98-1792. Unpublished study prepared by
Huntington Life Sciences. 43 p.
American Cyanamid Company (1999) Submission of Environmental Fate and Residue Chemistry Data in Support of the
Registration of Lightning Herbicide. Transmittal of 3 Studies.
Carver, L.; Johnson, L.; Kleiner, A. (1999) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Southeastern United States: First Progress Report: Lab Project Number: 44657: 007-202: EXA-99-015.
Unpublished study prepared by Research Options, Inc. and ABC Labs. 114 p.
Carver, L.; Johnson, L.; Kleiner, A. (1999) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Midwestern United States: First Progress Report: Lab Project Number: 44656: 007-198: EXA-99-014.
Unpublished study prepared by Research Options, Inc. and ABC Labs. 112 p.
Cavalier, T. (1997) CL 263499(Imazethapyr): Independent Laboratory Validation of Capillary Electrophoresis (CE)
Determinative and LC/MS Confirmatory Method M 2683 for the Determination of CL 263499 Residues in Soil: Lab
Project Number: RES 97-059. Unpublished study prepared by Centre Analytical Laboratories, Inc. 112 p.
American Cyanamid Company (1999) Submission of Environmental Fate Data in Support of the Registration of
Lightning Herbicide. Transmittal of 1 Study.
Carver, L.; Johnson, L.; Kleiner, A. (1999) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Southeastern United States (Georgia): Lab Project Number: 44657: 007-202: EXA-99-022. Unpublished
study prepared by ABC Labs, Inc., and Research Options, Inc. 161 p. (OPPTS 840.2100}
79
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45035200
45035201
45119700
45119701
45119702
45119703
45119704
45119705
45119706
45119707
American Cyanamid Co. (1999) Submission of Environmental Fate Data in Support of the Registration of Lightning
Herbicide. Transmittal of 1 Study.
Pease, C.; Johnson, L.; Kleiner, A. (1999) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Midwestern United States (Indiana): Second Progress Report: Lab Project Number: 44656: 007-198: EXA-
99-021. Unpublished study prepared by ABC Labs, and Centre Analytical Labs., Inc. 163 p. (OPPTS 840.2100}
American Cyanamid Company (2000) Submission of Environmental Fate, Residue and Toxicology Data in Support of the
Petition for Tolerances of Imazapyr for Aquatic Uses and for Use on Grass. Transmittal of 23 Studies.
Ta, C. (1999) AC 243997: Aerobic Soil Metabolism: Lab Project Number: ENV 98-029: E 98-029. Unpublished study
prepared by American Cyanamid Company. 72 p.
Ta, C. (1999) CL 119060 and CL 9140: Aerobic Aquatic Metabolism: Lab Project Number: ENV 98-018: E 98-018.
Unpublished study prepared by American Cyanamid Company. 158 p.
Borysewicz, R.; Corbett, M.; Duan, B.; et al. (2000) Methods of Analysis of Imazapyr Residue in Soil and Pond Water:
Lab Project Number: RES 98-047: RES 98-152: RES 99-127. Unpublished study prepared by American Cyanamid
Company and Centre Analytical Labs, Inc. 255 p.
Khunachak, A.; Ouyang, Z.; Singh, S.; et al. (1999) Freezer Storage Stability of Imazapyr Residue in Soil, Sediment, and
Pond Water: Lab Project Number: RES 99-056: RES 99-052: RES 99-053. Unpublished study prepared by American
Cyanamid Company and Centre Analytical Labs, Inc. 245 p.
Holman, J. (2000) AC 243997 (Imazapyr) and Metabolites: Adsorption/Desorption on Sediments: Lab Project Number:
ENV 98-025: E-98-025. Unpublished study prepared by American Cyanamid Company. 97 p.
Garrett, A. (2000) Rate of Dissipation of Soil Residues of Imazapyr: Lab Project Number: RES 99-108: RES 99-109:
AR96IA01. Unpublished study prepared by American Cyanamid Company, Centre Analytical Labs, Inc., and Midwest
Research, Inc. 333 p.
Borysewicz, R. (1999) Residues of CL 243997, CL 9140, and CL 119060 in Aquatic Field Dissipation and Aquatic Non-
Target Organisms for Arsenal Herbicide Applied to Freshwater Ponds: Lab Project Number: RES 99-059: RES 99-060:
AR96FL01. Unpublished study prepared by American Cyanamid Company, Centre Analytical Labs Inc., Florida
Pesticide Research, and Maxim Technologies, Inc. 681 p.
80
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45119708
45119709
45119710
45119711
45119712
45119713
45119714
45119715
45119716
Mangels, G.; Ritter, A.; Safarpour, M. (2000) Estimated Environmental Concentrations of Imazapyr Resulting from
Aquatic Uses of Arsenal Herbicide: Lab Project Number: EXA 00-008. Unpublished study prepared by American
Cyanamid Company. 346 p.
Drottar, K.; Swigert, J.; Wisk, J. (1996) Uptake, Depuration, Bioconcentration, and Metabolism of (carbon 14) AC
243997 in Eastern Oyster and Grass Shrimp: Lab Project Number: 954-93-165: ECO 93-165.01: 954-93-164.
Unpublished study prepared by American Cyanamid Company and Wildlife International Ltd. 228 p.
Drottar, K.; Olivieri, C.; Swigert, J. et al. (1997) Effect of AC 243997 on 96-Hour Shell Deposition in the Eastern Oyster
(Crassosstrea virginica) Under Flow-Through Test Conditions: Lab Project Number: ECO 97-139: 130A-111: 197.05.
Unpublished study prepared by American Cyanamid Company and Wildlife International Ltd. 64 p. (OPPTS 850.1025}
Drottar, K.; Olivieri, C.; Swigert, J. et al. (1998) Toxicity of AC 243997 During the Early Life-Stages of the Fathead
Minnow (Pimephales promelas): Lab Project Number: ECO 97-102: 954-97-137: 197.05. Unpublished study prepared by
American Cyanamid Company and Wildlife International Ltd. 154 p. {OPPTS 850.1400}
Drottar, K.; Olivieri, C.; Krueger, H. (1999) Toxicity of AC 243997 (Imazapyr) Technical during the Full Life-Cycle of
the Fathead Minnow (Pimephales promelas) under Flow-Through Test Conditions: Lab Project Number: ECO 97-101:
130A-113: 954-97-101. Unpublished study prepared by American Cyanamid Company and Wildlife International Ltd.
176 p. {OPPTS 850.1500}
Drottar, K.; Swigert, J.; Wisk, J. (1995) Acute Toxicity of Arsenal Herbicide to the Rainbow Trout (Oncorhynchus
mykiss) Under Flow-Through Test Condition: Lab Project Number: 954-94-127: 130A-107: 0199. Unpublished study
prepared by American Cyanamid Company and Wildlife International Ltd. 73 p. {OPPTS 850.1075}
Ahmed, M.; Kapustka, L.; Wisk, J. (1999) Avian Reproduction Studies on AC 243997 Technical: Lab Project Number:
ECO 97-147: ECO 97-146: 954-97-147. Unpublished study prepared by American Cyanamid Company and Wildlife
International Ltd. 362 p. {OPPTS 850.2300}
Wu, D. (1997) AC 243997: Metabolism in Bermuda Grass Under Field Conditions: Lab Project Number: MET 96-007:
RPT0084: XBL 91041. Unpublished study prepared by American Cyanamid Company, Pan-Agricultural Lab Inc., and
XenoBiotic Labs Inc. 221 p. {OPPTS 860.1300}
Tsalta, C. (2000) CL 243997: Metabolism of (carbon 14)-CL 243997 in the Lactating Goat: Lab Project Number: MET
00-002: M99A997PT1. Unpublished study prepared by American Cyanamid Company. 160 p. {OPPTS 860.1300,
860.1340}
81
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45119718
45119719
45119720
45119721
45119722
45119723
45139100
45139101
45139102
Mallipudi, N. (2000) Imazapyr (AC 243997): Confined Rotational Crop Study with (Carbon 14) Labled AC 243997: Lab
Project Number: MET 00-003: M97P997NC1: 0527. Unpublished study prepared by American Cyanamid Company and
American Agricultural Services, Inc. 338 p. (OPPTS 860.1850}
Bixler, T.; Fletcher, J.; Gross, J. et al. (1999) Validations of Methods of Analysis of Imazapyr Residues in Grass, Cattle
Tissue and Milk, Fish, and Shellfish: Lab Project Number: RES 99-001: RES98-108: RES 99-002. Unpublished study
prepared by American Cyanamid Company, ABC Labs Inc., and Maxim Tech Inc. 422 p. {OPPTS 860.1340}
Bixler, T.; Fletcher, J.; Khunachak, A.; et al. (2000) Freezer Storage Stability of Imazapyr Residues in Cattle Tissue,
Milk, and Fish: Lab Project Number: RES 99-035: RES 99-031: RES 99-064.01. Unpublished study prepared by
American Cyanamid Company, ABC Labs Inc., and Maxim Tech Inc. 102 p. {OPPTS 860.1380}
Garrett, A.; Baragary, N.; Khunachak, A. (1999) Magnitude of Residues of Imazapyr in Grass after Treatment with
Arsenal Herbicide: Lab Project Number: RES 98-038: RES 98-039: RES 99-017. Unpublished study prepared by
American Cyanamid Company, ABC Labs Inc., AgSearch Company, and AgSolutions Inc. 1147 p. {OPPTS 860.1500}
Khunachak, A. (1999) Arsenal (Imazapyr-CL 243997): Magnitude of CL 243997 in Milk, Milk Fat and Edible Tissues
from Dairy Cattle After Oral Administration for at Least 28 Days: Lab Project Number: RES 99-100: AR97PT07: 44390.
Unpublished study prepared by American Cyanamid Company, ABC Labs Inc., Fort Dodge Animal Health, and Maxim
Technologies. 232 p. {OPPTS 860.1480}
Christensen, G.; Madsen, T.; Skorczynski, S.; et al. (1999) Field Accumulation Study of Arsenal Herbicide in Freshwater
Clam: Lab Project Number: ECO 98-197: 44881: 954-98-1973. Unpublished study prepared by American Cyanamid
Company and ABC Laboratories, Inc. 62 p.
Lowe, C. (2000) Acute Oral LD50 Studies in Albino Rats with AC 119060 and AC 9140: Lab Project Number: T-0255:
T-0256: A90-133.01. Unpublished study prepared by American Cyanamid Company. 32 p. {OPPTS 870.1100}
American Cyanamid Company (2000) Submission of Environmental Fate Data in Support of the Application for
Registration of Lightning Herbicide. Transmittal of 2 Studies.
Carver, L.; Johnson, L.; Kleiner, A. (2000) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Southeastern United States (Georgia): Fourth Progress Report: Lab Project Number: 007-202: EXA-99-
022.02: EEA 98-04. Unpublished study prepared by Research Options, Inc. and ABC Laboratories. 137 p.
Carver, L.; Johnson, L.; Kleiner, A. (2000) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Midwestern United States (Indiana): Fourth Progress Report: Lab Project Number: 44656: 007-198: EXA-99-
021.02. Unpublished study prepared by AgSearch Company and ABC Laboratories. 188 p.
82
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45212600
45212601
45212602
45215100
45215101
45215102
45215103
45215104
45215105
45215106
BASF Corporation (2000) Submission of Environmental Fate Data in Support of the Registration of Lightning Herbicide.
Transmittal of 2 Studies.
Carver, L.; Johnson, L.; Kleiner, A. (2000) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Southeastern United States (Georgia)(Lightning Herbicide): Lab Project Number: 007-202: EXA-99-022.03.
Unpublished study prepared by Research Options,Inc., ABC Laboratories, and Centre Analytical Lab oratories, Inc. 143 p.
(OPPTS 840.2100}
Carver, L.; Johnson, L.; Kleiner, A. (2000) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Midwestern United States (Indiana)(Lightning Herbicide): Lab Project Number: 44656. Unpublished study
prepared by AgSearch Company, ABC Laboratories, and Centre Analytical Laboratories, Inc. 196 p. {OPPTS 840.2100}
BASF Corporation (2000) Submission of Product Chemistry and Toxicity Data in Support of the Application for
Registration of AC 1014109 Herbicide. Transmittal of 9 Studies.
Arthur, J. (2000) Product Identification and Disclosure of Ingredients, Description of Beginning Materials and
Manufacturing Process, Discussion of Formation of Impurities: AC 1014109 Herbicide. Unpublished study prepared by
BASF Corporation. 16 p. {OPPTS 830.1550, 830.1600, 830.1650, 830.1670}
Arthur, J.; Safarpour, H; Piznik, M. (2000) Certification of Limits and Analytical Methods: AC 1014109 Herbicide: Lab
Project Number: F1445/F1299: 99FA-0224-03: 0224. Unpublished study prepared by BASF Corporation. 99 p. {OPPTS
830.1750,830.1800}
Foitou, F. (2000) Summary of the Physical-Chemical Properties of AC 1014109 Herbicide: Lab Project Number: F-1452.
Unpublished study prepared by BASF Corporation. 5 p. {OPPTS 830.6302, 830.6303,830.6314, 830.6315, 830.6316,
830.6320, 830.7000, 830.7100, 830.7300}
Mason, S. (1998) Acute Oral Toxicity Study with Imazapyr/Glyphosate 75/180 g/1 AS in Rats: Lab Project Number:
CYD 606/982980/AC: CYD 606. Unpublished study prepared by Huntingdon Life Sciences Ltd. 49 p. {OPPTS
870.1100}
Mason, S. (1998) Acute Dermal Toxicity Study with Imazapyr/Glyphosate 75/180 g/1 AS in Rats: Lab Project Number:
CYD 607/98298I/AC: CYD 607. Unpublished study prepared by Huntingdon Life Sciences Ltd. 47 p. {OPPTS
870.1200}
Hoffman, G. (2000) Acute Inhalation Toxicity Study with Imazapyr/Glyphosate 75/180 g/1 AS in Rats: Lab Project
Number: 00-5437: TOX-00-114. Unpublished study prepared by Huntingdon Life Sciences Ltd. 92 p. {OPPTS 870.1300}
83
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45215107
45215108
45215109
45335300
45335301
45335302
45410000
45410001
45410002
45498200
Mason, S. (1998) Primary Eye Irritation Study with Imazapyr/Glyphosate 75/180 g/1 AS in Rabbits: Lab Project Number:
CYD 609/983013/SE: CYD 609. Unpublished study prepared by Huntingdon Life Sciences Ltd. 49 p. (OPPTS
870.2400}
Mason, S. (1998) Primary Dermal Irritation Study with Imazapyr/Glyphosate 75/180 g/1 AS in Rabbits: Lab Project
Number: CYD 608/982716/SE: CYD 608. Unpublished study prepared by Huntingdon Life Sciences Ltd. 40 p. {OPPTS
870.2500}
Coleman, D. (1998) Closed-Patch Dermal Sensitization Study with Imazapyr/Glyphosate 75/180 g/1 AS in Guinea Pigs:
Lab Project Number: CYD 610/983102/SS: CYD 610. Unpublished study prepared by Huntingdon Life Sciences Ltd. 59
p. {OPPTS 870.2600}
BASF Corporation (2001) Submission of Environmental Fate Data in Support of the Registration of Lightning Herbicide.
Transmittal of 2 Studies.
Carver, L.; Johnson, L.; Kleiner, A. (2001) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Southeastern United States(Georgia): Lab Project Number: 007-202: EXA-99-022.04. Unpublished study
prepared by Research Options, Inc. and Waterborne Environmental, Inc. 98 p. {OPPTS 840.2100}
Carver, L.; Johnson, L.; Kleiner, A. (2001) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Southeastern United States(Indiana): Lab Project Number: 007-198: EXA-99-021.04. Unpublished study
prepared by Agsearch Company Waterborne Environmental, Inc. 176 p. {OPPTS 840.2100}
BASF Corporation (2001) Submission of Environmental Fate Data in Support of the Registration of Lightning Herbicide.
Transmittal of 2 Studies.
Carver, L.; Johnson, L.; Kleiner, A. (2001) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Southeastern United States (Georgia): Lab Project Number: EXA-99-022.05. Unpublished study prepared by
Research Options, Inc. and Waterborne Environmental, Inc. 71 p. {OPPTS 840.2100}
Carver, L.; Johnson, L.; Kleiner, A. (2001) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr on
Corn in the Southeastern United States (Indiana): Lab Project Number: 007-198: EXA-99-021.05. Unpublished study
prepared by Agsearch Company and Waterborne Environmental, Inc. 136 p.
BASF Agro Research (2001) Submission of Environmental Fate Data in Support of the Registration of Lightning
Herbicide. Transmittal of 2 Studies.
84
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45498201
45498202
45663800
45663801
45663802
45677400
45677401
46274400
46274401
46274402
Carver, L.; Johnson, L.; Leonard, R. (2001) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr
on Corn in the Southeastern United States (Georgia): Eighth Progress Report: Lab Project Number: EXA-99-022.06: EEA
98-04: XA 99-022.06. Unpublished study prepared by Research Options, Inc., Waterborne Environmental, Inc., ABC
Laboratories, and Exygen Research. 92 p. (OPPTS 840.2100}
Carver, L.; Johnson, L.; Leonard, R. (2001) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr
on Corn in the Midwestern United States (Indiana): Eighth Progress Report: Lab Project Number: EXA-99-021.06: EEA-
98-03: 263.08. Unpublished study prepared by Agsearch Company, Waterborne Environmental, Inc., ABC Laboratories,
and Exygen Research. 100 p. {OPPTS 840.2100}
BASF Corp. (2002) Submission of Environmental Fate Data in Support of the Registration of Lightning Herbicide.
Transmittal of 2 Studies.
Carver, L.; Johnson, L.; Leonard, R. (2002) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr
(BAS 685H) on Corn in the Southeastern United States (Georgia): Lab Project Number: EXA-99-022.08: EEA 98-04:
RAN 01-016. Unpublished study prepared by Research Options, Inc. 118 p. {OPPTS 840.2100}
Carver, L.; Johnson, L.; Leonard, R. (2002) A Small-Scale Prospective Groundwater Monitoring Study for Imazethapyr
(BAS 685H) on Corn in the Midwestern United States (Indiana): Lab Project Number: EXA-99-021.08: EEA 98-03:
263.08. Unpublished study prepared by AGSEARCH Co. 183 p. {OPPTS 840.2100}
BASF Agro Research (2002) Submission of Environmental Fate Data in Support of the Registration of LIGHTNING
Herbicide. Transmittal of 1 Study.
Jackson, S. (2002) Summary Report: Request for Termination of Imazethapyr Prospective Groundwater Studies at Two
Sites: Lab Project Number: 2002/5002811. Unpublished study prepared by BASF Agro Research. 34 p. {OPPTS
840.2100}
BASF Corporation (2004) Submission of Product Chemistry Data In Support of the Registration of Arsenal Herbicide
Technical. Transmittal of 3 Studies.
Birk, J. (2004) Analysis of Imazapyr Herbicide Technical. Unpublished study prepared by BASF Corporation. 7 p.
Birk, J. (2004) Certified Limits: (Imazapyr Herbicide Technical). Unpublished study prepared by BASF Corporation. 17
P-
85
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46274403
46559100
46559101
46559102
46559103
46559104
46624600
46624601
46624602
46624603
46624604
46624605
Cortes, D. (2004) BAS 693 H, Imazapry Technical (Arsenal Technical, AC 243,997): Discussion of Formation of
Impurities. Project Number: 2004/5000054. Unpublished study prepared by BASF Corporation. 40 p.
Agan Chemical Mfg, Ltd. (2005) Submission of Product Chemistry Data in Support of the Application for Registration of
Imazapyr Technical. Transmittal of 4 Studies.
Gorban, I. (2005) Imazapyr Technical (Agan) - Product Properties. Project Number: 90007803. Unpublished study
prepared by Makhteshim-Agan of North America, Inc. and Agan Chemical Manufacturers, Ltd. 105 p.
Gorban, I. (2005) Imazapyr Technical (Agan) - Five Lots Analysis and Method Validation. Project Number: 04/11/3,
90007751. Unpublished study prepared by Agan Chemical Manufacturers, Ltd. 95 p.
Gorban, I. (2005) Imazapyr Technical (NUT) - Product Properties. Project Number: 90007804. Unpublished study
prepared by Makhteshim-Agan of North America, Inc. and Agan Chemical Manufacturers, Ltd. 113 p.
Gorban, I. (2005) Imazapyr Technical (NUT) - Five Lots Analysis and Method Validation. Project Number: 04/11/4,
90007752. Unpublished study prepared by Agan Chemical Manufacturers, Ltd. 95 p.
Etigra, LLC (2005) Submission of Product Chemistry and Toxicity Data in Support of the Application for Registration of
Imazapyr Technical. Transmittal of 10 Studies.
Kay, J. (2005) Product Identity and Composition, Description of the Materials Used, Description of the Production
Process, Discussion of the Formation of impurities, and Certified Limits for Imazapyr Technical. Project Number:
ET/200522. Unpublished study prepared by Etigra, LLC, C/O Pyxis Regulatory Consulting, Inc. 72 p.
Jian, Y. (2005) Preliminary Analysis of Imazapyr Technical. Project Number: NC/2005/002. Unpublished study prepared
by Nutrichem Laboratory Co. Ltd. 65 p.
Jian, Y. (2005) Chemical and Physical Characteristics of Imazapyr Technical: Color, Physical State, Odor, Stability,
Oxidation/Reduction, pH, UV-Vis, Melting Point, Density, Dissociation Constant, Partition Coefficient, Solubility and
Vapor Pressure. Project Number: NC/2005/003. Unpublished study prepared by Nutrichem Laboratory Co. Ltd. 84 p.
Kay, J. (2005) Waiver Request for Certain Data Requirements for Imazapyr Technical. Project Number: ET/200523.
Unpublished study prepared by Etigra, LLC, C/O Pyxis Regulatory Consulting, Inc. 6 p.
Mukherjee, A. (2005) Acute Oral Toxicity of Imazapyr Technical in Rats. Project Number: 5264. Unpublished study
prepared by Jai Research Foundation. 38 p.
86
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46624606
46624607
46624608
46624609
46633300
46633301
46683900
46683901
46731400
46731401
46775500
46775502
46775503
Mukherjee, A. (2005) Acute Dermal Toxicity Study of Imazapyr Technical in Rats. Project Number: 5265. Unpublished
study prepared by Jai Research Foundation. 39 p.
Mukherjee, A. (2005) Acute Inhalation Toxicity Study of Imazapyr Technical in Rats. Project Number: 5269.
Unpublished study prepared by Jai Research Foundation. 54 p.
Mukherjee, A. (2005) Acute Eye Irritation Study of Imazapyr Technical in Rabbits. Project Number: 5267. Unpublished
study prepared by Jai Research Foundation. 37 p.
Mukherjee, A. (2005) Acute Dermal Irritation Study of Imazapyr Technical in Rabbits. Project Number: 5266.
Unpublished study prepared by Jai Research Foundation. 34 p.
Etigra, LLC (2005) Submission of Toxicity Data in Support of the Application for Registration of Imazapyr Technical.
Transmittal of 1 Study.
Mukherjee, A. (2005) Skin Sensitization Study of Imazapyr Technical in Guinea Pigs (Guinea Pig Maximization Test).
Project Number: 5268. Unpublished study prepared by Jai Research Foundation. 53 p.
FBI/Gordon Corporation (2005) Submission of Product Chemistry Data in Support of the Amended Registration of EH
1135 PGR. Transmittal of 1 Study.
Sanson, D. (2005) Product Identity and Composition of EH 1135 PGR. Unpublished study prepared by FBI/Gordon Corp.
10 p.
Agan Chem MFG, Ltd (2006) Submission of Product Chemistry Data in Support of the Application for Registration of
Imazapyr Technical. Transmittal of 1 Study.
Gorban, I. (2006) Imazapyr Technical - Product Properties (NUT) (AGAN). Project Number: JR/1/9/06. Unpublished
study prepared by Agan Chem MFG, Ltd. 10 p.
Vegetation Management, LLC (2006) Submission of Product Chemistry and Toxicity Data in Support of the Application
for Registration of Mohave 70 EG. Transmittal of 7 Studies.
Woolley, A.; Mullee, D. (2005) Determination of Physico-Chemical Properties: Mohave 70 EG: AGN-SAH02. Project
Number: 008/595. Unpublished study prepared by Safepharm Laboratories Ltd. 22 p.
Sanders, A. (2005) Acute Oral Toxicity in the Rat - Up and Down Procedure: Mohave 7 EG: AGN-SAH02. Project
Number: 008/596. Unpublished study prepared by Safepharm Laboratories Ltd. 16 p.
87
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46775504
46775505
46775506
46775507
46775508
Sanders, A. (2005) Acute Dermal Toxicity (Limit Test) in the Rat: Mohave 70 EG: AGN-SAH02. Project Number:
008/598. Unpublished study prepared by Safepharm Laboratories Ltd. 19 p.
Griffiths, D. (2005) Acute Inhalation Toxicity (Nose Only) Study in the Rat: AGN-SAH02. Project Number: 008/597.
Unpublished study prepared by Safepharm Laboratories Ltd. 32 p.
Sanders, A. (2005) Acute Eye Irritation in the Rabbit: Mohave 7 EG: AGN-SAH02. Project Number: 008/600.
Unpublished study prepared by Safepharm Laboratories Ltd. 18 p.
Sanders, A. (2005) Acute Dermal Irritation in the Rabbit: AGN-SAH02. Project Number: 008/599. Unpublished study
prepared by Safepharm Laboratories Ltd. 14 p.
Hathorn, S. (2005) Skin Sensitisation in the Guinea-Pig-Buehler Test Method: Mohave 70 EG: AGN-SAH02. Project
Number: TL/277/05/1690, 0008/601. Unpublished study prepared by Safepharm Laboratories Ltd. 25 p.
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Appendix E. GENERIC DATA CALL-IN
Note that a complete Data Call-In (DCI), with all pertinent instructions, will be sent to registrants under
separate cover.
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Appendix F. PRODUCT SPECIFIC DATA CALL-IN
Note that a complete Data Call-In (DCI), with all pertinent instructions, will be sent to registrants
under separate cover.
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Appendix G. EPA'S BATCHING OF IMAZAPYR PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing IMAZAPYR as the active
ingredient, the Agency has batched products which can be considered similar for purposes of acute
toxicity. Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the Agency is not describing batched
products as "substantially similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It is
the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is referenced, registrants must clearly identify the
test material by EPA Registration Number. If more than one confidential statement of formula
(CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying
the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among:
Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If
a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a
91
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registrant should know that choosing not to participate in a batch does not preclude other registrants
in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
Thirty eight products were found which contain Imazapyr as the active ingredient. These
products have been placed eight batches and a no batch group in accordance with the active and
inert ingredients and type of formulation.
Batching Instructions:
No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational purposes
only. The data supporting these values may or may not meet the current acceptance criteria.
Batch 1
EPA Reg. No.
241-286
11603-42
Percent Active Ingredient
95.0
95.0
Batch 2
EPA Reg. No.
241-387
241-402
Percent Active Ingredient
75.0
75.0
Batch 3
EPA Reg. No.
228-480
241-299
241-401
34704-908
61202-1
Percent Active Ingredient
53.1
53.1
53.1
53.1
53.1
Batch 4
EPA Reg. No.
241-346
241-426
34704-896
Percent Active Ingredient
28.7
28.7
28.7
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Batch 5
EPA Reg. No.
241-273
241-296
241-336
241-398
34704-905
Percent Active Ingredient
27.6
27.6
27.6
27.6
27.6
Batch 6
EPA Reg. No.
241-308
34913-24
Percent Active Ingredient
5.0
5.0
Batch 7
EPA Reg. No.
228-307
241-295
34913-23
Percent Active Ingredient
0.5
0.5
0.5
Batch 8
EPA Reg. No.
228-308
241-344
13283-19
34913-22
Percent Active Ingredient
Imazapyr: 0.5
Diuron: 2.0
Imazapyr: 0.5
Diuron: 2.0
Imazapyr: 0.5
Diuron: 2.0
Imazapyr: 0.5
Diuron: 2.0
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No Batch
EPA Reg. No.
239-2622
239-2657
239-2686
241-294
241-330
241-372
241-377
241-384
241-400
241-414
2217-802
62719-526
Percent Active Ingredient
Imazapyr: 0.080
Oxyfluorfen: 0.700
Imazapyr: 0.080
Glyphosate: 5.000
Imazapyr: 0.016
Glyphosate: 1.000
14.200
3.600
Imazapyr: 7.780
Diuron: 62.220
Imazapyr: 17.500
Imazethapyr: 52.500
Imazapyr: 4.000
Imazethapyr: 12.000
Benzoic Acid: 58.900
Imazapyr: 5.050
Imazethapyr: 15.150
Imazapyr: 8.360
Glyphosate: 22.130
Imazapyr: 0.150
Acetamide: 21.450
Imazethapyr: 4.090
Imazapyr: 2.390
Glyphosate: 31.380
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Appendix H. LIST OF REGISTRANTS SENT THIS DATA CALL-IN NOTICE
1. BASF Corporation.
2. Nufarm Americas, Inc.
3. FBI/Gordon Corporation.
4. Agan Chemical MFG, Ltd.
5. Rainbow Technology Corporation.
7. SSI Maxim Company, Inc.
8. Vegetation Management, LLC.
9. Etigra, LLC.
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Appendix I. LIST OF AVAILABLE RELATED DOCUMENTS AND
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO 1 /forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions:
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive
Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at williams.nicole@epamail.epa.gov.
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The following Agency Pesticide Registration Forms are currently available via the Internet at the
following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
Regi stration/ Amendment
Confidential Statement of Formula
Notice of Supplemental
Registration of Distribution of a
Registered Pesticide Product
Application for an Experimental
Use Permit
Application for/Notification of
State Registration of a Pesticide To
Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with
Data Gap Procedures
Pesticide Registration
Maintenance Fee Filing
Certification of Attempt to Enter
into an Agreement with other
Registrants for Development of
Data
Certification with Respect to
Citations of Data (in PR Notice
98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical
Properties (in PR Notice 98-1)
Self-Certification Statement for
the Physical/Chemical Properties
(in PR Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-
l.pdf.
http://www.epa.sov/opprd001/forms/8570-
4.pdf
http://www.epa.sov/opprd001/forms/8570-
5.pdf
http://www.epa.sov/opprd001/forms/8570-
17.pdf.
http://www.epa.sov/opprd001/forms/8570-
25.pdf
http://www.epa.sov/opprd001/forms/8570-
27.pdf.
http://www.epa.sov/opprd001/forms/8570-
28.pdf
http://www.epa.sov/opprd001/forms/8570-
30.pdf.
http://www.epa.sov/opprd001/forms/8570-
32.pdf
http ://www. epa. sov/opppmsd 1 /PR Notices/pr9
8-5.pdf
http ://www. epa. sov/opppmsd 1 /PR Notices/pr9
8-5.pdf
http ://www. epa. sov/opppmsd 1 /PR Notices/pr9
8-l.pdf
http ://www. epa. sov/opppmsd 1 /PR Notices/pr9
8-l.pdf.
97
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Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendmentb.
EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader.)
a. Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
b. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
c. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
d. 40 CFR Part 158, Data Requirements for Registration (PDF format)
e. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' Web Site
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2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program
resulting from the passage of the FQPA and the reorganization of the Office of Pesticide
Programs. We anticipate that this publication will become available during the Fall of
1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does charge
a fee for subscriptions and custom searches. You can contact NPIRS by telephone at
(765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information
on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact
NPTN by telephone at (800) 858-7378 or through their Web site: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
• Date of receipt
• EPA identifying number
• Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date
of receipt and provide the EPA identifying File Symbol or petition number for the new
submission. The identifying number should be used whenever you contact the Agency
concerning an application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and
trade names, company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a CAS number if one has been assigned.
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Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and may
be included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are
not available electronically, but may be obtained by contacting the person listed on the respective
Chemical Status Sheet.
1. Health Effects Division and Environmental Fate and Effects Division Science Chapters,
which include the complete risk assessments and supporting documents.
2. Detailed Luis Report.
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