United States Office of Prevention, Pesticides
Environmental Protection and Toxic Substances
Agency (7505 P)
&EPA Pesticide
Fact Sheet
Name of Chemical: lodomethane
Reason for Issuance: New Chemical Registration
Year Issued: 2007
DESCRIPTION OF CHEMICAL
Generic Name: TM-425 Technical lodomethane:
Common Name: None recognized
Trade Name: Midas Bronze, Midas Gold, Midas 98:2, Midas 50:50,
Midas 33:67, and Midas 25:75
EPA Chemical Code: 000011
Chemical Abstracts
Service (CAS) Number: 74-88-4
Year of Initial Registration: 2007
Pesticide Type: Fumigant
Chemical Class: Alkyl Iodide
Registrant: Arysta LifeScienc North American Corporation
15401 Weston Parkway, Suite 150
Cary, North Carolina 27513
Page 1 of 36
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Chemical Structure:
USE PATTERNS AND FORMULATIONS
Pests/Application Sites:
Types of Formulations:
lodomethane is a pre-plant biocide used to control
insects, plant parasitic nematodes, soil borne pathogens,
and weed seeds. The compound is registered for use as
a preplant soil treatment for field grown strawberries,
peppers, tomatoes, stone fruits, tree nuts, grape vines,
ornamentals and turf and nursery grown strawberries,
stone fruits, tree nuts, and conifer trees.
lodomethane is a liquid under pressure, and is marketed
in the following formulations:
Table 1: Product Names
lodomethane Technical
Midas 98:2
Midas 50:50
Midas EC Bronze
Midas 33:67
Midas EC Gold
Midas 25:75
Percentage of lodomethane
99.8%
97.8%
49.9%
49.9%
32.93%
32.93%
24.95%
Percentage of Chloropicrin
—
1.99%
49.75%
44.78%
66.67%
61.69%
74.63%
Application Methods:
The application methods are as follows: Raised bed -
Shank Injection; Broadcast/Flat Fume - Shank Injection;
Auger Probe - Deep Injection; and Raised Bed - Drip
Application. Applications via raised bed and
broadcast/flat fume are covered with a tarp for a
minimum of five days and with a minimum of seven
days before planting occurs. For buried drip tape
application, ten days must elapse before planting.
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Application Rates:
The application rates for lodomethane are as follows:
• Raised bed - Shank Injection - 75 to 175 Ibs. active
ingredient (a.i.)/treated acre
• Raised Bed - Drip Application - 100 - 175 Ibs.
a.i./treated acre
• Broadcast/Flat Fume - 100 to 175 Ibs. a.i./acre
• Deep Auger Probe Injection - 0.5 to 2 Ibs. a.i./injection
site
SCIENCE FINDINGS
I. SUMMARY OF PHYSICAL AND CHEMICAL PROPERTIES
Table 2: Physical-Chemical Properties of lodomethane Technical - CHsI
Parameter
Color
Physical State
Odor
Molecular Weight
Molecular Formula
UV Absorption
Melting Point
Boiling Point
Specific Gravity
Henry's Law Constant
Partition Coefficient
(Octanol/Water, log Kow)
Water Solubility
Density
Vapor Density (Air =1)
Vapor Pressure
Comment
Clear to light yellow
Liquid
Ether-like
141.94g/Mol
CH3I
2.5 absorbance units (maximum) at ca. 200 nm, with a
smaller peak (0.25 au) at ca. 250 nm)
-66.5°C
42.4°C
2.8at20°C
5.23 xlO"3 atm-nrVmole
1.51-1.69
1420 mg/L at 25°C
2.28 g/mL at 20°C
4.9
405.9mmHgat25°C
Page 3 of 36
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II. SUMMARY OF TOXICITY DATA
HUMAN HEALTH
A. Acute Toxicity
Table 3: Acute Toxicity Summary for lodomethane Technical
Study Type
Acute Oral
(rat)
Acute Oral
(mouse)
Acute Dermal
(rat)
Acute Inhalation
(rat)
Primary Eye Irritation
(rabbit)
Primary Skin Irritation
(rabbit)
Dermal Sensitization
Results
LD50 > 79.8 mg/kg (males)
> 131.9 mg/kg (females)
LDso > 155 mg/kg (males)
> 214 mg/kg (females)
LD50 > 2000 mg/kg (both sexes)
(limit test)
LD50 > 4 mg/L
(both sexes)
Corrosive: Corneal opacity and bulging, conjunctivitis,
iritis, corneal neo-vascularization and sloughing of
epithelium, blanching of nictitating membrane,
Well defined erythema extending beyond test sites,
blanching, and light-severe edema
Non-sensitizer
Toxicity
Category
II
II
III
IV
I
II
N/A
Table 4: Acute Toxicity Categories for MIDAS 98:2, MIDAS 50:50, and MIDAS™ 25:75
Study Type/Findings
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
Primary Eye Irritation
Primary Dermal Irritation
Dermal Sensitization
Toxicity Categories for Midas 50:50,
Midas 33:67, Midas 25:75, Midas Gold
and Midas Bronze
II
III
II
I
I
Positive for Sensitization
Toxicity Categories for
Midas 98:2
II
III
IV
I
II
Positive for
Sensitization
Page 4 of 36
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B. Subchronic Inhalation Toxicity
In a subchronic inhalation toxicity study, rats were exposed via whole-body inhalation for 6
hours/day, 5 day/week for 13 weeks at analytical concentrations of 0, 5, 21, or 70 ppm (0, 0.029,
012, or 0.41 mg/L/day). Ten rats/sex/concentration were sacrificed after 4 weeks, and the
remaining 10 rats/sex/concentration were sacrificed after 13 weeks. There were no effects of
treatment on mortality, ophthalmology, urinalysis, hematology, organ weights, or gross
pathology. The systemic LOAEL for this study is 70 ppm based on initial decreases in body
weights, body weight gains, and food consumption (males). The NOAEL is 21 ppm (HEC = 3.8
or 15.8 ppm for non-occupational and occupational risk assessments, respectively). The port-of-
entry LOAEL is 70 ppm based on degeneration of the olfactory epithelium. The NOAEL is 21
ppm (HEC = 4.5 or 5.8 ppm for non-occupational and occupational risk assessments,
respectively).
C. Developmental Toxicity
In a developmental toxicity study, groups of 24 female New Zealand White rabbits were
dynamically exposed to iodomethane vapor in whole-body inhalation chambers at analytical
concentrations of 0, 2, 10, or 20 ppm (0, 0.012, 0.058, or 0.12 mg/L/day) six hours per day on
gestation days (GDs) 6 through 28. The maternal NOAEL is 20 ppm; no maternal LOAEL was
identified. The developmental toxicity LOAEL is 20 ppm based on increased fetal losses and
decreased fetal weights (|20%). The developmental toxicity NOAEL is 10 ppm (HEC = 7.4 or
23 ppm for non-occupational and occupational risk assessments, respectively).
In a developmental toxicity study, iodomethane was administered via the inhalation route (whole
body) to 24 New Zealand White rabbits/group at concentrations of 0 or 20 ppm during GD 6-28
(Control and Group 2), GD 6-14 (Group 3), GD 15-22 (Group 4), GD 23-24 (Group 5), GD 25-
26 (Group 6), or GD 27-28 (Group 7) for 6 hours/exposure day. This study was not intended to
fulfill the guideline requirement or establish NOAELs and LOAELs but rather was conducted to
determine the critical period of exposure during gestation that resulted in fetal loss as observed
in a previously evaluated guideline developmental toxicity study in rabbits.
D. Acute Neurotoxicity
In an acute neurotoxicity study in rats, iodomethane was administered via the inhalation route
(whole body) to 12 rats/sex/group at concentrations of 0, 27, 93, or 401 ppm for 6 hours. The
NOAEL is 27 ppm (HEC = 10 ppm for both bystander and occupational risk assessments). The
LOAEL is 93ppm based on clonic convulsions, decreased body temperatures, and decreased
motor activity.
E. Carcinogenicity
The Agency evaluated the rodent bioassays and mechanistic data available for iodomethane.
Evidence of carcinogenicity in the iodomethane database manifested as an increased incidence of
thyroid follicular cell tumors observed in both the Inhalation Chronic Toxicity/Carcinogenicity
Study in Rats and the Carcinogenicity Study in Mice. The Agency concluded that the key event
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influencing the thyroid tumor response is the sustained stimulation of cell proliferation by TSH,
consistent with the increase in thyroid follicular cell tumors only. Based on the evidence that
rats are substantially more sensitive than humans to the development of thyroid follicular cell
tumors in response to thyroid hormone imbalance, the Agency classified iodomethane as 'not
likely to be carcinogenic to humans in the absence of altered thyroid hormone homeostatis'. The
dose-response for cancer effects was considered in the risk assessments and the exposures
expected from this use are well below those that would cause thyroid effects leading to cancer.
F. Mutagenicity
Mutagenicity was not demonstrated in the following tests: Bacterial Reverse Mutation Test; In
Vitro Mammalian Cell Mutation Test in Chinese Hamster Ovary Cells; and a In Vitro
Micronucleus Assay in Mice. However, in the In Vitro Chromosomal Aberration in Chinese
Hamster Ovary Assay, iodomethane was positive for induction of structural chromosome
aberrations (clastogenesis), but negative for induction of numerical aberrations in CHO cells.
G. Metabolism
A rat metabolism study comparing absorption after oral and inhalation administration indicated
that iodomethane is quickly absorbed through both routes of exposure. In contrast, the
elimination profile indicates that excretion of 14C-labeled iodomethane is biphasic with an initial
half-life of 5-7 hours and a terminal half-life of approximately 116-136 hours.
H. Mechanistic Data
An extensive mechanistic data set, as well as a physiologically based pharmacokinetic (PBPK)
model, are available for iodomethane. These data and model constitute a sophisticated effort to
better characterize the toxicity profile for this compound in terms of developmental toxicity,
respiratory tract lesions, and thyroid hormone perturbations identified as the critical effects of
iodomethane exposure. In addition, the use of a PBPK model that takes into consideration the
toxicokinetic aspect of iodomethane exposure enables the Agency to use chemical-specific
parameters to determine the most appropriate dose metric and internal dose in calculating human
equivalent concentrations (HECs) instead of the default inputs used in the Agency's Reference
Concentration (RfC) methodology. The Agency has reviewed these data and their usefulness to
calculate human equivalent concentrations (HECs) based on chemical-specific data. In general,
the model and the mechanistic studies used to provide its inputs are considered adequate and
their results have been incorporated into this risk assessment.
I. Observational Human Data
The Observational Human Study was not intended to provide NOAELs/LOAELs for risk
assessment purposes but rather to better characterize the typical physiological distribution of
inorganic iodide between the fetus and its mother (a critical parameter in the iodomethane PBPK
model). In the study, maternal and cord blood samples (cord blood was used as a surrogate for
fetal blood) were collected from 92 mothers delivering at full-term (37-41 weeks gestation) and
31 mothers delivering pre-term (29 to < 37 weeks gestation). It is important to note that study
participants were not exposed to any test article and that the samples used in this study were
Page 6 of 36
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aliquots of samples routinely collected during labor and delivery.
The Agency has reviewed these data and its usefulness to calculate human equivalent
concentrations (HECs) based on chemical-specific data. The mechanistic and observational
human studies were intended to either define the dose metric or provide compound-specific
inputs for the PBPK model. To derive HECs using the PBPK model, internal dose metrics are
predicted for the test species in which the adverse effect occurred and then the version of the
PBPK model for humans is used to predict the inhalation exposure concentration (HEC) that
would result in the same dose metric as in the animal. The model is a sophisticated effort to
describe the kinetics of methyl iodide following inhalation exposure and the kinetics of iodide as
a metabolite. It describes nasal tract dosimetry and glutathione (GSH) depletion in the rat to
evaluate nasal toxicity, iodide kinetics in the pregnant rabbit to address developmental toxicity,
and distribution of methyl iodide to the brain to describe the dose metric for neurotoxic effects.
The model has also been parameterized for the human and Monte Carlo analyses were performed
to describe human variability. The review was carried out using the framework described in
Clark et al., 2004. The results of the evaluation were described focusing on the rat and human
nasal modeling , the rabbit and human pregnancy modeling, the rat and human neurotoxicity
model, modeling human variability, and model documentation. The strengths and limitations of
the modeling were identified. The nasal modeling for rat and human was concluded to be
adequate to estimate a human equivalent concentration. Selection of the appropriate degree of
GSH depletion to predict nasal olfactory toxicity was dependent on additional factors beyond the
PBPK/PD modeling, including judgments about the relationship of this measure with toxicity
and the linkage of the time-course of exposure concentrations with the prediction of GSH
depletion. The pregnancy modeling was found to be adequate to estimate a range of human
equivalent concentrations. The human variability analysis was considered to provide perspective
on the default value of 3 to address human pharmacokinetic variability. Similarly, the
neurotoxicity model was found to be adequate to estimate a human equivalent concentration
based on iodomethane brain concentrations. In general, the model and mechanistic studies used
to provide its inputs were considered adequate and their results have been incorporated into the
Agency's risk assessment.
II. TOXICITY ENDPOINTS
Based on the toxicity profile and the major exposure routes of iodomethane, endpoints have been
selected for the residential/bystanders and occupational human health risk assessments. The
Agency used the reference concentration (RfC) methodology along with a PBPK model to derive
the human equivalent concentration (HEC) for inhalation exposures. Under the RfC
methodology and the PBPK model approach, endpoint selection was based on the HECs which
were derived from the NOAELs in selected studies. The specific concentrations and endpoints
for the exposure scenarios are summarized below:
A. Acute Inhalation - Non-Occupational (Bystander) and Occupational
(Handler;
Page 7 of 36
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Three critical endpoints have been identified: nasal histopathology in the subchronic
inhalation toxicity study in rats, the fetal losses in the developmental toxicity study in
rabbits, and neurotoxicity in rats. An HEC of 4.5 or 5.8 ppm was selected (bystander
and occupational risk assessments, respectively) from the NOAEL of 21 ppm based on
degeneration of the olfactory epithelium. For the developmental endpoint, the Agency
selected an HEC of 7.4 or 23 ppm (bystander and occupational risk assessments,
respectively) from the NOAEL of 10 ppm based on fetal losses and decreased fetal
weights in a developmental toxicity study in rabbits at the LOAEL of 20 ppm. The
HEC for the neurotoxicity endpoint is 10 ppm (for both bystander and occupational
exposures) based on clonic convulsions, decreased body temperature, and decreased
motor activity.
B. Short-, and Intermediate-term Inhalation
1. Non-occupational (Bystander)
An HEC of 1.25 ppm from the NOAEL of 5 ppm was selected based on
decreased pup weight and weight gain, decreased thymus weights, and delays
in vaginal patency acquisition seen in the multigeneration reproduction toxicity
study at the LOAEL of 20 ppm.
2. Occupational (Handler)
An HEC of 3.7 ppm was selected from the NOAEL of 21 ppm based on minimal to mild
degeneration of the olfactory epithelium seen at the LOAEL of 70 ppm in the subchronic
inhalation toxicity study in rats.
C. Long-term Inhalation
1. Non-occupational (Bystander)
An HEC of 0.89 ppm from the NOAEL of 5 ppm was selected based on increased
incidence of salivary gland squamous cell metaplasia seen at the LOAEL of 20 ppm
observed in a rat chronic toxicity/carcinogenicity study.
2. Occupational (Handler)
An HEC of 3.75 ppm from the NOAEL of 5 ppm was selected based on increased
incidence of salivary gland squamous cell metaplasia seen at the LOAEL of 20 ppm
observed in a rat chronic toxicity/carcinogenicity study.
III. UNCERTAINTY FACTOR
lodomethane has been classified as a non-food use pesticide. Consequently, this chemical is not
subject to the FQPA (1996. When conducting inhalation risk assessments, the magnitude of the
Page 8 of 36
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UFs applied is dependent on the methodology used to calculate risk. The risk assessment was
based on the RfC methodology developed by the Office of Research and Development (ORD)
and the PBPK model developed by the registrant for the derivation of inhalation reference
concentrations (RfCs) and human equivalent concentrations (HECs) for use in margin of
exposure (MOE) calculations. Since both of these approaches take into consideration the
pharmacokinetic (PK) but not pharmacodynamic (PD) differences between test species and
humans, the UF for interspecies extrapolation was reduced to 3X while the UF for intraspecies
variation was retained at 10X. Thus, when using the RfC methodology, the overall UF is
customarily SOX.
IV. RESIDUE CHEMISTRY
Plant metabolism studies on strawberries and tomatoes showed that iodomethane is extensively
metabolized and incorporated into plant constituents, primarily carbohydrates. Iodide levels in
the raw commodities were comparable to background levels found in control samples. Finite
residues of toxicological concern are highly unlikely, and the pre-plant fumigant application of
iodomethane is considered to be a non-food use and tolerances are not needed.
V. FOOD QUALITY PROTECTION ACT CONSIDERATIONS
Since dietary exposure is not expected and there are no residential uses proposed for
iodomethane, the provisions of the Food Quality Protection Act (FQPA) of 1996. An aggregate
risk assessment was not conducted because inhalation is the only route of exposure.
VI. HUMAN EXPOSURE/RISK SUMMARY
A. Dietary Exposure and Risk
Iodomethane is considered a non-food use chemical, and the Agency concluded tolerances are
not required for iodomethane. As a result, a risk assessment was not conducted for this exposure
scenario.
B. Estimated Drinking Water Concentrations
Based on environmental fate data, the residual contents in soils, and Tier I and II models
estimated concentrations, the Agency does not expect iodomethane to adversely impact ground
water or surface water. Tier IIPRZMS for surface water and Tier I SCIGROW for ground water
were used to estimate iodomethane concentrations. These concentrations were in the nanograms
per Liter (ng/L), and parts per trillion range. The Agency conducted a qualitative drinking water
assessment and determined that no risk are expected from this potential exposure.
C. Dermal Exposure and Risk
In the general population, dermal exposure to iodomethane is not expected. Dermal exposure of
workers to iodomethane of any significance is not expected based on the delivery systems used
Page 9 of 36
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(e.g., soil injection or drip irrigation), packaging (i.e., pressurized cylinders), and emission
reduction technologies (e.g., tarping). The high vapor pressure of iodomethane also makes
significant dermal exposure unlikely and quantifying any potential low level exposures very
difficult. Therefore, a quantitative dermal exposure assessment was not conducted.
D. Acute Inhalation Exposure and Risk
The Agency conducted a quantitative acute exposure assessment. Because of iodomethane's
anticipated use pattern, its emission profile and the nature of its toxicity, the Agency believes
that the acute exposure assessment is protective for other durations of exposure.
Releases of fumigants such as iodomethane can be categorized in two distinct manners. Ambient
air levels from multiple area sources could occur from many applications in a region (e.g.,
several farms in a specific valley), or alternatively, off-gassing of iodomethane can occur from a
known area source (e.g., a treated agricultural field).
1. Non-Occupational (Bystander) Exposure and Risk - Ambient Air
Exposures from ambient sources were qualitatively evaluated based on physical-chemical
properties and environmental fate characteristics of iodomethane. Ambient air
monitoring data were not available since iodomethane is not currently widely used.
Ambient air exposures could potentially occur in proximity to agricultural areas where
there is significant use during a particular growing season on a regional basis (e.g. in
coastal areas of California during field fumigation prior to strawberry growing season).
However, the Agency does not believe that ambient air exposures to bystanders are likely
to be a significant concern based on a comparison of the characteristics of iodomethane
with those of methyl bromide and the ambient air monitoring data available for methyl
bromide.
2. Non-Occupational (Bystander) and Occupational (Handler Exposure and Risk -
Off-gassing
To estimate the bystander and occupational exposure and risk resulting from the off-
gassing of a treated agricultural field, the Agency used the Probabilistic Exposure and
Risk model for Fumigants (PERFUM model). The PERFUM model uses emissions data
from field volatility studies and five years of meteorological data to calculate downwind
air concentrations from a treated field. PERFUM analyses were completed for field sizes
ranging from 1 to 40 acres using weather data representative of the geographic locations
where major iodomethane use is anticipated and emissions data from representative
locations.
In determining the buffer zone distances to require for iodomethane the following tables
were used to analyze the risk. Three types of analysis were considered as follows: (1) Table 5
(Table 12 in the risk assessment) provides buffer distances (in meters) where target
concentrations (MOE=30) are achieved, for example the 95th percentile on the maximum
distance distribution; (2) Table 6 shows the percentile of exposure for pre-selected buffer
Page 10 of 36
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distances (in meters and feet) and; Table 7 uses distributions of air concentrations at a specific
buffer distance (in feet) from the field edge to calculate Margins of Exposure (MOEs) where the
target MOE=30.
These analyses demonstrate risks associated with a range of input factors including: (1)
Flux - High emissions for each application type; (2) Weather - Stations that have low, medium
and high results; (3) Field size - Largest field size for each buffer distance range (e.g. for the
range of 20 to 40 acres, the estimates are for 40 acres); (4) Application rate - Maximum rate was
used (Note: The risk picture is similar for all rates because the tables are scalable) and: (5)
Endpoints - Risk estimates for three distinct endpoints were examined (nasal lesions,
neurotoxicity, and fetal loss).
Buffer zones to be required for iodomethane were chosen by examining this type of
output in an iterative fashion. The buffer zone distances required for iodomethane are those
shown in Table 4. These distances were determined to provide adequate margins of safety based
on the magnitude of the MOEs considering the reasonable worst case represented by the
combination of the highest flux and weather in the analysis (Bradenton/Guadalupe). It was also
noted that because of the high percentiles of exposure being considered, there is a diminished
change in the MOEs as buffer distances increase.
Table 5: Buffer Distances (in meters) Where Target Concentrations (MOE=30) Are Achieved
Comparison Of Results For Iodomethane PERFUM Buffer Distributions Based On A 40 Acre Square Field, All Weather Data, And All Flux Profiles At A UF=}0
, , . •'. And Maximum Application Rate (175 Ibai/A) For All HECs Of Concern
%tile
Of
Expo,
• Ventura CA
' Nasal
Fetal
Loss
Neuro
Bakersfield CA . .
Nasal
Fetal
Loss
Neuro
Flint MI
Nasal
Fetal
Loss •
Neuro
Tallahassee FL
Nasal
'Fetal
Loss
Neuro
Bradenton FL
Nasal
'.Fetal
Loss
Neuro '
Flux - Watsonville CA Flat Fume
50
75
90
95
99
99.9
99.99
5
15
45
75
185
405
580
0
5
5
5
70
185
185
0
5
5
5
130
370
380
5
15
35
50
80
115
120
0
5
5
5
10
30
35
0
5
5
15
65
130
140
5
10
35
50
90
145
150
0
5
5
5
15
45
45
0
0
5
5
5
85
120
10
35
70
100
155
235
240
0
5
5
10
40
70
75
0
5
5
15
80
125
140
30
60
105
145
230
310
330
5
5
20
40
85
125
145
5
10
55
90
175
260
265
Flux - Manteca CA Flat Fume
50
75
90
95
99
99.9
99.99
25
50
90
125
255
425
480
5
5
5
25
100
230
305
5
25
50
95
295
520
565
25
45
70
95
130
175
190
5
5
5
20
45
70
70
15
40
75
100
150
225
235
15
40
70
90
145
240
245
0
5
5
15
50
90
90
5
30
60
85
155
260
290
40
70
115
155
215
355
360
5
5
30
45
75
130
130
15
45
95
120
170
280
415
70
110
170
215
325
415
425
5
30
60
85
140
195
210
50
95
150
195
295
410
445
Flux - Plant City FL Tarped Raised Bed
50
75
90
95
99
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
5
5
20
40
75
0
0
5
5
5
0
0
5
5
5
5
15
45
70
110
0
5
5
5
10
0
0
5
5
40
20
60
105
135
215
0
5
10
30
65
0
5
35
65
135
Page 11 of 36
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Comparison Of Results For lodomethane PERFUM Buffer Distributions Based On A 40 Acre Square Field, All Weather Data, And All Flux Profiles At A UF=}0
And Maximum Application Rate (175 Ib ai/A) For All HBCs Of Concern
%tile
. Of
, Expo.
99.9
99.99
Centura CA
Nasal
NA
NA
Fetal
Loss
NA
NA
.Neuro
NA
NA
Bakersfield CA
Nasal
NA
NA
Fetal -
Loss
NA
NA
Neuro
NA
NA
Flint MI . .
Nasal
125
130
Fetal
'"Loss '
25
25
Neuro
100
105
, Tallahassee FL ,
Nasal
210
215
Fetal
Loss-
55
55
Neuro
85
95
BradentonEL
Nasal
260
285
Fetal
Loss
105
130
Neuro
185
190
Flux - Oxnard CA Tarped Raised Bed
50
75
90
95
99
99.9
99.99
60
150
250
300
425
530
565
5
25
85
115
195
250
265
25
130
235
295
390
470
500
55
90
135
160
225
280
285
5
5
30
50
85
120
125
35
85
135
165
225
280
295
30
75
130
175
270
400
410
0
5
30
55
105
175
185
5
40
110
160
225
390
400
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Flux - Guadalupe CA Tarped Raised Bed
50
75
90
95
99
99.9
99.99
80
160
260
325
460
615
665
5
40
90
130
225
305
350
5
100
190
260
365
450
455
70
110
150
175
250
305
305
5
20
45
65
100
125
130
35
75
120
150
215
325
345
50
95
150
190
300
390
410
5
15
45
70
120
180
190
5
30
90
125
220
365
375
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Flux - LaSelva CA Drip Irrigation
50
75
90
95
99
99.9
99.99
20
85
160
245
345
500
515
0
5
35
70
150
215
225
5
55
135
185
280
350
380
35
75
125
165
235
340
375
5
5
20
45
85
125
125
5
40
90
125
195
260
275
5
30
80
120
185
385
460
0
5
5
10
65
145
175
0
5
45
85
165
270
275
15
75
150
195
300
475
490
0
5
30
55
110
205
210
0
10
100
160
240
310
315
60
140
260
345
475
660
685
5
35
95
145
220
330
350
5
110
205
285
430
555
560
Flux - Camarillo CA Drip Irrigation
50
75
90
95
99
99.9
99.99
5
5
45
70
165
325
425
0
5
5
5
50
175
245
0
5
5
5
145
320
360
5
10
25
40
65
110
115
0
5
5
5
5
20
25
0
5
10
25
55
105
110
5
10
30
50
90
135
165
0
5
5
5
10
40
50
0
5
5
15
60
95
125
5
25
60
85
135
225
230
0
5
5
5
30
65
70
0
5
5
20
55
110
135
30
65
110
140
220
290
315
5
5
20
40
75
130
130
5
5
15
30
85
155
170
Flux - Guadalupe CA Drip Irrigation
50
75
90
95
99
99.9
99.99
45
70
120
155
355
630
795
5
5
25
45
175
330
480
5
15
25
50
360
655
890
45
65
95
120
170
245
250
5
5
25
40
65
105
105
15
45
90
120
185
290
290
40
70
105
135
230
400
450
5
5
25
40
90
145
145
15
45
80
115
220
730
1440
60
105
165
210
295
460
505
5
25
55
75
120
195
210
15
40
85
125
195
345
370
95
145
215
270
400
525
530
25
50
85
120
190
270
285
35
60
100
135
250
390
410
Page 12 of 36
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Table 6: Percentile of Exposure at Designated Buffer Distances (in feet and meters)
lodomethane All Flux & Weather Data
Field Size
Buffer
(ft)
Buffer
(m)
Rate
Output
Percentile of Exposure At Designated Buffer Distances
Ventura CA
Nasal
Fetal Loss
Neuro
Flint MI
Nasal
Fetal Loss
Neuro
Bradenton FL
Nasal
Fetal Loss
Neuro
Flux - Manteca CA Flat Fume
>20
(40A)
>10 - 20
(20A)
>5- 10
(10A)
Up to 5
(5A)
500
300
100
50
152
91
30
15
175
(100%)
175
(100%)
175
(100%)
175
(100%)
Max
Whole
Max
Whole
Max
Whole
Max
Whole
95
99
95
99
90
99
95
99
99
99.9
99
99.9
99
99
99
99.9
97
99
97
99
95
99
95
99
99
99.9
99
99.9
95
99
97
99
99.99
99.99
99.99
99.99
99.9
99.99
99.99
99.99
97
99.9
99
99.9
95
99
97
99
85
97
85
97
65
95
70
95
99
99.9
99
99.9
95
99
97
99
90
99
85
99
70
95
70
95
Flux - Plant City FL Tarped Raised Bed
>20
(40A)
>10 - 20
(20A)
>5- 10
(10A)
Up to 5
(5A)
500
300
100
50
152
91
30
15
175
(100%)
175
(100%)
175
(100%)
175
(100%)
Max
Whole
Max
Whole
Max
Whole
Max
Whole
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
99.99
99.99
99.99
99.99
99
99.9
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
95
99
95
99
90
99
95
99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99.99
99
99.9
99
99.9
99
99.9
99.99
99.99
Flux - Guadalupe CA Tarped Raised Bed
>20
(40A)
>10 - 20
(20A)
>5- 10
(10A)
Up to 5
(5A)
500
300
100
50
152
91
30
15
175
(100%)
175
(100%)
175
(100%)
175
(100%)
Max
Whole
Max
Whole
Max
Whole
Max
Whole
70
95
70
97
65
95
75
97
95
99
97
99
95
99
97
99
85
97
85
97
80
97
90
99
90
99
90
99
80
97
85
99
99
99.9
99
99.9
99
99.9
99.99
99.99
95
99
97
99
95
99
99
99.9
55
90
50
90
35
90
45
90
85
99
85
99
80
97
85
97
70
97
70
97
65
95
75
97
Flux - Guadalupe CA Drip Irrigation
>20
(40A)
>10 - 20
(20A)
>5- 10
(10A)
Up to 5
(5A)
500
300
100
50
152
91
30
15
175
(100%)
175
(100%)
175
(100%)
175
(100%)
Max
Whole
Max
Whole
Max
Whole
Max
Whole
90
99
90
99
85
97
90
97
97
99
97
99
97
99
97
99
97
99
97
99
95
99
90
99
95
99
95
99
85
97
90
99
99.99
99.99
99.99
99.99
99
99.9
99
99.9
97
99
97
99
90
99
90
99
75
97
70
97
40
90
40
90
97
99
97
99
90
99
90
99
95
99
95
99
85
97
80
97
Table 7: MOEs At Required Buffer Distances (in feet)
lodomethane MOEs At Varied Distances From Treated Fields: All Field Sizes, Application Rate 175 Ib ai/acre, Various Weather & Emissions
Inputs
%tile
MOEs At Various Distances
Page 13 of 36
-------
Ventura &
Manteca FF
(Flat Fume)
Ventura & Guad
TRB (Tarped
Raised Bed)
Ventura & Guad
Drip (Drip
Application)
Flint & Manteca
FF (Flat Fume)
Flint & Plant City
TRB (Tarped
Raised Bed)
Flint & Guad TRB
(Tarp Raised
Beds)
Flint & Guad Drip
Bradenton &
Manteca FF
(Flat Fume)
50
75
90
95
99
99.9
50
75
90
95
99
99.9
50
75
90
95
99
99.9
50
75
90
95
99
99.9
50
75
90
95
99
99.9
50
75
90
95
99
99.9
50
75
90
95
99
99.9
50
75
90
Nasal Lesions
5A
50ft
272
81
51
43
32
20
199
70
45
35
25
18
231
70
43
37
28
16
335
97
64
53
39
29
594
157
97
81
59
43
272
81
49
40
29
23
335
81
48
40
29
21
177
61
38
10A
100ft
272
81
51
42
30
18
428
97
49
37
24
16
231
70
43
36
26
14
335
97
57
48
34
25
594
143
86
70
49
37
272
77
46
36
26
19
335
81
46
38
28
20
177
64
37
20A
300ft
594
131
70
55
38
22
594
104
51
36
23
16
594
111
59
48
33
17
594
143
77
64
45
31
1005
199
120
91
61
42
594
111
61
46
30
21
594
120
64
51
36
24
335
97
53
40A
500ft
1001
130
70
57
38
22
601
111
49
35
22
15
601
120
61
49
33
17
601
143
81
64
45
31
1001
231
120
91
61
42
601
120
61
46
30
20
601
120
67
53
37
24
428
103
57
Fetal Loss
5A
50ft
447
133
84
71
53
34
328
115
74
58
41
30
380
115
71
61
45
26
551
159
105
87
64
47
976
259
159
133
97
71
447
133
81
66
48
37
551
133
78
66
48
35
290
101
62
10A
100ft
447
133
84
70
50
30
704
159
81
61
39
27
380
115
71
59
43
23
551
159
93
78
57
41
976
235
141
115
81
61
447
126
76
59
42
31
551
133
76
62
46
32
290
105
61
20A
300ft
976
215
115
90
62
36
976
170
84
59
38
26
976
183
97
78
54
28
976
235
126
105
74
51
1652
328
197
150
101
70
976
183
101
76
50
35
976
197
105
84
59
40
551
159
87
40A
500ft
1646
214
115
93
62
35
988
183
81
58
37
25
988
197
101
81
54
28
988
235
133
105
74
51
1646
379
197
149
101
69
988
197
101
76
49
34
988
197
110
87
61
40
704
170
93
Page 14 of 36
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lodomethane MOEs At Varied Distances From Treated Fields: All Field Sizes, Application Rate 175 Ib ai/acre, Various Weather & Emissions
Inputs
Bradenton & Plant
City TRB
(Tarped Raised
Bed)
Bradenton & Guad
TRB (Tarped
Raised Bed)
Bradenton & Guad
Drip (Drip
application)
%tile
95
99
99.9
50
75
90
95
99
99.9
50
75
90
95
99
99.9
50
75
90
95
99
99.9
MOEs At Various Distances
Nasal Lesions
5A
50ft
31
22
17
335
103
64
51
34
27
177
57
32
24
17
14
157
53
32
26
19
14
10A
100ft
30
21
16
335
103
57
43
30
23
177
57
29
22
15
12
177
53
32
26
18
13
20A
300ft
41
28
20
594
157
77
57
37
27
335
86
39
29
18
14
335
86
45
35
24
17
40A
500ft
43
29
20
601
177
81
59
37
27
428
91
41
29
18
13
333
91
48
37
25
17
Fetal Loss
5A
50ft
51
37
27
551
170
105
84
57
44
290
93
52
40
28
22
259
87
52
43
31
23
10A
100ft
50
35
26
551
170
93
71
49
38
290
93
48
37
25
20
290
87
52
42
30
22
20A
300ft
68
45
32
976
259
126
93
61
44
551
141
64
47
30
22
551
141
74
58
39
27
40A
500ft
71
47
33
988
290
133
97
61
44
704
149
68
48
30
22
548
149
78
61
41
28
3. Occupational Exposure and Risk
Occupational exposure and risks exceed the Agency's level of concern for some workers
(tractor drivers, co-pilots, tarp monitors, and shovelers) when no respiratory protection is
used. These risks are sufficiently reduced with respiratory protection to levels below the
Agency's level of concern. Respirators will be required for all workers with
unacceptable risks. However, tractor drivers and co-pilots will have the option of using a
fan/air duct system that meets certain specifications in lieu of a respirator. Worker
exposure five days after application, even without any respiratory protection, does not
exceed the Agency level of concern.
E. Aggregate Exposure and Risk
The physical/chemical characteristics, the environmental fate data, and results of metabolism
studies in plants assure that there is no reasonable expectation of finite residues in or on food and
drinking water when iodomethane is applied according to label directions. Therefore,
iodomethane does not require food tolerances, is considered to be a 'non-food use' chemical, and
Page 15 of 36
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is not subject to the amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA)
promulgated under the Food Quality Protection Act (FQPA) of 1996, and an aggregate risk
assessment is not required.
F. Cumulative Risk
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 as to iodomethane and any other substances and iodomethane does not appear to produce
a toxic metabolite produced by other substances. For the purposes of this action, therefore, the
Agency has not assumed that iodomethane has a common mechanism of toxicity with other
substances.
ENVIRONMENTAL FATE AND EFFECTS
A. ENVIRONMENAL FATE
The high vapor pressure and low affinity for sorption on soil of iodomethane suggest that
volatilization is the most important environmental route of dissipation. Field data from
iodomethane applied via broadcast shank injection to a bare-ground plot and covered
simultaneously with a standard plastic tarpaulin over the treated plot suggests that 54 to 80
percent of iodomethane dissipated to the atmosphere before the tarpaulin was removed. Once
volatilized into the atmosphere, iodomethane degrades rapidly due to direct photolysis and the
estimated atmospheric residence time is less than 12 days.
Field dissipation data show that no residual iodomethane was detected at the end of the field
study period at any site tested. Even if any iodomethane exposure should occur in the surface
water, a low Henry's Law constant suggests rapid volatilization of iodomethane to the
atmosphere. Tier IIPRZM/EXAMS and Tier I SCIGROW were used to estimate iodomethane
concentrations in surface water and ground water, respectively. Based on environmental fate
data, the residual contents in soils, and Tier I and II model estimated concentrations, the Agency
does not expect iodomethane to adversely affect ground water or surface water. However, since
iodomethane is soluble in water, there is the possibility of leaching to ground water if slicing or
removal of the tarpaulin coincides with, or is followed soon by, a rain event. Consequently, the
Agency is requiring cautionary language on the label prohibiting the slicing or removal of the
tarpaulin if it is raining or if rain is expected within 48 hours after treatment.
B. ECOLOGICAL EFFECTS
1. Aquatic Exposure and Risk
The Agency does not consider iodomethane to pose an acute or chronic risk to fish and aquatic
invertebrates because of low potential of iodomethane runoff from the tarped post application
sites to surface water bodies. The low octanol/water partition coefficient indicates that
Page 16 of 36
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iodomethane is not likely to bioconcentrate in tissues of aquatic organisms. Comparing the
highest acute aquatic EEC to the acute toxicity value for the most sensitive test species (D.
magna) produces a maximum risk quotient of 0.0017. This risk quotient is well below the
lowest acute aquatic Level-of-Concern (LOG) of 0.05 for endangered species. The Agency also
believes that the low Henry's Law Constant of iodomethane suggests that chronic exposures to
aquatic invertebrates and fish are not likely to occur.
2. Terrestrial Exposure and Risk
The primary route of exposure of nontarget terrestrial organisms to iodomethane is from
inhalation of air residues near the treated sites. Estimated air concentration are the highest on the
application day with estimated concentrations ranging from 0.987 ppm at 30 cm above the tarp
and up to 0.453 ppm at 80 cm above the tarp. These values are estimated flux values based on
cumulative charcoal tube residues collected following an application of 242 Ib. a.i./acre.
The avian acute inhalation LCso based on a four-hour exposure of bobwhite quail is 395 ppm
which is 400X the peak estimated residues. Therefore, it does not appear that there is a
substantial risk of acute lethality to birds, even if they fly above or land on the tarp on the day of
application. At the lowest test concentration of 344 ppm, sublethal effects were seen and
included ataxia, gasping and rales. Given that a No Effect Level was not obtained, it is not
possible to say with certainty that there would be no sublethal effects at the expected maximum
exposure levels. However, given that the lowest test level was approximately 3SOX greater than
the expected maximum residues, it is quite possible that there would be no sublethal effects as
well. Iodomethane is also a short-lived chemical (direct photolysis, < 11.5 days) in the
atmosphere; therefore, there is low potential for chronic risk to birds and mammals.
Dispersion and photolysis of iodomethane will likely result in birds and wild mammals being
exposed to substantially lower residues and risk than those immediately above the tarp on the
day of application. Mammals appear to be less acutely sensitive than birds to iodomethane. The
reported mammal acute inhalation LCso is 4.0 mg/L (689 ppm). The inhalation maternal
NOAEL in a developmental toxicity study with female New Zealand White rabbits is 10 ppm
which is above the acute wild mammal exposure and thus substantial risk is not expected. It is
not expected that there would be any major use by wildlife of the soil under the tarp. However,
some wildlife (e.g. amphibians) may possibly seek dark, warm, moist areas such as the area
under a tarp which might result in a lethal exposure.
Iodomethane is phytotoxic and given the label statement referencing the potential to damage
caused by drift to other plants or crops, iodomethane may be hazardous to plants off-site.
However, based in part on a prior draft biological opinion from the U.S. Fish and Wildlife
Service for tarped uses of methyl bromide, the Agency does not presently have a concern for the
proposed tarped uses of iodomethane for endangered species, including endangered plants.
C. GLOBAL WARMING AND OZONE DEPLETION POTENTIAL
Once volatilized, iodomethane degrades rapidly in the lower atmosphere via direct photolysis
and lasts in the atmosphere less than twelve days, as compared with two years for methyl
bromide. Therefore, iodomethane is unlikely to the reach upper atmosphere to have an impact
Page 17 of 36
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upon the ozone layer. The estimated ozone depletion potential (ODP) for iodomethane is 0.029,
much lower than the 0.65 for methyl bromide. Iodomethane's ODP of 0.029 also is well below
the 0.20 level of Class I ozone depleters specified under Title VI, Section 602 of the Clean Air
Act. However, global uncertainty on volatilization rates, residence time in soil, photolytic
degradation of iodomethane, and the removal of iodine radicals from the troposphere means that
the possibility of detrimental effects of iodomethane on ozone layer and a contribution to global
warming can not be excluded entirely.
SUMMARY OF REGISTRATION DECISION
A. CONDITIONS OF REGISTRATION
The registrant has agreed in writing to the following conditions for registration: (1) to provide a
training/stewardship program using criteria agreed upon with the Agency; (2) to satisfy any
additional data requirements and to add any additional risk mitigation as required by the Agency
once the Agency makes a decision for the soil fumigant group and to submit label amendments
for each iodomethane product within the same timeframe imposed on other soil fumigant
registrants for similar label amendments. In addition, the registration will be time- limited for
one year.
B. Risk Mitigation
1. End use products are classified as restricted use.
2. Buffer zones are specified on product labels. The buffer zones provide flexibility based
on several factors such as application rate; field size; application method, type of tarp,
and soil characterization. The following table provides examples of the required buffer
zones:
Application Rate
(Ib a.i. /treated acre)
175 (max)
131 (75%)
Size Of Contiguously
Treated Area (acres)
>20 to 40
>10to20
>5 to 10
Up to 5
>20 to 40
>10to20
>5 to 10
Buffer Zone Distance in Feet
HOPE* orLDPE** Tarps are
If
Used
500
300
100
50
375
225
75
Page 18 of 36
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88 (50%)
44 (25%)
Up to 5
>20 to 40
>10to20
>5 to 10
Up to 5
>20 to 40
>10to20
>5 to 10
Up to 5
40
250
150
50
25
125
75
25
25
*High Density Polyethylene **Low Density Polyethylene
Buffer zone reductions of 10% each are allowed for applications where flat fume fumigation is
used, when high barrier films are used, and when the soil has an organic matter content of > 3.
The buffer zone for applications utilizing all 3 credits can be reduced by 30%. However, the
minimum buffer zone is always 25 ft regardless of credits.
Application sites must be limited to < 40 acres/day, and the buffer zone of the field to be treated
cannot overlap the buffer zone of another field treated within the last 48 hours.
3. The certified applicator is responsible for establishing the buffer zone and ensuring that
workers or bystanders do not enter the buffer zone for 48 hours following the end of the
application. An exception will be allowed for transit through the buffer zone, e.g. < 15
minutes for roads and vehicle passage ways where transit is unavoidable.
4. Currently, all certified applicators are required to maintain records related to their use of
restricted use pesticides. In addition, for iodomethane, certified applicators must
maintain records that demonstrate the method of buffer zone calculations, buffer zone
size, how applications met sensitive site requirements, and how occupied structures were
handled.
5. Use within 1A mile of any occupied sensitive site such as a school, day care facility,
nursing home, hospital, prison, or playground is prohibited.
6. Certified applicators must be on site and within the line of sight of the field during
application.
7. The registrant is instituting a training/stewardship program for certified applicators.
Product labels require that the certified applicator must complete the registrant's training
program and be certified by Arysta before using the iodomethane product. Sale of
iodomethane will be limited to certified applicators that have completed the registrant's
training and certification program.
8. The entry restricted period is five days.
9. Tarp monitors, shovelers, tractor drivers and co-pilots must wear a respirator which
meets standards specified by the Occupational Safety and Health Standards Agency
Page 19 of 36
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(OSHA). In addition, respirator users must be trained using a program that conforms to
OSHA requirements and must be examined by a qualified medical practitioner to ensure
physical ability to safely wear a respirator. Tractor drivers and co-pilots will have the
option of using a ducted fan/blower in lieu of the respirator.
10. Non-handler entry is prohibited while tarps are being removed.
DATA GAPS
There are no data gaps for iodomethane. The Agency has identified data which, if supplied,
could help to further refine the risks and possibly result in reduced buffer zones.
PUBLIC INTEREST FINDING
The registration of a new pesticide ingredient is presumed to be in the public interest if: 1) the
pesticide is a replacement for another pesticide that is of concern to the Agency; 2) the pesticide
has a use for which a Section 18 emergency exemption has been granted because of the lack of a
suitable alternative; or 3) the pesticide is to be used to control a pest of public health
significance. If none of the these criteria apply, then it must be shown that: 1) there is a need for
the new pesticide that is not being met by currently registered pesticides; 2) the new pesticide is
less risky than currently registered pesticides; or 3) the benefits from the new pesticide are
greater than those from currently registered pesticides or non-chemical control measures. The
Agency believes that registering iodomethane is in the public interest based on the designation of
iodomethane as a methyl bromide (MeBr) replacement, agricultural need, and the likely benefits.
Methyl bromide is an odorless, colorless gas used as an agricultural soil and structural fumigant
to control a wide variety of pests. However, MeBr has been implicated in the depletion of the
stratospheric ozone layer allowing increased amounts of radiation to reach the earth's surface,
with potential impact to not only human health and the environment, but to agricultural crops as
well. Consequently, the industrialized nations agreed to phase out the use of MeBr, except for
certain allowable exemptions. In the United States, the phaseout was finalized on January 1,
2005, except for specific exemptions. Specific exemptions were allowed because alternatives to
some MeBr uses that are technically and economically feasible, as well as acceptable from a
public health viewpoint, have not yet been identified.
UVB radiation (280 to 320 nanometer range) has been implicated in DNA damage and increased
incidence of melanoma type cancers. UVB has also been linked to changes in plant physiology;
marine ecosystems (particularly phytoplankton populations); buildup of greenhouse gasses; and
weakening of some materials. Increased amounts of UVB are expected to reach the earth's
surface if atmospheric ozone levels decrease. Since the sun's output of UVB is constant, less
ozone will result in less protection from this potential harmful radiation. Research demonstrates
that surface UVB levels can double during the annual ozone hole.
In addition to being implicated in malignant melanoma and non-melanoma skin cancers, UVB
has also been linked to cataracts in humans. Limited exposure to sunlight is important in
Page 20 of 36
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reducing exposure to UVB and its impact on health; however, a reduction in atmospheric ozone
levels will increase the amount of UVB and consequent health risks.
Solar UVB radiation affects the early developmental stages offish, shrimp, crab, amphibians,
and other animals, often causing exposed animals to exhibit decreased reproductive capacity and
impaired larval development. UVB may have an even more fundamental deleterious affect on
marine ecosystems by reducing survival rates in phytoplankton. Phytoplankton forms the
foundation of aquatic food webs and is limited to the upper layer of the water column in which
there is sufficient sunlight to support their growth.
Although plants have a limited ability to adapt to increased levels of UVB, the radiation can
change how nutrients are distributed within the plant and the timing of developmental stages.
The potential impact of such UVB-mediated changes on plant ecosystem competition, plant
disease, and biogeochemical cycles is largely unknown.
Increases in solar UV radiation could affect terrestrial and aquatic biogeochemical cycles, thus
altering both sources and sinks of greenhouse and chemically important trace gases e.g., carbon
dioxide (CO2), carbon monoxide (CO), carbonyl sulfide (COS) and possibly other gases,
including ozone. These potential changes would contribute to biosphere-atmosphere feedbacks
that attenuate or reinforce the atmospheric buildup of these gases.
UVB radiation can also weaken materials such as synthetic polymers, naturally occurring
biopolymers, and other materials of commercial interest. Today's materials are somewhat
protected from UVB by special additives. However, any increase in solar UVB levels will
accelerate their breakdown, thereby limiting the length of time for which they are useful
outdoors.
The Agency recognizes the importance of the pesticidal activity of a material like MeBr to the
agricultural community, and is committed to assist the agricultural sector with the transition to
alternative pest control tools. lodomethane was proposed for use as an alternative pre-plant
fumigant for MeBr in field grown ornamentals, nursery grown strawberries, stone fruits, tree
nuts, and conifer trees, and field grown peppers, strawberries, stone fruits, tree nuts, tomatoes,
and turf. lodomethane is short-lived in the lower atmosphere and unlikely to reach the upper
atmosphere to deplete the ozone layer.
CONTACT PERSON AT EPA
Mary L. Waller
Fungicide Branch
Registration Division (7505P)
Office of Pesticide Programs
Environmental Protection Agency
Ariel Rios Building
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460
Office Location and Telephone Number
Page 21 of 36
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One Potomac Yard
2777 Crystal Drive
S7319
Arlington, VA 22202
E-mail: waller.mary@epa.gov
Phone Number: 703308-9354
DISCLAIMER: The information presented in this Pesticide Fact Sheet is for informational
purposes only and may not be used to fulfill data requirements for pesticide registration or
reregi strati on.
Page 22 of 36
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Appendix I
GLOSSARY OF TERMS AND ABBREVIATIONS
ADNT Acute delayed neurotoxicity
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
ARI Aggregate Risk Index
BCF Bioconcentration Factor
CAS Chemical Abstracts Service
ChE Cholinesterase
ChEI Cholinesterase inhibition
cPAD Chronic Population Adjusted Dose
%CT Percent crop treated
DAT Days after treatment
DEEM-FCID Dietary Exposure Evaluation Model - Food Consumption Intake Database
DNA Deoxyribonucleic acid
DNT Developmental neurotoxicity
DIT Developmental Immunotoxicity
DWLOC Drinking Water Level of Comparison.
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration. The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EPA U.S. Environmental Protection Agency
FQPA Food Quality Protection Act
GLC Gas Liquid Chromatography
GLN Guideline Number
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 substance per weight or volume of water, air or feed, e.g., mg/1,
mg/kg or ppm.
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.
LOAEL Lowest Observed Adverse Effect Level
LOAEC Lowest Observed Adverse Effect Concentration
LOG Level of Concern
LOD Limit of Detection
LOQ Limit of quantitation
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MRID Master Record Identification (number), EPA's system of recording and tracking
studies submitted
MTD Maximum tolerated dose
NA Not Applicable
NOEC No Observable Effect Concentration
NOEL No Observed Effect Level
LD
50
Page 23 of 36
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOAEL No Observed Adverse Effect Level
NOAEC No Observed Adverse Effect Concentration
NPDES National Pollutant Discharge Elimination System
OP Organophosphate
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest 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
RBC Red Blood Cell
RED Reregi strati on Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
TGAI Technical Grade Active Ingredient
UF Uncertainty Factor
jig micrograms
|ig/L Micrograms Per Liter
uL/g Microliter per gram
USDA United States Department of Agriculture
WPS Worker Protection Standard
APPENDIX II - Data Base Supporting the Registration of lodomethane
MRID
45593700
45593701
45593702
45593703
Citation
Arvesta Corp. (2002) Submission of Residue, Product Chemistry, Toxicity and Environmental
Fate Data in Support of the Application for Registration of lodomethane Technical. Transmittal
of 26 of 49 Studies.
Curry, K.; Brookman, D. (2002) lodomethane Technical: Summary of Scientific Data
Supporting Registration: Product Properties: Lab Project Number: TM-425-07. Unpublished
study prepared by Technology Sciences Group Inc. 32 p. {OPPTS 830.0000}
Curry, K.; Brookman, D. (2002) lodomethane Technical: Product Properties-Group A TM-425
Manufacturing Use Product: Lab Project Number: TM-425-01. Unpublished study prepared by
Ricerca, LLC. 100 p. {OPPTS 830.1550, 830.1600, 830.1620, 830.1670, 830.1800, 830.1700,
830.1750}
Walker, R. (2001) Analysis of TM-425 for% lodomethane by Gas Chromatography: Lab
Page 24 of 36
-------
Project Number: TM-0410-00/C. Unpublished study prepared by Ricerca, LLC. 11 p. {OPPTS
830.1800}
45593704
Curry, K.; Brookman, D. (2002) lodomethane Technical: Product Properties-Group B TM-425
Manufacturing Use Product: Lab Project Number: TM-425-02. Unpublished study prepared by
Technology Sciences Group Inc. 183 p. {OPPTS 830.6302, 830.6303, 830.6304, 830.6313,
830.6314, 830.6315, 830.6316, 830.6317, 830.6319, 830.6320, 830.6321, 830.7000,
830.7050, 830.7100, 830.7200, 830.7220, 830.7300, 830.7370, 830.7550, 830.7560,
830.7570, 830.7840, 830.7950}
45593705
Wujcik, C. (2001) A Hydrolysis Study of (Carbon 14) lodomethane (TM-425) in Water: Lab
Project Number: 012522-1: 012522. Unpublished study prepared by Ricerca, LLC. 113 p.
45593706
McFadden, J. (2001) A Photolysis Study of (Carbon 14) lodomethane (TM-425) in Water: Lab
Project Number: 012521-1: 012521. Unpublished study prepared by Ricerca, LLC. 95 p.
45593707
Wujcik, C. (2001) Aerobic Soil Metabolism (Carbon 14) lodomethane (TM-425): Lab Project
Number: 012520-1: 012520. Unpublished study prepared by Ricerca, LLC. 97 p.
45593708
Wujcik, C. (2001) Anaerobic Aquatic Metabolism (Carbon 14) lodomethane (TM-425): Lab
Project Number: 013072-1: 013072. Unpublished study prepared by Ricerca, LLC. 105 p.
45593709
McFadden, J.; Landphair, C. (2001) Adsorption and Desorption of (Carbon 14) lodomethane
(TM-425) on Five Soils: Lab Project Number: 013136-1: 013136. Unpublished study prepared
by Ricerca, LLC. 118 p.
45593710
Baker, F.; Estigoy, L.; Reiss, R. et al. (2002) Volatility of (Carbon 14) lodomethane (TM-425)
Under Field Conditions in California and Florida: Lab Project Number: 893W: 893W-1: 893W-
FL. Unpublished study prepared by Plant Sciences, Inc. 929 p.
45593711
Baker, F.; Nelson, M.; Bolda, M. et al. (2002) Terrestrial Field Dissipation lodomethane (TM-
425) in California and Florida Bareground Soils: Final Report: Lab Project Number: 892W:
892W-1: MEIUSATD2000-03. Unpublished study prepared by Plant Sciences, Inc. 933 p.
45593712
Anonymous (2000) Estimates of the Atmospheric Lifetime, Global Warming Potential, and
Ozone Depletion Potential of lodomethane (CH3I). Unpublished study prepared by
Atmospheric and Environmental Research, Inc. 40 p.
45593713
Drottar, K.; Kendall, T.; Krueger, H. (2001) lodomethane (TM-425): A 48-Hour Static-Renewal
Acute Immobilisation Test with the Cladoceran (Daphnia magna): Final Report: Lab Project
Number: 443A-106. Unpublished study prepared by Wildlife International, Ltd. 57 p. {OPPTS
850.1010}
45593714
Drottar, K.; Kendall, T.; Krueger, H. (2002) lodomethane (TM-425): A 96-Hour Static-Renewal
Acute Toxicity Test with the Rainbow Trout (Oncorhynchus mykiss): Final Report: Lab Project
Number: 443A-107A. Unpublished study prepared by Wildlife International, Ltd. 65 p. {OPPTS
850.1075}
45593715
Nixon, W.; Kendall, T. (2001) Analytical Method Verification for the Determination of
lodomethane in Freshwater: Lab Project Number: 443C-107. Unpublished study prepared by
Wildlife International, Ltd. 31 p. {OPPTS 830.1800}
45593716
Gallagher, S.; Beavers, J. (2001) lodomethane: An Acute Oral Toxicity Study with the
Northern Bobwhite Quail: Final Report: Lab Project Number: 443-101. Unpublished study
prepared by Wildlife International, Ltd. 48 p. {OPPTS 850.2100}
45593717
Kiplinger, G. (2002) Acute Inhalation Toxicity Study of lodomethane in Bobwhite Quail: Final
Report: Lab Project Number: WIL-418005. Unpublished study prepared by WIL Research
Laboratories, Inc. 184 p.
Page 25 of 36
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45593718
45593719
45593720
45593721
45593722
45593723
45593724
45593725
45593726
45593800
45593801
45593802
45593803
45593804
45593805
McFadden, J. (2002) Metabolism of (Carbon 14)-lodomethane (TM-425) in Strawberries: Lab
Project Number: 012033-1: 012033. Unpublished study prepared by Ricerca, LLC. 138 p.
{OPPTS 860.1 300}
McFadden, J. (2002) Metabolism of (Carbon 14)-lodomethane (TM-425) by Tomato: Amended
Report: Lab Project Number: 012391-1-1: 012391. Unpublished study prepared by Ricerca,
LLC. 117 p. {OPPTS 860. 1300}
Cassidy, P. (2001) GLP Method Validation Determination of lodomethane (TM-425) by Gas
Chromatography Headspace Analysis: Lab Project Number: 012157-1: 012157-0-1: 916.
Unpublished study prepared by Ricerca, LLC. 55 p. {OPPTS 860.1340 and 860.1380}
Cassidy, P. (2002) Analytical Method: Determination of lodomethane in Tomato Fruit by
Headspace Analysis using Gas Chromatography: Lab Project Number: 012157-3.
Unpublished study prepared by Ricerca, LLC. 25 p. {OPPTS 860.1340}
Cassidy, P. (2001) Analytical Method: Determination of Iodide in Tomato Fruit by Ion
Chromatography: Lab Project Number: 012157-2. Unpublished study prepared by Ricerca,
LLC. 25 p. {OPPTS 860.1340}
Cassidy, P. (2001) GLP Method Validation Determination of lodomethane (TM-425) by Gas
Chromatography Headspace Analysis and Iodide by Ion Chromatography in Strawberries: Lab
Project Number: 012953-1: TM-425: 012953-0. Unpublished study prepared by Ricerca, LLC.
50 p. {OPPTS 860.1340 and 860.1380}
Cassidy, P. (2002) Analytical Method: Determination of lodomethane in Strawberry Fruit by
Headspace Analysis using Gas Chromatography: Lab Project Number: 012953-3.
Unpublished study prepared by Ricerca, LLC. 25 p.
Cassidy, P. (2002) Analytical Method: Determination of Iodide in Strawberry Fruit by Ion
Chromatography: Lab Project Number: 012953-2. Unpublished study prepared by Ricerca,
LLC. 26 p. {OPPTS 860.1340}
Cassidy, P. (2002) Magnitude of the Residue of lodomethane (TM-425) and Iodide in Tomato
Raw Agricultural Commodity: Lab Project Number: 012921-1-1: TOM425TOM:
425USATOM00.069X. Unpublished study prepared by Ricerca, LLC. 103 p. {OPPTS
860.1500}
Arvesta Corporation (2002) Submission of Residue, Toxicity, Environmental Fate, Risk,
Exposure Assessment and Efficacy Data in Support of the Application for Registration of
lodomethane Technical. Transmittal of 23 of 49 Studies.
Cassidy, P.; Hurstak, R.; Obrist, J. (2002) Magnitude of the Residue of lodomethane (TM-425)
and Iodide in Strawberry Raw Agricultural Commodity: Lab Project Number: TOM425STR:
013011-1: 17001. Unpublished study prepared by Pacific Ag Research Corp. and Ricerca,
LLC. 102 p. {OPPTS 860.1500}
Burin, G.; Mileson, B. (2002) lodomethane Technical: Summary of Scientific Data Supporting
Registration: Health Effects: Lab Project Number: TM-425-21. Unpublished study prepared by
Technology Sciences Group, Inc. 221 p. {OPPTS 835.0000}
Bonnette, K. (2001) An Acute Oral Toxicity Study in Rats with lodomethane (TM-425):
Amended Final Report: Lab Project Number: 3527.1. Unpublished study prepared by
Springborn Laboratories, Inc. 95 p. {OPPTS 870.1100}
Bonnette, K. (2001) An Acute Oral Toxicity Study in Mice with lodomethane (TM-425):
Amended Final Report: Lab Project Number: 3527.2. Unpublished study prepared by
Springborn Laboratories, Inc. 96 p. {OPPTS 870.1100}
Bonnette, K. (2001) An Acute Dermal Toxicity Study in Rabbits with lodomethane (TM-425):
Page 26 of 36
-------
Amended Final Report: Lab Project Number: 3527.3. Unpublished study prepared by
Springborn Laboratories, Inc. 66 p. {OPPTS 870.1200}
45593806
Kirkpatrick, D. (2001) Acute Inhalation Toxicity Study of lodomethane in Albino Rats: Final
Report: Lab Project Number: WIL-418006. Unpublished study prepared by WIL Research
Laboratories, Inc. 124 p. {OPPTS 870.1300}
45593807
Bonnette, K. (2001) A Primary Eye Irritation Study in Rabbits with lodomethane (TM-425):
Amended Final Report: Lab Project Number: 3527.5. Unpublished study prepared by
Springborn Laboratories, Inc. 55 p. {OPPTS 870.2400}
45593808
Bonnette, K. (2001) A Primary Skin Irritation Study in Rabbits with lodomethane (TM-425):
Amended Final Report: Lab Project Number: 3527.6. Unpublished study prepared by
Springborn Laboratories, Inc. 66 p. {OPPTS 870.2500}
45593809
Bonnette, K. (2001) A Dermal Sensitization Study in Guinea Pigs with lodomethane (TM-425):
Maximization Design: Amended Final Report: Lab Project Number: 3527.7. Unpublished study
prepared by Springborn Laboratories, Inc. 84 p. {OPPTS 870.2600}
45593810
Kirkpatrick, D. (2002) A 13-Week Inhalation Toxicity Study (With a Four-Week Interim
Necropsy) of lodomethane in Albino Rats: Final Report: Lab Project Number: WIL-418015.
Unpublished study prepared by WIL Research Laboratories, Inc. 829 p. {OPPTS 870.3465}
45593811
Nemec, M. (2002) An Inhalation Prenatal Developmental Toxicity Study of lodomethane in
Rabbits: Final Report: Lab Project Number: WIL-418002. Unpublished study prepared by WIL
Research Laboratories, Inc. 375 p. {OPPTS 870.3700}
45593812
Nemec, M. (2002) An Inhalation Prenatal Developmental Toxicity Study of lodomethane in
Rats: Final Report: Lab Project Number: WIL-418010. Unpublished study prepared by WIL
Research Laboratories, Inc. 288 p. {OPPTS 870.3700}
45593813
Wagner, V.; Dakoulas, E. (2001) Bacterial Reverse Mutation Assay (Ames) with lodomethane:
Final Report: Lab Project Number: AA38UL.504004.BTL: SPGT504004. Unpublished study
prepared by BioReliance. 59 p.
45593814
Gudi, R.; Brown, C. (2001) In Vitro Mammalian Chromosome Aberration Test with
lodomethane: Final Report: Lab Project Number: AA38UL.331.BTL. Unpublished study
prepared by BioReliance. 41 p.
45593815
San, R.; Clarke, J. (2001) In Vitro Mammalian Cell Gene Mutation Test (CHO/HGPRT Assay)
with lodomethane: Lab Project Number: AA38UL.782.BTL. Unpublished study prepared by
BioReliance. 28 p.
45593816
Gudi, R.; Krsmanovic, L. (2001) Mammalian Erythrocyte Micronucleus Test with lodomethane:
Final Report: Lab Project Number: AA38UL.123.BTL. Unpublished study prepared by
BioReliance. 34 p.
45593817
Schaefer, G. (2002) An Acute Neurotoxicity Study of lodomethane in Rats: Final Report: Lab
Project Number: WIL-418008. Unpublished study prepared by WIL Research Laboratories,
Inc. 1017 p. {OPPTS 870.6200}
45593818
Sved, D. (2002) A Comparative Oral (Gavage) and Inhalation Metabolism and Toxicokinetic
Study with lodomethane in Male Rats: Interim Report: Lab Project Number: WIL-418007.
Unpublished study prepared by WIL Research Laboratories, Inc. 284 p. {OPPTS 870.7485,
870.8340}
45593819
Lawyer, A.; Mileson, B. (2002) lodomethane Technical: Summary of Scientific Data
Supporting Registration: Occupational and Residential Exposure: Lab Project Number: TM-
425-32. Unpublished study prepared by Technology Sciences Group, Inc. 56 p. {OPPTS
875.0000}
Page 27 of 36
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45593820
Baker, F.; Estigoy, L; Belcher, T. (2002) Worker and Applicator Exposure Under Field
Conditions During Application of the Fumigant lodomethane (TM-425): Lab Project Number:
974W: 974W-1. Unpublished study prepared by PTRL West, Inc., Excel Research Services,
Inc. and Bolsa Research Associates, Inc. 318 p. {OPPTS 875.1300}
45593821
Baker, F.; Arndt, T.; Estigoy, L. et al. (2002) Method Validation for lodomethane Trapping,
Field Stability and Storage Stability on Worker Exposure Sample Media: Lab Project Number:
983W: 983W-1. Unpublished study prepared by PTRL West, Inc. 91 p. {OPPTS 875.1300}
45593822
Baker, F.; Estigoy, L.; Gillis, M. (2002) Environmental (Off-Site) Monitoring and Direct
Flux/Indirect Flux Determination of lodomethane (TM-425) under Field Conditions: Lab Project
Number: 975W: 975W-1. Unpublished study prepared by PTRL West, Inc., Excel Research
Services, Inc. and Bolsa Research Associates, Inc. 684 p.
45593823
Gorder, G.; Lawyer, A. (2002) lodomethane Technical: Summary of Scientific Data Supporting
Registration: Product Performance: Lab Project Number: TM-425-31. Unpublished study
prepared by Technology Sciences Group, Inc. 39 p. {OPPTS 810.0000}
45641400
Arvesta Corp. (2002) Submission of Toxicity Data in Support of the Application for Registration
of TM-425. Transmittal of 1 Study.
45641401
Sved, D. (2002) A Comparative Oral (Gavage) and Inhalation Metabolism and Toxicokinetic
Study with lodomethane in Male Rats: Final Report: Lab Project Number: WIL-418007.
Unpublished study prepared by WIL Research Laboratories, Inc. 337 p. {OPPTS 870.7485
and 870.8340}
45710300
Arvest Corp. (2002) Submission of Toxicity Data in Support of the Application for Registration
of TM-425. Transmittal of 1 Study.
45710301
Nemec, M. (2002) An Inhalation Two-Generation Reproductive Toxicity Study of lodomethane
in Rats: Comprehensive Final Report: Lab Project Number: WIL-418004: WIL-418004F: WIL-
418004M. Unpublished study prepared by WIL Research Laboratories, Inc. 3208 p. {OPPTS
870.3800}
45796200
Arvesta Corporation (2002) Submission of Toxicity Data in Support of the Application for
Registration of TM-425. Transmittal of 2 Studies.
45796201
Kirkpatrick, D. (2002) Acute Inhalation Toxicity Study of Idomethane (sic) in Albino Rats: Lab
Project Number: WIL-418006. Unpublished study prepared by Wil Research Laboratories, Inc.
28 p. {OPPTS 870.1300}
45796202
Schaefer, G. (2002) An Acute Neurotoxicity Study of lodomethane in Rats: Lab Project
Number: WIL-418008. Unpublished study prepared by Wil Research Laboratories, Inc. 49 p.
{OPPTS 870.6200}
45879100
Arvesta Corporation (2003) Submission of Environmental Fate and Exposure Data in Support
of the Applications for Registration of lodomethane Technical, TM-42501, and TM-42503.
Transmittal of 2 Studies.
45879101
Baker, F.; Estigoy, L.; Belcher, T. (2003) Environmental (Off-Site) Monitoring and Indirect Flux
Determination of lodomethane (TM-425) Under Field Conditions: Lab Project Number: 1142W:
1142W-1: ERS22087. Unpublished study prepared by PTRL West, Inc., Excel Research
Services, Inc., and Pacific Ag Group. 538 p.
45879102
Baker, F.; Hiler, R.; Belcher, T. (2003) Worker and Applicator Exposure Under Field
Conditions During Tarped/Raised Bed/Shank Injection Application of the Fumigant
lodomethane (TM-425): Final Report: Lab Project Number: 1140W: 1140W-1: ERS22086.
Unpublished study prepared by PTRL West, Inc., Excel Research Services, Inc., and Pacific
Ag Group. 312 p. {OPPTS 875.1300}
Page 28 of 36
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45939500
Arvesta Corporation (2003) Submission of Exposure Data in Support of the Registrations of
lodomethane Technical, TM-42501, and TM-42503. Transmittal of 1 Study.
45939501
3M Corporation (2003) Characterization of Efficiency of 3M Respirator Cartridge 3M 60928 in
Removal of lodomethane From Air. Unpublished study prepared by Technology Sciences
Group, Inc. 14 p. {OPPTS 875.1300}
46077000
Arvesta Corporation (2003) Submission of Toxicity Data in Support of the Applications for
Registration of TM-425, TM 42501 and TM 42503. Transmittal of 1 Study.
46077001
Nemec, M. (2003) A Phased-Exposure Prenatal Developmental Toxicity Study of
lodomethane in Rabbits: Final Report. Project Number: WIL/418023. Unpublished study
prepared by WIL Research Laboratories, Inc. 655 p.
46086300
Arvesta Corporation (2003) Submission of Toxicity Data in Support of the Applications for
Registration of TM-425, TM-42501 and TM-42503. Transmittal of 2 Studies.
46086301
Harriman, J. (2002) A 90-Day Oral (Capsule) Toxicity Study of lodomethane in Dogs: Final
Report. Project Number: WIL/418017. Unpublished study prepared by WIL Research
Laboratories, Inc. 894 p.
46086302
Harriman, J. (2003) A 90-Day Dietary Toxicity Study of Microencapsulated lodomethane in
Mice: Final Report. Project Number: WIL/418021. Unpublished study prepared by WIL
Research Laboratories, Inc. 657 p.
46175700
Arvesta Corporation (2003) Submission of Environmental Fate Data in Support of the
Application for Registration of lodomethane. Transmittal of 1 Study.
46175701
Reiss, R. (2003) An Analysis of the California Department of Pesticide Regulation's Methods
for Estimating Buffer Zones For Fumigants and Recommendations for Refining the Method for
lodomethane: Arvesta lodomethane (TM-425). Unpublished study prepared by Sciences
International, Inc. 42 p.
46203700
Arvesta Corporation (2004) Submission of Product Chemistry, Environmental Fate, Exposure
and Toxicity Data in Support of the Applications for Registration of lodomethane Technical,
TM-42501 and TM-42503. Transmittal of 8 Studies.
46203701
Baker, F.; Estigoy, L.; Belcher, T. (2003) Environmental (Off-Site) Monitoring and Indirect Flux
Determination of lodomethane (TM-425) Under Field Conditions Following Tarped/Raised
Bed/Drip Irrigation Application. Project Number: 1198W, 1198W/1, AR23006. Unpublished
study prepared by PTRL West, Inc., Sciences International, Inc. and Pacific Agricultural
Research Corp. 566 p.
46203702
Baker, F.; Hiler, R.; Belcher, T. (2003) Worker and Applicator Exposure Under Feld Conditions
During Drip Irrigation Application of the Fumigant lodomethane (TM-425). Project Number:
1197W, 1197W/1, AR23005. Unpublished study prepared by PTRL West, Inc., Agvise Inc.
and Pacific Agricultural Research Corp. 272 p.
46203704
Harriman, J. (2003) A 21-Day Dietary Range-Finding Study of Microencapsulated
lodomethane in Mice: Final Report. Project Number: WIL/418020. Unpublished study
prepared by WIL Research Laboratories, Inc. 277 p.
46203705
Harriman, J. (2004) A 12-Month Oral (Capsule) Toxicity Study of lodomethane in Dogs: Final
Report. Project Number: WIL/418018. Unpublished study prepared by WIL Research
Laboratories, Inc. 1455 p.
46203706
Mertens, J. (2002) A 3-Week Capsule Dose Range-Finding Study of lodomethane in Dogs:
Final Report. Project Number: WIL/418016. Unpublished study prepared by WIL Research
Laboratories, Inc. 271 p.
Page 29 of 36
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46203707
Kirkpatrick, D. (2003) A 24-Month Inhalation Combined Chronic Toxicity/Carcinogenicity Study
of lodomethane in Rats: Final Report. Project Number: WIL/418019. Unpublished study
prepared by WIL Research Laboratories, Inc. 1812 p.
46203708
Stetson, P. (2003) Stability Assessment of Microencapsulated lodomethane in Certified
Rodent Labdiet 5002 Admixes: Final Report. Project Number: WIL/418014. Unpublished study
prepared by WIL Research Laboratories, Inc. 193 p.
46203710
Nemec, M. (2003) An Inhalation Two-Generation Reproductive Toxicity Study of lodomethane
in Rats: Amended Final Report. Project Number: WIL/418004. Unpublished study prepared by
WIL Research Laboratories, Inc. 61 p.
46239700
Arvesta Corporation (2004) Submission of Toxicity Data in Support of the Application for
Registrations of TM-425, TM-42501 and TM-42503. Transmittal of 2 Studies.
46239701
Harriman, J. (2003) A 90-Day Dietary Toxicity Study On Microencapsulated lodomethane in
Mice. Project Number: WIL/418022. Unpublished study prepared by WIL Research
Laboratories, Inc. 657 p.
46239702
Harriman, J. (2003) A Single Dose Comparative Toxicity Study of Microencapsulated Versus
Non-Microencapsulated lodomethane in Rats: Final Report. Project Number: WIL/418022.
Unpublished study prepared by WIL Research Laboratories, Inc. 162 p.
46332700
Arvesta Corporation (2004) Submission of Environmental Fate Data in Support of the
Application for Registrations of TM-425, TM-42501, and TM-42503. Transmittal of 2 Studies.
46332701
McFadden, J. (2004) A Photolysis Study of [14-Carbon] lodomethane (TM-425) in Water.
Project Number: 012521/1, 012521. Unpublished study prepared by Ricerca Biosciences,
LLC. 70 p.
46332702
McFadden, J.; Landphair, C. (2004) Adsorption and Desorption of [14-Carbon] lodomethane
(TM-425) on Five Soils. Project Number: 013136/1, 013136. Unpublished study prepared by
Ricerca Biosciences, LLC. 60 p.
46385200
Arvesta Corp. (2004) Submission of Environmental Fate, Exposure and Risk Data in Support
of the Application for Registration of lodomethane. Transmittal of 4 Studies.
46385201
Baker, F.; Hiler, R.; Estigoy, L.; et. al. (2004) Environmental (Off-Site) Monitoring and Indirect
Flux Determination of lodomethane (TM-425) Under Field Conditions Following
Tarped/Raised Bed/Drip Irrigation Method: Final Report. Project Number: 1256W, 1256W/1,
AR24002. Unpublished study prepared by PTRL West, Inc., Access Research, Consulting,
Inc. and Pacific Agri. Labs. 592 p.
46385202
Baker, F.; Estigoy, L.; Belcher, T. (2004) Environmental (Off-Site) Monitoring and Indirect Flux
Determination of lodomethane (TM-425) Under Field Conditions Following Tarped/Raised
Bed/Shallow Shank Injection Application. Project Number: 1254W, 1254W/1, AR24004.
Unpublished study prepared by PTRL West, Inc., Access Research and Consulting, Inc. and
Pacific Agricultural Research Corp. 591 p.
46385203
Baker, F.; Hiler, R.; Belcher, T. (2004) Worker and Applicator Exposure Under Field
Conditions During Tarped/Raised Bed/Drip Irrigation Application of the Fumigant lodomethane
(TM-425). Project Number: 1255W, 1255W/1, AR42001. Unpublished study prepared by
PTRL West, Inc., Access Research and Consulting, Inc., and Pacific Agricultural Research
Corp. 306 p.
46385204
Baker, F.; Hiler, R.; Belcher, T. (2004) Worker and Applicator Exposure Under Field
Conditions During Tarped/Raised Bed/Shallow Shank Injection Application of the Fumigant
lodomethane (TM-425). Project Number: 1253W, 1253W/1, AR24003. Unpublished study
prepared by PTRL West, Inc., Access Research and Consulting, Inc. and Pacific Agricultural
Research Corp. 310 p.
Page 30 of 36
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46408800
Arvesta Corp. (2004) Submission of Product Chemistry, Fate, Exposure and Risk Data in
Support of the Application for Registration of lodomethane and Midas. Transmittal of 9
Studies.
46408801
Sweeney, L; Kirman, C.; Gargas, M. (2004) Derivation of Human Toxicity Reference Values
for Methyl Iodide using Physiologically Based Pharmacokinetic (PBPK) Modeling. Project
Number: 34501. Unpublished study prepared by Sapphire Group, Inc. 91 p.
46408802
Mileson, B. (2004) lodomethane Human Health Risk Assessment. Project Number: 810/01.
Unpublished study prepared by Technology Sciences Group, Inc. 161 p.
46408803
Reiss, R.; Griffin, J. (2004) A Bystander Risk Assessment Following Applications of
lodomethane. Project Number: 2004/01. Unpublished study prepared by Sciences
International, Inc. 68 p.
46408804
Thrall, K.; Woodstock, A.; Soelberg, J.; et. al. (2004) Uptake of Mel by the Rabbit Nasal
Cavity: Final Report. Project Number: 47542. Unpublished study prepared by Battelle-Pacific
Northwest Div. 23 p.
46408805
Thrall, K.; Woodstock, A.; Soelberg, J.; et. al. (2004) Uptake of Mel by the Rat Nasal Cavity:
Final Report. Project Number: 47542. Unpublished study prepared by Battelle-Pacific
Northwest Div. 18 p.
46408806
Thrall, K.; Woodstock, A.; Soelberg, J.; et. al. (2004) In Vivo Gas Uptake in Rabbits: Methyl
Iodide: Final Report. Project Number: 47542. Unpublished study prepared by Battelle-Pacific
Northwest Div. 19 p.
46408807
Corley, R.; Minard, K.; Trease, L.; et. al. (2004) Magnetic Resonance Imaging and
Computational Fluid Dynamics Simulations of Rabbit Nasal Airflows: Methyl Iodide: Final
Report. Project Number: 47542. Unpublished study prepared by Battelle-Pacific Northwest
Div. 18 p.
46408808
Morris, J.; Sasser, L.; Creim, J.; et. al. (2004) The Pharmacokinetics of Sodium Iodide (Nal) in
Pregnant Rabbits: Final Report. Project Number: 47542. Unpublished study prepared by
Battelle-Pacific Northwest Div. 43 p.
46408809
Poet, T.; Wu, H. (2004) In vitro GSH Conjugation STudy in Rat, Rabbit, and Human Blood and
Tissues with Methyl Iodide: Final Report. Project Number: 47542. Unpublished study prepared
by Battelle-Pacific Northwest Div. 36 p.
46412900
Arvesta Corporation (2004) Submission of Environmental Fate Data in Support of the
Application for Registration of lodomethane. Transmittal of 1 Study.
46412901
Baker, F.; Estigoy, L.; Belcher, T. (2004) Environmental (Off-Site) Monitoring and Indirect Flux
Determination of lodomethane (TM-425) Under Field Conditions Following Tarped/Raised
Bed/Drip Irrigation Application. Project Number: 1198W, 1198W/1. Unpublished study
prepared by PTRL West, Inc., Access Research and Consulting, Inc. and Sciences
International, Inc. 568 p.
46416200
Arvesta Corp. (2004) Submission of Toxicity Data in Support of the Registrations of
lodomethane Technical, TM-42501 and TM-42503. Transmittal of 1 Study.
46416201
Sweeney, L.; Kirman, C.; Gargas, M. (2004) Derivation of Human Toxicity Reference Values
for Methyl Iodide using Physiologically Based Pharmacokinetic (PBPK) Modeling Computer:
Computer Code for the Model. Project Number: 34501. Unpublished study prepared by
Sapphire Group, Inc. 90 p.
46441300
Arvesta Corporation (2005) Submission of Toxicity Data in Support of the Application for
Registrations of lodomethane Technical, TM-42501, and TM-42503. Transmittal of 4 Studies.
Page 31 of 36
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46441301
Himmelstein, M. (2004) lodomethane: In Vivo 2-Day Inhalation Mechanistic Toxicity Study in
the Rat. Project Number: DUPONT/14998, 15298, 1389. Unpublished study prepared by E. I.
Du Pont De Nemours and Co., Inc. and Exygen Research and University of Massachusetts
Medical. 463 p.
46441302
DeLorme, M. (2004) lodomethane: Pulmonary Function Study in the Rabbit. Project Number:
DUPONT/15453, 15298, 707. Unpublished study prepared by E. I. Du Pont De Nemours and
Co., Inc. and Exygen Research. 129 p.
46441303
Gannon, S. (2004) lodomethane: In Vitro Partition Coefficients in Rat and Rabbit Tissues and
Human Blood. Project Number: DUPONT/15617, 15298, 1388. Unpublished study prepared
by E. I. Du Pont De Nemours and Co., Inc. 47 p.
46441304
Fan/veil, A. (2004) Effect of TM-425 (Methyl iodide) on Deiodinase Activity: Final Report.
Project Number: DEIODINASE/1234. Unpublished study prepared by University of
Massachusetts Medical. 36 p.
46446900
Arvesta Corp. (2005) Submission of Toxicity, Exposure and Risk Data in Support of the
Application for Registrations of TM-42501, TM-42503 and lodomethane Technical. Transmittal
of 3 Studies.
46446901
Sweeney, L; Kirman, C.; Gargas, M. (2005) Derivation of Human Toxicity Reference Values
for Methyl Iodide Using Physiologically Based Pharmacokinetic (PBPK) Modeling (Revised
Report). Project Number: 34501. Unpublished study prepared by Sapphire Group, Inc. 103 p.
46446902
Reiss, R.; Griffin, J. (2005) A Bystander Risk Assessment Following Applications of
lodomethane Revised. Project Number: 2005/01. Unpublished study prepared by Sciences
International, Inc. 72 p.
46446903
Mileson, B. (2005) lodomethane Human Health Risk Assessment Revised. Project Number:
810/02. Unpublished study prepared by Technology Sciences Group, Inc. 162 p.
46451000
Arvesta Corporation (2005) Submission of Toxicity Data in Support of the Application for
Registration of lodomethane Technical. Transmittal of 2 Studies.
46451001
Sloter, E. (2005) A Combined Baseline/Inhalation Exposure Study of lodomethane-Related
Fetotoxicity in Rabbits: Final Report. Project Number: WIL/418031, WIL/418031H,
WIL/4180311. Unpublished study prepared by WIL Research Laboratories, Inc., E. I. du Pont
de Nemours and Company Inc. and Exygen Research. 1631 p.
46451002
Sloter, E. (2005) Mode of Action Study for lodomethane-Related Fetotoxicity in Rabbits: Final
Report. Project Number: WIL/418032, DUPONT/15855, P0000903. Unpublished study
prepared by WIL Research Laboratories, Inc. and E. I. du Pont de Nemours and Company
Inc. and Exygen Research. 911 p.
46463600
Arvesta Corporation (2005) Submission of Environmental Fate, Exposure and Risk Data in
Support of the Application for Registration of lodomethane. Transmittal of 2 Studies.
46463601
Baker, F.; Estigoy, L.; Hiler, R.; et al. (2005) Environmental (Off-Site) Monitoring and Indirect
Flux Determination of lodomethane (TM-425) Under Field Conditions Following
Tarped/Raised Bed/Drip Irrigation Application. Project Number: 1315W, 1315W/1.
Unpublished study prepared by PTRL West, Inc. and Access Research and Consulting, Inc.
and Pacific Agricultural Research Corp. 627 p.
46463602
Baker, F.; Hiler, R.; Lange, B. (2005) Worker and Applicator Exposure Under Field Conditions
During Tarped/Raised Bed/Drip Irrigation Application of the Fumigant lodomethane (TM-425).
Project Number: 1314W, 1314W/1. Unpublished study prepared by PTRL West, Inc., Access
Research and Consulting, Inc. and Pacific Agricultural Research Corp. 319 p.
46512400
Arvesta Corporation (2005) Submission of Toxicity, Exposure and Risk Data in Support of the
Page 32 of 36
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Application for Registration of lodomethane Technical. Transmittal of 2 Studies.
46512401
Kirkpatrick, D. (2005) A 24-Month Inhalation Combined Chronic Toxicity/Carcinogenicity Study
of lodomethane in Rats: Final Report. Project Number: WIL/418019, 418019, WIL/418019M.
Unpublished study prepared by WIL Research Laboratories, Inc. 4817 p.
46512402
Mileson, B.; Sweeney, L; Kirman, C. (2005) Risk Assessment of Thyroid Follicular Cell
Tumors in Rats Following 2-Year lodomethane Exposure by Inhalation. Project Number:
810/03. Unpublished study prepared by Technology Sciences Group, Inc. and Universitaet
Dortmund and Institute of Environmental Toxicology. 114 p.
46545200
Arvesta Corporation (2005) Submission of Toxicity Data in Support of the Application for
Registration of lodomethane Technical. Transmittal of 1 Study.
46545201
Sweeney, L.; Gargas, M. (2005) Data and References to Support the Derivation of Human
Toxicity Reference Values for Methyl Iodide Using Physiologically Based Pharmokinetic
(PBPK) Modeling. Project Number: 34503. Unpublished study prepared by Sapphire Group,
Inc. 154 p.
46559300
Arvesta Corp. (2005) Submission of Fate Data in Support of the Application for Registration of
lodomethane Technical. Transmittal of 3 Studies.
46559301
Sweeney, L.; Gargas, M. (2005) Age Specific NEC's for Potential Nasal Effects of Mel in
Children: Supplement to (PBPK) Modeling (MRID 46446901). Project Number: 34503.
Unpublished study prepared by Sapphire Group, Inc. 46 p.
46559302
Sweeney, L. (2004) Revision of HEC for Nasal Effects of Methyl Iodide (Mel): Supplement to
(PBPK) Modeling (MRID 46408801). Project Number: 45603. Unpublished study prepared by
Sapphire Group, Inc. 68 p.
46559303
Sweeney, L.; Gargas, M. (2005) Supplemental Information Regarding Human Fetal and
Maternal Iodide AUC Sensitivity and a Rabbit Model Sensitivity Analysis: Supplement to
(PBPK) Modeling (MRID 46446901). Project Number: 45603. Unpublished study prepared by
Sapphire Group, Inc. 65 p.
46570400
Arvesta Corporation (2005) Submission of Toxicity Data in Support of the Application for
Registration of lodomethane Technical. Transmittal of 1 Study.
46570401
Harriman, J.; Armstrong, A. (2005) A 12-Month Oral (Capsule) Toxicity Study of lodomethane
in Dogs: Evaluation of Injected Sclera in Dogs Exposed to lodomethane for 12 Months From
Study WIL-418018. Project Number: WIL/418018. Unpublished study prepared by WIL
Research Laboratories, Inc. 8 p.
46582800
Arvesta Corp. (2005) Submission of Toxicity Data in Support of FIFRA 6(a)(2) Data
Requirements for lodomethane Technical. Transmittal of 2 Studies.
46582801
Harriman, J. (2005) An 18 Month Dietary Carcinogenicity Study of Microencapsulated
lodomethane in Mice: Final Report. Project Number: WIL/418025. Unpublished study
prepared by WIL Research Laboratories, Inc. 3071 p.
46582802
Hardisty, J. (2005) A Pathology Working Group (PWG) Peer Review of Proliferative Lesions
Reported in the Uterus and Cervix: Microencapsulated lodomethane: Mice. Project Number:
758/011. Unpublished study prepared by Experimental Pathology Laboratories, Inc. 181 p.
46593800
Arysta LifeScience Corporation (2005) Submission of Fate Data in Support of the Application
for Registration of lodomethane Technical. Transmittal of 1 Study.
46593801
Gargas, M.; Sweeney, L.; Kirman, C. (2005) Weight of Evidence for Evaluation of the HEC for
Acute Developmental Toxicity of Methyl Iodide. Project Number: 34501. Unpublished study
prepared by Sapphire Group, Inc. 274 p.
Page 33 of 36
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46601700
Arysta LifeScience North America Corporation (2005) Submission of Toxicity Data in Support
of the Application for Registration of lodomethane Technical. Transmittal of 1 Study.
46601701
Mileson, B.; McDonald, T. (2005) Review of lodomethane Mutagenicity Studies. Project
Number: 34505. Unpublished study prepared by Arysta LifeScience North America
Corporation and Technology Services Group, Inc. 329 p.
46610900
Arysta LifeScience North America Corporation (2005) Submission of Exposure and Risk Data
in Support of the Application for Registration of lodomethane Technical. Transmittal of 1
Study.
46610901
Sweeney, L.; Mileson, B. (2005) Application of PBPK Modeling of lodomethane in Rat Cancer
Risk Assessment. Project Number: 34502. Unpublished study prepared by Sapphire Group,
Inc. 47 p.
46623400
Arysta Life Science North America Corp. (2005) Submission of Toxicity Data in Support of the
Application for Registration of lodomethane Technical. Transmittal of 1 Study.
46623401
Kurume Laboratory (2003) A 96-Hour Acute Toxicity Test of lodomethane with Common Carp:
(Final Report). Project Number: TMN/012, 92548, E01/2548E. Unpublished study prepared by
Chemicals Evaluation and Research Institute. 32 p.
46631400
Arysta LifeScience North America Corporation (2005) Submission of Toxicity Data in Support
of the Application for Registration of lodomethane Technical. Transmittal of 1 Study.
46631401
Sweeney, L.; Gargas, M. (2005) Revaluation of the HEC for Acute Nasal Toxicity of Methyl
Iodide. Project Number: 34510. Unpublished study prepared by Sapphire Group, Inc. 417 p.
46634200
Arysta LifeScience North America (2005) Submission of Product Chemistry Data in Support of
the Application for Registration of lodomethane Technical. Transmittal of 1 Study.
46634201
Walker, R. (2002) TM-425-Storage Stability/Corrosion. Project Number: 013124/1.
Unpublished study prepared by Ricerca Biosciences, LLC. 25 p.
46846900
Arysta LifeScience North America Corporation (2006) Submission of Exposure and Risk Data
in Support of the Application for Registration of lodomethane Technical. Transmittal of 1
Study.
46846901
Sweeney, L.; Mileson, B.; Gargas, M.; et al. (2006) lodomethane: Supplemental Toxicology
Information. Project Number: 34601. Unpublished study prepared by Arysta LifeScience North
America Corporation, Sapphire Group, Inc. and Technology Sciences Group, Inc. 283 p.
46882500
Arysta LifeScience North America (2006) Submission of Efficacy Data in Support of the
Application for Registration of lodomethane Technical. Transmittal of 1 Study.
46882501
Allan, M.; Mezin, L. (2006) lodomethane Technical: Additional Performance Data. Project
Number: ARV2006PERF. Unpublished study prepared by Arysta Lifescience North America
Corporation. 273 p.
46887000
Arysta LifeScience North America Corporation (2006) Submission of Efficacy and Economics
Data in Support of the Application for Registration of lodomethane Technical. Transmittal of 1
Study.
46887001
Sankula, S.; Marmon, G. (2006) Feasibility of MIDAS to Replace Methyl Bromide - A
Comparitive Analysis. Project Number: ARV2006ECON. Unpublished study prepared by
Arysta LifeScience North America Corporation. 159 p.
46928400
Arysta Life Science North America Corporation (2006) Submission of Toxicity Data in Support
of the Application for Registration of lodomethane Technical. Transmittal of 1 Study.
46928401
Sweeney, L.; Mileson, B.; Gargas, M. (2006) Concordance of the Nasal Epithelial
Page 34 of 36
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Compartments of the lodomethane PBPK Model and the Nasal Olfactory Epithelial Cell
Degeneration Following lodomethane Exposure. Project Number: 083006. Unpublished study
prepared by Technology Sciences Group, Inc and The Sapphire Group. 39 p.
46934300
Arysta LifeScience Corporation (2006) Submission of Toxicity Data in Support of the
Application for Registration of lodomethane Technical. Transmittal of 2 Studies.
46934302
Sved, D. (2005) A Comparative Oral (Gavage) and Inhalation Metabolism and Toxicokinetic
Study with lodomethane in Female Rats: Final Report. Project Number: WIL/476001.
Unpublished study prepared by WIL Research Laboratories, Inc. 351 p.
46934304
Mezin, L. (2006) Abstracts and Tables for Three Studies on the Effects of lodomethane on
Biological Functions in Mice, Rats and Dogs. Project Number: ALSNA/TOX/ABSTRACTS.
Unpublished study prepared by Shin Nippon Biomedical Laboratories, Ltd. 36 p.
46962700
Arysta LifeScience North America Corporation (2006) Submission of Toxicity Data in Support
of the Application for Registration of lodomethane Technical. Transmittal of 3 Studies.
46962701
Nishimura, Y. (2003) A 90-Day Repeated Dose Toxicity Study of lodomethane in Rats
Followed by a 28-Day Recovery (with amendments): Final Report. Project Number: SBL98/24.
Unpublished study prepared by Shin Nippon Biomedical Laboratories,ltd. 461 p.
46962702
Nemec, M. (2004) A Combined Inhalation Range-Finding Reproductive and Subchronic
Toxicity Study of lodomethane in Rats: Final Report. Project Number: WIL/418003.
Unpublished study prepared by WIL Research Laboratories, Inc. 1317 p.
46962703
Morris, T. (2002) A Repeated-Dose 21-Day Dermal Toxicity Study of lodomethane in Rats.
Project Number: WIL/418009. Unpublished study prepared by WIL Research Laboratories,
Inc. 629 p.
47028600
Arysta LifeScience North America Corporation (2007) Submission of Fate Data in Support of
the Application for Registration of lodomethane Technical. Transmittal of 1 Study.
47028601
Rayburn, W.; Robinson, A.; Braverman, L.; et. al. (2007) Iodide Concentrations in Matched
Maternal Plasma, Cord Plasma and Amniotic Fluid from Term and Pre-Term Human
Pregnancies: Supplemental to MRID 46446901: lodomethane. Project Number: 06/240.
Unpublished study prepared by Saphire Group. Technology Sciences Group Inc and New
Mexico St. University. 308 p.
47053400
Arysta LifeScience North America Corp. (2007) Submission of Fate, Environmental Fate,
Exposure and Risk Data in Support of the Application for Registration of lodomethane
Technical. Transmittal of 6 studies.
47053401
Desjardins, D.; Kendall, T.; Krueger, H. (2006) lodomethane: A 7-Day Static-Renewal Toxicity
Test with Duckweed (Lemna gibba G3): Final Report. Project Number: 443A/134B.
Unpublished study prepared by Wildlife International, Ltd. 50 p.
47053402
Porch, J.; Krueger, H. (2007) lodomethane, A Toxicity Test to Determine the Effects of the
Test Substance on Seedling Emergence of Ten Species of Plants: Final Report. Project
Number: 443/111. Unpublished study prepared by Wildlife International, Ltd. 148 p.
47053403
Baker, F.; Estigoy, L.; Belcher, T. (2003) Environmental (Off-Site) Monitoring and Indirect Flux
Determination of lodemethane (TM-425) Under Field Conditions Following Tarped/Raised
Bed/Drip Irrigation Application. Project Number: 1198W, 1198W/1, 1198W/2. Unpublished
study prepared by PTRL West, Inc. 569 p.
47053404
Dyer, N.; Brill, A. (2006) Maternal-Fetal Transport or Iron and Iodine in Humans Subjects.
Project Number: ALSNA/TOX/2007/01. Unpublished study prepared by Arysta LifeScience
North America Corp. 22 p.
Page 35 of 36
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47053405
Dyer, N.; Brill, A.; Glasser, S.; et. al. (2006) Maternal-Fetal Transport and Distribution of Fe
and I in Humans. Project Number: ALSNA/TOX/2007/02. Unpublished study prepared by
Arysta Life Science North America Corp. 11 p.
47053406
Fuse, Y. (2006) Development of the Hypothalamic-Pituitary-Thyroid Axis in Humans. Project
Number: ALSNA/TOX/2007/03. Unpublished study prepared by Arysta LifeScience North
America Corp. 25 p.
47086600
Arysta Life Science North America Corporation (2007) Submission of Exposure and Risk Data
in Support of the Registration of lodomethane Technical. Transmittal of 1 Study.
47086601
Mileson, B.; Sweeney, L.; Reiss, R.; et al. (2007) lodomethane Human Health Risk
Assessment: Revision Two (Previous MRID Nos. 46408802 and 46446903). Project Number:
810/07. Unpublished study prepared by Technology Sciences Group Inc. 144 p.
47106500
Arystal LifeScience North America Corporation (2007) Submission of Toxicity Data in Support
of the Application for Registration of lodomethane Technical. Transmittal of 1 Study.
47106501
Porch, J.; Krueger, H. (2007) lodomethane: A Toxicity Test to Determine the Effects of the
Test Substance on Vegetative Vigor of Ten Species of Plants: Final Report. Project Number:
443/112. Unpublished study prepared by Arysta LifeScience North America America
Corporation. 148 p.
47127300
Arysta LifeScience North America Corporation (2007) Submission of Product Chemistry Data
in Support of the Application for Registration of lodomethane Technical. Transmittal of 1 study.
47127301
Mungalachetty, P. (2007) Midas EC Bronze: Determination of Storage Stability and Corrosion
Characteristics. Project Number: 04/0262/G1, ARV/04/425/006, AA/31876/22. Unpublished
study prepared by Toxikon Corp. 47 p.
47132500
Arysta LifeSciences North America (2007) Submission of Product Chemistry Data in Support
of the Application for Registration of lodomethane Technical and the Experimental Use of
lodomethane. Transmittal of 1 Study.
47132501
Arysta LifeScience North Ameri (2007) Documentation Supporting Application for
Experimental Use Permit (EUP): lodomethane. Project Number: ARV2007EUP. Unpublished
study prepared by Arysta LifeScience North America. 57 p.
47172600
Arysta LifeScience North America (2007) Submission of Exposure and Risk Data in Support of
the Application for Registration of lodomethane Technical. Transmittal of 1 Study.
47172601
Tobia, A.; Mileson, B. (2007) Institutional Review Board Documentation Supplementary
Report to: Iodide Concentrations in Matched Maternal Plasma, Cord Plasma, and Amniotic
Fluid from Term and Pre-Term Human Pregnancies. Project Number: 070507. Unpublished
study prepared by Arysta LifeScience North America Corporation. 80 p.
47196700
Arysta LifeScience North America Corporation (2007) Submission of Fate Data in Support of
the Application for Registration of lodomethane Technical. Transmittal of 1 Study.
47196701
Mileson, B.; Tinsworth, E.; Rhodes, B. (2007) Documentation of Ethical Conduct of a Human
Study of Iodide Concentrations in Maternal Plasma, Cord Plasma, and Amniotic Fluid,
Supplemental to MRID 47028601. Project Number: 080607. Unpublished study prepared by
Technology Sciences Group, Inc., Exponent, Inc., and Arysta LifeScience North America
Corporation. 131 p.
Page 36 of 36
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