N-/EPA
United States Prevention, Pesticides EPA 738-R-05-010
Environmental Protection and Toxic Substances September 2005
Agency (7508C)
Reregistration
Eligibility Decision for
Ethofumesate
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Reregistration Eligibility Decision (RED) Document for
Ethofumesate
List [B]
Case No. 2265
Approved by:
Debra Edwards, Ph. D.
Director
Special Review and Reregistration Division
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TABLE OF CONTENTS
Ethofumesate Reregistration Eligibility Decision Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Case Overview 2
IE. Summary of Ethofumesate Risk Assessment 4
A. Human Health Risk Assessment 5
1. Dietary Exposure and Risk from Food and Drinking Water 5
a. Acute Dietary (Food and Drinking Water) 5
b. Chronic Dietary (Food and Drinking Water) 6
c. Drinking Water Estimates 6
2. Residential Exposure and Risk 7
a. Residential Handler Exposure and Risk 8
b. Residential Postapplication Exposure and Risk 8
3. Aggregate Exposure and Risk 9
4. Occupational Exposure and Risk 10
5. Occupational Incidents Reports 12
B. Environmental Risk Assessment 12
1. Environmental Fate and Transport Properties 12
2. Ecological Risk Assessment 12
3. Risk to Aquatic Animals: 13
4. Risk to Terrestrial Animals 13
5. Risk to Aquatic Plants 13
6. Risk to Terrestrial Plants 14
7. Endangered Species 14
8. Ecological Incidents 14
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 15
A. Determination of Reregistration Eligibility 15
B. Public Comments and Responses 15
C. Regulatory Position 16
1. Food Quality Protection Act Findings 16
2. Endocrine Disrupter Effects 16
3. Cumulative Risks 16
4. Tolerance Reassessment Summary 17
D. Regulatory Rationale 18
1. Human Health Risk Management 19
a. Aggregate Risk Summary 19
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1) Acute Aggregate Risk 19
2) Short and Intermediate-term Aggregate Risk 19
3) Long-term Aggregate Risk 20
b. Aggregate Risk Mitigation 20
c. Occupational Risk Mitigation 20
1) Handler Risk Mitigation 20
2) Post-application Risk Mitigation 20
2. Environmental Risk Mitigation 21
a. Endangered Species Considerations 21
b. Spray Drift Management 22
V. What Registrants Need to Do 23
A. Manufacturing Use Products 23
1. Additional Generic Data Requirements 23
2. Labeling for Manufacturing-Use Products 24
B. End-Use Products 24
1. Additional Product-Specific Data Requirements 24
2. Labeling for End-Use Products 25
VI. Conclusions 25
Appendix B: Data Supporting Guideline Requirements for the Reregistration of Ethofumesate . 33
Appendix C. Citations Considered to be Part of the Database Supporting the Reregistration
Eligibility Decision (Bibliography) 40
Appendix D. Generic Data Call-In 59
Appendix E. Product Specific Data Call-In 60
Appendix F. List of Registrants Sent This Data Call-In 61
Appendix G. EPA'S Batching of Ethofumesate Products for Meeting Acute Toxicity Data
Requirements for Reregistration 62
Appendix H. Technical Support Documents 65
Appendix! List of Available Related Documents and Electronically Available Forms 66
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Ethofumesate Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Nicole Zinn
Rafael Prieto
T.J. Wyatt
Environmental Fate and Effects Risk Assessment
Lewis Brown
Amer Al-Mudallal
Health Effects Risk Assessment
Jose Morales
Linnea Hansen
Nancy McCarroll
Robert Travaglini
Registration Support
Joanne Miller
Risk Management
Laura Parsons
Nathan Mottl
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Glossary of Terms and Abbreviations
AGDCI Agricultural Data Call-In
ai Active Ingredient
aPAD Acute Population Adjusted Dose
BCF Bioconcentration Factor
CFR Code of Federal Regulations
cPAD Chronic Population Adjusted Dose
CSF Confidential Statement of Formula
CSFII USDA Continuing Surveys for Food Intake by Individuals
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DFR Dislodgeable Foliar Residue
DNT Developmental Neurotoxicity
EC Emulsifiable Concentrate Formulation
ED WC Estimated Drinking Water Concentration
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
GLN Guideline Number
IR Index Reservoir
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the
test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOC Level of Concern
LOAEL Lowest Observed Adverse Effect Level
MATC Maximum Acceptable Toxicant Concentration
ug/g Micrograms Per Gram
ug/L Micrograms Per Liter
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
MUP Manufacturing-Use Product
NOAEL No Observed Adverse Effect Level
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PAD Population Adjusted Dose
PCA Percent Crop Area
PDF USDA Pesticide Data Program
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRZM/EXAMS Tier II Surface Water Computer Model
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Q! * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RAC Raw Agriculture Commodity
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
SCI-GROW Tier I Ground Water Computer Model
SAP Science Advisory Panel
SF Safety Factor
SLC Single Layer Clothing
TGAI Technical Grade Active Ingredient
USD A United States Department of Agriculture
USGS United States Geological Survey
UF Uncertainty Factor
UV Ultraviolet
WPS Worker Protection Standard
ill
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Abstract
This document presents the Environmental Protection Agency's (hereafter referred to as EPA or
the Agency) decision regarding the reregistration eligibility of the registered uses of the herbicide
ethofumesate. The Agency has determined that ethofumesate is eligible for reregistration. There are
currently 18 listed tolerances on sugar beets, grass, and livestock commodities.
In the human health risk assessment, dietary (food and drinking water) and residential risks do
not exceed the Agency's level of concern. Handler risks are being addressed by a label clarification
which will prohibit aerial applications for the highest rate and the requirement of engineering controls
for custom applications to fertilizer. There were no post-application concerns noted for agricultural
uses; however for the turf uses, a 9 day re-entry interval is imposed for maintenance activity and a 16
day pre-harvest interval is imposed for sod harvesting. This post-application worker assessment may
be refined with a submission of an acceptable dermal absorption study which may affect these re-
entry restrictions.
The screening level ecological risk assessment indicates slight exceedances of levels of concern
for freshwater fish and non-target terrestrial plants. Prohibition of high rate aerial applications will
result in lower exposures for fish and plants.
IV
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregistration of pesticide products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregistration of such products, as well as a review of all submitted data by the U.S. Environmental
Protection Agency (referred to as EPA or "the Agency"). Reregistration involves a thorough review
of the scientific database underlying a pesticide's registration. The purpose of the Agency's review is
to reassess the potential risks arising from the currently registered uses of the pesticide; to determine
the need for additional data on health and environmental effects; and to determine whether or not the
pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
On August 2, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This
Act amended FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA) to require reassessment
of all existing tolerances for pesticides in food. FQPA also requires EPA to review all tolerances in
effect on August 2, 1996 by August 2, 2006. In reassessing these tolerances, the Agency must
consider, among other things, aggregate risks from non-occupational sources of pesticide exposure,
whether there is increased susceptibility among infants and children, and the cumulative effects of
pesticides that have a common mechanism of toxicity. When the Agency determines that aggregate
risks are not of concern and concludes that there is a reasonable certainty of no harm from these
exposures, the tolerances are considered reassessed. EPA decided that, for those chemicals that have
tolerances and are undergoing reregistration, tolerance reassessment will be accomplished through the
reregistration process.
As mentioned above, FQPA requires EPA to consider "available information" concerning the
cumulative effects of a particular pesticide's residues and "other substances that have a common
mechanism of toxicity" when considering whether to establish, modify, or revoke a tolerance.
Potential cumulative effects of chemicals with a common mechanism of toxicity are considered
because low-level exposures to multiple chemicals causing a common toxic effect by a common
mechanism could lead to the same adverse health effect as would a higher level of exposure to any
one of these individual chemicals. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by the EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects from substances found to
have a common mechanism on EPA's website at http://epa.gov/pesticides/cumulative/.]
The Agency has found no information indicating ethofumesate shares a common mechanism of
toxicity with other substances. Ethofumesate does not appear to produce a toxic metabolite produced
by other substances. Therefore, for the purposes of tolerance reassessment and a decision on
reregistration eligibility, EPA has not assumed that ethofumesate shares a common mechanism of
toxicity with other compounds. In the future, if additional information suggests ethofumesate shares a
common mechanism of toxicity with other compounds, additional testing may be required and a
cumulative assessment may be necessary.
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This document presents EPA's revised human health and ecological risk assessments, its
progress toward tolerance reassessment, and the reregistration eligibility decision for ethofumesate.
The document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment. Section II provides a profile of the use and usage of the
chemical. Section III gives an overview of the revised human health and environmental effects risk
assessments based on data, public comments, and other information received in response to the
preliminary risk assessments. Section IV presents the Agency's reregistration eligibility and risk
management decisions. Section V summarizes label changes necessary to implement the risk
mitigation measures outlined in Section IV. Section VI provides information on how to access
related documents. Finally, the Appendices list related information and supporting documents. The
preliminary and revised risk assessments for ethofumesate are available in the Public Docket, under
docket number OPP-2004-0346 and on the Agency's web page, http://www.epa.gov/edockets.
n. Case Overview
A. Chemical Overview
The following active ingredient(s) are covered by this Reregistration Eligibility Decision:
• Common Name: Ethofumesate
• Chemical Name: 2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl-methanesulfonate
CAS Registry Number: 26225-79-6
OPP Chemical Code: 110601
• Trade and Other Names: Notron, Progress, and Prograss
Basic Manufacturer: Bayer CropScience and United Phosphorus, Inc.
Chemical Structure:
CH3SO2.O
O OCH2CH3
Ethofumesate (e.g.,2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate) is a
selective herbicide registered for preplant, preemergence and postemergence use to control broadleaf
and grass weeds. Products containing ethofumesate were first registered as NORTRON in 1977 and
the name was officially changed to ethofumesate upon acceptance of the new common name by the
American National Standards Institute (ANSI) in 1978. A Phase IV Data Call-In (DCI) was issued in
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June, 1991. Subsequent DCIs were issued in January, 1995 and October, 1995. This Reregistration
Eligibility Decision (RED) reflects a reassessment of all data submitted to date.
Use Sites:
• Ethofumesate is registered for use on sugar beets, garden beets, table beets, carrots, and turf
uses including grass seed, sod production, and ornamental turf. It is also registered for use in
seed production for Swiss chard and spinach.
Mode of Action:
The mode of action is related to inhibition of mitosis plus reduced photosynthesis and
respiration.
Formulations:
Formulation types registered include flowable concentrate, emulsifiable concentrate, and
granular products.
Methods and Timing of Application:
Methods of application include groundboom application, soil incorporation, broadcast spreader,
and bellygrinder.
• Timing of application for food and feed crops (sugar beets, carrots, etc.) primarily includes soil-
incorporated preplant and pre-emergence, and low rates used for post-emergence.
Timing of application for turf uses includes both pre- and post-emergence use for cool season
and warm season grasses (primarily to suppress Bermuda grass in St. Augustine grass)
Use rates:
Use rates vary from approximately 1.0 Ib active ingredient per acre (ai/A) to a maximum
application rate of 3.75 Ib ai/A. See Table 1.
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Table 1: Maximum Use Rates for Ethofumesate
Crop Group
Turf
Turf
(St. Augustine Grass)1
Food and Feed
Crop or Treated Area
Sod Farms, golf courses, and
ornamental uses on
residential lawns
Sod Farms, golf courses, and
ornamental uses on
residential lawns
Sugar Beets
Carrots
Beets
Maximum Application Rates
1.5 Ibai/acre
3 Ib ai/acre
3.75 Ib ai/acre
2.0 Ib ai/acre
1.9 Ibai/acre
a This rate represents a narrow turf use pattern specific for a particular warm season grass (suppression of Bermuda grass
weeds in St. Augustine grass).
Annual poundage:
• Based on available pesticide usage information from 1998 through 2002, approximately
200,000 pounds of active ingredient were used on sugar beets. An average of 35% of sugar
beets were treated with ethofumesate.
Tolerance information:
There are currently 18 listed tolerances on sugar beets, grass, and livestock commodities,.
These tolerances are expressed as ethofumesate and two metabolites (2-hydroxy-2,3-dihydro-
3,3-dimethyl-5-benzofuranyl methanesulfonate and 2,3-dihydro-3,3-dimethyl-2-oxo-5-
benzofuranyl methanesulfonate) expressed as parent compound.
Technical registrants:
• Bayer CropSciences
• United Phosphorus, Inc.
HI. Summary of Ethofumesate Risk Assessment
The following is a summary of EPA's human health and ecological risk findings and
conclusions for ethofumesate, as presented fully in the documents: "Ethofumesate: Human Health
Risk Assessment for Phase 2; Response to Error Only Comments from the Registrant PC Code
110601. DP Barcode DP304056" written by N. McCarroll (8/10/2005), and "Environmental Fate and
Effects Division Risk Assessment for the Reregistration Eligibility Document" written by A. Al-
Mudallal and L. Brown (8/31/2005).
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The purpose of this section is to summarize the key features and findings of the risk assessment
in order to help the reader better understand the risk management decisions reached by the Agency.
While the full risk assessments and related supporting documents are not included in this document
they are available in the public docket (docket # OPP-2004-0346) and the Agency's website at
http://www.epa.gov/pesticides/reregistration/status.htm.
A. Human Health Risk Assessment
The Agency has conducted a human health risk assessment for ethofumesate for the purposes of
making reregistration eligibility decisions. The Agency evaluated the toxicology, product and residue
chemistry and occupational/residential exposure studies submitted for ethofumesate and determined
that the data are adequate to support a reregistration decision. Details of the toxicity, residue
chemistry and/or occupational/residential exposure data are available in the risk assessment and
separate supporting disciplinary documents available in the electronic docket. A summary of the
human health risk assessment findings and conclusions are provided in the subsections below.
1. Dietary Exposure and Risk from Food and Drinking Water
a. Acute Dietary (Food and Drinking Water)
Acute dietary risk is calculated based on quantity of food eaten in one day and maximum
residue values in the food. A risk estimate that is less than 100% of the acute Population Adjusted
Dose (aPAD) (the dose at which an individual could be exposed on any given day with no adverse
health effects) does not exceed the Agency's level of concern. EPA evaluated the acute dietary risks
using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID™, Version 1.30) which incorporates food consumption data from USDA's
Continuing Survey of Food Intake by Individuals (CSFII), 1994-1996, and 1998. A summary of the
acute dietary exposure and risk for ethofumesate is presented in Table 2. The acute dietary estimates
are below the Agency's level of concern at 4% of the aPAD at the 95th percentile for the female (age
13-49 years old) subgroup population. No appropriate endpoint was identified for the general
population and infants.
An unrefined acute Tier 1 dietary exposure/risk analysis for ethofumesate was conducted using
tolerance residue values, default processing factors, a processing factor from sugar beet processing
studies, and the assumption of 100% crop treated for all commodities. For dietary risk from
ethofumesate residues in drinking water, a point estimate residue value derived from PRZM/EXAMS
modeling turf uses, was included in the dietary analyses. The dietary risk assessment used an
uncertainty factor (UF) of 100 (lOx for interspecies extrapolation, and lOx for intraspecies
variability). The Special FQPA safety factor, required by the 1996 Food Quality Protection act
(FQPA) as a special protection for infants and children, was reduced from the default lOx to Ix. The
toxicity database for ethofumesate includes acceptable developmental and reproductive toxicity
studies, and there is no evidence in the developmental toxicity study of susceptibility following in
utero exposure. Also, the Agency has a low level of concern and no residual uncertainties regarding
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exposure or concerns for the effects seen in the developmental toxicity studies after establishing
toxicity endpoints and traditional uncertainty factors to be used in the risk assessment.
No acute dietary risk endpoint has been identified for the general population including infants
and children. An acute dietary risk endpoint was identified for the population of females (13-49 yrs)
based on a developmental toxicity study in rabbits with a No Observed Adverse Effect Level
(NOAEL) of 30 mg/kg/day. A LOAEL of 300 mg/kg/day was observed with effects manifested by
increased resorptions, post-implantation loss and incomplete ossification of the vertebral arches.
Table 2: Summary of Acute Dietary (Food + Drinking Water) Exposure and Risk for Ethofumesate
Population Subgroup
Females (13-49 years old)
aPAD
(mg/kg/day)
0.3
%aPAD
at 95th Percentile
4
Exposure (mg/kg/day)
0.011722
For additional information, please see Section 6.1 of the human health risk assessment.
b. Chronic Dietary (Food and Drinking Water)
An unrefined Tier 1 chronic dietary risk analysis was conducted using the average consumption
value for food and average residue values on those foods. A risk estimate that is less than 100% of
the chronic Population Adjusted Dose (cPAD) (the dose at which an individual could be exposed
over the course of a lifetime and no adverse health effects would be expected) does not exceed the
Agency's level of concern. An uncertainty factor of lOOx was applied for the chronic dietary
assessment, and the FQPA safety factor was reduced to 1 (as discussed in the acute dietary
assessment section, above). DEEM™ was used to calculate the chronic dietary exposure estimates
based on average consumption for the U.S. population and population subgroups including infants
and children. As in the acute dietary assessment, the chronic dietary assessment assumed
ethofumesate residues in food at 100% of tolerance levels and a point estimate for drinking water
residues.
The chronic dietary risk endpoint for the general population including infants and children is
based on a chronic oral toxicity/carcinogenicity study in rats with a NOAEL of 127 mg/kg/day and a
LOAEL of 469 mg/kg/day; effects were decreased body weight gain in females. The calculated
cPAD is 1.3 mg/kg/day.
Estimated chronic dietary exposure (food and drinking water) for ethofumesate is below the
Agency's level of concern for the all population subgroups at <1% of the cPAD. For additional
information, please see Section 6.1 of the human health risk assessment.
c. Drinking Water Estimates
Typically EPA evaluates the potential for human exposure to pesticides in drinking water
through an assessment of available surface water and ground water monitoring data and modeling.
For ethofumesate, no monitoring data were available for use in this drinking water assessment.
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Therefore, potential human exposures to ethofumesate were evaluated through modeling. Estimated
exposure concentrations (EECs) in surface water were calculated using PRZM version 3.12 and
EXAMS version 2.98.04. Ground water concentrations were modeled using SCIGROW (version
2.3). Drinking water residues were then incorporated into the DEEM-FCID™ into the food
categories "water, direct, all sources" and "water, indirect, all sources."
Based on the modeling results, the estimated surface water-derived drinking water
concentration for the use of ethofumesate is 154 |ig/L (used for the acute analysis) based on the
Florida turf scenario. The 1 in 10 year annual average concentrations are 45.5 |ig/L (used for the
chronic analysis) for the Florida turf scenario, and 26 |_ig/L for the 30 year annual mean concentration
for the Minnesota sugar beet scenario. The maximum concentration modeled using SCIGROW for
ground water is 8.4 |ig/L for use on turf. For details regarding modeling inputs and additional
information, please see the Drinking Water Assessment Summary in Section V of the Environmental
Fate and Effects risk assessment.
2. Residential Exposure and Risk
Residential risk is expressed as a Margin of Exposure (MOE), which measures how close the
residential exposure comes to the NOAEL from animal studies. Generally, MOEs that are greater
than 100 do not exceed the Agency's level of concern (the standard target MOE incorporates the
standard uncertainty factors of lOx for interspecies variability and lOx for intraspecies variability).
EPA determined that the available data supports the removal of the default lOx FQPA factor. Thus,
scenarios that yield MOEs that are less than 100 may trigger concern.
An oral NOAEL of 190 mg/kg/day was selected from a 90-day oral study in rats for assessing
the dermal exposure route. The LOAEL in this study was 1900 mg/kg/day with the effects of
decreased body weight gain and liver microscopic lesions. Data on dermal absorption are unavailable
at this time; therefore, a default assumption of 100% absorption was used. Inhalation exposure is not
expected because residues are likely to be diluted outdoors in the air and ethofumesate has a low
vapor pressure (4.9 x 10"6torr).
Some residential (dermal) scenarios were assessed for females 13-49 based on an oral endpoint
from a developmental study in rabbits with effects manifested by increased resorptions, post-
implantation loss and incomplete ossification of the vertebral arches. While the residential
postapplication scenarios resulted in apparent risks of concern (see Table 3), the Agency believes that
these scenarios are very conservative and unlikely to occur. The developmental endpoint was based
on a study with a NOAEL (30 mg/kg/day) that is 10X lower than the LOAEL (300 mg/kg/day);
therefore the NOAEL may be an artifact of dose selection. Additionally, for the residential
exposures, the endpoint is oral while the assessed exposures are dermal and conservative SOP-based
default assumptions such as 100% dermal absorption, default turf transferable residue dissipation
assumptions, contact with turf immediately post-treatment and maximum application rates were used
in this assessment. The rate of 1.5 Ib ai/A covers the majority of uses; however, the label does permit
a 3.0 Ib ai/A rate specifically for suppression of Bermuda grass in St Augustine grass turf.
The acute toxicity profile for ethofumesate shows that the dermal LD50 for ethofumesate was
>20,050 mg/kg which was approximately three times higher than the highest dose tested for the oral
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route (oral LD50 = >6,400 mg/kg). Additionally, no effects were seen at the highest dose tested (1000
mg/kg/day) in a 21-day dermal study in rabbits. For more information on the toxicity profile for
ethofumesate, please see Section 4.1.7 of the Human Health Risk Assessment. Although the LD50
studies and the short term dermal study did not reach the desired endpoint and cannot be directly
compared, the information from these studies gives the Agency confidence that high dermal
exposures such as calculated for the residential risk assessments are unlikely to be a risk concern.
However, the Agency intends to call in a dermal absorption (or penetration) study to permit more
realistic estimation of dermal absorption.
a. Residential Handler Exposure and Risk
Since all ethofumesate products are intended for either agricultural use or require professional
application for ornamental turf, no residential handler use is expected. There is, however, potential
post-application residential exposure to ethofumesate for adults and children through its use on turf
(lawn care applications) and golf courses.
b. Residential Postapplication Exposure and Risk
Residential post-application exposure to ethofumesate on treated lawn was assessed for toddlers
and adults. The MOEs for residential turf exposures were calculated using conservative assumptions
of a screening-level assessment such as maximum application rates, 100% dermal absorption, default
assumptions for dissipation of turf transferable residues and a conservative endpoint for females 13-
49 years. The total MOE includes the dermal, hand-to-mouth, object to mouth and soil ingestion
pathways. Exposures were calculated for short and intermediate term exposures; ethofumesate use is
not expected to result in long term residential exposure. As shown in Table 3, estimated risks for all
population subgroups except females (13-49 yrs) were well above 100. The short-term total MOEs
for females (13-49 yrs) are 73 at an application rate of 1.5 Ib ai/acre and 27 at an application rate of
3.0 Ib ai/acre. The maximum application rate is solely for suppression of Bermuda grass growth in
St. Augustine grass.
To address this concern, the Agency intends to call in a dermal absorption study to permit more
realistic estimation of dermal absorption. It should be noted that estimated exposures are extremely
conservative due not only to assumption of 100% dermal absorption but also because they assume
exposure at levels immediately after application, maximal levels of dermal exposure activity,
maximum dermal contact, and maximum dermal surface contact areas. Additionally, ethofumesate
has minimal lawncare and commercial turf uses, which is the scenario where high dermal exposure
activities would occur. The predominant use is on golf courses and sod farms. High exposure
activities would likely not occur on a golf course. Ethofumesate residues resulting from sod farm
application would likely dissipate significantly before sod was transplanted to residential or
commercial turf.
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Table 3. Residential Exposure litunates & MQIi for ItMtanesate Treated Turf
Resident
Toddler
Toddler
Toddler
Toddler
Toddler
Adult
Adult
Females 13-49yrs
Females 13-49yrs
Ibal/A
1.5
3.0
1.5
1.5
1.5
1.5
3.0
1.5
3.0
Activity
Playing
Playing
Hand to mouth
Turf to mouth
Soil to mouth
High dermal
contact activity
High dermal
contact activity
High dermal
contact activity
High dermal
contact activity
Body Weight (kg)
15
15
15
15
15
70
70
60
60
NQAEL(mg/kg/day)
190
190
190
190
190
190
190
30**
30**
MOE • . •
330
160
8600
34000
2.5 E6
540
270
73
27
** based on a developmental toxicity study in rabbits; developmental LOAEL = 300, and assumes 100% dermal
absorption.
3. Aggregate Exposure and Risk
The FQPA amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section
408(b)(2)(A)(ii) require "that there is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue, including all anticipated dietary exposures and other
exposures for which there is reliable information." An aggregate risk assessment predicts the
combined risk from dietary exposure to residues in food and drinking water and, if applicable,
residential exposures.
In this assessment, risk assessments for aggregate exposure to food, drinking water, and
residential were considered only for the short- and intermediate-term exposure scenarios because use
patterns do not suggest a long-term residential exposure. Acute and chronic aggregate risks (food and
drinking water) exposures are below the level of concern for all population subgroups. Short and
intermediate term aggregate risks for food, drinking water, and residential exposures estimated for all
population subgroups (general population, infants and adult 50+ male), with the exception of females
(13-49 yrs), were below the level of concern with MOEs of 159-180.
Aggregate short- and intermediate-term risks for females (13-49 yrs) were not quantitatively
estimated due primarily to ethofumesate residential postapplication risks to turf. Dietary risks (food
and drinking water) for this sensitive subpopulation were well below the Agency's level of concern.
While the high-end residential postapplication scenarios resulted in apparent risks of concern (see
Table 3), the Agency believes that these scenarios are very conservative and unlikely to occur for
reasons detailed in the residential postapplication exposure and risk section above (section III.A.2.b)).
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However, the Agency intends to call in a dermal absorption study to permit more realistic estimation
of dermal absorption and to confirm that 100% is in fact an overestimate. For more information on
aggregate risks and assumptions, please see Section 7.0 of the human health risk assessment.
4. Occupational Exposure and Risk
Workers can be exposed by mixing, loading, or applying (handlers) ethofumesate or by entering
a previously treated site (postapplication). Worker risk is also measured as a MOE, which determines
how close the occupational exposure comes to a NOAEL. For handlers, the Agency initially assesses
risk at "baseline" which considers an individual's normal work clothing (e.g., long sleeve shirt and
long pants), no gloves, and no respirator. If there is a concern at this level, the Agency considers the
use of protective measures (e.g., personal protective equipment and engineering controls) to lower the
risk. Personal protective equipment (PPE) can include an additional layer of clothing, chemical-
resistant gloves, and respirator. Common examples of engineering controls include enclosed tractor
cabs, closed loading systems, and water-soluble packaging.
The Agency has determined that workers may be exposed to ethofumesate while mixing,
loading or applying ethofumesate pesticides. Sixteen occupational handler scenarios were evaluated
for short and intermediate term exposure to ethofumesate. All of the handler scenarios had MOEs
greater than 100 at either baseline (long pants and shirt, socks and shoes) or with the addition of
chemical-resistant gloves. When the handler scenarios were assessed for males or females over 49
years of age (NOAEL of 190 mg/kg/day from a 90-day rat oral study), MOEs ranged from 418 to
9200 with chemical-resistant gloves added. When the female (age 13-49 years) population (NOAEL
of 30 mg/kg/day from a 21-day rabbit developmental study) was assessed when adding chemical-
resistant gloves, the MOEs ranged from 100 to 1700 except for one scenario of mixing and loading
for aerial applications at 3.75 b ai/A to sugar beets which resulted in an MOE of 57. For detailed
information on handler aerial application assumptions and risks, please refer to section 9.4 of the
human health risk assessment.
Handler risks for grower (on-farm) and custom (commercial) mixing, loading and applying
ethofumesate to dry bulk fertilizers were not assessed in the original human health risk assessment.
For on-farm handlers, estimated MOEs were greater than 100 for applicators at baseline, but required
chemical-resistant gloves to reach MOEs of 100 for mixer/loaders. For commercial handlers,
estimated MOEs were greater than 100 for applicators at baseline, and required engineering controls
(closed mixing/loading) to reach MOEs of 100 for mixer/loaders. For dry bulk fertilizer assumptions,
refer to the memorandum entitled "Handler Risks to Dry Bulk Fertilizers on Sugar Beets."
The Agency has determined that workers may be exposed to ethofumesate upon entering areas
which have been previously treated with ethofumesate to work in these areas (e.g., scouting, weeding,
irrigating). When risks for males or females over 49 years of age were assessed (NOAEL of 190
mg/kg/day) for food and feed crops (sugar beets, carrots, etc), no concerns for re-entry workers were
identified for low exposure activities at the current reentry interval (REI) of 12 hrs. However, for
exposures associated with medium and high activities (transplanting, harvesting and thinning), a
reentry interval (REI) of 3 days after treatment would be needed to reach an MOE prediction of 100
at the high use rate. When the developmental endpoint (NOAEL of 30 mg/kg/day) was used, again,
no concerns for re-entry workers (females 13-49 years) were identified for low exposure activities at
10
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the current REI of 12 hrs, but for medium and high exposure activities, 10-22 days were required to
achieve the target MOE of 100. The conservative assumptions used in the risk assessment
significantly affected length of these re-entry intervals. Conservative, screening level procedures
were followed. The assumptions included: 100% dermal absorption, a default dislodgeable foliar
dissipation rate, and an endpoint used for females (13-49 yrs) derived from a developmental study
with a large difference between the LOAEL and NOAEL. Further, since ethofumesate use in
agricultural food crops (sugar beets, carrots, garden beets, etc.) is primarily pre-plant and pre-
emergence, medium and high exposure activities are not likely to occur. See the postapplication risk
mitigation section for more description and characterization (section IV.d.l.c.2).
Table 4 illustrates the reentry risks to workers from turf. For turf, estimated risks for males and
females > 49 years of age (using the NOAEL of 190 mg/kg/day) engaged in all activities
(maintenance and harvesting), resulted in MOEs of > 100 after 0 days reentry. For females (aged 13-
49 years old), the estimated MOEs for workers performing turf postapplication activities did not reach
100 until 9 days for maintenance activities and 16 days for harvesting sod using the highest
application rate. Conservative assumptions were used, such as using a 100% dermal absorption
assumption and default assumptions for dissipation of turf transferable residues. Risk mitigation
measures for turf are a reentry interval of 9 days for maintenance activities and a pre-harvest interval
of 16 days. The Agency intends to call-in a confirmatory dermal absorption (penetration) study to
provide a more realistic estimate of the dermal absorption and which, in turn, may alter these risk
mitigation requirements.
For detailed information and assumptions on postapplication, please see Section 9.5 of the human
health risk assessment
TableA .-Days After Trealmfnt Target MOE Achieved (Tarjet MOE = 1OJ)
Crop/Use Pattern
Golf Course Turf
Sod Farms
Application
Rate
(Ib ai/acre)
3
3
Postapplication
Activity
Maintenance
Harvesting
Transfer Coefficient
(cm2/hr)a
ARTF
3,400
6,800
Days After Treatment Target
MOE Achieved
NOAEL = 30
mg/kg/day b
9
16
NOAEL =190
mg/kg/day °
0
0
Golf Course
Turf
Sod Farms
1.5
1.5
Maintenance
Harvesting
ARTF
3,400
6,800
3
9
0
0
a Transfer coefficients are derived from ARTF data.
b MOE = NOAEL (30 mg/kg/day; based on an oral developmental study) / dermal dose.
0 MOE = NOAEL (190 mg/kg/day; based on an oral 90-day toxicily study) / dermal dose.
11
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5. Occupational Incidents Reports
Very few ethofumesate incidents have been reported to EPA's Incident Data System, Poison
Control Center data, and the California Pesticide Illness Surveillance Program. The symptoms, if
present, were minor (irritation, cramps, nausea, dizziness) and did not fit any identifiable patterns.
B. Environmental Risk Assessment
The Agency has conducted an environmental assessment for ethofumesate for the purposes of
making a reregistration decision. The Agency evaluated environmental fate and wildlife and aquatic
organism toxicity studies submitted for ethofumesate and determined that the data are adequate to
support a reregistration decision. More in depth details of the toxicity to aquatic and terrestrial
organisms and fate and persistence studies used to develop the risk assessments are provided in the
environmental risk assessment available in the electronic docket. A summary of the environmental
risk assessment findings and conclusions is provided in the following subsections below.
1. Environmental Fate and Transport Properties
The major route of dissipation for ethofumesate in surface soil appears to be photodegradation
(photolysis half lives were 28 to 31 hours in water and 165 hours in soil). However, ethofumesate
below the soil surface appears more stable. It may dissipate by microbial metabolism with aerobic
metabolism half lives between 83 and 253 days. Laboratory data indicate that ethofumesate is stable
to hydrolysis and anaerobic soil metabolism.
Furthermore, laboratory mobility data indicate that ethofumesate is very mobile in sand with a
Kd of 0.73 and moderately mobile in most other soils with Kds ranging from 2.35 to 6.16. Available
data indicate that degradate mobility is similar to that of parent ethofumesate. Supplemental
terrestrial field dissipation data indicate half lives of approximately 100 days with no detection of
ethofumesate below 12 inches.
2. Ecological Risk Assessment
To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity
using the quotient method. Risk quotients (RQs) are calculated by dividing exposure estimates by
ecotoxicity values, both acute and chronic, for various wildlife species. RQs are then compared to
levels of concern (LOCs). Generally, the higher the RQ, the greater the potential risk. Risk
characterization provides further information on the likelihood of adverse effects occurring by
considering the fate of the chemical in the environment, communities and species potentially at risk,
their spatial and temporal distributions, and the nature of the effects observed in studies.
12
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3. Risk to Aquatic Animals:
Ethofumesate is considered to be "slightly toxic" to freshwater fish on an acute basis with
LCSO's ranging from 17 to 22 ppm. When maximum application rates were assessed, there were no
exceedances of the LOC's for non-listed species. RQ's for risks to freshwater fish range up to 0.08.
Based on toxicity values and predicted environmental concentrations, there are no acute or
chronic risks of concern (including endangered species risks) for estuarine invertebrates or
estuarine/marine fish. There are also no chronic risk concerns for freshwater fish.
For a detailed discussion of risks to aquatic animals including a discussion of toxicity data and
aquatic exposure modeling, please see Section VT: Aquatic Exposure and Risk Assessment of the
Environmental Fate and Effects risk assessment.
4. Risk to Terrestrial Animals
For birds and mammals, ecotoxicity testing indicates that ethofumesate technical and
emulsifiable formulations are "slightly toxic" to "practically non-toxic" for acute toxicity.
For birds, no mortality or sublethal effects were observed in the ethofumesate avian
reproduction studies. For mammals, no chronic effects were observed in the rat 3-generation
reproduction study. Only at the highest doses were reduced food consumption, dyspnea and
weakness observed.
Based on predicted EECs from maximum application rates and available toxicity data, there are
no exceedances of any level of concern for terrestrial animals (including direct effects for endangered
species).
Available acute data from a honey-bee study indicate that ethofumesate is "practically non-
toxic" to honeybees with an 48-hour contact LD50 of >50 ug ai/bee. The Agency does not routinely
conduct risk assessments for non-target insects, but these data indicate that there will be no risk
concerns from use of ethofumesate.
For a detailed discussion of risks to terrestrial animals including a discussion of toxicity data
and pesticide residues on terrestrial food items and terrestrial exposure modeling, please see Section
VTI: "Terrestrial Exposure and Risk Assessment" of the Environmental Fate and Effects risk
assessment.
5. Risk to Aquatic Plants
Review of the non-vascular plant study did not identify any risks of concern for the use of
ethofumesate. Based on the recently submitted aquatic vascular plant study, no acute LOG
exceedances were seen based on maximum application rates of ethofumesate.
13
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6. Risk to Terrestrial Plants
For seedling emergence, wheat was the most sensitive monocot with an EC25 (the
concentration that affects 25% of test organisms) of 0.13 Ibs ai/acre. The most sensitive dicot was
lettuce with an EC25 of 0.14 Ibs ai/acre and tomato with a NOAEC (No Observable Adverse Effects
Concentration) of 0.006 Ibs ai/acre.
In general, toxicity tests demonstrate that ethofumesate may impact both seedling emergence
and vegetative vigor of vascular terrestrial plants. Because ethofumesate is mobile, there is potential
for runoff to adversely affect off target plants. Although aerial applications are at lower application
rate levels, there is also potential for spray drift impacts as well.
Based on predicted EECs using label maximum application rates and available toxicity data,
there are exceedances of the LOG for acute terrestrial non-endangered and endangered species plants
for both monocots and dicots.
7. Endangered Species
The screening level risk assessment for endangered species indicates that ethofumesate has the
potential for causing direct acute risk to endangered freshwater fish and terrestrial plants from uses on
sugar beets, vegetables and turf if exposure should actually occur at modeled levels. A preliminary
spatial analysis of the co-ocurrence of endangered plants and ethofumesate use suggests that in
general the major areas of potential risk to endangered plants are limited to the western United States.
These findings are based solely on EPA's screening level assessment and do not constitute "may
affect" findings under the Endangered Species Act.
Ethofumesate was found to have no direct acute or chronic effects to estuarine/marine
invertebrates, estuarine/marine fish, mammals, birds and aquatic plants and no chronic effects to
freshwater fish.
8. Ecological Incidents
According to the EFED Terrestrial Incidence Database there were three reported incidences of
plant damage from the use of ethofumesate. The reported incidences involved applications to sugar
beets, but did not specify whether damage was to target or non-target corps. The first occurred in
Richland county, Montana in June 2002 and involved 600 acres of sugar beets that were damaged
from broadcast application of liquid ethofumesate. In the second, again in Richland county, Montana,
500 acres of 1000 acres of sugar beets were damaged from broadcast application of liquid
ethofumesate. No residue analysis was performed in either case. The third incident involved
ethofumesate use in Malheur county, Oregon where over 60 acres of 68 acres were damaged. The
type of application was unknown and no residue analysis was performed.
14
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient, whether or not products containing the active ingredient are eligible
for reregistration. The Agency has previously identified and required the submission of the generic
(i.e., active ingredient-specific) data required to support reregistration of products containing
ethofumesate as an active ingredient. The Agency has reviewed these generic data, and has
determined that the data are sufficient to support reregistration of all products containing ethofumesate.
The Agency has completed its assessment of the dietary, occupational, residential, and ecological
risks associated with the use of pesticide products containing the active ingredient ethofumesate.
Based on a review of these data and on public comments on the Agency's assessments for the active
ingredient ethofumesate, the Agency has sufficient information on the human health and ecological
effects of ethofumesate to make decisions as part of the tolerance reassessment process under FFDCA
and reregistration process under FIFRA, as amended by FQPA. The Agency has determined that
ethofumesate containing products are eligible for reregistration provided that: (i) current data gaps and
confirmatory data needs are addressed; (ii) the risk mitigation measures outlined in this document are
adopted; and (iii) label amendments are made to reflect these measures. Label changes are described
in Section V. Appendix A summarizes the uses of ethofumesate that are eligible for reregistration.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of ethofumesate, and lists the submitted studies that the
Agency found acceptable.
Based on its evaluation of ethofumesate, the Agency has determined that ethofumesate products,
unless labeled and used as specified in this document, would present risks inconsistent with FIFRA.
Accordingly, should a registrant fail to implement any of the risk mitigation measures identified in this
document, the Agency may take regulatory action to address the risk concerns from the use of
ethofumesate. If all changes outlined in this document are incorporated into the product labels, then all
current risks for ethofumesate will be adequately mitigated for the purposes of this determination
under FIFRA. Once an Endangered Species assessment is completed, further changes to these
registrations may be necessary as explained in section 2a below.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked extensively with stakeholders
and the public to reach the regulatory decisions for ethofumesate. During the public comment period
on the risk assessments, which closed on May 31, 2005, the Agency received comments from three
commentors, Bayer CropSciences, University of Hawaii and a concerned citizen. Bayer's and the
concerned citizen's comments pertained to risk assessment methods and toxicological endpoints, and
the University of Hawaii comment was in support of benefits of use of ethofumesate for use on cool
season turf grasses in Hawaii. These comments in their entirety are available in the public docket
15
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(OPP-2004-0346) at http://www.epa.gov/edockets. A detailed Response to Comments has been
prepared by EPA and is available in the public docket (OPP-2004-0346).
C. Regulatory Position
1. Food Quality Protection Act Findings and "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with this
pesticide. EPA has determined that risk from dietary (food sources only) exposure to ethofumesate is
within its own "risk cup." An aggregate assessment was conducted for exposures through food,
drinking water, and residential uses. The Agency has determined that the human health risks from
these combined exposures are within acceptable levels. In other words, EPA has concluded that the
tolerances for ethofumesate meet FQPA safety standards. In reaching this determination, EPA has
considered the available information on the special sensitivity of infants and children, as well as
aggregate exposure from food, drinking water, and residential uses. The FQPA Safety Factor has
been removed (i.e., reduced to IX) for ethofumesate because acceptable developmental and
reproduction studies have been submitted and reviewed, and there is a low concern and no residual
uncertainties for pre- and postnatal toxicity
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may have
an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other
endocrine effects as the Administrator may designate." Following recommendations of its Endocrine
Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that EPA
include evaluations of potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the
extent that effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disrupter Screening Program
(EDSP).
The available data on ethofumesate indicated that there was no lexicologically significant
evidence of endocrine disruption effects. When the appropriate screening and/or testing protocols
being considered under the EDSP have been developed, ethofumesate may be subject to additional
screening and/or testing.
3. Cumulative Risks
Risks summarized in this document are those that result only from the use of ethofumesate. The
Food Quality Protection Act (FQPA) requires that the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and "other substances that have a
16
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common mechanism of toxicity." The reason for consideration of other substances is due to the
possibility that low-level exposures to multiple chemical substances that cause a common toxic effect
by a common toxic mechanism could lead to the same adverse health effect as would a higher level of
exposure to any of the substances individually. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding for ethofumesate.
4. Tolerance Reassessment Summary
A tolerance summary for ethofumesate is presented in Table 5. A full description of the tolerance
reassessment can be found in the Residue Chemistry Chapter for ethofumesate dated September 9,
2004. In this assessment, tolerances for residues are currently expressed in terms of the combined
residues of the herbicide ethofumesate (2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate) and its metabolites 2-hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl
methanesulfonate (NC 8493) and 2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate
(NC 9607), both calculated as parent compound.
Table 5. Tolerance Reassessment Summary for Ethofumesate
/CQmHiQd%
/
/Current
'*' Tolerfnee
{ppmj;
Reasiesscjl
. ToMpnee**
(pppi)
/Comment
/
Tolerances Listed Under 40 CFR §180.345(a)(l)
Beet, sugar, roots
Beet, sugar, tops
Grass, straw
Cattle, fat
Cattle, meat
Cattle, meat byproducts
Goat, fat
Goat, meat
Goat, meat byproducts
Hog, fat
Hog, meat
Hog, meat byproducts
0.1
1
1
0.05
0.05
0.05
0.3
4
TBD"
TBD"
TBD"
Revoke
Residue data indicate that the tolerances should be increased.
With respect to residues in tissues, the existing cattle feeding
study needs to be upgraded as residues of a major animal
metabolite (NC 20645) were not determined. A new cattle
feeding study is required as confirmatory data..
There are no active regulated swine feed items associated
ethofumesate uses; therefore, tolerances for hog commodities
should be revoked.
17
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Commodity
,•••
Horse, fat
Horse, meat
Horse, meat byproducts
Sheep, fat
Sheep, meat
Sheep, meat byproducts
Gunenl .
Ttfleranse/
' JBpml;
0.05
0.05
Reapiessejl .
Tj&Brgns?* .
' (PiPtt) •'
TBD1
TBD"
Comment
See note above under cattle.
See note above under cattle
See note above under cattle
See note above under cattle
Tolerances to be Proposed under 40 CFR §180.345(aXl)
Beet, garden, roots
Beet, garden, tops
Beet, sugar, refined sugar
None
None
None
0.5
5.0
0.2
Tolerances to be Proposed under 40 CFR §180.345(a)(2)
Sugar beet molasses
0.5
0.5
Based on HAFT residues of 0.25 ppm and the 1 .9x processing
factor, maximum expected residues are 0.48
Tolerances to be Proposed under 40 CFR §180.345(c)
Carrot, root
None
7.0
Residue data support a regional registration restricted to WA
State
a TBD = To be determined. Although additional data are required to confirm the existing tolerances in or on the following
commodities, the Agency has no dietary or drinking water concerns associated with these tolerances and considers them
reassessed: grass straw, cattle, goat, horse and sheep commodities.
D. Regulatory Rationale
The Agency has determined that ethofumesate is eligible for reregistration provided that
additional data that the Agency intends to require confirm this decision, the risk mitigation measures
outlined in this document are adopted, and label amendments are made to reflect these measures.
The following is a summary of the rationale for managing risks associated with the use of
ethofumesate. Where labeling revisions are warranted, specific language is set forth in the summary
tables of Section V of this document. Due to risk exceedences for scenarios such as mixing/loading
liquids for aerial applications, ethofumesate labels must be amended to prohibit aerial applications at
the highest application rate of 3.75 Ib ai/acre. Additionally, engineering controls are being required for
custom (commercial) mixing of ethofumesate onto dry bulk fertilizer. Although there are risk
exceedences for residential dermal exposure to turf, the Agency believes that these apparent
exceedences are driven by very conservative risk assumptions such as 100% dermal absorption of
ethofumesate. The Agency intends to issue a data call in to require the registrant to submit a dermal
absorption (or penetration) study to confirm that this assumption is conservative. There are also
18
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calculated reentry intervals which are quite lengthy for high exposure postapplication activities for the
agricultural uses of ethofumesate. The Agency believes that there are no high exposure activities for
ethofumesate which is primarily applied pre-emergence. Therefore, these longer restricted re-entry
intervals are not necessary for agricultural uses of ethofumesate. For use on turf, reentry intervals of 9
days are required for maintenance activities and a pre-harvest interval of 16 days is required for sod
harvesting.
1. Human Health Risk Management
a. Aggregate Risk Summary
As discussed in Chapter 3, aggregate risk refers to the combined risk from food, drinking water, and
residential exposures. In addition, aggregate risk can result from one-time (acute), short-term and/or
chronic exposures. Below is a discussion of the aggregate risk for each duration of exposure and
EPA's decision and rationale for addressing any risks of concern.
1) Acute Aggregate Risk
An analysis was performed for food and drinking water exposure for females 13-49 years of age
since this is the only population subgroup for which a relevant toxicological endpoint has been
identified. The acute dietary (food and drinking water) for females 13-49 years of age occupies 4% of
the aPAD at the 95th percentile. The contribution of food and food forms to this estimate, at the 95th
percentile, is 2.1%. A risk estimate that is less than 100% of the acute Population Adjusted Dose
(aPAD), the dose at which an individual could be exposed on any given day with no adverse health
effects, does not exceed the Agency's level of concern. Therefore, EPA has no acute food and drinking
water aggregate concerns.
2) Short and Intermediate-term Aggregate Risk
Aggregate assessments of food, drinking water, and residential exposure were considered only
for the short- and intermediate-term exposure scenarios because use patterns do not suggest a long-
term residential exposure to ethofumesate. For all population subgroups assessed, except females 13-
49 years of age, the aggregate MOEs (food + drinking water + residential) ranged from 159 to 180,
which are all higher than the target MOE of 100.
Dietary risks (food and drinking water) for females 13-49 years of age were also well below the
Agency's level of concern. While the high-end exposure residential postapplication scenarios resulted
in apparent risks of concern (see Table 3) for females 13-49 years of age, the Agency believes that
these scenarios are very conservative and unlikely to occur for reasons detailed in the residential
19
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postapplication exposure and risk section (section ni.A.2.b). Thus, the Agency concludes that
aggregate short-term/intermediate risks to females 13-49 years of age do not present a risk concern.
3) Long-term Aggregate Risk
Chronic exposure resulting from food and drinking water was estimated to be <1% of the cPAD
for all subpopulations including females 13 to 49 years of age; this value is below the Agency's level
of concern. Long term residential exposures are not expected from ethofumesate use; therefore, there
were no chronic aggregate concerns.
b. Aggregate Risk Mitigation
The Agency does not consider additional mitigation necessary at this time.
c. Occupational Risk Mitigation
1) Handler Risk Mitigation
Handlers may be exposed to ethofumesate while mixing, loading or applying ethofumesate
pesticides. For evaluations of short and intermediate term exposure to ethofumesate, most of the
handler scenarios had MOEs greater than 100 with long pants and long-sleeved shirt, socks and shoes
and chemical resistant gloves, which is consistent with the current ethofumesate labels. Therefore, the
Agency will require that chemical resistant gloves be maintained as a PPE requirement for all
handlers.
Two scenarios require mitigation:
One scenario of mixing and loading for aerial applications at 3.75 Ib ai/A to sugar beets resulted
in an MOE of 57 which is of potential concern. During the phase 3 public comment period, the
registrant commented that the 3.75 Ib ai/A rate for sugar beets was for pre-emergence use and required
a large volume of water for complete coverage. It is not practical to make this pre-emergence
application with aerial equipment. Therefore the label will be clarified to prohibit aerial applications at
the rate of 3.75 Ib ai/A.
The second scenario of mixing ethofumesate with fertilizer for custom applicators (commercial)
requires engineering controls to achieve MOEs > 100. While grower applications (on-farm) require
only the addition of chemical resistant gloves to achieve MOEs > 100, custom applicators can mix
larger amounts and therefore, need additional protection of closed systems to achieve MOEs > 100.
Engineering controls will be required on ethofumesate labels which allow application to fertilizers.
2) Post-application Risk Mitigation
Workers may be exposed to ethofumesate upon entering areas which have been previously
treated with ethofumesate to perform specific work activities in these areas (e.g., scouting, weeding,
20
-------
irrigating). There are no risk concerns for re-entry workers performing low exposure activities. There
were apparent risk concerns when considering medium and high exposure activities such as
transplanting, harvesting and thinning for the existing food and feed crops (sugar beets, carrots, etc.).
However, these high exposures are not likely to occur following use of a pre-plant, pre-emergence
herbicide. Also, the conservative assumptions used in the risk assessment significantly affected
exposure predictions for medium and high exposure activities. Conservative, screening level
procedures were followed, including assumption of 100% dermal absorption. No mitigation is
necessary to protect re-entry workers for food and feed crops. The dermal absorption study which the
Agency intends to require to refine the residential risks will be used to confirm this risk management
decision.
Most of the ethofumesate labels do not specify a re-entry interval. For agricultural non-turf
uses, a 12-hour re-entry interval will be added to all labels for products for use within the scope of the
Worker Protection Standard for Agricultural Pesticides (WPS), based on the acute toxicity of the
active ingredient
The required dermal absorption study will also allow refinement of predicted re-entry risks for
turf. However, in the interim, risk mitigation measures for golf course and sod farm turf include a
reentry interval of 9 days for maintenance activities and a pre-harvest interval of 16 days. An
acceptable dermal absorption study may enable EPA to alter these label requirement measures.
2. Environmental Risk Mitigation
No mitigation for environmental risks is being required for reregistration of ethofumesate. The
screening level ecological risk assessment resulted in slight endangered species risks for freshwater
fish when ethofumesate was assessed with maximum application rates.
The main risks from ethofumesate are for terrestrial plants. There are advantages to
ethofumesate use and, as an herbicide, plant risks are expected. Spray drift was a large contributor to
potential exposures of ethofumesate to aquatic resources, terrestrial animals and plants. Reducing
spray drift will lower, but not eliminate, risks to non-target plants. However, the label clarification to
prohibit aerial applications at the 3.75 Ib ai/A rate will reduce assessed risks to non-target organisms.
a. Endangered Species Considerations
Endangered Species Assessment
The Agency's screening level ecological assessment for ethofumesate resulted in a determination
that use of ethofumesate will have no direct acute or chronic effects on threatened and endangered
avian, mammalian, aquatic invertebrate, estuarine fish species. Additionally, a determination of no
direct chronic effects can be made for threatened and endangered freshwater fish. The screening level
risk assessment for endangered species indicates that ethofumesate RQs exceed the endangered species
LOCs for the following combinations of analyzed uses and species:
21
-------
• freshwater fish (direct acute effects) based on predicted EECs for runoff from terrestrial use of
ethofumesate on sugar beets, turf, and vegetables
terrestrial plants (direct effects) based on predicted EEC for the terrestrial use of ethofumesate
on sugar beets, turf, and vegetables for both monocots and dicots.
Refinement and comparative analysis suggest that risks to endangered freshwater fish can be
expected to be mitigated through either spray drift controls or rate reduction, while potential direct
risks to terrestrial plants could be mitigated through rate reductions. However, the refinement and
comparative analysis also indicates that the effect of mitigation on effects to non-target terrestrial
plants through spray drift controls is not likely to be effective at completely eliminating the potential
risk. Indirect effects to listed species dependant upon plants which may be affected from the use of
ethofumesate, will need to be further assessed when the Agency conducts a species specific analysis.
The Agency has developed the Endangered Species Protection Program to identify pesticides
whose use may cause adverse impacts on endangered and threatened species, and to implement
mitigation measures that address these impacts. The Endangered Species Act (ESA) requires federal
agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify
designated critical habitat. To analyze the potential of registered pesticide uses that may affect any
particular species, EPA uses basic toxicity and exposure data developed for the REDs and considers it
in relation to individual species and their locations by evaluating important ecological parameters,
pesticide use information, geographic relationship between specific pesticide uses and species
locations, and biological requirements and behavioral aspects of the particular species, as part of a
refined species-specific analysis. When conducted, this species-specific analysis will take into
consideration any regulatory changes recommended in this RED that are being implemented at that
time.
Following this future species-specific analysis, a determination that there is a likelihood of
potential impact to a listed species or its critical habitat may result in limitations on the use of
ethofumesate, other measures to mitigate any potential impact, or consultations with the Fish and
Wildlife Service or the National Marine Fisheries Service as necessary. If the Agency determines use
of ethofumesate "may affect" listed species or their designated critical habitat, EPA will employ the
provisions in the Services regulations (50 CFR Part 402). Until that species specific analysis is
completed, the risk mitigation measures being implemented through this RED will reduce the
likelihood that endangered and threatened species may be exposed to ethofumesate at levels of
concern. EPA is not requiring specific ethofumesate label language at the present time relative to
threatened and endangered species. If, in the future, specific measures are necessary for the protection
of listed species, the Agency will implement them through the Endangered Species Protection
Program.
b. Spray Drift Management
22
-------
The Agency has been working closely with stakeholders to develop improved approaches for
mitigating risks to human health and the environment from pesticide spray and dust drift. As part of
the reregistration process, we will continue to work with all interested parties on this important issue.
Prohibiting aerial applications at the highest rate for sugar beets will result in lower exposures
from drift. From its assessment of ethofumesate, as summarized in this document, the Agency
concludes that no additional drift mitigation measures are needed for ethofumesate. In the future,
ethofumesate product labels may need to be revised to include additional or different drift label
statements.
V. What Registrants Need to Do
The Agency has determined that ethofumesate is eligible for reregistration provided that
additional data are submitted to confirm this decision. In the near future, the Agency intends to issue
Data Call-In Notices (DCIs) requiring product specific data and generic (technical grade) data.
Generally, registrants will have 90 days from receipt of a DCI to complete and submit response forms
or request time extension and/or waiver requests with a full written justification. For product specific
data, the registrant will have 8 months to submit data and amended labels. For generic data, due dates
can vary depending on the specific studies being required. Below are tables of additional generic data
that the Agency intends to require for ethofumesate.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of ethofumesate for the above eligible uses
has been reviewed and determined to be substantially complete. However, the data listed in Table 6
below are necessary to confirm the reregistration eligibility decision documented in this RED.
23
-------
Table 6. Data Requirements for the Reregistration Eligibility Decision on Ethofumesate
Guideline Study Name
28-day Inhalation Toxicity
Dermal Penetration Study
Aerobic Aquatic Metabolism
Accumulation - aquatic, non-target (Reserved)
Ground Water - small prospective (Reserved)
Residue Analytical Method (Animal Commodities)
Multiresidue Method (Recovery data for the ethofumesate metabolites)
Storage Stability Data (Animal Commodities)
Magnitude of the Residue (Meat, Milk, Poultry, Eggs)
Crop Field Trials (Grass, straw)
Field Accumulation in Rotational Crops
New OPPTS
Guideline No.
840.3465
870.76
835.43
850.195
835.195
860.134
860.136
860.138
860.148
860.15
860.19
Old
Guideline
No.
82-4
85-3
162-4
165-5
835.71
171-4c
171-4d
171-4m
171-4e
171-4J
1714k
165-2
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. For
agricultural non-turf uses a 12-hour re-entry interval will be added to all labels for products for use
within scope of the Worker Protection Standard for Agricultural Pesticides (WPS) based on the acute
toxicity of the active ingredient. For turf labels a reentry interval of 9 days for maintenance activities
and a pre-harvest interval of 16 days will be required. An acceptable dermal absorption study may
enable EPA to refine the postapplication risk estimates for turf and could potentially result in altering
the existing risk mitigation label requirement measures proposed in this RED.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. The Registrant must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit
to conduct new studies. If a registrant believes that previously submitted data meet current testing
standards, then the study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product. The Agency intends
to issue a separate product-specific data call-in (PDCI), outlining specific data requirements.
24
-------
2. Labeling for End-Use Products
In order to be eligible for reregistration, amend all product labels to incorporate the risk
mitigation measures outlined in the Risk Mitigation Summary section. Table 7 describes how
language on the labels should be amended.
VL Conclusions
The Agency is issuing this Reregistration Eligibility Decision (RED) document for
ethofumesate, as announced in a Notice of Availability published in the Federal Register. This
RED document includes guidance and time frames for complying with any required label changes for
products containing ethofumesate. The Agency has determined that all currently registered uses of
ethofumesate are eligible for reregistration provided all required mitigation is put on the label and all
required studies are submitted.
The risk assessments for ethofumesate are based on the best scientific data currently available to
the Agency and are adequate for regulatory decision making.
25
-------
Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The
following table describes how language on the labels should be amended.
Table 7: Summary of Labeling Changes for Ethofumesate
Pllpsme-nt on LiW
For all Manufacturing
Use Products
"Only for formulation into herbicides" [for use fill blank only with those uses
that are being supported by MP registrant]."
Directions for Use
One of these statements
may be added to a label
to allow reformulation
of the product for a
specific use or all
additional uses
supported by a
formulator or user group
"This product may be used to formulate products for specific use(s)
not listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support
of suchuse(s)."
"This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required by
the RED and Agency
Label Policies
"This pesticide is toxic to fish and aquatic invertebrates. Do not
discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in
writing prior to discharge. Do not discharge effluent containing this
product to sewer systems without previously notifying the local
sewage treatment plant authority. For guidance contact your State
Water Board or Regional Office of the EPA. Do not contaminate
water when disposing of equipment washwaters."
Precautionary Statements
26
-------
ikid Use
;In
tende4''ff
'/ /> /
Front Panel Statement
for Granular and
Liquid
"For sale and use by professional applicators only. Not for sale or use
by homeowners/consumers."
Insert in a prominent position
associated with the brand name on the
front panel of the pesticide label.
PPE Requirements
Established by the RED1
for Liquid and Granular
Formulations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant
inserts correct chemical-resistant material). "If you want more options,
follow the instructions for category" [registrant inserts A,B, C,D,E,F, G, or H\
"on an EPA chemical-resistance category selection chart."
"All mixers, loaders, applications and other handlers must wear"
Long sleeved shirt, long pants, shoes and socks, and chemical resistant
gloves (except flaggers, or applicators in cockpits, and enclosed cabs)
"See engineering controls for additional requirements."
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
27
-------
Engineering Controls:
On-Site Closed Mixing
and Loading System for
Liquid Formulations
On-Site Closed Mixing and Loading System Engineering Controls for
Liquid Formulations
(Dermal Protection Only):
"Mixers and loaders must use a closed system that meets the
requirements listed in the Worker Protection Standard (WPS) for
agricultural pesticides [40 CFR 170.240(d)(4)] for dermal protection,
and must:
- wear the personal protective equipment required in the PPE section
of this labeling for mixers and loaders (this must consist of long-sleeve
shirt, long pants, shoes, socks, chemical-resistant gloves, and
chemical-resistant apron, or be listed here),
— wear protective eyewear, if the system operates under pressure, and
- be provided and must have immediately available for use in an
emergency, such as a broken package, spill, or equipment breakdown:
chemical-resistant footwear, and (insert the appropriate type of
respirator, if there are inhalation concerns)."
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
Engineering Controls:
Enclosed Cabs for
Aerial Applicators
"Pilots must use an enclosed cockpit that meets the requirements
listed in the Worker Protection Standard (WPS) for agricultural
pesticides [40 CFR 170.240(d)(6)]. "
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions for washables exist, use detergent and hot water.
Keep and wash PPE separately from other laundry."
Precautionary Statements: Hazards to
Humans and Domestic Animals
immediately following the PPE
requirements
28
-------
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing.
Users should remove PPE immediately after handling this product. Wash the
outside of gloves before removing*. As soon as possible, wash thoroughly
and change into clean clothing."
Precautionary Statements under: Hazards
to Humans and Domestic Animals
immediately following Engineering
Controls
(Must be placed in a box.)
Environmental Hazards
This pesticide may be toxic to fish. Do not apply directly to water, to
areas where surface water is present, or to intertidal areas below the
mean high water mark. Drift and runoff may be hazardous to aquatic
organisms in water adjacent to treated areas. Do not contaminate
water when disposing of equipment wash waters or rinsate.
Precautionary Statements immediately
following the User Safety
Recommendations
Restricted-Entry Interval
for products with
directions for use within
scope of the Worker
Protection Standard for
Agricultural Pesticides
(WPS)
"Do not enter or allow worker entry into treated areas during the restricted
entry interval (REI) of 12 hours for all crops, except turf grown for sod. The
REI for turf is 9 days. The REI for each crop is listed in the directions for use
associated with each crop."
Directions for Use, Under Agricultural Use
Requirements Box
Early Entry Personal
Protective Equipment
for products with
directions for use
within the scope of the
WPS
For minimum early entry PPE use the following:
"PPE required for early entry to treated areas that is permitted under the
Worker Protection Standard and that involves contact with anything that has
been treated, such as plants, soil, or water, is:
* coveralls,
* shoes plus socks
* chemical-resistant gloves made of any waterproof material"
Direction for Use
Agricultural Use Requirements box
29
-------
WPS Double
Notification Statement
"Notify workers of the application by warning them orally and by posting
warning signs at entrances to treated area."
Direction for Use
Agricultural Use Requirements box
Entry Restrictions for
products
Entry Restriction for non-WPS uses applied as a spray:
"Do not enter or allow others to enter until sprays have dried."
Professional pesticide applicators applying to residential turf,
including home lawns, parks, and recreation areas must inform their
customers that all persons and pets must be kept off the treated turf
until sprays have dried.
Entry Restriction for non-WPS uses applied dry:
"Do not enter or allow others to enter the treated area (except those
involved in the watering) until the recommended watering-in is
complete and the surface is dry."
"Professional pesticide applicators applying to residential turf,
including home lawns, parks, and recreation areas must inform their
customers that all persons (except those involved in the watering) and
pests must be kept off the treated turf until the recommended
watering-in is complete and the surface is dry."
If no WPS uses on the product label,
place the appropriate statement in the
Directions for Use Under General
Precautions and Restrictions. If the
product also contains WPS uses, then
create a Non-Agricultural Use
Requirements box as directed in PR
Notice 93-7 and place the appropriate
statement inside that box.
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may be in
the area during application."
Place in the Direction for Use directly
above the Agricultural Use Box.
30
-------
Other Application
Restrictions for labels
with directions for use
on sugar beets.
NOTE: The labels also must
list the maximum application
rates in pounds or gallons of
formulation
Sugar Beets:
"Do not apply more than 1.5 Ib ai/acre with aircraft."
Directions for Use
Other Application
Restrictions for labels
with directions for use
on sod farm turf
NOTE: The labels also must
list the maximum application
rates in pounds or gallons of
formulation
Sod Farm Turf:
"Do not harvest treated sod for 16 days following application."
Directions for Use
Spray drift language
for products applied as
spray
"SPRAY DRIFT MANAGEMENT"
This chemical can contaminate surface water through spray drift.
A variety of factors including weather conditions (e.g., wind direction,
wind speed, temperature, relative humidity) and method of application
(e.g., ground, aerial) can influence pesticide drift. The applicator must
evaluate all factors and make appropriate adjustments when applying
this product
Wind Speed
" Do not apply at wind speeds greater than 15 mph."
Temperature Inversions
"Do not make applications into areas of temperature inversion or
stable atmospheric conditions."
Directions for Use
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be placed
in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
-------
Appendix A: Use Patterns Eligible for Reregistration
Site
Garden Beets
Carrots
Ornamental Lawn and Turf -
Professional Use Only
(Golf course use, residential lawns,
and sod farms)
Sugar Beets
Formulations
Flowable
Concentrate, and
Emulsifiable
Concentrate
Flowable
Concentrate, and
Emulsifiable
Concentrate
Flowable
Concentrate
Emulsifiable
Concentrate, and
Granular
Emulsifiable
Concentrate
Flowable
Concentrate, and
Emulsifiable
Concentrate
Maximum
Single
Application
Rate
(Ib ai/acre)
1.9
preemergent
0.33
postemergent
2 0
preemergent/
postemergent
1.5
preemergent
/early
postemergent
3 0
1.5
postemergent
3.75
preemergent
and preplant
Maximum
Seasonal
Rate
0b ai/acre)
2.6
4.0
1.5
3 0
3.75
Preharvest
Interval (Days)
Ms
NS
16
prohibition for
harvesting of
sod
16
prohibition for
harvesting of
sod
NS
Reentry Interval
(Days)
Ms
NS
9
9
NS
Use Limitations
See label changes summary
table in ethofumesate RED.
Bermudagrass suppression
on St. Augustine sod farms
See label changes summary
table in ethofumesate RED.
32
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Appendix B: Data Supporting Guideline Requirements for the Reregistration of
Ethofumesate
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1620
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.7000
830.7050
Old
Guideline
Number
61-1
61-2
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-13
63-12
None
Product Identity and Composition
Description of materials used to
produce the product
Begin. Mat. & Mnfg. Process
Discussion of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Stability to normal and elevated
temperatures, metals, and metal
ions
PH
UV/Visable Absorption
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41997202, 41752101,
42956601,42956602,45884801
41752101
41752101
41997202, 41752101, 42956602, 45884801
41997202, 42956602, 45884801
41997202, 42956602, 49884801
41997202, 42956602, 45884801
41997203
41997203
41997203
41997203, 43066801
41752102
Data Gap
33
-------
Appendix B: Data Supporting Guideline Requirements for the Reregistration of
Ethofumesate
REQUIREMENT
830.7200
830.7220
830.7300
830.7370
830.7550
830.7840
830.7950
850.2100
850.2200
850.2300
850.1075
850.1010
850.1075
850.1025
850.1035
850.1045
63-5
63-6
63-7
63-10
63-11
63-8
63-9
Melting Point
Boiling Point
Density
Dissociation Constants in Water
Octanol/Water Partition
Coefficient
Solubility
Vapor Pressure
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
41752102
N/Aa
41752102
N/Ab, 41752102
41752102
41752102
41752102
ECOLOGICAL EFFECTS
71-1
71-2
71-4
72-1
72-2
72-3A
72-3B
72-3C
Avian Acute Oral LD50
Avian Dietary Toxicity LC50
Avian Reproduction
Freshwater Fish LC50
Freshwater Invertebrate Acute
^C50
Estuarine/Marine Fish LC50
Estuarine/Marine Toxicity -
Mollusk EC50
Estuarine/Marine Toxicity -
Shrimp EC50
ALL
ABCDEJK
ABCDEJK
ABCDEJK
ALL
A-K
A-K
A-K
00115064
ACC127694, ACC225319
45818111, 45855503
41970701, ACC232429, 40098001, 42015501,
46546301
ACC232429, ACC231232
42409301
42388101
42364502
34
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Appendix B: Data Supporting Guideline Requirements for the Reregistration of
Ethofumesate
REQUIREMENT
850.14
850.1300
850.1350
850.1500
850.4100
850.4150
850.4400
850.4225
850.4250
850.4400
850.3020
72-4A
72-4B
72-5
122-1A
122-1B
122-2
123-1A
123-1B
123-2B
141-1
Fish- Early Life Stage - Daphnid
Estuarine/Marine Invertebrate
Life Cycle
Freshwater Full Life Cycle Fish
Seed germ/seedling emergence
Vegetative vigor
Aquatic Plant Growth
Seed germ/seedleing emergence
Vegetative vigor
Aquatic Plant Growth, Tier 2
Honey Bee Acute Contact
USE PATTERN
A-K
A-K
A-K
A-K
A-K
A-K
A-K
A-K
A-K
A-K
CITATION(S)
42008901
42871901
Data Gap
Data Gap
Data Gap
46450701
45874702
45874701
41687601
41970703
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41214215, 00030418
00030419
41554101
41949204, 00030421
41949205, 00030421
41404601
44156201, 44093601
35
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Appendix B: Data Supporting Guideline Requirements for the Reregistration of
Ethofumesate
REQUIREMENT
870.3150
870.3200
870.3465
870.3700A
870.3700B
870.3800
870.4100A
870.4100B
870.4200
870.4200
870.4300
870.5100
870.5300
870.5375
870.5395
82-1B
82-2
82-4
83-3A
83-3B
83-4
83-1A
83-1B
83-2A
83-2B
83-5
84-2
84-2
84-2B
84-2B
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
90-Day Inhalation-Rat
Developmental Toxicity- Rat
Developmental Toxicity- Rabbit
2-Generation Reproduction - Rat
Chronic Feeding Toxicity -
Rodent
Chronic Feeding Toxicity - Non-
Rodent
Carcinogenicity Rat
Carcinogenicity - Mouse
Combined Chronic Toxicity/
Carcinogenicity- Rat
Gene Mutation (bacterial reverse
gene mutation)
Gene Mutation (mammalian
forward gene mutation in vitro)
Structural Chromosomal
Aberration
Mammalian bone marrow
micronucleus assay
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
00062822
42689902, 41997204
Data Gap
42067701, 42689901
00156606, 40263701, 41652501
00062823
44093602
00062822
44093603, 44093604
44156202
44093601, 44093602, 44093603, 44093604,
00041853
43529501
41710501
41214203
41214217
36
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Appendix B: Data Supporting Guideline Requirements for the Reregistration of
Ethofumesate
REQUIREMENT
870.5550
870.7485
84-2
85-1
Bacterial DNA Damage or Repair
General Metabolism
USE PATTERN
ALL
ALL
CITATION(S)
41214204
42689903, 42364503
ENVIRONMENTAL FATE
835.1240
835.2120
835.2240
835.2410
835.4100
835.4200
835.4300
835.6100
835.1730
840.1100
840.1200
860.1950
850.1950
163-1
161-1
161-2
161-3
162-1
162-2
162-4
164-1
166-1
201-1
202-1
165-4
165-5
Leaching/Adsorption/Desorption
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Aerobic Aquatic Metabolism
Terrestrial/Aquatic Field
Dissipation
Ground Water- small prospective
Droplet Size Spectrum
Drift Field Evaluation
Bioaccumalation in fish
Accumulation-aquatic nontarget
A-K
A-K
A-G
ABC
A-K
ABC
DEFGJ
ABCDEFI
A-K
A-K
A-K
A-G
A-K
41212212, 42438001
00115080
42200901, 42364501, 46157901
41214205
42413001
42413002
Data Gap"
419972056
Reserved
N/Af
N/Af
41970704
Reserved
RESIDUE CHEMISTRY
860.1100
171-2
Chemical Identity
ALL
41752101
37
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Appendix B: Data Supporting Guideline Requirements for the Reregistration of
Ethofumesate
REQUIREMENT
860.1300
860.1300
860.1340
860.1340
860.1360
860.1380
860.1380
860.1480
860.1500
860.1500
860.1500
860.1520
171-4A
171-4B
171-4C
171-4D
171-4M
171-4E
171-4F
171-4J
171-4K
171-4K
171-4K
171-4L
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method -
Plants
Residue Analytical Method-
Animals
Multiresidue Method
Storage Stability Data-Plants
Storage Stability Data- Animals
Magnitude of Residues -
Meat/Milk/Poultry /Egg
Crop Field Trials
(Beet, garden, root)
Crop Field Trials
(Beet, sugar, root)
Crop Field Trials
(Grass, Forage, Fodder, and Hay)
Processed Food/Feed (Beet, sugar,
molasses)
USE PATTERN
ABDHKL
ABDHK
ABDEHKL
ABDEHL
ALL
ABDE
ABDE
ABDHL
ABDHK
ABDHK
ABDHK
ABDHL
CITATION(S)
42495901,42495902
42364504,42364505
00036363, 41214206,
45818104, 45874703
41214209, 45818102,
4581101, 45818103,
45874703
41997206
00039810, 00115057,
45818108, 45818109,
45818105, 45818106,
45818110
Data Gap
Data Gap8, 41214208, 43458701
45892001
00036365, 00036366,
00041856, 00048415,
41214242, 43697201
41214214, 41214218,
41214221, 41214222,
43298103
00037839, 00041855,
41214228, 41214241,
41214219, 41214220,
41214223, 41214224,
45855501
38
-------
Appendix B: Data Supporting Guideline Requirements for the Reregistration of
Ethofumesate
REQUIREMENT
860.1850
860.1900
165-1
165-2
Confined Accumulation in
Rotational Crops
Field Accumulation in Rotational
Crops
USE PATTERN
ABCD
ABCD
CITATION(S)
42817201
4398104, 45855502
N/A not applicable.
a Data are not required because the TGAI is a solid at room temperature.
b Data are not required because of the low solubility of the PAI in water.
c No data requirements are specified.
d An aerobic aquatic study was classified as supplemental. Additional data is needed to upgrade this study to acceptable.
e A terrestrial field dissipation study was classified as supplemental. Additional data is needed to upgrade this study to acceptable.
f Satisfied through the Spray-Drift Task Force data.
g A new feeding study is required unless the registrant can upgrade the current cattle feeding study.
39
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Appendix C. Citations Considered to be Part of the Database Supporting the
Reregistration Eligibility Decision (Bibliography)
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregistration Eligibility Document. Primary sources for studies in this bibliography
have been the body of data submitted to EPA and its predecessor agencies in support of past
regulatory decisions. Selections from other sources including the published literature, in
those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or "MRTD" number. This number is unique to the citation, and
should be used whenever a specific reference is required. It is not related to the six-digit
"Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRTD entries. This temporary identifying number is also to
be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute (ANSI),
expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no author
or laboratory could be identified, the Agency has shown the first submitter as the
author.
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the bibliographer has deduced the date from
the evidence contained in the document. When the date appears as (1999), the
Agency was unable to determine or estimate the date of the document.
40
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c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted
to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit accession
number follows the symbol "CDL," which stands for "Company Data
Library." This accession number is in turn followed by an alphabetic suffix
which shows the relative position of the study within the volume.
41
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BIBLIOGRAPHY
MRID
ACC127694
CITATION
Fisons Corp. (1974) Summary of the Toxicity to Wild-life of Technical NC
8438. Summary of studies 127694-B through 127694-F. (Unpublished study
received Apr 12, 1974 under 10065-EX-4; CDL:127694-A)
ACC225319
ACC231232
Noakes, D. (1973) Acute Toxicity of Formulated NC 8438 to the Japanese
Quail: Tox/73/136-35. (Unpublished study received Jan 29, 1976 under
10065-5; prepared by Fisons Ltd., Eng., submitted by Fisons Corp.,
Agricultural Chemicals Div., Bedford, MA; CDL: 225319-C)
Drake, C.H. (1976) The Acute Toxicity of Technical NC 8438 (Etho-
fumesate) to~Daphnia magna-: BIOSC/76/E/14. (Unpublished study
received Aug 12, 1977 under 10065-6; prepared by Fisons, Ltd., England,
submitted by Fisons Corp., Agricultural Chemicals Div., Bedford, Mass.;
CDL:231232-A)
ACC232429
Vilkas, A. (1977) The Acute Toxicity of NC 8438 to the Bluegill Sunfish,
Lepomis macrochirus Rafmesque: UCES Proj. # 11506-49- 03.
(Unpublished study received Dec 6, 1977 under 40546-4; prepared by Union
Carbide Corp., submitted by Fisons, Inc., Bedford, MA; CDL:232429-A)
00030418
Ben-Dyke, R. (1973) The Acute Toxicity of NC 8438: Tox/73/136-31.
(Unpublished study received Mar 26, 1980 under 40546-4; prepared by
Fisons, Ltd., submitted by Fisons, Inc., Bedford, Mass.; CDL: 242165-B)
00030419
00030420
Cuthbert, J.A. (1979) Ethofumesate Technical CR 4805/4: Acute Dermal
Toxicity Study in Rabbits: Report No. 1242. (Unpublished study received
Mar 26, 1980 under 40546-4; prepared by Inveresk Research International,
submitted by Fisons, Inc., Bedford, Mass.; CDL:242165-C)
Cuthbert, J.A. (1978) Technical Ethofumesate: Primary Skin Irritancy Study
on Rabbits; Fisons Ltd., Agricultural Chemical Division, Chesterford Park
Research Station, Saffron Wai den, Essex, England; Report No. 1161
prepared by Inveresk Research International, Edinburgh, Scotland; Report
dated September, 1978. Unpublished study.
00030421
Kemp, A.; Wall, I. (1976) The Effects of the Application of Ethofumesate
(Technical Quality) to the Rabbit Eye and Associated Structures: Report No.
Tox/76/136-64. (Unpublished study received Mar 26, 1980 under 40546-4;
prepared by Fisons, Ltd, sub- mitted by Fisons, Inc., Bedford, Mass.;
CDL:242165-E)
00036363
Whiteoak, R.J.; Crofts, M.; Harris, R.J. (1973) Analytical Method for
Residues in Sugarbeet Treated with Nortron (3rd revision): Report No.
RESID/73/18/1. Method dated Dec 1973. (pp. 8-14 only; unpublished study
received on unknown date under 4G1495; prepared by Fisons, Ltd.,
submitted by Fisons Corp., Agricultural Chemicals Div., Bedford, Mass.;
CDL:093971-Q)
42
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00036365
00036366
00037839
00039810
00041853
Whiteoak, R.J.; Crofts, M. (1973) Residue Decline Studies in Colorado
(USA) with Sugarbeet Treated Pre-emergence with Nortron in 1972: Report
No. RESID/73/79. (Unpublished study received on unknown date under
4G1495; prepared by Fisons, Ltd., submitted by Fisons Corp., Agricultural
Chemicals Div., Bedford, Mass.; CDL:093971-S)
Crofts, M.; Whiteoak, R.J.; Hamilton, K.C.; et al. (1974) Nortron Residue in
Harvest Sugarbeet from Nine Regions of the USA in 1972: Report No.
RESID/74/7. Summary of studies 093971-S and 093971-T. (Unpublished
study received on unknown date under 4G1495; prepared in cooperation with
Fisons, Ltd. and others, submitted by Fisons Corp., Agricultural Chemicals
Div., Bedford, Mass.; CDL:093917-U)
Whiteoak, R.J.; Crofts, M.; Meggitt, W.F. (1974) Residue Data De- cline
Studies in Michigan (USA) with Sugarbeet Treated Pre- emergence with
Nortron in 1972: Report No. RESID/74/1. (Unpub- lished study received on
unknown date under 4G1495; prepared by Fisons, Ltd. in cooperation with
Michigan State Univ., Dept. of Crop and Soil Sciences, submitted by Fisons
Corp., Agricultural Chemicals Div., Bedford, Mass.; CDL:093971-T)
Whiteoak, RJ. (1975) Stability of Residues during Storage of Crop and Soil
Samples from Trials with Nortron: RESID/75/40. Summary of study
095900-K. (Unpublished study received Jan 29, 1976 under 6F1735;
prepared by Fisons, Ltd., submitted by Fisons Corp., Agricultural Chemicals
Div., Bedford, Mass.; CDL: 095900-O)
Noakes, D.N.; Roe, F.J.C.; Hounsell, I.A.; et al. (1976) The Ef- fects of the
Dietary Administration of NC 8438 to Male and Fe- male Rats for Two
Years: Report No. Tox/75/136-61. (Unpublished study received Jun 18,
1976 under 6F1735; prepared by Fisons, Ltd., England, submitted by Fison
Corp., Agricultural Chemicals Div., Bedford, Mass.; CDL:096752-B)
00041855
Crofts, M.; Harris, R.J.; Wilkie, P.M. (1976) Comparison of Residues in
Mature Sugar Beet Treated Pre-emergence with Nortron or TCA or a
Tank-Mix of Both Components in the U.S.A. in 1976: Laboratory Report
No. RESID/76/14. (Unpublished study received Jun 18, 1976 under 6F1735;
prepared by Fisons, Ltd., England, submitted by Fisons Corp., Agricultural
Chemicals Div., Bedford, Mass.; CDL:096752-D)
00041856
Crofts, M.; Harris, R.J.; Wilkie, P.M. (1976) Comparison of Resi- dues in
Mature Sugar Beet Treated Pre-emergence with Nortron or Pyramin or a
Tank-Mix of Both Components in the U.S.A. in 1975: Laboratory Report
No. RESID/76/26. (Unpublished study received Jun 18, 1976 under 6F1735;
prepared by Fisons, Ltd., England, submitted by Fisons Corp., Agricultural
Chemicals Div., Bedford, Mass.; CDL:096752-E)
00048415
Crofts, M.; Whiteoak, RJ. (1976) Nortron Residues in Mature Sugar Beet
following Post-emergence Applications as a Tank-Mix with Desmedipham
in the U.S.A. (Unpublished study received on un- known date under
10065-EX-4; prepared by Fisons, Ltd., submitted by Fisons Corp.,
Agricultural Chemicals Div., Bedford, Mass.; CDL:226428-A)
43
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00062822
Chester-man, H.; Heywood, R; Trennery, P.N.; et al. (1980) Technical NC
8438: Toxicity Study in Beagle Dogs: FPL/225-G/79663. Final rept, dietary
intake for 104 weeks. (Unpublished study received Dec 11, 1980 under
40546-5; prepared by Huntingdon Research Centre, England, submitted by
Fisons, Inc., Bedford, Mass.; CDL:243884-A)
00062823
Tesh, J.M., Bartlett, A., Tesh, S.A., Whitney, J.C. and Finn, J.P. (1980)
Technical NC 8438: Multigeneration Study in the Rat, Final Report,
Volumes I and II; Life Science Research, Inc., Stock, Essex, England;
Laboratory Study Nos. TOX/80/136-92, TOX 77003, RESID 79/31,
79/FON005/416; Report dated September 10, 1980. Unpublished study.
00115057
Whiteoak, R. (1975) Stability of Residues during Storage of Crop and Soil
Samples from Trials with Nortron: Resid/75/40. (Unpublished study received
Jan 29, 1976 under 10065-5; prepared by Fisons Ltd., Eng., submitted by
Fisons Corp., Agricultural Chemicals Div., Bedford, MA; CDL:225326-L)
00115064
Ross, D.; Roberts, N; Cameron, D.; et al. (1977) The Acute Oral Toxicity
(LD50) of NC 8438 to the Bobwhite Quail: FPL 245 WL/ 77934;
TOX/77/136-67. (Unpublished study received Dec 6, 1977 under 40546-4;
prepared by Huntingdon Research Centre, Eng., submitted by Fisons, Inc.,
Bedford, MA; CDL:232429-D)
00115080
00156606
40098001
Browne, P.; Reary, J.; Whiteoak, R. (1978) The Hydrolysis of Ethofumesate
under Acidic, Neutral and Basic Conditions: Fisons Report Resid/78/7.
(Unpublished study received May 8, 1979 under 40546-4; prepared by
Fisons Ltd., Eng., submitted by Fisons, Inc., Bedford, MA; CDL:238290-G)
Gunzel, P., Poggel, H.A. and Schuh, W. (1986) SN 49.913 (Ethofumesate) -
Embryotoxicity Including Teratogenicity Study in the Rabbit After Daily
Intragastric Administration From Day 6 to Day 18 of Gestation; Main
Department of Experimental Toxicology, Schering AG, Berlin, Germany;
Laboratory Study/Report Nos. TX 85.055/PF4/86; Report dated January 21,
1986. Unpublished study.
Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Inter- pretation
and Data Base for 410 Chemicals and 66 Species of Freshwater Animals. US
Fish & Wildlife Service, Resource Pub- lication 160. 579 p.
40263701
41214203
Poggel, H. (1987) Ethofumesate: Embryotoxicity Including Teratogenicity
Study in the Rabbit After Daily Intragastric Administration From Day 6 to
Day 18 of Gestation-Amendment 1: This Amendment Provides Negative
Reference Values; Schering Ag, Laboratory Project ID PF 4/86.
Unpublished study.
Allen, J.; Brooker, P.; Birt, D.; et al. (1986) T102-Technical Ethofumesate:
Metaphase Chromosome Analysis of Human Lymphocytes Cultured in vitro:
Proj. ID TOX/86/136-110. Unpublished study prepared by Huntingdon
Research Centre. 18 p.
44
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41214204
41214205
41214206
41214208
41214209
41214212
41214214
41214215
41214217
41214218
41214219
McBride, D.; McGregor, D. (1988) T108: Technical Ethofumesate:
Assessment of Unscheduled DNA Synthesis Using Rat Hepatocyte Cultures:
Proj. No. 736658. Unpublished study prepared by In- veresk Research
International. 104 p.
Brehm, M. (1989) W82 Ethofumesate: The Photodegradation of Ethofu-
mesate (...) on Soil Surfaces: Proj. ID APC 11/89; Study No. 877 216.
Unpublished study prepared by Schering AG. 50 p.
Whiteoak, R.; Crofts, M.; Harris, R. (1978) R93 Nortron (Ethofumesate):
Analytical Method for Residues of Grass Crops Treated with NORTRON:
Proj. ID RESID/78/31. Unpublished study prepared by Schering
Agrochemicals Ltd. 21 p.
Ross, D.; Roberts, N; Harris, R.; et al. (1977) R78 NORTRON (Etho-
fumesate): Residues in Milk and Tissues Following a 28-day Feed- ing Study
with Ethofumesate in Dairy Cows. Unpublished compi- lation prepared with
cooperation of Huntingdon Research Centre and Schering Agrochemicals
Ltd. 61 p.
Harris, R.; Whiteoak, R. (1976) R69 NORTRON (Ethofumesate): Analy-
tical Method for Residues of Ethofumesate and Its Metabolites in Milk &
Cattle Tissues: Proj. ID RESID/76/31. Unpublished study prepared by
Schering Agrochemicals Ltd. 15 p.
Allen, R. (1988) W78 Carbon 14|-ethofumesate: Addendum: Absorption
Desorption in Soil: Proj. No. 194/18. Unpublished study prepared by
Hazleton Laboratories UK Ltd. 71 p.
Bruhl, R. (1984) W29 Ethofumesate: The Adsorption and Desorption of
Ethofumesate in Soil: Proj. ID METAB/84/32. Unpublished study prepared
by Schering Agrochemicals Ltd. 18 p.
Crome, S.; Sanderson, D. (1980) T82 NORTRON (Ethofumesate): The
Acute Oral Toxicity of Technical NC8438 (...) to the Male and Female Rat:
Proj. ID TOX/80/136-89. Unpublished study prepared by Schering
Agrochemicals Ltd. 13 p.
Allen, J.; Proudlock, R; Pugh, L. (1985) T95 Technical Ethofumesate:
Mouse Micronucleus Test: Proj. ID TOX/85/136-103. Unpublished study
prepared by Huntingdon Research Centre. 25 p.
Crofts, M.; Whiteoak, R. (1977) R79 NORTRON (Ethofumesate): Decline
of Residues in Ryegrass Following the Application of Nortron in
Washington, USA, 1975-76: Proj. ID RESID/77/32. Unpublished study
prepared by Schering Agrochemicals Ltd. 52 p.
Crofts, M.; Whiteoak, R. (1977) R82 Nortron (Ethofumesate): Decline of
Residues in Ryegrass and Kentucky Bluegrass Following the Application of
45
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41214220
41214221
41214222
41214223
41214224
41214228
41214241
41214242
41404601
NORTRON in Oregon, USA, 1975-76: Proj. ID RESID/ 77/36.
Unpublished study prepared by Schering Agrochemicals Ltd. 49 p.
Harris, R.; Whiteoak, R. (1989) R87 NORTRON (Ethofumesate): Decline of
Residues of Ethofumesate and Diuron in Grass after Applica- tion of each
Compound Separately and as a Tank-mix (...): Proj. ID RESID/77/65.
Unpublished study prepared by Schering Agro- chemicals Ltd. 23 p.
Harris, R. (1978) R97 NORTRON (Ethofumesate): Residues in Grass Seed
and Hay Following the Application of NORTRON in Oregon, USA in
1974/75 and 75/76: Proj. ID RESID/78/90. Unpublished study prepared by
Schering Agrochemicals Ltd. 23 p.
Crofts, M.; Whiteoak, R. (1979) R106 NORTRON (Ethofumesate): Resi-
dues in Ryegrass and Kentucky Bluegrass at 41 to 115 Days after
Application of NORTRON in Oregon, 1977-78: Proj. ID RESID/79/69.
Unpublished study prepared by Schering Agrochemicals Ltd. 34 p.
Crofts, M.; Whiteoak, R. (1977) R66 NORTRON (Ethofumesate): Residue
Decline Study Following the Application of NORTRON to Establish- ed
Ryegrass in Washington, 1974-75: Proj. ID RESID/76/19/1. Unpublished
study prepared by Schering Agrochemicals Ltd. 39 p.
Crofts, M.; Whiteoak, R. (1977) R65 NORTRON (Ethofumesate): Residue
Decline Study Following the Application of NORTRON to Establish- ed
Ryegrass in Oregon, 1974-75: Proj. ID RESID/76/15/1. Unpub- lished study
prepared by Schering Agrochemicals Ltd. 41 p.
Reary, J. (1980) R108 Nortron (Ethofumesate): Residues in Mature Sugar
Beet Treated with Mixtures of Ethofumesate and/or Phenmedipham and
Desmedipham (Commercial EC Formulations) in USA, 19- 79): Project ID
RESID/80/38. Unpublished study prepared by Schering Agrochemicals Ltd.
15 p.
Crofts, M. (1975) R42 Nortron (Ethofumesate): Harvest Residues in
Sugarbeet From 1974 Pre-emergence Applications of Nortron in Ca- nada:
Project ID RESID/75/16. Unpublished study prepared by Schering
Agrochemicals Ltd. 9 p.
Reary, J. (1980) R109 Nortron (Ethofumesate): Residues in Mature Sugar
Beet Following Pre- plus Post-emergence Application of Ethofumesate
(20EC) in California, 1977: Project ID RESID/80/47. Unpublished study
prepared by Schering Agrochemicals Ltd. lip.
Liggett, M.; Seaber, J. (1984) T88 Technical Ethofumesate CR 4805:
Delayed Contact Hypersensitivity in the Guinea Pig: Lab Project Number:
TOX/84/136-98. Unpublished study prepared by Huntingdon Research
Centre. 24 p
46
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41554101
41652501
41687601
41710501
41752101
Sanderson, D.M., Mallyon, B. and Brooks, P.N (1977) Acute Inhalation
Toxicity to Rats of an Ethofumesate and Kaolin 50:50 Formulation (CR
13696/7); Schering Agrochemicals Ltd., Essex, England; Study No.
Tox/77/136-66; Report dated June, 1977. Unpublished study.
Jackson, C. (1990) Ethofumesate: Embryotoxicity Including Teratogenicity
Study in the Rabbit after Daily Intragastric Administration from Day 6 to
Day 18 of Gestation (Supplement to MRID 00156606; Supplement I to T96);
Schering AG; Laboratory Project No. PF 4/86. Unpublished study.
Hughes, J. (1990) The Toxicity of Ethofumesate Technical to Sele- nastrum
capricornutum: Lab Project Number: B643/01/2. Unpublished study
prepared by Malcolm Pirnie, Inc. 23 p.
Kennelly, J. (1986) Tl01-Technical Ethofumesate: Mouse Lymphoma (6TG)
Fluctuation Assay: Lab Project Number: TOX/86/136-109. Unpublished
study prepared by Microtest Research Ltd. 30 p.
Harris, J.; Johnson, M. (1991) Ethofumesate Technical: Product Chemistry:
Lab Project Number : AD 14/19: AD 23/90: AD 18/90. Unpublished study
prepared by Schering Agrochemicals Ltd. 88 p.
41752102
41949204
41949205
41970701
41970703
41970704
Johnson, M.; Ward, J.; Stalker, A. et al. (1991) Ethofumesate Technical:
Product Chemistry: Lab Project Number: AD 2/90: CHR/90/ 047:
CHR/90/052. Unpublished study prepared by Schering Agro- chemicals Ltd.
217 p.
Wood, E. (1991) T125 Technical Ethofumesate: Rabbit Eye Irritancy Study:
Lab Project Number: TOX/90/1363-124. Unpublished study prepared by
Schering Agrochemical Ltd. 17 p.
Wood, E. (1991) T124 Technical Ethofumesate: Rabbit Skin Irritancy Study:
Lab Project Number: TOX/90/136-123. Unpublished study prepared by
Schering Agrochemical Ltd. 17 p.
Barrett, K. (1991) W118 Ethofumesate: The Acute Toxicity of Carbon- 14
Ethofumesate to Rainbow Trout (Oncorhynchyus mykiss) Under Static
Conditions: Lab Project Number: ENVTR/91/19. Unpublished study
prepared by Schering Agrochemical Ltd. 35 p.
Barrett, K. (1991) Wl 17 Ethofumesate: The Acute Oral and Topical
Toxicities of Ethofumesate to Worker Honeybees (Apis mellifera L.): Lab
Project Number: ENVIR/91/018. Unpublished study prepared by Schering
Agrochemical Ltd. 21 p.
Barrett, K.; Lattimore, A. (1991) W114 Ethofumesate: Determination of the
Accumulation and Elimination of Carbon-14 Ethofumesate in Bluegill
Sunfish (Lepomis macrochirus L.): Lab Project Number: ENVTR/91/011.
Unpublished study prepared by Schering Agrochem- ical Ltd. 65 p.
47
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41997201
41997202
Johnson, M. (1991) Ethofumesate Technical- Product Chemistry: Lab
Project Number: AD3/91; AD 18/90; 2^ ED. Unpublished study prepared by
Schering Ag. Ltd. 34 p.
Bass, R; Johnson, M.; Scurrah, P.; et al. (1991) Ethofumesate Technical--
Product Chemistry: Lab Project Number: AM 1100/18/1: AM 1100/19/1:
AM 2800/6/4. Unpublished study prepared by Scher- ing Ag. Ltd. and Nor-
Am Chemical Co. 108 p.
41997203
Baker, G.; Johnson, M. (1991) Ethofumesate Technical-Product Chemistry:
Lab Project Number: Cl 18 2ND ED.: (AD 2/90, 2ND EDN): C144 (AD
17/91). Unpublished study prepared by Schering Ag. Ltd./Essex and
Schering Ag. Ltd./Cambridge. 32 p.
41997204
Jackson, C.M. (1991) Technical Ethofumesate: Rabbit Twenty-One Day
Dermal Toxicity Study. Huntingdon Research Center, Ltd., Cambridgeshire,
England; Laboratory Study No. TOX 90537; Report dated May 15, 1991.
Unpublished Study.
41997205
Castro, L. (1991) Dissipation of Ethofumesate in Soil Following Use of
Nortron EC in Sugar Beet Cultivation USA, 1989: Lab Project Number:
R312.01.89. Unpublished study prepared by Nor-Am Chemi- cal Co. 80 p.
41997206
42008901
42015501
42067701
42200901
42364502
Citation: Bowman, M. (1991) Testing of Ethofumesate Through US FDA
Multi- residue Methods: Lab Project Number: MCB/NOR-AM/MR-3:
R312.50. 90. Unpublished study prepared by M.C. Bowman & Assoc. 132
P-
Faggella, G. (1991) Ethofumesate: Fathead Minnow (Pimephales promelas):
Early Life Stage Toxicity Test: Lab Project Number: 502B. Unpublished
study prepared by Enseco-Marblehead. 85 p.
Barrett, K. (1991) Wl 16 Ethofumesate: The Acute Toxicity of Carbon
14|-Ethofumesate to Bluegill Sunfish (Lepomis macrochirus) Under
Semi-Static Conditions: Lab Project Number: ENVIR/91/27. Unpublished
study prepared by Schering Agrochemical Ltd. 36 p.
Clark, R. (1991) Technical Ethofumesate: Oral Teratology (Developmental
Toxicity) Study in the Rat: Lab Project Number: TOX/91/ 136-125: 6635-
194/37 & 38: TOX 90207/90284. Unpublished study prepared by Hazleton
UK. 214 p.
Citation: Brehm, M. (1991) W81 Ethofumesate Supplement: Comment to
EPA Phase 4 Data Evaluation Record of Report APC 01/89 "The Photolysis
of Ethofumesate (...) in Aqueous Solution. Unpublished study prepared by
Schering. AG 16 p.
Schupner, J.; Stachura, B. (1992) The Acute Toxicity of Ethofumesate
Technical to the Mysid Shrimp, Mysidopsis Bahia in a Static System: Lab
48
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42364503
42364504
42364505
Project Number: 508B. Unpublished study prepared by Nor-Am Chemical
Comp. 49 p.
Hawkins, D.; Elsom, L.; Dighton, M.; et al. (1992) M51 Ethofumesate: the
Metabolism of ?carbon 14|-Ethofumesate in Rats: Lab Project Number:
TOX/92/136-133. Unpublished study prepared by Huntingdon Research
Centre Ltd. 159 p.
Hawkins, D.; Kirkpatrick, D.; Dean, G.; et al. (1992) M52 Ethofumesate: the
Metablolism of ?carbon 14| Ethofumesate in the Cow: Lab Project Number:
TOX/92/136-134. Unpublished study prepared by Huntingdon Research
Centre Ltd. 58 p.
Hawkins, D.; Elsom, L.; Dighton, M.; et al. (1992) M53 Ethofumesate: The
Metabolism of (Carbon 14) Ethofumesate in Laying Hens: Lab Project
Number: TOX/92/136-135. Unpublished study prepared by Huntingdon
Research Center Ltd. 62 p.
42388101
42409301
42413001
42413002
42438001
42495901
42495902
Yurk, 1; Ache, B. (1992) W130 Ethofumesate: Effect of Ethofumesate
Technical on New Shell Growth in the Eastern Oyster (Crassostrea virginica)
Under Flow-through Test Conditions: Lab Project Number: 39230110200:
507B. Unpublished study prepared by Environmental Science &
Engineering, Inc. 41 p.
Schupner, J.; Stachura, B. (1992) The Acute Toxicity of Ethofumesate
Technical to the Sheepshead Minnow, Cyprinodon variegatus in a Static
System: Lab Project Number: 506B. Unpublished study prepared by
Nor-Am Chemical Co. 43 p.
Waring, A. (1992)Ethofumesate/W129: Carbon 14| Ethofumesate: Aerobic
Metabolism in Two Soils at Two Moisture Contents: Lab Project Number:
ENVIR89B: HUK 194/58. Unpublished study prepared by Hazleton UK,
Harrogate. 97 p.
Waring, A. (1992)Ethofumesate/W129: Carbon 14 Ethofumesate:
Anaerobic Soil Metabolism: Lab Project Number: ENVIR93B: HUK
194/60. Unpublished study prepared by Hazleton UK, Harrogate. 82 p.
Mackie, J.; Hall, B. (1992) W136 Ethofumesate: Aged Soil Leaching of
Carbon 14|-Ethofumesate: Lab Project Number: ENVIR/92/061.
Unpublished study prepared by Inveresk Research International, Ltd. 74 p.
Chaplet, S. (1992) Ethofumesate/M54: The Metabolism of Carbon
14|-Ethofumesate in Sugar Beet-A Glasshouse Study: Lab Project Number:
ENVER/92/067. Unpublished study prepared by Interest Research
International Limited. 207 p.
Chaplet, S. (1992) Ethofumesate/M55: The Metabolism of Carbon
14|-Ethofumesate in Annual Ryegrass—A Glasshouse Study: Lab Project
Number: ENVER/92/068: ENVER 85B. Unpublished study prepared by
Interest Research International Limited. 189 p.
49
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42689901
42689903
42817201
42871901
42956601
Jackson, C. (1993) T123 Ethofumesate—Oral Teratology (Developmental
Toxicity) Study in the Rat: Addendum 1: Lab Project Number: TOX/91/136-
125: 194/38: TOX 90284. Unpublished study prepared by Hazleton UK. 16
P-
Challis, I. (1992) M51 Ethofumesate-The Metabolism of (carbon
14)-Ethofumesate in Rats: Addendum 1: Lab Project Number:
TOX/92/136-133. Unpublished study prepared by Huntingdon Research
Centre, Ltd. 11 p.
Carlton, R. (1993) W153 Ethofumesate: The Uptake and Metabolism of
Ethofumesate and Its Soil Metabolites in a Confined Rotational Crop Study:
Lab Project Number: 90B: ENVER/93/009. Unpublished study prepared by
Schering Agrochemicals Ltd. 133 p.
Young, B. (1993) A Daphnia Magna 21 Day Reproduction Study of
Ethofumesate Technical in a Static Renewal System: Lab Project Number:
510B. Unpublished study prepared by Nor-Am Chemical Co. 66 p.
Johnson, M.; Audus, B. (1993) Ethofumesate Technical: Product Chemistry:
2nd Edition: Lab Project Number: AD 3/91: C-133: AD 3/91 2ND ED.
Unpublished study prepared by Schering Agrochemicals Ltd. 30 p.
42956602
Audus, B.; Shaw, B.; Chisholm, K. (1993) Ethofumesate Technical-Product
Chemistry: 2nd Edition: Lab Project Number: AD 6/91 2ND EDITION: AD
24/93: AD 25/93. Unpublished study prepared by Schering Agrochemicals
Ltd. 100 p.
43066801
Johnson, M.; Audus, B. (1993) Ethofumesate Technical-Product Chemistry
(Stability): Lab Project Number: AD 17/91: AD 30/93: C165. Unpublished
study prepared by Schering Agrochemicals Ltd. 33 p.
43298103
Brady, S. (1994) Ethofumesate-Derived Residues in or on Grass, Grass
Screenings and Straw Following Treatment with Nortron SC at Maximum
Use Rates USA 1991: Lab Project Number: B/91R/01. Unpublished study
prepared by Nor-Am Chemical Co. 134 p.
43298104
Castro, L. (1994) At-Harvest Residue of Ethofumesate and Metabolites in
Rotational Crops and Soil Following Application of Nortron EC to
Sugarbeets, USA, 1990: Lab Project Number: R312/01/90. Unpublished
study prepared by Nor-Am Chemical Co. 117 p.
43412901
Castro, L. (1994) Ethofumesate-Derived Residues in the Meat and Milk of
Dairy Cows Resulting from Oral Ingestion of Ethofumesate: Lab Project
Number: B-94R-04/05: B-93R-04/05: R179. Unpublished study prepared by
AgrEvoUSACo. 148 p.
43458701
Castro, L. (1994) Ethofumesate-Derived Residues in the Meat and Milk of
Dairy Cows Resulting from Oral Ingestion of Ethofumesate: Lab Project
Number: B/94R/04/05: B/93R/04/05. Unpublished study prepared by
AgrEvo USA Co. 148 p. (duplicate of MRID 43412901)
50
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43458701
Castro, L. (1994) Ethofumesate-Derived Residues in the Meat and Milk of
Dairy Cows Resulting from Oral Ingestion of Ethofumesate: Lab Project
Number: B/94R/04/05: B/93R/04/05. Unpublished study prepared by
AgrEvoUSACo. 148 p.
43529501
Gant, R. (1994) T191 Ethofumesate: Bacterial Mutation Assay: Lab Project
Number: AGV 20/941611: TOX 94329. Unpublished study prepared by
Huntingdon Research Centre Ltd. 38 p.
43697201
Cole, M. (1995) At-Harvest Ethofumesate-Derived Residues in or on Sugar
Beet Roots and Tops Following Sequential Applications of NORTRON SC
and BETAMIX at the Highest Recommended Pre-Emergence Plus
Post-Emergence Rate Combination, USA 1993: Lab Project Number:
B-93R-03: FSCA: GGH-01. Unpublished study prepared by AgrEvo USA
Co. 97 p.
43298104
Castro, L. (1994) At-Harvest Residue of Ethofumesate and Metabolites in
Rotational Crops and Soil Following Application of Nortron EC to
Sugarbeets, USA, 1990: Lab Project Number: R312/01/90. Unpublished
study prepared by Nor-Am Chemical Co. 117 p.
44093601
Powell, L.; Copeland, A.; Copinath, C. et al. (1989) T510 Ethofumesate:
Toxicity to Rats by Dietary Administration for 13 Weeks (According to
OECD Guidelines): (Final Report): Lab Project Number: A89580: RKY
86/881321: RKY/86. Unpublished study prepared by Huntingdon Research
Centre Ltd. 171 p.
44093602
Everett, D.; Perry, C.; Martin, T. et al. (1990) T513 Ethofumesate: 52 Week
Dietary Toxicity Study in Rats: Lab Project Number: 7393: 437609:
A89582. Unpublished study prepared by Inveresk Research International.
319 p.
44093603
Everett, D.; Perry, C.; Martin, T. et al. (1991) T514 Ethofumesate: 104 Week
Dietary Carcinogen!city Study in Rats: Lab Project Number: 7695: 437609:
A89583. Unpublished study prepared by Inveresk Research International.
828 p.
44093604
Everett, D.; Perry, C.; Martin, T. et al. (1992) T514, Addendum #1
Ethofumesate: 104 Week Dietary Carcinogen!city Study in Rats-Individual
Body Weights(g): Males: Lab Project Number: 437609: A89584: IRI
437609. Unpublished study prepared by Inveresk Research International. 66
P
44156201
Collins, D. (1990) T511 Ethofumesate: 13 Week Oral (Dietary) Dose
Rangefinding Study in the Mouse: Lab Project Number: KIR/3/89: A89579.
Unpublished study prepared by Toxicol Laboratories Ltd. 92 p.
44156202
Hill, R; Newman, A.; Lee, P. (1992) T515 Ethofumesate: 80 Week Oral
(Dietary) Carcinogen!city Study in the Mouse: (Final Report): Lab Project
Number: KIR/4/91: A89581. Unpublished study prepared by Toxicol
Laboratories Ltd. 1556 p.
51
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45395402
Mandava, N. (2001) Etho Tech Group A—Product Identity, Composition and
Analysis: Lab Project Number: AVT-PC-2. Unpublished study prepared by
Mandava Associates. 50 p.
45395403
Ramsay, N; Craig, W. (2001) Ethofumesate Preliminary Analysis, Certified
Limits and Methods to Verify Ceritfied Limits for Ethofumesate: Selected
Studies to Fulfil the Requirements of OPPTS Guidelines 830.1700, 830.1750
and 830.1800: Lab Project Number: 19766: 340599: 4059B. Unpublished
study prepared by Inveresk Research. 142 p.
45395404
Mandava, N. (2001) Etho Tech Group B~Physical and Chemical Properties:
Lab Project Number: AVI-PC-3. Unpublished study prepared by Mandava
Associates. 13 p.
45395405
Craig, W.; MacDonald, E. (2001) Ethofumesate Product Chemistry of
Ethofumesate: Lab Project Number: 19852: 340845: 4059A. Unpublished
study prepared by Inveresk Research. 93 p.
45395406
Tremain, S. (2001) Ethofumesate: Determination of Vapor Pressure: Lab
Project Number: 685/018. Unpublished study prepared by Safepharm
Laboratories Limited. 25 p.
45395407
Macnab, J. (2001) Determination of the Thermal Stability in Air of
Ethofumesate: Lab Project Number: PC/263. Unpublished study prepared by
SyngentaLtd. 17 p.
45818101
Williams, L. (2002) Ethofumesate AE B049913: Radiovalidation of the
Method of Analysis for Ethofumesate and its Metabolites in Plants Using
Gas Chromatography Equipped with Flame Photometric Detection: Lab
Project Number: 02XB31844P: B003865. Unpublished study prepared by
Aventis CropScience. 43 p.
45818102
Williams, L. (2002) Ethofumesate (AE B049913) Radiovalidation of the
Method of Analysis for Ethofumesate and its Metabolites in Animal Tissues
and Using Gas Chromatography Equipped with Flame Photometric
Detection: Lab Project Number: 02XB31844A: B003866: 201-0539B.
Unpublished study prepared by Bayer CropScience. 108 p.
45818103
Tew, E. (2002) Analytical Method for the Determination of Ethofumesate
and its Metabolites, NC 9607, NC 8493 and NC 20645 in Sugar Beet Roots
and Tops (Method Number XB/01/01): Lab Project Number: B004169:
XB/01/01. Unpublished study prepared by Bayer CropScience. 28 p.
45818104
Eckert, J. (2001) Independent Laboratory Validation of Aventis CropScience
Method—Analytical Method for the Determination of Ethofumesate and its
Metabolites, NC 9607, NC 8493 and NC 20645 in Sugar Beet Roots and
Tops: Lab Project Number: AV-01-01: 01BF28352: B003792. Unpublished
study prepared by Enviro-Bio-Tech, Ltd. 145 p.
52
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45818105
Cole, M. (2000) Stability of Ethofumesate, NC 9607 andNC 8493 in Carrots
During Frozen Storage, USA, 1993: Lab Project Number: B-93R-13:
B93R013: B002705. Unpublished study prepared by Aventis Crop Science.
42 p.
45818106
Cole, M. (2000) Stability of Ethofumesate, NC 9607 and NC 8493 in
Spinach During Frozen Storage, USA, 1993: Lab Project Number: B-93R-
12: B002728: B93R012. Unpublished study prepared by AgrEvo USA
Company. 42 p.
45818108
Cole, M. (2000) Stability of Ethofumesate, NC 9607 and NC 8493 in
Sorghum Straw During Frozen Storage, USA 1993: Lab Project Number:
B-93R-11: B93R011: B002748. Unpublished study prepared by Aventis
CropScience. 41 p.
45818109
Cole, M. (1995) Stability of Ethofumesate, NC 9607 and NC 8493 in Grass
During Frozen Storage, USA 1993: Lab Project Number: B-39R-09: NC
8438/R185: A54281. Unpublished study prepared by AgrEvo USA
Company. 44 p.
45818110
Cole, M. (1999) Stability of Ethofumesate, NC 9607 andNC 8493 in Barley
Grain During Frozen Storage, USA 1993: Lab Project Number: B-93R-10:
B93R010: A54282. Unpublished study prepared by Aventis CropScience. 40
P-
45818111
45855501
45855502
45855503
45874701
Ebert, E. (2001) Bobwhite Quail Dietary Reproduction Study: Ethofumesate:
Lab Project Number: 2000.0804: 1999.0060: TOX 99075. Unpublished
study prepared by Aventis Pharma Deutschland GmbH. 163 p.
Cole, M.; Benson, N. (2002) At-Harvest Ethofumesate-Derived Residues in
or on Sugar Beet Roots and Processed Sugar Beet Commodities Following a
Single Application of Nortron SC at Exaggerated Rates, USA, 1993: Lab
Project Number: B-93R-02: B93R002: B004036. Unpublished study
prepared by Bayer CropScience. 145 p.
Cole, M.; Benson, N. (2002) Ethofumesate-Derived Residues in or on
Rotational Crops Following Sequential Applications of Nortron SC and
Betamix at the Flighest Recommended Pre-Emergence Plus Post-Emergence
Rate Combination, USA, 1993: Lab Project Number: B-93R-16: B93R016:
B004038. Unpublished study prepared by Aventis CropScience. 190 p.
Frey, L.; Beavers, 1; Jaber, M. (2000) Ethofumesate: AE B049913 00 ID97
0002: Mallard Duck Dietary Reproduction Study: Lab Project Number:
312-124: TOX 99077: 312-120. Unpublished study prepared by Wildlife
International, Ltd. 275 p.
Christ, M.; Abedi, J. (2003) Effect on Vegetative Vigor of Non-Target
Terrestrial Plants (Tier II) AE B049913: Suspension Concentrate (43.8%
w/w): Lab Project Number: 02XB28225: B004218. Unpublished study
prepared by Bayer CropScience. 131 p
53
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45874702
45874703
45879001
45892001
45892101
45884801
Christ, M.; Abedi, J. (2003) Effect on Seedling Emergence of Non-Target
Terrestrial Plants (Tier II) AE B049913: Suspension Concentrate (43.8%
w/w): Lab Project Number: 02XB28224: B004219. Unpublished study
prepared by Bayer CropScience. 133 p.
Cole, M. (2000) Validation of an Analytical Method for the Residues of NC
20645 in Sugar Beet Roots and Whole Milk, USA, 1998: Lab Project
Number: B98R001: C004116. Unpublished study prepared by Aventis
CropScience. 30 p.
Fontaine, L. (2003) Product Chemistry of Ethofumesate Technical: Lab
Project Number: C028392: BR2261: PA02/071. Unpublished study
prepared by Bayer CropScience. 210 p.
Arsenovic, M. (2002) Ethofumesate: Magnitude of the Residue on Beet,
Garden: Lab Project Number: 00742: 00742.96-MNR02: 00742.96-TX14.
Unpublished study prepared by IR-4 Project Center for Minor Crop Pest
Management. 268 p
Arsenvic, M. (2002) Ethofumesate: Magnitude of the Residue on Carrot: Lab
Project Number: 06703: 06703.00-ABC02: 06703.99-WA43. Unpublished
study prepared by ABC Laboratories, Inc., and USDA/ARS-IAREC. 194 p.
Fontaine, L. (2003) Product Chemistry of Ethofumesate Technical: Lab
Project Number: C029134: BR2260: PA02/063. Unpublished study
prepared by Bayer CropScience. 312 p.
45892001
Arsenovic, M. (2002) Ethofumesate: Magnitude of the Residue on Beet,
Garden: Lab Project Number: 00742: 00742.96-MNR02: 00742.96-TX14.
Unpublished study prepared by IR-4 Project Center for Minor Crop Pest
Management. 268 p.
46157901
Keirs, D. (2000) (14 Carbon)- Ethofumesate: Aqueous Photolysis. Project
Number: 396835, C009667. Unpublished study prepared by Inveresk
Research International. 95 p.
46450701
Scheerbaum, D. (1998) Ethofumesate Substance Technical 98.9% w/w:
Lemna minor: Semi Static Phytotoxicity Test. Project Number:
ENVIR/98/22, 980219FC, TLA56991. Unpublished study prepared by Dr.
U. Noack-Laboratorium fuer. 44 p.
46471401
46546301
Citation: Bright, J. (1991) Stability of Ethofumesate Residues in Soil During
Deep Freeze Storage. Project Number: RESID/90/118, 041/02/002.
Unpublished study prepared by Schering Agrochemicals Ltd. 24 p.
Caley, C.; Cameron, B.; Chapleo, S.; et. al. (1989) Determination of Acute
Toxicity (LC50) to Rainbow Trout (96h Semi-Static) (EPA): Ethofumesate.
Project Number: A87614, NC/8438/W514/1, 7146. Unpublished study
prepared by Inveresk Research International. 36 p.
54
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Appendix D. Generic Data Call-In
See the following table for a list of generic data requirements. Note that a complete Data Call-in
(DCI), with all pertinent instructions, is being sent to registrants under separate cover.
55
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Appendix E. Product Specific Data Call-In
See attached table for a list of product-specific data requirements. Note that a complete Data Call-in
(DCI), with all pertinent instructions, is being sent to registrants under separate cover.
56
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Appendix F. List of Registrants Sent This Data Call-In
Bayer Cropscience Company
Fissions Inc.
United Phosphorus, Inc.
The Andersons Lawn Fertilizer Division, Inc.
The Scotts Company
57
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Appendix G. EPA'S Batching of Ethofumesate Products for Meeting Acute
Toxicity Data Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing ETHOFUMESATE as the active
ingredient, the Agency has batched products which can be considered similar for purposes of acute
toxicity. Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the Agency is not describing batched products
as "substantially similar" since some products within a batch may not be considered chemically
similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for a
batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is referenced, registrants must clearly identify the test
material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the
data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a
registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a
registrant should know that choosing not to participate in a batch does not preclude other registrants
in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
58
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Seventeen products were found which contain Ethofumesate as the active ingredient. These
products have been placed into 3 batches and a no batch group in accordance with the active and
inert ingredients and type of formulation.
Batching Instructions:
No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational purposes
only. The data supporting these values may or may not meet the current acceptance criteria.
Batch 1
EPA Reg. No.
264-611
70506-105
Percent Active Ingredient
97.7
98.0
Batch 2
EPA Reg. No.
264-613
264-615
432-938
70506-106
70506-107
Percent Active Ingredient
42.0
42.0
42.0
42.0
42.0
Batch 3
EPA Reg. No.
264-612
432-941
Percent Active Ingredient
19.0
19.0
No Batch
EPA Reg. No.
264-631
264-632
Percent Active Ingredient
Ethofumesate: 6.0
Desmedipham: 6.0
Phenmedipham: 6.0
Ethofumesate: 7.0
Desmedipham: 7.0
Phenmedipham: 7.0
59
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264-815
264-835
264-854
9198-206
45639-160
70506-90
Ethofumesate: 15.9
Desmedipham: 10.2
Phenmedipham: 13.1
Ethofumesate: 12.2
Desmedipham: 7.8
Phenmedipham: 10.1
Ethofumesate: 15.9
Desmedipham: 10.2
Phenmedipham: 13.1
2.1
Ethofumesate: 6.0
Desmedipham: 6.0
Phenmedipham: 6.0
Ethofumesate: 7.0
Desmedipham: 7.0
Phenmedipham: 7.0
60
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Appendix H. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket, located in Room
119, Crystal Mall #2, 1801 South Bell Street, Arlington, VA. It is open Monday through Friday,
excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained preliminary risk assessments and related documents as of March 30,
2005. Sixty days later the first public comment period closed. EPA has considered and responded
to the public comments, and revised the risk assessments.
All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed
via the Internet at the following site:
www. epa. gov/pesticides/
These documents include:
HED Documents:
1. Memorandum:HED Revised Occupational and Residential Exposure Chapter of the
Reregistration Eligibility Decision Document (RED)-Phase 4. Robert Travaglini, Chemist
(OPP/HED). DP Barcode: DP304056. August 10, 2005.
2. ETHOFUMESATE: HED Revised Human Health Risk Assessment For Phase 4;
Response to Bayer CropScience Phase 3 Comments. Nancy McCarroll
DP Barcode DP304056. August 10, 2005.
EFED Documents:
1. Memorandum: Revised Environmental Fate and Effects Division Preliminary Risk
Assessment for the Ethofumesate Reregistration Eligibility Decision Document. Amer Al-
Mudallal and Lewis Brown (OPP/EFED). DP Barcode D296942. August 20, 2005.
2. Revised Environmental Fate and Effects Division Preliminary Risk Assessment for the
Ethofumesate Reregistration Eligibility Decision Document. Amer Al-Mudallal and Lewis
Brown (OPP/EFED). D296942. August 20, 2005.
SRRD Documents:
1. Memorandum: Handler Risks to Dry Bulk Fertilizers on Sugar Beets. Nathan Mottl and
Laura Parsons (OPP/SRRD). September 27, 2005.
61
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Appendix I. List of Available Related Documents and Electronically Available
Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa. gov/opprdOO 1 /forms/
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat
reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded
can be filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with
the existing policy.
3. Mail the forms, along with any additional documents necessary to
comply with EPA regulations covering your request, to the address
below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information1 or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at
(703) 308-5551 or by e-mail at williams.nicole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet:
at the following locations:
8570-1
8570-4
8570-5
8570-1
7
8570-2
5
Application for Pesticide
Registration/Amendment
Confidential Statement of
Formula
Notice of Supplemental
Registration of Distribution of a
Registered Pesticide Product.
Application for an Experimental
Use Permit
Application for/Notification of
State Registration of a Pesticide
To Meet a Special Local Need
http://www.epa.gov/opprd001/forms/8570-l
.pdf
http://www.epa.gov/opprd001/forms/8570-4
.pdf
http://www.epa.gov/opprd001/forms/8570-5
.pdf
http://www.epa.gov/opprd001/forms/8570-l
7.pdf
http://www.epa.gov/opprd001/forms/8570-2
5.pdf
62
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8570-2
7
8570-2
8
8570-3
0
8570-3
2
8570-3
4
8570-3
5
8570-3
6
8570-3
7
Formulator's Exemption
Statement
Certification of Compliance with
Data Gap Procedures
Pesticide Registration
Maintenance Fee Filing,
Certification of Attempt to Enter
into an Agreement with other
Registrants for Development of
Data
Certification with Respect to
Citations of Data (PR Notice
98-5)
Data Matrix (PR Notice 98-5)
Summary of the
Physical/Chemical Properties (PR
Notice 98-1)
Self-Certification Statement for
the Physical/Chemical Properties
(PR Notice 98-1)
http://www.epa.gov/opprd001/forms/8570-2
7.pdf
http://www.epa.gov/opprd001/forms/8570-2
8.pdf
http://www.epa.gov/opprd001/forms/8570-3
O.pdf
http://www.epa.gov/opprd001/forms/8570-3
2.pdf
http://www.epa. gov/opppmsdl/PR Notices/
pr98-5.pdf
http://www.epa. gov/opppmsdl/PR Notices/
pr98-5.pdf
http://www.epa. gov/opppmsdl/PR Notices/
pr98-l.pdf
http://www.epa. gov/opppmsdl/PR Notices/
pr98-l.pdf
Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)ofl996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation
Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
63
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Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulatpr's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader).
a. Registration Division Personnel Contact List
a. Biopesticides and Pollution Prevention Division (BPPD) Contacts
b. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional
sources of information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does
charge a fee for subscriptions and custom searches. You can contact NPIRS by
telephone at (765) 494-6614 or through their website.
4. The National Pesticide Telecommunications Network (NPTN) can provide information
on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact
NPTN by telephone at (800) 858-7378 or through their website: ace.orst.edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
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petitioner encloses with his submission a stamped, self-addressed postcard. The
postcard must contain the following entries to be completed by OPP:
1.Date of receipt;
2.EPA identifying number; and
3.Product Manager assignment.
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the
date of receipt and provide the EPA identifying file symbol or petition number for the
new submission. The identifying number should be used whenever you contact the
Agency concerning an application for registration, experimental use permit, or tolerance
petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common
and trade names, company experimental codes, and other names which identify the
chemical (including "blind" codes used when a sample was submitted for testing by
commercial or academic facilities). Please provide a chemical abstract system (CAS)
number if one has been assigned.
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