United States Prevention, Pesticides EPA xxx-xxx-xx-xxxx
Environmental Protection and Toxic Substances September 2005
Agency (7508C)
Reregistration
Eligibility Decision
(RED) for Fluometuron
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REREGISTRATION ELIGIBILITY
DECISION
for
Fluometuron
Case No. 0049
Approved by:
Debra Edwards, Ph.D.
Director, Special Review and
Reregistration Division
Date
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TABLE OF CONTENTS
Fluometuron Reregistration Eligibility Decision Team v
Glossary of Terms and Abbreviations vi
Abstract viii
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification - Fluometuron 2
C. Use Profile 3
D. Estimated Usage of Fluometuron 3
HI. Summary of Fluometuron Risk Assessments 3
A. Human Health Risk Assessment 4
1. Toxicity of Fluometuron 4
a. Acute Toxicity Profile for Fluometuron 4
b. FQPA Safety Factor Considerations for Fluometuron 5
c. Toxicological Endpoints for Fluometuron 5
2. Carcinogenicity of Fluometuron 6
3. Metabolites and Degradates 7
4. Dietary Risk (Food and Drinking Water) 7
a. Exposure Assumptions 7
b. Population Adjusted Dose 8
c. Acute Dietary Risk (Food and Drinking Water) 9
d. Chronic Dietary Risk (Food and Drinking Water) 9
e. Cancer Dietary (Food and Drinking Water) 10
5. Residential Exposure and Risk 11
6. Aggregate Risk 12
7. Occupational Exposure and Risk 12
a. Handler Exposure and Risk 13
b. Post-Application Exposure and Risk 15
c. Incident Reports 16
B. Environmental Fate and Effects Risk Assessment 16
1. Environmental Fate and Transport 16
2. Ecological Exposure and Risk 16
a. Terrestrial Organisms 17
b. Aquatic Organisms 19
c. Endangered Species 20
3. Ecological Incidents 20
IV. Risk Management, Reregistration, and Tolerance Reassessment 21
A. Determination of Reregistration Eligibility 21
B. Public Comments and Responses 22
C. Regulatory Position 22
1. Food Quality Protection Act Findings 22
a. "Risk Cup" Determination 22
b. Determination of Safety to U.S. Population 22
c. Determination of Safety to Infants and Children 22
2. Endocrine Disrupter Effects 23
in
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3. Cumulative Risks 23
4. Endangered Species 24
D. Tolerance Reassessment Summary 24
E. Regulatory Rationale 27
1. Human Health Risk Management 27
a. Dietary (Food and Drinking Water) Risk Mitigation 27
b. Residential Risk Mitigation 30
c. Aggregate Risk Mitigation 30
d. Occupational Risk Mitigation 30
2. Non-Target Organism (Ecological) Risk Management 32
a. Terrestrial Organisms 33
b. Aquatic Organisms 34
3. Summary of Mitigation Measures 35
F. Other Labeling Requirements 35
1. Endangered Species Considerations 35
2. Spray Drift Management 36
V. What Registrants Need to Do 36
A. Manufacturing Use Products 36
1. Data Requirements 36
2. Labeling for Manufacturing-Use Products 38
B. End-Use Products 38
1. Additional Product-Specific Data Requirements 38
2. Labeling for End-Use Products 38
C. Labeling Changes Summary Table 38
VI. Appendices 45
Appendix A: Use Patterns Eligible for Reregi strati on
Appendix B: Data Supporting Guideline Requirements for the Reregi strati on of
Fluometuron
Appendix C: Technical Support Documents
Appendix D: Bibliography
Appendix E: Generic Data Call-In
Appendix F: Product Specific Data Call-In
Appendix G: EPA's Batching of Fluometuron Products for Meeting Acute Toxicity
Data Requirements for Reregi strati on
Appendix H: List of Registrants Sent This Data Call-In
Appendix I: List of Available Related Documents and Electronically Available Forms
IV
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Fluometuron Reregistration Eligibility Decision Team
Biological and Economic Analysis Assessment
Nicole Zinn
Steve Smearman
Tim Kiely
Environmental Fate and Effects Risk Assessment
Ibrahim Abdel-Saheb
Diana Eignor
Dana Spatz
Health Effects Risk Assessment
Samuel Ary
Elissa Reaves
Bill Smith
Registration Support
Donald Stubbs
Jim Tompkins
Risk Management
Kimberly Nesci
Kylie Rothwell
Office of General Counsel
Gautam Srinivasan
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Glossary of Terms and Abbreviations
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume of
water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
VI
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MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
POP USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
vn
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Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for fluometuron and is issuing its risk management
decision and tolerance reassessment. The risk assessments, which are summarized below, are
based on the review of the required target database supporting the use patterns of currently
registered products and additional information received through the public docket. After
considering the risks identified in the revised risk assessments, comments received, and
mitigation suggestions from interested parties, the Agency developed its risk management
decision for uses of fluometuron that pose risks of concern. As a result of this review, EPA has
determined that fluometuron-containing products are eligible for reregi strati on, provided that risk
mitigation measures are adopted and labels are amended accordingly. That decision is discussed
fully in this document.
Fluometuron is a phenylurea herbicide that was first registered in 1974 on cotton and
sugarcane and is now used only on cotton. Initial risk assessments indicated chronic (non-
cancer) and cancer dietary (food and drinking water) risks of concern. Risk estimates were
revised based on refinements to the assessments as well as mitigation measures, and the Agency
will be requiring groundwater monitoring data. Occupational risks have been mitigated through
PPE requirements on the labels, and ecological risks have been addressed through the rate
reductions and a requirement for use of a medium droplet size during pesticide application.
Further, additional ecotoxicology data are being required.
Vlll
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregi strati on of products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregi strati on of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (referred to as EPA or "the Agency"). Reregi strati on involves
a thorough review of the scientific database underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential hazards arising from the currently registered uses
of 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 3, 1996, the Food Quality Protection Act (FQPA) was signed into law. This
Act amends 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 3, 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 of infants and children, and the
cumulative effects of pesticides with a common mechanism of toxicity. When a safety finding
has been made that aggregate risks are not of concern and the Agency concludes that there is a
reasonable certainty of no harm from aggregate exposure, the tolerances are considered
reassessed. EPA decided that, for those chemicals that have tolerances and are undergoing
reregi strati on, tolerance reassessment will be accomplished through the reregi strati on 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." 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. However, EPA has
not made a common mechanism of toxicity finding as to fluometuron and any other substances,
and fluometuron does not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has not assumed that fluometuron has a
common mechanism of toxicity with other substances. 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 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://www.epa.gov/pesticides/cumulative/.
This document presents EPA's revised human health and ecological risk assessments, its
progress toward tolerance reassessment, and the reregi strati on eligibility decision for
fluometuron. 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 human health and environmental
effects risk assessments; Section IV presents the Agency's decision on reregi strati on eligibility
and risk management; and Section V summarizes the label changes necessary to implement the
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risk mitigation measures outlined in Section IV. Finally, the Appendices list related information,
supporting documents, and studies evaluated for the reregi strati on decision. The revised risk
assessments for fluometuron are available in the Office of Pesticide Programs (OPP) public
docket under docket number OPP-2004-0372 available on the Agency's web page at
http://www.epa.gov/oppsrrdl/reregistration/fluometuron/.
II. Chemical Overview
A. Regulatory History
Fluometuron was first registered in 1974 by Ciba-Geigy Corporation for use on cotton
and sugarcane as a preplant, pre-emergence, and post-emergence herbicide for the control of
broadleaf weeds and annual grasses. The tolerance for sugarcane was voluntarily revoked in
1998 (63 FR 57067). After a series of transfers of ownership, Agan Chemical Manufacturers,
Ltd., is the current basic manufacturer of fluometuron.
The Agency issued the Guidance for the Reregi strati on of Pesticide Products Containing
Fluometuron (or the "Registration Standard") in 1986. The Registration Standard summarized
available toxicity, product chemistry, ecological, and environmental fate data to determine the
adequacy of the fluometuron database to support continued registration. This document also
identified generic and product-specific chemistry data required for the reregi strati on eligibility of
fluometuron. Two Data Call-In (DCI) Notices requiring studies to support use patterns were
issued in 1991 and in 1995. The data received in response to the DCIs were used to reach the
reregi strati on eligibility conclusions for fluometuron that are presented in this RED document.
B.
Chemical Identification - Fluometuron
Chemical Structure:
H,C
Common Name:
Chemical Name:
Trade Name:
Chemical Family:
Case Number:
CAS Number:
PC Code:
Molecular Weight:
Empirical Formula:
Basic Manufacturer:
Other Technical Registrants:
Fluometuron
7V,7V-dimethyl-7V -(3 -(trifluoromethyl)phenyl)urea
Cotoran®
Phenylurea herbicide
0049
2164-17-2
035503
232.2
CioHnF3N20
Agan Chemical Manufacturers, Ltd.
Loveland Products, Inc.
Micro-Flo Company LLC
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c.
Use Profile
The following is information on the currently registered uses of fluometuron, including
an overview of use sites and application methods. A detailed table of the uses of fluometuron
eligible for reregi strati on is available in Appendix A.
Type of Pesticide:
Target Pest:
Mode of Action:
Use Site:
Use Classification:
Formulation Types:
Application Methods:
Application Rates:
Application Timing:
Herbicide
Broadleaf weeds
Inhibition of photosynthesis and bleaching and inhibition of carotenoid
biosynthesis
Cotton
General Use
Fluometuron formulations include dry flowable, soluble
concentrate/liquid, wettable powder, and emulsifiable concentrate
Fluometuron is applied by broadcast sprayer, band sprayer,
aircraft, or via ground/soil incorporation. It can be applied in
broadcast sprays, banding treatments, low volume sprays, directed
sprays, basal sprays, or incorporated directly into the soil. About
80% of fluometuron application is by ground.
Fluometuron is applied at a maximum one-time application rate of
2.0 pounds active ingredient per acre (Ib ai/A) with up to 3
treatments per year.
Fluometuron can be applied pre-plant (7%); at plant (57%); pre-
emergence (22%); or post-emergence (14%). Percentages
represent percent of fluometuron-treated acres.
D. Estimated Usage of Fluometuron
A screening-level estimate of the usage of fluometuron from 1998 to 2002 indicates that
approximately 2,400,000 pounds of fluometuron are used annually in the United States with an
average of 10% of cotton acreage and a maximum of 20% of cotton acreage (2000) being treated.
Annual usage appears to be declining as a result of the use of glyphosate-resistant cotton.
HI. Summary of Fluometuron Risk Assessments
The following is a summary of EPA's human health and ecological effects risk findings and
conclusions for the herbicide fluometuron, as presented fully in the following documents:
Fluometuron: Revised HED Risk Assessment for Phase III of the Reregistration Eligibility Decision
(RED) dated February 1, 2005; Fluometuron: Occupational Exposure Assessment for the
Reregistration Eligibility Decision Document dated December 7, 2004; Revised Environmental Fate
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and Ecological Risk Assessment ofFluometuron dated February 22, 2005; Fluometuron Revised
Drinking Water Assessment for the Health Effects Division (HED) Reregistration Eligibility Decision
Document dated December 8, 2004; Revised Drinking Water Assessment andEFED 's Response...
dated September 28, 2005; Impacts Assessment for Fluometuron dated September 26, 2005; Refined
Fluometuron Percent Crop Treated and Percentage of National Soybean, Corn, and Wheat Crops
Rotated with Fluometur'on-Treated Cotton dated August 9, 2005; and Addendum to Refined
Fluometuron Percent Crop Treated... dated September 21, 2005.
The purpose of this section of the document is to summarize the key features and findings of
the risk assessments in order to help the reader better understand the conclusions reached in the
assessments. While the risk assessments and related addenda are not included in this RED document,
they are available from the Office of Pesticide Programs (OPP) public docket: OPP-2004-0372 and
may also be accessed on the Agency's website at
http://www.epa.gov/oppsrrdl/reregistration/fluometuron/.
A. Human Health Risk Assessment
The human health risk assessment incorporates potential exposure risks from all sources,
which include food, drinking water, residential (if applicable), and occupational scenarios.
Aggregate assessments combine food, drinking water, and any residential or other non-
occupational (if applicable) exposures to determine potential exposures to the U.S. population.
The Agency's human health assessment is protective of all U.S. populations, including infants
and young children. For more information on the fluometuron human health risk assessment,
see: Fluometuron: Revised HED Risk Assessment for Phase 111 of the Reregistration Eligibility
Decision (RED) dated February 1, 2005.
1. Toxicity of Fluometuron
Toxicity assessments are designed to predict whether a pesticide could cause adverse health
effects in humans (including short-term or acute effects such as skin or eye damage, and lifetime or
chronic effects such as cancer, developmental effects, or reproductive effects), and the level or dose at
which such effects might occur. The Agency has reviewed all toxicity studies submitted for
fluometuron and has determined that the toxicological database is complete, reliable, and sufficient for
reregistration. For more details on the toxicity and carcinogen!city of fluometuron, see Fluometuron:
Revised HED Risk Assessment for Phase III of the Reregistration Eligibility Decision (RED) dated
February 1, 2005, which is available under docket number OPP-2004-0372.
a. Acute Toxicity Profile for Fluometuron
Fluometuron is classified as category III for acute oral and dermal toxicity and as category in
for acute inhalation toxicity. It is classified as category n for eye irritation potential and for skin
irritation potential. Results were negative for dermal sensitization in guinea pigs and rats. The acute
toxicity profile for fluometuron is summarized in Table 1 below.
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Table 1. Acute Toxicity Profile for Fluometuron
Guideline
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRID(s)
41216802
40409302
00142844
41216803
40409303
00142844
40409304
41216804
00142844
41216805
00142846
40409305
41216806
40409306
00142847
00068040
40409307
41216807
00160762
00142848
Results
LD50 > 1000 mg/kg
LD50 > 2000 mg/kg
LC50 > 0.6 mg/L
Moderate to severe eye irritant
(irritation to cornea and iris)
Slight to severe skin irritant
Non-sensitizing in guinea pig or
rat
Toxicity
Category
III
III
III
II
II
Not
Applicable
LD50 or LC50 = Median Lethal Dose or Concentration. A statistically derived single dose or concentration that can
be expected to cause death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation).
b. FQPA Safety Factor Considerations for Fluometuron
The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act (FQPA), directs the Agency to use an additional ten fold (lOx) safety factor (SF) to
account for potential pre- and postnatal toxicity and completeness of the data with respect to exposure
and toxicity to infants and children. FQPA authorizes the Agency to modify the lOx FQPA SF only if
reliable data demonstrate that the resulting level of exposure would be safe for infants and children.
For fluometuron, based on the hazard data and the exposure data, the FQPA SF was reduced
to Ix. There are low concerns and no uncertainties with regards to pre- and post-natal toxicity,
and there is no evidence of increased susceptibility of infants and children. Moreover, there is no
evidence that fluometuron is associated with significant reproductive or developmental toxicity.
In addition, the moderately refined dietary food assessment uses field trial data and percent crop
treated estimates for all commodities that will not underestimate exposure. The dietary drinking
water assessment uses values generated by models and associated modeling parameters that are
designed to provide health protective, high-end estimates of water concentrations. See
Fluometuron: Revised HED Risk Assessment for Phase III of the Reregistration Eligibility Decision
(RED) dated February 1, 2005, for additional details.
c. Toxicological Endpoints for Fluometuron
The toxicological endpoints used in the human health risk assessment for fluometuron are
listed in Table 2 below, as well as the estimated dermal and inhalation absorption factors used in the
risk assessment. For dermal absorption, a factor of 10% was estimated by comparing the oral
developmental rabbit Lowest Observed Adverse Effect Level (LOAEL) of 100 mg/kg/day and the
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rabbit 21-day dermal No Observed Adverse Effect Level (NOAEL) (because no LOAEL was
established) of 1000 mg/kg/day. For the inhalation absorption, a default factor of 100% was used.
The uncertainty factors (UF) and safety factors used to account for interspecies extrapolation,
intraspecies variability, and special susceptibility of infants and children (FQPA SF) are also described
in Table 2.
Table 2. Toxicology Endpoints for Fluometuron
Exposure Scenario
Dose, Uncertainty
Factors
FQPA Safety Factor and
Level of Concern
Study and Endpoint for Risk Assessment
Acute Dietary
females 13-49 years
NOAEL=10 mg/kg/day
UF=100X (inter and
intraspecies)
Acute RfD= 0.1 mg/kg/day
FQPA SF =1
aPAD = Acute RfD
FQPA SF
aP AD = 0.1 mg/kg/day
Developmental, Rat
LOAEL=100 mg/kg/day, based on delayed
urinary system development.
Chronic Dietary
all populations
NOAEL = 0.55 mg/kg/day
UF=100X (inter and
intraspecies)
Chronic RfD = 0.0055
mg/kg/day
FQPA SF = 1
cPAD = Chronic RfD
FQPA SF
cPAD = 0.005 mg/kg/day
Chronic/Carcinogenicity, Rat
LOAEL=100 mg/kg/day, based on
decreased body weight gain (9%), and
discoloration in the spleen.
Dermal and
Inhalation
Exposure: Short-
Term
(1 to 30 days)
OralNOAEL=10
mg/kg/day
Absorption Factors
Dermal=10%
Inhalation=100%
FQPA SF=NA
(occupational)
LOCforMOE=100
Developmental, Rat
LOAEL=100 mg/kg/day, based on delayed
urinary system development.
Dermal and
Inhalation
Exposure:
Intermediate-Term
(1 to 6 months)
OralNOAEL=10
mg/kg/day
Absorption Factors
Dermal=10%
Inahalation=100%
FQPA SF=NA
(occupational)
LOCforMOE=100
Subchronic, Dog
LOAEL=150 mg/kg/day, based on
inflammatory reactions in the liver and
kidney.
Cancer
Not mutagenic. Classified as Group C (Possible Human Carcinogen) with a Qi* (mg/kg/day)" of 1.80 x
10"2 in human equivalents (3/4's scaling factor to convert from animals to humans).
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference dose, MOE = margin of
exposure, LOG = level of concern, NA = Not Applicable
2. Carcinogenicity of Fluometuron
As described in Table 2 above, the Agency classified fluometuron as Group C, possible
human carcinogen. This was based on statistically significant increases in combined
adenomas/carcinomas of the lungs in male mice and malignant lymphocytic lymphomas in
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female mice. For the purpose of risk characterization, a low dose extrapolation model (Qi*) was
used. The Qi* is 1.8 x 10"2 (mg/kg/day)"1 was derived from the incidence of combined lung
tumors. For more information, see the document Carcinogenicity Peer Review of Fluometuron
dated August 28, 1996.
3. Metabolites and Degradates
The Agency reviewed the metabolism of fluometuron, and concluded that there are several
residues of concern in food. In plants, the residue of concern consists of parent fluometuron and
metabolites determined as trifluoromethylaniline (TFMA); in animals, the residue of concern consists
of fluometuron, TFMA, and the hydroxylated metabolites and their conjugates. The drinking water
assessment summarized in this document is for fluometuron and the only major degradate identified in
soil metabolism studies, desmethyl fluometuron (CGA-41686; l-methyl-3-(a,a,a-trifluoro-m-
tolyl)urea). All of the metabolites and degradates are assumed to be of equal toxicity to the
parent compound, and all metabolites of concern are calculated as fluometuron equivalents. See
Fluometuron: Revised HED Risk Assessment for Phase III of the Reregistration Eligibility Decision
(RED) dated February 1, 2005, for additional details.
4. Dietary Risk (Food and Drinking Water)
Acute dietary risk assessments were only considered for the population subgroup females
13-49 years old. For the general population, no acute dietary endpoint was selected because
effects attributable to a single dose were not seen in the available data. Chronic dietary analyses
were conducted for the general U.S. population and various population subgroups. A cancer
dietary risk assessment was conducted for the general U.S. population. Please note that the
dietary risk estimates presented in Section III of this document have subsequently been refined.
The refined estimates are presented in Section IV.
a. Exposure Assumptions
The Agency conducted acute, chronic and cancer dietary (food and drinking water) risk
assessments for fluometuron and its metabolites using the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID™, Version 2.03). To
conduct the assessments, both food consumption data from USDA's Continuing Survey of Food
Intakes by Individuals (CSFII), 1994-1996 and 1998, and screening-level model results for
drinking water exposure were incorporated in the DEEM-FCID™ to estimate combined food and
drinking water dietary risks.
Drinking water exposure to pesticides can occur through surface and groundwater
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks
and uses either modeling or monitoring data, if available and of sufficient quality, to estimate
those exposures. Fluometuron and its metabolites are mobile and persistent in the environment.
The primary route of degradation of fluometuron and its main major degradate is microbial
metabolism. However, since fluometuron and its degradates are not volatile, and these
degradative processes are not rapid, these compounds will be available for leaching to
groundwater and runoff to surface water in many use conditions. Once in groundwater or
surface water, fluometuron is expected to persist due to its stability to hydrolysis and photolysis.
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Parent fluometuron is also very stable to aerobic soil metabolism, anaerobic soil metabolism, and
anaerobic aquatic metabolism with half-lives of 181, 378, and 177 days respectively.
Estimated Drinking Water Concentrations (EDWCs) of fluometuron (parent and major
degradate CGA-41686) were calculated in groundwater and surface water sources of drinking
water for use in the dietary risk assessment. EDWCs for fluometuron were calculated, based on
maximum application rates, and using screening-level PRZM and EXAMS models (Tier II) with
the Index Reservoir and Percent Crop Area adjustment for surface water and the Screening
Concentration in Groundwater (SCI-GROW) model (Tier I) for groundwater, and are presented
in Table 3 below.
Table 3. Total EDWCs (ppb) in surface water and groundwater for fluometuron and its major degradate
Surface water/ peak (90th percentile annual daily max. - acute)
Surface water/average (90th percentile annual mean - chronic)
Surface water/3 6-year overall mean (cancer)
Groundwater (all exposures)
Use modeled
Percent Cropped Area (cotton)
CA
26.8
21.9
19.4
TX
47.5
20.1
12.4
MS
81.8
18.9
8.2
NC
45.0
16.9
12.0
241
3 aerial applications @ 2.0 Ib ai/acre to cotton*
20%
Please note that U.S. Geological Survey National Water Quality Assessment Program
(NAWQA) monitoring data are available for fluometuron. The NAWQA data show maximum
(peak) concentrations of 37.8 ppb sampled in surface water and 4.7 ppb in groundwater.
However, the vast majority of groundwater samples present substantially lower values (<0.1
ppb). In addition, over the course of the monitoring program, only two groundwater detections
showed concentrations greater than 2.5 ppb. However, these data are limited because the
majority of the NAWQA sampling sites are not located in high fluometuron use areas, and the
frequency of sampling and the length of the sampling period are insufficient. In the absence of
robust monitoring data, the Agency generally relies on modeling to estimate potential pesticide
exposure from drinking water.
b. Population Adjusted Dose
A population adjusted dose, or PAD, is the reference dose (RfD) adjusted for the FQPA
SF. A risk estimate that is less than 100% of the acute PAD (aPAD), the dose at which an
individual could be exposed over the course of a single day and no adverse health effects would
be expected, does not exceed EPA's level of concern. Likewise, a risk estimate that is less than
100% of the chronic PAD (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 EPA's
level of concern. For the cancer dietary risk assessment, risks in the negligible risk range of one
in a million (1 x 10"6) are generally below the Agency's level of concern.
-------
c. Acute Dietary Risk (Food and Drinking Water)
A moderately refined probabilistic (Monte-Carlo) acute dietary exposure assessment was
conducted to estimate the dietary (food and drinking water) risks associated with the registered
use of fluometuron on cotton. This assessment also considers exposure from residues in
rotational crops (i.e., crops planted in a field that has previously grown fluometuron-treated
cotton). No monitoring data for residues of fluometuron in/on food are available from the FDA
or USDA's Pesticide Data Program (PDF). The anticipated residue (AR) estimates in this
assessment are based on available field trial and field accumulation data, and incorporate
maximum (20%) percent crop treated estimates for cotton. This assessment likely overestimates
the food risk because food monitoring data are not available and because the percent crop treated
factor is based on 2000 data and is currently believed to be significantly less (10% crop treated).
For more information, see the document Refined Fluometuron Percent Crop Treated... dated
August 9, 2005; and Addendum to Refined Fluometuron Percent Crop Treated... dated September 21,
2005.
The acute risk estimate of 34% of the aPAD does not exceed the Agency's level of
concern (i.e., it is less than 100% of the aPAD) at the 99.9th exposure percentile for females 13-
49 years old. The acute dietary risk estimate is based on screening-level modeled groundwater
EDWCs. Because EDWCs for drinking water derived from surface water sources are less than
groundwater EDWCs (see Table 3), the risk estimates for food and surface water would be less
than risk estimates for food and groundwater. The acute dietary risk estimates are shown in
Table 4 below.
Table 4. Results of Acute Dietary (Food + Drinking Water from Groundwater Sources) Exposure
Analysis Using DEEM FCID.
Population Subgroup
Females 13-49 years old
aPAD
(mg/kg/day)
0.1
99.9th Percentile
Exposure (mg/kg/day)
0.033720
% aPAD
34
d. Chronic Dietary Risk (Food and Drinking Water)
A moderately refined chronic dietary (food and drinking water) exposure assessment was
conducted to estimate the dietary risks associated with the registered uses of fluometuron. No
monitoring data for residues of fluometuron are available. The AR residue estimates in this
assessment are based on available field trial and field accumulation data, and incorporated
maximum (20%) percent crop treated estimates for cotton. Feeding and metabolism studies
along with percent crop treated information on feed items were used to calculate AR estimates
for livestock commodities. Processing data were also used when available. Chronic dietary risk
estimates are provided for the general U.S. population and various population subgroups. This
assessment likely overestimates the food risk because food monitoring data are not available and
the percent crop treated factor for cotton is based on 2000 data, as above.
-------
The chronic risk estimates exceed the Agency's level of concern for infants less than one
year old at 306% of the cPAD, children 1-2 years old at 141% of the cPAD, and children 3-5
years old at 131% of the cPAD (see Table 5 below).
The significant contributor to chronic dietary risk is potential drinking water exposure
from groundwater sources. For food alone (excluding drinking water), the chronic risk estimates
are less than 4% of the cPAD for each population subgroup. In addition, risk estimates for food
plus drinking water from surface water sources do not exceed the Agency's level of concern.
The unrefined groundwater EDWC was calculated using a Tier 1, screening-level model and
likely overestimates the chronic drinking water exposure and resulting risk. Please note that the
chronic dietary risk estimates presented in this section have subsequently been refined, and are
further discussed in Section IV.
Table 5. Results of Chronic Dietary (Food + Drinking Water from Groundwater Sources) Exposure
Analysis Using DEEM FCID.
Population Subgroup
All populations
All infants (< 1 year old)
Children 1-2 years old
Children 3-5 years old
cPAD
(mg/kg/day)
0.0055
Exposure (mg/kg/day)
0.005147
0.016807
0.007726
0.007221
% cPAD
94
306
141
131
e. Cancer Dietary (Food and Drinking Water)
The cancer dietary assessment was conducted for the general U.S. population. To
estimate cancer risk, the 70-year lifetime average daily exposure is multiplied by the cancer
potency factor (Qi*) to yield a unitless number that represents the excess number of cancers
potentially attributed to exposure to the pesticide over a lifetime. For the cancer dietary risk, risk
estimates within the range of an increased cancer risk of one in a million (1 x 10"6) are generally
below EPA's level of concern. A Qi* is an estimate of the upper bound on risk.
The estimated exposure of the general U.S. population to fluometuron is 0.005147
mg/kg/day. Applying the Qi* of 1.80 x 10"2 (mg/kg/day)"1 to the exposure value results in a
combined cancer risk estimate of 9.27 x 10"5 for food and drinking water from groundwater
sources. As stated previously, the conservative predicted groundwater concentration used in this
assessment may have overestimated the cancer dietary risk of fluometuron. See Table 6 below
for cancer dietary risk estimates.
10
-------
Table 6. Fluometuron Cancer Dietary (Food + Drinking Water) Risk Estimates
Dietary Exposures Assessed
Food alone
Groundwater alone
Food + drinking water from groundwater sources
Surface water alone
Food + drinking water from surface water sources
Qi*
l.SOxlO'2
(mg/kg/day)"1
Cancer Risk Estimate
1.22X10'6
9.14xlO"5
9.27 x lO'5
7.36 x 10"6
8.58 x ID'6
The estimated exposure of the general U.S. population to fluometuron in surface water is
0.000476 mg/kg/day. Applying the Qi* of 1.80 x 10"2 (mg/kg/day)"1 to the exposure value
results in a combined cancer risk estimate of 8.58 x 10"6 for food and drinking water from surface
water sources.
For comparison, the cancer risk estimates for exposure through groundwater and surface
water sources of drinking water individually (excluding food) are 9.14 x 10"5 and 7.36 x 10"6,
respectively. The estimated cancer risk for food alone (excluding drinking water) is 1.22 x 10"6.
Each of these risk estimates individually exceeds the Agency's level of concern, except for the
estimated cancer risk for food alone.
The significant contributors to the cancer risk estimates have been identified as drinking
water (direct, all sources and indirect, all sources), and several rotational crops, with wheat
(flour), soybean (oil), and rice (white) having the highest contributions. The AR estimates are
considered moderately refined, although they are also highly conservative based on the nature of
the residue data source, since field trial and field accumulation studies use maximum application
rates and minimum pre-harvest intervals (PHI). Such AR estimates are likely to overestimate the
dietary exposure and risk from the use of fluometuron. Also, in the risk estimates above, a
maximum percent crop treated estimate of 20% was used for application to cotton. When the
Agency considered potential residues in rotational crops, the Agency used the conservative
percent crop treated value of 20% as well. Both the use of a maximum percent treated estimate
for cotton and the application of the maximum value to rotational crops likely overestimated the
cancer dietary risk of fluometuron. Moreover, the unrefined EDWCs were based on screening-
level models and likely overestimated the cancer dietary risk of fluometuron. Please note that
the cancer dietary risk estimates presented in this section have subsequently been refined, and are
further discussed in Section IV.
5. Residential Exposure and Risk
Fluometuron has no residential uses. In addition, no residential post-application exposure
is expected as a result of currently labeled uses. Therefore, a residential risk assessment was not
conducted.
11
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6. Aggregate Risk
In accordance with the FQPA, the Agency must consider the potential for aggregate risk
from all sources of pesticide exposures including food, drinking water, and, if applicable,
residential exposure to homeowners. In the case of fluometuron, the aggregate risk estimates are
the same as those presented in the dietary (combined food and drinking water) risk section of this
document (see Tables 4, 5, and 6), because there are no registered residential uses and no
residential exposures are expected to occur.
7. Occupational Exposure and Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying the
pesticide, or re-entering a treated site. For dermal and inhalation exposures, worker risk is
estimated by a Margin of Exposure (MOE) which determines how close the occupational
exposure comes to the No Observed Adverse Effect Level (NOAEL) selected from animal
studies. Please see Table 2 for the toxicological endpoints used in the fluometuron occupational
assessment. The dermal and inhalation MOEs were combined for fluometuron because the
toxicity endpoints for the dermal and inhalation routes of exposure were derived from the same
study. In addition, short- and intermediate-term risk estimates are the same because the
NOAELs for both exposure durations are identical. Long-term MOEs were not calculated since
long-term exposure is not expected as a result of the currently registered uses. Since
fluometuron is currently classified as a Group C carcinogen with a Qi* of 1.80 x 10"2
(mg/kg/day)"1, the Agency assessed both cancer and non-cancer risks for occupational handlers
and postapplication workers.
For fluometuron, MOEs that are greater than 100 and cancer risks within the range of an
increased cancer risk of 1 x 10"6 generally do not exceed the Agency's level of concern.
However, when occupational MOEs are less than 100 or occupational cancer risks exceed 1 x
10"6, EPA strives to reduce worker cancer risks through the use of personal protective equipment
and engineering controls. The Agency generally considers occupational cancer risks within the
range of 1 x 10"6 (1 in 1 million persons) or less to be negligible, but will consider risks as high
as 1 x 10"4 (1 in 10,000 persons) when all mitigation measures that are practical and feasible have
been applied and when there are critical pest management needs associated with the use of the
pesticide.
Nine occupational exposure scenarios based on active registered labels were assessed for
fluometuron, as follows:
la mixing/loading emulsifiable concentrates (ECs, liquids) for aerial applications
Ib mixing/loading ECs for groundboom applications
2a mixing/loading dry flowables (DF) for aerial application
2b mixing/loading DF for groundboom application
3a mixing/loading wettable powders (WP) for aerial application
3b mixing/loading WP for groundboom application
12
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4 applying liquid sprays via aerial equipment
5 applying liquid sprays via groundboom equipment
6 flagging for liquid sprays via aerial equipment
The Agency considered the following levels of personal protective equipment (PPE) or
engineering controls in the exposure assessments:
• Baseline, or long-sleeve shirt, long pants, no gloves, and no respirator. (Baseline)
• Baseline plus chemical-resistant gloves, and no respirator. (PPE-G-NR)
• Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves,
and no respirator. (PPE-G-DL-NR)
• Baseline plus chemical-resistant gloves and an 80% PF (quarter-face dust/mist)
respirator. (PPE-G-80%R)
• Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves,
and an 80% PF (quarter-face dust/mist) respirator. (PPE-G-DL-80%R)
• Engineering Controls, or closed mixing/loading system, enclosed cab, or enclosed
cockpit. (EC)
a. Handler Exposure and Risk
Risks for occupational handlers addressed the following scenarios: mixer/loader,
applicator, and flagger. These scenarios were used to estimate exposures based on application of
a variety of formulations (wettable powder, emulsifiable concentrate or liquid, and dry flowable)
via aircraft or by groundboom sprayer.
There were no chemical-specific handler data, so unit exposures from the Pesticide
Handlers Exposure Database (PFLED) Version 1.1 (August 1998) were used to estimate
exposures for a variety of clothing scenarios and combinations of PPE as listed above and
engineering controls. Standard assumptions were used for the number of acres treated, body
weight, hours worked, etc., for most handler scenarios.
Exposure assumptions for handler non-cancer exposure are based on a one-time
maximum application rate of 2.0 Ib ai/A determined from EPA registered labels for fluometuron.
PPE and engineering controls, as described above, were considered in the assessment. Both
dermal and inhalation MOEs for all occupational handler exposure scenarios are above 100 at
some level of PPE or engineering controls (see Table 7 below), and therefore below EPA's LOG.
Table 7. Predicted Handler Non-Cancer Risks for Fluometuron at the Maximum Application Rate of 2 Ib ai/A
Exposure Scenario
Acres
Treated
per Day
Dermal + Inhalation MOEs at Varying Levels of PPE
Baseline
PPE-G-NR
PPE-G-
DL-NR
PPE-G-
80%R
PPE-G-
DL-80%R
Eng.
Cont.
Eng. Cont.
(dermal
only)
Mixer/Loader
Mixing/Loading EC for Aerial Applications (la)
Mixing/Loading EC for Groundboom
Applications (Ib)
Mixing/Loading DF for Aerial Applications (2a)
1200
200
1200
0.86
5.2
34
71
430
34
86
520
46
98
590
37
130
770
52
260
1600
210
120
720
NA
13
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Table 7. Predicted Handler Non-Cancer Risks for Fluometuron at the Maximum Application Rate of 2 Ib ai/A
Exposure Scenario
Mixing/Loading DF for Groundboom
Applications (2b)
Mixing/Loading WP for Aerial Applications (3a)
Mixing/Loading WP for Groundboom
Applications (3b)
Acres
Treated
per Day
200
1200
200
Dermal + Inhalation MOEs at Varying Levels of PPE
Baseline
200
0.61
3.6
PPE-G-NR
200
4.2
25
PPE-G-
DL-NR
270
4.5
27
PPE-G-
80%R
220
9.8
59
PPE-G-
DL-80%R
310
12
69
Eng.
Cont.
1200
210
1200
Eng. Cont.
(dermal
only)
NA
NA
NA
Applicator
Applying Liquid Sprays via Aerial Equipment
(4)
Applying Liquid Sprays via Groundboom
Equipment (5)
1200
200
No Data
700
700
820
970
1200
440
2800
No Data
1200
Flagger
Flagging for Liquid Sprays via Aerial
Equipment (6)
350
590
No Data
630
No Data
800
1600
1000
G=gloves; NR=no respirator; DL=double layer, R=respirator, Eng. Cont.=engineering controls
EC=emulsifiable concentrate, WP=wettable powder, DF=dry flowable
Exposure assumptions for handler cancer risks included the average application rate of
1.5 Ib ai/A. It is assumed that private handlers would handle fluometuron approximately 6 days
per year and that commercial handlers would handle fluometuron approximately 18 days per
year, based on the use pattern of the chemical. Finally, a 35 year career and a 70 year life span
were used to complete the calculations. PPE and engineering controls were also used in the
assessment. Estimated cancer risks for most commercial grower scenarios are less than 1 x 10"4
at various levels of PPE, but are in the range of 1 x 10"6 with engineering controls (except for
handlers mixing and loading for aerial applications). Table 8 below presents the predicted
cancer risk estimates for commercial handlers at varying levels of PPE. Risk estimates for
private applicators are not presented here; however, risk estimates are less than risk estimates for
commercial handlers due to the handling of less material, and mitigation to address commercial
handlers will be protective of private applicators.
Table 8. Predicted Handler Cancer Risks for Fluometuron for Commercial Handlers Applying at the
Average Rate of 1.5 Ib ai/A
Exposure Scenario
Acres
Treated
per Day
Cancer Risks at Varying Levels of PPE
Baseline
PPE-G-NR
PPE-G-
DL-NR
PPE-G-
80%R
PPE-G-
DL-80%R
Eng. Cont.
Mixer/Loader
Mixing/Loading EC for Aerial Applications (la)
Mixing/Loading EC for Groundboom
Applications (Ib)
Mixing/Loading DF for Aerial Applications (2a)
Mixing/Loading DF for Groundboom
Applications (2b)
Mixing/Loading WP for Aerial Applications (3a)
1200
200
1200
200
1200
3.2x10-3
5.5x10-4
8.4x10-5
1.4x10-5
4.7xlO'3
4.0x10-5
6.7x10-6
8.4x10-5
1.4x10-5
6.8x10-4
3.3x10-5
5.5x10-6
6.2x10-5
1.0x10-5
6.4x10-4
2.9x10-5
4.8x10-6
7.7x10-5
1.3x10-5
2.9x10-4
2.2x10-5
3.7x10-6
5.5x10-5
9.2x10-6
2.5x10-4
1.1x10-5
1.8x10-6
1.4x10-5
2.3x10-6
1.4x10-5
14
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Table 8. Predicted Handler Cancer Risks for Fluometuron for Commercial Handlers Applying at the
Average Rate of 1.5 Ib ai/A
Exposure Scenario
Mixing/Loading WP for Groundboom
Applications (3b)
Acres
Treated
per Day
200
Cancer Risks at Varying Levels of PPE
Baseline
7.9x10-4
PPE-G-NR
1.1x10-4
PPE-G-
DL-NR
1.1x10-4
PPE-G-
80%R
4.9x10-5
PPE-G-
DL-80%R
4.1x10-5
Eng. Cont.
2.3x10-6
Applicator
Applying Liquid Sprays via Aerial Equipment
(4)
Applying Liquid Sprays via Groundboom
Equipment (5)
1200
200
No Data
4.1x10-6
No Data
4.1x10-6
No Data
3.5x10-6
No Data
2.9x10-6
No Data
2.4x10-6
6.5x10-6
1.0x10-6
Flagger
Flagging for Liquid Sprays via Aerial
Equipment (6)
350
4.8x10-6
No Data
4.5x10-6
No Data
3.6x10-6
1.8x10-6
G=gloves; NR=no respirator; DL=double layer, R=respirator, Eng. Cont.=engineering controls
EC=emulsifiable concentrate, WP=wettable powder, DF=dry flowable
b. Post-Application Exposure and Risk
Post-application exposure scenarios including irrigation, scouting, and hand weeding
were assessed. No chemical-specific dislodgeable foliar residue data were available for
fluometuron, so the Agency used dislodgeable foliar residue estimates based on standard default
assumptions. These values are presented in the Table 9 below.
Table 9. Summary of Fluometuron Post-Application Activities and Predicted Risks
Crop
(Rates)
Cotton
(2.0 Ib ai/A for short-
term & 1.5 Ib ai/A for
cancer)
Transfer Coefficients
(cm2/hr)a
100 (early season - low
crop)
1500 (later season - mature
crop)
Activities
Irrigation, Scouting,
Hand Weeding
Irrigation, Scouting,
Hand Weeding
MOE at Day 0
(12 hours after
application)
1700
110
Cancer Risk
DayO
7 x 10'7
1 x 10"5
Day 12
not
needed
9 x 10"7
Based on the maximum application rate of 2.0 Ib ai/A, short-term non-cancer post-
application risks do not exceed the Agency's level of concern (i.e., risks are greater than the
target MOE of 100) at day 0, approximately 12 hours following application.
Exposure assumptions for handler cancer risks included the average application rate of
1.5 Ib ai/A. Since the post-application tasks of concern for fluometuron uses in cotton include
hand weeding, scouting, and irrigating (but not harvesting), the Agency estimated that workers
typically would spend 6 days per season performing tasks in fluometuron treated areas. The
post-application risks for early season entry are less than 1 x 10"6 on day 0, approximately 12
hours following application. However, post-application cancer risks for later season entry are 1
x 10"5 on day 0 and are not in the negligible risk range until several days after treatment.
15
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c. Incident Reports
Available sources of incident data in humans were reviewed for fluometuron. Data were
available from the following sources: 1) Incident Data System consisting of reports submitted to
EPA by registrants, other federal and state health and environmental agencies and the public
since 1992; 2) Poison Control Centers for 1993 through 1998; 3) California Department of
Pesticide Regulation for pesticide poisonings since 1982; and 4) National Pesticide
Telecommunications Network (NPTN) for ranking of the top 200 active ingredients for which
telephone calls were received during calendar years 1984-1991, inclusive. Two of the four
available sources had information relevant to this review. The Incident Data System reported
two incidents. The first of which consisted of burns on the arm of an individual from a dermal
exposure and another individual reported dizziness, nausea, tingling face, and a locked jaw. No
further information on the disposition of the cases was reported. Poison Control Centers
reported five cases. Four of these five cases resulted from exposure to environmental residue
rather than direct contact. Symptoms reported differed from case to case indicating effects
reported were coincidental rather than fluometuron exposure. Fluometuron was not listed of the
top 200 chemicals for which the National Pesticide Information Center received calls from 1984-
1991. Therefore, no conclusions can be drawn from this very limited number of reported
exposures.
B. Environmental Fate and Effects Risk Assessment
A summary of the Agency's environmental fate and effects risk assessment is presented
below. For detailed discussion of all aspects of the environmental risk assessment, please see the
Revised Environmental Fate and Ecological Risk Assessment of Fluometuron dated February 22,
2005, which is available on the internet and in the public docket.
1. Environmental Fate and Transport
Fluometuron and its metabolites are both mobile and persistent in the environment. The
primary route of degradation of fluometuron and its main degradate, CGA-41686, is microbial
metabolism. However, since fluometuron and its degradates are not volatile, and these degradative
processes are not rapid, these compounds will be available for leaching to groundwater and runoff to
surface water under many use conditions. Once in groundwater or surface water, fluometuron is
expected to persist due to its stability to hydrolysis and photolysis. Since there is limited fate data on
the major metabolite, CGA-41686, and fluometuron is persistent and mobile, it is assumed that CGA-
41686 is equipotent to the parent compound. Therefore, it is assumed that the environmental risk
from the metabolite would be the same as from the parent.
2. Ecological Exposure and Risk
To estimate potential ecological risk, EPA integrates the results of exposure and
ecotoxicity studies using the risk quotient method. Risk quotients (RQs) are calculated by
dividing acute and chronic exposure estimates (EECs) by ecotoxicity values for various wildlife
and plant species. RQs are then compared to levels of concern (LOCs), and when the RQ
exceeds the level of concern for a particular category, the Agency presumes a risk of concern to
that category. In general, the higher the RQ, the greater the potential risk (see Table 10 below
16
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for the Agency's LOCs). Risk characterization provides further information on potential adverse
effects and the possible impact of those effects by considering the fate of the chemical and its
degradates in the environment, organisms potentially at risk, and the nature of the effects
observed. To the extent feasible, the Agency seeks to reduce environmental concentrations in an
effort to reduce the potential for adverse effects to non-target organisms.
Table 10. EPA's Levels of Concern (LOCs) and Risk Presumptions
If a calculated RQ is greater than the LOG presented, then the Agency presumes
that-
Acute Risk . . .there is potential for acute risk; regulatory action may be warranted in
addition to restricted use classification
Acute Restricted Use . . .there is potential for acute risk, but may be mitigated through
restricted use classification
Acute Endangered Species ...endangered species may be adversely affected
Chronic Risk . . .there is potential for chronic risk
LOC
terrestrial
animals
0.5
0.2
0.1
1
LOC
aquatic
animals
0.5
0.1
0.05
1
LOC
plants
1.0
NA
1.0
NA
a. Terrestrial Organisms
Birds and Mammals
To assess potential risks to terrestrial organisms, the Agency derives estimated environmental
concentrations (EECs) from the Kenaga nomograph based on a large set of actual field residue data.
For fluometuron, the Agency determined EECs based on 3 applications of 2 Ib ai/A fluometuron to
cotton. EECs are then compared to the most sensitive toxicity endpoints to calculate RQs (e.g., LCso
or LD50 for acute effects, or a NOAEC for chronic effects). Avian chronic RQs could not be
calculated for fluometuron because no chronic toxicity data are available. The Agency intends to
require these data to support reregistration.
As presented in Table 11 below, acute RQs based on maximum EECs for birds do not exceed
the Agency's acute LOC of 0.5. However, acute RQs for birds feeding on short grass, tall grass,
broadleaf plants, and small insects slightly exceed the Agency's acute endangered species LOC of 0.1
Also as seen in Table 11, acute RQs based on maximum EECs for smaller mammals feeding
on short grass slightly exceed the Agency's acute LOC of 0.5; acute RQs for all other mammals do
not exceed the Agency's acute LOC. However, acute RQs for smaller mammals feeding on short
grass, tall grass, broadleaf plants, and insects, and large mammals feeding on short grass exceed the
Agency's endangered species acute LOC of 0.1. All chronic mammalian RQs exceed the Agency's
chronic LOC of 1.
Table 11. Acute and Chronic Risk Quotients for Terrestrial Organisms Exposed to Fluometuron as a Result of Use on
Cotton
Food Item
Short grass
Tall grass
Maximum
EEC
(ppm)
1119
513
Mean
EEC
(ppm)
396
168
Bird
Acute
RQs*
0.36
0.16
Mammal Acute RQs**
by Body Weight
15g
0.71-1.06
0.33-0.49
35 g
0.49-0.74
0.23-0.34
1000 g
0.11-0.17
0.05-0.08
Mammal
Chronic RQs***
Based
on Max
EECs
112
51
Based on
Mean
EECs
40
17
17
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Table 11. Acute and Chronic Risk Quotients for Terrestrial Organisms Exposed to Fluometuron as a Result of Use on
Cotton
Food Item
Broadleaf plants
small insects
Fruits, pods
large insects
Seeds
Maximum
EEC
(ppm)
630
70
Mean
EEC
(ppm)
210
33
Bird
Acute
RQs*
0.20
0.02
Mammal Acute RQs**
by Body Weight
15g
0.44-0.60
0.04-0.07
0.01
35 g
0.28-0.42
0.03-0.05
0.01
1000 g
0.06-0.09
0.01
O.01
Mammal
Chronic RQs***
Based
on Max
EECs
63
7
Based on
Mean
EECs
21
3
* Based on maximum EECs and ring-necked pheasant LC50 of 3 150 ppm
** Based on maximum EECs and laboratory rat LD50 of >1000 ppm and <1500 ppm
*** Based on NOAEC of 10 ppm based on discoloration of the spleen in a rat chronic dietary/carcinogenicity
study (MRS) 0163772).
Non-Target Insects
EPA currently does not estimate RQs for terrestrial non-target insects. However, fluometuron
is practically non-toxic to honeybees with an acute contact LD50 of 193.38 ug/bee. The Agency does
not expect fluometuron exposure to pose acute risk to non-target insects because fluometuron is
practically non-toxic to honeybees and because there are no incident data reporting adverse effects to
honeybees.
Non-Target Plants
EECs for terrestrial and semi-aquatic plants were derived for dry and wetland (semi-aquatic)
areas adjacent to a potential treatment site that may be affected by fluometuron via runoff and spray
drift. Acute non-endangered species RQs were derived by dividing the EEC by the EC25 plant toxicity
value. For endangered species, the RQs were derived by dividing the EEC by the selected NOAEC.
Table 12 below summarizes the estimated RQs for non-target terrestrial and semi-aquatic plants; all
acute non-endangered and endangered RQs for non-target terrestrial and semi-aquatic plants are
greater than the LOG of 1.
Note that the predicted risks to semi-aquatic plants appears to be significantly greater than the
risk to plants in dry areas or the risk to plants exposed to spray drift. The model input for the
watershed for semi-aquatic areas adjacent to the field being treated is 10 times that of the input for
adjacent dry areas. Unlike runoff from an adjacent dry area, wetlands tend to be low-lying and would
typically collect field runoff from a larger area.
Table 12. Acute Risk Quotients for Terrestrial and Semi-Aquatic Plants Exposed to Fluometuron
Area
Dry Area Adjacent to the Treatment Site
Wetland (Semi-Aquatic Area) Adjacent to
the Treatment Site
Drift
EEC (Ib ai/A)
0.1600
0.7000
0.1000
Non-Endangered
Species RQs*
27
117
11
Endangered
Species RQs**
80
350
50
* Based on terrestrial plant £€25 of 0.006 Ib ai/A
** Based on terrestrial plant NOAEC of 0.002 Ib ai/A
18
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b. Aquatic Organisms
Freshwater and Estuarine/Marine Fish and Invertebrates
To assess potential risks to aquatic animals, the Agency considers predicted EECs in surface
water using the Tier II model PRZM/EXAMS. Unlike the drinking water assessment described in the
human health risk assessment section of this document, the exposure values used in the ecological risk
assessment do not include the Index Reservoir (TR) and Percent Cropped Area (PCA) factor
refinements. These factors represent a drinking water reservoir, not the variety of aquatic habitats
relevant to a risk assessment for aquatic animals, such as ponds adjacent to treated fields. Therefore,
the EEC values used to assess exposure and risk to aquatic animals are not the same as those used to
assess exposure and risk to humans from pesticides in drinking water.
For fluometuron, the Agency modeled EECs for four cotton growing states, Mississippi,
North Carolina, Texas, and California, based on 3 aerial applications of 2 Ib ai/A. Peak EECs were
compared to acute toxicity endpoints to derive acute RQs. Generally, 60-day EECs are compared to
chronic toxicity endpoints (NOAEC values) to derive chronic RQs for freshwater organisms and 21-
day EECs are compared to chronic toxicity endpoints to derive chronic RQs for estuarine/marine
organisms; however, in the case of fluometuron, chronic RQs could not be calculated because no
chronic toxicity data are available. The Agency intends to require these data to support reregistration.
Acute RQs for freshwater fish based on EECs modeled for Mississippi and freshwater
invertebrates based on EECs modeled for Mississippi, Texas, and North Carolina slightly exceed the
Agency's acute LOG of 0.5, as shown in Table 13 below. Acute RQs for freshwater fish and
freshwater invertebrates for all locations modeled exceed the Agency's endangered species LOG for
aquatic animals of 0.05.
Acute RQs for estuarine/marine fish and invertebrates do not exceed the Agency's acute LOG
of 0.5; however, for endangered species, the predicted RQs are equal to or slightly exceed the LOG of
0.05 for aquatic animals based on peak EECs modeled for Mississippi, Texas, and North Carolina.
Table 13. Acute Risk Quotients for Aquatic Organisms Exposed to Fluometuron
Crop
Cotton
Modeled
Location
Mississippi
Texas
North
Carolina
California
Peak
EECs
(ppb)
324
191
246
52
Freshwater RQs
Fish
LCso =
640 ug/L
0.51
0.29
0.38
0.08
Invertebrates
LC5o=
220ug/L
1.47
0.87
1.12
0.24
Estuarine/Marine RQs
Fish
LC5o =
55300 ug/L
0.006
0.003
0.004
0.001
Invertebrates
LC50 =
3800 ug/L
0.09
0.05
0.06
0.01
Mollusks
LC50 =
6530 ug/L
0.05
0.03
0.04
0.01
Non-Target Plants
For aquatic vascular and non-vascular plants, peak EECs were compared to acute EC50
toxicity endpoints to derive acute non-endangered species RQs. Peak EECs were compared to
NOAEC toxicity endpoints to derive acute endangered species RQs. The most sensitive endpoint
(ECso or NOAEC) from the most sensitive species was used for both endangered and non-endangered
species; therefore, the acute RQ for nonvascular plants is based on green algae, Selenastrum
19
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capricornatum. The most sensitive ECso for Selenastrum capricornatum was 30 ug/L from a
supplemental study in which no NOAEC was determined. Thus the NOAEC of 180 ug/L from a core
study on Selenastrum capricornatum was chosen for as the risk assessment endpoint for endangered
nonvascular aquatic plants.
The RQs are presented in Table 14 below. Almost all acute non-endangered species RQs
exceed the LOG of 1 except for vascular plants based on Texas and California use scenarios.
Endangered species RQs exceed the plant LOG of 1 for plants based on Mississippi, Texas, and North
Carolina use scenarios.
Table 14. Acute Risk Quotients for Aquatic Vascular and Non-Vascular Plants Exposed to Fluometuron as a Result of
Use on Cotton
Modeled
Location
Mississippi
Texas
North Carolina
California
Peak
EECs
(ppb)
324
191
246
52
Non-Endangered RQs
Vascular Plant
ECso = 220 ug/L
1.47
0.87
1.12
0.24
Non-Vascular Plant
ECSO= 30 ug/L
10.81
6.35
8.19
1.73
Endangered RQs
Vascular Plant
NOAEC = 115 ug/L
2.82
1.66
2.14
0.45
Non-Vascular Plant
NOAEC = 180 ug/L
1.80
1.06
1.37
0.29
c. Endangered Species
The preliminary risk assessment for fluometuron indicates a potential for acute effects on
listed species as noted below, should exposure actually occur at modeled levels:
• Freshwater fish and invertebrates (acute): Cotton (all scenarios modeled - MS, NC, TX,
and CA).
• Estuarine/marine invertebrates (acute): Cotton (scenarios modeled - MS, NC, and TX).
• Aquatic plants (acute): Cotton (MS, TX, and NC scenarios).
• Birds (acute): Cotton (short grass, tall grass, and broadleaf plants/small insects).
• Mammals (acute): Cotton (short grass, tall grass, broadleaf plants/small insects) for small
(15 g) and medium (35 g) mammals and cotton (short grass) for large mammals (1000 g).
• Mammals (chronic): Cotton (short grass, tall grass, broadleaf plants/small insects, and
fruits/pods/large insects/seeds).
• Terrestrial and semi-aquatic plants (acute): Cotton (dry areas, wetland areas, and drift).
EPA does not currently have enough chronic toxicity data to quantify risks for fluometuron at
the screening level and therefore cannot preclude potential chronic effects to the following taxonomic
groups: birds, freshwater fish and invertebrates, and estuarine/marine fish and invertebrates. These
data will be required by the Agency as part of this RED.
Further, indirect effects cannot be precluded based upon the screening level assessment for
listed species dependent upon a taxa that may experience effects from the use of fluometuron.
These conclusions are based solely on EPA's screening-level assessment and do not
constitute "may effect" findings under the Endangered Species Act for any listed species.
3. Ecological Incidents
20
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A review of the Ecological Incident Information System (EIIS) database for ecological
incidents involving fluometuron was completed on August 3, 2004. There were two fluometuron
incidents in the database, both involving cotton. Fluometuron can have detrimental effects on the
cotton crop if it is applied directly to the foliage after cotton emergence. The first incident occurred in
North Carolina, and involved 45 adversely affected acres of cotton out of a total acreage of 80. The
second incident occurred in North Carolina and involved a liquid formulation of fluometuron. Three
acres out of 26 acres were adversely affected. It was unclear in this incident if fluometuron was
applied directly to cotton foliage leading to decimation of the crop.
IV. Risk Management, Reregistration, and Tolerance Reassessment
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 reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing fluometuron as an active ingredient. The Agency has completed its
review of these generic data, and has determined that the data are sufficient to support
reregi strati on of all products containing fluometuron.
The Agency has completed its assessment of the dietary, occupational, residential, and
ecological risk associated with the use of pesticide products containing the active ingredient
fluometuron. Based on a review of these data and on public comments on the Agency's
assessments for the active ingredient fluometuron, the Agency has sufficient information on the
human health and ecological effects to make decisions as part of the tolerance reassessment
process under FFDCA and reregi strati on process under FIFRA, as amended by FQPA. The
Agency has determined that fluometuron-containing products are eligible for reregi strati on
provided that: (i) the risk mitigation measures outlined in this document are adopted and (ii)
label amendments are made to reflect these measures. Label changes are described in Section V.
Appendix A summarizes the uses of fluometuron that are eligible for reregi strati on (i.e., cotton).
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregi strati on eligibility of fluometuron, and lists the submitted studies that the
Agency found acceptable. Data gaps are identified as generic data requirements that have not
been satisfied with acceptable data.
Based on its evaluation of fluometuron, the Agency has determined that fluometuron
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 fluometuron. If all changes outlined in this document are incorporated
into the product labels, then all current risks for fluometuron 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 III.
B.2.c. of this document.
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B. Public Comments and Responses
Through the Agency's public participation process, EPA worked with stakeholders and
the public to reach the regulatory decisions for fluometuron. EPA released its fluometuron
preliminary risk assessments for public comment on April 6, 2005, for a 60-day public comment
period (Phase 3 of the public participation process). During the public comment period on the risk
assessments, which closed on June 6, 2005, the Agency received comments from the registrant
and one individual. These comments in their entirety, responses to the comments, as well as the
preliminary and revised risk assessments, are available in the public docket (OPP-2004-0372) at
the address given above and in the EPA's electronic docket at http://www.epa.gov/edockets.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with this pesticide. The Agency has determined that, if the mitigation described in this document
is adopted and labels are amended, human health risks as a result of exposures to fluometuron
are within acceptable levels. In other words, EPA has concluded that the tolerances for
fluometuron 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 exposures
to fluometuron from all possible sources.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for fluometuron, with
amendments and changes as specified in this document, meet the safety standards under the
FQPA amendments to section 408(b)(2)(D) of the FFDCA, and that there is a reasonable
certainty no harm will result to the general population or any subgroup from the use of
fluometuron. In reaching this conclusion, the Agency has considered all available information
on the toxicity, use practices and exposure scenarios, and the environmental behavior of
fluometuron and its degradate.
As discussed in Section III, the acute dietary (food and drinking water) risks from
fluometuron are not of concern. Chronic and cancer risks from fluometuron are not of concern
provided that mitigation measures outlined in this document are adopted and labels are amended.
c. Determination of Safety to Infants and Children
EPA has determined that the established tolerances for fluometuron, with amendments
and changes as specified in this document, meet the safety standards under the FQPA
amendments to section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no
harm for infants and children. The safety determination for infants and children considers
factors on the toxicity, use practices and environmental behavior noted above for the general
population, but also takes into account the possibility of increased dietary exposure due to the
22
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specific consumption patterns of infants and children, as well as the possibility of increased
susceptibility to the toxic effects of fluometuron residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic
effects from exposure to residues of fluometuron, the Agency considered the completeness of the
hazard database for developmental and reproductive effects, the nature of the effects observed,
and other information. On the basis of this information, the Special FQPA SF has been removed
(i.e., reduced to IX) for fluometuron. The rationale for the decisions on the FQPA SF can be
found in Section III and the following document: Fluometuron: Revised HED Risk Assessment for
Phase III of the Reregistration Eligibility Decision (RED) dated February 1, 2005.
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). In the available toxicity studies on fluometuron, there was no evidence of
estrogen, androgen, and/or thyroid-mediated toxicity.
3. Cumulative Risks
Section 408(b)(2)(D)(v) of FIFRA requires that, when considering whether to establish,
modify, or revoke a tolerance, the Agency consider "available information" concerning the
cumulative effects of a particular pesticide's residues and "other substances that have a common
mechanism of toxicity."
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
as to fluometuron and any other substances, and fluometuron does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that fluometuron has a common mechanism of toxicity with other
substances. 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 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://www.epa.gov/pesticides/cumulative/.
23
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4. Endangered Species
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
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 ecological parameters, pesticide use information, geographic
relationship between specific pesticide uses and species locations, and biological requirements
and behavioral aspects of the particular species. When conducted, this analysis will consider
regulatory changes recommended in this RED that are implemented at that time. A
determination that there is a likelihood of potential effects to a listed species may result in
limitations on use of the pesticide, other measures to mitigate any potential effects, or
consultations with the Fish and Wildlife Service or the National Marine Fisheries Service as
appropriate. If the Agency determines that the use of fluometuron "may affect" listed species or
their designated critical habitat, EPA will employ provisions in the Services regulations (50 CFR
Part 402). Until that species-specific analysis is complete, the risk mitigation measures being
implemented through this RED will reduce the likelihood that endangered and threatened species
may be exposure to fluometuron at levels of concern.
D. Tolerance Reassessment Summary
A tolerance is established for negligible residues of the herbicide fluometuron [1,1-
dimethyl-3-(a,a,a,-trifluoro-m-tolyl)urea] in or on the raw agricultural commodity cotton,
undelinted seed (40 CFR §180.229).
The tolerances listed in 40 CFR must be reorganized in order to: (i) incorporate the
recommendations made by the Agency concerning the fluometuron residues of concern that need
to be regulated for plant and animal commodities; (ii) include tolerances that are needed to cover
fluometuron residues of concern in/on the raw agricultural commodities and processed
commodities of rotational crops; and (iii) conform with the requirements of FQPA. FQPA
amends the FFDCA to bring all EPA pesticide tolerance-setting activities under a single section
of the statute, Section 408. The FQPA authorizes the conversion of all existing Section 409
tolerances for pesticide residues in processed food/feed into Section 408 tolerances. The
reorganization of fluometuron tolerances should be conducted as depicted below in Table 15. A
summary of fluometuron tolerance reassessments is presented in Table 16.
There are no Codex, Canadian, or Mexican maximum residue limits (MRLs) for
fluometuron.
24
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Table 15. Reorganization of Fluometuron Tolerances Required Under 40 CFR.
40 CFR Section
§ 180.229 (a)(l)
§ 180.229 (a)(2)
§ 180.229 (d)
§ 180.229 (d)
Section Reserved For
Plant commodities
Livestock commodities
Rotational crop commodities
Food/feed commodities
processed from rotational crops
Tolerance Expression
Fluometuron and its metabolites determined as TFMA.
Fluometuron and its metabolites determined as TFMA,
and the hydroxylated metabolites CGA-23643 1,
CGA-436432, CGA-13211, and their conjugates.
Fluometuron and its metabolites determined as TFMA.
Fluometuron and its metabolites determined as TFMA.
Tolerances Required Under 40 CFR §180.229 (a)(l):
The interim cottonseed field trial data suggest that the established 0.10 ppm tolerance for
cottonseed is too low to adequately cover fluometuron residues of concern that may result
following applications of WP and EC formulations according to the maximum use pattern
eligible for reregi strati on. The existing data indicate that an appropriate tolerance would be 1.0
ppm. However, additional field trial data reflecting use of the DF formulation are required, and
these data may indicate a need to further adjust the tolerance. An adequate cotton gin byproducts
field trial study has been submitted and reviewed. Residues of fluometuron are not expected to
exceed 3.1 ppm in cotton gin byproducts, therefore, an appropriate tolerance value would be 3.5
ppm.
Tolerances Required Under 40 CFR §180.229 (a)(2):
The data from ruminant feeding studies suggest that an appropriate tolerance level of 0.10
ppm should be established for milk and 0.10 ppm for ruminant and hog meat byproducts. This
recommendation is tentative pending submission and evaluation of the requested storage stability
data for the hydroxylated metabolites (CGA-236431, CGA-436432, CGA-13211, and their
conjugates).
The aggregate of data from poultry metabolism and poultry feeding studies suggest that
an appropriate tolerance level of 0.10 ppm should each be established for eggs, poultry fat,
poultry meat, and poultry meat byproducts. This recommendation is tentative pending
submission and evaluation of the requested storage stability data for the hydroxylated
metabolites (CGA-236431, CGA-436432, CGA-13211, and their conjugates).
Tolerances Required Under 40 CFR §180.229 (d):
Data from extensive field rotational trials suggest the need for tolerances for fluometuron
residues of concern in/on several raw agricultural commodities of rotational crops. The
recommended tolerances are listed below in Table 16.
Data from processing studies on rotational crops suggest the need for tolerances for
25
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fluometuron residues of concern in/on several processed commodities; the recommended
tolerances are listed below in Table 16.
Table 16. Tolerance Reassessment Summary for Fluometuron.
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comments
Tolerances Required Under 40 CFR §180.229 (a)(l)
Cotton, gin byproducts
Cotton, undelinted seed
None
0.1
3.5
l.O1
Based on field trial data
Tolerances Required Under 40 CFR §180.229 (a)(2)
Cattle, meat byproducts
Goat, meat byproducts
Hog, meat byproducts
Horse, meat byproducts
Sheep, meat byproducts
Milk
Egg
Poultry, fat
Poultry, meat
Poultry, meat byproducts
None
None
None
None
None
None
None
None
None
None
0.1
0.1
0.1
0.1
0.1
0.02
0.1
0.1
0.1
0.1
These recommendations
are based on feeding
studies, but tentative
pending submission of
supporting storage
stability data for the
hydroxylated
metabolites.
Tolerances Required Under 40 CFR §180.229 (d)
Grain, cereal, group 15
Grain, cereal, forage, group 16
Grain, cereal, fodder, and straw, group 16
Peanut
Peanut, hay
Soybean, seed
Soybean, forage
Soybean, hay
Peanut, meal
None
None
None
None
None
None
None
None
None
0.5
3.0
6.0
0.1
4.0
2.0
3.0
3.0
0.2
Proposed tolerance
levels are based on
available data.
26
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Table 16. Tolerance Reassessment Summary for Fluometuron.
Commodity
Rice, hulls
Wheat, milled byproducts
Current
Tolerance
(ppm)
None
None
Tolerance
Reassessment
(ppm)
1.0
1.0
Comments
1. Additional data are required for the DF formulation. These data may indicate the need for additional tolerance
adjustment.
E. Regulatory Rationale
The following is a summary of the rationale for mitigation measures necessary for
managing risks associated with the use of fluometuron for fluometuron to be eligible for
reregi strati on. Where labelling revisions are warranted, specific language is set forth in the
summary table of Section V.
1. Human Health Risk Management
a. Dietary (Food and Drinking Water) Risk Mitigation
Acute
Acute dietary risk is below the Agency's level of concern; risk estimates are 34% of the
aPAD for women of childbearing age, the only population subgroup for which the acute endpoint
applies. Therefore, no mitigation is needed to address acute dietary risks. Further, acute risk
estimates decrease to 5% of the aPAD when revised to incorporate the mitigation measures and
refinements described below.
Chronic and Cancer
Estimated chronic and cancer dietary risks are above the Agency's level of concern.
Chronic dietary risk estimates presented in Section III are driven by screening-level, modeled
drinking water exposure from groundwater sources, and cancer dietary risk estimates are driven
by predicted drinking water exposures (from both groundwater and surface water sources) and
food exposures from several rotational crops with wheat (flour), soybean (oil), and rice (white)
having the highest contributions.
To address these predicted risk concerns, the Agency used a number of
approaches which included a combination of risk assessment refinements and risk mitigation
measures. The Agency used an updated value of 10% percent crop treated for cotton and
updated information on the percent of national acreage of soybeans, corn, and wheat rotated in
following fluometuron-treated cotton. These updated values were incorporated into the
Agency's dietary risk assessment to refine the potential food exposure estimates. For details, see
also the following document: Refined Fluometuron Percent Crop Treated and Percentage of
National Soybean, Corn, and Wheat Crops Rotated with Fluometuron-Treated Cotton dated
27
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August 9, 2005 and Addendum to RefinedFluometuron Percent Crop Treated... dated September
21,2005.
In addition, the Agency calculated refined drinking water EDWCs for use in the dietary
risk assessment in order to account for mitigation measures (i.e., application rate reductions)
proposed by the registrant (see Table 17 below) and to account for differences between the fate
characteristics of parent fluometuron and its primary degradate, desmethyl fluometuron.
Different application rates are proposed for different soil types to reflect the rate necessary to
achieve efficacy of the product. See Table 18 below for refined drinking water EDWCs that
were used to revise the dietary (food and drinking water) exposure and risk estimates. See also
Revised Drinking Water Assessment andEFED 's Response... dated September 28, 2005 for
additional explanation of the modeling input parameters and results.
Table 17. Proposed Revised Fluometuron Application Rates by Soil Type
Soil Texture
Sand, Loamy Sand, Sandy Loam
Loam, Silt Loam, Silt, Sandy Clay
Loam, Silty clay loam, Clay loam
Sandy clay, Silty Clay, Clay
Maximum One-Time
Application Rate
1 Ib ai/A
1.6 Ib ai/A
2 Ib ai/A
Number of
Applications
2
2
2
Seasonal
Max. Rate
2 Ib ai/A
3 Ib ai/A
3 Ib ai/A
Minimum
Application
Interval
20 days
20 days
20 days
Table 18. Refined Total EDWCs (ppb) in Surface Water and Groundwater for Fluometuron and its
Major Degradate (by State)
Surface water/ peak (90th percentile annual daily max. - acute)
Surface water/average (90th percentile annual mean - chronic)
Surface water/3 6-year overall mean (cancer)
Groundwater (all exposures)
Use modeled*
Percent Cropped Area (cotton)
CA
13.8
10.9
9.3
TX
15.5
6.38
3.84
MS
31.2
6.34
2.54
NC
14.1
4.60
3.56
2 1.6 (light soils)
32.4 (intermediate soils)
22.8 (heavy soils)
3 Ib ai/A
2 Ib ai/A
3 Ib ai/A
2 Ib ai/A
20%
* The use modeled, specifically the application rate, was chosen based on proposed rate by soil type as described
in Table 17 above and the predominant soil type in the states modeled.
Revised chronic dietary (food and drinking water) risk estimates incorporating the
refinements and mitigation described above are no longer of concern to the Agency with the
most highly exposed subpopulation being all infants at 41% of the cPAD. The revised chronic
dietary risk estimates are presented in Table 19 below. As stated above, predicted groundwater
exposure is the chronic dietary risk driver and surface water estimates are not of concern to the
28
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Agency. For further information, see Fluometuron. Revised Acute, Chronic, and Cancer
Dietary Exposure Assessments for the Reregistration Eligibility Decision (RED) Document dated
September 27, 2005.
Table 19. Refined results of Chronic Dietary (Food + Drinking Water from Groundwater Sources)
Exposure Analysis Using DEEM FCID.
Population Subgroup
All populations
All infants (< 1 year old)
Children 1-2 years old
Children 3-5 years old
cPAD
(mg/kg/day)
0.0055
Exposure (mg/kg/day)
0.000688
0.002248
0.001028
0.000962
% cPAD
13
41
19
18
Revised cancer dietary risk estimates incorporating the refinements and mitigation
described above are presented in Table 20 below. Cancer dietary (food and drinking water) risk
estimates are within the negligible risk range of 10"6 based on predicted EDWCs from surface
water sources for the modeled scenarios and are not of concern to the Agency.
-v-5
The cancer dietary (food and drinking water) risk estimate is 1 x 10" , based on the
highest predicted EDWCs from groundwater sources (32. 4 ppb; intermediate soils), with
groundwater exposure being the risk driver. For further information, see Fluometuron. Revised
Acute, Chronic, and Cancer Dietary Exposure Assessments for the Reregistration Eligibility
Decision (RED) Document dated September 27, 2005. However, drinking water exposure
estimates are based on conservative, screening-level models which are used to determine if
further characterization or monitoring information is needed to evaluate whether risks are of
concern. Also, the cancer potency factor is, by nature, a conservative estimate of risk, and
exposure estimates from food remain conservative as they are based on field trial data.
Moreover, banded application of fluometuron, which is an application practice described on
product labels and often employed, would result in significantly less potential drinking water
exposure because the amount of active ingredient per acre used in banded applications is much
less than that used in broadcast applications.
Further, existing NAWQA drinking water monitoring data on fluometuron showed low
concentrations. While these data are spatially and temporally limited in cotton and fluometuron
use areas, the maximum groundwater concentration measurement of 4.7 ppb, which is the
highest concentration sampled, is well below an average concentration that results in estimated
risks of concern to the Agency. Moreover, the vast majority of groundwater samples present
substantially lower concentration levels (<0.1 ppb) and, over the course of the monitoring
program, only two groundwater detections showed concentrations greater than 2.5 ppb. Also, a
limited number of NAWQA groundwater samples from 1995 to 2004 are available from areas of
high planted cotton (counties with > 100,000 acres of planted cotton) and historic high use of
fluometuron use, which included areas in AR, MS, NC, and TX. Most samples of the parent
compound resulted in no detects and only five samples resulted in detects < 0.35 ppb. From the
same samples, some detections were available of TFMA, a common analyte for fluometuron
degradates including the primary degradate, desmethyl fluometuron. Similarly, TFMA
29
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concentrations from these samples were low, with all being < 0.05 ppb.
Based on the monitoring data and the conservative nature of the assessment as described
above, the Agency does not believe that long-term average residues of fluometuron and its
degradate in groundwater sources of drinking water will result in cancer risks above the
Agency's level of concern. To confirm that exposure is not likely to exceed the Agency's level
of concern, the Agency and the registrant have agreed that additional groundwater monitoring
data are necessary. A water monitoring program is being required as part of this RED. For
further information, the see the document Revised Drinking Water Assessment andEFED 's
Response...dated September 28, 2005.
Table 20. Revise Fluometuron Cancer Dietary (Food + Drinking Water) Risk Estimates
Dietary Exposures Assessed
Food alone
Groundwater alone
Food + groundwater
Surface water alone
Food + surface water
Qi*
l.SOxlO'2
(mg/kg/day)"1
Cancer Risk Estimate
9 x ID'8
1 x ID'5
1 x 10'5
1 x 10"6
2 x lO'6
b.
Residential Risk Mitigation
Fluometuron has no residential uses. In addition, no residential post-application exposure
is expected as a result of currently labeled uses. Therefore, no residential risk mitigation is
necessary.
c.
Aggregate Risk Mitigation
For fluometuron, the aggregate risk estimates are the same as those presented in the
dietary (combined food and drinking water) risk section of this document because there are no
registered residential uses of fluometuron. Therefore, no additional mitigation beyond that
presented in the dietary risk mitigation section is necessary.
d.
Occupational Risk Mitigation
It is the Agency's policy to mitigate occupational risk to the greatest extent practical and
feasible. Mitigation measures may include reducing application rates, adding personal protective
equipment (PPE) to end product labels, requiring the use of engineering controls, and other
measures. A wide range of factors is considered in making risk management decisions for
worker risks. These factors include, in addition to the estimated MOEs and cancer risk
estimates, incident data, the nature and severity of adverse effects observed in the animal studies,
uncertainties in the risk assessment, alternative registered pesticides, the importance of the
chemical in integrated pest management (IPM) programs, and other factors.
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Occupational exposure assessments are completed by the Agency considering the use of
baseline PPE and, if warranted, for handlers, increasing levels of PPE and engineering controls
in order to estimate the potential impact on exposure and risk. The target MOE for fluometuron
is 100, based on information provided in Section III of this document. For occupational cancer
risks, estimates within the negligible risk range of 10"6 do not exceed the Agency's level of
concern. When occupational risks are less than 100 or occupational cancer risks exceed the
general range of 10"6, EPA strives to reduce worker risks through the use of PPE and engineering
controls or other mitigation measures. The Agency generally considers occupational cancer risks
in the general range of 10"6 or less to be negligible, but may accept risks as high as 1 x 10"4 when
all mitigation measures that are feasible and practical have been applied, particularly when there
are critical pest management needs associated with the use of the pesticide. For example,
fluometuron is a useful tool to address weed resistance and weed shifts that occur as a result of
widespread glyphosate use, as well as for growers that do not grow glyphosate-tolerant cotton.
Handler Risk Mitigation
Handler risks were predicted for several fluometuron exposure scenarios as listed in
Tables 7 and 8 for both commercial handlers and private handlers. Predicted risk estimates for
commercial handlers only are presented in Section III of this document because MOEs for
private handlers are much less than MOEs for commercial handlers, and any mitigation to
address potential risks to commercial handlers will also address potential risks to private
handlers.
Commercial handlers mixing and loading WP for aerial or groundboom application (3a
and 3b), and handlers mixing and loading DF for aerial application (2a) have estimated risks
above the Agency's level of concern, with MOEs from 12 to 69 and cancer risk estimates
ranging from 3 x 10"4 to 4 x 10"5 at the highest level of PPE. To address these risk concerns, the
technical registrant has agreed to voluntarily cancel its WP formulation registrations. For a
separate WP product (EPA Reg. No. 5905-494), the end-product registrant has agree to package
its WP product in water soluble packaging, resulting in an MOE of 210 and a cancer risk
estimate of 1 x 10"5. Further, the technical registrant has agreed to prohibit the application of DF
formulations via aircraft.
To mitigate potential risks to commercial handlers mixing and loading EC formulation
for aerial application (la), the Agency is requiring the use of double-layer PPE plus gloves and
an apron. With this level of PPE, the MOE is greater than 86 and the cancer risk estimate is less
than 3 x 10"5. The Agency determined that a respirator does not provide significantly greater
levels of protection for handlers because the dermal route of exposure to fluometuron is of much
greater concern than the inhalation route of exposure, and additional PPE has minimal impact on
reducing the cancer risk estimates. Further, aerial application of fluometuron does not occur
frequently, as it is considered an emergency treatment if the ground is too wet for an applicator
to enter fields on a tractor to apply via groundboom. Agency information indicates that at least
80% of fluometuron is applied via groundboom with less than 20% being applied aerially.
Therefore, the risk estimate as a result of limited potential exposure from mixing and loading for
aerial application is not of concern to the Agency.
-------
To mitigate potential risks to commercial handlers mixing and loading EC and DF for
groundboom application (Ib and 2b), the Agency is requiring the use of single-layer PPE plus
gloves. With this level of PPE, the MOEs are 430 for EC formulations and 200 for DF
formulations and not of concern. Cancer risk estimates are 7 x 10"6 and 1 x 10"5, respectively.
Because additional PPE has minimal impact on reducing the estimated cancer risks for these
scenarios, no additional PPE is required.
For commercial handlers applying fluometuron via groundboom (applicators; 5), the
Agency does not have short/intermediate-term risk concerns and is requiring baseline PPE,
resulting in a MOE of 700. The cancer risk estimate considering this PPE is 4 x 10"6. To
mitigate potential risks to handlers applying fluometuron aerially (applicators; 4), the Agency is
requiring the use of engineering controls in the form of enclosed cockpits resulting in a MOE of
440 and a cancer risk estimate of 7 x 10"6. For handlers acting as flaggers (6), the Agency does
not have short/intermediate term risk concerns and is requiring baseline PPE, resulting in a MOE
of 590. The estimated cancer risk considering this PPE is 5 x 10"6; since additional PPE
requirements do not have a significant impact on reducing the risk estimates, no additional PPE
is required.
Post-Application Worker Risk Mitigation
For workers re-entering treated cotton fields to conduct post-application activities, such
as irrigation and hand weeding, the Agency's risk estimates are not of concern for early season
activities with MOEs of 1700 and cancer risk estimates of 7 x 10"7. Predicted cancer risks
exceed the Agency's level of concern for workers re-entering treated, mature cotton later in the
season (cancer risk estimate of 1 x 10"5; MOEs are not of concern at 110) as a result of increase
foliage; however, the Agency understands that the great majority (>88%) of fluometuron
application to cotton occurs early in the season (pre-emergence, pre-plant, or early post-
emergence). Because of the limited late season use, repeated exposures are not likely; therefore,
the Agency does not have post-application risk concerns for fluometuron and will maintain the
current 24 hour REI.
2. Non-Target Organism (Ecological) Risk Management
The Agency's policy is to mitigate ecological risks to the greatest extent practical and
feasible. Mitigation measures may include lowering application rates, reducing the number of
applications allowed in a year, restricting the timing of applications, extending the time between
applications, and changing pesticide use to minimize runoff or spray drift. In some situations,
registrants may choose to delete certain uses or application methods to address ecological risk
concerns. Fluometuron is expected to be useful for weed resistance and weed shifts that occur as
a result of widespread glyphosate use, as well as for growers that do not grow glyphosate-
tolerant cotton.
The screening-level risk assessment for fluometuron suggests that exposure to
fluometuron could result in acute risks of concern to birds, mammals, terrestrial and aquatic
plants, and chronic risks of concern to mammals. The Agency has addressed these risk concerns
32
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to the extent feasible while considering some of the factors listed above. Specific risk mitigation
measures are described in the following sections.
EPA does not currently have enough chronic toxicity data to quantify risks for fluometuron for
the following taxonomic groups: birds, freshwater fish, estuarine/marine fish, freshwater
invertebrates, estuarine/marine invertebrates. The Agency intends to require these data as part of this
RED.
To help address ecological risk concerns, the registrant has agreed to label changes to
significantly reduce the potential risk to non-target species, including significant reductions in the
maximum seasonal application rates (up to 66% of the rate assessed, for some soil types), as
presented in Table 17 above, and to require the use of medium to coarse droplet sizes during spray
applications. The use of a larger droplet size is expected to significantly reduce off-site drift to
nontarget organisms. See the following document for additional information on the effects of these
mitigation measures on predicted ecological risk estimates: Revised Risk Quotient Calculations for
Proposed New Application Rates for Fluometuron, dated September 23, 2005.
a. Terrestrial Organisms
Birds and Mammals
EPA's screening-level risk assessment based on estimated maximum potential rates and
aerial application for fluometuron suggests minimal acute risk concerns for birds and mammals,
with the highest RQ being approximately 1 (for the smallest mammals feeding on short grass)
and all others being 0.6 or less, and only slightly exceeding the LOCs (Table 11). The rate
reductions that the registrant has agreed to will reduce these risks so that all acute RQs are less
than 0.25.
EPA's screening-level risk assessment for fluometuron suggests chronic risks of concern
for mammals, with RQs ranging from 40 to 3 based on mean EECs and aerial application (Table
11). At most, only 20% of fluometuron used is applied aerially, and groundboom application
results in less exposure as a result of drift. Further, the significant reductions in seasonal
maximum application rates will reduce chronic risks to mammals, resulting in revised chronic
RQs of 0.18 to 2.82.
As stated above, the Agency does not have chronic toxicity data with which to estimate
potential chronic risks to birds. The mitigation described above will reduce any current,
potential chronic risks to birds, and the Agency intends to require the data necessary to evaluate
chronic risk as part of this RED decision.
Non-Target Insects
Available data show that fluometuron is practically non-toxic to honeybees. The Agency
does not have a risk concern for non-target insects. Therefore, no bee precautionary labelling is
required on fluometuron product labels.
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Plants
Consistent with its use as an herbicide, fluometuron is toxic to plants. Therefore, as
would be expected, EPA's screening-level risk assessment for fluometuron results in RQs for
terrestrial and semi-aquatic plants ranging from 11 to 117 (Table 12). As stated above, there are
significant reductions in seasonal maximum application rates; however, these reductions will not
reduce risks to plants because the maximum one-time application rate is still 2 Ib ai/A for heavy
soils; thus, RQs for terrestrial non-endangered plants remain 11 to 117. However, fluometuron is
useful for weed resistance and weed shifts that occur as a result of widespread glyphosate use, as
well as for growers that do not grow glyphosate-tolerant cotton. Further, the implementation of
spray drift reduction measures, including a requirement that sprays consist of medium to coarse
size droplets will reduce potential off-site drift.
b. Aquatic Organisms
Freshwater Fish and Invertebrates
EPA's screening-level risk assessment for fluometuron based on maximum rates and
aerial application suggests minimal acute risk concerns for freshwater fish and invertebrates,
with the highest RQ being approximately 1.5, and only slightly exceeding the Agency's LOG
(Table 13). The rate reductions for certain soil types that the registrant has agreed to will further
reduce these predicted risks. With this mitigation, the maximum acute RQ is reduced to 1. In
addition, at most, only 20% of fluometuron used is applied aerially, and groundboom application
results in less exposure as a result of drift and lower risk estimates.
As stated above, the Agency does not have chronic toxicity data with which to estimate
potential chronic risks to freshwater fish and invertebrates. The mitigation described above will
reduce any current, potential chronic risks to freshwater fish and invertebrates that have not been
estimated, and the Agency intends to require the necessary data as part of this RED decision.
Estuarine'/Marine Fish and Invertebrates
EPA's screening-level risk assessment for fluometuron based on maximum rates and
aerial application suggests minimal acute risks concerns for estuarine/marine fish and
invertebrates, with the highest RQ being approximately 0.09 and only slightly exceeding the
endangered species LOG (Table 13). The rate reductions for certain soil types that the registrant
has agreed to will further reduce these predicted risks. With this mitigation, the maximum acute
RQ is reduced to 0.06. In addition, at most, only 20% of fluometuron used is applied aerially,
and groundboom application results in less exposure as a result of drift.
As stated above, the Agency does not have chronic toxicity data with which to estimate
potential chronic risks to estuarine/marine fish and invertebrates. The mitigation described
above will reduce any current, potential chronic risks to estuarine/marine fish and invertebrates
that have not been estimated, and the Agency intends to require the necessary data as part of this
RED decision.
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Plants
Consistent with its use as an herbicide, fluometuron is toxic to plants. Therefore, as
would be expected, EPA's screening-level risk assessment for fluometuron results in RQs for
non-endangered aquatic vascular and non-vascular plants ranging from 0.24 to 11 (Table 14). As
stated above, the significant reductions in seasonal maximum application rates will reduce acute
risks to aquatic plants, resulting in revised RQs of 0.16 to 6.97. Similarly, revised RQs for
endangered plants would also be lower, ranging from 0.31 to 1.82.
3. Summary of Mitigation Measures
The following mitigation measures are necessary for fluometuron to be eligible for
reregi strati on.
• Require wettable powder formulations be packaged in water soluble packaging.
• Prohibit aerial application with dry flowable formulations.
• Reduce application rates, as follows:
o Sand, loamy sand, and sandy loam soils - the maximum one-time
application rate is 1 Ib ai/A, with 2 applications per year for a total annual
maximum application rate of 2 Ib ai/A.
o Loam, silt loam, silt, sandy clay loam, silty clay loam, and clay loam soils
- The maximum one-time application rate is 1.6 Ib ai/A, with 2
applications per year. The total annual maximum application rate is 3 Ib
ai/A.
o Sandy clay, silty clay, and clay soils - The maximum one-time application
rate is 2 Ib ai/A, with 2 applications per year. The total annual maximum
application rate is 3 Ib ai/A.
• Increase the interval between applications to 20 days.
• Add PPE requirements to labels, as follows:
o Handlers mixing and loading liquids and dry flowable formulations for
groundboom application must wear single layer PPE plus gloves,
o Handlers mixing and loading liquids for aerial application must wear
double-layer PPE plus gloves and an apron,
o Handlers applying via groundboom must wear baseline PPE,
o Handlers applying via aircraft must be in enclosed cabs, and
o Handlers acting as flaggers must wear baseline PPE.
F. Other Labeling Requirements
To be eligible for reregi strati on, various use and safety information will be included in
the labeling of all end-use products containing fluometuron. For the specific labeling statements
and a list of outstanding data, refer to Section V of this RED document.
1. Endangered Species Considerations
At this time, the Agency is not requiring label changes specific to the protection of listed
species. If, in the future, specific measures are necessary for the protection of listed species, the
35
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Agency will implement them through the Endangered Species Protection Program. While RQs
exceeded the Agency's endangered species LOG for several taxa, these results were based on a
screening-level assessment and do not constitute "may affect" findings under the Endangered
Species Act. As explained earlier, after a species-specific assessment is conducted, a
determination that there is a likelihood of potential effects to a listed species may result in
limitations on the use of the pesticide, other measures to mitigate any potential effects, or
consultations with the Fish and Wildlife Service or National Marine Fisheries Service as
appropriate. 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 fluometuron at levels of concern.
2. Spray Drift Management
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 reregi strati on process, EPA will continue to work with all interested parties on this
important issue.
From its assessment of fluometuron, as summarized in this document, the Agency
concludes that certain drift mitigation measures are needed to address the risks from off-target
drift for fluometuron, including a requirement for medium to coarse droplet size. Label
statements implementing these measures are listed in the "spray drift management" section of the
label table (Table 21) in Section V of this RED document. In the future, fluometuron 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 fluometuron is eligible for reregi strati on provided that
the risk mitigation measures outlined in this document are adopted, and label amendments are
made to reflect these measures. To implement the risk mitigation measures, the registrants will
be required to amend their product labeling to incorporate the label statements set forth in the
Label Changes Summary Table (Table 21) below. In the near future, the Agency intends to issue
Data Call-In Notices (DCIs) requiring product specific data and additional 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 eight 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 and label amendments that the Agency
intends to require for fluometuron to be eligible for reregi strati on.
A. Manufacturing-Use Products
1. Data Requirements
The generic data base supporting the reregistration of fluometuron for the above eligible
uses has been reviewed and determined to be substantially complete. However, there are a few
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data gaps remaining, and these are listed below. In addition, updated Confidential Statements of
Formula (CSFs) are required.
Human Health
• pH (OPPTS Guideline Number 830.7000).
• UV/Visible Absorption (OPPTS Guideline Number 830.7050).
• Directions for Use (OPPTS Guideline Number 860.1200). Certain label revisions are
required for cotton and rotational crops. This information will be considered
confirmatory, because adequate data are available to reassess tolerances and to conduct a
dietary risk analysis.
• Residue Analytical Method (OPPTS Guideline Number 860.1340). The registrant must
either improve Method AG-519A or develop a new method capable of determining
fluometuron residues that may be converted to TFMA in livestock commodities.
• Storage Stability (OPPTS Guideline Number 860.1380). Study required on the
hydroxylated metabolites, as a result of the Agency's decision to regulate the
hydroxylated metabolites in animal commodities.
• Magnitude of the Residue (OPPTS Guideline Number 860.1500). Magnitude of the
residue data in/on cottonseed from use of the DF formulation are needed.
Ecological Effects
• Avian Chronic Reproduction (Guideline Numbers 71-4a and 71-4b; OPPTS Guideline
Number 850.2300). The avian chronic reproduction tests with Northern bobwhite and
mallard duck using fluometuron technical grade active ingredient are needed.
• Freshwater Fish Early Life-Stage (Guideline Number 72-4a: OPPTS Guideline Number
850.1400). The freshwater fish early life-stage test using fluometuron technical grade
active ingredient is needed.
• Freshwater Invertebrate Early Life-Stage (Guideline Number 72-4 b: OPPTS Guideline
Number 850.1300). The freshwater invertebrate early life-stage test using fluometuron
technical grade active ingredient is needed.
• Estuarine/Marine Fish Early Life-Stage (Guideline Number 72-4a: OPPTS Guideline
Number 850.1400). The estuarine/marine fish early life-stage test using fluometuron
technical grade active ingredient is needed.
• Estuarine/Marine Invertebrate Life-Cycle (Guideline Number 72-4b: OPPTS Guideline
Number 850.1350). The estuarine/marine aquatic invertebrate life-cycle test using
fluometuron technical grade active ingredient is needed.
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Special Studies
• Information on the Proximity of Federally Listed Endangered Species to the Fluometuron
Use Sites (Special Study). This requirement may be satisfied by 1) having membership
in the FIFRA Endangered Species Task Force (PR Notice 2000-2); 2) citing FIFRA
Endangered Species Task Force data; or 3) independently producing these data.
• Prospective Groundwater Monitoring Study (Special Study).
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. The
MUP labeling should bear the labeling contained in Table 21.
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.
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures
outlined in Section IV above. Specific language to incorporate these changes is specified in
Table 21. Generally, conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved. However, specific
existing stocks time frames will be established case-by-case, depending on the number of
products involved, the number of label changes, and other factors.
C. Labeling Changes Summary Table
For fluometuron to be eligible for reregi strati on, all fluometuron labels must be amended to
incorporate the risk mitigation measures outlined in Section IV. Table 21 below describes how
language on the labels should be amended.
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Table 21. Summary of Labeling Changes for Fluometuron
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
For all Manufacturing Use
Products
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 aformulator
or user group
Environmental Hazards
Statements Required by
the RED and Agency
Label Policies
"Only for formulation into an herbicide for use on cotton."
Manufacturers of products formulated as dry flowables must prohibit aerial application.
End-use products manufactured as a wettable powder must be reformulated into water soluble packaging.
"This product may be used to formulate products for specific use(s) not listed on the manufacturing use
product label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the
manufacturing use product label if the formulator, user group, or grower has complied with U.S. EPA
submission requirements regarding support of such use."
"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 Eliminations 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
Environmental Protection Agency."
Directions for Use
Directions for Use
Precautionary Statements
End-Use Products Intended for WPS Use
PPE Requirements
Established by the RED
forDryFlowable(DF)
Formulation
PPE Requirements
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [registrant inserts correct material(s)]. If
you want more options, follow the instructions for category [insert A, B, C, D, E, F, G or H] on an EPA
chemical-resistance category selection chart."
"Mixers, loaders, applicators, and other handlers must wear:
- long-sleeved shirt,
- long pants,
- shoes and socks, and
hi addition, chemical-resistant gloves are required for all handlers (except applicators)"
"Personal Protective Equipment (PPE)"
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
Immediately following/below
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Table 21. Summary of Labeling Changes for Fluometuron
Description
Amended Labeling Language
Placement on Label
Established by the RED
for Liquid Concentrate
Formulations
"Some materials that are chemical-resistant to this product are [registrant inserts correct material(s)]. If
you want more options, follow the instructions for category [insert A, B, C, D, E, F, G or H] on an EPA
chemical-resistance category selection chart."
"Mixers and loaders supporting aerial application must wear:
- coveralls over long-sleeved shirt and long pants,
- chemical resistant gloves,
- chemical-resistant footwear and socks, and
- a chemical-resistant apron."
"All other mixers, loaders, applicators, flaggers, and other handlers must wear:
- long-sleeved shirt,
- long pants,
- shoes and socks, and
- chemical-resistant gloves (except applicators and flaggers)"
"See engineering controls for additional requirements and options."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
PPE Requirements for
Wettable Powder (WP)
Formulations packaged in
water soluble packaging.
(Note: all wettable powder
products must be packaged
in water soluble packaging
to be eligible for
reregistration.)
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [registrant inserts correct material(s)]. If
you want more options, follow the instructions for category [insert A, B, C, D, E, F, G or H] on an EPA
chemical-resistance category selection chart."
"Mixers, loaders, applicators, and flaggers must wear:
- long-sleeved shirt,
- long pants,
- shoes and socks.
Precautionary Statements:
Hazards to Humans and
Domestic Animals
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Table 21. Summary of Labeling Changes for Fluometuron
Description
Amended Labeling Language
Placement on Label
In addition, mixers and loaders must wear:
- chemical-resistant gloves and chemical-resistant apron."
"Handlers performing tasks that involve exposure to the concentrate, such as cleaning equipment or spill
clean-up must wear:
- coveralls over long-sleeved shirt and long pants,
- chemical resistant gloves,
- chemical-resistant footwear and socks,
- chemical-resistant apron, and
- a NIOSH-approved respirator with a dust/mist filter with MSHA/NIOSH approval number
prefix TC-21C or any N, R, P, or HE filter."
"See engineering controls for additional requirements."
Engineering Controls:
Enclosed Cockpits for
Aerial Applicators
Enclosed Cockpits
"Engineering Controls: 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
Engineering Controls:
Wettable Powder
Formulations packaged in
water soluble packaging
"Engineering Controls:
Water-soluble packets, when used correctly, qualify as a closed mixing/loading system under the Worker
Protection Standard for Agricultural Pesticides {40 CFR 170.240(d)(4)]. Mixers and loaders using
water-soluble packets must:
- wear the personal protective equipment required in the PPE section of this labeling for mixers
and loaders
- be provided, and must have immediately available for us in an emergency, such as a broken
package, spill, or equipment breakdown: chemical resistant footwear and a NIOSH-approved
respirator with a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or any
N,R,P, or HE filter."
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Table 21. Summary of Labeling Changes for Fluometuron
Description
User Safety Requirements
User Safety
Recommendations
Environmental Hazards
Statements Required by
the RED and Agency
Label Policies
Restricted-Entry Interval
Early Reentry Personal
Protective Equipment for
Products Subject to WPS
as required by Supplement
3 of PR Notice 93-7
General Application
Restrictions
Amended Labeling Language
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables
exist, use detergent and hot water. Keep and wash PPE separately from other laundry."
"Discard clothing or other absorbent materials that have been drenched or heavily contaminated with
this product's concentrate. Do not reuse them."
"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."
"Do not apply directly to water, or to areas where surface water is present, or to inter-tidal areas below
the mean high water mark. Do not contaminate water when cleaning equipment or disposing of
equipment washwaters or rinsate.."
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 24
hours."
"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 soil or water, is:
- Coveralls, worn over a short-sleeved shirt and short pants,
- Chemical-resistant gloves made of any waterproof material,
- Chemical-resistant footwear plus socks, and
- Protective eyewear.
"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."
Placement on Label
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements
Precautionary Statements
under: Hazards to Humans
and Domestic Animals
(Must be placed in a box.)
Precautionary Statements:
Hazards to Humans and
Domestic Animals
Directions for Use, in
Agricultural Use
Requirements box
Directions for Use, in
Agricultural Use
Requirements Box
Place in the Directions for Use
directly above the Agricultural
Use Box
42
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Table 21. Summary of Labeling Changes for Fluometuron
Description
Amended Labeling Language
Placement on Label
Application Restrictions
Dry Flowable (DF)
Formulation
"Aerial application is prohibited."
Directions for Use
Application Restrictions
Application Rates (Cotton)
Sand, loamy sand, and sandy loam soils The maximum one-time application rate is 1 Ib
ai/A, with 2 applications per year for a total annual maximum application rate of 2 Ib
ai/A.
Loam, silt loam, silt, sandy clay loam, siltv clay loam, and clay loam soils The maximum
one-time application rate is 1.6 Ib ai/A, with 2 applications per year. The total annual
maximum application rate is 3 Ib ai/A.
Sandy clay, siltv clay, and clay soils The maximum one-time application rate is 2 Ib ai/A,
with 2 applications per year. The total annual maximum application rate is 3 Ib ai/A.
All soils Require a 20 day interval between applications
The feeding restriction for cotton gin trash must be removed from product labels (cotton gin trash is a
livestock feed item not under control of the grower).
Plantback intervals must be as follows:
- 3 months for wheat
- 8 months for field corn, sweet corn, peanuts
- 9 months for rice, grain sorghum, and soybeans
Directions for Use
Spray Drift Label
Language for Products
Applied as a Spray
"Spray Drift Management"
"A variety of factors including weather conditions (e.g., wind direction, wind speed, temperature,
relative humidity) and method of application 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."
Directions for Use under
General Precautions or
Restrictions and/or
Application Instructions
43
-------
Table 21. Summary of Labeling Changes for Fluometuron
Description
Amended Labeling Language
Placement on Label
Droplet Size
"Apply as a medium or coarser spray (ASAE Standard 572)"
Temperature Inversions
"If applying at wind speeds less than 3 mph, the applicator must determine if a) conditions of
temperature inversion exist, or b) stable atmospheric conditions exist at or below nozzle height.
Do not make applications into areas of temperature inversions or stable atmospheric conditions."
Other State and Local Requirements
"Applicators must follow all state and local pesticide drift requirements regarding application of
fluometuron. Where states have more stringent regulations, they must be observed."
Equipment
"All application equipment must be properly maintained and calibrated using appropriate carriers
or surrogates."
Additional requirements for aerial applications (for liquid and wettable powder formulations
only):
1. "The boom length must not exceed 75% of the wingspan or 90% of the rotor blade diameter."
2. "Release spray at the lowest height consistent with efficacy and flight safety. Do not release
spray at a height greater than 10 feet above the crop canopy unless a greater height is required for
aircraft safety."
3. "When applications are made with a crosswind, the swath must be displaced downwind. The
applicator must compensate for this displacement at the up and downwind edge of the application
area by adjusting the path of the aircraft upwind."
Additional requirement for groundboom application:
1. "Do not apply with a nozzle height greater than 4 feet above the crop canopy."
44
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Appendix A: Fluometuron Use Patterns Eligible for Reregistration
Table 1. Fluometuron Use Patterns Eligible for Reregistration - Cotton
Site
Application Timing
Application Type
Application Equipment
Max. Single
Application Rate
(ai)1
Max. # of
Apps.
Minimum
Retreatment
Interval
Use Limitations
Cotton
Early Bloom
Broadcast
Sprayer
Foliar
Band Treatment/Basal Spray
Sprayer
Layby
Broadcast/Directed Spray /Soil Band Treatment
Band Sprayer/Sprayer
Postemergence
Band treatment/ Broadcast/ Directed Spray /Low
Volume Spray (concentrate)/Soil Band Treatment
Aircraft/Band Sprayer/Ground/Soil Incorporation
Equipment/Sprayer
Prebloom
Band Treatment/Directed Spray
Sprayer
Preemergence
Band treatment/ Broadcast/ /Low Volume Spray
(concentrate)/Soil Band Treatment/Soil
Incorporated Treatment/Soil Treatment
Aircraft/Band Sprayer/ Ground/ Sprayer
Preplant
Band treatment/ Broadcast/ /Low Volume Spray
(concentrate)/Soil Band Treatment/Soil
Incorporated Treatment
Aircraft/Band Sprayer/ Ground/ Soil Incorporation
Equipment/ Sprayer
2 Ib ai/A
2
20 days
Aerial application is prohibited for dry
flowable formulations.
Wettable powders formulations must be
packaged in water soluble bags
24 hour REI.
See application rate limitations based on
soil type in table 2 below.
60 day PHI
See additional application rate limitations based on soil type in table 2 below.
45
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Table 2. Fluometuron Use Patterns Eligible for Reregistration - Additional Required Use Rate Restrictions for Application of
Fluometuron on Cotton Based on Soil Type
Soil Texture
Max. Single
Application Rate
(ai)
Max. #of Apps.
Seasonal Max. Rate
Minimum
Retreatment Interval
(Days)
Cotton
Sand, Loamy Sand, Sandy Loam
Loam, Silt Loam, Silt, Sandy Clay Loam, Silty Clay
Loam, Clay loam
Sandy Clay, Silty Clay, Clay
1 Ib ai/A
1.6 Ib ai/A
2 Ib ai/A
2
2
2
2 Ib ai/A
3 Ib ai/A
3 Ib ai/A
20 days
20 days
20 days
46
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Appendix B: Data Supporting Guideline Requirements for the Reregistration of Fluometuron
Guide to Appendix B
Appendix B contains listing of data requirements which support the reregi strati on for
active ingredients within the case 0049 covered by this RED. It contains generic data
requirements that apply to fluometuron in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1). The data requirements are listed by Guideline Number.
The Guideline Numbers accompanying each test refer to the test protocols set in the
Pesticide Assessment Guidance available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial Food
B. Terrestrial Feed
C. Terrestrial Non-Food
D. Aquatic Food
E. Aquatic Non-Food Outdoor
F. Aquatic Non-Food Industrial
G. Aquatic Non-Food Residential
H. Greenhouse Food
I. Greenhouse Non-Food
J. Forestry
K. Residential
L. Indoor Food
M. Indoor Non-Food
N. Indoor Medical
O. Indoor Residential
3. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this
column list the identify number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRTD number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Fluometuron
Guideline Requirement
New
Old
Study Title
Use
Pattern
MRID Citation
PRODUCT CHEMISTRY
860.1200
830.7000
830.7050
830.7300
171-3
63-12
None
63-10
Directions for Use
pH
UV/visible absorption
Dissociation constant in water
A,B
A,B
A,B
A,B
Data Gap (for technical
registrants)
Data Gap (for technical
registrants)
Data Gap
42017302
47
-------
Appendix B. Data Supporting Guideline Requirements for the Reregistration of Fluometuron
Guideline Requirement
New
830.7550
830.7840
830.7860
830.7200
830.7300
830.7950
Old
63-11
63-8
63-8
63-5
63-7
63-9
Study Title
Octanol/water partition coefficient
Water solubility
Solvent solubility
Melting point/melting range
Density
Vapor pressure
Use
Pattern
A,B
A,B
A,B
A,B
A,B
A,B
MRID Citation
00160757
00152460
00019017
00019017
00019017
00019017
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
8354200
835.4400
835.1240
835.110
None
835.2100
161-1
Hydrolysis
161-2 Direct Aqueous Photolysis
161-3
162-1
162-2
162-3
163-1
164-1
165-4
166-1, 2
Soil Photolysis
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Terrestrial Field Dissipation
Bioaccumulation In Fish
Ground Water Monitoring
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
40864401, 40930601
41065101
40930602
42998702
42998703
43158901
42643601, 42643602,
42643603, 42643604
40459401, 40459402,
41931501
42017304, 42413502
41931501
ECOLOGICAL EFFECTS
850.2100
850.2100
850.2200
850.2200
850.2300
850.2300
850.1075
71-1 (b)
71-1 (b)
71-2 (a)
71-2 (b)
71-4 (a)
71-4 (b)
72-1
Avian Acute OralLDSO -Mallard Duck
Avian Acute Oral LD50 - Mallard Duck
Avian Subacute Dietary LC50
Bobwhite Quail
Avian Subacute Dietary LC50
Mallard Duck
Avian Reproduction Quail - Bobwhite
Quail
Avian Reproduction Quail - Mallard
Duck
Freshwater Fish LC50 - Channel Catfish
A,B
A,B
A,B
A,B
A,B
A,B
A,B
19221
160000
42498001, 42597401,
19222
19222
Data Gap
Data Gap
40098001
48
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Fluometuron
Guideline Requirement
New
850.1075
850.1075
850.1010
850.1010
None
None
None
850.1400
850.1400
850.1350
850.1300
850.5400
850.5400
850.4225
850.4250
None
None
850.3020
Old
72-1 (a)
72-1 (c)
72-2
72-2
72-3 (a)
72-3 (b)
72-3 (c)
72-4 (a)
72-4 (b)
72-4 (c)
72-4 (d)
122-2
122-2
123-l(a)
123-l(b)
123-2
123-2
144-1
Study Title
Freshwater Fish LC50- Bluegill Sunfish
Freshwater Fish LC50- Rainbow Trout
Freshwater Invertebrate LC50-Daphnia
magna
Freshwater Invertebrate LC50-
Chironomus plumosus
Estuarine/Marine FishLC50- Sheepshead
Estuarine/Marine Mollusk - Eastern
Oyster
Estuarine/Marine Shrimp - Mysid Shrimp
Freshwater Fish Early Life Stage Toxicity
Test - Fathead Minnow
Estuarine/Marine Fish Early -Life Stage
Test - Sheepshead Minnow
Estuarine/Marine Aquatic Invertebrate
Life-Cycle Test - Mysid
Freshwater Aquatic Invertebrate Life-
Cycle Test - Daphnia magna
Aquatic Plant Growth (Tier I) Vascular
plant species
Aquatic Plant Growth (Tier I) Non-
Vascular plant species
Seed Germ/Seedling Emergence (Tier II)
- Dicots, Monocots (TGAI)
Vegetative Vigor (Tier II) Dicots,
Monocots (TGAI)
Aquatic Plant Growth (Tier II) Vascular
plant species (TGAI)
Aquatic Plant Growth (Tier II) Non-
vascular plant species
Acute Contact LD50 - Honeybee
Use
Pattern
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
MRID Citation
42498002, 40098001
42498003, 40098001,
42505001
40098001
40098001
42498004, 42505002
42498005, 43848101
42498006, 42568501
Data Gap
Data Gap
Data Gap
Data Gap
42564102
42564103, 42568502,
42568503, 43025601
42718801, 42718802
42718803
43421601
43421602
114832
RESIDUE CHEMISTRY
49
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Fluometuron
Guideline Requirement
New
860.1300
860.1300
860.1340
860.1340
860.1360
860.1380
Old
171-4a
171-4b
171-4c
171-4d
171-4m
171-4e
Study Title
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plant
Commodities
Residue Analytical Method - Animal
Commodities
Multiresidue Methods
Storage Stability Data
Use
Pattern
A,B
A,B
A,B
A,B
A,B
A,B
MRID Citation
40492411,40492412,
40492413, 43654402,
43654403, 43654404
40047401, 40047402,
40190704, 40190706,
43413403,43413404
00019009, 00022940,
40190714, 40292001,
42017305, 42017306,
42498008, 43218104,
43654405, 44449401
44449402
00019014, 00019160,
40067501, 42017305,
42017306,43413405,
44623201
Data Gap2
42498008
00019021, 00019099,
41161903,41161904,
42258701
Data Gap3
860.1480 Magnitude of Residue - Meat, Milk, Poultry, and Eggs
860.1480
860.1480
171-4J
171-4J
Milk and the Fat, Meat, and Meat
Byproducts of Cattle, Goats, Hogs,
Horses, and Sheep
Eggs and the Fat, Meat, and Meat
Byproducts of Cattle, Goats, Hogs,
Horses, and Sheep
A,B
A,B
40190710, 44623202
40190711
860. 1500 Crop Field Trials
2 The registrant must either improve Method AG-519A or develop a new method capable of determining
floumeturon residues that may be converted to TFMA in livestock commodities.
3 Study required on the hydroxylated metabolites, as a result of the Agency's decision to regulate the hydroxylated
metabolites in animal commodities.
50
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Appendix B.
Data Supporting Guideline Requirements for the Reregistration of Fluometuron
Guideline Requirement
New
860.1500
Old
171-4k
Study Title
Cottonseed and gin byproducts
Use
Pattern
A,B
MRID Citation
00018930, 00018995,
00018997, 00019020,
00019022, 00019036,
00019085, 00019099,
00031739,00034005,
00065048, 00106374,
40190712,43218101
43218102, 44623203
Data gap4
860.1520 Magnitude of Residue - Processed Food/Feed
860.1520
860.1850
860.1900
171-41
None
None
Cottonseed processed commodities
(meal, hulls, and refined oil)
Confined Rotational Crops
Field Rotational Crops
A,B
A,B
A,B
402920026, 43218103
43654401, 43654402,
44084801
43218101,43218102,
43218103
Data Gap5
TOXICOLOGY
870.1000
870.1100
870.1200
870.2400
870.2500
870.2600
870.3100
870.3150
81-1
81-2
81-3
81-4
81-5
81.6
82-la
82- Ib
Oral LD50 - Rat
Dermal LD50 - Rabbit
Inhalation LD50 _ Rat
Eye Irritation - Rabbit
Dermal Irritation - Rabbit
Dermal Sensitization
90-day Oral Toxicity - Rat
13 -week Subchronic Oral Toxicity - Dog
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
41216802, 40409302,
00142844
00142845
40409304, 41216804,
00145431
41216805, 00142846
00145431
0068040, 41216806,
40409306, 00142847
40409307, 41216807,
0160762, 00142848
00019034
00019035
4 Magnitude of the residue in/on cottonseed from use of the DF formulation are needed.
5 Adequate data are available to support the following intervals: three months for wheat; eight months for field corn,
sweet corn, and peanuts; and none months for rice, grain sorghum, and soybeans. If the registrant wishes to support
rotational crops and plantback intervals other than those listed above, then additional rotational crop field trials must
be conducted.
51
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Appendix B. Data Supporting Guideline Requirements for the Reregistration of Fluometuron
Guideline Requirement
New
870.3200
870.4100a
870.4 lOOb
870.4200
870.4200
870.3700a
870.3700b
870.3800
870.4300
870.5100
None
870.7485
Old
82-2
83-la
83-lb
83-2
83-2b
83-3a
83-3b
83-4
83-5
84-2a
84-4
85-1
Study Title
21-Day Dermal - Rabbit
Chronic Feeding - Rodent
Chronic Feeding - Dog
Carcinogenicity - Rat
Carcinogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Chronic Feeding/Carcinogenicity - Rat
Mutagenicity - Ames
Mutagenic - DNA Synthesis
Metabolism
Use
Pattern
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
A,B
MRID Citation
00160763
83-5 satisfies this
guideline
40779001,41189501
83-5 satisfies this
guideline
00163854,42413501,
43506601
00163710, 42397601
00163774, 00147554,
42397602
00163773
00163772
40802901
42017303
40047403
52
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Appendix C: Technical Support Documents for Fluometuron
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard (South Building), 1777 S. Crystal Drive, Arlington,
VA. It is open Monday through Friday, excluding legal holidays, from 8:30 am to 4:00 pm.
The preliminary risk assessments for fluometuron are available in the public docket and
in e-dockets under docket number OPP-2004-0372. This contains risk assessments and related
documents as of August 2005. During the comment period, the registrant submitted additional
data for fluometuron. EPA reviewed these data and incorporated them into the revised risk
assessments for fluometuron. These revised risk assessments form the basis of the regulatory
decision described in this RED. These risk assessment and related documents are also available
under docket number OPP-2004-0372.
Technical support documents from the Fluometuron RED are as follows:
Federal Register Documents
• Fluometuron; Notice of Availability of Risk Assessments and Opening of Docket. 70 FR
17447; April 6, 2005
• Fluometuron; Reregi strati on Eligibility Decision; Notice of Availability
Special Review and Reregistration Division Administrative Documents
• Overview of Fluometuron; March 30, 2005
• Fluometuron Use Closure Memorandum; July 9, 2004
Benefits and Economic Analysis Division Documents
• Table 1. Maximum Fluometuron Use Rates and Management Practices by Crop Based on
Current Labels ; April 6, 2004
• Table A2. Food/Feed Use Patterns Summary for Fluometuron. April 6, 2004
• Screening Level Estimates of Agricultural Uses of Fluometuron (SLUA); March 15, 2004
• Refined Fluometuron Percent Crop Treated and Percentage of National Soybean, Corn, and
Wheat Crops Rotated with Fluometuron-Treated Cotton; August 9, 2005
• Usage Report in Support of Reregistration for the Herbicide Fluometuron; September 14,
2005
• Addendum to Refined Fluometuron Percent Crop Treated; September 21, 2005
• Impacts Assessment for Fluometuron September 26, 2005
Human Health Risk Assessment Documents
• Fluometuron: Occupational Exposure Assessment for the Reregistration Eligibility
Decision Document; July 19, 2004
• Fluometuron. Summary of Product Chemistry for the Reregistration Eligibility Decision
(RED) Document; November 3, 2004
53
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• Fluometuron. Summary of Analytical Chemistry and Residue Data for the Reregi strati on
Eligibility Decision (RED) Document; November 30, 2004
• Fluometuron. Acute, Chronic, and Cancer Dietary Exposure Assessments for the
Reregi strati on Eligibility Decision (RED) Document; November 30, 2004
• Fluometuron: Revised FLED Risk Assessment for Phase III of the Reregi strati on
Eligibility Decision (RED); February 1, 2005.
• Phase 2 Response to Error Comments for Fluometuron RED (FLED Risk Assessment);
February 1, 2005
• FED Response to a Proposal to Maintain the 24-Month CD-I Mouse Oncogenicity Study
Supplementary for the Fluometuron RED; July 28, 2005
• Fluometuron: Revised Acute, Chronic, and Cancer Dietary Exposure Assessments for
the Reregi strati on Eligibility Decision (RED) Document; September 27, 2005
Environmental Fate and Ecological Risk Assessment Documents
• Fluometuron Drinking Water Assessment for the Human Effects Division (FLED)
Reregi strati on Eligibility Decision Document; December 8, 2004
• EFED response to Registrant's 30 day Error Correction Comments on Fluometuron RED;
February 22, 2005
• Revised Environmental Fate and Ecological Risk Assessment of Fluometuron; February
22, 2005
• Revised Risk Quotient Calculations for Proposed New Use Rates; September 23, 2005
• Revised Drinking Water Assessment and EFED's Response; September 28, 2005
54
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Appendix D: Citations Considered to be Part of the Database Supporting the Fluometuron
Reregistration Eligibility Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Reregistration Eligibility Document. Primary sources for studies in this bibliography have been
the body of data submitted to EPA and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the published literature, in those instances
where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency
has also attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should
be used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the
review may be preceded by a nine character temporary identifier. These entries are listed after all
MRID entries. This temporary identifying number is also to be used whenever specific reference
is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA, by
a description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for certain
special needs.
a. Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory
could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (1999), the Agency was
unable to determine or estimate the date of the document.
55
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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.
Study Citations
MRID Citation
Product Chemistry
00019016 Barringer, M.; North, B. (1977) Analysis of Fluometuron in Cotoran SOW by
Derivatization and Gas Chromatographic Techniques. Method no. PA-42B dated
Sep 9, 1977. (Unpublished study received Jan 24, 1978 under 100-569; submitted
by Ciba-Geigy Corp., Greensboro, N.C.; CDL:232774-B).
00019017 Ciba-Geigy Corporation (1978) Fluometuron Technical Chemical Data Section.
(Unpublished study received Jun 22, 1978 under 100-561; CDL:234174-A).
00019018 Nirsberger, M.; Barringer, M.; Heinrichs, L. (1978) Complete Analysis of
Fluometuron and Related Impurities in Technical Material. Method no. PA-162A
dated May 25, 1978. (Unpublished study received Jun 22, 1978 under 100-561;
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:234174-B).
00019034 Fogleman, R.W. (1965) Cotoran-90 Day Feeding-Rats: Project # 20- 042.
(Unpublished study received May 11, 1965 under 8192-5; submitted by Ciba
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56
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00019035 Fogleman, R.W. (1965) Subacute Toxicity-90 Day Administration- Dogs:
Project # 20-042. (Unpublished study received May 11, 1965 under 8192-5;
prepared by AME Associates, submitted by Ciba Agrochemical Co., Summit,
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00068040 Siglin, J.C.; Becci, P.J.; Parent, R.A. (1981) Primary Skin Irrita- tion in Rabbits
(EPA-FIFRA): FDRL Study No. 6817A. (Unpublished study received May 7,
1981 under 100-549; prepared by Food and Drug Research Laboratories, Inc.,
submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:245045-C)
00118012 Ciba-Geigy Corp. (1982) Cotoran 4L: Chemical Data Section. (Compilation;
unpublished study received Nov 3, 1982 under 100-642; CDL:248811-A).
00132417 Ciba-Geigy Corp. (1983) [Study-Chemical: Fluometuron]. (Compilation;
unpublished study received Oct28, 1983 under 100-561; CDL:251618-A).
00142844 Galloway, C. (1985) Rat Acute Oral Toxicity: Fluometuron 80WP For- mulation
09084-A: Double Hammer Milled 12-14-84: Project No. 3595-85. Unpublished
study prepared by Stillmeadow, Inc. 20 p.
00142845 Galloway, C. (1985) Rabbit Acute Dermal Toxicity: Fluometuron 80WP Double
Hammer Milled 12-14-84: Project No. 3596-85. Unpublished study prepared by
Stillmeadow, Inc. 9 p.
00142846 Sabol, E. (1985) Rabbit Eye Irritation: Fluometuron 80WP Formula- tion: 09084-
A Double Hammer Milled 12-14-84: Project No. 3597- 85. Unpublished study
prepared by Stillmeadow, Inc. 17 p.
00142847 Sabol, E. (1985) Rabbit Skin Irritation: Fluometuron 80WP Formula- tion: 09084-
A Double Hammer Milled 12-14-84: Project No. 3598-85. Unpublished study
prepared by Stillmeadow, Inc. 10 p.
00142848 Sabol, E.; Galloway, C. (1985) Guinea Pig Sensitization: Fluome- turon 80WP
Formulation: 09084-A Double Hammer Milled 12-14-84: Project No. 3599-85.
Unpublished study prepared by Stillmeadow Inc. 14 p.
00145431 Maedgen, J. (1985) Rat Acute Inhalation Toxicity: Fluometuron 80WP
Formulation: 09084-A Double Hammer Milled 12-14-84: Project No. 3600-85.
Unpublished study prepared by Stillmeadow, inc. 15 p.
00147554 Arthur, A. (1984) A Teratology Study of Fluometuron Technical in New Zealand
White Rabbits: Report No. 217-84. Unpublished study prepared by Ciba-Geigy
Corp. 280 p.
00152460 Ciba-Geigy Corp. (1984) Fluometuron: Product Chemistry Data. Unpublished
study. 1 p.
57
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00160756 Ciba-Geigy Corp. (1986) Fluometuron: Certification of Ingredient Limits: PC 86-
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00160757 Carpenter, M. (1986) Determination of Octanol-water Partition Coefficient of
Fluometuron: ABC Final Report #34617. Unpublished study prepared by
Analytical Bio-Chemistry Laboratories,Inc. 152 p.
00160762 Lain, D. (1986) Guinea Pig Sensitization: Fluometuron Tech Fl- 851769
Expiration Date 9-88: Storage Conditions RT: Project No. 4046-86. Unpublished
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00160763 Morrow, L. (1986) Twenty-one Day Repeated Dose Dermal Toxicity Study Using
Fluometuron Technical in Albino Rabbits: Study No. 410-2626. Unpublished
study prepared by American Biogenics Corp. 354 p.
00163710 Arthur, A. (1986) A Teratology Study of Fluometuron Technical in the Albino
Rat: Report No. 199-84; Master Index No. 832125. Unpublished study prepared
by Ciba-Geigy Corp. 262 p.
00163772 Zurek, E. (1982) Two-year Chronic Oral Toxicity Study in Albino Rats:
Fluometuron Technical: Final Rept: Project No. 483-146. Unpublished study
prepared by Hazleton Laboratories America, Inc. 1761 p.
00163773 Cole, S. (1982) A Three-generation Reproduction Study in Albino Rats:
Fluometuron Technical: Final Rept.: Project No. 483-147. Unpublished study
prepared by Hazleton Laboratories America, Inc. 664 p.
00163774 Wallace, P.; Youreneff, M.; Infurna, R.; et al. (1986) Fluometuron Technical: A
Teratology Study in Rabbits: Rept. No. 86002. Un- published study prepared by
Ciba-Geigy Corp. 315 p.
00163854 Kundzins, W. (1986) Twenty-four Month Carcinogenicity Study in Mice:
Fluometuron Technical: Final Report: Project No. 483/145. Unpublished study
prepared by Hazleton Laboratories America, Inc. 2,511 p.
40047403 Orr, G. (1986) Disposition of Phi-[carbon-14]-fluometuron in the Rat (General
Metabolism): Report No. ABR-86120. Unpublished compilation prepared by
Ciba-Geigy Corp. and SRI International. 78 p.
40409302 Siglin, J. (1987) Acute Oral Toxicity Study of Meturon 80DF in Rats: LD50 Test
(EPA): SLS Study No. 3159.24. Unpublished study prepared by Springborn Life
Sciences, Inc. 66 p.
40409304 Siglin, J. (1987) Acute Inhalation Toxicity Study of Meturon 80DF in Rats: Limit
Test (EPA): SLS Study No. 3159.20. Unpublished study prepared by Springborn
58
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Life Sciences, Inc. 43 p.
40409306 Siglin, J. (1987) Primary Dermal Irritation Study of Meturon 80DF in Rabbits
(EPA): SLS Study No. 3159.19. Unpublished study pre- pared by Springborn Life
Sciences, Inc. 24 p.
40409307 Siglin, J. (1987) Delayed Contact Hypersensitivity Study in Guinea Pigs with
Meturon 80DF (EPA): SLS Study No. 3159.21. Unpub- lished study prepared by
Springborn Life Sciences, Inc. 46 p.
40779001 Rudzki, M. (1988) Chronic Toxicity in Dogs: Fluometron Technical: Project ID.
832047. Unpublished study prepared by Ciba-Geigy Corp. 483 p.
40802901 Ogorek, B. (1988) Fluometuron Technical: Gene Mutations Test:
Salmonella/Mammalian-microsome Mutagenicity Test: Project ID. 871498.
Unpublished study prepared by Ciba-Geigy Ltd. 27 p.
41189501 Rudzki, M.; Green, J. (1988) Supplement to Chronic Toxicity Study in Dogs:
Fluometuron Technical: Laboratory Project ID: K7/37/1: MIN 832047.
Unpublished study prepared by Ciba-Geigy Corp. 24 p.
41216802 Kuhn, J. (1989) Acute Oral Toxicity Study in Rats: Fluometuron 85DF: Study
No. 6188-89. Unpublished study prepared by Still- meadow, Inc. 21 p.
41216804 Kuhn, J. (1989).
41216805 Kuhn, J. (1989) Primary Eye Irritation Study in Rabbits: Fluometu- ron 85DF:
Study No. 6190-89. Unpublished study prepared by Stillmeadow, Inc. 20 p.
41216806 Kuhn, J. (1989) Primary Dermal Irritation Study in Rabbits: Fluome- turon 85DF:
Study No. 6191-89. Unpublished study prepared by Stillmeadow, Inc. 12 p.
41216807 Kuhn, J. (1989) Dermal Sensitization Study in Guinea Pigs: Fluome- turon 85DF:
Study No. 6192-89. Unpublished study prepared by Stillmeadow, Inc. 17 p.
41591601 Lovell, J. (1990) Product Identity and Composition, Description of Manufacturing
Process and Discussion of the Formation of Impurities in the Production of
Technical Fluometuron ...: Lab Project Number: 90F001. Unpublished study
prepared by North Hungarian Chemical Works. 54 p.
41591602 Lovell, J. (1990) Summary of Preliminary Analysis of Product Samples,
Certification Ingredient Limits, Analytical Methods, and Physical and Chemical
Properties of Chem-Flo Technical Fluometuron: Lab Project Number: 90F002.
Unpublished study prepared by Chem-Flo, Inc. lip.
41591603 Clark, A. (1990) Fluometuron: Preliminary Analysis of Product Samples and
59
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Physical and Chemical Characteristics: Lab Project Number: 9576-F.
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41655301 Lovell, J. (1990) Supplemental Data to MRID 41591601: Additional Information
on Manufacturing Process and Discussion of the Formation of Impurities in the
Production of Technical Fluometuron: Lab Project Number:
CFI/DOC/#90F001/A. 8 p.
41655302 Clark, A. (1990) Supplemental Data to MRID 41591603: Additional Data on
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42017301 Lail, L. (1991) Fluometuron Technical: Product Chemistry: Lab Project Number:
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42017302 Lail, L. (1991) Fluometuron Technical: Product Chemistry: Lab Project Number:
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42017303 Hertner, T. (1989) Tests for Other Genotoxic Effects: Autoradiogra- phic DNA
Repair Test on Rat Hepatocytes. Unpublished study pre- pared by Ciba-Geigy
Ltd. 97 p.
42365505 Orr, G. (1992) Griffin Corporation Test Methods: Physical and Chemical
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42397601 Breckenridge, C. (1992) Supplemental Information: Developmental Toxicity
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42397602 Breckenridge, C. (1992) Supplemental Information: Developmental Toxicity
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42413501 Breckenridge, C. (1992) Fluometuron Technical: Supplemental Information:
Twenty-Four Month Carcinogenicity Study in Mice: Lab Project Number: 482-
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42556601 Jackson, W. (1992) Product Chemistry: Technical Fluometuron: Lab Project
Number: MP 92-09: 92-013. Unpublished study prepared by Ciba-Geigy Corp.
19 p.
42581701 Dowler, C. (1992) Technical Fluometuron: Preliminary Five Batch Analysis of
Technical Grade Fluometuron: Lab Project Number: 92-006. Unpublished study
prepared by Griffin Corp. 10 p.
60
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42581702 Dowler, C. (1992) Griffin Analytical Method TM-1060: Technical Fluometuron
Assay Method: Lab Project Number: 92-006. Unpublished study prepared by
Griffin Corp. 35 p.
42581703 Dowler, C. (1992) Technical Fluometuron: Accelerated Storage Stability: Lab
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42581704 Dowler, C. (1992) Technical Fluometuron: Physical and Chemical
Characteristics: Lab Project Number: 92-009. Unpublished study prepared by
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42581705 Dowler, C. (1992) Technical Fluometuron: One-year Storage Stability: Progress
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P-
42834901 Jackson, W. (1993) Technical Fluometuron: Addendum to Product Chemistry.
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42834902 Jackson, W. (1993) Technical Fluometuron: Supplement to Product Chemistry.
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42998701 Jackson, W. (1993) Technical Fluometuron: Product Chemistry: Lab Project
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43506601 Breckenridge, C. (1994) Dose Selection Rationale for the Chronic Toxicity and
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Residue Chemistry
00018930 Ciba Agrochemical Company (1965) Analysis of Cotton Plants and Soil for
Cotoran Residues following a Postemergent, Broadcast, Over- the-top Treatment:
Research Report CF-303. (Unpublished study received Apr 30, 1966 under
6F0505; prepared in cooperation with Wisconsin Alumni Research Foundation,
CDL:090592-BA).
00018995 Ross, J.A.; Kahrs, R.A.; Cheung, M.W. (1976) Summary of Residue Data for
Aerial Application of Cotoran (R)I 80WP to Cotton: Report No. GAAC-76010.
(Unpublished study received Aug 26, 1976 under 100-549; submitted by Ciba-
Geigy Corp., Greensboro, N.C.; CDL:225522-A).
00018997 Smith, J.; Lignowski, E.; Coble, H.D.; et al. (1978) Summary: Prowl (CL 92,553)
plus Cotoran (Fluometuron) Preemergence Tank Mixture-Soil and Cottonseed
Residues.
61
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(Unpublished study received Sep 11, 1978 under 241-243; prepared in
cooperation with North Carolina State Univ., Crop Science Dept, Upper Coastal
Plain Research Station, submitted by American Cyanamid Co., Princeton, N.J.;
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00019009 Baunok, I; Geissbuehler, H. (1968) Specific determination of urea herbicide
residues by EC gas chromatography after hydrolysis and Iodine derivative
formation. Bulletin of Environmental Contamination & Toxicology 3(1): 11-21.
(Also, an unpublished submission received Sep 11, 1978 under 241-243;
submitted by American Cyanamid Co., Princeton, N.J.; CDL:235084-O).
00019014 Dure, P. (1964) Residue Analysis of C-2059, N'-(3-Trifluoromethyl)-phenyl-
N',N-dimethylurea, with Special Reference to Cottonseed. Method dated Sep 12,
1964. (Unpublished study received Sep 12, 1964 under unknown admin, no.;
prepared by Wisconsin Alumni Research Foundation, submitted by Ciba
Agrochemical Co., Summit, N.J.; CDL:124540-A).
00019020 Hamilton, K.C.; Arle, F. (1964) Analysis of Cotton Plants and Seeds for Cotoran
Residues following a Postemergent, Broadcast, Directed Lay-By Treatment:
Research Report CF-370. (Unpublished study received Sep 23, 1965 under 8192-
5; prepared by Univ. of Arizona, Dept. of Agronomy in cooperation with U.S.
Agricultural Research Service, Crops Research Div., Cotton Research Center and
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00019021 Wisconsin Alumni Research Foundation (19??) Storage Study with Cotoran
Treated Cottonseed. (Unpublished study received Sep 23, 1965 under 8192-5;
submitted by Ciba Agrochemical Co., Summit, N.J.; CDL:007075-C).
00019022 Overton, J.R. (1965) Analysis of Cottonseed for Cotoran Residues following a
Preemergent, Broadcast, Surface Treatment: Research Report CF-292.
(Unpublished study received Jul 20, 1965 under 8192-5; prepared by Univ. of
Tennessee, West Tennessee Experiment Station in cooperation with Wisconsin
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00019036 Thompson, J.T.; Hardcastle, W.S.; Frans, R.E.; et al. (1965) Cotoran (C-2059):
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00019085 Wisconsin Alumni Research Foundation (1967) Re-evaluation of Fluometuron
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15, 1967 under 6F0505; submitted by Ciba Agrochemical Co., Summit, N.J.;
CDL:090591-A).
62
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00019099 Thompson, J.T.; Hardcastle, W.S.; Frans, R.E.; et al. (1965) Results of Tests on
the Amount of Residues Remaining, Including a Description of the Analytical
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6F0505; submitted by Ciba Agrochemical Co., Summit, N.J.; CDL:090591-T).
00019160 Geissbuhler, H.; Haselbach, C.; Jacot-Guillarmod, A. (1964) Residue Analysis of
Preparation C-2059, N'-(3-Trifluoromethyl)-phenyl-N,N-dimethylurea, in Soils
and Plant Tissues. Includes method dated Jan 15, 1964. (Unpublished study
received Oct 8, 1964 under 100-549; prepared by Battelle Memorial Institute for
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CDL:007070-P).
00022940 Ciba-Geigy Corporation (1971) Fluometuron, l,l-Dimethyl-3-(alpha,alpha,alpha-
trifluoro-m-tolyl)urea, Spectrophotometric Residue Assay Method. Method no.
CF-R5 dated Nov 5, 1971. (Unpublished study received Apr 17, 1975 under
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Calif; CDL: 221088-D).
00031739 Whipp, A. A.; Kalens, K. J. (1972) Summary of Residue Test Data for the Tank-
Mixture of Paraquat CL Spray and Cotoran SOW (Fluometuron) on Cotton.
(Unpublished study received Jul 30, 1973 under 239-2186; prepared in
cooperation with Pattison's Laboratories, Inc. and others, submitted by Chevron
Chemical Co., Richmond, Calif; CDL:026962-C).
00034005 Pickens, R.A.; Cingalani, J.; Blackman, W.; et al. (1973) Crop Residue Report:
FSDS No. A-7562. (Unpublished study received Jul 20, 1973 under 476-2004;
prepared in cooperation with B.N. Word Co. and others, submitted by Stauffer
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00065048 Ciba-Geigy Corporation (1981) [Residue Tests with Cotton]. (Compilation;
unpublished study received Apr 28, 1981 under 100-597; CDL:070049-B).
00106374 United States Borax & Chemical Corp. (1975) Cobex (PPI) Fluometuron
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40047401 Madrid, S. (1986) Balance and Metabolism of Carbon-14 -fluometuron in
Lactating Goat Dosed at 5 PPM for Ten Consecutive Days (Nature of Residue -
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40047402 Madrid, S. (1986) Balance and Distribution of Radioactivity of Carbon-14 -
fluometuron in Chickens at a Daily Level of 5.0 PPM (Nature of Residue -
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Corp. 34 p.
63
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40067501 Hubbard, H. (1987) Determination of Total Fluometuron Residues as 2-
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40190704 Madrid, S. (1986) Balance and Metabolism of Carbon 14 -Fluometuron in
Lactating Goat Dosed at 5 ppm for Ten Consecutive Days: (Nature of Residue--
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40190706 Madrid, S. (1986) Balance and Distribution of Radioactivity of Carbon 14 -
Fluometuron in Chickens at a Daily Level of 5.0 ppm: (Nature of Residue--
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40190710 Cheng, M. (1987) Residues of Fluometuron Determined as 3-Trifluoro-
methylaniline in Tissues and Milk of Dairy Cows Receiving Fluometuron in Their
Diet: (Magnitude of Residues): Laboratory Study No. ABR-87028. Unpublished
compilation prepared by Ciba-Geigy Corp. 68 p.
40190711 Cheung, M. (1987) Residues of Fluometuron Determined as 3-
Trifluoromethylaniline in Tissues and Eggs of Chickens Receiving Fluometuron
in Their Diet: (Magnitude of Residues): Laboratory Study No. ABR-87029.
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40190712 Cheung, M. (1987) Residues of Fluometuron Determined as 3-
Trifluoromethylaniline in Cotton Fodder and Seeds Resulting from Applications
of Cotoran SOW or 4L: (Magnitude of Residue): Laboratory Study No. ABR-
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40190714 Smithers, V. (1987) Determination of Total Fluometuron Residues as
3-Trifluoromethylaniline in Cotton Fodder and Cotton Seed Using Capillary Gas
Chromatography: (Residue Analytical Method): Laboratory Study No. AG-528.
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40292001 Hubbard, L. (1987) Residue of Total Fluometuron Residues as 3-
Trifluoromethylaniline in Cotton Fractions Using Capillary Gas Chromatography
(Residue Analytical Method): Lab./Study No. AG-529. Unpublished study
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40292002 Gold, B. (1987) Residues of Fluometuron Determined as 3-Trifluoromethylaniline
in Cottonseed Fractions Resulting from Applications of Cotoran (Magnitude of
Residue): Lab./Study No. ABR-87066. Unpublished study prepared by Ciba-
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40492411 Madrid, S. (1982) Comparison of Two Moieties TFAA and TFMA in Cotton
64
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Treated with phi-(Carbon 14)-Fluometuron: Laboratory Project ID ABR-82020.
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40492412 Miles, J. (1988) Characterization of Fluometuron Metabolites in Greenhouse
Grown Cotton: Laboratory Project ID ABR-88005. Unpublished study performed
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40492413 Orr, G. (1988) Uptake and Characterization of Fluometuron in Greenhouse
Grown Cotton and Soil: Lab. Proj. ID ABR-88004. Unpublished study performed
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41161903 Cheung, M. (1989) Fluometuron: Residue Stability of Fluometuron in Cotton-
seeds, Refined Oil, and Cotton Fodder Under Freezer Storage Conditions: Interim
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41161904 Cheung, M. (1989) Fluometuron: Residue Stability of Fluometuron in Beef
Round, Beef Liver, Dairy Milk, and Poultry Eggs Under Freezer Storage
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42017305 Cheung, M. (1989) Validation of Analytical Methods AG-519, AG-528 and AG-
529 for the Determination of Fluometuron Metabolites: Response to EPA Residue
Chemistry Branch Questions: Lab Project Number: ABR-89035. Unpublished
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42017306 Cheung, M. (1989) Specificity of Analytical Methods AG-519, AG-528 and AG-
529 for the Determination of Total Residues of Fluometuron in Animal and Crop
Substrates: Lab Project Number: ABR-89034. Unpublished study prepared by
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42258701 Senzel, A. (1991) Fluometuron: Sample Storage Interval Summary: Lab Project
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42498008 Williams, R. (1989) Fluometuron: Determination of Fluometuron and its Major
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43218101 Ross, J. (1994) Fluometuron Residues in Cotton, Rotational Crops, and Processed
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49 p.
43218102 Ross, J. (1993) Fluometuron-Magnitude of Residues in Cottonseed, Soil, and Raw
Agricultural Commodities and Processed Fractions of Rotational Crops Following
65
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Applications of Cotoran 4L to Cotton: Lab Project Number: ABR-92045:21-90-
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43218103 Ross, J. (1994) Fluometuron-Magnitude of Residues in Processed Fractions of
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43218104 Joseph, T. (1993) Validation of Method AG-529 for the Determination of
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43413403 Carlin, T. (1994) Metabolism of (carbon 14)-Fluometuron in Laying Hens: Lab
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43413404 Carlin, T. (1994) Metabolism of (carbon 14)-Fluometuron in Lactating Goats: Lab
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43413405 Joseph, T. (1994) Determination of Fluometuron Residues As
3-Trifluoromethylaniline in Meat, Milk, and Eggs with Accountable Data: Lab
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43654401 Close, C.; Sanson, D. (1994) Uptake and Metabolism of Fluometuron in Field
Rotational Crops Following Cotton Treated at a Rate of 4.0 Ib. ai/A: Lab Project
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43654402 Swain, W. (1995) Fluometuron: Summary of Metabolism and Residue Data for
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43654403 Sanson, D. (1994) Uptake and Balance of (carbon 14)-Fluometuron and Its
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43654404 Simoneaux, B. (1995) Uptake and Balance of (carbon 14)-Fluometuron and Its
Metabolites in Field Grown Cotton: Amendment No. 1: Lab Project Numbers:
ABR-95064: 122925. Unpublished study prepared by Ciba-Geigy Corp. 101 p.
66
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43654405 Joseph, T. (1994) Validation of Method AG-529 for the Determination of
Fluometuron Residues as 3-Trifluoromethylaniline in Rotational Crops With
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44084801 Simoneaux, B. (1996) Uptake and Metabolism of Fluometuron in Field Rotational
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44449401 Schuster, L. (1997) Independent Laboratory Method Validation of CIBA
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44449402 Schuster, L. (1997) Independent Laboratory Method Validation of CIBA
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Ecological Effects
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18646 Takeda Chemical Ind., Limited (1963) Test on Fish Toxicity of C-1935, C-1983,
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42795001 Kegley, M. (1993) Fluometuron: Vegetative Vigor: Lab Project Number:
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42564101 Ward, G.; Lintott, D. (1992) Fluometuron: Acute Toxicity to the Saltwater
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42564102 Ward, G.; Lintott, D. (1992) Fluometuron: Acute Toxicity to Duckweed, Lemna
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42564103 Juarovisech, K.; Lintott, D. (1992) Fluometuron: Acute Toxicity to the Freshwater
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42568502 Lintott, D. (1992) Fluometuron: Acute Toxicity to the Freshwater Diatom,
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42718801 Chetram, R. (1993) Tier 2 Seed Germination Nontarget Phytotoxicity Study
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00018997 Smith, I; Lignowski, E.; Coble, H.D.; et al. (1978) Summary: Prowl (CL 92,553)
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(Unpublished study received Jul 20, 1965 under 8192-5; prepared by Univ. of
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40067501 Hubbard, H. (1987) Determination of Total Fluometuron Residues as 2-
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40190704 Madrid, S. (1986) Balance and Metabolism of Carbon 14 -Fluometuron in
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40190706 Madrid, S. (1986) Balance and Distribution of Radioactivity of Carbon 14 -
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40190710 Cheng, M. (1987) Residues of Fluometuron Determined as 3-Trifluoro-
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40190711 Cheung, M. (1987) Residues of Fluometuron Determined as 3-
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40190712 Cheung, M. (1987) Residues of Fluometuron Determined as 3-
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40190714 Smithers, V. (1987) Determination of Total Fluometuron Residues as
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40292001 Hubbard, L. (1987) Residue of Total Fluometuron Residues as 3-
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40292002 Gold, B. (1987) Residues of Fluometuron Determined as 3-Trifluoromethylaniline
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40492411 Madrid, S. (1982) Comparison of Two Moieties TFAA and TFMA in Cotton
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40492412 Miles, J. (1988) Characterization of Fluometuron Metabolites in Greenhouse
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40492413 Orr, G. (1988) Uptake and Characterization of Fluometuron in Greenhouse
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41161903 Cheung, M. (1989) Fluometuron: Residue Stability of Fluometuron in Cotton-
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41161904 Cheung, M. (1989) Fluometuron: Residue Stability of Fluometuron in Beef
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42017304 Shortelle, A.; Manning, C.; Ward, G. (1990) Carbon-14 Fluometuron:
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42017305 Cheung, M. (1989) Validation of Analytical Methods AG-519, AG-528 and AG-
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42017306 Cheung, M. (1989) Specificity of Analytical Methods AG-519, AG-528 and AG-
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529 for the Determination of Total Residues of Fluometuron in Animal and Crop
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42258701 Senzel, A. (1991) Fluometuron: Sample Storage Interval Summary: Lab Project
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43218102 Ross, J. (1993) Fluometuron-Magnitude of Residues in Cottonseed, Soil, and Raw
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43218103 Ross, J. (1994) Fluometuron-Magnitude of Residues in Processed Fractions of
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Cotton: Lab Project Number: ABR-90001: 126-88: 122925. Unpublished study
prepared by Ciba-Geigy Corp., Biochemistry Dept. 428 p.
43218104 Joseph, T. (1993) Validation of Method AG-529 for the Determination of
Fluometuron Residues as 3-Trifluoromethylaniline in Cotton Fractions with
Accountability Data and Amendment 1: Lab Project Number: ABR-93026:
AMENDMENT 1: 122925. Unpublished study prepared by Ciba-Geigy Corp.,
Biochemistry Dept. 126 p.
43413403 Carlin, T. (1994) Metabolism of (carbon 14)-Fluometuron in Laying Hens: Lab
Project Number: ABR-93076: 122925. Unpublished study prepared by Ciba-
Geigy Corporation. 259 p.
43413404 Carlin, T. (1994) Metabolism of (carbon 14)-Fluometuron in Lactating Goats: Lab
Project Number: ABR-94052. Unpublished study prepared by Ciba-Geigy
Corporation. 280 p.
43413405 Joseph, T. (1994) Determination of Fluometuron Residues As
3-Trifluoromethylaniline in Meat, Milk, and Eggs with Accountable Data: Lab
Project Number: AG-519A. Unpublished study prepared by Ciba-Geigy
Corporation. 86 p.
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43654401 Close, C.; Sanson, D. (1994) Uptake and Metabolism of Fluometuron in Field
Rotational Crops Following Cotton Treated at a Rate of 4.0 Ib. ai/A: Lab Project
Numbers: 40589: 158-92: M-9129. Unpublished study prepared by ABC Labs,
Inc.; Ciba Plant Protection (Vero Beach Research Center); and Ciba Plant
Protection (Delta Research Center). 97 p.
43654402 Swain, W. (1995) Fluometuron: Summary of Metabolism and Residue Data for
Cotton, Rotational Crops and Livestock Plus Analytical Method Validation
Results: Lab Project Number: ABR-95067: ABR-82040. Unpublished study
prepared by Ciba-Geigy Corp. 160 p.
43654403 Sanson, D. (1994) Uptake and Balance of (carbon 14)-Fluometuron and Its
Metabolites in Field Grown Cotton: Lab Project Number: 71-92: 40203: M-9132.
Unpublished study prepared by ABC Labs, Inc. 264 p.
43654404 Simoneaux, B. (1995) Uptake and Balance of (carbon 14)-Fluometuron and Its
Metabolites in Field Grown Cotton: Amendment No. 1: Lab Project Numbers:
ABR-95064: 122925. Unpublished study prepared by Ciba-Geigy Corp. 101 p.
43654405 Joseph, T. (1994) Validation of Method AG-529 for the Determination of
Fluometuron Residues as 3-Trifluoromethylaniline in Rotational Crops With
Accountability Data: Lab Project Numbers: ABR-94042: AG-529. Unpublished
study prepared by Ciba-Geigy Corp. 60 p.
44084801 Simoneaux, B. (1996) Uptake and Metabolism of Fluometuron in Field Rotational
Crops Following Cotton Treated at a Rate of 4.0 Ib. ai/A: Addendum No. 1 to
MRID 43654401: Lab Project Number: ABR-96065: 158-92: 122925.
Unpublished study prepared by Ciba Crop Protection. 64 p.
44449401 Schuster, L. (1997) Independent Laboratory Method Validation of CIBA
Analytical Method AG-528 for Fluometuron Analysis in Cotton Matrices: Lab
Project Number: 970009: 460-97: AG-528. Unpublished study prepared by
Central California Research Labs. 103 p. (OPPTS 860.1340}.
44449402 Schuster, L. (1997) Independent Laboratory Method Validation of CIBA
Analytical Method AG-529 for Fluometuron Analysis in Cotton Matrices: Lab
Project Number: 970010: 461-97: AG-529. Unpublished study prepared by
Central California Research Labs. 118 p. {OPPTS 860.1340}.
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Appendix E: Generic Data Call-In
Appendix F: Product-Specific Data Call-In
The Agency intends to issue both Generic and Product-Specific Data Call-Ins for fluometuron. See
Chapter V of the RED for a list of studies that the Agency plans to require.
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Appendix G: Batching of Fluometuron 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 reregi strati on of products containing FLUOMETURON 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
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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.
Twenty products were found which contain fluometuron as the active ingredient. These
products have been placed into five Batches and a No Batch group in accordance with the active
and inert ingredients and type of formulation.
Batching Instructions:
Batch 2a: Products in this Batch may cite data generated with products in Batch 2.
Batch 3: EPA Reg. Nos. 352-709 and 66222-32 may cite each other but may not cite data
generated by other products in this Batch.
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.
11603-31
66330-254
74694-27
Percent Active Ingredient
96.0
96.5
97.0
Batch 2
EPA Reg. No.
1812-438
66222-33
66222-34
Percent Active Ingredient
85.0
85.0
85.0
Batch 2a
EPA Reg. No.
352-687
5905-494
9779-311
66330-261
66222-30
Percent Active Ingredient
80.0
80.0
80.0
80.0
80.0
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Batch 3
EPA Reg. No.
1812-285
352-709
9779-312
66330-260
56077-79
66222-32
Percent Active Ingredient
41.2
41.7
41.7
41.7
43.0
41.7
Batch 4
EPA Reg. No.
9779-319
66222-29
Percent Active Ingredient
Fluometuron: 13.2%
MSMA: 27.6%
Fluometuron: 13.2%
MSMA: 27.6%
No Batch
EPA Reg. No.
19713-127
Percent Active Ingredient
Fluometuron: 13.2%
MSMA: 27.6%
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Appendix H: List of Registrants Sent The Data Call-In
Appendix H: List of Registrants Sent the Fluometuron DCI
Company
Number
352
1812
5905
9779
11603
19713
66222
66330
Company Name
E.I. Du Pont de Nemours and
Co., Inc.
Griffin LLC
Helena Chemical Co.
Agriliance, LLC
AGAN Chemical Mfg., LTD
Drexel Chemical Co.
Makhteshim-Agan of North
America Inc.
Arysta Lifescience North
America Corporation
Address
PO Box 30
Stine-Haskell Research Center
Newark, DE 19714
PO Box 30
Stine-Haskell Research Center
Newark, DE 19714
225 Schilling Boulevard, Suite 300
Collierville, TN 38017
PO Box 64089
St. Paul, MN 55164
4515 Falls of Neuse Rd., Suite 300
Raleigh, NC 27609
POBox 13327
1700 Channel Avenue
Memphis, TN 38113
4515 Falls of Neuse Rd., Suite 300
Raleigh, NC 27609
Park West II
15401 Weston Parkway, Suite 150
Cary,NC 27513
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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/opprd001/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 following address for the Document Processing
Desk.:
Document Processing Desk (distribution code)*
Office of Pesticide Programs (7504P)
Environmental Protection Agency
1200 Pennsylvania Ave, NW
Washington, DC 20460-0001
* Distribution Codes are as follows:
(APPL) Application for product registration
(AMEND) Amendment to existing registration
(CAN) Voluntary Cancellation
(EUP) Experimental Use Permit
(DIST) Supplemental Distributor Registration
(SLN) Special Local Need
(NEWCO) Request for new company number
(NOTIF) Notification
(PETN) Petition for Tolerance
(XFER) Product Transfer
DO NOT fax or e-mail any form containing "Confidential Business Information" or "Sensitive
Information."
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at williams.mcole@epamail.epa.gov. If you want these forms mailed or faxed
to you, please contact Lois White, white.lois@epa.gov or Floyd Gayles, gayles.floyd@epa.gov.
If you have any questions concerning how to complete these forms, please contact OPP's
ombudsperson for conventional pesticide products: Linda Arlington, (703) 305-5446
The following Agency Pesticide Registration Forms are currently available via the Internet at the
following locations:
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8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
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
Formulator's Exemption Statement
Certification of Compliance with Data
Gap Procedures
Pesticide Registration Maintenance
Fee Filing
Certification of Attempt to Enter into
an Agreement with other Registrants
for Development of Data
Certification with Respect to Citations
of Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical
Properties (in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR
Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprdOO l/forms/8570- 1 7.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http ://www. epa. sov/opppmsd I/PR Notices/pr98-
5.pdf
http ://www. epa. sov/opppmsd I/PR Notices/pr98-
5.pdf
http ://www. epa. sov/opppmsd I/PR Notices/pr98-
l.pdf
http ://www. epa. sov/opppmsd I/PR Notices/pr98-
l.pdf
Pesticide Registration Kit http://www.epa.sov/pesticides/resistrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)of 1996.
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2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document
is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. 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' Web Site
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.
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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: http://npic.orst.edu
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
• Date of receipt
• EPA identifying number
• Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date
of receipt and provide the EPA identifying File Symbol or petition number for the new
submission. The identifying number should be used whenever you contact the Agency
concerning an application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and
trade names, company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a CAS number if one has been assigned.
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