SEQ CHAPTER \h \r 1 United States			Prevention, Pesticides		EPA
xxx-xxx-xx-xxxx

Environmental Protection		and Toxic Substances		September 2005

Agency				(7508C)

Reregistration

Eligibility Decision (RED) for Fluometuron

REREGISTRATION ELIGIBILITY

DECISION

for

Fluometuron

Case No. 0049

Approved by:

______________________

Debra Edwards, Ph.D.

Director, Special Review and

Reregistration Division

________________________

Date

TABLE OF CONTENTS

  TOC \o "1-4" \u  Fluometuron Reregistration Eligibility Decision Team
 PAGEREF _Toc115659578 \h  v

Glossary of Terms and Abbreviations	  PAGEREF _Toc115659579 \h  vi

Abstract	  PAGEREF _Toc115659580 \h  viii

I.	Introduction	  PAGEREF _Toc115659581 \h  1

II.	Chemical Overview	  PAGEREF _Toc115659582 \h  2

A.	Regulatory History	  PAGEREF _Toc115659583 \h  2

B.	Chemical Identification - Fluometuron	  PAGEREF _Toc115659584 \h  2

C.	Use Profile	  PAGEREF _Toc115659585 \h  3

D.	Estimated Usage of Fluometuron	  PAGEREF _Toc115659586 \h  3

III.	Summary of Fluometuron Risk Assessments	  PAGEREF _Toc115659587 \h
3

A.	Human Health Risk Assessment	  PAGEREF _Toc115659588 \h  4

1.	Toxicity of Fluometuron	  PAGEREF _Toc115659589 \h  4

a.	Acute Toxicity Profile for Fluometuron	  PAGEREF _Toc115659590 \h  4

b.	FQPA Safety Factor Considerations for Fluometuron	  PAGEREF
_Toc115659591 \h  5

c.	Toxicological Endpoints for Fluometuron	  PAGEREF _Toc115659592 \h  5

2.	Carcinogenicity of Fluometuron	  PAGEREF _Toc115659593 \h  6

3.	Metabolites and Degradates	  PAGEREF _Toc115659594 \h  7

4.	Dietary Risk (Food and Drinking Water)	  PAGEREF _Toc115659595 \h  7

a.	Exposure Assumptions	  PAGEREF _Toc115659596 \h  7

b.	Population Adjusted Dose	  PAGEREF _Toc115659597 \h  8

c.	Acute Dietary Risk (Food and Drinking Water)	  PAGEREF _Toc115659598
\h  9

d.	Chronic Dietary Risk (Food and Drinking Water)	  PAGEREF
_Toc115659599 \h  9

e.	Cancer Dietary (Food and Drinking Water)	  PAGEREF _Toc115659600 \h
10

5.	Residential Exposure and Risk	  PAGEREF _Toc115659601 \h  11

6.	Aggregate Risk	  PAGEREF _Toc115659602 \h  12

7.	Occupational Exposure and Risk	  PAGEREF _Toc115659603 \h  12

a.	Handler Exposure and Risk	  PAGEREF _Toc115659604 \h  13

b.	Post-Application Exposure and Risk	  PAGEREF _Toc115659605 \h  15

c.	Incident  Reports	  PAGEREF _Toc115659606 \h  16

B.	Environmental Fate and Effects Risk Assessment	  PAGEREF
_Toc115659607 \h  16

1.	Environmental Fate and Transport	  PAGEREF _Toc115659608 \h  16

2.	Ecological Exposure and Risk	  PAGEREF _Toc115659609 \h  16

a.	Terrestrial Organisms	  PAGEREF _Toc115659610 \h  17

b.	Aquatic Organisms	  PAGEREF _Toc115659611 \h  19

c.	Endangered Species	  PAGEREF _Toc115659612 \h  20

3.	Ecological Incidents	  PAGEREF _Toc115659613 \h  20

IV.	Risk Management, Reregistration, and Tolerance Reassessment
PAGEREF _Toc115659614 \h  21

A.	Determination of Reregistration Eligibility	  PAGEREF _Toc115659615
\h  21

B.	Public Comments and Responses	  PAGEREF _Toc115659616 \h  22

C.	Regulatory Position	  PAGEREF _Toc115659617 \h  22

1.	Food Quality Protection Act Findings	  PAGEREF _Toc115659618 \h  22

a.	“Risk Cup” Determination	  PAGEREF _Toc115659619 \h  22

b.	Determination of Safety to U.S. Population	  PAGEREF _Toc115659620 \h
 22

c.	Determination of Safety to Infants and Children	  PAGEREF
_Toc115659621 \h  22

2.	Endocrine Disruptor Effects	  PAGEREF _Toc115659622 \h  23

3.	Cumulative Risks	  PAGEREF _Toc115659623 \h  23

4.	Endangered Species	  PAGEREF _Toc115659624 \h  24

D.	Tolerance Reassessment Summary	  PAGEREF _Toc115659625 \h  24

E.	Regulatory Rationale	  PAGEREF _Toc115659626 \h  27

1.	Human Health Risk Management	  PAGEREF _Toc115659627 \h  27

a.	Dietary (Food and Drinking Water) Risk Mitigation	  PAGEREF
_Toc115659628 \h  27

b.	Residential Risk Mitigation	  PAGEREF _Toc115659629 \h  30

c.	Aggregate Risk Mitigation	  PAGEREF _Toc115659630 \h  30

d.	Occupational Risk Mitigation	  PAGEREF _Toc115659631 \h  30

2.	Non-Target Organism (Ecological) Risk Management	  PAGEREF
_Toc115659632 \h  32

a.	Terrestrial Organisms	  PAGEREF _Toc115659633 \h  33

b.	Aquatic Organisms	  PAGEREF _Toc115659634 \h  34

3.	Summary of Mitigation Measures	  PAGEREF _Toc115659635 \h  35

F.	Other Labeling Requirements	  PAGEREF _Toc115659636 \h  35

1.	Endangered Species Considerations	  PAGEREF _Toc115659637 \h  35

2.	Spray Drift Management	  PAGEREF _Toc115659638 \h  36

V.	What Registrants Need to Do	  PAGEREF _Toc115659639 \h  36

A.	Manufacturing Use Products	  PAGEREF _Toc115659640 \h  36

1.	Data Requirements	  PAGEREF _Toc115659641 \h  36

2.	Labeling for Manufacturing-Use Products	  PAGEREF _Toc115659642 \h
38

B.	End-Use Products	  PAGEREF _Toc115659643 \h  38

1.	Additional Product-Specific Data Requirements	  PAGEREF _Toc115659644
\h  38

2.	Labeling for End-Use Products	  PAGEREF _Toc115659645 \h  38

C.	Labeling Changes Summary Table	  PAGEREF _Toc115659646 \h  38

  VI.
Appendices……………………………………………………
…………………………45

	Appendix A:	Use Patterns Eligible for Reregistration

Appendix B:	Data Supporting Guideline Requirements for the
Reregistration 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 Reregistration

Appendix H:	List of Registrants Sent This Data Call-In

Appendix I:	List of Available Related Documents and Electronically
Available Forms

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

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 Disruptor Screening Program

EDSTAC	Endocrine Disruptor 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/l, 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

LOC		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.

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

PDP		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

Abstract tc "EXECUTIVE SUMMARY"

	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 reregistration, 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.

I.	Introduction

	The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended in 1988 to accelerate the reregistration of products with active
ingredients registered prior to November 1, 1984.  The amended Act calls
for the development and submission of data to support the reregistration
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”).  Reregistration involves a thorough review of the scientific
database underlying a pesticide’s registration.  The purpose of the
Agency’s review is to reassess the potential hazards arising from the
currently registered uses of 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 reregistration, tolerance reassessment will be accomplished
through the reregistration process.

As mentioned above, FQPA requires EPA to consider available information
concerning the cumulative effects of a particular pesticide’s residues
and “other substances that have a common mechanism of toxicity.”
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
reregistration 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 reregistration eligibility and risk
management; and Section V summarizes the label changes necessary to
implement the risk mitigation measures outlined in Section IV.  Finally,
the Appendices list related information, supporting documents, and
studies evaluated for the reregistration 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/oppsrrd1/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 Reregistration 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 reregistration 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 reregistration eligibility conclusions for
fluometuron that are presented in this RED document.

	B.	Chemical Identification - Fluometuron

Chemical Structure:

Common Name:		Fluometuron

Chemical Name:		N,N-dimethyl-N’-(3-(trifluoromethyl)phenyl)urea

Trade Name:			Cotoran®

Chemical Family:		Phenylurea herbicide

Case Number:			0049

CAS Number:			2164-17-2

PC Code:			035503

Molecular Weight:		232.2

Empirical Formula:		C10H11F3N2O

Basic Manufacturer:		Agan Chemical Manufacturers, Ltd.

Other Technical Registrants:	Loveland Products, Inc.

				Micro-Flo Company LLC

	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 reregistration
is available in Appendix A.

Type of Pesticide:		Herbicide

Target Pest:			Broadleaf weeds

Mode of Action:	Inhibition of photosynthesis and bleaching and
inhibition of carotenoid biosynthesis

Use Site:	Cotton

Use Classification:	General Use

Formulation Types:	Fluometuron formulations include dry flowable,
soluble concentrate/liquid, wettable powder, and emulsifiable
concentrate

Application Methods:	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.

Application Rates: 	Fluometuron is applied at a maximum one-time
application rate of 2.0 pounds active ingredient per acre (lb ai/A) with
up to 3 treatments per year.

Application Timing:	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.

III.	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 and Ecological Risk
Assessment of Fluometuron 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 and EFED’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 Fluometuron-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/oppsrrd1/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 III 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
carcinogenicity 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 III for acute inhalation toxicity.  It is
classified as category II 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.

Table 1.  Acute Toxicity Profile for Fluometuron

Guideline	Study Type	MRID(s)	Results	Toxicity Category

870.1100	Acute Oral	41216802

40409302

00142844	LD50 > 1000 mg/kg	III

870.1200	Acute Dermal	41216803

40409303

00142844	LD50 > 2000 mg/kg	III

870.1300	Acute Inhalation	40409304

41216804

00142844	LC50 > 0.6 mg/L	III

870.2400	Primary Eye Irritation	41216805

00142846

40409305	Moderate to severe eye irritant (irritation to cornea and iris)
 	II

870.2500	Primary Skin Irritation	41216806

40409306

00142847

00068040	Slight to severe skin irritant	II

870.2600	Dermal Sensitization	40409307

41216807

00160762

00142848	Non-sensitizing in guinea pig or rat	Not Applicable

  SEQ CHAPTER \h \r 1 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 (10x) 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 10x 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, t  SEQ
CHAPTER \h \r 1 he FQPA SF was reduced to 1x.  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 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

aPAD = 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)	Oral NOAEL= 10 mg/kg/day

Absorption Factors

Dermal=10%

Inhalation=100%	FQPA SF=NA (occupational)

LOC for MOE=100	Developmental, Rat

LOAEL=100 mg/kg/day, based on delayed urinary system development.

Dermal and Inhalation Exposure: Intermediate-Term

(1 to 6 months)	Oral NOAEL= 10 mg/kg/day

Absorption Factors

Dermal=10%

Inahalation=100%	FQPA SF=NA (occupational)

LOC for MOE=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 Q1* (mg/kg/day)-1 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, LOC = 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 female mice.  For the
purpose of risk characterization, a low dose extrapolation model (Q1*)
was used.  The Q1* 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;
1-methyl-3-(,,-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)

  SEQ CHAPTER \h \r 1 	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.  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.

  SEQ CHAPTER \h \r 1 Table 3. Total EDWCs (ppb) in surface water and
groundwater for fluometuron and its major degradate

	CA	TX	MS	NC

Surface water/ peak (90th percentile annual daily max. - acute)	26.8
47.5	81.8	45.0

Surface water/average (90th percentile annual mean - chronic)	21.9	20.1
18.9	16.9

Surface water/36-year overall mean (cancer) 	19.4	12.4	8.2	12.0

Groundwater (all exposures)	241

Use modeled	3 aerial applications @ 2.0 lb ai/acre to cotton*

Percent Cropped Area (cotton)	20%

  SEQ CHAPTER \h \r 1 	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 (PDP).  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	aPAD (mg/kg/day)	99.9th Percentile

Exposure (mg/kg/day)	% aPAD

Females 13-49 years old	0.1	0.033720	34

d.	  SEQ CHAPTER \h \r 1 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	cPAD (mg/kg/day)	Exposure (mg/kg/day)	% cPAD

All populations	0.0055	0.005147	94

All infants (< 1 year old)

0.016807	306

Children 1-2 years old

0.007726	141

Children 3-5 years old

0.007221	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 (Q1*) 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 Q1* 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 Q1* 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.

Table 6.  Fluometuron Cancer Dietary (Food + Drinking Water) Risk
Estimates

Dietary Exposures Assessed	Q1*	Cancer Risk Estimate

Food alone	1.80 x 10-2 (mg/kg/day)-1	1.22 x 10-6

Groundwater alone

9.14 x 10-5

Food + drinking water from groundwater sources

9.27 x 10-5

Surface water alone

7.36 x 10-6

Food + drinking water from surface water sources

8.58 x 10-6

	The estimated exposure of the general U.S. population to fluometuron in
surface water is 0.000476 mg/kg/day.  Applying the Q1* 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.

6.	  SEQ CHAPTER \h \r 1 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 Q1*
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:

	1a	mixing/loading emulsifiable concentrates (ECs, liquids) for aerial
applications

1b	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

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 (PHED) 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 lb 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 LOC.

Table 7.  Predicted Handler Non-Cancer Risks for Fluometuron at the
Maximum Application Rate of 2 lb 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 (1a)	1200	0.86	71	86	98	130
260	120

Mixing/Loading EC for Groundboom Applications (1b)	200	5.2	430	520	590
770	1600	720

Mixing/Loading DF for Aerial Applications (2a)	1200	34	34	46	37	52	210
NA

Mixing/Loading DF for Groundboom Applications (2b)	200	200	200	270	220
310	1200	NA

Mixing/Loading WP for Aerial Applications (3a)	1200	0.61	4.2	4.5	9.8	12
210	NA

Mixing/Loading WP for Groundboom Applications (3b)	200	3.6	25	27	59	69
1200	NA

Applicator

Applying Liquid Sprays via Aerial Equipment (4)	1200	No Data	440	No Data

Applying Liquid Sprays via Groundboom Equipment (5)	200	700	700	820	970
1200	2800	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 lb 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 lb 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 (1a)	1200	3.2x10-3	4.0x10-5
3.3x10-5	2.9x10-5	2.2x10-5	1.1x10-5

Mixing/Loading EC for Groundboom Applications (1b)	200	5.5x10-4	6.7x10-6
5.5x10-6	4.8x10-6	3.7x10-6	1.8x10-6

Mixing/Loading DF for Aerial Applications (2a)	1200	8.4x10-5	8.4x10-5
6.2x10-5	7.7x10-5	5.5x10-5	1.4x10-5

Mixing/Loading DF for Groundboom Applications (2b)	200	1.4x10-5	1.4x10-5
1.0x10-5	1.3x10-5	9.2x10-6	2.3x10-6

Mixing/Loading WP for Aerial Applications (3a)	1200	4.7x10-3	6.8x10-4
6.4x10-4	2.9x10-4	2.5x10-4	1.4x10-5

Mixing/Loading WP for Groundboom Applications (3b)	200	7.9x10-4	1.1x10-4
1.1x10-4	4.9x10-5	4.1x10-5	2.3x10-6

Applicator

Applying Liquid Sprays via Aerial Equipment (4)	1200	No Data	No Data	No
Data	No Data	No Data	6.5x10-6

Applying Liquid Sprays via Groundboom Equipment (5)	200	4.1x10-6
4.1x10-6	3.5x10-6	2.9x10-6	2.4x10-6	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)	Transfer Coefficients (cm2/hr)a	Activities	MOE at Day 0 (12
hours after application)	Cancer Risk

Day 0	Day 12

Cotton

(2.0 lb ai/A for short-term & 1.5 lb ai/A for cancer)	100 (early season
- low crop)	Irrigation, Scouting, Hand Weeding	1700	7 x 10-7	not needed

	1500 (later season - mature crop)	Irrigation, Scouting, Hand Weeding
110	1 x 10-5	9 x 10-7

	Based on the maximum application rate of 2.0 lb 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 lb 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.

			c.	Incident  tc "Incident " \l 2  Reports

	  SEQ CHAPTER \h \r 1 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  tc "		1.	Environmental Fate and
Transport " \l 3

	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

	  SEQ CHAPTER \h \r 1 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 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 LOC presented, then the Agency
presumes that…	LOC

terrestrial animals	LOC

aquatic animals	LOC

plants

Acute Risk …there is potential for acute risk; regulatory action may
be warranted in addition to restricted use classification	0.5	0.5	1.0

Acute Restricted Use …there is potential for acute risk, but may be
mitigated through restricted use classification	0.2	0.1	NA

Acute Endangered Species …endangered species may be adversely affected
0.1	0.05	1.0

Chronic Risk …there is potential for chronic risk	1	1	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 lb ai/A fluometuron
to cotton.  EECs are then compared to the most sensitive toxicity
endpoints to calculate RQs (e.g., LC50 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	Maximum EEC (ppm)	Mean EEC (ppm)	Bird

Acute RQs*	Mammal Acute RQs**

by Body Weight	Mammal

Chronic RQs***

15g	35 g	1000 g	Based on Max EECs	Based on Mean EECs

Short grass	1119	396	0.36	0.71-1.06	0.49-0.74	0.11-0.17	112	40

Tall grass	513	168	0.16	0.33-0.49	0.23-0.34	0.05-0.08	51	17

Broadleaf plants

small insects	630	210	0.20	0.44-0.60	0.28-0.42	0.06-0.09	63	21

Fruits, pods

large insects	70	33	0.02	0.04-0.07	0.03-0.05	0.01	7	3

Seeds

0.01	0.01	<0.01

*  Based on maximum EECs and ring-necked pheasant LC50 of 3150 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 (MRID 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 LOC 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	EEC (lb ai/A)	Non-Endangered

Species RQs*	Endangered

Species RQs**

Dry Area Adjacent to the Treatment Site	0.1600	27	80

Wetland (Semi-Aquatic Area) Adjacent to the Treatment Site	0.7000	117
350

Drift	0.1000	11	50

* Based on terrestrial plant EC25 of 0.006 lb ai/A

**  Based on terrestrial plant NOAEC of 0.002 lb ai/A

			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 (IR) 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 lb 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 LOC 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 LOC for aquatic animals of 0.05.

	Acute RQs for estuarine/marine fish and invertebrates do not exceed the
Agency’s acute LOC of 0.5; however, for endangered species, the
predicted RQs are equal to or slightly exceed the LOC 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	Modeled Location	Peak EECs

(ppb)	Freshwater RQs	Estuarine/Marine RQs

	Fish

LC50 =

640 ug/L	Invertebrates

LC50=

220 ug/L	Fish

LC50 = 55300 ug/L	Invertebrates

LC50 =

3800 ug/L	Mollusks

LC50 =

6530 ug/L

Cotton	Mississippi	324	0.51	1.47	0.006	0.09	0.05

	Texas	191	0.29	0.87	0.003	0.05	0.03

	North Carolina	246	0.38	1.12	0.004	0.06	0.04

	California	52	0.08	0.24	0.001	0.01	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 (EC50 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 capricornatum.  The most sensitive
EC50 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 LOC of 1 except for vascular
plants based on Texas and California use scenarios.  Endangered species
RQs exceed the plant LOC 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	Peak EECs

(ppb)	Non-Endangered RQs	Endangered RQs

Vascular Plant

EC50 = 220 ug/L	Non-Vascular Plant

EC50= 30 ug/L	Vascular Plant

NOAEC = 115 ug/L	Non-Vascular Plant

NOAEC = 180 ug/L

Mississippi	324	1.47	10.81	2.82	1.80

Texas	191	0.87	6.35	1.66	1.06

North Carolina	246	1.12	8.19	2.14	1.37

California	52	0.24	1.73	0.45	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

	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

  SEQ CHAPTER \h \r 1 	Section 4(g)(2)(A) of FIFRA calls for the Agency
to determine, after submission of relevant data concerning an active
ingredient, whether or not products containing the active ingredient are
eligible for reregistration.  The Agency has previously identified and
required the submission of the generic (i.e., active
ingredient-specific) data required to support reregistration of products
containing 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 reregistration 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 reregistration process under FIFRA, as amended by FQPA.  The Agency
has determined that fluometuron-containing products are eligible for
reregistration 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
reregistration (i.e., cotton).  Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of
reregistration 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.

	B.	Public Comments and Responses  tc "	B.	Public Comments and Responses
" \l 2

	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   HYPERLINK "http://www.epa.gov/edockets"
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

  SEQ CHAPTER \h \r 1 	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

  SEQ CHAPTER \h \r 1

	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
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 1X) 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 Disruptor Effects

  SEQ CHAPTER \h \r 1

	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 Disruptor 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
Disruptor 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

  SEQ CHAPTER \h \r 1 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/.

		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

  SEQ CHAPTER \h \r 1 A tolerance is established for negligible residues
of the herbicide fluometuron
[1,1-dimethyl-3-(α,α,α,-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.

  SEQ CHAPTER \h \r 1 Table 15.  Reorganization of Fluometuron
Tolerances Required Under 40 CFR.

40 CFR Section	Section Reserved For	Tolerance Expression

§180.229 (a)(1)	Plant commodities	Fluometuron and its metabolites
determined as TFMA.

§180.229 (a)(2)	Livestock commodities	Fluometuron and its metabolites
determined as TFMA, and the hydroxylated metabolites CGA-236431,

CGA-436432, CGA-13211, and their conjugates.

§180.229 (d)	Rotational crop commodities	Fluometuron and its
metabolites determined as TFMA.

§180.229 (d)	Food/feed commodities processed from rotational crops
Fluometuron and its metabolites determined as TFMA.

  SEQ CHAPTER \h \r 1 Tolerances Required Under 40 CFR §180.229 (a)(1):

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 reregistration.  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 fluometuron residues of concern in/on several processed
commodities; the recommended tolerances are listed below in Table 16.

  SEQ CHAPTER \h \r 1 Table 16.  Tolerance Reassessment Summary for
Fluometuron.

Commodity	Current Tolerance  (ppm)	Tolerance Reassessment (ppm)	Comments

Tolerances Required Under 40 CFR §180.229 (a)(1)

Cotton, gin byproducts	None	3.5	Based on field trial data

Cotton, undelinted seed	0.1	1.01

	Tolerances Required Under 40 CFR §180.229 (a)(2)

Cattle, meat byproducts	None	0.1	These recommendations are based on
feeding studies, but tentative pending submission of supporting storage
stability data for the hydroxylated metabolites.

Goat, meat byproducts	None	0.1

	Hog, meat byproducts	None	0.1

	Horse, meat byproducts	None	0.1

	Sheep, meat byproducts	None	0.1

	Milk	None	0.02

	Egg	None	0.1

	Poultry, fat	None	0.1

	Poultry, meat	None	0.1

	Poultry, meat byproducts	None	0.1

	Tolerances Required Under 40 CFR §180.229 (d)

Grain, cereal, group 15	None	0.5	Proposed tolerance levels are based on
available data.

Grain, cereal, forage, group 16	None	3.0

	Grain, cereal, fodder, and straw, group 16	None	6.0

	Peanut	None	0.1

	Peanut, hay	None	4.0

	Soybean, seed	None	2.0

	Soybean, forage	None	3.0

	Soybean, hay	None	3.0

	Peanut, meal	None	0.2

	Rice, hulls	None	1.0

	Wheat, milled byproducts	None	1.0

	  SEQ CHAPTER \h \r 1 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 reregistration.  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 August 9, 2005 and Addendum to Refined Fluometuron 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 and
EFED’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	Maximum One-Time Application Rate	Number of Applications
Seasonal Max. Rate	Minimum Application Interval

Sand, Loamy Sand, Sandy Loam	1 lb ai/A	2	2 lb ai/A	20 days

Loam, Silt Loam, Silt, Sandy Clay Loam, Silty clay loam, Clay loam	1.6
lb ai/A	2	3 lb ai/A	20 days

Sandy clay, Silty Clay, Clay	2 lb ai/A	2	3 lb ai/A	20 days

  SEQ CHAPTER \h \r 1 Table 18.  Refined Total EDWCs (ppb) in Surface
Water and Groundwater for Fluometuron and its Major Degradate (by State)

	CA	TX	MS	NC

Surface water/ peak (90th percentile annual daily max. - acute)	13.8
15.5	31.2	14.1

Surface water/average (90th percentile annual mean - chronic)	10.9	6.38
6.34	4.60

Surface water/36-year overall mean (cancer) 	9.3	3.84	2.54	3.56

Groundwater (all exposures)	 21.6 (light soils)

32.4 (intermediate soils)

 22.8 (heavy soils)

Use modeled*	3 lb ai/A	2 lb ai/A	3 lb ai/A	2 lb ai/A

Percent Cropped Area (cotton)	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 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	cPAD (mg/kg/day)	Exposure (mg/kg/day)	% cPAD

All populations	0.0055	0.000688	13

All infants (< 1 year old)

0.002248	41

Children 1-2 years old

0.001028	19

Children 3-5 years old

0.000962	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.

The cancer dietary (food and drinking water) risk estimate is 1 x 10-5,
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 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 and EFED’s Response…dated September 28, 2005.

Table 20.  Revise Fluometuron Cancer Dietary (Food + Drinking Water)
Risk Estimates

Dietary Exposures Assessed	Q1*	Cancer Risk Estimate

Food alone	1.80 x 10-2 (mg/kg/day)-1	9 x 10-8

Groundwater alone

1 x 10-5

Food + groundwater

1 x 10-5

Surface water alone

1 x 10-6

Food + surface water

2 x 10-6

			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.

	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 (1a), 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 (1b 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 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.

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 lb 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 LOC
(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 LOC (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.

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.

  SEQ CHAPTER \h \r 1 		3.	Summary of Mitigation Measures

	The following mitigation measures are necessary for fluometuron to be
eligible for reregistration.

Require wettable powder formulations be packaged in water soluble
packaging.

Prohibit aerial application with dry flowable formulations.

Reduce application rates, as follows:

Sand, loamy sand, and sandy loam soils – the maximum one-time
application rate is 1 lb ai/A, with 2 applications per year for a total
annual maximum application rate of 2 lb ai/A.

Loam, silt loam, silt, sandy clay loam, silty clay loam, and clay loam
soils – The maximum one-time application rate is 1.6 lb ai/A, with 2
applications per year.  The total annual maximum application rate is 3
lb ai/A.

Sandy clay, silty clay, and clay soils – The maximum one-time
application rate is 2 lb ai/A, with 2 applications per year.  The total
annual maximum application rate is 3 lb ai/A.

Increase the interval between applications to 20 days.

Add PPE requirements to labels, as follows:

Handlers mixing and loading liquids and dry flowable formulations for
groundboom application must wear single layer PPE plus gloves,

Handlers mixing and loading liquids for aerial application must wear
double-layer PPE plus gloves and an apron,

Handlers applying via groundboom must wear baseline PPE,

Handlers applying via aircraft must be in enclosed cabs, and

Handlers acting as flaggers must wear baseline PPE.

	F.	Other Labeling Requirements  tc "	F.	Other Labeling Requirements "
\l 2

	To be eligible for reregistration, 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.

  SEQ CHAPTER \h \r 1 		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 Agency will
implement them through the Endangered Species Protection Program.  While
RQs exceeded the Agency’s endangered species LOC 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  tc "			2.	Spray Drift Management " \l 4

	The Agency has been working closely with stakeholders to develop
improved approaches for mitigating risks to human health and the
environment from pesticide spray and dust drift.  As part of the
reregistration process, 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.

  SEQ CHAPTER \h \r 1 V.	What Registrants Need to Do

	The Agency has determined that fluometuron is eligible for
reregistration 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
reregistration.

	A.	Manufacturing-Use Products  tc "	A.	Manufacturing Use Products " \l
2

		1.	Data Requirements  tc "			1.	Outstanding Data Requirements " \l 2

	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 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.

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  tc "			3.	Labeling for
Manufacturing-Use Products " \l 3

	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  tc "	B. 	End-Use Products " \l 2

		1.	Additional Product-Specific Data Requirements  tc "			1.	Additional
Product-Specific Data Requirements " \l 3

	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  tc "			2.	Labeling for End-Use
Products " \l 3

	To be eligible for reregistration, 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 reregistration, 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. tc "	C.	Labeling Changes Summary Table

"

Table 21.  Summary of Labeling Changes for Fluometuron

Description	Amended Labeling Language	Placement on Label

Manufacturing Use Products

For all Manufacturing Use Products	“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.	Directions for Use

One of these statements may be added to a label to allow reformulation
of the product for a specific use or all additional uses supported by a
formulator or user group	“This product may be used to formulate
products for specific use(s) not listed on the 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.”	Directions for Use

Environmental Hazards Statements Required by the RED and Agency Label
Policies	“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.” 	Precautionary Statements

End-Use Products Intended for WPS Use

PPE Requirements Established by the RED for Dry Flowable (DF)
Formulation 	“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

In addition, chemical-resistant gloves are required for all handlers
(except applicators)”	Immediately following/below Precautionary
Statements:  Hazards to Humans and Domestic Animals

PPE Requirements Established by the RED for Liquid Concentrate
Formulations	“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 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.”
Immediately following/below 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.

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.”
Precautionary Statements:  Hazards to Humans and Domestic Animals

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.”

	User Safety Requirements	 “Follow manufacturer’s instructions for
cleaning/maintaining PPE.  If no such instructions for washables exist,
use detergent and hot water.  Keep and wash PPE separately from other
laundry.”

 “Discard clothing or other absorbent materials that have been
drenched or heavily contaminated with this product’s concentrate.  Do
not reuse them.”	Precautionary Statements:  Hazards to Humans and
Domestic Animals immediately following the PPE requirements

User Safety Recommendations	“User Safety Recommendations”

“Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.”

“Users should remove clothing/ PPE immediately if pesticide gets
inside, then wash thoroughly and put on clean clothing.”

“Users should remove PPE immediately after handling this product.
Wash the outside of gloves before removing.  As soon as possible, wash
thoroughly and change into clean clothing.”	Precautionary Statements
under: Hazards to Humans and Domestic Animals

(Must be placed in a box.)

Environmental Hazards Statements Required by the RED and Agency Label
Policies	“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..”	Precautionary Statements: Hazards
to Humans and Domestic Animals

Restricted-Entry Interval	“Do not enter or allow worker entry into
treated areas during the restricted entry interval (REI) of 24 hours.”
Directions for Use, in Agricultural Use Requirements box

Early Reentry Personal Protective Equipment for Products Subject to WPS
as required by Supplement 3 of PR Notice 93-7	“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.	Directions for Use, in Agricultural Use Requirements
Box

General Application Restrictions 	“Do not apply this product in a way
that will contact workers or other persons, either directly or through
drift.  Only protected handlers may be in the area during
application.”	Place in the Directions for Use directly above the
Agricultural Use Box

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 lb ai/A, with 2 applications per year for a total annual
maximum application rate of 2 lb ai/A.

Loam, silt loam, silt, sandy clay loam, silty clay loam, and clay loam
soils The maximum one-time application rate is 1.6 lb ai/A, with 2
applications per year.  The total annual maximum application rate is 3
lb ai/A.