UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

     OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date: July 10, 2006

MEMORANDUM

SUBJECT:	Chlorflurenol Methyl Ester.  HED Chapter of the Reregistration
Eligibility Decision Document (RED).

PC Code:			098801

Decision #: 			362457

DP Barcode:			D323832.

			Risk Assessment Type: 		Single Chemical Aggregate

FROM:	David G Anderson, Risk Assessor and Toxicologist

		Shanna Recore, Occupational/Residential Risk Assessor

		Yvonne Barnes, Product Chemist

		Reregistration Branch II

		Health Effects Division (7509P)

THROUGH:	Alan Nielsen, Branch Senior Scientist

		William Hazel, Chief

		Reregistration Branch II

		Health Effects Division (7509P)

TO:		Tawanda Spears, Chemical Review Manager

		Reregistration Branch III

		Special Review and Reregistration Division

	Attached is the HED risk assessment for chlorflurenol methyl ester.

Table of Contents

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc139705740"  1.0 EXECUTIVE
SUMMARY	  PAGEREF _Toc139705740 \h  5

  HYPERLINK \l "_Toc139705741"  2.0	Ingredient Profile	  PAGEREF
_Toc139705741 \h  8

  HYPERLINK \l "_Toc139705742"  2.1	Summary of Registered/Proposed Uses
 PAGEREF _Toc139705742 \h  8

  HYPERLINK \l "_Toc139705743"  2.2	Registered Use Categories and Use
Sites	  PAGEREF _Toc139705743 \h  8

  HYPERLINK \l "_Toc139705744"  2.3	Application Methods	  PAGEREF
_Toc139705744 \h  11

  HYPERLINK \l "_Toc139705745"  2.4	Structure and Nomenclature	  PAGEREF
_Toc139705745 \h  11

  HYPERLINK \l "_Toc139705746"  2.5	Physical and Chemical Properties
PAGEREF _Toc139705746 \h  12

  HYPERLINK \l "_Toc139705747"  3.0	Hazard/Dose-Response
Characterization/Assessment	  PAGEREF _Toc139705747 \h  12

  HYPERLINK \l "_Toc139705748"  3.1	Hazard and Dose-Response
Characterization	  PAGEREF _Toc139705748 \h  12

  HYPERLINK \l "_Toc139705749"  3.1.1	Database Summary:	  PAGEREF
_Toc139705749 \h  12

  HYPERLINK \l "_Toc139705750"  3.1.2	Studies available and considered
(animal, human, general literature)				  PAGEREF _Toc139705750 \h  13

  HYPERLINK \l "_Toc139705751"  3.1.3	Mode of action, metabolism,
toxicokinetic data	  PAGEREF _Toc139705751 \h  14

  HYPERLINK \l "_Toc139705752"  3.1.4	Sufficiency of studies/data
PAGEREF _Toc139705752 \h  14

  HYPERLINK \l "_Toc139705753"  3.1.5	Toxicological Effects	  PAGEREF
_Toc139705753 \h  14

  HYPERLINK \l "_Toc139705754"  3.1.6	Dose-response	  PAGEREF
_Toc139705754 \h  14

  HYPERLINK \l "_Toc139705755"  3.2	Absorption, Distribution,
Metabolism, Excretion (ADME)	  PAGEREF _Toc139705755 \h  15

  HYPERLINK \l "_Toc139705756"  3.3	FQPA Considerations	  PAGEREF
_Toc139705756 \h  15

  HYPERLINK \l "_Toc139705757"  3.4	Hazard Identification and Toxicity
Endpoint Selection	  PAGEREF _Toc139705757 \h  15

  HYPERLINK \l "_Toc139705758"  3.4.1	Acute Reference Dose (aRfD) -
Females age 13-49, Children of the General Population.	  PAGEREF
_Toc139705758 \h  15

  HYPERLINK \l "_Toc139705759"  3.4.3	Chronic Reference Dose (cRfD)
PAGEREF _Toc139705759 \h  15

  HYPERLINK \l "_Toc139705760"  3.4.4	Incidental Oral Exposure (Short-
and Intermediate-Term)	  PAGEREF _Toc139705760 \h  17

  HYPERLINK \l "_Toc139705761"  3.4.5	Dermal Absorption	  PAGEREF
_Toc139705761 \h  17

  HYPERLINK \l "_Toc139705762"  3.4.6	Dermal Exposure (Short-,
Intermediate- and Long-Term)	  PAGEREF _Toc139705762 \h  17

  HYPERLINK \l "_Toc139705763"  3.4.7	Inhalation Exposure (Short-,
Intermediate- and Long-Term)	  PAGEREF _Toc139705763 \h  18

  HYPERLINK \l "_Toc139705764"  3.4.8	Level of Concern for Margin of
Exposure	  PAGEREF _Toc139705764 \h  18

  HYPERLINK \l "_Toc139705765"  3.4.9	Recommendation for Combining
Exposure Risk Assessments	  PAGEREF _Toc139705765 \h  18

  HYPERLINK \l "_Toc139705766"  3.4.10	Classification of Carcinogenic
Potential	  PAGEREF _Toc139705766 \h  19

  HYPERLINK \l "_Toc139705767"  3.4.11	Mutagenicity Studies	  PAGEREF
_Toc139705767 \h  19

  HYPERLINK \l "_Toc139705768"  3.4.12	Summary of Toxicological Doses
and Endpoints for chlorflurenol methyl ester for Use in Human Risk
Assessments	  PAGEREF _Toc139705768 \h  19

  HYPERLINK \l "_Toc139705769"  4.0	Public Health and Pesticide
Epidemiology Data	  PAGEREF _Toc139705769 \h  20

  HYPERLINK \l "_Toc139705770"  5.0	Dietary Exposure/Risk
Characterization	  PAGEREF _Toc139705770 \h  20

  HYPERLINK \l "_Toc139705771"  5.1	Drinking Water Residue Profile
PAGEREF _Toc139705771 \h  20

  HYPERLINK \l "_Toc139705772"  5.2	Food Residue Profile	  PAGEREF
_Toc139705772 \h  22

  HYPERLINK \l "_Toc139705773"  6.0	Residential Exposure and Risks
PAGEREF _Toc139705773 \h  22

  HYPERLINK \l "_Toc139705774"  6.1	Residential Handler Exposures and
Non-cancer Risk Estimates	  PAGEREF _Toc139705774 \h  23

  HYPERLINK \l "_Toc139705775"  6.1.1	Residential Handler Exposures and
Risks	  PAGEREF _Toc139705775 \h  23

  HYPERLINK \l "_Toc139705776"  6.1.2	Handler Exposure Scenarios
PAGEREF _Toc139705776 \h  23

  HYPERLINK \l "_Toc139705777"  6.1.3	Data and Assumptions for Handler
Exposure Scenarios	  PAGEREF _Toc139705777 \h  24

  HYPERLINK \l "_Toc139705778"  6.1.4	Residential Handler Exposure and
Non-Cancer Risk Estimates	  PAGEREF _Toc139705778 \h  25

  HYPERLINK \l "_Toc139705779"  6.1.5	Residential Handler Exposure and
Risk Estimates for Cancer	  PAGEREF _Toc139705779 \h  26

  HYPERLINK \l "_Toc139705780"  6.1.6 	Summary of Risk Concerns and Data
Gaps for Handlers	  PAGEREF _Toc139705780 \h  26

  HYPERLINK \l "_Toc139705781"  6.1.7	Recommendations for Refining
Residential Handler Risk Assessment				  PAGEREF _Toc139705781 \h  26

  HYPERLINK \l "_Toc139705782"  6.2	Residential Postapplication
Exposures and Assumptions	  PAGEREF _Toc139705782 \h  26

  HYPERLINK \l "_Toc139705783"  6.2.1	Residential Postapplication
Exposure Scenarios	  PAGEREF _Toc139705783 \h  27

  HYPERLINK \l "_Toc139705784"  6.2.2	Data and Assumptions for
Residential Postapplication Exposure Scenarios	  PAGEREF _Toc139705784
\h  29

  HYPERLINK \l "_Toc139705785"  6.2.3	Residential Postapplication
Exposure and Non-cancer Risk Estimates				  PAGEREF _Toc139705785 \h  30

  HYPERLINK \l "_Toc139705786"  6.2.4	Residential Postapplication
Exposure and Risk Estimates for Cancer				  PAGEREF _Toc139705786 \h  36

  HYPERLINK \l "_Toc139705787"  6.2.5	Summary of Residential
Postapplication Risk Concerns and Data Gaps		  PAGEREF _Toc139705787 \h
36

  HYPERLINK \l "_Toc139705788"  6.2.6	Recommendations for Refining
Residential Postapplication Risk Assessments	  PAGEREF _Toc139705788 \h
37

  HYPERLINK \l "_Toc139705789"  6.3	Residential Risk Characterization
PAGEREF _Toc139705789 \h  37

  HYPERLINK \l "_Toc139705790"  6.3.1	Characterization of Residential
Handler Risks	  PAGEREF _Toc139705790 \h  37

  HYPERLINK \l "_Toc139705791"  6.3.2	Characterization of Residential
Postapplication Risks	  PAGEREF _Toc139705791 \h  37

  HYPERLINK \l "_Toc139705792"  7.0	OCCUPATIONAL EXPOSURE AND RISKS
PAGEREF _Toc139705792 \h  38

  HYPERLINK \l "_Toc139705793"  7.1	Occupational Handler Exposures and
Risk Estimates	  PAGEREF _Toc139705793 \h  38

  HYPERLINK \l "_Toc139705794"  7.1.1	Data and Assumptions for Handler
Exposure Scenarios	  PAGEREF _Toc139705794 \h  39

  HYPERLINK \l "_Toc139705795"  7.1.2	Occupational Handler Exposure
Scenarios	  PAGEREF _Toc139705795 \h  45

  HYPERLINK \l "_Toc139705796"  7.1.3	Non-cancer Occupational Handler
Exposure and Assessment	  PAGEREF _Toc139705796 \h  46

  HYPERLINK \l "_Toc139705797"  7.1.4 	Cancer Occupational Handler
Exposure and Risk Assessment	  PAGEREF _Toc139705797 \h  58

  HYPERLINK \l "_Toc139705798"  7.1.5 	Summary of Risk Concerns and Data
Gaps for Occupational Handlers	  PAGEREF _Toc139705798 \h  58

  HYPERLINK \l "_Toc139705799"  7.1.6	Recommendations for Refining
Occupational Handler Risk Assessment	  PAGEREF _Toc139705799 \h  60

  HYPERLINK \l "_Toc139705800"  7.2	Occupational Postapplication
Exposures and Non-Cancer Risk Estimates	  PAGEREF _Toc139705800 \h  60

  HYPERLINK \l "_Toc139705801"  7.2.1	Occupational Postapplication
Exposure Scenarios	  PAGEREF _Toc139705801 \h  60

  HYPERLINK \l "_Toc139705802"  7.2.2	Data/Assumptions for
Postapplication Exposure Scenarios	  PAGEREF _Toc139705802 \h  63

  HYPERLINK \l "_Toc139705803"  7.2.3	Occupational Postapplication
Exposure and Non-cancer Risk Estimates	  PAGEREF _Toc139705803 \h  63

  HYPERLINK \l "_Toc139705804"  7.2.4	Occupational Postapplication
Exposure and Risk Estimates for Cancer	  PAGEREF _Toc139705804 \h  65

  HYPERLINK \l "_Toc139705805"  7.2.5	Summary of Occupational
Postapplication Risk Concerns and Data Gaps		  PAGEREF _Toc139705805 \h
65

  HYPERLINK \l "_Toc139705806"  7.2.6	Recommendations for Refining
Occupational Postapplication Risk Assessment	  PAGEREF _Toc139705806 \h
66

  HYPERLINK \l "_Toc139705807"  8.0	Data Needs and Label Requirements
PAGEREF _Toc139705807 \h  66

  HYPERLINK \l "_Toc139705808"  8.1	Toxicology	  PAGEREF _Toc139705808
\h  66

  HYPERLINK \l "_Toc139705809"  8.2	Residue Chemistry	  PAGEREF
_Toc139705809 \h  66

  HYPERLINK \l "_Toc139705810"  8.3	Occupational and Residential
Exposure	  PAGEREF _Toc139705810 \h  66

  HYPERLINK \l "_Toc139705811"  References:	  PAGEREF _Toc139705811 \h
67

  HYPERLINK \l "_Toc139705812"  A.1	Toxicology Data Requirements
PAGEREF _Toc139705812 \h  68

  HYPERLINK \l "_Toc139705813"  A.2  Toxicity Profiles	  PAGEREF
_Toc139705813 \h  69

  HYPERLINK \l "_Toc139705814"  A.3  Executive Summaries	  PAGEREF
_Toc139705814 \h  72

  HYPERLINK \l "_Toc139705815"  A.3.1	Subchronic Toxicity	  PAGEREF
_Toc139705815 \h  72

  HYPERLINK \l "_Toc139705816"  A.3.2	Prenatal Developmental Toxicity
PAGEREF _Toc139705816 \h  73

  HYPERLINK \l "_Toc139705817"  A.3.3	Reproductive Toxicity	  PAGEREF
_Toc139705817 \h  75

  HYPERLINK \l "_Toc139705818"  A.3.4	Chronic Toxicity	  PAGEREF
_Toc139705818 \h  78

  HYPERLINK \l "_Toc139705819"  A.3.5	Carcinogenicity	  PAGEREF
_Toc139705819 \h  79

  HYPERLINK \l "_Toc139705820"  A.3.6	Mutagenicity	  PAGEREF
_Toc139705820 \h  80

  HYPERLINK \l "_Toc139705821"  A.3.7	Neurotoxicity	  PAGEREF
_Toc139705821 \h  80

  HYPERLINK \l "_Toc139705822"  A.3.8	Metabolism	  PAGEREF _Toc139705822
\h  80

  HYPERLINK \l "_Toc139705823"  A.3.9	Dermal Absorption	  PAGEREF
_Toc139705823 \h  81

  HYPERLINK \l "_Toc139705824"  A.4	References	  PAGEREF _Toc139705824
\h  81

1.0 EXECUTIVE SUMMARY

	This assessment provides the evidence for reregistration of
chlorflurenol methyl ester.  The reregistration process provides
re-review of previously registered pesticides under the Federal
Insecticide, Fungicide and Rodenticide Act [FIFRA] to assure scientific
reliability and conformity to the data standards established under the
Food Quality Protection Act [FQPA] of 1996.

	Chlorflurenol methyl ester is a nonfood use herbicide, plant growth
retardant and plant growth regulator.  As a herbicide and plant growth
retardant it is used for the postemergent control of annual grasses,
broadleaf weeds, trees, shrubs and vines.  As a plant growth regulator,
chlorflurenol is used to produce pineapple planting material [sliplets]
well over one year before the pineapples are harvested.  As this use is
not expected to result in finite residues in pineapples, this is
considered to be a nonfood use and no tolerances are necessary in
pineapples.

	Chlorflurenol methyl ester [technical] is greater than 96% total ester
and is composed of three related chemicals chlorflurenol methyl ester
[65% to70%], dichlorflurenol methyl ester [10% to 15%] and
deschlorflurenol methyl ester [15% to 20%].

	Chlorflurenol methyl ester shows low acute toxicity by the oral, dermal
and inhalation routes [toxicity is category IV].  Clorflurenol methyl
ester was essentially non-irritating to the eye and skin, respectively
[toxicity category III and IV].  It is not a skin sensitizer in a Guinea
pig study.

	The acceptable and unacceptable studies with chlorflurenol methyl ester
show no severe toxicity.  The most sensitive species is the dog showing
slight red blood cell destruction at 4 weeks after the start of the
study and only at the highest dose tested.  A 13-week subchronic study
in rats showed toxicity, but did not confirm the hematological effects.
The female body weight decrement was seen in rats at higher dose levels
than in the dog study at month 13 or the effects on hematology at week
4.  A 21-day dermal study in rabbits with a formulation of chlorflurenol
methyl ester showed no systemic effects, but showed destruction of the
hair follicles and edema in the treated skin.  The skin effects were
dose related.  These effects were considered due to skin irritation from
the formulation containing 87.5% inerts, most of which are known skin
irritants.  Potential systemic effects of the technical grade could not
be definitively evaluated due to these inerts; however, systemic effects
are not likely to be seen at lower dose levels than those of the active
ingredient tested in the 21-day dermal study in rabbits.  Potential
reproductive effects were not tested in the 21-day dermal study.

	A carcinogenicity study in mice showed no evidence of carcinogenicity
at lower doses or above a limit dose of 1 g/kg/day.  A battery of
mutagenicity studies was all negative.

	Unacceptable kinetic/distribution studies suggest that each of the
three radiolabeled components comprising chlorflurenol methyl ester were
barely detectable in the rat mammary glands or in nursing pups.  Since
the studies used only one female/treatment, the findings could not be
verified.  However, this study showed that each of the three components
in chlorflurenol methyl ester is probably rapidly excreted mostly in the
urine within 24 hours.  Radiolabel in the mammary gland and the nursing
pups was not quantified in the treated animals.

	Prenatal studies in the rat and rabbit show no increased fetal
susceptibility.  At the highest dose tested, rats showed delayed
ossification at higher incidence than control incidence.  Maternal
toxicity in the form of body weight decrement was seen at mid- and
highest dose tested.  The rabbit showed no effects in fetuses or mothers
at the highest dose tested.  Post-natal studies were not required, but a
1973 three-generation reproduction study previously submitted for other
purposes showed equivocal litter size and pup weight decrement at birth
and subfertility in adult offspring, but showed a poor dose response.

	Due to these ambiguous findings in the reproduction study, an
additional uncertainty factor of 3X was used when calculating human oral
risk.  The additional 3X factor may be removed by another acceptable
reproduction study showing a more definitive NOAEL for effects on the
litters and fertility.

	Exposures to the pesticide were calculated assuming maximum application
rates from both labels and from a March 14, 2006 memorandum from the
Biological and Economic Analysis Division [BEAD] of the USEPA [BEAD
memo].  No dermal absorption studies are available.  This resulted in
the assumption of 100% dermal absorption from an oral study endpoint for
dermal exposure.

	When levels of exposure were above the Level of Concern [LOC],
suggesting an unacceptable exposure, the exposures to granular
formulations were recalculated using 10% dermal absorption for
comparison.

	There is opportunity for adult residential handler exposure from the
application to lawns and ornamentals. A Margin of Exposure [MOE] less
than 100 exceeds OPP’s LOC and suggests unacceptable risk.  All
residential handler activities showed MOE greater than 100, suggesting
acceptable risk.  Attire for residential handlers is assumed to be
short-sleeved shirts, short pants, shoes and socks.

	Several  residential postapplication scenarios were identified for
chlorflurenol methyl ester, including dermal exposure from residue on
lawns and turf (adult, youth and toddler), hand-to-mouth transfer of
residues on lawns (toddler), ingestion of pesticide residue on treated
grass (toddler), and incidental ingestion of soil from pesticide-treated
residential areas (toddler).

	For the adult populations, all postapplication risks were below HED’s
level of concern, except for the 3.0 lb ai/A (BEAD) application rates
where MOEs are 44 on day 0.  For the youth populations, all
postapplication noncancer risks were below HED’s level of concern.
For toddlers, postapplication noncancer risks are not of concern for the
oral route.  For the dermal route, risks to toddlers from high contact
activity on lawns exceed HED’s level of concern at the 1.0/1.1 lb ai/A
(Label) and 3.0 lb ai/A (BEAD) application rates, except when 10% dermal
absorption is assumed for the granular formulations.  Calculated
combined risks to toddlers (i.e., dermal high contact activity plus hand
to mouth activity plus object to mouth activity on treated turf plus
incidental soil ingestion of pesticide residue from treated turf areas)
are therefore, also of concern, except when 10 percent dermal absorption
is assumed for the granular formulations.

	There are potential exposures to occupational mixers, loaders,
applicators, and other handlers during the usual use-patterns associated
with chlorflurenol methyl ester. These risks were calculated assuming
maximum application rates from both the product labels and from the BEAD
memo. For all occupational scenarios, the inhalation risks were below
HED’s level of concern at the baseline level.

	The dermal risks were below HED's level of concern at some level of
mitigation for all occupational scenarios, except applying liquid sprays
using rights-of-way equipment:

to turf growing in culverts, rights of way, median strips, ditches,
and/or under security fences at the 3 lb ai/A rate (Label & BEAD);

to non-agricultural rights-of-ways/fence rows and hedge rows at the 3 lb
ai/A rate (Label & BEAD);

to gymnosperms and hardwoods at the 5 lb ai/A rate;

to shrubs, shade trees and vines at the 4.5 lb ai/A rate (BEAD); and

to high density forestry management at the 4.0 lb ai/A rate (BEAD).

Risks remain a concern at maximum personal protective equipment and no
engineering controls are available for rights-of-way application
equipment.

	Using ORETF data, the dermal risks were a concern at baseline for
handlers mixing/loading/applying liquids with an overhead directed low
pressure handwand equipment for the scenarios where BEAD application
rates are assessed.  No ORETF data currently are available to assess the
corresponding personal protective equipment exposures for these
scenarios.  However, using PHED data, the dermal risks were not a
concern with the addition of chemical-resistant gloves to baseline
attire.

	There are potential postapplication exposures to occupational workers
during the usual use-patterns associated with chlorflurenol.
Specifically, there is concerned about postapplication exposures from
treatment of pineapples and golf course turf. In agricultural crop
settings, a Restricted Entry Interval or REI – is used to mitigate
postapplication risks following applications to crops.  The REI is time
period following a pesticide application during which entry into the
treated area is restricted.  To establish REIs, EPA considers
postapplication risks on varying days after application. For pineapple
applications, the MOEs are greater than 100 on day 0 (REI = 12 hours)
for all of the exposure levels.

	For the golf course turf using the 1.0 and 1.1 lb ai/A (Label) rates
for sprays and granular applications respectively and assuming hand
weeding and transplanting tasks are performed and assuming 100% dermal
absorption, risks are not a concern at day 4 for liquid formulations and
at day 5 for granular formulations.  Assuming golf course mowing tasks
are performed, risks are not a concern on day 0 (12 hours following
application) for liquid or granular applications using these application
rates and assuming 100 percent absorption. Risks are not a concern at
day 0 (12 hours following application) for granular applications for any
postapplication tasks using the 1.1 lb ai/A application rate and
assuming 10% dermal absorption.

	For the golf course turf using the 3.0 lb ai/A (BEAD) rates for sprays
and granular applications and assuming 100% dermal absorption, risks are
not a concern for hand weeding and transplanting tasks at day 14 and for
mowing at day 8.  For the golf course turf using the 3.0 lb ai/A (BEAD)
rates for granular applications and assuming 10% dermal absorption,
risks are not a concern for any tasks at day 0 (REI = 12 hours).

	See Sections 6.0 through 7.2.6 for Residential Exposure and
Occupational Exposure for mixed exposure scenarios of concern.

	Potential contamination of surface water and ground water were modeled
by Tier II PRZM/EXAMS and Tier I SCIGROW.  Risk was assessed by DEEM for
chronic exposure to drinking water using modeled surface water estimated
concentrations and modeled groundwater estimated concentrations.  Using
surface water estimates, exposures to all groups were below the chronic
RfD and OPP’s LOC.  The highest exposure groups were non-nursing
infants at 20% of the chronic oral RfD and all infants (< one year) at
16% of the chronic oral RfD.  However, using ground water estimated
concentrations two groups were above the chronic RfD and above OPP’s
LOC.  The assessment by DEEM for ground water showed that the highest
estimated exposure was 176% of the chronic RfD for non-nursing infants
and 142% of the chronic RfD for all infants (< 1 year).  The next
highest estimated exposure was to children 1-2 years at 64% of the
chronic RfD.    These exposures were not combined  with infants and
children exposured to lawns treated with sprays or granulated
cholorflurenol.  It should be noted that since toddler exposure from
treated lawns was above OPP’s LOC, and any additional exposure from
drinking water would result in additional concern.

2.0	Ingredient Profile

Summary of Registered/Proposed Uses

	At this time, there are four products containing chlorflurenol that are
intended for occupational and/or residential uses.  All products are
registered by Repar Corporation. Two of the products (Maintain CF 125
and Reap Thru Herbicide) are emulsifiable concentrates and contain 12.5
and 15.9 percent active ingredient, respectively.  Maintain CF 125 is
also registered as a special local needs product under EPA SLN No.
HI-980007.  The other two products (Repar Broad Spectrum Weed and Feed
and Repar Weed and Feed 28-3-3) are granulars and contain 0.17 and 0.70
percent active ingredient, respectively.

2.2	Registered Use Categories and Use Sites

An analysis of the current labeling and available use information was
incomplete, in that frequency of application and number of applications
per season is not stated.  Chlorflurenol is registered for use in a
variety of agricultural, commercial, and residential scenarios and thus
these populations are potentially exposed while performing handling
tasks, including mixing/loading, applying, and flagging tasks.  It is
also possible for these populations to be exposed to chlorflurenol
during postapplication time periods.  Tables 1a, 1b, and 1c provided the
maximum application rates for the registered scenarios based on
information from the product labels.  Table 2 provides the maximum
application rates from a March 14, 2006 memo from the Biological and
Economic Analysis Division (BEAD) of USEPA (BEAD memo).

  SEQ CHAPTER \h \r 1 Table 1a: Summary of Maximum Application Rates
for Registered Chlorflurenol Methyl Ester Agricultural Uses – Label

Crop Site	Target of Application	Maximum Application Rate	Application
Equipment	Area Treated or Amount Handled Per Day

Liquid Formulations

Pineapple plants:

for plant material production (non food use)	Plant growth regulator	1 lb
a.i./A (Label)	Groundboom	80 acres

	Airblast	40 acres

  SEQ CHAPTER \h \r 1 Table 1b: Summary of Maximum Application Rates for
Registered Chlorflurenol Methyl Ester Commercial Uses – Label

Crop Site	Target of Application	Maximum Application Rate	Application
Equipment	Area Treated or Amount Handled Per Day

Liquid Formulations

Turf:  Lawns and Ornamental Turf  (including golf course and parks)
Broadleaf weeds and plant growth retardant	1.0 lb a.i./A	low pressure
handwand	40 gallons

	Handgun	5 acres for A and M/L/A

100 acres for M/L (for 20 LCOs)

	Groundboom	40 acres

Gymnosperms	Plant growth retardant	0.25 lb ai/100 gallons	low pressure
handwand	40 gallons

	Handgun	1,000 gallons

	rights-of-way sprayer	1,000 gallons

Hardwoods:

growing under utility lines, as screens or ground cover, adjacent to
highways	Plant growth retardant	1.0 lb ai/100 gallons	handgun	1,000
gallons

	rights-of-way sprayer	1,000 gallons

	low-pressure handwand	40 gallons

Hedges:

growing under utility lines, as screen	Plant growth retardant	1.0 lb
ai/100 gallons	handgun	1,000 gallons

	rights-of-way sprayer	1,000 gallons

	low-pressure handwand	40 gallons

Vines

growing under utility lines, as screens or ground cover, rights-of-way,
hedgerows	Plant growth retardant	1.0 lb ai/100 gal	handgun	1,000 gallons

	rights-of-way sprayer	1,000 gallons

	low-pressure handwand	40 gallons

Turf:

growing in culverts, rights-of-way, median strips, ditches, under
security fences	Plant growth regulator	3.0 lb a.i./acre	rights-of-way
sprayer	80 acres

	handgun	5 acres

	low-pressure handwand	5 acres

Trees:

bark banding	Plant growth retardant	0.083 lb a.i./gal	low-pressure
handwand	40 gallons

Granular Formulations

Turf:  Lawns and Ornamental Turf  (including golf course and parks)
Broadleaf weeds	1.1 lb a.i./acre	tractor-drawn spreader	40 acres

	push-type spreader	5 acres

	belly grinder	1 acre

  SEQ CHAPTER \h \r 1 Table 1c: Summary of Maximum Application Rates
for Registered Chlorflurenol Methyl Ester Residential Uses – Label

Crop Site	Target of Application	Maximum Application Rate	Application
Equipment	Area Treated or Amount Handled Per Day

Granular Formulations

Turf:  lawns	Broadleaf weeds	0.25 lb a.i./A	push-type spreader	0.5 acre

	belly grinder	1,000 ft2

Table 2.  Summary of Maximum Application Rates for Registered
Chlorflurenol Methyl Ester Uses – BEAD

Use Site	Treatment Type	Maximum Application Rate

(a.i. lb/acre)

Pineapple	Growth regulator	1.0

Ornamental trees	Growth regulator	2.5

Non-agricultural rights-of-ways/fence rows and hedge rows	Weed control &
growth retardant

3 .0

Established turf	Weed control & turf growth retardant	3.0

High density forestry vegetation management (plant density >1500 stems
per acre; plant height > 8 ft)	Weed control	4.0

Shrubs, shade trees and vines	Growth regulator	4.5

Hardwood and gymnosperm trees	Height control	5.0

2  SEQ CHAPTER \h \r 1 .3	Application Methods

	Chlorflurenol is applied with several types of application equipment,
including airblast sprayers, ground boom sprayers, low pressure handwand
sprayers, handgun sprayers, rights-of-way sprayers, tractor-drawn
spreaders, push-type spreaders, and belly grinders.  For information on
the Occupational Handler assumptions and variables used in the
calculation of exposure, see [Section 7.1  Occupational Handler
Exposures and Risk Estimates].

2.4	Structure and Nomenclature

  TC \l2 "2.2	Structure and Nomenclature

  SEQ CHAPTER \h \r 1 Table 3.   Nomenclature for Chlorflurenol Methyl
Ester

Chemical structure	Major product

Hydrolysis product

Common name	chlorflurenol-methyl, flurenol

Molecular formula	C15H11ClO3

Molecular weight	274.07 g/mol

IUPAC name	Methyl (RS)-2-chloro-9-hydroxyfluorene-9-carboxylate

CAS name	Methyl 2-chloro-9-hydroxy-9H-fluorene-9-carboxylate

CAS number	2536-31-4

PC Code	098801

2.5	Physical and Chemical Properties   TC \l2 "2.3	Physical and Chemical
Properties

Table 4  Physicochemical Properties of Chlorflurenol Methyl Ester

Parameter

Value

Reference

Melting point/range	136-142 degrees Celsius	MRID 434549-03

pH	 Not Applicable, Crystalline material	MRID 43154901

Density 	-1.5	MRID 431549-03

Water solubility 	18mg/L	MRID 431549-03

Solvent solubility at:

25 degrees Celsius	Cyclohexane 0.24 g/ 100 ml

Isopropanol 2.4 g/100 ml

Benzene 7.0 g/100 ml

Ethanol 8.0 g/100 ml

Methanol 15 g/100 ml

Acetone 26 g/100 ml

	MRID 431549-02

Vapor pressure 	5 - 10-5 Torr at 25 degrees Celsius	MRID 431549-03

Dissociation constant, pKa	None	MRID 431549-03

Octanol/water partition coefficient	Estimated Log P 2.86

Estimate from fate data on water 65 or log P=1.81	MRID 433554-01

MRID 43496202

UV/visible absorption spectrum	None provided	Data Gap

3.0	Hazard/Dose-Response Characterization/Assessment   TC \l1 "3.0
Hazard Characterization/Assessment

3.1	Hazard and Dose-Response Characterization   TC \l2 "3.1	Hazard and
Dose-Response Characterization

3.1.1	Database Summary:    TC \l3 "3.1.1	Database Summary

	Chlorflurenol methyl ester shows low acute toxicity by the oral, dermal
and inhalation routes [toxicity is category IV].  Eye and skin
irritation were mild and essentially non-irritating, respectively
[toxicity category III and IV].  It is not a skin sensitizer in a Guinea
pig study.

	The acceptable and unacceptable studies with chlorflurenol methyl ester
show no severe toxicity.  The most sensitive species is the dog showing
slight red blood cell destruction at 4 weeks after the start of the
study and only at the highest dose tested [NOAEL/LOAEL = 31/94
mg/kg/day].  This red blood cell destruction was supported by
hemosiderin deposits in the liver at the 2-year termination.  No studies
were seen that confirmed the hematological findings in the chronic dog
study.  At month 13, the study showed decreased body weight in males and
females, but not in females at termination.  An unacceptable 13 week
study in 3 dogs/sex/group at comparable dose levels showed inconsistent
nominally decreased red blood cells, but no hemosiderin deposits at
termination.  A 13-week subchronic study in rats showed a dose related
decreased body weight in females accompanied by decreased food
efficiency and at the mid dose tested and at the highest dose tested
decreased male body weight gain .  The female body weight decrement was
seen in rats at higher dose levels than in the dog study at month 13 or
the effects on hematology at week 4.  A 21-day dermal study in rabbits
with a formulation of chlorflurenol methyl ester showed no systemic
effects, but showed destruction of the hair follicles and edema in the
treated skin.  The skin effects were dose related.  These effects were
considered due to skin irritation from the formulation containing 87.5%
inerts, most of which are known skin irritants.  Potential systemic
effects of the technical grade could not be definitively evaluated due
to these inerts; however, systemic effects are not likely to be seen at
lower dose levels than those of the active ingredient tested in the
21-day dermal study in rabbits.  Potential reproductive effects were not
tested in the 21-day dermal study.

	A carcinogenicity study in mice showed no evidence of carcinogenicity
at lower doses or above a limit dose of 1 g/kg/day.  A battery of
mutagenicity studies was all negative.

	Unacceptable kinetic/distribution studies showed that each of  the
three radiolabeled components comprising chlorflurenol methyl ester were
barely detectable in the rat mammary glands or in nursing pups.  Since
the studies used only one female/treatment, the findings could not be
verified.  However, this study showed that each of the three components
in chlorflurenol methyl ester is probably rapidly excreted mostly in the
urine within 24 hours.  Radiolabel in the mammary gland and the nursing
pups was not quantified.

	Prenatal studies in the rat and rabbit show no increased fetal
susceptibility.  The rat showed delayed ossification at higher incidence
than control values.  This delayed ossification was shown at the highest
dose tested and maternal toxicity was seen at the mid- and highest dose
tested.  The rabbit showed no effects in fetuses or mothers at the
highest dose tested.  Postnatal studies were not required, but a 1973
three-generation reproduction study previously submitted for other
purposes showed equivocal litter size and pup weight decrement at birth
and subfertility in adult offspring.  The potential effects were more
variable than usual for a study on reproduction.  The reproducibility of
these effects can be questioned.  In addition, the study showed an
excessive number of  pregnancies in female rats that showed no sperm
during the period of cohabitation, i.e., no evidence that mating had
occurred.  Although, this finding could raise questions about the
conduct of the study, there was no suggestion in the data of a dose
related response among the generations of females that showed no sperm.
However, when all these females from all 6 groups of matings among the 3
generations in the study were added together, there was a suggestion of
a treatment related response.  Due to these ambiguous findings in the
reproduction study, an additional uncertainty factor of 3X was used when
calculating human oral risk.  The additional 3X factor may be removed by
another acceptable reproduction study showing a more definitive NOAEL
for effects on the litters and fertility.

3.1.2	Studies available and considered (animal, human, general
literature)   TC \l4 "<IP_ADDRESS>	Studies available and considered (animal,
human, general literature)

	No animal or human toxicity studies with chlorflurenol methyl ester
were found in the literature.  The toxicity studies available and
considered in the assessment of chlorflurenol methyl ester were:

1.  Acute – 		Oral LD50, Dermal LD50, Inhalation LC50, Eye and skin
irritation and dermal sensitization

2.  Subchronic -	An acceptable/nonguideline 21-day dermal study in
rabbits.  An acceptable 90-day subchronic study in rats

3. Chronic - 		An acceptable chronic 2-year feeding study in dogs  A
carcinogenicity study in mice.

4.  Developmental - 	An acceptable developmental toxicity study in rats
and an unacceptable developmental toxicity study in rabbits

5.  Reproduction -	An unacceptable 3-generation reproduction study in
rats

6  Mutagenicity - 	A study on reverse mutation in S. typhimurium;  A
study on chromosomal aberration in CHO cells;  An in vitro study for rat
hepatocyte unscheduled DNA synthesis;  An in vitro mammalian cell HGPRT
test.  The battery of guideline mutagenicity studies was acceptable.

7.  Kinetics/distribution -	An unacceptable/non-guideline study of
kinetics and distribution, including radiolabel in rat milk.

3.1.3	Mode of action, metabolism, toxicokinetic data   TC \l4 "<IP_ADDRESS>
Mode of action, metabolism, toxicokinetic data

	There was no data on a mode of action.  However, general information
about suggested distribution and kinetic data has been submitted.  The
data suggest that chlorflurenol methyl ester is circulated
enterohepatically and excreted in the feces and mostly in urine all
within 24 hours, resulting in no accumulation.

3.1.4	Sufficiency of studies/data   TC \l4 "<IP_ADDRESS>	Sufficiency of
studies/data

	The toxicity data base for chlorflurenol methyl ester is adequate for
risk assessment.  The toxicity data requirements for a nonfood use
pesticide depend on exposure and toxicity.  In the case of chlorflurenol
methyl ester which shows both low toxicity and moderate exposure, the
requirements are the 6 acute studies, a subchronic study, a
developmental toxicity study and a battery of mutagenicity studies.
These data requirements have been satisfied by acceptable studies.
However, a 1973 reproduction study submitted for other purposes shows
equivocal effects that add uncertainty to the data base.

3.1.5	Toxicological Effects   TC \l3 "3.1.2	Toxicological Effects

	Toxicological effects of concern are found in a chronic study in dogs
at 4 weeks.  Chlorflurenol methyl ester administered to dogs resulted in
treatment-related red blood cell destruction at the highest dose tested
within 4 weeks with a NOAEL/LOAEL of 31/94 mg/kg/day.  No other study
showed a lower NOAEL.

3.1.6	Dose-response   TC \l3 "3.1.3	Dose-response

	The acceptable and unacceptable subchronic studies in the rat and dog
showed treatment related effects at the highest dose tested [HDT] in the
dog..  The chronic dog study showed marginal hematological effects
within 4 weeks at the HDT.  The only studies showing a dose related
response were the rat subchronic and developmental toxicity studies in
the form of a body weight decrement in female rats and maternal rats,
respectively at the middle and high dose.

	An old reproduction study (1973)[See section A.3.3 in Appendix A], that
 was not required showed possible, but inconsistent subfertility in
rats.  This unacceptable reproduction study may have shown equivocal
effects on fertility, litter size at birth and pup weight decrement at
the HDT.  The fertility of P0 parents was unaffected; the next
generation apparently showed effects at all dose levels, but showed no
dose-related response and in the last generation there was statistically
significant dose-related decrease in fertility at the two top dose
levels.  The study also showed a peculiar effect at mating.  An unusual
number of pregnant females showed no sperm during cohabitation.  This
effect is rarely seen in studies on reproduction.  However, the method
for identification of sperm at mating was not described and may have
been inadequate.  Older studies show more variation in fertility than
current studies, raising the question that the potential decreased
fertility may not be reproducible. The study was unacceptable largely
due the variable fertility.  For these reasons an extra 3X database
uncertainty factor will be used in the Risk assessment for chlorflurenol
methyl ester, unless another study on reproduction is submitted that
shows a more definitive NOAEL for reproductive effects.

3.2	Absorption, Distribution, Metabolism, Excretion (ADME)   TC \l2 "3.2
Absorption, Distribution, Metabolism, Excretion (ADME)

	Chlorflurenol methyl ester is rapidly absorbed and excreted mostly in
the urine within 24 hours, with minor additional excretion between 24
and 72 hours.  In the study in one female rat/treatment, the report
authors claimed that very small amounts of radiolabel were retained in
the mammary gland and barely detectable amounts in nursing pups.  The
amount of label retained in the mammary gland and nursing pups was not
quantified, and is thus unknown.

The kinetic data submitted suggest that chlorflurenol in the rat was
circulated enterohepaticaly. Although the data also suggested that
chlorflurenol was not secreted in rat milk, these data were not
replicated or quantified and the sensitivity of the
radio-autography/radiological methods used were not described, the
absence in the milk supply was not proven.

3.3	FQPA Considerations   TC \l2 "3.3	FQPA Considerations

	As there are no uses of chlorflurenol methyl ester that qualify as food
uses, no tolerance has been established and the requirements of FQPA are
not applicable.

3.4	Hazard Identification and Toxicity Endpoint Selection   TC \l2 "3.5
Hazard Identification and Toxicity Endpoint Selection

3.4.1	Acute Reference Dose (aRfD) - Females age 13-49, Children of the
General Population.    TC \l3 "3.5.1	Acute Reference Dose (aRfD) -
Females age 13-49

	There is no study with a single dose suitable.

Comment:  An acute RfD is used to assess acute food exposure.  Since
exposure to chlorflurenol methyl ester does not occur through food,
addressing this endpoint is unnecessary.

3.4.3	Chronic Reference Dose (cRfD)   TC \l3 "3.5.3	Chronic Reference
Dose (cRfD)

	Selected Study:  Chronic Feeding study in Dogs [MRID# 0082863]     GDL
870.4100

EXECUTIVE SUMMARY:  In a chronic toxicity study (MRID 00082863) IT 3456
[Chlorflurenol, technical (96% a.i., batch/lot # 5/69)] was administered
to 4 Beagle dogs/sex/group in the diet at dose levels of 0, 300, 1000 or
3000 ppm ( for male/female equivalent to 0, 8.7/8.8, 30.6/29.9 or
94.0/94.4 mg/kg bw/day, calculated from test material consumption) for
104 weeks.  One extra dog/sex/group was treated with test material for
104 weeks, after which the dogs were untreated for 8 weeks.  Hematology
and clinical chemistry evaluation was performed at 6 intervals during
the study.  Animals were subjected to gross pathology and microscopic
examination.

	Body weight appeared to be slightly reduced by month 13 at the highest
dose tested [HDT].  Dogs showed this body weight decrement at month 13
when compared with initial body weights for males [the HDT gained 0% vs.
22.3% for control weight] and for females [the HDT gained 6.6% vs. 20.3%
for control body weight].  Male body weight gain appeared to be reduced
for the remainder of the study.  Male body weight gain was decreased at
104 weeks [body weight gain was 0.8 kg at the HDT and 2.5 kg for
controls].  At the end of the study female body weight gain was the same
as control weight gain.  Food consumption was unaffected in both sexes.

Erythrocytes [ERY], hemoglobin concentration [Hb] and hematocrit [Ht]
values appeared to be slightly decreased at the HDT in males and females
starting at week 4 [the first time period evaluated] and male dogs
maintained a decrease through out the study.   Some of the values in the
HDT were statistically significantly reduced, but were still within the
normal range for dogs.    The (ERY, (Hb and (Ht values [difference
between measured values and week -2 values] appeared to decrease in
males and females at the HDT starting at week 4 and male dogs maintained
the decrease through out the study.  This decrease is consistent with
the slightly higher incidence and/or severity of siderous in the spleen,
liver and Kupffer cells at the HDT.    Hemosiderin in the 1000 ppm group
was not considered sufficiently consistent to show that the mid dose
group was affected.  In addition the values for ERY, Hb and Ht from the
1000 ppm group of animals did not show consistent effects.  From week
26-52 to termination, the values for ERY, Hb and Ht for treated female
dogs did not appear to differ from control.

Clinical chemistry values showed no consistent treatment related
effects.  Organ weights were unchanged from control values.

On microscopic examination increased hemosiderin in liver and liver
Kupffer cells and possibly in the spleen at the HDT seemed to confirm
the hematological effects.  In addition, the highest dose group showed
higher incidence of gastritis and possible stomach lymphatic
hyperplasia.

A single dog/sex was allowed to recover for 2 months and although the
hemosiderin appeared to decrease, effects in one dog are difficult to
interpret.

The NOAEL was 30.6/29.9 mg/kg/day for males/females.  The LOAEL was
94.0/94.4 mg/kg/day for male/females based on decreased erythrocytes,
hemoglobin and hematocrit by week 4 in males and females, supported by
hemosiderin deposits in liver and increased incidence of gastritis and
possible decreased body weight in males and females by month 13 of the
study, but not in females by study termination at 24 months.

This study is ACCEPTABLE/GUIDELINE and satisfies the guideline
requirement [870.4100b] for a dog chronic study.   This DER takes
precedence over previous conclusions.

	Dose and Endpoint for Establishing cRfD:  NOAEL is 31 mg/kg/day.  The
LOAEL is 94 mg/kg/day based on male and females decreased erythrocyte,
hemoglobin and hematocrit by week 4 of the study and supported by
hemosiderin deposits in the liver at termination.  At this same dose
body weight decrement was seen in male and females at month 13, but not
in females by the end of the study.

	Uncertainty Factor:  300x [10 for interspecies extrapolation, 10 for
intraspecies variation and 3X for database uncertainty in the NOAEL in a
reproduction study].

	Comments about the Study/Endpoint/Uncertainty Factor:  The
hematological effects occurred at 4 weeks and remained until termination
where hemosiderin deposits confirmed the red blood cell destruction.
This endpoint will be unnecessary for current uses, since there are no
food uses.  However, this endpoint may be necessary at a later date
and/or handler exposures.

3.4.4	Incidental Oral Exposure (Short- and Intermediate-Term)   TC \l3
"3.5.4	Incidental Oral Exposure (Short- and Intermediate-Term)

	Selected Study:  Chronic Feeding study in Dogs [MRID 00082863]     GDL
870.4100

	[See Section 3.5.3  for the executive Summary of MRID 00082863]

	Dose for Establishing an Endpoint:  NOAEL is 31 mg/kg/day.  The LOAEL
is 94 mg/kg/day based on male and females decreased erythrocyte,
hemoglobin and hematocrit by week 4 of the study and supported by
hemosiderin deposits in the liver at termination.  At this same dose
body weight decrement was seen in male and females at month 13, but not
in females by the end of the study.

	Uncertainty Factor:  300x [10 for interspecies extrapolation, 10 for
intraspecies variation and 	3X for database uncertainty in the NOAEL in
a reproduction study].

	Comments about the Study/Endpoint/Uncertainty Factor:  The
hematological effects occurred at 4 weeks and remained until termination
with hemosiderin deposits confirming the red blood cell destruction.

3.4.5	Dermal Absorption  TC \l3 "3.5.5	Dermal Absorption

	There are no dermal absorption studies.  Therefore, 100% dermal
absorption will be assumed; exposure will also be calculated assuming
10% dermal absorption for comparitive purposes

3.4.6	Dermal Exposure (Short-, Intermediate- and Long-Term)   TC \l3
"3.5.6	Dermal Exposure (Short-, Intermediate- and Long-Term)

	Selected Study:  Chronic Feeding study in Dogs [MRID 00082863]     GDL
870.4100

	[See Section 3.5.3  for the executive Summary of  MRID 00082863]

	Dose for Establishing an Endpoint:  NOAEL is 31 mg/kg/day.  The LOAEL
is 94 mg/kg/day based on male and females decreased erythrocyte,
hemoglobin and hematocrit by week 4 of the study and supported by
hemosiderin deposits in the liver at termination.  At this same dose
body weight decrement was seen in males and females at month 13, but not
in females by the end of the study.

	Uncertainty Factor:  100x [10 for interspecies extrapolation, 10 for
intraspecies variation].

	Comments about the Study/Endpoint/Uncertainty Factor:  The
hematological effects occurred at 4 weeks and remained until termination
with hemosiderin deposits confirming the red blood cell destruction.
The 3x uncertainty factor is dropped for dermal exposure, since an
endpoint from an oral study is used.  In addition, since there is no
dermal absorption study, the default assumption is 100% dermal
absorption, which is excessive.  This built in extra safety factor is
adequate, especially since a non-guideline 21-day dermal study on a
formulation showed no systemic toxicity.

3.4.7	Inhalation Exposure (Short-, Intermediate- and Long-Term)   TC \l3
"3.5.7	Inhalation Exposure (Short-, Intermediate- and Long-Term)

	Selected Study:  Chronic Feeding study in Dogs [MRID 00082863]     GDL
870.4100

	[See Section 3.5.3  for the executive Summary of MRID 00082863]

	Dose for Establishing an Endpoint:  NOAEL is 31 mg/kg/day.  The LOAEL
is 94 mg/kg/day based on male and females decreased erythrocyte,
hemoglobin and hematocrit by week 4 of the study and supported by
hemosiderin deposits in the liver at termination.  At this same dose
body weight decrement was seen in male and females at month 13, but not
in females by the end of the study.

	Uncertainty Factor:  100x [10 for interspecies extraploationvariation,
10 for intraspecies variation].

	Comments about the Study/Endpoint/Uncertainty Factor:  The
hematological effects occurred at 4 weeks and remained until termination
with hemosiderin deposits confirming the red blood cell destruction.
This endpoint maybe unnecessary for current uses, since chlorflurenol
methyl ester is not irritating and shows low toxicity by the oral route
and effects from inhalation exposure are unlikely.

3.4.8	Level of Concern for Margin of Exposure  TC \l3 "3.5.8	Level of
Concern for Margin of Exposure

Table 5   Summary of Levels of Concern for Risk Assessment.

Route	Short-Term

(1 - 30 Days)	Intermediate-Term

(1 - 6 Months)	Long-Term

(> 6 Months)

Occupational (Worker) Exposure

Dermal	100	100	NA

Inhalation	100	100	NA

Residential Exposure

Dermal	100	100	NA

Inhalation	NA	NA	NA

Incidental Oral	300	300	300

	Occupational exposure:  Since oral studies are used for dermal and
inhalation endpoints, there is a built in safety factor associated with
absorption which is assumed to be 100%, but may be much lower.

	Residential exposure:  Since the potential exists for incidental oral
exposure to infants and children, a 3X database factor is applied when
infants or children are exposed.

3.4.9	Recommendation for Combining Exposure Risk Assessments  TC \l3
"3.5.9	Recommendation for Combined Aggregate Exposure Risk Assessments

	Since all endpoints are oral, all routes of exposure may be combined,
including incidental oral, dermal and inhalation.  However, a combined
risk index must be used when combining dermal and oral risk because the
uncertainty factors associated with the two types of exposures differ.

3.4.10	Classification of Carcinogenic Potential  TC \l3 "3.5.10
Classification of Carcinogenic Potential

	There is no indication of dose related or treatment related
carcinogenic effects in males or

 females in an acceptable carcinogenicity study in mice below or above
the limit dose of

1 g/kg/day [MRID 00082865].

3.4.11	Mutagenicity Studies

	A battery of acceptable mutagenicity studies were all negative.

3.4.12	Summary of Toxicological Doses and Endpoints for chlorflurenol
methyl ester for Use in Human Risk Assessments  TC \l3 "3.5.11	Summary
of Toxicological Doses and Endpoints for [Chemical] for Use in Human
Risk Assessments

	No studies in humans have been submitted.

Table 6.	Summary of Toxicological Doses and Endpoints for Chlorflurenol
methyl ester for Use in                           Human Health Risk
Assessments.

Exposure/

Scenario	Dose Used in Risk Assessment	Level of Concern [LOC] for Risk
Assessment and contributing factors	Study and Toxicological Effects

Acute Dietary

(Females 13-49 years of age)	No studies reflecting a single dose are
appropriate or available from which to select this endpoint.

Acute Dietary

(General population including infants and children)	No studies
reflecting a single dose are appropriate or available from which to
select this endpoint.

Chronic Dietary

(All populations)	NOAEL = [31] mg/kg/day

Chronic RfD = 0.10 mg/kg/day	LOC = 100% of the cRfD.  Total UF=300

Interspecies10X

Intraspecies 10X

Database 3X  	Chronic 2-year feeding study in dogs

LOAEL = 94 mg/kg/day based on decreased erythrocyte, hemoglobin and
hematocrit at 4 weeks.

Incidental Oral Short-Term

(1 - 30 days) and Intermediate-Term (1-6 moths)	NOAEL = 31 mg/kg/day

	LOC for MOE = 300	Chronic 2-year feeding study in dogs

LOAEL = 94 mg/kg/day based on decreased erythrocyte, hemoglobin and
hematocrit at 4 weeks.

Dermal

Short-Term

(1 - 30 days), intermediate-Term (1-6 months) and Long-Term (>6moths)
NOAEL = 31 mg/kg/day	LOC for MOE = 100

Residential

LOC for MOE = 100

Occupational	Chronic 2-year feeding study in dogs

LOAEL = 94 mg/kg/day based on decreased erythrocyte, hemoglobin and
hematocrit at 4 weeks.

Inhalation

Short-Term

(1 - 30 days), Intermediate-Term (1-6 months) and Log-Term (>6 months)
NOAEL = 31 mg/kg/day	LOC for MOE = 100

Residential

LOC for MOE = 100

Occupational	Chronic 2-year feeding study in dogs

LOAEL = 94 mg/kg/day based on decreased erythrocyte, hemoglobin and
hematocrit at 4 weeks.

Cancer (oral, dermal, inhalation)	Classification: Chlorflurenol methyl
ester is unlikely to be a human carcinogen

UF = uncertainty factor, FQPA SF = Any additional safety factor retained
due to concerns unique to the FQPA, 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

4.0	Public Health and Pesticide Epidemiology Data    TC \l1 "4.0	Public
Health and Pesticide Epidemiology Data

	Incidence reports /epidemiology data are not available at this time.
However, given the minimal nature of acute toxicity (Toxicity Categories
III for eye and IV for other acute studies, large numbers of incidence
are not expected.

5.0	Dietary Exposure/Risk Characterization    TC \l1 "5.0	Dietary
Exposure/Risk Characterization

	Chlorflurenol methyl ester is a nonfood use pesticide having no
tolerances to reassess.  Consequently, there are no residue chemistry
data requirements and thus, dietary exposure or risk assessments are not
applicable.  Chlorflurenol methyl ester is used on pineapple after fruit
harvest to stimulate production of vegetative planting material (slips).
 The time between pesticide treatment and the first harvest of pineapple
fruit would be 1.5 to 2 years.  No residues are expected in the fruit
according to a HED Greyberad Committee decision in 1995 [TXR# 012504].
HED upholds this decision in this RED chapter.

5.1	Drinking Water Residue Profile TC \l3 "5.1.9	Drinking Water Residue
Profile

	It should be noted that drinking water exposure to chlorflurenol methyl
ester is very limited.  Due to the limited number of pound per year
used, this water contamination is likely limited to use areas only.  It
follows that expanded use, would result in additional contamination.

	Chronic drinking water exposure were modeled by DEEM software using
surface water concentration, which showed all groups were exposed to
levels below the chronic oral endpoint of 0.1 mg/kg/day.  Non-nursing
infants and all infants (< one year) were exposed to highest percentage
of the RfD at 20% and 16 % respectively.  All other groups were exposed
to drinking water at 7.4% to 4.7% of the oral chronic RfD of 0.1
mg/kg/day.  These levels are below EPA LOC.  Selected levels for the
highest exposure within a group are given in Table 7a

	However, it should be noted that toddlers exposed to spray and granular
treated lawns are above HED’s LOC.  Any additional exposure from water
would exacerbate this concern.

Table 7a Selected population exposures (selected for highest surface
water exposures within a group)

Population subgroup	Mg/kg/day a	Margin of exposure	% of the endpoint of
0.10 mg/kg/day

US population (summer season)	0.005343	5,802	5.3%

Western region	0.005699	5,439	5.7%

Hispanics	0.005646	5,490	5.6%

Non-hispanic blacks	0.004722	6,565	4.7%

Non-hispanic/non-white/non-black	0.006098	5084	6.1%

All infants (1<year)]	0.016308	1,901	16.3%

Nursing infants	0.006049	5,125	6.0%

Non-nursing infants 	0.020201	1,535	20.2%

Females 20+ (not pregnant or nursing)	0.004965	6.243	5.0%

Females 13-50 years	0.004812	6,442	4.8%

Females 13+ nursing	0.006891	4,498	6.9%

Males 20+ yrs	0.004457	6,955	4.5%

Seniors 55+	0.004883	6,348	4.9%

Children 1-2 years	0.007387	4.197	7.4%

Children 3-5 years	0.006915	4,483	6.9%

Children 6-12 years	0.004770	6,499	4.8%

Youths 13-19 yrs	0.003596	8,622	3.6%

a   For drinking water, Deem software was modeled using surface water
concentration at 236 ppb.

	Chronic drinking water exposures were also modeled by DEEM software
using estimated ground water concentration, where only two groups were
exposed to levels above the LOC.  Non-nursing infants and all infants (<
one year) were exposed to highest percentage of the RfD at 176% and 142%
respectively.  All other groups were exposed to drinking water at 31% to
60% of the oral chronic RfD of 0.1 mg/kg/day.  The 176% and 142%  are
above  OPP’s LOC.  Selected levels for the highest exposure within a
group are given in Table 7b

Table 7b Selected population exposures (selected for highest ground
water exposures within a group)

Population subgroup	Mg/kg/day a	% of the endpoint of 0.10 mg/kg/day

US population (summer season)	0.046414	46.2%

Western region	0.049506	49.5%

Hispanics	0.049046	49.0%

Non-hispanic blacks	0.041015	41.0%

Non-hispanic/non-white/non-black	0.052870	53.0%

All infants (1<year)]	0.141662	141.7%

Nursing infants	0.052540	52.5%

Non-nursing infants 	0.175478	175.5%

Females 20+ (not pregnant or nursing)	0.043131	43.1%

Females 13-50 years	0.041801	41.8%

Females 13+ nursing	0.059862	59.9%

Males 20+ yrs	0.038717	38.7%

Seniors 55+	0.042420	42.4%

Children 1-2 years	0.064165	64.2%

Children 3-5 years	0.060069	60.1%

Children 6-12 years	0.041432	41.4%

Youths 13-19 yrs	0.031233	31.2%

For drinking water, Deem software was modeled using ground water
concentration at 2050 ppb.

	Potential drinking water residues were estimated for groundwater from
Tier I SCIGROW and surface water from Tier II PRZM and EXAMS models.
The environmental fate information is incomplete.  Due to this
incomplete information, conservative default values have been
substituted for missing data in order to proceed with this assessment.
The OPP/EFED Florida turf scenario was selected for this assessment as a
worst case based on the available usage and environmental fate
information.  It is likely that a more complete database for this
chemical would lead to reduced estimates of chlorflurenol methyl ester
concentrations in drinking water.  For this assessment, it was assumed
that 8 applications of chlorflurenol methyl ester were applied to turf
grass at a rate of 3.0 pounds active ingredient per acre with a 28 day
interval between applications and the pesticide is stable in the
environment.  The acute and chronic groundwater concentration of 2050
ppb is the highest estimated values.  This would represent a maximum
concentration in a shallow, private well in a high usage area.  Surface
water concentrations are for acute concentration: 386 ppb; for chronic
non-cancer: 236 ppb and for ground water concentration 2050 pbb. [Table
8].

Table 8  	Summary of Estimated Surface Water and Groundwater
Concentrations for [Chemical].

	[Chemical]

	Surface Water Conc., ppb a	Groundwater Conc., ppb b

Acute	386	2050

Chronic (non-cancer)	236	2050

a From the Tier II PRZM-EXAMS – Index Reservoir model.  Input
parameters are based on OPP/EFED Florida Turf scenario.

b From the SCI-GROW model assuming a maximum seasonal use rate of 3 lb
a.i./A, 8 applications/year spaced at 28 day intervals; a Koc of  65
L/mg and stable ½ life.

5.2	Food Residue Profile  TC \l3 "5.1.10	Food Residue Profile

	There are no residues in food.

6.0	Residential Exposure and Risks

		Chlorflurenol methyl ester is an herbicide, plant growth retardant,
and plant growth regulator that is used in agricultural, commercial, and
residential settings.  As an herbicide and/or plant growth retardant,
chlorflurenol is used for the postemergent control of annual grasses,
broadleaf weeds, trees, shrubs, and vines. As a plant growth regulator,
chlorflurenol is used in the production of pineapple planting material
(sliplets). Chlorflurenol is registered as emulsifiable concentrate and
granular formulations. The emulsifiable concentrate formulations are
applied using groundboom sprayer, rights-of-way sprayer, handgun
sprayer, low pressure handwand sprayer, and airblast sprayer. Granular
formulations are applied using a bellygrinder, push-type spreader, and
tractor-drawn spreader.

Hazard Concerns

  SEQ CHAPTER \h \r 1 Adverse effects were identified at durations of
exposure ranging from short-term (up to 30 days) to long-term (> 6
months).  The short- and intermediate-term dermal, inhalation, and
incidental oral endpoints are based on a NOAEL of 31 mg/kg/day from a
chronic 2-year feeding study in dogs where the LOAEL is 94 mg/kg/day.
The LOAEL is based on decreased erythrocyte, hemoglobin and hematocrit
at 4 weeks. Long-term exposures to chlorflurenol (i.e., greater than 6
months) are not expected for current registered uses.  Additionally, no
cancer endpoint was identified; therefore cancer risks are not assessed.

	HED’s level of concern (LOC) for chlorflurenol methyl ester
occupational and residential dermal and inhalation exposures is 100
(i.e., a margin of exposure (MOE) less than 100 exceeds HED’s level of
concern).  The dermal and inhalation margins of exposure were combined
for the occupational and residential handler risk assessments because
the toxicity endpoints for the dermal and inhalation routes of exposure
are based on the same toxicological effects.  For incidental oral
exposures, HED’s level of concern is 300 (i.e., a margin of exposure
(MOE) less than 300 exceeds HED’s level of concern). The dermal and
incidental oral ingestion margins of exposure for the residential
postapplication risk assessments for toddlers were also combined because
the toxicity endpoints for the dermal and oral routes of exposure are
based on the same toxicological effects.

6.1	Residential Handler Exposures and Non-cancer Risk Estimates

It has been determined there is a potential for exposure in residential
settings during the application process for homeowners who use granular
products containing chlorflurenol.  There is also a potential for
exposure from entering chlorflurenol-treated areas, such as lawns and
golf courses.  Risk assessments have been completed for both residential
handler and postapplication scenarios.

	In addition to homeowner uses in residential settings, chlorflurenol
products are labeled for weed control at residential settings, which is
applied by occupational applicators, but may result in postapplication
exposures in residential settings.  These potential postapplication
exposures to homeowners also have been considered in this assessment.

6.1.1	Residential Handler Exposures and Risks  tc "3.1	Residential
Handler Exposures and Risks " \l 2

	HED uses the term “handlers” to describe those individuals who are
involved in the pesticide application process.  HED believes that there
are distinct tasks related to applications and that exposures can vary
depending on the specifics of each task as was described under
occupational handlers.

6.1.2	Handler Exposure Scenarios  tc "3.1.1	Handler Exposure Scenarios "
\l 3

	Scenarios are used to define risks based on the U.S. EPA Guidelines for
Exposure Assessment (U.S. EPA; Federal Register Volume 57, Number 104;
May 29, 1992).  Assessing exposures and risks resulting from residential
uses is very similar to assessing occupational exposures and risks, with
the following exceptions:

Residential handler exposure scenarios are considered to be short-term
only, due to the infrequent use patterns associated with homeowner
products.

A tiered approach for personal protection using increasing levels of PPE
is not used in residential handler risk assessments.  Homeowner handler
assessments are based on the assumption that individuals are wearing
shorts, short-sleeved shirts, socks, and shoes.

Homeowner handlers are expected to complete all tasks associated with
the use of a pesticide product including mixing/loading if needed as
well as the application.

Label use-rates and use-information specific to residential products
serve as the basis for the risk calculations.

Area/volumes of spray or chemical used in the risk assessment are based
on HED’s guidance specific to residential use-patterns.

	HED has determined that there is potential exposure to residential
mixer, loader, and applicators during the usual use-patterns associated
with chlorflurenol.  Based on the use patterns, two major residential
exposures were identified.

	Mixers/Loaders/Applicators

	(1) Mixing/loading/applying granular with push-type spreader (ORETF);
and

	(2) Mixing/loading/applying gra  nular with a belly grinder (PHED).

6.1.3	Data and Assumptions for Handler Exposure Scenarios  tc "3.1.2
Data and Assumptions For Handler Exposure Scenarios " \l 3

	A series of assumptions and exposure factors served as the basis for
completing the residential handler risk assessments.  Each assumption
and factor is detailed below. In addition to these factors, unit
exposure values were used to calculate risk estimates.  These unit
exposure values were taken from the Outdoor Residential Exposure Task
Force (ORETF) studies.  Both PHED and ORETF studies are presented below.

	Assumptions and Factors:  The assumptions and factors used in the risk
calculations include:

Exposure factors used to calculate daily exposures to handlers were
based on applicable data, if available.  When appropriate data is
unavailable, values from a scenario deemed similar might be used.

HED always considers the maximum application rates allowed by labels in
its risk assessments.  If additional information such as average or
typical rates is available, these values also may be used to allow risk
managers to make a more informed risk management decision.
Average/typical application rates were not available for residential
scenarios.

Residential risk assessments are based on estimates of what homeowners
would typically treat, such as the size of a lawn or the size of a
garden.  The factors used for the chlorflurenol assessment were from the
Health Effects Division Science Advisory Committee Policy 12:
Recommended Revisions to the Standard Operating Procedures for
Residential Exposure Assessment which was completed on February 22,
2001, and on professional judgment.  The daily volumes handled and area
treated used in each residential scenario are provided in Table 2 of
that policy recommendation.

Residential Handler Exposure Studies:  The unit exposure values that
were used in this assessment were based on the Outdoor Residential
Exposure Task Force studies and the Pesticide Handler Exposure Database
(PHED, Version 1.1 August 1998).  The ORETF data used in the residential
assessment is described below.

ORETF Handler Studies -- OMA001-OMA004 (MRID 449722-01)

A report was submitted by the ORETF (Outdoor Residential Exposure Task
Force) that

presented data in which the application of various products used on turf
by homeowners and lawncare operators (LCOs) was monitored.  All of the
data submitted in this report were completed in a series of studies.

OMA003: Homeowner Granular Applications with a Rotary (Push-type)
Spreader tc "OMA003\: Homeowner Granular Applications with a Rotary
(Push-type) Spreader"  (MRID 449722-01): A mixer/loader/applicator study
was performed by the Outdoor Residential Exposure Task Force (ORETF)
using Dacthal (active ingredient DCPA, dimethyl
tetrachloroterephthalate) as a surrogate compound to determine
“generic” exposures of individuals applying a granular pesticide
formulation to residential lawns.  A total of 30 volunteers were
monitored using passive dosimetry (inner and outer whole body
dosimeters, hand washes, face/neck wipes, and personal inhalation
monitors).  Each volunteer carried, loaded, and applied two 25-lb bags
of fertilizer (0.89% active ingredient) with a rotary type spreader to a
lawn covering 10,000 ft2.  The target application rate was 2 lb
a.i./acre (actual rate achieved was about 1.9 lbs a.i./acre).   The
average application time was 22 minutes, including loading the rotary
push spreader and disposing of the empty bags.  Each replicate handled
approximately 0.45 lbs a.i.  Dermal exposure was measured using inner
and outer whole body dosimeters, hand washes, face/neck washes, and
personal air monitoring devices with OVS tubes. The results for the
rotary (push-type) spreader are summarized in Table 9 below.

Table 9: Unit Exposure Values for Homeowner Granular Applications with a
Rotary (Push-type) Spreader Obtained From ORETF Study (MRID 449722-01)

Scenario Monitored	Unit Exposures

	Dermal

(mg a.i./lb handled)	Inhalation

(µg a.i./lb handled)

	Short Pants, Short Sleeves	Long Pants, Short Sleeves	Long Pants, Long
Sleeves

	Homeowner Granular Applications with a Push-type Spreader	0.67	0.09
0.07	0.88

	1 All unit exposure values are geometric means.

 	6.1.4	Residential Handler Exposure and Non-Cancer Risk Estimates  tc
"3.1.3	Residential Handler Exposure and Non-Cancer Risk Estimates " \l 3

	Non-cancer risks were calculated using the Margin of Exposure (MOE) as
described in Section 7.1.3.  Assessing exposures and risks resulting
from residential uses is very similar to assessing occupational
exposures and risks, except as described in Section 7.1.1.  The other
major difference with residential risk assessments is that the
uncertainty factor which defines the level of risk concern has the
additional FQPA safety factor applied.  In the case of chlorflurenol, it
was decided by HED that the factor for handler risk assessments is 100,
which is based on the FQPA safety factor of 1X along with the 10X for
inter-species extrapolation and 10X for intra-species sensitivity.

	The residential exposure and risk estimates associated with the use of
chlorflurenol are presented in Table 10.  The risk calculations for
residential chlorflurenol handlers are included in Appendix D of the
June  30, 2006 Chlorflurenol Methyl Ester:  Occupational and Residential
Exposure Assessment for the RED.

Table 10:  Residential Handler Short- and Intermediate-term Dermal,
Inhalation and Total Exposure and Risks

Exposure Scenario1	Crop or Target	Application Rate	Area Treated Daily
(acres)	Baseline Unit Exposures	Baseline MOEs

(Level of Concern = 100)

Dermal (mg/lb a.i.)	Inhalation (µg/lb a.i.)	Dermal	Inhalation	Total

Mixer/Loader/Applicator

1) Mixing/loading/ applying granular with push-type spreader (ORETF OMA
003)	Turf	0.25 lb. a.i./acre

(Label - 100% DA)	0.5 acres	0.67	0.88	26,000	2,000,000	26,000

0.25 lb. a.i./acre (Label – 10% DA)

260,000	20,000,000	260,000

2) Mixing/loading/ applying with a belly grinder (PHED)	Turf	0.25 lb.
a.i./acre

(Label - 100% DA)	0.023	110	62	3,400	6,100,000	3,400

0.25 lb ai/acre (Label – 10% DA)

34,000	61,000,000	34,000

		6.1.5	Residential Handler Exposure and Risk Estimates for Cancer

	No cancer endpoints of concern for chlorflurenol were identified;
therefore cancer risks to residential handlers were not assessed.

		6.1.6 	Summary of Risk Concerns and Data Gaps for Handlers  tc "3.1.5
Summary of Risk Concerns and  Data Gaps for Handlers " \l 3

	All non-cancer risks (i.e., MOEs) to handlers associated with the
scenarios are not of concern, because they exceed HED’s uncertainty
factor of 100.

		6.1.7	Recommendations for Refining Residential Handler Risk Assessment
 tc "3.1.6	Recommendations For Refining Residential Handler Risk
Assessment " \l 3

	In order to refine this residential risk assessment, more data on
actual use patterns including rates, timing, and areas treated would
better characterize chlorflurenol risks.  Exposure studies for many
equipment types that lack data or that are not well represented in PHED
(e.g., because of low replicate numbers or data quality) should also be
considered based on the data gaps identified above and based on a review
of the quality of the data used in this assessment.

	6.2	Residential Postapplication Exposures and Assumptions

 	 tc "3.2	Residential Postapplication Exposures and Risks " \l 2

	HED uses the term “postapplication” to describe exposures to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide.  Chlorflurenol can be used in
many areas that can be frequented by the general population including
residential areas (e.g., home lawns and gardens).  As a result,
individuals can be exposed by entering these areas if they have been
previously treated.

		6.2.1	Residential Postapplication Exposure Scenarios  tc "3.2.1
Residential Postapplication Exposure Scenarios " \l 3

	A wide array of individuals of varying ages can potentially be exposed
to chlorflurenol when they are in areas that have been previously
treated.  Postapplication exposure scenarios were developed for each
residential setting where chlorflurenol can be used.  The scenarios
likely to result in postapplication exposures are as follows:

Dermal exposure from residue on lawns and turf (adult, youth and
toddler);

Hand-to-mouth transfer of residues on lawns (toddler);

Ingestion of pesticide treated grass (toddler); and

Incidental ingestion of soil from pesticide-treated residential areas
(toddler).

	Incidental ingestion of chlorflurenol granules from pesticide-treated
residential areas was not assessed because there an acute dietary
endpoint was not identified.

HED relies on a standardized approach for completing residential risk
assessments that is based on current labels and guidance contained in
the following four documents:

Series 875, Residential and Residential Exposure Test Guidelines: Group
B - Postapplication Exposure Monitoring Test Guidelines (V 5.4, Feb.
1998) This document provides general risk assessment guidance and
criteria for analysis of residue dissipation data.

Standard Operating Procedures for Residential Exposure Assessment (Dec.
1997) This document provides the overarching guidance for developing
residential risk assessments including scenario development, algorithms,
and values for inputs.

Science Advisory Council For Exposure Policy 12 (Feb. 2001): Recommended
Revisions To The Standard Operating Procedures (SOPs) For Residential
Exposure Assessment This document provides additional, revised guidance
for completing residential exposure assessments.

Overview of Issues Related To The Standard Operating Procedures For
Residential Exposure Assessment (August 1999 Presentation To The FIFRA
SAP) This document provides rationale for Agency changes in SOPs.

	When the guidance in current labels and these documents is considered,
it is clear that HED should consider children of differing ages as well
as adults in its assessments.  It is also clear that different age
groups should be considered in different situations.  The populations
that were considered in the assessment include:

Residential Adults: these individuals are members of the general
population that are exposed to chemicals by engaging in activities at
their residences (e.g., in their lawns or gardens) and also in areas not
limited to their residence (e.g., golf courses or parks) previously
treated with a pesticide.  These kinds of exposures are attributable to
a variety of activities and are usually addressed by HED in risk
assessments by considering a representative activity as the basis for
the exposure calculation.

Residential Children: children are members of the general population
that can also be exposed in their residences (e.g., on lawns and other
residential turf grass areas). These kinds of exposures are attributable
to a variety of activities such as playing outside. Toddlers have been
selected as the sentinel (representative) population for the turf
assessment. Youth-aged children (ages 10 to 12) are considered the
sentinel population for a golfing assessment, because it is likely that
children of this age would be playing golf.  Children are addressed by
HED in risk assessments by considering representative activities for
each age group in an exposure calculation.

	The SOPs for Residential Exposure Assessment defines several scenarios
that apply to uses specified in current labels.  These scenarios served
as the basis for the residential postapplication assessment along with
the modifications to them and the additional data and approaches
described above.  HED used this guidance to define the exposure
scenarios that essentially include dermal and nondietary ingestion
exposure to toddlers on treated lawns and dermal exposure to adults and
youth on treated lawns.  The SOPs and the associated scenarios are
presented below:

Dose from dermal exposure on treated turf:  Postapplication dermal dose
calculations for toddlers from playing on treated turf, for youth and
adults playing golf on treated turf, and for adults mowing and
exercising on treated turf

Dose from hand-to-mouth activity from treated turf:  Postapplication
dose calculations for toddlers from incidental nondietary ingestion of
pesticide residues on treated turf from hand-to-mouth transfer (i.e.,
those residues that are swallowed when toddlers get pesticide residues
on their hands from touching treated turf and then put their hands in
their mouth);

Dose from object-to-mouth activity from treated turf:  Postapplication
dose calculations for toddlers from incidental nondietary ingestion of
pesticide residues on treated turf from object-to-mouth transfer (i.e.,
those residues that are swallowed when toddlers put treated turf in
their mouths);

Dose from soil ingestion activity from treated turf:  Postapplication
dose calculations for toddlers from incidental nondietary ingestion of
pesticide residues from ingesting soil in a treated turf area (i.e.,
those soil residues that are swallowed when toddlers get pesticide
residues on their hands from touching treated soil and then put their
hands in their mouth); and

The detailed residential postapplication calculations are presented in
Appendix E of this document.

		6.2.2	Data and Assumptions for Residential Postapplication Exposure
Scenarios  tc "3.2.2	Data and Assumptions for Residential
Postapplication Exposure Scenarios " \l 3

	Assumptions and Exposure Factors

	A series of assumptions and exposure factors served as the basis for
completing the residential postapplication risk assessments.  The
assumptions and factors used in the risk calculations are consistent
with current Agency policy for completing residential exposure
assessments (i.e., SOPs for Residential Exposure Assessment).  The
values used in this assessment include:

There are many factors that are common to the occupational and
residential postapplication risk assessments, such as body weights for
adults, and analysis of residue dissipation data.  Please refer to the
assumptions and factors in Section 7.1.2 for further information
concerning these common values.

HED combines risks resulting from exposures to individual applications
when it is likely they can occur simultaneously based on the use pattern
and the behavior associated with the exposed population.  The
toxicological endpoints used in assessing risks must have the same
toxicological effect in order for the risks to be combined.  HED has
combined risks using the aggregated risk index (ARI) for different kinds
of exposures for the following scenario: toddlers on turf – dermal
(high contact lawn activity) plus hand-to-mouth plus object-to-mouth
plus soil ingestion.

Exposures to adults and children on treated turf have been addressed
using the latest HED  standard operating procedures for this scenario
including:

the transfer coefficients used are those presented during the 1999
Agency presentation before the FIFRA Science Advisory Panel that have
been adopted in routine practice by HED;

3 year old toddlers are expected to weigh 15 kilograms (representing an
average weight from years one to six);

hand-to-mouth exposures are based on a frequency of 20 events/hour and a
surface area per event of 20 cm2, representing the palmar surfaces of
three fingers;

saliva extraction efficiency is 50 percent meaning that every time the
hand goes in the mouth approximately ½ of the residues on the hand are
removed;

object-to-mouth exposures are based on a 25 cm2 surface area;

ingestion rate of soil is 100 mg/day;

exposure durations for turfgrass scenarios are estimated to be 2 hours
and exposure durations for home gardening (ornamental) scenarios are
estimated to be 0.67 hours for adults and 0.33 hours for youth - based
on information in HED’s Exposure Factors Handbook;

soil residues are contained in the top centimeter and soil density is
0.67 mL/gram; and

dermal, hand- and object-to-mouth, and soil ingestion are combined to
represent an overall risk from exposure to turf.

Postapplication residential risks are based on maximum application rates
or values specified in the SOPs for Residential Exposure Assessment.

The Jazzercize approach is the basis for the dermal transfer
coefficients as described in HED’s Series 875 guidelines, SOPs for
Residential Exposure Assessment, and the 1999 FIFRA SAP Overview
document.

		6.2.3	Residential Postapplication Exposure and Non-cancer Risk
Estimates  tc "3.2.3	Residential Postapplication Exposure and Non-cancer
Risk Estimates " \l 3

	Non-cancer risks were calculated using the Margin of Exposure (MOE)
approach, which is a ratio of the body burden to the toxicological
endpoint of concern. Exposures were calculated by considering the
potential sources of exposure (i.e., TTRs on lawns), then calculating
dermal and nondietary ingestion exposures.

	Dermal exposures and risks from lawn uses were calculated in the same
manner as described above in Section 7.2.3.  Along with calculating
these dermal exposures, other aspects of the turf exposure scenarios
were calculated such as the dose from nondietary ingestion.  The
algorithms used for each type of calculation are presented below which
have not been previously addressed in Section 7.2.3.

	Nondietary Ingestion Exposure from Treated Turf:  Nondietary ingestion
exposure from treated turf was calculated using the following equations.
 These values were then used to calculate MOEs.

	Dermal Exposure from Treated Lawns (adult and toddler)

The approach used to calculate the dermal doses that are attributable to
exposure from contacting treated lawns is:

ADD = (TTR0 * ET * TC * DA * CF1) / BW

Where:

ADD	=	average daily dose (mg/kg/day);

TTRt	=	turf transferable residue on day "0" (µg/cm2).  TTR =
application rate (µg/cm2) * fraction of a.i. retained on foliage (5%
for turf activities, 20% for gardening activities) ;

	ET	=	exposure time (2 hr/day);

 	TC	=	transfer coefficient (14,500 cm2/hr for adults and 5,200 cm2/hr
for toddlers);

	DA	=	dermal absorption factor;

CF1	=	weight unit conversion factor to convert µg units to mg for the
daily exposure (0.001 mg/µg); and

	BW	=	body weight (70 kg for adults and 15 kg for toddlers).

	Hand-to-mouth Transfer of Pesticide Residues on Lawns (toddler)

The approach used to calculate the nondietary ingestion exposures that
are attributable to hand-to-mouth behavior on treated turf is:

ADD = (TTR0 * SA * FQ * ET * SE * CF1) / BW

Where:

ADD	=	average daily dose (mg/kg/day);

TTRt	=	turf transferable residue on day "0" (µg/cm2); TTR = application
rate (µg/cm2) * fraction of a.i. retained on foliage (5%) ;

	SA	=	surface area of the hands (20 cm2/event);

	FQ	=	frequency of hand-to-mouth activity (20 events/hr);

ET	=	exposure time (2 hr/day);

 	SE	=	extraction by saliva (50%);

CF1	=	weight unit conversion factor to convert µg units in the TTR
value to mg for the daily exposure (0.001 mg/µg); and

	BW	=	body weight (15 kg).

	Object-to-mouth Transfer of Pesticide Residues on Lawns (toddler)

The approach used to calculate doses that are attributable to
object-to-mouth behavior on treated turf that is represented by a child
mouthing on a handful of turf is:

ADD = (TTR0 * IgR* CF1) / BW

Where:

ADD	=	average daily dose (mg/kg/day);

TTRt	=	turf transferable residue on day "0" (µg/cm2); TTR = application
rate (µg/cm2) * fraction of a.i. retained on foliage (20%)

IgR	=	ingestion rate of grass (25 cm2/day);

CF1	=	weight unit conversion factor to convert the µg of residues on
the grass to mg to provide units of mg/day (1E-3 mg/µg); and

	BW	=	body weight (15 kg).

Incidental Ingestion of Soil from Pesticide-Treated Residential Areas
(toddler)

The approach used to calculate doses that are attributable to soil
ingestion is:

ADD = (SR0 * IgR * CF1) / BW

Where:

ADD	=	average daily dose (mg/kg/day);

SR0t	=	soil residue on day "0" (0.0022 µg/g);

IgR	=	ingestion rate of soil (100 mg/day);

CF1	=	weight unit conversion factor to convert the µg of residues on
the soil to grams to provide units of mg/day (1E-6 g/µg); and

	BW	=	body weight (15 kg).

And

SRt = AR * F * CF2 * CF3 * CF4

Where:

AR	=	application rate (lb a.i./acre);

F	=	fraction of a.i. available in uppermost cm of soil (1 fraction/cm)
(100%);

CF2	=	volume to weight unit conversion factor to convert the volume
units (cm3) to weight units for the SR value (U.S. EPA, 1992) (0.67
cm3/g soil);

CF3	=	area unit conversion factor to convert the surface are units
(acres) in the application rate to cm2 (2.47E-8 acre/cm2); and

CF4	=	weight unit conversion factor to convert the lbs a.i. in the
application rate to µg (4.54E8 µg/lb).

	Non-cancer Risk Summary  tc "Non-cancer Risk Summary\: " \l 4

	Adults

	Table 11 presents the postapplication MOE values calculated for adults
after lawn, turf and home garden applications chlorflurenol.  All
postapplication non-cancer risks were below HED’s level of concern,
except for high contact activities on residential turf assuming the 3.0
lb a.i./A (BEAD) application rates where MOEs are 44 on day 0.

Table 11: Adult Residential Risk Estimates (Dermal) for Postapplication
Exposure

Exposure Scenario	Dermal Transfer Coefficient (µg/cm2)	Application Rate

(lb a.i./acre)	MOE at Day 0 (Level of Concern = 100)

Spray

Residential Turf (High Contact Activities)	14,500	1.0 (Label)	130

3.0 (BEAD)	44

Residential Turf (Mowing)	3,400	1.0 (Label)	570

3.0 (BEAD)	190

Golfer	500	1.0 (Label)	1,900

3.0 (BEAD)	650

Granular

Residential Turf  (High Contact Activities)	14,500	1.1 (Label – 100%
DA)	120

1.1 (Label – 10% DA)	1,200

3.0 (BEAD - 100% DA)	44

3.0 (BEAD - 10% DA)	440

Residential Turf (Mowing)	3,400	1.1 (Label – 100% DA)	520

1.1 (Label – 10% DA)	5,200

3.0 (BEAD - 100% DA)	190

3.0 (BEAD - 10% DA)	1,900

Golfer	500	1.1 (Label – 100% DA)	1,800

1.1 (Label – 10% DA)	18,000

3.0 (BEAD - 100% DA)	650

3.0 (BEAD - 10% DA)	6,500

Youths (11-12 years old)

	Table 12 summarizes the risk assessment for youths [10 to 12 years
old].  Short-term MOEs for chlorflurenol for these youths were >100 for
all scenarios considered.

Table 12: Youth Residential Risk Estimates (Dermal) for Postapplication
Exposure

Exposure Scenario	Dermal Transfer Coefficient (µg/cm2)	Application Rate

(lb a.i./acre)	MOE at Day 0 (Level of Concern = 100)

Spray

Residential Turf (Mowing)	3,400	1.0 (Label)	320

3.0 (BEAD)	110

Golfer	500	1.0 (Label)	1,100

3.0 (BEAD)	360

Granular

Residential Turf (Mowing)	3,400	1.1 (Label- 100% DA)	290

1.1 (Label- 10% DA)	2,900

3.0 (BEAD - 100% DA)	110

3.0 (BEAD - 10% DA)	1,100

Golfer	500	1.1 (Label- 100% DA)	980

1.1 (Label- 10% DA)	9,800

3.0 (BEAD - 100% DA)	360

3.0 (BEAD - 10% DA)	3,600

	Toddler (3 year old)

	Table 13 summarizes the risk assessment for toddlers.  The
postapplication non-cancer risks are not of concern for the oral route
(MOE’s >300).  For the dermal route, risks to toddlers from high
contact activity on lawns exceed HED’s level of concern (MOE’s <100)
at the 1.0/1.1 lb a.i./A (Label) and 3.0 lb a.i./A (BEAD) application
rates, except when 10% dermal absorption is assumed for the granular
formulations.  Calculated combined risks to toddlers (i.e., dermal high
contact activity plus hand to mouth activity plus object to mouth
activity on treated turf plus incidental soil ingestion of pesticide
residue from treated turf areas) are therefore, also of concern, except
when 10 percent dermal absorption is assumed for the granular
formulations.

Table 13: Toddler Residential Risk Estimates for Postapplication
Exposure

Exposure Scenario	Route of Exposure	Dermal Transfer Coefficient
(µg/cm2)	Application Rate

(lb a.i./acre)	MOE at Day 0 (Level of Concern = 100 for dermal and 300
for oral)

Spray

Residential Turf  (High Contact Activities)	Dermal	5,200	1.0 (Label)	80

	3.0 (BEAD)	27

Hand to Mouth Activity on Turf	Oral	NA	1.0 (Label)	2,100

	3.0 (BEAD)	690

Object to Mouth Activity on Turf

NA	1.0	8,300

	3.0 (BEAD)	2,800

Incidental Soil Ingestion

NA	1.0	620,000

	3.0 (BEAD)	210,000

Granular

Residential Turf  (High Contact Activities)	Dermal	5,200	1.1 (Label

100% DA)	72

	1.1 (Label 10% DA)	720

	3.0 (BEAD – 100% DA)	27

	3.0 (BEAD - 10% DA)	270

Hand to Mouth Activity on Turf	Oral	NA	1.1	1,900

	3.0 (BEAD)	690

Object to Mouth Activity on Turf

NA	1.1	7,500

	3.0 (BEAD)	2,800

Incidental Soil Ingestion

NA	1.1	560,000

	3.0(BEAD)	210,000

Combined Risk Assessment for Residential Scenarios

	HED combines risk values resulting from separate postapplication
exposure scenarios when it is likely they can occur simultaneously based
on the use-pattern and the behavior associated with the exposed
population.  In the case of the chlorflurenol, the dermal and incidental
oral ingestion toxicological endpoints have the same toxicological
effect, therefore dermal and oral doses were combined.

A total aggregated risk index (ARI) was used since the target MOE values
for dermal exposure (100) and incidental oral exposure (300) are
different. The target ARI is 1; therefore, ARIs of less than 1 are risks
of concern.  The combined risk index was calculated from the aggregate
risk index (ARI) as follows.

Aggregate Risk Index (ARI) = 1/(1/RIhigh contact activity) +
(1/RIhand-to-mouth) + (1/RIobject-to-mouth) + (1/RIincidental soil
ingestion)

Where:

	Risk Index (RI) = MOE/Uncertainty Factor

	Table 14 summarizes the combined risk assessment for toddlers.
Calculated combined risks to toddlers (i.e., dermal high contact
activity, hand-to-mouth activity, object-to-mouth activity on treated
turf plus incidental soil ingestion of pesticide residue from treated
turf areas) are of concern for applications of chlorflurenol at:

1.0 lb a.i./A (label) for spray applications assuming 100% dermal
absorption (ARI = 0.70);

1.1 lb a.i./A (label and 100% dermal absorption) for granular
applications (ARI = 0.63)

3.0 lb a.i./A (BEAD) for spray applications assuming 100% dermal
absorption (ARI = 0.23); and

3.0 lb a.i./A (BEAD) for granular applications assuming 100% dermal
absorption (ARI = 0.23.

	The ARIs are greater than 1 for the 1.1 and 3.0 lb a.i./A (label and
BEAD respectively) for granular applications if 10% dermal absorption is
assumed.  The ARI for the 1.1 lb a.i./A scenario is 3 and the ARI for
the 3 lb a.i./A scenario is 1.1.

Table 14: Residential Scenarios for Short-Term Risk Estimates - Toddlers

Postapplication Exposure Scenario	Risk Index (RI)	Combined Risk Index
(ARI)

Toddler	Turf - Spray Application

(1.0 lb a.i./acre - Label)	Dermal – High Contact Activity	0.80

	0.70

Hand to Mouth	6.9

	Object to Mouth	27

	Incidental Soil Ingestion	2100

Turf - Spray Application

(3.0 lb a.i./acre – BEAD)	Dermal – High Contact Activity	0.27	0.23

Hand to Mouth	2.3

	Object to Mouth	9.2

	Incidental Soil Ingestion	688

Turf – Granular Application

(1.1 lb a.i./acre – Label - 100% DA)	Dermal – High Contact Activity
0.72	0.63

Hand to Mouth	6.3

	Object to Mouth	25

	Incidental Soil Ingestion	1800

Turf – Granular Application

(1.1 lb a.i./acre – Label - 10% DA)	Dermal – High Contact Activity
7.3	3

Hand to Mouth	6.3

	Object to Mouth	25

	Incidental Soil Ingestion	1800

Turf – Granular Application

(3.0 lb a.i./ acre – BEAD - 100% DA)	Dermal – High Contact Activity
0.27	0.23

Hand to Mouth	2.3

	Object to Mouth	9.2

	Incidental Soil Ingestion	688

Turf – Granular Application

(3.0 lb a.i./acre – BEAD - 10% DA)	Dermal – High Contact Activity
2.7	1.1

Hand to Mouth	2.3

	Object to Mouth	9.2

	Incidental Soil Ingestion	688

		6.2.4	Residential Postapplication Exposure and Risk Estimates for
Cancer

	Residential postapplication cancer risks were not assessed for
chlorflurenol because no cancer endpoints of concern were identified.

		6.2.5	Summary of Residential Postapplication Risk Concerns and Data
Gaps    tc "3.2.5	Summary of Residential Postapplication Risk Concerns
and Data Gaps " \l 3

	HED considered a number of exposure scenarios for products that can be
used in the residential environment representing different segments of
the population including toddlers, youth-aged children, and adults.
Short-term non-cancer MOEs were calculated for all scenarios.  Cancer
risks were not calculated, since no toxicological endpoint for cancer
was selected.  In residential settings, HED does not use
restricted-entry intervals or other mitigation approaches to limit
postapplication exposures, because they are viewed as impractical and
not enforceable.  As such, risk estimates on the day of application are
the key concern.

For the adult populations, all postapplication non-cancer risks were
below HED’s level of concern, except for the 3.0 lb a.i./A (BEAD)
application rate where MOEs are 44 on day 0.  For the youth populations,
all postapplication non-cancer risks were below HED’s level of
concern.  For toddlers, postapplication non-cancer risks are not of
concern for the oral route.  For the dermal route, risks to toddlers
from high contact activity on lawns exceed HED’s level of concern at
the 1.0/1.1 lb a.i./A (Label) and 3.0 lb a.i./A (BEAD) application
rates, except when 10% dermal absorption is assumed for the granular
formulations.  Calculated aggregated risks to toddlers (i.e., dermal
high contact activity plus hand to mouth activity plus object to mouth
activity on treated turf plus incidental soil ingestion of pesticide
residue from treated turf areas) are therefore, also of concern, except
when 10 percent dermal absorption is assumed for the granular
formulations.

		6.2.6	Recommendations for Refining Residential Postapplication Risk
Assessments    tc "3.2.6	Recommendations For Refining Residential
Postapplication Risk Assessments " \l 3

	In order to refine this residential assessment, data on actual use
patterns including rates, timing, and the kinds of tasks performed are
required to better characterize chlorflurenol risks.

6.3	Residential Risk Characterization    tc "3.3	Residential Risk
Characterization " \l 2

	Characterization of the residential risks included in this document
must consider each of the approaches used to calculate risks as well as
the information that could be forthcoming in any probabilistic
assessment that is submitted for chlorflurenol methyl ester.

		6.3.1	Characterization of Residential Handler Risks

   tc "3.3.1  Characterization Of Residential Handler Risks " \l 3

	The data that were used in the chlorflurenol residential handler
assessment represent the best data and approaches that are currently
available.  The inputs for application rate and other use/usage
information (e.g., area treated and frequency of use) used by the Agency
were supported by the proposed chlorflurenol labels.  There are also
many uncertainties in the assessment that are common with the
occupational assessment as well.  These factors and their impacts on the
results should be considered as well in the interpretation of the
results for residential handlers.  Section 2.3.1 provides a summary of
these issues.

	In summary, with respect to residential handler risks, the Agency
believes that the values presented in this assessment represent the
highest quality results that could be produced given the exposure, use,
and toxicology data that are available.

		6.3.2	Characterization of Residential Postapplication Risks    tc
"3.3.2  Characterization Of Residential Postapplication Risks " \l 3

	The general population can be exposed through many different pathways
that result from uses on lawns and from indoor surface treatments.  To
represent the wide array of possible exposures, the Agency relies on the
scenarios that have been defined in the SOPs for Residential Exposure
Assessment and accompanying documents such as the overview presented to
the FIFRA Science Advisory Panel.  For turf uses, the Agency considered
only toddlers (3 year olds) in the assessments.  Toddler MOEs were
calculated for nondietary ingestion (hand-/object-to-mouth, soil
ingestion and granules ingestion).  MOEs from treated indoor surfaces
were also evaluated for toddlers for whom exposures may occur from
hand-to-mouth behavior.

	The data that were used in the chlorflurenol residential
postapplication assessment represent the best data and approaches that
are currently available.  To the extent possible, the Agency has
attempted to use chlorflurenol methyl ester specific data.  When
chemical-specific data were unavailable, the Agency used the current
approaches for residential assessment, many of which include recent
upgrades to the SOPs.  For example, for the toddler hand-to-mouth
calculations, no TTR data were available but a 5 percent transferability
factor was applied to calculate residue levels appropriate for this
exposure pathway.

	Finally, the Agency believes that the values presented in this
assessment represent the highest quality results that could be produced
based on the currently available postapplication exposure data.  The
Agency believes that the risks represent reasonable worse-case estimates
of exposure because maximum application rates are used to define residue
levels upon which the calculations are based.

7.0	OCCUPATIONAL EXPOSURE AND RISKS

	7.1	Occupational Handler Exposures and Risk Estimates

	HED uses the term “handlers” to describe those individuals who are
involved in the pesticide application process.  HED believes that there
are distinct job functions or tasks related to applications and that
exposures can vary depending on the specifics of each task.  Job
requirements (e.g., amount of chemical to be used in an application),
the kinds of equipment used, the target being treated, and the level of
protection used by a handler can cause exposure levels to differ in a
manner specific to each application event.

	HED uses exposure scenarios to describe the various types of handler
exposures that may occur for a specific active ingredient. The use of
scenarios as a basis for exposure assessment is very common as described
in the U.S. EPA Guidelines for Exposure Assessment (U.S. EPA; Federal
Register Volume 57, Number 104; May 29, 1992).  Information from the
current labels, use and usage information, toxicology data, and exposure
data were all key components in the development of the exposure
scenarios.  HED has developed a series of general descriptions for tasks
that are associated with pesticide applications.  Tasks associated with
occupational pesticide handlers are categorized using one of the
following terms:

●	Mixers and/or Loaders:  these individuals perform tasks in
preparation for an application.  For example, prior to application,
mixer/loaders would mix the chemical and load it into the holding tank
of the airplane or groundboom...

●	Applicators: these individuals operate application equipment during
the release of a pesticide product into the environment.  These
individuals can make applications using equipment such as airplanes or
groundboom.

●	Mixer/Loader/Applicators and or Loader/Applicators: these
individuals are involved in the entire pesticide application process
(i.e., they do all job functions related to a pesticide application
event).  These individuals would transfer the chemical into the
application equipment and then also apply it.

  SEQ CHAPTER \h \r 1 A chemical can produce different effects based on
how long a person is exposed, how frequently exposures occur, and the
level of exposure.  HED classifies exposures up to 30 days as short-term
and exposures greater than 30 days up to several months as
intermediate-term.  HED completes both short- and intermediate-term
assessments for occupational scenarios in essentially all cases, because
these kinds of exposures are likely and acceptable use/usage data are
not available to justify deleting intermediate-term scenarios. Based on
use data and label instructions, HED believes that occupational
chlorflurenol exposures may occur over a single day or up to weeks at a
time for many use-patterns and that intermittent exposures over several
weeks also may occur.  Some applicators may apply chlorflurenol over a
period of weeks, because they are custom or commercial applicators who
are completing a number of applications for a number of different
clients. Long-term handler exposures are not expected to occur for
chlorflurenol.

	Other parameters are also defined from use and usage data such as
application rates and application frequency.  HED always completes
non-cancer risk assessments using maximum application rates for each in
order to ensure there are no concerns for each specific use.

	Occupational handler exposure assessments are completed by HED using
different levels of risk mitigation.  Typically, HED uses a tiered
approach.  The lowest tier is designated as the baseline exposure
scenario (i.e., long-sleeve shirt, long pants, shoes, socks, and no
respirator).  If risks are of concern at baseline attire, then
increasing levels of personal protective equipment or PPE (e.g., gloves,
double-layer body protection, and respirators) are evaluated.  If risks
remain a concern with maximum PPE, then engineering controls (e.g.,
enclosed cabs or cockpits, water-soluble packaging, and closed
mixing/loading systems) are evaluated.  This approach is used to ensure
that the lowest level of risk mitigation that provides adequate
protection is selected, since the addition of PPE and engineering
controls involves an additional expense to the user and – in the case
of PPE – also involves an additional burden to the user due to
decreased comfort and dexterity and increased heat stress and
respiratory stress.

		7.1.1	Data and Assumptions for Handler Exposure Scenarios

 tc "2.1.1	Data and Assumptions For Handler Exposure Scenarios " \l 3

		<IP_ADDRESS>	Assumptions for Handler Exposure Scenarios tc "<IP_ADDRESS>
Assumptions for Handler Exposure Scenarios " \l 4

	A series of assumptions and exposure factors served as the basis for
completing the occupational handler risk assessments.  Each assumption
and factor is detailed below on an individual basis. The assumptions and
factors used in the risk calculations include:

Occupational handler exposure estimates were based on surrogate data
from: (1) the Pesticide Handlers Exposure Database (PHED) and (2) the
Outdoor Residential Exposure Task Force (ORETF).

●	The toxicological endpoint of concern for dermal and inhalation
risks are from studies where the effects were observed in males and
females, therefore, the average body weight of an adult male handler
(i.e., 70 kg) is used to complete the handler dermal and inhalation
non-cancer risk assessment.

●	 The dermal absorption for liquid concentrate formulations was
assumed to be 100 percent, since no dermal absorption data are
available.  Certain solvents in liquid formulations can result in a high
percent of dermal absorption.  The dermal absorption for granular
formulation was assessed assuming both 100 percent and 10 percent, since
although there are no dermal absorption data available, it is rare for
dermal absorption of a granular formulation to exceed 10 percent.

●	Generic protection factors (PFs) were used to calculate exposures
when data were not available.  For example, a 50 percent protection
factor was assumed for the use of a double layer body protection.

●	  For non-cancer assessments, HED assumes the maximum application
rates allowed by the master labels in its risk assessments (see Tables
1a, 1b, 1c and 2).

●	The average occupational workday is assumed to be 8 hours.

	The daily areas treated were defined for each handler scenario (in
appropriate units) by determining the amount that can be reasonably
treated in a single day (e.g., acres, square feet, or gallons per day).
When possible, the assumptions for daily areas treated are taken from
the Health Effects Division Science Advisory Committee on Exposure SOP
#9: Standard Values for Daily Acres Treated in Agriculture, which was
completed on July 5, 2000.  However, no standard values are available
for numerous scenarios.  Assumptions for these scenarios are based on
HED estimates and could be further refined from input from affected
sectors (see Tables 1a, 1b, and 1c)

<IP_ADDRESS>	Exposure Data for Handler Exposure Scenarios

	HED uses unit exposure to assess handler exposures to pesticides.  Unit
exposures are estimates of the amount of exposure to an active
ingredient a handler receives while performing various handler tasks and
are expressed in terms of micrograms or milligrams of active ingredient
per pound of active ingredient handled.  HED has developed a series of
unit exposures that are unique for each scenario typically considered in
our assessments (i.e., there are different unit exposures for different
types of application equipment, job functions, and levels of
protection).  The unit exposure concept has been established in the
scientific literature and also through various exposure monitoring
guidelines published by the U.S. EPA and international organizations
such as Health Canada and OECD (Organization for Economic Cooperation
and Development).  Unit exposures were based on surrogate data from PHED
and ORETF, which are described below.

	Pesticide Handler Exposure Database (PHED) Version 1.1 (August 1998):
PHED was designed by a task force of representatives from the U.S. EPA,
Health Canada, the California Department of Pesticide regulation, and
member companies of the American Crop Protection Association.  PHED is a
software system consisting of two parts – a database of measured
exposures for workers involved in the handling of pesticides under
actual field conditions and a set of computer algorithms used to subset
and statistically summarize the selected data.  Currently, the database
contains values for over 1,700 monitored individuals (i.e., replicates).

	Users select criteria to subset the PHED database to reflect the
exposure scenario being evaluated.   The subsetting algorithms in PHED
are based on the central assumption that the magnitude of handler
exposures to pesticides are primarily a function of activity (e.g.,
mixing/loading, applying), formulation type (e.g., liquids, granulars),
application method (e.g., aerial, groundboom), and clothing scenarios
(e.g., gloves, double layer clothing).

	Once the data for a given exposure scenario have been selected, the
data are normalized (i.e., divided by) by the amount of pesticide
handled resulting in standard unit exposures (milligrams of exposure per
pound of active ingredient handled).  Following normalization, the data
are statistically summarized.  The distribution of exposure for each
body part (e.g., chest, upper arm) is categorized as normal, lognormal,
or “other” (i.e., neither normal nor lognormal).  A central tendency
value is then selected from the distribution of the exposure for each
body part.  These values are the arithmetic mean for normal
distributions, the geometric mean for lognormal distributions, and the
median for all “other” distributions.  Once selected, the central
tendency values for each body part are composited into a “best fit”
exposure value representing the entire body.

	The unit exposures calculated by PHED generally range from the
geometric mean to the median of the selected data set.  To add
consistency and quality control to the values produced from this system,
the PHED Task Force has evaluated all data within the system and has
developed a set of grading criteria to characterize the quality of the
original study data.  The assessment of data quality is based on the
number of observations and the available quality control data. These
evaluation criteria and the caveats specific to each exposure scenario
are summarized in Appendix A, Table A1 of the June 30, 2006
Chlorflurenol Occupational and Residential Exposure RED.  While data
from PHED provide the best available information on handler exposures,
it should be noted that some aspects of the included studies (e.g.,
duration, acres treated, pounds of active ingredient handled) may not
accurately represent labeled uses in all cases.  HED has developed a
series of tables of standard unit exposure for many occupational
scenarios that can be utilized to ensure consistency in exposure
assessments.  Unit exposures are used which represent different levels
of personal protection as described above.  Protection factors were used
to calculate unit exposures for varying levels of personal protection if
data were not available.

	ORETF Handler Studies (MRID 449722-01):  A report was submitted by the
ORETF (Outdoor Residential Exposure Task Force) that presented data in
which the application of various products used on turf by homeowners and
lawncare operators (LCOs) was monitored.  All of the data submitted in
this report were completed in a series of studies.  The studies relevant
to the scenarios used for the chlorflurenol assessment are described
below and are summarized in Appendix A, Table A1 in the June 30, 2006,
Chlorflurenol Occupational and Residential Exposure Assessment for the
RED .

  SEQ CHAPTER \h \r 1 OMA001: LCO Granular Applications with a Rotary
Spreader (MRID 449722-01):  A loader/applicator study was performed by
the Outdoor Residential Exposure Task Force (ORETF) using Dacthal
(active ingredient DCPA, dimethyl tetrachloroterephthalate) as a
surrogate compound to determine “generic” exposures of lawn care
operators (LCOs) applying a granular pesticide formulation to
residential lawns. Surrogate chemicals were chosen by the Task Force for
their representativeness based on physical chemical properties and other
factors.  Dacthal, which was the surrogate chemical used for the
granular spreader studies, has a molecular weight of 331.97 and a vapor
pressure of 1.6 x 10-6, and is believed to be an appropriate surrogate
for many relatively nonvolatile pesticides.

	The study was designed to simulate a typical work day for a LCO
applying granular pesticide formulation to home lawns.  Each LCO
replicate involved loading and applying approximately 3.3 lb a.i. (360
lb formulated product) over a period of about 4 hours to 15 simulated
residential lawns (6480 ft2 each) with a rotary type spreader.  The
average industry application rate of 2 lb a.i./acre was simulated
(actual rate achieved was about 1.9 lb a.i./acre).  The monitoring
period included driving, placing the spreader onto and off of the truck,
carrying and loading the formulation in the spreader, and the actual
application.  Incidental activities such as repairs, cleaning up spills,
and disposing of empty bags were monitored.  A total of 40 replicates
(individual application events) were monitored using passive dosimetry
(inner and outer whole body dosimeters, hand washes, face/neck wipes,
and personal inhalation monitors with OVS tubes).  The inner samples
represent a single layer of clothing.  Inhalation exposure was
calculated using an assumed respiratory rate of 17 Lpm for light work
(NAFTA, 1999), the actual sampling time for each individual, and the
pump flow rate.  In 20 of the replicates, the subjects wore
chemical-resistant gloves while in the remaining replicates, no gloves
were worn.  No gloves were worn in any replicate while driving.

	All results were normalized for the amount of active ingredient
handled.  Nearly all samples (for every body part and for inhalation)
were above the level of quantitation (LOQ) for dacthal.  Where results
were less than the reported LOQ, ½ LOQ value was used for calculations,
and no recovery corrections were applied.  The overall laboratory
recoveries ranged from 83 to 101% and the field recoveries ranged from
73 to 98%.  The unit exposure values are presented in Table 15 below.
[Note the inhalation exposure value is a median because the data were
found to be neither normally nor lognormally distributed.  All dermal
values are geometric means as the data were lognormally distributed.]

Table 15: Unit Exposure Values for LCO Granular Applications with a
Rotary Spreader Obtained From ORETF Studies (MRID 449722-01)

Type	Unit Exposure1 (mg exp./lb a.i. handled)

	Dermal	Inhalation

	Single Layer,

No Gloves	Single Layer,

Gloves	Double Layer2,

Gloves

	LCO Granular Applications with a Rotary Spreader	0.35	0.22	0.11	0.0073

1 All dermal unit exposure values are geometric means. The inhalation
value is a median.  2  Double layer value calculated using a 50%
protection factor.

OMA002:  MA002: LCO Spray Applications with a Low Pressure Handgun (MRID
449722-01):

A mixer/loader/applicator study was performed by the Outdoor Residential
Exposure Task Force (ORETF) using Dacthal as a surrogate compound to
determine “generic” exposures to individuals applying a pesticide to
turf with a low-pressure “nozzle gun” or “handgun” sprayer.
Dermal and inhalation exposures were estimated using whole-body passive
dosimeters and breathing-zone air samples on OVS tubes. Inhalation
exposure was calculated using an assumed respiratory rate of 17 liters
per minute for light work (NAFTA, 1999), the actual sampling time for
each individual, and the pump flow rate.   All results were normalized
for pounds active ingredient handled.

A total of 90 replicates were monitored using 17 different subjects.
Four different formulations of dacthal [75% wettable powder (packaged in
4 and 24 pound bags), 75% wettable powder in water soluble bags (3 pound
bag), 75% water dispersible granules (2 pound bag) and 55% liquid
flowable (2.5 gallon container)] were applied by five different LCOs to
actual residential lawns at each site in three different locations
(Ohio, Maryland, and Georgia) for a total of fifteen replicates per
formulation.  An additional ten replicates at each site were monitored
while they performed spray application only using the 75 percent
wettable powder formulation.  A target application rate of 2 pounds
active ingredient was used for all replicates (actual rate achieved was
about 2.2 pounds active ingredient per acre). Each replicate treated a
varying number of actual client lawns to attain a representative target
of 2.5 acres (1 hectare) of turf.   The exposure periods averaged five
hours twenty-one minutes, five hours thirty-nine minutes, and six hours
twenty-four minutes, in Ohio, Maryland and Georgia, respectively.
Average time spent spraying at all sites was about two hours.  All
mixing, loading, application, adjusting, calibrating, and spill clean up
procedures were monitored, except for typical end-of-day clean-up
activities, e.g. rinsing of spray tank, etc.  Dermal exposure was
measured using inner and outer whole body dosimeters, hand washes,
face/neck washes, and personal air monitoring devices.  All test
subjects wore one-piece, 100 percent cotton inner dosimeters beneath 100
percent cotton long-sleeved shirt and long pants, rubber boots and
nitrile gloves.  Gloves are typically worn by most LCOs, and required by
many pesticide labels for mixing and loading.

	Overall, residues were highest on the upper and lower leg portions of
the dosimeters.  In general, concurrent lab spikes produced mean
recoveries in the range of 78-120 percent, with the exception of OVS
sorbent tube sections which produced mean recoveries as low as 65.8
percent.  Adjustment for recoveries from field fortifications were
performed on each dosimeter section or sample matrix for each study
participant, using the mean recovery for the closest field spike level
for each matrix and correcting the value to 100 percent.  The unit
exposure values are presented below in Table 16.  [Note the data were
found to be lognormally distributed.  As a result, all exposure values
are geometric means.]

Table 16: Unit Exposure Values Obtained for LCO Spray Applications with
a Low Pressure Handgun from ORETF Handgun Studies (MRID 449722-01)

Application Method4	Total Dermal Unit Exposure1 (mg/lb a.i.)	Inhalation
Unit Exposure1,2

(µg/lb a.i.)

	Single Layer, No Gloves	Single Layer, Gloves	Double Layer, Gloves 3

	LCO Handgun Spray Mixer/Loader/Applicator

Liquid Flowable	No Data	0.45	0.245	1.8

1 Unit exposure values reported are geometric means.  2 Air
concentration (mg/m3/lb a.i.) calculated using NAFTA ‘99 standard
breathing rate of 17 lpm (1 m3/hr).

3 Exposure calculated using OPP/HED 50% protection factor (PF) for
cotton coveralls on torso, arms, and legs.

4 All commercial handlers wore long pants, long-sleeved shirt, nitrile
gloves and shoes.

  SEQ CHAPTER \h \r 1 OMA005: Homeowner Liquid Applications to Fruit
Trees and Ornamental Plants with a Hose-end Sprayer and a Low Pressure
Handwand (MRID 445185-01):

	Applications of Sevin Liquid® Carbaryl insecticide [RP-2 liquid (21%)]
were made by volunteers to two young citrus trees and two shrubs in each
replicate that was monitored in the study.  The test field was located
only in Florida.  Twenty (20) replicates were monitored using hose-end
sprayer (Ortho® DIAL or Spray® hose end sprayer), and 20 replicates
were monitored using hand held pump sprayers (low pressure handwands).

	Each replicate opened the end-use product, added it to the hose-end
sprayer or hand held pump and then applied it to the trees and shrubs.
After application to two trees and two shrubs dosimeters were collected.
 Inhalation exposure was monitored with personal air sampling pumps with
OVS tubes attached to the shirt collar in the breathing zone.  Dermal
exposure was assessed by extraction of carbaryl from inner and outer 100
percent cotton dosimeters. The inner and outer dosimeters were segmented
into: lower and upper arms, lower and upper legs, front and back torso.
No gloves were worn therefore hand exposure was assessed with 400 ml
handwash with 0.01 percent Aerosol OT-75 sodium dioctyl sulfosuccinate
(OTS).  One hundred percent cotton handkerchiefs wetted with 25 ml OTS
were used to wipe face and neck to determine exposure.

	Field fortification recoveries for passive dosimeters averaged 88.3
percent for inner and 76.2 percent for outer dosimeters.  Face and neck
wipe fortifications average 82.5 percent.  Handwash and inhalation OVS
tube field fortification averaged >90 percent.  Inner and outer
dosimeter and face and neck wipe residues were adjusted for field
fortification results.  Handwash and inhalation residues were not
adjusted.

	Laboratory method validation for each matrix fell within the acceptable
range of 70 to 120 percent.   The limit of quantitation (LOQ) was 1.0
µg/sample for all media except the inhalation monitors where the LOQ
was 0.01 µg/sample.  The limit of detection (LOD) was 0.5 µg/sample
for all media except the inhalation monitors where the LOQ was 0.005
µg/sample.

	For use in reregistration documents, the dermal exposure was calculated
by adding the values from the hand rinses, face/neck wipes to the outer
dosimeter lower legs and lower arms plus the inner dosimeter front and
rear torso, upper legs and upper arms.  This accounts for the
residential handler wearing short-sleeved shirt and short pants.  The
results for the low pressure handwand are summarized in Table 17 below.

	The distribution of the unit exposure values is categorized as normal,
lognormal, or “other” (i.e., neither normal nor lognormal).  A
central tendency value is selected from the distribution of the exposure
values.  These values are the arithmetic mean for normal distributions,
the geometric mean for lognormal distributions, and the median for all
“other” distributions.   The dermal exposure had a lognormal
distribution so the geometric mean value was used to determine dermal
exposure.  The inhalation exposure had neither a normal or lognormal
distribution so the median was used to determine inhalation exposure.

Table 17: Unit Exposure Values for Homeowner Liquid Applications to
Fruit Trees and Ornamental Plants with a Low Pressure Handwand Obtained
From ORETF Study (MRID 445185-01)

Scenario Monitored	Total Dermal Unit Exposure1 (mg/lb a.i.)	Inhalation
Unit Exposure2

(µg/lb a.i.)

	Short Pants, Short Sleeves	Long Pants, Short Sleeves	Long Pants, Long
Sleeves

	Homeowner Liquid Applications with a Hand Held Sprayer (Low Pressure
Handwand)	56	36	30	2.6

	1 Dermal unit exposure values reported are the geometric means.

	2 Inhalation unit exposure values reported are the median values.

  SEQ CHAPTER \h \r 1 OMA006: Homeowner Liquid Application to Garden
with a Dial type Sprayer, a Low Pressure Handwand and a Ready-to-use
Bottle (MRID 444598-01):    SEQ CHAPTER \h \r 1 The study was designed
to quantify dermal and inhalation exposure of homeowners as they mixed,
loaded and applied liquid formulations of a carbaryl end-use product to
home garden vegetables.  A hose end sprayer and a hand held pump sprayer
(low pressure handwand) were used to apply Sevin Liquid® Brand Carbaryl
Insecticide.  A ready-to-use sprayer was used to apply Sevin® Ready to
Use Insect Spray. For each application method, twenty replicates were
conducted with gloves and 20 replicates were conducted without gloves.
Inhalation exposure was monitored using personal air samplers (average
flow rate of 1.5 liter/minute) and dermal exposure was monitored by
using inner and outer dosimeters, facial/neck wipes, and hand washes.
The overall mean field fortification recovery of each matrix ranged from
77.6 ± 13.6% (outer dosimeters) to 98.4 ± 3.8% (OVS tubes). Laboratory
fortified recovery samples were analyzed with each set of samples
analyzed on a particular day; however, the results of the laboratory
recoveries were not provided in the Study Report. The results for the
low pressure handwand are summarized in Table 18 below.

  SEQ CHAPTER \h \r 1 Table 18.  Unit Exposure Values for Homeowner
Liquid Application to Garden with a Low Pressure Handwand Obtained From
ORETF Study (MRID 444598-01)

Scenario Monitored	Total Dermal Unit Exposure1 (mg/lb a.i.)	Inhalation
Unit Exposure1

(µg/lb a.i.)

	Short Pants, Short Sleeves	Long Pants, Short Sleeves	Long Pants, Long
Sleeves

Gloves	No Gloves	Gloves	No Gloves	Gloves	No Gloves

	Homeowner Liquid Applications with a Low Pressure Handwand Sprayer	10.5
38	0.78	17	0.33	15	2.7

1 Unit exposure values reported are geometric means.

		7.1.2	Occupational Handler Exposure Scenarios  tc "2.1.2	CAMA Handler
Exposure Scenarios " \l 3

	 It has been determined that exposure to pesticide handlers is likely
during the occupational use of chlorflurenol on agricultural crops,
non-crop areas, and on turfgrass. The anticipated use patterns and
current labeling indicate occupational exposure scenarios based on the
types of equipment and techniques that can potentially be used for
chlorflurenol applications.  The quantitative exposure/risk assessment
developed for occupational handlers is based on the following scenarios.

	Mixer/Loaders:

	(1a) Mixing/loading liquids for airblast application (PHED);

 	(1b) Mixing/loading liquids for ground application (PHED);

(1c) Mixing/loading liquids to support LCO handgun applications (PHED);

(1d) Mixing/loading liquids for rights-of-way application (PHED); and

(2) Mixing/loading granules for tractor drawn spreader application
(PHED).

	Applicators:

	(3) Applying sprays with airblast sprayer (PHED);

(4) Applying sprays with groundboom sprayer (PHED);

(5) Applying sprays with a handgun sprayer (PHED);

(6) Applying sprays with rights-of-way sprayer (PHED); and

(7) Applying granules with tractor drawn spreader (PHED).

	Mixer/Loader/Applicators:

(8) Mixing/loading/applying liquids with low pressure handwand sprayer
(PHED);

(9) Mixing/loading/applying liquids with low pressure handwand sprayer
(ground

directed) (ORETF);

(10) Mixing/loading/applying liquids with low pressure handwand sprayer

(overhead directed) (ORETF);

	(11) Mixing/loading/applying liquids with a handgun sprayer (LCO
ORETF);

	(12) Mixing/loading/applying granules with a bellygrinder (PHED); and

	(13) Mixing/loading/applying granules with a push-type spreader (LCO
ORETF).

	7.1.3	Non-cancer Occupational Handler Exposure and Assessment  tc
"2.1.3	Non-cancer CAMA Handler Exposure and Assessment " \l 3

<IP_ADDRESS>	Non-cancer Occupational Handler Exposure and Risk Calculations
tc "<IP_ADDRESS>	Non-cancer CAMA Handler Exposure and Risk Calculations " \l
4

	Daily Exposure: Daily dermal or inhalation handler exposures are
estimated for each applicable handler task with the application rate,
the area treated in a day, and the applicable dermal or inhalation unit
exposure using the following formula:

Daily Exposure (mg a.i./day) = Unit Exposure (mg a.i./lb a.i. handled) x
Application Rate (lbs a.i./area) x Daily Area Treated (area/day)

Where:

Daily Exposure		=	Amount (mg or µg a.i./day) deposited on the surface
of the skin that is available for dermal absorption or amount inhaled
that is available for inhalation absorption;

Unit Exposure 		=	Unit exposure value (mg or µg a.i./lb a.i.) derived
from August 1998 PHED data or from ORETF data;

Application Rate		=	Normalized application rate based on a logical unit
treatment, such as acres, square feet, or gallons. Maximum values are
generally used (lb a.i./A, lb a.i./sq ft, lb a.i./gal); and

	Daily Area Treated 	=	Normalized application area based on a logical
unit treatment such as acres (A/day), square feet  (sq ft/day), gallons
per day (gal/day).

	Daily Dose:  The daily dermal or inhalation dose is calculated by
normalizing the daily exposure by body weight and adjusting, if
necessary, with an appropriate dermal or inhalation absorption factor.
For all dermal and inhalation exposure, an average male and female body
weight of 70 kilograms was used, since the toxicological endpoint is not
sex-specific.  100% absorption was used for inhalation exposures.
Dermal exposure was assessed assuming 100% dermal absorption for liquid
formulations and both 100% and 10% dermal absorption for granular
formulations.  Daily dose was calculated using the following formula:

Average Daily Dose (mg/kg/day) = Daily Exposure (mg a.i./day) x
(Absorption Factor (%/100) / Body Weight (kg)

Where:

Average Daily Dose 		= 	Absorbed dose received from exposure to a
pesticide in a given scenario (mg pesticide active ingredient/kg body
weight/day);

Daily Exposure 			=	Amount (mg a.i./day) deposited on the surface of the
skin that is available for dermal absorption or amount inhaled that is
available for inhalation absorption;

Absorption Factor 		= 	A measure of the amount of chemical that crosses
a biological boundary such as the skin or lungs (% of the total
available absorbed); and

Body Weight 			= 	Body weight determined to represent the population of
interest in a risk assessment (kg).

	Margins of Exposure:  Non-cancer dermal and inhalation risks for each
applicable handler scenario are calculated using a Margin of Exposure
(MOE), which is a ratio of the toxicological endpoint of concern to the
daily dose.  All MOE values were calculated separately for dermal and
inhalation exposure levels using the formula below:

MOE= NOAEL or LOAEL (mg/kg/day) / Average Daily Dose (mg/kg/day)

Where:

MOE 			= 	Margin of Exposure, value used by HED to represent risk or how
close a chemical exposure is to being a concern (unitless);

ADD 			= 	Average Daily Dose or the absorbed dose received from exposure
to a pesticide in a given scenario (mg pesticide active ingredient/kg
body weight/day); and

NOAEL or LOAEL	= 	Dose level in a toxicity study, where no observed
adverse effects (NOAEL) or where the lowest observed adverse effects
(LOAEL) occurred in the study