Document ID: EPA-HQ-OPP-2006-0874-0041
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-05-02T04:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

						     		OFFICE OF PREVENTION, PESTICIDES

									AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	23 March 2007  

SUBJECT:	Chlorflurenol Methyl Ester.  Chronic Drinking Water Exposure
and Risk Assessment for the Section 3 Reregistration Eligibility
Decision

PC Code:	098801		Decision Number: 362457

DP Number:	337212		Case Number: 2095

FROM:          P. Yvonne Barnes, Chemist

RRB2/Health Effects Division (7509P)

THROUGH:	Donald Wilbur, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Alan Nielsen, Branch Senior Scientist

RRB2/Health Effects Division (7509P)

TO:		Tracy Perry

			Reregistration Branch 3

		Special Review and Reregistration Division (7508P)

Executive Summary

xposure Evaluation Model (DEEM-FCID™, Version 2.03) which use food
consumption data from the U.S. Department of Agriculture’s Continuing
Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.
The analyses were performed to support the reregistration eligibility
decision Case Number 2095.

Surface Water

The chronic dietary exposure estimates from drinking water (surface)
concentration are below HED’s level of concern (<100% cPAD) for the
U.S. population and all population subgroups.  Non-nursing infants and
all infants (<1 year) were exposed to the highest percentage of the RfD
at 0.4% and 0.3% respectively. All other groups were exposed to residues
in drinking water at 0.1% to 0.2% of the oral chronic RfD of 0.1
mg/kg/day.  

Ground Water

The chronic dietary exposure estimates from drinking water (ground
water) concentration are below HED’s level of concern (<100% cPAD) for
the U.S. population and all population subgroups.  Non-nursing infants
and all infants (< 1 year) were exposed to the highest percentage of the
RfD at 3.7% and 3.0% respectively.  All other groups were exposed to
drinking water at 0.7% to 1.3% of the oral chronic RfD of 0.1 mg/kg/day.
 

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For chronic assessments, the risk is expressed as a
percentage of a maximum acceptable dose (i.e., the dose which HED has
concluded will result in no unreasonable adverse health effects).  This
dose is referred to as the population adjusted dose (PAD).  The PAD is
equivalent to the reference dose (RfD) divided by the Food Quality
Protection Act (FQPA) Safety Factor.

For non-cancer chronic exposures, HED is concerned when estimated
dietary risk exceeds 100% of the PAD.  HED is generally concerned when
estimated cancer risk exceeds one in one million (i.e., the risk exceeds
1 x 10-6).  References which discuss the chronic risk assessments in
more detail are available on the EPA/pesticides web site: “Available
Information on Assessing Exposure from Pesticides, A User’s Guide,”
06/21/2000, web link:    HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see
SOP 99.6 (08/20/1999).

II.	Residue Information

Chlorflurenol methyl ester is a non-food use pesticide having no
tolerances to reassess.  Consequently, there are no residue chemistry
data requirements and thus, dietary exposure and risk assessments are
not applicable except for drinking water analysis.  Chlorflurenol methyl
ester is used on pineapple plants 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 Greybeard Committee decision in 1995 [TXR# 012504].  HED upholds
this decision in the HED Chapter of the Reregistration Eligibility
Decision Document (RED), (Anderson, issued 10 July 2006).

 

 Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by the Environmental Fate and Effects Division (EFED) in the
following memorandum: “Revised Drinking Water Assessment for
Chlorflurenol Growth Regulator and Herbicide” (Parker, D336694 dated
14 March 2007) and incorporated directly into this dietary assessment. 
Water residues were incorporated in the DEEM-FCID into the food
categories “water, direct, all sources” and “water, indirect, all
sources.”   

Potential drinking water residues were estimated for groundwater from
Tier I SCIGROW and surface water from Tier II PRZM and EXAMS models. 
The OPP/EFED Florida turf scenario was selected for this assessment. 

 For this assessment, it was assumed that 1 application of chlorflurenol
methyl ester was applied to turf grass at a rate of 0.5 pounds active
ingredient per acre and the pesticide is stable in the environment. 
This would represent a maximum concentration in a shallow, private well
in a high usage area. Surface water concentrations are 9.4 ppb for acute
concentration; 5.0 ppb for chronic non-cancer and 42.7 ppb for ground
water concentration (see Table 1).

The model and its description are available at the EPA internet site:  
HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .  

Table 1

Model	Chlorflurenol Methyl Ester Drinking Water Concentration (ppb)

Exposure Duration	Acute	Chronic Non-cancer

Annual Rate & (Number) of Applications	0.5(1)	0.5(1)

PRZM/EXAMS (Surface Water)	9.4	5.0

SCIGROW (Ground Water)	42.7	42.7

.	DEEM-FCID™ Program and Consumption Information

Chlorflurenol chronic dietary exposure assessments were conducted using
the Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID™, Version 2.03), which incorporates
consumption data from USDA’s Continuing Surveys of Food Intakes by
Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based
on the reported consumption of more than 20,000 individuals over two
non-consecutive survey days.  Foods “as consumed” (e.g., apple pie)
are linked to EPA-defined food commodities (e.g. apples, peeled fruit -
cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S,
baked) using publicly available recipe translation files developed
jointly by USDA/ARS and EPA. 

 For chronic exposure assessment, consumption data are averaged for the
entire U.S. population and within population subgroups, but for acute
exposure assessment are retained as individual consumption events. 
Based on analysis of the 1994-96, 98 CSFII consumption data, which took
into account dietary patterns and survey respondents, HED concluded that
it is most appropriate to report risk for the following population
subgroups: the general U.S. population, all infants (<1 year old),
children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49,
females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue
level in each food or food-form (e.g., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form to produce a residue intake
estimate.  The resulting residue intake estimate for each food/food form
is summed with the residue intake estimates for all other food/food
forms on the commodity residue list to arrive at the total average
estimated exposure.  Exposure is expressed in mg/kg body weight/day and
as a percent of the cPAD.  This procedure is performed for each
population subgroup.

V.	Toxicological Information

Toxicology data requirements are acceptable and satisfied. However,
another study on reproduction with a more definitive NOAEL for effects
on pups and fertility will be necessary to remove the 3X uncertainty
factor see (Table 2).

Table 2	

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

Chronic Dietary

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

Chronic RfD = 0.10 mg/kg/day	LOC = 100% of the cRfD

Total UF = 300 

Interspecies 10X; 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 wks.  

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.

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

VI.	Results/Discussion 

Surface Water

The chronic dietary exposure estimates from drinking water (surface)
concentration are below HED’s level of concern (<100% cPAD) for the
U.S. population and all population subgroups.  Non-nursing infants and
all infants (< 1 year) were exposed to the highest percentage of the RfD
at 0.4% and 0.3% respectively.  All other groups were exposed to
residues in drinking water at 0.1% to 0.2% of the oral chronic RfD of
0.1 mg/kg/day.  

Ground Water

The chronic dietary exposure estimates from drinking water (ground
water) concentration are below HED’s level of concern (<100% cPAD) for
the U.S. population and all population subgroups.  Non-nursing infants
and all infants (< 1 year) were exposed to the highest percentage of the
RfD at 3.7% and 3.0% respectively.  All other groups were exposed to
drinking water at 0.7% to 1.3% of the oral chronic RfD of 0.1 mg/kg/day.
 

tary risk exceeds 100% of the PAD. The DEEM-FCID™ analyses estimate
the dietary exposure of the U.S. population and various population
subgroups.  In this analysis all population subgroups have risk
estimates which are below HED’s level of concern.  

Results of Chronic Dietary Exposure Analysis

The results of the chronic dietary exposure analysis are reported in the
two summary tables below. All population subgroups have risk estimates
which are below HED’s level of concern.   Table 3 reports the surface
water analysis and Table 4 reports the ground water analysis. 

Table 3

 Chlorflurenol Methyl Eater:  Selected population exposures (selected
for  surface water exposures within a group)

Population subgroup	mg/kg/day 	Percent of the endpoint of

0.10 mg/kg/day

US population (summer season)	0.000113	0.1

Western region	0.000121	0.1

Hispanics	0.000120	0.1

Non-hispanic blacks	0.000100	0.1

Non-hispanic/non-white/non-black	0.000129	0.1

All infants (<1 year)	0.000346	0.3

Nursing infants	0.000128	0.1

Non-nursing infants 	0.000428	0.4

Females 20+ (not pregnant or nursing)	0.000105	0.1

Females 13-50 years	0.000102	0.1

Females 13+ nursing	0.000146	0.1

Males 20+ years	0.000094	0.1

Seniors 55+ years	0.000103	0.1

Children 1-2 years	0.000156	0.2

Children 3-5 years	0.000147	0.1

Children 6-12 years	0.000101	0.1

Youths 13-19 years	0.000076	0.1

For drinking water, the Deem software was modeled using surface water
concentration at 5.0 ppb.

** The highest affected populations are bolded.

Table 4    

Chlorflurenol Methyl Ester:  Selected population exposures (selected for
 ground water exposures within a group)

Population subgroup	mg/kg/day	Percent of the endpoint of

0.10 mg/kg/day

US population (summer season)	0.000967	1.0

Western region	0.001031	1.0

Hispanics	0.001022	1.0

Non-hispanic blacks	0.000854	0.9

Non-hispanic/non-white/non-black	0.001103	1.1

All infants (<1 year)	0.002951	3.0

Nursing infants	0.001094	1.1

Non-nursing infants 	0.003655	3.7

Females 20+ (not pregnant or nursing)	0.000898	0.9

Females 13-50 years	0.000871	0.9

Females 13+ nursing	0.001247	1.2

Males 20+ years	0.000806	0.8

Seniors 55+ years	0.000884	0.9

Children 1-2 years	0.001337	1.3

Children 3-5 years	0.001251	1.3

Children 6-12 years	0.000863	0.9

Youths 13-19 years	0.000651	0.7

For drinking water, the Deem software was modeled using ground water
concentration at 42.7 ppb.

** The highest affected populations are bolded.

VII.	Conclusion

The chronic analyses of surface and ground water concentrations indicate
that all population subgroups have risk estimates which are below
HED’s level of concern.  

VIII.		List of Attachments 

Attachment 1   Chronic Inputs  (Surface Water)

Attachment 2   Chronic Inputs  (Ground Water)

Attachment 3   Chronic Results (Surface Water)

Attachment 4   Chronic Results (Ground Water)

cc:	RRB2 Team

Attachment 1:  Chronic Input (Surface Water)

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for CHLORFLURENOL                     
1994-98 data

Residue file: C:\Documents and Settings\pbarnes\Desktop\chlorflurenol 6
13 2006\new water only runs\chlorflurenol 03 01 2007.R98

                                                           Adjust. #2
NOT used

Analysis Date 03-01-2007             Residue file dated:
03-01-2007/09:41:47/8

Reference dose (RfD) = 0.1 mg/kg bw/day

Comment: Application Rate 0.5 lbs/acre

------------------------------------------------------------------------
--------

Food Crop                                       Residue      Adj.
Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

-------- ---- -------------------------------   ---------- ------    
------   -------

86010000 O    Water, direct, all sources         0.005000   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.005000   1.000     
1.000   

Attachment 2:  Chronic Input (Ground Water)

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for CHLORFLURENOL                     
1994-98 data

Residue file: C:\Documents and Settings\pbarnes\Desktop\chlorflurenol 6
13 2006\new water only runs\chlorflurenol 03 01 2007 ground water
only.R98

                                                           Adjust. #2
NOT used

Analysis Date 03-01-2007             Residue file dated:
03-01-2007/09:45:50/8

Reference dose (RfD) = 0.1 mg/kg bw/day

Comment: ground water

------------------------------------------------------------------------
--------

Food Crop                                       Residue      Adj.
Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

-------- ---- -------------------------------   ---------- ------    
------   -------

86010000 O    Water, direct, all sources         0.042700   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.042700   1.000     
1.000   

Attachment 3:  Chronic Results (Surface Water)

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for CHLORFLURENOL                    (1994-98
data)

Residue file name: C:\Documents and
Settings\pbarnes\Desktop\chlorflurenol 6 13 2006\new water only
runs\chlorflurenol 03 01 2007.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 03-01-2007/09:42:27     Residue file dated:
03-01-2007/09:41:47/8

Reference dose (RfD, Chronic) = .1 mg/kg bw/day

COMMENT 1: Application Rate 0.5 lbs/acre

========================================================================
=======

                    Total exposure by population subgroup

------------------------------------------------------------------------
-------

                                                    Total Exposure

                                        
-----------------------------------

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

--------------------------------------   -------------      
---------------

U.S. Population (total)                     0.000105                
0.1%

U.S. Population (spring season)             0.000104                
0.1%

U.S. Population (summer season)             0.000113                
0.1%

U.S. Population (autumn season)             0.000102                
0.1%

U.S. Population (winter season)             0.000102                
0.1%

Northeast region                            0.000096                
0.1%

Midwest region                              0.000107                
0.1%

Southern region                             0.000100                
0.1%

Western region                              0.000121                
0.1%

Hispanics                                   0.000120                
0.1%

Non-hispanic whites                         0.000103                
0.1%

Non-hispanic blacks                         0.000100                
0.1%

Non-hisp/non-white/non-black                0.000129                
0.1%

All infants (< 1 year)                      0.000346                
0.3%

Nursing infants                             0.000128                
0.1%

Non-nursing infants                         0.000428                
0.4%

Children 1-6  yrs                           0.000147                
0.1%

Children 7-12 yrs                           0.000096                
0.1%

Females 13-19 (not preg or nursing)         0.000074                
0.1%

Females 20+ (not preg or nursing)           0.000105                
0.1%

Females 13-50 yrs                           0.000102                
0.1%

Females 13+ (preg/not nursing)              0.000102                
0.1%

Females 13+ (nursing)                       0.000146                
0.1%

Males 13-19 yrs                             0.000078                
0.1%

Males 20+ yrs                               0.000094                
0.1%

Seniors 55+                                 0.000103                
0.1%

Children 1-2 yrs                            0.000156                
0.2%

Children 3-5 yrs                            0.000147                
0.1%

Children 6-12 yrs                           0.000101                
0.1%

Youth 13-19 yrs                             0.000076                
0.1%

Adults 20-49 yrs                            0.000098                
0.1%

Adults 50+ yrs                              0.000104                
0.1%

Females 13-49 yrs                           0.000098                
0.1%

Attachment 4:  Chronic Results (Ground Water)

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for CHLORFLURENOL                    (1994-98
data)

Residue file name: C:\Documents and
Settings\pbarnes\Desktop\chlorflurenol 6 13 2006\new water only
runs\chlorflurenol  03 01 2007 ground water only.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 03-01-2007/09:46:24     Residue file dated:
03-01-2007/09:45:50/8

Reference dose (RfD, Chronic) = .1 mg/kg bw/day

COMMENT 1: ground water

========================================================================
=======

                    Total exposure by population subgroup

------------------------------------------------------------------------
-------

                                                    Total Exposure

                                        
-----------------------------------

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

--------------------------------------   -------------      
---------------

U.S. Population (total)                     0.000900                
0.9%

U.S. Population (spring season)             0.000892                
0.9%

U.S. Population (summer season)             0.000967                
1.0%

U.S. Population (autumn season)             0.000870                
0.9%

U.S. Population (winter season)             0.000870                
0.9%

Northeast region                            0.000821                
0.8%

Midwest region                              0.000910                
0.9%

Southern region                             0.000855                
0.9%

Western region                              0.001031                
1.0%

Hispanics                                   0.001022                
1.0%

Non-hispanic whites                         0.000878                
0.9%

Non-hispanic blacks                         0.000854                
0.9%

Non-hisp/non-white/non-black                0.001103                
1.1%

All infants (< 1 year)                      0.002951                
3.0%

Nursing infants                             0.001094                
1.1%

Non-nursing infants                         0.003655                
3.7%

Children 1-6  yrs                           0.001257                
1.3%

Children 7-12 yrs                          
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Females 13+ (preg/not nursing)              0.000875                
0.9%

Females 13+ (nursing)                       0.001247                
1.2%

Males 13-19 yrs                             0.000662                
0.7%

Males 20+ yrs                               0.000806                
0.8%

Seniors 55+                                 0.000884                
0.9%

Children 1-2 yrs                            0.001337                
1.3%

Children 3-5 yrs                            0.001251                
1.3%

Children 6-12 yrs                           0.000863                
0.9%

Youth 13-19 yrs                             0.000651                
0.7%

Adults 20-49 yrs                            0.000840                
0.8%

Adults 50+ yrs                              0.000884                
0.9%

Females 13-49 yrs                           0.000837                
0.8%

Chlorflurenol	        Dietary Exposure and Risk Assessment	             
    DP Number: 337212

PC Code: 098801

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