  SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	22- JAN-2007

SUBJECT:	Coumaphos Acute and Chronic Aggregate Dietary Exposure and Risk
Assessments for the Proposed Section 3 Registration on Honey.

PC Code:	036501			

DP Number:	D335163

REVIEWER:	Sheila Piper, Chemist

Chemistry and Exposure Branch/Health Effects Division (7509P)

THROUGH:	Toiya Goodlow, Chemist

Susan Stanton, Environmental Scientist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

David J. Miller, Chief

Chemistry and Exposure Branch/Health Effects Division (7509P)

TO:		Kelly Schumacher, Risk Assessor

		Registration Action Branch 2/Health Effects Division (7509P)

and

Shaja Brothers, RM 05

Daniel Rosenblatt, RM 05

Insecticide Branch/ Registration Division (7505P)

	

Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure
and risk assessments were conducted using the Dietary Exposure
Evaluation Model DEEM-FCID™, Version 2.03 which uses food consumption
data from the U.S. Department of Agriculture’s Continuing Surveys of
Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  These
dietary exposure and risk assessments for coumaphos include the
following: (1) Section 3 requests for coumaphos in honey; (2) new acute
toxicological endpoint; (3) and the latest PDP monitoring data for beef
and milk.

   

Acute Dietary (Food and Drinking Water) Exposure Results and
Characterization

A partially refined acute dietary exposure assessment was conducted to
estimate the dietary exposure and risk associated with the proposed
Section 3 registration of coumaphos on honey.  The acute dietary
exposure assessment incorporated 2002 PDP monitoring data for beef and
2004 PDP monitoring data for milk.  Field trial data were used for honey
to support the proposed use pattern.  The dietary exposure assessment
assumes 100% crop treated for the acute analysis.  

The GENEEC and SCI-GROW screening models were used to estimate surface
water and groundwater concentrations of coumaphos and its oxygen analog,
coumaphoxon.  Tier 1 GENEEC screening model, representing a worst-case
runoff scenario for pesticides in surface water, was used to estimate
the upper-bound concentrations in surface water.  Total coumaphos
(coumaphos + coumaphoxon) acute estimated environmental concentrations
in drinking water derived from surface water sources are not likely to
exceed 1.86 ppb.

The acute aggregate dietary exposure estimates are below HED’s level
of concern (<100 % aPAD) for the U.S. population and all population
subgroups.  Combined dietary exposure from food and drinking water at
the 99.9th percentile of exposure is 15% of the aPAD for the U.S.
population and 38% of the aPAD for all infants (<1 yr), the most highly
exposed population subgroup.

Chronic Dietary (Food and Drinking Water) Exposure Results and
Characterization

A partially refined chronic dietary exposure assessment was conducted to
estimate the dietary risks associated with the registration of
coumaphos.  The chronic dietary exposure assessment incorporated the
latest PDP monitoring data, average field trial data for honey and
assumed 100% crop treated.  Total coumaphos (coumaphos + coumaphoxon)
chronic estimated environmental concentrations in drinking water derived
from surface water sources are not likely to exceed 0.41 ppb.

The chronic aggregate dietary exposure estimates are below HED’s level
of concern (< 100% of the cPAD) for the U.S. population and all
population subgroups. Combined dietary exposure from food and drinking
water is 6% of cPAD for the U.S. population and 13% of the cPAD for all
infants (<1 yr), the most highly exposed population subgroup.

Cancer Dietary (Food and Drinking Water) Exposure Results and
Characterization

Coumaphos was classified as “not likely to be a human carcinogen,”
therefore a cancer dietary assessment was not performed.

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For acute and 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 point of departure (POD; NOAEL, LOAEL,
e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 100% of the PAD.  References which
discuss the acute and 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,” 21-JUN-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 (20-AUG-1999).

The most recent dietary risk assessment for coumaphos was conducted by
W. Cutchin (13-OCT-2000, D267978).

II. Residue Information

Coumaphos (O-[3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl] O,O-diethyl
phosphorothioate) is an organophosphate insecticide/acaricide currently
used for the control of mites and insects on livestock.  Permanent
tolerances are established for the residues of coumaphos and its oxygen
analog (coumaphos-OP) at 1.0 ppm in fat, meat, and meat byproducts of
cattle, goats, hogs, horses, and sheep, along with a tolerance at 0.5
ppm in milk fat (40CFR §180.189[a]).  Time-limited tolerances have also
been established for residues of coumaphos and its oxygen analog at 0.1
and 100 ppm, respectively, in honey and honeycomb (40CFR §180.189[b]),
associated with Section 18 emergency uses in beehives; these tolerances
are set to expire on 12/31/2007.

No plant metabolism data are required as coumaphos is not registered for
use on plants. The nature of the residue in livestock is understood,
based on an adequate cow metabolism study reflecting dermal dosing.  The
residues of concern in livestock are coumaphos and its oxygen analog. 
The existing animal metabolism data are adequate for purposes of the
proposed use on honeybees.  The residues of concern in honeybee products
(honey and honeycomb) are coumaphos and coumaphos-OP.

Residue Data used for Acute and Chronic Dietary Assessments

Interregional Research Project #4 (IR-4) has submitted a petition
(PP#2E6504) proposing a Section 3 registration for the use of
coumaphos-impregnated strips in beehives for the control of varroa mites
and small hive beetles.  The strips (CheckMite+ Bee Hive Pest Control
Strips) contain 10% coumaphos, the active ingredient (ai), by weight. 
The proposed label would allow for use of up to two 10% strips hung in
the hive’s brood chamber for control of varroa mites, and the
concurrent use of another 10% strip attached to the bottom board for
control of small hive beetles.  The strips could remain in the hive for
up to 45 days, and the application could be made at anytime during the
year, including during honey flow (honey accumulation).  HED  SEQ
CHAPTER \h \r 1  recommends the establishment of permanent tolerances
for the combined residues of coumaphos and its oxygen analog at 0.15 ppm
in honey, and 45 ppm in honeycomb (W. Drew, D036501).

Honey (partially blended): The entire distribution of field trial
residues (0.034, 0.034, 0.071, 0.032, 0.055, 0.034, 0.074, 0.037, 0.052,
0.020, and 0.021 ppm) from two 10% strips (1x rate) at 0-13 days were
used at 100% crop treated in the acute dietary analysis.  An average
field trial residue value of 0.042 ppm was calculated for chronic
dietary assessment.  See Table 1 below.

Beef (Adipose): PDP data from 2002 were used for beef adipose.  A total
of 301 samples were analyzed for coumaphos and coumaphos oxygen analog. 
Coumaphos and coumaphos oxygen analog were not detected in any samples.
An anticipated residue value of 0.00375 ppm which represents ½ the
combined LOQ (limit of quantitation) values of coumaphos and its oxygen
analog was used for the acute and chronic dietary analyses and 100% crop
treated was assumed.

Beef (liver): PDP data from 2002 were used for beef liver.  A total of
313 samples were analyzed for coumaphos and coumaphos oxygen analog. 
Coumaphos and coumaphos oxygen analog were not detected in any samples.
An anticipated residue value of 0.00375 ppm which represents ½ the
combined LOQ (limit of quantitation) values of coumaphos and its oxygen
analog was used for the acute and chronic dietary analyses and 100% crop
treated was assumed.

Beef (muscle): PDP data from 2002 were used for beef liver.  A total of
310 samples were analyzed for coumaphos and coumaphos oxygen analog. 
Coumaphos and coumaphos oxygen analog were not detected in any samples. 
An anticipated residue value of 0.00375 ppm which represents ½ the
combined LOQ (limit of quantitation) values of coumaphos and its oxygen
analog was used for the acute and chronic dietary analyses and 100% crop
treated was assumed.

Milk: PDP data from 2004 were used for milk.  A total of 739 samples
were analyzed for coumaphos and coumaphos oxygen analog.  Coumaphos and
coumaphos oxygen analog were not detected in any samples.  An
anticipated residue value of 0.00013 ppm which represents ½ the
combined LOQ (limit of quantitation) values of coumaphos and its oxygen
analog was used for the acute and chronic dietary analyses and 100% crop
treated was assumed.

Processing Factors:   	An adequate honey processing study is available,
which used samples of raw honey fortified with coumaphos, and samples of
raw honey with field-incurred residues of coumaphos.  Following
processing of raw honey by heating and filtration, coumaphos residues
were reduced in the final honey fractions by 0.5x.  A default processing
factor for dried beef of 1.92 was also used.



	

Table 1.  Data and Residue Estimates Used in Dietary Analyses for
Couamphos

RAC1	Food

Forms	Classification2	Data

Source	No. of

Samples	No. of

Detectable

Residues	LOQ3

(ppm)	%CT	Processing

Factors	Anticipated Residue Estimates/Tolerance







	Ave.	Max.

Acute (Tol., AR, RDF) ppm	Chronic (Tol., AR) ppm

Honey	All	PB	

Field Trial

	11	11	0.010	100	100	0.5	RDF #1

Honey FT 100%CT

TOTALNZ=11

TOTALZ=0

0.034, 0.034

0.071, 0.032

0.055, 0.034

0.074, 0.037

0.052, 0.020

0.021	0.042

Beef (adipose-fat)	All	--	2002 PDP	301	0	0.0075	100	100	--	0.00375
0.00375

Beef (liver)	All	--	2002 PDP	313	0	0.0075	100	100	--	0.00375	0.00375

Beef (muscle-meat)	All	--	2002 PDP	310	0	0.0075	100	100	1.92 meat dried
meat	0.00375	0.00375

Milk	All	--	2004 PDP	739	0	0.0003	100	100	--	0.00013	0.00013

Beef was translated for goat, sheep horse, hog and rabbit.

Classification of blended (B), partially blended (PB), not blended (NB).

3.	Average LOQs of coumaphos + oxygen analog

 Drinking Water Data

Reference:  Finalization of Interim Reregistration Eligibility Decisions
(IREDs) and Interim Tolerance Reassessment and Risk Management Decisions
(TREDs) for the

Organophosphate Pesticides, and Completion of the Tolerance Reassessment
and

Reregistration Eligibility Process for the Organophosphate Pesticides;
D. Edwards, 31-JUL-2006.

The GENEEC and SCI-GROW screening models were used to estimate surface
water and groundwater concentrations of coumaphos and its oxygen analog,
coumaphoxon.  This degradate is considered in the drinking water
assessment, because it is part of the tolerance expression. The acute
and chronic surface water values (1.86 ppb and 0.41 ppb) were
incorporated directly into these dietary assessments under the DEEM-FCID
food categories “water, direct, all sources” and “water, indirect,
all sources.”  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/ .  

Surface Water:  Tier 1 GENEEC screening model, representing a worst-case
runoff scenario for pesticides in surface water, was used to estimate
the upper-bound concentrations in surface water.  Total coumaphos
(coumaphos + coumaphoxon) acute and chronic estimated environmental
concentrations in drinking water derived from surface water sources are
not likely to exceed 1.86 ppb and 0.41 ppb, respectively.

Ground Water: A Tier 1 screening model, SCI-GROW, was used to estimate
total coumaphos concentrations in ground water.  This is an empirical
model based on field data from prospective ground water studies. 
Estimated environmental concentration of total coumaphos, representing
acute and chronic exposures to ground water, is 0.17 ppb.  Ground water
sources were not included in this assessment, as the estimated
environmental concentration for this water source is minimal in
comparison to surface water.  

The recommended application rate for coumaphos spent solution from dip
vat operations on non-agricultural land is 10,000 liters (L) of
coumaphos spent solution containing 10 ppb spread over a one-acre field.
 A conversion efficiency of coumaphos to coumaphoxon of 10.2% was
derived from available (supplemental) data on photodegradation in water.
 This conversion efficiency was used to estimate a coumaphoxon
application rate of 0.02 lbs ai/A.

DEEM-FCID™ Program and Consumption Information

Coumaphos acute and 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.

For acute exposure assessments, individual one-day food consumption data
are used on an individual-by-individual basis.  The reported consumption
amounts of each food item can be multiplied by a residue point estimate
and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or “matched” in multiple random
pairings with residue values and then summed in a probabilistic
assessment.  The resulting distribution of exposures is expressed as a
percentage of the aPAD on both a user (i.e., only those who reported
eating relevant commodities/food forms) and a per-capita (i.e., those
who reported eating the relevant commodities as well as those who did
not) basis.  In accordance with HED policy, per capita exposure and risk
are reported for all tiers of analysis.  However, for tiers 1 and 2, any
significant differences in user vs. per capita exposure and risk are
specifically identified and noted in the risk assessment.



V. Toxicological Information

The acute dietary endpoint for the general population is based on
plasma, erythrocyte and brain ChE inhibition (measured at time of peak
inhibition) in PND 11 rats following a single oral dose in the
comparative cholinesterase study.  This endpoint, selected by the
coumaphos risk assessment team (Dec 2006), is considered appropriate for
the general population because the effects were observed following a
single dose, and the route of administration (oral) is appropriate for
dietary considerations.  Previously, the acute dietary endpoint was
based on plasma and erythrocyte ChE inhibition observed in rats at a
LOAEL of 2 mg/kg (no NOAEL was observed) in an acute neurotoxicity
study.  The newly selected endpoint is protective of this effect, as
well as all others seen in the mammalian toxicology database
attributable to a single dose.

A separate acute dietary endpoint for female ages 13-49 years was not
selected because coumaphos does not induce any effects attributable to a
single dose, including developmental effects that would affect this
population subgroup. 

The chronic dietary endpoint, previously selected by the HED HIARC, is
based on plasma and RBC ChE inhibition in males and females in the
chronic toxicity study in dogs.  This endpoint is considered appropriate
for chronic dietary exposure due to the oral route of administration and
the chronic duration of exposure.  The study and endpoint were selected
because they are protective of effects observed in all the other
available studies, including offspring effects seen in the recently
submitted developmental neurotoxicity study.

 A summary of the toxicological doses and endpoints selected for the
dietary exposure assessments is provided in Table 2.

Table 2: Toxicological Doses and Endpoints for Coumaphos for Use in
Dietary Human Health Risk Assessments.

Exposure/

Scenario	Point of Departure	Uncertainty/

FQPA Safety Factors	RfD, PAD, Level of Concern for Risk Assessment	Study
and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)	NOAEL
=  0.25 mg/kg/day	UFA= 10x

UFH = 10x

FQPA SF = 1x

	Acute RfD = 0.0025 mg/kg/day

aPAD = 0.0025 mg/kg/day	Comparative cholinesterase study in rats

LOAEL = 0.5 mg/kg/day based on plasma (19%/22%; M/F), RBC (20%/19%;
M/F), and brain (8%/7%; M/F) ChE inhibition in PND 11 males and females

Chronic Dietary (All Populations)	NOAEL = 0.025 mg/kg/day	UFA= 10x

UFH = 10x

FQPA SF = 1x

	Chronic RfD = 0.00025

mg/kg/day

cPAD = 0.00025 mg/kg/day	Chronic toxicity study in dogs LOAEL =
0.775/0.705 mg/kg/day (M/F) based on plasma and RBC ChE inhibition in
males and females

Cancer Classification	Not likely to be a Human Carcinogen

Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures.  NOAEL = no observed adverse effect level. 
LOAEL = lowest observed adverse effect level.  UF = uncertainty factor. 
UFA = extrapolation from animal to human (interspecies).  UFH =
potential variation in sensitivity among members of the human population
(intraspecies).  UFDB = to account for the absence of key data (i.e.,
lack of a comparative cholinesterase study).  FQPA SF = FQPA Safety
Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD =
reference dose. 

VI. Results/Discussion 

As stated above, for acute and chronic assessments, HED is concerned
when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses
estimate the dietary exposure of the U.S. population and various
population subgroups.  The results reported in Tables 3 and 4 are for
the general U.S. Population, all infants (<1 year old), children 1-2,
children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49,
and adults 50+ years.  Cancer risk is determined for the general U.S.
population only.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

The acute aggregate dietary exposure estimates are below HED’s level
of concern (<100 % aPAD) for the U.S. population and all population
subgroups.  Combined dietary exposure from food and drinking water at
the 99.9th percentile of exposure is 15% of the aPAD for the U.S.
population and 38% of the aPAD for all infants (<1 yr), the most highly
exposed population subgroup. The acute aggregate dietary exposure
results are shown in Tables 3 and 4.

Table 3.  Results of Coumaphos Acute Dietary Exposure Analysis (Food &
Drinking Water) Using DEEM FCID 



Population Subgroup	aPAD (mg/kg/day)	95th Percentile	99th Percentile
99.9th Percentile



Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% aPAD	Exposure
(mg/kg/day)	% aPAD

General U.S. Population	0.0025	0.000107	4.3	0.000192	7.7	0.000370	15

All Infants (< 1 year old)	0.0025	0.000367	15	0.000524	21	0.000945	38

Children 1-2 years old	0.0025	0.000173	6.9	0.000278	11	0.000399	16

Children 3-5 years old	0.0025	0.000157	6.3	0.000239	9.6	0.000383	15

Children 6-12 years old	0.0025	0.000111	4.4	0.000173	6.9	0.000239	9.6

Youth 13-19 years old	0.0025	0.000089	3.6	0.000142	5.7	0.000252	10

Adults 20-49 years old	0.0025	0.000097	3.9	0.000158	6.3	0.000276	11

Adults 50+ years old	0.0025	0.000087	3.5	0.000124	4.9	0.000199	8.0

Females 13-49 years old 	0.0025	0.000097	3.9	0.000149	6.0	0.000263	11



Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The chronic aggregate dietary exposure estimates are below HED’s level
of concern (< 100% of the cPAD) for the U.S. population and all
population subgroups. Combined dietary exposure from food and drinking
water is 6% of cPAD for the U.S. population and 13% of the cPAD for all
infants (<1 yr), the most highly exposed population subgroup. The
chronic aggregate dietary exposure results are shown in Table 4.

Table 4.  Summary of Dietary Exposure and Risk Estimates for Coumaphos

Population Subgroup	Acute Dietary

(99.9th Percentile)	Chronic Dietary	Cancer

	Dietary Exposure (mg/kg/day)	% aPAD	Dietary Exposure

(mg/kg/day)	% cPAD	Dietary Exposure

(mg/kg/day)	Risk

General U.S. Population	0.000370	15	0.000015	5.9	N/A	N/A

All Infants (< 1 year old)	0.000945	38	0.000032	13



Children 1-2 years old	0.000399	16	0.000027	11



Children 3-5 years old	0.000383	15	0.000025	10



Children 6-12 years old	0.000239	9.6	0.000018	7.1



Youth 13-19 years old	0.000252	10	0.000012	5.0



Adults 20-49 years old	0.000276	11	0.000013	5.3



Adults 50+ years old	0.000199	8.0	0.000013	5.1



Females 13-49 years old	0.000263	11	0.000012	5.0





VII.	Characterization of Inputs/Outputs

In the course of conducting a refined dietary exposure analysis,
decisions are made regarding the following:  the residue data used in
the analysis (e.g., field trials, monitoring data, etc.), refinements
incorporated in the analysis (such as percent crop treated and
processing factors).

Coumaphos is an organophosphate insecticide/aracicide currently used for
the control of mites and insects on livestock. The assessment for food
incorporates refined anticipated residue estimates for livestock
commodities that were derived from PDP monitoring (coumaphos and
coumaphos oxygen analog). Refinements to percent livestock treated
information were not necessary because risk estimates assuming 100% crop
treated were below HED’s level of concern.

Total coumaphos (coumaphos + coumaphoxon) acute and chronic estimated
environmental concentrations in drinking water were derived from surface
water sources. HED believes the environmental concentrations (EECs) are
still conservative estimates because most of the coumaphos spent
solution resulting from the dip use on livestock is collected and
transported to concrete-lined evaporation pits, thereby negating any
potential for groundwater contamination.

VIII.	Conclusions

Acute and chronic aggregate dietary (food and drinking water) exposure
and risk assessments were conducted using the Dietary Exposure
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.  These
dietary exposure and risk assessments for coumaphos include the
following: (1) Section 3 requests for coumaphos in honey; (2) new acute
toxicological endpoint; (3) and the latest monitoring data for beef and
milk.

The partially refined acute and chronic aggregate dietary exposure
estimates for coumaphos are below HED’s level of concern for the
general U.S. population and all population subgroups.  

IX.		List of Attachments

Attachment 1: DEEM Acute (Food + Drinking Water) Input File

Attachment 2: DEEM Acute (Food + Drinking Water) Results File

Attachment 3: DEEM Chronic (Food + Drinking Water) Input File

Attachment 4: DEEM Chronic (Food + Drinking Water) Results Filecc:
S.Piper, CEB 

RDI: DE SAC Reviewer: T. Goodlow & S. Stanton 1/9/2007; D.Miller
1/22//2007

7509P: CEB PY-Rm 10244: 308-2717: Coumaphos

Attachment 1: DEEM Acute (Food + Drinking Water) Input File

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for COUMAPHOS

Residue file name: C:\Documents and
Settings\spiper\SPIPER\coumaphos\coumaphos_acute2006.R98

Analysis Date 01-03-2007             Residue file dated:
01-03-2007/11:03:26/8

Reference dose: aRfD = 0.0025 mg/kg bw/day NOEL = 0.25 mg/kg bw/day

Comment: new use honey; new pdp data for beef and milk

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

RDL indices and parameters for Monte Carlo Analysis:

Index Dist Parameter #1           Param #2    Param #3    Comment

  #   Code 

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

  1    6   C:\Documents and Settings\spiper\SPIPER\coumaphos\honey.rdf

  EPA    Crop Food Name                         Def Res     Adj.Factors 
RDL  Comment

  Code    Grp                                    (ppm)       #1     #2  
Pntr

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

21000440 M    Beef, meat                         0.003750   1.000  1.000
     

21000441 M    Beef, meat-babyfood                0.003750   1.000  1.000
     

21000450 M    Beef, meat, dried                  0.003750   1.920  1.000
     

21000460 M    Beef, meat byproducts              0.003750   1.000  1.000
     

21000461 M    Beef, meat byproducts-babyfood     0.003750   1.000  1.000
     

21000470 M    Beef, fat                          0.003750   1.000  1.000
     

21000471 M    Beef,fat-babyfood                  0.003750   1.000  1.000
     

21000480 M    Beef, kidney                       0.003750   1.000  1.000
     

21000490 M    Beef, liver                        0.003750   1.000  1.000
     

21000491 M    Beef, liver-babyfood               0.003750   1.000  1.000
     

23001690 M    Goat, meat                         0.003750   1.000  1.000
     

23001700 M    Goat, meat byproducts              0.003750   1.000  1.000
     

23001710 M    Goat, fat                          0.003750   1.000  1.000
     

23001720 M    Goat, kidney                       0.003750   1.000  1.000
     

23001730 M    Goat, liver                        0.003750   1.000  1.000
     

95001860 O    Honey                              0.074000   0.500  1.000
  1  

95001861 O    Honey-babyfood                     0.074000   0.500  1.000
  1  

24001890 M    Horse, meat                        0.003750   1.000  1.000
     

28002210 M    Meat, game                         0.003750   1.000  1.000
     

27002220 D    Milk, fat                          0.000130   1.000  1.000
     

27002221 D    Milk, fat - baby food/infant for   0.000130   1.000  1.000
     

27012230 D    Milk, nonfat solids                0.000130   1.000  1.000
     

27012231 D    Milk, nonfat solids-baby food/in   0.000130   1.000  1.000
     

27022240 D    Milk, water                        0.000130   1.000  1.000
     

27022241 D    Milk, water-babyfood/infant form   0.000130   1.000  1.000
     

27032251 D    Milk, sugar (lactose)-baby food/   0.000130   1.000  1.000
     

25002900 M    Pork, meat                         0.003750   1.000  1.000
     

25002901 M    Pork, meat-babyfood                0.003750   1.000  1.000
     

25002910 M    Pork, skin                         0.003750   1.000  1.000
     

25002920 M    Pork, meat byproducts              0.003750   1.000  1.000
     

25002921 M    Pork, meat byproducts-babyfood     0.003750   1.000  1.000
     

25002930 M    Pork, fat                          0.003750   1.000  1.000
     

25002931 M    Pork, fat-babyfood                 0.003750   1.000  1.000
     

25002940 M    Pork, kidney                       0.003750   1.000  1.000
     

25002950 M    Pork, liver                        0.003750   1.000  1.000
     

29003120 M    Rabbit, meat                       0.003750   1.000  1.000
     

26003390 M    Sheep, meat                        0.003750   1.000  1.000
     

26003391 M    Sheep, meat-babyfood               0.003750   1.000  1.000
     

26003400 M    Sheep, meat byproducts             0.003750   1.000  1.000
     

26003410 M    Sheep, fat                         0.003750   1.000  1.000
     

26003411 M    Sheep, fat-babyfood                0.003750   1.000  1.000
     

26003420 M    Sheep, kidney                      0.003750   1.000  1.000
     

26003430 M    Sheep, liver                       0.003750   1.000  1.000
     

86010000 O    Water, direct, all sources         0.001860   1.000  1.000
     

86020000 O    Water, indirect, all sources       0.001860   1.000  1.000
     

Attachment 2: DEEM Acute (Food + Drinking Water) Results File

U.S. Environmental Protection Agency                                 
Ver. 2.02

DEEM-FCID ACUTE Analysis for COUMAPHOS                          
(1994-98 data)

Residue file: coumaphos_acute2006.R98                 Adjustment factor
#2 used.

Analysis Date: 01-03-2007/11:07:57    Residue file dated:
01-03-2007/11:03:26/8

NOEL (Acute) =   0.250000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

MC iterations = 1000      MC list in residue file     MC seed = 10

Run Comment: "new use honey; new pdp data for beef and milk"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

 Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  %
aRfD     MOE  

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

U.S. Population:

  0.000107    4.29    2333    0.000192    7.67    1303    0.000370  
14.80     675  

All infants:

  0.000367   14.68     680    0.000524   20.95     477    0.000945  
37.79     264  

Children 1-2 yrs:

  0.000173    6.92    1445    0.000278   11.13     898    0.000399  
15.95     626  

Children 3-5 yrs:

  0.000157    6.29    1588    0.000239    9.58    1043    0.000383  
15.34     652  

Children 6-12 yrs:

  0.000111    4.43    2259    0.000173    6.92    1445    0.000239   
9.56    1046  

Youth 13-19 yrs:

  0.000089    3.57    2802    0.000142    5.68    1761    0.000252  
10.10     990  

Adults 20-49 yrs:

  0.000097    3.88    2576    0.000158    6.31    1583    0.000276  
11.05     905  

Adults 50+ yrs:

  0.000087    3.47    2880    0.000124    4.94    2024    0.000199   
7.97    1254  

Females 13-49 yrs:

  0.000097    3.86    2587    0.000149    5.96    1676    0.000263  
10.51     951

Attachment 3: DEEM Chronic (Food + Drinking Water) Input File

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for COUMAPHOS                         
1994-98 data

Residue file: C:\Documents and
Settings\spiper\SPIPER\coumaphos\coumaphos_chronic2006.R98

                                                               Adjust.
#2 used

Analysis Date 01-03-2007             Residue file dated:
01-03-2007/11:10:13/8

Reference dose (RfD) = 0.00025 mg/kg bw/day

Comment:new use honey; new pdp data for beef and milk

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

21000440 M    Beef, meat                         0.003750   1.000     
1.000   

21000441 M    Beef, meat-babyfood                0.003750   1.000     
1.000   

21000450 M    Beef, meat, dried                  0.003750   1.920     
1.000   

21000460 M    Beef, meat byproducts              0.003750   1.000     
1.000   

21000461 M    Beef, meat byproducts-babyfood     0.003750   1.000     
1.000   

21000470 M    Beef, fat                          0.003750   1.000     
1.000   

21000471 M    Beef,fat-babyfood                  0.003750   1.000     
1.000   

21000480 M    Beef, kidney                       0.003750   1.000     
1.000   

21000490 M    Beef, liver                        0.003750   1.000     
1.000   

21000491 M    Beef, liver-babyfood               0.003750   1.000     
1.000   

23001690 M    Goat, meat                         0.003750   1.000     
1.000   

23001700 M    Goat, meat byproducts              0.003750   1.000     
1.000   

23001710 M    Goat, fat                          0.003750   1.000     
1.000   

23001720 M    Goat, kidney                       0.003750   1.000     
1.000   

23001730 M    Goat, liver                        0.003750   1.000     
1.000   

95001860 O    Honey                              0.042000   0.500     
1.000   

95001861 O    Honey-babyfood                     0.042000   0.500     
1.000   

24001890 M    Horse, meat                        0.003750   1.000     
1.000   

28002210 M    Meat, game                         0.003750   1.000     
1.000   

27002220 D    Milk, fat                          0.000130   1.000     
1.000   

27002221 D    Milk, fat - baby food/infant for   0.000130   1.000     
1.000   

27012230 D    Milk, nonfat solids                0.000130   1.000     
1.000   

27012231 D    Milk, nonfat solids-baby food/in   0.000130   1.000     
1.000   

27022240 D    Milk, water                        0.000130   1.000     
1.000   

27022241 D    Milk, water-babyfood/infant form   0.000130   1.000     
1.000   

27032251 D    Milk, sugar (lactose)-baby food/   0.000130   1.000     
1.000   

25002900 M    Pork, meat                         0.003750   1.000     
1.000   

25002901 M    Pork, meat-babyfood                0.003750   1.000     
1.000   

25002910 M    Pork, skin                         0.003750   1.000     
1.000   

25002920 M    Pork, meat byproducts              0.003750   1.000     
1.000   

25002921 M    Pork, meat byproducts-babyfood     0.003750   1.000     
1.000   

25002930 M    Pork, fat                          0.003750   1.000     
1.000   

25002931 M    Pork, fat-babyfood                 0.003750   1.000     
1.000   

25002940 M    Pork, kidney                       0.003750   1.000     
1.000   

25002950 M    Pork, liver                        0.003750   1.000     
1.000   

29003120 M    Rabbit, meat                       0.003750   1.000     
1.000   

26003390 M    Sheep, meat                        0.003750   1.000     
1.000   

26003391 M    Sheep, meat-babyfood               0.003750   1.000     
1.000   

26003400 M    Sheep, meat byproducts             0.003750   1.000     
1.000   

26003410 M    Sheep, fat                         0.003750   1.000     
1.000   

26003411 M    Sheep, fat-babyfood                0.003750   1.000     
1.000   

26003420 M    Sheep, kidney                      0.003750   1.000     
1.000   

26003430 M    Sheep, liver                       0.003750   1.000     
1.000   

86010000 O    Water, direct, all sources         0.000410   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.000410   1.000     
1.000   

Attachment 4: DEEM Chronic (Food + Drinking Water) Results File

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and
Settings\spiper\SPIPER\coumaphos\coumaphos_chronic2006.R98

                                                     Adjustment factor
#2 used.

Analysis Date 01-03-2007/11:10:35     Residue file dated:
01-03-2007/11:10:13/8

Reference dose (RfD, Chronic) = .00025 mg/kg bw/day

COMMENT 1: new use honey; new pdp data for beef and milk

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000015                
5.9%

U.S. Population (spring season)             0.000015                
5.9%

U.S. Population (summer season)             0.000016                
6.2%

U.S. Population (autumn season)             0.000015                
5.8%

U.S. Population (winter season)             0.000014                
5.8%

Northeast region                            0.000014                
5.5%

Midwest region                              0.000015                
6.2%

Southern region                             0.000014                
5.7%

Western region                              0.000016                
6.4%

Hispanics                                   0.000017                
6.7%

Non-hispanic whites                         0.000014                
5.7%

Non-hispanic blacks                         0.000015                
6.1%

Non-hisp/non-white/non-black                0.000018                
7.1%

All infants (< 1 year)                      0.000032               
12.9%

Nursing infants                             0.000012                
4.7%

Non-nursing infants                         0.000040               
16.0%

Children 1-6  yrs                           0.000026               
10.2%

Children 7-12 yrs                           0.000017                
6.7%

Females 13-19 (not preg or nursing)         0.000011                
4.4%

Females 20+ (not preg or nursing)           0.000013                
5.1%

Females 13-50 yrs                           0.000013                
5.3%

Females 13+ (preg/not nursing)              0.000014                
5.6%

Females 13+ (nursing)                       0.000017                
6.8%

Males 13-19 yrs                             0.000014                
5.5%

Males 20+ yrs                               0.000014                
5.4%

Seniors 55+                                 0.000013                
5.1%

Children 1-2 yrs                            0.000027               
11.0%

Children 3-5 yrs                            0.000025               
10.1%

Children 6-12 yrs                           0.000018                
7.1%

Youth 13-19 yrs                             0.000012                
5.0%

Adults 20-49 yrs                            0.000013                
5.3%

ho

@

„@

„`ú^„@

	

2

3

7

8

N

g

™

š

›

/

0

8

M

N

z

‘

’

–

—

˜

š

œ

 

¡

²

¹

½

Å

Æ

Ð

×

Þ

ð

ò

þ

h]

ž

Ÿ

 

¡

³

´

@

h

h

h

h

h

h

$

h

h

h

h

$

h

h

h

h

h

h

h

hÛT

hÅ0

hÅ0

 h

  h

'

h

&

&

&

&

&

&

h

h

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

h

&

&

&

&

&

&

&

&

@

@

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

&

@

&

@

&

@

@

&

@

&

@

&

@

hÅ0

&

@

&

@

&

@

&

@

&

@

Adults 50+ yrs                              0.000013                
5.1%

Females 13-49 yrs                           0.000012                
5.0%

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

Coumaphos	Dietary Exposure and Risk Assessment	DP Number:	D335163

PC Code:  036501

________________________________________________________________________
___________________	

 PAGE   

Page   PAGE  2  of   NUMPAGES  16 

DRAFT – Confidential, Internal, and Deliberative Material

[Chemical Name]	Dietary Exposure and Risk Assessment	DP Number:
[xxxxxxx]

PC Code:  [xxxxxx]		

Coumaphos	Dietary Exposure and Risk Assessment	DP Number: D335163	

PC Code:  036501	

________________________________________________________________________
______________	

Coumaphos	Dietary Exposure and Risk Assessment	DP Number: D335163	

PC Code:  036501		

________________________________________________________________________
______________

Coumaphos	Dietary Exposure and Risk Assessment	DP Number: D335163

PC Code:  [036501		

________________________________________________________________________
______________

 

