Document ID: EPA-HQ-OPP-2008-0362-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-04-01T04:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	2- DEC-2008  

SUBJECT:	Quinoxyfen: Chronic Aggregate Dietary (Food and Drinking Water)
Exposure and Risk Assessment for the Proposed Section 3 Registration on
Proposed New Uses of Quinoxyfen on Stone Fruits crop group 12 (excluding
cherry), Artichoke, Winter Squash, Pumpkin and Edible Gourds
(PP#8E7325). 

PC Code:  055459	DP Barcode:   354561

Decision No.:   390599	Registration No.:   62719-375

Petition No.:  8E7325 	Regulatory Action:  Section 3

Risk Assessment Type: NA	Case No.:  NA

TXR No.:   NA	CAS No.:   124495-18-7

MRID No.:   NA	40 CFR:    §180.588

REVIEWER:	Wesley C. Carr, Jr., Associate Toxicologist

Medical Toxicology Branch

California Department of Pesticide Regulation

THROUGH:	Joyce Gee, Ph.D., Senior Toxicologist

Medical Toxicology Branch

		California Department of Pesticide Regulation

And

		William Cutchin, Acting Senior Branch Scientist

Debra Rate, Ph.D., Biologist

ARIA Team

Risk Integration Minor Use, Inerts, Emergency Response Branch (RIMUERB)

Registration Division (RD; 7505P)

TO:		John Redden, Team Leader

ARIA Team

RIMUERB/RD (7505P)

and

William T. Drew, Chemist

ARIA Team

RIMUERB/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a dietary
(food + drinking water) exposure analysis for the fungicide quinoxyfen. 
In this analysis, the chronic dietary exposure and risk estimates
resulting from food and water intake were determined for the general
U.S. population and various population subgroups.

A chronic dietary risk assessment was 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. 
This analysis was performed to support an Interregional Research Project
No. 4 (IR-4) petition (PP# 8E7325), and establish Section 3 tolerances
for residues of the fungicide, quinoxyfen, on stone fruits crop group 12
(excluding cherry), artichoke, winter squash, pumpkin and edible gourds.
 

No toxic effects attributable to a single (i.e., acute) exposure to
quinoxyfen have been identified; therefore, an acute Reference Dose
(aRfD) has not been established for quinoxyfen and an acute dietary
exposure assessment has not been conducted.  Also, since there is no
evidence that quinoxyfen is carcinogenic to humans, a dietary cancer
assessment is not required.   

Chronic Dietary Exposure Results and Characterization

The unrefined chronic assessment assumed that quinoxyfen residues are
present in all commodities at tolerance levels and that 100% of all
crops are treated.  DEEM™ Version 7.81 default processing factors were
used to estimate residues in dried fruit (apricot, peach, prune and
raisin) and fruit juices (cherry, grape and prune).  Drinking water was
incorporated directly into the dietary assessment using the estimated
drinking water concentration (EDWC) generated by the FIRST surface water
and SCI-GROW ground water models.

The resulting chronic dietary exposure estimates for food and water
combined are well below ARIA’s level of concern (i.e., <100% of the
chronic population-adjusted dose (cPAD) of 0.2 mg/kg bw/day) for the
overall U.S. population and all population subgroups.  Using the
DEEM-FCID software, dietary exposure is estimated at 0.002566 mg/kg/day
for the general U.S. population (1% of the cPAD) and 0.004169 mg/kg/day
(2% of the cPAD) for children 1 to 2 years old, the population subgroup
with the highest estimated chronic dietary exposure to quinoxyfen.  The
chronic dietary risk assessment shows that for all included commodities
plus drinking water, the chronic dietary risk estimates are below
ARIA’s level of concern (i.e. <100% cPAD).

Cancer

HED classified quinoxyfen as not likely to be carcinogenic to humans,
based on the lack of evidence of carcinogenicity in rats and mice;
therefore, a cancer dietary assessment was not performed.

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 PAD.  The PAD is equivalent to point of
departure (POD, NOAEL, LOAL, e.g.) divided by the required uncertainty
or safety factors.

For chronic exposures, HED is concerned when estimated dietary risk
exceeds 100% of the cPAD.  References which discuss the chronic risk
assessment in more detail are available on the EPA/pesticides web site: 
“Available Information on Assessing Exposure from Pesticides, A
User’s Guide,” 6/21/2000, 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 (8/20/99).

The most recent dietary risk assessment for quinoxyfen was conducted by
the Registration Division’s ARIA team in April, 2006.  The assessment
was done by Susan L. Stanton (04/25/2006, DP Num: 328363) to support
quinoxyfen use on peppers, melons (subgroup 9A), strawberry and lettuce
(head and leaf).

II.	Residue Information

Residues of Concern:  Based on the previously submitted cucumber, grape,
sugar beet and tomato metabolism studies, the nature of the residue in
plants is adequately understood. The residue of concern for tolerance
and risk assessment purposes is quinoxyfen, per se.

                                

Tolerances:  Permanent tolerances have been established under 40 CFR
§180.588(a) for residues of quinoxyfen,
5,7-dichloro-4-(4-fluorophenoxy) quinoline, in or on cherry (sweet and
tart) at 0.30 ppm, dried hop cones at 3.0 ppm, grape at 0.60 ppm,
lettuce (head) at 7.0 ppm, lettuce (leaf) at 19.0 ppm, melon (subgroup
9A) at 0.08 ppm, pepper (bell) at 0.35 ppm, pepper (non-bell) at 1.7 ppm
and strawberry at 0.90 ppm.  There are currently no active time-limited
tolerances, FIFRA §18 emergency exemptions, for residues of quinoxyfen.
 The time-limited tolerances for melons (subgroup 9A), pumpkin and
winter squash expired on 12/31/2007.

IR-4 has proposed new tolerances for residues of quinoxyfen in or on the
following commodities: artichoke; winter squash (includes pumpkin and
edible gourds); and stone fruits (crop group 12, peach and plum).  The
California Department of Pesticide Regulation and ARIA have reviewed
residue data submitted (Table 1) to support these tolerances and
concluded that the following tolerances are appropriate [Jonathan
Sullivan and Michael Papathakis; August, 2008; DP Num: 354561].

DEEM™ Version 7.81 default processing factors were used to estimate
residues in dried fruit (apricot, peach, prune and raisin) and fruit
juices (cherry, grape and prune).

Table 1.  Summary of Recommended Tolerances for Quinoxyfen 

Crop Commodity	

Recommended Tolerance (ppm)

Artichoke	1.4

Winter Squash	0.2

Stone Fruit, Group 12	0.7

The recommended permanent tolerance for melons of 0.08 ppm was used
instead of the higher, time-limited tolerance of 0.3 ppm, since ARIA is
recommending that the expired time-limited tolerance be revoked
concurrent with the establishment of the permanent tolerance for melons.
  

The proposed use of quinoxyfen on eggplant was also not considered in
this assessment, since additional data are required and ARIA is not
recommending that a tolerance be established at this time.  

 Drinking Water Data

The drinking water residues used in the quinoxyfen dietary risk
assessment were provided by EFED in the following memorandum: “Tier 1
Drinking Water Exposure Assessment in Support of New Uses of Quinoxyfen
on Stone Fruits (Excluding Cherry), Artichokes, Winter Squash, Pumpkin
and Edible Gourds” (DP Num: 351023; Amy McKinnon; 10/20/2008) and
incorporated directly into the dietary assessment.  Additional
information was also referenced from an earlier EFED memorandum: 
“EFED Drinking Water Assessment for the IR-4 Tolerance Petition for
Use of Quinoxyfen on Lettuce, Strawberries, Melons, Peppers (Bell and
Non-bell), and Eggplants” (DP Num: 314492; Cheryl Sutton; 03/23/2006).
 Water residues were included in the DEEM-FCID file into the food
categories “water, direct, all sources” and “water, indirect, all
sources.” 

Estimates reflect drinking water exposure to residues of concern for
quinoxyfen, which include the parent compound and the degradate of
concern, 3-OH quinoxyfen.  The first drinking water assessment titled
”EFED Risk Assessment for the Section 3 Registration of Quinoxyfen“
(DP Nums: 278515, 285770, 286376) was completed in March 2006.  Uses
included in the assessment were grapes, hops and cherries.  EDWCs for
use in the human health risk assessment were determined using a maximum
annual application rate for cherries of 0.55 lb a.i./A.  Because the
maximum application rates for the proposed uses on lettuce,
strawberries, melons and peppers did not exceed the application rate for
cherries, the EDWCs previously generated in the August 2003 EFED memo
were considered applicable and used in the April 2006 quinoxyfen dietary
exposure assessment. 

However, the drinking water EDWCs for quinoxyfen were reexamined due to
several proposed new 2008 uses.  The “Tier 1 Drinking Water Exposure
Assessment in Support of New Uses of Quinoxyfen on Stone Fruits
(Excluding Cherry), Artichokes, Winter Squash, Pumpkin and Edible Gourds
(DP Num: 351023)” memo was completed October 20, 2008.  Uses included
in the recent assessment were in addition to the previous maximum
application rate for cherries listed in the March 2006 EFED memo.  In
the current assessment, EDWCs for use in the human health risk
assessment were determined using both the maximum annual aerial
application of 0.52 lb a.i./A (0.13 lb a.i./A x4 apps/yr) for the
proposed 2008 new uses and the maximum orchard air blast annual rate of
0.57 lb a.i./A (0.114 lb a.i./A x5 apps/yr) for cherries (Table 2).  The
2 screening programs used in the 2008 EFED quinoxyfen evaluation for
drinking water are the Tier I FIRST aquatic model (FQPA Index Reservoir
Screening Tool, v1.1.1) and the SCI-GROW ground water model (Screening
Concentration in Ground Water, v2.3).  Since the maximum application
rates for the proposed uses on stone fruits group 12, artichoke, winter
squash, pumpkin and edible gourds do not exceed the maximum annual
application rate for cherries, both the cherry EDWCs previously
generated from the August 2003 EFED memo and the proposed 2008 new uses
were modeled and the results were included in the October 2008 EFED
memo.    

Table 2.  Quinoxyfen drinking water assessment EDWCs based on stone
fruit (excluding cherries), artichoke, winter squash, pumpkin and edible
gourds uses.

Surface water drinking water sources1	acute: 9.3 ug/L (ppb)

1-in-10-years (chronic): 0.66 ug/L (ppb) 30-year average: 5.95 ug/L
(ppb)

Groundwater drinking water sources1	0.0031 ug/L (ppb) or 3.1 ng/L (parts
per trillion)

1EDWC values were generated using the FIRST and SCI-GROW models. 
Cherries used an orchard airblast  application scenario.  This
represents the highest annual application rate among the registered and
proposed new uses.  The cherry results were: surface water, 9.9 ppb
(acute) and 0.62 ppb (chronic); the groundwater result was 0.0034 ug/L
(ppb). For the proposed new uses, an aerial application scenario was
used.  The new application results were: surface water, 93 ppb (acute)
and 0.66 ppb (chronic); the groundwater result was 0.0031 ug/L (ppb).  

The highest chronic quinoxyfen concentration was estimated for surface
water using the FIRST model.  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/ .  The chronic (1 in 10 year
annual mean) value of 0.66 ppb was incorporated directly as a point
estimate in the DEEM analysis to assess exposure to quinoxyfen from
drinking water.

IV.	DEEM-FCID™ Program and Consumption Information

A quinoxyfen chronic dietary exposure assessment was 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 assessments, 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

Quinoxyfen was presented to the HED Hazard Identification Assessment and
Review Committee (HIARC) on 12/10/02 (Memo, D. Nixon, 1/28/03; TXR No.
0051474).  Based on the HIARC conclusions and the quinoxyfen risk
assessment team’s evaluation of the hazard and exposure data, the team
recommended that the FQPA Safety Factor be reduced to 1x.  A summary of
the 

toxicological doses and endpoints selected for dietary exposure
assessment is provided in Table 3.

Table 3  Summary of Toxicological Doses and Endpoints for Quinoxyfen for
Use in Dietary Exposure Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD,
Level of Concern 	Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children)	There
were no appropriate toxicological effects attributable to a single
exposure (dose) observed in available oral toxicity studies.

No endpoint attributable to a single exposure for risk assessment was
identified for the general population or females of reproductive age.

Acute Dietary

(Females 13-49 years of age)	There were no appropriate toxicological
effects attributable to a single exposure (dose) observed in available
oral toxicity studies.

No endpoint attributable to a single exposure for risk assessment was
identified for the general population or females of reproductive age.

Chronic Dietary (All Populations)	NOAEL= 20 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x

	Chronic RfD = 0.2

mg/kg/day

cPAD = 0.2 mg/kg/day	Combined chronic toxicity/carcinogenicity - rat

LOAEL = 80 mg/kg/day based on increases in severity of chronic
progressive glomerulonephropathy in the males and minimal decreases in
body weight and body weight gain in both sexes.

Cancer (oral, dermal, inhalation)   	Classification: “Not likely to be
Carcinogenic to Humans” based on the lack of evidence of
carcinogenicity in rats and mice.

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 (intraspecies).  UFH =
potential variation in sensitivity among members of the human population
(interspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use
of a short-term study for long-term risk assessment.  UFDB = to account
for the absence of key data (i.e., lack of a critical study).  FQPA SF =
FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c =
chronic).  RfD = reference dose.  MOE = margin of exposure.  LOC = level
of concern.  N/A = not applicable.

VI.	Results/Discussion 

For chronic assessments, ARIA is concerned when dietary risk exceeds
100% of the cPAD.  The DEEM-FCID™ analyses estimate the dietary
exposure of the U.S. population and various population subgroups.  The
summary results reported in Table 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.  

Quinoxyfen chronic dietary (food + drinking water) exposure estimates
using the DEEM-FCID™ software are well below ARIA’s level of concern
for the U.S. population and each of the population subgroups.  Dietary
exposure was estimated at 0.002566 mg/kg/day for the U.S. population (1%
of the cPAD) and 0.004169 mg/kg/day (2% of the cPAD) for the most highly
exposed population subgroup (children, 1-2 years old).  

Table 4.  Summary of Chronic Dietary Exposure and Risk for Quinoxyfen

Population Subgroup	Acute Dietary

(95th Percentile)	Chronic Dietary*

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

(mg/kg/day)	% cPAD*

General U.S. Population	Not calculated: No acute dietary exposure
endpoint identified	0.002566	1

All Infants (< 1 year old)

0.001685	< 1

Children 1-2 years old

0.004169	2

Children 3-5 years old

0.003583	2

Children 6-12 years old

0.002566	1

Youth 13-19 years old

0.002135	1

Adults 20-49 years old

0.002569	1

Adults 50+ years old

0.002394	1

Females 13-49 years old

0.002668	1

*The population subgroup with the highest estimated chronic dietary
(food + drinking water) exposure and risk is indicated by bold text. 
The % cPAD is reported to 1 significant figure.

VII.	Characterization of Inputs/Outputs

These chronic dietary exposure and risk estimates are conservative since
they assume that 100% of crops are treated with quinoxyfen and that
residues are present at tolerance levels.  In addition, drinking water
exposure estimates were based on screening level estimates generated by
the FIRST surface water and SCI-GROW ground water models.  Dietary
exposure estimates could be refined through the use of anticipated
residues and percent crop treated data, as well as refined estimated
drinking water concentrations.  However, since estimated exposures and
risks using conservative assumptions are well below ARIA’s level of
concern, such refinement is not warranted.

VIII.	Conclusions

 using DEEM-FCID™ indicates that chronic dietary (food + drinking
water) exposure to quinoxyfen is well below ARIA’s level of concern
for this pesticide.  Estimated chronic dietary exposures are less than
or equal to 2% of the cPAD for the general U.S. population and all
population subgroups.

IX.		List of Attachments

Attachment 1:  Chronic Food plus Water Residue Input File 

Attachment 2:  Chronic Results File

**    SEQ CHAPTER \h \r 1 This assessment was developed as part of a
cooperative work-share program between the California Department of
Pesticide Regulation (CDPR) and the U.S. Environmental Protection Agency
(USEPA).  The toxicity studies/endpoints, No Observable Effects Levels
(NOELs), exposure assumptions and consumption databases used in this
document were selected by the U.S. EPA. 

Attachment 1: Chronic Food plus Water Residue Input File

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: D:\DEEM_FCID\residue files\res\IR4\Quinoxyfen EPA
FY08 DPR work share Chronic with H2O Tier1.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 11-12-2008/10:50:15     Residue file dated:
11-12-2008/10:43:02/8

Reference dose (RfD, Chronic) = .2 mg/kg bw/day

COMMENT 1: Chronic dietary assessment to support new uses on globe
artichoke, winter squash,

& Stone Fruit Crop Group (180.588).

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)      #1       
#2                                                               

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

12000120 12   Apricot                            0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12000121 12   Apricot - babyfood                 0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12000130 12   Apricot, dried                     0.700000   6.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12000140 12   Apricot, juice                     0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12000141 12   Apricot, juice - babyfood          0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

95000160 O    Artichoke, globe                   1.400000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

09010750 9A   Cantaloupe                         0.080000   1.000     
1.000   

09010800 9A   Casaba                             0.080000   1.000     
1.000   

12000900 12   Cherry                             0.300000   1.000     
1.000   

12000901 12   Cherry-babyfood                    0.300000   1.000     
1.000   

12000910 12   Cherry, juice                      0.300000   1.500     
1.000   

12000911 12   Cherry, juice-babyfood             0.300000   1.500     
1.000   

95001750 O    Grape                              0.600000   1.000     
1.000   

95001760 O    Grape, juice                       0.600000   1.200     
1.000   

95001761 O    Grape, juice-babyfood              0.600000   1.200     
1.000   

95001770 O    Grape, leaves                      0.600000   1.000     
1.000   

95001780 O    Grape, raisin                      0.600000   4.300     
1.000   

95001790 O    Grape, wine and sherry             0.600000   1.000     
1.000   

09011870 9A   Honeydew melon                     0.080000   1.000     
1.000   

95001880 O    Hop                                3.000000   1.000     
1.000   

04012040 4A   Lettuce, head                      7.000000   1.000     
1.000  

04012050 4A   Lettuce, leaf                     19.000000   1.000     
1.000  

12002300 12   Nectarine                          0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002600 12   Peach                              0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002601 12   Peach - babyfood                   0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002610 12   Peach, dried                       0.700000   7.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002611 12   Peach, dried - babyfood            0.700000   7.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002620 12   Peach, juice                       0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002621 12   Peach, juice - babyfood            0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

08002700 8    Pepper, bell                       0.350000   1.000     
1.000   

08002701 8    Pepper, bell-babyfood              0.350000   1.000     
1.000   

08002710 8    Pepper, bell, dried                0.350000   1.000     
1.000   

08002711 8    Pepper, bell, dried-babyfood       0.350000   1.000     
1.000   

08002720 8    Pepper, nonbell                    1.700000   1.000     
1.000   

08002721 8    Pepper, nonbell-babyfood           1.700000   1.000     
1.000   

08002730 8    Pepper, nonbell, dried             1.700000   1.000     
1.000   

12002850 12   Plum                               0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002851 12   Plum - babyfood                    0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002860 12   Plum, prune, fresh                 0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002861 12   Plum, prune, fresh - babyfood      0.700000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002870 12   Plum, prune, dried                 0.700000   5.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002871 12   Plum, prune, dried - babyfood      0.700000   5.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002880 12   Plum, prune, juice                 0.700000   1.400     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

12002881 12   Plum, prune, juice - babyfood      0.700000   1.400     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

09023080 9B   Pumpkin                            0.200000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

09023090 9B   Pumpkin, seed                      0.200000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

09023570 9B   Squash, winter                     0.200000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

09023571 9B   Squash, winter-babyfood            0.200000   1.000     
1.000   

  Full comment: 8E7325 Proposed Tolerance (11-30-08)

95003590 O    Strawberry                         0.900000   1.000     
1.000   

95003591 O    Strawberry-babyfood                0.900000   1.000     
1.000   

95003600 O    Strawberry, juice                  0.900000   1.000     
1.000   

95003601 O    Strawberry, juice-babyfood         0.900000   1.000     
1.000   

86010000 O    Water, direct, all sources         0.00066    1.000     
1.000   

  Full comment: EFED Memo of 10/20/2008

86020000 O    Water, indirect, all sources       0.00066    1.000     
1.000   

  Full comment: EFED Memo of 10/20/2008

09013990 9A   Watermelon                         0.080000   1.000     
1.000   

09014000 9A   Watermelon, juice                  0.080000   1.000     
1.000   

 

Attachment 2:  Chronic Results File

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: D:\DEEM_FCID\residue files\res\IR4\Quinoxyfen EPA
FY08 DPR work share Chronic with H2O Tier1.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 11-12-2008/10:50:15     Residue file dated:
11-12-2008/10:43:02/8

Reference dose (RfD, Chronic) = .2 mg/kg bw/day

COMMENT 1: Chronic dietary assessment to support new uses on globe
artichoke, winter squash,

& Stone Fruit Crop Group (180.588).

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.002566                
1.3%

U.S. Population (spring season)             0.002673                
1.3%

U.S. Population (summer season)             0.002658                
1.3%

U.S. Population (autumn season)             0.002423                
1.2%

U.S. Population (winter season)             0.002516                
1.3%

Northeast region                            0.002688                
1.3%

Midwest region                              0.002630                
1.3%

Southern region                             0.002213                
1.1%

Western region                              0.002948                
1.5%

Hispanics                                   0.002426                
1.2%

Non-hispanic whites                         0.002743                
1.4%

Non-hispanic blacks                         0.001644                
0.8%

Non-hisp/non-white/non-black                0.002622                
1.3%

	

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All infants (< 1 year)                      0.001685                
0.8%

Nursing infants                             0.000920                
0.5%

Non-nursing infants                         0.001976                
1.0%

Children 1-6  yrs                           0.003650                
1.8%

Children 7-12 yrs                           0.002520                
1.3%

Females 13-19 (not preg or nursing)         0.002160                
1.1%

Females 20+ (not preg or nursing)           0.002665                
1.3%

Females 13-50 yrs                           0.002648                
1.3%

Females 13+ (preg/not nursing)              0.003049                
1.5%

Females 13+ (nursing)                       0.002792                
1.4%

Males 13-19 yrs                             0.002080                
1.0%

Males 20+ yrs                               0.002327                
1.2%

Seniors 55+                                 0.002339                
1.2%

Children 1-2 yrs                            0.004169                
2.1%

Children 3-5 yrs                            0.003583                
1.8%

Children 6-12 yrs                           0.002566                
1.3%

Youth 13-19 yrs                             0.002135                
1.1%

Adults 20-49 yrs                            0.002569                
1.3%

Adults 50+ yrs                              0.002394                
1.2%

Quinoxyfen          Dietary Exposure and Risk Assessment         DP
Number: 354561        PC Code:  055459	

________________________________________________________________________
______________	

Page   PAGE  12  of   NUMPAGES  12