

                                       
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                                               
                                        OFFICE OF CHEMICAL SAFETY              
                                                       AND POLLUTION PREVENTION

MEMORANDUM

Date:  		6/6/2012

SUBJECT:	Clopyralid  Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action on Apples, Teff, the Leafy Brassica Greens Subgroup (5-B), and the Rapeseed Subgroup (20-A) 


PC Codes:  117403 (acid)
           117401 (alkanolamine salts)
DP Barcode:  D399390
Decision No.:  450262
Registration Nos.: 62719-73, 62719-80, 62719-81,   and 62719-84  
Petition No.:  1E7882
Regulatory Action:  Section 3 Registration
Risk Assessment Type:  Dietary
Case No.:  NA
TXR No.:  NA
CAS No.:  1702-17-6 (acid)
         57754-85-5 (monoethanolamine salt)
MRID No.:  NA
40 CFR:  180.431


		              									
FROM:  	Douglas Dotson, Ph.D., Chemist
		Risk Assessment Branch II
		Health Effects Division (7509P)	
		
THROUGH:	Meheret Negussie, Chemist
		Dennis McNeilly, Chemist
		Dietary Exposure Science Advisory Council (DESAC)
		
TO:		Laura Nollen/Barbara Madden, RM Team 5
	RIMUERB
		Registration Division (7505P)		
		


Executive Summary

A chronic dietary (food + drinking water) exposure and risk assessment was conducted for the herbicide clopyralid using the Dietary Exposure Evaluation Model DEEM-FCID(TM), 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.  The analyses were performed to support Section 3 requests for the use of clopyralid on apples, teff, the Brassica leafy greens subgroup (Subgroup 5-B), and the rapeseed subgroup (Subgroup 20-A), except gold of pleasure.

The assessment is highly conservative with regard to protecting human health.  The assessment is based on tolerance-level residues for all commodities and the assumption that 100% of all commodities with tolerances will be treated (i.e., 100% crop treated).  In addition, DEEM (Version 7.81) default processing factors were used for all processed commodities for which they were available.  Modeled estimates of clopyralid residues in drinking water were incorporated into the analyses.  The general U.S. population uses 9.3% of the chronic population-adjusted dose (cPAD).  The population subgroup Children 1-2 years old is estimated to have the highest dietary exposure to clopyralid.  This subgroup uses 25% of the cPAD.  Generally, HED is concerned about dietary risk when the exposure estimate exceeds 100% of the PAD.  The combined dietary risk from exposure to residues of clopyralid in food and drinking water are not of concern for the U.S. population or any of the population groups.

There is no acute dietary endpoint for clopyralid.  As a result, an acute dietary exposure assessment was not conducted for the chemical.  Clopyralid is classified as "not likely to be carcinogenic to humans."  As a result, quantification of cancer risk is not required.

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 the 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.  HED is generally concerned when estimated cancer risk exceeds one in one million. 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:  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 clopyralid was conducted by M. Doherty (D368855, 10/27/2009).

II.  Residue Information

This chronic dietary exposure assessment is based on tolerance-level residues for all commodities.  Tolerances are established for residues of clopyralid in/on a wide variety of plant commodities at levels ranging from 0.5 ppm in/on stone fruits and the Bushberry subgroup (13-07B) to 500 ppm in/on grass forage and hay [40 CFR §180.431(a)].  Tolerances are also established for residues of clopyralid in livestock commodities at levels ranging from 0.1 ppm in eggs to 36 ppm in meat byproducts, except liver, of cattle, goats, horses and sheep.  There currently are no tolerances for inadvertent or indirect residues of clopyralid.  The residue of concern for both tolerance enforcement and risk assessment is the parent compound only.

The Interregional Project No. 4 (IR-4) submitted a petition proposing the use of clopyralid on apples, Brassica leafy greens (Subgroup 5-B), and rapeseed (Subgroup 20-A) except gold of pleasure.  In addition, IR-4 intends to submit a tolerance petition for the use of clopyralid on teff.  The only study that IR-4 submitted in support of the current petition was a combined field trial/processing study for apples.  The recommended tolerance for apple is 0.05 ppm.  For the other commodities, IR-4 is proposing that currently established tolerances be extended to the proposed commodities.  A tolerance of 5.0 ppm is established for mustard greens.  IR-4 is proposing that this tolerance be extended to the Brassica leafy greens subgroup.  A tolerance of 3.0 ppm is established for canola seed.  IR-4 is proposing that this tolerance be extended to rapeseed (Subgroup 20-A) except gold of pleasure.  The following tolerances are established for wheat and barley commodities:  3.0 ppm for grain, 9.0 ppm for straw, 9.0 ppm for forage (wheat only), and 9.0 ppm for hay (barley only).   IR-4 is proposing that these tolerances be extended to teff commodities.  These requested uses do not impact existing tolerances for livestock commodities.  Table 1 provides a summary of the recommended tolerances.


Table 1.  Recommended Tolerances

                                   Commodity
                             Recommended Tolerance
                                     (ppm)
Apple
                                     0.05
Leafy Brassica Greens, Subgroup 5-B
                                      5.0
Rapeseed, Subgroup 20-A, Except Gold of Pleasure
                                      3.0
Teff, Grain
                                      3.0
  

   Percent Crop Treated Information

The assessment is based on the assumption that 100% of all commodities with established or proposed tolerances will be treated.  

   Drinking Water Data

The estimated drinking water concentrations (EDWCs) used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in the following memorandum: "Tier I Drinking Water Assessment for Proposed New Use of Clopyralid on Apple, Leafy Brassica Greens Subgroup 5B, and Rapeseed Subgroup 20A, except Camelina (Gold of Pleasure)" (D391398, W. Shaughnessy, 12/19/2011) 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."  
A modeled estimate of the surface water concentration from the FQPA Index Reservoir Screening Tool (FIRST) Model was used for the assessment (Table 2).  This value is 11.9 ppb.  This estimate is greater than that for groundwater from the Screening Concentration in Ground Water (SCIGROW) Model.  The same value was used in the previous dietary exposure assessment.  The drinking water models and their descriptions are available at the EPA internet site:  http://www.epa.gov/oppefed1/models/water/. 


Table 2.  Maximum Tier 1 Estimated Drinking Water Concentrations
 
                             Drinking Water Source
                              Model Used and Rate
                                  EDWC (ppb)
Groundwater
NAWQA (Oregon)
                                    0.2588
Surface Water (Acute)
FIRST (non-food crop, one application per year @ 0.5 lb ai/A)
                                      45
Surface Water (Chronic)
FIRST (non-food crop, one application per year @ 0.5 lb ai/A)
                                     11.9


V.  DEEM-FCID(TM) Program and Consumption Information

The clopyralid chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID(TM), 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.


VI.  Toxicological Information

The toxicology database for clopyralid is incomplete at this time.  Based on the toxicology data requirements outlined in the recently revised 40 CFR Part 158, there are additional requirements for acute and subchronic neurotoxicity studies in the rat (§870.6200a and b), and an immunotoxicity study (§870.7800).  In addition, a 28-day inhalation toxicity study in the rat (§870.3465) is required.  Nevertheless, HED recommends reduction of the FQPA Safety Factor to 1x.  There was no evidence of increased pre- and/or postnatal qualitative or quantitative susceptibility in the developmental rat or rabbit studies, or the rat 2-generation reproduction study.  In the developmental rat study, no developmental effects were seen in at a dose that caused maternal toxicity.  Although acute and subchronic neurotoxicity studies and an immunotoxicity study have not been submitted and are required under the revised 40 CFR Part 158 guidelines, the available subchronic and chronic studies show no evidence of either neurotoxicity or immunotoxicity at doses up to or exceeding the limit dose.  The endpoints selected for risk assessment are therefore considered adequately protective of pre- and/or postnatal toxicity.  The endpoints selected for use in dietary risk assessment are summarized in Table 3, below.


Table 3.  Toxicological Doses and Endpoints for Clopyralid for Use in Dietary Human Health Risk Assessments

Exposure/
Scenario
Point of Departure
Uncertainty/FQPA Safety Factors
Level of Concern for Risk Assessment
Study and Toxicological Effects
Acute Dietary 
(All populations including infants and children) 
NA
NA
NA
There is no effect attributable to a single dose.  As a result, an acute dietary endpoint was not selected.
Chronic Dietary
(All populations including infants and children)
NOAEL= 
15 mg/kg/day 
UFA= 10x
UFH= 10x
SFFQPA=1
cRfD=
0.15 mg/kg/day

cPAD=
0.15 mg/kg/day
2-Year Combined Chronic Toxicity/Carcinogenicity (oral)  -  rat

LOAEL = 150 mg/kg/day, based on increased epithelial hyperplasia and thickening of the limiting ridge of the stomach in both sexes.
Cancer
Classified as "Not likely to be carcinogenic to humans."  Quantification of cancer risk is not required.
Point of Departure = 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).  FQPA SF = FQPA Safety Factor. c PAD = chronic population adjusted dose.  RfD = reference dose.  N/A = not applicable.

VII.  Results 

As stated above, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID(TM) analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The 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.  Risk estimates are not of concern for the general U.S. population or any of the population subgroups.  The general U.S. population uses 9.3% of the cPAD.  The most highly exposed population subgroup, Children 1-2 years old, uses 25% of the cPAD.

 
 
 Table 4.  Summary of the Combined Dietary (Food + Drinking Water) Exposure and Risk Estimates for Clopyralid
 
 Population Subgroup
                                     Acute
                                    Chronic
                                     Cancer
 
                          Dietary Exposure (mg/kg/day)
                                    % aPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                    % cPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                      Risk
 General U.S. Population
                                      NA
                                       
                                       
                                       
                                       
                                      NA
                                       
                                       
                                       
                                       
0.013895
9.3
                                      N/A
                                      N/A
 All Infants (< 1 year old)
                                       
                                       
0.013726
9.2
 
 
 Children 1-2 years old
                                       
                                       
0.037039
25
 
 
 Children 3-5 years old
                                       
                                       
0.033869
23
 
 
 Children 6-12 years old
                                       
                                       
0.022590
15
 
 
 Youth 13-19 years old
                                       
                                       
0.013383
8.9
 
 
 Adults 20-49 years old
                                       
                                       
0.010847
7.2
 
 
 Adults 50+ years old
                                       
                                       
0.009407
6.3
 
 
 Females 13-49 years old
                                       
                                       
0.010170
6.8
 
 
 The values for the highest exposed population subgroup are bolded.



 VIII.  Characterization of Inputs/Outputs
HED considers the chronic dietary exposure assessment to be very conservative.  It is based on tolerance-level residues for all commodities.  Conservative processing factors (DEEM default) were used for all processed commodities.  In addition, it is assumed that 100% of all crops with registered or proposed will be treated.  The EDWCs were also conservative.  As all risk estimates are not of concern, it is not necessary to make any refinements to the dietary exposure assessment.  
 
 
 IX.  Conclusions
 
The exposure estimates that were generated are very conservative estimates of the actual dietary exposures that might occur.  The aggregate (food + water) dietary risk estimates are below HED's level of concern for all population subgroups.  HED is confident that the dietary exposure assessment does not underestimate risk to the general U.S. population or any population subgroup.
 
 
 List of Attachments
 
 Attachment 1.  Chronic Residue Input File
 Attachment 2.  Results of Chronic Dietary Exposure Analysis

 Attachment 1:  Chronic Residue Input File
 
Chronic NOAEL:  15 mg/kg bw/day
Chronic PAD:  0.15 mg/kg bw/day  

DEEM-FCID Program Version 2.03
Filename: C:\Documents and Settings\ddotson\My Documents\Deemfcid\Clopyralid\
        ClopyralidChronic2.R98

Date created/last modified: 03-02-2012/16:56:18/8

--------------------------------------------------------------------------------
  EPA    Crop                                   Def Res     Adj.Factors   Comment
  Code    Grp  Commodity Name                    (ppm)       #1    #2   
-------- ---- -------------------------------  ----------  ------ ------  -------
01010500 1AB  Beet, garden, roots                4.000000   1.000  1.000  
01010501 1AB  Beet, garden, roots-babyfood       4.000000   1.000  1.000  
01010520 1A   Beet, sugar                        2.000000   1.000  1.000  
01010521 1A   Beet, sugar-babyfood               2.000000   1.000  1.000  
01010530 1A   Beet, sugar, molasses             10.000000   1.000  1.000  
01010531 1A   Beet, sugar, molasses-babyfood    10.000000   1.000  1.000  
01013880 1AB  Turnip, roots                      1.000000   1.000  1.000  
02000510 2    Beet, garden, tops                 3.000000   1.000  1.000  
04013550 4A   Spinach                            5.000000   1.000  1.000  
04013551 4A   Spinach-babyfood                   5.000000   1.000  1.000  
04023670 4B   Swiss chard                        3.000000   1.000  1.000  
05010610 5A   Broccoli                           2.000000   1.000  1.000  
05010611 5A   Broccoli-babyfood                  2.000000   1.000  1.000  
05010620 5A   Broccoli, Chinese                  2.000000   1.000  1.000  
05010640 5A   Brussels sprouts                   2.000000   1.000  1.000  
05010690 5A   Cabbage                            2.000000   1.000  1.000  
05010710 5A   Cabbage, Chinese, napa             2.000000   1.000  1.000  
05010720 5A   Cabbage, Chinese, mustard          2.000000   1.000  1.000  
05010830 5A   Cauliflower                        2.000000   1.000  1.000  
05011960 5A   Kohlrabi                           2.000000   1.000  1.000  
05020630 5B   Broccoli raab                      5.000000   1.000  1.000  1E7882
05020700 5B   Cabbage, Chinese, bok choy         5.000000   1.000  1.000  1E7882
05021170 5B   Collards                           5.000000   1.000  1.000  1E7882
05021940 5B   Kale                               5.000000   1.000  1.000  1E7882
05022290 5B   Mustard greens                     5.000000   1.000  1.000  1E7882
05023180 5B   Rape greens                        5.000000   1.000  1.000  1E7882
05023890 5B   Turnip, greens                     4.000000   1.000  1.000  1E7882
11000070 11   Apple, fruit with peel             0.050000   1.000  1.000  1E7882
11000080 11   Apple, peeled fruit                0.050000   1.000  1.000  1E7882
11000081 11   Apple, peeled fruit-babyfood       0.050000   1.000  1.000  1E7882
11000090 11   Apple, dried                       0.050000   8.000  1.000  1E7882
11000091 11   Apple, dried-babyfood              0.050000   8.000  1.000  1E7882
11000100 11   Apple, juice                       0.050000   1.300  1.000  1E7882
11000101 11   Apple, juice-babyfood              0.050000   1.300  1.000  1E7882
11000110 11   Apple, sauce                       0.050000   1.000  1.000  1E7882
11000111 11   Apple, sauce-babyfood              0.050000   1.000  1.000  1E7882
12000120 12   Apricot                            0.500000   1.000  1.000  
12000121 12   Apricot-babyfood                   0.500000   1.000  1.000  
12000130 12   Apricot, dried                     0.500000   6.000  1.000  
12000140 12   Apricot, juice                     0.500000   1.000  1.000  
12000141 12   Apricot, juice-babyfood            0.500000   1.000  1.000  
12000900 12   Cherry                             0.500000   1.000  1.000  
12000901 12   Cherry-babyfood                    0.500000   1.000  1.000  
12000910 12   Cherry, juice                      0.500000   1.500  1.000  
12000911 12   Cherry, juice-babyfood             0.500000   1.500  1.000  
12002300 12   Nectarine                          0.500000   1.000  1.000  
12002600 12   Peach                              0.500000   1.000  1.000  
12002601 12   Peach-babyfood                     0.500000   1.000  1.000  
12002610 12   Peach, dried                       0.500000   7.000  1.000  
12002611 12   Peach, dried-babyfood              0.500000   7.000  1.000  
12002620 12   Peach, juice                       0.500000   1.000  1.000  
12002621 12   Peach, juice-babyfood              0.500000   1.000  1.000  
12002850 12   Plum                               0.500000   1.000  1.000  
12002851 12   Plum-babyfood                      0.500000   1.000  1.000  
12002860 12   Plum, prune, fresh                 0.500000   1.000  1.000  
12002861 12   Plum, prune, fresh-babyfood        0.500000   1.000  1.000  
12002870 12   Plum, prune, dried                 1.500000   1.000  1.000  
12002871 12   Plum, prune, dried-babyfood        1.500000   1.000  1.000  
12002880 12   Plum, prune, juice                 0.500000   1.400  1.000  
12002881 12   Plum, prune, juice-babyfood        0.500000   1.400  1.000  
13020570 13B  Blueberry                          0.500000   1.000  1.000  
13020571 13B  Blueberry-babyfood                 0.500000   1.000  1.000  
13021360 13B  Currant                            0.500000   1.000  1.000  
13021490 13B  Elderberry                         0.500000   1.000  1.000  
13021740 13B  Gooseberry                         0.500000   1.000  1.000  
13021910 13B  Huckleberry                        0.500000   1.000  1.000  
15000250 15   Barley, pearled barley            12.000000   1.000  1.000  
15000251 15   Barley, pearled barley-babyfood   12.000000   1.000  1.000  
15000260 15   Barley, flour                      3.000000   1.000  1.000  
15000261 15   Barley, flour-babyfood             3.000000   1.000  1.000  
15000270 15   Barley, bran                      12.000000   1.000  1.000  
15001200 15   Corn, field, flour                 1.000000   1.000  1.000  
15001201 15   Corn, field, flour-babyfood        1.000000   1.000  1.000  
15001210 15   Corn, field, meal                  1.000000   1.000  1.000  
15001220 15   Corn, field, bran                  1.000000   1.000  1.000  
15001230 15   Corn, field, starch                1.000000   1.000  1.000  
15001231 15   Corn, field, starch-babyfood       1.000000   1.000  1.000  
15001240 15   Corn, field, syrup                 1.000000   1.500  1.000  
15001241 15   Corn, field, syrup-babyfood        1.000000   1.500  1.000  
15001250 15   Corn, field, oil                   1.000000   1.000  1.000  
15001251 15   Corn, field, oil-babyfood          1.000000   1.000  1.000  
15001260 15   Corn, pop                          1.000000   1.000  1.000  
15001270 15   Corn, sweet                        1.000000   1.000  1.000  
15001271 15   Corn, sweet-babyfood               1.000000   1.000  1.000  
15002310 15   Oat, bran                          3.000000   1.000  1.000  
15002320 15   Oat, flour                         3.000000   1.000  1.000  
15002321 15   Oat, flour-babyfood                3.000000   1.000  1.000  
15002330 15   Oat, groats/rolled oats            3.000000   1.000  1.000  
15002331 15   Oat, groats/rolled oats-babyfood   3.000000   1.000  1.000  
15003810 15   Triticale, flour                   3.000000   1.000  1.000  
15004010 15   Wheat, grain                       3.000000   1.000  1.000  
15004011 15   Wheat, grain-babyfood              3.000000   1.000  1.000  
15004020 15   Wheat, flour                       3.000000   1.000  1.000  
15004021 15   Wheat, flour-babyfood              3.000000   1.000  1.000  
15004030 15   Wheat, germ                       12.000000   1.000  1.000  
15004040 15   Wheat, bran                       12.000000   1.000  1.000  
20001630 20   Flaxseed, oil                      3.000000   1.000  1.000  1E7882
20003190 20   Rapeseed, oil                      3.000000   1.000  1.000  1E7882
20003191 20   Rapeseed, oil-babyfood             3.000000   1.000  1.000  1E7882
21000440 M    Beef, meat                         1.000000   1.000  1.000  
21000441 M    Beef, meat-babyfood                1.000000   1.000  1.000  
21000450 M    Beef, meat, dried                  1.000000   1.920  1.000  
21000460 M    Beef, meat byproducts             36.000000   1.000  1.000  
21000461 M    Beef, meat byproducts-babyfood    36.000000   1.000  1.000  
21000470 M    Beef, fat                          1.000000   1.000  1.000  
21000471 M    Beef,fat-babyfood                  1.000000   1.000  1.000  
21000480 M    Beef, kidney                      36.000000   1.000  1.000  
21000490 M    Beef, liver                        3.000000   1.000  1.000  
21000491 M    Beef, liver-babyfood               3.000000   1.000  1.000  
23001690 M    Goat, meat                         1.000000   1.000  1.000  
23001700 M    Goat, meat byproducts             36.000000   1.000  1.000  
23001710 M    Goat, fat                          1.000000   1.000  1.000  
23001720 M    Goat, kidney                      36.000000   1.000  1.000  
23001730 M    Goat, liver                        3.000000   1.000  1.000  
24001890 M    Horse, meat                        1.000000   1.000  1.000  
25002900 M    Pork, meat                         0.200000   1.000  1.000  
25002901 M    Pork, meat-babyfood                0.200000   1.000  1.000  
25002910 M    Pork, skin                         0.200000   1.000  1.000  
25002920 M    Pork, meat byproducts              0.200000   1.000  1.000  
25002921 M    Pork, meat byproducts-babyfood     0.200000   1.000  1.000  
25002930 M    Pork, fat                          0.200000   1.000  1.000  
25002931 M    Pork, fat-babyfood                 0.200000   1.000  1.000  
25002940 M    Pork, kidney                       0.200000   1.000  1.000  
25002950 M    Pork, liver                        0.200000   1.000  1.000  
26003390 M    Sheep, meat                        1.000000   1.000  1.000  
26003391 M    Sheep, meat-babyfood               1.000000   1.000  1.000  
26003400 M    Sheep, meat byproducts            36.000000   1.000  1.000  
26003410 M    Sheep, fat                         1.000000   1.000  1.000  
26003411 M    Sheep, fat-babyfood                1.000000   1.000  1.000  
26003420 M    Sheep, kidney                     36.000000   1.000  1.000  
26003430 M    Sheep, liver                       3.000000   1.000  1.000  
27002220 D    Milk, fat                          0.200000   1.000  1.000  
27002221 D    Milk, fat - baby food/infant for   0.200000   1.000  1.000  
27012230 D    Milk, nonfat solids                0.200000   1.000  1.000  
27012231 D    Milk, nonfat solids-baby food/in   0.200000   1.000  1.000  
27022240 D    Milk, water                        0.200000   1.000  1.000  
27022241 D    Milk, water-babyfood/infant form   0.200000   1.000  1.000  
27032251 D    Milk, sugar (lactose)-baby food/   0.200000   1.000  1.000  
40000930 P    Chicken, meat                      0.200000   1.000  1.000  
40000931 P    Chicken, meat-babyfood             0.200000   1.000  1.000  
40000940 P    Chicken, liver                     0.200000   1.000  1.000  
40000950 P    Chicken, meat byproducts           0.200000   1.000  1.000  
40000951 P    Chicken, meat byproducts-babyfoo   0.200000   1.000  1.000  
40000960 P    Chicken, fat                       0.200000   1.000  1.000  
40000961 P    Chicken, fat-babyfood              0.200000   1.000  1.000  
40000970 P    Chicken, skin                      0.200000   1.000  1.000  
40000971 P    Chicken, skin-babyfood             0.200000   1.000  1.000  
50003820 P    Turkey, meat                       0.200000   1.000  1.000  
50003821 P    Turkey, meat-babyfood              0.200000   1.000  1.000  
50003830 P    Turkey, liver                      0.200000   1.000  1.000  
50003831 P    Turkey, liver-babyfood             0.200000   1.000  1.000  
50003840 P    Turkey, meat byproducts            0.200000   1.000  1.000  
50003841 P    Turkey, meat byproducts-babyfood   0.200000   1.000  1.000  
50003850 P    Turkey, fat                        0.200000   1.000  1.000  
50003851 P    Turkey, fat-babyfood               0.200000   1.000  1.000  
50003860 P    Turkey, skin                       0.200000   1.000  1.000  
50003861 P    Turkey, skin-babyfood              0.200000   1.000  1.000  
60003010 P    Poultry, other, meat               0.200000   1.000  1.000  
60003020 P    Poultry, other, liver              0.200000   1.000  1.000  
60003030 P    Poultry, other, meat byproducts    0.200000   1.000  1.000  
60003040 P    Poultry, other, fat                0.200000   1.000  1.000  
60003050 P    Poultry, other, skin               0.200000   1.000  1.000  
70001450 P    Egg, whole                         0.100000   1.000  1.000  
70001451 P    Egg, whole-babyfood                0.100000   1.000  1.000  
70001460 P    Egg, white                         0.100000   1.000  1.000  
70001461 P    Egg, white (solids)-babyfood       0.100000   1.000  1.000  
70001470 P    Egg, yolk                          0.100000   1.000  1.000  
70001471 P    Egg, yolk-babyfood                 0.100000   1.000  1.000  
86010000 O    Water, direct, all sources         0.011900   1.000  1.000  
86020000 O    Water, indirect, all sources       0.011900   1.000  1.000  
95000190 O    Asparagus                          1.000000   1.000  1.000  
95001300 O    Cranberry                          4.000000   1.000  1.000  
95001301 O    Cranberry-babyfood                 4.000000   1.000  1.000  
95001310 O    Cranberry, dried                   4.000000   1.000  1.000  
95001320 O    Cranberry, juice                   4.000000   1.100  1.000  
95001321 O    Cranberry, juice-babyfood          4.000000   1.100  1.000  
95001880 O    Hop                                5.000000   1.000  1.000  
95002750 O    Peppermint                         3.000000   1.000  1.000  
95002760 O    Peppermint, oil                    3.000000   1.000  1.000  
95003520 O    Spearmint                          3.000000   1.000  1.000  
95003530 O    Spearmint, oil                     3.000000   1.000  1.000  
95003590 O    Strawberry                         4.000000   1.000  1.000  
95003591 O    Strawberry-babyfood                4.000000   1.000  1.000  
95003600 O    Strawberry, juice                  4.000000   1.000  1.000  
95003601 O    Strawberry, juice-babyfood         4.000000   1.000  1.000

  
Attachment 2:  Results of Chronic Dietary Exposure Analysis

Chronic PAD:  0.15 mg/kg bw/day  

Residue file name: C:\Documents and Settings\ddotson\My Documents\Deemfcid\Clopyralid\
                ClopyralidChronic2.R98

Residue file dated: 03-02-2012/16:56:18/8            Analysis Date 03-02-2012/16:57:23

===============================================================================
                    Total exposure by population subgroup
-------------------------------------------------------------------------------

                                                    Total Exposure
                                         -----------------------------------
          Population                         mg/kg             Percent of   
           Subgroup                       body wt/day             Rfd       
--------------------------------------   -------------       ---------------
U.S. Population (total)                     0.013895                 9.3%

U.S. Population (spring season)             0.014217                 9.5%
U.S. Population (summer season)             0.013855                 9.2%
U.S. Population (autumn season)             0.013748                 9.2%
U.S. Population (winter season)             0.013769                 9.2%
Northeast region                            0.014195                 9.5%
Midwest region                              0.014629                 9.8%
Southern region                             0.013132                 8.8%
Western region                              0.014052                 9.4%
Hispanics                                   0.014065                 9.4%
Non-hispanic whites                         0.013701                 9.1%
Non-hispanic blacks                         0.014851                 9.9%
Non-hisp/non-white/non-black                0.013954                 9.3%

All infants (< 1 year)                      0.013726                 9.2%
Nursing infants                             0.005766                 3.8%
Non-nursing infants                         0.016748                11.2%
Children 1-6  yrs                           0.034090                22.7%
Children 7-12 yrs                           0.021466                14.3%
Females 13-19 (not preg or nursing)         0.011665                 7.8%
Females 20+ (not preg or nursing)           0.009456                 6.3%
Females 13-50 yrs                           0.010835                 7.2%
Females 13+ (preg/not nursing)              0.011582                 7.7%
Females 13+ (nursing)                       0.012518                 8.3%
Males 13-19 yrs                             0.015007                10.0%
Males 20+ yrs                               0.011198                 7.5%
Seniors 55+                                 0.009329                 6.2%

Children 1-2 yrs                            0.037039                24.7%
Children 3-5 yrs                            0.033869                22.6%
Children 6-12 yrs                           0.022590                15.1%
Youth 13-19 yrs                             0.013383                 8.9%
Adults 20-49 yrs                            0.010847                 7.2%
Adults 50+ yrs                              0.009407                 6.3%
Females 13-49 yrs                           0.010170                 6.8%

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

