Document ID: EPA-HQ-OPP-2009-0002-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-09-16T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF           

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM			

July 1, 2009									

SUBJECT:	Acetochlor – Acute and Chronic Dietary and Drinking Water
Exposure and Risk Assessments.  

PC Code:  121601	DP Barcode: 360868

Decision No.:  400596	Registration No.: 524-496 and 524-LOR

Petition No.:  PP#8F7443, PP8E7448	Regulatory Action:  Section 3 

Risk Assessment Type:  Dietary	Case No.:  NA

TXR No.:  NA	CAS No: 34256-82-1

MRID No.:  NA	40 CFR:  180.470

FROM:	Becky Daiss, Biologist

Risk Assessment Branch IV

Health Effects Division (7509P)

THROUGH:	Thurston Morton, Chemist 

Dietary Exposure Science Advisory Council (DESAC), 

Health Effects Division (7509P)

TO:		James Thomkins, Risk Manager

		Herbicide Branch

		Registration Division (7505P)

This document provides an acute and chronic dietary and drinking water
risk analyses of exposures resulting from use of acetochlor on food
crops for weed control.  This assessment supports a Section 3 requests
for use of acetochlor on cotton and soybean.  Executive Summary

Acute and chronic dietary risk assessments were conducted for acetochlor
using the Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03),
which uses food consumption data from the USDA’s Continuing Surveys of
Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The
analyses were performed to support Section 3 requests for use of
acetochlor on cotton and soybean.

   

Acute Dietary Exposure Analysis Results and Characterization

A screening level acute dietary exposure analysis was performed for the
general population and all population subgroups.  The acute dietary
analysis assumed tolerance level residues and 100% crop treated for all
commodities.  Experimentally derived processing factors were used for
cereal grain commodities.  Default processing factors were used for all
other commodities.  The acute analysis incorporated the 1 in 10 year
peak surface drinking water estimate from application of acetochlor to
sorghum.    SEQ CHAPTER \h \r 1 The resulting 95th percentile acute
exposure estimate for infants < 1 year old (the most highly exposed
subgroup) is not of concern to HED (11% acute population adjusted dose
(aPAD)).  The exposure estimate for the U.S. population was 3% of the
aPAD. . 

Chronic Dietary Exposure Analysis Results and Characterization

A partially refined chronic dietary exposure analysis was performed for
the general U.S. population and various population subgroups. 
Anticipated residues from field trial data and 100% crop treated
assumptions for all commodities.    Experimentally derived processing
factors were used for cereal grain commodities.  Default processing
factors were used for all other commodities.  The chronic analysis
incorporated the 10 year average surface drinking water estimate from
application of acetochlor to sorghum.  Chronic dietary risk estimates
are not of concern for general population or other population subgroups.
 The subgroup with the highest risk estimate was infants < 1 year old
with an exposure estimate of 6% of the cPAD.  The general U.S.
population estimated exposure was 2% of the cPAD. 

Cancer Dietary Exposure Analysis Results and Characterization

HED has determined that linear quantification of carcinogenic potential
is not required for the mouse tumors.  There are acceptable mode of
action data for the rat tumors (nasal olfactory epithelial tumors and
thyroid follicular cell tumors) which are adequate to support a
non-linear MOE approach for assessment of cancer risk.  The rat nasal
tumors, with a POD of 10 mg/kg/day are the most sensitive effect for
cancer risk.  Quantification of cancer risk is not required since the
chronic RfD of 0.02 mg/kg/day will be protective of both non-cancer and
cancer effects, including rat nasal tumors, thyroid tumors, and mouse
tumors.  As noted above, chronic dietary risks do not exceed HED’s
level of concern.

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 Reference Dose (RfD) divided by the
FQPA Safety Factor.

For acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 100% of the PAD.  References that 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,” 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).

II.	Residue Information

Residues of Concern 

The residues of concern in plants includes parent and any metabolites
containing the ethyl methyl aniline (EMA) or hydroxyethyl methyl aniline
(HEMA) moiety, expressed in acetochlor equivalents.  The residues of
concern in rotational crops are acetochlor, its EMA and HEMA type
metabolites as well as its hydroxymethyl ethyl aniline (HMEA) type
metabolites.  HED has concluded that the tolerance expression for
rotational crops should include only acetochlor and its EMA and HEMA
type metabolites; however the acetochlor HMEA type metabolites should be
included in the risk assessment (M. Flood, MARC Memorandum, 9/30/93). 
Table 1 provides a summary of the MARC decisions regarding residues of
concern for acetochlor.  

Table 1:  Summary of MARC Decisions for Acetochlor 

Matrix	Residues of Concern 

	For Risk Assessment 	For Tolerance Expression

Plants	Parent and metabolites containing the EMA

or HEMA or HMEA moiety	Parent and metabolites containing the EMA or HEMA
moiety

Rotational Crops 	Parent and metabolites containing the EMA

or HEMA or HMEA moiety	Parent and metabolites containing the EMA or HEMA
moiety

Drinking Water	Parent Only	NA

Established/Recommended Tolerances

Tolerances for acetochlor are currently established under 40 CFR
§180.470(a) and (d)  Tolerances for acetochlor are expressed in terms
of acetochlor and its metabolites containing the EMA
(2-ethyl-6-methylaniline) and HEMA (2-(1-hydroxyethyl)-6-methylaniline)
moieties.   Tolerances for field corn, pop corn, sweet corn, and sorghum
commodities range from 0.05 ppm to 3.0 ppm.  Tolerances for rotational
crops, nongrass animal feeds, sugar beet root and tops, cereal grain
commodities, peas and beans, potato, soybean commodities, sunflower
seed, and wheat commodities range from 0.1 ppm to 1.0 ppm.  No
tolerances have been established for livestock commodities.  Recommended
tolerances for the proposed new uses are as follows.  

Cotton, undelinted seed	0.6 ppm

Cotton, gin byproducts	4.0 ppm

Soybean, seed	1.0 ppm

Soybean, meal	1.2 ppm

The submitted field trial data for all rotational commodities did not
sample for the HMEA metabolite.  However, no quantifiable residues of
acetochlor or HEMA were found in any of the cereal grain, sugar beet, or
potato commodities.  Based on the available rotational crop metabolism
studies conducted on lettuce, radish, and wheat, the EMA producing
metabolites were present at the highest concentrations, followed by the
HEMA- and HMEA-type metabolites. Therefore, if acetochlor or HEMA were
non-quantifiable in any samples, it is reasonable to assume that HMEA
would be less than LOQ and use of established tolerances for rotational
crops is appropriate.  

Residues Used in the Acute Analysis

For the acute dietary analysis, tolerance level residues were used for
all crops.  100% crop treated was assumed for all commodities in the
assessment.  Experimentally derived processing factors were applied to
processed cereal grain commodities.  

Residues Used in the Chronic Analysis

For the chronic dietary analysis, tolerance level residues were used for
soybean and cotton commodities.  Average field trial residue values were
used for all other crops.  100% crop treated was assumed for all
commodities in the assessment.  Experimentally derived processing
factors were applied to processed cereal grain commodities.  

Residues used in the acute and chronic dietary analyses are provided in
Table 2.

Table 2.  Data and Residue Estimates Used in Acetochlor Dietary and
Drinking Water Analyses

RAC	Blending Status1	Data

Source	LOD	%CT	PF	Residues (ppm)

Acute (Tol)	Chronic (AR)

Beet, Sugar	B	Tolerance & Field Trial Data 45322103

24 samples	0.04	100	None	0.05	0.02

Cereal grain, except corn, sorghum and rice, group 15 (barley,
buckwheat, millet, oat, rye, triticale, wheat)	B	Tolerance & Field Trial
Data 45322108

17 samples	0.035	100	Flour  0.5X  Groats  0.4X	0.05	0.02

Corn, field and pop, grain	B	Tolerance & Field Trial Data 41592014
42713114; 15 40365601

2 samples	0.03	100	Flour, meal, starch and oil 0.6X	0.05	0.02

Corn, sweet, K-CWHR	NB/PB	Tolerance & Field Trial Data 44107105

32 samples	0.04	100	None	0.05	0.02

Pea and bean, dried shelled, except soybean, subgroup 6C	B	Tolerance &
Field Trial Data 45322104 45322105

28 samples	0.04	100	None	0.05	0.02

Potato	NB/PB/B	Tolerance & Field Trial Data 45322107

10 samples	0.04	100	Dried 6.5X	0.05	0.02

Soybean, seed	B	Tolerance	N/A	100	Flour 0.75X Oil 0.2X	1.0	Tol 1.0

Sorghum	B	Tolerance	N/A	100	None	0.05	Tol 0.05

Sunflower seed	PB/B	Tolerance & Field Trial Data 45322106

16 samples	0.04	100	None	0.05	0.02

Water	N/A	Modeling Data	N/A	N/A	N/A	0.01821	0.00143

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

III.	Water Data

Drinking water residues were incorporated directly into the acute and
chronic dietary analyses (“water, direct, all sources” and “water,
indirect, all sources”) and were provided by the Environmental Fate
and Effects Division (EFED) (D359995, M. Barrett, 6/x/2009).  EFED
generated the surface water using the PRZM (Pesticide Root Zone Model;
version 3.12 Beta compiled May 24, 2001) and EXAMS (Exposure Analysis
Modeling System; version 2.98.04, compiled November 12, 2002).   SEQ
CHAPTER \h \r 1  The drinking water assessment provides modeling-based
Tier 2 drinking water exposure estimates for the proposed uses of
acetochlor on soybeans and cotton along with the existing uses on corn
(including sweet corn, popcorn, field corn, and corn for silage) and
sorghum.  Estimates for the use of acetochlor on sorghum were used in
the screening level dietary assessment because this use produces the
EDWCs of the registered uses.  Surface water EDWCs for acetochlor are
provided in Table 3.  Using Tier 2 estimation methods, parent acetochlor
concentrations in drinking water are estimated to be up to 74.9 ug/L
(ppb) for instantaneous  exposure, 72.2 ppb for 96-hour exposure, and 
4.84 ppb for annual exposure.

Table 3.  Modeled EDWCs for Use of Acetochlor on Sorghum (ug/L)
Underlined values Recommended by EFED for Dietary Exposure Assessment. 

Exposure Scenario	Peak Day	Peak 96 Hr Avg	365 Day Avg	Lifetime (30 yr 
Avg)

KS Sorghum (2.5 lb ai/ A)	49.9 to 74.9 	47.4 to 72.2	4.14 to 4.84	0.29
to 1.12

Corn – scenarios from IL, MS, NC, OH, and PA (3 lb ai/A rate)	14.3 to
44.5	13.7 to 41.9	2.08 to 6.56	0.72 to 2.96

Cotton – scenarios from CA, MS, and NC	3.56 to 20.0	3.42 to 18.65	0.55
to 2.16	0.29 to 1.12

MS Soybean 	28.0	26.4	4.68	2.18

EEM-FCID™ Program and Consumption Information

Acetochlor 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.  The resulting residue
consumption estimate for each food/food form is summed with the residue
consumption 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., 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,
significant differences in user vs. per capita exposure and risk are
identified and noted in the risk assessment.

V.	Toxicological Information

HED evaluated the toxicology data base for acetochlor and selected the
following doses and endpoints for acute and chronic dietary and drinking
water risk assessments.  

Table 4. Summary of Toxicological Doses and Endpoints for Acetochlor 
for Use in Dietary and Non-Occupational Human Health Risk Assessments

Exposure/Scenario	Point of Departure	Uncertainty/FQPA Safety Factors
RfD, PAD, LOC for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(All populations)	NOAEL = 150 mg/kg/day	UFA= 10x

UFH=10x

UFDB = 10x

FQPA SF= 1x	Acute RfD = 0.15 mg/kg/day

aPAD = 0.15 mg/kg/day	Acute oral neurotoxicity screening in rats

LOAEL = 500mg/kg/day based on decreased motor activity in females.

Chronic Dietary 

(All Populations)	NOAEL = 2.0 mg/kg/day	UFA= 10x

UFH=10x

FQPA SF= 1x	Chronic RfD = 0.02

mg/kg/day

cPAD = 0.02 mg/kg/day	Chronic oral toxicity in beagle dogs

LOAEL = 10 mg/kg/day based on increased salivation and histopathology in
the testes, kidney and liver.

Cancer (all routes)	Classification: “Suggestive Evidence of
Carcinogenic Potential".  Quantification of cancer risk is not required
since the cRfD of 0.02 mg/kg/day will be protective of both non-cancer
and cancer effects

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.  

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.  

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 5 and 6 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.

Results of Acute Dietary Exposure Analysis

The results of the acute dietary exposure analysis at the 99.9th
percentile of exposure are reported in Table 5.

Table 5:  Summary of Acute Dietary Exposure and Risk for Acetochlor

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

Exposure (mg/kg/day)	% aPAD

General U.S. Population	0.15	0.0045	3

All Infants (< 1 year old)

0.0159	11

Children 1-2 years old

0.0075	5

Children 3-5 years old

0.0066	4

Children 6-12 years old

0.0046	3

Youth 13-19 years old

0.0036	2

Adults 20-49 years old

0.0040	3

Adults 50+ years old

0.0035	2

Females 13-49 years old

0.0040	3

Results of Chronic Dietary Exposure Analysis

The results of the chronic dietary exposure analysis are reported in
Table 6.  

Table 6:  Summary of Chronic Dietary Exposure and Risk for Acetochlor

Population Subgroup	cPAD (mg/kg/day)	Chronic

Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.02	0.0004	2

All Infants (< 1 year old)

0.0012	6

Children 1-2 years old

0.0009	4

Children 3-5 years old

0.0008	4

Children 6-12 years old

0.0005	3

Youth 13-19 years old

0.0004	2

Adults 20-49 years old

0.0004	2

Adults 50+ years old

0.0004	2

Females 13-49 years old

0.0004	2

VI.	Characterization of Inputs/Outputs

The acute dietary analysis is an unrefined screening level analysis.  In
addition, the 100% crop treated estimate used for all crops in the
assessment will considerably overestimate the actual percent  crop
treated.  

The chronic dietary analysis is somewhat refined.  Average field trial
residues used in the analysis are expected to exceed the residues
actually consumed.  In addition, the 100% crop treated estimate used for
all crops in the assessment will considerably overestimate the actual
percent  crop treated.  

VII.	Conclusions

Acute and chronic dietary exposure analyses were performed for the
general U.S. population and various population subgroups.  The risk
estimates for the general U.S. population and all population subgroups
are below HED’s level of concern.  HED is confident that acute and
chronic dietary exposures to acetochlor are not underestimated.

VIII.  Cumulative Risk

	As part of the provisions of the Food Quality Protection Act (FQPA,
1996), EPA must consider the cumulative effects on human health that may
result from exposure to different chemicals that cause toxic effects by
the same mode of action. The chloroacetanilides have been evaluated by
the Agency and the FIFRA Scientific Advisory Panel (SAP) as a related
group of chemicals for this purpose.  Acetoclor is included in a
Cumulative Assessment Group (CAG) of Chloroacetanilide pesticides. 
Structurally related chloroacetanilides include acetochlor, alachlor,
butachlor, propachlor and metolachlor.  For purposes of a cumulative
risk assessment, it was determined that the common mechanism of toxicity
group consists of alachlor, acetochlor and butachlor.  Butachlor is
excluded from the group for risk assessment purposes at present there
are no registered uses or tolerances for this chemical in the US.  The
group was selected based on common endpoints of (1) nasal turbinate
tumors in rats, and a known mechanism of toxicity for development of
these tumors and (2) induction of hepatic UDP-Glucuronosyl Transferase
(UDPGT), which results in increased incidence of thyroid follicular cell
tumors secondary to disruption of pituitary-thyroid homeostasis. 
Thyroid effects were not included in the final cumulative assessment of
the chloroacetanilide herbicides because they were determined to occur
at excessively toxic dose levels, and therefore were not considered
relevant to human risk assessment.  Nasal tumors represent the most
sensitive endpoint for both compounds.

	An updated cumulative risk assessment of the Chloroacetanilide (CAG)
pesticides acetoclor and alechlor conducted in April, 2007 provides an
assessment of existing and new uses of those chemicals to date (Y.
Donovan, D336214, 4/30/07).  Based on the most recent chloroacetanilide
CAG cumulative risk assessment, cumulative risk is not of concern.  A
revised quantitative cumulative assessment was not conducted for the
current assessment of proposed new uses for acetochlor because
acetochlor is a very minor contributor to the cumulative when compared
to alachlor and the proposed new use would not affect the cumulative
risk results.  

VIII.	List of Attachments

1.  Acute DEEM-FCID Residue Input File.

2.  Results of Acute DEEM-FCID Dietary Exposure Analysis.

3.  Chronic DEEM-FCID Residue Input File.

4.  Results of Chronic DEEM-FCID Dietary Exposure Analysis.

Attachment 1 Acute DEEM-FCID Residue Input File

U.S. Environmental Protection Agency                                
Ver. 2.02

DEEM-FCID Acute analysis for ACETOCHLOR

Residue file name: C:\Documents and Settings\rdaiss\My
Documents\Acetochlor\acet acute 100CT f_w-6-3-09.R98

Analysis Date 06-04-2009             Residue file dated:
06-03-2009/14:54:40/8

Reference dose: aRfD = 0.15 mg/kg bw/day  NOEL = 150 mg/kg bw/day

Comment: Run with new commodities at tolerance & 100% CT

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

15000250 15   Barley, pearled barley             0.050000   1.000  1.000
rot crop tol; 100%CT          15000251 15   Barley, pearled
barley-babyfood    0.050000   1.000  1.000 rot crop tol; 100%CT         
15000260 15   Barley, flour                      0.050000   0.500  1.000
rot crop tol; 100% CT; PF 

15000261 15   Barley, flour-babyfood             0.050000   0.500  1.000
rot crop tol; 100% CT; PF         

15000270 15   Barley, bran                       0.050000   1.000  1.000
rot crop tol; 100%CT              

06030300 6C   Bean, black, seed                  0.050000   1.000  1.000
rot crop tol; 100%CT          06030320 6C   Bean, broad, seed           
      0.050000   1.000  1.000 rot crop tol; 100%CT              

06030340 6C   Bean, cowpea, seed                 0.050000   1.000  1.000
rot crop tol; 100%CT              

06030350 6C   Bean,  great northern, seed        0.050000   1.000  1.000
rot crop tol; 100%CT              

06030360 6C   Bean, kidney, seed                 0.050000   1.000  1.000
rot crop tol; 100%CT              06030380 6C   Bean, lima, seed        
          0.050000   1.000  1.000 rot crop tol; 100%CT             
06030390 6C   Bean, mung, seed                   0.050000   1.000  1.000
rot crop tol; 100%CT              06030400 6C   Bean, navy, seed        
          0.050000   1.000  1.000 rot crop tol; 100%CT          

06030410 6C   Bean, pink, seed                   0.050000   1.000  1.000
rot crop tol; 100%CT              06030420 6C   Bean, pinto, seed       
          0.050000   1.000  1.000 rot crop tol; 100%CT              

01010520 1A   Beet, sugar                        0.050000   1.000  1.000
rot crop tol; 100%CT              01010521 1A   Beet, sugar-babyfood    
          0.050000   1.000  1.000 rot crop tol; 100%CT             
01010530 1A   Beet, sugar, molasses              0.050000   1.000  1.000
rot crop tol; 100%CT              15000650 15   Buckwheat               
          0.050000   1.000  1.000 rot crop tol; 100%CT             
15000660 15   Buckwheat, flour                   0.050000   0.500  1.000
rot crop tol; 100%CT; PF          06030980 6C   Chickpea, seed          
          0.050000   1.000  1.000 rot crop tol; 100%CT              

06030981 6C   Chickpea, seed-babyfood            0.050000   1.000  1.000
rot crop tol; 100%CT              

06030990 6C   Chickpea, flour                    0.050000   1.000  1.000
rot crop tol; 100%CT              

15001200 15   Corn, field, flour                 0.050000   0.600  1.000
existing use; 100% CT

15001201 15   Corn, field, flour-babyfood        0.050000   0.600  1.000
existing use; 100% CT

15001210 15   Corn, field, meal                  0.050000   0.600  1.000
existing use; 100% CT

15001211 15   Corn, field, meal-babyfood         0.050000   0.600  1.000
existing use; 100% CT

15001220 15   Corn, field, bran                  0.050000   1.000  1.000
existing use; 100% CT

15001230 15   Corn, field, starch                0.050000   0.600  1.000
existing use; 100% CT

15001231 15   Corn, field, starch-babyfood       0.050000   0.600  1.000
existing use; 100% CT

15001240 15   Corn, field, syrup                 0.050000   1.000  1.000
existing use; 100% CT

15001241 15   Corn, field, syrup-babyfood        0.050000   1.000  1.000
existing use; 100% CT

15001250 15   Corn, field, oil                   0.050000   0.600  1.000
existing use; 100% CT

15001251 15   Corn, field, oil-babyfood          0.050000   0.600  1.000
existing use; 100% CT

15001260 15   Corn, pop                          0.050000   1.000  1.000
existing use; 100% CT

15001270 15   Corn, sweet                        0.050000   1.000  1.000
existing use; 100% CT

15001271 15   Corn, sweet-babyfood               0.050000   1.000  1.000
existing use; 100% CT

95001280 O    Cottonseed, oil                    0.600000   1.000  1.000
new tolerance; 100% CT

95001281 O    Cottonseed, oil-babyfood           0.600000   1.000  1.000
new tolerance; 100% CT

06031820 6C   Guar, seed                         0.050000   1.000  1.000
existing use; 100% CT

06031821 6C   Guar, seed-babyfood                0.050000   1.000  1.000
existing use; 100% CT

06032030 6C   Lentil, seed                       0.050000   1.000  1.000
existing use; 100% CT

15002260 15   Millet, grain                      0.050000   1.000  1.000
existing use; 100% CT

15002310 15   Oat, bran                          0.050000   1.000  1.000
rot crop tol; 100%CT              

15002320 15   Oat, flour                         0.050000   0.500  1.000
rot crop tol; 100%CT   

15002321 15   Oat, flour-babyfood                0.050000   0.500  1.000
rot crop tol; 100%CT 

15002330 15   Oat, groats/rolled oats            0.050000   0.400  1.000
rot crop tol; 100%CT              15002331 15   Oat, groats/rolled
oats-babyfood   0.050000   0.400  1.000 rot crop tol; 100%CT            
 

06032560 6C   Pea, dry                           0.050000   1.000  1.000
rot crop tol; 100%CT              

06032561 6C   Pea, dry-babyfood                  0.050000   1.000  1.000
rot crop tol; 100%CT              

06032580 6C   Pea, pigeon, seed                  0.050000   1.000  1.000
rot crop tol; 100%CT              

01032960 1C   Potato, chips                      0.050000   1.000  1.000
rot crop tol; 100%CT              

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500  1.000
rot crop tol; 100%CT; PF          

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500  1.000
rot crop tol; 100%CT; PF         01032980 1C   Potato, flour            
         0.050000   1.000  1.000 rot crop tol; 100%CT              

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000
rot crop tol; 100%CT              

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000
rot crop tol; 100%CT              

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000
rot crop tol; 100%CT              

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000
rot crop tol; 100%CT              

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000
rot crop tol; 100%CT              

15003280 15   Rye, grain                         0.050000   1.000  1.000
rot crop tol; 100%CT              

15003290 15   Rye, flour                         0.050000   0.500  1.000
rot crop tol; 100%CT              

15003440 15   Sorghum, grain                     0.050000   1.000  1.000
existing use; 100% CT

15003450 15   Sorghum, syrup                     0.050000   1.000  1.000
existing use; 100% CT

06003470 6    Soybean, seed                      1.000000   1.000  1.000
new tolerance; 100% CT

06003480 6    Soybean, flour                     1.000000   0.750  1.000
new tolerance; 100%CT; PF         

06003481 6    Soybean, flour-babyfood            1.000000   0.750  1.000
new tolerance; 100%CT; PF         06003490 6    Soybean, soy milk       
          1.000000   1.000  1.000 new tolerance; 100%CT            
06003491 6    Soybean, soy milk-babyfood or in   1.000000   1.000  1.000
new tolerance; 100%CT             

06003500 6    Soybean, oil                       1.000000   0.200  1.000
new tolerance; 100%CT; PF         

06003501 6    Soybean, oil-babyfood              1.000000   0.200  1.000
new tolerance; 100%CT; PF

20003640 20   Sunflower, seed                    0.050000   1.000  1.000
rot crop tol; 100%CT             20003650 20   Sunflower, oil           
         0.050000   1.000  1.000 rot crop tol; 100%CT              

20003651 20   Sunflower, oil-babyfood            0.050000   1.000  1.000
rot crop tol; 100%CT             15003810 15   Triticale, flour         
         0.050000   0.500  1.000 rot crop tol; 100%CT; PF          

15003811 15   Triticale, flour-babyfood          0.050000   0.500  1.000
rot crop tol; 100%CT; PF          

86010000 O    Water, direct, all sources         0.075000   1.000  1.000
modeled peak

86020000 O    Water, indirect, all sources       0.075000   1.000  1.000
modeled peak

15004010 15   Wheat, grain                       0.050000   1.000  1.000
rot crop; 100 % CT

15004011 15   Wheat, grain-babyfood              0.050000   1.000  1.000
rot crop; 100 % CT

15004020 15   Wheat, flour                       0.050000   0.500  1.000
rot crop; 100 % CT; PF

15004021 15   Wheat, flour-babyfood              0.050000   0.500  1.000
rot crop; 100 % CT; PF

15004030 15   Wheat, germ                        0.050000   1.000  1.000
rot crop; 100 % CT

15004040 15   Wheat, bran                        0.050000   1.000  1.000
rot crop; 100 % CT

Attachment 2  Results of Acute DEEM-FCID Dietary Exposure Analysis

U.S. Environmental Protection Agency                                 
Ver. 2.02

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

Residue file: acet acute 100CT f_w-6-24-09.R98    Adjustment factor #2
NOT used.

Analysis Date: 06-24-2009/14:52:43    Residue file dated:
06-24-2009/14:50:18/8

NOEL (Acute) = 150.000000 mg/kg body-wt/day

Daily totals for food and foodform consumption used.

Run Comment: "Run with new commodities at tolerance & 100% CT"

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

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

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

U.S. Population:

  0.004465    2.98   33591    0.008201    5.47   18289    0.016186  
10.79    9266  

All infants:

  0.015910   10.61    9427    0.022620   15.08    6631    0.038370  
25.58    3909  

Children 1-2 yrs:

  0.007494    5.00   20016    0.012541    8.36   11960    0.045524  
30.35    3294  

Children 3-5 yrs:

  0.006582    4.39   22789    0.010266    6.84   14611    0.035651  
23.77    4207  

Children 6-12 yrs:

  0.004581    3.05   32740    0.007532    5.02   19913    0.010122   
6.75   14818  

Youth 13-19 yrs:

  0.003594    2.40   41730    0.005810    3.87   25816    0.009887   
6.59   15170  

Adults 20-49 yrs:

  0.004037    2.69   37154    0.006701    4.47   22385    0.011796   
7.86   12716  

Adults 50+ yrs:

  0.003530    2.35   42488    0.005159    3.44   29077    0.008468   
5.65   17714  

Females 13-49 yrs:

  0.004016    2.68   37354    0.006616    4.41   22672    0.010883   
7.26   13782  



Attachment 3  Chronic DEEM-FCID Residue Input File.

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for ACETOCHLOR                        
1994-98 data

Residue file: C:\Documents and Settings\rdaiss\My
Documents\Acetochlor\acet chronic f_w-6-4-09.R98

                                                               Adjust.
#2 used

Analysis Date 06-04-2009             Residue file dated:
06-04-2009/06:46:38/8

Reference dose (RfD) = 0.02 mg/kg bw/day

Comment:Run with new commodities at tolerance & 100% CT

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

15000250 15   Barley, pearled barley             0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15000251 15   Barley, pearled barley-babyfood    0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15000260 15   Barley, flour                      0.020000   0.500     
1.000   rot crop use;1/2 L0Q; 100%CT; PF 

15000261 15   Barley, flour-babyfood             0.020000   0.500     
1.000   rot crop use;1/2 L0Q; 100%CT; PF 

15000270 15   Barley, bran                       0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030300 6C   Bean, black, seed                  0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030320 6C   Bean, broad, seed                  0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030340 6C   Bean, cowpea, seed                 0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030350 6C   Bean,  great northern, seed        0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030360 6C   Bean, kidney, seed                 0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030380 6C   Bean, lima, seed                   0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030390 6C   Bean, mung, seed                   0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030400 6C   Bean, navy, seed                   0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030410 6C   Bean, pink, seed                   0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030420 6C   Bean, pinto, seed                  0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01010520 1A   Beet, sugar                        0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01010521 1A   Beet, sugar-babyfood               0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01010530 1A   Beet, sugar, molasses              0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15000650 15   Buckwheat                          0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15000660 15   Buckwheat, flour                   0.020000   0.500     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

06030980 6C   Chickpea, seed                     0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030981 6C   Chickpea, seed-babyfood            0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06030990 6C   Chickpea, flour                    0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15001200 15   Corn, field, flour                 0.020000   0.600     
1.000   existing use1/2 LOQ; 100% CT

15001201 15   Corn, field, flour-babyfood        0.020000   0.600     
1.000   existing use1/2 LOQ; 100% CT

15001210 15   Corn, field, meal                  0.020000   0.600     
1.000   existing use1/2 LOQ; 100% CT

15001211 15   Corn, field, meal-babyfood         0.020000   0.600     
1.000   existing use1/2 LOQ; 100% CT

15001220 15   Corn, field, bran                  0.020000   1.000     
1.000   existing use1/2 LOQ; 100% CT

15001230 15   Corn, field, starch                0.020000   0.600     
1.000   existing use1/2 LOQ; 100% CT

15001231 15   Corn, field, starch-babyfood       0.020000   0.600     
1.000   existing use1/2 LOQ; 100% CT

15001240 15   Corn, field, syrup                 0.020000   1.000     
1.000   existing use1/2 LOQ; 100% CT

15001241 15   Corn, field, syrup-babyfood        0.020000   1.000     
1.000   existing use1/2 LOQ; 100% CT

15001250 15   Corn, field, oil                   0.020000   0.600     
1.000   existing use1/2 LOQ; 100% CT

15001251 15   Corn, field, oil-babyfood          0.020000   0.600     
1.000   existing use1/2 LOQ; 100% CT

15001260 15   Corn, pop                          0.020000   1.000     
1.000   existing use1/2 LOQ; 100% CT

15001270 15   Corn, sweet                        0.020000   1.000     
1.000   existing use1/2 LOQ; 100% CT

15001271 15   Corn, sweet-babyfood               0.020000   1.000     
1.000   existing use1/2 LOQ; 100% CT

95001280 O    Cottonseed, oil                    0.600000   1.000     
1.000   existing use1/2 LOQ; 100% CT

95001281 O    Cottonseed, oil-babyfood           0.600000   1.000     
1.000   existing use1/2 LOQ; 100% CT

06031820 6C   Guar, seed                         0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06031821 6C   Guar, seed-babyfood                0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06032030 6C   Lentil, seed                       0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15002260 15   Millet, grain                      0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15002310 15   Oat, bran                          0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15002320 15   Oat, flour                         0.020000   0.500     
1.000   rot crop use;1/2 L0Q; 100%CT

15002321 15   Oat, flour-babyfood                0.020000   0.500     
1.000   rot cropuse;1/2 LOQ;100%CT; PF 

15002330 15   Oat, groats/rolled oats            0.020000   0.400     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

15002331 15   Oat, groats/rolled oats-babyfood   0.020000   0.400     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

06032560 6C   Pea, dry                           0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06032561 6C   Pea, dry-babyfood                  0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

06032580 6C   Pea, pigeon, seed                  0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01032960 1C   Potato, chips                      0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

01032980 1C   Potato, flour                      0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01032981 1C   Potato, flour-babyfood             0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01032990 1C   Potato, tuber, w/peel              0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15003280 15   Rye, grain                         0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15003290 15   Rye, flour                         0.020000   0.500     
1.000   rot crop use;1/2 L0Q; 100%CT

15003440 15   Sorghum, grain                     0.050000   1.000     
1.000   tol; 100% CT

15003450 15   Sorghum, syrup                     0.050000   1.000     
1.000   tol; 100% CT

06003470 6    Soybean, seed                      1.000000   1.000     
1.000   tol; 100% CT

06003480 6    Soybean, flour                     1.000000   0.750     
1.000   tol; 100% CT

06003481 6    Soybean, flour-babyfood            1.000000   0.750     
1.000   tol; 100% CT

06003490 6    Soybean, soy milk                  1.000000   1.000     
1.000   tol; 100% CT

06003491 6    Soybean, soy milk-babyfood or in   1.000000   1.000     
1.000   tol; 100% CT

06003500 6    Soybean, oil                       1.000000   0.200     
1.000   tol; 100% CT

06003501 6    Soybean, oil-babyfood              1.000000   0.200     
1.000   tol; 100% CT

20003640 20   Sunflower, seed                    0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

20003650 20   Sunflower, oil                     0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

20003651 20   Sunflower, oil-babyfood            0.020000   1.000     
1.000   rot crop use;1/2 L0Q; 100%CT

15003810 15   Triticale, flour                   0.020000   0.500     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

15003811 15   Triticale, flour-babyfood          0.020000   0.500     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

86010000 O    Water, direct, all sources         0.009500   1.000     
1.000   modelled EDWCs

86020000 O    Water, indirect, all sources       0.009500   1.000     
1.000   modelled EDWCs

15004010 15   Wheat, grain                       0.020000   1.000     
1.000   rot crop use; 100% CT

15004011 15   Wheat, grain-babyfood              0.020000   1.000     
1.000   rot crop use; 100% CT

15004020 15   Wheat, flour                       0.020000   0.500     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

15004021 15   Wheat, flour-babyfood              0.020000   0.500     
1.000   rot cropuse;1/2 LOQ;100%CT; PF

15004030 15   Wheat, germ                        0.020000   1.000     
1.000   rot crop use; 100% CT

15004040 15   Wheat, bran                        0.020000   1.000     
1.000   rot crop use; 100% CT

Attachment 4  Results of Chronic DEEM-FCID Dietary Exposure Analysis.

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: F:\Acetochlor\acet chronic f_w-6-24-09.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 06-24-2009/14:56:40     Residue file dated:
06-24-2009/14:51:05/8

Reference dose (RfD, Chronic) = .02 mg/kg bw/day

COMMENT 1: Run with new commodities at tolerance & 100% CT

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.000417                
2.1%

U.S. Population (spring season)             0.000413                
2.1%

U.S. Population (summer season)             0.000433                
2.2%

U.S. Population (autumn season)             0.000413                
2.1%

U.S. Population (winter season)             0.000408                
2.0%

Northeast region                            0.000379                
1.9%

Midwest region                              0.000421                
2.1%

Southern region                             0.000398                
2.0%

Western region                              0.000476                
2.4%

Hispanics                                   0.000447                
2.2%

Non-hispanic whites                         0.000402                
2.0%

Non-hispanic blacks                         0.000408                
2.0%

Non-hisp/non-white/non-black                0.000612                
3.1%

All infants (< 1 year)                      0.001169                
5.8%

Nursing infants                             0.000403                
2.0%

Non-nursing infants                         0.001460                
7.3%

Children 1-6  yrs                           0.000775                
3.9%

Children 7-12 yrs                           0.000497                
2.5%

Females 13-19 (not preg or nursing)         0.000325                
1.6%

Females 20+ (not preg or nursing)           0.000346                
1.7%

Females 13-50 yrs                           0.000370                
1.8%

Females 13+ (preg/not nursing)              0.000382                
1.9%

Females 13+ (nursing)                       0.000489                
2.4%

Males 13-19 yrs                             0.000381                
1.9%

Males 20+ yrs                               0.000357                
1.8%

Seniors 55+                                 0.000322                
1.6%

Children 1-2 yrs                            0.000847                
4.2%

Children 3-5 yrs                            0.000774                
3.9%

Children 6-12 yrs                           0.000518                
2.6%

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Youth 13-19 yrs                             0.000354                
1.8%

Adults 20-49 yrs                            0.000367                
1.8%

Adults 50+ yrs                              0.000326                
1.6%

Females 13-49 yrs                           0.000353                
1.8%

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

Acetochlor (PC Code 121601)	Dietary Exposure and Risk Assessment        
                          DP #:  360868

Page  PAGE  1  of  NUMPAGES  16