Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

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This is a revision to a food only acute dietary exposure assessment (28 October 2011, DP 

# 383216) that was conducted using the Dietary Exposure Evaluation Model DEEMFCIDTM, Version 2.03. This model 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 analysis was performed to support a Section 3 request for 

registration of amitraz for use as Apivar strips in bee hives. While the exposure estimates 

resulting from this new revision are higher, they do not change enough to require 

alteration of any of the decisions based upon the previous assessment. This revision is 

only needed to repair a technical inaccuracy.

This revision corrects an error in estimating amitraz residues in milk. In the previous 

assessment the amitraz residues in milk were taken from USDA’s Pesticide Data Program 

(PDP) residue testing results. However PDP had only tested for parent amitraz, not for 

all of the metabolites containing the dimethylaniline moiety, but the entire residues of 

concern for amitraz do include all residues containing the dimethylaniline moiety. For 

that reason it is necessary to use a source of residue values that includes measurement of 

all dimethylaniline containing metabolites. 

Because residues in milk following dermal treatment with amitraz are expected to be 

much more important than those derived from current feed sources, the total residues of 

concern can be obtained from a study showing residues in milk following dermal 

treatment of lactating cows with an amitraz spray. At this time this reviewer does not 

have access to the full original study, but the 1995 TRED (D300301; Amitraz TRED, J. 

Morales, 4/30/04) states that the 1X treatment rate produced residues between 0.006 to 

0.025 ppm. These values are the basis of the 0.03 ppm tolerance. The maximum value 

of 0.025 ppm is used in the current dietary assessment. [Note that if these results need 

further refinement at some later date it would be completely reasonable to examine the 

original study and use all of the results between 0.006 to 0.025 ppm found at the 1X 

treatment rate.] 

This assessment only addresses acute exposure through foods. Currently registered uses 

of amitraz are not expected to result in dietary exposures from drinking water in the 

United States. The acute assessment is assumed to be protective of chronic risks. 

 

Acute (Food Only) Dietary Exposure Results and Characterization

This dietary analysis is based upon potential exposure through meat and milk from 

dermal treatments of livestock, residues in imported cottonseed oil, and residues in 

honey. The values used for livestock products, except for milk, are based upon tolerance 

level residues and percents of livestock treated as estimated by the Biological and 

Economic Analysis Division (BEAD) (attachment 4) Milk residues were based upon the 

high end result from the original dosing study (as cited in D300301; Amitraz TRED, J. 

Morales, 4/30/04TRED) and is therefore conservative. The very low estimates for 

percent of livestock treated cause these livestock residues to be well refined. Amitraz is 

not used within the US for cotton, so residues in cottonseed oil were estimated at 
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tolerance for imported cottonseed oil only. For honey the residues at 57 days after 

treatment (DAT) from MRID 48341001 were used and it was assumed that 100% of the 

honey was treated. 

The most highly exposed sub-population is children 1-2 years of age at 0.000956

mgs/kg/day, or 76.5% of the aPAD. The general population is estimated to be exposed at 

0.000199 mgs/kg/day, or 15.9% of the aPAD. 

Chronic Dietary Exposure Results and Characterization

Because the most sensitive toxic effects from exposure to amitraz are not cumulative with 

longer durations of exposure, HED has determined that the acute assessment representing 

one day exposure is protective of any chronic dietary exposures to amitraz and a chronic 

dietary exposure assessment is therefore not needed. (However, see attachments 7 and 8, 

for a chronic exposure estimate that was done for possible aggregation with non-dietary 

exposure.)

Cancer Dietary Exposure Results and Characterization

HED has determined that amitraz is to be classified as producing suggestive evidence of 

carcinogenicity, but that the cancer risk should not be quantified. Therefore, no 

quantitative cancer assessment is needed; risks quantified using the cPAD (or in this case 

the aPAD) are protective for any potential carcinogenicity concerns. 

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For 

acute and chronic assessments, the risk is expressed as a percentage of a maximum 

acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable 

adverse health effects). This dose is referred to as the population adjusted dose (PAD). 

The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by 

the required uncertainty or safety factors, including the FQPA safety factor.

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 Amitraz was conducted by David Soderberg, 

(28 October 2011, DP # 383216).

II. Residue Information
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Currently amitraz is registered for use in the U.S. only on cattle and hogs (40 CFR 

180.287). A tolerance also remains in effect for cottonseed. There are no registered uses 

on cottonseed in the U.S., but Foreign Agriculture Service data show that about 2% of 

cottonseed oil is imported. The tolerances for residues of amitraz are currently expressed 

in terms of the combined residues of amitraz (N'-[2,4-dimethylphenyl]-N-[[(2,4-

dimethylphenyl)imino]methyl]]-N-methylmethanimid-amide) and its metabolites 

containing the 2,4-dimethylaniline moiety calculated as the parent compound [40 CFR 

180.287]. These are also the residues of concern in foods for dietary exposure 

assessment. 

The submitted petition requests that amitraz, in the form of “Apivar” strips, be allowed 

for use in beehives. Limited Residue data was provided in MRID 48341001. Residues in 

honey collected at 57 DAT from the supers of 4 hives (at 0.047, 0.062, 0.084 and 0.045 

ppm) were assumed to be the most appropriate to use in this assessment. It was assumed 

that 100% of the honey is treated. 

We note that there also was an earlier tolerance for amitraz in beeswax that has since 

been revoked. It has not been requested that this beeswax tolerance be reinstated to 

support the requested use of the Apivar strips. Further, although residues in beeswax 

may be of some potential concern for exposure through food because some beeswax is 

used in food, the use is rare and collection of beeswax from supers is not ordinarily 

economically feasible. In addition, no beeswax has been incorporated into the DEEM 

recipes, so the current analysis does not account for any exposure to amitraz through the 

consumption of beeswax. 

Current tolerances are summarized in the table below, taken from the e-CFR. 

§ 180.287 Amitraz; tolerances for residues.

(a) General . Tolerances are established for residues of the insecticide amitraz (N'-[2,4-dimethylphenyl]-N-

[[(2,4-dimethylphenyl)imino] methyl]]- N-methylmethanimidamide) and its metabolites containing the 2,4-

dimethylaniline moiety (calculated as the parent) in or on the following food commodities:

Table 1. Amitraz Tolerances

Commodity Parts per million

Cattle, fat 0.1

Cattle, meat 0.02

Cattle, meat byproducts 0.2

Cotton, undelinted seed11.0

Hog, fat 0.1

Hog, kidney 0.1

Hog, liver 0.1
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Hog, meat 0.05

Hog, meat byproducts 0.3

Milk 0.03

Milk, fat 0.2

1There are no U.S. registrations on cottonseed as of May 3, 2006.

Residue Data used for Acute Assessment:

Tolerance level residues and percent livestock head treated were used to generate the 

cattle/hog muscle, organ, and meat byproduct and milk fat RDFs. Adequate monitoring 

data from PDP was available for milk during 2004-2005: 1485 samples, all non-detects at 

0.0006 ppm, however, PDP only tested for parent amitraz. According to the 2004 TRED 

(D300301; Amitraz TRED, J. Morales, 4/30/04) total residues containing the dimethylaniline moiety in milk after lactating cows were treated at 1X were 0.006 to 0.025 ppm 

Because the original set of results could not be obtained at this time, an RDF for milk was 

created based upon the high value of 0.025 ppm found in this study. Because this 

approach omits incorporation of the results below 0.025 in that study, the current results 

could be further refined by obtaining the full study and incorporating all 1X data points. 

Cottonseed oil is a blended commodity. There are no monitoring data available for 

cottonseed oil so tolerance level residues were used and it was assumed that 2% of the oil 

had been treated. This number is based upon a memo from BEAD (Attachment 4) 

estimating that no more than 2% of cottonseed oil is likely to be imported, and there are 

no registered domestic uses of amitraz on cottonseed. 

The four residue values in honey at day 57 from MRID 48341001 and 100% crop treated 

were used to create an RDF for honey (honey is considered to be partially blended). 

III. Drinking Water Data

EPA has concluded that the current uses and the bee hive use are not likely to produce 

residues in drinking water, so a drinking water assessment has not been conducted.

IV. DEEM-FCIDTM Program and Consumption Information

An amitraz acute dietary exposure assessment was conducted using the Dietary Exposure 

Evaluation Model software with the Food Commodity Intake Database DEEM-FCIDTM,

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 nonconsecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPAdefined 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 
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developed jointly by USDA/ARS and EPA. For chronic exposure assessment, 

consumption data are averaged for the entire U.S. population and within population 

subgroups, but for acute exposure assessment are retained as individual consumption 

events. Based on analysis of the 1994-96, 98 CSFII consumption data, which took into 

account dietary patterns and survey respondents, HED concluded that it is most 

appropriate to report risk for the following population subgroups: the general U.S. 

population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-

19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or 

food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied 

by the average daily consumption estimate for that food/food form to produce a residue 

intake estimate. The resulting residue intake estimate for each food/food form is summed 

with the residue intake estimates for all other food/food forms on the commodity residue 

list to arrive at the total average estimated exposure. Exposure is expressed in mg/kg 

body weight/day and as a percent of the cPAD. This procedure is performed for each 

population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on 

an individual-by-individual basis. The reported consumption amounts of each food item 

can be multiplied by a residue point estimate and summed to obtain a total daily pesticide 

exposure for a deterministic exposure assessment, or “matched” in multiple random 

pairings with residue values and then summed in a probabilistic assessment. The 

resulting distribution of exposures is expressed as a percentage of the aPAD on both a 

user (i.e., only those who reported eating relevant commodities/food forms) and a percapita (i.e., those who reported eating the relevant commodities as well as those who did 

not) basis. In accordance with HED policy, per capita exposure and risk are reported for 

all tiers of analysis. However, for tiers 1 and 2, any significant differences in user vs. per 

capita exposure and risk are specifically identified and noted in the risk assessment.

V. Toxicological Information

The toxicological endpoints are as described in Table 2. As noted in this table, the acute 

endpoint is considered protective of any chronic endpoint and of any cancer endpoint.

Table 2 Summary of Toxicological Doses and Endpoints for Amitraz 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)

NOAEL = 

0.125 

mg/kg/day

UFA= 10x

UFH=10x

FQPA SF= 1x

Acute RfD = 

0.00125 mg/kg

Acute PAD = 

0.00125 mg/kg

2 combined human studies (a 

single oral dose and a single oral 

dose metabolism) 

LOAEL = 0.25 mg/kg/day based 

on dry mouth, drowsiness, 

decreased temperature, decreased 

blood pressure and decreased heart 

rate.
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Chronic 

Dietary (All 

Populations)

The chronic toxicity is assumed to be the same as repeated, reversible acute dose toxicity, 

therefore a separate chronic endpoint is not calculated

Cancer (oral) Classification: Amitraz is classified as producing “suggestive evidence of 

carcinogenicity,” but is not considered to be quantifiable.

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 longterm 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 

As stated above, for acute and chronic assessments, HED is concerned when dietary risk 

exceeds 100% of the PAD. The DEEM-FCIDTM analyses estimate the dietary exposure 

of the U.S. population and various population subgroups. The results reported in Tables

3 and 4 are for the general U.S. Population, all infants (<1 year old), children 1-2, 

children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ 

years. As discussed above, chronic and cancer risks have not been quantified. (But note

attachments 7 and 8, which were provided to support any aggregate assessment involving 

non-dietary exposures.)

Results of Acute Dietary (Food Only) Exposure Analysis

The results of the acute dietary exposure analysis at the 95th, 99th, and 99.9th percentiles 

of exposure are reported in Table 3. This is a refined assessment so results are reported at 

the 99.9th percentile. The most highly exposed sub-population is children 1-2 years of 

age at 0.000956 mgs/kg/day, or 76.5% of the aPAD at the 99.9th percentile. The general 

population is estimated to be exposed at 0.000199 mgs/kg/day, or 15.9% of the aPAD at 

the 99.9th percentile. 

Table 3. Results of Acute Dietary (Food Only) Exposure Analysis Using DEEM FCID 

Population Subgroup aPAD 

(mg/kg/day)

95th Percentile 99th Percentile 99.9th Percentile

Exposure 

(mg/kg/day)

% 

aPAD

Exposure 

(mg/kg/day)

% 

aPAD

Exposure 

(mg/kg/day)

% 

aPAD

General U.S. Population 0.00125 0.000008 <1.0 0.000040 3.2 0.000199 15.9

All Infants (< 1 year old) 0.00125 0.000005 <1.0 0.000021 1.7 0.000286 22.9

Children 1-2 years old 0.00125 0.000017 1.3 0.000127 10.1 0.000956 76.5

Children 3-5 years old 0.00125 0.000017 1.4 0.000102 8.2 0.000606 48.5

Children 6-12 years old 0.00125 0.000011 <1.0 0.000061 4.9 0.000367 29.3
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Table 3. Results of Acute Dietary (Food Only) Exposure Analysis Using DEEM FCID 

Population Subgroup aPAD 

(mg/kg/day)

95th Percentile 99th Percentile 99.9th Percentile

Exposure 

(mg/kg/day)

% 

aPAD

Exposure 

(mg/kg/day)

% 

aPAD

Exposure 

(mg/kg/day)

% 

aPAD

Youth 13-19 years old 0.00125 0.000006 <1.0 0.000038 3.0 0.000160 12.8

Adults 20-49 years old 0.00125 0.000006 <1.0 0.000033 2.7 0.000117 9.4

Adults 50+ years old 0.00125 0.000006 <1.0 0.000031 2.5 0.000118 9.4

Females 13-49 years old 0.00125 0.000006 <1.0 0.000032 2.6 0.000117 9.3

Results of Chronic Dietary (Food Only) Exposure Analysis

The acute exposure assessment is assumed to be protective of any chronic exposure and a 

chronic assessment was not formally performed. (However, see attachments 7 and 8.)

Results of Cancer Dietary (Food Only) Exposure Analysis

A cancer assessment is not required.

Summary Analysis

Table 4. Summary of Dietary (Food Only) Exposure and Risk for Amitraz

Population Subgroup

Acute Dietary

(99.9th Percentile)

Cancer

Dietary 

Exposure 

(mg/kg/day)

% 

aPAD*

Dietary 

Exposure

(mg/kg/day)

Risk

General U.S. Population 0.000199 15.9 Acute endpoint is protective of any 

possible cancer effects

All Infants (< 1 year old) 0.000286 22.9

N/A N/A

Children 1-2 years old 0.000956 76.5

Children 3-5 years old 0.000606 48.5

Children 6-12 years old 0.000367 29.3

Youth 13-19 years old 0.000160 12.8

Adults 20-49 years old 0.000117 9.4

Adults 50+ years old 0.000118 9.4

Females 13-49 years old 0.000117 9.3
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VII. Characterization of Inputs/Outputs

There are a number of uncertainties associated with this assessment. The honey residues 

are based upon a small sampling of honey at 57 days from only 4 hives. (We note 

however that honey collected at other time periods in the study were quite consistent with 

the four values at 57 days.) Multiyear data are not exactly described, but these 57 day 

residues were reported to have been assessed following several previous years of use. 

Beeswax is occasionally used in foods, but its collection is not ordinarily economically 

feasible and beeswax is not included in the FCID recipes, so its importance for amitraz 

exposure through foods has not been demonstrated within this assessment. Therefore,

residues from beeswax have not been incorporated into this food assessment. No 

restriction has been submitted to prevent beeswax from treated hives from being used in 

food, nor has it been shown that such a restriction would be enforceable. 

The usage of amitraz in beehives is assumed to be 100%. No possible restrictions on use 

have been proposed, nor do we know what proportion of imported honey might contain 

amitraz once a tolerance has been set. 

PDP monitoring data on beef, milk and butter are not adequate to use to estimate residues 

expected from the treated portion of the livestock because PDP tests only for parent 

amitraz, not for all residues containing the dimethylaniline moiety. In addition, for beef 

tissues and butter there are simply too few samples by PDP when compared to the very 

low percent of livestock treated. For that reason it was necessary to apply the calculated 

tolerance level residues to the treated portion of these commodities. For some partial 

refinement residues in milk were assigned the highest residue found in the dosing study 

(0.025 ppm), rather than the tolerance (0.03 ppm). In addition only tolerance level 

residues can be assumed for pork products. 

We also note that there is a Federal Register notice (FR 74, No. 1, p. 1, 2 Jan 2009: FR 

Doc. E8–31212 Filed 12–31–08; 8:45 am) that states that cattle are dipped in amitraz in 

Mexico before being imported into the United States to prevent importation of Boophilus

ticks that can transmit Babesia, or cattle tick fever. The impact of this recently 

announced use of amitraz on overall residues in beef meat is hard to judge, and at this 

time USDA does require that cattle cannot be imported from Mexico for immediate 

slaughter, so this use has not been included within this assessment. The use should not 

affect residues in milk. 

However, we note that extrapolation of this kind of use to other similar situations could 

also yield an important potential uncertainty attached to residues in milk. This is because 

there is no required withdrawal period after treatment of dairy animals with amitraz 

before those animals can be milked. Should a domestic infestation of Boophilus/Babesia

occur that is treated with amitraz, it is likely that the proportion of treated dairy animals 

in that local area may rise substantially, and that this could create an increased local risk 

of exposure through milk and dairy foods. At this time we have tried to check for such 

uses and have found none, nor have we found any that are possibly anticipated.
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The effect of consumption on these results is interesting (see Attachment 6 – CEC files 

for a breakdown of consumption patterns). In general it appears that in the current 

assessment infants are most highly exposed through honey, while children are most 

highly exposed to amitraz through milk fat. This predominance of milk fat gradually 

diminishes as the ages of the consumers increase and exposure for adults is estimated to 

be predominantly from honey. Whole milk is not a predominant source of exposure for 

any population subgroup. We note, of course, that once use becomes sufficiently well 

established to allow estimates of the percent of honey that is treated with amitraz the 

estimated exposure to amitraz through honey will likely decrease. 

VIII.Conclusions

A probabilistic, acute, food only dietary assessment has been performed to evaluate the 

use of amitraz in beehives. Amitraz is currently used as a dermal application for 

livestock and potentially on imported cottonseed commodities. The assessment was well 

refined by percent livestock treated and percent cottonseed oil imported. Field trial 

values were used for honey with an assumption of 100% crop treated. At the 99.9th

percentile HED’s level of concern is not exceeded for any population subgroup. The 

most highly exposed population subgroup is children 1-2 at 76.5% aPAD. The general 

U.S. population was exposed at 15.9% aPAD. 

IX. List of Attachments

1. Summary of Data and Residue Estimates Used in the Dietary Analyses.

2. Acute Food Residue Input file.

3. Residue Distribution Files (if applicable).

4. Percent Crop Treated Memo from BEAD.

5. Acute Results file.

6. CEC Summary file.

7. Chronic/Food Residue Input file.

8. Chronic Results file.

cc: D. Soderberg; D. Drew; M. Metzger
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Attachment 1. Summary of Data and Residue Estimates Used in Dietary Analyses

RAC Food

Forms

Classific

ation1

Data

Source

No. of

Samples

No. of

Detectable

Residues

LOD %CT Processing

Factors

Anticipated Residue 

Estimates/Tolerance

Acute (Tol., AR, RDF)2

Honey All PB Field Trials 4 4 0.010 100 None Honey.RDF

Cottonse

ed Oil All B Tolerance NA NA NA 2 None 1 ppm

Beef 

Meat All NB Tolerance NA NA NA 0.3 None Cattlemeat.RDF

Beef 

Meat, 

Dried

All NB Tolerance NA NA NA 0.3 1.92 Cattlemeat.RDF

Beef 

meat 

Byproduc

ts

All NB Tolerance NA NA NA 0.3 None Cattlembyp.RDF

Beef Fat All NB Tolerance NA NA NA 0.3 None CattleFat.RDF

Beef 

Kidney All NB Tolerance NA NA NA 0.3 None Cattlembyp.RDF

Beef 

Liver All NB Tolerance NA NA NA 0.3 None Cattlembyp.RDF

Pork 

Meat All NB Tolerance NA NA NA 1.2 None PigMeat

Pork 

Skin All NB Tolerance NA NA NA 1.2 None PigMbyp.RDF
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Pork 

meat 

byproduc

ts

All NB Tolerance NA NA NA 1.2 None PigMbyp.RDF

Pork Fat All NB Tolerance NA NA NA 1.2 None Pigfat.RDF

Pork 

Kidney All NB Tolerance NA NA NA 1.2 None PigMbyp.RDF

Pork 

Liver All NB Tolerance NA NA NA 1.2 None PigMbyp.RDF

Milk fat All PB Tolerance NA NA NA 0.3 None Milkfat.RDF

Milk 

Non-fat 

Solids

All PB

Dosing 

Study as 

Cited in 

TRED

5(?) at 

1X, only

highest 

used

All 5(?) Unknown 0.3 None Milk.rdf

Milk 

Water All PB

Dosing 

Study as 

Cited in 

TRED

5(?) at 

1X, only

highest 

used

All 5(?) Unknown 0.3 None Milk.RDF

Milk 

Sugar All PB

Dosing 

Study as 

Cited in 

TRED

5(?) at 

1X, only

highest 

used

All 5(?) Unknown 0.3 None Milk.RDF

1. Classification of blended (B), partially blended (PB), not blended (NB), but we note that these classifications have not been formally established for livestock commodities, so 

the notations here for these livestock commodities represent assumptions used in this assessment rather than formal policy.

2. Please see Attachment 3.
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Attachment 2. Acute Residue Input File

U.S. Environmental Protection Agency Ver. 2.02

DEEM-FCID Acute analysis for AMITRAZ

Residue file name: C:\Documents and Settings\dsoderbe\My 

Documents\amitrazreque\6aprilamitrazachimilkFThoneyrdf.R98

Analysis Date 04-12-2012 Residue file dated: 04-09-2012/11:51:10/8

Reference dose (aRfD) = 0.00125 mg/kg bw/day

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

RDL indices and parameters for Monte Carlo Analysis:

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

 # Code 

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

 1 6 CattleFat.rdf

 2 6 Cattlembyp.rdf

 3 6 Cattlemeat.rdf

 4 6 MilkhighFT.rdf

 5 6 Milkfat.rdf

 6 6 Pigfat.rdf

 7 6 PigkidLiv.rdf

 8 6 PigMbyp.rdf

 9 6 PigMeat.rdf

 10 6 Cottonseed Oil.rdf

 11 6 Honey.rdf

 EPA Crop Food Name Def Res Adj.Factors RDL Comment

 Code Grp (ppm) #1 #2 Pntr

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

21000440 M Beef, meat 0.020000 1.000 1.000 3 

21000441 M Beef, meat-babyfood 0.020000 1.000 1.000 3 

21000450 M Beef, meat, dried 0.020000 1.920 1.000 3 

21000460 M Beef, meat byproducts 0.200000 1.000 1.000 2 

21000461 M Beef, meat byproducts-babyfood 0.200000 1.000 1.000 2 

21000470 M Beef, fat 0.040000 1.000 1.000 1 

21000471 M Beef,fat-babyfood 0.040000 1.000 1.000 1 

21000480 M Beef, kidney 0.200000 1.000 1.000 2 

21000490 M Beef, liver 0.200000 1.000 1.000 2 

21000491 M Beef, liver-babyfood 0.200000 1.000 1.000 2 

95001280 O Cottonseed, oil 1.000000 1.000 0.020 

95001281 O Cottonseed, oil-babyfood 1.000000 1.000 0.020 

95001860 O Honey 0.200000 1.000 1.000 11 

95001861 O Honey-babyfood 0.200000 1.000 1.000 11 

27002220 D Milk, fat 0.200000 1.000 1.000 5 

27002221 D Milk, fat - baby food/infant for 0.200000 1.000 1.000 5 

27012230 D Milk, nonfat solids 0.030000 1.000 1.000 4 

27012231 D Milk, nonfat solids-baby food/in 0.030000 1.000 1.000 4 

27022240 D Milk, water 0.030000 1.000 1.000 4 

27022241 D Milk, water-babyfood/infant form 0.030000 1.000 1.000 4 

27032251 D Milk, sugar (lactose)-baby food/ 0.030000 1.000 1.000 4 

25002900 M Pork, meat 0.050000 1.000 1.000 9 

25002901 M Pork, meat-babyfood 0.050000 1.000 1.000 9 

25002910 M Pork, skin 0.100000 1.000 1.000 8 

25002920 M Pork, meat byproducts 0.300000 1.000 1.000 8 

25002921 M Pork, meat byproducts-babyfood 0.300000 1.000 1.000 8 

25002930 M Pork, fat 0.100000 1.000 1.000 6 

25002931 M Pork, fat-babyfood 0.100000 1.000 1.000 6 

25002940 M Pork, kidney 0.100000 1.000 1.000 7 

25002950 M Pork, liver 0.100000 1.000 1.000 7 
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

14 of 24

Attachment 3. Residue Distribution Files

PigFat(%CT=1.2)

TOTALZ=988

TOTALFREQ=1

12, 0.1

PigMbyp(%CT=1.2)

TOTALZ=988

TOTALFREQ=1

12, 0.3

CattleMbyp(%CT=0.3)

TOTALZ=997

TOTALFREQ=1

3, 0.2

Pig Kidney/Liver(%CT=1.2)

TOTALZ=988

TOTALFREQ=1

12, 0.1

PigMeat(%CT=1.2)

TOTALZ=988

TOTALFREQ=1

12, 0.05

CattleFat(%CT=0.3)

TOTALZ=997

TOTALFREQ=1

3, 0.1

CattleMeat(%CT=0.3)

TOTALZ=997

TOTALFREQ=1

3, 0.02

Milk(%CT=0.3)

TOTALZ=1480

TOTALFREQ=1

5, 0.025

MilkFat(%CT=0.3)

TOTALZ=997

TOTALFREQ=1

3, 0.2

Amitraz-honey at 15 days PHI

TOTALZ=0

TOTALNZ=4

0.047

0.062

0.084

0.045
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

15 of 24

Attachment 4. Percent Animals Treated Memo from BEAD

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

OFFICE OF

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES

MEMORANDUM

SUBJECT: Response to Request for Percent of Animals Treated with Amitraz, PC 

106201, to support Registration Review HED Scoping Document, DP# 

367939

FROM: Cynthia Doucoure, EPS

Science Information and Analysis Branch

Biological and Economic Analysis Division (7503P)

THRU: Diann Sims, Chief

Science Information and Analysis Branch 

Biological and Economic Analysis Division (7503P)

TO: David Soderberg

Health Effects Division (7509P)

BEAD received a request for percent of animals treated with amitraz to support 

HED’s registration review scoping document. In 2004, BEAD provided HED percent of 

animals treated with amitraz for dairy cattle heads (0.1%), which was used in the RED. 

This document provides a review and update of the previously provided data. In 

addition, HED is requesting percent of animals treated with amitraz in either Puerto Rico 

or Texas or both. The data will be used to support the exposure assessment, which is 

considered important because fluid milk is mostly distributed locally within a so-called 

“milk shed,” which is analogous to a watershed. According to HED, since milk is 

generally mixed together from multiple local farms, any percent of dairy cattle treated 

factor would directly affect children’s exposure. 

Percent of Animals Treated with Amitraz

Amitraz is an insecticide/acaricide used to control lice, livestock ticks, and mange 

mites on beef and dairy cattle and swine, and ticks on dogs. For this request, BEAD 

reviewed available data in USDA NASS for cattle and swine to determine the percent of 
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

16 of 24

animal heads treated with amitraz. NASS does not report the total number of dairy cattle 

treated with a particular chemical because the applications vary significantly based on 

product formulation, method of application, and pest stress at particular locations. 

Rather, they report chemical usage on a rate per head per application and rate per head 

per year basis. To determine the number of cattle treated, BEAD divided the total pounds 

of amitraz applied by the total rate per head per year, which NASS defines as the average

number of pounds applied counting multiple applications. The assumption is that the 

average rate captures the variation in number of cows treated. 

The percent of animal heads treated was obtained by dividing the total number of 

heads treated with amitraz by the total number of heads in U.S. production. For dairy 

cattle, the average percent of cattle heads treated is 0.2% or less than 1%. The maximum 

percent of cattle heads treated is 0.3% or less than 1%. Less than 1% is recommended for 

use in chronic and acute dietary exposure assessments. 

 

See Table 1 below.

Table 1. Percent of Dairy Cattle Heads Treated with Amitraz, 2001 & 2006

Dairy Cattle Heads Years

2001 2006

Total Pounds of Amitraz Applied* 100 400

Total Rate / Head / Year (pounds)* 0.008157 0.017637

Avg # of Heads Treated w/ Amitraz 12,259 22,680

Total # of Heads in U.S. Production* 9,115,000 7,523,000

Percent of Heads Treated 0.1% 0.3%

Avg Percent of Heads Treated 0.2%

Max Percent of Heads Treated 0.3%

*Source: USDA NASS: Agricultural Chemical Usage, Dairy Cattle and Dairy Facilities, 2001 & 2006

For swine, the average percent of swine heads treated is 0.7% or less than 1%, which is 

recommended for use in chronic exposure assessments. The maximum percent of swine 

heads treated is 1.2%, which is recommended for acute dietary exposure assessments. 

See Table 2 below. 

Table 2. Percent of Swine Heads Treated with Amitraz, 1999 & 2005 

Swine Heads Years

1999 2005

Total Pounds of Amitraz Applied* 12260 637

Total Rate / Head / Year (pounds)* 0.017857 0.005168

Total # of Heads Treated w/ Amitraz 686,565 123,259

Total # of Heads in U.S. Production* 59,337,000 61,417,000
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

17 of 24

Percent of Heads Treated 1.2% 0.2%

Avg Percent of Heads Treated 0.7%

Max Percent of Heads Treated 1.2%

*Source: USDA NASS: Agricultural Chemical Usage, Swine and Swine Facilities, 2000 & 2006 

Percent of Animals Treated with Amitraz in Puerto Rico or Texas

BEAD also searched available sources and literature for data on percent of dairy 

cattle treated with amitraz in the U.S. and percent of dairy cattle treated with amitraz in 

Texas and/or Puerto Rico. No data were found for either of these sites. However, USDA 

NASS surveyed Texas in 2001 and 2006, reported 325,000 and 345,000 dairy cattle 

heads in production in Texas respectively, but did not report any usage of amitraz on 

those dairy cattle. According to NASS, in order to publish data for an active ingredient, 

there must be a minimum of five reports for the specific active ingredient at the summary 

level (by State or all Program States). 

cc: J. Parker

J. Arthur

L. Parsons

Appended E-mail re Percent imported for cottonseed oil

From Jihad Alsadek To David Soderberg 10/13/2010 11:04 AM

Hi David,

Luckily I have just finished the calculations for the percent of cottonseed oil consumed in the 

US that is imported . Data show that almost two percent of the cottonseed oil consumed in the

U.S. are imported. Assuming 100 percent amitraz cotton treatment, we can conservatively use 

2% as PCT for your model. I am attaching the file that shows the calculations.
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

18 of 24

Attachment 5. Acute Residue Output File

U.S. Environmental Protection Agency Ver. 2.02

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

Residue file: 6aprilamitrazachimilkFThoneyrdf.R98 Adjustment factor #2 used.

Analysis Date: 04-09-2012/12:01:18 Residue file dated: 04-09-2012/11:51:10/8

Daily totals for food and foodform consumption used.

MC iterations = 2000 MC list in residue file MC seed = 10

Run Comment: ""

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

Summary calculations (per capita):

 95th Percentile 99th Percentile 99.9th Percentile

 Exposure % aRfD Exposure % aRfD Exposure % aRfD 

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

U.S. Population:

 0.000008 0.61 0.000040 3.17 0.000199 15.91 

All infants:

 0.000005 0.36 0.000021 1.69 0.000286 22.87 

Children 1-2 yrs:

 0.000017 1.34 0.000127 10.13 0.000956 76.50 

Children 3-5 yrs:

 0.000017 1.35 0.000102 8.20 0.000606 48.45 

Children 6-12 yrs:

 0.000011 0.91 0.000061 4.90 0.000367 29.34 

Youth 13-19 yrs:

 0.000006 0.49 0.000038 3.04 0.000160 12.80 

Adults 20-49 yrs:

 0.000006 0.48 0.000033 2.65 0.000117 9.36 

Adults 50+ yrs:

 0.000006 0.52 0.000031 2.48 0.000118 9.44 

Females 13-49 yrs:

 0.000006 0.45 0.000032 2.57 0.000117 9.32 
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

19 of 24

Attachment 6 CEC files (To reduce clutter commodities contributing 

leas than 1% of the dietary exposure have been clipped from these 

files.)

U.S. Environmental Protection Agency

DEEM-FCID Acute Critical Exposure Contribution Analysis (Ver 2.02)

CSFII 1994-98

Residue file = C:\Documents and Settings\dsoderbe\My 

Documents\amitrazreque\6aprilamitrazachimilkFThoneyrdf.R98

Date and time of analysis: 04-09-2012 15:30:09

Daily totals for food and foodform consumption used.

Adjustment factor #2 used.

Minimum exposure contribution = 1%

Monte Carlo Iterations = 2000 Seed = 10

CEC records generated for first 970 iterations.

Exposures divided by body weight

Subpopulations:

 1 U.S. Population

 2 All infants

 3 Children 1-2 yrs

 4 Children 3-5 yrs

 5 Children 6-12 yrs

 6 Youth 13-19 yrs

 7 Adults 20-49 yrs

 8 Adults 50+ yrs

 9 Females 13-49 yrs

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

U.S. Population

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000148

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.000324

Number of actual records in this interval: 84203

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

95001860 110 22440 24.20% Honey-Uncooked; Fresh or N/S; Cook Meth N/S

27022240 110 19048 23.78% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

27002220 110 14850 17.51% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

25002900 250 3746 4.03% Pork, meat-Cooked; Cured etc; Cook Meth N/S

27012230 110 3277 3.22% Milk, nonfat solids-Uncooked; Fresh or N/S; Cook Meth 

N/S

25002900 211 2082 2.28% Pork, meat-Cooked; Fresh or N/S; Baked

25002900 213 1841 1.91% Pork, meat-Cooked; Fresh or N/S; Fried

27032251 130 1549 1.88% Milk, sugar (lactose)-baby food/infant-Uncooked; 

Dried; Cook Meth N/S

27002220 120 1537 1.65% Milk, fat-Uncooked; Frozen; Cook Meth N/S

27032251 240 1297 1.64% Milk, sugar (lactose)-baby food/infant-Cooked; 

Canned; Cook Meth N/S

25002900 210 1579 1.58% Pork, meat-Cooked; Fresh or N/S; Cook Meth N/S

25002920 210 1085 1.14% Pork, meat byproducts-Cooked; Fresh or N/S; Cook Meth 

N/S

95001860 210 730 0.96% Honey-Cooked; Fresh or N/S; Cook Meth N/S

All infants

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000216

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.000422

Number of actual records in this interval: 2792

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

20 of 24

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

27032251 240 993 36.36% Milk, sugar (lactose)-baby food/infant-Cooked; 

Canned; Cook Meth N/S

27032251 130 916 31.62% Milk, sugar (lactose)-baby food/infant-Uncooked; 

Dried; Cook Meth N/S

27002220 110 241 9.09% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

27022240 110 164 5.83% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

27012230 110 148 5.09% Milk, nonfat solids-Uncooked; Fresh or N/S; Cook Meth 

N/S

25002900 250 64 2.31% Pork, meat-Cooked; Cured etc; Cook Meth N/S

27032251 110 63 2.17% Milk, sugar (lactose)-baby food/infant-Uncooked; 

Fresh or N/S; Cook Meth N/S

Children 1-2 yrs

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000733

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.001364

Number of actual records in this interval: 4178

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

27022240 110 3772 90.49% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

27002220 110 368 7.79% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

Children 3-5 yrs

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000479

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.000825

Number of actual records in this interval: 8677

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

27022240 110 7728 89.10% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

27002220 110 587 5.93% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

25002900 250 112 1.08% Pork, meat-Cooked; Cured etc; Cook Meth N/S

Children 6-12 yrs

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000288

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.000520

Number of actual records in this interval: 4341

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

27022240 110 3443 80.00% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

27002220 110 320 6.53% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

95001860 110 312 4.97% Honey-Uncooked; Fresh or N/S; Cook Meth N/S

25002900 250 75 1.53% Pork, meat-Cooked; Cured etc; Cook Meth N/S

Youth 13-19 yrs

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000125

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.000240

Number of actual records in this interval: 2294
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

21 of 24

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

27022240 110 1398 62.32% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

27002220 110 299 11.98% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

25002900 211 119 4.85% Pork, meat-Cooked; Fresh or N/S; Baked

25002900 210 61 2.45% Pork, meat-Cooked; Fresh or N/S; Cook Meth N/S

27002220 120 51 2.14% Milk, fat-Uncooked; Frozen; Cook Meth N/S

25002900 250 53 1.76% Pork, meat-Cooked; Cured etc; Cook Meth N/S

25002920 232 36 1.56% Pork, meat byproducts-Cooked; Dried; Boiled

27002220 232 31 1.13% Milk, fat-Cooked; Dried; Boiled

25002930 250 35 1.03% Pork, fat-Cooked; Cured etc; Cook Meth N/S

27002220 210 27 1.01% Milk, fat-Cooked; Fresh or N/S; Cook Meth N/S

25002900 212 26 0.96% Pork, meat-Cooked; Fresh or N/S; Boiled

Adults 20-49 yrs

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000097

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.000159

Number of actual records in this interval: 9188

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

27022240 110 3422 37.88% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

95001860 110 1702 14.89% Honey-Uncooked; Fresh or N/S; Cook Meth N/S

27002220 110 876 9.09% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

25002900 250 606 6.36% Pork, meat-Cooked; Cured etc; Cook Meth N/S

25002900 210 480 5.08% Pork, meat-Cooked; Fresh or N/S; Cook Meth N/S

25002900 211 487 4.99% Pork, meat-Cooked; Fresh or N/S; Baked

25002900 213 323 3.21% Pork, meat-Cooked; Fresh or N/S; Fried

25002920 232 135 1.42% Pork, meat byproducts-Cooked; Dried; Boiled

25002920 210 113 1.10% Pork, meat byproducts-Cooked; Fresh or N/S; Cook Meth 

N/S

27002220 120 111 1.08% Milk, fat-Uncooked; Frozen; Cook Meth N/S

Adults 50+ yrs

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000094

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.000178

Number of actual records in this interval: 9513

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

27022240 110 4533 48.58% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

95001860 110 1205 7.37% Honey-Uncooked; Fresh or N/S; Cook Meth N/S

25002900 211 625 6.19% Pork, meat-Cooked; Fresh or N/S; Baked

27002220 110 567 5.51% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

25002900 250 446 4.48% Pork, meat-Cooked; Cured etc; Cook Meth N/S

25002920 232 411 4.09% Pork, meat byproducts-Cooked; Dried; Boiled

25002900 210 413 3.95% Pork, meat-Cooked; Fresh or N/S; Cook Meth N/S

25002920 210 205 1.95% Pork, meat byproducts-Cooked; Fresh or N/S; Cook Meth 

N/S

25002900 213 210 1.88% Pork, meat-Cooked; Fresh or N/S; Fried

27022240 212 140 1.27% Milk, water-Cooked; Fresh or N/S; Boiled

27002220 120 124 1.25% Milk, fat-Uncooked; Frozen; Cook Meth N/S

25002900 212 128 1.20% Pork, meat-Cooked; Fresh or N/S; Boiled

25002930 213 128 1.07% Pork, fat-Cooked; Fresh or N/S; Fried

Females 13-49 yrs
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

22 of 24

Low percentile for CEC records: 99.85 Exposure (mg/day) = 0.000095

High percentile for CEC records: 99.95 Exposure (mg/day) = 0.000161

Number of actual records in this interval: 5742

Critical foods/foodforms for this population (as derived from these records):

 N=number of appearances in all records (including duplicates)

 %=percent of total exposure for all records (including duplicates)

Food FF N Percent Food Name 

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

27022240 110 2428 42.52% Milk, water-Uncooked; Fresh or N/S; Cook Meth N/S

95001860 110 1152 15.92% Honey-Uncooked; Fresh or N/S; Cook Meth N/S

27002220 110 633 10.44% Milk, fat-Uncooked; Fresh or N/S; Cook Meth N/S

25002900 250 224 3.70% Pork, meat-Cooked; Cured etc; Cook Meth N/S

25002900 211 201 3.42% Pork, meat-Cooked; Fresh or N/S; Baked

25002900 210 186 3.12% Pork, meat-Cooked; Fresh or N/S; Cook Meth N/S

25002900 213 153 2.41% Pork, meat-Cooked; Fresh or N/S; Fried

27022240 120 96 1.48% Milk, water-Uncooked; Frozen; Cook Meth N/S

27002220 120 83 1.32% Milk, fat-Uncooked; Frozen; Cook Meth N/S

25002920 232 72 1.31% Pork, meat byproducts-Cooked; Dried; Boiled

25002920 210 67 1.00% Pork, meat byproducts-Cooked; Fresh or N/S; Cook Meth 

N/S
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

23 of 24

Attachment 7. Chronic Residue Input File

U.S. Environmental Protection Agency Ver. 2.00

DEEM-FCID Chronic analysis for AMITRAZ 1994-98 data

Residue file: C:\Documents and Settings\dsoderbe\My 

Documents\amitrazreque\amitraz2plushoneychmilkhiFTapr12.R98

 Adjust. #2 used

Analysis Date 04-12-2012 Residue file dated: 04-12-2012/09:22:42/8

Reference dose (RfD) = 0.00125 mg/kg bw/day

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

Food Crop Residue Adj.Factors Comment

EPA Code Grp Food Name (ppm) 

 #1 #2 

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

21000440 M Beef, meat 0.020000 1.000 0.002 

21000441 M Beef, meat-babyfood 0.020000 1.000 0.002 

21000450 M Beef, meat, dried 0.020000 1.920 0.002 

21000460 M Beef, meat byproducts 0.200000 1.000 0.002 

21000461 M Beef, meat byproducts-babyfood 0.200000 1.000 0.002 

21000470 M Beef, fat 0.100000 1.000 0.002 

21000471 M Beef,fat-babyfood 0.100000 1.000 0.002 

21000480 M Beef, kidney 0.200000 1.000 0.002 

21000490 M Beef, liver 0.200000 1.000 0.002 

21000491 M Beef, liver-babyfood 0.200000 1.000 0.002 

95001280 O Cottonseed, oil 1.000000 1.000 0.020 

95001281 O Cottonseed, oil-babyfood 1.000000 1.000 0.020 

95001860 O Honey 0.060000 1.000 1.000 

95001861 O Honey-babyfood 0.060000 1.000 1.000 

27002220 D Milk, fat 0.200000 1.000 0.002 

27002221 D Milk, fat - baby food/infant for 0.200000 1.000 0.002 

27012230 D Milk, nonfat solids 0.025000 1.000 0.002 

27012231 D Milk, nonfat solids-baby food/in 0.025000 1.000 0.002 

27022240 D Milk, water 0.025000 1.000 0.002 

27022241 D Milk, water-babyfood/infant form 0.025000 1.000 0.002 

27032251 D Milk, sugar (lactose)-baby food/ 0.025000 1.000 0.002 

25002900 M Pork, meat 0.050000 1.000 0.007 

25002901 M Pork, meat-babyfood 0.050000 1.000 0.007 

25002910 M Pork, skin 0.100000 1.000 0.007 

25002920 M Pork, meat byproducts 0.300000 1.000 0.007 

25002921 M Pork, meat byproducts-babyfood 0.300000 1.000 0.007 

25002930 M Pork, fat 0.100000 1.000 0.007 

25002931 M Pork, fat-babyfood 0.100000 1.000 0.007 

25002940 M Pork, kidney 0.100000 1.000 0.007 

25002950 M Pork, liver 0.100000 1.000 0.007 
Amitraz Dietary Exposure and Risk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

24 of 24

Attachment 8. Chronic Exposure Output File

U.S. Environmental Protection Agency Ver. 2.00

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

Residue file name: C:\Documents and Settings\dsoderbe\My 

Documents\amitrazreque\amitraz2plushoneychmilkhiFTapr12.R98

 Adjustment factor #2 used.

Analysis Date 04-12-2012/09:24:21 Residue file dated: 04-12-2012/09:22:42/8

Reference dose (RfD, Chronic) = .00125 mg/kg bw/day

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

 Total exposure by population subgroup

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

 Total Exposure

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

U.S. Population (total) 0.000002 0.2%

U.S. Population (spring season) 0.000002 0.2%

U.S. Population (summer season) 0.000002 0.1%

U.S. Population (autumn season) 0.000002 0.2%

U.S. Population (winter season) 0.000002 0.2%

Northeast region 0.000002 0.1%

Midwest region 0.000002 0.2%

Southern region 0.000002 0.2%

Western region 0.000002 0.2%

Hispanics 0.000002 0.1%

Non-hispanic whites 0.000002 0.2%

Non-hispanic blacks 0.000002 0.1%

Non-hisp/non-white/non-black 0.000002 0.2%

All infants (< 1 year) 0.000001 0.1%

Nursing infants 0.000000 0.0%

Non-nursing infants 0.000002 0.1%

Children 1-6 yrs 0.000005 0.4%

Children 7-12 yrs 0.000003 0.2%

Females 13-19 (not preg or nursing) 0.000001 0.1%

Females 20+ (not preg or nursing) 0.000001 0.1%

Females 13-50 yrs 0.000002 0.1%

Females 13+ (preg/not nursing) 0.000002 0.2%

Females 13+ (nursing) 0.000002 0.1%

Males 13-19 yrs 0.000002 0.2%

Males 20+ yrs 0.000002 0.1%

Seniors 55+ 0.000001 0.1%

Children 1-2 yrs 0.000006 0.5%

Children 3-5 yrs 0.000005 0.4%

Children 6-12 yrs 0.000003 0.3%

Youth 13-19 yrs 0.000002 0.1%

Adults 20-49 yrs 0.000001 0.1%

Adults 50+ yrs 0.000001 0.1%

Females 13-49 yrs 0.000001 0.1%

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