Amitraz Dietary Expos ure and Risk Assessment DP Number: 383216

PC Code: 106201

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### This is a revision to a food only a cute dietary exposure assessment (28 October 2011, DP # 383216) that was conducted using the Dietary E xposure Evaluation Model DEEM

FCIDTM, 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

reg istration of amitraz for use as Apivar strips in b ee h ives

. 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 revisio n 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 ne cessary to use a source of residue values that include s 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 fe ed 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 TR ED ( D300301; Amitraz TRED, J. Morales, 4/30/04 ) states that the 1X treatment rate produced residues between 0.006 to 0.025 ppm. The se 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 i f 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 address es 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 a cute assessment is assumed to be protective of ch r onic risks

.

Acute ( Food Only ) Die tary 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. Th e values used for livestock product s , 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 s tudy ( as cited in D300301; Amitraz TRED, J. Morales, 4/30/04 TRED) 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 r esidues in cottonseed oil were estimated atAmitraz Dietary Expos ure and Risk Assessment DP Number: 383216

PC Code: 106201

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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 0.00 0 956 mgs/kg/day, or 76.5 % of the aPAD. The general p opulation is estimated to be exposed at

0.00 01 9 9 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 ha s determined that the acute assessment representing one day exposure is protective of any chronic dietary exposures to amitraz and a c hronic dietary exposure assessment is therefore not needed

. (However, see attachments 7 and 8

, for a chronic exposure estimate that w as done for p ossible aggregation with non

- dietary

exposure .)

C ancer Dietary Exposure Results and Characterization

HED has deter mined that amitraz is to be classified as producing suggestive evidence of carcinogenicity, but that the cancer risk should not be quantified

. Therefore

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

the aP AD) 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

excee ds one in one m illion

. 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 Soderb erg
, ( 2 8 October 201 1 , DP # 3 83216 ).

II. Residue InformationAmitraz Dietary Expos ure and Risk Assessment DP Number: 383216

PC Code: 106201

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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. T he t olerances 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]. Th ese are also the residue s of concern in foods for dietary exposure

assessment.

The submitted pe tition 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 b eeswax tolerance be reinstated to support the requested use of the Apivar strips. Further, a lthough r esidues 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 bees wax 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 tolerance s a re summarized in the t able 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

- me thylmethanimidamide) 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, me at byproducts 0.2

Cotton, undelinted seed 1 1.0

Hog, fat 0.1

Hog, kidney 0.1

Hog, liver 0.1Amitraz Dietary Expos ure and Risk Assessment DP Number: 383216

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5 of 24 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 Acut e 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, a ll 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 dimethyl

aniline 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

, a n RDF for milk was created based upon th e 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.

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

cottonseed oil so tolerance level residues were use d 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 cottons eed.

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 hiv e 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 Da tabase DEEM

- FCIDTM,

Version 2.03 which incorporates consumpt ion 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 filesAmitraz Dietary Expos ure and Risk Assessment DP Number: 383216

PC Code: 106201

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### developed jointly by USDA/ARS and EPA. For ch ronic 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 consumptio n 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, ch ildren 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 multi plied 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 co mmodity 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 a ssessment, 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 re levant 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, fo r 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 ta ble, 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 Unce rtainty/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 UF A = 10 x

UF H = 10 x FQPA SF= 1 x 

### 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.Amitraz Dietary Expos ure and Risk Assessment DP Number: 383216

PC Code: 106201

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7 of 24 Chronic Dietary (All Populations) Th e 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

environme ntally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = potential variation in sensitivity among m embers of the human population (interspecies). UF L = use of a LOAEL to extrapolate a NOAEL. UF S = use of a short

- term study for long

term risk assessment. UF DB = to account for the absence of key dat a (i.e., lack of a critical study). FQPA SF = FQPA Sa fety 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 co ncerned 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 Table s 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 not e attachments 7 and 8 , which were provided to support an y aggregate assessment involving

non

- dietary exposures. )

Results of Acute Dietary (Food Only ) Exposure Analy s is

The results of the acute dietary exposure analysis at the 95 th 

### , 99 th 

### , and 99.9 th 

### percentiles of exposure are reported in Table 3

. This is a re fined assessment so results are reported at

the 99.9 th 

### percentile. The most highly exposed sub

- population is children 1

- 2 years of

age at 0.000 956 mgs/kg/day, or 76.5 % of the aPAD at the 99.9 th 

### percentile . The general population is estimated to be expose d at 0.0001 9 9 mgs/kg/day, or 15. 9% of the aPAD at
the 99.9 th 

### percentile

.

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

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

Expos ure (mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD

General U.S. Population 0.00125 0.0000 0 8 <1.0 0.000 0 40 3.2 0.00 01 9 9 15. 9

All Infants (< 1 year old) 0.00125 0.00000 5 <1.0 0.000 0 21 1. 7 0.00 0 286 22.9

Children 1

- 2 years ol d 0.00125 0.000 01 7 1. 3 0.000 127 10.1 0.00 0 956 76.5

Children 3

- 5 years old 0.00125 0.000 01 7 1. 4 0.000 102 8.2 0.00 0 606 48.5

Children 6

- 12 years old 0.00125 0.0000 11 <1.0 0.000 0 61 4.9 0.00 0 367 29.3Amitraz Dietary Expos ure and Risk Assessment DP Number: 383216

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

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

Expos ure (mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD

Youth 13

- 19 years old 0.00125 0.0000 0 6 <1.0 0.000 03 8 3.0 0 .000 160 12.8

Adults 20

- 49 years old 0.00125 0.0000 0 6 <1.0 0.000 0 33 2. 7 0.000 117 9.4

Adults 50+ years old 0.00125 0.0000 0 6 <1.0 0.000 0 31 2. 5 0.000 118 9 .4

Females 13

- 49 years old 0.00125 0.000 0 0 6 <1.0 0.000 0 32 2. 6 0.00 0 117 9.3



### Results of Chronic Dietar y (Food Only ) Exposure Analy s is

The acute exposure assessment is assumed to be protective of any chronic exposure and a chronic assessment was not formally performed . (However, see attachment s 7 and 8 .)

Results of Cancer Dietary (Food Only) Exposure Ana ly s is

A cancer assessment is not required.

Summary Analysis

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

Population Subgroup Acute Dietary

( 99.9 th Percentile) Cancer

Dietary Exposure (mg/kg/day) %

aPAD* Dietary

Exposure (mg/ kg/day) Risk

General U.S. Population 0.00 01 9 9 15.9 A cute endpoint is protective of any possible cancer effects

All Infants (< 1 year old) 0.00 0 286 22.9

N/A N/A Children 1

- 2 years old 0.00 0 956 76.5

Children 3

- 5 years old 0.00 0 606 48.5

Children 6

- 12 years old 0.00 0 367 29.3

Youth 13

- 19 years old 0.000 160 12.8

Adults 20

- 49 years old 0.000 117 9.4

Adults 50+ years old 0.000 118 9 .4

Females 13

- 49 years old 0.00 0 117 9.3Amitraz Dietary Expos ure and Risk Assessment DP Number: 383216

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### VII. Characterization of Inputs/Outputs

There are a number of uncertain ties 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 be eswax 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 be en 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, no r 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 PD P 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 w as 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 (0.0 3 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 am itraz 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 ext rapolation of this ki nd of use to other similar situations could also yield an important potential uncertainty attached to residues in milk. Th is is because

th ere 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 a n increased local risk of exposure th rough 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.Amitraz Dietary Expos ure and Risk Assessment DP Number: 383216

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### The effect of consumption on these results is interesting (see Attachment 6

– CEC files

for a breakdow n 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 o f 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

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


### percentile HED’s level of concern is not exceeded for any population subgroup . The most highly expo sed population subgroup is child ren 1

- 2 at 76.5 % aPAD. The general U.S. popu lation 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 BE AD.

5. Acute Results file.

6. CEC Summary file.

7. Chronic/Food Residue Input file.

8. Chronic Results file.

cc: D

. Soderberg; D. Drew; M. MetzgerAmitraz Dietary Expos ure and Risk Assessment DP Number: 383216

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### Attachment 1

. Summary of Data and Residue Estimates Used in Dietary Analyses

RAC Food

Forms Classific

ation 1 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 N A 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.RDFAmitraz Dietary Expos ure and Risk Assessment DP Number: 383216

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12 of 24 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 Al l 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(?) Un

known 0.3 None Milk.rdf

Milk

Water All PB Dosing Study as

Cited in

TRED 5(?) at

1X, only highest

used All 5(?) Un

known 0.3 None Milk.RDF

Milk Sugar All PB Dosing Study as

Cited in

TRED 5(?) at

1X, only highest

used All 5(?) Un

known 0.3 None Milk.RDF

1. Classification of blended (B), partially blended (PB), not blended (NB) , but we note that these classificati ons 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.Amitraz Dietary Exposure and R isk Assessment DP Number: 383216

PC Code: 106201

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13 of 24 Att a chment 2. Acute Residue In put 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 P arameter #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 0.2 00000 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 1.00 0 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

- bab yfood 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 7Amitraz Dietary Exposure and R isk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

14 of 24 Attachment 3. Residue Distribution Files

P igFat(%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

TOTALFRE Q=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

T OTALNZ=4

0.047

0.062

0.084

0.045Amitraz Dietary Exposure and R isk Assessment DP Number: 383216

PC Code: 106201

______________________________________________________________________________________

15 of 24 Attachment 4. Percent Animals Treated Memo from BEAD



### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

W ASHINGTON D.C., 20460

OFFICE OF PREVENTION, PESTICIDES AND
TOXI C 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

Biolo gical 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 perce nt 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 upd ate 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 US DA NASS for cattle and swine to determine the percent ofAmitraz Dietary Exposure and R isk 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 ap plied 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 tr eated is 0.3% or less than 1%. Less than 1% is recommended for use in chronic and acute dietary exposure assessments.

See Table 1 bel ow.

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/ Amitra z 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 a nd 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

Swi ne 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 61,417,000Amitraz Dietary Exposure and R isk 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. H owever, 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 activ e 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 J ihad 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 R isk 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 dat ed: 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 calcu lations (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 9.32Amitraz Dietary Exposure and R isk 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 the se 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 b y 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 211 208 2 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 120 153 7 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 2 10 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 percen tile 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 R isk 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

- Unc ooked; 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 th is 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

Child ren 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 de rived 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

2 5002900 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 r ecords in this interval: 2294Amitraz Dietary Exposure and R isk 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 F F 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

- Uncooke d; 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

2500 2920 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 1.2 7% 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; Fr esh or N/S; Fried

Females 13

- 49 yrsAmitraz Dietary Exposure and R isk 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 fo r 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/SAmitraz Dietary Exposure and R isk 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 Cr op 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 0.007Amitraz Dietary Exposure and R isk 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 0.0 00005 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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