### Aldicarb Die1ary Exposure and Ri s k Assessment DP Nu mb er: 0430197



### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON

, D

. C

. 20460

OF F IC E O F CH EM ICA L S AFE TY AND
POLLUT I ON P REV EN T I O N



### MEMORAN D UM

D ate : 03 / 28 / 20 16



### SU BJ ECT: A ldic a rb

. Ac ute Aggregate Diet ary (Food and Drinking Wat e r ) Exposure and

Risk Asse ss ments for Registration Re v ie w Ri sk Assessment.



### P C Code : 09830 I



### D ecis i o n No

. :

- 1 

### 498310



### P e ti t i o n No.: NA 

### D P B a r co d e: D430197



### R eg i st r a ti o n No.: 87895-1



### R eg ul a to ry A ction : Reg i stra tion Review



### Case No.: 0 140 

### Ri s k Assess m e nt Ty p e : Dietary



### TX R No.: NA 

### CAS No.: 116-06-3



### M RI D No. : NA 

### 40 CFR: 

### § 180.269



### F RO M :

T HR OUG H : Ideliz Negr6n

- Encarnac i 6 n
, Ph.D.

, C h emist

# ~Lc....c...----­ Risk Asse ss m e nt Branch V 

### (RA B V) 

# '"7

Health Effec t s Di v ision ( H E D ; 7509P)

Danette Dr ew, Chemist (RABY; HED) ./ 

# i

T ;/ 

# J j

Michael S. Metzger, Branch C hief(RAJ?V ; H E D

# ~tl{/**'** 

# ·

Steve Nako, Ph.D.

, Statistician 

## .f./1.v111- 

## h!t 

## 7,,J-€7

Chemist r y and Exposure Branch (HE ) ·

and 

# e

Thurston Mo11on

, Chemi s t · Kristin Rickard

, Biologi s t 

# \L!

Dietary Exposure Science Adv i sory Council ( DESAC ; HED )



### TO: Susan Bartow

, C hemical R ev i ew Manager

Tom M yers
, Team Leader

Pesticide Re-evaluation Divi s ion ( PRD ; 7508P )



### Exec uti ve S umm ary

Acute agg r ega te dietary (food o nl y, food and drinking w ater, and drinkin g wate r o nl y) exposure
and risk assessments were conducted using the Dietary Expo s ur e Evaluation Mode l software

with the Food Commod i ty Intake Datab ase (DEEM-FCID) Version 3 .1 6. Thi s so ftware use s
2003-2008 food consumption data from the U .S. Department of Agriculture 's (US D A ' s)

Pa ge I of34

### Aldicarb Dietary Expo s ure and Risk A ssess ment DP Numbe r : 0430197



### National He a lth a nd Nutrition Exami nati on Survey

, What We Eat in America

, (NHANES / WWEIA). The analyses were cond ucted in s upport of the r eg i stration review ri s k

draft risk assessment ( DRA ). T his m emo randum was r ev iewed by two peer r ev i ewe r s of the

D ESAC (and the e ntire DESA C on 12110 12 015)

, per D ESAC SOP 20 12.1.

Acute dietary exposu r e assess m ents in corporated US DA Pesticide Data P rogram ( POP ) monitoring data for aldicarb and its met aboli te s aldicarb s ulfoxid e a nd a ldi carb su lfone

, anticipated re s idue s, field trial data, tol e r ances, empirical proces s in g factors, default D EEM

pr ocess ing factors

, and p e rc e nt crop tr ea t e d (CT) estimates

. A ldi carb metabolit es were assumed

to h ave s imilar t oxic it y to th e parent. The E n v ironm e nt a l Fate and Effec t s Division (EFE D ) provided dail y time series ou tput s for the scenar i o that provided the highest and l owes t estimated drinking water co ncentration s (E DW Cs)

. The highe st E OWC was for s urfac e wate r in M inn esota (MN sugar be e t s PRZM scenario) after app lic ation of the rate used for s ugar be e t s ( named

th e r eafte r MN S u gar Be e t s)

. T h e scenario that pro v ided the low es t E DWC was s urfac e wa t e r in

Californ ia (CA cqtton PRZM sce nari o) after application of the rate used for cotton ( nam ed

th ereafte r CA Cotto n )

.

Acute assessments were conducted for food only

, drinkin g water only

, and food and drinkin g

water. Although the 2010 miti gat ion ag r ee m e nt indi cated that toler ances for p eca n
, so rghum

, sugarca ne
, c itru s

. and potato were going to be re voked these commodities sti ll h ave tolerances

for a ldicarb in the 40 CFR. T he r efo re
, the se commodities were considered in th e dietary

assessment assuming that r es idues of ald i ca rb may be p r esen t in imported commodi tie s. As

s u c h

, the se commodities were included in th e dietar y a ssess ment considering th e percent of imp orts fo r tho se for w hi c h data was available and assuming that I 00% o f the imported crop i s

tr ea t e d. Coffee was included in th e 2010 dietary assessment in s upport of u se o n the imp o rt ed commodity. Co mmoditie s with register e d u ses in th e U.S.A. wer e included with their corresponding %CT

. Sugar b eet and s u ga rcane were excluded from the assessments, since

aldi c arb re s idu es wo uld not b e expec t ed in the processed co mm od iti es a s consumed.

This assessment incorporat e d an estimated half-life for red blood cell (RBC) c h o linestera se (ChE) inhibition o f two hour s which i s b ase d on data of a ldi ca rb from rats and human subjects.

H E D also refined th e acute di e ta ry ri s k from food and drinking waler b y incorp o rating the time

and amoun t s consumed for each eat in g occas i on fr om the US DA N H ANES/WWE I A food

diaries to estimate exposures and ri s k s on eac h eating occas ion thr oug hout th e d ay and factoring

in th e ChE I half-life r e l ated to a ldi carb ex po s ure. R e f e r to C. Olin ge r memo ( 0 2998 83

, 08 / 1 6 / 20 10 ) for add itional in fo rmation o n th e eating occas ion ana l ys i s.

A preliminary scree nin g s h owed that the ac ute dietary expos ure es timates from food alone was above HED 's l eve l of concern ( i.e. > 100 % of the aPAD) at the 99.9 111 

### percentile of exposure.
The commodity with hi g h es t contr ibuti on to the risk was potato tub e r s which do not hav e
d o m est ic u ses c urr e ntl y r egiste r e d for a ldi carb

. PDP data for potat o (2006

- 2009) we r e modified

to e liminat e con tribution from domestic sa mples. An acute diet a r y assess m ent us i ng only d etec t s from s ample s of imported potatoes re s ult s in risk s be l ow the le ve l of co ncern ( i. e

. < 100 % of the

a P A D ) at th e 99.9 111 

### percentil e of exposure. A ldicarb food o nly di e tary exposu r e es timate i s 65%

of th e aPAD for c hildren 1- 2 years old

, th e mo s t hi g hl y ex posed population s ub gro up
, and 25%

of the a P AD for the ge n era l pop ulati on. H owever, the commo dit y spec ific ana l ys i s results in

Page 2 of34Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 3 of 34 

### exposure estimates above 100% of the aPAD following consumption of an estimated single serving of sweet potato or potatoes.

Exposures are abo ve the level of concern (LOC) for drinking water only. Dietary exposure estimates ranged from 1, 4 00% to 2, 9 00%, and 150% to 3 4 0% of the aPAD at the 99.9 th


### percentile of exposure for the general population and most population subgroups using the

scenarios t hat resulted in the highest EDWC (MN sugar beets) and lowest EDWC (CA Cotton), respectively. Similarly, for food and drinking water, the dietary exposure is above HED’s LOC using drinking water scenarios that provided the highest EDWC (MN sugar beets).

A chronic assessment was not conducted because the toxicity database for aldicarb indicates that cholinesterase inhibition (ChEI) is the most sensitive effect found, the magnitude of ChEI does not increase with continued exposure, and that ChEI is generally reversible within 24 hours at the levels relevant to the dietary risk assessment

. The longer

- term exposures could be considered as a series of acute exposures , with regard to ChEI. All other effects noted in the sub

- chronic and chronic toxicity studies w ere observed at higher doses. Aldicarb is classified as not likely to be carcinogenic to humans ; therefore a cancer dietary assessment was not conducted

.

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 that HED has concluded will result in no unreasonab le adverse health effects).

This dose is referred to as the population

- adjusted dose (PAD). The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety

factors.

For acute and non

- cancer chronic exposures, HED is concerned when estimated dietary risk

exceeds 100% of the PAD. References that discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure fro m 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 aldicarb was conducted by C. Olinger ( 08/16/2010,

D299883 ).

II. Residue Information

Residues of Concern

The residues of concern for tolerance enforcement and risk assessment are the combined residues

of aldicarb and its two cholinesterase

- inhibiting metabolites aldicarb sulfoxide [2

- methyl

- 2

- (methylsulfinyl)propionaldehyde O

- (methyl carbamoyl) oxime] and aldicarb sulfone [2

- methyl

2

- (methylsulfonyl)propionaldehyde O

- (methyl ca rbamoyl) oxime]. In field trials, parent aldicarb is typically at or just above the limit of detection ( LOD ) ; however, residues of aldicarb sulfoxideAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 4 of 34 

### and/or aldicarb sulfone are detected more often and at higher levels than that of aldicarb.

Aldicarb sul foxide residues are found more frequently than the sulfone, and tend to be higher than sulfone residues when both are present. In monitoring data, parent aldicarb is rarely detected. Aldicarb sulfoxide is considered to be as potent as the parent in terms of toxicity, while the sulfone is less potent. For risk assessment, the metabolites are assumed to have toxicity equivalent to parent compound aldicarb.

Tolerances

Tolerances are est ablished in the 40 CFR § 180.269 for the use of aldicarb on bean, suga r beet, coffee, cotton, grapefruit, lemon, lime, orange, peanut, pecan, potato, sorghum, soybean, sugarcane and sweet potato . These tolerances are based on measurement of combined residues

of aldicarb and its cholinesterase

- inhibiting metabolites aldicarb sulfoxide [2

- methyl

- 2

- (methylsulfinyl)propionaldehyde O

- (methyl carbamoyl) oxime] and aldicarb sulfone [2

- methyl

2

- (methylsulfonyl)propionaldehyde O

- (methyl carbamoyl) oxime] and range from 0.02 to 1 ppm. The tolerances for dry bean, sugar beet, cotton, peanut, soybean and sweet potato are based on

domestic uses of aldicarb. Coffee was included in the 2010 dietary assessment in support of use on the imported commodity. Although tolerances for potato, citrus, coffee, pecan, sorghum and

sugar cane are est ablished in the CFR, there are no registered uses in the U.S.A. As tolerances for these commodities are in the CFR at this time, these commodities were considered in the dietary assessment assuming that residues of aldicarb may be present in imported comm odities. Although livestock feedstuffs are associated with uses of aldicarb, t olerances are not establish ed

for livestock commodities because transfer of residue s to livestock commodities is not expected (i.e., a 40 CFR §180.6(a)(3) situation applies) (W. Donovan, D425180, In Progress )

.

Anticipated Residues

USDA PDP monitoring data for potato, sweet potato

, and orange (translated to other citrus commodities) were incorporated in the dietary assessment. The PDP was specifically designed for risk assessment; analysts prepare samples in a manner similar to typical consumer practices, such as washing, coring, and peeling. In years 2006 to 2012 , USDA PDP analyzed several

commodities for residues of aldicarb and its metabolites separately

. PDP monitoring data were used for residues of aldicarb and its metabolites in/on potato, sweet potato, and citrus ( orange
, lemon, lime and grapefruit)

. F ield trial data provided in the previous dietary assessment (C. Oling er, D299883, 08/16/2010) were used for soybean, dry beans, pecan, cottonseed, coffee and

peanut

. Tolerance

- level residue was used for sorghum. Sugar beet and sugarcane were excluded from the assessments, since aldicarb residues would not be expected in t he pr ocessed

commodities as consumed. Attachment A.1.2 and A.1.3 summarizes the residue inputs (anticipated residues, processing factors, PCT, etc.) and all of the residue distribution files ( RDF s) , respectively, used for the acute assessment

.

R esidues of parent aldicarb, aldicarb sulfone

, and aldicarb sulfoxide were combined using a Statistical Analysis System (SAS) program that matches residues from the same samples using the PDP sample IDs

. The SAS program directly created the RDFs for use in the acute analys is

. In some cases, residues of either aldicarb or its metabolites may have not been detected or the samples may not have been analyzed for all residues. The set of rules outlined in Table 1 wereAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 5 of 34 

### used to combine the residues for each samp le. T he total residue was calculated as aldicarb using the following formula, which accounts for the difference in molecular weights of the parent and

two metabolites:

Total residue (as aldicarb) = aldicarb + (aldicarb sulfone x 0.86) + (aldicarb sulfoxi de x 0.92)

In order to incorporate non

- detectable residues into the exposure assessment, HED used the current policy [refer to ChemSAC memo dated 5/19/98 and HED SOP 99.6] of assigning residue values of 1⁄2 LOD to these samples. If the residues were determ ined as the sulfone, then the 1⁄2 LOD for the total residue determined as the sulfone was used in the analysis. When the parent and metabolites were determined individually, using a 1⁄2 LOD of 0.005 ppm (i.e., LOD = 0.01 ppm) for aldicarb and each of its meta bolites, for example, the combined 1⁄2 LOD is as follows:

Total 1⁄2 LOD residue (ppm) = 0.005 + (0.005 x 0.86) + (0.005 x 0.92) = 0.0139 ppm

In the case of field trial data, which is reported on an aldicarb sulfone basis, the conversion to the

aldicarb basis is done using the following formula, which accounts for the differences in molecular weights:

Aldicarb residues = aldicarb sulfone residues (ppm) x 0.86

Table 1 . Method for Combining Residues of Aldicarb and it Sulfone and Sulfoxide Metabolites from the Same PDP Sample.

Aldicarb Metabolite Data Treatment 1,2

detect detect Aldicarb detect + Metabolite detect

detect non

- detect Aldicarb detect + 1⁄2 LOD for Metabolite for that sample

non

- detect detect 1⁄2 LOD for Aldicarb for that sample + Metabolite detect

non

- detect non

- detect Highest 1⁄2 LOD for Aldicarb + 1⁄2 LOD for Metabolite

1 The highest limit of detection (LOD) for aldicarb and its metabolites was used to estimate the LOD to be included in the RDF file or used in point estimate calcul ations. When aldicarb or its metabolites w ere not detected, the

1⁄2 LOD of that sample was used and added to the concentration of the analyte that was detected.



### Processing Factors

Processing factors (PFs) for aldicarb in cooked potato food forms (0.62 for fried; 0.5 for boiled)

, dry beans (0.05 for baked, boiled, fried, canned:cooked, canned:boiled, cooked:no food form specified) , soybean oil (0.3) , peanut oil (0.18)

, and cottonseed oil (0.1 ), sugarcane, and sugar beet have been generated in proc essing/cooking studies submitted in support of reregistration. The studies were considered to be acceptable and appropriate for use in risk assessment and tolerance reassessment. The processing/cooking studies indicate a general reduction of residues;

si nce residues are systemic, the reduction in residues is not related to removal of certain inedible commodity fractions, e.g., peel. A ldicarb processing factors to specific food forms in DEEM is

described in Table 2

. Moreover, DEEM default processing fact ors of 6.5 for dry potato and 1 for the remaining processed commodities were used. Processing factors for citrus juice were not needed as PDP data for orange juice was available.Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 6 of 34 

### Table 2. Summary of Aldicarb Processing Factors (PFs) Used in the Dietary Exposure Analyses Commodity/Processed Food Form PF 1 

### Application of PF to Relevant Food Forms in

DEEM Potato, dry 6.5 Potato, dry; Potato, flour

Potatoes/fried 0.62 Potato and Sweet potato:Fried
Potatoes/boiled, cooked 0.5 Potato and Sweet potato

- boiled, canned:cooked,

canned:boiled Beans, dry 0.05 Baked, boiled, fried, canned:cooked; canned:boiled; cooked:NFS

Peanut/oil 0.18 Peanut/Oil Soybean/oil 0.3 Soybean/Oil

Cottonseed/oil 0.1 Cottonseed/Oil Sugarcane/sugar beet NA NA

1 Processing factors were entered into the DEEM software as Adjustment Factor 1.



### Residues in Fish

The USDA PDP monitored pesticide residues in catfish in 2008, 2009, and 2010. Over this 3

- year period, PDP analyzed 1479 samples of catfish for residues of aldicarb and aldicarb sulfone

, and 552 samples for residues of aldicarb sulfoxide . None of the samples contained detectable

residues. Moreover, PDP monitor ed pesticide residues in salmon in 2013. Over t his 1

- year period, PDP analyzed 88 and 29 samples of salmon for residues of aldicarb sulfone and aldicarb

sulfoxide , respectively . None of the samples contained detectable residues. As a result, residues

in fish were not included in the assessment.

I I I. Percent Crop Treated Information

The Bi ological Economic Analysis Division (BEAD) provided percent of crop treated estimates for the years 2004 to 2012. The following maximum percent crop treated estimates (Updated Screening Level Usage Analysis Report for Aldicarb , PC Code 098301 ; 12/18/ 2014 ) were used in the acute dietary risk assessment for the following crops that are currently registered for

aldicarb : cotton: 35%; dry beans: 2.5%; peanuts: 45%; soybeans: 2.5%; and sugar beets: 10%

. 100% of crop treated was assumed for sweet potato. Perc ent of crop treated estimates were provided for grapefruit, oranges, lemon, pecans, potato, sorghum, and sugarcane; however, these were not used as these crops do not have uses registered in the U.S.A

. BEAD provided information on the percent of imported commodities for which data was available from 2009

- 2013 (e

- mail from Donald Atwood; 11/25/2015). The percent of imports were included for the following crops: grapefruit: 2%; lemons: 10%; orange: 8%; pecans: 58%; fresh potato: 8%; frozen potato: 21%; and 100% was assumed for limes and coffee.

IV. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the EFED in the following memorandum: “ Aldicarb : Drinking Water Exposure Assessment for Preliminary

Risk Assessment ” (D 427697

, Edmund Wong

, 06/17/2015 ) and incorporated directly into this dietary assessment. Water residues were incorporated in the DEEM

- FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 7 of 34 

### Tier II surface water EDWCs we re estimated with the Surface Water Concentration Calculator ( SWCC ). The Pesticide Root Zone Model

- Groundwater (PRZM

- GW) was used to estimate groundwater EDWCs at a pH of 6. TTR degradation varies across pH; therefore, slight acidic conditions yielded the highest concentration of aldicarb TTR in groundwater. Available monitoring data were also evaluated, however, the monitoring studies were non

- targeted. Thus, these data are not expected to provide an upper bound estimate of the pot ential exposure to aldicarb TTR and it is recommended that the Health Effects Division adopt the EDWC generated from the modeling in this assessment. Surface water and groundwater monitoring data indicated that aldicarb and its degradates were monitored si nce February 1986 to December 2014. Based on the analysis of the data, even with the mitigation implemented in 2009, there is no discerning

trend of decline in concentrations in groundwater.

The groundwater EDWCs are less than those for surface water; the refore, it is recommended that

the EDWCs for surface water be used in dietary assessments conducted by the Health Effects

Division. The highest one

- in

- ten year peak, annual mean, and 30

- year mean EDWCs ( 187, 16,

and 5.3 μg/L, respectively) are based on the labeled use of aldicarb on sugar beets at 4.05 lbs a.i./acre per year (MN Sugar Beets) . Please note that the application rates for modeling inputs on

SWCC and PRZM

- GW are different due to application instructions on the label. Application rate

for PRZM

- GW was based on the highest application rate that is allowed for labeled use in sugar beets but the granules have to be covered with soil or drilled to a specified soil depth. Meanwhile, the application rate used for SWCC modeling was the highest rate for s ugar beets that can be applied without soil cover, which significantly increases the risks of surface water

exposure. The scenario that provided the lowest EDWC was surface water in California ( CA

cotton PRZM scenario ) after application of the rate used for cotton (CA Cotton)

. Results are

summarized in Table 3.

Table 3 . Screening

- Level TTR EDWCs for Proposed Uses of Aldicarb A



### Source (Model) Use Site

(Max. Annual App. Rate) 1

- in

- 10

- year
30

- Year Mean
Peak (μg/L) Annual Mean

(μg/L)

Surface water (SWCC) Sugar beets (4.05 lbs a.i./A) B 

### 187 16 5.3

Cotton (1.05 lbs ai/A at Planting; 2.1 lbs ai /A Side Dress) C 

### 23.1 1.75 0.45

Peak Post

- Breakthrough Average

Ground water (PRZM

- GW) (pH 6) Sugar beets (4.95 lbs a.i./A) B 

### 93.2 40

A Maximum values in bold.

B Application rates are different for both surface and ground water modeling because application instructions on the label specified that the 4.95 lbs a.i./A rate is cover ed with soil, thus minimizing surface runoff exposure

, while 4.05 lbs a.i./A is the highest application rate that can be applied over irrigation furrow without soil cover , which increases potential surface water

exposure.

C Use site that resulted in the low est EDWC for aldicarb.Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 8 of 34 

### T he entire 30

- year distribution of estimated daily concentrations in surface water obtained for the MN Sugar beet and CA Cotton scenarios was incorporated into DEEM

- FCID and used in the

acute probabilistic analyses. The drinking w ater model s and t heir description s are available at

the EPA internet site: http://www2.epa.gov/pesticide

- science

- and

- assessing

- pe sticide

risks/about

- water

- exposure

- models

- used

- pesticide

.

V. DEEM

- FCID Program and Consumption Information

Aldicarb acute dietary exposure assessments were conducted using the DEEM

- FCID, Version

3.16 , which incorporates 2003

- 2008 consumption data from USDA’s NHANES/WWEIA. The 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

- cooke d; fresh or N/S; baked; or wheat flour

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For acute exposure assessment

, consumption data are retained as individual consumption events. Based on analysis of the 2003

- 2008 WWEIA 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

in fants (<1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, adults 20

- 49,

females 13

- 49, and adults 50

- 99 years old.

For an acute exposure assessment, 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

a nd then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per

- capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for a nalyses performed at all levels of refinement . However, for

deterministic assessments , any significant dif ferences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

The acute adverse effect of red blood cell cholinesterase inhibition tends to reverse itself within 2 hours following exposure to aldicarb. Si nce the food diaries used by DEEM

- FCID ( Version

3.16 ) Model are based on total daily intake, the estimated risks produced by this software are overestimate s, to the extent that foods and drinking water are consumed throughout the day, rather than during on ly one event. To provide a better approximation of the potential exposure leading to peak RBC ChE inhibition, potential exposure from food and/or water to aldicarb was computed incrementally throughout the day. This computation was made by incorporating information on the time of day and amounts consumed during each occasion from the USDA

NHANES/WWEIA food diaries. The potential for accumulation of toxicity was accounted for by computing the degree to which exposures could be discounted between exposure occasions, assuming a two

- hour half

- life. Further discussion of the methodology used to compute theAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 9 of 34 

### exposure based on the eating and drinking occasions may be found in a 2006 memo by S. Nako (D299889, 11/1/2006).

VI. Toxicological Information

The Agency evaluated the toxicity profile for aldicarb and considered the human acute oral study to be appropriate for assessment of the acute dietary exposure and risks , refer to Aldicarb Human

Health Risk Assessment for the evaluation of EPA’s Human Studies Review Board (D424564, In Progress )

. A chronic assessment was not conducted because the toxicity database for aldicarb

indicates that cholinesterase inhibition is the most sensitive effect found, the magnitude of

cholinesterase inhibition does not increas e with continued exposure, and that cholinesterase inhibition is generally reversible within 24 hours at the levels relevant to the dietary risk

assessment . The longer

- term exposures could be considered as a series of acute exposures , with regard to cholin esterase inhibition. All other effects noted in the sub

- chronic and chronic toxicity studies were observed at higher doses. Aldicarb is classified as not likely to be carcinogenic to humans

.

A Comparative Cholinesterase Assay (CCA) was used to modify the Food Quality Protection Act ( FQPA ) factor for aldicarb (L. Taylor, 7/13/10, D376136 ). The acute adverse effect of cholinesterase inhibition tends to reverse itself within hours following exposure to aldicarb. Th e available toxicological data indicate s that aldicarb has an estimated half

- life for RBC ChE inhibition of two hours based on data from rats and human subjects. A summary of the doses and endpoints relevant to dietary exposure assessment are shown in Table 4 below.

Table 4 . Summary of Toxicological Doses and Endpoints for Aldicarb for Use in Dietary Exposure Risk

Assessments

Exposure

Scenario Point of

Departure Uncertainty/

FQPA Safety

Factors 1 

### RfD, PAD, Level

of Concern Study and Toxicological

Effects

Acute Dietary: (All Populations) BMDL 10



### = 0.013 mg/kg FQPA SF =

4.8X

UF H 

### = 10

UF A 

### = 1x Acute RfD =

aPAD = 0.00027 mg/kg/day Human oral study

MRIDs. 43829602, 45068601, 43442302, 43442305, 42373001

BMD 10 

### = 0.02 mg/kg,

based on RBC

cholinesterase inhibition

Chronic Dietary: (All Populations) A quantitative chronic assessment was not conducted because the toxicity database for

aldicarb indicates that the magnitude of ChEI does not increase with continued exposure, due to the reversibility of ChEI (< 24 hours). There are no chr onic toxic

effects more sensitive than ChEI.

Cancer Classification: Aldicarb is classified as “Not Likely to be Carcinogenic to Humans”,

based on the lack of evidence of carcinogenicity in studies in rats and mice and the absence of a mutagenicity concern. ChEI = acetylcholinesterase inhibition. 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 riskAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 10 of 34 associated with lower environmentally 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 (interspecies). UF H = potential v ariation in sensitivity among members of the human population (intraspecies). BMD 10 = Benchmark Dose; dose that corresponds to 10% response in ChEI. BMDL 10 = Benchmark

Dose estimate based on the lower 95% confidence interval where 10% ChEI would be obser ved. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose. a = acute. RfD = reference dose. MOE = margin of exposure.

LOC = level of concern.



### VII. Results/Discussion

As stated above, for acute assessments, HED is concerned when dietary risk exceeds 100% of

the PAD. The DEEM

- FCID analyses estimate the dietary exposure and risk of the U.S. population and various population subgroups. The results reported in Table(s) 5, 6

, and 7 are for the general U.S. Population, all infants (<1 year ol d), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adults 50

- 99 years. Acute assessments were conducted for food only (Table s 5 and 6 ) , drinking water only (Attachment 3.b.) , and food and drinking water (Table 6 )

.

A preliminary screening showed that t he acute dietary exposure estimates from food alone was above HED’s level of concern (i.e. > 100 % of the aPAD ) at the 99.9 th 

### percentile of exposure

. The commodity with highest contribution to the risk was potato whi ch do not have domestic uses currently registered. PDP data for potato has contribution from domestic and imported samples. This data was modified to eliminate contribution from domestic samples (refer to Section VII for additional discussion)

. A n acute dietary assessment using only detects from samples of imported potatoes results in risks below the level of concern (<100 % of the aPAD).

Exposures are above the level of concern (LOC) for drinking water only. D ietary exposure

estimates ranged from 1, 4 00% to 2, 9 00%, and 1 5 0 % to 3 4 0% of the aPAD at the 99.9 th


### percentile of exposure for the general population and most population subgroups using the

scenarios that resulted in the highest EDWC ( MN sugar beets ) and lowest EDWC ( CA Cotton )

, respectively. Simi larly, for food and drinking water, the dietary exposure is above HED’s LOC using drinking water scenarios that provided the highest EDWC (MN sugar beets)

, see Table 6

.

Table 5 . Results of Acute Dietary (Food with Imported Potatoes Only ) Exposure and Risk Analysis

.

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

Exposure (mg/kg/day) %

aPAD Exposure

(mg/kg/day) %

aPAD Exposure (mg/kg/day) %

aPAD
General U.S. Population

0.00027 0.000006 2.2 0.000024 8.7 0.00006 7 2 5

All Infants (<1 year old) 0.000023 8.5 0.000043 16 0.0000 89 3 3

Children 1

- 2 years old * 0.000012 4.6 0.000071 26 0.00017 7 65

Children 3

- 5 years old 0.000010 3.6 0.000053 20 0.00013 3 4 9

Children 6

- 12 years old 0.000005 2.0 0.000032 12 0.000076 28

Youth 13

- 19 years old 0.000003 1.3 0.000022 8.0 0.0000 50 18

Adults 20

- 49 years old 0.000004 1.6 0.000020 7.2 0.00004 4 16

Adults 50

- 99 years old 0.000007 2.8 0.000022 8.1 0.00004 9 1 8

Females 13

- 49 years old 0.000004 1.6 0.000020 7.0 0.00004 6 1 7
* The population with the highest risk estimate is in bold.Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 11 of 34 

### Table 6 . Summary of Acute Dietary (Food Only, and Food and Drinking Water) Exposure and Risk

for Aldicarb at the 99.9 th 

### Percentile of Exposure.

Population Subgroup Water Only for CA

Cotton Scenario Water Only for MN Sugar Beets Scenario Food and Water for MN Sugar Beets Scenario Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % a PAD Dietary Exposure (mg/kg/day) % a P AD

General U.S. Population 0.000492 180 0.004616 1700 0.004607 1700

All Infants (<1 year old) * 0.000909 340 0.007775 2900 0.007723 2900

Children 1

- 2 years old 0.000743 280 0.006928 2600 0.006976 2600

Children 3

- 5 years old 0.000628 230 0.005760 2100 0.005750 2100

Children 6

- 12 years old 0.000446 170 0.004206 1600 0.004220 1600

Youth 13

- 19 years old 0.000396 150 0.003696 1400 0.003664 1400

Adults 20

- 49 years old 0.000501 190 0.004677 1700 0.004672 1700

Adults 50

- 99 years old 0.000448 170 0.004186 1600 0.004155 1500

Females 13

- 49 years old 0.000498 180 0.004688 1700 0.004677 1700
* The population with the highest risk estimate is in bold.



### VIII. Characterization of Inputs/Outputs

HED has conducted mostly refined acute dietary exposure and risk assessments for aldicarb and its metabolites. The assumption with respect to food made in this acute dietary assessment

include the latest PDP monitoring data, anticipated residues, empirical proces sing factors, default DEEM processing factors, and percent crop treated when available. Moreover, the percent of commodity imported was considered for potato, grapefruit, lemons, orange s, coffee and pecans. Dietary assessments for food plus drinking wate r and drinking water only show that d rinking

water was a main driver for the U.S. general population and all population subgroups

. These factors resulted in the acute aggregate (food and drinking water) dietary exposure estimates to be

above HED’s level of concern.

A screening for food only showed risk of concern; therefore, a critica l exposure contribution analysis was conducted. This analysis show ed that risks of concern for food only were mainly associated with consumption of potato tuber. PDP data f or potato used in this dietary assessment

was generated from 2006 to 2009. Because the use of aldicarb on potato was eliminated from the U.S.A. label on August 16, 2010 (EPA Reg. No. 264

- 330, label currently inactive), the PDP data used represents domesti c and imported potatoes treated with aldicarb. To refine the dietary

exposure
, a dietary assessment was done for food only considering only the detected samples from imported potato, see Table 6. This analysis was prepared by modifying the two RDF files for potato, with and without peel, to include only the samples of potato that were imported

. USDA PDP analyzed 31 samples of imported potato with peel (2008 and 2009 monitoring) resulting in one detect, and 318 samples of imported frozen potatoes without peel (2006 and 2007 monitoring) resulting in zero detects. The percent of imported potatoes with peel that were analyzed (2%) is smaller than the percent of imports reported by BEAD (8%) while the percent of imported frozen potatoes without peel that were analyzed is identical to that reported by BEAD (21%). Overall, HED understand that these RDF files are more representative of the

current situation than those that include the results of domestic samples. This refinement results in a dietary risk for fo od only below the level of concern

, 2 5 % of the aPAD for the generalAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 12 of 34 

### population

, and 65% of the aPAD for children 1

- 2 years old, the highest exposed population subgroup.

Overall, the dietary a ssessments for food only could be refined if percent of crop treated data for the imported commodities were available

. Although d ietary risk estimates for food are below

HED ’s level of concern, n ote that drinking water is the main contributor to the dietary exposure, as such, it has to be considered in agg regate dietary assessment in support of domestic uses of

aldicarb. For measures to address the dietary risk associated with residues of aldicarb in drinking water refer to EFED memo ( E. Wong, D427697, 06/17/2015 )

. Mitigation measures discussed in

2010 ( re vocation of tolerances for pecan, sorghum and sugarcane, and removing uses on citrus and potato ) may be necessary to accommodate exposure to drinking water as deem ed necessary

.

The results of a DEEM

- FCID acute dietary risk assessment vary due to the ran dom selection of residues performed during the Monte Carlo procedure. Dietary exposures at the per capita 99.9 th


### percentile may vary between 1% and 3% when different random seeds are used in a DEEM

FCID acute assessment. This effect generally differs for d ifferent subpopulations: e.g., the results for infants may increase, while the results for children 1

- 2 years old decrease. Those slight variations often lead to the unintuitive result that aggregate Food + Drinking Water dietary exposure estimates are low er than exposure estimates for Drinking Water alone for particular subgroup(s). We are most likely to observe such results when food provides relatively small contributions among high

- end outcomes. The relative contributions from Food can be assessed by a detailed inspection of all high

- end person

- day outcomes ( 99.9 th



### – 100 th 

### percentiles ), or indirectly infer red when the results for Food + Drinking Water are similar to the results for drinking water alo ne, as is the case for aldicarb

- MN Sugar beets.

IX. Commodity Specific Analysis

Commodity specific analysis (CSA) was conducted for aldicarb to obtain estimates of the acute exposure and risk following a single consumption event for potatoes and for sweet potatoes. Dietary exposures were calculated using typical serving sizes for amo unts consumed and USDA PDP monitoring data. While aldicarb is no longer used domestically on potatoes, tolerances remain in place which allows import into the U.S. of potatoes containing aldicarb residues. Dietary exposures were expressed as a percent of the acute population adjusted dose (0.00027 mg/kg/day).

Table E.2 summarizes the commodity specific analysis for aldicarb. The highest %aPAD were for pre

- school age children eating the equivalent of one average size potato (130% aPAD) or

sweet potato (300% aPAD). This CSA is considered a highly refined assessment for the following reasons:

 The aPAD was calculated using:

o an endpoint/NOAEL from a human study (the inter

- species factor was reduced to 1X),

o a 4.8X data

- derived factor for children, and

o a 10X intra

- species factor;Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 13 of 34 

###  PDP monitoring data were used to estimate residues, and processing/cooking data was considered, as appropriate.

A cooking factor of 1x was applied based on empirical data. Although processing factors of 0.5 (boiled, canned:cook ed, canned:boiled) and 0.62 (fried) are available for sweet potato or potato, these do not apply to cooked baked sweet potato. Also, because aldicarb is applied as a soil

incorporated, granular formulation, residues may be significantly higher in individu al potatoes or sweet potatoes relative to residues measured in the PDP samples, which are composites of many individual potatoes, i.e., the composite samples represent an average residue in all of the potatoes in the analyzed sample, whereas all of the res idue may actually be present in only a subset of the individual potatoes. In fact, limited residue data available indicate that residues of aldicarb and its metabolites in the individual samples could be at least 2.4 times that of the composite sample

sug gesting that the CSA risk estimates may underestimate actual risks from consumption of individual potatoes or sweet potatoes.

For these reasons, the conservative inputs used to estimate the aldicarb CSA risks should be considered marginal, with risk est imates closely approximating actual potential risks to the small portion of the U.S. population consuming commodities containing residues at these levels.

Sweet Potato

The PDP monitoring data (2008

- 2010) for sweet potatoes show two detects, 0.07784 pp m and 0.06894 ppm of 1476 samples of unpeeled sweet potato, that are above the threshold (i.e. residue level that would result in risk at the level of concern) for preschoolers (0.026 ppm). PDP monitoring data is available for sweet potato baby food which showed no detects above the limit of detection of 0.0083 ppm. This results in exposures below the level of concern for infants, 24% of the aPAD. The dietary exposure is above HED’s level of concern (i.e. >100% of the aPAD) for preschoolers consuming one medium size sweet potato (157 g); exposure is 300% of the aPAD. Exposures are below the level of concern for adults consuming one medium size sweet potato (75% of the aPAD).

Potato

PDP monitoring data for imported potatoes were used in the CSA; domes tically cultivated potato

data from 2006

- 2009 PDP monitoring were excluded since aldicarb is not registered for use in the U.S. as part of the 2010 mitigation. PDP monitoring data generated after cancelation of the U.S.A. use on potato is not available at this time. The dietary exposure do not exceed the level of concern for infants (100% of the aPAD) consuming 1⁄2 medium size potato (71 g), is above HED’s level of concern for preschoolers (130% of the aPAD) consuming one medium size sweet potato (142 g), a nd is below the level of concern for adults consuming 1 medium size potato (33% of the aPAD).

X. Conclusions

Risks are below the level of concern for food only after refinement considering PDP data for imported potatoes; however, the commodity specific analysis results in exposure estimates aboveAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 14 of 34 

### 100% of the aPAD following consumption of an estimated single servi ng of sweet potato and potatoes. The aggregate (food and drinking water) acute analys i s demonstrate that the register ed

uses for aldicarb result in risk of concern for the general U.S. population and all population subgroups. Overall, t he dietary risk is mainly associated with drinking water; refer to EFED memo for mitigation measures and Attachment 4 for estimates of drinking level of comparison. HED is confident that the assessment does not underestimate risk to the general U.S. population

or any population subgroup.

X I

. List of Attachments

Attachment 1. Data and Residue Estimates Used in the Dietary Exposure Analyses

Attachment 2. SLUA for Aldicarb

Attachment 3. Aldicarb Input and Result Files

Attachment 4. EDWC at the LOC Considering Exposure through Drinking Water Only

Attachment 5. Commodity Specific Analysis Conducted for AldicarbAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 15 of 34 

### Attachment 1. Data and Residue Estimates Used in the Dietary Exposure Analyses

Table A.1. 1 . Summary of PDP Data for Aldicarb and its Sulfone and Sulfoxide Metabolites.*
Number of Samples Analyzed
Commodity 2006 2007 2008 2009 2010 2011 2012
Potato w/peel

uncooked 744 744

Potato w/o peel

frozen 744 800

Sweet Potato 184 739 533

Sweet Potato Baby Food 191 585

Orange 744 744

Orange Juice 191 199 330

* The three residues of concern were measured in each sample.



### A.1.2. PDP Data for Select Commodities

Commodity PDP Total Samples PDP Total Detects

Total Domestic Imports or

Unknown Total Domestic Imports or

Unknown

Potato (2008, 2009) 1488 1457 31 62 61 1

Potato

- Frozen (2006, 2007) 1544 1226 318 93 93 0
Sweet Potatoes (2008, 2009, 2010) 1476 1458 18 5 4 1
Sweet Potatoes baby food (2010, 2011) 776 771 5 0 0 0
Oranges (2009, 2010) 1488 1365 123 5 4 0
Grapefruit (2005, 2006) 1462 1441 21 5 5 0Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 16 of 34 

### Table A.1. 3 . Data and Residue Estimates Used in the Dietary Exposure Analyses

.

RAC Food

Forms Blending

Classif

ication 1 Data

Source 2 No. of

Samples No. of

Detectable

Residues 3 1⁄2 LOD %CT 4

or % Import* Processing

Factors Anticipated Residue

Estimates/Tolerance
Acute (Tol., AR, RDF) 2

Potato, chips Potato, fried All B PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 0.62 0.000437 (Import)

Potato, dry All B PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 6.5 0.000437 (Import)

Potato, dry, baby food (bf) All B PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 6.5 0.000437 (Import)

Potato, flour All B PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 6.5 0.000437 (Import)

Potato, flour bf All B PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 6.5 0.000437 (Import)

Potato, tuber, w/peel Boiled NB PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 0.5 RDF 1

Canned :Cooked;

Canned :Boiled PB PDP Potato w/peel

2008/2009 1488 62/1 0.0052 41* 0.5 RDF 14

All Others PB/NB PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* RDF 1

Potato, tuber, w/peel bf Canned:Cooked PB/NB PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 0.5 RDF 1

Potato, tuber, w/o peel Boiled; Canned :Cooked;

Canned :Boiled PB/NB PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 0.5 RDF 1

Frozen Baked (FB)

Frozen Fried PB/NB PDP Potato w/o peel

2006/2007 1544 93 /0 0.0041 21 * RDF 2Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 17 of 34 All Others PB/NB PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* RDF 1

Potato, tuber, w/o peel, bf Cooked :Canned PB/NB PDP Potato w/peel

2008/2009 1488 62 /1 0.0052 8* 0.5 RDF 1

Sweet potato Boiled; Canned :Cooked;

Canned :Boiled PB/NB PDP Sweet

potato
20 08

- 2010 1476 5 0.0109 100 0.5 RDF 3

All Others PB/NB PDP Sweet

potato
2008

- 2010 1476 5 0.0109 100 RDF 3

Sweet potato,

bf Cooked :Fresh PB/NB PDP Sweet

potato
2010/2011 776 0 0.0083 100 RDF 4

Cooked :Canned PB/NB PDP Sweet

potato
2010/2011 776 0 0.0083 100 0.5 RDF 4

Soybean, seed All B FTD

D299883 2.5 0.00855 Mean

0.000214 AR Soybean, soy

milk All B FTD

D299883 2.5 0.00855 Mean

0.000214 AR Soybean, soy milk, bf All B FTD

D299883 2.5 0.00855 Mean

0.000214 AR

Soybean, oil All B FTD

D299883 2.5 0.3 0.00855 Mean

0.000214 AR Soybean, oil,

bf All B FTD

D299883 2.5 0.3 0.00855 Mean

0.000214 AR

Soybean, flour All B FTD

D299883 2.5 0.00855 Mean

0.000214 AR Soybean, flour,

bf All B FTD

D299883 2.5 0.00855 Mean

0.000214 AR

Bean, black,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Bean, broad,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 ARAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 18 of 34 Bean, cowpea,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Bean, great northern, seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Bean, kidney,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Bean, lima,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Bean, mung,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Bean, navy,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Bean, pink,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Bean, pinto,

seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Chickpea, seed Baked, boiled, fried,

canned:cooked; canned:boiled; cooked: NS B FTD

D299883 2.5 0.05 0.00855 Mean

0.000214 AR

Orange All NB/PB PDP Orange

2009/2010 1488 4 0.0131 8* RDF 9_O_Modif 8 Perc Imports

Orange, juice All PB PDP Orange

Juice 2010/

2011/2012 1106 5 0.0042 8* RDF 10_OJ_Modif 8 Perc Imports

Orange, juice,

bf All PB PDP Orange

Juice 2010/

2011/2012 1106 5 0.0042 8* RDF 10_OJ_Modif 8 Perc Imports

Orange, peel All PB PDP Orange

2009/2010 1488 4 0.0131 8* RDF 9_O_Modif 8 Perc Imports

Lemon All NB/PB PDP Orange

2009/2010 1488 4 0.0131 10* RDF 9_O_Modif 10 Perc Lemon ImportsAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 1 9 of 34 Lemon, juice All PB PDP Orange

Juice 2010/

2011/2012 1106 5 0.0042 10* RDF 10_OJ_Modif

10 Perc Lemon Import

Lemon, peel All PB PDP Orange

2009/2010 1488 4 0.0131 10* RDF 9_O_Modif 10 Perc Lemon Imports

Lime All NB PDP Orange

2009/2010 1488 4 0.0131 100 RDF 9

Lime, juice All PB PDP Orange

Juice 2010/

2011/2012 1106 5 0.0042 100 RDF 10

Lime, juice, bf All PB PDP Orange

Juice 2010/

2011/2012 1106 5 0.0042 100 RDF 10

Grapefruit All NB/PB PDP Orange

2009/2010 1488 4 0.0131 2* RDF 9_O_Modif 2 Perc Grapefruit Imp

Grapefruit, juice All PB PDP Orange

Juice 2010/

2011/2012 1106 5 0.0042 2* RDF 10_OJ_Modif 2 Perc Grapefruit Imports

Pecan All PB FTD

D299883 22 58* RDF 13

Sorghum, grain All B Tolerance 100 0.2

Sorghum,

syrup All B Tol erance 100 0.2

Cottonseed, oil All B FTD

D425180 35 0.1 0.0453 Mean

0.0159 AR
Cottonseed, oil, bf All B FTD

D425180 35 0.1 0.0453 Mean

0.0159 AR
Coffee, roasted

bean All B FTD

D299883 100 0.00855

Coffee, instant All B FTD

D299883 100 0.00855

Peanut All B FTD

D299883 45 0.0047 Mean

0.002115 AR

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

2. Field Trial Data (FTD); Residue Distribution File (RDF); Anticipated Residue (AR); Baby food (bf) ; with (w); without (w/o); Orange (O); Orange Juice (OJ).Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 20 of 34 Table A.1. 4 . RDF Files and Point Estimate Calculations

Refinement for Potatoes (Import Samples Only)

RDF 1_Potato_wPeel_

Uncooked _1 _Imports .rdf PDP Data: POFR (2008,2009), Total Samples=1488, Total

Detects= 1 , Total LODs= 118 , Total

Zeros= 1369; 8% Imported

Potatoes , Avg Residue (Detects)=0.083327, Avg Residue (TOTALS)=0.0085, Avg Residue Avg HLOD (NonDetects)=0.0052

TOTALZ= 1369

TOTALLOD= 118

LODRES=0.0052

0.03796 RDF 2_ Potato_wopeel_Frozen_ Baked_2 _Imports .rdf

PDP Data: PZFZ (2006,2007), Total Samples=1544, Total Detects=0,

Total LODs= 3 24, Total Zeros=1 2 20

21 % of Imported Potatoes , Avg Residue (Detects)=0.011659, Avg

Residue (TOTALS)=0.0045, Avg HLOD (NonDetects)=0.0041

TOTALZ=1 2 20

TOTALLOD= 3 24

LODRES=0.0041 Potato Blended Processed

Commodities : Anticipated

Residues

Residue estimate for a blended processed commodity based on monitoring data and % of imports.

PDP Data for Potato with Peel

Uncooked : POFR (2008, 2009), Total Samples=1488, Total

Detects= 1, Sum of Detects=0.03796 ppm, Total LODs=118, Avg HLOD=0.0052; 8% of Imported Potatoes.

Total Samples with Residues = 119 1⁄2LOD = 0.0052 ppm Total Samples 1⁄2 LOD = 118

Sum of Detects = 0.03796 ppm

Anticipated residue: 0.000437 ppm [(118 samples*0.0052 ppm + 0.03796 ppm)/1488]
RDF 14_Potato_wPeel_
Uncooked_Canned _1 4_Imports .rdf PDP Data: POFR (2008,2009), Total Samples=1488, Total

Detects= 1 , Total LODs= 609 , Total

Zeros= 878; 41% Imported

Potatoes , Avg Residue (Detects)=0.083327, Avg Residue (TOTALS)=0.0085, Avg Residue Avg HLOD (NonDetects)=0.0052

TOTALZ= 878

TOTALLOD= 609

LODRES=0.0052

0.03796

All Other RDFsAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 21 of 34 RDF 3 _Potato_Sweet _3.rdf

PDP Data: SWFR (2008,2009,2010), Total Samples=1476, Total Detects=5,

Total LODs= 1471 , Total Zeros= 0

MaxPCT= 100 , Avg Residue (Detects)=0.038920, Avg Residue (TOTALS)=0.0017, Avg Residue (Blended, PCT=100)=0.010967, Avg HLOD (NonDetects)=0.0109

TOTALZ= 0

TOTALLOD= 1471

LODRES=0.0109

0 .07784

0.06594

0.02126

0.01478

0.01478 RDF 4 _Potato_Sweet _4.rdf
PDP Data: ISGJ,ISPC,ISSE ; Baby food; (2010,2011), Total Samples=776, Total Detects=0, Total LODs=116, Total Zeros= 0

MaxPCT= 100 , Avg Residue (Detects)=., Avg Residue (TOTALS)=0.0012, Avg Residue (Blended, PCT=100)=0.008340, Avg HLOD (NonDetects)=0.0083

TOTALZ= 0

TOTALLOD= 776

LODRES=0.0083 Soybean and Dry Bean: Anticipated Residues

Average residue values reported in D299883 (C. Olinger, 08/16/2010) were used. The %CT for soybean and dry beans is 2.5%.

Average residue: 0.00855 ppm

Anticipated residue: 0.000214 ppm [0.00855 ppm x 0.025 (fraction of crop treated)]

RDF 9_Orange _9.rdf PDP Data: OGFR (2009,2010), Total Samples=1488, Total Detects=4, Total LODs=1484,

Total Zeros=0 ; MaxPCT=1.000, Avg Residue (Detects)=0.018950, Avg Residue (TOTALS)=0.0131, Avg Residue (Blended, PCT=100)=0.013133, Avg HLOD (NonDetects)=0.0131

TOTALZ=0

TOTALLOD=1484

LODRES=0.0131

0.02126

0.02034

0.01942

0.01478 RDF 9_Orange _9 _Modified_8Perc Imports .rdf PDP Data: OGFR (2009,2010), Total Samples=1488, Total Detects=4, Total LODs=115, Total

Zeros=1369 ; 8% Imports, Avg Residue (Detects)=0.018950, Avg Residue (TOTALS)=0.0131, Avg HLOD (NonDetects)=0.0131

TOTALZ=1369

TOTALLOD=115

LODRES=0.0131

0.02126

0.02034

0.01942

0.01478 RDF 9_Orange _9 _Modified _10Perc Lemon Import .rdf PDP Data: OGFR (2009,2010), Total Samples=1488, Total Detects=4, Total LODs=145, Total

Zeros=1339 ; 10% Imports, Avg Residue (Detects)=0.018950, Avg Residue (TOTALS)=0.0131, Avg

HLOD (NonDetects)=0.0131

TOTALZ=1339

TOTALLOD=145

LODRES=0.0131

0.02126

0.02034

0.01942

0.01478

RDF 9_Orange _9 _Modified_2Perc Grapefruit Import.rdf PDP Data: OGFR (2009,2010), Total Samples=1488, Total Detects=4, Total LODs=26, Total

Zeros=1458 ; 2% Imports, Avg Residue (Detects)=0.018950, Avg Residue (TOTALS)=0.0131, Avg HLOD (NonDetects)=0.0131

TOTALZ=1458

TOTALLOD=26

LODRES=0.0131

0.02126

0.02034

0.01942

0.01478 RDF 10_Orange_Juice _10.rdf
PDP Data: OJCO,OJFZ,OJRE (2010,2011,2012), Total Samples=1106, Total Detects=5, Total LODs=1101, Total Zeros=0 MaxPCT=1.000, Avg Residue (Detects)=0.006102, Avg Residue (TOTALS)=0.0042, Avg Residue (Blended, PCT=100)=0.004179, Avg HLOD (NonDetects)=0.0042

TOTALZ=0

TOTALLOD=1101

LODRES=0.0042

0.00647

0.00647

0.00647

0.00555

0.00555 RDF 10_Orange_Juice _10

_ Modified 8Perc Imports .rdf
PDP Data: OJCO,OJFZ,OJRE (2010,2011,2012), Total Samples=1106, Total Detects=5, Total LODs=83, Total Zeros=1018 8% Imports, Avg Residue (Detects)=0.006102, Avg Residue (TOTALS)=0.0042, Avg HLOD (NonDetects)=0.0042

TOTALZ=1018

TOTALLOD=83

LODRES=0.0042

0.00647

0.00647

0.00647

0.00555

0.00555Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 22 of 34 RDF 10_Orange_Juice

_ 10_
Modified_10Perc Lemon Imports .rdf
PDP Data: OJCO,OJFZ,OJRE (2010,2011,2012), Total Samples=1106, Total Detects=5,

Total LODs=106, Total Zeros=995 ; 10% Imports, Avg Residue (Detects)=0.006102, Avg Residue (TOTALS)=0.0042, Avg HLOD (NonDetects)=0.0042

TOTALZ=995

TOTALLOD=106

LODRES=0.0042

0.00647

0.00647

0.00647

0.00555

0.00555 RDF 10_Orange_Juice

_ 10_ Modified_2Perc Grapefru it Imports .rdf
PDP Data: OJCO,OJFZ,OJRE (2010,2011,2012), Total Samples=1106, Total Detects=5, Total LODs=17, Total Zeros=1084

, 2% Imports, Avg Residue (Detects)=0.006102, Avg Residue (TOTALS)=0.0042, Avg HLOD (NonDetects)=0.0042

TOTALZ=1084

TOTALLOD=17

LODRES=0.0042

0.00647

0.00647

0.00647

0.00555

0.00555 RDF 13_Pecan

_ 13 .rdf Pecan Aldicarb FTD; 22 Samples Field Trial Residue Data [MRID No. 102123] 58% Imported Pecan

TOTALZ=16 4,0.0043 2,0.0171 2,0.0256
2,0.0427 2,0.00855

0.0342

0.0684

0.0598

0.0513

0.0769

0.0940

0.0855

0.231

0.103

0.145 Cotton seed oil: Anticipated

Residues

Residue estimate for a blended commodity based on crop field trial

data. Mean residue: 0.0453 ppm Anticipated residue: 0.0159 ppm [0.0453 ppm x 0.35 (fraction of crop treated)]Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 23 of 34 

### Attachment 2. Import Usage and SLUA for Aldicarb

A.2.1. Import Usage for Commodities with Tolera nces and No U.S.A. Registration The following report was provided by the Biological and Economic Analysis Divison (D. Atwood, e

- mail s received on 11/25/2015 and on 12/28/2015 ).

Aldicarb Import Usage (Average 2009

- 2013)

US

Production (million lbs) Commodity

Export (million lbs) Available

domestic (million lbs) Commodity

Imports (million lbs) Total

Available for consumption (million lbs) % Import

Component

Grapefruit 1,304.8 489.2 815.6 20 835.6 2%

Lemons 1155.2 210.6 944.6 100.8 1,045.4 10%

Limes 0 6

- 6.0 833.8 827.8 101%*

Orange 4289.2 1449.3 2,839.9 245.1 3,085.0 8%

Pecans 133753 75107 58646 82459 141105 58%

Coffee 7.8 388.2

- 380.4 3359.7 2979.3 113%*

Potatoes 11010 972 10038 910 10948 8%

Citrus dry pulp Data not available

Sorghum, grain,

bran Data not available

Sorghum, grain, grain Data not available

Sorghum, grain,

stover Data not available

Sugarcane, cane Data not available

Source: USDA/ERS. 2015. Food Availability (Per Capita) Data System http://www.ers.usda.gov/data

- products/food

- availability

- (per

- capita)

- data

- system.aspx#.Up9c9dLkvMY 

### * For limes and coffee, a 100% of import component was used for dietary assessment purposes.

US

Production (million lbs) Commodity

Export (million lbs) Available

domestic (million lbs) Commodity

Imports (million lbs) Total

Available for consumption (million lbs) % Import

Component

Potatoes (Fresh) 11020.1 923.2 10096.9 915.2 11012.1 8%

Potaotes (Freezing) 15744.4 3707.6 12036.8 3285.7 15322.5 21%

Potatoes (Canning) 239.3 106.2 133.1 91.9 225 41%

Potatoes (Chips) 5411.3 461.3 4950 106.9 5056.9 2%

Potaotes (Dehydrated) 4364 1114.7 3249.3 532.9 3782.2 14%

Potatoes (Total) 36779.2 6313.1 30466.1 4932.6 35398.7 14%



### A.2.2. Screening Level Usage Analysis for AldicarbAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 24 of 34 

### Aldicarb (098301) Screening Level Usage Analysis (SLUA) Date: December 18, 2014

What is a Screening Level Usage Analysis (SLUA)?

 Available estimates of pesticide usage data for a particular active ingredient that is

used on agricultural crops in the United States.

 Pesticide usage data obtained from various sources. The data are then merged, averaged, and rounded so that the presented information is not proprietary, business confidential, or trade secret.

What does it contai n?

 Pesticide usage data for a single active ingredient only.

 Agricultural use sites (crops) that the pesticide is reported to be used on.

 Available pesticide usage information from U.S. states that produce 80% or more of a crop, in most cases, or less tha n 80%, in rare cases, depending on the scope of the survey and available resources.

 Annual percent of crop treated (average & maximum) for each agricultural crop.

 Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the

stat es surveyed, not for the entire United States). What assumptions can I make about the reported data?

 Average pounds of active ingredient applied

- Values are calculated by merging pesticide usage data sources together; averaging across all observations, th en rounding. Note: If the estimated value is less than 500, then that value is labeled <500. Estimated values between 500 & <1,000,000 are rounded to 1 significant digit. Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)

 Av erage percent of crop treated

- Values are calculated by merging data sources together; averaging by year, averaging across all years, & rounding to the nearest multiple of 5. Note: If the estimated value is less than 2.5, then the value is labeled

<2.5. If the estimated value is less than 1, then the value is labeled <1.

 Maximum percent of crop treated

- Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5.

Note: If the estimat ed value is less than 2.5, then the value is labeled <2.5.

What are the data sources used?

 USDA

- NASS (United States Department of Agriculture’s National Agricultural Statistics Service)

– pesticide usage data from 2004 to 2012.

 Private pesticide market res earch

– pesticide usage data from 2004 to 2012.

 California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR) data for 2004 to 2011.

What are the limitations to the data?

 Additional registered uses may exist but are not included because the available surveys do not report usage (e.g., small acreage crops).

 Lack of reported usage data for the pesticide on a crop does not imply zero usage.

 Usage data on a particular site may be noted in data sources, but not quantified . In

these instances, the site would not be reported in the SLUA.Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 25 of 34 

###  Non

- agricultural use sites (e.g., turf, post

- harvest, mosquito control, etc.) are not reported in the SLUA. A separate request must be made to receive these estimates.

 Some sites show some use, even though they are not on the label. This usage could be due to various factors, including, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors, and experimental use permits (EUPs).Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 26 of 34 

### December 18, 2014

Screening Level Estimates of Agricultural Uses of Aldicarb (098301)

Sorted Alphabetically (Reporting Timeframe: 2004

- 2012)
Percent Crop Treated

Crop Average

Lbs. A.I. Average Maximum

1 Almonds + 2,000 <1 <2.5

2 Cantaloupes + <500 <1 <2.5

3 Cotton 1,600,000 20 35

4 Dry Beans/Peas 10,000 <2.5 <2.5

5 Grapefruit + 100,000 35 55

6 Lemons + <500 <1 <2.5

7 Oranges + 500,000 15 35

8 Peanuts 400,000 35 45

9 Pecans + 10,000 <2.5 <2.5

10 Potatoes + 200,000 5 15

11 Sorghum + 2,000 <1 <2.5

12 Soybeans 60,000 <1 <2.5

13 Sugar Beets 100,000 5 10

14 Sugarcane + 7,000 <2.5 <2.5

15 Tangerines + 6,000 5 5

16 Tobacco + 20,000 5 10

17 Watermelons + <500 <1 <2.5

All numbers rounded.

<500 Less than 500 pounds of active ingredient

<2.5 Less than 2.5 percent of crop treated

<1 Less than 1 percent of crop treated

+ There is no current active registration for this use.

SLUA data sources include:

USDA

- NASS (United States Department of Agriculture's National Agricultural Statistics Service)

Private Pesticide Market Research

These results reflect amalgamated data developed by the Agency and are releasable to the public.Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 27 of 34 

### Attachment 3

. Aldicarb Input and Result Files

A) 

### Input File for Food (Refined Potato Imports) + Drinking Water (Sugar beet)

Filename: C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ DEEM Files \ Aldicarb Acute_Food Water SugarBeet_Refined_PotatoImports.r08

Chemical: Aldic arb Acute Dietary Assessment RfD(Chronic): 0 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .00027 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day
Date created/last modified: 02

- 18

- 2016/10:43:52 Program ver. 3.16, 03

- 08

- d

------------------------ ----------------------------------------------------------- RDL indices and parameters for Monte Carlo Analysis:
Index Dist Parameter #1 Param #2 Param #3 Comment

# Code

----- ---- ------------ -------- -------- ------- 1 6 C: \ Users \ IEncarna \ Dietary

Assessments \ Aldicarb \ Scenario2 \ Potato_wPeel_Uncooked_1_Imports.rdf

2 6 C: \ Users \ IEncarna \ Dietary

Assessments \ Aldicarb \ Scenario2 \ Potato_wopeel_Frozen_Baked_2_Imports.rdf

3 6 C: \ Users \ IEncarna \ Dietary Assess ments \ Aldicarb \ Scenario2 \ Potato_Sweet_3.rdf

4 6 C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ Scenario2 \ Potato_Sweet_BF_4.rdf

5 6 C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ Scenario2 \ Orange_9_Modified 8Perc
Import.rdf

6 6 C: \ Users \ IEncarna \ Dietary

Assessments \ Aldicarb \ Scenario2 \ Orange_Juice_10_Modified 8 Perc Imports.rdf

7 6 C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ Scenario2 \ Orange_9_Modified 10Perc Lemon Import.rdf

8 6 C: \ Users \ IEncarna \ Dietary

Assessments \ Aldi carb \ Scenario2 \ Orange_Juice_10_Modified 10 Perc Lemon Imports.rdf

9 6 C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ Scenario2 \ Orange_9.rdf

10 6 C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ Scenario2 \ Orange_Juice_10.rdf

11 6 C: \ Users \ I Encarna \ Dietary Assessments \ Aldicarb \ Scenario2 \ Orange_9_Modified 2Perc Grapefruit Import.rdf

12 6 C: \ Users \ IEncarna \ Dietary

Assessments \ Aldicarb \ Scenario2 \ Orange_Juice_10_Modified 2 Perc Grapefruit Imports.rdf

13 6 C: \ Users \ IEncarna \ Dietary Ass essments \ Aldicarb \ Scenario2 \ Pecan_FTD_13.rdf

14 6 C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ Scenario2 \ Aldicarb_SWCC_pH7_MN Sugarbeets_12.rdf

15 6 C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ Scenario2 \ Potato_wPeel_Uncooked Baked_14_Impor ts.rdf

EPA Crop Commodity Name Def Res Adj.Factors RDLComment Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- -- ----- 0103296000 1C Potato, chips 0.000437 0.620 1.000 0103297000 1C Potato, dry (granules/ flakes) 0.000437 6.500 1.000 0103297001 1C Potato, dry (granules/ flakes)

- b 0.000437 6.500 1.000

0103298 000 1C Potato, flour 0.000437 6.500 1.000
0103298001 1C Potato, flour

- babyfood 0.000437 6.500 1.000 0103299000 1C Potato, tuber, w/peel

110

- Uncooked; Fresh or N/S; Cook Meth N/S

1.000000 1.000 1.000 1

210

- Cooked; Fresh or N/S; Cook Meth N/S

1.000000 1.000 1.000 1

211

- Cooked; Fres h or N/S; Baked

1.000000 1.000 1.000 1

212

- Cooked; Fresh or N/S; Boiled

1.000000 0.500 1.000 1

213

- Coo ked; Fresh or N/S; Fried

1.000000 0.620 1.000 1 0103299001 1C Potato, tuber, w/peel

- babyfood 1.000000 1.000 1.000 1 0103300000 1C Potato, tuber, w/o peel

110

- Uncook ed; Fresh or N/S; Cook Meth N/SAldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 28 of 34

1.000000 1.000 1.000 1

210

- Cooked; Fresh or N/S; Cook Meth N/S

1.000000 1.000 1.000 1

211

- Cooked; Fresh or N/S; Baked

1.000000 1.000 1.000 1

212

- Cooked; Fresh or N/S; Boiled

1.000000 0.500 1.000 1

213

- Cooked; Fresh or N/S; Fried

1.000000 0.620 1.000 1

221

- Cooked; Frozen; Baked 1.000000 1.000 1.000 2

223

- Cooked; Frozen ; Fried 1.000000 0.620 1.000 1

232

- Cooked; Dried; Boiled 1.000000 0.500 1.000 1

233

- Cooked; Dried; Fried 1.000000 0.620 1.000 1

240

- Cooked; Canned; Cook Meth N /S

1.000000 0.500 1.000 15

242

- Cooked; Canned; Boiled 1.000000 0.500 1.000 15

252

- Cooked; Cured etc; Boiled 1.000000 0.500 1.000 1

0103300001 1C Potato, tuber, w/o peel

- babyfood

240

- Cooked; Canned; Cook Meth N/S

1.000000 0.500 1.000 1 0103366000 1CD Sweet potato

210

- Cooked; Fresh or N/S; Cook Meth N/S

1.000000 1.000 1.000 3

211

- Cooked; Fresh or N/S; Baked

1.000000 1.000 1.000 3

212

- Cooked; Fresh o r N/S; Boiled

1.000000 0.500 1.000 3

213

- Cooked; Fresh or N/S; Fried

1.000000 0.620 1.000 3

215

- Cooked ; Fresh or N/S; Boiled/baked

1.000000 1.000 1.000 3

240

- Cooked; Canned; Cook Meth N/S

1.000000 0.500 1.000 3

242

- Cooked; Canned; Boiled 1.000000 0.500 1.000 3 0103366001 1CD Sweet potato

- babyfood

211

- Cooked; Fresh or N/S; Baked

1.000000 1.000 1.000 4

240

- Cooked; Canned; Cook Meth N/S

1.000000 0.500 1.000 4 0600347000 6 Soybean, seed 0.000214 1.000 1.000 0600349000 6 Soybean, soy milk 0.00021 4 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.000214 1.000 1.000 0600350000 6 Soybean, oil 0.000214 0.300 1.000 0600350001 6 Soybean, oil

- babyfood 0.000214 0.300 1.000
0603030000 6C Bean, black, seed 0.000214 0.050 1.000
0603032000 6C Bean, broad, seed 0.000214 0.050 1.000

0603034000 6C Bean, cowpea, seed

232

- Cooked; Dried; Boiled 0.000214 0.050 1.000 0603035000 6C Bean, great northern, seed 0.000214 0.050 1.000 0603036000 6C Bean, kidney, seed 0.000214 0.050 1.0 00
0603038000 6C Bean, lima, seed 0.000214 0.050 1.000 0603039000 6C Bean, mung, seed 0.000214 0.050 1.000 0603040000 6C Bean, navy, seed 0.000214 0.050 1.000

0603 041000 6C Bean, pink, seed 0.000214 0.050 1.000 0603042000 6C Bean, pinto, seed 0.000214 0.050 1.000 0603098000 6C Chickpea, seed 0.000214 0.050 1.000

0603098001 6C C hickpea, seed

- babyfood 0.000214 0.050 1.000 0603099000 6C Chickpea, flour 0.000214 0.050 1.000
0603182000 6C Guar, seed 0.000214 0.050 1.000
0603182001 6C Guar, seed

- bab yfood 0.000214 0.050 1.000 0603348000 6C Soybean, flour 0.000214 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.000214 1.000 1.000 1001240000 10A Orange 1.000000 1.000 1.000 5 1001241000 10A Orange, juice 1.000000 1.000 1.000 6 1001241001 10A Orange, juice

- babyfood 1.000000 1.000 1.000 6 1001242000 10A Orange, peel 1.000 000 1.000 1.000 5

1002199000 10B Lemon 1.000000 1.000 1.000 7Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 29 of 34 1002200000 10B Lemon, juice 1.000000 1.000 1.000 8 1002200001 10B Lemon, juice

- babyfood 1.000000 1.000 1.000 8 1002201000 10B Lemon, peel 1.000000 1.000 1.000 7

1002206000 10B Lime 1.000000 1.000 1.000 9 1002207000 10B Lime, juice 1.000000 1.000 1.000 10 1002207001 10B Lime, juice

- babyfood 1.000000 1.000 1.000 10 1003180000 10C Grapefruit 1.000000 1.000 1.000 11 1003181000 10C Grapefruit, juice 1.000000 1.000 1.000 12

1400269000 14 Pecan 1.000000 1.000 1.000 13 1500344000 15 Sorghum, grain 0.200000 1.000 1.000 1500345000 15 Sorghum, syrup 0.200000 1.000 1.000

2003128000 20C Cottonseed , oil 0.015900 0.100 1.000
2003128001 20C Cottonseed, oil

- babyfood 0.015900 0.100 1.000
8601000000 86A Water, direct, all sources 1.000000 1.000 1.000 14
8602000000 86B Water, indirect, all so urces 1.000000 1.000 1.000 14
9500115000 O Coffee, roasted bean 0.008550 1.000 1.000
9500116000 O Coffee, instant 0.008550 1.000 1.000

9500263000 O Peanut 0 .002115 1.000 1.000



### B) 

### Result files

Food (Refined Potato Imports) and Drinking Water (Sugar beets)

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for ALDICARB ACUTE DIETARY ASSESSMENT

NHANES 2003

- 2008 2

- Day Residue file: Aldicarb Acute_Food Water SugarBeet_Refined_PotatoImports.r08 Adjustment factor #2 NOT used. Analysis Date: 03

- 23

- 2016/17:48:49 Residue file dated: 02

- 18

- 2016/10:43:52 RAC/FF intake reported by eating occasion
Reversal analysis used with half life = 2 hr(s)
MC iterations = 1000; MC list in residue file; MC seed = 155; RNG = MS VB MC residues held constant for each RAC/FF intake on same day/iteration

R un Comment: ""

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposur e % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population:

0.000240 88.88 0.001356 502.11 0.004607 1706.15

All Infants:

0.000353 130.79 0.002603 964.03 0.007723 2860.41

Children 1

- 2:

0.000348 129.05 0.002022 748.86 0.006976 2583.69

Children 3

- 5:

0.000304 112.76 0.001780 659.41 0.005750 2129.81

Children 6

- 12 :
0.000214 79.30 0.001270 470.25 0.004220 1562.94

Youth 13

- 19:

0.000171 63.35 0.001051 389.20 0.003664 1356.94

Adults 20

- 49:

0.000243 90.10 0.001373 508.49 0.004672 1730.31

Adults 50

- 99:

0.000247 91.55 0.001299 481.03 0.004155 1538.98

Female 13

- 49:

0.000239 88.39 0.001364 505.09 0.00 4677 1732.13



### Food Only (Refined Potato Imports)Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 30 of 34 Result File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for ALDICARB ACUTE DIETARY ASSESSMENT

NHANES 2003

- 2008 2

- Day Residue file: Aldicarb Acute_Food Only_Refined_PotatoImports.r08 Adjustment factor #2 NOT used.
Analysis Date: 03

- 24

- 2016/09:46:53 Residue file dated: 02

- 18

- 2016/10:46:19 RAC/FF intake reported by eating occasion

Reversal analysis used with half life = 2 hr(s)
MC iterations = 1000; MC list in residue file; MC seed = 155; RNG = MS VB MC residues held constant for each RAC/FF intake on same day/iteration

Run Comment: ""

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population:

0.000006 2.15 0.000024 8.73 0.000067 24.99

All Infants:

0.000023 8.46 0.000043 16.05 0.000089 33.01

Children 1

- 2:

0.000012 4.62 0.000071 26.31 0.000177 65.47

Children 3

- 5:

0.000010 3.63 0.000053 19.70 0.000133 49.42

Children 6

- 12:

0.000005 2.01 0.000032 11.73 0.000076 28.08

Youth 13

- 19:

0.000003 1.28 0.000022 7.98 0.000050 18.48

Adults 20

- 49:

0.000004 1.64 0.000020 7.24 0.000044 16.41

Adults 50

- 99:

0.000007 2.76 0.000022 8.05 0.000049 18.14

Female 13

- 49:

0.000004 1.59 0.000020 7.24 0.000046 16.89

CEC Analysis for Food Only (Children 1

- 2)

US EPA

DEEM

- FCID Acute Critical Exposure Contribution Analysis (Ver. 3.18, 03

- 08

- d)

NHANES 2003

- 2008 2

- Day

Residue file = C: \ Users \ IEncarna \ Dietary Assessments \ Aldicarb \ DEEM Files \ Aldicarb Acute_Food Only_Refined_PotatoImports.r08
Acute report = C: \ Users \ IEncarna \ Dietary Assessments \ Aldi carb \ DEEM Files \ Aldicarb_Food Only_24May2016.AC8 Date and time of analysis: 03

- 24

- 2016 09:33:19 Food and foodform consumption evaluated by eating occasion. Adjustment factor #2 not used. Minimum exposure contribution = 5%

MC Iterations = 1000 Seed = 155 RNG = MS VB CEC records generated for first 812 iterations. Exposures divided by body weight

Children 1

- 2 Low percentile for CEC records: 99.9 Exposure (mg/day) = 0.000177 High percentile for CEC records: 100 Exposure (mg/day) = 0.001026

Number of actual records in this interval: 2582

Critical foods with foodforms for this population (as derived from these records): Only foods/foodforms with percent contribution >= 5 are reported.
N=number of appearances in all records (including duplicates) %=percent of total exposure for all records (including duplicates)Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 31 of 34 Food FF N Percent Food Name

---------- --- ----- ------- ------------- 1001240000 110 1359 48.97% Orange

- Uncooked; Fresh or N/S; Cook Meth N/S
1001241000 110 897 33.08% Orange, juice

- Uncooked; Fresh or N/S; Cook Meth N/S
1001241000 120 291 9.20% Orange, juice

- Uncooked; Frozen; Cook Meth N/S

Critical foods (without foodforms) for this population (as derived from these records): Only foods with percent contribution >= 5 are reported. N=number of appearances in all records (including duplicates) %=percent of total exposure for all records (including duplicates)

Food N Percent Food Name

---------- ----- ------- ------------- 1001240000 1359 48.97% Orange 1001241000 1192 42.29% Orange, juice



### Drinking Water Only (Sugar beets)

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Anal ysis for ALDICARB WATER ONLY (SUGARBEET)

NHANES 2003

- 2008 2

- Day Residue file: Aldicarb Acute_Water Only SugarBeets.r08 Adjustment factor #2 NOT used. Analysis Date: 03

- 23

- 2016/15:42:45 Residue fil e dated: 11

- 12

- 2015/11:05:07 RAC/FF intake reported by eating occasion
Reversal analysis used with half life = 2 hr(s)
MC iterations = 1000; MC list in residue file; MC seed = 155; RNG = MS VB
MC residues held constant for each RAC/FF intake on same day/iteration

Run Comment: ""

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile
Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population:

0.000238 88.32 0.001353 501.17 0.004616 1709.59

All Infants:

0.000354 131.01 0.002611 967.15 0.007775 2879.72

Children 1

- 2:

0.000343 126.89 0.002007 743.50 0.006928 2566.09

Children 3

- 5:

0.000303 112.15 0.001778 658.44 0.005760 2133.24

Children 6

- 12:

0.000212 78.36 0.001263 467.71 0.004206 1557.62

Youth 13

- 19:

0.000171 63.24 0.001051 389.14 0.003696 1368.78

Adults 20

- 49:

0.000242 89.78 0.001371 507.62 0.004677 1732.14

Adults 50

- 99:

0.000245 90.75 0.001293 478.94 0.004186 1550.47

Female 13

- 49:

0.000237 87.94 0.001362 504.43 0.004688 1736.41



### Drinking Water Only (Cotton)

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for ALDICARB WATER ONLY (SUGARBEET)Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 32 of 34 NHANES 2003

- 2008 2

- Day Residue file: Aldicarb Acute_Water O nly Cotton.r08 Adjustment factor #2 NOT used.
Analysis Date: 03

- 23

- 2016/18:09:15 Residue file dated: 11

- 12

- 2015/11:13:42 RAC/FF intake reported by eating occasion
Reversal analysis used with half life = 2 hr(s)
MC iterations = 1000; MC list in residue f ile; MC seed = 155; RNG = MS VB MC residues held constant for each RAC/FF intake on same day/iteration

Run Comment: ""

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

Summary calculations

-- per capita:

95 th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- -------- Total US Population:

0.000016 5.84 0.000125 46.32 0.000492 182.24

All Infants:

0.000021 7.82 0.000241 89.13 0.000909 336.58

Children 1

- 2:

0.000023 8.39 0.000186 69.05 0.000743 275.23

Children 3

- 5:

0.000020 7.51 0.000165 61.04 0.000628 232.45

Children 6

- 12:

0.000014 5.12 0.000116 42.99 0.000446 165.07

Youth 13

- 19:

0.000011 4.05 0.000096 35.55 0.000396 146.73

Adults 20

- 49:

0.000016 5.91 0.000127 47.16 0.000501 185.56

Adults 50

- 99:

0.000017 6.19 0.000120 44.47 0.000448 165.94

Female 13

- 49:

0.0 00016 5.81 0.000126 46.65 0.000498 184.33Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 33 of 34 

### Attachment 4. EDWC at the LOC Considering Exposure through Drinking Water Only

A scree ning tool was used to provide an estimate of the contribution of pesticide residues in drinking water to the dietary risk of the pesticide. Rough estimates of the estimated drinking water concentration (EDWC) at the level of concern (LOC) are provided without considering contribution from food and residential exposures. Therefore, even if estimated drinking wat er risks are relatively low, aggregate risk may be of concern. The water consumption values were obtained using the dietary exposure and risk model, DEEM

- FCID Version 4.02, which uses food consumption data from the USDA National Health and Nutrition Exami nation Survey, What We Eat in America, conducted from 2005 to 2010; refer to Table A.4.2. In general, the population subgroup with higher exposure to residues in drinking water is infants (<1 yr old). The equation used to estimate the dietary risk and th e results of the screening are presented below.

The lowest EDWC at the level of concern is 1.5 ppb and 0.8 ppb at the 95 th 

### and 99.9 th 

### percentile of exposure , respectively . It is important to note that a distribution of water residues will be used

for die tary assessment of aldicarb ; therefore, the distribution from the modeling a scenario that

results in a peak concentration similar to those estimated here is likely to result in lower dietary risk than that obtained using a point estimate.

Table A. 4

. 1. Results of the screening of the Dietary Risk Contribution from Drinking Water

Assessment Population aPAD (mg/kg/day) EDWC at LOC (ppb)

95 th 

### 99.9 th



### Acute General 0.00027 5.075188 1.5

All Infants 0.00027 1.47541 0.794118

Females 0.00027 5.13308 2.347826 Equation to estimate the dietary risk:

Table A. 4 .2. Water consumption (L / kg

- bw*day) for Acute Analysis

Population Subgroup Acute

95 th 

### 99.9 th



### General Population 0.0532 0.180

All Infants (< 1yr old) 0.183 0.340

Females (13

- 49 yrs) 0.0526 0.115Aldicarb Dietary Exposure and Risk Assessment DP Number: D430197

Page 34 of 34 

### Attachment 5. Commodity Specific Analysis Conducted for Aldicarb.

Table A.5.1. Aldicarb PDP Monitoring Data Used for the Commodit y Specific Analysis

.

Source of D ata Used For Refinement Maximum Residue / LOD (ppm)

Potato PDP Data (Import) 0.03796

Sweet Potato PDP Data (Domestic Plus Import) 0.07784

Sweet Potato Baby Food PDP Data (Domestic and Import) 0.0083

Table A.5.2 . Commodity Specific Analysis for Aldicarb

Commodity (Food) Age Group Source Exposure %aPAD

Amount Consumed (g) Anticipated Residue (ppm) Using FTD or PDP Data

Infant (10 kg) Pre

schooler (15 kg) Females

13to49 (60 kg) Monitoring

(PDP) Residue

Threshold 1 Infant Pre

schooler Adult

Female

Potato 71 142 142 0.0380 0.029 100 133 33

Sweet Potato 78 156 156 0.0778 0.026 300 75

Sweet Potato (bf) 78 156 156 0.0083 0.026 24

bf = baby food

1 Residue Threshold = aPAD / Consumption = 0.00027 mg/kg

- bw/day / [Amount Consumed (kg/day) / Body Weight (kg)]. The residue threshold (i.e. residue level that would result in risk at the level of concern) presented in this table is based on preschoolers, the subgroup with highest exposure.