### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460



### Date: September 15

, 2015 OFFICE OF

CHEMICAL SAFETY AND
POLLUTION PREVENTION



### SUBJECT: Tcrbufos. Acute and Steady State Aggregate Di etar y Exposure and Ri sk Assessment of

Food a n d Drinking Water to Support Registration R ev i ew.

PC Code: 105001 DP Bar codc: 04 2 2672

D ecis ion No.:**~72CJL//** R egis trati o n No.: 5481-545 & 5481-547

Petition No.: NA R c2 u l at o r y Action: Registration Review

Ri sk A ssess ment T y p e: Dietary Case N o. : 27605

T XR No.: NA CAS No.: 13071-79-9

M RID No.: Non e 40 CF R: § 18 0.352



### FROM: Peter Savo ia

, Chemist 

# Q-fcJ'._

-**L~~** Risk Assessment Branch V

THRU:

TO: Health Effects Division (7509P)



## Michael S. Metzger

, Br anch Chief I 

# J (} 

# J)

1

# ~ Risk Assessment Branch V

# J/**~'** V {- /

Health Effects Division (7509P)**~**



### And

# ~ Thurston

. Morton

, Chemist

Sheila Pip er
, Chem i st 

# Sl 

# .t

- r'1' 

### Dietary Exposure

### Scie~~Advisory Cou n c il

Health Effects Division (7509P)

Matthew Lloyd

, Risk Assessor

Risk Assessment Branch V N II

Health Effec t s Division (7509P)

And



### Matthew Manupclla

, Ri sk Manager R eviewe r
Ri sk Management and Impl ementation Branch II

P esticide Re-Evaluation Divi s i on (7508P)

E xecutive S umm ary

Acute and steady state (acute 2 -d ay average) aggregate food and drinking water dietary e xposure and

risk assessments fo r terbufos were conducted using th e Dietary Exposure Eva lu ation Model software

w ith the Food Commodity Intak e D atabase (DEEM-FC ID ) Version 3. 16. This software uses 2003-

2008 food consumption data from the U.S. Department of Agriculture ' s (USDA ' s) Nat i ona l H ea lth

and Nut riti on Examination Survey / What We Eat in America

, (N HANES / WWE J A). These ana l yses

r e flect the latest consumption data which are being made to support the registration review risk

a s se s sment ofterbufos. This memorandum was rev i ewed by two peer reviewers of the DESAC (and

Page I of 44Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 2 of 44 the entire DESAC on 10/02/2014) , per DESAC Standard Operating Procedures ( SOP ) 201 2.1.

Acute Dietary (Food and Water) Exposure Results and Characterization Terbufos is an organophosphate (OP) insecticide that is marketed in closed loading systems as granular products intended for use in agriculture as a soil incorporated insecticide. It is used to control a variety of pests which affect bananas, coffee, corn, sugar beets, and sorghum . Ter b ufos is typically applied at planting with concurrent soil incorporation using ground based application equipment

, but can also be applied at post

- emergence or during cultivation activities.

An un r efined acute dietary exposure assessment was conducted to estimate the dietary exposure and risk for registration review. The acute dietary exposure assessment was conducted us ing field trial

residues and 100% crop treated data

. The distribution of drinking water concentration s was based on

the maximum use rate (max rate) of terbufos from the Texas sorghum application scenario.

The acute aggregate dietary exposure estimates ar e above HED’s level of concern (>100%) for the acute population adjusted dose (aPAD) for the U.S. population and all population subgroups.

Combined dietary exposure for the U.S. population from food and drinking water (max rate) is

1900 % of the aPAD with an exposure of 0.00 0389 mg/kg/day at the 95 th 

### percentile. The most highly exposed population subgroup is all infants (<1 year old ) having an estimate of 530 0 % of the a PAD with an exposure of 0.0 01055 mg/kg/day at the 95 th 

### percentile

.

Steady

- State Dietary (Food and Drinking Water) Exposure Results and Characterization

OP insecticide active ingredients can exhibit a phenomenon known as “ steady

- state ” acetylcholinesterase (AChE) inhibition which is the most sensitive endpoint for all lifestages. After repeated dosing at the same level, the amount of AChE inhibition in a given dose remains consistent

across duration. For this reason, a steady

- state point of departure (PoD) was selected for oral exposure to terbufos (Table 4 ).

A n un r efined steady

- state dietary exposure assessment was conducted to estimate the dietary risks associated with the registration of terbufos. For this analysis, the DEEM acute module is used to

conduct a 2

- day average assessment of the OP active ingredient using the steady

- state PoD, 2

- day average food consumptions, and 21

- day forward rolling drinking water averages. These 2

- day average assessments provide an estimate of 21

- day (“steady

- state”) average daily food and drinking

water exposures. The steady

- state expos ure assessment was also conducted using field trial residues

and 1 00% crop treated data

. The distribution of drinking water concentrations is calculated as a 21

- day forward rolling average based on the maximum use rate of terbufos from the Texas sorghum application scenario.

The resulting steady

- state (ss) aggregate dietary exposures are all above HED’s level of concern ( >100%) of the ss PAD for the U.S. population and all population subgroups. Combined dietary exposure for the U.S. population from food and drinking water (max rate) is 38 00 % of the ss PAD with an exposure of 0.0 003 80 mg/kg/day at the 95 th 

### percentile

. The most highly exposed population subgroup is all infants (<1 year old) having an estimate of >100 00% of the ss PAD with an exposure

of 0.00 103 8 mg/kg/day at the 95 th 

### percentile

.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 3 of 44 Cancer Dietary (Food and Drinking Water) Exposure Result and Characterization A cancer dietary exposure and risk assessment was not conducted for terbufos since it is classified as “not likely to pose a carcinogeni c hazard to humans”.

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For the acute
and steady state (acute 2

- day average) assessments, the risk is expressed as a percentage of a maximum acceptable do se (i.e., the dose that HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the point of departure (P o D, NOAEL, LOAEL, e.g.) divided by the req uired uncertainty or safety factors.

For the acute and steady state (acute 2

- day average) assessments , HED is concerned when estimated dietary risk exceeds 100% of the PAD. References that discuss dietary 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.regulation.gov/#!docu mentDetail;D=EPA

- HQ

- OPP

- 2007

- 0780

- 0001 ; or see SOP 99.6 (20

- AUG

- 1999).

For the OP insecticide terbufos, HED has conducted un refined acute and steady

- state (acute 2

- day average) dietary risk assessments using DEEM

- FCID Version 3.16 modeling software. OPs exhibit a phenomenon known as steady

- state AChE inhibition. After repeated dosing at the same dose level, the degree of inhibition comes into equilibrium with the production of new, uninhibited enzyme. Therefore, 2

- day average assessments were conducted instead of traditional chronic assessments.

The DEEM acute model is typically used to conduct 2

- day average assessments for the OPs using the steady

- state PoD, 2

- day food consumptions, and 21

- day forward

- rolling water averages. These 2

- day

average assess ments provide an estimate of 21

- day (“steady

- state”) average daily food and drinking water exposures. For terbufos, a screening level high

- end point estimate was used for the drinking water concentrations as opposed to a distribution of the 21

- day forward

- rolling averages. For food,

the 2

- day average assessments reflect an average daily exposure for a 2

- day exposure duration rather

than a 21

- day exposure duration. Since the DEEM 2

- day average assessment does not capture day

to

- day variation in food resid ues, it will generally result in higher food

- only exposure estimates than a

model that calculates 21

- day rolling averages for food. Although the DEEM 2

- day average assessment for terbufos may result in higher exposure estimates for both drinking water and food, the assessment provides an acceptable estimate of 21

- day (“steady

- state”) average daily exposure for food and drinking water for use in risk assessment.

The most recent dietary exposure analysis of terbufos was conducted in support of th e interim registration eligibility decision (IRED) issued in 1999 (D 258668, C. Swartz, 08/26/1999 ).

II. Residue Information

Terbufos (S

- [[(1,1

- Dimethylethyl)thio]0,0

- diethyl phosphorodithioate) is an organophosphate insecticide used in agriculture to con trol pests which affect bananas, coffee, corn, sugar beets, and sorghum. Existing and reassessed tolerances are established for the combined residues of terbufosTerbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 4 of 44 and its cholinesterase

- inhibiting metabolites in or on plant commodities under 40 CFR §180.35 2

. The cholinesterase

- inhibiting metabolites of terbufos include terbufos oxygen analog (oxon), terbufos sulfoxide, terbufos sulfone, terbufos oxygen analog sulfoxide, and terbufos oxygen analog sulfone. Adequate data collection and enforcement methods are available to detect terbufos residues in plant commodities. Tolerances are not required for residues in livestock commodities since there is no reasonable expectation of detectable residues, 40 CFR §180. 6(a)3.

Residues of Concern in Plants and Drinking Water : The terbufos residues of concern for p lants and drinking water are shown below in Table 1.

Table 1. Summary of Terbufos Residues of Concern.

Matrix Residues included in Risk

Assessment Residues included in Tolerance Expression

Plants Terbufos (parent), T erbufos

O xygen A nalog ( O xon),

T erbufos S ulfoxide,

T erbufos S ulfone, T erbufos

O xygen A nalog S ulfoxide,

and T erbufos O xygen A nalog S ulfone. Terbufos (parent), T erbufos

O xygen A nalog ( O xon),

T erbufos S ulfoxide,

T erbufos S ulfone, T erbufos

O xygen A nalog S ulfoxide,

and T erbufos O xygen A nalog S ulfone.

Drinking Water Terbufos (parent) , Terbufos Sulfoxide, and Terbufos

Sulfone. 1 Not applicable

1 Upon submission of additional information, the ROCKS Committee revisited the residues of concern in drinking water

and determined the residues of concern to be parent, terbufos sulfoxide, and terbufos sulfone since the oxon degradates

are not being detected in surface or ground water (D 417464

, E. Scollon

, 02 / 03 /1 4 )

.



### Residues used in Acut e and Steady

- State (Acute 2

- Day Average) Dietary Analyses : Un refined acute and steady

- state (acute 2

- day average) dietary exposure assessments were conducted with 1 00% crop

treated data which used residue inputs from field trial results. USDA PDP data were not used for dietary assessment because all of the metabolites of concern were not analyzed. No new residue data have been generated for th is assessment and there are no changes in the residue inputs from the existing field trial data. Therefore, residue inputs from the previous dietary analyses have been used

in th is assessment. These data are summarized below in Table 2 with the residue distribution files (RDFs) used in the current acute analysis shown in detail in Appendix 1.

Table 2

. Data Sources and Residue Estimates for Terbufos Dietary Analysis

. Commodity DEEM

Food Form (Classificat ion) Data Source

(MRID No.) # of Samples/#of

Detects 1⁄2 LOQ

(ppm) Processing

Factor % Crop

Treated Anticipated

Residue (ppm) (Tol., AR, or RDF)

Bananas NB/PB Field Trials /

44629302

00158608

00158610

00158612

00158613 “13”samples/”1”

detects NA 1 NA 100 RDF #1

Totalz=0

Totalnz=13Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 5 of 44 Table 2

. Data Sources and Residue Estimates for Terbufos Dietary Analysis

. Commodity DEEM

Food Form (Classificat ion) Data Source

(MRID No.) # of Samples/#of

Detects 1⁄2 LOQ (ppm) Processing

Factor % Crop

Treated Anticipated

Residue (ppm) (Tol., AR, or RDF)
Bananas, dried B Field Trials/

44629302

00158608

00158610

00158612

00158613 “13”samples/”1”

detects NA 3.9 (default value) 100 0.0043 avg.

(blended commodity; avg. of 13 field trials)

Field Corn B Field Trials/

44629303 “10” samples/”0”

detects 0.005 1 100 0.005

Sweet Corn NB/PB Field Trials/

43237802 “10” samples/”0”

detects 0.005 1 100 RDF #2

Totalz= 0

Totalnz=10 Sugar Beets B Field Trials/

00036127 “11” samples/”0”

detects 0.025 1 100 0.025

Sorghum, grain B Field Trials/

00079431 Not Noted/”0”

detects 0.025 NA 100 0.025

Coffee B 40365901 “8” samples/”1”

detect NA 1 100 0.028 (blended commodity; avg. of 8 field trials)

1 NA

– Not Applicable



### Anticipated residues (ARs) were previously calculated for a prior dietary assessment made for terbufos (D244268, W. J. Hazel, 03/19/1998).

Banana Using these data, banana pulp results totaling 13 data points were used to create a residue data file (RDF) for assessment which includes plantains since cultural practices are similar for both

commodities. This data set did include one positive detected result of 0.015 ppm. Dried banana is a blended commodity and the average of the 13 field trial results are used for this residue input.

Corn The residue values used for field corn and popcorn are based on non

- detectable residues and a half LOQ value is used for the assessment o f these ble nded commodities . Because the se data were acquired as exaggerated rate field trials

, there is no expectation of residues in any byproducts and the corn processing study was thus waived. For sweet corn, 10 data points acquired from prior field trial

studi es were used to create an RDF for assessment.

Sugar beet The prior field trials made for sugar beet showed no detectable residues of terbufos which results in a half LOQ value of 0.025 ppm to be used for assessment. In regard to sugar beet byproducts, no residues were detected in the processing study made on thick juice as noted in the 1983 registration standard. As a result, there is no expectation of residues in sugar beet molasses and syrup.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 6 of 44 Sorghum The prior field trials made for sorghum grain s howed no detectable residues of terbufos which results in a half LOQ value of 0.025 ppm to be used for assessment

. Since no detectable residues are found in sorghum grain, there is no reasonable expectation that detectable residues will be found in any byp roducts (Terbufos Registration Standard, C. Trichilo, 01/19/1983).

Coffee For coffee, the average of 8 field trial results were used as the residue input of this blended commodity for assessment

.

Fish: The USDA PDP monitored pesticides data in catfish between 2008 through 2010. PDP analyzed 1479 samples of catfish for terbufos residues. None of these samples contained detectable

residues and fish is not included in the assessment.

III. Percent Crop Treated Information

The acute and stead y

- state (acute 2

- day average) aggregate dietary analyses were performed assuming 100% of each commodity was treated with terbufos. The use of percent crop treated data would not further refine these dietary analyses since the majority of the field trial d ata are non

- detect

results

. Irrespective, the Biological and Economic Analysis Division (B EAD ) has recommend ed that 100% crop treated data be used for the representation of banana and coffee residues (D419906, J. Alsadek, 06/11/2014).

I V . Drinking Water Data

The drinking water residues determined for terbufos used for dietary risk assessment were provided by the Environmental Fate and Effects Division ( EFED ). The EFED determination uses maximum application rates but also considers typical applicat ion rates and reduction through bounding from vegetative buffers for the additional characterization of d ietary risk. It provides e stimated drinking water concentrations (EDWCs) for terbufos and its two major oxidative degradates, terbufos

sulfoxide and t erbufos sulfone in both surface water and groundwater. It considers a parent only approach but also considers the oxidative degradates of terbufos as parent in a total toxic residue (TTR) approach. Inclusion of the TTR approach is provided for a complete characterization of

EDWCs. Some OPs require metabolic activation to the oxon metabolite. However, terbufos is not one of these OPs and is already in the oxon form.

Registered use sites include corn at the maximum application rate of 1.3 lbs. a.i./A, so rghum at 1.68 lbs. a.i./A, and sugar beet at 1.98 lbs. a.i./A. Modeling for the se ground application scenarios of

terbufos used the coupled models PRZM and EXAMS for surface water and SCI

- GROW as well as

PRZM

- GW for groundwater. The highest EDWCs for the TTR of terbufos result from the Texas sorghum OP scenario (D418656, F. Khan, 04/08/2014)

. For the characterization of dietary risk, an

amended time

- series of TTR using a typical application rate for sorghum was also provided by EFED (D423572, F. Khan, 10 /29/2014). In th is amended assessment, the reported time

- series values were adjusted based on a typical use rate of 0.895 lbs a.i./A for sorghum, which is 53 percent of the maximum rate of 1.68 lbs a.i./A. Since there is a linear relationship between the application rate and modeled EDWCs, pre viously reported time

- series values for the Texas sorghum scenario were adjusted simply by multiplying with 0.53 to represent the typical rate for sorghum. An additionalTerbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 7 of 44 characterization scenario also considered by EFED for use in dietary assessment was a n assumed

90% reduction in the EDWCs determined for terbufos through the bounding of residues in vegetative

buffers ( D 428089 , F. Khan, 07/ 10 /2015)

. No additional modeling was considered since all of the input parameters from previous modeling using the ma ximum use rates remain unchanged. Recommended EDWCs for terbufos and TTRs of terbufos in surface water and ground are summarized below in Table 3. Daily time series outputs for the thirty year simulation were provided to HED for use in dietary exposure m odeling.

Table 3

. Recommended EDWCs for Drinking Water Risk Assessment for Terbufos and its Degrates

. Source of Drinking Water Estimated Drinking Water Concentration (μg/L)

1

- in

- 10

- year Peak Exposure 1

- in

- 10

- year Annual Mean Exposure 30

- year Mean Exposure

Total Toxic Residues of Terbufos (Terbufos plus Terbufos Sulfoxide and terbufos Sulfone)

Surface Water (Max Rate for sorghum) 1, 2 63.06 11.53 6.13

Surface Water (Typical Rate for sorghum) 1, 2, 3 33.42 6.11 3.25

Groundwater 4 33.54

-- 14.02 Terbufos (Parent only)

Surface Water 2, 5 46.02 0.28 0.12

Groundwater 6 0.02 0.02 0.02

1 EDWCs based on PRZM/EXAMS model and residue summation method for TX sorghum OP scenario.

2 PCA adjusted modeled values.

3 0.53 adjustment factor used in calculating EDWCs.

4 Highest EDWCs based summation of terbufos, terbufos sulfoxide, and terbufos sulfone derived from PRZM

- GW

model for Delmarva scenario.

5 EDWCs based on PRZM/EXAMS model for parent terbufos alone for MS co rn STD scenario.

6 EDWCs for parent terbufos were derived from SCI

- GROW model.



### V. DEEM

- FCIDTM Program and Consumption Information

The terbufos acute and steady

- state (acute 2

- day average) dietary exposure and risk assessment s were conducted using the DEEM

- FCIDTM, Version 3.16. This software uses 2003

- 2008 food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The se 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 flo ur

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but

f or acute exposure assessment 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 ris k for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1

- 2, children 3

- 5, children

6

- 12, youth 13

- 19, adults 20

- 49, females 13

- 49, and adults 50

- 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 exposu re assessment, or “matched” in multiple random pairings with residue values andTerbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 8 of 44 thgen 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 eati ng 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 analyses performed a t all leve ls of refinement. However, for deterministic assessments, any significant differences in user vs. per

- capita exposure and risk are specifically identified and

noted in the risk assessment.

For the steady

- state (acute 2

- day average) exposure assessment, 2

- day average food consumptions are

calculated on an individual

- by

- individual basis. The reported consumption amounts of each food item for each day are added together and then divided by two (2) days. For example, if an individual reports eating 100 gra ms of apple on the first day and 0 grams of apple on the second day, the 2

- day average consumption amount would be 50 grams/day of apple [(100 grams + 0 grams)/2

- days = 50 grams/day]. The resulting 2

- day average consumption amount can then be multiplied b y a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distributio n of exposures is expressed as a percentage of the

PAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and per

capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.

In a ccordance with HED policy, per capita exposure and risk are reported for analyses performed at all levels of refinement. However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically identifi ed and noted in the risk assessment.

V I

. Toxicological Information

Terbufos is a member of the O P class of pesticides. Like other O P s, the initiating event in the adverse outcome pathway (AOP), also often called the mode of action (MOA), for terbufos involves inhibition of the enzyme acetylcholinesterase (AChE) via phosphorylation of the serine residue at the active site of the enzyme. This inhibition leads to accumulation of acetylcholine and ultimately to neurotoxicity in the central and/or periphe ral nervous system. For terbufos, AChE inhibition is the most sensitive endpoint in the toxicology database in multiple species, durations, lifestages, and

routes. After repeated dosing at the same dose, the degree of inhibition comes into equilibrium wi th the production of new, uninhibited enzyme. At this point the amount of AChE inhibition at a given

dose remains consistent across duration.

The RAB V/VII toxicologists have re

- evaluated the terbufos database and updated the endpoints as

necessary. In the case of terbufos, many of the data sets were not amenable to benchmark dose ( BMD ) modeling. For the BMD analyses that were made, there is no pattern of increasing toxicity apparent with time; the BMD values vary within a narrow range. In general , following terbufos exposure, RBC and brain ChE inhibition are similarly/equally sensitive. In addition to the consistency across durations, the data across multiple studies (repeat CCA study, gestational data from the DNT, subchronic neurotoxicity study ) are similar. The se data are concluded to be consistent with the OP cumulative risk assessment, which included subchronic and chronic data for

terbufos. Given the results for terbufos, acute (single day) and steady state durations are appropriate

for hu man health risk assessment. HED’s ToxSAC met (04/03/2014) to consider the endpoints of toxicological concern for dietary exposure.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 9 of 44 An uncertainty factor of 100X (10X to account for interspecies extrapolation and 10X for intraspecies variation) is appli ed to the BMDL 10 

### to obtain the resulting endpoint. The 10X for FQPA SF due to uncertainty in the human dose

- response relationship for neurodevelopmental effects will be retained

for the population subgroups that include infants, children, youths, and wome n of child

- bearing age

for all exposure scenarios. A summary of the endpoint selection is presented below in Table 4 which

focuses on presenting the acute, single day effects and steady state effects. For purposes of consistency with the OP cumulative ri sk assessment (CRA) and other OPs, exposure assessments of 21 days and longer will be conducted.

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

Assessment

. Exposure/

Scenario Point of Departure Uncertainty/FQP

A Safety Factors RfD, PAD, Level

of Concern Study and Toxicological Effects
Acute Dietary (All Populations except
adults 50

- 99 years old ) BMDL 10 = 0.02 mg/kg /day UF = 100x

FQPA SF = 1 0 x aRfD = aPAD =

0.00 0 02 mg/kg/day CCA Study (MRID No. 46247601)

in the rat

– RBC inhibition in PND

11 males. Acute Dietary ( adults

50

- 99 years old) BMDL 10 = 0.02 mg/kg/day UF = 100x

FQPA SF = 1x aRfD = aPAD =

0.0002 mg/kg/day CCA Study (MRID No. 46247601)

in the rat

– RBC inhibition in PND

11 males. Steady

- State Dietary (All Populations except adults 50

- 99 years old ) BMDL 10 = 0.01 mg/kg/day UF = 1 0 0x

FQPA SF = 1 0 X ss RfD = ssPAD =

0.00001 mg/kg/day Neurotoxicity Studies (MRID Nos.

46240802 & 46214301) in the rat

- RBC ChE inhibition in female

PND 21 pups & GD 20 male fetuses, and brain cholinesterase

inhibition in PND 21 males & GD

20 dams.

Steady

- State Dietary ( adults 50

- 99 years

old ) BMDL 10 = 0.01 mg/kg/day UF = 1 0 0x

FQPA SF = 1X ss RfD = ssPAD =

0.0001 mg/kg/day Neurotoxicity Studies (MRID Nos.

46240802 & 46214301) in the rat

- RBC ChE inhibition in female PND 21 pups & GD 20 male fetuses, and brain cholinesterase

inhibition in PND 21 males & GD

20 dams.

Cancer (oral, dermal, inhalation) Classification: “ Not Likely to be Carcinogenic to Humans ”

Point of Departure (P o D) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human

exposures. BMDL 10 = benchmark dose lower limit 10% response. UF = uncertainty factor. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose ( a = acute, and ss = steady

- state ). RfD = reference dose.



### V I I . Results/Discussion

As stated above, for acute and steady

- state assessments, HED is concerned when dietary risk exceeds

100% of the PAD. The DEEM

- FCID (ver. 3.16 ) analyses estimate the dietary exposure of the U.S. population and all its various population subgroups. The results reported in Tables 5 and 6 are fo r estimating the dietary exposure of the U.S. population and all its various population subgroups. The results reported below 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 1 3

- 49, adults 20

- 49, and adults 50

- 99 years.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 1 0 of 44 Results of Acute Dietary (Food plus Drinking Water) Exposure Analysis

For food plus drinking water, the acute dietary risk estimate exceeded HED’s level of concern at the

95 th 

### percentile of exposure. The acute dietary exposure was estimated for the U.S. population to be

190 0 % of the aPAD with an exposure of 0.00 0389 mg/kg/day at the 95 th 

### percentile. The most highly exposed population subgroup is all infants (<1 year old) havi ng an estimate of 530 0 % of the a PAD with an exposure of 0.0 01055 mg/kg/day at the 95 th 

### percentile

.

Table 5. Results of Acute Dietary Exposure Analysis for Terbufos (Food and Drinking

Water

- Max Rate). Population Subgroup aPAD (mg/kg/day) 95 th 

### Percentile

Exposure (mg/kg/day) % aPAD
General U.S. Population 0.000 0 2 0.000389 190 0 All Infants (<1 year old) 0.000 0 2 0.001055 530 0

Children 1

- 2 years old 0.000 0 2 0.000587 290 0

Children 3

- 5 years old 0.000 0 2 0.000502 250 0

Children 6

- 12 years old 0.000 0 2 0.000359 180 0

Youth 13

- 19 years old 0.000 0 2 0.000289 140 0

Adults 20

- 49 years old 0.000 0 2 0.000388 190 0

Adults 50

- 99 years old 0.0002 0.000378 190

Females 13

- 49 years old 0.000 0 2 0.000387 190 0

1 Acute dietary analysis derived from a 0. 000 0 2 mg/kg/day a PAD for the general population except for adults 50

- 99 years old which use a 0.0002 mg/kg/day aPAD.

2 Highest exposures found for assessment is noted in bold.



### Results of Steady

- State Acute 2

- Day Average Dietary (Food plus Drinking Water) Exposure Analysis The steady

- state aggregate dietary (food plus drinking water) exposure estimates are above HED’s level of concern for the U.S. population and all populations subgroups. Combined dietary exposure for the U.S. population f

rom food and drinking water is 38 00% of the ss PAD with an exposure of

0.00 03 80 mg/kg/day at the 95 th 

### percentile

. The most highly exposed population subgroup is all infants (<1 year old) having an estimate of >10000 % of the ss PAD with an exposure of 0.00 103 8 mg/kg/day at the 95 th 

### percentile

.

Table 6

. Results of Steady

- State Dietary Exposure Analysis for Terbufos (Food and Drinking

Water

- TX Sorghum Maximum Rate) using the Acute 2

- Day Avereage Analysis. 

### Population Subgroup aPAD (mg/kg/day) 95 th 

### Percentile

Exposure (mg/kg/day) % aPAD
General U.S. Population 0.00 0 0 1 0.0003 80 3800 All Infants (<1 year old) 0.00 0 0 1 0.0010 3 8 >100 0 0

Children 1

- 2 years old 0.00 0 0 1 0.0005 7 4 57 0 0

Children 3

- 5 years old 0.00 0 0 1 0.000 4 86 4900

Children 6

- 12 years old 0.00 0 0 1 0.0003 50 3500

Youth 13

- 19 years old 0.00 0 0 1 0.00028 4 28 0 0

Adults 20

- 49 years old 0.00 0 0 1 0.0003 77 3800

Adults 50

- 99 years old 0.0001 0.0003 6 8 370

Females 13

- 49 years old 0.00 0 0 1 0.0003 7 8 3800

1 Acute 2

- day dietary analysis derived from a 0. 0 0 00 1 mg/kg/day ss PAD for the general population except for adults 50

- 99 years old which use a 0.0001 mg/kg/day ssPAD.

2 Highest exposures found for assessment is noted in bold.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 11 of 44 VII I

. Characterization of Inputs/Outputs

HED has conducted un refined acute and steady

- state dietary risk assessments for terbufos using 100% crop treated data with residue inputs from field trial results

. USDA PDP data were not used for dietary assessment because all of the metabolites of concern were not analyzed. The u se of percent crop treated data w ere not used to further refine these dietary analyses since the majority of the field

trial data are non

- detect result s

. Although averag ing the 2 consumption days for each individual consumer in the DEEM consumption databa se e assessments may result in higher exposure estimates

for food than in a typical chronic DEEM analysis, this provides a high

- end estimate of 21

- day (“steady

- state”) exposure for food and drinking water. E xposures were above HED’s level of

concern for t he U.S population and all population subgroups. The critical exposure contribution (CEC) analysis performed for all infants <1 year of age (the population subgroup with the highest dietary exposure) shows that drinking water is the driver of dietary risk (Attachment 10). The CEC analyses for all infants < 1 year of age also shows that the greatest contribution to dietary risk from

food

, although minor in comparison to that of drinking water , is f rom bananas

.

Characterization of Acute Dietary Risk Assessed with M aximum Rate EDWCs The highest EDWCs for the TTR of terbufos result from the Texas sorghum scenario using the highest maximum application rate

. These analyses presented in Table 7 show acute dietary exposure

estimates for food only, water on ly , as well as for food and drinking water are all above H ED’s level of concern for the U.S. population and all its population subgroups at the 95 th 

### percentile. For the U.S. population

, the combined dietary exposure from food plus drinking water is 1900 % of the a PAD with an exposure of 0.000 389 mg/kg/day at the 95 th 

### percentile. All infants <1 y ear old was the population subgroup with the highest combined exposure from food plus drinking water at 5300 % of the a PAD with an exposure of 0.001055 mg/kg/day at the 95 th 

### percentile.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 12 of 44 Table 7

. Results of Acute Dietary Exposure Analysis for Terbufos Food only and Drinking Water only

,

a nd Food plus Drinking Water using Maximum Rate EDWCs

. Population Subgroup aPAD

(mg/kg/day) Food only Drinking Water only ( Maximum Rate) Food plus Drinking

Water ( Maximum Rate)

95 th Percentile 95 th Percentile 95 th Percentile Exposure (mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD

General U.S. Population 0.000 0 2 0.000 056 280 0.000366 1800 

### 0.000389 190 0

All Infants (<1 year old) 0.000 0 2 0.000122 610 0.001020 5100 

### 0.001055 530 0

Children 1

- 2 years old 0.000 0 2 0.000126 630 0.000527 2600 

### 0.000587 290 0

Children 3

- 5 years old 0.000 0 2 0.000 109 540 0.000450 2200 

### 0.000502 250 0

Children 6

- 12 years old 0.000 0 2 0.000 079 390 0.000323 1600 

### 0.000359 180 0

Youth 13

- 19 years old 0.000 0 2 0.000 049 240 0.000269 1300 

### 0.000289 140 0

Adults 20

- 49 years old 0.000 0 2 0.000 042 210 0.000370 1800 

### 0.000388 190 0

Adults 50

- 99 years old 0.00 0 2 0.000 035 18 0.000362 180 

### 0.000378 190

Females 13

- 49 years old 0.000 0 2 0.000 040 200 0.000370 1800 

### 0.000387 190 0

1 Acute dietary analysis derived from a 0.0 0 002 mg/kg/day aPAD for the general population except for adults 50

- 99 years old which use a 0.0002 mg/kg/day aPAD

. 2 Highest exposures found for assessment is noted in bold.



### Characterization of Acute Dietary Risk Assessed with Typical Rate EDWCs To further depict dietary exposure, typical application rates were also considered to provide for a complete characterization of the EDWCs. For the Texas sorghum scenario modeled for terbufos, a

0.53 reduction factor is realized in determining these EDWCs. The acute dietary results at the 95 th


### percentile for the analysis of food only, drinking water only, and food plus drinking water determined using typical rate EDWCs are presented in Table 8

. Although lower results are obtained , all acute analyses still exceed HED’s level of concern at the 95 th 

### percentile o f exposure (except for adults 50

- 99 years old for food only ). These analyses show that f or the U.S. population the combined dietary

exposure from food plus drinking water is 1100 % of the a PAD with an exposure of 0.000 220 mg/kg/day at the 95 th 

### percentile. All infants <1 y ear old was the population subgroup with the highest combined exposure from food plus drinking water at 2900 % of the a PAD with an exposure of 0.000580 mg/kg/day at the 95 th 

### percentile.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 13 of 44 Table 8. Results of Acute Dietary Exposure Analysis for Terbufos Food only, Drinking Water only, a nd

Food plus Drinking Water using Typical Rate EDWCs

. Population Subgroup aPAD

(mg/kg/day) Food only Drinking Water only (Typical Rate) Food plus Drinking

Water (Typical Rate)

95 th Percentile 95 th Percentile 95 th Percentile Exposure (mg/kg/day) %

aPAD Exposure

(mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD

General U.S. Population 0.000 0 2 0.000 056 280 0.000 195 980 0.00 0220 1100

All Infants ( <1 year old) 0.000 0 2 0.000 122 610 0.00 0543 2700 0.00 0580 2900

Children 1

- 2 years old 0.000 0 2 0.000 126 630 0.000 281 1400 0.00 0347 1700

Children 3

- 5 years old 0.000 0 2 0.000 109 540 0.000 239 1200 0.00 0294 1500

Children 6

- 12 years old 0.000 0 2 0.000 079 390 0.000 171 860 0.00 0212 1100

Youth 13

- 19 years old 0.000 0 2 0.000 049 240 0.000 143 720 0.00 0165 820

Adults 20

- 49 years old 0.000 0 2 0.000 042 210 0.00 0197 980 0.00 0215 1100

Adults 50

- 99 years old 0.00 0 2 0.000 035 18 0.000 193 96 0.00 0209 100

Females 13

- 49 years old 0.000 0 2 0.000 040 200 0.000 197 980 0.00 0214 1100

1 Acute dietary analysis derived from a 0.0 0 002 mg/kg/day aPAD for the general population except for adults 50

- 99 years old which use a 0.0002 mg/kg/day aPAD

. 2 Highest exposures found for assessment is noted in bold.



### Characterization of Acute Dietary Risk Assessed with a Vegetative Buffer Reduction of EDWCs

An additional characterization scenario was also considered by EFED for use in dietary assessment

which assumes a 90% reduction in the EDWCs through the use of vegetative buffers. The acute dietary results at the 95 th 

### percentile for the analysis of food only, drinking water only, and f ood plus drinking water determined using 90% reduced EDWCs are presented in Table 9

. Although much lower, all acute analyses still exceed HED’s level of concern at the 95 th 

### percentile of exposure (except

for adults 50

- 99 years old). These analyses show that f or the U.S. population the combined dietary

exposure f

rom food plus drinking water is 400 % of the a PAD with an exposure of 0.000 079 mg/kg/day at the 95 th 

### percentile. All infants <1 y ear old was the population subgroup with the highest combined exposure from food plus drinking water at 870 % of the a PAD with an exposure of 0.000175 mg/kg/day at the 95 th 

### percentile.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 14 of 44 Table 9. Results of Acute Dietary Exposure Analysis for Terbufos Food only, Drinking Water only , a nd

Food plus Drinking Water using 90% Reduced EDWCs for a Vegetative Buffer

. Populatio n Subgroup aPAD

(mg/kg/day) Food only Drinking Water only ( 90% Reduced EDWCs for a Vegetative Buffer ) Food plus Drinking Water ( 90% Reduced EDWCs for a Vegetative

Buffer )

95 th Percentile 95 th Percentile 95 th Percentile Exposure (mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD

General U.S. Population 0.000 0 2 0.000 056 280 0.000037 180 0.000079 400

All Infants (<1 year old) 0.000 0 2 0.000122 610 0.000102 510 0.000175 870

Children 1

- 2 years old 0.000 0 2 0.000126 630 0.000053 260 0.000157 790

Children 3

- 5 years old 0.000 0 2 0.000 109 540 0.000045 220 0.000133 660

Children 6

- 12 years old 0.000 0 2 0.000 079 390 0.000032 160 0.000095 480

Youth 13

- 19 years old 0.000 0 2 0.000 049 240 0.000027 130 0.000064 320

Adults 20

- 49 years old 0.000 0 2 0.000 042 210 0.000037 180 0.000064 320

Adults 50

- 99 years old 0.00 0 2 0.000 035 18 0.000036 18 0.000059 29

Females 13

- 49 years old 0.000 0 2 0.000 040 200 0.000037 180 0.000063 310

1 Acute dietary analysis derived from a 0.0 0 002 mg/kg/day aPAD for the general population except for adults 50

- 99 years old which use a 0.0002 mg/kg/day aPAD

. 2 Highest exposures found for assessment is noted in bold.



### Characterization of Steady

- State Dietary Risk Assessed with M aximum Rate EDWCs For the steady

- state dietary analyses determined using maximum application rate derived EDWCs,

the results of food only, drinking water only, and food plus drinking water at the 95 th 

### percentile are presented in Table 10. Risks are all above HED’s level of concern for the U.S. population and all its population subgroups at the 95 th 

### percentile (except for adults 50

- 99 years old for food only ). For the U.S. population the combined dietary exposure from food plus drinking water is 3800 % of the ss PAD

with an e xposure of 0.000 3 80 mg/kg/day at the 95 th 

### percentile. All infants <1 yr old was the population subgroup with the highest combined exposure from food plus drinking water at >1000 0 %

of the ss PAD with an exposure of 0.00103 8 mg/kg/day at the 95 th 

### percentile.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 15 of 44 Table 10. Results of Steady

- State Dietary Exposure Analysis for Terbufos Food only, Drinking Water

only, a nd Food plus Drinking Water

- using Maximum Rate EDWCs

. Population Subgroup ss PAD

(mg/kg/day) Food only Drinking Water only ( Maximum Rate) Food plus Drinking

Water ( Maximum Rate)

95 th Percentile 95 th Percentile 95 th Percentile Exposure (mg/kg/day) % ss PAD Exposure (mg/kg/day) % ss PAD Exposure (mg/kg/day) % ss PAD

General U.S. Population 0.000 01 0.000 053 530 0.0003 5 7 3600 0.000 3 80 3800

All Infants (<1 year old) 0.000 01 0.0001 11 1100 0.00 0999 10000 0.00 103 8 >10000

Children 1

- 2 years old 0.000 01 0.000 113 1100 0.000 51 7 5 2 00 0.000 57 4 5700

Children 3

- 5 years old 0.000 01 0.000 097 970 0.000 43 6 4 4 00 0.000 4 86 4900

Children 6

- 12 years old 0.000 01 0.000 072 720 0.000 31 4 3100 0.000 3 50 3500

Youth 13

- 19 years old 0.000 01 0.000 044 440 0.000 26 3 2600 0.000 28 4 2800

Adults 20

- 49 years old 0.000 01 0.000 039 390 0.000 360 3600 0.000 377 3800

Adults 50

- 99 years old 0.00 01 0.000 032 32 0.000 35 1 350 0.000 36 8 370

Females 13

- 49 years old 0.000 01 0.000 037 370 0.000 360 3600 0.000 37 8 3800

1 Steady

- Stat e dietary analysis derived from a 0.0 0 00 1 mg/kg/day ss PAD for the general population except for adults 50

- 99 years old which use a 0.000 1 mg/kg/day ss PAD

. 2 Highest exposures found for assessment is noted in bold.



### Characterization of Steady

- State Dietary Risk Assessed with Typical Rate EDWCs In order to provide a complete characterization of the steady

- state dietary exposure of terbufos

, EDWCs derived using typical application rates are also considered for assessment. In accordance,

t he steady

- state dietary results for the analysis of food only, drinking water only, food plus drinking

water at the 95 th 

### percentile determined with t ypical rate EDWCs are presented in Table 11

. Although

lower results are obtained

, s teady

- state dietary exposure estimates for food only, water only, as well

as for food plus drinking water are also all above HED’s level of concern for the U.S. population and all its population subgroups at the 95 th 

### percentile (except for adults 50

- 99 years old for food only ). These analyses show that for the U.S. population the combined dietary exposure from food plus drinking water is 21 00 % of the ss PAD with an exposure of 0.000 213 mg/kg/day at the 95 th 

### percentile. All infants <1 yr old was the population subgroup with the highest combined exposure from food plus drinking water at 5 7 0 0 % of the ss PAD with an exposure of 0.000 56 9 mg/kg/day at the 95 th 

### percentile.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 16 of 44 Table 1 1

. Results of Steady

- State Dietary Exposure Analysis for Terbufos Food only, Drinking Water

only, a nd Food plus Drinking Water

- using Typical Rate EDWCs

. Population Subgroup ss PAD

(mg/kg/day) Food only Drinking Water only (Typical Rate) Food plus Drinking

Water (Typical Rate)

95 th Percentile 95 th Percentile 95 th Percentile Exposure (mg/kg/day) % ss PAD Exposure (mg/kg/day) % ss PAD Exposure (mg/kg/day) % ss PAD

General U.S. Population 0.000 01 0.000 053 530 0.000189 1900 0.000213 2100

All Infants (<1 year old) 0.000 01 0.0001 11 1100 0.0005 29 5300 0.00056 9 5700

Children 1

- 2 years old 0.000 01 0.000 113 1100 0.00027 4 2700 0.00033 5 3300

Children 3

- 5 years old 0.000 01 0.000 097 970 0.00023 1 2300 0.00028 4 2900

Children 6

- 12 years old 0.000 01 0.000 072 720 0.00016 6 1 7 00 0.00020 5 2000

Youth 13

- 19 years old 0.000 01 0.000 044 440 0.0001 39 1400 0.000161 1600

Adults 20

- 49 years old 0.000 01 0.000 039 390 0.000191 1900 0.00020 9 2100

Adults 50

- 99 years old 0.00 01 0.000 032 32 0.00018 6 190 0.00020 3 200

Females 13

- 49 years old 0.000 01 0.000 037 370 0.00019 0 1900 0.000208 2100

1 Steady

- State dietary analysis derived from a 0.0 0 00 1 mg/kg/day ss PAD for the general population except for adults 50

- 99 years old which use a 0.0001 mg/kg/day ssPAD

. 2 Highest exposures found for assessment is noted in bold.



### Characterization of Steady

- State Dietary Risk Assessed with a Vegetative Buffer Reduction of

EDWCs Steady

- state dietary analyses were also performed to consider the additional characterization scenario developed by EFED which assumes a 90% reduction in the EDWCs through the use of vegetative

buffers. The steady

- state dietary results at the 95 th 

### percentile for the analysis of food only, drinking

water only, and f

ood plus drinking water determined using 90% reduced EDWCs are presented in

Table 12

. Although much lower, all steady

- state analyses still exceed HED’s level of concern at the

95 th 

### perce ntile of exposure (except for adults 50

- 99 years old). These analyses show that f or the U.S. population the combined dietary exposure from food plus drinking water is 750 % of the ss PAD with an exposure of 0.000 07 5 mg/kg/day at the 95 th 

### percentile. All in fants <1 y ear old was the population subgroup with the highest combined exposure from food plus drinking water at 160 0 % of the ss PAD with an exposure of 0.0001 6 4 mg/kg/day at the 95 th 

### percentile.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 17 of 44 Table 12

. Results of Steady

- State Dietary Exposure Analysis for Terbufos Food only, Drinking Water

only, a nd Food plus Drinking Water using 90% Reduced EDWCs for a Vegetative Buffer

. Population Subgroup ss PAD

(mg/kg/day) Food only Drinking Water only (90% Reduced EDWCs for a Vegetative Buffer) Food plus Drinking Water (90% Reduced EDWCs for a Vegetative Buffer)

95 th Percentile 95 th Percentile 95 th Percentile Exposure (mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD

General U.S. Population 0.000 01 0.000 053 530 0.000036 360 0.000075 750

All Infants (<1 year old) 0.000 01 0.0001 11 1100 0.000100 1000 0.00016 4 1600

Children 1

- 2 years old 0.000 01 0.000 113 1100 0.00005 2 5 2 0 0.000144 1400

Children 3

- 5 years old 0.000 01 0.000 097 970 0.00004 4 4 4 0 0.000119 1200

Children 6

- 12 years old 0.000 01 0.000 072 720 0.000031 310 0.000089 890

Youth 13

- 19 years old 0.000 01 0.000 044 440 0.000026 260 0.000058 580

Adults 20

- 49 years old 0.000 01 0.000 039 390 0.000036 360 0.000061 600

Adults 50

- 99 years old 0.00 01 0.000 032 32 0.000035 35 0.00005 6 5 6

Females 13

- 49 years old 0.000 01 0.000 037 370 0.000036 360 0.000059 590

1 Steady

- State dietary analysis derived from a 0.0 0 00 1 mg/kg/day ss PAD for the general population except for adults 50

- 99 years old which use a 0.000 1 mg/kg/day ss PAD

. 2 Highest exposures found for assessment is noted in bold.



### Drinking Water Level of Comparison (DWLOC)

The acute CEC analysis made for all infants <1 year of age shows that drinking water is the driver of dietary risk from terbufos. As a further characterization of dietary exposure, a drinking water level of comparison (DWLOC) was determined for the general U.S. population and the sentinel population subgroups of all infants < 1 year old and females 13

- 49 years old. The DWLOC calculatio n is a function of the PoD and daily water consumption used to provide the EDWC at the targeted level of concern for dietary assessment ( ≤ 100% of the PAD )

. The DWLOC calculation characterizes the amount of exposure available in the total ‘risk cup’ for th e residues of terbufos in drinking water irrespective of its exposures from food. It provides a rough estimate to determine the potential need for further drinking water refinement of the calculated peak EDWCs determined for assessment.

Because the senti nel population subgroup s of all infants <1 year old and females 13

- 49 years old have the highest e xposures to residues in drinking water, mitigating the acute and steady

- state risks for these population subgroups would therefore be protective of all others . For terbufos, Table 13 shows

the lowest DWLOC calculated in Attachment 19 was for all infants <1 year old at a peak

concentration of 0. 1093 ppb for the acute and 0.0546 ppb for the steady

- state determinations at the

95 th 

### percentile

.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 18 of 44 Table 13. Acute and Steady

- State Calculation of DWLOCs 1 for Terbufos 2
Population Acute Terbufos DWLOC (ppb) Steady

- State Terbufos DWLOC (ppb)
General Population 0.37594 0.20367

All Infants <1 y ears old 0.10929 0.05464

Females 13

- 49 y ea rs old 0.38023 0.20661

1 DWLOC

– drinking water level of comparison.

2 DWLOC: DWLOC (EDWC ppb) = (% aPAD or %ssPAD)(1000ug/mg)( PoD )/(water consumption L/kgBW/day )(100).

3 Concentrations are represented in ppb for the drinking water residues of concern of terbufos parent, and i ts two oxidative degradates terbufos sulfoxide and terbufos sulfone.



### I X

. Conclusions

These un ref

ined analyses demonstrate that the current uses of terbufos will result in acute dietary risk

estimates for food and drinking water which exceed HED’s level of concern for any of the regulated population subgroups, including those comprised of infants and children. Steady

- state dietary exposure estimates are also above HED’s level of concern for the U.S. population and all population subgro ups.

References

DP No. : D 258668

Sub ject: Terbufos

. List A Reregistration Case No. 0109/Chemical ID No. 105001. Revised

Acute and Chronic Dietary Exposure Analysis for the HED Revised Risk Assessment.

No MRID No. DP Barcode No. D258668.

From: C. S wartz

To: W. J. Hazel

Dated: 0 8/26/1999

MRID No. : None

DP No. : D417464

Sub ject: Terbufos

. Report of the Residues of Concern Knowledgebase Subc ommittee

(ROCKS)

. From: E. Scollon

To: Terbufos Risk Assessment Team

Dated: 0 2 / 03 /201 4

MRID No. : None

DP No. : D 244268 Subject: Terbufos. List A Reregistration Case No. 0109/Chemical ID No. 105001.

Anticipated Residue Assessment. No MRID No. DP Barcode D244268.

From: W. J. Hazel

To: C. Swartz/F. Fort

Dated: 0 3 / 19 / 1998

MRID No. : NoneTerbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 19 of 44 DP No. : None Subject: Terbufos Registration Standard

From: C. Trichilo

To: A. Rispin

Dated: 01 / 19 / 1983

MRID No. : 00036127, 00036246, 00079431, 00062872, 00042020, 00088211, 00049235,

00087687, 00036242, 00036241, 00087702, 00087703, and 00087704

DP No. : D419906 Subject: Percen t of Banana and Coffee Imports Treated with Terbufos, BEAN DP No. 419906,

and PC Code # 105001.

From: J. Alsadek

To: P. Savoia

Dated: 06 / 11 / 2014

MRID No. : None

DP No. : D 418656

Sub ject: Drinking Water Assessment for the registration Review of Terbufos

. From: F. Khan

To: D. Friedman

Dated: 0 4 / 08 /201 4

MRID No. : None

DP No. : D423572

Sub ject: Adjusted Time

- Series Distribution of Total Toxic Residues for Estimated Drinking

Water Concentrations Based on Typical Rate of Sorghum for Terbufos

From: F. Khan

To: D. Friedman, T. Myers, K. Costello, P. Savoia & M. Metzger

Dated: 10 / 29 /201 4

MRID No. : None

DP No. : D428089

Sub ject: Adjusted Time

- Series Distribution of the Total Toxic Residues of Terbufos from Use

on Sorghum to Account for the Theoretical Loading Reduction of Terbufos and its Degradates to Surface Water in the Presence of Label

- Prescribed Vegetative Buffers

. From: F. Khan

To: M. Manupella, T. Myers, K. Costello, P. Savoia & M. Metzger

Dated: 07 / 10 /201 5

MRID No. : NoneTerbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 20 of 44 X I

. List of Attachments

1. Attachment 1: Terbufos Residue Distribution Files (RDFs) for Existing Food Uses based on

Field T rial Data and those modeled for Drinking Water based on time

- series

simulation

. 2. Attachment 2 : Acute (Food + Drinking Water

- Max Rate ) Residue Input Fi le and Summation of

the A dditional Residue Input Files used for the Characterization of Acute Dietary

Risk

. 3. Attachment 3: Acute Analysis ( Food + Drinking Water

- Max Rate ) Results File.

4. Attachment 4: Acute Analysis ( Food only) Results File.

5. Attachment 5: Acute Analysis (Drinking Water only

- Max Rate) Results File.

6. Attachment 6: Acute Analysis (Drinking Water only

- Typical Rate) Results File.

7. Attachment 7: Acute Analysis (Food + Drinking Water

- Typical Rate) Results File.

8. Attachment 8: Acute Analysis (Drinking Water only

- Vegetative Buffer Reduction of EDWCs )

Results File.

9

. Attachment 9: Acute Analysis (Food + Drinking Water only

- Vegetative Buffer Reduction of

EDWCs) Results File.

10. Attachment 10: Critical Exposure Contribution (CEC) Analysis for the Acute A nalysis of Food +

Drinking Water

- Max Rate of All Infants

. 11. Attachment 11: Steady

- State Analysis (Food + Drinking Water

- Max Rate) Residue Input File

and Summation of the Additional Residue Input Files used for the Characterization of Steady

- State Dietary Risk

. 12. Attachment 12: Steady

- State Analysis (Food + Drinking Water

- Max Rate) Results File.

13. Attachment 13: Steady

- State Analysis (Food only) Results File.

14. Attachment 14: Steady

- State Analysis (D rinking Water only

- Max Rate) Results File.

15. Attachment 15: Steady

- State Analysis (Drinking Water only

- Typical Rate) Results File.

16. Attachment 16: Steady

- State Analysis (Food + Drinking Water

- Typical Rate) Results File.

17. Attachment 17: Steady

- State Analysis (Drinking Water only

- Vegetative Buffer Reduction of

EDWCs) Results File.

18. Attachment 18: Steady

- State Analysis (Food + Drinking Water only

- Vegetative Buffer

Reduction of EDWCs) Results File.

19. Attachment 19: DWLOC Calculation for S creening the Dietary Risk Contribution of Terbufos

from Drinking Water.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 21 of 44 ATTACHMENT 1

Terbufos Residue Distribution Files (RDFs) for Existing Uses based on Field Trial Data

A. Residue Data Files for Food

Terbufos Food Residue Data Files for Acute Dietary Analysis

Banana
(Data File; Banana_pulp_2014Reregistration.rdf Sweet Corn

Data File; Sweet Corn_100 CT_2014

Reregistration.rdf

Field trials

- Bananas pulp (half lod/loq)
3 g ai and 4 g ai rates 100% CT

totalz=0

0.015

0.005

0.005

0.01

0.005

0.005

0.005

0.001

0.001

0.001

0.001

0.001

0.001 CORN, SWEET 100% CT

Totalz = 0

Totalnz = 10

0.005

0.005

0.005

0.005

0.005

0.01

0.01

0.01

0.005

0.005



### B. Residue Data Files for Drinking Water

For utilization in dietary analysis, EFED generated daily time

- series outputs that simulate 29 years (1962

- 1990) of terbufos residues in surface drinking water . This modeling us ed the highest EDWCs determined for terbufos which are found to result from the maximum application rate of the Texas sorghum OP scenari o. In addition, the terbufos time

- series developed by EFED was also amended for analysis using a typical sorghum application rate (53% of the maximum rate) and a 90% reduction implied through the bounding of residues in vegetative buffers to provide for a complete characterization of dietary risk. No further adjustments were

made to the acute distribution files. Since the two

- day average dietary assessments used 21

- day rolling averages for drinking water, the steady

- state distributions were further adjus ted by HED to be 21

- day rolling averages. In the 21

- day rolling average distributions, the first data point is the average of days 1

- 21, the second data point is the average of days 2

- 22, the third data point is the average of days 3

- 23, etc. The 21

- day rolling average continues until the last 20 days of residues of the final distribution year (1990). For these residues, the average was taken only of the remaining days, resulting in residue values that are not 21

- day averages. This is not expected to ha ve a large impact on the dietary exposure assessment since the data points

which are not true 21

- day rolling averages represent only 20 days out of 29 years and the simulated drinking water estimates do not include applications at the end of the year.

Dietary assessments were not completed using groundwater values since the peak EDWCs for groundwater were substantially lower than for surface waters.

Water Data Files for Acute Analyses

1. Terbufos Texas Surghum_Drinking Water.rdf

– Maximum rate data fil e
2. Terbufos Texas Surghum_Drinking Water_with point 53 multiplier.rdf

– Typical rate data file

3. Sorghum_TTR_PCA and 90% reduction adjusted.rdf

– V egetati ve buffer reduction data file



### Water Data Files for Steady

- State Acute 2

- Day Analyses

1. DrinkingWaterTerbufosTXsorghumMaxRate Parent plus Metabolites For Acute 2day.rdf

– Maximum rate

data file

2. DrinkingWaterTerbufosTXsorghumTypicalRate with Point 53 Multiplier Parent plus Metabolites For Acute 2day.rdf

– Typical rate data fileTerbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 22 of 44 3. Sorghum_TTR_PCA and 90% reduction adjusted for 2 day acute.rdf

– Vegetative buffer reduction data

file 

### ATTACHMENT 2

Acute (Food + Drinking Water

- Max Rate ) Residue Input File

Filename: E: \ Terbufos Dietary \ 2015 Revised Analyses Using a 10x FQPA Safety Facto r \ Terbufos Acute Files with 10x FQPA_June 2015 \ 105001_Terbufos_Reregistration June 2015_Acute_Food and Water Max Rate_100 CT_with 10x FQPA .r08

Chemical: 105001 Terbufos RfD(Chronic): 0 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .00002 mg/kg b w/day NOEL(Acute): 0 mg/kg bw/day
Date created/last modified: 06

- 16

- 2015/11:04:21 Program ver. 3.16, 03

- 08

- d Comment: 105001 Terbufos Reregistration includes EWDCs and revised PODs with 10x FQPA Safety Factor

and 100%CT data

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

# Code

----- ---- ------------ -------- -------- ------- 1 6 B anana_pulp_2014Reregistration.rdf 2 6 Sweet Corn_100 CT_2014 Reregistration.rdf 3 6 Terbufos Texas Surghum_Drinking Water.rdf

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

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 0101052000 1A Beet, sugar 0.025000 1.000 1.000

0101052 001 1A Beet, sugar

- babyfood 0.025000 1.000 1.000
1500120000 15 Corn, field, flour 0.005000 1.000 1.000
1500120001 15 Corn, field, flour

- babyfood 0.005000 1.000 1.000

1500121000 15 Corn , field, meal 0.005000 1.000 1.000
1500121001 15 Corn, field, meal

- babyfood 0.005000 1.000 1.000
1500122000 15 Corn, field, bran 0.005000 1.000 1.000
1500123000 15 Corn, field, star ch 0.005000 1.000 1.000
1500123001 15 Corn, field, starch

- babyfood 0.005000 1.000 1.000 1500124000 15 Corn, field, syrup 0.005000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.005000 1.500 1.000
1500125000 15 Corn, field, oil 0.005000 1.000 1.000
1500125001 15 Corn, field, oil

- babyfood 0.005000 1.000 1.000 1500126000 15 Corn, pop 0.005000 1.000 1.000
1500127000 15 Corn, sweet 0.005000 1.000 1.000 2
1500127001 15 Corn, sweet

- babyfood 0.005000 1.000 1.000 2 1500344000 15 Sorghum, grain 0.025000 1.000 1.0 00
8601000000 86A Water, direct, all sources 0.063060 1.000 1.000 3
8602000000 86B Water, indirect, all sources 0.063060 1.000 1.000 3

9500023000 O Banana 0.025000 1.000 1.000 1

9500 023001 O Banana

- babyfood 0.025000 1.000 1.000 1
9500024000 O Banana, dried 0.004300 3.900 1.000
9500024001 O Banana, dried

- babyfood 0.004300 3.900 1.000
9500115000 O Coffee, roasted bean 0.028000 1.000 1.000
9500116000 O Coffee, instant 0.028000 1.000 1.000

9500283000 O Plantain 0.025000 1.000 1.000 1

9500284000 O Plantain, dried 0.004300 3.900 1.000



### Additional Residue Input Files used for the C haracterization of Acute Dietary Risk

To provide for the complete characterization of acute dietary risk, analyses were also made which considered

EDWCs determined using a typical rate of application as well as a 90% implied reduction of EDWCs through bounding in vegetative buffers. For each scenario, food only, drinking water only, and food plus drinking

water were determined using derivatives of the Acute (Food + Drinking Water

- Max Rate) Residue Input File.

Residue Input Files used for Acute Dietary Characterization

1. 105001_Terbufos_Reregistration June 2015_Acute_Food only_100 CT_with 10x FQPA.r08

2. 105001_Terbufos_Reregis tration June 2015_Acute_Water Max Rate only_with 10x FQPA .r08

3. 105001_Terbufos_Reregistration June 2015_Acute_Water Typical Rate only_with point 53 multiplier _with 10x FQPA .r08Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 23 of 44 4. 105001_Terbufos_Reregistration June 2015_Acute_Food and Water Typical Rate_100 CT_with point 53 multiplier _with 10x FQPA .r08

5. 105001_Terbufos_Reregistration June 2015_Acute_Water only using 90% Reduced EDWCs for a Vegetative Buffer_with 10x FQPA .r08

6. 105001_Terbufos_Reregistration June 2015_Acute_Food and Water using 90 % Reduced EDWCs for a Vegetative Buffer_100 CT_with 10x FQPA .r08Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 24 of 44 ATTACHMENT 3 Acute Analysis (Food + Drinking Water

- Max Rate ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration June 2015_Acute_Food and Water Max Rate_ 100 CT_with 10x FQPA .r08 Adjustment factor #2 used. Analysis Date: 06

- 16

- 2015/11:40:21 Residue file dated: 06

- 16

- 2015/11:04:21
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports
RAC/FF intake summed over 24 hours

MC iterations = 1000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration in cludes EWDCs and revised PODs with 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9 th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000389 1947.15 0.001103 5513.49 0.003205 >10000

All Infants:

0.001055 5273.27 0.003177 >10000 0.009678 >10000

Female 13

- 50:

0.000387 1936.15 0.001090 5447.67 0.003103 >10000

Children 1

- 2:

0.000587 29 34.96 0.001658 8291.71 0.004974 >10000

Children 3

- 5:

0.000502 2509.14 0.001360 6799.84 0.003915 >10000

Children 6

- 12:

0.000359 1793.60 0.000998 4992.11 0.002941 >10000

Youth 13

- 19:

0.000289 1447.26 0.000843 4216.85 0.002529 >10000

Adults 20

- 49:

0.000388 1939.89 0.001086 5429.74 0.003082 >10000

Adults 50

- 99:

0.000378 189.23 0.001031 515.50 0.00 2842 1421.19

Female 13

- 49:

0.000387 1934.76 0.001090 5449.42 0.003106 >10000Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 25 of 44 ATTACHMENT 4 Acute Analysis (Food only ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID A CUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration June 2015_Acute_Food only_100 CT_with
10x FQPA.r08 Adjustment factor #2 used. Analysis Date: 06

- 16

- 2015/11:22:59 Residue file dated: 0 6

- 16

- 2015/11:03:02
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports
RAC/FF intake summed over 24 hours

MC iterations = 1000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000056 281.90 0.000098 489.74 0.000173 866.50

All Infants:

0.000122 611.47 0.000181 903.48 0.000366 1831.44

Female 13

- 50:

0.000040 200.93 0.000060 301.31 0.000096 481.86

Children 1

- 2:

0.000126 631.99 0.000197 986.74 0.000419 2094.02

Children 3

- 5:

0.000109 544.03 0.000152 758.73 0.000223 1115.74

Children 6

- 12:

0.000079 393.68 0.000120 599.89 0.000174 871.47

Youth 13

- 19:

0.000049 244.39 0.000072 358.49 0.000123 616.37

Adults 20

- 49:

0.000042 210.85 0.000063 316.43 0.000103 512.55

Adults 50

- 99:

0 .000035 17.54 0.000052 26.20 0.000080 40.00

Female 13

- 49:

0.000040 200.39 0.000060 299.17 0.000096 482.46Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 26 of 44 ATTACHMENT 5 Acute Analysis ( Drinking Water only

- Max Rate ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration June 2015_Acute_Water Max Rate only _with 10x FQPA .r08 Adjustment facto r #2 used. Analysis Date: 06

- 16

- 2015/11:31:07 Residue file dated: 06

- 16

- 2015/11:03:49
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports
RAC/FF intake summed over 24 hours

MC iterations = 1000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capi ta:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000366 1832.39 0.001075 5373.07 0.003167 >10000

All Infants:

0.001020 5098.54 0.003171 >10000 0.009774 >10000

Female 13

- 50:

0.000371 1853.18 0.001069 534 4.72 0.003077 >10000

Children 1

- 2:

0.000527 2634.30 0.001575 7876.23 0.004743 >10000

Children 3

- 5:

0.000450 2251.79 0.001324 6618.07 0.003875 >10000

Children 6

- 12:

0.00 0323 1616.45 0.000963 4812.94 0.002884 >10000

Youth 13

- 19:

0.000269 1345.00 0.000823 4114.29 0.002516 >10000

Adults 20

- 49:

0.000370 1852.42 0.001062 5311.48 0.003042 >10000

Adults 50

- 99:

0.000362 180.90 0.001009 504.48 0.002797 1398.38

Female 13

- 49:

0.000370 1851.95 0.001070 5348.03 0.003081 >10000Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 27 of 44 ATTACHMENT 6 Acute Analysis ( Drinking Water only

- Typical Rate ) Results Fi le

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration June 2015_Acute_Water Typical Rate only _with point 53 multiplier.r08 Adjustment factor #2 used. Analysis Date: 06

- 16

- 2015/12:30:03 Residue file dated: 06

- 16

- 2015/11:05:31
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports
RAC/FF intake summed over 24 hours

MC iterati ons = 1000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes Typical Rate EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000195 975.20 0.000578 2888.20 0.001710 8551.01

All Infants:

0.000543 2716.64 0.001705 8526.96 0.005129 >10000

Female 13

- 50:

0.000197 985.40 0.000574 2869.08 0.001663 8316.21

Children 1

- 2:

0.000281 1405.01 0.000860 4297.74 0.002618 >10000

Children 3

- 5:

0.000239 1194.84 0.000705 3526.92 0.00 2102 >10000

Children 6

- 12:

0.000171 856.58 0.000519 2596.23 0.001549 7745.36

Youth 13

- 19:

0.000143 716.94 0.000446 2229.16 0.001360 6801.10

Adults 20

- 49:

0.000197 984.63 0.000571 2855.07 0.001647 8236.17

Adults 50

- 99:

0.000193 96.42 0.000542 270.91 0.001504 752.09

Female 13

- 49:

0.000197 984.95 0.000575 2873.05 0.00 1667 8334.95Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 28 of 44 ATTACHMENT 7 Acute Analysis ( Food + Drinking Water only

- Typical Rate ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration June 2015_Acute_Food and Water Typical Rate_100 CT_with point 53 multiplier.r08 Adjustment factor #2 used. Analysis Date: 06

- 16

- 2015/12:48:35 Residue file dated: 06

- 16

- 2015/11:06:26
Acute Pop Adju sted Dose (aPAD) varies with population; see individual reports
RAC/FF intake summed over 24 hours

MC iterations = 1000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes Typical Rate EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000220 1099.30 0.000604 3021.87 0.001731 8657. 00

All Infants:

0.000580 2900.82 0.001721 8606.64 0.005117 >10000

Female 13

- 50:

0.000214 1069.87 0.000595 2973.34 0.001686 8429.60

Children 1

- 2:

0.000347 1733.50 0.000926 4629.14 0.002691 >10000

Children 3

- 5:

0.000294 1471.55 0.000765 3824.49 0.002149 >10000

Children 6

- 12:

0.000212 1059.67 0.000557 2784.14 0.001595 7977.33

Youth 13

- 19:

0.000165 824.45 0.000464 2321.91 0.001375 6874.00

Adults 20

- 49:

0.000215 1074.78 0.000592 2959.54 0.001667 8332.95

Adults 50

- 99:

0.000209 104.72 0.000561 280.49 0.001510 754.83

Femal e 13

- 49:

0.000214 1068.66 0.000594 2972.16 0.001689 8445.64Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 29 of 44 ATTACHMENT 8 Acute Analysis ( Drinking Water only

- Vegetative Buffer Reduction of EDWCs ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration June 2015_Acute_Water only using 90% Reduced EDWCs for a Vegetative Buffer_with 10x FQPA .r08 Adjustment fa ctor #2 used. Analysis Date: 06

- 16

- 2015/14:08:16 Residue file dated: 06

- 16

- 2015/11:09:20
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports
RAC/FF intake summed over 24 hours

MC iterations = 1000; MC list in residue file; MC s eed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per c apita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000037 183.24 0.000107 537.31 0.000317 1583.61

All Infants:

0.000102 509.85 0.000317 1585.39 0.000977 4886.84

Female 13

- 50:

0.000037 185.32 0.000107 534 .47 0.000308 1538.64

Children 1

- 2:

0.000053 263.43 0.000158 787.62 0.000474 2371.27

Children 3

- 5:

0.000045 225.18 0.000132 661.81 0.000387 1937.35

Children 6

- 12:

0.000 032 161.64 0.000096 481.29 0.000288 1441.96

Youth 13

- 19:

0.000027 134.50 0.000082 411.43 0.000252 1258.11

Adults 20

- 49:

0.000037 185.24 0.000106 531.15 0.000304 1520.89

Adults 50

- 9 9:

0.000036 18.09 0.000101 50.45 0.000280 139.84

Female 13

- 49:

0.000037 185.19 0.000107 534.80 0.000308 1540.67Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 30 of 44 ATTACHMENT 9 Acute Analysis ( Food + Drinking Water only

- Vegetative Buffer Reduction of EDWCs ) Results

File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration June 2015_Acute_Fo od and Water using 90% Reduced EDWCs for a Vegetative Buffer_100 CT_with 10x FQPA .r08 Adjustment factor #2 used. Analysis Date: 06

- 16

- 2015/14:43:10 Residue file dated: 06

- 16

- 2015/11:10:25
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports
RAC/FF intake summed over 24 hours

MC iterations = 1000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD E xposure % aPAD

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

0.000079 396.59 0.000153 763.64 0.000359 1794.04

All Infants:

0.000175 873.39 0. 000377 1884.59 0.001023 5116.57

Female 13

- 50:

0.000063 314.07 0.000128 641.28 0.000328 1639.86

Children 1

- 2:

0.000157 787.32 0.000271 1353.46 0.000635 3174.25

Children 3

- 5:

0.000133 664.16 0.000213 1062.54 0.000449 2243.23

Children 6

- 12:

0.000095 477.08 0.000159 796.29 0.000338 1689.64

Youth 13

- 19:

0.000064 318.45 0.000118 588.55 0.00 0275 1374.41

Adults 20

- 49:

0.000064 321.22 0.000130 648.56 0.000327 1634.87

Adults 50

- 99:

0.000059 29.43 0.000122 60.84 0.000302 151.22

Female 13

- 49:

0.000063 313.13 0.000128 640.74 0.000328 1641.01Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 31 of 44 ATTACHMENT 10

Critical Exposure Contribution (CEC) Analysis for the Acute Analysis of Food + Drinking

Water

– Max Rate of All Infants

All Infants

Low percentile for CEC records: 99.9 Exposure (mg/day) = 0.009678

High percentile for CEC records: 100 Exposure (mg/day) = 0.033353

Number of actual records in this interval: 2251

Critical foods with 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

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

8.6E+09 130 1902 77.20% Water indirect all sources

- Uncooked; Dried; Cook Meth N/S

8.6E+09 110 811 7.79% Water direct all sources

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

8.6E+09 240 185 6.18% Water indirect all sources

- Cooked; Canned; Cook Meth N/S

8.6E+09 230 189 6.15% Water indirect all sources

- Cooked; Dried; Cook Meth N/S

8.6E+09 110 320 1.72% Water indirect all sources

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

8.6E+09 232 98 0.39% Water indirect all sources

- Cooked; Dried; Boiled

8.6E+09 212 59 0.14% Water indirect all sources

- Cooked; Fresh or N/S; Boiled

8.6E+09 210 7 0.02% Water indirect all sources

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

8.6E+09 242 7 0.01% Water indirect all sources

- Cooked; Canned; Boiled

9.5E+09 240 4 0.01% Banana

- babyfood

- Cooked; Canned; Cook Meth N/S

Critical foods (without 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 N Percent Food Name

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

8.6E+09 2767 91.81% Water indirect all sources

8.6E+09 811 7.79% Water direct all sources

9.5E+09 4 0.01% Banana

- babyfood

Number of printed records = 10

Number of records represented = 12

(nf = number of foods/ff reported for this daily exposure amount (exceeding minimum contribution)

(nx = number of times this exposure amount was computed for the same person on the same day.)Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 32 of 44 ATTACHMENT 11 Steady

- State Analysis (Food + Drinking Water

- Max Rate ) Residue Input File

Filename: E: \ Terbufos Dietary \ 2015 Revised Analyses Using a 10x FQPA Safety Factor \ Terbufos 2 Day
Acute Files with 10x FQPA June 2015 \ 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_Food only_100 CT_wit h 10x FQPA.r08

Chemical: 105001 Terbufos RfD(Chronic): 0 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): .00001 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day
Date created/last modified: 06

- 17

- 2015/14:18:51 Program ver. 3.16, 03

- 08

- d

Comment: 105 001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor

and 100%CT data

----------------------------------------------------------------------------------- RDL indices and parameters for Monte Carlo Analysis:

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

# Code

----- ---- ------------ -------- -------- ------- 1 6 Banana_pulp_2014Reregistration.rdf 2 6 Sweet Corn_100 CT_2014 Reregistration.rdf 3 6 DrinkingWaterTerbufosTXsorg humMaxRate Parent plus Metabolites For Acute 2day.rdf

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

---------- ---- ------------------- ------------ ---------- ------ ------ --- ------- 0101052000 1A Beet, sugar 0.025000 1.000 1.000 0101052001 1A Beet, sugar

- babyfood 0.025000 1.000 1.000
1500120000 15 Corn, field, flour 0.005000 1.000 1.000
1500120001 15 Corn, field, flour

- babyfood 0.005000 1.000 1.000
1500121000 15 Corn, field, meal 0.005000 1.000 1.000
1500121001 15 Corn, field, meal

- babyfood 0.0 05000 1.000 1.000
1500122000 15 Corn, field, bran 0.005000 1.000 1.000
1500123000 15 Corn, field, starch 0.005000 1.000 1.000
1500123001 15 Corn, field, starch

- babyfood 0.005000 1.000 1.000 1500124000 15 Corn, field, syrup 0.005000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.005000 1.500 1.000
1500125000 15 Corn, field, oil 0.005000 1.000 1.000
1500125001 15 Corn, field, oil

- babyfood 0.005000 1.000 1.000 1500126000 15 Corn, pop 0.005000 1.000 1.000
1500127000 15 Corn, sweet 0.005000 1.000 1.000 2

1500127001 1 5 Corn, sweet

- babyfood 0.005000 1.000 1.000 2 1500344000 15 Sorghum, grain 0.025000 1.000 1.000

9500023000 O Banana 0.025000 1.000 1.000 1

9500023001 O Banana

- babyfood 0.025000 1.000 1.000 1
9500024000 O Banana, dried 0.004300 3.900 1.000
9500024001 O Banana, dried

- babyfood 0.004300 3.900 1.000

9500115000 O Coffee, roasted bean 0.028000 1.000 1.000
9500116000 O Coffee, instant 0.028000 1.000 1.000

9500283000 O Plantain 0.025000 1.000 1.000 1
9500284000 O Plantain, dried 0.004300 3.900 1.000



### Additional Residue Input Files used for the characterization of Steady

- State Dietary Risk

To provide for the complete characterization of the steady

- state dietary risk, analyses were also made which considered EDWCs determined using a typical rate of application as well as a 90% implied reduction of EDWCs through bounding in vegetative buffers. For each scenario, food only, drinking water only, and food plus drinking water were determined using deriv atives of the Acute (Food + Drinking Water

- Max Rate) Residue Input File.

Acute 2

- Day Analysis Residue Input Files used for Steady

- State Dietary Characterization

1. 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_Food only_100 CT_with 10x
FQPA.r08

2. 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_Water only_Max Rate_with 10x
FQPA.r08

3. 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_Water only_Typical Rate with point 53 multiplier_with a 10x FQPA.r08Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 33 of 44 4

. 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_Food 100 CT and Water Typical Rate with point 53 multiplier_with a 10x FQPA.r08

5. 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_Water only using 90% Reduced

EDWCs for a Vegetative Buffer_with 10x FQPA.r08

6. 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_Food 100 CT and Water using 90% Reduced EDWCs for a Vegetative Buffer_with a 10x FQPA.r08Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 34 of 44 ATTACHMENT 12 Steady

- State Analysis (Food + Drinking Water

- Max Rate ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_ Food and Water Max Rate_100 CT_with 10xFQPA.r08 Adjustment factor #2 used. Analysis Date: 07

- 22

- 2015/07:13:22 Residue file dated: 06

- 17

- 2015/13:43:24
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Two

- Day Average Results Reported RAC/FF intake summed over 24 hours

MC iterations = 2000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPA D Exposure % aPAD

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

0.000380 3796.30 0.001023 >10000 0.002764 >10000

All Infants:

0.001038 >100 00 0.002962 >10000 0.008518 >10000

Children 1

- 2:

0.000574 5737.53 0.001516 >10000 0.004234 >10000

Children 3

- 5:

0.000486 4863.65 0.001255 >10000 0.003311 >10000

Children 6

- 12:

0.000350 3504.11 0.000923 9233.28 0.002488 >10000

Youth 13

- 19:

0.000284 2836.49 0.000777 7768.37 0.002166 >10000

Adults 20

- 49:

0.000377 3772.85 0.001001 >10000 0.002 624 >10000

Adults 50

- 99:

0.000368 367.87 0.000965 964.61 0.002472 2471.99

Female 13

- 49:

0.000378 3775.73 0.001005 >10000 0.002672 >10000Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 35 of 44 ATTACHMENT 13 Steady

- State Analysis (Food only ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_

Fo od only_100 CT_with 10xFQPA.r08 Adjustment factor #2 used. Analysis Date: 07

- 22

- 2015/07:23:16 Residue file dated: 06

- 17

- 2015/14:18:51
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Two

- Day Average Results Reported RAC/FF intake summed over 24 hours

MC iterations = 2000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000053 531.77 0.000089 891.85 0.000148 1482.88

All Infants:

0.000111 1109.99 0.000161 1606.25 0 .000283 2833.39

Children 1

- 2:

0.000113 1130.51 0.000173 1733.20 0.000303 3026.76

Children 3

- 5:

0.000097 966.06 0.000134 1340.33 0.000182 1818.91

Children 6

- 12:

0.000072 72 1.82 0.000103 1032.55 0.000132 1319.61

Youth 13

- 19:

0.000044 435.87 0.000062 622.75 0.000121 1207.98

Adults 20

- 49:

0.000039 386.35 0.000055 547.31 0.000088 882.69

Adults 50

- 99:

0.000032 32.28 0.000046 46.43 0.000065 64.79

Female 13

- 49:

0.000037 366.55 0.000052 517.92 0.000088 882.76Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 36 of 44 ATTACHMENT 14 Steady

- State Analysis ( Drinking Water only

- Max Rate ) Results Fil e

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_ Water only_Ma x Rate_with 10xFQPA.r08 Adjustment factor #2 used. Analysis Date: 07

- 22

- 2015/07:29:14 Residue file dated: 06

- 17

- 2015/13:48:51
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Two

- Day Average Results Reported RAC/FF intak e summed over 24 hours
MC iterations = 2000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000357 3567.51 0.000997 9969.18 0.002748 >10000

All Infants:

0.000999 9986.03 0.002932 >10000 0.008515 >10000

Children 1

- 2:

0.000517 5169.20 0.001456 >10000 0.004146 >10000

Children 3

- 5:

0.000436 4357.00 0.001207 >10000 0.003203 >10000

Children 6

- 12:

0.000314 3135.35 0.000882 8821.89 0.002432 >10000

Youth 13

- 19:

0.000263 2626.75 0.000752 7519.61 0.002125 >10000

Adults 20

- 49:

0.000360 3597.68 0.000981 9814.27 0.002620 >10000

Adults 50

- 99:

0.000351 351.27 0.000946 946.32 0.002489 2488.90

Female 13

- 49:

0.000359 3593.83 0.000987 9865.37 0.002680 >10000Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 37 of 44 ATTACHMENT 15 Steady

- State Analysis ( Drinking Water only

- Typical Rate ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_

Water onl y_Typical Rate with point 53 multiplier_with a 10xFQPA.r08 Adjustment factor #2 used. Analysis Date: 07

- 22

- 2015/07:59:33 Residue file dated: 06

- 17

- 2015/13:49:43
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Two

- Day Av erage Results Reported RAC/FF intake summed over 24 hours

MC iterations = 2000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT dat a"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000189 1890.83 0.000528 5283.27 0.001456 >10000

All Infants:

0.000529 5292.04 0.001554 >10000 0.004513 >10000

Children 1

- 2:

0.000274 2739.34 0.000772 7716.19 0.002198 >10000

Children 3

- 5:

0.000231 2309.31 0.000640 6396.50 0.001698 >10000

Children 6

- 12:

0.000166 1661.62 0.000467 4674.47 0.001290 >10000

Youth 13

- 19:

0.000139 1392.20 0.000398 3984.99 0.001127 >10000

Adults 20

- 49:

0.000191 1906.68 0.000520 5201.70 0.001 389 >10000

Adults 50

- 99:

0.000186 186.17 0.000502 501.59 0.001319 1319.38

Female 13

- 49:

0.000190 1904.64 0.000523 5228.83 0.001420 >10000Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 38 of 44 ATTACHMENT 16 Steady

- State Analysis ( Food + Drink ing Water

- Typical Rate ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration_June 2015_Acut e 2 Day Steady State_ Food 100 CT and Water Typical Rate with point 53 multiplier_with a 10xFQPA.r08 Adjustment factor #2 used. Analysis Date: 07

- 22

- 2015/08:08:46 Residue file dated: 06

- 17

- 2015/13:52:38
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Two

- Day Average Results Reported RAC/FF intake summed over 24 hours

MC iterations = 2000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000213 2133.27 0.000554 5543.06 0.001479 >10000

All Inf ants:

0.000569 5689.89 0.001587 >10000 0.004541 >10000

Children 1

- 2:

0.000335 3346.96 0.000837 8371.14 0.002275 >10000

Children 3

- 5:

0.000284 2835.66 0.000690 6903.94 0.001785 >10000

Children 6

- 12:

0.000205 2046.13 0.000508 5078.13 0.001338 >10000

Youth 13

- 19:

0.000161 1607.37 0.000422 4216.66 0.001159 >10000

Adults 20

- 49:

0.000209 2 085.82 0.000539 5393.24 0.001400 >10000

Adults 50

- 99:

0.000203 202.76 0.000519 519.44 0.001319 1318.95

Female 13

- 49:

0.000208 2083.21 0.000541 5407.18 0.001423 >10000Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 39 of 44 ATTACHMENT 17 Steady

- State Analysis ( Drinking Water only

- Vegetative Buffer Reduction of EDWCs ) Results

File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 200 3

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_ Water only using 90% Reduced EDWCs for a Vegetative Buffer_with 10xFQPA.r08 Adjustment factor #2 used. Analysis Date: 07

- 22

- 2015/08:14:30 Residue file date d: 06

- 17

- 2015/13:55:06
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Two

- Day Average Results Reported RAC/FF intake summed over 24 hours

MC iterations = 2000; MC list in residue file; MC seed = 10281; RNG = MS VB

Run Comment : "105001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

---------- -------- ---------- -------- ---------- -------- Total US Populatio n:
0.000036 356.72 0.000100 996.81 0.000275 2747.93

All Infants:

0.000100 998.31 0.000293 2930.31 0.000853 8530.06

Children 1

- 2:

0.000052 517.17 0.000146 1457.02 0. 000415 4150.46

Children 3

- 5:

0.000044 435.62 0.000121 1205.25 0.000320 3202.30

Children 6

- 12:

0.000031 313.55 0.000088 882.57 0.000243 2430.19

Youth 13

- 19:

0.000026 262. 70 0.000075 751.71 0.000213 2126.43

Adults 20

- 49:

0.000036 359.82 0.000098 981.29 0.000262 2621.38

Adults 50

- 99:

0.000035 35.13 0.000095 94.62 0.000249 248.75

Female 13

- 49:

0.000036 359.48 0.000099 986.54 0.000268 2682.21Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 40 of 44 ATTACHMENT 18 Steady

- State Analysis ( Food plus Drinking Water only

- Vegetative Buffer Reduction of

EDWCs ) Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for 105001 TERBUFOS NHANES 2003

- 2008 2

- Day Residue file: 105001_Terbufos_Reregistration_June 2015_Acute 2 Day Steady State_ Food 100 CT and Water using 90% Reduced EDWCs for a Vegetative Buffer_with a 10xFQPA.r08 Adjustment factor #2 used. Analysis Date: 07

- 22

- 2015/08:23:19 Residue file dated: 06

- 17

- 2015/13:58:37
Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports

Two

- Day Average Results Reported RAC/FF intake summed over 24 hours
MC iterations = 2000; MC list in residue file; MC seed = 10281; RNG = MS VB Run Comment: "105001 Terbufos Reregistration includes EWDCs and revised PODs with a 10x FQPA Safety Factor and 100%CT data"

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

Summary calculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

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

0.000075 751.08 0.000139 1391.06 0.000310 3099.00

All Infants:

0.000164 1639.16 0.000344 3441.93 0.000894 8937.41

Children 1

- 2:

0.000144 1441.67 0.000245 2447.54 0.000538 5377.85

Children 3

- 5:

0.000119 1192.50 0.000188 1882.67 0.000383 3834.69

Children 6

- 12:

0.000089 891.11 0.000140 1395.06 0.000289 2894.32

Youth 13

- 19:

0.000058 584.20 0.000107 1071.02 0.000238 2375.67

Adults 20

- 49:

0.000061 605.63 0.000118 1184.57 0.000281 2806.57

Adults 50

- 99:

0.0 00056 55.55 0.000114 113.75 0.000265 265.29

Female 13

- 49:

0.000059 588.89 0.000118 1178.96 0.000283 2834.43Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 41 of 44 ATTACHMENT 19

DWLOC Calculation for S creening the Dietary Risk Contribution of Terbufos from Drinking

Water



## Screening of the Dietary Risk Contribution from Drinking Water

This tool aims to provide a quick estimate of the contribution of pesticide residues in drinking water to the dietary risk of the
pesticide. This screening level tool is designed to provide rough estimates that are helpful to determine the potential need for further refinement of the estimated drinking water concentration (EDWC). Food and residential exposures are not
considered; therefore, even if estimated DW risks are relatively low, aggregate risk conce rns may still result, and refinement to the DW residue estimates may still be necessary. The formulas used to estimate the dietary risk are presented below.

HED’s toxicologist and/or risk assessor would be able to provide the acute, steady state and/or chronic population adjusted dose in mg ai/kg

- bw/day, the cancer Q* in (mg ai/kg

- bw/day)

- 1 

### and information about the level of refinement (if percent of crop treated assumptions are made). EFED’s drinking water assessor would be able to provide the EDWC for acute/steady
state, chronic or cancer assessments expressed in terms of the pesticide, e.g. residues of acephate and it degradate methamidophos expressed as parent acephate. The water consumption values (see Input Values tab) were obtained using the
dietary exposure and risk model, DEEM

- FCID Version 4.02, which uses food consumption data f rom the USDA National Health and Nutrition Examination Survey, What We Eat in America, conducted from 2005 to 2010. In general, the population subgroup with higher exposure to residues in drinking water is infants (<1 yr old); therefore, acute or chronic risks for this subgroup would be protective of other subgroups. Occasionally, a different PAD is selected for females in reproductive age o r other population subgroups. In such case a separate calculation for that population subgroup would be needed.

Screening of the Dietary Risk Contribution from Drinking Water

This tool aims to provide a quick estimate of the contribution of pesticide residues in drinking water to the dietary risk of the pesticide. This screening level tool is designed to provide rough estimates that are helpful to determine the potential need for further refinement of the estimated drinking water concentration (EDWC). Food and residential exposures are not considered; therefore, even if estimated DW risks are relatively low, aggregate risk concerns may still result , and refinement to the DW residue estimates may still be necessary. The formulas used to estimate the dietary risk are presented below.

%aPAD, %ssPAD or %cPAD (Water) = ( Water Consumption, L/kgbw/day) (EDWC, ppb) x 100 (1000 ug/mg) (aPAD, ssPAD or cPAD, mg/kg/day)Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 4 2 of 44 Therefore; EDWC, ppb = (%aPAD, %ssPAD or %cPAD) (1000 ug/mg) (aPAD, ssPAD or cPAD, mg/kg/day) (Water Consumption, L/kgbw/day) (100)

Example; EDWC, ppb Gen. Pop. aPAD 0f 100 

### = (100) (1000 ug/mg) (0.00002 mg/kg/day) = 0.37594 (0.0532) (100)

HED’s toxicologist and/or risk assessor would be able to provide the acute, steady state and/or chronic population adjusted dose in mg ai/kg

- bw/day, the cancer Q* in (mg ai/kg

- bw/day)

- 1 and information about the

level of refineme nt (if percent of crop treated assumptions are made). EFED’s drinking water assessor would be able to provide the EDWC for acute/steady state, chronic or cancer assessments expressed in terms of the pesticide, e.g. residues of acephate and it degradate me thamidophos expressed as parent acephate. The water consumption values (see Input Values tab) 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

Exa mination Survey, What We Eat in America, conducted from 2005 to 2010. In general, the population subgroup with higher exposure to residues in drinking water is infants (<1 yr old); therefore, acute or chronic risks for this subgroup would be protective of other subgroups. Occasionally, a different PAD is selected for females in reproductive age or other population subgroups. In such case a separate calculation for that population subgroup would be needed.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 43 of 44 

# Risk is f(Toxicity, Exposure)

Toxicity Input Values

HED's risk assessor or toxicologist would be able to provide the safe dietary intake(s) to be considered for
dietary assessments. In cases that the chemical toxicology database will be re

- evaluated the division may

not be able to provide these values.

(1) The exposure of the general population is used for cancer risk assessments. (2) The population subgroup with highest exposure to drinki ng water is All Infants (<1 yr old). Generally, a risk calculation for All Infants will cover the risk of other subgroups and the general population. In the case that a separate endpoint is available for females in reproductive age (13

- 49 yrs) then the w ater consumption for that population subgroup should be used to estimate the risk. (3) The water consumption for steady state was obtained using the two

- day average consumption from individuals participating in the WWEIA survey. The EDWC used for stea dy state screening may be the same used for acute exposure or that corresponding to the 21

- day average.Terbufos Aggregate Dietary Exposure Assessment DP No. D422672



### Page 44 of 44