### UN IT ED STATES ENVI RO NMENT AL PROTECTION AGENCY
WASH I NG TO N
, D .C. 20460



### MEMORANDUM

D A T E: 15-SEP-2015 OFF I CE OF C H EM I C AL SA F E TY AN D POLL U TIO N PR EVEN TIO N



### SUBJECT: Profenofos. Acute and Steady

- State Dietary (Foo d + Drinking Water) Expos ur e

a nd Ri sk Assess m e nt s t o Suppo rt R egistra ti o n R ev i ew.



### PC Code : 11140 

### I 

### DP Barcode: 0 427269 

### Decision No.: 482022 

### Registration No.: NA 

### Pet ition N o .: NA 

### R eg ulatory Action: R eg i s t rat i on Revie w 

### Risk Assessment T ype : D i etary 

### Case No. : 2540 

### TXR No. : NA 

### CAS No.: 41198-08-7
MRID N o.: NA ,,// / •

## § 1 80.404



### FROM: Sarah J. 

### L evy ,

# mi**~** ( 

# }J}J1Vt 

# X/

Risk Assessme n t Branch 1 (RAB l ) 

# j 

# r----

H ea lth Effec t s Divis i o n (HED ; 7509P) /,) ;/ 

# h.11/f.JJ

THROUGH: J u li e Van A l st in e , E n v i ronmen!."

, I Hea l th Jl>. i e nti st'f 

# r- f 

# pl 7 '
Sheila Pip e r , Se ni o r Chem i st {)

## ~**\}(...~** Di etary Exposure Science Advisory Council '(DESAC) H E D (7509 P )

a nd

George F

. Kramer
, Ph

. D.
, Branch Senior C h em ist RABl / H E D (7509P)



### TO: Christina Scheltema/Ke ll y Sherman Ri sk Management and Implementation Branch 53 P est i c id e R e-Eva lu at i on Di v i s i o n ( PRD ; 7508 P )



### E xecutive S umma ry

Profenofos [ 0-( 4- br omo

- 2

- c hl orop h eny l )O

- et h y l- S -prop y l p h osphorot hi oate] is an organophospha te (O P ) insecticide registered for u se o n co tton

. Acute a nd two

- day average dietary ( food o nl y , drinking wate r only

, and food + drinkin g water) e xpo s ur e and ri sk

as s essment s for profenofos we r e conducted using t h e Di e tary Ex po s ur e Eva lu a ti o n Model

s oftware with the Food Commodity lnt a k e Database ( D EEM- FC ID ) Ve r s i on 3. 1 6. This mode l

uses 2003

- 2008 food cons umpti o n data from the U

. S. D e partment of Ag ricu l tur e ' s (US D A ' s) Page I of28

### Profcnofos Dietary E xposure & 

### Ri s k Assessment 

### 0427269



### Na ti o n a l Health and N utriti o n Exa minati on Survey

, What We Eat in America

, (N H ANES / WWEIA). These ana l yses were performed to s upp or t the R eg i st ration R ev i ew of profen ofos

. The analyses we r e r ev i ewed by two DE SAC peer reviewers

, per the DE SAC S tandard Operat i n g Pr oce dur e (SOP) 20 1 2. l.

Ac ute Dietary (Food + Drinking Water) Ex p osu r e an d Ri sk R es ult s and C h a ra c teri za tion

An 

### unrefined acute dietary exposure assess m e nt was conducted to est imate the dietary exposure and ri sk associated w ith R eg i s tration R ev i ew. T o lerance s for r es idu es of profenofos are only established fo r cotto n and li vestoc k. Th e ac ut e dietary ex po s ur e a ssess ment in corporated tolerance-level residues

, D E EM default processing fa cto r s , and 100% crop treated (PC T ) fo r the
acute analys i s. T h e Env ironment a l Fate and Effects Di v i s ion (EFE D ) provid ed a s ur face water
est im ated drinking wate r concentration (E DWC ) of 5.92 ppb fr o m th e Tier 2 Su r face Water Concen tr at i o n Calc ul ato r (S WCC ) from T exas cotton.

The acu t e aggrega t e diet a r y (foo d + drinking wate r ) ri sk es timat es are below HED ' s le ve l of

concern ( < l 00% th e ac ute population-adjusted dose (aPAD)) fo r the U.S. p o pulati on and all population s ub gro up s

. C ombined dietar y risk from food + drinking water at the 95 111 

### percentile of expos ure i s 3 8 % of the aPAD for th e U.S. population an d 80% of the a PAD for c hildr en 1- 2
yea r s o ld

, the hi g h es t expose d popul a ti o n s ub group.

S t ea d y-S tat e Diet a ry 

### (Food + Drinkin g Water) Exposure Results and C h aracte ri zat i o n O P s ma y ex hibit a phenomenon known as stea d y

- s t ate acetylcholinesterase (AC h E) inhibition

, which i s th e m os t se n s iti ve endpoi nt for a ll lifestages. Afte r r epeate d do s in g a t th e same dose

, the amount of AChE inhibiti on in a give n dose r e m a in s co n s i s t en t across duration

. Fo r this

r easo n , a stea d y

- state point of departure (P OD ) w a s se l ecte d for oral ex p os ure to profenofos (see Tab le 3). '

The DEEM acute module was u sed to co ndu c t r efined two-day (s t ea d y

- s tat e) ave rag e assessments using t h e steady

- state e ndp o int

, 2 -d ay average dietary exposure, and 2 1-da y ro llin g wate r averages. The se steady-state average assess m e nt s es timate 2 1-da y ( " s t eady-s t a t e

.. )
average daily food + drinking water exposu r es

. T h e stea d y

- st at e di eta r y exposure assessme nt s assumed a n average fie l d tr ial va lu e for cotton , a cottonseed oil proc ess in g facto r , and tolerancelevel and processing factors fo r meat and 111ilk commodities. The cotto n P CT was applied to
cotton and a ll meat/milk commodities; th e refore

, re s ult s are discussed at the 99.9 1 

### h percentile of
exposure. H oweve r , w h e n di sc u ss in g drinkin g water only

, r es ults are di sc u ssed at the 95lli percentile of exposu r e as P C T was n o t app li ed t o drinkin g w ate r. E FED pro v id ed daily t imese ri es o utput s that s imul ate 29 years of r esid ues of prof e nofo s in drink i n g water fo r 5 cotton appl ic at i on sce n a rio s ( T X
, MS

, NC, CA co tton r eservo ir

, and MS cotton pond). These distributions were u sed as a re s idue-distributi o n fi l e (RDF) in D EEM fo r dir ect all sources and indirect all so urc es.

For the p a rt i a ll y- r e fin e d /ood 

### alone steady-state assess m e nt , chil dr en 1- 2 yea r s o ld are the hi g h es t exposed s ubp op ulat i on at 350% ss P A D at the 99.9 111 

### percenti l e of exposure.

Fou r o ut of the five 

### d rin king water only scenar i os had at least one subpop ul at i on that was > l 00%

a PAD at the 95 111 

### p erce ntil e (CA cotton scenario had est im ates 

### < 100% for all p o pulation s at the 95ih percentile). F or the partially-refined/ood 

### + drinking water exposure estimates at th e 99.9 111



### Pa g e 2 of28Profenofos Dietary Exposure & Risk Assessment D427269

Page 3 of 28 

### percentile, all five scenarios are of concern to HED (>100% ssPAD). The TX d rinking water scenario had the overall highest risk estimates (all infants <1 year old (1600% ssPAD)). The CA cotton scenario had the overall lowest risk estimates ( children 1

- 2 years old was the highest exposed population subgroup at the 99.9 th 

### percentil e at 350% ssPAD)). The other three food + drinking water scenarios were similar to (but lower than ) the TX scenario.

Cancer Dietary (Food + Drinking Water) Exposure Results and Characterization Profenofos is classified as “not likely to be carcinogenic to humans” based on the lack of carcinogenic potential noted in the available studies; therefore, a cancer dietary exposure assessment was not conducted.

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticid e. For the acute and steady

- state assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose that HED has concluded will result in no unreasonable adverse health effects). This dose is referred to as the PAD . The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and steady

- state (two

- day average ) assessments, HED is concerned when estimated dietary risk exceeds 100% of the PAD. Refe rences 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.regulations.gov/#!documentDetail;D= EPA

- HQ

- OPP

- 2007

- 0780

- 0001.

T he steady

- state assessments were conducted in the DEEM acute module using the steady

- state endpoint and 21

- day forward

- rolling water averages to provide an estimate of 21

- day (“ steady

state ”) average daily exposures. These ste ady

- state assessments were completed for drinking water alone, food alone, and food + drinking water. For drinking water alone, the steady

- state average assessments, using a 21

- day forward

- rolling average water file, provide an accurate overall estimate o f the 21

- day (“ steady

- state ”) average daily exposures at the per

- capita 95 th 

### or 99.9 th 

### percentile for drinking water, to the extent that predicted drinking water concentrations for any 21

- day duration is known for any given year. For food alone, steady

- state assessments reflect an average daily exposure for a two

- day exposure duration rather than a 21

- day exposure duration. Since the DEEM steady

- state assessment does not capture day

- to

- day variation in food residues, it will generally result in h igher food

- only exposure estimates than a model that calculates 21

- day rolling averages for food. Although the DEEM steady

- state assessments may result in higher exposure estimates for food, the assessments provide an acceptable estimate of 21

- day (“ stead y

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

The most recent dietary risk assessment for profenofos was conducted in support of the 2000 Interim Reregistration Eligibility Decision 

### ( IRED; E PA

- 738

- R

- 00

- 006 

### ).

II. Food Residue Information

The existing residue chemistry database for profenofos is adequate for risk assessment purposes.Profenofos Dietary Exposure & Risk Assessment D427269

Page 4 of 28 

### a. Residues of Concern

The qualitative nature of the residue of profenofos in cotton and livestock has been adequately identified/charact erized and is understood. The HED Metabolism Committee decided that profenofos per se is the compound of toxicological concern in cotton, milk

, and ruminant tissues (28

- JUL

- 1995). The Committee also concluded there is no reasonable expe ctation of finite residues of profenofos in poultry tissues and eggs.

b. Tolerances

Permanent t olerances are established for the residues of profenofos are established under 40 CFR §180. 4 04 in/on cotton, undelinted seed at 2.0 ppm and cotton gin byproducts at 55.0 ppm. Codex has a maximum residue limit (MRL) for “ cotton seed ” at 3 ppm. For purposes of harmonization, HED recommends increasing the existing U.S. cotton, undelinted seed tolerance of 2.0 ppm to 3.0 ppm. Tolerances for residues of pr ofenofos are also established in/on the following livestock commodities: milk at 0.01 ppm ; and the fat, meat

, and meat byproducts of cattle, goat, horse, and sheep at 0.05 ppm

.

c. Residues in Fish

The U SDA ’s Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010 and in salmon in 2013. In general, pesticide residues would not be expected to be found in fish unless the pesticide bioaccumulates or has an aquatic use. To de termine whether or not residues are present in fish, HE D now routinely checks PDP monitoring data regardless of the pesticide’s uses and physicochemical properties. In 2008, PDP analyzed catfish samples for profenofos but did not find any detectable resid ues. In 2009 and 2010 PDP did not analyze catfish samples for profenofos . In 2013 , PDP did not analyze salmon samples for profenofos. As a result, residues in fish were not included in the assessment.

Residue Data used for Acute and Steady

- S tate Diet ary Assessments

The acute dietary exposure assessment was conducted using tolerance

- level residues (HED’s recommended 3.0 ppm for cottonseed for purposes of harmonization)

, DEEM default processing factors , and assumed 100% CT.

The steady

- state dietary exposure assessment assumed an average field trial value for cotton of 0.382 ppm ( Memo, C. Eiden, 01

- AUG

- 1995; D217739) , median cottonseed oil processing factor of 0. 0 7x ( Memo, C. Eiden, 01

- AUG

- 1995; D217744) , and default tolerance

- level and processing fac tors for meat and milk commodities. The cotton PCT was applied to cotton and all meat/milk commodities. RDFs were used for milk and meat commodities.

III. Percent Crop Treated Information

The acute aggregate dietary analyses were performed assuming 100% of each commodity was treated with profenofos. A Screening Level Usage Analysis (SLUA) memo was provided by the Biological and Economics Analysis Division ( BEAD ; see Attachment 16) ; however, HED did not use the PCT in the acute assessment as the results were <100% aPAD

. For the steady

- state assessments (food only and food + drinking water), PCT for cotton (1%) was applied to cottonProfenofos Dietary Exposure & Risk Assessment D427269

Page 5 of 28 

### and all meat and milk commodities

.

IV. Drinking Water Data

The residues of concern in drinking water for purposes of risk assessment are profenofos

. EFED provided EDWCs for profenofos in the following drinking water assessment, “Drinking Water Assessment for Profenofos for Registration Review ( M. Colletti

, D42575 5 ). EFED noted that no current monitoring data available for profenofos. Thus, this drinking water assessment relies on modeled estimates.

Drinking Water Estimates for Acute Assessment

The recommended EDWC s for profenofos are based on the only currently registered use site, cotton, which is grown in several states. The modeled use pattern and locations represent values that are expected to be exceeded only rarely in drinking water in watersheds where cotton is grown. The per cent cropped area (PCA) for cotton, 0.21, was used for a national assessment. For the acute assessment, the surface water EDWC from the Texas cotton OP scenario ( 5.92 ppb ) was utilized, as it was the highest peak concentration.

Surface Water Modeling

Fo r Tier 2 surface water assessments, the SWCC model was used to estimate environmental fate and transport of the active ingredient profenofos in surface waters. The Tier 2 assessment reports the EDWCs for profenofos that are expected once every ten years. The estimates are generated using 30

- years of meteorological data, encompassing the years from 1961 to 1990. For further information on these models see: http://www.epa.gov/oppefed1/model s/water/index.htm

. The profenofos concentrations simulated by SWCC assume that 100% of the watershed is planted to the simulated crop. The raw SWCC concentrations (output) are then multiplied by the PCA factor for cotton to account for the less than 100% coverage by the crop in a watershed large enough to support a drinking water facility. The SWCC output concentrations multiplied by the PCA are the EDWCs. PCAs are the maximum proportion of a drinking water basin that might be planted with a specific cr op (EFED, 2014) . The PCA for cotton was determined to be 0.21.

The recommended EDWCs modeled using the Tier II SWCC for the surface water drinking water exposure assessment for Registration Review are 5.92 μg/L (ppb) for the peak concentration, 0.2 83 μg/L for the annual mean concentration, and an overall mean concentration of 0.1 67 μg/L. The highest peak concentration, the highest annual, and overall mean values occurred with the Texas cotton OP scenario.

Table 1. EDWC of Profenofos Residues for Cotton in an Index Reservoir with the SWCC Model.

1

- in

- 10

- year Profenofos Concentration (μg/L) Concentration (μg/L)

Scenario

- State Crop 1,2 Peak Annual Mean Overall Annual Mean
CA

- Cotton 0.527 0.0382 0.0365 MS

- Cotton 4.87 0.214 0.113 NC

- Cotton 4.43 0.206 0.0945 TX

- Cotton 5.92 0.283 0.167

1 The bold value represents the recommend ed EDWC to be use d in the acute drinking water assessment.Profenofos Dietary Exposure & Risk Assessment D427269

Page 6 of 28 2 The simulations used the maximum labeled number (10) of applications and application rate (0.5 lb ai/A/application), and a maximum seasonal application rate (5 lb ai/A). The concentrations have been adjusted with the PCA of 0.21 for cotton for a national assessment.


### Groundwater Modeling

Tier 1 ground water EDWCs for profenofos, resulting from its use on cotton were derived with (Pesticide Root Zone Model for Groundwater, version 1.0, 31

- AUG

- 2012). PRZM

- GW accounts for pesticide fate in the crop root zone by simulating pesticide transport and degradation through the soil profile after a pesticide is applied to an agricultural field. PRZM

- GW permits the assessment of multiple years of pesticide application (up to 100 years) on a single site. Six stand ard scenarios, each representing a different region known to be vulnerable to groundwater contaminations, are available for use with PRZM

- GW for risk assessment purposes. The WI sands scenario was excluded from modeling of profenofos for ground water EDWC s since it is not relevant to the cotton

- growing region. PRZM

- GW output values represent pesticide concentrations in a vulnerable groundwater supply that is located directly beneath a rural agricultural field. For this reason, use of a PCA adjustment fac tor is not appropriate for PRZM

GW. For further information on this model see: http://www.epa.gov/oppefed1/models/water/index.htm.

PRZM

- GW estimates likely ground water concentrations if the pesticide is used at the maximum allowable application rate in areas where ground water is exceptionally vulnerable to contamination. The profenofos EDWCs were modeled for each scenario over 30 years and 100 years, and can be found in Table 2 . An extended weather file was used in all five of the PRZM

GW scenarios to simulate 100 years of use because breakthrough was unobserved in each of the scenarios over a 30

- year period. Breakthrough, for the purposes of PRZM

- GW, is defined as the point at which the full concentration of the active ingredient applied to the crop is observed to reach the groundwater layer.

Table 2

. E DWCs of Profenofos R esidues C alculated using the PRZM

- GW M odel over 30 Y ears and 100 Y ears.
Scenario 1 Daily Peak (μg/L) Post Breakthrough

Average (μg/L) Average Breakthrough Time (Days) NJ/DE

– 30 years 0.00106 Incomplete Incomplete NJ/DE

– 100 years 6.38 Incomplete Incomplete FL

– Citrus

– 30 years 2.51 Incomplete Incomplete FL

– Citrus

– 100 years 16 Incomplete Incomplete FL

– Potato

– 30 years 8.79 x 10

- 5 Incomplete Incomplete FL

– Potato

– 100 years 1.96 Incomplete Incomplete GA

– 30 years 3.03 x 10

- 9 Incomplete Incomplete GA

– 100 years 0.0266 Incomplete Incomplete NC

– 30 years 0.0193 Incomplete Incomplete NC

– 100 years 0.478 Incomplete Incomplete Abbreviations: NJ/DE=Delmarva Sweet Corn; NC=NC cotton; GA=Georgia Peanuts

1 The bold values represent the recommend EDWCs to be use in the drinking water assessment.



### Drinking Water Estimates for Steady

- State Assessment

For the steady

- state assessments, EFED provided daily time

- serie s outputs that simulate 29 years of residues of profenofos in drinking water for the following 5 cotton application scenarios: TXProfenofos Dietary Exposure & Risk Assessment D427269

Page 7 of 28 

### cotton reservoir; MS cotton reservoir; MS cotton pond; NC cotton reservoir; and CA cotton reservoir. Each scenario was run i ndividually in DEEM. These distributions were adjusted so that the data points were 21

- day forward rolling averages and these values were incorporated into RDFs for use in DEEM for “water direct all sources” and “water indirect all sources.” In the 21

- da y 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 res idues 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 have a large impact on the dietary exposure assessment si nce 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.

V. DEEM

- FCID Program and Consumption Information

Acute and steady

- state average dietary exposure assessments were conducted for profenofos using DEEM

- FCID, Version 3.16, which incorporates 2003

- 2008 consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumption of more than 20,000 individuals over two non

- consecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA

- defined food commodities (e.g., apples, peeled fruit

- cooked; fresh or N/S; baked; or wheat flour

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic e xposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups. However, for acute exposure assessment, consumption data are retained as individual consumption events. Based on analysis of the 2003

- 2008 W WEIA consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1

- 2, c hildren 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 o f each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic as sessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per

- capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for analyses performed at all levels of refinement. However, for deterministic assessments, any significant differences in user vs. per capita expo sure and risk are specifically identified and noted in the risk assessment.

For a steady

- state exposure assessment, two

- 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 days. For example, if an individual reports eating 100 grams of apple on the first day and 0 grams of apple on the second day, the two

- day average consumption amount would be 50 grams/day of apple [( 100 grams + 0 grams)/2 days = 50 grams/day]. The resulting two

- day average consumption amount can then be multiplied by aProfenofos Dietary Exposure & Risk Assessment D427269

Page 8 of 28 

### residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is ex pressed as a percentage of the PAD on both a user (i.e., only those who reported eating relevant commodities/food for ms) 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 at all levels 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.

VI. Toxicological Information

Profenofos is a member of the OP class of pesticides. Like other OPs, the initiating event in the adverse outcome pathway (AOP), also often called the mode of action (MOA), for profenofos involves inhibition of the enzyme acetylcholinesterase (AChE) via phosphorylation of the serine residue at the active site of the enz yme. Some OPs require metabolic activation to the oxon metabolite; however, for profenofos, the parent compound is responsible for AChE inhibition activity

. This inhibition leads to accumulation of acetylcholine and ultimately to neurotoxicity in the cen tral and/or peripheral nervous system . For profenofos , AChE inhibition is the most sensitive endpoint in the toxicology database in multiple species, durations, lifestages, and routes. AChE inhibition is the focus of this hazard characterization; the ava ilability of reliable AChE inhibition dose response data is one of the key determinants in evaluating the toxicology database. In general, OPs reach steady state within 2

- 3 weeks but this can vary among OPs. In the case of p rofenofos , the results show a clear pattern of steady state reached at or near 15 days of exposure. In addition to the consistency across durations, the data across multiple studies (repeat CCA study, gestational data from the DNT, subchronic neurotoxicity study, and subchronic rat to xicity study) are similar. Although the durations of the toxicity and exposure assessments may differ, an exact match is not necessary and would suggest a level of precision that the toxicity data do not support. Furthermore, humans would be expected to be slower and closer to the typical 2

- 3 week window of duration. Given this, the 21

- day and longer exposure assessment is scientifically supportable and also provides consistency across the OPs. Given the results for profenofos , acute (single day) and st eady state durations are appropriate for human health risk assessment.

HED’s ToxSAC met ( 11

- FEB

- 2015) to consider the endpoints of toxicological concern for the dietary exposure

. Please refer to the risk assessment for a discussion of the 10x Safety Fa ctor (SF). The FQPA 10x SF will be retained for infants, children, youths, and women of childbearing age for all exposure scenarios. Therefore, the dietary exposure results for the general U.S. population, all infants (<1 year old), children 1

- 2, childre n 3

- 5, children 6

- 12, youth 13

- 19, and adults 20

- 49 will include an 10 FQPA SF with the exception of adults 5 0

- 99 years old

.Profenofos Dietary Exposure & Risk Assessment D427269

Page 9 of 28 Table 3. Summary of Toxicological Doses and Endpoints for Profenofos for use in Human Health Risk Assessments 1

.

Exposure/ Scenario P O D Uncertainty Factors 2 RfD, PAD,

Level of Concern for Risk Assessment Study and Toxicological

Effects

Acute Dietary (all populations except adults 50

- 99 years) BMDL 10 =

1.99 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 10X aRfD = 0.00199

aPAD = 0.00199 Acute CCA study in rats

(MRID 46025406)

BMD 10 = 3.17 mg/kg/day.

Inhibition of RBC AChE in adult female rats.

Acute Dietary (adults 50

- 99 years) BMDL 10 =

1.99 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X aRfD = 0.0199

aPAD = 0.0199 Acute CCA study in rats

(MRID 46025406)

BMD 10 = 3.17 mg/kg/day.

Inhibition of RBC AChE in adult female rats.

Steady

- State Dietary (all populations except adults 50

- 99 years) BMDL 10 =

0.12 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 10X ssRfD =

0.00012

ssPAD = 0.00012 Combined chronic oral

toxicity/carcinogenicity study (MRID 00081685)

BMD 10 = 0.14/0.13 mg/kg/day (males/females).

Inhibition of RBC AChE in adult rats at 13 week interim
measurement.

Steady

- State Dietary (adults 50

- 99 years) BMDL 10 =

0.12 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X ssRfD = 0.0012

ssPAD = 0.0012 Combined chronic oral

toxicity/carcinogenicity study (MRID 00081685)

BMD 10 = 0.14/0.13 mg/kg/day (males/females).

Inhibition of RBC AChE in adult rats at 13 week interim
measurement. Cancer (oral, dermal, inhalation) Classification: Group E Chemical

– Not likely to be carcinogenic to humans

.

1 Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. BMD= benchmark dose

. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. RfD = reference dose (a = acute, ss = steady state)

. PAD = population adjusted dose (a = acute, ss = steady state)

.

2 FQPA SF retained for infants, children, youths, and women of ch ildbearing age for all exposure scenarios due to uncertainty in the human dose

- response relationship for neurodevelopmental effects. This includes all exposure scenarios, except the dietary exposure scenarios for the population subgroup adults 50

- 99 for w hich the FQPA SF has been reduced to 1X.Profenofos Dietary Exposure & Risk Assessment D427269

Page 10 of 28 

### VII. 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 analyses estimate the dietary exposure of the U.S. population and var ious population subgroups. Food only, drinking water only, and food + drinking water assessments were completed. See the Appendix for a full listing of results for acute and steady state exposures.

Acute

The acute assessments are summarized in Tables 4

- 6 (Table 4

- food only; Table 5

- drinking water only; Table 6

- food + drinking water). At the 95 th 

### percentile of e xposure (as no PCT was included)

, risk from food + drinking water is <100% aPAD for all population subgroups

. The risk to the U.S. p opulation utilized 3 8 % aPAD

, and the highest exposure population subgroup was children 1

- 2 years old

, which utilized 80 % of the aPAD.

Table 4 . Summary of Acute Dietary (Food Only) Exposure and Risk for Profenofos 1

. Population Subgroup aPAD (mg/kg/day) 2 95 th Percentile

Exposure (mg/kg/day) % aPAD General U.S. Population

0.00199 0.000551 28 All Infants (<1 year old) 0.000714 36 Children 1

- 2 years old 0.001359 68 Children 3

- 5 years old 0.001024 51 Children 6

- 12 years old 0.000736 37 Youth 13

- 19 years old 0.000428 22 Adults 20

- 49 years old 0.000320 16 Adults 50

- 99 years old 2 0.000259 1.3 Females 13

- 49 years old 0.000312 16

1 Highest exposur e at the 95th p ercentile is in bold.

2 Subpopulation adults 50

- 99 years old: a PAD = 0.0199 m g/kg/day

.

Table 5 . Summary of Acute Dietary (Drinking Water Only

– TX Cotton OP Scenario ) Exposure and Risk for Profenofos 1

. Population Subgroup aPAD (mg/kg/day) 2 95 th Percentile

Exposure (mg/kg/day) % aPAD General U.S. Population

0.00199 0.000323 16 All Infants (<1 year old) 0.001011 51 Children 1

- 2 years old 0.000498 25 Children 3

- 5 years old 0.000404 20 Children 6

- 12 years old 0.000309 16 Youth 13

- 19 years old 0.000269 14 Adults 20

- 49 years old 0.000318 16 Adults 50

- 99 years old 2 0.000283 1.4 Females 13

- 49 years old 0.000322 16

1 Highest exposure at the 95th percentile is in bold.

2 Subpopulation adults 50

- 99 years old: a PAD = 0.0199 m g/kg/day

.Profenofos Dietary Exposure & Risk Assessment D427269

Page 11 of 28 Table 6 . Summary of Acute Dietary (Food + Drinking Water

– TX Cotton OP Scenario ) Exposure and Risk for Profenofos 1

. Population Subgroup aPAD (mg/kg/day) 2 95 th Percentile

Exposure (mg/kg/day) % aPAD General U.S. Population

0.00199 0.000746 38 All Infants (<1 year old) 0.001311 66 Children 1

- 2 years old 0.001595 80 Children 3

- 5 years old 0.001306 66 Children 6

- 12 years old 0.000907 46 Youth 13

- 19 years old 0.000574 29 Adults 20

- 49 years old 0.000527 26 Adults 50

- 99 years old 2 0.000461 2.3 Females 13

- 49 years old 0.000524 26

1 Highest exposure at the 95th percentile is in bold

. 2 Subpopulation adults 50

- 99 years ol d: a PAD = 0.0199 m g/kg/day

. 

### Steady Stat e
The following steady

- state assessments are summarized below : T able 7

– food only; and Table 8

– drinking water only for each drinking water scenario as well as food + drinking water results for the subgroup with the highest exposure.

Food only : Table 7 shows the results for the steady

- state food only assessment

. At the 99.9 th 

### percentile

, the h ighest exposed subgroup is children 1

- 2 years old

, which occupies 35 0 % of the

s sPAD

.

Table 7. Summary of Steady

- State Dietary (Food Only) Exposure and Risk for Profenofos 1

.
Population Subgroup ssPAD ( mg/kg/day ) 2 95 th Percentile 99 th Percentile 99.9 th Percentile

Exposure ( mg/kg/day ) %

ssPAD Exposure

( mg/kg/day ) %

ssPAD Exposure

( mg/kg/day ) %

ssPAD General U.S. Population

0.00012 0.000003 2.2 0.000025 21 0.000115 96 All Infants (<1 year old) 0.000002 1.3 0.00003 4 29 0.0002 17 180 Children 1

- 2 years old 0.000013 11 0.000162 13 0 0.00042 1 35 0 Children 3

- 5 years old 0.000009 7.9 0.00009 1 76 0.00023 2 190 Children 6

- 12 years old 0.000006 4.9 0.000051 4 2 0.000144 120 Youth 13

- 19 years old 0.000003 2.2 0.000026 21 0.00008 4 7 0 Adults 20

- 49 years old 0.000002 1.7 0.0000 19 16 0.000067 56 Adults 50

- 99 years old 3 0.000002 <1.0 0.000017 1.4 0.000055 4.6 Females 13

- 49 years old 0.000002 1.6 0.00001 8 15 0.000064 53

1 Highest exposure at the 99.9 th each percentile is in bold.

2 mkd = mg/kg/day. ssPAD = steady

- state population

- adjusted dose.

3 Subpopulation adults 50

- 99 years old: ssPAD = 0.0012 mkd.



### Drinking water only : EFED provided a total of five drinking water scenarios for the steady

- state assessment. Table 8 shows the results for each drinking water scenario. Four out of the five dr inking water only scenarios had at least one subpopulation that was >100% ss PAD at the 95 th 

### percentile (CA cotton scenario had estimates <100% for all populations at the 95 th 

### percentile). The subpopulation “all infants (<1 year old) ” was the highest exposed population for all five water scenarios. For CA cotton (the lowest exposure scenario), all infants (<1 year old) utilized 52 % of the ss PAD and for TX cotton (the highest exposure scenario)

, all infants (<1 year old) utilized 2 20 % of the ss PAD at the 95 th 

### percentile.Profenofos Dietary Exposure & Risk Assessment D427269

Page 12 of 28 

### Food + Drinking water : Table 8 also s hows the food + drinking water results for the highest exposed population subgroup for each drinking water scenario. Results are shown at the 99.9 th 

### percentile as PCT was incorporated into the residue files. All five food + drinking water scenarios are of concern to HED (>100% ssPAD).

Table 8. Summary of Steady

- State Dietary (Food Only) Exposure and Risk for Profenofos 1

.

Drinking Water Scenario Steady

- State DRINKING WATER ONLY (All Infants <1 year old) Steady

- State FOOD + DRINKING WATER Highest Exposure Estimate 95 th 99.9 th Population Subgroup 99.9 th

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

MS Cotton reservoir 0.00022 7 190 0.0015 7 7 1300 All infants 0.0015 77 1300

TX Cotton Reservoir 0.00026 2 220 0.0019 19 1600 All infants 2 0.0019 22 1600

MS Cotton pond 0.00015 3 130 0.0015 25 1300 All infants 0.0015 27 1300

NC Cotton 0.0001 30 110 0.0013 52 1100 All infants 0.00134 2 1100

CA Cotton 0.00006 4 52 3 0.0003 18 280 3 Children 1

- 2 years old 2 0.0004 2 9 3 6 0

1 ssPAD = steady

- state population

- adjusted dose.

2 The results for all population subgroups (general U.S. population, all infants (< 1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adults 50

- 99 years) for the lowest and highest food + drinking water runs are s hown in Attachments 12 and 14.

3 For reference, drinking water exposure for children 1

- 2 years old was 1 4 0% at the 99.9 th percentile.



### VIII. Characterization of Inputs/Outputs

HED has conducted acute an d steady

- state dietary exposure and risk assessments using DEEM version 3.16 for p r ofenofos

. The following three scenarios for the acute assessments are presented in this memorandum: food only; drinking water only; and food + drinking water

. For the steady

- state assessments the following assessments were conducted: food only; drinking water onl y (for each drinking water scenario ); food + drinking water (for each drinking water
assessment ).

The acute assessment s are not considered to be refined assessments as anticipated residues, monitoring data, PCT data, empirical processing factors, cooking factors derived from literature studies , or refined drinking water values were not incorporated

. PCT for cotton w as provided to HED; however

, HED did not utilize the data as the acute assessments are not of concern to HED (<100% aPAD) . Results are theref ore reported at the 95 th 

### percentile of exposure. Tolerance

level residues, DEEM default processing factors, EDWC s , and 100% CT data were utilized. The
acute assessments (food only; drinking water only (for highest drinking water assessme nt); and food + d rinking water (for highest drinking water assessment)) are all <100% aPAD. For the food + drinking water assessment (highest drinking water)

, the U.S

. population utilized 3 8 % of the aPAD. C hildren 1

- 2 years old w ere the population with the high est exposu re ( 80 % aPAD).Profenofos Dietary Exposure & Risk Assessment D427269

Page 13 of 28 

### The steady

- state average assessments are not considered to be highly refined assessments as they did not incorporate monitoring data or empirical processing /cooking factors

. Cottonseed oil is considered a blended commodity; therefore, HED utilized an average field trial residue, an average processing factor, and PCT

. Meat and milk commodities are considered blended commodities; therefore, the tolerance level, along with PCT were incorporated into an RDF that was used in DEEM for the approp riate meat and milk commodities. EFED provided daily time

series output s that simulate 29 years of residues of profenofos in drinking water for five different cotton application scenario s . Th e s e distribution s were converted into 21

- day forward rolling

av erages and incorporated into RDF s that were used in DEEM for direct all sources and indirect all sources.

For the steady

- state food alone exposure estimates, results are shown at the 99.9 th 

### percentile as PCT was incorporated into the food residue files

. C hildren 1

- 2 years old are the highest exposed subpopulation at 350% of the ssPAD (99.9 th 

### percentile of exposure)

. For drinking water only

, t he 95 th 

### percentile is shown as no PCT was incorporated. EFED provided a total of five drinking water scenarios. Four out of the five drinking water only scenarios had at least one subpopulation that was >100% ss PAD at the 95 th 

### percentile (CA cotton scenario had estimates <100% for all populations at the 95 th 

### percentile). The subpopulation “all infants (<1 year old)” was the highest exposed population for all five drinking water only scenarios at all percentiles. For CA cotton (the lowest exposure scenario), all infants (<1 year old) utilized 52% of the ssPAD and for TX co tton (the highest exposure scenario), all infants (<1 year old) utilized 220% of the ssPAD at the 95 th 

### percentile. For the food + drinking water exposure estimates, results are shown at the 99.9 th 

### percentile as PCT was incorporated into the food residue files. All five food + drinking water scenarios are of concern to HED (>100% ssPAD). The TX scenario had the overall highest exposure estimates (all infants (<1 year old) as the highest exposed population subgroup at the 99.9 th 

### percentile with 1 600% of the ssPAD). The CA cotton scenario had the overall lowest exposure estimates (children 1

- 2 years old was the highest exposed population subgroup at the 99.9 th 

### percentile with 350% of the ssPAD). The other three food + drinking water scenarios wer e similar to (but lower than ) the TX scenario.

IX. Conclusions

The unrefined acute analys i s demonstrate that the profenofos uses will not result in acute dietary risk estimates that exceed HED’s LOC for any of the regulated population subgroups, includin g those comprised of infants and children. The risk to the U.S. p opulation utilized 3 8 % aPAD and the highest exposure population subgroup was children 1

- 2 years old

, which utilized 80 % of the aPAD.

For the steady

- state food alone assessment, children 1

- 2 years old are the highest exposed subpopulation at 350% ssPAD a t the 99.9 th 

### percentile of exposure

. Four out of the five drinking water only scenarios had at least o ne subpopulation that was >100% ss PAD at the 95 th 

### percentile (CA cotton scenario had estimates <100% for all populations at the 95 th 

### percentile). For the partially

- refined food + dr inking water risk estimates at the 99.9 th 

### percentile , all five scenarios are of concern to HED (>100% ssPAD). The TX drink ing water scenario had the overall highest exposure estimates (all infants <1 year old (16 0 0% ssPAD)). The CA cotton scenario had the overall lowest risk estimates ( children 1

- 2 years old was the hig hest exposed population subgroup at the 99.9 th 

### percentil e at 35 0 % ssPAD)). The other three food + drinking water scenarios were similar to (but lower than ) the TX scenario.Profenofos Dietary Exposure & Risk Assessment D427269

Page 14 of 28 

### X. List of Attachments

Attachment 1. DEEM

- FCID Acute Residue Input File

- Food O nly. Attachment 2. DEEM

- FCID Acute Exposure Estimates

- Food O nly. Attachment 3. DEEM

- FCID Acute Residue Input File

- Drinking Water O nly (TX Cotton OP

Scenario)

. Attachment 4. DEEM

- FCID Acute Exposure Estimates

- Drinking Water Only (TX Cotton OP

Scenario)

. Attachmen t 5. DEEM

- FCID Acute Residue Input File

- Food + Drinking Water (TX Cotton OP

Scenario)

. Attachment 6. DEEM

- FCID Acute Exposure Estimates

- Food + Drinking Water (TX Cotton

OP Scenario)

. Attachment 7. DEEM

- FCID Steady State Residue Input File

- Food Only. Attachment 8. DEEM

- FCID Steady State Exposure Estimates

- Food Only. Attachment 9. DEEM

- FCID Steady State Residue Input File

- Drinking Water Only (TX Cotton

Scenario). Attachment 10. DEEM

- FCID Steady State Exposure Estimates

- Drinking Water Only (TX

Cotton Scenario). Attachment 11. DEEM

- FCID Steady State Residue Input File

- Food + Drinking Water (CA

Cotton Scenario). Attachment 12. DEEM

- FCID Steady State Exposure Estimates

- Food + Drinking Water (CA

Cotton Scenario). Attachment 13. D EEM

- FCID Steady State Residue Input File

- Food + Drinking Water (TX

Cotton Scenario). Attachment 14. DEEM

- FCID Steady State Exposure Estimates

- Food + Drinking Water (TX

Cotton Scenario). Attachment 15. RDF Files. Attachment 16. SLUA Report.

RDI: DESAC Reviewers ( 17

- AUG

- 2015 ); G. Kramer ( 06

- AUG

- 2015 ) DP No.: 427269 Petition No.: NA PC Code: 111401 S. Levy :S

- 1095 3 :PY

- S:(703) 3 0 5

- 07 8 3 :7509P:RAB1Profenofos Dietary Exposure & Risk Assessment D427269

Page 15 of 28 

### Attachment 1. DEEM

- FCID Acute Residue Input File

- Food only.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID Acute analysis for PROFENOFOS Residue file name: C: \ Users \ slevy \ Desktop \ Profenofos \ July \ acute food only 7 10.r08 Analysis Date 07

- 10

- 2015 Residue file dated: 07

- 10

- 2015/10:50:30 Reference dos e: aRfD = 0.00199 mg/kg bw/day NOEL = 1.99 mg/kg bw/day Comment: Acute 10x food only; 1x adults 50

- 99; new cotton

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

----- ---- ------------ ----------- ----------- ---------- 1 6 111401_MScotton_02

- 10

- 15_MScottonSTD_Reservoir_Parent_DEEM.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.050000 1.000 1.000 3100047000 31 Beef, fat 0.050000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0.050000 1.000 1.000 3100048000 31 Beef, kidney 0.050000 1.000 1.000 3100049000 31 Beef, liver 0.050000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 0.050000 1.000 1.000 2003128000 20C Cottonseed, oil 3.000000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 3.000000 1.000 1.000 3200169000 32 Goat, meat 0 .050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 3200171000 32 Goat, fat 0.050000 1.000 1.000 3200172000 32 Goat, kidney 0.050000 1.0 00 1.000 3200173000 32 Goat, liver 0.050000 1.000 1.000 3300189000 33 Horse, meat 0.050000 1.000 1.000 3800221000 38 Meat, game 0.050000 1.000 1.000 3600222000 36 Milk, fat 0.010000 1.000 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.010000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.010000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.010000 1.000 1.000 3600224000 36 Milk, water 0.010000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.010000 1.000 1.000 3600225001 36 Milk, s ugar (lactose)

- baby food/ 0.010000 1.000 1.000 3900312000 39 Rabbit, meat 0.050000 1.000 1.000 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 3500341000 35 Sheep, fat 0.050000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.050000 1.000 1.000 3500342000 35 Sheep, kidney 0.050000 1.000 1.000 3500343000 35 Sheep, liver 0.050000 1.000 1.000Profenofos Dietary Exposure & Risk Assessment D427269

Page 16 of 28 

### Attachment 2. DEEM

- FCID Acute Exposure Estimates

- Food on ly.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for PROFENOFOS NHANES 2003

- 2008 2

- Day Residue file: acute food only 7 10.r08 Adjustment factor #2 used. Analysis Da te: 07

- 10

- 2015/10:55:23 Residue file dated: 07

- 10

- 2015/10:50:30 NOEL (Acute) = 1.990000 mg/kg body

- wt/day Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports RAC/FF intake summed over 24 hours Run Comment: "Acute 10x food onl y; 1x adults 50

- 99; new cotton "

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aPAD MO E Exposure % aPAD MOE Exposure % aPAD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.000551 27.67 3614 0.000994 49.93 2002 0.002019 101.44 985 All Infants: 0.000714 35.87 2787 0.001476 74.18 1348 0.001775 89.22 1120 Children 1

- 2: 0.001359 68.28 1464 0.002164 108.72 919 0.004859 244.20 409 Children 3

- 5: 0.001024 51.48 1942 0.001626 81.69 1224 0.004885 245.46 407 Children 6

- 12: 0.000736 36.99 2703 0.001076 54.08 1849 0.003421 171.93 581 Youth 13

- 19: 0.000428 21.51 4648 0.000683 34.33 2912 0.001914 96.20 1039 Adults 20

- 49: 0.0003 20 16.07 6222 0.000500 25.13 3978 0.001374 69.03 1448 Adults 50

- 99: 0.000259 1.30 7672 0.000383 1.92 5196 0.000663 3.33 3001 Female 13

- 49: 0.000312 15.68 6378 0.000479 24.07 4154 0.000998 50.13 1994



### Attachment 3. DEEM

- FCID Acute Residue Input File

– Drinking Water Only.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID Acute analysis for PROFENOFOS Residue file name: C: \ Users \ slevy \ Desktop \ Profenofos \ July \ acute water only 10x water TX scenario pt est 7 10.r08 Analysis Date 07

- 10

- 2015 Residue file dated: 07

- 10

- 2015/10:29:45 Reference dose: aRfD = 0.00199 mg/kg bw/day NOEL = 1.99 mg/kg bw/ day Comment: Acute 10x water pt ext TX scenario; 1x adults 50

- 99

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

----- ---- ------------ ----------- ----------- ---------- 1 6 111401_MScotton_02

- 10

- 15_MScottonSTD_Reservoir_Parent_DEEM.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 8601000000 86A Water, direct, all sources 0.005920 1.000 1.000 TX sce Full comment: TX scenario 8602000000 86B Water, indirect, all sources 0.005920 1.000 1.000 TX sce Full comment: TX scenarioProfenofos Dietary Exposure & Risk Assessment D427269

Page 17 of 28 

### Attachment 4. DEEM

- FCID Acute Exposure Estimates

- Drinking Water Only.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for PROFENOFOS NHANES 2003

- 2008 2

- Day Residue file: acute water only 10x water TX scenario pt est 7 10.r08 Adjustment factor #2 used. Analysis Date: 07

- 10

- 2015/11 :01:27 Residue file dated: 07

- 10

- 2015/10:29:45 NOEL (Acute) = 1.990000 mg/kg body

- wt/day Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports RAC/FF intake summed over 24 hours Run Comment: "Acute 10x water pt ext TX scenario; 1x adults 50

- 99"

=============================================================================== Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aPAD MOE Exposure % aPAD MOE Exposure % aPAD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.000323 16.22 6164 0.000532 26.75 3738 0.001011 50.81 1967 All Infants: 0.00101 1 50.81 1968 0.001369 68.82 1453 0.002007 100.86 991 Children 1

- 2: 0.000498 25.01 3997 0.000750 37.67 2654 0.001846 92.76 1078 Children 3

- 5: 0.000404 20.30 4926 0.000619 31.08 3216 0.000993 49.90 2004 Children 6

- 12: 0.000309 15.51 6448 0.000506 25.45 3929 0.000781 39.23 2549 Youth 13

- 19: 0.000269 13.51 7402 0.000443 22.25 4494 0.000669 33.59 2976 Adults 20

- 49: 0.000318 15.96 6264 0.000473 23.75 4209 0.000688 34.56 2893 Adults 50

- 99: 0.000283 1.42 7032 0.000429 2.16 4638 0.000676 3.40 2942 Female 13

- 49: 0.000322 16.19 6176 0.000474 23.81 4200 0.000664 33.39 2995Profenofos Dietary Exposure & Risk Assessment D427269

Page 18 of 28 

### Attachment 5. DEEM

- FCID Acute Residue Input File

- Food + Drinking Water.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID Acute analysis for PROFENOFOS Residue file name: C: \ Users \ slevy \ Desktop \ Profenofos \ July \ acute food + water 10x water pt est 7 10.r08 Analysis Date 07

- 10

- 2015 Residue file dated: 07

- 10

- 2015/10:11:26 Reference dose: aRfD = 0.00199 mg/kg bw/day NOEL = 1.99 mg/kg bw/day Comment: Acute 10x food + water point estimate; 1x adults 50

- 99 ; new cotton and water

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

----- ---- -------- ---- ----------- ----------- ---------- 1 6 111401_MScotton_02

- 10

- 15_MScottonSTD_Reservoir_Parent_DEEM.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.050000 1.000 1.000 3100047000 31 Beef, fat 0.050000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0.050000 1.000 1.000 3100048000 31 Beef, kidney 0.050000 1.000 1.000 3100049000 31 Beef, liver 0.050000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 0.050000 1.000 1.000 2003128000 20C Cottonseed, oil 3.000000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 3.000000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 320017 1000 32 Goat, fat 0.050000 1.000 1.000 3200172000 32 Goat, kidney 0.050000 1.000 1.000 3200173000 32 Goat, liver 0.050000 1.000 1.000 3300189000 33 Hor se, meat 0.050000 1.000 1.000 3800221000 38 Meat, game 0.050000 1.000 1.000 3600222000 36 Milk, fat 0.010000 1.000 1.000 3600222001 36 Milk, fat

- baby f ood/infant formu 0.010000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.010000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.010000 1.000 1.000 3600224000 36 Milk, water 0.010000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.010000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.010000 1.000 1.000 3900312000 39 Rabbit, meat 0.05000 0 1.000 1.000 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 3500341000 35 Sheep, fat 0.050000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.050000 1.000 1.000 3500342000 35 Sheep, kidney 0.050000 1.000 1.000 3 500343000 35 Sheep, liver 0.050000 1.000 1.000 8601000000 86A Water, direct, all sources 0.005920 1.000 1.000 TX sce Full comment: TX scenario 8602000000 86B Water, indirect, all sources 0.005920 1.000 1.000 TX sce Full comment: TX scenarioProfenofos Dietary Exposure & Risk Assessment D427269

Page 19 of 28 

### Attachment 6. DEEM

- FCID Acute Exposure Estimates

- Food + Drinking Water.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for PROFENOFOS NHANES 2003

- 2008 2

- Day Residue file: acute food + water 10x water pt est 7 10.r08 Adjustment factor #2 used. Analysis Date: 07

- 10

- 2015/10:14:30 Residue file dated: 07

- 10

- 2015/10:11:26 NOEL (Acute) = 1.990000 mg/kg body

- wt/day
Acu te Pop Adjusted Dose (aPAD) varies with population; see individual reports RAC/FF intake summed over 24 hours Run Comment: "Acute 10x food + water point estimate; 1x adults 50

- 99; new cott on and water"

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aPAD MOE Exposure % aPAD MOE Exposure % aPAD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.000746 37.50 2666 0.001236 62.12 1609 0.002260 113.58 880 All Infants: 0.001311 65.90 1517 0.001761 88.50 1129 0.002558 128. 52 778 Children 1

- 2: 0.001595 80.17 1247 0.002283 114.70 871 0.004928 247.65 403 Children 3

- 5: 0.001306 65.64 1523 0.001851 93.04 1074 0.005044 253.49 394 Children 6

- 12: 0.000907 45.58 2194 0.001287 64.69 1545 0.003537 177.74 562 Youth 13

- 19: 0.000574 28.86 3465 0.000891 44.76 2234 0.001983 99.66 1003 Adults 20

- 49: 0.000527 26.48 3775 0.000762 38.29 2611 0.001398 70.24 1423 Adul ts 50

- 99: 0.000461 2.32 4318 0.000658 3.31 3025 0.001073 5.39 1854 Female 13

- 49: 0.000524 26.35 3795 0.000727 36.53 2737 0.001331 66.89 1494Profenofos Dietary Exposure & Risk Assessment D427269

Page 20 of 28 

### A ttachment 7. DEEM

- FCID Steady State Residue Input File

- Food Only.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID Acute analysis for PROFENOFOS Residue file name: C: \ Users \ slevy \ Desktop \ Profenofos \ July \ SS food only 10x 7 11.r08 Analysis Date 07

- 11

- 2015 Resi due file dated: 07

- 11

- 2015/09:43:00 Reference dose: aRfD = 0.00012 mg/kg bw/day NOEL = 0.12 mg/kg bw/day Comment: Steady State

- Food only 10x; 1x for adults 50

- 99; new cotton; 2000 iterat

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

----- ---- ------------ ----------- ----------- ---------- 1 6 21dayrollingavewater.rdf 2 6 Milk.rdf 3 6 LivestockTissue.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr

---------- ---- ----------------------- -------- ---------- ------ ------ --- ------- 3100044000 31 Beef, meat 0.050000 1.000 1.000 3 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 3 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 3 3100046001 31 Beef, meat byproducts

- babyfood 0.050000 1.000 1.000 3 3100047000 31 Beef, fat 0.05000 0 1.000 1.000 3 3100047001 31 Beef, fat

- babyfood 0.050000 1.000 1.000 3 3100048000 31 Beef, kidney 0.050000 1.000 1.000 3 3100049000 31 Beef, liver 0.050000 1.000 1.000 3 3100049001 31 Beef, liver

- babyfood 0.050000 1.000 1.000 3 2003128000 20C Cottonseed, oil 0.382000 0.070 0.010 2003128001 20C Cottonseed, oil

- babyfood 0.382000 0.070 0.010 3 200169000 32 Goat, meat 0.050000 1.000 1.000 3 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 3 3200171000 32 Goat, fat 0.050000 1.000 1.000 3 3200172000 32 Goat, kidney 0.050000 1.000 1.000 3 3200173000 32 Goat, liver 0.050000 1.000 1.000 3 3300189000 33 Horse, meat 0.050000 1.000 1.000 3 3800221000 38 Meat, game 0.010000 1.000 1.000 3 3600222000 36 Milk, fat 0.010000 1.000 1.000 2 3600222001 36 Milk, fat

- baby food/infant formu 0.010000 1.000 1.000 2 3600223000 36 Milk, nonfat solids 0.010000 1.000 1.000 2 3600223001 36 Milk, nonfat solids

- baby food/in 0.010000 1.000 1.000 2 3600224000 36 Milk, water 0.010000 1.000 1.000 2 3600224001 36 Milk, water

- babyfood/infant form 0. 010000 1.000 1.000 2 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.010000 1.000 1.000 2 3900312000 39 Rabbit, meat 0.010000 1.000 1.000 3 3500339000 35 Sheep, meat 0.050000 1.00 0 1.000 3 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 3 3500341000 35 Sheep, fat 0.050000 1.000 1.000 3 3500341001 35 Sheep, fat

- babyfood 0.050000 1.000 1.000 3 3500342000 35 Sheep, kidney 0.050000 1.000 1.000 3 3500343000 35 Sheep, liver 0.050000 1.000 1.000 3Profenofos Dietary Exposure & Risk Assessment D427269

Page 21 of 28 

### Attachment 8. DEEM

- FCID Steady State Exposure Estimates

- Food Only.

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for PROFENOFOS NHANES 2003

- 2008 2

- Day Residue file: SS food onl y 10x 7 11.r08 Adjustment factor #2 used. Analysis Date: 07

- 11

- 2015/10:11:14 Residue file dated: 07

- 11

- 2015/09:43:00 NOEL (Acute) = 0.120000 mg/kg body

- wt/day 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 = 50; RNG = MS VB Run Comment: "Steady State

- Food only 10x; 1x for adults 50

- 99; new cotton; 2 000 iterat"

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aPAD MOE Exposure % aPAD MOE Exposure % aPAD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.000003 2.17 46028 0.000025 20.89 4787 0.000115 96.04 1041 All Infants: 0.000002 1.25 79693 0.000034 28.48 3511 0.000217 180.98 552 Children 1

- 2: 0.000013 10.97 9114 0.000162 134.98 740 0.000421 351.05 284 Children 3

- 5: 0.000009 7.91 12642 0.000091 75.94 1316 0.000232 193.62 516 Children 6

- 12: 0.000006 4.84 20654 0.000051 42.37 2360 0.000144 120.25 831 Youth 13

- 19: 0.000003 2.22 45044 0.000026 21.39 4675 0.000084 70.29 1422 Adults 20

- 49: 0.000002 1.66 60151 0.000019 16.24 6157 0 .000067 55.89 1789 Adults 50

- 99: 0.000002 0.15 68421 0.000017 1.41 7086 0.000055 4.62 2164 Female 13

- 49: 0.000002 1.54 65076 0.000018 15.38 6500 0.000064 53.27 1877Profenofos Dietary Exposure & Risk Assessment D427269

Page 22 of 28 

### Attachment 9. DEEM

- FCID St eady State Residue Input File

- Drinking Water Only (TX Cotton Scenario).

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID Acute analysis for PROFENOFOS Residue file name: C: \ Users \ slevy \ Desktop \ Profenofos \ July \ SS dw TX cotton.r08 Analysis Date 07

- 12

- 2015 Residue file dated: 07

- 11

- 2015/14:50:55 Reference dose: aRfD = 0.00012 mg/kg bw/day NOEL = 0.12 mg/kg bw/day Comment: Steady State

- DW only TX cotton adults 50

- 99; 2000 iterat

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

----- ---- ------------ -------- --- ----------- ---------- 1 6 Tx cotton 21 day rolling ave.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 8601000000 86A Water, direct, all sources 1.000000 1.000 1.000 1 8602000000 86B Water, indirect, all sources 1.000000 1.000 1.000 1



### Attachment 10. DEE M

- FCID Steady State Exposure Estimates

- Drinking Water Only (TX Cotton Scenario).

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for PROFENOFOS NHANES 2003

- 2008 2

- Day Residue file : SS dw TX cotton.r08 Adjustment factor #2 used. Analysis Date: 07

- 11

- 2015/14:57:22 Residue file dated: 07

- 11

- 2015/14:50:55 NOEL (Acute) = 0.120000 mg/kg body

- wt/day 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 = 50; RNG = MS VB Run Comment: "Steady State

- DW only TX cotton adults 50

- 99; 2000 iterat"

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aPAD MOE Exposure % aPAD MOE Exposure % aPAD M OE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.000099 82.54 1211 0.000277 230.68 433 0.000646 538.57 185 All Infants: 0.000262 218.29 458 0.000864 720.20 138 0.001919 1599.42 62 Children 1

- 2: 0.000143 119.22 838 0.000412 343.72 290 0.000967 805.74 124 Children 3

- 5: 0.000121 101.23 987 0.000337 280.73 356 0.000753 627.34 159 Children 6

- 12: 0.00 0087 72.19 1385 0.000244 202.97 492 0.000580 483.74 206 Youth 13

- 19: 0.000072 59.66 1676 0.000212 176.34 567 0.000503 418.93 238 Adults 20

- 49: 0.000101 83.80 1193 0.000277 230.54 433 0.00060 3 502.10 199 Adults 50

- 99: 0.000100 8.31 1202 0.000263 21.89 456 0.000560 46.64 214 Female 13

- 49: 0.000100 83.11 1203 0.000280 233.54 428 0.000612 510.26 195Profenofos Dietary Exposure & Risk Assessment D427269

Page 23 of 28 

### Atta chment 11. DEEM

- FCID Steady State Residue Input File

- Food + Drinking Water (CA Cotton Scenario).
US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID Acute analysis for PROFENOFOS Residue file name: C: \ Users \ slevy \ Desktop \ Profenofos \ July \ SS food + dw CA Cotton 10x 7 15.r08 Analysis Date 07

- 15

- 2015 Residue file dated: 07

- 15

- 2015/09:36:10 Reference dose: aRfD = 0.00012 mg/kg bw/day NOEL = 0.12 mg/kg bw/day Comment: Steady State

- F+DW CA cotton 10x; 1x for adults 50

- 99; 2000 itera t. 7 15

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

----- ---- ------------ ----------- ----------- ---------- 1 6 CA cotton 21 day rolling ave.rdf 2 6 Milk.rdf 3 6 LivestockTissue.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 3100044000 31 Beef, meat 0.050000 1.000 1.000 3 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 3 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 3 3100046001 31 Beef, meat byproducts

- babyfood 0.0500 00 1.000 1.000 3 3100047000 31 Beef, fat 0.050000 1.000 1.000 3 3100047001 31 Beef, fat

- babyfood 0.050000 1.000 1.000 3 3100048000 31 Beef, kidney 0.050000 1.000 1 .000 3 3100049000 31 Beef, liver 0.050000 1.000 1.000 3 3100049001 31 Beef, liver

- babyfood 0.050000 1.000 1.000 3 2003128000 20C Cottonseed, oil 0.382000 0.070 0.010 20 03128001 20C Cottonseed, oil

- babyfood 0.382000 0.070 0.010 3200169000 32 Goat, meat 0.050000 1.000 1.000 3 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 3 3200171000 32 Goat, fat 0.050000 1.000 1.000 3 3200172000 32 Goat, kidney 0.050000 1.000 1.000 3 3200173000 32 Goat, liver 0.050000 1.000 1.000 3 3300189000 33 Horse, meat 0.050000 1.000 1.000 3 3800221000 38 Meat, game 0.050000 1.000 1.000 3 3600222000 36 Milk, fat 0.010000 1.000 1.000 2 3600222001 36 Milk, fat

- baby food/infan t formu 0.010000 1.000 1.000 2 3600223000 36 Milk, nonfat solids 0.010000 1.000 1.000 2 3600223001 36 Milk, nonfat solids

- baby food/in 0.010000 1.000 1.000 2 3600224000 36 Milk, water 0.010000 1.000 1.000 2 3600224001 36 Milk, water

- babyfood/infant form 0.010000 1.000 1.000 2 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.010000 1.000 1.000 2 3900312000 39 Rabbit, meat 0.050000 1.000 1.000 3 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3 3500340000 35 Sheep, mea t byproducts 0.050000 1.000 1.000 3 3500341000 35 Sheep, fat 0.050000 1.000 1.000 3 3500341001 35 Sheep, fat

- babyfood 0.050000 1.000 1.000 3 3500342000 35 Sheep, kidney 0.050000 1.000 1.000 3 3500343000 35 Sheep, liver 0.050000 1.000 1.000 3 8601000000 86A Water, direct, all sources 1.000000 1.000 1.000 1 8602000000 86B Water , indirect, all sources 1.000000 1.000 1.000 1Profenofos Dietary Exposure & Risk Assessment D427269

Page 24 of 28 

### Attachment 12. DEEM

- FCID Steady State Exposure Estimates

- Food + Drinking Water (CA Cotton Scenario).

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCI D ACUTE Analysis for PROFENOFOS NHANES 2003

- 2008 2

- Day Residue file: SS food + dw CA Cotton 10x 7 15.r08 Adjustment factor #2 used. Analysis Date: 07

- 15

- 2015/09:51:47 Residue file dated: 07

- 15

- 2015/09:36:10 NOEL (Acute) = 0.120000 mg/kg body

- wt/day 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 = 50; RNG = MS VB Run Comment: "Stea dy State

- F+DW CA cotton 10x; 1x for adults 50

- 99; 2000 ite rat. 7 15"

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Percentile

---- --- 99.9th Percentile

---- Exposure % aPAD MOE Exposure % aPAD MOE Exposure % aPAD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.000028 23.36 4281 0.000064 53.12 18 82 0.000153 127.49 784 All Infants: 0.000070 58.33 1714 0.000190 158.09 632 0.000355 295.55 338 Children 1

- 2: 0.000050 41.87 2388 0.000180 149.60 668 0.000429 357.47 279 Children 3

- 5: 0.000042 34.73 2879 0.000110 91.40 1094 0.000242 201.29 496 Children 6

- 12: 0.000029 23.97 4171 0.000072 60.13 1663 0.000157 130.67 765 Youth 13

- 19: 0.000022 18.05 5539 0.000053 44.36 2254 0.000104 8 6.73 1153 Adults 20

- 49: 0.000028 22.95 4357 0.000059 49.57 2017 0.000108 90.40 1106 Adults 50

- 99: 0.000027 2.22 4501 0.000054 4.53 2208 0.000099 8.26 1210 Female 13

- 49: 0.000027 22.65 4415 0.000060 50.39 1984 0.000107 89.34 1119Profenofos Dietary Exposure & Risk Assessment D427269

Page 25 of 28 

### Attachment 13. DEEM

- FCID Steady State Residue Input File

- Food + Drinking Water (TX Cotton Scenario).

US EPA Ver . 3.18, 03

- 08

- d
DEEM

- FCID Acute analysis for PROFENOFOS Residue file name: C: \ Users \ slevy \ Desktop \ Profenofos \ July \ SS food + dw TX Cotton 10x 7 15.r08 Analysis Date 07

- 15

- 2015 Residue file dated: 07

- 15

- 2015/11:17:16 Reference dose: aRfD = 0.0001 2 mg/kg bw/day NOEL = 0.12 mg/kg bw/day Comment: Steady State

- F+DW TX cotton 10x; 1x for adults 50

- 99; 7 15

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

----- ---- ------------ ----------- ----------- ---------- 1 6 Tx cotton 21 day rolling ave.rdf 2 6 Milk.rdf 3 6 LivestockTissue.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr

---------- ---- ------------------------------- ---------- ------ ------ --- ------- 3100044000 31 Beef, meat 0.050000 1.000 1.000 3 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 3 3100045000 31 Beef, meat, dried 0.050000 1.920 1.000 3 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 3 3100046001 31 Beef, meat byproducts

- babyfood 0.050000 1.000 1.000 3 3100047000 31 Beef, fat 0.050000 1.000 1.000 3 3100047001 31 Beef, fat

- babyfood 0.050000 1.000 1.000 3 3100048000 31 Beef, kidney 0.050000 1.000 1.000 3 3100049000 31 Beef, liver 0.050000 1.000 1.000 3 3100049001 31 Beef, liver

- babyfood 0.050000 1.000 1.000 3 2003128000 20C Cottonseed, oil 0.382000 0.070 0.010 2003128001 20C Cottonseed, oil

- babyfood 0.382000 0.070 0.010 3200169000 32 Goat, meat 0 .050000 1.000 1.000 3 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 3 3200171000 32 Goat, fat 0.050000 1.000 1.000 3 3200172000 32 Goat, kidney 0.050000 1.0 00 1.000 3 3200173000 32 Goat, liver 0.050000 1.000 1.000 3 3300189000 33 Horse, meat 0.050000 1.000 1.000 3 3800221000 38 Meat, game 0.050000 1.000 1.000 3 3600222000 36 Milk, fat 0.010000 1.000 1.000 2 3600222001 36 Milk, fat

- baby food/infant formu 0.010000 1.000 1.000 2 3600223000 36 Milk, nonfat solids 0.010000 1.000 1.000 2 3600223001 36 Milk, nonfat solids

- baby food/in 0.010000 1.000 1.000 2 3600224000 36 Milk, water 0.010000 1.000 1.000 2 3600224001 36 Milk, water

- babyfood/infant form 0.010000 1.000 1.000 2 3600225001 36 Milk, s ugar (lactose)

- baby food/ 0.010000 1.000 1.000 2 3900312000 39 Rabbit, meat 0.050000 1.000 1.000 3 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 3 3500341000 35 Sheep, fat 0.050000 1.000 1.000 3 3500341001 35 Sheep, fat

- babyfood 0.050000 1.000 1.000 3 3500342000 35 Sheep, kidney 0.050000 1.000 1.000 3 3500343000 35 Sheep, liver 0.050000 1.000 1.000 3 8601000000 86A Water, direct, all sources 1.000000 1.000 1.000 1 8602000000 86B Water, indirect, all sources 1.000000 1.000 1.000 1Profenofos Dietary Exposure & Risk Assessment D427269

Page 26 of 28 

### Attachment 14. DEEM

- FCID Steady State Exposure Estimates

- Food + Drinking Water (TX Cotton Scenario).

US EPA Ver. 3.18, 03

- 08

- d
DEEM

- FCID ACUTE Analysis for PROFENOFOS NHANES 2003

- 2008 2

- Day Residue file: SS food + dw TX Cotton 10x 7 15.r08 Adjustment factor #2 used. Analysis Date: 07

- 15

- 2015/11:31:41 Residue file dated: 07

- 15

- 2015/11:17:16 NOEL (Acute) = 0.120000 mg/kg body

- wt/day 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 = 50; RNG = MS VB Run Comment: "Steady State

- F+DW TX cotton 10x; 1x for adults 50

- 99; 7 15"

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

Summary calculations

-- per capita:

--- 95th Percentile

---- --- 99th Pe rcentile

---- --- 99.9th Percentile

---- Exposure % aPAD MOE Exposure % aPAD MOE Exposure % aPAD MOE

---------- ------- -------- ---------- ------- -------- ---------- ------- -------- Total US Population: 0.000102 85.16 117 4 0.000281 233.98 427 0.000649 541.11 184 All Infants: 0.000269 223.93 446 0.000865 721.23 138 0.001922 1601.34 62 Children 1

- 2: 0.000172 142.92 699 0.000437 364.57 274 0.000980 816.51 122 Children 3

- 5: 0.000135 112.77 886 0.000344 286.36 349 0.000759 632.40 158 Children 6

- 12: 0.000094 78.47 1274 0.000250 208.08 480 0.000586 488.39 204 Youth 13

- 19: 0.000075 62.31 1604 0.000213 177 .77 562 0.000506 422.01 236 Adults 20

- 49: 0.000102 84.77 1179 0.000278 231.55 431 0.000601 501.13 199 Adults 50

- 99: 0.000101 8.40 1189 0.000264 22.01 454 0.000560 46.64 214 Female 13

- 49: 0.000101 84.27 1186 0.000282 234.82 425 0.000610 507.92 196Profenofos Dietary Exposure & Risk Assessment D427269

Page 27 of 28 

### Attachment 15. RDF Files.

Milk Livestock Tissue Milk DOC ASSUMING 1% crop treated TOTALZ=99 TOTALFREQ=1

1,0.01 Tissue DOC ASSUMING 1% crop treated TOTALZ=99 TOTALFREQ=1

1,0.05

Drinking Water: CA Cotton Drinking Water: TX Cotton

'Profenofos 'CA cotton 'email from M. Coletti 5 5 15 '21

- day Rolling average 1.27E

- 11 1.2165E

- 11 1.1639E

- 11 1.11386E

- 11 1.06626E

- 11 1.02094E

- 11 9.77781E

- 12............ 'Profenofos 'TX cotton 'email M. Colletti 5

- 5

- 15 '21

- day Rolling average 6.01E

- 12 5.67735E

- 12 5.36404E

- 12 5.07073E

- 12 4.79602E

- 12 4.53865E

- 12 4.29736E

- 12............

Drinking Water: MS Cotton Pond Drinking Water: NC Cotton

'Profenofos 'MS Cotton Pond 'Email M. Colletti 5/5/15 '21

- day Rolling average 4.72E

- 11 4.4617E

- 11 4.22097E

- 11 3.99722E

- 11 3.78864E

- 11 3.59094E

- 11 3.40676E

- 11

............ 'Profenofos 'NC cotton 'email M. Colletti 5

- 5

- 15 '21

- day Rolling average 2.67E

- 09 2.5587E

- 09 2.45155E

- 09 2.35006E

- 09 2.25381E

- 09 2.16246E

- 09 2.07067E

- 09............

Drinking Water: MS Cotton Pond
'21

- day Rolling average 'Profenofos 'M. Colletti 3/19 'water 1.38E

- 12 1.29E

- 12 1.21E

- 12 1.14E

- 12 1.07297E

- 12 1.00967E

- 12 9.50945E

- 13............Profenofos Dietary Exposure & Risk Assessment D427269

Page 28 of 28 

### Attachment 16. SLUA Report.

From BEAD Memo, N. Mallampalli/M. Ranville, 19

- AUG

- 2014; No DP#.

Table 1 shows profenofos usage on cotton, pounds applied and total acres treated for the years 1998 through 2012. Since 1998, percent crop treated has averaged less than 2% annually and has averaged less than 1% annually since 2007. Proprietary usage data indicates that profenofos is primarily applied through ground applications. The percent of total acres treated with aerial application was approximately 50% on average over the years 1998

- 20 00 but shrank to 25% or less, on average, in subsequent years. The average acres treated with aerial applications increased again in the years 2007

- 2009, but this was primarily due to a high incidence of aerial applications in one state. There were no aeri al applications in 2010 or 2011 and no reported usage in 2012. Overall, total acres treated has decreased substantially in recent years with average acres treated over the most recent three years being less than 2% of the three

- year average from 1998 to 20 00. The average total lbs applied annually from 1998

- 2000 was less than 60% of average total l bs applied annually over the years 1995

- 1997 (775,000 lbs) (Sterling 1999). Percent crop treated has also declined in recent years but at a slower rate than total usage since total acreage of cotton grown has also decreased (Proprietary data; USDA NASS). Use (in terms of average total acres treated across 2005

- 20 11) appears to be concentrated in the Southeastern U.S., mainly Arkansas, Mississippi, Missouri, and Ge orgia.

Table 1. Profenofos Usage on Cotton in the U.S., Three

- Year Averages, 1998

- 2012 1

. 1998

- 2000 2001

- 2003 2004

- 2006 2007

- 2009 2010

- 2012 2 Total lbs Applied 447,154 159,067 67,938 19,757 6,767 Total Acres Treated 696,415 197,499 107,316 25,044 9,454 Proportion of Acres Treated Aerially 50% 17% 24% 34% 0%

Percent Crop Treated 1.7% 1.4% 1.1% 0.6% 0.7% 1 States reporting use in 1998

- 2006: AL, AZ, AR, CA, FL GA, LA, MS, MO, NC, OK, SC, TN, TX; States reporting use in 2007

- 2011: AR, GA, MS, MO, TX 2 No usage reported in 2012 Source: Proprietary Usage Data, 1998

- 2012



### Table 2 shows profenofos usage on cotton in California, in terms of both amount applied and total acres treated for the years 1998

- 2012. Like the national

- level proprietary data, the California usage data show that profenofos usage has decreased to near ze ro in recent years. No usage was reported in 2009 or 2011. Only one application was reported in the state in 2012 and only seven in 2010, compared to more than 400 applications in 1 998.

Table 2. Profenofos Usage on Cotton in California, 2000

- 2012

. 1998

- 2000 2001

- 2003 2004

- 2006 2007

- 2009 1 2010

- 2012 2 Total lbs Applied 50,025 19,1776 20,143 1,927 805 Total Acres Treated 45,810 21,098 19,105 2,399 895 Proportion of Acres Treated Aerially 90% 90% 94% 100% 94%

Number of applications reported 380 159 115 13 3

1 No usage reported in 2009 2 No usage reported in 2011 Source: California Dept of Pesticide Regulation, 1998

- 2012