UNITED STATES ENVIRONMENT AL PROTECTION AGENCY 

WASH INGTON, D.C. 20460 

MEMORANDUM 

DATE: 15-SEP-2015 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Profenofos. Acute and Steady-State Dietary (Food + Drinking Water) Exposure 

and Risk Assessments to Support Registration Review. 

PC Code: 11140 I DP Barcode: 0 427269 

Decision No.: 482022 Registration No.: NA 

Petition No.: NA Regulatory Action: Registration Review 

Risk Assessment Type: Dietary Case No.: 2540 

TXR No.: NA CAS No.: 41198-08-7 

MRID No.: NA ,,// / • § 180.404 

FROM: Sarah J. Levy, mi ~ ( }J}J1Vt X/ 

Risk Assessment Branch 1 (RAB l) j r----

Health Effects Division (HED; 7509P) /,) ;/ h.11/f.JJ 

THROUGH: Julie Van Alstine, Environmen!.",I Health Jl>.ientist'f r-f pl 7

' 

Sheila Piper, Senior Chemist {) ~ \}(...~ 

Dietary Exposure Science Advisory Council '(DESAC) 

HED (7509P) 

and 

George F. Kramer, Ph.D., Branch Senior Chemist 

RABl /HED (7509P) 

TO: Christina Scheltema/Kelly Sherman 

Risk Management and Implementation Branch 53 

Pesticide Re-Evaluation Division (PRD; 7508P) 

Executive Summary 

Profenofos [ 0-( 4-bromo-2-chlorophenyl)O-ethyl-S-propyl phosphorothioate] is an 

organophosphate (OP) insecticide registered for use on cotton. Acute and two-day average 

dietary (food only, drinking water only, and food + drinking water) exposure and risk 

assessments for profenofos were conducted using the Dietary Exposure Evaluation Model 

software with the Food Commodity lntake Database (DEEM-FCID) Version 3. 16. This model 

uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) 

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Profcnofos Dietary Exposure & Risk Assessment 0427269 

National Health and Nutrition Examination Survey, What We Eat in America, 

(NHANES/WWEIA). These analyses were performed to support the Registration Review of 

profenofos. The analyses were reviewed by two DESAC peer reviewers, per the DESAC 

Standard Operating Procedure (SOP) 2012. l. 

Acute Dietary (Food + Drinking Water) Exposure and Risk Results and Characteri zation 

An unrefined acute dietary exposure assessment was conducted to estimate the dietary exposure 

and risk associated with Registration Review. Tolerances for residues of profenofos are only 

established for cotton and livestock. The acute dietary exposure assessment incorporated 

tolerance-level residues, DEEM default processing factors, and 100% crop treated (PCT) for the 

acute analysis. The Environmental Fate and Effects Division (EFED) provided a surface water 

estimated drinking water concentration (EDWC) of 5.92 ppb from the Tier 2 Surface Water 

Concentration Calculator (SWCC) from Texas cotton. 

The acute aggregate dietary (food + drinking water) risk estimates are below HED's level of 

concern ( <l 00% the acute population-adjusted dose (aPAD)) for the U.S. population and all 

population subgroups. Combined dietary risk from food + drinking water at the 95111 percentile 

of exposure is 38% of the aPAD for the U.S. population and 80% of the aPAD for children 1-2 

years old, the highest exposed population subgroup. 

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

OPs may 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 dose, 

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 profenofos (see 

Table 3). ' 

The DEEM acute module was used to conduct refined two-day (steady-state) average 

assessments using the steady-state endpoint, 2-day average dietary exposure, and 2 1-day rolling 

water averages. These steady-state average assessments estimate 21-day ("steady-state .. ) 

average daily food + drinking water exposures. The steady-state di etary exposure assessments 

assumed an average field trial value for cotton, a cottonseed oil processing factor, and tolerancelevel and processing factors for meat and 111ilk commodities. The cotton PCT was applied to 

cotton and a ll meat/milk commodities; therefore, results are discussed at the 99.91

h percentile of 

exposure. However, when discussing drinking water only, results are discussed at the 95lli 

percentile of exposure as PCT was not applied to drinking water. EFED provided daily timeseries outputs that simulate 29 years of residues of profenofos in drinking water for 5 cotton 

application scenarios (TX, MS, NC, CA cotton reservoir, and MS cotton pond). These 

distributions were used as a residue-distribution fi le (RDF) in DEEM for direct all sources and 

indirect all sources. 

For the partia ll y-re fined/ood alone steady-state assessment, children 1-2 years old are the 

highest exposed subpopulation at 350% ssPAD at the 99.9111 percentile of exposure. 

Four out of the five drinking water only scenarios had at least one subpopul ation that was > l 00% 

a PAD at the 95111 percentile (CA cotton scenario had estimates < 100% for all populations at the 

95ih percentile). For the partially-refined/ood + drinking water exposure estimates at the 99.9111 

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Profenofos Dietary Exposure & Risk Assessment D427269

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percentile, all five scenarios are of concern to HED (>100% ssPAD). The TX drinking 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 99.9th percentile 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 pesticide. 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. 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.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2007-0780-0001.

The 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 (“steadystate”) average daily exposures. These steady-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 of the 21-day (“steady-state”) average daily exposures at the per-capita 95th or 

99.9th 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 higher 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 (“steady-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; EPA-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

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a. Residues of Concern

The qualitative nature of the residue of profenofos in cotton and livestock has been adequately 

identified/characterized 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 expectation of finite 

residues of profenofos in poultry tissues and eggs. 

b. Tolerances

Permanent tolerances are established for the residues of profenofos are established under 40 CFR 

§180.404 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 profenofos 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 USDA’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 determine whether 

or not residues are present in fish, HED 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 residues. 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-State Dietary 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 0.07x (Memo, C. Eiden, 01-AUG-1995; D217744), and default tolerance-level and processing 

factors 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 cotton 
Profenofos Dietary Exposure & Risk Assessment D427269

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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, D425755). 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 EDWCs 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 percent 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

For 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/models/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 crop 

(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, 0.283 μg/L for the annual mean concentration, and an overall mean concentration 

of 0.167 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 Crop1,2 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 recommended EDWC to be used in the acute drinking water assessment.
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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 

standard 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 EDWCs 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 factor is not appropriate for PRZMGW. 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 PRZMGW 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. EDWCs of Profenofos Residues Calculated using the PRZM-GW Model over 30 Years and 100 

Years. 

Scenario1 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 10-5Incomplete Incomplete

FL – Potato – 100 years 1.96 Incomplete Incomplete

GA – 30 years 3.03 x 10-9Incomplete 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-series outputs that simulate 29 years 

of residues of profenofos in drinking water for the following 5 cotton application scenarios: TX 
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cotton reservoir; MS cotton reservoir; MS cotton pond; NC cotton reservoir; and CA cotton 

reservoir. Each scenario was run individually 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-

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 have 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. 

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 exposure 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 WWEIA consumption data, which took into account dietary 

patterns and survey respondents, HED concluded that it is most appropriate to report risk for the 

following population subgroups: the general U.S. population, all 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 exposure assessment, or “matched” in multiple random pairings with residue values 

and then summed in a probabilistic assessment. The resulting distribution of exposures is 

expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating 

relevant commodities/food forms) and a 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.

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 a 
Profenofos Dietary Exposure & Risk Assessment D427269

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residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic 

exposure assessment, or “matched” in multiple random pairings with residue values and then 

summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a 

percentage of the PAD 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 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 enzyme. 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 central 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 availability 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 profenofos, 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 toxicity 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 steady 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 Factor 

(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, children 3-5, children 6-12, youth 

13-19, and adults 20-49 will include an 10 FQPA SF with the exception of adults 50-99 years

old.
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Table 3. Summary of Toxicological Doses and Endpoints for Profenofos for use in Human Health 

Risk Assessments1.

Exposure/

Scenario POD

Uncertainty

Factors2

RfD, PAD, 

Level of 

Concern for 

Risk 

Assessment

Study and Toxicological 

Effects

Acute Dietary 

(all populations 

except adults 50-99 

years)

BMDL10 = 

1.99 mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 

10X

aRfD = 0.00199

aPAD = 

0.00199

Acute CCA study in rats 

(MRID 46025406)

BMD10 = 3.17 mg/kg/day.

Inhibition of RBC AChE in 

adult female rats.

Acute Dietary 

(adults 50-99 

years)

BMDL10 = 

1.99 mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 

1X

aRfD = 0.0199

aPAD = 0.0199

Acute CCA study in rats 

(MRID 46025406)

BMD10 = 3.17 mg/kg/day.

Inhibition of RBC AChE in 

adult female rats.

Steady-State 

Dietary

(all populations 

except adults 50-99 

years)

BMDL10 = 

0.12 mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 

10X

ssRfD = 

0.00012

ssPAD = 

0.00012

Combined chronic oral 

toxicity/carcinogenicity study 

(MRID 00081685)

BMD10 = 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)

BMDL10 = 

0.12 mg/kg/day

UFA = 10X

UFH = 10X

FQPA SF = 

1X

ssRfD = 0.0012

ssPAD = 

0.0012

Combined chronic oral 

toxicity/carcinogenicity study 

(MRID 00081685)

BMD10 = 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. UFA = extrapolation from animal to human (interspecies). UFH = 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 childbearing 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 which the FQPA SF has been reduced to 1X.
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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 various 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 95th percentile of exposure (as no PCT was 

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

risk to the U.S. population utilized 38% 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 Profenofos1.

Population Subgroup aPAD 

(mg/kg/day)2

95th 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 old2 0.000259 1.3

Females 13-49 years old 0.000312 16

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

 2 Subpopulation adults 50-99 years old: aPAD = 0.0199 mg/kg/day.

Table 5. Summary of Acute Dietary (Drinking Water Only – TX Cotton OP Scenario) Exposure and 

Risk for Profenofos1.

Population Subgroup aPAD 

(mg/kg/day)2

95th 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 old2 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: aPAD = 0.0199 mg/kg/day.
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Table 6. Summary of Acute Dietary (Food + Drinking Water – TX Cotton OP Scenario) Exposure 

and Risk for Profenofos1.

Population Subgroup aPAD 

(mg/kg/day)2

95th 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 old2 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 old: aPAD = 0.0199 mg/kg/day.

Steady State

The following steady-state assessments are summarized below: Table 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 99.9th

percentile, the highest exposed subgroup is children 1-2 years old, which occupies 350% of the 

ssPAD.

Table 7. Summary of Steady-State Dietary (Food Only) Exposure and Risk for Profenofos1.

Population Subgroup ssPAD 

(mg/kg/day)

2

95th Percentile 99th Percentile 99.9th 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 0.000034 29 0.000217 180

Children 1-2 years old 0.000013 11 0.000162 130 0.000421 350

Children 3-5 years old 0.000009 7.9 0.000091 76 0.000232 190

Children 6-12 years old 0.000006 4.9 0.000051 42 0.000144 120

Youth 13-19 years old 0.000003 2.2 0.000026 21 0.000084 70

Adults 20-49 years old 0.000002 1.7 0.000019 16 0.000067 56

Adults 50-99 years old3 0.000002 <1.0 0.000017 1.4 0.000055 4.6

Females 13-49 years old 0.000002 1.6 0.000018 15 0.000064 53

1 Highest exposure at the 99.9th 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 

drinking water only scenarios had at least one subpopulation that was >100% ssPAD at the 95th

percentile (CA cotton scenario had estimates <100% for all populations at the 95th 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 ssPAD and for TX cotton (the highest exposure scenario), all infants (<1 year old) 

utilized 220% of the ssPAD at the 95th percentile. 
Profenofos Dietary Exposure & Risk Assessment D427269

Page 12 of 28

Food + Drinking water: Table 8 also shows the food + drinking water results for the highest 

exposed population subgroup for each drinking water scenario. Results are shown at the 99.9th

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 Profenofos1.

Drinking Water 

Scenario 

Steady-State DRINKING WATER ONLY 

(All Infants <1 year old)

Steady-State FOOD + DRINKING WATER 

Highest Exposure Estimate

95th 99.9th

Population 

Subgroup

99.9th

Exposure 

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

MS Cotton reservoir 0.000227 190 0.001577 1300 All infants 0.001577 1300

TX Cotton Reservoir 0.000262 220 0.001919 1600 All infants2 0.001922 1600

MS Cotton pond 0.000153 130 0.001525 1300 All infants 0.001527 1300

NC Cotton 0.000130 110 0.001352 1100 All infants 0.001342 1100

CA Cotton 0.000064 523 0.000318 2803 Children 1-2 

years old2 0.000429 360

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 shown in Attachments 12 and 14.

3 For reference, drinking water exposure for children 1-2 years old was 140% at the 99.9th percentile. 

VIII. Characterization of Inputs/Outputs

HED has conducted acute and steady-state dietary exposure and risk assessments using DEEM 

version 3.16 for profenofos. 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 only (for each drinking water scenario); food + drinking water (for each drinking water 

assessment).

The acute assessments 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 was provided to 

HED; however, HED did not utilize the data as the acute assessments are not of concern to HED 

(<100% aPAD). Results are therefore reported at the 95th percentile of exposure. Tolerancelevel residues, DEEM default processing factors, EDWCs, and 100% CT data were utilized. The

acute assessments (food only; drinking water only (for highest drinking water assessment); and 

food + drinking water (for highest drinking water assessment)) are all <100% aPAD. For the 

food + drinking water assessment (highest drinking water), the U.S. population utilized 38% of 

the aPAD. Children 1-2 years old were the population with the highest exposure (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 appropriate meat and milk commodities. EFED provided daily timeseries outputs that simulate 29 years of residues of profenofos in drinking water for five different

cotton application scenarios. These distributions were converted into 21-day forward rolling 

averages and incorporated into RDFs 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 99.9th percentile as 

PCT was incorporated into the food residue files. Children 1-2 years old are the highest exposed 

subpopulation at 350% of the ssPAD (99.9th percentile of exposure). For drinking water only, 

the 95th 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% ssPAD at the 95th percentile (CA cotton scenario had estimates 

<100% for all populations at the 95th 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 cotton (the highest exposure scenario), all infants (<1 year old) utilized 220% 

of the ssPAD at the 95th percentile. For the food + drinking water exposure estimates, results are 

shown at the 99.9th 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 99.9th percentile with 1600% 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 99.9th percentile with 350% of the ssPAD). The other three food + drinking 

water scenarios were similar to (but lower than) the TX scenario.

IX. Conclusions

The unrefined acute analysis 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, including 

those comprised of infants and children. The risk to the U.S. population utilized 38% 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 at the 99.9th percentile of exposure. Four out of the five drinking 

water only scenarios had at least one subpopulation that was >100% ssPAD at the 95th percentile 

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

partially-refined food + drinking water risk estimates at the 99.9th percentile, all five scenarios 

are of concern to HED (>100% ssPAD). The TX drinking water scenario had the overall highest 

exposure 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 99.9th percentile at 350% 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 Only.

Attachment 2. DEEM-FCID Acute Exposure Estimates - Food Only.

Attachment 3. DEEM-FCID Acute Residue Input File - Drinking Water Only (TX Cotton OP 

Scenario).

Attachment 4. DEEM- FCID Acute Exposure Estimates - Drinking Water Only (TX Cotton OP 

Scenario).

Attachment 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. DEEM-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-10953:PY-S:(703)305-0783:7509P:RAB1
Profenofos 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 dose: 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 1.000 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, sugar (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 1.000 
Profenofos Dietary Exposure & Risk Assessment D427269

Page 16 of 28

Attachment 2. DEEM-FCID Acute 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: acute food only 7 10.r08 Adjustment factor #2 used.

Analysis Date: 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 only; 1x adults 50-99; new cotton "

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

Summary calculations--per capita:

--- 95th Percentile---- --- 99th Percentile---- ---99.9th Percentile----

Exposure % aPAD MOE 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:

 0.000320 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 scenario
Profenofos 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:

 0.001011 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 2995 
Profenofos 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 

3200171000 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 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, sugar (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 1.000 

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 scenario
Profenofos 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

Acute 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 

Adults 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 1494 
Profenofos Dietary Exposure & Risk Assessment D427269

Page 20 of 28

Attachment 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 Residue 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 0.050000 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 1.000 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 1.000 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 
Profenofos 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 only 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 1877 
Profenofos Dietary Exposure & Risk Assessment D427269

Page 22 of 28

Attachment 9. DEEM-FCID Steady 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. DEEM- 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 MOE 

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

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:

 0.000087 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 0.000603 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 510.26 195 
Profenofos Dietary Exposure & Risk Assessment D427269

Page 23 of 28

Attachment 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 iterat. 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 0.050000 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 1.000 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/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 0.050000 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 1 
Profenofos 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-FCID 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: "Steady 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 1882 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 86.73 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 1119 
Profenofos 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 = 0.00012 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 Dist 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 1.000 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/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 0.050000 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 1 
Profenofos 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 Percentile---- ---99.9th Percentile----

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

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

Total US Population:

 0.000102 85.16 1174 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 507.92 196 
Profenofos 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 1998-2000 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 aerial 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 2000. The average total lbs applied annually from 1998-2000 was less

than 60% of average total lbs 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 Georgia.

Table 1. Profenofos Usage on Cotton in the U.S., Three-Year Averages, 1998-20121.

1998-2000 2001-2003 2004-2006 2007-2009 2010-20122

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 zero 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 1998.

Table 2. Profenofos Usage on Cotton in California, 2000-2012.

1998-2000 2001-2003 2004-2006 2007-20091 2010-20122

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