UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

MEMORANDUM 

DATE: 18 February 2016 

SUBJECT: Pirimiphos-methyl. Acute and Steady-State Dietary (Food+ Drinking Water) 

Exposure and Risk Assessments to Support Registration Review. 

FROM: 

THROUGH: 

TO: 

PC Code: 108102 DP Barcode: D430461 

Decision No.: 477390 Registration No.: NA 

Petition No.: NA Regulatory Action: Registration Review 

Risk Assessment Type: Dietary Case No.: 2535 

TXR No.: NA CAS No.: 29232-93-7 

MRID No.: NA 40 CFR: §180.409 

Michael A. Doherty, Ph.D., Senior Chemist f{v~ ~ § j · 

Risk 

Health 

Assessment 

Effects Division 

Branch 

(HED

II 

; 7509P) 

U~ 

Tom Bloem, Senior Chemis~ ~ . · 

Thurston Morton, Senior Chemist . 

Dietary Exposure Science Advisory c?o':incil (D C 

HED (7509P) 

Caitlin Newcamp and Neil Anderson 

Risk Management and Implementation Branch 1 

Pesticide Re-Evaluation Division (PRD; 7508P) 

Executive Summary 

Pirimiphos-methyl (0-[2-diethylamino-6-methyl-4-pyrimidinyl] 0 ,0-dimethyl 

phosphorothioate) is an organophosphate insecticide registered for post-harvest use on stored 

com and sorghum grains, for treatment of iris bulbs, and for application to livestock via ear tags. 

Organophosphate insecticides (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. 

Acute and steady-state dietary (food+ drinking water) exposure and risk assessments for 

pirimiphos-methyl were conducted using the Dietary Exposure Evaluation Model software with 

the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This model uses 2003-2008 

Page l of 16 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 2 of 16 

food consumption data from the U.S. Department of Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). These 

analyses were performed to support the Registration Review of pirimiphos-methyl. The analyses 

were reviewed by the DESAC on 10 December 2015. 

Both the acute and steady-state dietary assessments used data from the USDA’s Pesticide Data 

Program (PDP) for all food forms except poultry fat, which used an anticipated residue point 

estimate, and both assessments assumed 100% crop treated (i.e., no “zero” data in the residue 

distribution files). The data reflect analysis of pirimiphos-methyl only; therefore, factors derived 

from metabolism studies were used to account for the des-ethyl metabolite, which is a residue of 

concern for risk assessment. The Environmental Fate and Effects Division (EFED) provided an 

estimated drinking water concentration (EDWC) of 0.39 parts-per-trillion arising from the 

planting of treated corn grain. 

Probabilistic analyses resulted in acute dietary (food + drinking water) risk estimates that are not 

of concern (<100% the acute population-adjusted dose (aPAD)) for the U.S. population and all 

population subgroups. Combined dietary risk from food + drinking water at the 99.9th percentile 

of exposure is <1% of the aPAD for the U.S. population and 3.6% of the aPAD for children 3-5 

years old, the highest exposed population subgroup. 

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

assessments. Steady-state dietary risk estimates are not of concern (<100% the steady-state 

population-adjusted dose (ssPAD)) for the U.S. population and all population subgroups. 

Combined dietary risk from food + drinking water at the 99.9th percentile of exposure is 1.2% of 

the ssPAD for the U.S. population and 40% of the ssPAD for children 6-12 years old, the highest 

exposed population subgroup. 

Pirimiphos-methyl is classified as “not likely to be carcinogenic to humans” based on the lack of 

carcinogenic potential noted in the available studies; therefore, cancer risk is not an issue for this 

active ingredient. 

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 a point estimate for drinking water to provide an estimate of 2-day (“steady-state”) 

average daily exposures. 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

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The most recent dietary risk assessment for pirimiphos-methyl was conducted in 2007 

(D332652, A. Parmar, 25 December 2007). 

II. Food Residue Information

The existing residue chemistry database for pirimiphos-methyl is adequate for risk assessment 

purposes. Pirimiphos-methyl is registered for post-harvest treatment of stored field corn, sweet 

corn, popcorn, and sorghum grain, as well as for an ear-tag product applied to cattle. 

a. Residues of Concern 

The qualitative nature of the residue of pirimiphos-methyl in corn, sorghum, and livestock has 

been adequately identified/characterized and is understood. The HED Metabolism Assessment 

Review Committee determined that pirimiphos-methyl and is des-ethyl metabolite are the 

compounds of toxicological concern in crops and livestock tissues (D228695, J. Stokes, 15 May 

1998). 

b. Tolerances 

Permanent tolerances are established for the residues of pirimiphos-methyl, under 40 CFR 

§180.409 in/on grain of field corn, popcorn, and sorghum at 8 ppm, in aspirated grain fractions at 

20 ppm, and in fat and meat by-products of cattle, goats, hogs, horses, sheep, and poultry (fat 

only) at 0.02 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 2008-2010, PDP analyzed catfish 

samples for pirimiphos-methyl and found detectable residues (presumably from the use of treated 

corn in catfish chow). Those data were used in the assessment. Residues of pirimiphos-methyl 

were not found in salmon. 

Residue Data used for Acute and Steady-State Dietary Assessments 

Both the acute and steady-state dietary assessments used data from the USDA’s Pesticide Data 

Program (PDP) for beef fat (extrapolated to all mammalian fat), beef liver (extrapolated to all 

mammalian organ meats), catfish (extrapolated to all farm-raised freshwater finfish), corn grain 

(extrapolated to popcorn and sorghum after removing all non-detect values; i.e., 100% crop 

treated), and corn syrup. For poultry fat, these analyses use the anticipated residue calculated for 

the last dietary assessment (D332652, A. Parmar, 25 December 2007). The data reflect analysis 

of pirimiphos-methyl only; therefore, factors derived from metabolism studies were used to 

account for the des-ethyl metabolite. For corn, the metabolism study showed a maximum of the 

metabolite occurring at 1/6 the level of pirimiphos-methyl, resulting in a factor of 1.17. In beef 

fat, the metabolite occurred at a maximum of 1/3 the level of pirimiphos-methyl (factor = 1.3), 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 4 of 16 

and in poultry fat the maximum was 1/150 (factor = 1.007). Metabolism studies showed no 

measurable levels of the des-ethyl metabolite in organ meats, and the metabolite is not a residue 

of concern for drinking water. 

III. Percent Crop Treated Information 

A conservative assumption that 100 percent of the commodities in the assessment were treated 

(100% CT) was used in both the acute and steady-state dietary exposure assessments. This 

assumption is reflected in the “TotalZ=0” parameter setting in the residue distribution files. 

IV. Drinking Water Data 

The Environmental Fate and Effects Divison had provided HED with estimated residues of 

pirimiphos-methyl in drinking water based on planting pirimiphos-methyl-treated corn and 

sorghum grain and subsequent transport of residues to drinking water (D431010, G. Rothman, 1 

February 2016). The environmental loading from the use of pirimiphos-methyl-impregnated ear 

tags was also considered, and was determined to have a negligible contribution relative to that 

estimated from the planting of treated grain. Estimated drinking water concentrations (EDWCs) 

modeled from that scenario were <0.01 ppb for both acute and chronic scenarios (Table 1, 

expressed in ppm). Unlike other organophosphate dietary assessments recently completed by 

OPP, this assessment does not use a 21-day rolling average for water). 

Table 1. Summary of Estimated Surface Water and Groundwater Concentrations for Pirimiphos-methyl 

(Total Toxic Residues). D431010, G. Rothman, 1 February 2016

Scenario Surface Water Conc., ppma Groundwater Conc., ppmb

Acute <0.00001 <0.00001 

Chronic (non-cancer) <0.00001 <0.00001 a

 Upper-bound EDWCs in surface water calculated from FIRST model (see memo DP Barcode 328151, Dated 

Feb. 22, 2007 for exact results). 2

 Upper-bound EDWCs in ground water based on PRZM-GW FL Citrus scenario.

V. DEEM-FCID Program and Consumption Information

Acute and steady-state average dietary exposure assessments were conducted for pirimiphosmethyl 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. 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 5 of 16 

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 

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

Pirimiphos-methyl is a member of the organophosphate (OP) class of pesticides. Like other OPs, 

the initiating event in the adverse outcome pathway (AOP)/ mode of action (MOA), for 

pirimiphos-methyl involves inhibition of the enzyme acetylcholinesterase (AChE) via 

phosphorylation of the serine residue at the active site of the enzyme. Formation of an oxon 

metabolite is not an issue of concern for pirimiphos-methyl. None of the guideline 

developmental and reproduction toxicity studies for pirimiphos-methyl demonstrated quantitative 

and/or qualitative susceptibility. In the acute CCA study, pups were more sensitive to RBC and 

brain AChE inhibition compared to adults. However, RBC and brain AChE inhibition was 

comparable in adults and pups after repeated exposure. The available data for pirimiphos-methyl 

do not allow a comparative AChE evaluation of pregnant dams and fetuses due to the absence of 

the gestational component in the CCA studies. 

Epidemiology studies consistently identified associations with neurodevelopmental outcomes 

associated with OP exposure such as delays in mental development in infants (24-36 months), 

attention problems and autism spectrum disorder in early childhood, and intelligence decrements 

in school age children. Therefore, there is a need to protect children from exposures that may 

cause these effects; this need prevents the agency from reducing or removing the statutory FQPA 

Safety Factor. Thus, the FQPA 10X Safety Factor will be retained for pirimiphos-methyl for the 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

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population subgroups that include infants, children, youths, and women of childbearing age for 

all exposure scenarios. The FQPA 10X Safety Factor also accounts for the lack of gestational 

data for pirimiphos-methyl. Endpoints and points of departure for assessing dietary risk from 

pirimiphos-methyl are summarized in Table 2. 

Table 2. Summary of Toxicological Doses and Endpoints and Points of Departure for Pirimiphos-methyl in Dietary 

and Non-Occupational Human Health Risk Assessments 

Exposure 

Scenario 

Point of Departure 

(mg/kg/day) 

Uncertainty/FQP

A Factors 

RFD, PAD 

Level of Concern for 

Risk Assessment 

Study and Toxicological 

Effects 

Acute Dietary 

(all populations, 

except adults 

(50-99 years) 

BMDL10 = 6.07 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 10x a

Total 1000 

Acute RfD=0.006 

mg/kg/day 

Acute PAD= 0.006 

mg/kg/day 

Acute CCA Study (MRID 

49037404) in the rat 

BMD10 = 7.06 mg/kg/day 

Inhibition of RBC AChE 

in pups on PND 12. 

Acute Dietary 

(adults (50-99 

years) 

BMDL10 = 6.07 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Total 100 

Acute RfD= 0.06 

mg/kg/day 

Acute PAD= 0.06 

mg/kg/day 

Acute CCA Study (MRID 

49037404) in the rat 

BMD10 = 7.06 mg/kg/day 

Inhibition of RBC AChE 

in pups on PND 12. 

Steady-State 

Dietary 

(all populations, 

except adults 

(50-99 years) 

BMDL10 = 0.73 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 

(UFDB)= 10x a

Total=1000X 

Steady State 

RfD=0.00073 

mg/kg/day 

Steady State PAD = 

0.00073 mg/kg/day 

Repeat CCA Study 

(MRID 49037406) in the 

rat 

BMD10 = 1.01mg/kg/day 

Inhibition of RBC AChE 

in pups on PND 21 

Steady-State 

Dietary 

(adults (50-99 

years) 

BMDL10 = 0.73 

mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Total 100 

Steady State RfD = 

0.0073 mg/kg/day 

Steady State PAD = 

0.0073 mg/kg/day 

Repeat CCA Study 

(MRID 49037406) in the 

rat 

BMD10 = 1.01mg/kg/day 

Inhibition of RBC AChE 

in pups on PND 21 

Cancer (oral, 

dermal, 

inhalation) 

Classification: "Not likely to be carcinogenic to humans.” 

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. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = 

uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). UFDB= Database Uncertainty Factor. FQPA SF = 

FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. RfC = 

reference concentration. MOE = margin of exposure. LOC = level of concern. N/A = not applicable. a database 

uncertainty factor for uncertainty in the human dose-response relationship for neurodevelopmental effects. 

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. See the Appendices for a full listing of results for 

acute and steady state exposures. 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

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Acute 

The results of the acute dietary (food+water) assessment for pirimiphos-methyl are summarized 

in Table 3. Risk estimates are below 100% of the aPAD for all population groups and are not of 

concern. 

Table 3. Summary of Acute Dietary (Food+Water) Exposure and Risk for Pirimiphos-methyl 

Population Subgroup Acute PAD 

(mg/kg/day) 

95th Percentile 99th Percentile 99.9th Percentile 

Exposure 

(mg/kg/day)

% 

aPAD 

Exposure 

(mg/kg/day)

% 

aPAD 

Exposure 

(mg/kg/day) % aPAD

General U.S. Population 0.006 0.000004 <1 0.000007 <1 0.000074 1.2 

All Infants (<1 year old) 0.006 0.000008 <1 0.000012 <1 0.000093 1.5 

Children 1-2 years old 0.006 0.000007 <1 0.000014 <1 0.000193 3.2 

Children 3-5 years old 0.006 0.000006 <1 0.000014 <1 0.000216 3.6 

Children 6-12 years old 0.006 0.000005 <1 0.000010 <1 0.000174 2.9

Youth 13-19 years old 0.006 0.000004 <1 0.000007 <1 0.000075 1.2 

Adults 20-49 years old 0.006 0.000003 <1 0.000005 <1 0.000055 <1 

Adults 50-99 years old 0.06 0.000002 <1 0.000004 <1 0.000040 <1 

Females 13-49 years old 0.006 0.000003 <1 0.000005 <1 0.000057 <1 

The highest exposure at the 99.9th percentile is in bold. 

Steady State 

The results of the steady-state dietary (food+water) assessment for pirimiphos-methyl are 

summarized in Table 4. Risk estimates are below 100% of the ssPAD for all population groups 

and are not of concern. 

Table 4. Summary of Steady-State Dietary (Food+Water) Exposure and Risk for Pirimiphos-methyl 

Population Subgroup 

Steady-State 

PAD 

(mg/kg/day) 

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 0.00073 0.000004 <1 0.000008 <1 0.000089 12 

All Infants (<1 year old) 0.00073 0.000008 <1 0.000012 1.5 0.000106 14 

Children 1-2 years old 0.00073 0.000006 <1 0.000017 2.2 0.000241 33 

Children 3-5 years old 0.00073 0.000006 <1 0.000020 2.7 0.000295 40 

Children 6-12 years old 0.00073 0.000005 <1 0.000015 2.0 0.000223 31

Youth 13-19 years old 0.00073 0.000003 <1 0.000008 1.0 0.000103 14 

Adults 20-49 years old 0.00073 0.000003 <1 0.000006 <1 0.000070 9.6 

Adults 50-99 years old 0.0073 0.000002 <1 0.000004 <1 0.000046 <1 

Females 13-49 years old 0.00073 0.000002 <1 0.000005 <1 0.000074 10 

The highest exposure at the 99.9th percentile is in bold. 

VIII. Characterization of Inputs/Outputs

Both the acute and steady-state assessments are considered to be refined, with the majority of the 

residue inputs being from PDP monitoring data. Some conservatism is retained in the assumption 

of 100% crop treated for all commodities. 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 8 of 16 

IX. Conclusions 

Refined estimates of dietary exposure to the residues of concern for pirimiphos-methyl are not of 

concern. Evaluation of aggregate exposure will be conducted in the forthcoming human health 

aggregate risk assessment. 

X. List of Attachments 

Attachment 1. DEEM-FCID Residue Input File

Attachment 2. DEEM-FCID Acute Exposure Estimates 

Attachment 3. DEEM-FCID Steady State Exposure Estimates 

Attachment 4. RDF Files 

Attachment 5. DEEM-FCID Residue Input File – Food Only 

Attachment 6. DEEM-FCID Acute Exposure Estimates – Food Only 

Attachment 7. DEEM-FCID Steady State Exposure Estimates – Food Only 

 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 9 of 16 

Attachment 1. DEEM-FCID Acute and Steady-State Residue Input File. 

OPP Health Effects Division Ver. 3.16, 03-08-d 

DEEM-FCID Acute analysis for PIRIMIPHOS-METHYL 

Residue file name: C:\Users\Mike\EPA OneDrive\OneDrive for Business\Chemistry Reviews\!DEEM Runs\Pirimiphosmethyl\108102 Pirim Me wRFDs 2015 water.R08 

Analysis Date 01-11-2016 Residue file dated: 01-11-2016/13:08:58 

Reference dose (aRfD) = 0.0073 mg/kg bw/day 

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

RDL indices and parameters for Monte Carlo Analysis: 

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

 # Code 

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

 1 6 Beef_Fat.rdf 

 2 6 Beef_Liver.rdf 

 3 6 Corn_Grain.rdf 

 4 6 Corn_Syrup.rdf 

 5 6 Catfish.rdf 

 EPA Crop Food Name Def Res Adj.Factors RDL Comment 

 Code Grp (ppm) #1 #2 Pntr 

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

3100046000 31 Beef, meat byproducts 0.000500 1.000 1.000 2 

3100046001 31 Beef, meat byproducts-babyfood 0.000500 1.000 1.000 2 

3100047000 31 Beef, fat 0.000500 1.300 1.000 1 Fact. 1 for des-ethyl metab. 

3100047001 31 Beef, fat-babyfood 0.000500 1.300 1.000 1 Fact. 1 for des-ethyl metab. 

3100048000 31 Beef, kidney 0.000500 1.000 1.000 2 

3100049000 31 Beef, liver 0.000500 1.000 1.000 2 

3100049001 31 Beef, liver-babyfood 0.000500 1.000 1.000 2 

4000096000 40 Chicken, fat 0.000261 1.007 1.000 Fact. 1 for des-ethyl metab. 

4000096001 40 Chicken, fat-babyfood 0.000261 1.007 1.000 Fact. 1 for des-ethyl metab. 

4000097000 40 Chicken, skin 0.000261 1.007 1.000 

4000097001 40 Chicken, skin-babyfood 0.000261 1.007 1.000 

1500120000 15 Corn, field, flour 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500120001 15 Corn, field, flour-babyfood 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500121000 15 Corn, field, meal 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500121001 15 Corn, field, meal-babyfood 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500122000 15 Corn, field, bran 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500123000 15 Corn, field, starch 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500123001 15 Corn, field, starch-babyfood 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500124000 15 Corn, field, syrup 0.000250 1.170 1.000 4 Fact. 1 for des-ethyl metab. 

1500124001 15 Corn, field, syrup-babyfood 0.000250 1.170 1.000 4 Fact. 1 for des-ethyl metab. 

1500125000 15 Corn, field, oil 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500125001 15 Corn, field, oil-babyfood 0.001499 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

1500126000 15 Corn, pop 0.045000 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

8000158000 80 Fish-freshwater finfish, farm ra 0.000500 1.000 1.000 5 

3200170000 32 Goat, meat byproducts 0.000500 1.000 1.000 2 

3200171000 32 Goat, fat 0.000500 1.300 1.000 1 Fact. 1 for des-ethyl metab. 

3200172000 32 Goat, kidney 0.000500 1.000 1.000 2 

3200173000 32 Goat, liver 0.000500 1.000 1.000 2 

6000304000 60 Poultry, other, fat 0.000261 1.007 1.000 Fact. 1 for des-ethyl metab. 

6000305000 60 Poultry, other, skin 0.000261 1.007 1.000 

3500340000 35 Sheep, meat byproducts 0.000500 1.000 1.000 2 

3500341000 35 Sheep, fat 0.000500 1.300 1.000 1 Fact. 1 for des-ethyl metab. 

3500341001 35 Sheep, fat-babyfood 0.000500 1.300 1.000 1 Fact. 1 for des-ethyl metab. 

3500342000 35 Sheep, kidney 0.000500 1.000 1.000 2 

3500343000 35 Sheep, liver 0.000500 1.000 1.000 2 

1500344000 15 Sorghum, grain 0.045000 1.170 1.000 3 Fact. 1 for des-ethyl metab. 

5000385000 50 Turkey, fat 0.000261 1.007 1.000 Fact. 1 for des-ethyl metab. 

5000385001 50 Turkey, fat-babyfood 0.000261 1.007 1.000 Fact. 1 for des-ethyl metab. 

5000386000 50 Turkey, skin 0.000261 1.007 1.000 

5000386001 50 Turkey, skin-babyfood 0.000261 1.007 1.000 

8601000000 86A Water, direct, all sources 0.000010 1.000 1.000 

8602000000 86B Water, indirect, all sources 0.000010 1.000 1.000 

 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 10 of 16 

Attachment 2. DEEM-FCID Acute Exposure Estimates 

OPP Health Effects Division Ver. 3.16, 03-08-d 

DEEM-FCID ACUTE Analysis for PIRIMIPHOS-METHYL NHANES 2003-2008 2-Day 

Residue file: 108102 Pirim Me wRFDs 2015 water.R08 

Adjustment factor #2 NOT used. 

Analysis Date: 01-11-2016/13:40:45 Residue file dated: 01-11-2016/13:08:58 

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports 

RAC/FF intake summed over 24 hours 

MC iterations = 2000; MC list in residue file; MC seed = 75; RNG = MS VB 

Run Comment: "" 

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

Summary calculations--per capita: 

 95th Percentile 99th Percentile 99.9th Percentile 

 Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

Total US Population: 

 0.000004 0.01 0.000007 0.01 0.000074 0.12 

All Infants: 

 0.000008 0.14 0.000012 0.21 0.000093 1.55 

Children 1-2: 

 0.000007 0.12 0.000014 0.23 0.000193 3.22 

Children 3-5: 

 0.000006 0.11 0.000014 0.23 0.000216 3.60 

Children 6-12: 

 0.000005 0.08 0.000010 0.17 0.000174 2.89 

Youth 13-19: 

 0.000004 0.06 0.000007 0.11 0.000075 1.25 

Adults 20-49: 

 0.000003 0.05 0.000005 0.09 0.000055 0.92 

Adults 50-99: 

 0.000002 0.00 0.000004 0.01 0.000040 0.07 

Female 13-49: 

 0.000003 0.05 0.000005 0.08 0.000057 0.94 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 11 of 16 

Attachment 3. DEEM-FCID Steady State Exposure Estimates. 

OPP Health Effects Division Ver. 3.16, 03-08-d 

DEEM-FCID ACUTE Analysis for PIRIMIPHOS-METHYL NHANES 2003-2008 2-Day 

Residue file: 108102 Pirim Me wRFDs 2015 water.R08 

Adjustment factor #2 NOT used. 

Analysis Date: 01-11-2016/13:48:27 Residue file dated: 01-11-2016/13:08:58 

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 = 75; RNG = MS VB 

Run Comment: "" 

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

Summary calculations--per capita: 

 95th Percentile 99th Percentile 99.9th Percentile 

 Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

Total US Population: 

 0.000004 0.05 0.000008 0.10 0.000089 1.22 

All Infants: 

 0.000008 1.04 0.000012 1.60 0.000106 14.47 

Children 1-2: 

 0.000006 0.88 0.000017 2.32 0.000241 33.07 

Children 3-5: 

 0.000006 0.81 0.000020 2.75 0.000295 40.44 

Children 6-12: 

 0.000005 0.63 0.000015 2.02 0.000223 30.53 

Youth 13-19: 

 0.000003 0.45 0.000008 1.04 0.000103 14.12 

Adults 20-49: 

 0.000003 0.39 0.000006 0.77 0.000070 9.57 

Adults 50-99: 

 0.000002 0.03 0.000004 0.06 0.000046 0.63 

Female 13-49: 

 0.000003 0.36 0.000005 0.73 0.000074 10.07 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 12 of 16 

Attachment 4. RDF Files. 

Beef Fat (RDF 1) 

'Pirimiphos_Methyl, Created by SAS Program: CreateRDF_031714, 04JUN14 

'Subdirectory: G:\USDA_PDP\SAS\Chemicals\Pirimiphos, RDF Filename=Beef_Fat.rdf 

'Residue=CONCEN, RPF=RPF, Brigetable=BT_Recent, PFactor=PF1, PCT=PCT_Max, LOD Rule=LOD1 

'PDP Data: BAFZ (2001,2002), Total Samples=592, Total Detects=0, Total LODs=592, Total Zeros=0 

'MaxPCT=1.000, Avg Residue (Detects)=., Avg Residue (TOTALS)=0.0010, 

'Avg Residue (Blended, PCT=100)=0.001000, Avg HLOD (NonDetects)=0.0010 

TOTALZ=0 

TOTALLOD=592 

LODRES=0.0010 

Beef Liver (RDF 2) 

'Pirimiphos_Methyl, Created by SAS Program: CreateRDF_031714, 04JUN14 

'Subdirectory: G:\USDA_PDP\SAS\Chemicals\Pirimiphos, RDF Filename=Beef_Liver.rdf 

'Residue=CONCEN, RPF=RPF, Brigetable=BT_Recent, PFactor=PF1, PCT=PCT_Max, LOD Rule=LOD1 

'PDP Data: BLFZ (2001,2002), Total Samples=624, Total Detects=0, Total LODs=624, Total Zeros=0 

'MaxPCT=1.000, Avg Residue (Detects)=., Avg Residue (TOTALS)=0.0010, 

'Avg Residue (Blended, PCT=100)=0.001000, Avg HLOD (NonDetects)=0.0010 

TOTALZ=0 

TOTALLOD=624 

LODRES=0.0010 

Corn Grain (RDF 3) 

'Pirimiphos_Methyl, Created by SAS Program: CreateRDF_031714, 04JUN14 

'Subdirectory: G:\USDA_PDP\SAS\Chemicals\Pirimiphos, RDF Filename=Corn_Grain.rdf 

'Residue=CONCEN, RPF=RPF, Brigetable=BT_Recent, PFactor=PF1, PCT=PCT_Max, LOD Rule=LOD1 

'PDP Data: COGR (2007,2008), Total Samples=722, Total Detects=20, Total LODs=702, Total Zeros=0 

'MaxPCT=1.000, Avg Residue (Detects)=0.045350, Avg Residue (TOTALS)=0.0017, 

'Avg Residue (Blended, PCT=100)=0.001742, Avg HLOD (NonDetects)=0.0005 

TOTALZ=0 

TOTALLOD=702 

LODRES=0.0005 

0.634 

0.075 

0.049 

0.046 

0.045 

0.008 

0.007 

0.007 

0.006 

0.005 

0.005 

0.003 

0.003 

0.002 

0.002 

0.002 

0.002 

0.002 

0.002 

0.002 

Corn Syrup (RDF 4) 

'Pirimiphos_Methyl, Created by SAS Program: CreateRDF_031714, 04JUN14 

'Subdirectory: G:\USDA_PDP\SAS\Chemicals\Pirimiphos, RDF Filename=Corn_Syrup.rdf 

'Residue=CONCEN, RPF=RPF, Brigetable=BT_Recent, PFactor=PF1, PCT=PCT_Max, LOD Rule=LOD1 

'PDP Data: CYOT (1998,1999), Total Samples=408, Total Detects=0, Total LODs=408, Total Zeros=0 

'MaxPCT=1.000, Avg Residue (Detects)=., Avg Residue (TOTALS)=0.0005, 

'Avg Residue (Blended, PCT=100)=0.000500, Avg HLOD (NonDetects)=0.0005 

TOTALZ=0 

TOTALLOD=408 

LODRES=0.0005 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 13 of 16 

Catfish (RDF 5) 

'Pirimiphos_Methyl, Created by SAS Program: CreateRDF_031714, 04JUN14 

'Subdirectory: G:\USDA_PDP\SAS\Chemicals\Pirimiphos, RDF Filename=Catfish.rdf 

'Residue=CONCEN, RPF=RPF, Brigetable=BT_Recent, PFactor=PF1, PCT=PCT_Max, LOD Rule=LOD1 

'PDP Data: FCFR,FCFZ (2008,2009,2010), Total Samples=1479, Total Detects=9, Total LODs=1470, 

'Total Zeros=0 

'MaxPCT=1.000, Avg Residue (Detects)=0.007833, Avg Residue (TOTALS)=0.0010, 

'Avg Residue (Blended, PCT=100)=0.001043, Avg HLOD (NonDetects)=0.0010 

TOTALZ=0 

TOTALLOD=1470 

LODRES=0.0010 

0.0229 

0.0182 

0.0132 

0.004 

0.0032 

0.003 

0.0027 

0.0019 

0.0014 

 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 14 of 16 

Attachment 5. DEEM-FCID Residue Input File – Food Only 

Filename: 108102 Pirim Me wRFDs Food Only.R08 

Chemical: Pirimiphos-methyl 

RfD(Chronic): .00073 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day 

RfD(Acute): .006 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day 

Date created/last modified: 12-17-2015/14:16:28 Program ver. 3.16, 03-08-d 

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

RDL indices and parameters for Monte Carlo Analysis: 

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

 # Code 

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

 1 6 Beef_Fat.rdf 

 2 6 Beef_Liver.rdf 

 3 6 Corn_Grain.rdf 

 4 6 Corn_Syrup.rdf 

 5 6 Catfish.rdf 

 EPA Crop Commodity Name Def Res Adj.Factors RDLComment 

 Code Grp (ppm) #1 #2 Pntr 

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

1500120000 15 Corn, field, flour 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500120001 15 Corn, field, flour-babyfood 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500121000 15 Corn, field, meal 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500121001 15 Corn, field, meal-babyfood 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500122000 15 Corn, field, bran 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500123000 15 Corn, field, starch 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500123001 15 Corn, field, starch-babyfood 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500124000 15 Corn, field, syrup 0.000250 1.170 1.000 4 Fact 1 for des-ethyl metab. 

1500124001 15 Corn, field, syrup-babyfood 0.000250 1.170 1.000 4 Fact 1 for des-ethyl metab. 

1500125000 15 Corn, field, oil 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500125001 15 Corn, field, oil-babyfood 0.001499 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500126000 15 Corn, pop 0.045000 1.170 1.000 3 Fact 1 for des-ethyl metab. 

1500344000 15 Sorghum, grain 0.045000 1.170 1.000 3 Fact 1 for des-ethyl metab. 

3100046000 31 Beef, meat byproducts 0.000500 1.000 1.000 2 

3100046001 31 Beef, meat byproducts-babyfood 0.000500 1.000 1.000 2 

3100047000 31 Beef, fat 0.000500 1.300 1.000 1 Fact 1 for des-ethyl metab. 

3100047001 31 Beef, fat-babyfood 0.000500 1.300 1.000 1 Fact 1 for des-ethyl metab. 

3100048000 31 Beef, kidney 0.000500 1.000 1.000 2 

3100049000 31 Beef, liver 0.000500 1.000 1.000 2 

3100049001 31 Beef, liver-babyfood 0.000500 1.000 1.000 2 

3200170000 32 Goat, meat byproducts 0.000500 1.000 1.000 2 

3200171000 32 Goat, fat 0.000500 1.300 1.000 1 Fact 1 for des-ethyl metab. 

3200172000 32 Goat, kidney 0.000500 1.000 1.000 2 

3200173000 32 Goat, liver 0.000500 1.000 1.000 2 

3500340000 35 Sheep, meat byproducts 0.000500 1.000 1.000 2 

3500341000 35 Sheep, fat 0.000500 1.300 1.000 1 Fact 1 for des-ethyl metab. 

3500341001 35 Sheep, fat-babyfood 0.000500 1.300 1.000 1 Fact 1 for des-ethyl metab. 

3500342000 35 Sheep, kidney 0.000500 1.000 1.000 2 

3500343000 35 Sheep, liver 0.000500 1.000 1.000 2 

4000096000 40 Chicken, fat 0.000261 1.007 1.000 Fact 1 for des-ethyl metab. 

4000096001 40 Chicken, fat-babyfood 0.000261 1.007 1.000 Fact 1 for des-ethyl metab. 

4000097000 40 Chicken, skin 0.000261 1.007 1.000 

4000097001 40 Chicken, skin-babyfood 0.000261 1.007 1.000 

5000385000 50 Turkey, fat 0.000261 1.007 1.000 Fact 1 for des-ethyl metab. 

5000385001 50 Turkey, fat-babyfood 0.000261 1.007 1.000 Fact 1 for des-ethyl metab. 

5000386000 50 Turkey, skin 0.000261 1.007 1.000 

5000386001 50 Turkey, skin-babyfood 0.000261 1.007 1.000 

6000304000 60 Poultry, other, fat 0.000261 1.007 1.000 Fact 1 for des-ethyl metab. 

6000305000 60 Poultry, other, skin 0.000261 1.007 1.000 

8000158000 80 Fish-freshwater finfish, farm ra 0.000500 1.000 1.000 5 

 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 15 of 16 

Attachment 6. DEEM-FCID Acute Exposure Estimates – Food Only 

OPP Health Effects Division Ver. 3.16, 03-08-d 

DEEM-FCID ACUTE Analysis for PIRIMIPHOS-METHYL NHANES 2003-2008 2-Day 

Residue file: 108102 Pirim Me wRFDs Food Only.R08 Adjustment factor #2 NOT used. 

Analysis Date: 12-17-2015/15:57:47 Residue file dated: 12-17-2015/14:15:39 

Acute Pop Adjusted Dose (aPAD) varies with population; see individual reports 

RAC/FF intake summed over 24 hours 

MC iterations = 2000; MC list in residue file; MC seed = 75; RNG = MS VB 

Run Comment: "" 

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

Summary calculations--per capita: 

 95th Percentile 99th Percentile 99.9th Percentile 

 Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

Total US Population: 

 0.000003 0.01 0.000007 0.01 0.000073 0.12 

All Infants: 

 0.000008 0.13 0.000012 0.20 0.000095 1.58 

Children 1-2: 

 0.000006 0.11 0.000014 0.23 0.000204 3.40 

Children 3-5: 

 0.000006 0.10 0.000013 0.22 0.000231 3.85 

Children 6-12: 

 0.000005 0.08 0.000010 0.17 0.000164 2.73 

Youth 13-19: 

 0.000003 0.06 0.000006 0.11 0.000074 1.23 

Adults 20-49: 

 0.000003 0.00 0.000005 0.01 0.000055 0.09 

Adults 50-99: 

 0.000002 0.00 0.000004 0.01 0.000040 0.07 

Female 13-49: 

 0.000003 0.04 0.000005 0.08 0.000055 0.92 

 

 
Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461 

Page 16 of 16 

Attachment 7. DEEM-FCID Steady State Exposure Estimates – Food Only 

OPP Health Effects Division Ver. 3.16, 03-08-d 

DEEM-FCID ACUTE Analysis for PIRIMIPHOS-METHYL NHANES 2003-2008 2-Day 

Residue file: 108102 Pirim Me wRFDs Food Only.R08 Adjustment factor #2 NOT used. 

Analysis Date: 12-17-2015/16:14:48 Residue file dated: 12-17-2015/14:15:39 

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 = 75; RNG = MS VB 

Run Comment: "" 

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

Summary calculations--per capita: 

 95th Percentile 99th Percentile 99.9th Percentile 

 Exposure % aPAD Exposure % aPAD Exposure % aPAD 

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

Total US Population: 

 0.000003 0.05 0.000007 0.10 0.000086 1.17 

All Infants: 

 0.000007 0.97 0.000011 1.53 0.000109 14.90 

Children 1-2: 

 0.000006 0.81 0.000016 2.22 0.000240 32.83 

Children 3-5: 

 0.000006 0.77 0.000020 2.71 0.000285 39.07 

Children 6-12: 

 0.000004 0.60 0.000014 1.97 0.000213 29.13 

Youth 13-19: 

 0.000003 0.43 0.000007 1.02 0.000096 13.21 

Adults 20-49: 

 0.000003 0.04 0.000005 0.07 0.000069 0.95 

Adults 50-99: 

 0.000002 0.02 0.000004 0.05 0.000044 0.61 

Female 13-49: 

 0.000002 0.34 0.000005 0.69 0.000073 9.99