### 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 Assessment Branch II

# U~ Health Effects Division (HED ; 7509P)

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-E v aluation 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 16Pirimiphos-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 Registra tion Review of pirimiphos-methyl. The analyses were reviewed by the DESAC on 10 December 2015.

Both the acute and steady-state dietary assessme nts 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 refl ect 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-tril lion arising from the planting of treated corn grain.

Probabilistic analyses resulted in acute dietary (food + drinking wa ter) 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 99.9 th 

### 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 ex posed 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 f ood + drinking water at the 99.9 th 

### 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 av ailable studies; therefore, cancer risk is not an issue for this active ingredient.

I. Introduction

Dietary risk assessment incorpor ates both exposure and toxicity of a given pesticide. For the acute and steady-state assessmen ts, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose that HED has conc luded will result in no unreasonable adverse health effects). This dose is referred to as th e PAD. The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required unc ertainty 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/#!docum entDetail;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 es timate 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 fo r pirimiphos-methyl was conducted in 2007 (D332652, A. Parmar, 25 December 2007).

II. Food Residue Information

The existing residue chemistry database for pi rimiphos-methyl is adequate for risk assessment purposes. Pirimiphos-methyl is registered for post- harvest treatment of st ored 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 pirimi phos-methyl in corn, sorghum, and livestock has been adequately identified/characterized a nd is understood. The HED Metabolism Assessment Review Committee determined that pirimiphos-m ethyl and is des-ethyl metabolite are the compounds of toxicological concern in crops an d livestock tissues (D228695, J. Stokes, 15 May 1998).

b. Tolerances

Permanent tolerances are established for th e 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 cat tle, goats, hogs, horses, sheep, and poultry (fat only) at 0.02 ppm.

c. Residues in Fish

The USDA’s Pesticide Data Program (PDP) mon itored pesticide residues in catfish in 2008, 2009, and 2010 and in salmon in 2013. In general, pes ticide 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 fis h, HED now routinely checks PDP monitoring data regardless of the pesticide’s uses and physicochemical pr operties. 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 assessme nts used data from the USDA’s Pesticide Data Program (PDP) for beef fat (extra polated to all mammalian fat), beef liver (extrapolated to all mammalian organ meats), catfish (ext rapolated to all farm-raised fr eshwater finfish), corn grain (extrapolated to popcorn and sorghum after re moving all non-detect values; i.e., 100% crop treated), and corn syrup. For poultry fat, these an alyses 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 de rived 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

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### and in poultry fat the maximum was 1/150 (f actor = 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 th e commodities in the assessment were treated (100% CT) was used in both th e acute and steady-state dietar y exposure assessments. This assumption is reflected in the “TotalZ=0” parame ter setting in the resi due distribution files.

IV. Drinking Water Data

The Environmental Fate and Effects Divison ha d 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 resi dues 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. Es timated drinking water concentrations (EDWCs) modeled from that scenario were <0.01 ppb fo r both acute and chroni c scenarios (Table 1, expressed in ppm). Unlike othe r 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., ppm a Groundwater Conc., ppm b

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 in corporates 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., a pples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using p ublicly available recipe translation files developed jointly by USDA /ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. populati on and within population subgroups. However, for acute exposure assessment, consumption data ar e retained as individual consumption events. Based on analysis of the 2003-2008 WWEIA consump tion 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. popul ation, 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

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### For an acute exposure assessment, individual one -day food consumption data are used on an individual-by-individual basis. The reported consumption am ounts 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 reporte d eating the relevant commodities as well as those who did not) basi s. In accordance with HED policy, per capita exposure and risk are reported for analyses perfor med at all levels of refinement. However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and not ed in the risk assessment.

For a steady-state exposure assessment, two-day av erage 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 i ndividual 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 co nsumption amount can then be multiplied by a residue point estimate and summed to obtain a to tal daily pesticide expos ure for a deterministic exposure assessment, or “matched” in multiple ra ndom pairings with residue values and then summed in a probabilistic assessment. The resulti ng distribution of exposur es 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 re ported eating the relevant commodities as well as those who did not) basi s. In accordance with HED policy, per capita exposure and risk are reported for analyses perfor med at all levels of refinement. However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and not ed 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 th e enzyme acetylcholinesterase (AChE) via phosphorylation of the serine resi due at the active si te of the enzyme. Formation of an oxon metabolite is not an issue of concern for pirimiphos-methyl. None of the guideline developmental and reproduction t oxicity studies for pirimiphos-met hyl 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 ex posure. The available data for pirimiphos-methyl do not allow a comparative AChE evaluation of pre gnant dams and fetuses due to the absence of the gestational component in the CCA studies.

Epidemiology studies consistently identified as sociations 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 agen cy from reducing or removing the statutory FQPA Safety Factor. Thus, the FQPA 10X Safety Factor will be retained for pirimiphos-methyl for thePirimiphos-methyl Dietary Exposure & Risk Assessment D430461

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### population subgroups that include infants, child ren, youths, and women of childbearing age for all exposure scenarios. The FQPA 10X Safety F actor also accounts for the lack of gestational data for pirimiphos-methyl. Endpoints and points of departure for assessi ng dietary risk from pirimiphos-methyl are summ arized 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) BMDL 10 = 6.07 mg/kg/day UF A = 10x UF H = 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 BMD 10 = 7.06 mg/kg/day

Inhibition of RBC AChE in pups on PND 12. Acute Dietary (adults (50-99 years) BMDL 10 = 6.07 mg/kg/day UF A = 10x UF H = 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 BMD 10 = 7.06 mg/kg/day

Inhibition of RBC AChE in pups on PND 12. Steady-State Dietary (all populations, except adults (50-99 years) BMDL 10 = 0.73 mg/kg/day UF A = 10x UF H = 10x FQPA SF = (UF DB )= 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 BMD 10 = 1.01mg/kg/day

Inhibition of RBC AChE in pups on PND 21 Steady-State Dietary (adults (50-99 years) BMDL 10 = 0.73 mg/kg/day UF A = 10x UF H = 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 BMD 10 = 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 poin t that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower en vironmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF DB= 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 asse ssments, 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 su bgroups. 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 dietar y (food+water) assessment for pi rimiphos-methyl are summarized in Table 3. Risk estimates are below 100% of th e 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) 95 th Percentile 99 th Percentile 99.9 th Percentile Exposure (mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD Exposure (mg/kg/day) % aPAD

General U.S. Population 0.006 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 99.9 th percentile is in bold.



### Steady State

The results of the steady-state dietary (f ood+water) assessment for pirimiphos-methyl are summarized in Table 4. Risk estimates are be low 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) 95 th Percentile 99 th Percentile 99.9 th Percentile

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

General U.S. Population 0.00073 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 99.9 th percentile is in bold.



### VIII. Characterization of Inputs/Outputs

Both the acute and steady-state assessments are cons idered 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

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### IX. Conclusions

Refined estimates of dietary exposure to the resi dues 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 Resi due Input File – Food Only Attachment 6. DEEM-FCID Acute Exposure Estimates – Food Only Attachment 7. DEEM-FCID Steady Stat e Exposure Estimates – Food OnlyPirimiphos-methyl Dietary Exposure & Risk Assessment D430461

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### 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-METHYLResidue 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 1.000Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461

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### 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 0.94Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461

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### 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 10.07Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461

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

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### 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 0.0014Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461

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### Attachment 5. DEEM-FCID Resi due 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 5Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461

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### 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 0.92Pirimiphos-methyl Dietary Exposure & Risk Assessment D430461

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### Attachment 7. DEEM-FCID Steady Stat e 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