## UNITED STATES ENVIRONMENT AL PROTE C TION AGENCY WASHINGTON
, D.C. 20460

OFFICE OF C HE M I CAL SAFE TY AND POLLUT IO N PREV EN TIO N



## MEMORA N DUM

DA TE: 04-FEB-2016

SUBJECT: Tr icl opyr: Acute and Chron i c Aggregate Dietary (Food and Drinking Wate r ) Exposure and Risk Assessment fo r the Propo sed Cha nge s to th e Tolerances for R es idues in / on Livestock Commodities.

P C Co d es: I 16 00 I
, I 16002
, I 16004 D ec i s i o n No

. : 488478

P etitio n No s.: 4F8249 and 4F8279 Ri s k Assess m e n t Type: Dietary TXR No.: 

### NA MRID No.: 

### NA OP 

### No.: 0426072 R egis tr at ion Nos.: 62719-37
, 62719-53
, 62719

- 87
, 62719-552
, 62719-637 Regu l a tor y Action: Section 

### 3 Case No.: 2710 CAS Nos.: 55335-06-3
, 5 72 13-69-1
, 64700-56

- 7 40 

### CF R : § 1 80.417



## REV I EWER : J ennifer R. Tyler
, Che mi st

# C~~**~r--­** Risk Assessment Br anch l (RAB I )



## THROUGH:

TO:

Exe cutive S umm ary Health Effects Division (HE D
, 7509P)

Julie 

## L. Van Alstine, MP H
, Envjronmental Health Sc i e nti st 

# -Y AA-.A---- Seyed Tadayon
,**Chemist ~~** **--.....** 

## Dietary Exposure Science xcfv i sory Counc il (DESAC)!HE D (7 509P )

And

George F. Kramer, Ph.D.
, Branch Se ni o r

# ~~ RAB 1 / HE D (7509P)
Mindy Ondish, Risk Reviewer Reuben Baris, Product Manager 25 Herbicide Branch ( HB ) Registration D iv i sion (RD
, 7505 P )

Acute a nd chronic dietary exposure and risk assessments we r e conducted for the ge neral U.S. populat i o n a nd various population s ubgroup s using the Dietary Expos ur e Evaluation Model softwa r e with the Food Commodity Intake Databa se ( DEEM-FCJD ) Versio n 3.16. This software

uses 2003

- 2008 food consumptio n data from the U.S. Department of Agr i culture's (US D A ' s) Nationa l H ea l th and Nutr i tion Examination Survey
, What We E a t in America, (NHANES / WW E IA). The ana l yses we r e perform e d to s upport a pet i t i on to remove the grazi n g P age I of 1 5

### Triclopyr Dietary Exposure and Risk Assessment DP# 426072

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Page 2 of 15 

## restriction for lactating dairy cattle, and to amend tolerances of triclopyr on milk and livestock commodities. This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

Acute Diet ary Exposure Results and Characterization
An acute analysis was performed using DEEM

- FCID estimating the dietary exposure of the general U.S. population and various population subgroups. The acute assessment was unrefined, assuming that triclopyr residue s are present in all commodities at tolerance levels and that 100% of all crops are treated (100% CT). DEEM Version 7.81 default processing factors were used to estimate residues in all processed commodities. Drinking water was incorporated directly into the dietary assess ment

.
For females 13

- 49 years old, the resulting acute dietary (food and drinking water) risk estimate is not of concern to HED (<100% acute population

- adjusted dose (aPAD) ) at the 95 th 

## percentile of the exposure distribution (53 % of the aPAD). For the general U.S. population and all other population subgroups, the resulting acute dietary ( food and drinking water ) risk estimates are not of concern to HED (< 100% aPAD) at the 95 th 

## percentile of the exposure distribution. The most highl y exposed population subgroup i s all infants (<1 year old) at 8 % of the aPAD. It should be noted that females 13

- 49 years old have a lower aPAD (0.05 mk/kg/day) than the general U.S. population and all other population subgroups (1.0 mg/kg/day). As a res ult, even though the exposure estimate for females 13

- 49 years old was lower than the exposure estimate for the general U.S. population, females 13

- 49 years old have the highest risk estimate.
Chronic Dietary Exposure Results and Characterization

A chro nic analysis was performed using DEEM

- FCID estimating the dietary exposure of the general U.S. population and various population s ubgroups . The chronic assessment was slightly refined, assuming that triclopyr residues are present in all commodities at tol erance levels except milk, and 100% CT for all crops. An anticipated residue (AR) was used for milk. The resulting chronic (food and drinking water) risk estimates are not of concern to HED (<100% chronic population

- adjusted dose (cPAD) ) for general U.S. population and all population subgroups. The most highly exposed population subgroup i s all infants <1 year old at 46% of the cPAD

.
Cancer Dietary Exposure Assessment
A cancer dietary assessment was not conducted because triclopyr is classified as a “G roup D Chemical

– unable to be classified as to human carcinogenicity.”

I. Introduction
Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic (non

- cancer) assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no

- unreasonable

- adverse

health

– effects, NOAEL). This dose is referred to as the PAD. The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL) divide d by the required uncertainty factors (UFs).
For acute and chronic (non

- cancer) exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD for acute and non

- cancer chronic assessment. References which

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## discuss the acute and chronic ri sk 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/contentStreamer?documentId=EPA

- HQ

- OPP

2007

- 0780

- 0001&disposition=attachment&contentType=pdf ; or see SOP 99.6 (20

- AUG

- 1999).
The most recent acute and chronic dietary exposure analyses (food only) w ere conducted by HED in 2002 ( Memo, W. Donovan, 16

- APR

- 2002; D275030 ).

II. Residue Information
Permanent tolerances are established for the combined residues of triclopyr per se , as a result of the application/use of but oxyethyl ester of triclopyr and triethylamine salt of triclopyr, in or on eggs; fish; grass forage and hay; milk; poultry fat, meat, and meat byproducts, except kidney; rice, grain and straw; and shellfish [40 CFR §180.417 (a)(1)]. In addition, permanent tolerances are established for residues of triclopyr acetic acid and its metabolite 3,5,6

- trichloro

- 2

- pyridinol ( TCP), as a result of the application/use of butoxyethyl ester of triclopyr and triethylamine salt of triclopyr, in or on the meat, fat, and mea t byproducts of cattle, goats, hogs, horses, and sheep [40 CFR §180.417 (a)(2)].
Residues of Concern in Plants and Livestock
The qualitative nature of the residue in rice, grass, fish, shellfish, and livestock is adequately understood based on the availa ble metabolism studies. The residues of concern are as follows (Memos, W. Smith, 15

- JUL

- 1996; W. Donovan, 27

- APR

- 2001, D274243): triclopyr per se in grass, rice, milk, poultry, and eggs; triclopyr and TCP in meat, meat byproducts
, and drinking water; and triclopyr, TCP, and 2

- methoxy

- 3,5,6

- trichloropyridine (TMP) in fish and shellfish. It should be noted that 40 CFR §180.417(a)(1) lists the tolerance expression for fish and shellfish as triclopyr per se

. 40 CFR §180.417 should be updated to include the recommended tolerance expression for fish and shellfish.

Recommended Tolerances
As part of the current petition, HED recommends establishing the following permanent tolerances:

Milk 1 

## 0.60 ppm Meat* 2 

## 0.10 ppm Fat* 2 

## 0.10 ppm Meat byproducts* 2 

## 0.50 ppm * of cattle, goat, hog, horse, and sheep.
1 40 CFR §180.417 (a)(1)
2 40 CFR §180.417 (a)(2) 

## Food Residues and processing factors used in the Acute and Chronic Analysis
The acute analysi s assumed DEEM (ver. 7

. 81) default processing factors and toler a nce

- level residues for all commodities. The chronic analyses assumed DEEM (ver. 7.81) default processing factors for all commodities, and tolerance

- level residues for all commodities except milk. For milk, an anti cipated residue was calculated using residue s from the recently submitted livestock feeding study (MRID# 49741901) . In that study the a verage residue in milk was 0.084

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## ppm at the 1000

- ppm dose level [0.8x and maximum reasonable dietary burden (MRDB) of 12 55 ppm], which results in an aver age anticipated residue of 0.10 ppm when extrapolated to 1x.
III. Percent Crop Treated Information
The acute and chronic analyses assumed that 100% of the crops were treated

.
IV. Drinking Water Data

A revised drinking water assessment was not required since the proposed uses will not have an effect on the concentration of triclopyr in drinking water . EFED provided estimated drinking water concentrations (EDWCs) for triclopyr based on the registered aquatic use (Memos, L. Liu, 4

- JUN

- 2015, D419489; M. Mahoney, 17

- JUN

- 2002, D283715). T he estimated drinking water concentrations (EDWCs) of triclopyr for surface water are estimated to be 1,049 parts per billion (ppb) for acute (peak) exposures and 390 ppb for chroni c (annual average) exposures. EPA calculated and required setback distances from the application site to the functional potable water intake in order to maintain average drinking water concentration levels below 400 ppb. Furthermore, since potable water intakes are required to be turned off until triclopyr concentration levels are below 400 ppb, EPA has determined that for acute and chronic dietary risk assessments, the water concentration value of 400 ppb is appropriate to use to assess the contribution to drinking water.
It should be noted that EDWCs were not incorporated directly in the 2002 dietary exposure assessment, but HED calculated drinking water levels of comparison (DWLOCs), which is a theoretical upper limit on a pesticide’s concentration in drinking water in light of total aggregate exposure to a pesticide in food, drinking water, and through residential uses. In this assessment, the EDWC of 400 ppb was incorporated directly in the acute and chronic dietary exposure assessments.

V. DEEM

- FCID Program and Consumption Information
Triclopyr acute and chronic dietary exposure assessments were conducted using the DEEM

FCID, Version 3.16, which incorporates 2003

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

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

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

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

- cooked; fr esh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposu re assessment are retained as individual consumption events. Based on analysis of the 1994

- 96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the fol lowing population subgroups: the general U.S. population, all infants (<1 year old), children 1

- 2 years old, children 3

- 5 years old, children 6

- 12 years old, youth 13

- 19 years old, adults 20

- 49 years old, females 13

- 49 years old, and adults 50

- 99 years ol d.

For the chronic dietary exposure assessment, an estimate of the residue level in each food or food

- form ( i.e. , orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form. The resulting residue consumption

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## estimate for each food/food form is summed with the residue consumption estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure. Exposure is expressed in mg/ kg body weight/day and as a percent of the cPAD. This procedure is performed for each population subgroup.
For acute exposure assessments, individual one

- day food consumption data are used on an individual

- by

- individual basis. The reported consumption a mounts 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 probabil istic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user ( i.e. , 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 all levels (tiers) of analysis. However, for unrefined and partially refined assessments (Tiers 1 and 2), significant differences in user vs . per capita exposure and risk are identified and noted in the risk assessment.

V I . Toxicological Information
The toxicology endpoints and decisions made by the Hazard Identification Assessment Review Committee ( HIARC ) concerning dietary ex posure are summarized in Table 1

. Based on toxicological considerations (evaluated by HIARC) and the residue assumptions used in the dietary analyses (evaluated by the risk assessment team; RAB1/HED), it was concluded that the Food Quality Protection Act ( FQPA ) Safe ty Factor should be reduced to 1X when assessing dieta ry exposure to triclopyr

.
Table 1 . Summary of Toxicological Doses and Endpoints for Triclopyr for Use in Dietary Exposure Assessments. Exposure/ Scenario POD Uncertainty/FQP A Safety Factors RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects Acute Dietary (General Population including infants and children) NOAEL = 100 mg/kg/day UF A = 10X UF H = 10X FQPA SF = 1X aRfD = 1.0 mg/kg/day aPAD = 1.0 mg/kg/day Developmental Rat Toxicity Study with ester Maternal LOAEL = 300 mg/kg/day based on mortality, clinical signs, necropsy findings, decreased food and water consumption, and increased kidney and liver weights.
Acute Dietary (Females 13

- 50 years old) NOAEL = 5 mg/kg/day UF A = 10X UF H = 10X FQPA SF = 1X aRfD = 0.05 mg/kg/day aPAD = 0.05 mg/kg/day Two

- Generation Rat Reproduction Study with acid LOAEL = 25 mg/kg/day based on increased incidence of rare malformations (exencephaly and ablepharia).
Chronic Dietary (All Populations) NOAEL = 5 mg/kg/day UF A = 10X UF H = 10X FQPA SF = 1X cRfD = 0.05 mg/kg/day cPAD = 0.05 mg/kg/day Two

- Generation Rat Reproduction Study with acid LOAEL = 25 mg/kg/day based on degeneration of the proximal renal tubules. Cancer (oral, dermal, inhalation) Classified as a “Group D Chemical

– unable to be classified as to human carcinogenicity.”

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 det ermine risk associated with lower environmentally 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). FQPA SF = FQPA Safety Factor. PAD = population

adjusted dose (a = acute, c = chronic). RfD = reference dose.

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## VI I

. Results/Discussion
As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the aPAD or cPAD, respectively. The following paragraphs are summaries of the DEEM

- FCID (ver. 3.16 ) acute and chronic exposure analyses.
Acute Dietary Exposure Results

Ac ute aggregate ( food and drinking water ) analys i s w as performed using DEEM

- FCID estimating the dietary exposure of the general U.S. population and various population subgroups. The acute results are summarized in Table 2

. For females 13

- 49 years old, t he resulting acute ( food and drinking water ) risk estimates are not of concern to HED ( < 100% aPAD) at the 95 th 

## percentile of the exposure distribution ( 53 % of the aPAD ). For the general U.S. population and all other population subgroups, the resulting acute food and drinking water risk estimates are not of concern to HED (< 100% aPAD) at the 95 th 

## percentile of the exposure distribution. The most highly exposed population subgroup is all infants (<1 year old) at 8 % of the aPAD. It should be noted that females 13

- 49 year s old have a lower aPAD (0.05 mg /kg/day) than the general U.S. population and all other population subgroups (1.0 mg/kg/day). As a result, even though the exposure estimate for females 13

- 49 years old was lower than the exp osure estimate for the general U.S. population , females 13

- 49 years old have the highest risk estimate

. Chronic Dietary Exposure Results

A c hronic (food and drinking water) analysis was performed using DEEM

- FCID estimating the dietary exposure of the ge neral U.S. population and various population subgroups. The chronic

r esults are summarized in Table 2 . Th e resulting chronic ( food and drinking water ) risk estimates are not of concern to HED (<100% cPAD) for general U.S. population and all population subgroups

. T he most highly exposed population subgroup is all infants <1 year old at 46 % of the cPAD.

Table 2. Summary of Dietary Exposure and Risk for Triclopyr.*

Population Subgroup Acute Dietary (Food and Drinking Water) (95 th Percentile) Chronic Dietary (Food and Drinking Water) Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % aPAD General U.S. Population 0.033198 3.3 0.0 100 08 20 All Infants (<1 year old) 0.080077 8.0 0.023 278 4 6 Children 1

- 2 years old 0.075543 7.6 0.01 7810 3 6 Children 3

- 5 years old 0.050707 5.1 0.013 791 2 8 Children 6

- 12 years old 0.034563 3.5 0.009 6 12 19 Youth 13

- 19 years old 0.025114 2.5 0.0073 25 15 Adults 20

- 49 years old 0.026457 2.6 0.009 698 19 Adults 50

- 99 years old 0.024208 2.4 0.0095 80 19 Females 13

- 49 years old 0.026561 53 0.009 493 19 *Population subgroup with the highest exposure and risk is in bold type. The aPAD for females 13

- 49 years of age is 0.0 5 mg/kg/day; aPAD for general U.S. population and all other population subgroups is 1.0 mg/kg/day . The cPAD for general U.S. population and all population subgroups is 0.05 mg/kg/day.



## VII I

. Characterization of Inputs/Outputs

The acute and chronic dietary exposure and risk estimates are conservative since they assume that 100% of crops are treated with triclopyr and that residues are presen t at tolerance levels. Dietary exposure estimates could be refined through the use of anticipated residues and percent

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## crop treated data, as well as refined estimated drinking water concentratio ns

. I n order to provide a comparison for reference, the dietary results for the analysis of food exposures (only) are presented in attachments 5 and 6.

IX

. Conclusions
Unrefined acute aggregate (food and drinking water; food only; and drinking water only) analyses were performed using DEEM

- FCID estimating the dietary exposure of the general U.S. population and various population subgroups. For females 13

- 49 years old, the resulting acute (food and drinking water) risk estimates are not of concern to HED (< 100% aPAD) at the 95 th 

## percentile of the exposure distribution ( 53 % of the aPAD). For the general U.S. population and all other population subgroups, the resulting acute food and drinking water risk estimates are not of concern to HED (< 100% aPAD) at the 95 th 

## percentile of the exposure distribution. The most highly exposed population subgroup is all infants (<1 year old) at 8 % of the aPAD.
A slightly refined chronic aggregate (food and drinking water) analysis was performed using DEEM

- FCID estimating t he dietary exposure of the general U.S. population and various population subgroups. The resulting chronic (food and drinking water) risk estimates are not of concern to HED (<100% cPAD) for general U.S. population and all population subgroups. The most highly exposed population subgroup is all infants <1 year old at 46% of the cPAD

.
X. List of Attachments

Attachment 1: Acute (Food and Drinking Water ) Residue Input File Attachment 2: Acute Results (Food and Drinking Water) File Attachment 3: Chronic Food plus Water Residue Input File Attachment 4 : Chronic Results (Food plus Water) File Attachment 5: Acute Results (Food Only) File Attachment 6: Chronic Results (Food Only) File

cc: J. Tyler RDI: DE SAC Reviewers ( 25

- FEB

- 2015 ); G. Kramer ( 4

- FEB

- 2016 ) J. Tyler:S10943:PY

- S:(703)305

- 5564:7509P:RAB1

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## Attachment 1: DEEM

- FCID Acute Residue File

– Food and Drinking Wate r

Filename: C: \ Users \ jtyler \ Documents \ JenWork \ $Triclopyr \ Dairies and Choline Salt \ Dietary Assessment \ run with new tolerances \ 116000 116002 116004 acute.r08 Chemical: Triclopyr RfD(Chronic): .05 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 12

- 21

- 2015/10:31:11 Program ver . 3.16, 03

- 08

- d

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 3100047000 31 Beef, fat 0.100000 1.000 1.000 3100047001 31 Beef , fat

- babyfood 0.100000 1.000 1.000 3100048000 31 Beef, kidney 0.500000 1.000 1.000 3100049000 31 Beef, liver 0.500000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 0.500000 1.000 1.000 3100044000 31 Beef, meat 0.100000 1.000 1.000 3100046000 31 Beef, meat byproducts 0.500000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.500000 1.000 1 .000 3100045000 31 Beef, meat, dried 0.100000 1.920 1.000 3100044001 31 Beef, meat

- babyfood 0.100000 1.000 1.000 4000096000 40 Chicken, fat 0.100000 1.000 1.000 4000096001 40 Ch icken, fat

- babyfood 0.100000 1.000 1.000 4000094000 40 Chicken, liver 0.100000 1.000 1.000 4000093000 40 Chicken, meat 0.100000 1.000 1.000 4000095000 40 Chicken, meat byproducts 0.100000 1.000 1.000 4000095001 40 Chicken, meat byproducts

- babyfoo 0.100000 1.000 1.000 4000093001 40 Chicken, meat

- babyfood 0.100000 1.000 1.000 4000097000 40 Chicken, skin 0.100000 1.000 1.000 4000097001 40 Chicken, skin

- babyfood 0.100000 1.000 1.000 7000146000 70 Egg, white 0.050000 1.000 1.000 7000146001 70 Egg, white (solids)

- babyfood 0.050000 1.000 1.000 7000145000 70 Egg, whole 0.050000 1.000 1.000 7000145001 70 Egg, whole

- babyfood 0.050000 1.000 1.000 7000147000 70 Egg, yolk 0.050000 1.000 1.000 7000147001 70 Egg, yolk

- babyfood 0.050000 1.000 1.000 8000157000 80 Fish

- freshwater finfish 3.000000 1.000 1.000 8000158000 80 Fish

- freshwater finfish, farm ra 3.000000 1.000 1.000 8000160000 80 Fish

- saltwater finfish, other 3.000000 1.000 1.000 8000159000 80 Fish

- saltwater finfish, tuna 3.000000 1.000 1.000 8000161000 80 Fish

- shellfish, crustacean 3.500000 1.000 1.000 8000162000 80 Fish

- shel lfish, mollusc 3.500000 1.000 1.000 3200171000 32 Goat, fat 0.100000 1.000 1.000 3200172000 32 Goat, kidney 0.500000 1.000 1.000 3200173000 32 Goat, liver 0.500000 1.000 1.000 3200169000 32 Goat, meat 0.100000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.500000 1.000 1.000 3300189000 33 Horse, meat 0.100000 1.000 1.000 3600222000 36 Milk, fat 0.600000 1.000 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.600000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.600000 1.000 1.000 3600223001 36 Milk, n onfat solids

- baby food/in 0.600000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.600000 1.000 1.000 3600224000 36 Milk, water 0.600000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.600000 1.000 1.000 3400293000 34 Pork, fat 0.100000 1.000 1.000 3400293001 34 Pork, fat

- babyfood 0.100000 1.000 1.000 3400294000 34 Pork, kidney 0.500000 1.000 1.00 0 3400295000 34 Pork, liver 0.500000 1.000 1.000 3400290000 34 Pork, meat 0.100000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.500000 1.000 1.000 3400292001 34 Pork, meat byproducts

- babyfood 0.500000 1.000 1.000 3400290001 34 Pork, meat

- babyfood 0.100000 1.000 1.000 3400291000 34 Pork, skin 0.500000 1.000 1.000 6000304000 60 Poultry, other, fat 0.100000 1.000 1.000 6000302000 60 Poultry, other, liver 0.100000 1.000 1.000 6000301000 60 Poultry, other, meat 0.100000 1.000 1.000 6000303000 60 Poultry, other, meat byproducts 0.100000 1.000 1.000 6000305000 60 Poultry, other, skin 0.100000 1.000 1.000 1500326000 15 Rice, bran 0.300000 1.000 1.000 1500326001 15 Rice, bra n

- babyfood 0.300000 1.000 1.000 1500324000 15 Rice, brown 0.300000 1.000 1.000 1500324001 15 Rice, brown

- babyfood 0.300000 1.000 1.000

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Page 9 of 15 1500325000 15 Rice, flour 0.300000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 0.300000 1.000 1.000 1500323000 15 Rice, white 0.300000 1.000 1.000 1500323001 15 Rice, white

- babyfood 0.300000 1.000 1.000 3500341000 35 Sheep, fat 0.100000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.100000 1.000 1.000 3500342000 35 Sheep, kidney 0.500000 1.000 1.000 3500343000 35 Sheep, liver 0.500000 1.000 1.000 3500339000 35 Sheep, meat 0.100000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.500000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.100000 1.000 1.000 5000385000 50 Turkey, fat 0.100000 1.000 1.000 5000385001 50 Turkey, fat

- babyfood 0.100000 1.000 1.000 5000383000 50 Turkey, liver 0.100000 1.000 1.00 0 5000383001 50 Turkey, liver

- babyfood 0.100000 1.000 1.000 5000382000 50 Turkey, meat 0.100000 1.000 1.000 5000384000 50 Turkey, meat byproducts 0.100000 1.000 1.000 5000384001 50 Turke y, meat byproducts

- babyfood 0.100000 1.000 1.000 5000382001 50 Turkey, meat

- babyfood 0.100000 1.000 1.000 5000386000 50 Turkey, skin 0.100000 1.000 1.000 5000386001 50 Turkey, skin

- babyfood 0.100000 1.000 1.000 8601000000 86A Water, direct, all sources 0.400000 1.000 1.000 400 pp Full comment: 400 ppb EDWC 8602000000 86B Water, indirect, all sources 0.400000 1.000 1.000 400 pp Full comment: 400 ppb EDWC

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## Attachment 2: DEEM

- FCID  Acute Exposure Estimates

– Food and Drinking Water

US EPA Ver. 3.18, 03

- 08

- d DEEM

- FCID ACUTE Analysis for TRICLOPYR NHANES 2003

- 2008 2

- Day Residue file: 116000 116002 116004 acute.r08 Adjustment factor #2 used. Analysis Date: 12

- 21

- 2015/10:47:08 Residue file dated: 12

- 21

- 2015/10:31:11 Acute Pop Adjusted Dose (aPAD) varies with population; see individual re ports RAC/FF intake summed over 24 hours Run Comment: ""

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

-- per capita:

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

---------- -------- ---------- -------- ---------- -------- Total US Population: 0.033198 3.32 0.056512 5.65 0.091412 9.14 All Infants: 0.080077 8.01 0.107209 10.72 0.155723 15.57 Children 1

- 2: 0.075543 7.55 0.106053 10.61 0.142313 14.23 Children 3

- 5: 0.050707 5.07 0.069834 6.98 0.093588 9.36 Children 6

- 12: 0.034563 3.46 0.049927 4.99 0.069963 7.00 Youth 13

- 19: 0.025114 2.51 0.036462 3.65 0.053758 5.38 Adults 20

- 49: 0.0 26457 2.65 0.038240 3.82 0.060328 6.03 Adults 50

- 99: 0.024208 2.42 0.034039 3.40 0.048890 4.89 Female 13

- 49: 0.026561 53.12 0.037113 74.23 0.054370 108.74

### Triclopyr Dietary Exposure and Risk Assessment DP# 426072

_____________________________________________________________________________________________

Page 11 of 15 

## Attachment 3 : DEEM

- FCID Chronic Residue File

– Food and Drinking Water

Filename: C: \ Users \ jtyler \ Documents \ JenWork \ $Triclopyr \ Dairies and Choline Salt \ Dietary Assessment \ run with new tolerances \ 116000 116002 116004 chronic.r08 Chemical: Triclopyr RfD(Chr onic): .05 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): 1 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 02

- 01

- 2016/14:07:16 Program ver. 3.16, 03

- 08

- d

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

---------- -- -- ------------------------------- ---------- ------ ------ ------- 3100047000 31 Beef, fat 0.100000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0.100000 1.000 1.000 3100048000 31 Beef, kidney 0.500000 1.000 1.000 3100049000 31 Beef, liver 0.500000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 0.500000 1.000 1.000 3100044000 31 Beef, meat 0.100 000 1.000 1.000 3100046000 31 Beef, meat byproducts 0.500000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.500000 1.000 1.000 3100045000 31 Beef, meat, dried 0.100000 1.920 1.000 3100 044001 31 Beef, meat

- babyfood 0.100000 1.000 1.000 4000096000 40 Chicken, fat 0.100000 1.000 1.000 4000096001 40 Chicken, fat

- babyfood 0.100000 1.000 1.000 4000094000 40 Chicken, live r 0.100000 1.000 1.000 4000093000 40 Chicken, meat 0.100000 1.000 1.000 4000095000 40 Chicken, meat byproducts 0.100000 1.000 1.000 4000095001 40 Chicken, meat byproducts

- babyfoo 0.1 00000 1.000 1.000 4000093001 40 Chicken, meat

- babyfood 0.100000 1.000 1.000 4000097000 40 Chicken, skin 0.100000 1.000 1.000 4000097001 40 Chicken, skin

- babyfood 0.100000 1.000 1.000 70 00146000 70 Egg, white 0.050000 1.000 1.000 7000146001 70 Egg, white (solids)

- babyfood 0.050000 1.000 1.000 7000145000 70 Egg, whole 0.050000 1.000 1.000 7000145001 70 Egg, whole

- babyfood 0.050000 1.000 1.000 7000147000 70 Egg, yolk 0.050000 1.000 1.000 7000147001 70 Egg, yolk

- babyfood 0.050000 1.000 1.000 8000157000 80 Fish

- freshwater finfish 3.000000 1.000 1.000 8000158000 80 Fish

- freshwater finfish, farm ra 3.000000 1.000 1.000 8000160000 80 Fish

- saltwater finfish, other 3.000000 1.000 1.000 8000159000 80 Fish

- salt water finfish, tuna 3.000000 1.000 1.000 8000161000 80 Fish

- shellfish, crustacean 3.500000 1.000 1.000 8000162000 80 Fish

- shellfish, mollusc 3.500000 1.000 1.000 3200171000 32 Goat, fat 0.100000 1.000 1.000 3200172000 32 Goat, kidney 0.500000 1.000 1.000 3200173000 32 Goat, liver 0.500000 1.000 1.000 3200169000 32 Goat, meat 0.100000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.500000 1.000 1.000 3300189000 33 Horse, meat 0.100000 1.000 1.000 3600222000 36 Milk, fat 0.100000 1.000 1.000 AR of Full comment: AR of 0.10 ppm 3600222001 36 Milk, fat

- baby food/infant formu 0.100000 1.000 1.000 AR of Full comment: AR of 0.10 ppm 3600223000 36 Milk, nonfat solids 0.100000 1.000 1.000 AR of Full comment: AR of 0.10 ppm 3600223001 36 Milk, nonfat solids

- baby food/in 0.100000 1.000 1.000 AR of Full comment: AR of 0.10 ppm 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.100000 1.000 1.000 AR of Full comment: AR of 0 .10 ppm 3600224000 36 Milk, water 0.100000 1.000 1.000 AR of Full comment: AR of 0.10 ppm 3600224001 36 Milk, water

- babyfood/infant form 0.100000 1.000 1.000 AR of Full comment: AR of 0.10 ppm 3400293000 34 Pork, fat 0.100000 1.000 1.000 3400293001 34 Pork, fat

- babyfood 0.100000 1.000 1.000 3400294000 34 Pork, kidney 0.500000 1.000 1.000 3400295000 34 Pork, liver 0.500000 1.000 1.000 3400290000 34 Pork, meat 0.100000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.500000 1.000 1.000 3400292001 34 Pork, mea t byproducts

- babyfood 0.500000 1.000 1.000 3400290001 34 Pork, meat

- babyfood 0.100000 1.000 1.000 3400291000 34 Pork, skin 0.500000 1.000 1.000 6000304000 60 Poultry, other, fat 0.100000 1.000 1.000 6000302000 60 Poultry, other, liver 0.100000 1.000 1.000

### Triclopyr Dietary Exposure and Risk Assessment DP# 426072

_____________________________________________________________________________________________

Page 12 of 15 6000301000 60 Poultry, other, meat 0.100000 1.000 1.000 6000303000 60 Poultry, other, meat byproducts 0.100000 1.000 1.000 6000305000 60 Poultry, other, skin 0.100000 1.000 1.000 1500326000 15 Rice, bran 0.300000 1.000 1.000 1500326001 15 Rice, bran

- babyfood 0.300000 1.000 1.000 1500324000 15 Rice, b rown 0.300000 1.000 1.000 1500324001 15 Rice, brown

- babyfood 0.300000 1.000 1.000 1500325000 15 Rice, flour 0.300000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 0.300000 1.000 1.000 1500323000 15 Rice, white 0.300000 1.000 1.000 1500323001 15 Rice, white

- babyfood 0.300000 1.000 1.000 3500341000 35 Sheep, fat 0.100000 1.000 1.00 0 3500341001 35 Sheep, fat

- babyfood 0.100000 1.000 1.000 3500342000 35 Sheep, kidney 0.500000 1.000 1.000 3500343000 35 Sheep, liver 0.500000 1.000 1.000 3500339000 35 Sheep , meat 0.100000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.500000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.100000 1.000 1.000 5000385000 50 Turkey, fat 0.100000 1.000 1.000 5000385001 50 Turkey, fat

- babyfood 0.100000 1.000 1.000 5000383000 50 Turkey, liver 0.100000 1.000 1.000 5000383001 50 Turkey, liver

- babyfood 0.100000 1.000 1.000 5000382000 50 Turkey, meat 0.100000 1.000 1.000 5000384000 50 Turkey, meat byproducts 0.100000 1.000 1.000 5000384001 50 Turkey, m eat byproducts

- babyfood 0.100000 1.000 1.000 5000382001 50 Turkey, meat

- babyfood 0.100000 1.000 1.000 5000386000 50 Turkey, skin 0.100000 1.000 1.000 5000386001 50 Turkey, skin

- babyfood 0.100000 1.000 1.000 8601000000 86A Water, direct, all sources 0.400000 1.000 1.000 400 pp Full comment: 400 ppb edwc 8602000000 86B Water, indirect, all sources 0.400000 1.000 1.000 400 pp Full comment : 400 ppb edwc

### Triclopyr Dietary Exposure and Risk Assessment DP# 426072

_____________________________________________________________________________________________

Page 13 of 15 

## Attachment 4 : DEEM

- FCID Chronic Exposure Estimates

– Food and Drinking Water

US EPA Ver. 3.16, 03

- 08

- d DEEM

- FCID Chronic analysis for TRICLOPYR NHANES 2003

- 2008 2

- day Residue file name: C: \ Users \ jtyler \ Documents \ JenWork \ $Triclopyr \ Dairies and Choline Salt \ Dietary Assessment \ run with new tolerances \ 116000 116002 116004 chronic.r08 Adjustment factor #2 u sed. Analysis Date 02

- 01

- 2016/14:32:17 Residue file dated: 02

- 01

- 2016/14:23:52 Reference dose (RfD, Chronic) = .05 mg/kg bw/day

=============================================================================== Total exposure by population subgroup

-------------------------------------------------------------------------------
Total Exposure

--------- -------------------------- Population mg/kg Percent of

Subgroup body wt/day Rfd

-------------------------------------- ------------- -------------- -- Total US Population 0.010008 20.0% Hispanic 0.009918 19.8% Non

- Hisp

- White 0.010130 20.3% Non

- Hisp

- Black 0.008462 16.9% Non

- Hisp

- Other 0.012301 24.6% Nursing Infants 0.008249 16.5% Non

- Nursing Infants 0.029990 60.0% Female 13+ PREG 0.009246 18.5% Children 1

- 6 0.014956 29.9% Children 7

- 12 0.009155 18.3% Male 13

- 19 0.007077 14.2% Female 13

- 19/NP 0.007572 15.1% Male 20+ 0.009267 18.5% Female 20+/NP 0.010007 20.0% Seniors 55+ 0.009389 18.8% All Infants 0.023278 46.6% Female 13

- 50 0.009509 19.0% Children 1

- 2 0.017810 35.6% Children 3

- 5 0.013791 27.6% Children 6

- 12 0.009612 19.2% Youth 13

- 19 0.007325 14.7% Adults 20

- 49 0.009698 19.4% Adults 50

- 99 0.009580 19.2% Female 13

- 49 0.009493 19.0%

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

### Triclopyr Dietary Exposure and Risk Assessment DP# 426072

_____________________________________________________________________________________________

Page 14 of 15 

## Attachment 5: DEEM

- FCID  Acute Exposure Estimates

– Food Only

US EPA Ver. 3.18, 03

- 08

- d DEEM

- FCID ACUTE Analysis for TRICLOPYR NHANES 2003

- 2008 2

- Day Residue file: 116000 116002 116004 acute food only.R08 Adjustment factor #2 used. Analysis Date: 12

- 21

- 2015/10:51:52 Residue file dated: 12

- 21

- 2015/10:32:25 Acute Pop Adjusted Dose (aPAD) varies with populatio n; see individual reports RAC/FF intake summed over 24 hours Run Comment: ""

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

-- per capita:

95th Percentile 99th Percentile 99. 9th Percentile Exposure % aPAD Exposure % aPAD Exposure % aPAD

---------- -------- ---------- -------- ---------- -------- Total US Population: 0.017471 1.75 0.036882 3.69 0.067615 6.76 All Infants: 0.035320 3.53 0.063656 6.37 0.089536 8.95 Children 1

- 2: 0.061033 6.10 0.089754 8.98 0.118 422 11.84 Children 3

- 5: 0.033635 3.36 0.048674 4.87 0.079028 7.90 Children 6

- 12: 0.022137 2.21 0.028948 2.89 0.044392 4.44 Youth 13

- 19: 0.012209 1.22 0.018245 1.82 0.029702 2.97 Adults 20

- 49: 0.009399 0.94 0.016229 1.62 0.035900 3.59 Adults 50

- 99: 0.009118 0.91 0.014781 1.48 0.026326 2.63 Female 13

- 49: 0.009251 18.50 0.015412 30.82 0.031373 62.75

### Triclopyr Dietary Exposure and Risk Assessment DP# 426072

_____________________________________________________________________________________________

Page 15 of 15 

## Attachment 6: DEEM

- FCID  Chronic Exposure Estimates

– Food Only

US EPA Ver. 3.16, 03

- 08

- d DEEM

- FCID Chronic analysis for TR ICLOPYR NHANES 2003

- 2008 2

- day Residue file name: C: \ Users \ jtyler \ Documents \ JenWork \ $Triclopyr \ Dairies and Choline Salt \ Dietary Assessment \ run with new tolerances \ 116000 116002 116004 chronic food only.r08 Adjustment factor #2 used. Analysis Date 02

- 01

- 2016/14:31:25 Residue file dated: 02

- 01

- 2016/14:24:57 Reference dose (RfD, Chronic) = .05 mg/kg bw/day

=============================================================================== Total exposure by population subgroup

-------------------------------------------------------------------------------
Total Exposure

--------- -------------------------- Population mg/kg Percent of

Subgroup body wt/day Rfd

-------------------------------------- ------------- -------------- -- Total US Population 0.001632 3.3% Hispanic 0.001921 3.8% Non

- Hisp

- White 0.001515 3.0% Non

- Hisp

- Black 0.001551 3.1% Non

- Hisp

- Other 0.002648 5.3% Nursing Infants 0.000672 1.3% Non

- Nursing Infants 0.002132 4.3% Female 13+ PREG 0.001360 2.7% Children 1

- 6 0.004228 8.5% Children 7

- 12 0.002172 4.3% Male 13

- 19 0.001319 2.6% Female 13

- 19/NP 0.001120 2.2% Male 20+ 0.001464 2.9% Female 20+/NP 0.001210 2.4% Seniors 55+ 0.001291 2.6% All Infants 0.001681 3.4% Female 13

- 50 0.001174 2.3% Children 1

- 2 0.005727 11.5% Children 3

- 5 0.003612 7.2% Children 6

- 12 0.002270 4.5% Youth 13

- 19 0.001217 2.4% Adults 20

- 49 0.001341 2.7% Adults 50

- 99 0.001319 2.6% Female 13

- 49 0.001167 2.3%

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