### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , 

### D. C . 20460



### MEM O RAN D UM 

### D ate: 3 / 1 6/ 20 1 6 O F FICE OF CH EMI CA L SAF ETY A N D PO L LUT I ON P R E V E N T IO N

SU B JECT : Am inocyclopyrachlor: Ac ut e and Chro ni c Di etary Exposure Analy s i s for the Tol e ran ce Petition in Milk an d Li vestoc k Commodities. PC Code: 28800 8 , 288009 Decision No.: 443551 Petit ion No.: OF78 I 7 Risk Assessment Type: Si ngle Ch em/No Agg. TX R No.: None MRID No.: None FROM : Thurston 

### G. M o rton , Che mi s t DP Number: 0432084 Registration No.: None Regulatory Action: Tolerance without U.S. registration Case No.: No ne CAS No.: 858956 -08- 8 , 858954-83-3 40 CF R: None ( First Food Use)

Ri sk Assess m ent Branch JV ( RABI V) THRO UG H:

T O: Hea lth Effect s Di vis ion ( H E D ; 

### 7509P) ,**~ ~**  D e nni s McNeilly , Chemist 

### ( RAB IV ) 

# tPr· 

# /:11 zrt ,, - P. Y vo nn e Barnes , C hemi st (RAB V l )

## lf>/l{)~-t~**f~** Di e tary Ex po s ure S cienc e Advisory Co uncil 

### ( DE SAC) 

### HED ( 7509P ) and E li ssa R eaves, P hD, Bran c h C hi ef RAB I V H ED 

### (7509 P ) Reub e n Baris/Mindy Ondi sh Herbicide Bran ch/ RD 

### (7505 P)

Pa ge I of 16

# ~--Aminocyclopyrachlor Dietary Exposure and Ri sk Assessment DP Number: 0432084 Executive Summary 

### Aminocyclopyrachlor is an herbicide active ingredie nt (a.i.) currently registered for non-fo od use. The registrant , E. 

### I. du Pont de Nemours and Company , previously requested a Section 3 reg istrati on for the first food uses on rangeland and pastures. However , that request was withdrawn and the reg istrant is proposing to estab li s h import tolerances in milk and li vestock commod iti es. Th erefore , this memorandum serves to update the previous assessment (T. Morton, D387446, 04/18 / 20 12) by assessing exposure and risk from li vestock ti ssues and mi lk from imported so urce s only. f

### n addition, the registered uses on lawn and turf which resu lted in residential exposure have been r emoved. An acute and chronic dietary exposure analysis (food and drinking wate r) was performed in order to sup port a request for the prop osed new import tolerances of aminocyclopyrac hlor in milk and li vestock commodities. The analysis was perform e d using the Dietary Ex posure Evaluation Model software with the Food Commodity Intake Database (DEEM

- FC ID ) Version 3.16. This software uses 2003-2008 food co n s umpti on data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Su rvey, What We Eat in America, (NHANES / WWE IA). A ne w drinking water assessment was cond ucted and incorp orated int o this dietary exposure analysis. Since the action r eques ted i s fo r the establishment of import- o nly tolerances only, no new occupational/residential exposure assessment were conducted. Therefore, this memorandum will serve as an addendum to the previous risk assessment conducted by HED and to serve as an update to the dietary exposure and tolerance recommendations. Please refer to the previous ri sk assessment ( J. 

### Ryman, 0387448, 04 / 18/2 012) This memorandum was reviewed by two peer reviewers of the DESAC per DE SAC SOP 2012 . 1 . Acute Dietary Exposure Resu lt s and Characterization An 

### acute dietary endpoint was not identifi ed for the pa rent aminocyclopyrachlor but one was identifi ed for the water degradat e cyclopropane carboxy li c acid (fN-V0977) . In the acute dietary exposure anal ysis for fN

- V0977 , the most highly exposed population subgroup is A ll Infants ( < l year old) with an estimated risk of 11 % of the aPAD . The general U . S. population has an es timated risk of3.6% of the aPAD . Chronic Dietary (Drinking Water Onlv) Exposure Results and Characterization The conservative chron ic dietary exposure ana lysis is based on tolerance level res idues in food and drinking water for parent and drinking water only for the water metabolite IN-V0977. In the conservative chronic dietary exposure ana l ysis for aminocyclopy rachlor, the most highly exposed population subgroup is All Infants (<1 year old) which utili zes < l % of the cPAD. The general U.S . population utilizes < l % of the cPAD for the parent. In the chronic dietary expos ure analysis , the most highly exposed population subgroup is A ll Infants (< l year old) whic h has an estimated risk of 7.4% of the c PAD. The general U.S. population has an estimated risk of2.9% of the cPAD.

Page 2of16Aminocy clopyrach for Die tary Exposure and Risk Asse ss ment DP Number: 0432084 

### Canc er Dietar y Ex po s ure Resu lts and Characterization No can ce r endpoint has been id e ntified , therefore no cance r di e tary assess ment is necessary . I. Intr o du ction 

### Dietary ri sk assessment in corporates both exposure and toxicity of a give n pesticide. For acu te and chronic assess me nts , th e ri sk is expressed as a percentage of a max imum acceptable dose ( i. e . , the dose that H ED ha s co ncluded will res u l t in n o unreasonabl e adverse hea lth effec t s) . This dose i s referred to as th e population-adjusted dose ( PAD ). Th e PAD i s eq ui va lent to th e point of departure ( POD , NOAEL, L OAEL , e.g.) divided by the required uncertainty or safe ty factors . For ac ut e and non-cancer c hroni c exposures , HED is concerned when es timated dietary ri sk exceeds 1 00% of the PAD. R eferen c es that discuss the acute and chro ni c risk assessment s in more deta il are ava ilabl e o n the EPA/ p esticides web s ite: .. Availab le Information on Assessing Exposu re from P est icides, A Use r 's Gu id e ," 21

- JUN-2000, we b link: http ://www.epa.gov/ f e drg s tr/E PA-PEST / 200 0 / July/ D av- 12/ 6061.pdf; or see S OP 99.6 (2 0- AUG1999). The most recent dietary risk assess ment fo r aminocyc l opyrac hl or was co ndu cted by T. M orto n (04 / 18/ 20 12, D 387446). II . Re s idu e Information 

### Aminocyclopyrachlor is a relatively new a .i. and previously was not registered fo r an y food o r feed u ses . T he Res idue of Co nc ern Knowl e d ge base S ubcommittee ( RO CKS), concluded that th e residues of concern for livestock co mm odi ties are aminocyclopyrachlor and ami noc yclopyrachlor methyl este r ( D 3936 l 9 , I. 

### Neg ron-Enc arnacio n , 09/ 22/2011 ). To lerances level s were used for li vestock co mmoditi es. The R OCKS , a lso conclu d ed that the resi du es of co nc e rn for drinkin g water are parent and I N-Y0977 (0370638, G . Kramer, 10 / 1 5/ 20 09 ) . The rat iona le is as foll ows . B ased o n (geductive**~s timat** **e** 

### of r is k from**~xisti g**  

### _knowledge) ( D EREKTM) a lerts and toxicology studies in the open scientific literature, degradate IN

- Y0977 (cyclopropane carboxylic acid) appears to have a different mode of toxicity than th e parent co mp ou nd. Hepat ic s teatos is was observed w hen mal e S D rats were admini s tered cyclo propan e carboxylic acid at 5 00 m g / kg/day (i.p. ) for I or 3 d ays (Jol l y 

### et al. 2004). Thi s indi cates that 1NY0977 may be more toxic than the parent compo un d , am in ocyclopyrachlo r , since no ev id e nce of hepatic steatos is was observed in toxicity database for the parent. R OCKS thus recommends the petitioner provide toxico lo gy studies so that HED can determine the ap propri ate endpo int s fo r IN-Y0977 or provid e an acceptab le ration a le for ex c lu s ion of IN-Y0977 as a resi du e of co ncern in drinking wa t er.

Page 3of16Aminocyclopyrachlor Dietary Exposu re and Ri sk Assessment DP Number: D4320 84 Tab le I. Sum m ary of Metabo lit es and Deg radat es to be in clu ded in t he R i s k Assessme nt and Tole r ance Exp r ess i on. Matrix R es idu es in cl ud e d in Ri sk Assessment R esid u es in c lud ed in Tole rance Ex press ion Plants Primary Crop Aminocyclopyrachlor and Aminocyclopy rachlor an d (g ra sses only) Aminocyclopyrachlo r meth y l ester 1 Aminocyclopyrachlor meth y l es ter Rotational Crop Am in ocyclopyrach lor and Aminocyclopyrachlor and Aminocyclopyrachlor meth y l este r Amino cyc lop y rachl o r meth y l es t e r Livestock Ruminant Ami nocyclopyrachlor and Aminocyclopyrach lor and Aminocyclopyrachlor meth y l este r Aminocyclopyrac hl or methyl ester Pou ltry Not Applicable Not Applicable Drin king Water Amin ocyclopy r ac hl or , IN -V0977 Not Appl icable 1 Aminocyc lopyrac hl or is 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylic acid; Aminocyclopyrachlor meth yl ester is methyl 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylate. 

### Tolerances from memorandum 

### T. Morton , 387442, 4/18 / 12. Ho weve r , meat and mi lk to le rances hav e been re du ced to 0.01 ppm to harm o ni ze wi th PMRA along w ith fat to 0.05 ppm.

Table 2. Rec o mmend ed To l era n ces fo r Ami n ocv cloovrac h lo r . Commo dity Du Pont HED PMRA Proposed Recommendation Established Fat (Cattle , H o rse, Goat, 0.07 0 . 05 0.05 Sheep) Meat (C attle , Horse, Goat, 0.02 0.01 0.01 Sheeo) Meat byp roduct s (Cattle , 

### -- 0.3 0.3 H

orse, Goat , Sheep) Meat byproducts , excep t li ver 0.4 

## -- -- (Ca ttle , H orse , Goat , Sheep) Liver ( Cattle. H orse. Goat , 0.06 

## -- -- Sheeo) M il k 0.035 0.01 0 . 0 1 

### III. Percent C rop Treated Information 1 00% CT was assu med for all co mm od iti es. 

### IV. Drinkin g W ate r D ata Th e Estimated Drinking Water Conce ntrat ions (EDWCs) used in th e acute and chronic dietary ri sk assessment was pro v id ed by the Env ironmenta l Fate and Effects Di v i s ion (EFE D ) (Me mo , 04 322 1 5, W. Ecke l , 3/14 / 20 1 6). The a nnual average E DWC for chronic exposu r e assessment was incorporated directly into the dietary assessment in the food categories "water , direc t , a ll sources'· and "water, indirect , all sou rces:· A revised drink in g water assessment ( OWA) fo r a min ocyclopyrach lo r ac id (AC P) and it s degradate I N-Y097 7 was completed on January 8 , 20 1 0 ( DP 368238). This memora ndum upd at es the p revio u s DWA by rev i ew in g the T ier I surface water analysis ( FIR ST model) and by updating the ground wa te r analysis using the PRZM -GW model. Page 4of 1 6Aminocyclopyrachlor Dietary Exposure and R i s k Assessmen t OP Number: 0432084 

### S urf ace W ater . Th e p rev io u s F IRST s urface water m ode l ing was fo und to be a pp rop ri ate l y conservative by testi ng in the Tier 

### TI mode l SWCC, in cl ud ing both the expe r imental T ie r I scenario and the PA turf scenario. The acute and chronic estimated drinking water concentrat ions (EDWCs) for surface water were reported in the 20 10 DWA to be 25 . 6 and 15.9 ug/L (ppb) , respecti ve ly for a si ngle ground or aerial appl i cat i on at 0.284 l b / A. Howeve r, a p e rce nt cropped area (PCA) of 0. 87 was app li ed t o these res ult s , w hi c h i s no t app rop ri at e for thi s use patte rn . 

### T h e correc te d re s ul ts , with a P CA va lu e of 1. 0 , a r e 29 .4 ppb ( ac u te) and 18 . 3 ppb (c h ro ni c). The r esu lts for the degradate fN-V0977 are l. 7 pp b (ac ute) and 1.2 ppb (chron ic) after correct ing the P CA factor. T hese results apply to both aeria l and grou nd application. P ease refer to the 2010 DWA for detai ls of the env i ronmental fate profile and properties of AC P . 

### G round W a te r. Fo r gro un d wa t e r, the s i x P RZM

- GW scena ri os we r e rw 1, a nd t h e hi g hes t res ult was fo r th e NC C o asta l sce n ario . Th e ac ute ED WC is 1 1 6 ug/ L ( pp b), and th e c h roni c E D WC is 78 ppb. 

### R eco mm e n de d ED WCs . EFE D therefore recommends the fo ll owing EDWCs for the non - crop areas use. 

### S urfa c e w a te r ( p a r e nt) , ac ute: 29 .4 p p b ; c hro ni c, 18 .3 p pb . S u rface w a te r (I N - V 0 977), ac ute, 1. 7 ppb ; chroni c 1. 2 ppb . Gro u n d wate r, ac ute ( p a ren t o nly): 11 6 pp b ; chro ni c 78 ppb. Additiona l infor m at ion concern i ng the water models i s available at the EPA internet s i te: h ttp: // www. cpa. govI

### o ppef ed / m ode l s / wa te r / . 

### V. D E E M -F C ID P ro gram a nd C on s u mpti o n Informati on The aminocyclopyrachlor acute and chronic d ietary exposure assessment was conducted using the DEEM-FCID, Version 3. 1 6, w hic h inco r porates 2003-2008 co n sumption da ta fro m USDA ' s N HANES / W WE IA . T h e d a ta are b ased o n th e repo rte d cons ump t io n of m o r e tha n 20, 000 i nd ividua ls over two non-consecuti ve survey days . F oods "as cons ume d " (e.g. , app le p ie) are linked to E P A-defi ned food commodities (e . g .. app les, peeled fruit

- cooked ; fresh or N/ S; baked ; or wheat fl our - cooked; fresh or N/ S, baked) using publ i cly available recipe trans lation files developed jointly by USD A/ ARS and E P A. For chronic exposure assessment , consumption data are averaged fo r the e n ti re U.S. po pul at ion and wi thin populati o n subgro up s. H oweve r , fo r ac ute exp osure assess m e n t, co n s um p ti o n d ata are retai ned as in d i v i dua l co n s um pt ion eve nt s . B ased on analysis of the 2003

- 2008 WWE IA co n s um ption data, wh ic h took i nto accou nt d ietary patterns and survey respondents , H ED concluded that it is most appropriate to report risk for the followi ng populatio n subgroups: the general U.S. population , all infants ( < 1 year old), children 1- 2, children 3-5, c h ildren 6-12 , youth 13-19 , adul t s 20-49, females 13

- 49 , and adults 50

- 99 years o l d. For a chro ni c dietary exposu r e assessme nt , an esti mate of the resid ue leve l in each food o r foodforrn (e.g.. orange o r orange ju ice) on the food commodity residue list is multiplied by the average dail y consumption estimate for tha t food/food form to produce a residue intake estimate. Page 5of16Ami nocyclopyrachlor Di etary Exposure and Risk Assessment DP Number: 0432084 

### The resulting re s idue intake estimate for each food / food form is sununed with the residue intake estimates for all other food/ food forms on the commodity re sidue list to arri ve at the total average estimated exposure. Exposure is expressed in mg/kg body weight/day an d as a percent of the c PAD. This procedur e is performed for eac h population subgroup . For an acute exposure assessme n t , indi v idual one-day food consumption data a re used on an individual

- by-individual ba s is. The reported consumption amount s of each food item can be multiplied by a residue point est imate and s ununed to obtain a tot a l daily pesticide exposu re for a deterministic exposure assessment, or "matc h ed" in multiple rand om pa irings w ith 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 .. o nl y those who reported eating relevant commodities/ food forms) and a per-capita (i.e. , those who reported eat in g the relevant commod ities as well as those who did not) bas is. In accordance with HED policy , per capita exposure and ri s k are reported for analyse s performed at all levels of refinement. However , for deterministic assessments. any significant difference s in user vs. per capita exposure and risk are spec i fically id e ntified and noted in the ri s k assessment. VI . Tox ic o logica l Information 

### The toxicolo g ical doses and e ndpoints fo r aminocyclopyrachlor and its degradate fN-V0977 for use in the dietary assessment are summarized in Tables 4 and 5 , re s pectively.

Page 6of16Aminocyclopyrachlor Dietary Exposure and Risk Assessment DP N umber : D432084 Table 4. Summary of To xico log ic a l Doses and Endpoin ts for Aminocyclopyrachlor for Use in Hum a n H ea lth Ri s k Assess me n ts. RID , PAD ,

Ex po s ure/ Point o f Uncertainty/ FQP Level of Sce n a rio Departu re A Sa fety Factors Co n ce rn for S tud y and To x ico lo g ica l E ffe cts Ri s k Assess me nt Acute Dietary (Gene r al Population , NA Acute Neurotoxicity-rat (870.6200a) including (No hazard NOA EL = 2000 mg/kg/day. No acute Females 13

- NA NA neuroto xicity. 49 years of was age and identified). In fants and Chi ldren) Chronic RID Combined chronic Ch ronic NOA EL= UF "= IOx =2.79 toxicity/ carcinogeni city-rat Dietary (A ll 279 UF11 = IOx mg/kg/day Populations) mg/k g/day FQPA SF= Ix LOA EL = 892/957 mg/k g/day based on c P

AD = 2.79 mild decreases in body weig ht/body mg/k g/day weie.ht gain Cancer (oral, dennal, .. Not likel y " to be carcinogenic in humans (J. Kidwell, TXR 0056120, 11 /9/11) inhalation) Point of Departure (POD) = A data po in t or an estimated point that i s derived from observed do se -response data and used to mark the beginning of ex trapolation to detern1ine risk associated with lower environmentally re levant human expo s ures. NOA EL = no observed adverse effect level. LOAEL = l owest observed adverse effect level. UF = uncenainty factor. UF " = extrapolati on from animal 10 human (inte r species). UF11 = potential variation in sensitivity among members of the human populati on (imraspecics). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = c hroni c). RID = refe rence dose. NIA = not appl icabl e.

Page 7of16Am inocyclopyrac hlor Di etary Exposure and Risk A ssessme nt DP N umb e r: D4 320 84 T a bl e 5. Summa ry o f To x ic o log ica l Do ses and Endpoints for IN-V097 7 (cyc lo propan e c a rb o xy lic acid ) d e 2r a dat e for Us e in Human H ea lth Risk Assess m e nts RID , PAD , Lev el of Ex po s ure/ Point of Uncertainty Concern for Ri s k Scen a ri o Dep a rtur e Factors Ass ess me nt S tudy and Toxi c ol o gical E ffe c t s UF A= IOx Rabbit study LOAEL = U F11 = I Ox RID = 47916803( 1998 ) Acute Dietary 2 .55 UF LN= IO x 0.0026 mg/k g/ day Non-g uidelin e, oral (gavage) for 2 1 days (A ll Popu lat ion s) mg/kg/day C hil d

- aRfD = 0 , I0. 20 mg/k g/da y (panad ipl o n) LOAEL = I0 mg/ kg/ day based on hepatic CPCA protectiv e SF 0.0026 mg/kg/day s t ea tos is = I UF A= I Ox RID= R abbi t s tud y LOAEL = UF1t = !O x 0.00087 47916803 ( 1998 ) Chron ic Dietary 2.5 5 UFLN= I Ox mg/k g/day Non-guide line , oral (gavage) for 2 1 days m

g/

k

g/

day UFs c= 3x cRfD = 0 , I0 , 20 mg/kg/da y (panadip l on) (A ll population) C PCA C hild- 0.00087 LOAEL = 10 mg/kg/da y ba sed o n hepatic protective SF mg/kg/day s teatosis = \ Ca ncer (oral, d e rma l, NI A inhalati on ) Point of Depanure (PoD) = A data point or an estimated point that is derived from observed**dos~re sponse**  data and u sed to mark the beginning o f extrapola ti on 10 dc1cm1ine risk associated with lower environmentally relevant human exposure s . NOA EL= n o observed adverse c fC c t level. LOA E L = lowes t o bserve d adverse effect level. SF= safe ty fac t or . UF = m ccrtai nty factor . UF,. = cx trapo lali on from animal 1 0 human ( int erspecies). UFH = potential variation in scnsi1i1 •i t y amon g mcnt>e r s of th e human populat io n ( intraspccics). UF LN • datab ase uncertaint y for ex tra po lat ion of LOA E L 1 0 NOAEL. UFsc • database un certain t y for extrapolati o n of s ubc rh o ni c 1 0 chronic . RID = refe r ence d ose . N I A = n o t available . No cancer study avai lool c at thi s tim e. 

### VII. Result s/Di s cu ss ion A s s tated above , for acute and chronic assessments, H ED is co ncerned when dietary risk exceeds 100 % of the P A D. The DE E M-FCID analysis estimates the dietary exposure of the U.S. population and various popul ation subgroups . Table 3 lists the r es ult s of the chronic d ietar y exposure analy s i s for the general U.S. Popu lat ion , a ll in fants (< 1 year old) , c h i ld ren 1- 2 , ch il dren 3-5 , chi ldren 6-12 , yo uth 1 3- 19 , fe m ales 1 3-49, ad ul ts 20

- 49, an d ad ul ts 50-99 years fo r the pare nt aminocyclopyrachlor. In th e conservative chro n ic di e tary exposure analysi s for arninoc yc lo pyrachlor , th e most hi g hl y expose d pop u la ti on s ubg roup is A ll Infan t s ( < l year o ld ) wh i c h ut ili zes < l % 

### of the cPAD . The genera l 

### U . S. popu lat ion utili zes < 1 

### % of the cPAD .

Page 8of1 6

### Aminoc yclo p y

r achlor Dietary Exposure and Ri sk Assessment DP Number: D43 20 84 Table 3. Summary of Diet ary Exposure and Risk for Ami n ocyc lopyrac hl or Pare nt (Food and Dri n king Water) 

### Acute Dietary Chronic Dietary Cancer Dietary Dietar y Dietary Expos ure Exposure Ex posure Populati on Subg roup * ( m g/kg/ da y) %a PA D (mg/kg/day) %c PAD ( mg/k g/day) Ri sk General U.S. Population 0.001717 < I 

### Not applic abl e: No acute No t Applicab l e at thi s All I nfant s(< I year old) dietary endp oi nt wa s 0.0043 36 < I 

### time. C

hildren 1- 2 yea r s o ld identifi ed 0.00 2827 < I 

### Children 3 -5 years old 0.002259 < I 

### Childre n 6-12 years old 0.00158 7 < I 

### Youth 13-19 years old 0.001263 < I 

### Adult s 20-49 yea r s old 0.001680 < I 

### Adults 50 + year s old 0.001657 < I 

### F

emales 13-49 years old 0.00 1 673 < I 

### *The values for the high est exposed populati on for eac h type of ri sk assess m ent are bolded. T able 4 li s t s th e result s of the acu te and chronic di e tary exposure analyse s for the ge neral 

### U.S . P opulation , a ll infants (

### < 1 yea r o ld) , c hildre n 1- 2, ch ildre n 3-5. c hildren 6 -1 2, yo uth 13-19 , femal es 13-49 , ad ult s 20 -4 9, and ad ults 50- 99 yea rs fo r the degradate of aminocyclopyrachlor TN

- Y0977. J n the acut e dietary exposu re analysis for TN-Y0977, th e mo s t ni g hJ y exposed population s ub g roup is A ll Infant s ( < l year old) with an es timated ri s k of 11 % of the aP A D . The general 

### U . S. popu la ti o n has an es timated risk of 3.6% of th e aPAD. In the ch r onic dietary exposu re analysi s, t h e most highl y ex p osed population s ub g roup i s A ll In fants 

### (< I year old) which ha s an estimated ri sk of 7.4 % of th e cPAD. The ge ne ra l 

### U .S. popul a ti on ha s an estim ated ri s k of2.9% of the cPAD.

Page 9of 16Aminocyclopyrachlor Dietary Exposure and Risk Assessmen t DP Number: D432084 Tab le 4 . S u mmary of D ieta ry Ex po s ur e a nd Ri s k fo r A m in ocy cl o py r a c hl o r D eg ra da te (INV 09 77) (Drinkin g W a te r On ly) Acute Dietary Chro ni c D ie t ary Cance r 95ih percen t ile Dietary D ietary D i etary Exposure Exposure Exposure Population Subgroup* (mg/kg/day) % a P AD (mg/kg/day) % c P A D (mg/kg/day) Risk Ge n era l U.S. P op u la tion 0.000093 3.6 0.000025 2.9 No t app l icab le at th is A ll In fa nt s(< I year ol d) 0 . 00 0 29 0 I I 0. 000 065 7.4 tim e. Children 1 -2 years o l d 0.000 1 43 5.5 0.000036 4 . 2 Children 3-5 years old 0.000116 4.5 0.000031 3.5 C h ildren 6- 12 year s old 0.0000 8 9 3.4 0.000022 2.5 Y o uth 13- 1 9 year s o ld 0. 00 0 0 77 3.0 0.0000 1 8 2. 1 Adu lt s 20-49 years old 0.000091 3.5 0.000025 2.9 Adults 50 + years old 0.000081 3. 1 0.000025 2.8 Fema les 1 3-49 year s o ld 0.000093 3.6 0 . 000025 2.9 

### * Th e va lu es for the hi g hes t expose d p o pul a ti o n fo r eac h ty p e of ri sk assess me nt a r e b o l ded. 

### VIII . C h a r a ct e r iz ation of Inp uts/ Outp uts In th e ac u te a nd c hro ni c di e ta ry ex po s ure a n a l yses, co n se r va ti ve E D WCs we re u se d for b o th th e parent a min ocy clop y rac h lor and t he d eg ra d a t e I N -V0977 . T he ge neral U . S . p o pulation a n d a ll r egu lated po pula t ion s u bg ro ups h av e ri s k es tim ate s th at ar e b e low HED 's leve l of c on ce rn. T herefore , res idu e refi n eme nts are not requ ired a t thi s time. To le rance leve l res idu es i n l ivestock co mm od it ies a l ong wi th 100% cro p trea t ed were used in the co n servati ve chron ic di etary e xp os ure assess m e nt for a m i n ocy cl o p yrac hl o r pare nt. As p revio u s l y state d , use i f an imp ort o nl y u s e , th e refo re , u s in g 1 00% cro p tre at e d w ill n o t res ult in a n und e res t imati o n of ri s k . IX . 

### C oncl us i o ns B ase d o n a relat ive l y conservati ve es timat e of am inocyc lo p y rach l o r and IN-V0977 c once ntra ti ons in drinkin g wa te r , t he ac ute and c hr o ni c di e t ary ri sk es tim a t es fo r th e ge n era l U.S. p o pu la ti o n a nd a ll re g ul a t ed p o pulat io n s ubg ro ups are b e low H E D 's leve l of co n ce rn. T o leran ce lev e l res idu es o f aminocyc lo p yrachl o r in li ves to ck commoditi es we re u s ed i n the c hroni c di e t a r y ex po s ure assess men t fo r pa r en t a nd r es ulted i n chro ni c di eta ry ri s k es tim a tes fo r th e ge ne ral U.S. pop u lat ion and all regula ted p o p u latio n subgro u ps be low HED 's leve l of conce rn . Gi v en the conservati ve natu re of the inputs, these assess m e nt s are u n li ke ly to un d e r est im a te risks to am in ocyc lopyrac hl o r and IN

- V0977.

Page 10o fl 6Aminocyclopyrachlor Di e tary Exposure and Risk Assessment DP Number: D432084



### X . List of Attachments Attachment 

### I: Resid ue In put Fi le for Acute Di etary Expos ure Analysis A tt achme nt 2: Residue Input Fil e for Chron ic Di etary Exposure Ana lysis Attachment 3: Results of Acute Dietary Exposure Analysis Attachment 4: Results of Chron ic Di etary Ex posure Anal ys is

Page 11of16Aminoc yc lo py rachlor Di etary Expo s ure a nd Ri s k Asse ss ment DP umb e r: 0 432084 

### Attachment 1: Residue Input File for Acute Dietary Ex posure Analysis IN

- V0977 O nl y Filename : C : \Users\tmorton\Documents\ M y Files\DEEM Files\288008 Aminocyclopyrachlor\Import Pasture and Grass uses So Imported Livestock MMPE only\288008 Acute Water Only IN-V0977 . R08 Chemical : Arninocyclopyrac h lor Me t abolite IN-V0977 R

f D(Chronic) : . 00087 mg/kg bw/day NO E L(Chronic) : 0 mg/kg b w /day R

f D(Acute) : . 0026 mg/kg bw/day NOEL(Acute) : 0 mg/kg bw/day Date created/last modified : 03-15-2016/08 : 30 : 20 Program ver . 3 . 16 , 03-08-d EPA Code Crop Grp Commodity Name 8601000000 86A Water , direct , all sources 8602000000 86B water , indirect , all sources Def Res ( ppm ) 0 . 001700 0 . 001700 Adj . Factors Comment li1 82 1.000 1.000 1 . 000 1 . 000 

### Attachment 2: Re s idue Input File for C hronic Dietary E xpo s ure Analy s i s P arent Onl y Filename : C : \Users\tmorton\Documents\My Files\DEEM Files\288008 Aminocyclopyrachlor\Import Pasture and Grass Uses So Imported Livestock MMPE on l y\288008 Chronic Food and Water Parent O

n ly . ROS C

h emical : Arninocyclopyrachlor RfD(Chronic) : 2 . 79 mg/kg bw/day NOEL(Chronic) : 350 mg/kg bw/day RfD(Acute) : 0 mg/kg bw/day NOEL ( Acute) : 0 mg/kg bw/day Date created/last modified : 03-15

- 2016/08 : 31 : 23 Program ver . 3 . 16 , 03-08-d Crop EPA Code Grp Commodity Name Def Res (ppm) 3 1 00044000 31 3100044001 31 3100045000 31 3100046000 31 3100046001 31 3100047000 31 3100047001 31 3 1 00048000 31 3100049000 31 3100049001 31 3200169000 32 3200170000 32 3200171000 32 3200172000 32 3200173000 32 3300189000 33 3500339000 35 3500339001 35 3500340000 35 3500341000 35 3500341001 35 3500342000 35 3500343000 35 3600222000 36 3600222001 36 3600223000 36 3600223001 36 3600224000 36 3600224001 36 3600225001 36 8601000000 86A 8602000000 86B Beef , meat Beef , meat-babyfood Beef , meat, dried Beef , meat byproducts Beef , meat byproducts

- babyfood Beef , fat Beef , fat-babyfood Beef , kidney Beef , liver Beef , liver-babyfood Goat , meat Goat , meat byproducts Goat , fat Goat , kidney Goat, liver Horse , meat Sheep, meat Sheep , meat-babyfood S h ee p , meat byproducts S h eep , fat Sheep , fat-babyfood Sheep , kidney Sheep , liver Milk , fat Milk , fat-baby food/infant formu Milk , nonfat solids Milk , nonfat solids-baby food/in Milk , w ater Milk , water-babyfood/infa n t form Milk , sugar (lactose)

- baby food/ Water , direct , all sources Water, indirect , all sources 0 . 010000 0 . 010000 0 . 010000 0 . 300000 0 . 300000 0 . 050000 0 . 050000 0 . 300000 0 . 300000 0 . 300000 0 . 0 1 0000 0 . 300000 0 . 050000 0 . 300000 0 . 300000 0 . 010000 0 . 010000 0 . 010000 0 . 300000 0 . 050000 0 . 050000 0 . 300000 0 . 300000 0 . 010000 0 . 010000 0 . 010000 0 . 010000 0 . 010000 0 . 010000 0 . 010000 0 . 078000 0 . 078000

Pa g e 1 2 of16 AdJ . Factors Comment H #2 1 . 000 1 . 000 1 . 920 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1. 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000 1 . 000Aminocyclopyrachlor Di etary Exposure and Ri sk Asse ss ment DP Numb er : 0432084 

### IN-V0977 On l y Filename : C : \Users\tmorton\Documents\My files\DEEM flles\288008 Aminocyclopyrachlor\Import Pasture and Grass Uses So Imported Livestock MMPE only\288008 Chronic Water Only IN -V0977 . R08 Chemical : Aminocyclopyrachlor Metabolite IN-V0977 RfD(Chronic) : . 00087 mg/kg bw/day NOEL(Ch ronic) : O mg/kg bw/day RfD(Acute) : . 0026 mg/l:g bw/day NOEL (Acute) : 0 mg/kg bw/day Date created/last modified : 03-15-2016/08 : 32 : 29 Program ver . 3 . 16 , 03

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



## -- -------- 

## ------- ---- -------- ----- ------- ---------- --- ---- 8601000000 86A Water , direct , all sour ces 0 . 001200 l . 000 1 . 000 8602000000 868 Water, indirect, all sources 0 . 001200 1 . 000 1 . 000

Page 13of16Aminocyclopyrachlor Dietary Exposure and Risk Asse s s ment DP Number : D432084 

### Attachment 3: Re s ults of Acute Di e ta ry Ex po s ur e Analysis fN-V0977 Only US EPA Ver . 3 . 18 , 03-08-d DEEM-FCID ACUTE Analysis for AMINOCYCLOPYRACHLOR METABOLITE IN

- V0977 NHAN E S 2003-2008 2-Day Residue file : 288008 Acute Water Only IN-V0977 . R08 Adjustment factor H2 N OT used . Analysis Date : 03-15-20 1 6/15 : 18 : 37 Residue f il e dated : 03

- 15-2016/15 : 15 : 24 RAC/FF intake summed over 24 hours Run Comment : "" Summary calculations--per capita : 95th Percentile 99th Percentile 99 . 9th Percentile Exposure % aRfD Exposure**~** aRfD Exposure % aRfD



## - ----- ---- -- ----- - 

## ------ ---- ------- - ------ ---- - ------ - Total us Population : 0 . 000093 3 . 57 0 . 000153 5 . 88 0 . 000290 11.17 All Infants : 0 . 000290 11 . 17 0 . 000393 15 . 13 0 . 000576 22 . 17 Children 1

- 2 : 0 . 000143 5 . 50 0 . 000215 8 . 28 0 . 000530 20 . 39 Children 3

- 5 : 0 . 000116 4 . 46 0 . 000178 6 . 83 0 . 000285 10 . 97 Children 6

- 12 : 0 . 000089 3 . 41 0 . 000145 5 . 59 0 . 000224 8 . 62 Youth 13-19 : 0 . 000077 2 . 97 0 . 000127 4 . 89 0 . 000192 7 . 38 Adults 20-49 : 0 . 000091 3 . 51 0 . 000136 5 . 22 0 . 000197 7 . 60 Adults 50

- 99 : 0 . 000081 3 . 13 0 . 000123 4 . 74 0 . 000194 7 . 47 Female 13-49 : 0 . 000093 3 . 56 0 . 000136 5 . 23 0 . 000191 7 . 34

Page 14ofl6Arn inocyclopyrachlor Dietary Exposure and Risk Assessment DP Number: 0432084 

### Attachment 4 : Re s ults of C hronic Dietary E xpo s ur e A nalys i s Parent Only

us EPA Ver . 3 . 16 , 03-08-d DEEM-FCID Chronic analysis for AMINOCYCLOPYRACHLOR NHANES 2003

- 2008 2

- day Residue file name : C : \Users\tmorton\Documents\My Files\DEEM Files\288008 Aminocyclopyrachlor\Import Pasture and Grass Uses So Imported Livestock**~~lPE** only\288008 Chronic Food and Water Parent Only . ROS Adjustment factor #2 NOT used . Analysis Date 03-15-2016/15 : 17 : 14 Residue file dated : 03

- 15

- 2016/15 : 14 : 32 Reference dose ( RfD , Chronic) = 2 . 79 mg/kg bw/day

Population

Subgroup Total US Population Hispanic Non

- Hisp-White Non

- Hisp-Black Non-Hisp-Other Nursing Infants Non-Nursing Infants Female 13+ PREG Chi l dren 1-6 Children 7-12 Male 13

- 19 Female 13

- 19/NP Male 20+ Female 20+/NP Seniors 55+ All Infants Female 13

- 50 Children 1

- 2 Children 3

- 5 Children 6

- 12 Youth 13-19 Adults 20-49 Adults 50

- 99 Female 13

- 49 Total exposure by population subgroup Total Exposure mg/kg Percent of body wt/day Rfd



## ----- - - ----- - 

## ---------------- 0 . 001717 0 . 1% 0 . 001664 0 . 1% 0 . 001761 0 . 1% 0 . 001420 0 . 1% 0 . 001968 0 . 1% 0 . 001516 0 . 1% 0 . 005595 0 . 2 % 0 . 001602 0 . 1% 0 . 002426 0 . 1% 0 . 001506 0 . 1% 0 . 001206 0 . 0 % 0 . 001319 0 . 0 % 0 . 001574 0

. 1% 0 . 001761 0 . 1% 0 . 001626 0 . 1 % 0 . 004336 0 . 2 % 0 . 001675 0 . 1 % 0 . 002827 0 . 1 % 0 . 002259 0 . 1 % 0 . 001587 0 . 1 % 0 . 001263 0 . 0 % 0 . 001680 0 . 1% 0 . 001657 0 . 1% 0 . 001673 0 . 1%

Page 15of16Am inocyclopy rach lor Dietary Exposure and Risk Assessme n t DP N umbe r : D432084



### IN

- V0977 On l y

us EPA Ver . 3 . 16 , 03-08-d DEEM

- FCID Chronic analysis for AMINOCYCLOPYRACHLOR METABOLITE IN

- V0977 NHANES 2003-2008 2-day Residue file name : C : \Users\tmorton\Documents\My Files\DEEM Files\288008 Arninocyclopyrachlor\Import Pasture and Grass Uses So Imported Livestock MMPE only\288008 Chronic Water Only IN-V0977 . R08 Adjustment factor #2 NOT used . Analysis Date 03

- 15

- 2016/15 : 17 : 38 Residue file dated : 03-15

- 2016/15 : 16 : 20 Reference dose (RfD , Chronic) = . 00087 mg/kg bw/day Total exposure by populat i on subgroup Total Exposure Population

Subgroup Total US Population Hispanic Non

- Hisp-White Non

- Hisp

- Black Non-Hisp-Other Nursing Infants Non-Nursing Infants Female 13+ PREG Children 1-6 Children 7

- 12 Male 1 3

- 19 Female 13

- 19/NP Male 20+ Female 20+/NP Seniors 55+ All Infants Female 13-50 Children 1-2 Children 3-5 Children 6

- 12 Youth 13

- 19 Adults 20

- 49 Adults 50

- 99 Female 13-49 mg/kg Percent of body wt/day Rfd



## ------------- 

## - - ------- - - - ---- 0 . 000025 2 . 9 % 0 . 000024 2 . 8 % 0 . 000026 3 . 0 % 0 . 000021 2 . 4 % 0 . 000029 3 . 3 % 0 . 000023 2 . 6 % 0 . 000084 9 . 6 % 0 . 000024 2 . 7 % 0 . 000032 3 . 7 % 0 . 000021 2 . 4 % 0 . 000017 2 . 0 % 0 . 000019 2 . 2% 0 . 000023 2 . 7 % 0 . 000026 3 . 0 % 0 . 000024 2 . 8 % 0 . 000065 7 . 4 % 0 . 000025 2 . 9 % 0 . 000036 4 . 2 % 0 . 000031 3 . 5 % 0 . 000022 2 . 5 % 0 . 000018 2 . 1 % 0 . 000025 2 . 9 % 0 . 000025 2 . 8 % 0 . 000025 2 . 9 %

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