### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON , 

### D.C. 20460



### MEMORANDUM Date: 09/16/ 20 1 5 O FFICE OF CHEM I CAL SAFETY AND P O LL U TI ON PREVENTION



### SUBJECT: Pronamide. Acute and Chro ni c Aggregate Dietary ( Food and Drinking Water) Ex posure and Ri s k Assessment in Support of R eg i stration. Re v iew an d the Section (3) Registrati on Act ion for Leaf Le ttu ce. 

### PC Code: 10170 1 

### Decision No. : 

## 494q 

# J.!.,., Petition No.: 4F830 I 

### Risk Assessment Type: Di e tary 

### TXRNo . : NA 

### MRIDNo.: NA 

### DP Barcode: D427082 

### Registration No . : 62719-394 

### Regulatory Action: Section 3 Reg i s tration 

### Case No. : 0082 

### CAS No.: 23950 -58- 5 

### 40 CFR: § 180. 3 17 

### FROM: Ideliz Negr6n-E ncarnaci6n , Ph . D. , Chemist 

# ;t{/tt. 7 '1 ..___- Ri s k Assessment Branch V 

### THROUGH:

TO: H ealth Effects Di v i s ion (I-TED; 7509P) Pete Savoia , C hemi st 

# 0-: r <

,. t:__ ......

# /a-
v

# ~ W illiam C utc hin , C hemi st 1:

### ·'-~ 

## ,z, ,.. _l**~.** 1, .... - 

### Di e tary Exposure Science Advisory Council (DESAC) Mindy Ondi s h , Ri s k Manager Registrati on Division (7505P) 

### Exec uti ve S umma ry Acu te and chronic aggregate dietary (food and drinking water) ex po sure and ri sk assess ment s were conducted using the Di eta ry Ex p os ure Eva luation Model softwa re with th e Food Commodi ty Intake Databa se ( D EEM -FCID ) Version 3 .16 . This software uses 2003-2008 food consumption data from the U.S. D e partment of Agri cu lture's (US DA 's) Nati o n a l H ea l th and N utrition Exa mination Survey, What We Eat in America, (NHANES/WWE IA ). For registration action s : T he an a ly s is was conducted in s upp o rt of a human-h ea lth risk assessment for the proposed Section 3 u ses of pronamide o n leaf lettuce . This memorandum was rev iewe d by two peer reviewers of the D ESAC , pe r D ESAC SOP 20 12. 1. Page I of 16

### Pron amide Dietary Exposure and Risk Assessment DP Number: D427082 

### Unrefined acute and c hronic dietary assessments were perfonned. To lerance le ve l residues of pronamide (residues convertibl e to meth yl 3,5-d ichlorob enzoate) we r e used for the registered uses a nd proposed new use on leaf lettuce. Default processing factors and 100% of crop treated (CT) assumptio n s were incorporated. Drinking water was incorporated directly in the dietary assessment using th e T ier II acute and chronic es tim ated drinking water concentrat ion (EDWC) for surface water generated by the Surface Water Concentration Calculator (SWCC). 

### Acu te Dieta1y Exposu re Assessment The resulting acute dietary exposure estimates u s in g th e DEEM-FCIOTM model were l ess than 100% of the ac ute population adjusted dose (aPAD ) at the 95ih percentile of expos ure for the ge ne ra l U.S. po pulation and all population s ub gro up s. Pronamid e acute di e tary exposure (food + drinkin g water) wa s estimated at 0 . 007144 mg/kg/ day for the ge nera l U.S. population ( 18 % of the aPAD) and 0.018539 mg/kg/day (46% of th e aPAD) fo r the mo s t hi g hly exposed population subgro up (A ll Infants 

### < 1 year old). The results per u ser a nd per capi ta are s imilar. 

### Chronic Dieta1y Exposure Assessment The resulting chronic dietary exposure es tim ates using the DEEM-FCIDTM model were less than 100 % of the chronic population adjusted dose (cPAD) fo r the ge neral U.S. population and all population s ubgroups. Pronam ide chronic dietary exposure (food+ d rinkin g water) was estimated at 0.001706 mg/kg/day for the ge neral U.S. population (4.3% of the cPAD) and 0.004410 m g/ k g/day ( 11 % of the cPAD) for the most highly exposed population subgroup (C hildren 1-2 years o ld ). Pronamide was c lassified as "Not Likely to be Carcinogeni c to Humans" at doses that do not resu lt in indu ction of hepatic cell proliferation or metabolic enzymes leadi n g to disruption of thyroid o r go nadal endocrin e axes; therefore, a cancer risk assess me nt i s not needed. 

### I. Intro duc tion 

### Di e tary ri s k assess m e nt incorporate s both exposure and tox ic ity of a given pesticide. For ac ute a nd c hro ni c assess me nt s, the risk i s expressed as a perce ntage of a maximum acceptable do se ( i. e., th e dose that H ED has concluded will result in no unreasonable adverse hea lth effects) . This dose is referred to as the population-adjusted dose (PAD). T he PAD is eq ui valent to the point o f departure ( POD , NOAEL, LOAEL , e.g.) divided by the required uncertainty o r safety factors. Fo r acute and non-cancer chronic exposures , H ED is co ncerned w hen estim ated dietary risk exceeds I 00% of the P AD. References that discuss the acute and c hronic risk assessmen ts in more detail are avai lab l e on the EPNpesticides web site: ' ·Available Information on Assessing Exposure from Pesticides , A User's Guide ," 2 l-JUN-2000 , web link: http: //www.epa.gov/fed rgstr / EPA-PE S T/ 2000/Jul y/ Day-l 2/606 l .pdf ; or see SO P 99.6 (20-AUG1999).

Page 2 of 16Pronamide Dietary Exposure and Ris k Assessment D P Number: D427082 

### The mos t recent dietary risk assess ment fo r pronamide was co ndu cted b y Sarah 

### J. Levy 

### (07 1 2012007, D340385). Recently , it was determin ed t hat pronamide is not lik e ly to be a carcinogen in humans (CARC repo rt 101701.004 CA. D OC; J. 

### Row land, 1 2/02/ 2014). Moreover, th e ToxSAC has reevaluated the toxicolog ical database for pronamide re su lting in new endpoints a nd points of departure bei ng selected for dietary assessme n t p urposes (S. Dapson , Th jdi azuron Human Hea lth Ri sk Assess m ent, In Process). This reeva lu a ti o n included the se lect io n of an ac ute endp o int fo r dietary assessme n t purposes. 

### II. Re s idue Information Tolerances for pronamide are currentl y established under 40 CFR § l 80.3 l 7(a) , (b) , and (c). The tolerance expression, li sted for th ese sections , is in terms of th e combi ned res idu es of th e herbicide pronamides and its metabolites (co nta inin g the 3,5-d ic hlorob enzoy l mo iet y and calculated as 3 , 5-dichl oro-N-( 1 , l-dim ethy l- 2 -p ropyny l)benzam ide). Prona mide and it s metabolites containi n g the 3 , 5-d ichlorobenzoyl mo iety are considered the residu es of co n cern for risk assessment in plant , livestock , and rotational crop commod ities as well. Th erefore , the curre nt and proposed tolerances account for all the residues of concern for risk assessment.

Table 1. Summary of Pronamide M etab olite s a nd Oegra date s to be inc lud ed in th e Ri s k Assessment and Tolerance Express ion Matrix Res idu es included in Risk Residue s included in A s se s sment Tolerance Express ion Plants Primary C rop Rotational Crop pronamide and its metabolites pronamide and its metabolites Livestock Rumin ant containing the 3,5- containing the 3,5- Poultry dichlorobenzoy l moi e ty dichlorobcn zoy l moiety Drinking Water Not Applicable 

### Pending label modifications , HED recommended in favor of th e new use of pronamide on leaf lettuce 

### ( 1. Negron-E ncarnacion, D424598 , 0l/15 / 2015) . The sub mitted data s up port the permanent tolerance of 2 ppm for th e residues of propyzamide and its m etabo lites (co n tainin g the 3 , 5-dic hl orobenzoy l moi ety and ca lc ul ated as 3 , 5-d ic h loro-N-( I , l-dimethyl-2- propynyl)benzamide) in/on leaf lettuce. Fo r all registered and proposed new uses , the acute and chron ic dietary assessments assumed DEEM-FCIDTM default processing factors , and to lerance-le ve l res idu es. The tole rance for radiacchio was trans l ate d to Be lgium end i ve. The establis hed to lerances for livestock co mmod iti es a re adeq u ate to s upport registrat io n review; therefore , the exi st in g to le rance leve l s for live stock were incorporated in the dietary assessment. T h e USDA Pesticide Data Pro gram (PD P ) monitored pestic ide residues in catfish in 2008 , 2009 , and 20 I 0. Over thi s 3-year period , PDP analyzed 1479 samples of catfish for residues of pronamide . None of the samples contruned detectab le residues. As a result , residues in fish were not included in the assessment. 

### III. Percent C rop Treated Information The acute and chronic assessments were performed by assuming that l 00% of the crop was treated for all food commodities.

Page 3of 16Pronamide D ietary Exposure a nd R is k As sess ment DP Number: D427082 

### IV. Drinkin g Water D a ta The drinking water res idues used in t he die tary risk asse ss ment we re provided by the Environmenta l Fate and Effects Division (EFED) in the following memorandum: ' ·Propyzamide ( Pronamide ): T ier II Drink ing Water Exposure Assessment in s upport of the Proposed Use of Propyzam ide on Leaf Lettuce " (0 414467 , K. Milians , 04/2 1 / 2015) and incorporated directly into thi s dietary a ssess ment. Water residues we re incorporated in the D EEM-FC ID into the food categories " water , direct , all sources" and "water , indirect , all so urces.'' Bes ides mode ling the use of leaf lettuce , EFED modeled the u se of art ichoke becau se this use all ow s the max i m um app li catio n rate (fo r an y cro p) of 8 lbs a.i./acre ( i .e. , 4 lbs a . i ./acre x 2 ass umed app licati o n s/y r ). T abl e 2 s h ows the es tim ated d rin kin g water co n centratio n s in surface wate r a nd groun d wat e r ( in c ludin g valu es u s in g Sc i -Grow and P RZ M-G W fo r ground water). T he es tim ated d rinkin g water co n ce n trat io n s reco mm e nded by EFE D are 1 02 p p b fo r the acute d ie ta ry assessme n t and 47.0 ppb for the c hro ni c and cancer d ietary assessme nts .

T a bl e 2 . Ti e r U T o ta l R es i d u e of Conc ern EDWC s in S urfa ce Wate r a n d G r o u n d Wate r fro m Pro p yza m id e Uses o n N e w Us e s ( M axi m u m EDWC s in Bo l d ).

Drinkin g Wate r S o urce (Mode l, E DWCs Use, M o de l ed rat e) Scena r io A c u t e ( μg /L) C h r o n i c ( μ g/L) Cance r (μg/ L) S urf ace Water ( SWCC , Artichokes. CA row crop 4 lb a. i./ A x 2 applic.: total of8 RLF ( aerial 61.4 33.4 26.0 lb/ A/y r) application) S urface Water (SWCC, Leaf CA lenuce Lettuce , 2 lb a. i./ A x 2 applic.: total (ae rial 1 0 2 47.0 33. 6 of4 lb/ A/yr) application) G round Water (PRZM-GW, Artichokes , WI sa nd s 2 1 1 8.6 18.6 4 lb a.i ./A x 2 applic.; total of4 lb/ A / y r) Gro und Water (SC I-GROW, Artichokes, N/ A 0.802 0.802 0.802 4 lb a.i./A x 2 applic. ; total of8 lb / A / y

r ) Ground Wate r (SC I- GROW, Leaf Lenuce , 2 lb a. i./ A x 2 applic.; total N IA 0.401 0.401 0.401 of4 lb/ A/y r) N I A = Not Applicable Value s in bold s how the EDWC s recommended for HED 's acute ( 10 2 ppb) and chron ic (47.0 ppb) and cancer (33.6 ppb) di etary ri s k a ssess men t as they are considered protective of all the reg istered uses ofpronamide. 

### The drinking wat er models and their descriptions are avai lable at the EPA internet site: http ://www . e p a.gov/o pp efe d 1 / mo de ls/ water / .

Page 4of16Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

### V . DEEM - FC ID Prog ra m and Co ns um ption I nfo rm a t io n Pronamide chron ic dietary exposure assessments was co ndu cted u s in g the D EEM-FC ID , Version 3 .1 6, w hi c h inc orporat es 2003-2008 consumption data from US DA 's N HANE S/W WEIA. T h e data are based on the reported consumpti o n of more than 2 0 , 000 indi v idual s over two nonconsecutive survey days . Foods " as consumed" (e.g. , app le pi e) are linked to E P A-defined food commodities (e.g. , ap p les, peeled fruit

- cooke d ; fresh or N / S; baked ; or w heat fl our - cooked ; fresh or N / S, b aked) u si n g publi c ly avail ab le r ec ipe translatio n fi les deve loped joint ly by USDNAR S and E P A . For c hron ic expo s ure assessment , co nsumpti o n data are averaged for the entire U.S . p op ul ati on and within population s ub groups. However, for acute exposure assessmen t, consumption data are retained as individual consumpt ion eve nt s. Based on analy s is of the 2003-2008 WWEI A co ns umpti o n data , w hi ch took into acco unt dietary patterns and survey respondents , H E D conc lud ed that it i s mo st appropriate to re p ort risk for th e fo ll owing population subgro up s: the ge ne ra l U .S . population, all infants (< I year old) , c hildre n 1-2 , chi ldren 3

- 5, children 6-12, youth 13-19 , adults 20

- 49 , fe males 13-49 , a nd adults 50-99 years old. For a c hronic di eta ry expos ure assess ment , an estimate of the re s idu e leve l in each food or food

fonn (e.g., oran ge or orange juice) on the food commod it y residue list i s multipl ied by the average daily consumption estimate for that food/food form to produce a residue intake esti mate. The resulting residue intak e es timate fo r eac h food/food fonn is s umm ed with the residue intake estimates for all other food/food forms on the commodity res idu e li s t to arri ve at the total average estimated expos ure . Expos ure is expressed in m g/ kg body weight / d ay and as a percent of the c PAD. Thi s procedure is performed for each popu lation subgroup. 

### VI. Toxico logic a l I n fo rmati o n Toxicity endpo ints and points of departure ( PODs ) fo r dietary expos ure sce nari os to pro nam ide are summarized in Table 3. An 

### acute reference do se ( RID ) 

### for general population was se lec t ed based on an acute neurotoxicity s tud y in rats that showed r ed uc ed motor activity in both genders and in c rease in foot s play in fe ma les on d ay 1. An unc e rt a inty factor of I OOOx ( I Ox to account for interspecies extrapo lati o n , and 1 Ox for intraspecies variat ion 1 Ox for FQ P A) was applied to the acute RID. This results in a PoD of 4 m g/ kg/day. There are no e ndpo int s that could be used for an acute 

### RfD fo r fe male s aged 13 -49. The chronic RID also used th e extrap o la ted POD of 4 mg/kg/day based o n th e acute n eurotoxici ty s tud y which is protective of potential tumor s as supported by the c h ron ic toxicity/ carc in oge ni ci ty stud y. Pronamid e i s classified as " No t Like ly to be Ca rcinogenic to Human s " at doses that do not result in induction of hep atic ce ll proliferation or metabolic enzymes leading to disruption of thyro id or go nad a l endoc rine axes.

Page 5of16Pronamide Dietary Exposure and Ri s k Assessment DP Nu mber: D427082
Tabl e 3 . S ummary o f Toxicologica l Do ses a nd E ndpoint s for Pronamide / Pro pyza mid e for Use in Di eta ry a nd Non-Occupati o na l Human H ealth Ri s k A ss ess m ents RID , PAD , Leve l o f Uncertainty/ Co ncern for Ex po s ure/ Point o f F QPA Safety Ri s k Sc enario De partur e Fa cto rs Assessme nt Stu d y a nd Toxicolog ical Effects Acute Dietary NOAEL < U F A= IOx aRfD =aPAD Acute neurotoxi c ity in rat : NOAEL was not (A ll 40 mg/kg UFu=IOx 

## = 0.04 mg/kg established; LOA EL = 40 mg/kg (t h e Pop ul ati ons) Extrapolated lowest do s e tes t ed ) based on the incre ase in P00

- 4 FQPA SF (UF1.) landing foo t sp lay in female rats and the mg/kg/day = IOx decrease in motor activity see n in both ge nd ers on Day I . Acu te Dieta ry An e ndp o in t attribut able to a si n g le exposure was not availabl e in the database in cluding the Females 1 3- developmen tal toxicity studies in rat s and rabbits. 49 years of age Chro nic Extrapolated UFA = IOx Chro ni c RID The PO D of4 mg/kg/day was selected Dietary (A ll POD = 4 U F11= IOx = 0.04 based on a weight of evidence approach Populations) mg/kg/day FQ PA SF (UFL) mg/kg/day using the re s ult s from the 3 studies li s ted from ACN below. = !O x S ubchr o ni c n c ur o toxicity ( SCN}: NOAEL c PA D 

## = 0.04 of2.38 m g/kg/day is based o n the mg/ kg/day s ig nific ant decreases in body weig ht , body weig ht gai n, and food co nsum pti o n seen at 11.28 m g/

kg/day (LO A EL) in male s. Acute nc urotox ic it v (ACN}: NOAEL was not established. The LOA EL of40 m

g/kg/day with a IOX LOAEL to NOAEL uncertainty factor (UFL) y ields a POD of 4 m g / kg/ d ay (4 0+ 10) . Co mbin ed chro ni c to x icity/ carcinogenicity NOA EL of 8.46/ 10 .69 mg/ kg/day is ba se d o n increase d re lativ e li ver weight and hi s topatho log ical lesions in the li ver, thyroid , and ovarie s a t 42.59/55.09 mg/kg/day (LOAE L ). Cancer (ora l. C la ssification: " Not Like ly to b e C arc ino gen ic to Hum a ns" at doses that do not result in dermal, induction of hepatic cell proliferation or metabolic en = ymes leading to disruption of th

yroid o r inhalation) gonadal endocrine axes. Point of Departure (POD) = A data point or an estim at ed point that is derived from observed dose-response data and used to mark the beginning of ex tr apolation to determine ri sk associated with lower enviro nm entally relevant human exposures. NOA EL = no observed adverse effec t lev e l. LOAEL = lowe s t observed adverse effect level. UF = uncertainty factor. UFA = ex trapolation from animal t o human (interspecies). UF11 = p o

t enti al variat ion in se n si tivity among m embers of the human population (intraspecies). UFL. = u se of a LOA EL to extrapolate a NOAEL. U F

s =

u

se of a sh ort-term**tudy** for long-term risk assessme nt. UFon = to accou nt for th e abse nce of key data (i.e . . lack ofa criti cal s tud y). FQPA SF = FQPA Safet y Factor. PAD = population adjusted dose (a = acute, c =c hronic ). RID = reference dose. MOE= margin of expo s ure . LOC = level of concern. NIA = not applicable .

Page 6of 1 6Pronamide Dietary Exposure and Risk Assessment DP Number: D427082 

## VII. R es u lt s/Di s cu ss ion As stated above, fo r acute and c hronic assessments , H E O is concerned when dietary ri sk exceeds 100% of th e PAD. The DE EM

- FC ID analy ses esti mate th e dietary exposure of the U.S. pop ulation and vari ou s population su bgro up s . T he res ult s reported in Table 4 are fo r the genera l U . S. Pop u latio n , a ll infant s (< I year old) , c hildre n 1-2, children 3 -5 , children 6- 12, yo uth 1 3 -1 9, fe mal es 1 3-49, adults 20- 49 , and adult s 50-99 yea rs . 

### Results of Acute Dietmy (Food and Drinkin g Wate1) Exposure Analysis The results of the acute di etary ex po s ure analysis at the 95th percentile of ex p os ure are reported in t h e s umm a r y tab le be low . An 

### unrefine d ac ute di e tary ri sk assessment for pronam ide showed that acute di e ta r y risk estim ates are bel ow H ED 's level of conc ern ( i .e . < 100 % a P AD) for th e ge n eral population an d all population subgroups. The h i gh es t ri s k was observed fo r All Infants (46% of th e aP A D). 

### Results of Ch ronic Dietary (Food and Drin king Wate1) Exposure Anal ysis The res ult s of the c hronic di e tary expos ure anal ys i s are reported in the summary tab le be l ow. The chronic d ie tary risk assess me nt for pron amide s howe d that c hronic d ietary ri sk estimates are below H ED's leve l of co nce rn ( i .e.> 100 % cPA D ) for the genera l population a nd a ll population s ubgroups ; in particul ar, c hil dren 1-2 year old were the hi g hest exposed population subgro up (11% of the cPA D ). Ta bl e 4. S umm ary of D ie tary (Fo o d and Dr i nkin g W a t e r) Ex p os ure and Ri s k for P ronamid e. Ac ute D ie t ary C h ro ni c D ietary (95 1 h P e r ce nti l e) Po p u l atio n S u bg r o u p Di etary Ex p os u r e Di et a r y Ex p os u r e**l!/ 1~** **av)** % a P A D * ( m2/ kl!/d av) % cPAD* Ge nera l U.S. Population 0.007144 18 0.001706 4.3 All In fants(< I year o ld ) 0 . 01 8539 46 0.003854 9.6 Children 1-2 yea rs old 0.0 1 3317 33 0 . 00 44 10 11 Children 3-5 years old 0.010013 25 0.003083 7.7 Children 6-12 years old 0.006963 17 0.001804 4.5 Youth 13-19 years o ld 0.005480 14 0.00 124 1 3. 1 Ad ults 2 0-49 years old 0.006570 16 0.0015 34 3.8 Adu lt s 50-99 years old 0.005893 15 0 .001526 3.8 Females 1 3-49 years old 0.006753 17 0.001558 3.9 

## VIII. C h a r ac t e rization of I nput s/Output s The acute and c hronic diet ary expos ure assessments for pronamide are unrefin ed, m aking u se of tole ran ce leve l residue leve ls, DEEM default p rocess in g fac to rs, and 100 % crop treated assumptions for a ll crops. In add iti on, a Tier 

### If ana lys is using th e SWCC was conducted to es tablish the EDWCs u sed in the assess me n t. This co n servati ve a na lys is proved ad eq uate fo r the

Page 7of16

### Pronam id e Dietary Exposure and Ri sk Assessment DP Number: D427082



### acu t e and c hronic dietary assessments, as the acute and chronic risk for the population subgroup w ith the hi ghes t ri s k assoc iated w ere 45 % of the a PAD (A ll Infants < I year old) and 11% of th e c PA D (C hildre n 1-2 years o l d) . For compari so n purpo ses , th e ac ute and c h ronic analyses co ns id erin g food only are included in Attachment 

### I. Various r e fin e me nt s cou ld be made to th e assess me nt s . H owever, as there are no risk est imates o f co ncern , no refinem e nt s were incorporated . I X. C onclu s i o ns 

### U nre fin e d acute and chron ic d ietary risk as sess ment were performed u s ing DEEM

- FCIDTM to s uppo rt the registered and proposed u ses of pronam id e. Pro namid e was class ified by the CARC as "No t Likely to be Carc in ogen ic to H umans " . Ba se d on thi s a cancer risk assessme nt is no lon ger ne c ess ary. To lerance leve l res idu es (res id ues co nve rt ible to meth y l 3,5 -di ch l orobenzoate) , D EE M de fau lt processing facto rs, and 100% CT ass umption s we re used in the analyses . In add it ion, a Tier ll dr inking water asses s ment u s ing th e S WC C was u se d to estab li s h the EDWCs u se d in th e assessment. The dietary risks are below HED 's level of concern for the general po pul a tion a nd all population subgroups. These assess me nt s could be refined by the use of pe r ce nt of cro p treated assumptions, crop field tri a l dat a and mon itorin g data ; howe ver , as th ere are no ri sks co nc e rn refinement is not necessa r y. Overall , HED i s confident that the assessment does not und erestimate ri s k to t h e general U.S. popul ation o r an y population subgroup. X . Li s t o f A tta chm e nts • • 

### Ac ute Resi du e Input fil e Ac ute R es ult s file C hro n ic R es idue Input fi le C hronic Res ult s Fil e

Page 8of16Pronamide Di etary Ex p os ure and Ri s k Assess m e nt 

### A ttachm e nt 1. 

### Dietary Assess men t I nput F il es and Res ul t s Ac ute Di e tary Assess m ent 

### Acu te Input Fil e Filename: F:\Dietary Assessments\Pronamide\Pronamide 2014 AcuteDietary_FoodWater_ToleranceLevel.R08 Chemical: Pronamide RfD(Chronic): . 04 mg/kg bw/day NOEL(Chronic): O mg/kg bw/day RfD(Acute) : . 04 mg/kg bw/day NOEL(Acute): 

### o mg/kg bw / day DP N umbe r : D427082

Date created/last modified: 05

- 14-2015/10:16 : 04 Program ver. 3.16, 03-08-d Comment: Old & new uses + water



## - -- -- -- --- - ----- --- ------ - -- ------- --- --- - ------ --- ------ ---- ------ -- -------- -- ---- EPA Crop Def Res Adj.Factors Comme nt Code Grp Commodity Nam e (ppm) #1 #2



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

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

## -- ------- - - -- ---- 0401150000 4A Endive 1 . 000000 1 . 000 1.000 0401204000 4A Lettuce, head 1.000000 1 . 000 1.000 0401205000 4A Lettuce, leaf 2.000000 1. 000 1.000 New us Full comment : New use 0401313000 4A Radicchio 2 . 000000 1 . 000 1. 000 0402322000 48 Rhubarb 0 .1 00000 1 . 000 1.000 0603256000 6C Pea, dry 0 . 100000 1 . 000 1.000 0603256001 6C Pea, dry- babyfood 0 . 100000 1.000 1. 000 1100007000 11 Apple, fru it with pee l 0 . 100 000 1 . 000 1. 000 1100008000 11 Apple, peeled frui t 0 .1000 00 1 .0 00 1. 000 1100008001 11 Apple, peeled fruit -bab yfood 0 .1 00000 1 . 000 1.000 11 0 0009000 11 Apple, dried 0 .1 00000 8 . 000 1.000 1100009001 11 Apple, dried-babyfood 0 . 100000 8 . 000 1.000 1100010000 11 Appl e, ju ice 0 .100 000 1 .300 1 .000 1100010001 11 App le, juice-babyfood 0 . 100000 1 .3 00 1. 000 1100011000 11 Apple, sauce 0 . 100000 1 . 000 1.000 1100011001 11 Apple, sauce-babyfood 0.100000 1 . 000 1 . 000 1100266000 11 Pear 0.100000 1 . 000 1.000 1100266001 11 Pear-baby food 0 .10 0000 1 . 000 1 .000 1100267000 11 Pear, dried 0 .10 0000 6.250 1.000 1100268000 11 Pear, juice 0 .1 00000 1 . 000 1. 000 1100268001 11 Pear, juice-babyfood 0.100000 1 . 000 1.000 1201090000 12A Cherry 0 .1 00000 1 . 000 1. 000 1201090001 12A Cherry-babyfood 0 .1000 00 1 .0 00 1. 000 120109 1 000 12A Cherry, JU1Ce 0.100000 1.500 1 .000 1201091001 12A Cherry, juice-babyfood 0 . 100000 1. 500 1.000 1202012000 128 Apricot 0.100000 1 . 000 1.000 1202012001 128 Apricot-babyfood 0 .1 00000 1 . 000 1 . 000 1202013000 12B Apricot, dried 0 .10 0000 6.000 1 . 000 1202014000 12B Apric ot, juice 0.100000 1 . 000 1 .000 1202014001 128 Apricot, juice

- babyfood 0 .1 00000 1.000 1 . 000 1202230000 128 Nectarine 0.100000 1.000 1.000 1202260000 128 Peach 0.100000 1. 000 1 . 000 1202260001 128 Peach

- baby f ood 0 .10 0000 1 .0 00 1 . 000 1202261000 12B Peach, dried 0.100000 7.000 1 .000 1202261001 12B Peach, dried-babyfood 0.100000 7 . 000 1 . 000 1202262000 128 Peach, juice 0.100000 1.000 1.000 1202262001 12B Peach, juice-babyfood 0.100000 1 . 000 1.000 1203285000 12C Plum 0 .1 00000 1. 000 1 . 000 1203285001 12C Plum-babyfood 0 . 100000 1. 000 1 . 000 1203286000 12C Plum, prune, fres h 0.100000 1. 000 1.000 1203286001 12C Plum, prune, fresh-babyfood 0.100000 1. 000 1.000 1203287000 12C Plum, prune, dried 0.100000 5 . 000 1.000 1203287001 12C Plum, prune, dried-babyfood 0 .10 0000 5 . 000 1 . 000 1203288000 12C Plum , prune, juice 0.100000 1.400 1.00 0 1203288001 12C Plum, prune , juice -bab yfood 0.100000 1.4 00 1.000 1301055000 13A Blackberry 0.050000 1 . 000 1.000 1301056000 13A Blackberry, juice 0.050000 1 . 000 1.000 Page 9of 16

### Pro namide Di etary E xp os ure and Risk Assess ment DP Numb er : 0 42 708 2
13010S6001 13A Blackberry, juice-babyfood 

### o . osoooo 1.000 1 . 000 13010S8000 13A Boysenberry 

### o.osoooo 1.000 1.000 1301320000 13A Raspberry 

### o.osoooo 1.000 1.000 1301320001 l3A Raspberry- babyfood 

### o . osoooo l.000 l.000 1301321000 13A Raspberry, JUl.Ce 

### o.osoooo 1 . 000 1.000 1301321001 13A Ras p berry , juice-babyfood 

### o . osoooo l . 000 1 . 000 13020S7000 13B Blueberry 

### o.osoooo l. 000 1 . 000 1302057001 138 Blueberry-babyfood 0.050000 1.000 1.000 1304175000 130 Grape 0.100000 1.000 l.000 1304176000 130 Grape, juice 0.100000 1 . 200 l.000 1304176001 130 Grap e, juice-babyfood 0 . 100000 1 . 200 1.000 1304179000 130 Gr a pe , wine and sh erry 0 .1 00000 l. 000 1. 000 3100044000 31 Beef , meat 0 . 020000 l. 000 1 . 000 3100044001 31 Beef, meat-babyfood 0.020000 l. 000 1.000 310004SOOO 31 Beef, meat, dried 0.020000 1 . 920 1.000 3100046000 31 Beef, meat byproducts 0.020000 1.000 1.000 3100046001 31 Beef, meat byproducts-babyfood 0.020000 1.000 1.000 3100047000 31 Beef , fat 0 . 200000 1 . 000 1 . 000 3100047001 31 Beef , fat-babyfood 0.200000 1 . 000 1 . 000 3100048000 31 Beef , kidney 0 .400000 1.000 1.000 3100049000 31 Beef, liver 0.400000 1.000 1.000 3100049001 31 Beef , liver-babyfood 0.400000 1.000 1.000 3200169000 32 Goat, meat 0.020000 1.000 1.000 3200170000 32 Goat , meat byproducts 0 . 020000 1 . 000 1.000 3200171000 32 Goat , fat 0.200000 l. 000 1 . 000 3200172000 32 Goat, kidney 0 .400000 l.000 1. 000 3200173000 32 Goat, liver 0.400000 l. 000 1.000 3300189000 33 Horse, meat 0.020000 l.000 1.000 3400292000 34 Pork , meat byproducts 0.020000 1.000 1.000 3400292001 34 Pork, meat byproducts-babyfood 0.020000 l.000 1.000 34 00293000 34 Pork , fat 0 . 200000 1 . 000 1 . 000 3400293001 34 Pork , fat-babyfood 0.200000 1 . 000 1. 000 3400294000 34 Pork, kidney 0 .400000 1 . 000 1.000 3400295000 34 Pork, liver 0.400000 1.000 l. 000 3500339000 3S Sheep, meat 0.020000 1.000 1.000 3S00339001 35 She e p, meat-babyfood 0.020000 1. 000 1.000 3S00340000 3S Sheep, meat byproducts 0 . 020000 1.000 1.000 3S00341000 3S Shee p , fat 0 . 200000 1 . 000 1.000 3S0034100l 3S Sheep, fat-babyfood 0 . 200000 l . 000 1.000 3S00342000 3S Sheep, kidney 0.400000 l.000 1. 000 3500343000 3S Sheep, liver 0.400000 1.000 1.000 3600222000 36 Milk, fat 0.020000 1. 000 1. 000 3600222001 36 Milk, fat-baby food/infant formu 0 . 020000 1 . 000 1.000 3600223000 36 Milk , nonfat solids 0 . 020000 1.000 1. 000 3600223001 36 Milk, nonfat solids-baby food/in 0 . 020000 l . 000 1.000 3600224000 36 Milk, water 0 . 020000 1.000 1.000 3600224001 36 Milk, water-babyfood/infant form 0.020000 l.000 1.000 3600225001 36 Milk, sugar (lactose)-baby food/ 0.020000 1.000 1.000 3900312000 39 Rabbit, meat 0 . 020000 1.000 1.000 4000093000 40 Chicken , meat 0 . 020000 1 . 000 1. 000 4000093001 40 Chicken, meat-babyfood 0.020000 l.000 1.000 4000094000 40 Chicken, liver 0.200000 l.000 1.000 400009SOOO 40 Chicken, meat byproducts 0.020000 1.000 1.000 4000095001 40 Chicken, meat byproducts-babyfoo 0.020000 1.000 1 . 000 4000096000 40 Chicken , fat 0.020000 1. 000 1.000 4000096001 40 Chicken , fat-babyfood 0 . 020000 1.000 1.000 4000097000 40 Chicken , skin 0 . 020000 l.000 1.000 4000097001 40 Chicken, skin-babyfood 0.020000 1.000 1.000 S000382000 

### so Turkey, meat 0.020000 1.000 1.000 S00038200l 

### so Turkey, meat-babyfood 0.020000 1.000 1.000 S000383000 

### so Turkey, liver 0.200000 1.000 1.000 5000383001 

### so Turkey, liver-babyfood 0 . 200000 1.000 1 . 000 5000384000 50 Turk e y , meat b yp rodu cts 0 . 020000 1. 000 1 . 000 S000384001 

### so Turkey, meat byproducts-babyfood 0.020000 1. 000 1. 000 500038SOOO 

### so Turkey, fat 0 . 020000 1.000 1.000 S00038500l 

### so Turkey, fat

- babyfood 0.020000 1.000 1.000 S000386000 

### so Turkey, skin 0.020000 1.000 1 . 000 

### Page 1 0 o f16

### Pro na mid c Dietar y Ex posure and Ri s k A ssess m ent DP Number: D4 27 082
5000386001 so Turkey, skin-babyfood 0.020000 1.000 1. 000 6000301000 60 Poultry, other, meat 0.020000 1 . 000 1.000 6000302000 60 Poultry, other, liver 0 . 200000 1. 000 1. 000 6000303000 60 Poultry, other, meat byproducc:s 0.020000 1.000 1.000 6000304000 60 Poultry, other, fat 0 . 020000 1.000 1. 000 6000305000 60 Pou l try, oth er , ski n 0.020000 1.000 1. 000 7000145000 70 Egg, whole 0.020000 1.000 1.000 7000145001 70 Egg, whole-babyfood 0 . 020000 1.000 1.000 7000146000 70 Egg, white 0.020000 1. 000 1.000 7000146001 70 Egg, wh ite (solids)-babyfood 0 . 020000 1. 000 1.000 7000147000 70 Egg, yolk 0.020000 1. 000 1.000 7000147001 70 Egg, yolk-babyfood 0 . 020000 1.000 1.000 8601000000 86A water, direct, all sources 0.102000 1. 000 1.000 Surfac Full comment : Surface Wate r Lettuce Scenario 8602000000 868 water, indirect , all sources 0 . 102000 1.000 1. 000 Surfac Full comment:: Surface Water Lec:tuce Scenario 9500016000 0 Arc:ichoke, globe 0 . 010000 1 . 000 1.000 9500054000 0 Belgium endive 2 . 000000 1 . 000 1.000 9500177000 0 Grape, leaves 0 . 100000 1.000 1. 000 9500178000 0 Grape, raisin 0.100000 4.300 1.000 

### Acute Re s ults l. Foo d and Water us EPA Ver. 3 . 18, 03-08-d DEEM-FCID ACUTE Analysis for PRONAMIDE NHANES 2003-2008 2-Day Residue file: Pronamide_2014 Acuc:eDietary_FoodWac:er_ToleranceLevel . R08 Adjustment factor #2 NOT used. Analysis Date : 05-14-2015/10 : 21:10 Residue file dat ed : 05-14

- 2015/10:16 : 04 RAC/FF intake summed over 24 hours Run Comment : "Old & new uses + wac:er" 

## =

=============:======== m= ====== === ==== ===== === ================================= Summary calc ula tions--per capita: 95th Percentile 99th Percentile 99.9c:h Percentile Exposure % aRf D Exposure % aRfD Exposure % aRfD



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

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

# -------- ---------- -------- Toc:al us Population: 0.007144 17 . 86 0.011411 28.53 0.019370 48.42 All Infants: 0 . 018539 46 . 35 0.026244 65 . 61 0.035446 88 . 62 Children 1-2: 0.013317 33 .2 9 0 . 018993 47. 48 0 . 034326 85.82 Children 3-5 : 0.010013 25 . 03 0.014522 36.31 0 . 019238 48.10 Children 6-12: 0.006963 17 . 41 0 . 010501 26.25 0 . 015847 39 . 62 Youth 13-19 : 0. 005480 13 . 70 0 . 008700 21.75 0.012 4 56 31 .1 4 Adults 20-49: 0.006570 16 . 42 0.009614 24 . 04 0. 013010 32.52 Adults 50-99: 0.005893 14 . 73 0 . 008513 21. 28 0.011946 29.86 Female 13-49 : 0.006753 16 .88 0 . 009907 24.77 0.013020 32.55



### Page 11 of l6Pronamide Dietary Expo s ur e and Ri s k Asses s ment DP Number: D427082



### 2 . Foo d Onl y US EPA DEEM-FCID ACUTE Analysis for PRONAMIDE Residue file: Pronamide_2014 AcuteDietary_Food Ver. 3.18, 03-08- d NHANES 2003-2 008 2-Day Only_ToleranceLevel.R08 Adjustment factor #2 NOT used . Analysis Date : 05-14-2015/10 : 35 :1 6 RAC/FF intake summed over 24 hours Run Comment: "Old & new uses + water" Residue file dated: 05-14-2015/10:31 : 58



## ============== ======== ========================== ====== ==•=&== ====== ============ Su mmary calculations--per capit a: 95th Percentile 99th Percentile Exposure % aRfD Exposure % aRf D



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

# --------- - ---- ---- Total us Population: 0.002604 6.51 0.005170 12.93 All Infants: 0.004601 11.50 0 . 008300 20.75 Children 1-2 : 0.007317 18.29 0 . 01208 6 30.22 Children 3-5 : 0.005154 12.89 0.00816 1 20 .40 Children 6-12 : 0. 002716 6.79 0.005349 13.37 Youth 13-19 : 0 . 001725 4 . 31 0 .003080 7.70 Adults 20-49 : 0 . 001970 4 . 93 0 . 003680 9.20 Adult s 50-99: 0 . 001891 4 . 73 0 . 003327 8.32 Fema le 13-49 : 0 . 002091 5.23 0 . 004009 10.02



### C hronic Dietary Asse ss me nt Chronic Input File Filename: F:\Dietary Assessments\Pronamide\Pronamide 2014 Chron icDietary_FoodWater _Tole ranceLeve l .R08 Chemical: Pronamide 99.9th Percentile Exposure \ aRf D



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

## ------ --

0 . 009606 24.02 0 . 013269 33 .1 7 0 . 017450 43.62 0 . 011395 28 . 46 0.006475 16 .19 0 . 006818 17 . 04 0.006604 16.51 0 . 005471 13 .68 0 . 006969 17.42

RfD (Chronic) : . 04 mg /kg bw/day NOEL (Chronic) : O mg / kg bw/day RfD(Acut e) : .04 mg/kg bw/day NOEL(Acut e) : o mg/kg bw /day Date created/ last modified : 05 -1 4 -2 015/10:18 : 50 Program ver . 3.16, 03-08-d Comment: Old & new uses + water EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) jj 1 112



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

## ---- ------ ----- -- 0401150000 4A Endive 1.000000 1.000 1.000 0401204000 4A Let tuce, head 1. 000000 1.000 1.000 0401205000 4A Let tuce, leaf 2.000000 1 .0 00 1.000 New Us Full comment: New use 0401313000 4A Radicch io 2 . 000000 1.000 1.000 0402322000 48 Rhubarb 0 . 100000 1 . 000 1. 000 0603256000 6C Pea, dry 0 . 100000 1 . 000 1 . 000 0603256001 6C Pea, dry-baby food 0 . 100000 1 . 000 1.000 1100007000 11 Apple, fruit with peel 0.100000 1 . 000 1.000 1100008 000 11 Apple, peeled fruit 0.100000 1. 000 1 . 000

Page 1 2 of 16

### Pronamide
1100008001 11 1100009000 11 1100009001 11 1100010000 11 1100010001 11 1100011000 11 1100011001 11 1100266000 11 1100266001 11 1100267000 11 1100268000 11 1100268001 ll 1201090000 12A 1201090001 l2A 1201091000 12A 1201091001 12A 1202012000 12B 1202012001 12B 1202013000 12B 1202014000 l2B 1202014001 129 1202230000 129 1202260000 12B 1202260001 129 1202261000 12B 1202261001 l2B 1202262000 12B 1202262001 12B 1203285000 12C 1203285001 12C 1203286000 12C 1203286001 l2C 1203287000 12C 1203287001 12C 1203288000 12C 1203288001 12C 1301055000 13A 1301056000 l3A 1301056001 13A 1301058000 13A 1301320000 13A 1301320001 13A 1301321000 13A 1301321001 13A 1302057000 13B 1302057001 13B 1304175000 130 1304176000 130 1304176001 130 1304179000 130 3100044000 31 3100044001 31 3100045000 31 3100046000 3l 3100046001 31 3100047000 31 3100047001 31 3100048000 3l 3100049000 31 3100049001 31 3200169000 32 3200170000 32 3200171000 32 3200172000 32 320017 3000 32 3300189000 33 3400292000 34 

### Dietary Ex posure and Risk Assess ment Apple, peeled fruit -babyfood Apple, dried Appl e , dried-babyfood Appl e , j uice Apple, ju ice -babyfood Apple, sauce Apple, sauce-babyfood Pear Pear-babyfood Pear, dried Pear, juice Pear, jui ce -babyfood Cherry Cherry-babyfood Cherry, Juice Cherry, juice-babyfood Apricot Apricot-babyfood Apricot, dried Apricot, juice Apricot, juice-babyfood Nectarine Peach Peach-babyfood Peach, dried Peach, dried-babyfood Peach, juice Peach , juice-babyfood Plum Plum-babyfood Plum, prune, fresh Plum, prune, fresh-babyfood Plum, prune, dried Plum, prune , dried-babyfood Plum, prune, juice Plum, prune, juice -baby food Blackberry Blackberry. juice Blackberry, juice- baby food Boysenberry Raspberry Raspberry-babyfood Raspberry, Juice Raspberry, juice-babyfood Blueberry Blueberry-babyfood Grape Grape, juice Grape, juice-babyfood Grape, wi n e and sherry Beef, meat Beef, meat.-babyfood Beef, meat, dried Beef, meat byproducts Beef, meat byproduct.s-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 Pork, meat byproducts 0 . 100000 0 .1 00000 0.100000 0.100000 0.100000 0.100000 0 .100000 0 .1 00000 0 .1 00000 0.100000 0 .10 0000 0.100000 0.100000 0 . 100000 0 .100 000 0 . 100000 0 . 100000 0 . 100000 0 .1 00000 0.100000 0 . 100000 0 .100 000 0 .1 00000 0.100000 0.100000 0 . 100000 0 .1000 00 0.100000 0 . 100000 0 .10000 0 0.100000 0 .1000 00 0.100000 0 .1 00000 0 .10000 0 0 .1 00000 0.050000 0.050000 0.050000 0.050000 0 . 050000 0 . 050000 0 .050000 0 . 050000 0.050000 0.050000 0 .1 00000 0.100000 0 . 100000 0 . 100000 0 . 020000 0 . 020000 0.020000 0 . 020000 0 . 020000 0.200000 0.200000 0 . 400000 0 .4 00000 0 . 400000 0.020000 0 . 020000 0 . 200000 0.400000 0.400000 0 .02 0000 0.020000 

### Page 13ofl6 DP Numb er: D4 27 082

1 . 000 8 . 000 8.000 1. 300 1 . 300 1.000 1. 000 1 . 000 1. 000 6 . 250 1.000 1. 000 1 . 000 1. 000 1.500 1 . 500 1 . 000 1 .0 00 6.000 1.000 1 . 000 1.000 1. 000 1 . 000 7 . 000 7 . 000 1. 000 1. 000 1. 000 1 . 000 l . 000 1 . 000 5 . 000 5.000 1.400 1.400 1 . 000 1 . 000 1 . 000 1.000 1 . 000 1.000 1 . 000 1. 000 1. 000 1 . 000 1. 000 1. 200 1. 200 1 . 000 1.000 1 . 000 1 .9 20 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 l.000 1.000 1 . 000 l.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

### Pronamide Di etary Exposure and Ri sk Assessment
340029 2 001 34 Pork, meat byproducts -babyfood 0 . 020000 3400293000 34 Pork , fat 0 . 200000 340029300 1 34 Pork, fat-babyfood 0 .2 00000 3400294000 34 Pork, k i dney o .4 00000 3400295000 34 Pork, liver 0.400000 350033 9000 35 Sheep , m eat 0.020000 3500339001 35 Sheep , meat-babyfood 0.020000 3500340000 35 Sheep, meat byproducts 0 . 020000 3500341000 35 Sheep, fat 0 .200000 3500341001 35 Sheep, fat-babyfood 0 . 200000 3500342000 35 Sheep, kidney 0 . 400000 3500343000 35 Sheep, liver 0 . 400000 3600222000 36 Milk, fat 0 . 020000 3600222001 36 Milk, fat-baby food/infant formu 0 . 020000 3600223000 36 Milk, nonfat solids 0 . 020000 360022300 1 36 M ilk , nonfat soli ds

- baby food/in 0 . 020000 360022 4000 36 M ilk , wate r 0.020000 360022 4001 36 M il k, water - babyfood/infant form 0 . 020000 360022 5001 36 M ilk , s ugar (lactose)-baby food/ 0 . 020000 390031 2000 39 Rabbit, meat 0 . 020000 4000093000 40 Chicken , meat 0 .020000 4000093001 40 Chicken, meat-babyfood 0 . 020000 4000094000 40 Chicken, liver 0.200000 4000095000 40 Chicken, meat byproducts 0.020000 4000095001 40 Chicken, meat byproducts -babyfoo 0 . 020000 4000096000 40 Chicken, fat 0.020000 4000096001 40 Chicken, fat-babyfood 0 . 020000 4000097000 4 0 Chicken, skin 0 . 020000 4000097001 4 0 Chicken , skin-babyfood 0 . 020000 5000382000 50 Turkey, meat 0 .020000 50003 82001 50 Turkey , meat - babyfood 0 . 020000 5000383000 SO Turkey , liver 0 .2000 00 500038300 1 50 Turkey, liver- babyfood 0 .200000 500038 400 0 50 Turkey, meat byproducts 0 .0200 00 500038 4 001 50 Turkey, meat byproducts-babyfood 0 . 020000 5000385000 50 Turkey, fat 0.020000 5000385001 50 Turkey, fat-babyfood 0 . 020000 5000386000 50 Turkey, skin 0 . 020000 5000386001 50 Turkey, skin-baby food 0.020000 6000301000 60 Poultry, other, meat 0 . 020000 6000302000 60 Poultry, other, liver 0 .200 000 6000303000 60 Poultry, other, meat bypr oducts 0 . 020000 6000304000 60 Poultry , other, fat 0 . 020000 6000305000 60 Poultry, other , skin 0 .020000 7000145000 70 Egg , whole 0.020000 70001 4500 1 70 Egg, wh ole-ba byfood 0 . 020000 7000146000 70 Egg, white 0 . 020000 7000146001 70 Egg, white (soli ds )-babyfood 0 . 020000 70001 4 7000 70 Egg, yolk 0 . 020000 7000147001 70 Egg, yolk-babyfood 0 . 020000 8601000000 86A Water, direct , all s ources 0 . 047000 Full comment: Surface Water Lettuce Scenario 8602000000 86B Water , indirect, all sources 0 . 047000 Full comment: Surface Water Lettuce Scenario 9500016000 O Artichoke , globe 0 . 0 100 00 9500054000 O Belgium e nd ive 2 . 000000 9500177000 0 Grape , l ea ves 0.100000 9500178000 O Grape , raisin 0.100000



### Page 14 of 16 DP Number: D427082

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 1.0 00 1.000 1.000 1.000 1.000 1.000 1.000 1 . 000 1 . 000 1. 000 1. 000 4.300 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 Surfac Surfac

### P ronamide Dietary Ex pos ure an d Ri sk Assess m e nt DP Numb er: D 4270 82



### C hronic Re s ult s 

### I. Fo od a nd Wate r 

### us EPA Ver . 3.16, 03

- 08-d DEEM-FCID Chronic analysis for PRONAMIDE NHANES 2003-2008 2-day Residue file name: F : \Dietary Assessments\Pronamide\Pronamid e_ 2014 ChronicDietary_FoodWater_ToleranceLevel.R08 Adjustment factor #2 NOT used. Analysis Dat e 05-14-2015/10:22:56 Residue file dated: 05-14-2015/10:18:50 Reference dose (RfD, Chronic) 

### = .04 mg/kg bw/day COMMENT 1 : Old & new uses +water 

## ===================================================3===:=======================

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 -1 2 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 e xposure by population subgroup Total Exposure mg/kg body wt/day 0.001706 0 . 001718 0.001741 0.001434 0 . 001852 0 . 001611 0.004855 0.001557 0.003471 0.001667 0 . 001190 0.001290 0.001429 0.001622 0 . 001505 0 . 003854 0.001559 0.004410 0.003083 0.001804 0.001241 0.001534 0 . 001526 0.001558



### Page 15of 1 6 Percent of Rfd4.3% 4.3% 4.4% 3.6% 4.6% 4.0% 12 .1%

3.9% 8.7% 4.2% 3 . 0% 3.2% 3.H 4 .1% 3 .8% 9.6% 3.9% 11. 0%

7.7% 4.5% 3 .1% 3.8% 3.8% J.9%

### Pronamide Dietary Exposure and Ri s k As sess men t DP Number: 042708 2



### 2. Food O nl y us EPA Ver. 3.16, 03-08-d DEEM-FCID Chronic analysis for PRONAMIDE NHANES 2003-2008 2-day Residue file name: F : \Dietary Assessments\Pronamide\Pronamide_2014 ChronicDietary_Food_ToleranceLevel.R08 Adjustment factor #2 NOT used. Analysis Date 05-14-2015/10:44 :2 1 Residue file dated: 05-14-2015/10:32:46 Reference dose (RfD, Chronic) 

## = . 04 mg/kg bw/day COMMENT 1 : Old & new us es 

## ========= === === == ========================================= == === === == === •= == ==== Total exposure by population subgroup

Population

Subgroup Total US Population Hispani c Non-Hisp-White Non-Hisp-Black Non-Hisp-Other Nursing Inf ants Non-Nursing Infants Female 13+ PREG Children 1- 6 Children 7-12 Ma le 13-19 Female 13-19/NP Male 20+ Female 20+/NP Seniors 55+ A ll 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 mg/kg Perce nt of body wt/day Rf d



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

## --- - ---- -- -- --- - 0 . 000722 1. 8% 0 .000 778 1. 9\ 0. 000729 1. 8% 0 . 000622 1.6% 0.000718 1.8% 0. 000721 1.8% 0 . 001582 4.0% 0.000631 1. 6\ 0.002210 5. 5% 0 . 000847 2 . 1\- 0.000513 1.3% 0.000532 1.3% 0 . 000513 1.3% 0.000588 1. 5% 0 .0005 53 1.4 % 0.001316 3.3% 0.000580 1.4% 0. 002991 7.5\ 0.001887 4. 7% 0.000942 2
. 4% 0.000523 1. 3% 0.000552 1.4% 0.000555 1.4% 0 . 000580 1.4%

Page 16of16