### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D

. C

. 20460

O FF I CE OF C H E MI CA L SAFETY A ND POLL UT ION PREV ENT IO N



### MEMORANDUM

DATE:

SUBJECT: 23 -J AN-20 14

Saflufenacil. Acu te and Chronic Aggregate Di etary (Food and Drinking Water) Exposu r e and Risk Assessment for Tolerance s fo r Res i dues in/on Fish, C r ayfish
, a nd Import ed Sugarcane.

PC Code: 1 18203 DP Barcodes: D4 05 747 & D41 2991 Decision N os.: 467996 & 473447 Registration No: 7969

- 278 Petition N o s. : 2 E 8065 & 2F8 1 29 Regulatory Act ion: Sec. 3 Re g i strat ion and Tolerance With No U.S. Re gistration Risk Assessment Type: D i etary Cas e No

. : 7277 TXRNo.: N A C AS No.: 372137-35-4 MRID No.: NA 40 CFR: §180

. 649

FROM:

THROU GH : Geo r ge F. Kramer
, Ph

. D
., Se ni or Chemist**,e~~~~~~.....,~-­** 

### Risk Assessment Branch 1 (RA Bl )/Health Effects Di v isi on ( H E D ; 7509P)

Julie 

### L. V an Alst i ne,**M~H, nvir** **<? ~~Jliea!** **th ~~**  

### Thurs to n M o rt on, Chemi st**/~r ?~**  

### Dietar y Exposu r e Sc i ence Advisory Council (DESAC) HED (7509P)

and

Cha rl es 

## w

. Sm i t h III
, Bran c h C hie C

- 

# r**~** RABI
, H ED(7509 P )

### ~ 

# e:rTO: George F. Kramer
, Ph.D
., Risk Assessor RAB 1 / HED ( 7509P)

and
Kathryn Montague / Be tha n y Benb ow, P M T eam 23 Registrati on Division ( RD ) (7505P)

Executive S ummary

A cute and ch ronic dietary-exposure and r i sk assess ment s w ere co nducted u si n g the Die ta ry Exposure Eva lu at ion Model -Food Consumption In t ak e Database ( D E EM- FCID, ve r. 3.16) 

### wh i ch incorporates consumptio n data from Unite d States Department of Agricul t ure (US D A) Na ti onal Health and Nutrition Exa mination Survey, Wha t We Ea t in Amer i ca , (N H ANES / WWEIA; 2003-2008)

. These analyses were performed to support tolerance petitions

P

age 1 o f 18Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747



### for residues in/on fish, crayfish, and sugarcane. This memorandum was reviewed by two peer reviewers of the DESAC, per DESAC SOP 2012.1.

Acute Dietary (Food and Drinking Water) Exposure Results and Characteriza t ion

The unrefined acute ana l ysis assumed 100% crop treated (CT), DEEM 7.81 defau l t concentration factors
, and to l erance-level residues for all commodities [except for cottonseed; sunflower subgroup 208; soybean, seed; vegetab l e, legume
, subgroup 6C
, pea and bean (except soybean); and rapeseed subgroup 20A

- see Section II for more details). The drinking water est i mate from the proposed U.S. use was incorporated directly into the dietary assessment using the concentration for surface water ge n erate d by Tier I Rice modeling. The ac u te d i e t ary r i sk
est im ates (food 

## + water) at th e 95th 

### percen t ile are < 1% of t h e acute po p ula t ion

- a d j u ste d dose (aPAD) for t h e general U.S

. p opulat i o n and <1% of the aPAD for t he mos t highly ex p os e d pop u la t ion subgro u p (all i nf a nt s (<1 y e ar old)), and are thus below H E D 's leve l of con c ern ( < 1 00% aPAD).

Chronic Dietary (Food and D r inking W ater) Exposure Resu l ts and Charac t erization

The unrefined chronic analysis assumed 100% CT
, DEEM 7.81 defau l t concentratio n factors
, and to l erance-level residues for a ll commodities [except for cottonseed; sunflower subgroup 208; soybean, seed; vegetable, legume, subgroup 6C
, pea and bean (excep t soybean); and rapeseed subgroup 20A

- see Section II for more details ]. The drinking water estimate from the proposed U.S. use was incorporated directly i nto the dietary assessment using the concentration for surface water generated by Tier I Rice mode li ng. The chronic dietary risk estimates (food 

## + water) 6.7% of the chron i c population

- adjusted dose (cPAD) for the general U.S. population and 1 8 % of the cP AD for the most highly exposed population subgroup (all i nfants ( <1 year o l d)) and are thus be l ow HED's l evel of co n cern (<100% cPAD).

Cancer Dietary (Food and D rinking Water) Exposure Results and Charac t erization

Saflufenaci l is classifie d as "not lik e l y ca r c in ogen i c to humans. " The r efore, cance r risk i s n ot a
co n ce rn fo r th is c h em i cal.



### I. I nt ro du ct i on


### Dietary risk assessment incorporates both exposure and toxic i ty of a given pesticide. For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptab l e dose (i.e.
, t he dose wh i ch HED has concluded will result i n no unreasonable adve r se health effects). This dose i s referred to as the PAD. The PAD is equiva l ent to point of departure ( P OD, NOAEL
, LOA E L, i.e.) divided by the required uncertainty or safe ty factors.

For acute and non-cancer chronic exposures , HED is concerned when est i mated dietary risk exceeds l 00% of the PAD. References which discuss the acute and chronic risk assessments in

more detail are ava i lable on the EPA/pesticides web site: "Avai lable Informa ti on on Assessing Exposure from Pesticides
, A Use r 's Gu i de," 21-JUN-2000, web link: http: //www .cpa.gov / fedrgstr/EPA -P EST/ 2000 / July / Day-12 /6 06l.pdf; or see S O P 99.6 (20-AUG1999)

.

P age 2 of 1 8Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 3 of 18 

### The most recent dietary exposure risk assessment for safl ufenacil was conducted by G. Kramer (Memo, 04

- AUG

- 2011
, D 3 9 0 923 ).

II. Residue Information

Saflufenacil Proposed and Registered Uses:

Saflufenacil is currently registered for use on legume vegetabl es ( crop group 06), the foliage of legume vegetables ( crop group 07), cereal grains ( crop group 15), forage, fodder
, and straw of cereal grains ( crop group 16), cottonseed ( subgroup 20C )
, r apeseed ( subgroup 20A ), and

s unflower ( subgroup 20B )

. BASF has submitted a tolerance petition for residues in/on importe d sugarcane (PP# 2E8065 )

. In addition, BASF has submitted a proposal to allow post

- emergence application of saflufenacil to rice in the U.S. and to permit crayfish and fish to be grown in the treated rice fields (PP# 2F8129 )

. Residues of Concern: The nature of the residue in plants, rotational crops, and livestock is adequately understood based on acceptable metabolism studies conducted on corn (preplant application), soybean (preplant and pre harvest application), tomato (preplant application), rotatio nal crops, lactating goats, and laying hens. The HED Residues of Concern Knowledgebase Subcommittee (ROCKS) determined that residues of concern for the tolerance expression and risk assessment in plants consist of saflufenacil, M800H11, and M800H35 ; and
t hat saflufenacil is the only residue of concern in livestock (Memo, B. Daiss, 1/6/09; D 359645 ). An additional major metabolite ( M800H02 ) that is not included in the tolerance expression was observed in soybean seed following pre harvest (harvest aid) application . As the structure of M800H02 is closely related to the parent compound and it is the precursor of the regulated metabolite M800H11, RAB1 conclude d that M800H02 is a residue of concern for risk

assessment purposes in crops following post

- emerg ence treatment.
The petitioner submitted a metabolism study on rice following post

- emergence treatment . The combined residues of saflufenacil, M800H11, and M800H35 in rice forage were 71

- 89% of the TRR. The only other major metabolite was M800H02, whic h accounted for 4

- 1 6 % of the TRR. HED thus concludes that current tolerance expression adequately accounts for the residues of concern in sugarcane. Additional ly, as residues of the parent compound were generally less than the limit of quantitation (LOQ) in the field trials, M800H02 does not need to be included as a residue of concern for risk

- assessment purposes for sugarcane . In rice grain, the combined residues of saflufenacil and all metabolites was <10% of the TRR (≤0.01 ppm). HED thus concludes th at current tolerance expression adequately accounts for the residues of concern in rice grain following post

- emergence foliar application to rice.

Table 1. Summary of Metabolites and Degradates to be I ncluded in the Risk Assessment

. Matrix Residues I ncluded in Risk Assessment Residues I ncluded in Tolerance Expression

Plants Primary Crops (preplant

application) Saflufenacil + M800H11, M800H35 Saflufenacil + M800H11, M800H35 Primary Crops (pre harvest application) * Saflufenacil + M800H11, M800H02
, M800H35 Rotational Crops Saflufenacil + M800H11, M800H35Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

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Page 4 of 18 Table 1. Summary of Metabolites and Degradates to be I ncluded in the Risk Assessment

.
Matrix Residues I ncluded in Risk Assessment Residues I ncluded in Tolerance Expression

Livestock Ruminants Saflufenacil Saflufenacil

Poultry

Drinking Water Saflufenacil + M800H 0 1, M800H 0 2, M800H 07, M800H 0 8, M800H 15, M800H 22, P roduct 8 Not Applicable

* Excluding sugarcane and rice

.


### Established Tolerances: Permanent tolerances for “ saflufenacil, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of saflufenacil, 2

- chloro

- 5

- [3,6

- dihydro

- 3

- methyl

- 2,6

- dioxo

- 4

- (trifluoromethyl)

- 1(2 H )

- pyrimidinyl]

- 4

- fluoro

- N

- [[methyl(1

- methylethyl)amino]sulfonyl]benzamide, and its metabolites N

- [2

- chloro

- 5

- (2,6

- dioxo

- 4

- (trifluoromethyl)

- 3,6

- dihydro

- 1(2 H )

- pyrimidinyl)

- 4

- fluorobenzoyl]

- N '

- isopropylsulfamide and N

- [4

- chloro

- 2

- fluoro

- 5

- ({[(isopropylamino)sulfonyl]amino}carbonyl)phenyl]urea, calculated as the stoichiometric equivalent of saflufenacil ” are currently established under 40 CFR §180.649 (a)(1) for r esidues on citrus fruit ( Crop Group 10), pome fruit ( Crop Group 11), stone fruit ( Crop Group 12), grape, tree nuts ( Crop Group 1 4 ), legume vegetables ( crop group 06), the foliage of legume vegetables ( crop group 07), cereal grains ( crop group 15), forage, fodder
, and straw of cereal grains ( crop group 16), cottonseed ( subgroup 20C ), r apeseed ( subgroup 20A ),

s unflower ( subgroup 20B )
, coffee, banana, and mango

. Additionally, permanent tolerances for

“ saflufenacil, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only saflufenacil, 2

- chloro

- 5

- [3,6

- dihydro

- 3

- methyl

- 2,6

- dioxo

- 4

- (tri fluoromethyl)

- 1(2 H )

- pyrimidinyl]

- 4

- fluoro

- N

- [[methyl(1

- methylethyl)amino]sulfonyl]benzamide ” are currently established under 40 CFR §180.649 (a)(2) for residues on livestock commodities

.
Recommended Tolerances: Based on the residue chemistry data submitte d with the current petition s , HED recommended for establishment of the following tolerances (G. Kramer
, 02

- APR

- 2013 ; D 405746 and G. Kramer
, 23

- JAN

- 2014 ; D407976 ):

Table 2. Tolerance Summary for Saflufenacil. Commodity Recommended Tolerance (ppm) 40 CFR §180.649(a)( 1 ) Sugarcane, cane 0.05 Sugarcane, molasses 0.08 40 CFR §180.649(a)(2) Fish

- freshwater finfish 0.01 Fish

- shellfish, crustacean 0.01



### Residue Data used for Acute and Chronic Assessments:

The acute and chronic assessments were based on the assumption of tolerance

- level residues for all commodities, except for cottonseed; sunflower subgroup 20 B ; soybean, seed; vegetable, legume, subgroup 6C, pea and bean (except soybean); and rapeseed subgroup 20A . For the se crops , residues were also based on the recommended tolerances; however, a correction factor was applied to the tolerance level to account for the M800H02 metabolite included in the risk
assessment as a result of preharvest uses . The additional metabolite, M800H02 , w as observed inSaflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 5 of 18 

### the metabolism studies of preharvest

- treated soybean seed, comprising 2 6

. 3 % of the total radioactive residues ( G. Kramer, 3/ 24 / 11 ; DP# 381129 ). Since the toxicity of the M800H02 is expected to be comparable to the parent compound, it was included in the risk assessment for preharvest uses , but not in the tolerance expression. To account for this additional toxicity exposure, the recommended tolerance level was multiplied by a correction factor of 1.7X , where 1. 7 = (Metabolites in Risk Assessment)/(Metabolites in Tolerance Expression).

1.7 = (Saflufenacil + M800H11 + M800H02 + M800H35)/(Saflufenacil + M800H11 + M800H35) = (2 6

. 1 % + 10. 9 % + 2 6

. 3 % + 0% )/( 2 6

. 1 % + 10. 9 % + 0% )


### Therefore, in the acute and chronic assessments , a residue of 0.34 ppm was used for cottonseed; a residue of 1.7 ppm was used for sunflower subgroup 20 B ; a residue of 0.17 ppm was used for soybean, seed; a residue of 0.51 ppm was used for vegetable, legume, subgroup 6C, pea and bean (except soybean); and a residue of 0.76 ppm was used for rapeseed subgroup 20A (see Table 3 ).

Table 3 . Corrected Residues Used in the Chronic Assessment. Crop Group and/or Commodity Tolerance (ppm) 2 Corrected Residue Used in Dietary Assessment s 1 Cottonseed Subgroup 20C 0.20 0. 34 Sunflower Subgroup 20B 1.0 1. 7 Soybean, seed 0.10 0.1 7 Vegetable, Legume, Subgroup 6C, pea and bean (except soybean) 0.30 0. 51 Rapeseed Subgroup 20A 0.45 0. 76

1 Tolerance level residues were corrected to account for the addition of the M800H02 metabolite which was observed in the metabolism studies of preharvest

- treated soybean seed . The recommended tolerance level was multiplied by a correction factor of 1. 7 X
, where 1. 7 = (Metabolite s in Risk Assessment)/(Metabolite s in Tolerance Expression). 2 These are HED

- recommended tolerances based on Petition s 0F7744 and 0F7766

. 

### Processing Factors: DEEM 7.81 default processing factors were used for all processed commodit ies (where provided).

III. Percent Crop Treated Information

The acute and chronic assessments were based on the assumption of 100% CT for all commodities.

IV

. Drinking Water Data

The Estimated Drinking Water Concentrations (EDWC s ) used in the dietary exposure risk assessment were provided by the Environmental Fate and Effects Division (EFED) in a memorandum dated 12

- AUG

- 2013 (Memo, M

. Ruhman ; DP# 413592 ) . Water residues were incorporated directly into the DEEM

- FCID into the food c ategories “water, direct, all sources” and “water, indirect, all sources.”

Screening EDWC s ( Table 4 ) of saflufenacil were generated with surface water generated by Tier I Rice modeling

. Modeled application rates represent the maximum use patterns for dry

- seeded rice: the 1 st 

### application at planting, the second application 14 days after planting and flooding at 45 days after planting . Remaining model input parameters were chosen according to currentSaflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

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Page 6 of 18 

### guidance (USEPA, 2002). EDWCs reflect exposure to safl ufenacil and all degradates of concern in drinking water ( Table 1 ).

Table 4 . Tiered EDWCs for Proposed Saflufenacil Uses.

Source (Tier: Model) 1

- in

- 10

- year Peak Exposure ( ppb ) 1

- in

- 10

- year Annual Mean Exposure ( ppb ) Surface water ( Tier I : Rice Model ) 13 3 (used in acute analysis) 1 2 0 (used in chronic analysis) Ground water (Tier II: PRZM GW) 69.2 51.5



### V. DEEM

- FCID Program and Consumption Information

Saflufenacil 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 reported consumption of more than 20,000 individuals over two non

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

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

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

- cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups. However, for acute exposure assessment, consumption data are retained as individual consumption events. Based on analysis of the 2003

- 2008 WWEIA co nsumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, adults 20

- 49, females 13

- 49, and adults 50

- 99 years old.

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

form (e.g., orange or orange juice) on the food commodity residue l ist is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food for ms 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 an acute exposure assessment, individual one

- day food consumption data are used on an individual

- by

- individual basis. The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a determinis tic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who repo rted eating relevant commodities/food forms) and a per

- capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis. In accordance with HED policy, per capita exposure and risk are reported for analyses performed at all levels of refinement. However, for deterministic assessments, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

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Page 7 of 18 

### V I

. Toxicological Information

Table 5

. Summary of Toxicological Doses and Endpoints for S aflufenacil for Use in Dietary Human

- Health Risk

Assessments. Exposure/ Scenario Point of

Departure Uncertainty/

FQPA SF s RfD, PAD,

LOC for Risk Assessment Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children) NOAEL = 500

mg/kg/day UF A = 10X

UF H = 10X

FQPA SF = 1X Acute RfD =

5.0 mg/kg

aPAD = 5.0 mg/kg Acute Neurotoxicity Study

.

NOAEL = 500 (M) and 2000 (F) mg/kg/day

. LOAEL was 2000 mg/kg/day (males) based on the decreased motor activity representing mild and transient systemic toxicity. LOAEL was not established for females. Chronic Dietary (All Populations) NOAEL = 4.6

mg/kg/day UF A = 10X

UF H = 10X

FQPA SF = 1X Chronic RfD

= 0.046 mg/kg/day

cPAD = 0.046 mg/kg/day Chronic/Carcinogenicity (mouse)

.

NOAEL = 4.6 mg/kg bw/d (males) and 18.9 mg/kg bw/d (females). LOAELs = 13.8 mg/kg bw/d (males) and 38.1 mg/kg bw/day (females) based on decreased red blood cells, hemoglobin, and hematocrit and porphyria observed in the satellite group. Cancer (oral, dermal, inhalation) Classification: Not carcinogenic based on the lack of tumors in the mouse and rat carcinogenicity

studies and lack of mutagenicity.

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 (in traspecies). FQPA SF = FQPA Safety Factor. PAD = population

- adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.



### V I I. Results/Discussion

For acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The DEEM

- FCID analyses estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 6 are for 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, females 13

- 49 years old, adults 20

- 49 years old, and adults 50

- 99 years old.

Results of Acut e and Chronic Dietary Exposure Analyses

The acute dietary risk for food and drinking water utilized (<1 % of the aPAD for the U.S. population. The acute dietary risk for the highest exposed population subgroup, a ll i nfants (<1 year old)
, i s <1 % of the aPA D at the 95 th 

### percentile

. The chronic dietary risk for food and drinking water utilized 6.7 % of the cPAD for the U.S. population. T he chronic dietary risk for the highest exposed population subg roup, a ll i nfants (<1 year old)
, i s 18 % of the cPAD.

The results of the acute and chronic dietary exposure analyses are reported in Table 6

.Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 8 of 18 Table 6 . Summary of Dietary (Food and Drinking Water) Exposure Risk for Saflufenacil

.

Population Subgroup Acute Dietary (95 th Percentile) Chronic Dietary Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD General U.S. Population 0.008199 <1 0.003105 6.7 All Infants (<1 year old) 0.026256 <1 0.008506 18 Children 1

- 2 years old 0.014271 <1 0.005786 1 3 Children 3

- 5 years old 0.011052 <1 0.004637 1 0 Children 6

- 12 years old 0.008171 <1 0.003098 6. 7 Youth 13

- 19 years old 0.006825 <1 0.002347 5. 1 Adults 20

- 49 years old 0.007652 <1 0.002943 6. 4 Adults 50

- 99 years old 0.006909 <1 0.002867 6. 2 Females 13

- 49 years old 0.007849 <1 0.002923 6. 4 *The values for the highest exposed population for each type of risk assessment are bolded.



### V I II. Characterization of Inputs/Outputs

These acute and chronic dietary exposure and risk estimates are conservative since they assumed 100% CT, DEEM 7.81 default concentration factors
, and tolerance

- level or higher residues and were based on screening level estimates of drinking water concentrations generated by Tier I Rice modeling . They could be further refined through the use of anticipated residues, empirical processing factors and % CT data, as well as refined drinking water estimates.

IX

. Conclusions

The acute and chronic dietary exposure and risk analys e s using DEEM

- FCID indicates that dietary risk s to saflufenacil from food and drinking water are well below HED’s levels of concern for this pesticide. Estimated acute dietary risk s are <1 % of the a PAD at the 95 th 

### percentile for the general U.S. population and all population subgroups and estimated chronic dietary risks are ≤ 18 % of the cPAD for the general U.S. population and all population subgroups

. HED is confident that the assessment does not underestimate risk to the general U.S. population or any population subgroup.

X. List of Attachments

· Acute Food plus Water Residue Input File.

· Acute Results File.

· Chronic Food plus Water Residue Input File.

· Chronic Results File.

cc: G. Kramer (RAB1) RDI : DESAC ( 8 / 8 / 1 3 ) G.F. Kramer: S10 95 7 :PY

- S:(703)305

- 5079:7509P:RAB1Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 9 of 18 

### Acute Food plus Water Residue Input File

Filename: C: \ Documents and Settings \ gkramer \ My Documents \ Gk \ ##Saflufenacil \ SAFLUFENACIL_ACUTE.R08 Chemical: Saflufenacil RfD(Chronic): .046 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day
R fD(Acute): 5 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 08

- 08

- 2013/09:20:20 Program ver. 3.16, 03

- 08

- d

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 0600347000 6 Soybean, seed 0.170000 1.000 1.000 0600349000 6 Soybean, soy milk 0.170000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.170000 1.000 1.000 0600350000 6 Soybean, oil 0.170000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.170000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.030000 1.000 1.000 0601043001 6A Bean, snap, succulent

- babyfood 0.030000 1 .000 1.000 0601257000 6A Pea, edible podded, succulent 0.030000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.030000 1.000 1.000 0602033000 6B Bean, cowpea, succulent 0.030000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.030000 1.000 1.000 0602255000 6B Pea, succulent 0.030000 1.000 1.000 0602255001 6B Pea, succulent

- babyfood 0.030000 1.000 1.000 0602259000 6B Pea, pigeon, succule nt 0.030000 1.000 1.000 0603030000 6C Bean, black, seed 0.510000 1.000 1.000 0603032000 6C Bean, broad, seed 0.510000 1.000 1.000 0603034000 6C Bean, cowpea, seed 0.510000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.510000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.510000 1.000 1.000 0603038000 6C Bean, lima, seed 0.510000 1.000 1.000 060303900 0 6C Bean, mung, seed 0.510000 1.000 1.000 0603040000 6C Bean, navy, seed 0.510000 1.000 1.000 0603041000 6C Bean, pink, seed 0.510000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.510000 1.000 1.000 0603098000 6C Chickpea, seed 0.510000 1.000 1.000 0603098001 6C Chickpea, seed

- babyfood 0.510000 1.000 1.000 0603099000 6C Chickpea, flour 0.510000 1.000 1.000 0603182000 6C Guar, seed 0.510000 1.000 1.000 0603182001 6C Guar, seed

- babyfood 0.510000 1.000 1.000 0603203000 6C Lentil, s eed 0.510000 1.000 1.000 0603256000 6C Pea, dry 0.510000 1.000 1.000 0603256001 6C Pea, dry

- babyfood 0.510000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.510000 1.000 1.000 0603348000 6C Soybean, flour 0.170000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.170000 1.000 1.000 1001106000 10A Citron 0.030000 1.000 1.000 1001107000 10A Citrus hybrids 0.030000 1.000 1.000 1001108000 10A Citrus, oil 0.030000 1.000 1.000 1001240000 10A Orange 0.030000 1.000 1.000 1001241000 10A Orange, juice 0.030000 1.800 1.000 1001241001 10A Orange, juice

- babyfood 0.030000 1.800 1.000 1001242000 10A Orange, peel 0.030000 1.000 1.000 1001369000 10A Tangerine 0.030000 1.000 1.000 1001370000 10A Tangerine, juice 0.030000 2.300 1.000 1002197000 10B Kumquat 0.030000 1.000 1.000 1002199000 10B Lemon 0.030000 1.000 1.00 0 1002200000 10B Lemon, juice 0.030000 2.000 1.000 1002200001 10B Lemon, juice

- babyfood 0.030000 2.000 1.000 1002201000 10B Lemon, peel 0.030000 1.000 1.000 1002206000 10B Lime 0.030000 1.000 1.000 1002207000 10B Lime, juice 0.030000 2.000 1.000 1002207001 10B Lime, juice

- babyfood 0.030000 2.000 1.000 1003180000 10C Grapefruit 0.030000 1.000 1.000 1003181000 10C Grapefruit, juice 0.030000 2.100 1.000 1003307000 10C Pummelo 0.030000 1.000 1.000 1100007000 11 Apple, fruit with peel 0.030000 1.000 1.000 1100008000 11 Apple, peeled fruit 0.030000 1.000 1.000 1100008001 11 Apple, peeled fruit

- babyfood 0.030000 1.000 1.000Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 10 of 18 1100009000 11 Apple, dried 0.030000 8.000 1.000 1100009001 11 A pple, dried

- babyfood 0.030000 8.000 1.000 1100010000 11 Apple, juice 0.030000 1.300 1.000 1100010001 11 Apple, juice

- babyfood 0.030000 1.300 1.000 1100011000 11 Apple, sauce 0.030000 1.000 1.000 1100011001 11 Apple, sauce

- babyfood 0.030000 1.000 1.000 1100129000 11 Crabapple 0.030000 1.000 1.000 1100210000 11 Loquat 0.030000 1.000 1.000 1100266000 11 Pear 0.030000 1.000 1.000 1100266001 11 Pear

- babyfood 0.030000 1.000 1.000 1100267000 11 Pear, dried 0.030000 6.250 1.000 1100268000 11 Pear, juice 0.030000 1.000 1.000 1100268001 11 Pear, juice

- babyfood 0.030000 1.000 1.000 1100310000 11 Quince 0.030000 1.000 1.000 1201090000 12A Cherry 0.030000 1.000 1.000 1201090001 12A Cherry

- babyfood 0.030000 1.000 1.000 1201091000 12A Cherry, juice 0.030000 1.500 1.000 1201091001 12A Cherry, juice

- babyfood 0.030000 1.5 00 1.000 1202012000 12B Apricot 0.030000 1.000 1.000 1202012001 12B Apricot

- babyfood 0.030000 1.000 1.000 1202013000 12B Apricot, dried 0.030000 6.000 1.000 1202014000 12 B Apricot, juice 0.030000 1.000 1.000 1202014001 12B Apricot, juice

- babyfood 0.030000 1.000 1.000 1202230000 12B Nectarine 0.030000 1.000 1.000 1202260000 12B Peach 0.030000 1.000 1.000 1202260001 12B Peach

- babyfood 0.030000 1.000 1.000 1202261000 12B Peach, dried 0.030000 7.000 1.000 1202261001 12B Peach, dried

- babyfood 0.030000 7.000 1.000 1202262000 12B Peach, juice 0.030000 1.000 1.000 1202262001 12B Peach, juice

- babyfood 0.030000 1.000 1.000 1203285000 12C Plum 0.030000 1.000 1.000 1203285001 12C Plum

- babyfood 0.030000 1.000 1.000 1203286000 12C Plum, prune, fresh 0.030000 1.000 1.000 1203286001 12C Plum, prune, fresh

- babyfood 0.030000 1.000 1.000 1203287000 12C Plum, prune, dried 0.030000 5.000 1.000 1203287001 12C Plum, prune, dried

- babyfood 0.030000 5.000 1.000 1203288000 12C Plum, prune, juice 0.030000 1.400 1.000 1203288001 12C Plum, prune, juice

- babyfood 0.030000 1.400 1.000 1304175000 13D Grape 0.030000 1.000 1.000 1304176000 13D Grape, juice 0.030000 1.200 1.000 1304176001 13D Grape, juice

- babyfood 0.030000 1.200 1.000 1304179000 13D Grape, wine and sherry 0.030000 1.000 1.000 1400003000 14 Almond 0.030000 1.000 1.000 1400003001 14 Almond

- babyfood 0.030000 1.000 1.000 14000040 00 14 Almond, oil 0.030000 1.000 1.000 1400004001 14 Almond, oil

- babyfood 0.030000 1.000 1.000 1400059000 14 Brazil nut 0.030000 1.000 1.000 1400068000 14 Butternut 0.030000 1.000 1.000 1400081000 14 Cashew 0.030000 1.000 1.000 1400092000 14 Chestnut 0.030000 1.000 1.000 1400155000 14 Hazelnut 0.03000 0 1.000 1.000 1400156000 14 Hazelnut, oil 0.030000 1.000 1.000 1400185000 14 Hickory nut 0.030000 1.000 1.000 1400213000 14 Macadamia nut 0.030000 1.000 1.000 140026 9000 14 Pecan 0.030000 1.000 1.000 1400282000 14 Pistachio 0.030000 1.000 1.000 1400391000 14 Walnut 0.030000 1.000 1.000 1500025000 15 Barley, pearled barley 0.030000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 0.030000 1.000 1.000 1500026000 15 Barley, flour 0.030000 1.000 1.000 1500026001 15 Barley, f lour

- babyfood 0.030000 1.000 1.000 1500027000 15 Barley, bran 0.030000 1.000 1.000 1500065000 15 Buckwheat 0.030000 1.000 1.000 1500066000 15 Buckwheat, flour 0.030000 1.000 1.000 1500120000 15 Corn, field, flour 0.030000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.030000 1.000 1.000 1500121000 15 Corn, field, meal 0.030000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.030000 1.000 1.000 1500122000 15 Corn, field, bran 0.030000 1.000 1.000 1500123000 15 Corn, field, starch 0.030000 1.000 1.000 1500123001 15 Corn, f ield, starch

- babyfood 0.030000 1.000 1.000Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 11 of 18 1500124000 15 Corn, field, syrup 0.030000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.030000 1.500 1.000 1500125000 15 Corn, field, oil 0.030000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.030000 1.000 1.000 1500126000 15 Corn, pop 0.030000 1.000 1.000 1500127000 15 Corn, sweet 0.030000 1.000 1.00 0 1500127001 15 Corn, sweet

- babyfood 0.030000 1.000 1.000 1500226000 15 Millet, grain 0.030000 1.000 1.000 1500231000 15 Oat, bran 0.030000 1.000 1.000 1500232000 15 Oat, flour 0.030000 1.000 1.000 1500232001 15 Oat, flour

- babyfood 0.030000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 0.030000 1.000 1.000 1500233001 15 Oat, groats/rolled oats

- babyfo od 0.030000 1.000 1.000 1500323000 15 Rice, white 0.030000 1.000 1.000 1500323001 15 Rice, white

- babyfood 0.030000 1.000 1.000 1500324000 15 Rice, brown 0.030000 1.000 1.000 1500324001 15 Rice, brown

- babyfood 0.030000 1.000 1.000 1500325000 15 Rice, flour 0.030000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 0.030000 1.000 1.000 1500326000 15 R ice, bran 0.030000 1.000 1.000 1500326001 15 Rice, bran

- babyfood 0.030000 1.000 1.000 1500328000 15 Rye, grain 0.030000 1.000 1.000 1500329000 15 Rye, flour 0.030000 1.000 1.000 1500344000 15 Sorghum, grain 0.030000 1.000 1.000 1500345000 15 Sorghum, syrup 0.030000 1.000 1.000 1500381000 15 Triticale, flour 0.030000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.030000 1.000 1.000 1500401000 15 Wheat, grain 0.030000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.030000 1.000 1.000 1500402000 15 Wheat, flour 0.030000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.030000 1.000 1.000 1500403000 15 Wheat, germ 0.030000 1.000 1.000 1500404000 15 Wheat, bran 0.030000 1.000 1.000 1500405000 15 Wild rice 0.030000 1.000 1.000 2001163000 20A Flax seed, oil 0.760000 1.000 1.000 2001319000 20A Rapeseed, oil 0.760000 1.0 00 1.000 2001319001 20A Rapeseed, oil

- babyfood 0.760000 1.000 1.000 2001336000 20A Sesame, seed 0.760000 1.000 1.000 2001336001 20A Sesame, seed

- babyfood 0.760000 1.000 1.000 2001337000 20 A Sesame, oil 0.760000 1.000 1.000 2001337001 20A Sesame, oil

- babyfood 0.760000 1.000 1.000 2002330000 20B Safflower, oil 1.700000 1.000 1.000 2002330001 20B Safflower, oil

- babyfood 1.700000 1.000 1.000 2002364000 20B Sunflower, seed 1.700000 1.000 1.000 2002365000 20B Sunflower, oil 1.700000 1.000 1.000 2002365001 20B Sunflower, oil

- babyfood 1.700 000 1.000 1.000 2003128000 20C Cottonseed, oil 0.340000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 0.340000 1.000 1.000 3100044000 31 Beef, meat 0.010000 1.000 1.000 3100 044001 31 Beef, meat

- babyfood 0.010000 1.000 1.000 3100045000 31 Beef, meat, dried 0.010000 1.920 1.000 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 3100046001 31 Beef, meat by products

- babyfood 0.050000 1.000 1.000 3100047000 31 Beef, fat 0.010000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0.010000 1.000 1.000 3100048000 31 Beef, kidney 0.0 50000 1.000 1.000 3100049000 31 Beef, liver 2.500000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 2.500000 1.000 1.000 3200169000 32 Goat, meat 0.010000 1.000 1.000 32 00170000 32 Goat, meat byproducts 0.050000 1.000 1.000 3200171000 32 Goat, fat 0.010000 1.000 1.000 3200172000 32 Goat, kidney 0.050000 1.000 1.000 3200173000 32 Goat, liver 2.500000 1.000 1.000 3300189000 33 Horse, meat 0.010000 1.000 1.000 3400290000 34 Pork, meat 0.010000 1.000 1.000 3400290001 34 Pork, meat

- babyfood 0 .010000 1.000 1.000 3400291000 34 Pork, skin 0.010000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.020000 1.000 1.000 3400292001 34 Pork, meat byproducts

- babyfood 0.020000 1.000 1.000 3400293000 34 Pork, fat 0.010000 1.000 1.000 3400293001 34 Pork, fat

- babyfood 0.010000 1.000 1.000Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 12 of 18 3400294000 34 Pork, kidney 0.010000 1.000 1.000 3400295000 34 Pork, liver 0.800000 1.000 1.000 3500339000 35 Sheep, meat 0.010000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.010000 1.000 1.000 3500340000 35 Sheep, me at byproducts 0.050000 1.000 1.000 3500341000 35 Sheep, fat 0.010000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.010000 1.000 1.000 3500342000 35 Sheep, kidney 0.050000 1.000 1.000 3500343000 35 Sheep, liver 2.500000 1.000 1.000 3600222000 36 Milk, fat 0.010000 1.000 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.010000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.010000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.010000 1.000 1.000 3600224000 36 Milk, water 0.010000 1.000 1.000 3600224001 36 Milk, w ater

- babyfood/infant form 0.010000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.010000 1.000 1.000 3900312000 39 Rabbit, meat 0.010000 1.000 1.000 8000157000 80 Fish

- freshwater finfish 0.010000 1.000 1.000 8000158000 80 Fish

- freshwater finfish, farm ra 0.010000 1.000 1.000 8000159000 80 Fish

- saltwater finfish, tuna 0.010000 1.000 1.000 8000160000 80 Fish

- saltwater finfish, other 0.010000 1.000 1.00 0 8000161000 80 Fish

- shellfish, crustacean 0.010000 1.000 1.000 8601000000 86A Water, direct, all sources 0.133000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.133000 1.000 1.000 9500023000 O Banan a 0.030000 1.000 1.000 9500023001 O Banana

- babyfood 0.030000 1.000 1.000 9500024000 O Banana, dried 0.030000 3.900 1.000 9500024001 O Banana, dried

- babyfood 0.030000 3.900 1.000 9500115000 O Coffee, roasted bean 0.030000 1.000 1.000 9500116000 O Coffee, instant 0.030000 1.000 1.000 9500177000 O Grape, leaves 0.030000 1.000 1.000 9500178000 O Grape, raisin 0.030000 4.300 1.000 9500215000 O Mango 0.030000 1.000 1.000 9500216000 O Mango, dried 0.030000 1.000 1.000 9500217000 O M ango, juice 0.030000 1.000 1.000 9500217001 O Mango, juice

- babyfood 0.030000 1.000 1.000 9500283000 O Plantain 0.030000 1.000 1.000 9500284000 O Plantain, dried 0.030000 1.000 1.000 9500362000 O Sugarcane, sugar 0.050000 1.000 1.000 9500362001 O Sugarcane, sugar

- babyfood 0.050000 1.000 1.000 9500363000 O Sugarcane, molasses 0.080000 1.000 1.000 9500363001 O Sugarcane, molasses

- babyfood 0.080000 1.000 1.000Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 13 of 18 

### Acute Results File.

EPA Ver. 3.16, 03

- 08

- d DEEM

- FCID ACUTE Analysis for SAFLUFENACIL NHANES 20 03

- 2008 2

- Day Residue file: SAFLUFENACIL_ACUTE.R08 Adjustment factor #2 used. Analysis Date: 08

- 27

- 2013/15:12:34 Residue file dated: 08

- 27

- 2013/15:09:55 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: 0.008199 0.16 0.013523 0.27 0.025641 0.51 All Infants: 0.026256 0.53 0.034048 0.68 0.050261 1.01 Children 1

- 2: 0.014271 0.29 0.021256 0.43 0.044029 0.88 Children 3

- 5: 0.011052 0.22 0.015952 0.32 0.024441 0.49 Children 6

- 12: 0.008171 0.16 0.012431 0.25 0.018932 0.38 Youth 13

- 19: 0.006825 0.14 0.010675 0.21 0.015523 0.31 Adults 20

- 49: 0.007652 0.15 0.011132 0.22 0.016150 0.32 Adults 50

- 99: 0.006909 0.14 0.010361 0.21 0.015754 0.32 Female 13

- 49: 0.007849 0.16 0.011152 0.22 0.015397 0.31Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 14 of 18 

### Chronic Food plus Water Residue Input File.

Filename: C: \ Documents and Settings \ gkramer \ My Documents \ Gk \ ##Saflufenacil \ SAFLUFENACIL_CHRONIC.R08 Chemical: Saflufenacil RfD(Chronic): .046 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): 5 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 08

- 08

- 2013/0 9:07:46 Program ver. 3.16, 03

- 08

- d

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

---------- ---- ------------------------------- ---------- ------ ------ ------- 9500023000 O Banana 0.030000 1.000 1.000 9500024000 O Banana, dried 0.030000 3.900 1.000 9500024001 O Banana, dried

- babyfood 0.030000 3.900 1.000 9500023001 O Banana

- babyfood 0.030000 1.000 1.000 9500116000 O Coffee, instant 0.030000 1.000 1.000 9500115000 O Coffee, roasted bean 0.030000 1.000 1.000 9500177000 O Grape, leaves 0.030000 1.000 1.000 9500178000 O Grape, raisin 0.030000 4.300 1.000 9500215000 O Mango 0.030000 1.000 1.000 9500216000 O Mango, dried 0.030000 1.000 1.000 9500217000 O Mango, juice 0.030000 1.000 1.000 9500217001 O Mango, juice

- babyfood 0.030000 1.0 00 1.000 9500283000 O Plantain 0.030000 1.000 1.000 9500284000 O Plantain, dried 0.030000 1.000 1.000 9500363000 O Sugarcane, molasses 0.080000 1.000 1.000 9500363001 O Sugarcane, molasses

- babyfood 0.080000 1.000 1.000 9500362000 O Sugarcane, sugar 0.050000 1.000 1.000 9500362001 O Sugarcane, sugar

- babyfood 0.050000 1.000 1.000 0603035000 6C Bean, great northern, seed 0.510000 1.000 1.000 0603030000 6C Bean, black, seed 0.510000 1.000 1.000 0603032000 6C Bean, broad, seed 0.510000 1.000 1.000 0602031000 6B Bean, broad, succulent 0.030000 1 .000 1.000 0603034000 6C Bean, cowpea, seed 0.510000 1.000 1.000 0602033000 6B Bean, cowpea, succulent 0.030000 1.000 1.000 0603036000 6C Bean, kidney, seed 0.510000 1.000 1.000 0603038000 6C Bean, lima, seed 0.510000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.030000 1.000 1.000 0603039000 6C Bean, mung, seed 0.510000 1.000 1.000 0603040000 6C Bean, navy, seed 0.510000 1.000 1.000 0603041000 6C Bean, pink, seed 0.510000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.510000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.030000 1.000 1.000 0601043001 6A Bean, snap, succulent

- babyfood 0.030000 1.000 1.000 0603099000 6C Chickpea, flour 0.510000 1.000 1.000 0603098000 6C Chickpea, seed 0.510000 1.000 1.000 060309800 1 6C Chickpea, seed

- babyfood 0.510000 1.000 1.000 0603182000 6C Guar, seed 0.510000 1.000 1.000 0603182001 6C Guar, seed

- babyfood 0.510000 1.000 1.000 0603203000 6C Lentil, seed 0.510000 1.000 1.000 0603256000 6C Pea, dry 0.510000 1.000 1.000 0603256001 6C Pea, dry

- babyfood 0.510000 1.000 1.000 0601257000 6A Pea, edible podded, succulent 0.030000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0.510000 1.000 1.000 0602259000 6B Pea, pigeon, succulent 0.030000 1.000 1.000 0602255000 6B Pea, succulent 0.030000 1.000 1.000 0602255001 6B Pea, succulent

- babyfood 0.030000 1.000 1.000 0603348000 6C Soybean, flour 0.170000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.170000 1.000 1.000 0600350000 6 Soybean, oil 0.170000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.170000 1.000 1.000 0600347000 6 Soybean, seed 0.170000 1.000 1.000 0600349000 6 Soybean, soy milk 0.170000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.170000 1.000 1.000 1001106000 10A Citron 0.030000 1.000 1.000 1001107000 10A Citrus hybrids 0.030000 1.000 1.000 1001108000 10A Citrus, oil 0.030000 1.000 1.000 1003180000 10C Grapefruit 0.030000 1.000 1.000 1003181000 10C Grapefruit, juice 0.030000 2.100 1.000Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 15 of 18 1002197000 10B Kumquat 0.030000 1.000 1.000 1002199000 10B Lemon 0.030000 1.000 1.000 1002200000 10B Lemon, juice 0.030000 2.000 1.000 1002200001 10B Lemon, juice

- babyfood 0.030000 2.000 1.000 1002201000 10B Lemon, peel 0.030000 1.000 1.000 1002206000 10B Lime 0.030000 1.000 1.000 1002207000 10B Lime, juice 0.030000 2.000 1.00 0 1002207001 10B Lime, juice

- babyfood 0.030000 2.000 1.000 1001240000 10A Orange 0.030000 1.000 1.000 1001241000 10A Orange, juice 0.030000 1.800 1.000 1001241001 10A Orang e, juice

- babyfood 0.030000 1.800 1.000 1001242000 10A Orange, peel 0.030000 1.000 1.000 1003307000 10C Pummelo 0.030000 1.000 1.000 1001369000 10A Tangerine 0.030000 1.000 1.000 1001370000 10A Tangerine, juice 0.030000 2.300 1.000 1100009000 11 Apple, dried 0.030000 8.000 1.000 1100009001 11 Apple, dried

- babyfood 0.030000 8.000 1.000 1100007000 11 Apple, fruit with peel 0.030000 1.000 1.000 1100010000 11 Apple, juice 0.030000 1.300 1.000 1100010001 11 Apple, juice

- babyfood 0.030000 1.300 1.000 1100008000 11 A pple, peeled fruit 0.030000 1.000 1.000 1100008001 11 Apple, peeled fruit

- babyfood 0.030000 1.000 1.000 1100011000 11 Apple, sauce 0.030000 1.000 1.000 1100011001 11 Apple, sauce

- babyfood 0.030000 1.000 1.000 1100129000 11 Crabapple 0.030000 1.000 1.000 1100210000 11 Loquat 0.030000 1.000 1.000 1100266000 11 Pear 0.030000 1.000 1.000 1100267000 11 Pear, dried 0.030000 6.250 1.000 1100268000 11 Pear, juice 0.030000 1.000 1.000 1100268001 11 Pear, juice

- babyfood 0.030000 1.000 1.000 1100266001 11 Pear

- babyfood 0.030000 1.000 1.000 1100310000 11 Quince 0.030000 1.000 1.000 1202012000 12B Apricot 0.030000 1.000 1.000 1202013000 12B Apricot, dried 0.030000 6.000 1.000 1202014000 12B Apricot, juice 0.030000 1.000 1.000 1202014001 12B Apricot, juice

- babyfood 0.030000 1.000 1.000 1202012001 12B Apricot

- babyfood 0.030000 1.0 00 1.000 1201090000 12A Cherry 0.030000 1.000 1.000 1201091000 12A Cherry, juice 0.030000 1.500 1.000 1201091001 12A Cherry, juice

- babyfood 0.030000 1.500 1.000 1201090001 12 A Cherry

- babyfood 0.030000 1.000 1.000 1202230000 12B Nectarine 0.030000 1.000 1.000 1202260000 12B Peach 0.030000 1.000 1.000 1202261000 12B Peach, dried 0.030000 7.000 1.000 1202261001 12B Peach, dried

- babyfood 0.030000 7.000 1.000 1202262000 12B Peach, juice 0.030000 1.000 1.000 1202262001 12B Peach, juice

- babyfood 0.030000 1.000 1.000 1202260001 12B Peach

- babyfood 0.030000 1.000 1.000 1203285000 12C Plum 0.030000 1.000 1.000 1203287000 12C Plum, prune, dried 0.030000 5.000 1.000 1203287001 12C Plum, prune, dried

- babyfood 0.030000 5.000 1.000 1203286000 12C Plum, prune, fresh 0.030000 1.000 1.000 1203286001 12C Plum, prune, fresh

- babyfood 0.030000 1.000 1.000 1203288000 12C Plum, prune, juice 0.030000 1.400 1.000 1203288001 12C Plum, prune, juice

- babyfood 0.030000 1.400 1.000 1203285001 12C Plum

- babyfood 0.030000 1.000 1.000 1304175000 13D Grape 0.030000 1.000 1.000 1304176000 13D Grape, juice 0.030000 1.200 1.000 1304176001 13D Grape, juice

- babyfood 0.030000 1.200 1.000 1304179000 13D Grape, wine and sherry 0.030000 1.000 1.000 1400003000 14 Almond 0.030000 1.000 1.000 1400004000 14 Almond, oil 0.030000 1.000 1.000 1400004001 14 Almond, oil

- babyfood 0.030000 1.000 1.000 14000030 01 14 Almond

- babyfood 0.030000 1.000 1.000 1400059000 14 Brazil nut 0.030000 1.000 1.000 1400068000 14 Butternut 0.030000 1.000 1.000 1400081000 14 Cashew 0.030000 1.000 1.000 1400092000 14 Chestnut 0.030000 1.000 1.000 1400155000 14 Hazelnut 0.030000 1.000 1.000 1400156000 14 Hazelnut, oil 0.03000 0 1.000 1.000 1400185000 14 Hickory nut 0.030000 1.000 1.000Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

______________________________________________________________________________________

Page 16 of 18 1400213000 14 Macadamia nut 0.030000 1.000 1.000 1400269000 14 Pecan 0.030000 1.000 1.000 1400282000 14 Pistachio 0.030000 1.000 1.000 1400391000 14 Walnut 0.030000 1.000 1.000 1500027000 15 Barley, bran 0.030000 1.000 1.000 1500026000 15 Barley, f lour 0.030000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 0.030000 1.000 1.000 1500025000 15 Barley, pearled barley 0.030000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 0.030000 1.000 1.000 1500065000 15 Buckwheat 0.030000 1.000 1.000 1500066000 15 Buckwheat, flour 0.030000 1.000 1.000 1500122000 15 Corn, field, bran 0.030000 1.000 1.000 1500120000 15 Corn, field, flour 0.030000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.030000 1.000 1.000 1500121000 15 Corn, field, meal 0.030000 1.000 1.000 1500121001 15 Corn, f ield, meal

- babyfood 0.030000 1.000 1.000 1500125000 15 Corn, field, oil 0.030000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.030000 1.000 1.000 1500123000 15 Corn, field, starch 0.030000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.030000 1.000 1.000 1500124000 15 Corn, field, syrup 0.030000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.030000 1.500 1.00 0 1500126000 15 Corn, pop 0.030000 1.000 1.000 1500127000 15 Corn, sweet 0.030000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.030000 1.000 1.000 1500226000 15 Mille t, grain 0.030000 1.000 1.000 1500231000 15 Oat, bran 0.030000 1.000 1.000 1500232000 15 Oat, flour 0.030000 1.000 1.000 1500232001 15 Oat, flour

- babyfood 0.030000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 0.030000 1.000 1.000 1500233001 15 Oat, groats/rolled oats

- babyfood 0.030000 1.000 1.000 1500326000 15 Rice, bran 0.030000 1.000 1.000 1500326001 15 Rice, bran

- babyfood 0.030000 1.000 1.000 1500324000 15 Rice, brown 0.030000 1.000 1.000 1500324001 15 Rice, brown

- babyfood 0.030000 1.000 1.000 1500325000 15 R ice, flour 0.030000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 0.030000 1.000 1.000 1500323000 15 Rice, white 0.030000 1.000 1.000 1500323001 15 Rice, white

- babyfood 0.030000 1.000 1.000 1500329000 15 Rye, flour 0.030000 1.000 1.000 1500328000 15 Rye, grain 0.030000 1.000 1.000 1500344000 15 Sorghum, grain 0.030000 1.000 1.000 1500345000 15 Sorghum, syrup 0.030000 1.000 1.000 1500381000 15 Triticale, flour 0.030000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.030000 1.000 1.000 1500404000 15 Wheat, bran 0.030000 1.000 1.000 1500402000 15 Wheat, flour 0.030000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.030000 1.000 1.000 1500403000 15 Wheat, germ 0.030000 1.000 1.000 1500401000 15 Wheat, grain 0.030000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.030000 1.000 1.000 1500405000 15 Wild rice 0.030000 1.0 00 1.000 2003128000 20C Cottonseed, oil 0.340000 1.000 1.000 2003128001 20C Cottonseed, oil

- babyfood 0.340000 1.000 1.000 2001163000 20A Flax seed, oil 0.760000 1.000 1.000 2001319000 20 A Rapeseed, oil 0.760000 1.000 1.000 2001319001 20A Rapeseed, oil

- babyfood 0.760000 1.000 1.000 2002330000 20B Safflower, oil 1.700000 1.000 1.000 2002330001 20B Safflower, oil

- babyfoo d 1.700000 1.000 1.000 2001337000 20A Sesame, oil 0.760000 1.000 1.000 2001337001 20A Sesame, oil

- babyfood 0.760000 1.000 1.000 2001336000 20A Sesame , seed 0.760000 1.000 1.000 2001336001 20A Sesame, seed

- babyfood 0.760000 1.000 1.000 2002365000 20B Sunflower, oil 1.700000 1.000 1.000 2002365001 20B Sunflower, oil

- babyfood 1.700000 1.000 1.000 2002364000 20B Sunflower, seed 1.700000 1.000 1.000 3100047000 31 Beef, fat 0.010000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0.010000 1.000 1.0 00 3100048000 31 Beef, kidney 0.050000 1.000 1.000 3100049000 31 Beef, liver 2.500000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 2.500000 1.000 1.000Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

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Page 17 of 18 3100044000 31 Beef , meat 0.010000 1.000 1.000 3100046000 31 Beef, meat byproducts 0.050000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dried 0.010000 1.920 1.000 3100044001 31 Beef, meat

- babyfood 0.010000 1.000 1.000 3200171000 32 Goat, fat 0.010000 1.000 1.000 3200172000 32 Goat, kidney 0.050000 1.000 1 .000 3200173000 32 Goat, liver 2.500000 1.000 1.000 3200169000 32 Goat, meat 0.010000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.050000 1.000 1.000 3300189000 33 Ho rse, meat 0.010000 1.000 1.000 3400293000 34 Pork, fat 0.010000 1.000 1.000 3400293001 34 Pork, fat

- babyfood 0.010000 1.000 1.000 3400294000 34 Pork, kidney 0.010000 1.000 1.000 3400295000 34 Pork, liver 0.800000 1.000 1.000 3400290000 34 Pork, meat 0.010000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.020000 1.000 1.000 3400292001 34 Pork, meat byproducts

- babyfood 0.020000 1.000 1.000 3400290001 34 Pork, meat

- babyfood 0.010000 1.000 1.000 3400291000 34 Pork, skin 0.010000 1.000 1.000 3500341000 35 Sheep, fat 0.010000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.010000 1.000 1.000 3500342000 35 Sheep, kidney 0.050000 1.000 1.000 3500343000 35 Sheep, li ver 2.500000 1.000 1.000 3500339000 35 Sheep, meat 0.010000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.050000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.010000 1.000 1.000 3600222000 36 Milk, fat 0.010000 1.000 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.010000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.010000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.010000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.010000 1.000 1.000 3600224000 36 Milk, water 0.010000 1.000 1.000 3600224001 36 Milk, w ater

- babyfood/infant form 0.010000 1.000 1.000 3900312000 39 Rabbit, meat 0.010000 1.000 1.000 8000157000 80 Fish

- freshwater finfish 0.010000 1.000 1.000 8000158000 80 Fish

- freshwater finfish, farm ra 0.010000 1.000 1.000 8000160000 80 Fish

- saltwater finfish, other 0.010000 1.000 1.000 8000159000 80 Fish

- saltwater finfish, tuna 0.010000 1.000 1.000 8000161000 80 Fish

- shellfish, crustacean 0.010000 1.000 1.00 0 8601000000 86A Water, direct, all sources 0.120000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.120000 1.000 1.000Saflufenacil Dietary Exposure and Risk Assessment DP Number: 405747

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Page 18 of 18 

### Chronic Results File.

EPA Ver. 3.16, 03

- 08

- d DEEM

- FCID Chronic analysis for SAFLUFENACIL NHANES 2003

- 2008 2

- day Residue file name: C: \ Documents and Settings \ gkramer \ My Documents \ Gk \ ##Saflufenacil \ SAFLUFENACIL_CHRONIC.R08 Adjustment factor #2 used. Analysis Date 08

- 27

- 2013/14:20:33 Residue file dated: 08

- 27

- 2013/14:18:10 Reference dose (RfD, Chronic) = .046 mg/kg bw/day

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

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

---------------------------- ------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Populat ion 0.003105 6.7% Hispanic 0.003163 6.9% Non

- Hisp

- White 0.003137 6.8% Non

- Hisp

- Black 0.002661 5.8% Non

- Hisp

- Other 0.003570 7.8% Nursing Infants 0.003135 6.8% Non

- Nursing Infants 0.010906 23.7% Fema le 13+ PREG 0.002886 6.3% Children 1

- 6 0.004956 10.8% Children 7

- 12 0.002923 6.4% Male 13

- 19 0.002267 4.9% Female 13

- 19/NP 0.002426 5.3% Male 20+ 0.002777 6.0% Female 20+/NP 0.003033 6.6 % Seniors 55+ 0.002813 6.1% All Infants 0.008506 18.5% Female 13

- 50 0.002925 6.4% Children 1

- 2 0.005786 12.6% Children 3

- 5 0.004637 10.1% Children 6

- 12 0.003098 6.7% Youth 13

- 19 0.002347 5.1% Adults 20

- 49 0.002943 6.4% Adults 50

- 99 0.002867 6.2% Female 13

- 49 0.002923 6.4%

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