### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D

. C. 20460



### MEMORANDUM

DATE: 24

- JUN-2014 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Saflufenacil

. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Ex posur e and Risk Assessment for To l erances for Residues inion Barley, Wheat, Grass, and Olives.

PC Code: 118203 DP Barcode: D418585 Decision Nos.: 480698,481309, & 

### Registration Nos.: 7969

- 275, 7969-276, & 

### 7969- 486544 278 Petition Nos.: 3F8185, 3F8192, & 

### Regulatory Action: Sec

. 3 Registration 4F8229 Risk Assessment Type: Dietary Case No.: 7277 TXRNo.: NA CAS No.: 372137-35-4 MRIDNo.: NA 40 CFR: § 

### 180.649

FROM: George F. Kramer, Ph.D., Senior Chemist

# ~~,.-7cs;;..~~.:~-- Risk Assessment Branch 1 (RABI) /Hea lth Ef fects Division (HED; 7509P)

THROUGH: Douglas Dotson
, Ph.D.,

# Che~· t /). 

# Jof:Um

Kristin Rury, Biologist 

# ' ¥- Dietary Expo sure Science Advisory il (DESAC) HED (7509P)

and

Charles W. Sm i th III
, Branch**Chi~q_---~** 

### RABl, HED (7509P)

TO: George F

. Kramer, Ph.D

. , Risk Assessor RAB 1/HED (7509P)

and
Kathryn Montague/Bethany Benbow, PM Team 23 Registration Division (RD) (7505P)

Executive Summary

Acute and chronic dietary-exposure and risk assessments were conducted using the Die t ary Exposure Evaluation Model- Food Consumption Intake Database (DEEM-FCID, ver

. 3.16) which incorporates consumption data from United States Departmen t of Agr i culture (USDA) Nat i ona l Healt h and Nutr i t ion Examina t ion Survey, What We Eat in America, (NHANES/WWEIA; 2003

- 2008). These analyses were performed to support tol erance petitions Page 1 of20Saflufenacil Dietary Exposure and Risk Assessment DP Number: 418585



### for residues inion barley, wheat, grass, and olives. Thi s 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 analysis assumed 100% crop treated (CT), D EEM 7

. 8 1 default concentration factors, and tolerance-level residues for all commodities [except for cottonseed; sunflower subgroup 20B; soybean, seed; vegetab l e, legume, subgroup 6C, pea and bean (except soybean); and rapeseed subg ro up 20A

- see Section II for more deta il s]. The drinking water estimate from the proposed U.S. use was incorporated directly into the dietary assessment using the peak concentration for surface water generated by Tier I Rice modeling. The acute dietary ri s k estimates (food+ water) at the 95 1 h 

### percentile are <1% of the acute popu l ation-adjusted dose (aP AD) for t he general U.S. population and <1% of the aP AD for the most highly exposed population subgroup (a ll in fants (<1-year old)), and are thus below HED's level of concern (<100% aPAD).

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The unrefined chronic ana l ys i s assumed 100% CT, DEEM 7.81 default concentration factors, and tolerance-level residues for all commodities [except for cottonseed; sunflower subgroup 20B; soybean, seed; vegetable, legume, subgroup 6C, pea and bean (except soybean); and rapeseed subgroup 20A

- see Section II for more details ]

. The drinking water estimate from the proposed U.S. use was incorpora ted directly into the dietary assessment using the average concentration for surface water generated by Tier I Rice modeling. The chronic dietary risk estimates (food + water) are 9.2% of the chronic population-adjus ted dose (cPAD) for the general U.S. population and 20% of the cPAD for the most highly ex posed population subgroup (a ll infants (<1-year o ld) ) and are thus be l ow l-IED's l evel of concern (<100% cPAD)

.

Cancer Dietary (Food and Drinking Water) Exposure Re s ul ts and Characterization

Saflufenacil is class ifi ed as " not likely carcinogenic to humans." Therefore, cancer risk is not a

concern for this chemical.

I. 

### Introduction



### Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk i s expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded w ill resu l t in no unreasonable adverse hea l th effects). T his dose is ref e rred to as the PAD

. The PAD is equivalent to point of departure (POD
, NOAEL, LOAE L
, i.e.) divided by the required uncertainty or safety factors

.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% ofthe PAD. References which d i scuss th e acute and chronic risk assessments in

more detai l are available on the EPA/pesticides web site: "Available In format ion on Assessing Exposure from Pesticides, A User's Guide," 21-JUN-2000
, web link: http: / / www

. epa

. gov / fedrgstr /E PA -P EST / 2000 / Jul y / Da y -1 2 / 606l. pd f ; or see SOP 99

. 6 (20-AUG1999).

Page 2 of20Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

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Page 3 of 20 

### The most recent dietary exposure risk assessment for sa flufenacil was conducted by G. Kramer (Memo, 23

- JAN

- 2014
, D405747 ).

II. Residue Information

Saflufenacil Proposed and Registered Uses:

Saflufenacil is currently registered for use on legume vegetables (Crop Group 06), the foliage of legume vegetables (Crop Group 07), cereal grains (Crop Group 15; pre

- plant/pre

- emergence application only, except for early post

- emergence application to rice), the forage, fodder, and straw of cereal grai ns (Crop Group 16; pre

- plant/pre

- emergence application only, except for early post

- emergence application to rice), cotton, and sunflower. BASF has submitted a proposal to amend the established tolerances for saflufenacil on wheat and barley (PP# 3F8185 ). The amended tolerances on these crops are the result of the proposed harvest

- aid/desiccation use pattern for Sharpen ® 

### Powered by Kixor ® 

### Herbicide (EPA Reg. No. 7969

- 278); the currently registered uses are for preplant application. In addition, BASF has su bmitted a proposal for a new use of Sharpen ® 

### Powered by Kixor ® 

### Herbicide and Heat ® 

### Powered by Kixor ® 

### Herbicide (EPA Reg. No. 7969

- 297) on grass group 17 as harvest aid/desiccant (PP# 3F8192 ) and for a new use of Treevix ® 

### Powered by Kixor ® 

### Herbicide (EPA Reg . No. 7969

- 276) to the base of olive trees (PP# 4F8229 ).

Residues of Concern: The previously

- submitted metabolism data for corn, soybean, and tomato were adequate to elucidate the nature of the residue in plants resulting from pre

- plant/pre

emergence ap plication. The HED Residues of Concern Knowledgebase Subcommittee (ROCKS) determined that residues of concern for the tolerance expression and risk assessment consist of saflufenacil, M800H11, and M800H35 (Memo, B. Daiss, 1/6/09; D 359645 ). Subsequently, the petitioner submitted a rice metabolism study following post

- emergence foliar application of saflufenacil. The combined residues of saflufenacil, M800H11, and M800H35 (the current residues of concern for the tolerance expression and risk assessment) in rice forage were 71

- 89% of the total radioactive residue (TRR). The only other major metabolite was M800H02, which accounted for 4

- 16% of the TRR in forage. In rice grain, the combined residues of saflufenacil and all metabolites were <10% of the TRR (≤ 0.01 ppm). HED thus concludes that current tolerance expression adequately accounts for the residues of concern following post

- emergence foliar application to rice (and related crops; i.e., cereal grains and grasses). Additional metabolism data may be re quired to support foliar application to crops other than grasses and legume vegetables

. The nature of the residue in livestock is adequately understood based on acceptable metabolism studies conducted on lactating goats and laying hens. The HED ROCKS de termined that saflufenacil per se is the only residue of concern for the tolerance expression and risk assessment for all livestock commodities (Memo, B. Daiss, 1/6/09; D 359645 ).Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

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Page 4 of 20 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 Registered/proposed

Primary Crops (preplant application)* Saflufenacil + M800H11, M800H35 Saflufenacil + M800H11, M800H35

Registered/proposed Primary Crops ( foliar application) Saflufenacil + M800H11, M800H02 , M800H35

Rotational Crops Saflufenacil + M800H11, M800H35

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

* Plus post

- emergence foliar application to cereal grains and grasses

.


### Established Tolerances ( 40 CFR §180.649 ) : Permanent tolerances are established 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

- d ioxo

- 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 ” under 40 CFR §180.649 (a)(1) for residues on a variety of crops, including citrus fruit ( Crop Group 10), pome fruit ( Crop Group 11), stone fruit ( Crop Group 12), grape s , 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 are established 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 ” under 40 CFR §180.649 (a)(2) for residues on livestock commodities

.

Recommended Tolerances: Based on the residue chemistry data submitted with the current petitio n s , HED recommended for establishment of the following tolerances (G. Kramer
, 24

- JUN

2014 ; D414003 ):

Table 2. Tolerance Summary for Saflufenacil. Commodity Recommended Tolerance (ppm) 40 CFR §180.649(a)(1) Barley, bran 1.5 Barley, grain 1.0 Barley, straw 15 Grain, aspirated fractions 50 Grain, cereal group 15 (except barley and wheat 0.03Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

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Page 5 of 20 Table 2. Tolerance Summary for Saflufenacil. Commodity Recommended Tolerance (ppm) 40 CFR §180.649(a)(1) grain) Grain, cereal, forage, fodder and straw group 16 (except barley and wheat straw) 0.10

Wheat, grain 0.60 Wheat, straw 6.0 Grass forage 15 Grass hay 20 Grass seed screenings 0.15 Grass straw 0.15 Olive 0.03 40 CFR §180.649(a)(2) Cattle, fat 0.04 Cattle, liver 50 Cattle, meat byproducts, except liver 0.30 Cattle, meat 0.02 Goat, fat 0.04 Goat, liver 50 Goat, meat byproducts, except liver 0.30 Goat, meat 0.02 Sheep, fat 0.04 Sheep, liver 50 Sheep, meat byproducts, except liver 0.30 Sheep, meat 0.02 Horse, fat 0.04 Horse, liver 50 Horse, meat byproducts, except liver 0.30 Horse, meat 0.02 Hog, liver 2.0



### 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 (exce pt 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 res ult of preharvest uses . The additional metabolite, M800H02 , w as observed in 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 that of 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 forSaflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

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Page 6 of 20 

### 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) 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).



### Processing Factors: DEEM 7.81 default processing factors were used for all processed commodities (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

- M A R

- 201 4 (Memo, M

. Ruhman ; DP# 414485 ) . 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 for surface water 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 current guidance (USEPA, 2002). EDWCs reflect exposure to saflufenaci l 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 51.5Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

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Page 7 of 20 

### 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) are 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 consumption d ata, 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, child ren 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 list is mult iplied 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 forms on the c ommodity 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 deterministic exposur e assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per

- capita (i.e., those who 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 Expo sure and Risk Assessment DP Number: 418585

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Page 8 of 20 

### 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 hematocri t 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 gener al 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 Acute and Chronic Diet ary Exposure Analyses

The acute dietary risk for food and drinking water utilized <1 % of the aPAD for the U.S. population at the 95 th 

### percentile of exposure

. The acute dietary risk for the highest exposed population subgroup, a ll i nfants ( <1

- year old )
, i s <1 % of the aPAD at the 95 th 

### percentile

. The chronic dietary risk for food and drinking water utilized 9.2% 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 20% of the cPAD.

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

.Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

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Page 9 of 20 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 0.010106 <1 0.004223 9.2 All Infants ( <1

- year old ) 0.026582 <1 0.009099 20 Children 1

- 2 years old 0.017044 <1 0.008368 1 8 Children 3

- 5 years old 0.013965 <1 0.006993 1 5 Children 6

- 12 years old 0.010852 <1 0.004872 11 Youth 13

- 19 years old 0.008383 <1 0.003409 7.4 Adults 20

- 49 years old 0.009103 <1 0.003946 8.6 Adults 50

- 99 years old 0.007781 <1 0.003679 8.0 Females 13

- 49 years old 0.009078 <1 0.003759 8.2 *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. pop ulation and all population subgroups
, and estimated chronic dietary risks are ≤ 20% 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 ( 3 / 26 / 1 4 ) G.F. Kramer: S10 95 7 :PY

- S:(703)305

- 5079:7509P:RAB1Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

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Page 10 of 20 

### Acute Food plus Water Residue Input File

Filename: C: \ Users \ gkramer \ Documents \ Gk \ ##Saflufenacil \ SAFLUFENACIL_ACUTE.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: 03

- 13

- 2014/09:46:30 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 1.0 00 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 Grap e, 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 1.000 1.000 9500235000 O Olive 0.030000 1.000 1.000 9500236000 O Olive, oil 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 9500363000 O Sugarcane, molasses 0.080000 1.000 1.000 9500363001 O Su garcane, 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, bro ad, 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, s nap, 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 0603098001 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 1.00 0 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 1 0A 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 1.000Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 11 of 20 1003181000 10C Grapefruit, juice 0.030000 2.100 1.000 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 1.000 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 Orange, 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 11000090 01 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 Apple, peeled fruit 0.030000 1.000 1.000 1100008001 11 Apple, peeled fruit

- babyfood 0.030000 1.000 1.000 1100011000 11 Apple, sauce 0.0 30000 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 11 00266000 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 1.000 1.000 1201090000 12A Cherry 0.030000 1.000 1.000 1201091000 12A Cherry, juice 0.030000 1.500 1.000 1201091001 12A Cherry, j uice

- babyfood 0.030000 1.500 1.000 1201090001 12A 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

- baby food 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 1 3D 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 1400003001 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 0.030000 1.000 1.000Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 12 of 20 1400185000 14 Hickory nut 0.030000 1.000 1.000 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 1.500000 1.000 1.000 1500026000 15 Barley, flour 1.000000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 1.000000 1.000 1.000 1500025000 15 Barley, pearled barley 1.000000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 1.000000 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, fie ld, 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, field, 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, f ield, syrup

- babyfood 0.030000 1.500 1.000 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 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 1.00 0 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 Rice, 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 150034400 0 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

- b abyfood 0.030000 1.000 1.000 1500404000 15 Wheat, bran 0.600000 1.000 1.000 1500402000 15 Wheat, flour 0.600000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.600000 1.000 1.000 1500403000 15 Wheat, germ 0.600000 1.000 1.000 1500401000 15 Wheat, grain 0.600000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.600000 1.000 1.000 1500405 000 15 Wild rice 0.030000 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 2001163000 20A Flax seed, oil 0.760000 1.000 1.000 2001319000 20A Rapeseed, oil 0.760000 1.000 1.000 2001319001 20A Rapeseed, oil

- babyfood 0.760000 1.000 1.000 2002330000 20B Safflower, oil 1.7000 00 1.000 1.000 2002330001 20B Safflower, oil

- babyfood 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 20013 36000 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 0.040000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0 .040000 1.000 1.000 3100048000 31 Beef, kidney 0.300000 1.000 1.000 3100049000 31 Beef, liver 50.000000 1.000 1.000Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 13 of 20 3100049001 31 Beef, liver

- babyfood 50.000000 1.000 1.000 3100044000 31 Beef, meat 0.020000 1.000 1.000 3100046000 31 Beef, meat byproducts 0.300000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.300000 1.000 1.000 3100045000 31 Beef, mea t, dried 0.020000 1.920 1.000 3100044001 31 Beef, meat

- babyfood 0.020000 1.000 1.000 3200171000 32 Goat, fat 0.040000 1.000 1.000 3200172000 32 Goat, kidney 0.300000 1.000 1.000 3200173000 32 Goat, liver 50.000000 1.000 1.000 3200169000 32 Goat, meat 0.020000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.300000 1.000 1.000 3300189000 33 Horse, meat 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 1.000 3400294000 34 Pork, k idney 0.010000 1.000 1.000 3400295000 34 Pork, liver 2.000000 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 1.00 0 3500341000 35 Sheep, fat 0.040000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.040000 1.000 1.000 3500342000 35 Sheep, kidney 0.300000 1.000 1.000 3500343000 35 Sheep, liver 50.000000 1.000 1.000 3500339000 35 Sheep, meat 0.020000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.300000 1.000 1.000 3500339001 35 Sheep, me at

- babyfood 0.020000 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, water

- 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

- fr eshwater 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 1.000 8601000000 86A Water, direct, all sources 0.133000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.133000 1.000 1.000Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 14 of 20 

### Acute Results File.

US EPA Ver. 3.18, 03

- 08

- d DEEM

- FCID ACUTE Analysis for SAFLUFENACIL NHANES 2003

- 2008 2

- Day Residue file: SAFLUFENACIL_ACUTE.R08 Adjustment factor #2 used. Analysis Date: 03

- 13

- 2014/09:56:46 Residue file dated: 03

- 13

- 20 14/09:46:30 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: 0.010106 0.20 0.015835 0.32 0.034046 0.68 All Infants: 0.026582 0.53 0.035623 0.71 0.050604 1.01 Children 1

- 2: 0.017044 0.34 0.025485 0.51 0.048979 0.98 Children 3

- 5: 0.013965 0.28 0.019 801 0.40 0.028593 0.57 Children 6

- 12: 0.010852 0.22 0.015593 0.31 0.026214 0.52 Youth 13

- 19: 0.008383 0.17 0.013120 0.26 0.018114 0.36 Adults 20

- 49: 0.009103 0.18 0.012821 0.26 0.023217 0.46 Adults 50

- 99: 0.007781 0.16 0.011959 0.24 0.052739 1.05 Female 13

- 49: 0.009078 0.18 0.012576 0.25 0.01 9767 0.40

FOOD ONLY US EPA Ver. 3.18, 03

- 08

- d DEEM

- FCID ACUTE Analysis for SAFLUFENACIL NHANES 2003

- 2008 2

- Day Residue file: SAFLUFENACIL_FoodOnly.R08 Adjustment factor #2 NOT used. Analysis Date: 03

- 27

- 2014/12:59:47 Residue file dated: 03

- 27

- 2014/12:57:07 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 : 0.004477 0.09 0.007208 0.14 0.015677 0.31 All Infants: 0.006190 0.12 0.009403 0.19 0.015002 0.30 Children 1

- 2: 0.008661 0.17 0.012648 0.25 0.024995 0.50 Children 3

- 5: 0.007521 0.15 0.009929 0.20 0.012606 0.25 Children 6

- 12: 0.005519 0.11 0.007804 0.16 0.0 13281 0.27 Youth 13

- 19: 0.003519 0.07 0.005619 0.11 0.010282 0.21 Adults 20

- 49: 0.003337 0.07 0.005336 0.11 0.011284 0.23 Adults 50

- 99: 0.002441 0.05 0.003862 0.08 0.051383 1.03 Female 13

- 49: 0.002837 0.06 0.004470 0.09 0.008087 0.16Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 15 of 20 

### Chronic Food plus Water Residue Input File.

Filename: C: \ Users \ gkramer \ 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: 03

- 13

- 2014/09:4 1:01 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 95002150 00 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

- baby food 0.030000 1.000 1.000 9500235000 O Olive 0.030000 1.000 1.000 9500236000 O Olive, oil 0.030000 1.000 1.000 9500283000 O Plantain 0.03000 0 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 950036 2000 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, se ed 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 0.510 000 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, pin k, 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 0603098001 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, dr y 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 1.00 0 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 Soybe an, 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 1.000Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 16 of 20 1003181000 10C Grapefruit, juice 0.030000 2.100 1.000 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 1.000 1002207001 1 0B 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 Orange, juice

- babyfoo d 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 Apple, 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

- baby food 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 1.000 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 12A 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 1.00 0 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 1400003001 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 1 4 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 0.030000 1.000 1.000Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

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Page 17 of 20 1400185000 14 Hickory nut 0.030000 1.000 1.000 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 1.500000 1.000 1.000 1500026000 15 Barley, flour 1.000000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 1.000000 1.000 1.000 1500025000 15 Barley, pearled barley 1.000000 1.000 1.000 1500025001 15 Barley, pearled bar ley

- babyfood 1.000000 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, field, 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, fie ld, 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 1.000 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 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, fl our
- 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 1.00 0 1500325000 15 Rice, 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 0.600000 1.000 1.000 1500402000 15 Wheat, flour 0.600000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.600000 1.000 1.000 1500403000 15 Wheat, germ 0.600000 1.000 1.000 1500401000 15 Wheat, grain 0.600000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.600000 1.000 1.000 1500405000 15 Wild rice 0.030000 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 2001163000 20A Flax se ed, oil 0.760000 1.000 1.000 2001319000 20A 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

- babyfood 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 1.00 0 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 Sunfl ower, oil

- babyfood 1.700000 1.000 1.000 2002364000 20B Sunflower, seed 1.700000 1.000 1.000 3100047000 31 Beef, fat 0.040000 1.000 1.000 3100047001 31 Beef, fat

- babyfood 0.040000 1.000 1.000 3100048000 31 Beef, kidney 0.300000 1.000 1.000 3100049000 31 Beef, liver 50.000000 1.000 1.000Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 18 of 20 3100049001 31 Beef, liver

- babyfood 50.000000 1.000 1.000 3100044000 31 Beef, meat 0.020000 1.000 1.000 3100046000 31 Beef, meat byproducts 0.300000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.300000 1.000 1.000 3100045000 31 Beef, meat, dried 0.020000 1.920 1.000 3100044001 31 Beef, meat

- babyfood 0.020000 1.000 1.000 3200171000 32 Goat, fat 0.040000 1.000 1.000 320017200 0 32 Goat, kidney 0.300000 1.000 1.000 3200173000 32 Goat, liver 50.000000 1.000 1.000 3200169000 32 Goat, meat 0.020000 1.000 1.000 3200170000 32 Goat, meat byprodu cts 0.300000 1.000 1.000 3300189000 33 Horse, meat 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 1.000 3400294000 34 Pork, kidney 0.010000 1.000 1.000 3400295000 34 Pork, liver 2.000000 1.000 1.000 3400290000 34 Pork, meat 0.010000 1.000 1.000 3400292 000 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 0.040000 1.000 1.000 3500341001 35 Sheep, fat

- babyfood 0.040000 1.000 1.000 3500342000 35 Sheep, kidney 0.3000 00 1.000 1.000 3500343000 35 Sheep, liver 50.000000 1.000 1.000 3500339000 35 Sheep, meat 0.020000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.300000 1.000 1.000 35003 39001 35 Sheep, meat

- babyfood 0.020000 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, wat er 0.010000 1.000 1.000 3600224001 36 Milk, water

- 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 1.000 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 Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 19 of 20 

### Chronic Results File.

US EPA Ver. 3.16, 03

- 08

- d DEEM

- FCID Chronic analysis for SAFLUFENACIL NHANES 2003

- 2008 2

- day Residue file name: C: \ Users \ gkramer \ Documents \ Gk \ ##Saflufenacil \ SAFLUFENACIL_CHRONIC.R08 Adjustment factor #2 used. Analysis Date 03

- 13

- 2014/09:47:43 Residue file dated: 03

- 13

- 2014/09:47:24 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 Population 0.004223 9.2% Hispanic 0.004317 9.4% Non

- Hisp

- White 0.004263 9.3% Non

- Hisp

- Black 0.003716 8.1% Non

- Hisp

- Other 0.004652 10.1% Nursing Infants 0.003456 7.5% Non

- Nursing Infants 0.011620 25.3% Female 13+ PREG 0.003713 8.1% Children 1

- 6 0.007392 16.1% Children 7

- 12 0.004597 10.0% Male 13

- 19 0.003445 7.5% Female 13

- 19/NP 0.003378 7.3% Male 20+ 0.003891 8.5% Female 20+/NP 0.003785 8.2% Seniors 55+ 0.003608 7.8% All Infants 0.009099 19.8% Female 13

- 50 0.003756 8.2% Children 1

- 2 0.008368 18.2% Children 3

- 5 0.006993 15.2% Children 6

- 12 0.004872 10.6% Youth 13

- 19 0.003409 7.4% Adults 20

- 49 0.003946 8.6% Adults 50

- 99 0.003679 8.0% Female 13

- 49 0.003759 8.2%

FOOD ONLY
DEEM

- FCID Chronic analysis for SAFLUFENACIL NHANES 2003

- 2008 2

- day Residue file name: C: \ Users \ gkramer \ Documents \ Gk \ ##Saflufenacil \ SAFLUFENACIL_FoodOnly.R08
A djustment factor #2 used. Analysis Date 03

- 27

- 2014/12:57:52 Residue file dated: 03

- 27

- 2014/12:57:07 Reference dose (RfD, Chronic) = .046 mg/kg bw/day

=============================================================================== To tal exposure by population subgroup

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

Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.001710 3.7% Hispanic 0.001918 4.2% Non

- Hisp

- White 0.001678 3.6% Non

- Hisp

- Black 0.001643 3.6% Non

- Hisp

- Other 0.001756 3.8% Nursing Infants 0.001183 2.6% Non

- Nursing Infants 0.003263 7.1% Female 13+ PR EG 0.001347 2.9% Children 1

- 6 0.004173 9.1% Children 7

- 12 0.002503 5.4% Male 13

- 19 0.0 01717 3.7% Female 13

- 19/NP 0.001442 3.1% Male 20+ 0.001550 3.4%Saflufenacil Dietary Expo sure and Risk Assessment DP Number: 418585

______________________________________________________________________________________

Page 20 of 20 Female 20+/NP 0.001146 2.5% Seniors 55+ 0.001178 2.6% All Infants 0.002620 5.7% Female 13

- 50 0.001255 2.7% Children 1

- 2 0.004743 10.3% Children 3

- 5 0.003939 8.6% Children 6

- 12 0.002669 5.8% Youth 13

- 19 0.001577 3.4%
A dults 20

- 49 0.001439 3.1% Adults 50

- 99 0.001201 2.6% Female 13

- 49 0.001261 2.7%