Fluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 3 of 11 II. Residue Information

Registered and Proposed Fluroxypyr Tolerances Tolerances have been established for the combined residues of fluroxypyr 1

- methylheptyl ester [1

- methylheptyl ((4

- amino

- 3,5

- dichloro

- 6

- fluoro

- 2

- pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4

- amino

- 3,5

- dichloro

- 6

- fluoro

- 2

- pyridinyl)oxy)acetic ac id] under 40 CFR 180.535. The established tolerances for plant commodities range from 0.02 ppm (field corn grain, sweet corn K+CWHR, and sorghum grain) to 160 ppm (grass hay) [40 CFR 180.535(a)]. The established tolerances for livestock commodities range from 0.1 ppm (fat, meat, and meat byproducts) to 1.5 ppm (kidney).

New use for fluroxypyr is proposed for rice

. The proposed label recommends application of fluroxypyr to the rice field up to 60

- days before harvest. HED has recommended that a tolerance of 1.5 ppm be established for rice

.

Residue Data used for Chronic Assessment: The chronic dietary (food and drinking water) analys i s assumed 100% crop treated, DEEM 7.81 default processing factor s and tolerance

- level residues for all commodities. The recommended tolerances for rice ( 1.5 ppm) and rice bran ( 3.0 ppm) were incorporated into the assessment for the new use.

III. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED). Estimated Environmental Concentrations ( EEC ) values were provided to HED in the memorandum entitled Drinking Water Assessment for New Use of Fluroxypyr in Rice (Paddies) (DP 396343

, Ronald Parker, 08 / 21 / 12 ). Water residue s were incorporated in the DEEM FCIDTM into the food categories “water, direct, all sources” and “water, indirect, all sources.”

The fluroxypyr estimated drinking water concentration (EDWC) value is 540 μg/L (ppb) for both acute and chronic exposure. Details of the EFED Tier 1 Rice Model can be found at http://www.epa.gov/oppefed1/models/water/rice_tier_i.htm

. A screening assessment for the impact of fluroxypyr on potential groundwater drinking water sources, using the Tier 1 groundwater model SCI

- GROW ( S creening C oncentration In GRO und W

ate r ) 

### , was also conducted. EDWC values based on use of the EFED SCI

GROW model is 0.05 5 μg/L (ppb) for both acute and chronic exposures. SCI

- GROW model details can be found at: http://www.epa.gov/oppefed1/models/water/#scigrow

. Estimation of Exposure Concentrations for Su rface Water in Rices Paddies (Tier 1 Rice Model)

The proposed new use label for application to rice permits a single maximum application
rate of 0.34 lb ai / acre / year and allows for two applications with a maximum total of 0.568 lb ai / acre / year with a minimum retreatment interval (RTI) of ten days. The label alsoFluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 4 of 11 requires a pre

- harvest interval (PHI) of 60 days. This assessment reflects a high

- exposure scenario by assuming the maximum application rate of 0.568 lb ai/A (0.64 kg/ha) is used
pe r year.

Tier 1 Rice Model (v1) : w hen using the Tier 1 rice model, EFED assumes pesticide application to a static rice paddy with no inflow from rainfall or outflow from seepage, overflow or evaporation. The only process simulated by the model is partition ing of the applied chemical between the 10

- centimeter deep water column and the 1

- centimeter deep sediment layer of the paddy. The partitioning is based on the pesticide’s deredation coefficient K d 

### . Degradation in the paddy is not calculated by the model s o the pesticide is assumed to remain at the initial concentration in the water indefinitely. Results of the tier 1 rice modeling are presented in Table 1 . Acute and chronic values are equal because the model does not simulate degradation of the pesticide i n the paddy.

Table 1 . Summary of Tier 1 Rice Model EDWC for Use on Rice

Assessment Type Acute EDWC Chronic EDWC Tier 1 Rice Model (conc in paddy) 540 μg/L (ppb) 540 μg/L (ppb)



### IV. DEEM

- FCIDTM Program and Consumption Information

Fluroxypyr chronic dietary exposure assessments was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM

FCIDTM, Version 3.1 6 which incorporates consumption data from USDA’s National Health and Nutritio n Examination Survey)/“What We Eat in America” (NHANES/WWEIA) dietary survey conducted in 2003

- 2008 . The 2003

- 2008 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 chr onic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment 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+ years old.

For 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 multipli ed 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 commo dity 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.Fluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 5 of 11 V. Toxicological Information

The toxicology data base is considered complete for the purposes of this risk assessment. The Fluroxypyr Risk Assessment Team has reviewed the toxicity database and has concluded that the doses and endpoints previously selected for risk assessment purposes remain consistent with current HED policy and are appropriate for the routes and durations of exposure anticipated from the existing and newly proposed uses of fluroxypyr.

Endpoints for risk assessment were based on kidney effects seen in the database. Doses selected fo r dietary risk assessment purposes are summarized below. The FQPA safety factor was reduced to 1X since the toxicity database was considered complete, there were no residual uncertainties for pre

- and/or post natal toxicity, no evidence of neurotoxicity

or neuropathology was found, and the estimated exposures were not likely to underestimate risk.

Table 2

. Summary of Toxicological Doses and Endpoints for Fluroxypyr for Use in Human Risk Assessments

Exposure Scenario Dose Used

in Risk Assessmen t, UF FQPA SF* and Level

of Concern for Risk Assessment Study and Toxicological Effects

Acute Dietary (All populations) No adverse effects were identified following a single oral dose and there are no developmental concerns noted in the database. A risk assessment for this route and duration is not required.

Chronic Dietary (All populations) NOAEL= 100 mg/kg/day

UF = 100

chronic RfD = 1 mg/kg/day FQPA SF = 1x

chronic PAD = 1 mg/kg/day Chronic/Onco

- Rat LOAEL = 500 mg/kg/day based on kidney effects, which include increased kidney weights, alterations in clinical chemistry parameters indicative of impaired renal functions, and increase in severity of chronic progressive glomerulonephropathy (both sexes).

Cancer (oral, dermal, inhalation) Classification: “not likely” human carcinogen

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose, RfD = reference dose, NA = Not Applicable



### VI. Results/Discussion

As stated above, for chronic assessments, HED is concerned when dietary risk exceeds 100% of the cPAD. The DEEM

- FCIDTM analyses estimate the dietary exposure of the U.S. population and various population subgroups. The results of the chronic dietary

asses sment reported in Table 3 are for the general U.S. Population, all infants (<1 yearFluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 6 of 11 old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adults 50+ years.Fluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 7 of 11 Results of Chronic Dietary Exposure Analysis The results of the chronic dietary exposure analysis are reported in the summary table below.

Table 3. Summary of Chronic Dietary (Food and Drinking Water) Exposure and Risk for Fluroxyp yr

Population Subgroup Chronic Dietary

Dietary Exposure (mg/kg/day) % cPAD

General U.S. Population 0.0147 31 1.5

All Infants (< 1 year old) 0.035101 3.5

Children 1

- 2 years old 0.032830 3.3

Children 3

- 5 years old 0.024049 2.4

Children 6

- 12 years old 0.015918 1.6

Youth 13

- 19 years old 0.011206 1.1

Adults 20

- 49 years old 0.013 645 1.4

Adults 50+ years old 0.013107 1.3

Females 13

- 49 years old 0.0134 5 9 1.3



### VII. Characterization of Inputs/Outputs

The Tier 1 chronic dietary assessment is considered to be highly conservative, using tolerance level residues and 100% crop treated information for all commodities, as well as default drying concentration factors. The results of the dietary risk assessment are unlikely to underestimate risk.

VIII. Conclusions

An unrefined, Tier 1 chronic dietary exposure assessment using t olerance level residues and 100% crop treated incorporating modeled water residues was conducted to support

new use on rice . The assessment is considered highly conservative. Exposures from fluroxypyr for the U.S. population resulted in an estimated risk equivalent to 1.5 % of the cPAD. The most highly exposed population subgroup is infants (<1 year old) with an exposure equivalent to an estimated risk of 3.5% of the cPAD.Fluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 8 of 11 IX. List of Attachments

• Chronic Food and Water Residue Input file.

• Chronic Results file.Fluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 9 of 11 Attachment 1. Chronic Food and Water Residue Input file.

Company Name Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for FLUROXYPYR Residue file: C: \ Documents and Settings \ stadayon \ My Documents \ Work in Progress \ Fluroxypyr \ FLUR_CHRON_FW.R08 Adjust. #2 used Analysis Date 08

- 28

- 2012 Residue file dated: 08

- 28

- 2012/14:10:55 Reference dose (RfD) = 1 mg/kg bw/day

----- ----------------------------------------------------------------------------- Food Crop Residue Adj.Factors EPA Code Grp Food Name (ppm) #1 #2

---------- ---- -------- ----------------------- ---------- ------ ------ 1100007000 11 Apple, fruit with peel 0.020000 1.000 1.000 1100008000 11 Apple, peeled fruit 0.020000 1.000 1.000 1100008001 11 Apple, peeled fruit

- b abyfood 0.020000 1.000 1.000 1100009000 11 Apple, dried 0.020000 8.000 1.000 1100009001 11 Apple, dried

- babyfood 0.020000 8.000 1.000 1100010000 11 Apple, juice 0.020000 1.300 1.000 1100010001 11 Apple, juice

- babyfood 0.020000 1.300 1.000 1100011000 11 Apple, sauce 0.020000 1.000 1.000 1100011001 11 Apple, sauce

- babyfood 0.0200 00 1.000 1.000 1500025000 15 Barley, pearled barley 0.500000 1.000 1.000 1500025001 15 Barley, pearled barley

- babyfood 0.500000 1.000 1.000 1500026000 15 Barley, flour 0.500000 1.000 1.000 1500026001 15 Barley, flour

- babyfood 0.500000 1.000 1.000 1500027000 15 Barley, bran 0.500000 1.000 1.000 3100044000 31 Beef, meat 0.100000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.100000 1.000 1.000 3100045000 31 Beef, meat, dried 0.100000 1.920 1.000 3100046000 31 Beef , meat byproducts 0.100000 1.000 1.000 3100046001 31 Beef, meat byproducts

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

- baby food 0.100000 1.000 1.000 3100048000 31 Beef, kidney 1.500000 1.000 1.000 3100049000 31 Beef, liver 0.100000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 0.100000 1.000 1.000 1500120000 15 Corn, field, flour 0.020000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.020000 1.000 1.000 1500121000 15 Corn, field, meal 0.020000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.020000 1.000 1.000 1500122000 15 Corn, field, bran 0.020000 1.000 1.000 1500123000 15 Corn, field, starch 0.020000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.020000 1.000 1.000 1500124000 15 Corn, field, syrup 0.020000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.020000 1.500 1.000 1500125000 15 Corn, field, oil 0.020000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.020000 1.000 1.000 1500126000 15 Corn, pop 0.020000 1.000 1.000 1500127000 15 Corn, sweet 0.020000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.020000 1.000 1.000 1100129000 11 Crabapple 0.020000 1.000 1.000 0301165000 3A Garlic, bulb 0.030000 1.000 1.000 0301165001 3A Garlic, bulb

- babyfood 0.030000 1.000 1.000 3200169000 32 Goat, meat 0.100000 1.000 1.000 3200170000 32 Goat, meat byproducts 0.100000 1.000 1.000 3200171000 32 Goat, fat 0.100000 1.000 1.000 3200172000 32 Goat, kidney 1.500000 1.000 1.000 3200173000 32 Goat , liver 0.100000 1.000 1.000 3300189000 33 Horse, meat 0.100000 1.000 1.000 1100210000 11 Loquat 0.020000 1.000 1.000 3800221000 38 Meat, game 0.100000 1.000 1.000 3600222000 36 Milk, fat 0.300000 1.000 1.000 3600222001 36 Milk, fat

- baby food/infant formu 0.300000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.300000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.300000 1.000 1.000Fluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 10 of 11 3600224000 36 Milk, water 0.300000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.300000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.300000 1.000 1.000 1500226000 15 Millet, grain 0.500000 1.000 1.000 1500231000 15 Oat, bran 0.500000 1.000 1.000 1500232000 15 Oat, flour 0.500000 1.000 1.000 1500232001 15 Oat, flour

- babyfood 0.500000 1.000 1.000 1500233000 15 Oat, groats/rolled oats 0.500000 1.000 1.000 1500233001 15 Oat, groats/rolled oats

- babyfood 0.500000 1.000 1.000 0301237000 3A Onion, bulb 0.030000 1.000 1.000 0301237001 3A Onion, bulb

- babyfood 0.030000 1.000 1.000 0301238000 3A Onion, bulb, dried 0.030000 9.000 1.000 0301238001 3A Onion, bulb, dried

- babyfood 0.030000 9.000 1.000 1100266000 11 Pear 0.020000 1.000 1.000 1100266001 11 Pear

- babyfood 0.020000 1.000 1.000 1100267000 11 Pear, dried 0.020000 6.250 1.000 1100268000 11 Pear, juice 0.020000 1.000 1.000 1100268001 11 Pear, juice

- babyfood 0.020000 1.000 1.000 3400290000 34 Pork, meat 0.100000 1.000 1.000 3400290001 34 Pork, meat

- babyfood 0.100000 1.000 1.000 3400291000 34 Pork , skin 0.100000 1.000 1.000 3400292000 34 Pork, meat byproducts 0.100000 1.000 1.000 3400292001 34 Pork, meat byproducts

- babyfood 0.100000 1.000 1.000 3400293000 34 Pork, fat 0.100000 1.000 1.000 3400293001 34 Pork, fat

- babyfood 0.100000 1.000 1.000 3400294000 34 Pork, kidney 1.500000 1.000 1.000 3400295000 34 Pork, liver 0.100000 1.000 1.000 1100310000 11 Quince 0.020000 1.000 1.000 3900312000 39 Rabbit, meat 0.100000 1.000 1.000 1500323000 15 Rice, white 1.500000 1.000 1.000 1500323001 15 Rice, white

- babyfood 1.500000 1.000 1.000 1500324000 15 Rice, brown 1.500000 1.000 1.000 1500324001 15 Rice, brown

- babyfood 1.500000 1.000 1.000 1500325000 15 Rice, flour 1.500000 1.000 1.000 1500325001 15 Rice, flour

- babyfood 1.500000 1.000 1.000 1500326000 15 Rice, bran 3.000000 1.000 1.000 1500326001 15 Rice, bran

- babyfood 3.000000 1.000 1.000 0302338500 3B Shallot, fresh leaves 0.030000 1.000 1.000 3500339000 35 Sheep, meat 0.100000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.100000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.100000 1.000 1.000 3500341000 35 Sheep, fat 0.100000 1.000 1.000 35003410 01 35 Sheep, fat

- babyfood 0.100000 1.000 1.000 3500342000 35 Sheep, kidney 1.500000 1.000 1.000 3500343000 35 Sheep, liver 0.100000 1.000 1.000 1500344000 15 Sorghum, grain 0.020000 1.000 1.000 1500345000 15 Sorghum, syrup 0.020000 1.000 1.000 8601000000 86A Water, direct, all sources 0.540000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.540000 1.000 1.000 1500401000 15 Wheat, grain 0.500000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.500000 1.000 1.000 1500402000 15 Whea t, flour 0.500000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.500000 1.000 1.000 1500403000 15 Wheat, germ 0.500000 1.000 1.000 1500404000 15 Wheat, bran 0.500000 1.000 1.000Fluroxypyr Dietary Exposure and Risk Assessment DP Number: 40 5555



### Page 11 of 11 Attachment 2. Chronic Dietary (Food and Water) Results ompany Name Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for FLUROXYPYR NHANES 2003

- 2008 2

- day Residue file name: C: \ Documents and Settings \ stadayon \ My Documents \ Work in Progress \ Fluroxypyr \ FLUR_CHRON_FW.R08 Adjustment factor #2 used. Analysis Date 08

- 28

- 2012/14:12:26 Residue file dated: 08

- 28

- 2012/14:10:55 Reference dose (RfD, Chronic) = 1 mg/kg bw/day

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

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

Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.014731 1.5% Hispanic 0.014948 1.5%
Non

- Hisp

- White 0.014940 1.5%
Non

- Hisp

- Black 0.012199 1.2%
Non

- Hisp

- Other 0.017401 1.7% Nursing Infants 0.012936 1.3%
Non

- Nursing Infants 0.045000 4.5% Female 13+ PREG 0.013 384 1.3% Children 1

- 6 0.026661 2.7% Children 7

- 12 0.015023 1.5% Male 13

- 19 0.011055 1.1% Female 13

- 19/NP 0.011360 1.1% Male 20+ 0.012939 1.3% Female 20+/NP 0.013854 1.4% Seniors 55+ 0.012866 1.3% All Infants 0.035101 3.5% Female 13

- 50 0.013459 1.3% Children 1

- 2 0.032830 3.3% Chi ldren 3

- 5 0.024049 2.4% Children 6

- 12 0.015918 1.6% Youth 13

- 19 0.011206 1.1% Adults 20

- 49 0.013645 1.4% Adults 50

- 99 0.013107 1.3% Female 13

- 49 0.013459 1.3%

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