### UNIT ED STA TES ENV IRONMENTA L PROTECTION AGENCY

WASHIN GT ON, D

. C. 20460

MEMORANDUM

Date: 2 8-J UL- 2014 OF FI CE OF
CHEMICAL S AFE TY AND
POLLUTION PREV E NTI O N



### SUBJECT : Metaldehyde

. Acu t e and Chronic Aggregate Dietary (Food and Drinking Water)

Ex posure a nd R i sk Assessments to Support New Uses on Vegetab l e, Legume

,

e dible podded [subgroup 6A], Pea and bean, succu l e nt s helled [subgro up 6B]

, Vegetable, Fo li age ofLegum e, except Soy b ea n [subgroup 7A], C l over forage and hay

, and Ginseng; and fo r Amendments to Exis tin g Tolerances fo r T omato [ s ub grou p 8-lOA], and Fruit, Citrus [group 10-10).

P C Code: 05300 I
Decision No.: 4g(,t/U.



### Petition No.: 3E8223
Risk Assess ment Type: Dietary Aggr e gate Ri sk


### TXRNo.: NA

MRIDNo. : NA DP Barcode : 0420705 Registration No. : NA Regulatory Act ion: Sectio n 3 Registration


### Case No.: NA
CAS No.: I 08-62-3
40 CFR : 

### § 180.523



### Austin Doh

, Chemist**~** 

### Ri s k Assessmen t Branch V**.,...- ~** **~** 

### FROM:

Health Effects D i vision (7509P)

### -·~~6~...-.:::::---**-- --** **--**

THROUGH: Moh se n Sahafeye n , Chemist

# ~4**~ ~**  Thur sto n Mor t on, Chemist /" / 

# 'A/ .j<J Dietary Exposure Science Ad 1 s ory Coun c il ( D ESA

HED (7509P)

TO: Matthew Lloyd, Risk Assessor

RAB VII

HED (7509 P )

Pag e 1 of20Metaldehyde (05300 I) D ietary E xposure and Risk A s se s sment 0420 7 05



### Executive Summary

Acute and chronic aggregate dietary (food and drinking water) exposure and risk assessments

were conducted using the Dietary E xposu r e Evaluation Model with the Food Commodity Intake

Da t abase (DEEM-FCID) Version 3.18. T his software incorporates 2003

- 2008 food consumption

da t a from the U

. S

. Department of Agricu l ture's National Health and Nutrition Examination
Surve y , What We Eat in America, (NHAN E S/WWEIA). The analyses were performed to support Section 3 registration requests for new uses on crop subgroups 6A, 6B

, 7 A, and 8-1 OA;
clover

, ginseng ; and crop group 10-10. This memo was rev i ewed by two membe r s ofthe

DESAC

, per the current DESAC SOP.

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

An unrefined acute dieta r y assessment was conduc t ed using to l erance -l evel residues, I 00% crop

trea t ed assumptions

, and modeled water numbers. At the 95th percentile of exposure, th e estimated risk is :5 55% of the acute popu l ation adjusted dose (aPAD) for the U.S. population and

all population subgroups

.

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

A conservative chronic dietary assessment was conducted us in g tolerance-level residues

, I 00%

crop treated assumptions, and modeled water numbers

. The estima t ed risk is :551% of the
chronic popula t i on adjusted dose ( cP A D ) for the U.S. popu l ation and all population subgroups

.

I. Introduct i on

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute
and chron i c assessments

, the risk i s expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonab l e adverse health effects).

This dose is referred to as the population adjusted dose (PAD). The PAD is equivalent to the point of departure (PO D

, NOAEL, LOAEL, e.g.) div i ded by the required unc e rtainty or saf e ty factors.

Fo r acute and chronic exposures , HED is concerned when estimated dietary risk exceeds 100%

ofthe PAD. References which discuss the acute and chronic risk assessments in more detai l are available on the EPA / pesticides web s i te : "Available Information on Assessing Exposure from Pesticides, A User's Guide," 21

- JUN-2000, web l ink : h ttp : //www

. e p a

. g ov/ f ed rg str /E PA

P E ST / 2000 /J ul v / Day-I2 / 606l.pdf; or see SOP 99.6 (20

- AUG-1999)

.

The most recent d i etary risk assessment for metaldehyde was conducted by W

. Donovan (D408746, 23-MA Y -20 1 3).

II

. Residue Information

T olerances for metaldehyde are established under 40 CFR 

### § 180 .523, see Table 1

. The residue of

concern in plants consists of the parent compound

.

Page 2 of20Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 3 of 20 Table 1. Established Metaldehyde Tolerances Commodity Parts Per Million Artichoke, globe 0.07 Berry group 13 0.15 Berry, low growing, subgroup 13

- 07G 6.25 Bushberry subgroup 13

- 07B 0.15

Cactus 0.07 Caneberry subgroup 13

- 07A 0.15 Corn, field, grain 0.05 Corn, sweet, kernel plus cob with husks removed 0.05 Fruit, citrus, group 10 0.26 Leaf petioles subgroup 4B 0.5 0

Lettuce 1.73 Peppermint, oil 12 .0 Peppermint, tops 4 .00 Soybean 0.05 Spearmint, oil 12 .0 Spearmint, tops 4 .00 Strawberry 6.25 Taro, corm 0.15 Taro, leaves 1 .00

Tomato 0.24 Vegetable, brassica, leafy, group 5 2.5 0

Watercress 3.2 0



### Requirements for animal metabolism and feeding studies have been waived. The Agency concluded that residues are unlikely to occur in livestock commodities based upon the rapid degradation of metaldehyde in livestock systems and the subsequent incorporation of degradates into naturally occurring components

.

The recommended tolerances for metaldehyde for the current action are shown in Table 2 (D418047

, A. Doh

, 7/10/14 )

. Table 2

. Tolerance Summary for M etaldehyde

. Commodity Proposed Tolerance (ppm) Recommended

Tolerance (ppm) Comments; Correct Commodity

Definition
Vegetable, legume, edible podded, subgroup 6A 0.80 0.80

Pea and bean, succulent shelled, subgroup 6B 0.20 0.20

Tomato subgroup 8

- 10A 0.24 0.24
Fruit, citrus, group 10

- 10 0.26 0.26
Ginseng 0.05 0.05



### For all dietary risk assessments, the established and recommended tolerances were used and 100% crop treated was assumed

. Processing studies for tomatoes and oranges indicate that metaldehyde residues do not concentrate in processed commodities derived from these crops (D311889, F. Fort, 05

- MAY

- 2005). The orange juice processing factor of 1.0 was extrapolated
to other c itrus juices. Exaggerated rate studies in corn and soybean showed no detectable grainMetaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 4 of 20 or seed residues at rates of 5× and 10×, respectively. Therefore, no processing factors were used in the analyses except for those processed commodities for which no processing studies are typically conducted (tomato, dried; tomato, juice; cranberry, juice; and high fructose corn syrup),
for which default factors were used.

The USDA Pesticide Data Program (PDP) monitored pesticide residues in catfish in 2008, 2009, and 2010. In general, pesticide re sidues would not be expected to be found in fish unless the pesticide bio accumulates or has an aquatic use. This is unlikely based on the K OW 

### of 1.33 (which is less than 2.5). To determine whether or not residues are present in fish, HED now routinely
che cks PDP monitoring data regardless of the pesticide’s uses and physicochemical properties. However, PDP did not analyze catfish samples for metaldehyde. As a result, residues in fish
were not included in the assessment.

III. Percent Crop Treated Inform ation

The acute and chronic assessments assumed 100% crop treated for all registered and proposed

new use crops.

IV. Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the
Environmental Fat e and Effects Division (EFED) : D404861, J. Hetrick and M. Biscoe, 17

- JUL

2013; and email message from M. Biscoe to W. Donovan, 15

- JUL

- 2014

. In addition to point estimates for deterministic assessments, a full distribution of water values was provided for a probabilisti c assessment. Water residues were incorporated in the DEEM

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

T here are no monitoring data currently available for metaldehyde in drinking water

. E stimated drinking water concentrations (EDWCs) were generated using computer modeling procedures

. The highest EDWCs resulted from the special mollusk eradication use on turf, and these values were used in the present dietary analysis. Surface water estim ates were determined using the

PRZM

- EXAMS model and ground water estimates were determined using the PRZM

- GW
model. These latter values were recommended for use in the human

- health dietary risk

assessment as they were the highest values obtained

. Additio nal information concerning the
water models is available at the EPA internet site: http://www.epa.gov/pesticides/science/models_pg.htm#aquatic

.

Maximum application rates for metaldehyde as a high

- end estimate of exposure in drinking water were modeled based on the proposed labels

. C hemical specific and model input values
were chosen in accordance with current EFED input parameter guidance (USEPA, 2009). The
maximum surface an d ground w ater EDWCs for use in the human

- health risk assessment for metaldehyde are shown in Table 3

.Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 5 of 20 Table 3. Maximum Tier II estimated drinking water concentrations (EDWCs) in parts per billion (μg/L) resulting from 6 applications of 2 lb a.i./acre of metaldehyde to turf with a reapplication interval of 14 days.

Drinking water source (model) 1

- in

- 10 year 30

- year simulation

Acute Chronic Acute Chronic

Surface water (PRZM

EXAMS) 1 

### 205 136

- 83

Ground water (PRZM

GW) 2 

### - - 1 880 915

1 

### D404861

, J. Hetrick and M. Biscoe, 7/17/13

. 2 

### Values updated by M

. Biscoe in email message to W. Donovan , 7/15 /14

.

V. DEEM

- FCID Program and Consumption Information

Metaldehyde acute and chronic dietary exposure assessments were conducted using the DEEM

FCID, Version 3.1 8 , which incorporates 2003

- 2008 food consumption data from USDA’s NHANES/WWEIA. The data are based on the reported consumption of more than 20,000
individuals ov er 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 t ranslation 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 a s individual consumption events. Based on analysis of the 2003

- 2008 WWEIA consumption 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: t he general U.S. population, all infants (<1 year old), children

1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19, adults 20

- 4 9, females 13

- 49, and adults 50

- 99 years old.

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

form (e.g., orange or orange juice) on the food commodity residue list 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 forms 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 i s 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 es timate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment. The resulting distribution of exposures is

ex pressed 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 relevantMetaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 6 of 20 commodities as well as those who did not) basis. In accordance with HE D 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 t he risk assessment.

VI. Toxicological Information

The Metaldehyde risk assessment team in consultation with the ToxSAC (Toxicology Science Advisory Co uncil ) selected doses and endpoints for risk assessment. The toxicological doses and endpoints used f

or dietary risk as sessment are summarized in T able 4

.

Table 4

. Summary of Toxicological Doses and Endpoints for Metaldehyde for Use in Dietary Human
Health Risk Assessments

.

Exposure/
Scenario Point of

Departure Uncertainty/

FQPA Safety
Factors RfD, PAD, Level of

Concern for Risk
A ssessment Study and Toxicological Effects

Acute Dietary (All Populations) NOAEL =

30 mg/kg/day UF A 10x

UF H 10x

FQPA SF =

1X aRfD = 0.30

mg/kg/day

aPAD = 0.30 mg/kg/day Chronic dog oral toxicity study
LOAEL = 90 mg/kg/day , based on clinical signs (ataxia, tremor, salivation, twitching) seen on day 1 of dosing (both sexes).

Chronic Dietary (All Populations) NOAEL =

10 mg/kg/day UF A 10x

UF H 10x

FQPA SF =

1X cRfD = 0.10

mg/kg/day

cPAD = 0.10 mg/kg/day Chronic dog oral toxicity study LOAEL = 30 mg/kg/day, based on death and atrophy of the testes and
prostate

Cancer Classification: Suggestive Evidence of Carcinogenicity; EPA has determined that quantification

of risk using a non

- linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (intraspecies). UF H = potential v ariation in sensitivity among members of the human population (interspecies). FQPA SF = FQPA Safety Factor. PAD = populatio n adjusted dose (a = acute, c = chronic). RfD = reference dose.



### The Agency recommends that the 10X FQPA safety factor for the p ro tection of infants and
children be reduce d to 1X. T he risk assessments conducted for metaldehyde were based on the most sensitive endpoints in the toxicity database, and the NOAELs selected for risk assessment are considered protective of potential deve lopmental , neurotoxic, and immunotoxic effects for
infants and children. C onservative exposure estimates were incorporated into the risk
assessment for metaldehyde

. T here are no residual uncertainties with regard to pre

- and/or postnatal toxicity

, neurot oxicity , or exposure; therefore, reduction of the 10X FQPA safety factor to 1X is appropriate.

VII. Results/Discussion

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

- FCID analys es estimate the dietary exposure of the U.S. population and various population subgroups. The results reported in Table 5 are for the generalMetaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 7 of 20 U.S. Population, all infants (<1 year old), children 1

- 2, children 3

- 5, children 6

- 12, youth 13

- 19,
females 13

- 49, adults 20

- 49, and adul ts 50

- 99 years.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

A n unrefined acute dietary assessmen t was conducted using tolerance

- level residues, 100% crop treated assumptions, and modeled water number s. At the 95 th 

### percentile of e xposure, the estimated risk is ≤ 55 % of the acute population adjusted dose (aPAD) for the U.S. population and all population subgroups

. Results are shown in Table 5

.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis A conservative chronic dietary assessmen t was conducted using tolerance

- level residues, 100% crop treated assumptions, and modeled water n umbers. The estimated risk is ≤ 51 % of the chronic popul ation adjusted dose (cPAD) for the U.S. population and all subpopulations. Results
are shown in Table 5

.

Table 5 . Summary of Dietary (Food and Drinking Water) Exposure and Risk for M etaldehyde

. 1

Population Subgroup Acute Dietary ( 95th Percentile) Chronic Dietary Cancer

Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD Dietary Exposure (mg/kg/day) Risk

General U.S. Population 0.053956 18.0 0.016151 22.0

N/A N/A All Infants (< 1 year old) 0.165402 55.1 0.051359 51.4

Children 1

- 2 years old 0.090370 30.1 0.035775 35.8

Children 3

- 5 years old 0.072701 24.2 0.029568 29.6

Children 6

- 12 years old 0.051399 17.1 0.020479 20.5

Youth 13

- 19 years old 0.041418 13.8 0.016263 16

. 3

Adults 20

- 49 years old 0.053415 17.8 0.021418 21.4

Adults 50

- 99 years old 0.051142 17.0 0.021529 21.5

Females 13

- 49 years old 0.054209 18.1 0.021545 21.5

1 Highest exposure identified in bold.



### To assess the contribution of drinking water to the dietary exposure of metaldehyde, both acute and chronic analysis were run without modeled water estimate s. The results are reported in Table 6, including the general U.S. Population, all infants (<1 year old), children 1

- 2, children 3

- 5,
children 6

- 12, youth 13

- 19, females 13

- 49, adults 20

- 49, and adults 50

- 99 year population subgroups.Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 8 of 20 Results of Acute Dietary (Food Only ) Exposure Analysis

A conservative acute dietary assessment was conducted using tolerance

- level residues and 100% crop treated assu mptions. At the 95 th 

### percentile of expos ure, the estimated risk from food

sources is ≤11 % of the acute population adjusted dose (aPAD) for the U.S. population and all population subgroups. Results are shown in Table 6.

Results of Chronic Dietary (Food Only ) Exposure Analysis A conservative chronic dietary assessment was conducted using tolerance

- level residues and 100% crop treated assumptions. The estimated risk from food sources is ≤8.1% of the chronic population adjusted dose (cPAD) for the U.S. population and all subpopulations. Results are
shown in Table 6.

Table 6 . Summary of Dietary (Food only ) Exposure and Risk for M etaldehyde

. 1

Population Subgroup Acute Dietary ( 95th Percentile) Chronic Dietary Cancer

Dietary Exposure (mg/kg/day) % aPAD Dietary Exposure (mg/kg/day) % cPAD Dietary Exposure (mg/kg/day) Risk

General U.S. Population 0.011030 3.7 0.002854 2.9

N/A N/A All Infants (< 1 year old) 0.007663 2.6 0.001957 2.0

Children 1

- 2 years old 0.033819 11. 3 0.008137 8.1

Children 3

- 5 years old 0.022429 7.5 0.006282 6.3

Children 6

- 12 years old 0.014674 4.9 0.003686 3.7

Youth 13

- 19 years old 0.009390 3.1 0.002291 2.3

Adults 20

- 49 years old 0.009133 3.0 0.002302 2.3

Adults 50

- 99 years old 0.009830 3.3 0.002632 2.6

Females 13

- 49 years old 0.010292 3.4 0.002499 2.5

1 Highest exposure identified in bold.



### VIII. Characterization of Inputs/Outputs

HED has conducted conservative acute and chronic dietary risk assessments. These assessments could be refined using highest and mean residue levels instead of tolerance level residues and/or percent crop treated data. However, since risks were not of concer n, such refinements were not conducted

. The full distribution of modeled d rinking water estimates were included in the acute analysis using a residue distribution file ( see Attachment 5) . For the chronic analysis, the water contribution of 915 ppb was in cluded as a point estimate.Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 9 of 20Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 10 of 20 IX. Conclusions

HED conducted acute and chronic dietary risk assessments which incorporated tolerance level residues, 100% crop treated assumptions

, and modeled water numbers. For food and water

exposures, a cute and chr onic dietary risks to all population subgroups were ≤ 55 % and ≤ 51 % of
th e aPAD and cPAD, respectively. For food only exposures, acute and chronic dietary risks to all population subgroups were ≤11% and ≤8.1% of the aPAD and cPAD, respectively. Comparison of food and drinking water results to the food only results demonstrate that water is the primary contributor to risk. HED is confident that the se assessment s do not underestimate risk to the general U.S. population or any population subgroup.

X. List of Attachments

Attachment 1. Acute Residue Input File
Attachment 2. Acute Results File
Attachment 3. Ch ronic Residue Input File
Attachment 4 . Chronic Results File
Attachment 5. Water Residue Distribution File
Attachment 6. Acute Results File (F ood

- only)
Attachment 7. Chronic Results File (Food

- only)Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 11 of 20 A ttachment 1. Acute Residue Input File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID Acute analysis for METALDEHYDE

Residue file name: C: \ Users \ adoh \ Des ktop \ Metaldehyde \ 053001a.R08 Analysis Date 07

- 28

- 2014 Residue file dated: 07

- 28

- 2014/07:31:30 Reference dose (aRfD) = 0.3 mg/kg bw/day Comment: metaldehyde food and water (PRZM

- GW model) acute monte

---------------------------------------------------------------------------------- RDL indices and parameters for Monte Carlo Analysis:
Index Dist Parameter #1 Param #2 Param #3 Comment
# Code

----- ---- ------------ -------- --- ----------- ---------- 1 6 Water.rdf

EPA Crop Food Name Def Res Adj.Factors RDL Comment Code Grp (ppm) #1 #2 Pntr

---------- ---- ----------------------- -------- ---------- ------ ------ --- ------- 9500016000 O Artichoke, globe 0.070000 1.000 1.000 0602037000 6B Bean, lima, succulent 0.200000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.800000 1.000 1.000 0601043001 6A Bean, snap, succulent

- babyfood 0.800000 1.000 1.000 1301055000 13A Blackberry 0.150000 1.000 1.000 1301056000 13A Blackberry, juice 0.15000 0 1.000 1.000 1301056001 13A Blackberry, juice

- babyfood 0.150000 1.000 1.000 1302057000 13B Blueberry 0.150000 1.000 1.000 1302057001 13B Blueberry

- babyfood 0.150000 1.000 1. 000 1301058000 13A Boysenberry 0.150000 1.000 1.000

0501061000 5A Broccoli 2.500000 1.000 1.000

0501061001 5A Broccoli

- babyfood 2.500000 1.000 1.000

050 1062000 5A Broccoli, Chinese 2.500000 1.000 1.000

0502063000 5B Broccoli raab 2.500000 1.000 1.000 0501064000 5A Brussels sprouts 2.500000 1.000 1.000

0501069000 5A Cabbage 2.500000 1.000 1.000 0502070000 5B Cabbage, Chinese, bok choy 2.500000 1.000 1.000 0501071000 5A Cabbage, Chinese, napa 2.500000 1.000 1.000 0501072000 5A Cabbage, Chinese, mustard 2.500000 1.000 1.000

9500073000 O Cactus 0.070000 1.000 1.000

0402076000 4B Cardoon 0.500000 1.000 1.000

0501083000 5A Cauliflower 2.500000 1.000 1.000 0402085000 4B Celery 0.500000 1.000 1.000 0402085001 4B Celery

- babyfood 0.500000 1.000 1.000 0402086000 4B Celery, ju ice 0.500000 1.000 1.000

0402087000 4B Celtuce 0.500000 1.000 1.000

1001106000 10A Citron 0.260000 1.000 1.000 1001107000 10A Citrus hybrids 0.260000 1.000 1.000 1001108000 10A Citrus, oil 0.260000 1.000 1.000

0502117000 5B Collards 2.500000 1.000 1.000 1500120000 15 Corn, field, flour 0 .050000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.050000 1.000 1.000 1500121000 15 Corn, field, meal 0.050000 1.000 1.000 1500121001 15 Corn, field, meal

- babyfood 0.050000 1.0 00 1.000 1500122000 15 Corn, field, bran 0.050000 1.000 1.000 1500123000 15 Corn, field, starch 0.050000 1.000 1.000 1500123001 15 Corn, field, starch

- babyfood 0.050000 1.000 1.000 1500124000 15 Corn, field, syrup 0.050000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.050000 1.500 1.000 1500125000 15 Corn, field, oil 0.050000 1.000 1.000

1500125001 15 Corn, field, oil

- babyfood 0.050000 1.000 1.000 1500127000 15 Corn, sweet 0.050000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.050000 1.000 1.000

1307130000 13G Cranber ry 6.250000 1.000 1.000 1307130001 13G Cranberry

- babyfood 6.250000 1.000 1.000 1307131000 13G Cranberry, dried 6.250000 1.000 1.000 1307132000 13G Cranberry, juice 6.250000 1.000 1.000 1307132001 13G Cranberry, juice

- babyfood 6.250000 1.000 1.000Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 12 of 20 1302136000 13B Currant 0.150000 1.000 1.000

1302137000 13 B Currant, dried 0.150000 1.000 1.000 0103139000 1CD Dasheen, corm 0.150000 1.000 1.000 0200140000 2 Dasheen, leaves 1.000000 1.000 1.000 1302149000 13B Elderberry 0.150000 1.000 1.000 0402152000 4B Fennel, Florence 0.500000 1.000 1.000 0101168000 1AB Ginseng, dried 0.050000 1.000 1.000 1302174000 13B Gooseberry 0.150000 1.000 1.000 1003180000 10C Grapefruit 0.260000 1.000 1.000 1003181000 10C Grapefruit, juice 0.260000 1.000 1.000 1302191000 13B Huckleberry 0 .150000 1.000 1.000

0502194000 5B Kale 2.500000 1.000 1.000

0501196000 5A Kohlrabi 2.500000 1.000 1.000 1002197000 10B Kumquat 0.260000 1.0 00 1.000

1002199000 10B Lemon 0.260000 1.000 1.000 1002200000 10B Lemon, juice 0.260000 1.000 1.000 1002200001 10B Lemon, juice

- babyfood 0.260000 1.000 1.000 1002201000 10B Lemon, peel 0.260000 1.000 1.000 0401204000 4A Lettuce, head 1.730000 1.000 1.000 0401205000 4A Lettuce, leaf 1.730000 1.000 1.000

1002206000 10B Lime 0.260000 1.000 1.000 1002207000 10B Lime, juice 0.260000 1.000 1.000 1002207001 10B Lime, juice

- babyfood 0.260000 1.000 1.000 1301208000 13A Loganbe rry 0.150000 1.000 1.000 0502229000 5B Mustard greens 2.500000 1.000 1.000 1001240000 10A Orange 0.260000 1.000 1.000 1001241000 10A Orange, juice 0.260000 1.000 1.000 1001241001 10A Orange, juice

- babyfood 0.260000 1.000 1.000 1001242000 10A Orange, peel 0.260000 1.000 1.000

0602255000 6B Pea, succulent 0.200000 1.000 1.000 0601257000 6A Pea, edible podded, succulent 0.800000 1.000 1.000 9500275000 O Peppermint 4.000000 1.000 1.000 9500276000 O Peppermint , oil 12.000000 1.000 1.000

1003307000 10C Pummelo 0.260000 1.000 1.000 0502318000 5B Rape greens 2.500000 1.000 1.000 1301320000 13A Raspberry 0.150000 1.000 1.000 1301320001 13A Raspberry

- babyfood 0.150000 1.000 1.000 1301321000 13A Raspberry, juice 0.150000 1.000 1.000 1301321001 13A Raspberry, juice

- babyfood 0 .150000 1.000 1.000

0402322000 4B Rhubarb 0.500000 1.000 1.000 0600347000 6 Soybean, seed 0.050000 1.000 1.000 0603348000 6C Soybean, flour 0.050000 1.0 00 1.000 0603348001 6C Soybean, flour

- babyfood 0.050000 1.000 1.000 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 0.050000 1.000 1.000 0600350000 6 Soybean, oil 0.050000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.050000 1.000 1.000 9500352000 O Spearmint 4.000000 1.000 1.000

9500353000 O Spearmint, oil 12.000000 1.000 1.000 1307359000 13G Strawberry 6.250000 1.000 1.000 1307359001 13G Strawberry

- babyfood 6.250000 1.000 1.000

1307360000 13G Strawbe rry, juice 6.250000 1.000 1.000 1307360001 13G Strawberry, juice

- babyfood 6.250000 1.000 1.000

0402367000 4B Swiss chard 0.500000 1.000 1.000 1001369000 10A Tangerine 0.260000 1.000 1.000 1001370000 10A Tangerine, juice 0.260000 1.000 1.000

0801375000 8A Tomato 0.240000 1.000 1.000

0801375001 8A Tomato

- babyfood 0.240000 1.000 1.000 0801376000 8A Tomato, paste 0.240000 1.000 1.000 0801376001 8A Tomato, paste

- babyfood 0.240000 1.000 1.000 0801377000 8A Tomato, pu ree 0.240000 1.000 1.000 0801377001 8A Tomato, puree

- babyfood 0.240000 1.000 1.000 0801378000 8A Tomato, dried 0.240000 14.300 1.000 0801378001 8A Tomato, dried

- babyfood 0.240000 14.300 1.000 0801379000 8A Tomato, juice 0.240000 1.500 1.000 0801380000 8A Tomato, Tree 0.240000 1.000 1.000 0502389000 5B Turnip, greens 2 .500000 1.000 1.000Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 13 of 20 8601000000 86A Water, direct, all sources 1.880000 1.000 1.000 1 8602000000 86B Water, indirect, all sources 1.880000 1.000 1.000 1

9500398000 O Watercress 3.200000 1.0 00 1.000 0601349500 6AB Soybean, vegetable 0.050000 1.000 1.000Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 14 of 20 Attachment 2. Acute Results File

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for METALDEHYDE NHANES 2003

- 2008 2

- Day Residue file: 053001a.R08 Adjustment factor #2 NOT used. Analysis Date: 07

- 28

- 2014/07:38:36 Residue file dated: 07

- 28

- 2014/07:31:30 RAC/FF intake su mmed over 24 hours
MC iterations = 1000; MC list in residue file; MC seed = 8; RNG = MS VB Run Comment: "metaldehyde food and water (PRZM

- GW model) acute monte"

===============================================================================

Summary calcul ations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- ------ -- Total US Population:

0.053956 17.99 0.099460 33.15 0.191026 63.68

All Infants:

0.165402 55.13 0.285053 95.02 0.467265 155.75

Children 1

- 2:

0.090370 30.12 0.164459 54.82 0.295551 98.52

Children 3

- 5:

0.072701 24.23 0.128486 42.83 0.223913 74.64

Children 6

- 12:

0.051399 17.13 0.094222 31.41 0.1 72531 57.51

Youth 13

- 19:

0.041418 13.81 0.082112 27.37 0.154290 51.43

Adults 20

- 49:

0.053415 17.80 0.094663 31.55 0.154756 51.59

Adults 50

- 99:

0.051142 17.05 0.084483 28.16 0.142694 47.56

Female 13

- 49:

0.054209 18.07 0.096056 32.02 0.154266 51.42Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 15 of 20 Attachment 3. Chronic Residue Input File

US EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for METALDEHYDE

Residue file: C: \ Users \ adoh \ Desktop \ Metaldehyde \ 053001c.R08Adjust. #2 NOT used Analysis Date 07

- 28

- 2014 Residue file dated: 07

- 28

- 2014/07:31:50 Reference dose (RfD) = 0.1 mg/kg bw/day

Com ment:metaldehyde food and water (PRZM

- GW) chronic

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

---------- ---- ------------------------------- ---------- ------ ------ 9500016000 O Artichoke, globe 0.070000 1.000 1.000

0602037000 6B B ean, lima, succulent 0.150000 1.000 1.000 0601043000 6A Bean, snap, succulent 0.800000 1.000 1.000 1301055000 13A Blackberry 0.150000 1.000 1.000 1301056000 13A Blackberry, juice 0.150000 1.000 1.000 1301056001 13A Blackberry, juice

- babyfood 0.150000 1.000 1.000 1302057000 13B Blueberry 0.150000 1.000 1.000 1302057001 13B Blueberry

- babyfood 0.150000 1.000 1.000 1301058000 13A Boysenberry 0.150000 1.000 1.000

0501061000 5A Broccoli 2.500000 1.000 1.000

0501061001 5A Broccoli

- babyfood 2.500000 1.000 1.000 0501062000 5A Broccoli, Chinese 2.500000 1.000 1.000

0502063000 5B Broccoli raab 2.500000 1.000 1.000 0501064000 5A Brussels sprouts 2.5000 00 1.000 1.000 0501069000 5A Cabbage 2.500000 1.000 1.000 0502070000 5B Cabbage, Chinese, bok choy 2.500000 1.000 1.000 0501071000 5A Cabbage, Chinese, napa 2.500000 1.000 1.000 0501072000 5A Cabbage, Chinese, mustard 2.500000 1.000 1.000

9500073000 O Cactus 0.070000 1.000 1.000

0402076000 4B Cardoon 0.500000 1.000 1.00 0

0501083000 5A Cauliflower 2.500000 1.000 1.000 0402085000 4B Celery 0.500000 1.000 1.000 0402085001 4B Celery

- babyfood 0.500000 1.000 1.000

04020 86000 4B Celery, juice 0.500000 1.000 1.000

0402087000 4B Celtuce 0.500000 1.000 1.000

1001106000 10A Citron 0.260000 1.000 1.000 1001107000 10A Citrus hybrids 0.260000 1.000 1.000 1001108000 10A Citrus, oil 0.260000 1.000 1.000

0502117000 5B Collards 2.500000 1.000 1.000

1500120000 15 Corn, field, flour 0.050000 1.000 1.000 1500120001 15 Corn, field, flour

- babyfood 0.050000 1.000 1.000 1500121000 15 Corn, field, meal 0.050000 1.000 1.000

1500121001 15 Corn , field, meal

- babyfood 0.050000 1.000 1.000 1500122000 15 Corn, field, bran 0.050000 1.000 1.000 1500123000 15 Corn, field, starch 0.050000 1.000 1.000 1500123001 15 Corn, field, s tarch

- babyfood 0.050000 1.000 1.000 1500124000 15 Corn, field, syrup 0.050000 1.500 1.000 1500124001 15 Corn, field, syrup

- babyfood 0.050000 1.500 1.000 1500125000 15 Corn, field, oil 0.050000 1.000 1.000 1500125001 15 Corn, field, oil

- babyfood 0.050000 1.000 1.000 1500127000 15 Corn, sweet 0.050000 1.000 1.000 1500127001 15 Corn, sweet

- babyfood 0.050000 1.000 1.000 1307130000 13G Cranberry 6.250000 1.000 1.000 1307130001 13G Cranberry

- babyfood 6.250000 1.000 1.000 1307131000 13G Cranberry, dried 6.250000 1.000 1.000 1307132000 13G Cranberry, juice 6.250000 1.000 1.000 1307132001 13G Cranberry, juice

- babyfood 6.250000 1.000 1.000

1302136000 13B Currant 0.150000 1.000 1.000 1302137000 13B Currant, dried 0.150000 1.000 1.000 0103139000 1CD Dasheen, corm 0.150000 1.000 1.000 0200140000 2 Dasheen, leaves 1.000000 1.000 1.000 1302149000 13B Elderberry 0.150000 1.000 1.000 0402152000 4B Fennel, Florence 0.500000 1.000 1.000 0101168000 1AB Ginseng, dried 0.050000 1.000 1.000Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 16 of 20 1302174000 13B Gooseberry 0.150000 1.000 1.000 1003180000 10C Grapefruit 0.260000 1.000 1.000 1003181000 10C Grapefruit, juice 0.260000 1.000 1.000

1302191000 13B Huckleberry 0.150000 1.000 1.000

0502194000 5B Kale 2.500000 1.000 1.000

0501196000 5A Kohlrabi 2.500000 1.000 1.000 1002197000 10B Kumq uat 0.260000 1.000 1.000

1002199000 10B Lemon 0.260000 1.000 1.000 1002200000 10B Lemon, juice 0.260000 1.000 1.000 1002200001 10B Lemon, juice

- b abyfood 0.260000 1.000 1.000 1002201000 10B Lemon, peel 0.260000 1.000 1.000 0401204000 4A Lettuce, head 1.730000 1.000 1.000 0401205000 4A Lettuce, leaf 1.730000 1.000 1.000

1002206000 10B Lime 0.260000 1.000 1.000 1002207000 10B Lime, juice 0.260000 1.000 1.000 1002207001 10B Lime, juice

- babyfood 0.260000 1.000 1.000 1301208000 13A Loganberry 0.150000 1.000 1.000 0502229000 5B Mustard greens 2.500000 1.000 1.000 1001240000 10A Orange 0.260000 1.000 1.000 1001241000 10A Orange, juice 0.260000 1.000 1.000 1001241001 10A Orange, juice

- babyfood 0.260000 1.000 1.000 1001242000 10A Orange, peel 0.260000 1.000 1.000 0602255001 6B Pea, succulent

- babyfood 0.150000 1.000 1.000 0601257000 6A Pea, edible podded, succulent 0.800000 1.000 1.000 9500275000 O Peppermint 4.000000 1.000 1.000 9500276000 O Peppermint, oil 12.000000 1.000 1.000

1003307000 10C Pummelo 0.260000 1.000 1.000 0502318000 5B Rape greens 2.500000 1.000 1.000 1301320000 13A Raspberry 0.150000 1.000 1.000 1301320001 13A Raspberry

- babyfood 0.150000 1.000 1.000 1301321000 13A Raspberry, juice 0.150000 1.000 1.000

1301321001 13A Raspberry, juice

- babyfood 0.150000 1.000 1.000

0402322000 4B Rhubarb 0.500000 1.000 1.000 0600347000 6 Soybean, seed 0.050000 1.000 1.000 0603348000 6C Soyb ean, flour 0.050000 1.000 1.000 0603348001 6C Soybean, flour

- babyfood 0.050000 1.000 1.000 0600349000 6 Soybean, soy milk 0.050000 1.000 1.000 0600349001 6 Soybean, soy m ilk

- babyfood or in 0.050000 1.000 1.000 0600350000 6 Soybean, oil 0.050000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 0.050000 1.000 1.000 9500352000 O Spearmint 4.000000 1.000 1.000 9500353000 O Spearmint, oil 12.000000 1.000 1.000 1307359000 13G Strawberry 6.250000 1.000 1.000 1307359001 13G Strawberry

- babyfood 6.250000 1.000 1.000 1307360000 13G Strawberry, juice 6.250000 1.000 1.000 1307360001 13G Strawberry, juice

- babyfood 6.250000 1.000 1.000

0402367000 4B Swiss chard 0.500000 1.000 1.000 1001369000 10A Tangerine 0.260000 1.000 1.000 1001370000 10A Tangerine, juice 0.260000 1.000 1.000

0801375000 8A Tomato 0.240000 1.000 1.000

0801375001 8A Tomato

- babyfood 0.240000 1.000 1.000 0801376000 8A Tomato, paste 0.240000 1.000 1.000 0801376001 8A Tomato, paste

- babyfood 0.240000 1.000 1.000 0801377000 8A Tomato, puree 0.240000 1.000 1.000 0801377001 8A Tomato, puree

- babyfood 0.240000 1.000 1.000 0801378000 8A Tomato, dried 0.240000 14.300 1.000 0801378001 8A Tomato, dried

- babyfood 0.240000 14.300 1.000 0801379000 8A Tomato, juice 0.240000 1.500 1.000 0801380000 8A Tomato, Tree 0.240000 1.000 1.000

0502389000 5B Turnip, greens 2.500000 1.000 1.000 8601000000 86A Water, direct, all sources 0.915000 1.000 1.000 8602000000 86B Water, indirect, all sources 0.915000 1.000 1.000

9500398000 O Wate rcress 3.200000 1.000 1.000 0601349500 6AB Soybean, vegetable 0.050000 1.000 1.000Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 17 of 20 A ttachment 4. Chronic Results File

US EPA Ver. 3. 16, 03

- 08

- d

DEEM

- FCID Chronic analysis for METALDEHYDE NHANES 2003

- 2008 2

- day

Residue file name: C: \ Users \ adoh \ Desktop \ Metaldehyde \ 053001c.R08 Adjustment factor #2 NOT used. Analysis Date 07

- 28

- 2014/07:42:48 Residue file dated: 07

- 28

- 2014/07:31:50 Reference dose (RfD, Chronic) = .1 mg/kg bw/day COMMENT 1: metaldehyde food and water (PRZM

- GW) chronic

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

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

Total Exposure

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

------------------------- ------------- ------------- ---------------- Total US Population 0.022014 22.0% Hispanic 0.021021 21.0%

Non

- Hisp

- White 0.022579 22.6%

Non

- Hisp

- Black 0.018608 18.6%

Non

- Hisp

- Other 0.025151 25.2% Nursing Infants 0.018547 18.5%

Non

- Nursing Inf ants 0.066013 66.0%

Female 13+ PREG 0.020653 20.7%

Children 1

- 6 0.031265 31.3%

Children 7

- 12 0.019 429 19.4%

Male 13

- 19 0.015322 15.3%

Female 13

- 19/NP 0.017201 17.2%

Male 20+ 0.020010 20.0%

Female 20 +/NP 0.022812 22.8%

Seniors 55+ 0.021245 21.2%

All Infants 0.051359 51.4%

Female 13

- 50 0.021566 21.6%

Children 1

- 2 0.035775 35.8%

Children 3

- 5 0.029568 29.6%

Children 6

- 12 0.020479 20.5%

You th 13

- 19 0.016263 16.3%

Adults 20

- 49 0.021418 21.4%

Adults 50

- 99 0.021529 21.5%

Female 13

- 49 0.021545 21.5%

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



### Attachment 5. Water Residue D istribution F ile for Monte Carlo AnalysisMetaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 18 of 20 Metaldehyde Ground Water Melanie Biscoe 7/ 15/14 Florida Scenario, Citrus

Przm

- GW

=============================================================================== EDWC (ppm)

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

0.0009751

0.0009751

0.000975

0.000975

0.0009749

0.0009748

0.0009748

0.0009747

0.0009747

0.0009746

0.0009746

0.0009745

0.0009745

0.0009744

0.0009744

0.0009743

0.0009743

0.0009742

0.0009742

0.0009741

0.0009741

0.000974

0.000974

0.0009739

0.0009738

0.0009738

0.0009737

0.0009737

0.0009736

0.0009736

0.0009735

0.0009735

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001034

0.001033

0.001033

.........Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 19 of 20 Attachment 6. Acute Results File (Food only)

US EPA Ver. 3.18, 03

- 08

- d

DEEM

- FCID ACUTE Analysis for METALDEHYDE NHANES 2003

- 2008 2

- Day Residue file: 053001a1.R08 Adjustment factor #2 NOT used.

A nalysis Date: 07

- 28

- 2014/07:52:11 Residue file dated: 07

- 28

- 2014/07:31:42 RAC/FF intake summed over 24 hours Run Comment: "metaldehyde food (PRZM

- GW model) acute"

===============================================================================

Summary c alculations

-- per capita:

95th Percentile 99th Percentile 99.9th Percentile Exposure % aRfD Exposure % aRfD Exposure % aRfD

---------- -------- ---------- -------- ---------- - ------- Total US Population:

0.011030 3.68 0.024364 8.12 0.065577 21.86

All Infants:

0.007663 2.55 0.029183 9.73 0.144282 48.09

Children 1

- 2:

0.033819 11.27 0.071416 23.81 0.156856 52.29

Children 3

- 5:

0.022429 7.48 0.048223 16.07 0.090580 30.19

Children 6

- 12:

0.014674 4.89 0.035211 11.74 0.0 74085 24.70

Youth 13

- 19:

0.009390 3.13 0.022405 7.47 0.039018 13.01

Adults 20

- 49:

0.009133 3.04 0.018829 6.28 0.039600 13.20

Adults 50

- 99:

0.009830 3.28 0.019493 6.50 0.042323 14.11

Female 13

- 49:

0.010292 3.43 0.020609 6.87 0.037126 12.38Metaldehyde (053001 ) Dietary Exposure and Risk Assessm ent D420705



### Page 20 of 20 Attachment 7 . Chronic Results File (Food only)

US EPA Ver. 3.16, 03

- 08

- d

DEEM

- FCID Chronic analysis for METALDEHYDE NHANES 2003

- 2008 2

- day

Residue file name: C: \ Users \ adoh \ Desktop \ Metaldehyde \ 053001c1.R08 Adjustment factor #2 NOT used. Analysis Date 07

- 28

- 2014/07:50:06 Residue file dated: 07

- 28

- 2014/07:32:03 Reference dose (RfD, Chronic) = .1 mg/kg bw/day COMMENT 1: metaldehyde food and water (PRZM

- GW) ch ronic

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

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

Total Exposure

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

-------------------------------------- ------------- ---------------- Total US Population 0.002854 2.9% Hispanic 0.002728 2.7%

Non

- Hisp

- White 0.002873 2.9%

Non

- Hisp

- Black 0.002799 2.8%

Non

- Hisp

- Other 0.003069 3.1% Nursing Infants 0.001214 1.2%

Non

- Nursing Infants 0.002288 2.3%

Female 13+ PREG 0.002613 2.6%

Children 1

- 6 0.006726 6.7%

Children 7

- 12 0.003455 3.5%

Male 13

- 19 0.002152 2.2%

Female 13

- 19/NP 0.002443 2.4%

Male 20+ 0.0 02160 2.2% Female 20+/NP 0.002689 2.7%

Seniors 55+ 0.002721 2.7%

All Infants 0.001957 2.0%

Female 13

- 50 0.002499 2.5%

Children 1

- 2 0.008137 8.1%

Children 3

- 5 0.006282 6.3%

Children 6

- 12 0.003686 3.7%

Youth 13

- 19 0.002291 2.3%

Adults 20

- 49 0.002302 2.3%

Adults 50

- 99 0.002632 2.6%

F emale 13

- 49 0.002499 2.5%

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