Date:

Subject: 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, 

### D

. C. 20460

November 21,2013 OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

Metaflumizone: Revised Re s idential Exposure Assessment to Su pport Imp ort
Tolerances for Pepper, Tom ato and Eggplan t.

PC Code: 281250 DP Barcode : D414616

Decision N o.: 474810 Registration No

. : NA

Petition No. : 3E8146 Regulatory Action: Section 3, Amended Tolerance

- Tolerance w i thout a US r egistration (Import Tole r ance)

Risk Assess ment Type: Case No.: OccupationaVResidential Exposure Assessment

TXRNo .:N A CAS No.: 139968-49-3

MRIDNo.:NA 40 CFR : §180.657

From : Kelly Lowe

, Environmental Scientist

# ~**~** Risk Assessment Branch I 

# V

Health Effects Di v ision (7509 P)

Thro ugh:

## C~arles W. Smith, Branch Chief /

## ~ .. 

### 1z.)d

Risk Assessment Branch I (____- (__,/ 

### dfCJ r l 

### 5't l(

Health Effects Division (7509P)

and

Zaida F igueroa )

Ana Rivera-Lupianez 

## 6{

Exposure Sc i ence Adv i s ry Committee (ExpoSAC) I HED

To: Reuben Baris, RM07 Registration Division (RD) (7509P)

To assess aggregate risks from po tential exposures to metaflumizone as a re s ult of import

tolerances on pepper, tomato and eggplant, the following document re-evaluates exist in g residential (non-food) uses of metaflumizone according to recent Health Effects Di v ision (HED) policy and guidance revisions (e.g., the 2012 " Re s i dential SO P s").

P age I of 20It is HED po licy to use the best available data to assess exposure. Several sources of generic

data were used in this assessment as surrogate data in the absence of chemical-specific data, including the Residential SOPs (Turf SOP). Some of these data are proprietary

, and subject to

the data protection provisions of th e Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Note: This memorandum was r eviewe d by the Exposure Science Advisory Committee (ExpoSAC) on October 31,2013.

Page 2 of20Page 3 of 20 

### Table of Contents

1.0 Executive Summary

................................ ................................ ................................ ............. 4

2.0 Summary of Conclusions and Data Requirements

................................ ............................... 5

3.0 Hazard Profile

................................ ................................ ................................ ....................... 6

4.0 Use Profile

................................ ................................ ................................ ............................ 8

5.0 Residential Exposure and Risk Estimates

................................ ................................ ............ 8

5.1 Residential Bystander Post

- Application Inhalation Exposure

................................ ....... 10 Appendix A. Summa ry of Residential Handler and Post

- application Algorithms

...................... 12Page 4 of 20



### 1.0 Executive Summary

A s a result of a petition by the metaflumizone registrant

, BASF

, currently petitioning for import

tolerances ( only ) on pepper, tomato and eggplant

, HED has conducted a residential exposure /risk

assessment for existing residential uses of metaflumizone in order to address potential aggregate (dietary + non

- dietary) risks

. There are no new metaflumizon e residential uses associated with this regulatory action. This document presents the re

- evaluation of existing metaflumizon e residential uses

– home lawn/turf uses

– following updated policies and guidance in place since previous risk assessments

.

Metaflumizone (2

- [2

- (4

- cyanophenyl)

- 1

- [3

- (trifluoromethyl)phenyl]ethylidene]

- N

- [4

- (trifluoromethoxy)phenyl]hydrazinecarboxamide; E and Z isomers) is a semicarbazone insecticide that blocks the sodium channels of the nervous system in susceptible insects leading to inhibited feeding and paralysis

. It is registered as a fire ant bait for application to lawns, landscapes, golf courses, and other non

- cropland , as well as citrus fruits, grap es, tree nuts,
orchards

, and nurseries containing field

- or container

- grown nonbearing stone and pome f ruit

trees

. M etaflumizone is also registered as a granular fly bait for control of the adult common housefly around industrial build ings, commercial facilities, and agricultural structures and premises. It can also be used around recreational facilities and outdoor recreational areas.

Metaflumizone demonstrated low acute toxicity (Category IV) via the oral, dermal, and

inhalation routes. It is neither a dermal irritant (Category IV), eye irritant (Category IV), nor a

dermal sensitizer. Metaflumizone was classified as a “not likely” human carcinogen.

The following points of departure were chosen for the metaflumizone residentia l assessment: 1)

a no observed adverse effect level ( NOAEL ) of 20 mg/kg/day from a 2

- generation reproduction toxicity study for incidental oral exposures; 2) a NOAEL of 100 mg/kg/day from a 90

- day dermal rat toxicity study for dermal exposures; and 3) a lo west observed adverse effect level ( LOAEL ) of 0

. 03 mg/L ( HEC = 0.084 mg/L and HED=2.4 mg/kg/day ) from a 28

- day inhalation toxicity study for inhalation exposures. The standard adult body weight for the general population (80 kg) was used for all exposure scenarios covered in this risk assessment since the endpoint s were not developmental and/or fetal effects.

For the dermal exposure scenarios, the level of concern (LOC) is 100 based on a combined uncertainty factor (UF) of 100 for interspecies (10x) and intraspecies (10x) extrapolation. For the inhalation exposure scenarios, s ince a NOAEL was not achieved in the 28

- day inhalation toxicity study in rats, and this study was the most relevant for inhalation exposure scenarios, the Food Quality Protection A ct ( FQPA ) Safety Factor ( SF ) is being retained as an uncertainty factor for the use of a LOAEL in the absence of a NOAEL (UF L 

### ) . In addition

, t he standard interspecies extrapolation uncertainty factor can be reduced from 10X to 3X due to the HEC calculatio n accounting for pharmacokinetic (not pharmacodynamic) interspecies differences. The intraspecies unce rtainty factor remains at 10X; t herefore, the LOC for this scenario is 30 0 . For the incidental oral scenarios, a combined UF of 300 was applied to account for interspecies (10x) and intraspecies (10x) extrapolation

, and an FQPA SF of 3x to account for the 2

- fold greaterPage 5 of 20



### absorption observed in dietary exposures (see detailed explanation in Memo, K. Lowe et. al

, D393447).

Short

- term d ermal and inhalation handler exposures are expected for those making applications

at their homes

, and short

- term dermal and incidental oral exposures are expected via contact with

residues following applications in outdoor home environments. No risk s of concern were identified for any scenario

– all MOEs were greater than the respective LOCs (100 for dermal,

300 for inhalation, and 300 for incidental oral)

.

Human Studies Review This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical. These data, which include studies from the Residential SOPs (Turf SOP ) , are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics requirements. For certain studies, the ethics review may have included review by the Human Studies Review Board. Descriptions of data sources, as well as guidance on their use, can be found at the Agency

website 1



### .

2.0 Summary of Conclusions and Data Requirements

Based on a re

- evaluation using the 2012 Residential SOPs , n o existing metaflumizone residential

use s presents a risk of concern

.

Residue Data Requirements

There are no data deficiencies for metaflumizone at this time.

Turf Transferable Residue: In accordance with the updated Part 158 data requirements (2007), a TTR study is required for all occupational (e.g., sod farms, golf courses, parks, and recreational areas) or residential turf uses. As part of the recent revision to the Health Effects Di vision’s 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment , HED analyzed all available data and selected new liquid and granular default values for the fraction of the application rate available for transfer after a turf appl ication (F AR 

### ). 2 

### These defaults are 1% for formulations applied as liquids (i.e., emulsifiable concentrates, liquids, wettable powders, dry flowables, etc.) and 0.2% for granular formulations. Of the available TTR studies submitted to the Agency, the maxi mum F AR 

### value seen using a liquid product was 6.1% or 6.1 times higher

than the default residue transfer value. The maximum F AR 

### value seen in a TTR study using a granular product was 0.69% or 3.5X the default residue transfer value. Therefore, for both l iquid and granular formulations, a calculated MOE of approximately 10 times higher than the level of concern (e.g., an MOE > 1,000 if the LOC = 100) using the default residue transfer values would provide an adequate margin of safety for any potentially hi gher residues seen in a chemical

specific TTR study ( Guidance for Requiring/Waiving Turf Transferrable Residue (TTR) and Dislodgeable Foliar Residue (DFR) Studies

. 12/12 /2012, Exposure Science Advisory Council).

1 http://www.epa.gov/opp00001/science/residential

- exposure

- sop.html

2 http://www.epa.gov/pesticides/science/residential

- exposure

- sop.htmlPage 6 of 20



### A TTR study is not required for metaflumizo ne at this time since the dermal and hand

- to

- mouth

MOE s are greater tha n 10 times the LOC (MOEs>44,000) based on default values for the fraction of application rate available for transfer after a turf application.

3 .0 Hazard Profile

Metaflumizone caused both hematotoxicity (toxicity of the blood) and immunotoxicity as primary toxic effects following subchronic or chronic oral exposure. In the rat 90

- day dermal toxicity study, increased hemosiderin was observed in the livers of female s, along with increased macrophages in the thymus, lymphocyte necrosis in the mesenteric lymph nodes, and diffuse atrophy of the mandibular lymph node. Lymphocyte necrosis in the mesenteric lymph node was also the critical effect (i.e., observed at the lo west dose) reported in a rat 28

- day inhalation toxicity study, thereby supporting the conclusion that metaflumizone is immunotoxic across all routes of exposure tested. In the 2

- generation reproductive toxicity study in rats, perinatal mortality was obser ved in offspring. However, the mortality was most likely the result of the improper nursing behavior, as well as the decreased body weight and clinical signs of toxicity, exhibited by the parents at the same dose.

As noted in Table 3.1, m etaflumizone dem onstrated low acute toxicity (Category IV) via the oral, dermal, and inhalation routes. It is neither a dermal irritant (Category IV), eye irritant (Category IV), nor a dermal sensitizer.

Table 3.1. Acute Toxicity Profile

- M etaflumizone Technical (96% ai).

Guideline No./Study Type MRID No. Results Toxicity Category
870.1100/Acute oral toxicity rat 46264232 LD 50 => 5,000 mg/kg (males, females combined) IV
870.1100/Acute oral toxicity mouse 46264234 LD 50 => 5,000 mg/kg (males, females combined) IV
870.1200/Acute dermal toxicity rat 46264235 LD 50 > 5,000 mg/kg (males, females combined) IV
870.1300/Acute inhalation toxicity rat 46264236 LC 50 > 5.2 mg/L (males, females combined) IV

870.2400/Primary eye irritation rabbit 46264238 Conjunctivitis in 2/3, 1/3, 0/3 at 1, 24, and 48 hours, resp.; no positive effects IV

870.2500/Primary dermal irritation

rabbit 46264237 non

- irritant PII = 0 IV

870.2600/Dermal sensitization guinea pig 46264239 is not a sensitizer N/A



### As shown in Table 3.2, t he following points of departure were chosen for metaflumizone

residential assessment: 1) a NOAEL of 20 mg/kg/day from the 2

- generation reproduction toxicity study for incidental oral exposures; 2) a NOAEL of 100 mg/kg/day from the 90

- day dermal rate toxicity study for dermal exposures; and 3) a LOAEL of 0.03 mg/L ( HEC = 0.084 mg/L and HED=2.4 mg/kg/day ) from the 28

- day inhalation toxicity study for inhalation

exposures.Page 7 of 20

Table 3.2. Summary of Toxicological Doses and Endpoints for Metaflumizone Used in Human Health Risk

Assessment. 1

Exposure Scenario Dose Used in

Risk Assessment,

UF FQPA SF or LOC for

Risk Assessment Study and Toxicological Effects

Acute Dietary

general population, including infants

and children N/A N/A An endpoint of concern (effect) attributable to a single dose was not identified in the database. Quantification of acute risk to general population including infants and children is not required.

Short

- (1

- 30 days)

and Intermediate

- (1

- 6 months) Term

Incidental Oral NOAEL = 20

mg/kg/day LOC (residential) =

MOE < 300 2

- generation reproduction (rat); Maternal LOAEL = 50 mg/kg/day based on poor health state and decreased bodyweight.

Short

- (1

- 30 day s)

and Intermediate

- (1

- 6 months) Term

Dermal NOAEL =

100 mg/kg/day LOC (residential) =

MOE < 100 90

- day dermal (rat); LOAEL = 300 mg/kg/day based on decreased BW gain and food consumption (M&F); anogenital smearing, decreased BW, increased macrophages in the thymus, lymphocyte necrosis in the mesenteric lymph nodes, diffuse atrophy of the mandibular lymph node, and increased hemosiderin in the liver (F).

Short

- (1

- 30 days)

and Intermediate

- (1

- 6 months) Term

Inhalation LOAEL =

0.030 mg/L

NOAEL not

observed LOC (residential) =

MOE < 300 (includes 10x FQPA SF

in form of UF L ) 28

- day inhalation (rat); LOAEL = 0.03 mg/L *
based lymphocyte necrosis in the mesenteric lymph node (F).

HEC = 0.084 mg/L 2

HED=2.4 mg/kg/day 3

Cancer (oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans.

1 UF = uncertainty factor, FQPA SF = FQPA Safety Factor, NOAEL = no

- observed adverse

- effect level, LOAEL = lowest

- observed adverse

effect level, MOE = margin of exposure, LOC = level of concern, UF DB = database uncertainty factor, UF L = uncertainty factor for lack of a

NOAEL

2 HEC = LOAEL x RDDR = 0.030 x 2.809 = 0.084

3 HED = HEC x human specific conversion factor (CF) x relative activity factor (AF) x exposure duration = 0.084 mg/L x 11.8 L/hr/kg BW x 1.2 x 2 hrs = 2.4 mg/kg/day



### The standard adult body weight for the general population (80 kg) was used for all exposure scenarios covered in this risk assessment since the endpoint selected was not developmental

and/or fetal effects. In addition, the following body weights were used for the residential assessment to assess exposures to children: 11 kg for 1 to<2 year olds, 32 kg for 6 to <11 year olds, and 57 kg for 11 to <16 year olds. For the dermal exposure scenarios, the level of concern (LOC) is 100 based on a combined uncerta inty factor (UF) of 100 for interspecies (10x) and intraspecies (10x) extrapolation. For the inhalation exposure scenarios, s ince a NOAEL was not

achieved in the 28

- day inhalation toxicity study in rats, and this study was the most relevant for

inhalation exposure scenarios, the Food Quality Protection Act (FQPA) Safety Factor (SF) is being retained as an uncertainty factor for the use of a LOAEL in the absence of a NOAELPage 8 of 20



### (UF L 

### ). In addition, the standard interspecies extrapolation uncertainty factor can be reduced from 10X to 3X due to the HEC calculation accounting for pharmacokinetic (not pharmacodynamic) interspecies differences. The intraspecies uncertainty factor remains at 10X; therefore, the LOC for this scenario is 300 . For the incidental oral sc enarios, a combined UF of 300 was applied to account for interspecies (10x) and intraspecies (10x) extrapolation, and an FQPA SF of 3x to account for the 2

- fold greater absorption observed in dietary exposures (see detailed explanation in Memo, K. Lowe et. al , D393447).

4 .0 Use Profile

A summary of the existing residential uses of metaflumizone is provided in Table 4.1 below

. These uses represent all of the existing residential uses/products currently registered for

metaflumizone at this time.

Table 4. 1 . Summary of Use Directions for Existing Residential Uses of Metaflumizone

.

Residential Use Formulation Application Rate s Application Equipment HED

Reference/

Source

Fly Bait for use on

Turf

(outdoor recreational areas) Solid Bait

0.063% ai

[ Metaflumizone Fly Bait: 7969

- 293 ] Broadcast: 0.014 lb

ai/ A or 3.2 x 10 - 7 lb

ai/ft 2 P ush

- type

spreader, belly grinder, cup/spoon, by

hand D393548

Fire Ant Bait for

use on Turf

(residential and golf course turf) Solid Bait

0.063% ai [ Metaflumizone

Insecticide Fire Ant Bait:

7969

- 231] Broadcast: 0.001 lb

ai/A or 2.3 x 10 - 8 lb

ai/ft 2

Per mound: 0.0001

lb ai/mound Push

- type

drop spreader, belly grinder, cup/spoon D393548 and

D345154/

D315785 [ Siesta Insecticide Fire

Ant Bait: 7969

- 232 ]

[ Cando Granular Fire Ant

Bait: 7969

- 346]



### 5 .0 Residential Exposure and Risk Estimates

There are no new proposed residential uses at this time; however, f or the purposes of evaluating aggregate (dietary and non

- dietary) exposure for the current regulatory action, there are existing residential uses that have been reassessed in this document to reflect updates to HED’s 2012

Residential SOPs 3 

### along with policy changes for body weight assumptions. The revision of residential exposures w ill impact the human health aggregate risk assessment for the tolerance assessment for imported pepper, tomato and eggplant

.

Metaflumizone has ex isting residential uses on turf . Both residential handler and post

application exposures are expected. Expos ures are expected to be short

- term (i.e., up to 30 days)

in duration. Since there is an acute dietary endpoint, a post

- application episodic incidental

3 Available: http://www.epa.gov/pesticides/science/residential

- exposure

- sop.htmlPage 9 of 20



### ingestion of granules/pellets assessment for children was also conducted. Appendix A provides

exposure algorithms and descriptions of inputs from HED’s revised “Residential SOPs.”

A total aggregated risk index (ARI) was used since the LOCs for incidental oral exposure (300), dermal exposure (100)

, and inhalation exposure ( 3 00) are different. The target AR I is 1; therefore, ARIs of less than 1 are risk estimates of concern. The aggregate risk index (ARI) was

calculated as follows.

Aggregate Risk Index (ARI) = 1÷ [(Dermal LOC ÷ Dermal MOE) + (Inhalation or Incidental Oral LOC ÷

Inhalation or Incidental oral MOE)]



### A summary of the risk estimates are provided in Tables 5.1 (residential handler), Table 5.2 (residential post

- application) and 5.3 (residential scenarios recommended for the aggregate assessment). Based on HED’s revised “Resident ial SOPs”, no risks of concern were identified for the existing residential uses of metaflumizone

.

Table 5. 0. 1

. Residential Handler Non

- cancer Exposure and Risk Estimates for Existing Residential Uses of

Metaflumizone

.

Scenario Formulation Equipment Dose (mg/kg/day) 1 MOE 2

ARI 3 Dermal Inhalation Dermal

(LOC = 100) Inhalation

(LOC = 3 00)

Lawns/Turf Granule Push

- type rotary spreader 5.1E

- 06 1.6E

- 08 2.0E+07 1.5E+08 140,000

Belly Grinder 1.2E

- 04 1.3E

- 08 8.1E+05 1.8E+08 7,900

Spoon 1.8E

- 07 2.5E

- 09 5.6E+08 9.6E+08 2,000,000

3.9E

- 05 5.4E

- 07 2.6E+06 4.4E+06 9,400

Cup 3.2E

- 09 3.7E

- 10 3.2E+10 6.4E+09 20,000,000

6.9E

- 07 8.1E

- 08 1.5E+08 3.0E+07 92,000

1. Dose (mg/kg/day) equations provided in Appendix A. Application rates = 0.001 lb ai/A, 2.3 x 10

- 8 lb ai/ft 2 , or 0.0001 lb ai/mound based on fire ant bait product (see Table 4.1 ).

2. MOE = POD (mg/kg/day) ÷ Dose (mg/kg/day) , where dermal POD = 100 mg/kg/day and inhalation POD = 8 mg/kg/day.

3. ARI = Aggregate Risk Index = 1÷ [(Dermal LOC ÷ Dermal MOE) + (Inhalation LOC ÷ Inhalation MOE)] , where dermal LOC = 100

and inhalation LOC = 3 00

.

Table 5. 0. 2

. Residential Post

- application Non

- cancer Exposure and Risk Estimates for Existing Residential Uses of

Metaflumizone

.

Use/Target Lifestage Post

- application Exposure Scenario Application

Rate (lb ai/A) Dose 1

(mg/kg / day) MOE 2 Combined

Routes (X indicates

included in

ARI ) ARI 3

Tur f Adult Dermal High

- contact (playing) 0.014 0.0012 86,000

N/A

0.001 0.00008 1,200,000
Mowing 1.5E

- 06 65,000,000 Golfing 5.9E

- 06 17,000,000

Child 11<16

yrs Dermal Mowing 1.8E

- 06 57,000,000

Golfing 6.9E

- 06 15,000,000

Child 6<11

yrs Dermal Golfing 8.1E

- 06 12,000,000

Child 1<2 yrs Dermal (high

- contact

play) 0.014 0.0023 44 ,000 X 380Page 10 of 20

Table 5. 0. 2

. Residential Post

- application Non

- cancer Exposure and Risk Estimates for Existing Residential Uses of

Metaflumizone

.

Use/Target Lifestage Post

- application Exposure Scenario Application

Rate (lb ai/A) Dose 1

(mg/kg / day) MOE 2 Combined

Routes (X indicates

included in

ARI ) ARI 3

Hand to Mouth 2.1E

- 05 950,000 X Object to Mouth 1.3E

- 06 15,000,000 N/A Incidental Soil Ingestion 4.7E

- 07 42,000,000
Dose (mg/kg/day) equations provided in Appendix A. Application rates = 0.001 lb ai/A based on fire ant bait product (see Table 4.1 ) and 0.0 14 lb ai/A based on the fly bait product (see Table 4.1)

. MOE = POD (mg/kg/day) ÷ Dose (mg/kg/day), where dermal POD = 100 mg/kg/day and incidental oral POD = 20 mg/kg/day. ARI = Aggregate Risk Index = 1÷ [(Dermal LOC ÷ Dermal MOE) + ( Incidental oral LOC ÷ Incidental oral MOE)] , where dermal LOC = 100 and incidental oral LOC = 300)

.

Table 5. 0.3 . Recommendations for the Residential Exposures for the Metaflumizone Aggregate Assessment. 1

Lifestage (Scenario) Dose (mg/kg/day) 2,4 MOE 3,5

Dermal Inhalation Oral Total Dermal (LOC = 100) Inhalation

(LOC = 3 00) Oral

(LOC = 300) Total

Residential Handler

Adult Male (Belly Grinder) 1.2E

- 04 1.3E

- 08 N/A 1.2E

- 04 8.1E+05 1.8E+08 N/A ARI = 7,900

Residential Post

- application

Adult Male ( High contact activity on turf

) 0.0012 NA N/A 0.0012 86,000 NA N/A 86,000

Child (High contact activity on turf) 0.0023 NA 2.1E

- 05 0.0023 44,000 NA 950,000 ARI = 380

1 Bolded risk estimates should contribute to the residential exposure portion of the aggregate assessment.

2 Residential Handler Dose = the highest handler dose for each applicable lifestage of all residential handler scenarios assess ed. Total =

dermal + i nhalation.

3 Residential Handler MOE = the MOEs associated with the highest residential handler doses. Total = ARI = 1÷ [(Dermal LOC ÷

Dermal MOE) + (Inhalation LOC ÷ Inhalation MOE)]

. 4 Residential Post

- application Dose = the highest post

- application dos e for each applicable lifestage of all post

- application scenarios

assessed. Total = dermal + inhalation + incidental oral (where applicable).

5 Residential Post

- application MOE = the MOEs associated with the highest post

- application doses. Total = ARI = 1÷ [(Dermal LOC ÷

Dermal MOE) + (Incidental oral LOC ÷ Incidental oral MOE)]

.



### 5. 1 Residential Bystander Post

- Application Inhalation Exposure

Based on the Agency's current practices, a quantitative post

- application inhalation exposure

assessment was not performed for metaflumizone at this time primarily because of the low acute inhalation toxicity (Toxicity Category IV), low vapor pressure ( 9.3 x 10 - 11 

### mmHg ), and the low proposed use rate (0. 014 lb ai/A). However, volatilization of pesticides may be a so urce of post

application inhalation exposure to individuals nearby pesticide applications. The Agency sought expert advice and input on issues related to volatilization of pesticides from its Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 4 

### . The Agency is in the process of evaluating the SAP report and may, as appropriate, develop policies and procedures to identify the need for and, subsequently, th e way to incorporate post

- application inhalation exposure into

4 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.htmlPage 11 of 20



### the Agency's risk assessments. If new policies or procedures are developed, the Agency may revisit the need for a quantitative post

- application inhalation exposure assessment for

metaflumizone

.Page 12 of 20



### Appendix A. Summary of Residential Handler and Post

- application Algorithms

1.0 Residential Handlers /Turf and Lawns SOP

Dermal and Inhalation Handler Exposure Algorithm Daily dermal and inhalation exposure (mg/day) for residential pesticide handlers , for a given

formulation

- application method combination, is estimated by multiplying the formulation

application method

- specific unit exposure by an estimate of the amount of active ingredient handled in a day, using the equation below:

E = UE * AR * A

where:

E = exposure (mg/day);

UE = unit exposure (mg/lb ai);

AR = application rate (e.g., lb ai/ft 2 

### , lb ai/gal); and

A = area treated or amount handled (e.g., ft 2 

### /day, gal/day).

Dermal and/or inhalation absorbed doses normalized to body weight are calculated as:

D = E *AF / BW

where:

D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor (dermal and/or inhalation); and

BW = body weight (kg).

Post

- application Dermal Exposure Algorithm

– Physical Activities on Turf Exposure resulting from contacting previously treated turf while performing physical activities is calculated as shown below. Residential post

- application exposure assessment must include calculation of exposure on the day of application. Therefore, though an as sessment can present exposures for any day “t” following the application, it must include “day 0” exposure.

E = TTRt * CF1 * TC * ET

where:

E = exposure (mg/day);

TTRt = turf transferable residue on day t (μg/cm 2 

### );

CF1 = weight unit conversion factor (0.001 mg/μg);Page 13 of 20



### TC = transfer coefficient (cm 2 

### /hr); and

ET = exposure time (hr/day).

If chemical

- specific TTR data are available, then surface residues from the day of application should be used (assume that individuals could be exposed to resid ues immediately after application). However, if data are not available, then TTR t 

### can be calculated using the following

formula:

TTR t 

### = AR * F * (1

- FD) t 

### * CF2 * CF3

where:

TTRt = turf transferable residue on day t (μg/cm 2 

### );

AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F = fraction of ai as transferable residue following application (unitless);

FD = fraction of residue that dissipates daily (unitless);

t = post

- application day on which exposure is being assessed;

CF2 = weight unit conv ersion factor (4.54 x 10 8 

### μg/lb); and

CF3 = area unit conversion factor (1.08 x 10 - 3 

### ft 2 

### / cm 2 

### or 2.47 x 10 - 8 

### acre/cm 2 

### ).

Dermal absorbed doses are calculated as:

where:

D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor (dermal); and

BW = body weight (kg).

Table A

- 1

. Turf (Physical Activities)

-- Inputs for Residential Post

- application Dermal Exposure

. Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate

(mass active ingredient per unit area) 0.001 and 0.014 lb

ai/A

F Fraction of AR as TTR following

application (if chemical

- specific data is unavailable) L/WP/WDG 0.01

Granules 0.002

F D Daily residue dissipation (if chemical

specific data is unavailable) (fraction) L/WP/WDG 0.1

Granules 0.1

TC Transfer Coefficient

(cm 2 /hr) L/WP/WDG Adults 180,000
Children 1 < 2 years old 49,000

Granules Adults 200,000

Children 1 < 2 years old 54,000

ET Exposure Time Adults 1.5Page 14 of 20

Table A

- 1

. Turf (Physical Activities)

-- Inputs for Residential Post

- application Dermal Exposure

. Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

(hours per day) Children 1 < 2 years old 1.5

BW Body Weight

(kg) Adults 80 Children 1 < 2 years old 11 L/WP/WDG = Liquids/Wettable Powders/Water

- dispersible Granules



### Post

- application Hand

- to

- Mouth Exposure Algorithm

– Physical Activities on Turf Exposure from hand

- to

- mouth activity is calculated as follows (based on the algorithm utilized in

the SHEDS

- Multimedia model ):

E = [HR * ( F

M 

### * SA H 

### ) * (ET * N_Replen) * (1

- (1

- SE ) (Freq_HtM/N

- Replen) 

### )]

where:

E = exposure (mg/day);

HR = hand residue loading (mg/cm 2 

### );

FM = fraction hand surface area mouthed / event (fraction/event);

SAH = typical surface area of one hand (cm 2 

### );

ET = exposure time (hr/day); N_Replen = number of replenishment intervals per hour (intervals/hour);

SE = saliva extraction factor (i.e., mouthing removal efficiency); and Freq_HtM = number of hand

- to

- mouth contacts events per hour (events/hour).

and

where:

HR = hand residue loading (mg/cm 2 

### );

Fai hands 

### = fraction ai on hands compared to total surface residue from dermal transfer

coefficient study (unitless);

DE = dermal exposure (mg); and

SA H 

### = typical surface area of one hand (cm 2 

### ).

Dose, normalized to body weight, is calculated as:

where:Page 15 of 20



### D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- 2

. Turf (Physical Activities)

– Inputs for Residential Post

- application Hand

- to

- Mouth Exposure

. Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

Fai hands Fraction of ai on hands

from dermal transfer coefficient study (unitless) Liquid formulations 0.06

Granular formulations 0.027

DE Dermal exposure (mg) Calculated

SA H Typical surface area of one hand (cm 2 ), children 1 <

2 years old 150

AR Application rate

(mass active ingredient per unit area) 0.001 and 0.014 lb ai/A

HR Residue available on the hands (mg/cm 2 ) Calculated via (DE * Fai hands )/SA H

F M Fraction hand surface area mouthed

(fraction/event) 0.127

N_Replen Replenishment intervals per hour

(intervals/hr) 4

ET Exposure time

(hrs/day) 1.5

SE Saliva extraction factor

(unitless) 0.48

Freq_HtM Hand

- to

- mouth events per hour

(events/hr) 13.9

BW Body Weight

(kg) Children 1 < 2 years old 11



### Post

- application Object

- to

- Mouth Exposure Algorithm

– Physical Activities on Turf Exposure from object

- to

- mouth activity is calculated as follows (based on the algorithm utilized

in SHEDS

- Multimedia):

E = [OR* CF1 * SAM O 

### * (ET * N_Replen) * (1

- (1

- SE O 

### ) (Freq_OtM/N_Replen) 

### )]

where:

E = exposure (mg/day);

OR = chemical residue loading on the object on day “t” (ug/cm 2 

### );

CF1 = weight unit conversion factor (0.001 mg/μg);

SAM O 

### = area of the object surface that is mouthed (cm 2 

### /event);

ET = exposure time (hr/day); N_Replen = number of replenishment intervals per hour (intervals/hour);

SE O 

### = saliva extraction factor (i.e., mouthing removal efficiency); andPage 16 of 20



### Freq_OtM = number of object

- to

- mouth contact events per hour (events/hour).

and

OR = AR * F O 

### * CF2 * CF3

where:

OR = chemical residue loading on the object (μg/cm 2 

### );

AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F O 

### = fraction of residue available on the object (unitless);

CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); and

CF3 = area unit conversion factor (1.08 x 10 - 3 

### ft 2 

### /cm 2 

### or 2.47 x 10 - 8 

### acre/cm 2 

### ).

Dose, normalized to body weight, is calculated as:

where:

D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- 3

. Turf (Physical Activities)

– Inputs for Residential Post

- application Object

- to

- Mouth Exposure

. Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate (to turf)

(mass active ingredient per unit area) 0.001 and 0.014 lb ai/A

F O Fraction of AR as OR following application 1 0.01

SAM O Surface area of object mouthed

(cm 2 /event) 10

N_Replen Replenishment intervals per hour (intervals/hour) 4

SE O Saliva extraction factor

(fraction) 0.48

ET Exposure time

(hours per day) 1.5

Freq_OtM Object

- to

- mouth events per hour (events/hr) 8.8

BW Body Weight (kg) Children 1 < 2 years old 11

1 This SOP assumes that all of the residue on the turf could be transferred to the object (e.g., object residue is equal to turf transferable residue).



### Post

- application Incidental Soil Ingestion Exposure Algorithm

– Physical Activities on Turf Exposure from incidental soil ingestion is calculated as follows:

E = SRt * SIgR * CF1Page 17 of 20



### where:

E = exposure (mg/day);

SRt = soil residue on day "t" (μg/g); SIgR = ingestion rate of soil (mg/day); and

CF1 = weight unit conversion factor (1 x 10 - 6 

### g/μg).

and

SRt = AR * FS * (1

- F D 

### ) t 

### * CF2 * CF3 * CF4

where:

SR t 

### = soil residue on day "t" (μg/g);

AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

FS = fraction of ai available in uppermost cm of soil (fraction/cm);

F D 

### = fraction of residue that dissipates daily (unitless);

t = post

- application day on which exposure is being assessed;

CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb);

CF3 = area unit conversion factor (1.08 x 10 - 3 

### ft 2 

### /cm 2 

### or 2.47 x 10 - 8 

### acre/cm 2 

### ); and

CF4 = soil volume to weight unit conversion factor (0.67 cm 3 

### /g soil).

Dose, normalized to body weight, are calculated as:

where :

D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).

Table A

- 4

. Turf (Physical Activities)

– Inputs for Residential Post

- application Incidental Soil Ingestion Exposure

. Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate

(mass active ingredient per unit area) 0.001 and 0.014 lb ai/A

FS Fraction of AR available in uppermost 1 cm of soil

(unitless) 1

F D Daily residue dissipation

(fraction) 0.1

SIgR Soil ingestion rate (mg/day) 50

BW Body weight (kg) Children 1 < 2 years old 11Page 18 of 20



### Post

- application Dermal Exposure Algorithm

– Mowing Exposure resulting from contacting previously treated turf while mowing is calculated as

follows:

E = TTRt * CF1 * TC * ET

where :

E = exposure (mg/day);

TTR t 

### = turf transferable residue on day "t" (μg/cm 2 

### );

CF1 = weight unit conversion factor (0.001 mg/μg);

TC = transfer coefficient (cm 2 

### /hr); and

ET = exposure time (hr/day).

and

TTRt = AR * F AR 

### * (1

- F

D 

### ) t 

### * CF2 * CF3

where :

TTR t 

### = turf transferable residue on day "t" (μg/cm 2 

### );

AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F AR 

### = fraction of ai retained on turf (unitless);

F D 

### = fraction of residue that dissipates daily (unitless);

t = post

- application day on which exposure is being assessed;

CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); and

CF3 = area unit conversion factor (1.08 x 10 - 3 

### ft 2 

### /cm 2 

### or 2.47 x 10 - 8 

### acre/cm 2 

### ).

Absorbed dose, normalized to body weight, are calculated as:

where :
D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor (dermal); and

BW = body weight (kg).

Table A

- 5

. Turf (Mowing)

– Inputs for Residential Post

- application Dermal Exposure

. Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate

mass active ingredient per unit area 0.001 lb ai/APage 1 9 of 20

Table A

- 5

. Turf (Mowing)

– Inputs for Residential Post

- application Dermal Exposure

.

F AR Fraction of AR as TTR following

application L/WP/WDG 0.01

Granules 0.002

F D Daily residue dissipation L/WP/WDG 0.1

Granules 0.1

TC Transfer Coefficient

(cm 2 /hr) Adult 5,500 Children 11 < 16 years

old 4,500

ET Exposure time

(hours per day) 1

BW Body Weight

(kg) Adults 80 Children 11 < 16 years

old 57

L/WP/WDG = liquid/wettable powder/water dispersible granule



### Post

- application Dermal Exposure Algorithm

– Golfing Exposure resulting from contacting previously treated turf while golfing is calculated as follows:

E = TTRt * CF1 * TC * ET

where :

E = exposure (mg/day);

TTR t 

### = turf transferable residue on day "t" (μg/cm 2 

### );

CF1 = weight unit conversion factor (0.001 mg/μg);

TC = transfer coefficient (cm 2 

### /hr); and

ET = exposure time (hr/day).

and

TTRt = AR * F * (1

- F D 

### ) t 

### * CF2 * CF3

where :

TTR t 

### = turf transferable residue on day "t" (μg/cm 2 

### );

AR = application rate (lbs ai/ft 2 

### or lb ai/acre);

F = fraction of ai retained on turf (unitless);’

F D 

### = fraction of residue that dissipates daily (unitless);

t = post

- application day on which exposure is being assessed;

CF2 = weight unit conversion factor (4.54 x 10 8 

### μg/lb); and

CF3 = area unit conversion factor (1.08 x 10 - 3 

### ft 2 

### /cm 2 

### or 2.47 x 10 - 8 

### acre/cm 2 

### ).

Absorbed dose, normalized to body weight, is calculated as:Page 20 of 20



### where :
D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor (dermal); and

BW = body weight (kg).

Table A

- 6

. Turf (Golfing)

– Inputs for Residential Post

- application Dermal Exposure

. Algorithm

Notation Exposure Factor

(units) Point Estimate(s)

AR Application rate

(mass active ingredient per unit area) 0.001 lb ai/A

F Fraction of AR as TTR

following application L/WP/WDG 0.01

Granules 0.002

F D Daily residue dissipation L/WP/WDG 0.1

Granules 0.1

TC Transfer Coefficient

(cm 2 /hr) Adult 5,300 Children 11 < 16 years old 4,400 Children 6 < 11 years old 2,900

ET Exposure time

(hours per day) Pesticides used on greens, tees, and fairways 4

Pesticides used only on greens

and tees 1

BW Body Weight

(kg) Adults 80 Children 11 < 16 years old 57 Children 6 < 11 years old 32 NA = not applicable

L/WP/WDG = liquid/wettable powder/water dispersible granule