Page 3 of 27 Tabl e of Contents

1.0 Executive Summary

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

2.0 Summary of Conclusions and Data Requirements

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

3.0 Hazard Characterization

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

4.0 Use Profile

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

5.0 Residential Exposure and Risk Estimates

................................ ................................ ............ 9

5.1 Spray Drift

................................ ................................ ................................ ...................... 10

5.2 Residential Bystander Post

- Application Inhalation Exposure

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

- application Algorithms

...................... 12

1.0 Residential Handlers

................................ ................................ ................................ .......... 12

1.1 Residential Handler Exposure Calculations

................................ ................................ ... 12

1.1.1 Turf and Indoor Environments

................................ ................................ ................ 12

1.2 Residential Handler Dose Calculations

................................ ................................ .......... 12

2.0 Residential Post

- application

................................ ................................ ............................... 12

2.1 Turf/Physical Activities on Turf

................................ ................................ .................... 12

2.2 Turf/Mowing

................................ ................................ ................................ .................. 18

2.3 Turf/Golfing

................................ ................................ ................................ ................... 19

2.4 Indoor Envir onments

................................ ................................ ................................ ...... 20Page 4 of 27

1.0 Executive Summary

A s a result of a petition by the thiamethoxam registrant, Syngenta, requesting an increased

tolerance for residues of thiamethoxam and its metabolite, CGA

- 322704 (chlothianidin)

, in or on coffee from use of new formulations and higher maximum seasonal use rates on imported coffee,

HED has conducted a residential exposure /risk assessment for existing residential uses of

th iamethoxam in order to address potential aggregate (dietary + non

- dietary) risks. There are no new thiamethoxam residential uses associated with this regulatory action. This document presents the re

- evaluation of existing thiamethoxam residential uses

– home lawn/turf and indoor

crack

- and

- crevice uses

– following updated policies and guidance in place since previous risk

assessments

.

Thiamethoxam is a broad spectrum nitroguanidine insecticide which belongs to the pesticidal class of compounds known as t he neonicotinoids (Group 4A; Insecticide Resistance Action Committee). It has activity against sucking and chewing insects on a wide variety of crops. Thiamethoxam appears to interfere with the nicotinic acetylcholine receptors of the insect’s

nervous sy stem, but the specific receptor site is unknown at this time. It does not inhibit cholinesterase or interfere with sodium channels and, therefore, has a different mode of action than organophosphate, carbamate, and pyrethroid insecticides.

Thiamethoxam i s classified as Toxicity Category III for acute oral toxicity and Category IV for

acute dermal and acute inhalation toxicity and for skin and eye irritation potential.

Thiamethoxam is not a dermal sensitizer. Thiamethoxam has been classified as “Not Likely to be Carcinogenic to Humans” , therefore, there is no concern over cancer risk with the proposed or existing uses.

The incidental oral point of departure (POD) for all durations is a no observed adverse effect level (NOAEL) of 8.23 mg/kg/day

, and is based on effects seen in the kidney, liver, testis, ovary, and hematopoietic system in a 90

- day or al study in the dog. The adult dermal POD for all

durations is a NOAEL of 1.2 mg/kg/day

, and is based on sperm abnormalities and testicular

effects obser ved after in utero and post

- natal exposure in the rat reproduction studies. Although

a 21

- day dermal toxicity study in rats is available, HED selected a reproductive NOAEL because the reproductive parameters are not evaluated in the dermal toxicity study and thus

, the consequences of these effects cannot be ascertained for the dermal route of exposure. Since the adult dermal endpoint was based on an oral study, a 5 % dermal absorption factor was used to estimate dermal exposure for all durations. The infa nts and children’s (1

- 6 years) dermal POD

for all durations is a NOAEL of 60 mg/kg/day

, and is based on liver effects seen in a 28

- day dermal toxicity study in rats. The inhalation POD for all durations is a NOAEL of 1.2 mg/kg/day and is based on the same study used for the adult dermal POD . Other than acute toxicity, no inhalation studies are available ; t herefore, the reproductive endpoint is selected for inhalation exposure . Inhalation toxicity is assumed to be equivalent to oral toxicity.

S ince the dermal and inhalation toxicological endpoints of concern for adults are based on a reproductive study, the body weight of an adult female ( 69 kg) is used to estimate dermal and

inhalation dose s

. Resulting dermal and inhalation risk estimate s were combined into t otal risk

estimates because the same endpoint was chosen to evaluate both routes of exposure. For risksPage 5 of 27

to children, the dermal and incidental oral exposures were combined due to a common toxicological endpoint. For all exposure scenarios , uncertainty factors (UF) of 10 X for interspecies and 10X for intraspecies variation (total UF of 100 X ) were used. Therefore, for all residential exposure scenarios, the level of concern for the margin of exposure (MOE) is 100. Based upon the hazard dat a and the methods used to estimate exposure , it is recommended that the 10X FQPA SF for the protection of infants and children be reduced to 1X.

Thiamethoxam has existing registrations for home uses on lawns/turf and indoor crack

- and

crevice uses. Short

- term d ermal and inhalation handler exposures are expected for those making applications at their homes and short

- term dermal, inhalation, and incidental oral exposures are expected via contact with residues following applications in outdoor and indoor home

environments. No risks of concern were identified for any scenario

– all MOEs were greater

than 100.

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 and Indoor Environments SOP ) , are (1) subject to ethics review pursuant to 40 CFR 26, (2) have received that review, and (3) are compliant with applicable ethics requ irements. 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 Requi rements

Based on a re

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

use presents a risk of concern

.

Residue Data Requirements

Turf Transferable Residue: In accordance with the updated Part 158 data requirements (2007), a turf transferable residue ( TTR ) study is required for all occupational (e.g., sod farms, golf courses, parks, and recreational areas) or residential turf uses . An existing thiamethoxam TT R study (“ Determination of Transferable Turf Residues on Turf Treated with Granular and Water Dispersible Granular Formulation of Thiamethoxam”, L. Rosenheck; EPA MRID 46402915) was used and continues to provide reliable information for residential turf us e risk assessments.

No additional data are required.

3 .0 Hazard Characterization

The database for acute toxicity for thiamethoxam is complete and is summarized below in Table

3.1. Thiamethoxam is classified as Toxicity Category III for acute oral toxic ity and Category IV

for acute dermal and acute inhalation toxicity, and for skin and eye irritation potential.

Thiamethoxam is not a dermal sensitizer.

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

- exposure

- sop.htmlPage 6 of 27

The incidental oral POD for all durations is a NOAEL of 8.23 mg/kg/day

, and is based on slightly prolonged prothrombin times and decreased plasma albumin and A/G ratio (both sexes); decreased calcium levels and ovary weights and delayed maturation in the ovaries; decreased cholesterol and phospholipid levels, t estis weights, spermatogenesis, and spermatic giant cells in

testes from a 90

- day oral study in the dog. The lowest

- observed

- adverse

- effect

- level ( LOAEL ) ranged from 32 mg/kg/day in males to 33.9 mg/kg/day in females.

The adult dermal POD for all duratio ns is a NOAEL of 1.2 mg/kg/day

, and is based on sperm

abnormalities and testicular effects observed after in utero and post

- natal exposure in the rat reproduction studies. Since no data are available to indicate how much exposure will induce the effects, t he effects are considered to be appropriate for all exposure durations. Although a 21

- day dermal toxicity study in rats is available, HED selected a reproductive NOAEL because the reproductive parameters are not evaluated in the dermal toxicity study and thus

, the consequences of these effects cannot be ascertained for the dermal route of exposure. Since the adult dermal endpoint was based on an oral study, a 5% dermal absorption factor was used to estimate dermal exposure for all durations.

The infants and children’s (1

- 6 years) dermal POD for all durations is a NOAEL of 60 mg/kg/day and is based on increased plasma glucose, triglyceride levels, and alkaline phosphatase activity and inflammatory cell infiltration in the liver and necrosis of sing le hepatocytes in females from a 28

- day dermal toxicity study in rats. The LOAEL is 250 mg/kg/day (females).

The inhalation POD for all durations is a NOAEL of 1.2 mg/kg/day and is based on sperm

abnormalities and testicular effects observed after in utero and post

- natal exposure in the rat reproduction studies. Since no data are available to indicate how much exposure will induce the effects, the effects are considered to be appropriate for all exposure durations. Other than acute toxicity, no inhal ation studies are available. Therefore, the reproductive endpoint is selected for inhalation exposure . Inhalation toxicity is assumed to be equivalent to oral toxicity. Table 3. 1. Acute Toxicity Profile of Thiamethoxam

Guideline No. Study Type MRID Results Toxicity Category

870.1100 Acute oral [rat] 44703314 LD 50 : 1563 mg/kg III

870.1200 Acute dermal [rabbit] 44703316 LD 50 = 13.3 g/kg IV

870.1300 Acute inhalation [rat] 44703317 LC 50 > 3.72 mg/L IV

870.2400 Acute eye irritation [rabbit] 44703318 PIS = 10 at 1 hr

PIS = 0 at 24 hr

Minimally irritating IV

870.2500 Acute dermal irritation 44703319 PIS = 0 IV

870.2600 Skin sensitization 44710401 Is not a sensitizer using method of Magnusson and Kligman N/APage 7 of 27

On April 27, 2005

, the Cancer Assessment Review Committee (CARC) of the Health Eff ects Division of the Office of Pesticide Programs met to re

- evaluate the carcinogenic potential of

t hiamethoxam. In accordance with the EPA’s Final Guidelines for Carcinogen Risk Assessment (March, 2005), the CARC classified Thiamethoxam as “Not Likely to be Carcinogenic to

Humans” based on convincing evidence that a non

- genotoxic mode of action for liver tumors was established in the mouse and that the carcinogenic effects are a result of a mode of action dependent on sufficient amounts of a hepatotoxic m etabolite produced persistently. Quantification of cancer risk is not required

.

A summary of the toxicological doses and endpoints is provided in Table 3.2.

Table 3.2 Summary of Toxicological Doses and Endpoints for Thiamethoxam for Use in Non

- Occupational

Human Health Risk Assessments

Exposure/

Scenario Point of

Departure Uncertainty/

FQPA Safety

Factors Level of

Concern for

Risk

Assessment Study and Toxicological Effects

Incidental Oral (all durations) NOAEL=

8.23 mg/kg/day UF A = 10x

UF H = 10x FQPA SF =1 MOE= 100

(residential) 90

- day Dog study

LOAEL= 32 (males) 33.9 (females) mg/kg/day based on slightly prolonged prothrombin times and decreased plasma albumin and A/G ratio (both sexes); decreased calcium levels and ovary weights and delayed maturation in the ovaries (females); decreased cholesterol and phospholipid levels, testis weights, spermatogenesis, and spermatic giant cells in testes (males). Dermal (all durations) (Adults) Oral study

NOAEL= 1.2 mg/kg/day (dermal absorption rate = 5%) UF A = 10x

UF H = 10x FQPA SF =1 MOE= 100

(residential) 2

- Generation reproduction study

LOAEL = 1.8 mg/kg/day based on

increased incidence and severity of tubular atrophy in testes of F 1 generation

males.

2

- Generation reproduction study LOAEL = 3 (males), not determined (females) mg/kg/day based on sperm

abnormalities in F 1 males. Dermal (all durations) (infants/

children 1

- 6

yrs ) Dermal

Study

NOAEL=60 mg/kg/day UF A = 10x

UF H = 10x FQPA SF =1 MOE= 100

(residential) Rat 28

- Day Dermal Toxicity Study

LOAEL = 250 (females) mg/kg/day based on increased plasma glucose, triglyceride levels, and alkaline phosphatase activity and inflammatory

cell infiltration in the liver and necrosis of single hepatocytes in females. Inhalation (all durations) Oral st udy

NOAEL= 1.2 mg/kg/day (inhalation toxicity = oral toxicity) UF A = 10x

UF H = 10x FQPA SF =1x MOE= 100

(residential) 2

- Generation reproduction study

LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F 1 generation

males.

2

- Generation reproduction study LOAEL = 3 (males), not determined (females) mg/kg/day based on sperm

abnormalities in F 1 males.Page 8 of 27

Table 3.2 Summary of Toxicological Doses and Endpoints for Thiamethoxam for Use in Non

- Occupational

Human Health Risk Assessments

Exposure/

Scenario Point of

Departure Uncertainty/

FQPA Safety

Factors Level of

Concern for

Risk

Assessment Study and Toxicological Effects

Cancer (oral, dermal, inhalation) “Not Likely to be Carcinogenic to Humans” based on convincing evidence th at a non

genotoxic mode of action for liver tumors was established in the mouse. Quantification of

cancer risk is not required.
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 = extrapolatio n from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. MOE = margin of exposure. LOC = level of concern.

Since the dermal and inhalation toxi cological endpoints of concern for adults are based on a reproductive study, the body weight of an adult female ( 69 kg) is used to estimate dermal and

inhalation dose in the assessment. Resulting dermal and inhalation risk estimate s for adults were combin ed into t otal risk estimates because the same endpoint was chosen to evaluate both routes of exposure. For children, dermal and incidental oral risk estimates are combined because of similar toxicological endpoints. For all exposure scenarios, uncertaint y factors (UF) of 10x for interspecies and 10x for intraspecies variation (total UF of 100x) were used. Therefore, for all residential exposure scenarios, the level of concern for the margin of exposure (MOE) is 100.

Based upon the hazard data and the m ethods used to estimate exposure , it is recommended that the 10X FQPA SF for the protection of infants and children be reduced to 1X. There is no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero

exposur e to thiamethoxam in the developmental toxicity studies. The developmental NOAELs are either higher than or equal to the maternal NOAELs. The Developmental Neurotoxicity DNT workgroup concluded there was no evidence of increased susceptibility in the DNT study in rats, based on evaluation of additional brain morphometric data for the low

- and mid

- dose pups (January 17, 2007). Although there is evidence of increased quant itative susceptibility for male pups of both two generation reproductive studies, NOAELs and LOAELs were established in these studies and the Agency selected the NOAEL for testicular effects in F1 pups as the basis for risk assessment. The Agency has conf idence that the NOAEL selected for risk assessment is protective of the most sensitive effect (testicular effects) for the most sensitive subgroup (pups) observed in the toxicological database.

4 .0 Use Profile

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

.

Table 4

. 1 . Summary of Use Directions for Existing Residential Use s of Thiamethoxam

Residential Use Formulation Applic ation

Rate Application Equipment HED

Reference/ Source

Turf (golf courses,

home lawns, recreational fields) Water

dispersible granule 0.266 lb ai/acre;

0.00133 lb ai/gallon Groundboom

(professional applicators) D359207;

D332064 Manually

- pressurized handwand

Mechanically

- pressurized handgunPage 9 of 27

Table 4

. 1 . Summary of Use Directions for Existing Residential Use s of Thiamethoxam

Residential Use Formulation Applic ation

Rate Application Equipment HED

Reference/ Source

(professional applicators)

Backpack sprayer

Granule 0.248 lb ai/acre Tractor

- drawn spreader

(professional applicators)

Rotary spreader

Belly grinder

Indoor (crack

- and

crevice) Liquid

concentrate
(21.6% ai) 0.5 gallon/1000

ft 2 of 0.1% solution (0.0084 lb ai/gallon) Manually

- pressurized handwand D359207

(rate re

- calculated from label)

5 .0 Residential Exposure and Risk Estimates

There are no 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 2 along with policy changes for body weight assumptions. The revision of residential exposures will impact the human health aggregate risk assessment for the tolerance assessment for imported coffee

.

Thiamethoxam has existing residential uses on turf and indoor environments (crack

- and

- crevice uses). Both residential handler and post

- application exposures are expected. Exposures are expected to be short

- term (i.e., up to 30 days) in duration. Based on HED’s revised “Residential SOPs”, no risks of concern were identified for the existing residential uses of thiamethoxam.

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

ass essment). Appendix A provides exposure algorithms and descriptions of inputs from HED’s

revised “Residential SOPs”.

Table 5.1 Residential Handler Non

- cancer Exposure and Risk Estimates for Existing Residential Uses of Thiamethoxam

.

Scenario Formulation Equipment Dose

(mg/kg

- day) MOE

Dermal Inhalation Dermal Inhalation Combined

Lawns/Turf WDG Manually

- pressurized handwand 0.00033 0.00011 3

, 600 11

, 000 2

, 700

Backpack 0.00033 0.00011 3

, 600 11

, 000 2

, 700

Granule Rotary / push

- type spreader 0.000073 0.0000047 16

, 000 260

, 000 15

, 000

Belly grinder 0.0018 0.0000039 670 310

, 000 670

Indoor (crack

- and

crevice) Liquid Manually

- pressurized handwand 0.00021 0.000067 5

, 700 18

, 000 4

, 300

2 Available: http://www.epa.go v/pesticides/science/residential

- exposure

- sop.htmlPage 10 of 27

Table 5.2: Residential Post

- application Non

- cancer Exposure and Risk Estimates for Existing Residential Uses of

Thiamethoxam

.

Use/Target Lifestage Post

- application Exposure Scenario Dose

(mg/kg

- day) MOE 3 Combined Routes
(X indicates included in Combined MOE) Combined

MOE

Turf (spray application) 1 Adult Dermal High

- contact (playing) 0.0024 500

-- NA Mowing 0.000049 25

, 000

-- Golfing 0.00019 6

, 400

--

Child 11<16 Dermal Mowing 0.000048 25

, 000 NA Golfing 0.00019 6

, 400

-- Child 6<11 Dermal Golfing 0.00022 5

, 400

-- NA

Child 1<2 Dermal (high

- contact

play) 0.082 740 X

640 Hand to Mouth 0.0017 4

, 900 X
Object to Mouth 0.00005 160

, 000

-- Incidental Soil Ingestion 9.0E

- 06 910

, 000

--

Indoor
(crack

- and

- crevice) Adult Dermal (playing on carpet) 2 0.00049 2

, 500 X 2 5 00

Inhalation 9.1 E

- 0 7 1,300,000 X

Child 1<2 Dermal (playing on

carpet) 3 0.0081 7

, 400 X

3500 Inhalation 3.4 E

- 0 6 36 0,000

-- Hand to Mouth (playing on carpet) 2 0.0012 6

, 800 X

1 Risk estimates are based on the maximum day

- of

- application value from a submitted turf transferable residue study (MRID

46402915 ) conducted at the maximum application. Risks from liquid spray applications are presented and are considered health

protective of granule for mulation uses as most measured TTR values for granule formulations were < LOD.

2 Risk estimates presented only in this table from contacting treated carpets, as risks from contacting other surfaces are lowe r.

3 MOEs are for short

- term exposures only.

Table 5. 3 Recommendations for the Residential Exposures for the Thiamethoxam Aggregate Assessment. 1

Lifestage Handler Exposure

(mg/kg/day) 2 Residential

Handler

Total Exposure (mg/kg/day) 3 Residential

Handler

Total MOE Post

- application Exposure

(mg/kg/day) 4 Residential

Post

application

Total Exposure (mg/kg/day) Residential

Post

application

MOE 5 Dermal Inhalation Dermal Inhalation Oral

Short

- /Intermediate

- Term

Adult 0.0018 0.0000039 0.0 018 6 7 0 0.0024 N/A N/A 0.0 024 50 0

Child 1<2 N/A 0.0 8 2 N/A 0.0 0 17 0.0 83 64 0

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 scenarios assessed from Table 5.1 (i.e., belly grinder)

. Total = dermal + inhalation.

3 Residential Handler MOE = the MOEs associated with the highest doses identified in Table 5. 1 (i.e., belly grinder) . Total = 1/ (1/Dermal MOE) + (1/Inhalation MOE).

4 Residential Post

- application Dose = the highest post

- application dose for each applicable lifestage of all scenarios assessed from Table 5.2 (adults: turf post

- application; children 1< 2: turf post

- application) . Total = dermal + inhalation + incidental oral, where applicable.

5 Residential Post

- application MOE = the MOEs associated with the highest doses identified in Table 5.2 (adults: turf post

- application; children 1< 2: turf post

- application) . Total = 1/ (1/Dermal MOE) + (1/Inhalation M OE) + (1/Incidental oral MOE).

5

. 1 Spray Drift

Spray drift is always a potential source of exposure to residents nearby to spraying operations. This is particularly the case with aerial application s , but, to a lesser extent, could also be aPage 11 of 27

potential source of exposure from ground applic ation method s employed for thiamethoxam . The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices (see the Age ncy’s Spray Drift website for more information ) 3

. On a chemical by chemical basis, the Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling. The Agency has completed its

evaluation of the new database submitted by the Spray Drift Task Force, a membership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, or chard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off

- target drift with specific products with significant risk estimates associated with drif t.

Note that an application rate of 0. 266 lb ai/acre was used in the updated assessment of the existing lawn/ turf registration to estimate post

- application residential exposure of children. As this rate is equal to or higher than those from other thiamethoxam uses, exposures resulting from direct application to lawns/turf are likely protective of an y exposure via spray drift from other

thiamethoxam uses

.

5

. 2 Residential Bystander Post

- Application Inhalation Exposure

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

- application inhalation exposure assessment was not performed at this time for the agricultural thiamethoxam uses primarily because of the low acute inhalation toxicity ( Toxicity Categor y I V ) and low vapor pressure ( 6.6

x 10 - 9 mmHg ) . However, volatilization of pesticides may be a source 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 Feder al 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, the way to incorporate post

- application inhalation exposure into the Agency's risk assessments. If new policies or procedures are developed, the Agency may revisit the need for a quantitative post

- ap plication inhalation exposure assessment for the existing uses of

thiamethoxam

.

Note, however, that inhalation exposure from volatilization of thiamethoxam foll owing indoor

uses was assessed and no risks of concern were identified.

3 Available: http://www.epa.gov/opp00001/factsheets/spraydrift.htm

4 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.htmlPage 12 of 27

Appendix A. Summary of Residential Handler and Post

- application Algorithms

1.0 Residential Handlers

1.1 Residential Handler Exposure Calculations

1.1.1 Turf and Indoor Environments

Dermal and Inhalation Handler Exposure Algorithm Daily dermal and inhalation expo sure (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 d ay, 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).

1.2 Residential Handler Dose Calculations

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).

2.0 Res idential Post

- application

2.1 Turf/Physical Activities on Turf

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 assessment can present exposures for any day “t” following the application, it must include “day 0” exposure.Page 13 of 27 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); 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 residues immediately after application). However, if data are not available, then TTR t can be calcula ted 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 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 acr e/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) [input]

F Fraction of AR as TTR

following application (if

chemical

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

Granules 0.002Page 14 of 27

Table A

- 1 : Turf (Physical Activities)

-- Inputs for Residential Post

- application Dermal Exposure

Algorithm Notation Exposure Factor (units) Point Estimate(s)

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

(hours per day) Adults 1.5 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 l oading (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 ).Page 15 of 27

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

- 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) [input]

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);Page 16 of 27

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); and Freq_OtM = number of object

- to

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

and

OR = AR * F O * CF 2 * 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 u nit 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) [input]

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:Page 17 of 27 E = SRt * SIgR * CF1

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) [input]

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 27

2.2 Turf/Mowing

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 bei ng 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 [input]

F AR Fraction of AR as L/WP/WDG 0.01Page 19 of 27

Table A

- 5 : Turf (Mowing)

– Inputs for Residential Post

- application Dermal Exposure TTR following application 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

2.3 Turf/Golfing

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 co nversion 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 = are a 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 27

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) [input]

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

2. 4 Indoor Environments

Exposure to pesticide vapors The following algorithm is used to determine post

- application inhalation exposure from indoor

surface

- directed sprays:

where :
E = exposure (mg/day);

IR = inhalation rate (m 3 /hr);

M label = mass of active ingredient applied, determined from product label (mg);

V
room = volume of room (m 3 );

ACH = air exchanges per hour (1/hr);

k = first order decay rate (1/hr); and

ET = exposure time (hr).Page 21 of 27

In the above equation, a mass of pesticide is applied to a surface and the emission of the pesticide from the surface is assumed to decline over time due to dissipation of the pestici de (i.e., emission from the treated surface and removal due to the air exchange rate). The mass of active ingredient applied can be calculated using the following formula:

where:

M label = mass of active ingredient applied, determined from product label (mg);

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

A = area treated or amount handled (e.g., ft 2 /day, gal/day); and

CF1 = conversion factor (4.54x10 5 mg/lb).

The exposure equation models an emission rate that decreases over time, which is based on a

first

- order decay rate constant (k). Evans (1994) proposed calculating such a decay rate based on work done by Chinn (1981). Chinn developed the following relationship between the volatility,

or saturation concen tration (C sat ), of a chemical and the time required for 90% of the chemical to evaporate (EvapT):

where : EvapT = evaporation time (sec); and

C sat = saturation concentration (mg/m 3 ).

Evans proposed the following equation to calculate the decay rate (or dissipation rate) that defines the change in the emission rate based on the evaporation time described by Chinn:

where : k = first order decay rate (1/hr),

CF1 = conversion f

actor (sec/hr), and EvapT = evaporation time (sec).

**Saturation concentration verification** In the vapor emission assessment, post

- application inhalation exposure occurs from the release of vapors following a surface treatment indoors. The concentratio n of pesticide in the air is modeled over time to calculate exposure. The maximum concentration allowed in the air should be the saturation concentration, calculated as a function of the pesticide’s molecular weight and vapor pressure. The equation used to model the air concentration is not boundPage 22 of 27

by the saturation concentration; therefore, the reviewer must perform a check to make sure the exposures being calculated are valid.

The exposure equation above is based on the mass of pesticide applied, not the concentration of the pesticide in the air; therefore, the reviewer must check that the input for mass applied (M label ) is predicting an air concentration less than or equal to the saturation concentration. The following equation can be used to calcula te the theoretical mass applied that would result in an air concentration that reaches the saturation concentration for a pesticide (M Csat ):

M Csat should be compared to M label

.

If M label > M Csat  M label will predict an air concentration higher than the saturation

concentration. Use M Csat in the exposure calculation.

If M label < M Csat ,  M label will not predict an air concentration higher than the saturation

concentration. Use M label in the exposure c alculation.

Once the post

- application inhalation exposure is calculated, the inhalation dose normalized to body weight is calculated as:

where :

D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor (inhalation); and

BW = body weight (kg).

Table A

- 7 : Indoor Environments

– Inputs for Residential Post

- applica tion Inhalation Exposure Algorithm

Notation Exposure Factor (units) Point Estimate(s)

Generic Variables Used in Calculating Post

- application Inhalation Exposure

IR Inhalation rate

(m 3 /hour) Adult 0.64 Children 1 < 2 years old 0.33

ACH Air changes per hour (hr - 1 ) 0.45

BW Body weight

(kg) Adult 80

Children 1 < 2 years old 11

V

room Volume of room (m 3 ) 33Page 23 of 27

Table A

- 7 : Indoor Environments

– Inputs for Residential Post

- applica tion Inhalation Exposure Algorithm

Notation Exposure Factor (units) Point Estimate(s)

Variables Specific to Post

- application Inhalation Exposure to Pesticide Aerosols

C

o Initial air concentration (mg/m 3 ) Calculated; concentration at

time “0”

AR Application rate (lb ai/ ft 3 ) [input]

A.I. Percent ai in product (%) [input]

V product Volume of product (mL) [input]

D product Product density

(g/mL) Water

- based products 1

Solvent

- based products 0.8

ET Exposure time (hr/day) 2

Variables Specific to Post

- application Inhalation Exposure to Pesticide Vapors

C sat Saturation concentration (mg/m 3 ) Calculated

VP Vapor pressure (mmHg) [input]

MW Molecular weight (g/mol) [input]

R Gas constant (L

- atm/mol

- K) 0.0821

T Temperature of the air (kelvin, K) 298

M label Mass of active ingredient applied (mg) [input]

K First order decay rate Calculated

ET Exposure time

(hr/day) Adult 16

Children 1 < 2 years old 18

Post

- Application Dermal Exposure Algorithm (hard surfaces and carpets) The algorithm to calculate exposure is as follows:

where :
E = exposure (mg/day);

TR = indoor surface transferable residue (μg/cm 2 );

TC = transfer coefficient (cm 2 /hr);

ET = exposure time (hr/day); and

CF1 = conversion factor (0.001 mg/μg).

If chemical

- specific TR data are available, this is preferred and should be used to calculate exposure. However, if chemical

- specific TR data are not available, then TR can be calculated using the following formula:Page 24 of 27

where :
TR = indoor surface transferable residue (μg/cm 2 );
DepR = deposited residue ( g/cm 2 ), based on (in order of preference):

(1) Chemical

- specific residue deposition data ( g/cm 2 ), (2) Application rate (lb ai/area), or (3) Default residue based on type of application ( g/cm 2 ); and

F ai = fraction of ai available for transfer from carpet or hard surface (unitles s).

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

where :
D = dose (mg/kg

- day);

E = exposure (mg/day);

AF = absorption factor; and

BW = body weight (kg).

Table A

- 8 : Indoor Environments (Hard Surfaces and Carpets)

– Inputs for Residential Post

- application Dermal Exposure Algorithm

Notation Exposure Factor (units) Point Estimate(s)

TR Transferable residue
( g/cm 2 ) (1) Chemical

- specific transferable

residue data OR (2) Estimated: DepR * F ai

DepR Deposited residue
( g/cm 2 ) (1) Chemical

- specific residue deposition data, (2) Estimated based on application

rate, or (3) Estimated based on default residue related to type of application

F ai Fraction of DepR as TR

following application Carpets 0.06

Hard surfaces 0.08

TC Transfer Coefficient

(cm 2 /hr) Adult 6,800

Children 1 < 2 years old 1,800

ET Exposure Time (hrs/day) Adults Carpets 8

Hard

Surfaces 2

Children 1 < 2 years old Carpets 4

Hard

Surfaces 2

BW Body weight (kg) Adult 80 Children 1 < 2 years old 11Page 25 of 27

Post

- application Hand

- to

- Mouth Exposure Algorithm Exposure from hand

- to

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

SHEDS

- Multimedia):

where:

E = exposure (mg/day);

HR = hand residue loading (mg/cm 2 );

F M = fraction hand surface area mouthed / event (fraction/event);

ET = exposure time (hr/day);

SA H = surface area of one hand (cm 2 ); 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 jazzercise

study (unitless);

DE = dermal exposure (mg); and

SA H = typical surface area of one hand (cm 2 ).

and

Dose, normalized to body weight, is calculated as:

where :
D = dose (mg/kg

- day);

E = exposure (mg/day); and

BW = body weight (kg).Page 26 of 27

Table A

- 9 : Indoor Environments

– 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 jazzercise study (unitless) 0.15

DE Dermal exposure calculated in Section Error! Reference source not

ound. of the 2012 Residential SOPs

(mg) Calculated

HR Residue available on the hands (mg/cm 2 ) Calculated

SA H Surface area of one hand

(cm 2 ) Children 1 < 2 years old 150

AR Application rate (mass active ingredient per unit area) [input]

F M Fraction of hand mouthed per event (fraction/event) 0.13

N_Replen Replenishment intervals per hour (intervals/hr) 4

ET Exposure time

(hours per day) Children 1 < 2 years old Carpets 4

Hard Surfaces 2

SE Saliva extraction factor (fraction) 0.48

Freq_HtM Hand

- to

- mouth events

per hour (events/hr) Children 1 < 2 years old 20

BW Body Weight

(kg) Children 1 < 2 years old 11

Post

- application Object

- to

- Mouth Exposure Algorithm Exposure from object

- to

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

SHEDS

- Multimedia):

where:

E = exposure (mg/day);

OR = chemical residue loading on an object ( g/cm 2 );

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

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 = saliva extraction factor (i.e., mouthing removal efficiency); and Freq_OtM = number of object

- to

- mouth contact events per hour (events/hour).Page 27 of 27

and

where :

OR = chemical residue loading on the object (μg/cm 2 ); DepR = deposited residue (μg/cm 2 ); and

F O = fraction of residue transferred to an object (unitless).

and

Oral 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

- 1 0 : Indoor Environments

– Inputs for Residential Post

- application Object

- to

- Mouth Exposure
Algorithm

Notation Exposure Factor (units) Point Estimate(s)

AR Application rate

(mass active ingredient per unit area) [input]

F O Fraction of residue

transferred to an object Carpets 0.06

Hard surfaces 0.08

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 0.48

ET Exposure Time

(hours per day) Children 1 <

2 years old Carpets 4

Hard Surfaces 2

Freq_OtM Object

- to

- mouth events

per hour (events/hour) Children 1 < 2 years old 14

BW Body Weight

(kg) Children 1 < 2 years old 11