Page 1 of 42 UNITED STATES ENVIRONM ENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION

Date: 06/18/2014

Subject: Chlorfenapyr. Revised Occupati onal and Residential Exposure Registration

Review Assessment

PC Code: 129093 DP Barcode: D417598 Decision No.: 485596 Registration No.: NA Petition No.: NA Regulatory Action: Reg Review Risk Assessment Type: Occupational/Residential Exposure Assessment Case No.: NA

TXR No.: NA CAS No.: 122453-73-0 MRID No.: NA 40 CFR: §180.513

FROM: Lata Venkateshwara, Environmental Scientist Health Effects Division (HED)/Ri sk Assessment Branch (RAB) 1 (7509P)

THRU : Bridgett Boboweic, ExpoSAC Designated Reviewer Alexandra LaMay, ExpoSAC Designated Reviewer Exposure Science Advisory Council (ExpoSAC)

Kelly Lowe, Environmental Scientist Charles Smith III, Branch Chief HED/RAB 1 (7509P)

TO : Margaret Hathaway Kevin Costello, Branch Chief

Pesticide Re-evaluati on Division (PRD; 7508P)

The HED of the Office of Pesticide Programs (OPP) is charged with estimating the risk to human health from exposure to pesticid es. As part of Registration Re view, the Pesticid e Re-evaluation Division (PRD) of OPP has requested that HE D evaluate the hazard and exposure data and conduct occupational and residential exposure asse ssments, as needed, to estimate the risk to

human health that will result from the currently registered uses of pesticides. This memorandum serves as HED’s Registration Review risk assess ment of the occupational and residential handler and post-application exposure and risk from th e current registered uses of chlorfenapyr.

It is HED policy 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: Pesticide Handlers Exposure Data base Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) database ; the Outdoor Residential Exposure Task ForcePage 2 of 42 (ORETF) database; and the Agricultural Reentry Task Force (ARTF) database. Some of these data are proprietary, and subject to the data pr otection provisions of th e Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Note: This memorandum was reviewed by the Exposure Science Advisory Committee (ExpoSAC) on March 27, 2014Page 3 of 42 Table of Contents 1.0 Executive Summary ......................................................................................................... .... 4

2.0 Risk Assessment Conclusions and Recommendations ........................................................ 5

2.1 Label Recommendations from Occupa tional/Residential Assessment ............................. 6

2.2 Data Deficiencies and Requirements ................................................................................. 7

3.0 Hazard Characterization ....................................................................................................... 7

4.0 Use Profile ................................................................................................................... ........ 8

5.0 Residential Exposure and Risk Estimates .......................................................................... 12

5.1 Residential Handler Exposure/Risk Estimates ................................................................ 12

5.2 Residential Post-application Exposure/Risk Estimates ................................................... 12

5.2.1 Post-application Inhalation Exposure and Risk Estimates........................................ 13

5.2.2 Post-application Dermal Exposure and Risk Estimates ............................................ 14

5.2.3 Post-application Incidental Oral Exposure and Risk Estimates ................................ 16

5.2.4 Combined Residential Risk Estimates from the Indoor Surfaces and Bed Bug

Mattress Use................................................................................................................... ....... 19

5.3 Residential Risk Estimates for Use in Aggregate Assessment .................................... 20

5.4 Spray Drift ................................................................................................................... .... 20

6.0 Occupational Exposure and Risk Estimates ...................................................................... 21

6.1 Occupational Handler Expos ure/Risk Estimates ............................................................. 21

6.2 Occupational Post-application Exposure ......................................................................... 27

6.2.1 Occupational Post-application Inhala tion Exposure/Risk Estimates ........................ 27

6.2.2 Occupational Post-application Derm al Exposure/Risk Estimates ............................ 28 Appendix A: Summary of Occupati onal and Residential Algorithms ......................................... 32 Appendix B. Registered Chlo rfenapyr End Use Products ........................................................... 42Page 4 of 42 Executive Summary

The Health Effects Division has conducted an occupational and residential exposure assessment for Registration Review of the active ingredient (ai) chlorfen apyr. Chlorfenapyr is an

insecticide/miticide

. The parent compound is converted to the N-dealkylated metabolite in the organism. The pesticidal mode of action of this active form functions as an uncoupler of oxidative phosphorylation in mitochondria, wh ich disrupts ATP production leading to cell dysfunction and subsequent deat h of the organism. Chlorfena pyr is registered for use on greenhouse food and non-food crops, and as an in secticide/termiticide for use on indoor and outdoor residential sites, f ood/feed handling areas, indoor and outdoor commercial sites (including sewers), and indoor medical sites. It is currently form ulated into soluble concentrate (SC), emulsifiable concentrate (EC) and pressurized release li quid end-use products (e.g., total release foggers and aerosol cans) containing between 0.05% to 21.45% ai. This memorandum contains HED’s occupational and residential expo sures and risk estimates to pesticide handlers (i.e., mixers, loaders, applicat ors) and to agricultural work ers and residents conducting postapplication activities.

For short-term (ST) and intermediate-term (IT) de rmal exposure, ST and IT inhalation exposure, and ST incidental oral exposure for the occupational and residen tial assessment, a no observable adverse effect level (NOAEL) of 5 mg/kg/day was selected from a developmental neurotoxicity study. The LOAEL of 10 mg/kg/day is based on in creased pup deaths (post-natal days 1-4) and decreased motor activity. Chlorfenapyr is classi fied as “suggestive evid ence of carcinogenicity, but not sufficient to assess human carcinogenic potential”. A cancer risk assessment is not required. A dermal penetration study (MRI D 49315901) has been submitted since the most recent risk assessment. The dermal absorption was found to be 13% and should be applied for converting oral doses to dermal equivalent doses to assess the potential risk associated with dermal exposures for chlorfenapyr. Since no inha lation absorption data are available, toxicity by

the inhalation route is considered to be equivalent to the estimat ed toxicity by the oral route of exposure. A body weight of 69 kg was used in the assessment since the effects were developmental and/or fetal effects. The total uncertainty factor (UF) that was applied to occupational and residential risk assessments is 100 for short- and intermediate-term risk

estimates. Since the dermal and inhalation ro utes of exposure are assessed using the same endpoint/point of departure (POD), the exposures from these routes were combined to estimate a total (dermal + inhalation) risk estimate.

An assessment of occupational handler exposure fr om the use of total re lease foggers is not performed because dermal and inhalation exposure is expected to be negligible based on the use pattern for this method of application. Occupational handler exposure from the other uses/application methods was assessed. Most occupational handler inha lation risk estimates resulted in margins of exposure (MOEs) great er than the level of concern (LOC = MOE ≥ 100) at baseline or label specified personal protective equipment (PPE), and th erefore, are not of concern. However, there were several exposure scenarios that required additional PPE (some beyond what is currently on the re gistered labels) to reach MOEs greater than the LOC. For mixers/loaders/applicators of liquids using a mechanically -pressurized handgun for greenhouse applications, there are risks of concern (M OEs < 100) even with maximum PPE (i.e., double layer, gloves and PF10 respirator).Page 5 of 42 An occupational post-application assessment was conducted for workers entering greenhouses after treatment of crops and/or ornamentals to pe rform various activities. Risk estimates for all activities were not of concern (MOEs ≥ 100). The restricted entry interval (REI) of 12 hours is adequate based on the acute toxicity of the activ e ingredient. Under 40 CFR 156.208 (c) (2) (iii),

a.i.’s classified as Acute III or IV for acute de rmal, eye irritation and primary skin irrigation are assigned a 12-hour REI. Only two labels specify a REI. These are Pylon ® TR (Total Release miticide/insecticide) (TC-307) and Pylon ® (241-374).

Based on the Agency's current practices, a quant itative non-cancer occupational post-application inhalation exposure assessment was not performed for chlorfenapyr at this time. If new policies or procedures are put into place, the Agency may revisit the need for a quantitative occupational post-application inhalation exposur e assessment for chlorfenapyr.

Chlorfenapyr is registered for residential pest c ontrol and can be applied as a termiticide and/or a crack and crevice/spot spray to indoor surfaces to control various pests. There are currently no registered residential uses that permit residential handlers – all labels indi cate that products are “for sale to, use and storage onl y by individuals/firms licensed or registered by the state to apply termiticide and/or general pest control products.” Therefore, quantitative residential handler

assessments were not conducted. The residentia l post-application exposure assessment yielded margins of exposure (MOEs) that are not of concern to HED (MOEs ≥ 100) for all scenarios except the combined (incidental oral, dermal, a nd inhalation) MOE for children (1 to <2 years old) with coarse-stream applications. Howeve r, use of equipment with a pin stream nozzle results in a combined MOE for children (1 to <2 years old) that is above the level of concern (LOC).

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. Thes e data, which include studies from PHED 1.1; the AHETF database; the Outdoor Residential Exposure Task Force (ORETF) database; the ARTF database; the Residential SOP (Indoor Envi ronments) are (1) subject to ethics review pursuant to 40 CFR 26, (2) have r eceived that review, and (3) are compliant with applicable ethics requirements. For certain studi es, the ethics review may have included review by the Human Studies Review Board. Descriptions of data sources, as we ll as guidance on their use, can be found at the Agency website 1

.

2.0 Risk Assessment Conclusions and Recommendations

 Most occupational handler inha lation risk estimates resulted in MOEs greater than the level of concern (LOC = MOE ≥ 100) at baseline or with ad ditional PPE, and therefore, are not of concern. The following is a summ ary of the occupational handler combined

1 http://www.epa.gov/pesticides/science/handler-exposure-data.html and http://www.epa.gov/pesticides/science/post-app-exposure-data.htmlPage 6 of 42 risk estimates:

o For mixers/loaders/applicators (MLAs) of liquids using an injector for termiticide applications, combined MOEs were a bove the LOC of 100 at baseline (single layer of clothing, no gloves, no respirator).

o For MLAs of liquids using a backpack or manually-pressurized handwand for applications to greenhouse ornamentals, combined MOEs were above the LOC of

100 at baseline.

o For applicators using ready-to-use aeroso l cans, combined MOEs were above the LOC of 100 with a single layer of clothing, no respirator and gloves.

o For MLAs of liquid using a manually-pre ssurized handwand for application to greenhouse vegetables, combined MOEs were above the LOC of 100 with a single layer of clothing, no respirator and gloves.

o For MLAs of liquids using a manually-pre ssurized handwand for applications to

indoor environments such as food ha ndling establishments, warehouses, and residential living spaces, combined MOEs were above the LOC of 100 with a single layer of clothing, gl oves and a PF5 respirator.

o For mixers/loaders/applicators of liqu ids using a mechanically-pressurized handgun for termiticide applications to st ructures, combined MOEs were above the LOC of 100 with a single layer of clothing, gloves and a PF5 respirator.

o For mixers/loaders/applicators of liqu ids using a mechanically-pressurized handgun for greenhouse applications, combin ed MOEs did not reach the LOC of 100 even with maximum PPE (i.e., double layer, gloves and PF10 respirator).

 The short-and intermediate-term occupationa l post application scenarios resulted in MOEs greater than the LOCs of 100 on day 0 (12 hours after applic ation) ranging from 150 to 300 and therefore, are not of concern to HED.

 All residential post-application scenarios result s in risk estimates that were greater than the LOC, except for the combined MOE for ch ildren 1 to <2 years old from dermal and incidental oral exposure to treated indoor su rfaces and mattresses from a coarse perimeter or spot treatment (MOE = 69). If the applica tion method is restricted to equipment with a pin stream nozzle, the MOEs are grea ter than the LOC and not of concern.

2.1 Label Recommendations from Occupa tional/Residential Assessment

 For several occupational scenarios, HED r ecommends that additional PPE be placed on

the Phantom ® label (EPA Reg. No. 241-392) to reach the LOC of 100 (see Section 9.1).

 For mixers/loaders/applicators of liquids using a mechanically-pressurized handgun for greenhouse applications, there are risks of concern (MOEs = 15-26) even with maximum PPE (i.e., double layer, gloves and PF10 respirator).

 Based on the combined residential estimates for indoor perimeter/spot/bed bug and mattress applications, as well as aggregate ri sk incorporating these estimates, there are

risks of concern with coarse-s tream applications for children (1 to <2 years old). Therefore, HED recommends the Phantom ® labels (EPA Reg. No. 241-392) should prohibit the use of coarse-stream equipment a nd only allow for the use of equipment with a pin-stream nozzle.Page 7 of 42 2.2 Data Deficiencies and Requirements

Dislodgeable Foliar Residue (DFR): In accordance with 40 CFR Part 158, dislodgeable foliar residue (DFR) data are required for all occupationa l or residential uses th at could result in postapplication exposure to foliage. As part of the recent revision to the Health Effects Division’s 2012 Standard Operating Procedures for Residential Pesticide Exposure Assessment , HED analyzed a number of DFR studies and selected a new default value for the fraction of the application rate available to be di slodged after a fo liar application (F AR ). This default value is 25% and is based on an analysis of 19 DFR studies where the F AR value ranged from 2% to 47%.

This value is recommended for use in both residential and occupa tional post-application assessments. Of the analyzed DFR studies, the maximum F AR value seen was 47% or approximately two times higher than the default re sidue transfer value. Therefore, the HED has decided that a calculated margin of exposure (MOE) of approximately two times higher than the LOC (e.g., an MOE ≥ 200 if the LOC = 100) using the defa ult dislodged residue values would provide an adequate margin of safety for any potentially higher residues seen in a chemicalspecific DFR study. A DFR study is required for chlorfenap yr at this time since the dermal MOEs are less than two times the LOC (i.e., < 200) based on default values for the fraction of application rate available for tr ansfer after a foliar application.

3.0 Hazard Characterization

Chlorfenapyr is classified as having moderate ac ute toxicity via the oral route (Toxicity Category II) and low acute toxicity via the dermal and i nhalation routes of exposure (Toxicity Category III). It is a mild eye irritant, but it is not a dermal irritant or sensitizer. Table 3.1 presents a summary of the acute toxicity information for chlorfenapyr.

Table 3.1. Acute Toxicity Profile – Chlorfenapyr.

Guideline

No. Study Type MRID(s) Results Toxicity Category

870.1100 Acute oral (rat) 42770207

42884201 441 mg/kg, males 1152 mg/kg, females 626 mg/kg, combined II*

870.1200 Acute dermal (rabbit) 42770208 >2000 mg/kg III

870.1300 Acute inhalation (rat) 42770209 0.83 mg/L, males >2.7 mg/L, females 1.9 mg/L, combined III

870.2400 Acute eye irritation (rabbit) 42770210 Corneal opacity, iritis, and conjunctivitis present at 48 hours. All rabbits normal by Day 7. III

870.2500 Acute dermal irritation (rabbit) 42770211 Non-irritating IV

870.2600 Skin sensitization (guinea pig) 42770212 Non-sensitizer Not applicable

*Based on most sensitive sex A summary of the toxicological PODs and doses chosen for the relevant exposure scenarios for

human risk assessment are found in Table 3.2. A cancer assessment is not required.Page 8 of 42 Table 3.2. Summary of Toxicologica l Doses and Endpoints for Chlorfenapyr for Use in Human-Health Risk

Assessments.

Exposure/

Scenario POD Uncertainty/ FQPA Safety

Factors RfD, PAD, LOC

for Risk

Assessment Study and Toxicological Effects

Incidental Oral

Short-Term (1-30 days) and

IntermediateTerm (1-6 months) NOAEL = 5 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X Residential LOC

for MOE = 100 Developmental Neurotoxicity Study

LOAEL = 10 mg/kg/day based on increased pup deaths (post-natal days 1-4) and decreased motor activity

Dermal ShortTerm (1-30 days) and

IntermediateTerm (1-6 months) NOAEL = 5 mg/kg/day

Dermal absorption

factor = 13% UF A = 10X

UF H = 10X FQPA SF = 1X Occupational and

Residential LOC

for MOE = 100 Developmental Neurotoxicity Study

LOAEL = 10 mg/kg/day based on increased pup deaths (post-natal days 1-4) and decreased motor activity

Inhalation ShortTerm (1-30 days) and

Intermediateterm (1-6 months) NOAEL = 5 mg/kg/day

Inhalation absorption assumed equivalent to oral absorption. UF A = 10X

UF H = 10X FQPA SF = 1X Occupational and

Residential LOC

for MOE = 100 Developmental Neurotoxicity Study

LOAEL = 10 mg/kg/day based on increased pup deaths (post-natal days 1-4) and decreased motor activity

Cancer (oral, dermal, inhalation) Classified as “Suggestive Evidence of Carcinog enicity, but Not Sufficient to Assess Human Carcinogenic Potential”. A cancer risk assessment is not required.

Point of departure (POD) = A data point or an estimated point th at is derived from observed dose -response data and used to mark the beginning of extrapolation to determine risk associ ated with lower environmentally relevant human exposures. NOAEL = no-observed adverse -effect

level. LOAEL = lowest-observed adverse-eff ect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human popula tion (intraspecies). FQPA SF = FQPA Safety Factor. PAD = populationadjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

Absorption A dermal penetration study (MRID 49315901) has b een submitted since the most recent risk assessment. The dermal absorption was found to be 13% and should be applied for converting oral doses to dermal equivalent doses to asse ss the potential risk associated with dermal exposures for chlorfenapyr. Inhalation exposure is assumed to be equivale nt to oral exposure.

Body Weight A body weight of 69 kg was used in the assessment since the effects were developmental and/or

fetal effects.

4.0 Use Profile

Chlorfenapyr is registered for use on greenhouse food and non-food crops, and as an

insecticide/miticide for use on indoor and outdoor residential sites, food/feed handling areas,

indoor and outdoor commercial site s (including sewers), and indoor medical sites. A summary of occupational uses is presented in Table 4.1. The pre-harvest interv al (PHI) and maximum seasonal application rates are not specified on most of the labels.Page 9 of 42Table 4.1. Existing Use Patterns/ Exposure Scenarios for Chlorfenapyr.Registration Number andProduct NameFormulationaApplicationEquipmentMaximumApplication RatesMax. No.ApplicationsPer SeasonUse Directions and LimitationsREIGreenhouse ornamentals including Bedding Plants, Cut Flowers, Evergreens, Flowering plants, FoliagePlants, Fruiting Vegetables, Containerized Plants, Ground Covers,Non-Bearing Nut Trees, Non-Bearing Vines, Ornamental Trees and Shrubs499-544TC-307 Pylon®TR (TotalRelease miticide/insecticide)bPRLTotal releasefogger0.011 lb ai/3000 ft2(0.163 lb ai/A)3Do not make more than 2 consecutiveapplications.Not for indoor, residential use (e.g., homes,apartments, mobile homes).Re-treatment for fruiting vegetables is 5-7days.12 hoursGreenhouse (roses, cut flowers, container stock)241-374Pylon®SCbBackpackManuallypressurizedhandwandMechanicallypressurizedhandgun0.0016 lb ai/gal 3Wait at least 5 to 7 days between eachapplication.Do not apply this product through any type ofirrigation system.12 hoursGreenhouse (vegetable,fruiting, group 8-10d)241-374Pylon®SCbBackpackManuallypressurizedhandwandMechanicallypressurizedhandgun0.20 lb ai/A0.04 lb ai/gal3This product can be applied up to andincluding the day of harvest.Wait at least 5 to 7 days between eachapplication.Do not apply this product through any type ofirrigation system.Do not apply this product as an ultra-lowvolume spray.Do not use on tomato varieties with a diameterof less than one inch when mature.12 hoursPage 10 of 42Residential and Nonagricultural UsesCommercial and Food Use Sitecand Household/domestic dwellings (indoor and outdoor)7969-285Prescription Treatment®brand Phantom®(General Pest-Controlincluding bed bugs)PRL17.5 oz Aerosolcan0.5% ai =0.005 lb ai/canNot specifiedSpot and/or crack andcrevice applications.For sale to, use and storage only byindividuals/firms licensed or registered by thestate to apply termiticide and/or general pestcontrol products.Do not use in schools when occupied.Do not apply directly to food, food packaging,or food contact surfaces.Do not make surface applications to mattressesor bedding. Mattress treatments must beconfined to the seams, folds, and edges only.Do not use to use to treat soil directly.Do not reapply to treated area more than everyfour weeks.Notapplicable499-548TC-314 (Phantom®Pressurized InsecticideFormula 2)(General Pest-Control,including bed bugs, andSubterranean TermiteControl)499-556TC-326 (Phantom®Pressurized Insecticidewith IGR)(General Pest-Control,including bed bugs, andSubterranean TermiteControl)241-392Phantom®(General Pest-Controlincluding bed bugs)EC2 lb ai/galManual- orMechanicallypressurizedhandwand/gun0.5% dilution = 0.05lb ai/galLimited exteriorapplications todoors, windows,eaves, attic vents:0.00023 lb ai/ft2Not specifiedFor sale to, use and storage only byindividuals/firms licensed or registered by thestate to apply termiticide and/or general pestcontrol products.Do not reapply more often than every fourweeks.Do not make surface applications tomattresses. Mattress treatment must beconfined to the seams folds and edges only.NotapplicablePage 11 of 42Nonagricultural outdoorbuildings/structures241-392Phantom®(Pre-construction and Postconstruction TermiticideSoil Treatments)EC2 lb ai/galManual- orMechnicallypressurizedhandwand/gunInline injectionwith lateraldispersal nozzleTrenching androdding0.25% dilution =0.0234 lb ai/gal0.0936 lb ai/ft2Not SpecifiedFor sale to, use and storage only byindividuals/firms licensed or registered by thestate to apply termiticide and/or general pestcontrol products.Do not reapply more often than every fourweeks.Liquid and foam applications can be made. Iffoam applications are made, 75% of totalapplication must be liquid and 25% can befoam.All applications are to soil. Drilled holes mustbe plugged following application.Notapplicablea. PRL = pressurized release liquid; SC= soluble-concentrate; EC = emulsifiable-concentrate.b. HED assumes the product Chlorfenapyr SC (assessed in D288704) to be similar in formulation and application to Pylon, the product listed for use on these sites in the Biologicaland Economics Analysis Division’s(BEAD’s) LabelData Report.c. This includes commercial storages/warehouse premises, apartments, food storage areas, homes, hospitals, hotels, meat packingand food processing plants, motels, nursinghomes, restaurants, and other food handling establishments, schools, hospitals/medical institutions,supermarkets, warehouses and other commercial andindustrial buildings,sewage systems, and zoos. Foodhandling establishments includedairies/cheese processing plant equipment (food contact), eating establishments, egg packing plants(commercial), feed mills/ feed processing plants, and food/grocery/marketing/storage/distribution facility premise.d See 40 CFR §180.513.Page 12 of 42 5.0 Residential Exposure and Risk Estimates

Chlorfenapyr is registered for residential (indoor and outdoor) and medical (indoor) uses. The representative residential use pa tterns, application rate s and formulations are provided in Table

4.1.

5.1 Residential Handler Ex posure/Risk Estimates

HED uses the term “handlers” to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct tasks related to applications and that exposures can vary depending on the specifics of each task. Residential handlers are addressed somewhat differently by HED as homeowners are assumed to complete all elements of an application without use of any protective equipment.

Four labels [7969-285 Prescription Treatment ® brand Phantom ® , 499-548 TC-314 (Phantom ®

Pressurized Insecticide Form ula 2), 499-556 TC-326 (Phantom ® Pressurized Insecticide with IGR), and 241-392 Phantom ® ] have residential uses. These resi dential uses are for general pest control (including bed bugs) and allow for spot a nd crack/crevice applications in residential sites (for example, surfaces beneath cabinets and sinks, windows, and mattres s seams). However, there are currently no registered residential uses that permit residential handlers – all labels indicate that products are “for sale to, use and storage only by individuals/firms licensed or registered by the state to apply termiticide and/or general pest control products.” Therefore,

residential handler assess ments were not conducted.

5.2 Residential Post-applicatio n Exposure/Risk Estimates

There is the potential for post-app lication exposure for individuals e xposed as a result of being in an environment that has been previously tr eated with chlorfenapyr. The quantitative exposure/risk assessment for residential post-ap plication exposures is based on the following

scenarios:

 Post-application inhalation expos ure to adults and children (1 to <2 years old) after indoor perimeter/spot/crack and crevice applications.

 Post-application dermal exposure to adults and children (1 to <2 year s old) after indoor perimeter/spot/crack and crevice applications.

 Post-application incidental oral exposure to children (1 to <2 years old) after indoor perimeter/spot/crack and crevice applications.

The lifestages selected for each pos t-application scenario are based on an analysis provided as an Appendix in the 2012 Residential SOPs 2 . While not the only life stage potentially exposed for these post-application scenarios, the lifestage th at is included in the quantitative assessment is health protective for the exposures and risk estimates for any other potentially expose d lifestage.

2 Available: http://www.epa.gov/pesticides/scien ce/residential-exposure-sop.htmlPage 13 of 42 Based on the suggested retreatment interval fo r the proposed product and the use pattern, it is anticipated that exposures will be short-term in duration only. The short-term assessment has assumed no dissipation (i.e., day zero residues) for the entire expos ure duration (up to 30 days). In addition, the short- and inte rmediate-term PODs are the same; therefore, the short-term assessment is expected to be protective of a ny repeated exposure for longer than 30 days.

5.2.1 Post-application Inhalation Exposure and Risk Estimates

Post-application inhalation exposure occurs whil e occupying living spaces within a residence after a pesticide treatment has occurred. Post-a pplication inhalation expo sure to chlorfenapyr can result from the registered perimeter/spot/crack and crevice pest control use (including control of bed bugs) from the volatilization of the pesticide after application.

Residential Post-application Inhala tion Exposure Data and Assumptions A series of assumptions and exposure factors serv ed as the basis for completing the residential post-application inhalation risk as sessment. Each assumption and factor is detailed in the 2012

Residential SOPs2.

Application Rate: The application rate for general resi dential indoor pest control was used to estimate post-application inhalati on exposure (0.05 lb ai /gal). To determine the mass of pesticide applied for use in the post-applica tion inhalation equation, it was assumed that 0.5 gallons of spray would be applied in one residence. This value is taken from the assumptions for

amount handled for residential handlers ma king indoor applications (see Residential SOPs/Indoor Environments). Using these assumpti ons results in an estimated mass of pesticide applied of 11,350 mg ai.

Residential Post-application Non-Cancer Inhalation Exposure and Risk Equations The algorithms used to estimate residential post-a pplication inhalation exposure and dose can be found in Appendix A and/or the 2012 Residential SOPs2.

Summary of Residential Post-a pplication Non-Cancer Inhalati on Exposure and Risk Estimates All post-application inhalation scenarios resulted in MOEs greater than the Agency’s level of concern (LOC = MOE ≥ 100) for children and adults and, therefore, are not of concern. Table

5.2.1 summarizes the post-applica tion inhalation exposure and risk from the indoor uses of chlorfenapyr.

Table 5.2.1. Post-application Inhalation Expo sure and Risk Estimates for Children and Adults.

Lifestage M Label (mg) a ACH (1/hr) k (1/hr) b Vol (m 3 ) ET (hr) Inhalation Dose (mg/kg/day) c, d Short-term

Inhalation

MOE e

Adult
11,350 0.45 1.02E-06 33 16 0.0001 50,000

Child 1 to < 2

years old 18 0.00037 13,000

a. Mass of active ingredient applied determined from pr oduct label (mg). b. k (1/hr) = [ln(0.1)*CF1] /EvapT, where EvapT = 10 [7.3698-0.9546*log10(Csat) ] and C sat = [Vapor pressure (1x10 -7 mm Hg) * Conversion factor (atm/760 mm Hg) * Mol ecular Weight (g/mol) * Conversion factor (10 3 mg/g) * Conversion factor (10 3 L/m3)] / [R (0.0821 L-atm/mol-K)* Temperature (296 K)] c. Inhalation Dose (mg/kg/day) = Exposur e (mg/day) * Inhalation absorption fact or (unitless) / Body Weight (kg).

d

. Exposure (mg/day) = IR*M Label * 1 - [((ACH * e -k*ET ) – (K e -ACHET ))]Page 14 of 42 ACH * V
room ACH-k e. Inhalation MOE = NOAEL (5 mg/kg/day) / Inhalation dose (mg/kg/day)).

5.2.2 Post-application Dermal Exposure and Risk Estimates

Post-application dermal exposure can result from pesticide residue tran sfer to the skin of individuals who contact previous ly treated indoor surfaces (e.g., carpets, floors, furniture, and other surfaces) during standard activities. For purpos es of assessing dermal post-application exposure resulting from the use of chlorfenapyr to treat indoor pests (including bed bugs), HED has performed an indoor surface (i.e., perimete r/spot/bedbug and crack an d crevice) assessment in addition to performing an assessment for treat ed mattresses. For the bed bug use, applications are allowed for mattresses (seams, folds and edges). The label does not allow for surface applications to mattresses. The assessment for the mattress application is based on an assumption regarding the amount of product ap plied per area (i.e., a twin size bed).

Residential Post-application Dermal Exposure Data and Assumptions A series of assumptions and exposure factors serv ed as the basis for completing the residential post-application dermal risk as sessment. Each assumption and factor is detailed in the 2012

Residential SOPs2.

Application Rate: An application rate in units of mass per area was not provided on the labels registered for general pest control, which is necessary for estimation of deposited residue for indoor surfaces. Therefore, default assumptions for deposited residue (ug/cm 2 ) were used for

this assessment based on the HED Resi dential SOPs/Indoor Environments. For perimeter/spot/bedbug (coarse) applica tions, a default assumption of 4.5 ug/cm 2 was used; for perimeter/spot/bedbug (pin stream) applications, a default assumption of 1.1 ug/cm 2 was used; and for crack and crevice appl ications, a default of 0.3 ug/cm 2 was used. For the mattress application, using the application rate of 0.05 lb ai/gal and assuming that 20% of the mattress is treated and 0.005 gallons of spray is used per area of the mattress, the resulting deposited residue value is 24.3 ug/cm 2

.

Residential Post-application Non-Cancer Dermal Exposure and Risk Equations The algorithms used to estimate residential pos t-application dermal exposure and dose can be found in Appendix A and/or the 2012 Residential SOPs2.

Summary of Residential Post-a pplication Non-Cancer Dermal Exposure and Risk Estimates

Table 5.2.2.1 summarizes the dermal post-application exposure and risk estimates from the perimeter/spot/bed bug use of chlorfenapyr. All post-application dermal scenarios resulted in MOEs greater than the Agency’s level of concern (LOC = MOE ≥ 100) for children and adults and, therefore, are not of concern.Page 15 of 42 Table 5.2.2.1. Post-application Dermal Exposure and Risk Estimates for Adults and Children 1 to < 2 years old for the Use of Chlorfenapyr.

Surface

Type Lifestage DepR a (ug/cm 2 ) F ai Fraction

transferred b TC

Transfer

Coefficient

(cm 2 /hr) ET Exposure

time (hr/day) E Exposure (mg/day) Dermal Dose b (mg/kg/day) Dermal

MOE c

Perimeter/Spot/Bedbug (coarse)

Carpet Adult

4.5 0.06 6,800 8 14.7 0.028 180

Child 1 to < 2 years old 1,800 4 1.9 0.023 220

Hard

Surfaces Adult

0.08 6,800

2 4.9 0.0092 540

Child 1 to < 2 years old 1,800 1.3 0.015 330

Perimeter/Spot/Bedbug (pin stream)

Carpet Adult

1.1 0.06 6,800 8 3.6 0.0068 740

Child 1 to < 2 years old 1,800 4 0.5 0.0056 890

Hard

Surfaces Adult

0.08 6,800

2 1.2 0.0023 2,200

Child 1 to < 2 years old 1,800 0.3 0.0037 1,300

Crack and Crevice

Carpet Adult

0.3 0.06 6,800 8 1.0 0.0018 2,700

Child 1 to < 2 years old 1,800 4 0.1 0.0015 3,300

Hard

Surfaces Adult

0.08 6,800

2 0.3 0.00061 8,100

Child 1 to < 2 years old 1,800 0.1 0.001 4,900

a. DepR = = Deposited residue based on default assumptions in HED’s Residential SOPs.

b. Fraction transferred is based on the Revise d Residential SOP (2012) Default Value.

c. Dose (mg/kg/day) = Deposited residue (ug/cm 2 ) * Fraction transferred * Transfer coefficient (cm 2 /hr) * Exposure time (hr/day) * Conversion factor (0.001 mg/ug) * Dermal Absorption Factor (13 %) / Body Weight (69 kg for adults and 11 kg for children 1 to < 2 years old).

d. MOE = PoD (mg/kg/day) / Dose (mg/kg/ day), where Short-term dermal PoD = NOAEL of 5 mg/kg/day and level of concern = 100 for adults and children 1 to < 2 years old).

All post-application dermal scen arios for the bed bug use on mattresses resulted in MOEs greater

than the LOC and are not of concern. Table 5.2.2.2 summarizes the post-application dermal exposure and risk from the bed bug use on mattresses.

Table 5.2.2.2. Post-application Dermal Exposure and Risk Estimates for Adults and Children 1 to < 2 years old for Bed Bug Mattress Use.

Surface

Type Lifestage Deposited

Residue (ug/cm 2 ) a Surface

area / Body Weight

Ratio (cm 2 /kg) Fraction of

skin in

contact

with

surface F ai Fraction

transferred Protection

factor Dermal Dose (mg/kg/day) b Dermal

MOE c

Mattress Adult

24.3 280

0.5 0.06 0.5 0.013 380

Child 1 to 2

years old 640 0.03 160

a. Residue value determined based on appl ication rate (0.05 lb ai/gal) and a ssumptions for area treated and amount applied (see Appendix a nd Residential SOPs).

b. Dermal dose (mg/kg/day) = Surface residue (μg/cm 2 ) * Surface area / Body weight Ratio (cm 2 /kg) * Fraction of body

that contacts residue (0.5) * Conversion factor (0.001 mg/ug) * Fracti on transferred (0.06) * Protection factor (0.5) * Dermal Absorption Factor (13 %). c. MOE = PoD (NOAEL = 5 mg/kg/day) / Dose (mg/kg/day), mg/kg/day and level of concern = 100 for adults and children 1 to < 2 years old).Page 16 of 42 5.2.3 Post-application Incidental Or al Exposure and Risk Estimates

Post-application incidental oral exposure re sulting from hand-to-mouth and object-to-mouth

activities can occur as a result of the indoor perimeter/spot/b ed bug application and the bed bug/mattress use. Only incidental oral exposures resulting from the indo or surface application have been assessed here since they are considered to be protective of the mattress application for the following reasons: (1) a protect ion factor of 0.5 is assumed fo r the mattress exposures due to the presence of a bed sheet over the mattress, and (2) the replenishment interval for hand-tomouth activity is assumed to be less while a child is sleeping than while they are awake.

Table 5.2.3.1 summarizes the MOEs for hand-to-mouth tran sfer of pesticide residues from the indoor perimeter/spot/bed bug use. All hand- to-mouth post-application exposure scenarios resulted in MOEs higher than 100 a nd are therefore not of concern.

Table 5.2.3.2 summarizes the MOEs for object-to-mouth exposure of pesticide residues from the indoor perimeter/spot/bed bug use. All objec t-to-mouth post-application exposure scenarios resulted in MOEs higher than 100 a nd are therefore not of concern.Page 17 of 42Table 5.2.3.1. Post-application Incidental Oral (Hand-to-Mouth) Exposure and Risk Estimatesfor Children for Perimeter/Spot/Bed Bug Use ofChlorfenapyr.SurfaceTypeDermalExposurea(mg/day)FaihandsbSAHc(cm2)ExposureFrequencyd(events/hr)FmeSEfETghours/day)Replen_ Intervalh(min)N_ReplenishiHRj(mg/cm2)Oral Dose(mg/kg/day)kIncidentalOralMOElPerimeter/Spot/Bedbug (coarse)Carpet4.5 0.15 150 20 0.13 0.48415 40.0010 0.026 190HardSurfaces2 0.0006 0.009 570Perimeter/Spot/Bedbug (pin stream)Carpet1.1 0.15 150 20 0.13 0.48415 4 0.00020.0065 770HardSurface2 0.0021 2,300Crack and crevice – CarpetsCarpet0.3 0.15 150 20 0.13 0.48415 4 0.00010.0018 2,800HardSurface2 0.00059 8,500a.Dermal Exposure value from Table 5.2.2.1.b.Fraction of ai on hands.c.Surface area of the hand (cm2).d.Number of hand-to-mouth contactsevents per hour (events/hr).e.Fraction of hand mouthed.f.Saliva Extraction Factor.g.Exposure Time.h.Replenishment Interval.i.Number of Replenishment Intervals per hour.j.Hand Residue Loading (mg/cm2) = (Faihands* Dermal exposure) / (SAH* 2).k.Oral Dose (mg/kg/day) = Exposure (mg/day)/ Body Weight (11 kg); where Exposure (mg/day) = HR * *FM* SAH) * (ET * N_Replen) * [1-(1-SE)(Freq_Replen / N_Replen)].l.MOE = PoD (mg/kg/day) / Daily Dose (mg/kg/day); incidental oral PoD = NOAEL =5 mg/kg/day and level of concern =100.Page 18 of 42Table 5.2.3.2. Post-application Incidental Oral (Object-to-Mouth) Exposure and Risk Estimatesfor Perimeter/Spot/Bed Bug Use of Chlorfenapyr.Surface TypeDepRa(ug/cm2)FobORcSAMOd(cm2)Freq_ReplenExposureFrequencye(events/hr)SEfETg(hours/day)Replen_Intervalh(min)N_RepleniExposurej(mg/day)Oral Dose(mg/kg/day)kIncidentalOral MOElPerimeter/Spot/Bedbug (coarse)Carpet4.50.06 0.27010 4 0.48415 140.04 0.004 1,400Hard Surfaces 0.08 0.360 2 0.03 0.002 2,100Perimeter/Spot/Bedbug (pin stream)Carpet1.10.06 0.06610 4 0.48415 140.0095 0.0009 5,800Hard Surface0.08 0.088 2 0.0063 0.0006 8,700Crack and crevice – CarpetsCarpet0.30.06 0.01810 4 0.48415 140.0026 0.0002 21,000Hard Surface 0.08 0.0242 0.0017 0.0002 32,000a.DepR = Deposited residueb.Fraction of residue transferred to an object (unitless).c.Chemical residue loading on the object (μg/cm2) = Deposited residue (ug/cm2) * Fo.d.Area of the object surface that is mouthed (cm2).e.Number of object-to-mouth contactevents per hour (events/hr).f.Saliva Extraction Factor.g.Exposure Time (hours/day)h.Interval between object-to-mouth contact events (minutes).i.Number of Replenishment Intervals per hour.j.Exposure (mg/day) =ܱܴ ∗ ܨܥ1 	 ∗ ܵܯܣை∗ 	൫ܧܶ ∗ ܰோ௘௣௟௘௡൯ ∗ 	ቆ1 െሺ1 െ ܵܧሻಷೝ೐೜ೃ೐೛೗೐೙ಿೃ೐೛೗೐೙ቇk.Oral Dose (mg/kg/day) = Exposure(mg/day)/ Body Weight (11 kg).l.MOE = PoD (mg/kg/day) / Daily Dose (mg/kg/day); incidental oral PoD = NOAEL =5 mg/kg/day and level of concern = 100.Page 19 of 42 5.2.4 Combined Residential Risk Estimates from the Indoor Surfaces and Bed Bug

Mattress Use

There is the potential for post-application dermal , oral, and inhalation exposure for children and post-application dermal and inhalation exposure fo r adults resulting from use of chlorfenapyr as an indoor perimeter/spot/bed bug and bed bug/mattre ss use. As indicated previously, the dermal, incidental oral, and inhalation e ndpoints are the same and have th e same LOCs; therefore, these

routes were combined for a total MOE.

The incidental oral scenarios (i.e., hand-to-m outh and object-to-mouth) should be considered inter-related and it is likely that they occu r interspersed amongst each other across time. Combining these scenarios with the dermal a nd inhalation exposure scen arios would be overlyconservative because of the conservative nature of each individual assessment. Therefore, the post-application exposure scenarios that were combined for children 1 < 2 years old are the dermal, inhalation and hand-to-mouth scenarios. This combination should be considered a protective estimate of ch ildren’s exposure to pe sticides used indoors.

A summary of the combined MOEs for the bed bug scenario is provided in Table 5.2.4

.

Table 5.2.4. Combined Residential Exposure and Risk Esti mates from the Indoor Perimet er/Spot/Bed Bug and Bed Bug

Mattress Use

Population Post-application Scenarios Daily Dose (mg/kg/day) a MOE b Combined MOE c

Short-and Intermediate-term

Adult Dermal – Perimeter/Spot/Bed Bug (coarse) 0.028 180

120 Inhalation – Perimeter/Spot/Bed Bug 0.0001 50,000

Dermal - bed bug/mattress 0.013 380

Adult Dermal – Perimeter/Spot/Bed Bug (pin-stream) 0.0068 740

250 Inhalation – Perimeter/Spot/Bed Bug 0.0001 50,000
Dermal - bed bug/mattress 0.013 380

Child (1 to <2

years old) Dermal - Perimeter/Spot/Bed Bug (coarse) 0.023 220

62 Inhalation – Perimeter/Spot/Bed Bug 0.00037 13,000
Hand-to-Mouth – Perimeter/Spot/Bed Bug (coarse) 0.027 190

Dermal – bed bug/mattress 0.03 160

Child (1 to <2

years old) Dermal - Perimeter/Spot/Bed Bug (pin-stream) 0.0056 890

120 Inhalation – Perimeter/Spot/Bed Bug 0.00037 13,000
Hand-to-Mouth – Perimeter/Spot/Bed Bug (pin-stream) 0.0065 770

Dermal – bed bug/mattress 0.03 160

Bolded values are below the LOC of 100. a. For calculations of Daily Dose, see Tables 6.2.2.1, 6.2.2.2, 6.2.3.1, and 6.2.3.2. b. MOE = NOAEL (5 mg/kg/day) / Dose (mg/kg/day). c. Adult Combined MOE = 1/ [(1/MOE Dermal – Perimeter/Spot/Bed Bug ) + (1/MOE Dermal – bed bug mattress ) + (1/MOE Inhalation )] Child (1 to <2 years old) Combined MOE = 1/ [(1/MOE Dermal – Perimeter/Spot/Bed Bug ) + (1/MOE Dermal – bed bug mattress ) + (1/MOE Inhalation ) + (1/MOE Hand-to-Mouth )]Page 20 of 42 5.3 Residential Risk Estimates fo r Use in Aggregate Assessment

Table 5.3.1 reflects the residential risk estimates that are recommended for use in the aggregate assessment for chlorfenapyr.

 The recommended residential exposure for use in the adult aggregate assessment reflects combined post-application dermal and inha lation exposure from indoor applications (surfaces and mattresses) to control bed bugs.

 The recommended residential exposure for use in the children 1<2 years old aggregate assessment reflects combined post-applica tion dermal, inhalation, and hand-to-mouth exposures from indoor applica tions (surfaces and mattresse s) to control bed bugs.

 Table 5.3.1. Recommendations for the Residential Exposures for the Chlorfenapyr Aggregate Assessment.

Lifestage Exposure

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

Dermal 3 Inhalation Oral Total Dermal Inhalation Oral Total

Adult

Male/Female Postapplication

exposure from indoor bed bug applications (coarse) 0.041 0.0001 N/A 0.041 120 50,000 N/A 120

Postapplication

exposure from indoor bed bug applications (pin-stream) 0.020 0.0001 N/A 0.020 250 50,000 N/A 250

Child Postapplication

exposure from indoor bed bug applications (coarse) 0.053 0.00037 0.027 0.08 90 13,000 190 62

Postapplication

exposure from indoor bed bug applications (pin-stream) 0.0356 0.00037 0.0065 0.042 140 13,000 770 120

1 Dose = the highest dose for each applicable lifestage of all resi dential scenarios assessed. Total = dermal + inhalation + inc idental oral (where applicable).

2 MOE = the MOEs associated with the highest residential doses. Total = 1 ÷ (1/Dermal MOE) + (1/Inhalation MOE) + (1/Incidental Oral MOE), where applicable.

3 Dermal values represent the sum of post-application ex posure from perimeter/spot/bed bug and bed bug/mattress.

5.4 Spray Drift

A spray drift assessment is not included in this memo because chlorfenapyr is not registered on use sites that are likely to result in spray drift. As stated above, chlorfenapyr is registered for use only on greenhouse food and non-food crops, and as an insecticide/termiticide for use on indoorPage 21 of 42 and outdoor residential sites, food/feed handling areas, indoo r and outdoor commercial sites (including sewers), and i ndoor medical sites.

6.0 Occupational Exposure and Risk Estimates

6.1 Occupational Handler Ex posure/Risk Estimates

HED uses the term handlers to describe those individuals who are invo lved in the pesticide application process. HED believe s that there are distinct job functions or tasks related to applications and exposures can vary depending on the specifics of each task. Job requirements (amount of chemical used in each application), the kinds of equipment used, the target being treated, and the level of protection used by a ha ndler can cause exposure levels to differ in a manner specific to each application event.

Based on the anticipated use patterns and curr ent labeling, types of equipment and techniques that can potentially be used, occupational handler dermal and inhalation exposures are expected from the existing uses of chlorfenapyr. The quantitative exposure/risk assessment developed for occupational handlers is based on the following scenarios which cover all the registered uses of chlorfenapyr:

 Mixing/loading/applying liquids via injector (termiticide)

 Mixing/loading/applying liquids vi a mechanically-pressurized handgun

 Applying pressurized liquids vi a ready-to-use aerosol cans

 Mixing/loading/applying liquids via manually-pressurized handwand

 Mixing/loading/applying liqui ds via backpack sprayer

In addition to the above exposure scenarios, there is also a total release fogger product registered for use in greenhouses. An assessment of handler exposure from the use of total release foggers was not performed because dermal and inhalation exposure is expected to be negligible based on the use pattern for this method of application. A total release fogger is an aerosol pesticide device designed to automatically release its to tal content in one operation for the purpose of creating a permeating fog within a space to de liver the pesticide throughout the space. Therefore, total release aerosol s do not need any other applica tion equipment (PR NOTICE 98-6, 1998). Furthermore, most product la bels for total release foggers in clude directions for use that limit exposure to the handler, such as: 1) “tilt can away from face and depress tab,” 2) “aim spray away from face and set fogger in treatment area,” and 3) “immedi ately leave the treatment area and close the door.” As a common integrated pe st management (IPM) and preventive safety practice, if multiple foggers are to be activated, the labels typically recommend that the handler “start at the far end of the area, opposite from the exit door, activati ng and placing cans as you move across the area until you have reached the ex it door.” Once the handler has left the area, the labels also direct users to stay out of th e treated area for a certain amount of time and to

ventilate the area before re-ent ry. HED recommends that RD ensure the appropriate safety directions and re-entry restrict ions are included in the label.Page 22 of 42 Occupational Handler Exposur e Data and Assumptions A series of assumptions and exposure factors serv ed as the basis for completing the occupational handler risk assessments. Each assumption and fact or is detailed below on an individual basis.

Application Rate : A summary of the maximum applicati on rates for each crop or use site are provided in Table 4.1.

Unit Exposures: It is the policy of HED to use the best av ailable data to assess handler exposure. Sources of generic handler data, used as surrogate data in the absence of chemical-specific data, include PHED 1.1, the AHETF database, the Outdoor Residential Exposure Task Force (ORETF) database, or other registrant-submitted occupational exposure studies. Some of these data are proprietary (e.g., AHETF data), and subject to the data protection provisions of FIFRA. The standard values recommended for use in pred icting handler exposure that are used in this assessment, known as “unit exposures”, are outlin ed in the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table 3 ”, which, along with additional information on HED policy on use of surrogate data, including descriptions of the various sources, can be found at the Agency website 4

.

Area Treated or Amount Handled: The daily areas treated or amounts handled were defined for each handler scenario (in appropriate units) by determining the amount that can be reasonably treated by an individual in a single day. When possible, the assumptions for daily areas treated

or amounts handled are taken from the HED’s E xpoSAC Policy 9.1: “Standard Values for Daily Acres Treated in Agriculture”. Values used for area treated or amount handled include the following:

 124 gallons/day for mixing/loading/applying of liquids via injector (see note below)

 1,000 gallons/day for mixing/loading/applying liquids via mechanically pressurized handgun

 20 cans/day for applicator for ready-to -use aerosol cans (see note below)

 40 gallons for backpack and manually -pressurized handwand applications

Note:

 Since there is no information with regards to “typical” applicati ons of ready-to-use aerosol cans for termiticide, HED has assumed an applicator is exposed to the entire contents of a 17.5 fl ounce spray can. HED doe s not have information with regards to how many cans might be used (i.e., applied by an individual) in a given work day. Further, there is no information as to what fr action of a container might typically be used in a given work day. Therefore, for purposes of a Tier I or “screen ing” level assessment, HED presented estimates of exposure and risk that might result from applying 20 cans in a given work day.

 For the termiticide assessment, HED assume d 124 gallons for mixi ng/loading/applying liquids via injector based on a prev ious assessment (D266562, D, Smegal et al. , 20- JUNE- 2000). This is the average amount applied per residence for termiticide

treatments.

3 Available: http://www.epa.gov/opp00001/science/handler-exposure-table.pdf

4 Available: http://www.epa.gov/pesticides/science/handler-exposure-data.htmlPage 23 of 42 Exposure Duration: HED classifies exposures from 1 to 30 days as short-term and exposures 30 days to six months as intermediate-term. Exposure duration is determined by many things, including the exposed population, the use site, the pest pressure triggeri ng the use of the pesticide, and the cultural prac tices surrounding that use site. Fo r most agricultural uses, it is reasonable to believe that occupational handlers will not apply the same chemical every day for more than a one-month time frame; however, there may be a large agribusiness and/or commercial applicators who may apply a pr oduct over a period of weeks (e.g., completing multiple applications for multiple clients within a region).

For chlorfenapyr, based on the existing labeled use patterns, short- and intermediate-term exposures are expected. The greenhouse ornament als and vegetables allo w multiple applications with most having a 5 to 7 day retreatment interval . The labels for the non agricultural uses do not specify a frequency. Since chlorfenapyr is an ins ecticide it is not expected that the number of applications will be more than a handful of times per year. Long-term exposure is therefore not expected.

Mitigation/Personal Protective Equipment: Occupational handler exposure assessments are completed by HED using different levels of ri sk mitigation. Typically, HED uses a tiered approach. The lowest tier is designed as the base line exposure scenario (i.e., long-sleeve shirt, long pants, shoes, socks, no respirator). If risk estimates are of concern at baseline attire, then increasing levels of PPE (i.e., glove s, respirators) are evaluated. Th is approach is used to ensure that the lowest level of risk mitigation that provi des adequate protection is selected. Estimates of inhalation exposure were calculated for “basel ine,” defined as a single layer of clothing consisting of a long sleeved shirt, long pants, shoes plus socks, no protective gloves, and no respirator. The chlorfenapyr produ ct labels direct mixers, loader s, applicators and other handlers to wear long-sleeved shirt and long pants, chemical resistant gloves, shoes plus socks. Some of the labels (499-544, 499-556) require additiona l PPE, including protec tive eyewear. The

Phantom ® Termiticide-Insecticide label (241-292) also requires all handlers to wear a dust/mist filtering respirator (MSHA/NIOSH Approved Nu mber Prefix TC-21C) or a NIOSH approved respirator with any N, R, P or HE filter when working in a non-ventilated space, including but not limited to crawl-spaces and basements. All termiticide handlers must wear protective eyewear when working in a non-ventilated spac e when applying termiticide by rodding or subslab injection.

Occupational Handler Non-Cancer E xposure and Risk Estimate Equations The algorithms used to estimat e non-cancer exposure and dose fo r occupational handlers can be found in Appendix A.

Combining Exposures/Risk Estimates:

Dermal and inhalation risk estimates were combin ed in this assessment, since the toxicological effects for these exposure routes were similar. Dermal and inhalation risk estimates were combined using the following formula:

Total MOE = Point of Departure (mg/kg/day) ÷ Combined dermal + inhalation dose (mg/kg/day)Page 24 of 42 Summary of Occupational Handler Non-Cancer Exposure and Risk Estimates Most occupational handler inhalatio n risk estimates resulted in MOEs greater than the level of concern (LOC = MOE ≥ 100) at baseline or with additiona l PPE, and therefore, are not of concern. The following is a summary of the o ccupational handler combined risk estimates:

 For mixers/loaders/applicators (MLAs) of liquids using an injector for termiticide applications, combined MOEs were above th e LOC of 100 at baseline (single layer of clothing, no gloves, no respirator).

 For MLAs of liquids using a backpack or manually-pressurized handwand for applications to greenhouse ornamentals, co mbined MOEs were above the LOC of 100 at

baseline.

 For applicators using ready-to -use aerosol cans, combined MOEs were above the LOC of 100 with a single layer of clothi ng and gloves, but no respirator.

 For MLAs of liquid using a manually-pre ssurized handwand for application to greenhouse vegetables, combined MOEs were above the LOC of 100 with a single layer of clothing and gloves, but no respirator.

 For MLAs of liquids using a manually-pressuri zed handwand for applications to indoor environments such as food handling establis hments, warehouses, and residential living spaces, combined MOEs were above the LO C of 100 with a single layer of clothing, gloves and a PF5 respirator.

 For mixers/loaders/applicators of liquids using a mechanically-pressurized handgun for termiticide applications to structures, combin ed MOEs were above the LOC of 100 with a single layer of clothing, gl oves and a PF5 respirator.

 For mixers/loaders/applicators of liquids using a mechanically-pressurized handgun for greenhouse applications, combined MOEs did not reach the LOC of 100 even with maximum PPE (i.e., double layer, gloves and PF10 respirator).Page 25 of 42Table 6.1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Chlorfenapyr.Exposure ScenarioCrop or TargetDermal UnitExposure (μg/lbai)1InhalationUnit Exposure(μg/lb ai)1MaximumApplicationRate2AreaTreated orAmountHandledDaily3DermalInhalationTotalMitigation Level(Baseline unlessspecifiedotherwise)Mitigation Level(Baseline unlessspecifiedotherwise)MOE5MOE8Dose4(mg/kg/day)4Dose6(mg/kg/day)4MOE7Mixer/Loader/ApplicatorInjector (termiticide)Structural (termiticide)1,30020.0234 lb ai/gal124 gal90.00717000.000092554,000690BackpackGreenhouse(ornamentals)13,200 1400..0016lbai/gal40 gal0.001593,1000.00013 38,000 2,900Greenhouse (fruitingvegetables)13,200 1400.04 lb ai/gal40 gal0.0390 130 0.00325 1,500120Manually-PressurizedHandwandGreenhouse(ornamentals)100,000300.0016lbai/gal40 gal0.01214100.0000278 180,000410Greenhouse (fruitingvegetables)100,000300.04 lb ai/gal40 gal0.301170.0006967,20017430(SL with G)0.00133,800 2,500Crack and crevice –residential living spaces,food handlingestablishments,warehouses29,0001,1000.05 lb ai/gal0.109460.0319 160368,600(SL with G)0.032415077220(PF5 R)0.00638 780150MechanicallyPressurized HandgunGreenhouse(ornamentals)3,5001200.0016lbai/gal1000 gal0.01064700.00278 1,800370Greenhouse (fruitingvegetables)3,5001200.04 lb ai/gal1000 gal0.264190.069672 152,500(SL with G)24(PF5R)0.188270.0139360201,600(DL with G)12(PF10R)0.121410.0069672026Structural (termiticide)1,80079 0.0234 lb ai/gal1000 gal0.0793630.026819047640(SL with G)0.028318092365 (DL with G) 0.0161310 120Page 26 of 42Table 6.1. Occupational Handler Non-Cancer Exposure and Risk Estimates for Chlorfenapyr.Exposure ScenarioCrop or TargetDermal UnitExposure (μg/lbai)1InhalationUnit Exposure(μg/lb ai)1MaximumApplicationRate2AreaTreated orAmountHandledDaily3DermalInhalationTotalMitigation Level(Baseline unlessspecifiedotherwise)Mitigation Level(Baseline unlessspecifiedotherwise)MOE5MOE8Dose4(mg/kg/day)4Dose6(mg/kg/day)4MOE7ApplicatorReady-to-useAerosol cans0.087 0.0557Crack and crevice(termiticide)190,000 1,3000.005 lb ai/can 20 cans0.0358 140 0.00188 2,700130Bolded values are below the LOC of 100.1 Based on the “Occupational Pesticide HandlerUnit Exposure Surrogate Reference Table”;Level of mitigation: Baseline, Eng. Controls.2 Based on all registered labels (See Appendix B).3 Exposure Science Advisory Council Policy #9.1.4 Dermal Dose = Dermal Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/gal or can) × Amount Handled Daily (gal or can/day) × DAF (13%) ÷ BW (69 kg).5 Dermal MOE = Dermal NOAEL (5 mg/kg/day) ÷ DermalDose (mg/kg/day).6 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb ai/gal or can)× Amount Handled Daily (gal or can/day) ÷ BW (69 kg).7 Inhalation MOE = Inhalation NOAEL (5 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).8 Total MOE = 1 ÷ (1/Dermal MOE) + (1/Inhalation MOE)9 The unit treated for injector are from Memo D. Smegal and T.Leighton, 20 June 2000, D266562indicates an average of 124 gallons per residence for termiticide treatments.Page 27 of 42 6.2 Occupational Post-application Exposure

HED uses the term post-application to describe exposures that occur when individuals are present in an environment that has been previously treated with a pe sticide (also referred to as reentry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, including ac tivities related to crop producti on, such as scouting for pests or harvesting. Post-application e xposure levels vary over time and depend on such things as the type of activity, the nature of the crop or target that was trea ted, the type of pesticide application, and the chemical’s degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatly reduce the potential for post-application exposure.

6.2.1 Occupational Post-application I nhalation Exposure/Risk Estimates

Based on the Agency's current practices, a quant itative post-application inhalation exposure assessment was not performed for chlorfenapyr at this time primarily because of the low acute inhalation toxicity (Toxicity Categor y III), low vapor pressure 1.0 x 10 -7 mm HG @ 25  ̊ C, and the low registered use rate (0.04 -0.2 lb ai/A). However, there are multiple potential sources of post-application inhalation exposur e to individuals performing post-application activities in previously treated fields. Th ese potential sources include vol atilization of pesticides and resuspension of dusts and/or pa rticulates that contain pesticid es. The Agency sought expert advice and input on issues related to volatilization of pe sticides 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 5 . The Agency is in the process of evaluating the SAP report as well as available post-applic ation inhalation exposure data generated by the ARTF and may, as appropriate, develop policies and procedures, to iden tify the need for and, subsequently, the way to incorporate occupational post-application inhala tion exposure into the Agency's risk assessments. If new policies or procedures are put into place, the Agency may

revisit the need for a quantitative occupational post-applic ation inhalation exposure assessment for chlorfenapyr.

The Worker Protection Standard for Agricultural Pesticides contains requ irements for protecting workers from inhalation exposures during and af ter greenhouse applications through the use of ventilation requirements [40 CFR 170.110, (3) (Restrictions a ssociated with pesticide applications)].

Commercial applicators do not t ypically return to the treated areas after an indoor commercial pesticide application (sites such as warehouses, food handling establishments, and hotels, etc.) and thus an occupational post-ap plication inhalation exposure a ssessment was not performed for commercial applicators.

5 Available: http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.htmlPage 28 of 42 6.2.2 Occupational Post-application Dermal Exposure/Risk Estimates

Occupational Post-application Dermal Exposure Data and Assumptions

A series of assumptions and exposure factors serv ed as the basis for completing the occupational post-application risk assessments. Each assumpti on and factor is detailed below on an individual

basis.

Exposure Duration: HED classifies exposures from 1 to 30 days as short-term and exposures 30 days to six months as intermediate-term. For th e registered use pattern, short- and intermediateterm exposures are anticipated for the following reasons only up to three applications can be made. The same exposure durations are anticipate d for all registered chlorfenapyr uses, and it

should be noted that the short- and intermediate -term PODs are the same; therefore, short-term risk estimates are protective of longer-term exposures.

Transfer Coefficients: It is the policy of HED to use the best available data to assess postapplication exposure. Sources of generic post-application data, us ed as surrogate data in the absence of chemical-specific data, are derived from ARTF exposure monitoring studies, and, as proprietary data, are subject to the data protection provisions of FIFRA. The standard values recommended for use in predicting post-applicati on exposure that are used in this assessment, known as “transfer coefficients”, ar e presented in the ExpoSAC Policy 3 6 ” which, along with

additional information about the ARTF da ta, can be found at the Agency website 7

.

Table 6.2.2.1. Anticipated Po st-Application Activities and Dermal Transfer Coefficients.

Proposed

Crops Policy Crop Group Category Crop Height Foliage Density Transfer

Coefficients

(cm 2 /hr ) Activities

Greenhouse Vegetables No subcrop Low Min 230 Transplanting, High Full Irrigation (hand watering)

High Full

1,200 Hand harvesting, Pinching, Pollination, Scouting, Turing, Tying/training, Hand Weeding, Hand Pruning,
Low Full Hand harvesting, Hand Pruning

Low Min Pinching, Propagating, Hand Pruning Scouting, Hand Weeding,

Greenhouse Ornamentals, Non-bearing

Plant No subcrop High Full

0 Mechanical Weeding, Irrigation (non-hand set), Spreading Bins Low Full Low Min Fertilizing

High Full

230 Hand harvesting, Hand Pruning, Scouting, Container Moving, Hand Weeding, Transplanting, Pinching,

Low Full Hand harvesting, Hand Pruning, Scouting, Hand Weeding, Transplanting, Pinching, Tying/Training
Low Min Grafting, Propag ating, Transplanting

High Min Hand harvesting, Hand pruning, Transplanting

6 Available: http://www.epa.gov/pesticides/science/exposac_policy3.pdf

7 Available: http://www.epa.gov/pesticides/scien ce/post-app-exposure-data.htmlPage 29 of 42 Table 6.2.2.1. Anticipated Po st-Application Activities and Dermal Transfer Coefficients.

Proposed

Crops Policy Crop Group Category Crop Height Foliage Density Transfer

Coefficients

(cm 2 /hr ) Activities

Floriculture Crop Flowers cut Low Full

230 Container Moving, Pinching, Hand Pruning, Hand Weeding, Scouting, Transplanting High Full Hand Pruning, Hand Weeding, Scouting, Low Min Hand Weeding, Transplanting, Pinching High Full 1,900 Irrigation (hand set) High Full 4,800 Hand Harvesting Low Full

Application Rate: The application rates used in this assessment are provided in Table 4.1.

Exposure Time: The average occupational workda y is assumed to be 8 hours.

Dislodgeable Foliar Residues: In accordance with 40CFR158, DFR data are required for all occupational (e.g., crop, nursery, gr eenhouse use sites) or reside ntial (e.g., ornamental and vegetable gardens, pick your ow n farms, retail tree farms) uses that could result in postapplication exposure to foliage. In the absence of chemical-specific DFR data, EPA uses default

values. The 2012 Standard Operating Procedures for Residential Pesticide Exposure

Assessment includes an analysis of a number of DFR st udies, which resulted in the selection of a revised default values for the fraction of the appl ication rate available fo r transfer after a foliar application (F AR ). These values are based on an analysis of 19 DFR studies. Since that time, the Agricultural Re-entry Task Force has submitted information (MRID 49299201) that corrects an application rate error made in the original submission of “ARF039 – Determination of Dermal and Inhalation Exposure to Reentry Workers Du ring Chrysanthemum Pinching in a Greenhouse” (EPA MRID 45344501). As a result, the range of F AR values was revised from 2% - 89% to 2%

- 47%. In the data, a large range of transferability is observed and this variability can potentially be attributable to many factors such as active ingredient; formulation; field conditions in the studies; weather conditions (e .g., humidity); or many other difficult to quantify factors. Although witnessed across multiple chemicals, this range in F AR values is not expected when considering DFR data for a single chemical. At this time, the ARTF submission did not alter the

selection of 25% as the reasonabl e, high-end default value. Because DFR data are not available for chlorfenapyr, EPA is using the default value of 25%. Although there may be a small degree of uncertainty in the us e of the default DFR value for chlorf enapyr (i.e., there is a small chance

that the F AR value may exceed the applicable default value ), it is likely that the health-protective aspects of EPA’s occupational post-applic ation assessment methodology will more than compensate for this potential uncertainty. Fo r example, when asse ssing residential and occupational post-application exposu re to gardens and ornamentals, EPA assumes the following: exposures occur to zero-day (i.e., day of app lication ) residues every day of the assessed exposure duration (i.e., EPA assume s that no dissipation or degrad ation occurs, it doesn’t rain, etc); individuals perform the same post-application activities performed in the transfer coefficient study day after day (e.g., weeding, harv esting, pruning, etc.); a nd individuals engage in these post-applicati on activities for a high-end amount of time every day (represented by data reflecting time spent gardening based on survey data).Page 30 of 42 Given the conservatisms discussed above a nd the potential compounding nature of these conservatisms, EPA is able to re ly upon the calculated exposure estimates with confidence that exposure is not being underestimated.

Since the highest estimated occupational post-application exposure using default DFR values for chlorfenapyr is not minimal in comparison to th e level of concern (i.e ., the calculated MOE is not greater than 2 times highe r than the level of concern, MOE = 120 compared to the LOC of 200); EPA is requiring the 40CFR DFR data. EPA is requiring the 40CFR DFR data requirement to facilitate any necessary exposur e assessments refinements and to further EPA’s general understanding of the av ailability of dislodgeable foliar pesticide residues.

Occupational Post-application Non-Cancer Derm al Exposure and Risk Estimate Equations The algorithms used to estimat e non-cancer exposure and dose fo r occupational post-application workers can be found in Appendix A.

Occupational Post-application Non- Cancer Dermal Risk Estimates The short- and intermediate-term post-applica tion exposure scenarios associated with the registered uses of chlorfenapyr are summarized in Table 6.2.2.2. A ll scenarios resulted in MOEs greater than the LOC of 100 (ra nging from 120 to 2,600) on day 0 (12 hours after application) and, therefore, are not of concern to HED.

Table 6.2.2.2. Occupational Post-application Non-Cancer Exposure and Risk Estimates for Chlorfenapyr.

Crop/Site Activities Transfer

Coefficient

(cm 2 /hr) DFR/TTR 1 Dermal Dose (mg/kg/day) 2 MOE 3

Short and Intermediate-Term

Floriculture Crop

(cut flowers) Container Moving, Pinching, Hand Pruning, Hand Weeding, Scouting, Transplanting, 230

0.56 0.002 2,600

Irrigation (hand set) 1,900 0.016 310

Hand Harvesting 4,800 0.041 120

Greenhouse Vegetables Transplanting, Irrigation (hand watering) 230 0.002 2,600

Hand harvesting, Pinching, Pollination, Hand Pruning, Scouting, Turing, Tying/training, Hand Weeding, Propagating, Hand Pruning, Scouting 1200 0.010 490

GreenhouseOrnamental, Nonbearing Plant Hand harvesting, Hand Pruning, Scouting, Container Moving, Hand Weeding, Transplanting, Pinching, Tying/Training, Grafting, Propagating 230 0.002 2,600

1 DFR = Application Rate × F × (1-D) t × 4.54E8 μg/lb × 2.47E-8 acre/cm 2 ; where F = 0.25 and D = 0.10 per day
2 Daily Dermal Dose = [DFR (μg/cm 2 ) × Transfer Coefficient × 0.001 mg/μg × 8 hrs/day × dermal absorption (%)]  BW (kg).
3 MOE = POD (5 mg/kg/day) / Daily Dermal Dose. Daily Dermal Dose = [DFR (μg/cm 2 ) × TC × 0.001 mg/μg × 8 hrs/day × dermal

absorption factor (13 %)]  BW 69 kg).Page 31 of 42 Restricted Entry Interval The REIs specified on existing labels are base d on the acute toxicity of chlorfenapyr. Chlorfenapyr is classified as Toxicity Category I II or IV via the dermal route and skin irritation potential. It is not a sk in sensitizer. Under 40 CFR 156.208 (c) (2) (iii), a.i.’s classified as Acute III or IV for acute dermal, eye irritation and prim ary skin irrigation are assigned a 12-hour REI. Therefore, the [156 subpart K] Worker Protecti on Statement interim REI of 12 hours is adequate to protect agricultural workers fr om post-application exposures to chlorfenapyr. Only two labels specify a REI. These are Pylon ® TR (Total Release miticide/insecticide) (TC-307) and Pylon ®
(241-374).Page 32 of 42 Appendix A: Summary of Occupati onal and Residential Algorithms

Occupational Non-cancer Handler Algorithms

Potential daily exposures for occupational handler s are calculated using the following formulas:

E=UE * AR * A * 0.001 mg/ug

where:

E = exposure (mg ai/day), UE = unit exposure (μg ai/lb ai), AR = maximum application rate according to label (lb ai A or lb ai/gal), and

A = area treated or amount ha ndled (e.g., A/day, gal/day).

The daily doses are calculated using the following formula:

ADD= E * AF

BW

where:

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day), E = exposure (mg ai/day), AF = absorption factor (der mal and/or inhalation), and BW = body weight (kg).

Margin of Exposure: Non-cancer risk estimates for each application handler scenario are calculated using a Margin of Exposure (MOE), whic h is a ratio of the to xicological endpoint to the daily dose of concern. The daily dermal and inhalation dose received by occupational handlers are compared to the a ppropriate POD (i.e., NOAEL) to a ssess the risk to occupational handlers for each exposure route. All MOE values are calculated using the following formula:

MOE= PODADD

where:

MOE = margin of exposure: value used by HE D to represent risk estimates (unitless), POD = point of departure (mg/kg/day), and ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).

Occupational Non-cancer Post -application Algorithms

Potential daily exposures for occupational post- application workers are calculated using the following formulas:Page 33 of 42 DFR t =AR * F* (1-D) t * ቀ 4.54E8 ug

lb ቁ * ൬ 2.47E-8 A

cm 2 ൰

where:

DFR t = dislodgeable foliage residue on day "t" (μg/cm 2 ), AR = application rate (lb ai/acre),

F = fraction of ai retained on foliage or 25% (unitless), D = fraction of residue that dissipa tes daily or 10% (unitless), and t = number of days afte r application day (days).

E=TC * DFR t * ET * 0.001 mg

ug

where: E = exposure (mg ai/day), TC = transfer coefficient (cm 2 /hr),

DFR t = dislodgeable foliar re sidue on day “t” (μg/cm 2 ), and ET = exposure time (hours/day).

The daily doses are calculated using the following formula:

ADD= E * AF

BW

where:

ADD = average daily dose absorbed in a given scenario (mg ai/kg/day), E = exposure (mg ai/day), AF = absorption factor (der mal and/or inhalation), and BW = body weight (kg).

Margin of Exposure: Non-cancer risk estimates for each sc enario are calculated using a Margin of Exposure (MOE), which is a ratio of the toxico logical endpoint to the daily dose of concern. The daily dermal dose received by occupational po st-application workers is compared to the appropriate POD (i.e., NOAEL) to assess the risk to occupational post-application workers. All

MOE values are calculated using the following formula:

MOE= POD

ADD

where:

MOE = margin of exposure: value used by HE D to represent risk estimates (unitless), POD = point of departure (mg/kg/day), and ADD = average daily dose absorbed in a given scenario (mg ai/kg/day).Page 34 of 42 Residential Non-cancer Handler Algorithms

Residential Non-cancer Po st-application Algorithms

Exposure to pesticide vapors The following algorithm is used to determine pos t-application inhalatio n exposure from indoor surface-directed sprays:

ൌ ܧ ܯ	 ∗ ܴܫ ௟௘௕௔௟
ܣ ܪܥ	 ∗ ܸ
௠௢௢௥ ቈ 1െቆ ሺ ܣ ܪܥ ∗ ݁ ି∗௞ா் ሻ െ ሺ݇ ∗ ݁ ି஺஼ு∗ா்

ܣ ܪܥ െ ݇ ቇ ቉

where: E = exposure (mg/day); IR = inhalation rate (m 3 /hr);

M label = mass of active ingredie nt 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).

In the above equation, a mass of pesticide is applied to a su rface and the emission of the pesticide from the surface is assumed to decline ov er time due to dissipatio n of the pesticide (i.e.,

emission from the treated surface and removal due to the air exchange rate). The mass of active ingredient applied can be calcula ted using the following formula:

ܯ ௟௔௕௘௟ ൌ ܣ ∗ ܴ ܣ 1ܨܥ ∗

where:

M label = mass of active ingredie nt 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 concentration (C sat ), of a chemical and the time required for 90% of the chemical to evaporate (EvapT):

ݒܧܽ݌ܶ ൌ 10 ሾ ଻.ଷ଺ଽ଼ି଴.ଽହସ଺∗ ௟௢௚ భబ ሺ ஼ ೞೌ೟ ሻ ሿ

where:Page 35 of 42 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 base d on the evaporation time described by Chinn:

݇ ൌ ln ሺ 0.1 ሻ ∗ ܨܥ1

ܶ݌ܽݒܧ

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

CF1 = conversion fact or (sec/hr), and EvapT = evaporation time (sec).

The exposure equation above is based on the mass of pesticide applied, not the concentration of the pesticide in the air; therefore, the review er must check that the input for mass applied (M label ) is predicting an air concentr ation less than or equal to th e saturation concentration. The following equation can be used to calculate the th eoretical mass applied that would result in an

air concentration that reaches the satu ration concentration for a pesticide (M Csat ):

ܯ ஼ ೞೌ೟ ൌ ܥ ௦௔௧ ∗ ሺ ܣ ܪܥ െ ݇ ሻ ∗ ܸ

݇

M Csat should be compared to M label

.

 If M label > M Csat  M label will predict an air concentra tion higher than the saturation

concentration. Use M Csat in the exposure calculation.

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

concentration. Use M label in the exposure calculation.

Once the post-applicatio n inhalation exposure is calculated, the inhalation dose normalized to body weight is calculated as:

ൌ ܦ ∗ ܧ ܣ ܨ

ܹܤ

where:

D = dose (mg/kg-day); E = exposure (mg/day); AF = absorption fact or (inhalation); andPage 36 of 42 BW = body weight (kg).

Table A-X: Indoor Environments – Inputs for Re sidential Post-application Inhalation Exposure Algorithm

Notation Exposure Factor (units) Point Estimate(s)

Generic Variables Used in Calculati ng 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 69 Children 1 < 2 years old 11

V room Volume of room (m 3 ) 33

Variables Specific to Post-application Inhalation Exposure to Pesticide Vapors

C sat Saturation concentration (mg/m 3 ) Calculated

VP Vapor pressure (mmHg) 1.0 x 10 -7 mm HG @ 25  ̊ C

MW Molecular weight (g/mol) 407.6

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 Al gorithm (hard surfaces and carpets) The algorithm to calculate exposure is as follows:

1ܨܥ ∗ ܶܧ ∗ ܥܶ ∗ ܴܶ ൌ ܧ

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 fact or (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:

ܨ ∗ ܴ݌݁ܦ ൌ ܴܶ ௜௔

where:Page 37 of 42 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 ra te (lb ai/area), or (3) Default residue base d on type of application (  g/cm 2 ); and

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

Absorbed dermal dose, normalized to body weight, ar e calculated as:

ൌ ܦ ∗ ܧ ܣ ܨ

ܹܤ

where: D = dose (mg/kg-day); E = exposure (mg/day); AF = absorption factor; and BW = body weight (kg).

Table A-X: Indoor Environments (Hard Surfaces and Carp ets) – Inputs for Residential Post-application Dermal Exposure Algorithm

Notation Exposure Factor (units) Point Estimate(s)

TR Transferable residue (  g/cm 2 ) Estimated: DepR * F ai

DepR Deposited residue (  g/cm 2 ) Estimated based on default residue related to type of application

F ai Fraction of DepR as TR following application Carpets 0.06 a

Hard surfaces 0.08 a

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 69 Children 1 < 2 years old 11

Post-Application Dermal Exposure Algorithm (mattresses) The algorithm to calculate absorbed dose is as follows:

∗ ܴܦ ൌ ܦ ܣܵ

ܹܤ ܨ∗ܨ∗ ௜௔ ∗ ܨܲ ∗ ܣ 1ܨܥ ∗ ܨ

where:

D = Dermal dose (mg/kg-day);Page 38 of 42 DR = Deposited residue (mg/cm 2 );

SA/BW = Surface area / Body Weight Ratio (cm 2 /kg); F = Fraction of body th at contacts residue; CF1 = Conversion factor (mg/  g); AF = Absorption factor;

F ai = fraction of ai available for tr ansfer from treated mattress; and

PF = Protection factor to account for the presence of a single layer of fabric (e.g. bed sheet) between the treated material and individual.

Table A-X: Indoor Environments (mattresses) – I nputs for Residential Post-application Dermal Exposure

Algorithm

Notation Exposure Factor (units) Point Estimate(s)

DR Deposited residue (  g/cm 2 ) Based on default residue values

SA/BW Surface area / Body Weight

Ratio (cm 2 /kg) Adult 280

Children 1 < 2 years old 640

F Fraction of body that contacts residue 0.5

F ai Fraction of DR available for transfer 0.06

PF Protection Factor 0.5

Post-application Hand-to-Mouth Exposure Algorithm Exposure from hand-to-mouth activity is calculat ed as follows (based on algorithm utilized in SHEDS-Multimedia):

ܧ ൌ ቈ ܪܴ 	∗ ሺ ܨ ெ ∗ 	 ܵܣ ு ሻ ∗ ሺ ܧܶ ∗ ܰ

_ ܴ݁݌݈݁݊ ሻ ∗ ቆ1 െ ሺ 1 െ ܵܧ ሻ ி௥௘௤

_ ு௧ெ

ே

_ ோ௘௣௟௘௡ ቇ ቉

where: E = exposure (mg/day);

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

F M = fraction hand surface area mout hed / event (fraction/event); ET = exposure time (hr/day);

SA H = surface area of one hand (cm 2 ); N_Replen = number of replenishmen t intervals per hour (intervals/hour); SE = saliva extraction factor (i.e ., mouthing removal efficiency); and Freq_HtM = number of hand-to-mouth cont acts events per hour (events/hour).

and

ൌ ܴܪ ܽ݅ܨ ௗ௦௛௔௡ ܧܦ ∗

ܣܵ ு 2 ∗Page 39 of 42 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 we ight, is calculated as:

ൌ ܦ ܧ

ܹܤ

where: D = dose (mg/kg-day); E = exposure (mg/day); and BW = body weight (kg).

Table A-X: Indoor Environments – Inputs for Re sidential 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 5.2.2 (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) 11,350

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 11Page 40 of 42 Post-application Object-to- Mouth Exposure Algorithm Exposure from object-to-mouth activity is calculate d as follows (based on algorithm utilized in SHEDS-Multimedia):

ܧ ൌ ܱܴ ∗ ܨܥ1 	∗ ܵܯܣ ை ∗ ሺ ܧܶ ∗ ܰ

_ ܴ݁݌݈݁݊ ሻ ∗ ቆ1 െ ሺ 1 െ ܵܧ ሻ ி௥௘௤_ை௧ெ

ே

_ ோ௘௣௟௘௡ ቇ

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 replenishmen t intervals per hour (intervals/hour); SE = saliva extraction factor (i .e., mouthing removal efficiency); and Freq_OtM = number of object-to-mouth contac t events per hour (events/hour).

and

ܨ ∗ ܴ݌݁ܦ ൌ ܱܴ ை

where:

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

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

and

Oral dose, normalized to body weight, is calculated as:

ൌ ܦ ܧ

ܹܤ

where:

D = dose (mg/kg-day); E = exposure (mg/day); and BW = body weight (kg).Page 41 of 42 Table A-X: Indoor Environments – Inputs for Re sidential 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 a

Hard surfaces 0.08 a

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 11Page 42 of 42 Appendix B. Registered Chlorfenapyr End Use Products

Table B.1. Registered Clorfenapyr End Use Products.

EPA Reg. No. Formulation Type Product Label Name Company

241-366 Chlorfenapyr Technical BASF Corporation

241-374 EC Pylon ® Miticide-Insecticide BASF Corporation

241-392 EC Phantom Termiticide Insecticide BASF Corporation

499-544 PRL TC-307 Whitmire Micro-Gen Research Laboratories, Inc

499-548 PRL TC-314 Whitmire Micro-Gen Research Laboratories, Inc

499-556 PRL TC-326 Whitmire Micro-Gen Research Laboratories, Inc

7969-285 PRL Prescription Treatment ® Brand

Phantom ® Pressurized Insecticide BASF Corporation