UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES April 4, 2006 MEMORANDUM:

Subject: Revised Occupational and Residential Exposure Chapter for Orthophenylphenol & Ortho phenylphenol Salts To: Rebecca Miller, Chemical Review Manager, Reregistration Team 36 Regulatory Management Branch II Antimicrobials Division ( 7510C)

AND Najm Shamim, Risk Assessor Regulatory Management Branch II Antimicrobials Division ( 7510C)

From: Talia Milano, Chemist Cassi Walls, Ph. D., Chemist Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

Thru: Norm Cook, Branch Chief Risk Assessment and Science Support Branch ( RASSB) Antimicrobials Division ( 7510C)

DP Barcode: 320537 Chemical Name: PC Codes: CAS Registry No. Abbreviation Ortho phenylphenol 064103 90 43 7 OPP Sodium ortho phenylphenate 064104 132 27 4 OPP ( Na) Salt Potassium ortho phenylphenol 064108 13707 65 8 OPP ( K) Salt 2 TABLE OF CONTENTS EXECUTIVE SUMMARY.................................................................................................... 3 1.0 INTRODUCTION............................................................................................................ 7 1.1 Purpose ........................................................................................................................... 7 1.2 Criteria for Conducting Assessments ............................................................................... 7 1.3 Chemical Identification.................................................................................................... 9 1.4 Physical/ Chemical Properties ........................................................................................... 9 2.0 USE INFORMATION ................................................................................................... 10 2.1 Formulation Types and Percent Active Ingredient .......................................................... 10 2.2 Summary of Use Pattern and Formulations .................................................................... 10 3.0 SUMMARY OF TOXICITY DATA ............................................................................. 13 3.1 Acute Toxicity............................................................................................................... 13 3.2 Summary of Toxicity Endpoints..................................................................................... 14 3.3 FQPA Considerations .................................................................................................... 17 4.0 RESIDENTIAL EXPOSURE ASSESSMENT.............................................................. 18 4.1 Summary of Registered Uses ......................................................................................... 18 4.2 Dietary Exposure........................................................................................................... 18 4.3 Drinking Water Exposure .............................................................................................. 18 4.4 Residential Exposure ..................................................................................................... 18 4.4.1 Residential Handler Exposures................................................................................. 20 <IP_ADDRESS> Residential Painter Inhalation ( vapor) Exposure ................................................. 23 4.4.2 Residential Post application Exposure...................................................................... 24 <IP_ADDRESS> Hard Surface/ Floor Cleaners .............................................................................. 24 <IP_ADDRESS> Textiles.............................................................................................................. 28 <IP_ADDRESS> Plastics ( Toys) ................................................................................................... 32 <IP_ADDRESS> Air Deodorizers ................................................................................................. 34 <IP_ADDRESS> Paints................................................................................................................. 36 <IP_ADDRESS> Foggers ............................................................................................................. 37 4.4.3 Data Limitations/ Uncertainties................................................................................. 39 5.0 RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION..................................................................................................... 39 5.1 Acute and Chronic Dietary Aggregate Risk.................................................................... 39 5.2 Short and Intermediate Term Aggregate Risk ................................................................ 39 6.0 OCCUPATIONAL EXPOSURE ASSESSMENT......................................................... 44 6.1 Occupational Handler Exposures ................................................................................... 47 6.1.1 Professional Painter Inhalation ( vapor) Exposure ..................................................... 55 6.1.2 Industrial Bystander Inhalation Exposure ................................................................. 56 6.2 Occupational Post application Exposures ...................................................................... 56 6.2.1 Fogging                 .................       .  56 6.3 Metalworking Fluids: Machinist..................................................................................... 57 6.4 Wood Preservation........................................................................................................ 60 6.5 Data Limitations/ Uncertainties....................................................................................... 66 7.0 REFERENCES............................................................................................................... 67 APPENDIX A: Summary of CMA and PHED Data............................................................... 68 APPENDIX B: Input/ Output from Residential MCCEM Modeling........................................ 71 APPENDIX C: Conversion of DDAC Exposure Values to OPP Exposure Values................. 78 APPENDIX D: Input/ Output from Occupational MCCEM Modeling.................................... 81 3 APPENDIX E: Wallpaint Exposure Model ( WPEM) Outputs ............................................... 84 EXECUTIVE SUMMARY This document is the Occupational and Residential Exposure Chapter of the Reregistration Eligibility Decision Document ( RED) for ortho phenylphenol ( OPP) and the OPP salts, which is representative of both sodium o phenylphenate ( OPP Na salt) and potassium o phenylphenate ( OPP K salt). It addresses the potential risks to humans that result from the use of these chemicals in occupational and residential settings.

At this time OPP and OPP salts are active ingredients in products such as disinfectants and deodorizers used in agricultural, food handling, commercial/ institutional/ industrial, residential and public access, and medical settings ( Use Site Categories I, II, III, IV, and V respectively). There are also OPP and OPP salt containing products that are used for materials preservation ( Use Site Category VII) and wood preservation ( Use Site Category X). Examples of registered uses for OPP and salts include application to indoor and outdoor hard surfaces ( e. g., walls, floors, tables, and fixtures), textiles ( e. g., clothing, diapers, mattresses, bedding), carpets, air conditioner coils, agricultural tools, medical instruments, and fruits and vegetables ( post harvest). Additionally, there are registered uses for fogging and air deodorization in both occupational and residential settings. As a materials preservative, the products are used in items such as metalworking fluids, stains and paints, cleaning solutions, glues, building materials, glazes, paper, polymers, and leather. The percentage of OPP and OPP salts in various products can range from 0.0137% to 99.5%. Products containing OPP and its salts are formulated as ready to use solutions, pressurized sprays, soluble concentrates, impregnated wipes or as emulsifiable concentrates.

The routes of exposure evaluated in this assessment include: short term ( ST), intermediate term ( IT), and long term ( LT) dermal and inhalation exposures as well as ST and IT oral exposures. For all exposure routes, the ST NOAEL is 100 mg/ kg/ day and the IT/ LT NOAEL is 39 mg/ kg/ day. A human dermal absorption factor of 43% was used in the IT and LT dermal exposures calculations because the dermal MOE calculations were based on an oral endpoint. An inhalation absorption factor of 100% was used ( default value, assuming oral and inhalation absorption are equivalent) in all exposure calculations since the inhalation MOE calculations were based on an oral endpoint.

The uncertainty factor or " target" margin of exposure ( MOE) for all routes of exposure and all durations is 100 for both occupational and residential scenarios. Although the target MOE is also 100 for inhalation occupational and residential scenarios, the Agency may request a confirmatory inhalation toxicity study in cases where the inhalation MOEs are below a value of 1,000 since the inhalation endpoint is based on an oral study. In the occupational assessment, intermediate term dermal and inhalation exposures were combined together to estimate Total MOEs since the toxicity effects from the intermediate term dermal and inhalation routes are the same while, the oral, dermal, and inhalation exposures were combined together in the residential assessment. Additionally, since the toxicological endpoints selected for both OPP and the OPP salts are identical, a separate assessment was not conducted for each active ingredient.

Based on examination of product labels describing uses for the product, it has been determined that exposure to handlers can occur in a variety of occupational and residential environments. Additionally, postapplication exposures are likely to occur in these settings. 4 The representative scenarios selected by the Antimicrobials Division ( AD) for assessment were evaluated using maximum application rates as stated on the product labels. The maximum application rates were from products containing either OPP or OPP Na salt.

To assess the handler risks, AD used surrogate unit exposure data from the following proprietary resources: Chemical Manufacturers Association ( CMA) antimicrobial exposure study, the Pesticide Handlers Exposure Database ( PHED), and the proprietary sapstain study ( task force # 73154), Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride ( DDAC) Used in the Protection of Cut Lumber ( Phase III) ( Bestari et al., 1999, MRID 455243 04). Additionally, EPA's Health Effects Division's ( HED) Standard Operating Procedures ( SOPs) for Residential Exposure Assessments, MCCEM ( Multi Chamber Concentration and Exposure Model), and WPEM ( Wall Paints Exposure Model) were used to estimate postapplication/ bystander exposures.

Handler Risk Summary For the residential handler dermal and inhalation risk assessment, the MOEs were above the target MOE of 100 for all scenarios. Furthermore, all of the inhalation MOEs were above 1,000 therefore a confirmatory inhalation toxicity study is not warranted based on the results from these scenarios.

For the occupational handler dermal and inhalation risk assessment, the MOEs were above target MOE of 100 for all scenarios except the following:

  IT exposure from fogging ( mixing and loading): IT Total MOE = 98.   ST and IT dermal exposure from wiping without gloves in the commercial/ institutional premises category: ST MOE = 74, IT dermal MOE = 68, and IT Total MOE = 64.   ST and IT dermal exposure from mopping without gloves in the medical use site category: ST dermal MOE = 93, IT dermal MOE = 84, and IT Total MOE = 78.   ST and IT dermal exposure resulting from the gloved liquid pour of the material into textiles in the materials preservatives category: ST dermal MOE= 92, IT dermal MOE = 83 and IT Total MOE = 78.   ST dermal exposures without gloves from painting through the use of an airless sprayer: Without gloves, the ST dermal MOE = 66. With gloves, however, the dermal ST MOE = 180 and is not of a concern.   ST inhalation exposure from vapors of paint: ST MOE = 43.

A confirmatory inhalation toxicity study may be warranted because inhalation MOEs were below 1,000 for the following scenarios:

  IT inhalation exposure from fogging ( mixing and loading): IT inhalation MOE = 880   IT inhalation exposure as a result of the blender/ spray operators adding the chemical via closed liquid pumping for wood preservation. The IT inhalation MOE = 840.

Post application/ Bystander Risk Summary For the residential postapplication risk assessment, MOEs are above the respective target MOEs ( ST/ IT/ LT Dermal and Inhalation = 100) for all scenarios except for the following: 5   ST dermal exposure from children wearing treated clothing: The ST dermal MOE using 100% residue transfer < 1 and using 5% residue transfer = 16   ST dermal exposure for adults wearing treated clothing: ST MOE using 100% residue transfer = 1 and using 5% residue transfer = 25.   ST/ IT/ LT dermal exposure for infants wearing treated diapers: ST/ IT/ LT MOE using 100% residue transfer < 1; ST MOE using 5% residue transfer = 11; IT/ LT MOE using 5% residue transfer = 10.

A confirmatory inhalation toxicity study is may be warranted because inhalation MOEs were below 1,000 for the following scenarios:

  ST vapor inhalation exposure to adult and children in the home of a house being painted by a professional: adult ST MOE = 600 and child ST inhalation MOE = 120.   The ST vapor inhalation exposures to adults that result from fogging applications in residential homes where MOEs were estimated for a 0 hr REI and a 4 and 24 hour exposure duration.   The ST vapor inhalation exposure to adults that results from fogging applications in residential homes where the MOE was estimated for a 4 hr REI and 24 hour exposure duration.   All ST vapor inhalation exposures to children that result from fogging applications in residential homes where MOEs were estimated for a 0 hr and a 4 hr REI and 2, 4, and 24 hr exposure durations.

For the occupational postapplication risk assessment, MOEs are above the respective target MOEs ( ST/ IT/ LT Dermal and Inhalation = 100) for all scenarios except for the following:

  ST dermal exposure from a machinist using metalworking fluid: The ST dermal MOE = 54.

A confirmatory inhalation toxicity study is may be warranted because inhalation MOEs were below 1,000 for the following scenarios:

  IT vapor inhalation exposure from fogging a poultry barn: The IT inhalation MOE = 270, and ST inhalation MOE = 690.

Aggregate exposure risk summary Short and intermediate term aggregate exposures and risks were assessed for adults and children that could be exposed to OPP and OPP salt residues from the use of products in nonoccupational environments. The short term dermal toxicity endpoint was based on skin irritation. This study is different from what the oral and inhalation endpoints were based on, such that the short term dermal exposures were aggregated in a separate analysis from the short term inhalation and oral exposures. However, the intermediate term toxicity endpoints for all of the routes of exposure ( oral, dermal and inhalation) are based on the same study and same toxic effect therefore, all intermediate term routes were aggregated together. The target MOE for all routes of exposure is 100, and all of the calculated aggregate MOEs are not of concern, as further discussed in Section 5.2, " Short and Intermediate Term Aggregate Risk." 6 Data Limitations and Uncertainties:

There are a number of uncertainties associated with this assessment and these have been reiterated from Sections 4.4.3 ( residential) and 6.3 ( occupational) respectively.

The data limitations and uncertainties associated with the residential handler and postapplication exposure assessments include the following:

  Surrogate dermal and inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix A for summaries of these data sources). Most of the CMA data are of poor quality therefore, AD requests that confirmatory monitoring data be generated to support the values used in these assessments.   The quantities handled/ treated were estimated based on information from various sources, including HED's Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA 2000, and 2001) and standard AD assumptions that can be further refined from input from registrants.   The low pressure spray unit exposure data from PHED were used to assess outdoor applications to hard surfaces ( exterior of homes). As the low pressure spray data are representative of treating low to mid level shrubs and the scenario assessed in this document represents treatments above the waist, the unit exposure value may underestimate exposure to the head and the upper body.   The method used to estimate exposure from mouthing treated plastic toys is conservative because it does not account for washing of the toy or depletion of residue after each toy to mouth episode.   The textile exposure methods were very conservative because they assumed that the textiles were saturated with the product, dried, and worn. No laundering was accounted for because the labels did not provide specific use instructions pertaining to washing of the clothing/ diapers.   A confirmatory study is needed to verify the 5% transfer factor for clothing and diapers.   The Wall Paint Exposure Model is designed to estimate indoor air concentrations and associated inhalation exposures for interior applications involving alkyd or latex primer/ paint. The chamber tests on which the emission algorithms are based involve a limited set of chemicals with a correspondingly limited range of properties ( molecular weight and vapor pressure). Further, the emission algorithms are valid only for chemicals that are formulated into alkyd/ latex primers or paints. Actual monitoring data could be used to refine the exposures and risks estimated in this assessment.

The data limitations and uncertainties associated with the occupational handler and postapplication exposure assessments include:

  Surrogate dermal and inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix A for summaries of these data sources). Since the CMA data are of poor 7 quality, the Agency requests that confirmatory data be submitted to support the occupational scenarios assessed in this document.   Although the data libraries contained in MCCEM are limited to residential settings, the model can be used to assess other indoor environments. For this assessment, assumptions were made regarding barn dimensions and air changes per hour. The results could be refined with actual ventilation rates. Also the half life for the chemical would useful to refine the results.   Currently, no exposure data are available to assess the bystanders' inhalation exposure to OPP vapors in industrial settings. Appropriate air monitoring data in the manufacturing setting are needed to support the preservative uses.

1.0 INTRODUCTION 1.1 Purpose In this document, the Antimicrobials Division ( AD) presents the results of its review of the potential human health effects of occupational and residential exposure to OPP and OPP salts. This information is for use in EPA's development of the OPP and OPP salts Reregistration Eligibility Decision Document ( RED).

1.2 Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For OPP and OPP salts, both criteria are met.

In this document, scenarios were assessed by using unit exposure data to estimate occupational and residential handlers' exposures. Unit exposures are estimates of the amount of exposure to an active ingredient a handler receives while performing various handler tasks and are expressed in terms of micrograms or milligrams ( 1mg = 1,000 µ g) of active ingredient per pounds of active ingredient handled. A series of unit exposures have been developed that are unique for each scenario typically considered in assessments ( i. e., there are different unit exposures for different types of application equipment, job functions, and levels of protection). The unit exposure concept has been established in the scientific literature and also through various exposure monitoring guidelines published by the USEPA and international organizations such as Health Canada and OECD ( Organization for Economic Cooperation and Development).

Using surrogate unit exposure data, maximum application rates from labels, and EPA estimates of daily amount handled, exposures and risks to handlers were assessed. The exposure/ risks were calculated using the following equations:

Daily Exposure: Daily dermal or inhalation handler exposures are estimated for each applicable handler task with the application rate, quantity treated/ handled in a day, and the applicable dermal or inhalation unit exposure using the following formula:

Daily Exposure: E = UE x AR x AT ( Eq. 1) 8 Where: E = Amount ( mg or Fg ai/ day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption; UE = Unit exposure value ( mg ai/ lb ai) derived from August 1998 PHED data or from 1992 CMA data; AR = Maximum application rate based on a logical unit treatment, such as acres ( A), square feet ( sq. ft.), gallons ( gal), or cubic feet ( cu. ft). Maximum values are generally used ( lb ai/ A, lb ai/ sq ft, lb ai/ gal, lb ai/ cu ft); and AT = Normalized application area based on a logical unit treatment such as acres ( A/ day), square feet ( sq ft/ day), gallons ( gal/ day), or cubic feet ( cu ft/ day).

Daily Dose: The daily dermal or inhalation dose is calculated by normalizing the daily exposure by body weight and adjusting, if necessary, with an appropriate absorption factor. An oral endpoint was used for dermal exposures of intermediate and long term duration and inhalation exposures of all durations, therefore, an absorption factor of 43% was necessary for the intermediate and long term dermal exposures and an absorption factor of 100% was necessary for all inhalation exposures. A dermal absorption factor was not necessary for the short term exposures because the short term endpoint is based on a dermal study. Daily dose was calculated using the following formula:

Daily Dose: ADD = E x ABS ( Eq. 2) BW Where: ADD = Absorbed dose received from exposure to a chemical in a given scenario ( mg active ingredient/ kg body weight/ day); E = Amount ( mg ai/ day) deposited on the surface of the skin that is available for dermal absorption or amount inhaled that is available for inhalation absorption; ABS = A measure of the amount of chemical that crosses a biological boundary such as lungs (% of the total available absorbed); and BW = Body weight determined to represent the population of interest in a risk assessment ( kg).

Margins of Exposure: Non cancer inhalation and dermal risks for each applicable handler scenario are calculated using a Margin of Exposure ( MOE), which is a ratio of the daily dose to the toxicological endpoint of concern.

Margins of Exposure: MOE = NOAEL or LOAEL ( Eq. 3) ADD Where: MOE = Margin of exposure, value used to represent risk or how close a chemical exposure is to being a concern ( unitless); NOAEL or LOAEL = Dose level in a toxicity study, where no observed adverse effects ( NOAEL) or where the lowest observed adverse effects ( LOAEL) occurred in the study; and ADD = Average daily dose or the absorbed dose received from exposure to a chemical in a given scenario ( mg ai/ kg body weight/ day).

In addition to the target MOEs from Table 3.2 that were used for the analysis, a series of assumptions and exposure factors served as the basis for completing the handler risk assessment. Each general assumption and factor for both residential and occupational assessments is detailed below. Assumptions specific to the use site category are listed in each separate section of this document. The general assumptions and factors include: 9   OPP and OPP salt products are widely used disinfectants and have a large number of use patterns that are difficult to completely capture in this document. As such, AD has patterned this risk assessment on a series of likely representative scenarios for each use site that are believed by AD to represent the vast majority of OPP and OPP salt uses.   Based on the adverse effects for the endpoints, the average body weight of an adult handler of 70 kg was used to complete the non cancer risk assessment.   Exposure factors used to calculate daily exposures to handlers were based on applicable data, if available. When appropriate data were lacking, values from a scenario deemed similar were used.   The maximum application rates allowed by labels were assumed.

1.3 Chemical Identification Three chemicals are considered in this document: ortho phenylphenol, sodium ophenylphenate and potassium o phenylphenate. Table 1.1 shows chemical identification information for the three chemicals.

Table 1.1. Chemical Identification Information for OPP and salts Ortho phenylphenol OPP Sodium o phenylphenate OPP ( Na) Salt Potassium o phenylphenate OPP ( K) Salt Chemical Code 64103 64104 64108 CAS Number 90 43 7 132 27 4 13707 65 8 Molecular Formula C12H10O C12H9NaO C12H9KO 1.4 Physical/ Chemical Properties Table 1.2 shows physical/ chemical characteristics that have been reported for ophenylphenate sodium o phenylphenate, and potassium o phenylphenate.

Table 1.2. Physical/ Chemical Properties of OPP and Salts Parameter OPP OPP ( Na) Salt OPP ( K) Salt Molecular Weight 170.2 g/ mol 192.19 g/ mol 208.30 g/ mol Color Colorless White to light buff White Physical State Crystallized as solid flakes Solid ( flake) Solid Specific Gravity 1.2 0.61 0.69

Dissociation Constant 9.9 at 25EC 10 at 20EC

pH 6.1 in aqueous solution at 22.7EC 12 13.5

Stability Stable under normal conditions Stable under controlled conditions

Melting Point 56 58EC 298.5EC 230.07 EC 10 Table 1.2. Physical/ Chemical Properties of OPP and Salts Boiling Point 286EC

Water Solubility 700 mg/ L at 25EC 60.6 g/ 100 mL, 53.37% ( w/ w) 12.4g/ L Kow 3.3 0.59 0.59 Vapor Pressure 0.002 mm Hg at 25oC 1.8 x 10 9 mm Hg @ .25EC 1.91 x 10 11 mm Hg @ 25EC 2.0 USE INFORMATION 2.1 Formulation Types and Percent Active Ingredient The products containing OPP and OPP salts as the active ingredient ( a. i) are formulated as soluble concentrates, emulsifiable concentrates, ready to use solutions, pressurized sprays, and impregnated wipes. Concentrations of OPP and OPP salts in these products range from 0.0137% to 99.5%.

2.2 Summary of Use Pattern and Formulations OPP and OPP salts are active ingredients in numerous disinfecting and deodorizing products and are also used as a materials preservative and a wood preservative. The majority of the products are virucidal, fungicidal, tuberculocidal, bactericidal, pseudomonacidal, or staphylocidal. The Agency determines potential exposures to handlers of the product by identifying exposure scenarios from the various application methods that are plausible, given the label uses. These scenarios are identified in Table 2.1. Based on a review of product labels, products containing OPP and salts are intended for use in agricultural, food handling, commercial/ institutional/ industrial, residential and public access, and medical settings ( Use Site Categories I, II, III, IV and V, respectively), as well as a materials preservative for a variety of products ( Use Site Category VII) and as a wood preservative ( Use Site Category X). Examples of registered uses for OPP and salts include application to indoor and outdoor hard surfaces ( e. g., walls, floors, tables, and fixtures), textiles ( e. g., clothing, diapers, mattresses, or bedding), carpets, air conditioner coils, and medical instruments. Additionally, there are registered uses for fogging and air deodorization. As a materials preservative, the products are used in metalworking fluids, stains and paints, glues, building materials, glazes, paper, leather, and polymers.

Table 2.1. Potential Use Scenarios Based on Product Labels for Ortho phenylphenol and Ortho phenylphenol salts Use Site Category Example Use Sites Scenarios Ortho phenylphenol Use Site Category I Agricultural Premises and Equipment Poultry houses; Livestock facilities; Mushroom houses; Hatching   Application to hard surfaces and equipment through low pressure handwand, high pressure handwand, trigger pump spray, sponge, mop, and immersion 11 Table 2.1. Potential Use Scenarios Based on Product Labels for Ortho phenylphenol and Ortho phenylphenol salts Use Site Category Example Use Sites Scenarios facilities; Incubators   Application to hatching eggs through immersion, automatic washing system, foaming apparatus, low pressure handwand and fogging.   Application to fruits and vegetables post harvest as a wax through overhead brushes   Shoebaths Use Site Categories II, II, and V Food Handling, Commercial/ Institutional/ Industrial, Medical Food processing plants; Hospitals; Public places ( e. g., restaurants, hotel/ motel rooms); Medical/ Dental offices; Nursing home; Schools   Application to hard surfaces through trigger pump spray, low pressure spray, aerosol spray, mop, cloth, sponge, and impregnated wipe   Application to instruments ( e. g. surgical, dental and salon tools) through immersion and spray   Application to ultrasonic machines through liquid pour   Application to carpets though extraction machine, spin bonnet, and immersion   Application to textiles such as bedding, linens, and uniforms through aerosol spray, trigger pump spray, immersion   Fogging   Application to air conditioning coils   Application to conveyors in food industry as a lubricant, spray or solid applications   Air deodorization through aerosol spray   Application of paint containing OPP as a material preservative Use Site Category VII Material Preservatives Used in the production of various household, institutional and industrial items   glues and adhesives   gaskets   concrete Admixes   slurries ( clay, calcium carbonate, kaolin, and other filler suspensions)   ceramics   metalworking fluids   leather ( shoe liners, hat bands, gloves)   polishes   photographic solutions   stains and paints   textiles   textile auxiliaries ( sizing agents, spinning preparations, wetting agents)   dyes, pigments and filler suspensions   biopolymers   fire extinguishing medium   cleaning solutions   wax emulsions and polishes   paper slurries and auxiliaries   polymers and plastics   inks   other construction applications ( concrete, plaster, caulk)

Use Site Category X Used in preservation of   Application to construction woods and fruit and 12 Table 2.1. Potential Use Scenarios Based on Product Labels for Ortho phenylphenol and Ortho phenylphenol salts Use Site Category Example Use Sites Scenarios Wood Preservatives wood products vegetable pallets by non pressure treatment methods Use Site Category IV Residential and Public Access Premises Homes, bathrooms, laundry rooms, trash cans   Application to indoor hard surfaces ( e. g., floors, walls) through mop, sponge, and cloth   Application to indoor household contents ( trash cans, fixtures) through trigger pump spray and aerosol spray   Application to textiles such as bedding, clothing and upholstery through trigger pump spray and aerosol spray   Fogging   Application of paint containing OPP as a material preservative   Air deodorization through aerosol spray   Application to carpets and rugs though extraction machine and immersion   Application to laundry machines through liquid pour OPP ( Na) Salt Use Site Category I Agricultural Premises and Equipment Poultry houses; Livestock facilities; Mushroom houses   Application to hard surfaces and equipment through mop, cloth, pressure spray, fogger and immersion   Application to fruits and vegetables postharvest through spraying and dipping..   Shoebaths Use Site Categories II, III, and V Food Handling, Commercial/ Institutional/ Industrial, Medical Hospitals; Public places ( e. g., restaurants, hotel/ motel rooms); Medical/ Dental offices; Nursing home; Schools   Application to hard surfaces through cloth, mop sponge, trigger pump spray, and bowl mop   Application to instruments ( e. g. surgical, dental and salon tools) through immersion and spray   Application to exterior hard surfaces using an airless sprayer   Application to produce packaging containers via spray, dip or brush Use Site Category IV Residential and Public Access Premises Homes, bathrooms, laundry rooms, trash cans   Application to indoor hard surfaces ( e. g., floors, walls) through mop, sponge, aerosol spray, and cloth   Application to exterior hard surfaces, such as homes, using a tank type garden sprayer   Application of paint containing OPP Na salt as a material preservative Use Site Category VII Material Preservatives Used in the production of for household, institutional and industrial items   adhesives and glues   household products and construction products ( caulk, bipolymers, cleaning solutions, concrete, fire extinguishing, photographic gelatins, plasters, rubber systems, wax emulsions)   paper auxiliaries and paper slurries   leather tanning   metalworking fluids, lubricants and mineral oil based products ( boring and cutting oil, cooling fluids, fuel oils, hydraulic oils)   paints, coatings, and stains   pigments dyes, and filler suspensions 13 Table 2.1. Potential Use Scenarios Based on Product Labels for Ortho phenylphenol and Ortho phenylphenol salts Use Site Category Example Use Sites Scenarios   polymer dispersions and emulsions   textiles ( carpets, felts, awnings, shower curtains, upholstery, wool protection) and textile auxiliaries   laundry starch Use Site Category X Wood Preservatives Used in the product of wood products   Application to wood by non pressure treatment methods OPP ( K) Salt Use Site Categories II, II, and V Food Handling, Commercial/ Institutional/ Industrial, Medical Hospitals; Public places ( e. g., restaurants, hotel/ motel rooms); Medical/ Dental offices; Nursing home; Schools   Application to hard surfaces through cloth, mop sponge and spray   Application to ultrasonic machines through liquid pour   Application to instruments ( e. g. surgical, dental and salon tools) through immersion and spray Use Site Category IV Residential and Public Access Premises Bathrooms   Application to hard surfaces through aerosol spray From Table 2.1, AD selected representative exposure scenarios to assess in this document. These scenarios were selected to be representative of the vast majority of uses and are believed to provide high end degrees of dermal, inhalation, or incidental ingestion exposure. The representative scenarios assessed in this document are shown in Table 4.1 ( residential) and Table 6.1 ( occupational).

3.0 SUMMARY OF TOXICITY DATA 3.1 Acute Toxicity Adequacy of database for Acute Toxicity: The acute toxicity database for ortho phenylphenol and salts is considered incomplete. Acute dermal toxicity ( 870.1200), acute inhalation toxicity ( 870.1300), and primary eye irritation studies must be submitted. Ortho phenylphenol has a moderate order of acute toxicity via the oral route of exposure ( Toxicity Category III). For dermal irritation, ortho phenylphenol and its sodium salt are severe ( Toxicity Cateogry I) and moderate to severe ( Toxicity Category II) irritants, respectively. Ortho phenylphenol and its sodium salt are not dermal sensitizers. The acute toxicity data for ortho phenylphenol and salts is summarized below in Table 3.1.

Table 3.1. Acute Toxicity Profile for Ortho  Phenylphenol and Salts Guideline Number Study Type/ Test substance (% a. i.) MRID Number/ Citation Results Toxicity Category 14 Table 3.1. Acute Toxicity Profile for Ortho  Phenylphenol and Salts Guideline Number Study Type/ Test substance (% a. i.) MRID Number/ Citation Results Toxicity Category 870.1100 ( § 81 1) Acute Oral Toxicity  Rat 2 phenylphenol,

purity 99.9% 43334201 LD50 = 2733 mg/ kg III 870.1100 ( § 81 1) Acute Oral Toxicity  Rat 2 phenylphenol,

sodium salt purity 99.1% 433342402 LD50 = 846 mg/ kg ( male) LD50 = 591 mg/ kg ( female) III 870.1200 ( § 81 2) Acute Dermal Toxicity NS NS

870.1300 ( § 81 3) Acute Inhalation Toxicity NS NS

870.2400 ( § 81 4) Acute Eye Irritation NS NS

870.2500 ( § 81 5) Acute Dermal Irritation Rabbit 2 phenylphenol purity 99.9% 43334202 Dermal irritant I 870.2600 ( § 81 6) Dermal Sensitization  Guinea pig 2 phenylphenol,

purity 99.9% 43334203 Non sensitizer. NA 870.2600 ( § 81 6) Dermal Sensitization  Guinea pig 2 phenylphenol,

sodium salt purity 99.1% 43334205 Non sensitizer. NA 3.2 Summary of Toxicity Endpoints Table 3.2 summarizes the toxicological endpoints for OPP and OPP salts and has been extracted from the toxicological chapter of this RED ( USEPA, 2006). The toxicological endpoints selected for OPP and OPP salts are identical.

Table 3.2 Summary of Toxicological Doses and Endpoints for Ortho Phenylphenol for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE, UF, Special FQPA SF, for Risk Assessment Study and Toxicological Effects Dietary Risk Assessments Acute Dietary ( general population and females 13 49) No appropriate endpoints were identified that represent a single dose effect. Therefore, this risk assessment is not required.

Chronic Dietary ( all populations) NOAEL = 39 mg/ kg/ day FQPA SF = 1 UF = 100 ( 10x inter species Combined oral toxicity/ carcinogenicity study in rats ( MRID 43954301, 44852701, 44832201) 15 Table 3.2 Summary of Toxicological Doses and Endpoints for Ortho Phenylphenol for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE, UF, Special FQPA SF, for Risk Assessment Study and Toxicological Effects extrapolation, 10x intra species variation)

Chronic RfD = 0.39 mg/ kg/ day Chronic PAD = 0.39 mg/ kg/ day LOAEL of 200 mg/ kg/ day based upon decreased body weight, body weight gain, food consumption and food efficiency, increased clinical and gross pathological signs of toxicity.

Non Dietary Risk Assessments Incidental Oral Short Term ( 1  30 days) NOAEL ( maternal) = 100 mg/ kg/ day Target MOE = 100 FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) Developmental ( gavage) toxicity studies in rats ( MRID 00067616, 92154037) and rabbits ( MRID 41925003; co critical developmental toxicity study)

Maternal LOAEL of 300 mg/ kg/ day based upon clinical observations of toxicity, decreased weight gain, food consumption and food efficiency observed in the rat developmental toxicity study.

Incidental Oral Intermediate Term ( 1  6 months) NOAEL = 39 mg/ kg/ day Target MOE = 100 FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) Combined oral toxicity/ carcinogenicity study in rats ( MRID 43954301, 44852701, 44832201)

LOAEL of 200 mg/ kg/ day based upon decreased body weight, body weight gain, food consumption and food efficiency, increased clinical and gross pathological signs of toxicity.

Dermal Short Term ( 1  30 days)

( residential and occupational) NOAEL ( dermal) = 100 mg/ kg/ day ( 7872 ug/ cm2) c Target MOE = 100 FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) 21 Day Dermal toxicity study in rats ( MRID 42881901)

LOAEL ( dermal) of 500 mg/ kg/ day based upon dermal irritation ( erythema, scaling) at the site of test substance application.

Dermal Intermediate and Long Term ( 1  6 months and > 6 months)

( residential and occupational) NOAEL = 39 mg/ kg/ daya Target MOE = 100 FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) Combined oral toxicity/ carcinogenicity study in rats ( MRID 43954301, 44852701, 44832201)

LOAEL of 200 mg/ kg/ day based upon decreased body weight, body weight gain, food consumption and food efficiency ( effects observed as early as 13 weeks in this study), increased clinical and gross pathological signs of toxicity.

Inhalation Short Term NOAEL ( maternal) = 100 mg/ kg/ dayb Target MOE = 100 Developmental ( gavage) toxicity studies in rats ( MRID 00067616, 92154037) and 16 Table 3.2 Summary of Toxicological Doses and Endpoints for Ortho Phenylphenol for Use in Human Risk Assessments Exposure Scenario Dose Used in Risk Assessment ( mg/ kg/ day) Target MOE, UF, Special FQPA SF, for Risk Assessment Study and Toxicological Effects ( 1  30 days)

( residential and occupational) FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) DB UF = an additional 10x is necessary for route extrapolation. If results are below an MOE of 1,000, a confirmatory inhalation study is warranted. rabbits ( MRID 41925003; co critical developmental toxicity study)

Maternal LOAEL of 300 mg/ kg/ day based upon clinical observations of toxicity, decreased weight gain, food consumption and food efficiency observed in the rat developmental toxicity study.

Inhalation Intermediate and Long Term ( 1  6 months and > 6 months)

( residential and occupational) NOAEL = 39 mg/ kg/ dayb Target MOE = 100 FQPA SF = 1 UF = 100 ( 10x inter species extrapolation, 10x intra species variation) DB UF = an additional 10x is necessary for route extrapolation. If results are below an MOE of 1,000, a confirmatory inhalation study is warranted. Combined oral toxicity/ carcinogenicity study in rats ( MRID 43954301, 44852701, 44832201)

LOAEL of 200 mg/ kg/ day based upon decreased body weight, body weight gain, food consumption and food efficiency ( effects observed as early as 13 weeks in this study), increased clinical and gross pathological signs of toxicity.

Cancer ( oral, dermal, inhalation) Classification: ortho Phenylphenol is classified as A Not likely to be carcinogenic below a specific dose range @, without quantification of risk.

UF = uncertainty factor, DB UF = data base uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic), RfD = reference dose, MOE = margin of exposure a A human dermal absorption factor of 43% is used because an oral endpoint was selected for the intermediateand long term dermal exposure scenarios. b The inhalation absorption factor of 100% ( default value, assuming oral and inhalation absorption are equivalent) should be used since an oral endpoint was selected for the inhalation exposure scenarios. c 100mg x 200g x 1 sq. in = 7874 ug/ cm2 kg rat 2.54 sq. cm 3.3 FQPA Considerations 17 Developmental Toxicity Study Conclusions:

Developmental toxicity studies for ortho phenylphenol are available in both the rat and rabbit, as summarized in this toxicology chapter. Both studies were well conducted and considered acceptable by the Agency. The examination of these studies shows that adverse effects in offspring occurred at doses higher than those producing maternal toxicity. In addition, the effects on offspring were not considered more severe than those occurring in maternal animals. Therefore, there is no increased concern for developmental toxicity of ortho phenylphenol when comparing effects in adult animals with those in offspring. This conclusion is similar to that reached by the Department for Environment, Food and Rural Affairs of the Pesticides Safety Directorate in their 1993 publication on the Evaluation of 2 phenyl phenol.

Reproductive Toxicity Study Conclusions:

An acceptable two generation reproduction toxicity study conducted according to Agency guidelines is available for ortho phenylphenol. There were no toxicologically significant effects on reproductive parameters in this study. Therefore, there is no increased concern for potential reproductive toxicity of ortho phenylphenol.

Information from Literature Sources:

Peer reviewed scientific literature is available on both the reproductive and developmental toxicity of ortho phenylphenol ( IPCS, 1999). None of these studies indicates increased concern for developmental or reproductive toxicity of ortho phenylphenol.

Pre and/ or Postnatal Toxicity:

( a) Determination of Susceptibility From the available data submitted to the Agency and the available peer reviewed scientific literature on developmental and reproductive toxicity, there was no increased concern for susceptibility from exposure to ortho phenylphenol.

( b) Degree of Concern Analysis and Residual Uncertainties There are no residual uncertainties identified from examination of the available data on developmental and reproductive toxicity of ortho phenylphenol. Available submitted studies are well conducted and identify clear dose response relationships for parental and offspring toxicity. Peer reviewed literature supports the findings of the submitted studies.

( c) Proposed Hazard based Special FQPA Safety Factor( s):

The special hazard based FQPA safety factor can be reduced to 1x for ortho phenylphenol.

Recommendation for a Developmental Neurotoxicity Study:

There is no need for a developmental neurotoxicity study with ortho phenylphenol at this time. 18 The available data show no significant neurotoxic effects from administration of the chemical in experimental animal studies.

4.0 RESIDENTIAL EXPOSURE ASSESSMENT 4.1 Summary of Registered Uses Some products containing OPP and OPP salts are labeled for residential uses such as disinfectants and deodorizers. These products are for use on indoor and outdoor hard surfaces ( e. g., floors, walls, bathroom fixtures, trash cans, household contents), textiles ( e. g., clothing, diapers, and bedding), and carpets. There are also fogging products and aerosol air deodorizing products which can be used in the home. Additionally, residents may be exposed to household items that have been treated with OPP and OPP salts through material preservation ( i. e., paints and plastics). Table 2.1 presents a summary of all exposure scenarios that may occur from the residential use site category based on examination of product labels. Table 4.1 identifies the representative exposure scenarios assessed in this document.

4.2 Dietary Exposure Any risks pertinent to dietary exposures are discussed in the Preliminary Risk Assessment.

4.3 Drinking Water Exposure Any risks pertinent to drinking water exposures are discussed in the Preliminary Risk Assessment.

4.4 Residential Exposure The exposure scenarios assessed in this document for the representative uses selected by AD are shown in Table 4.1. The table also shows the maximum application rate associated with the representative use and the EPA Registration number for the corresponding product label. For handlers, the representative uses assessed through direct product application to indoor hard surfaces ( mopping, wiping, and aerosol foam spray), outdoor hard surfaces ( tanktype garden sprayer), textiles ( trigger pump spray), and air deodorization ( aerosol spray). Additionally, handler exposures were assessed for the application of already treated paint ( paint brush/ roller and airless sprayer). It should be noted, for the calculation of application rates in which 8.34 lb a. i./ gal is noted, the product was assumed to have the density of water because no product specific density was available.

Table 4.1. Representative Uses Associated with Residential Exposure Representative Use Exposure Scenario Application Method Registration # Application Rate 19 Table 4.1. Representative Uses Associated with Residential Exposure Representative Use Exposure Scenario Application Method Registration # Application Rate ST Handler: Dermal and Inhalation;

ST and IT Post app1,9: child incidental ingestion and dermal Mopping ST Handler: Dermal and Inhalation Wiping 40510 5 ( OPP Salt) 0.126 lb a. i./ diluted gal ( 8 oz. product / 4 gal water x 97% a. i. x 8.34 lb/ gal x 1 gal/ 128 oz) Indoor Hard Surfaces ST Handler: Dermal and Inhalation Aerosol foam spray3 777 27 ( OPP) 0.42% a. i. by weight Outdoor Hard Surfaces ( i. e. exterior house cleaner) ST Loader and Handler: Dermal and Inhalation Tank type garden sprayer ( i. e. low pressure sprayer) 71240 1 ( OPP Salt) 0.00104 lb a. i./ gal ( 0.25 gal product / 5 gal water x 0.25% a. i. x 8.34 lb/ gal: assuming product has the density of water)

Textiles ( i. e., clothing and cloth diapers) ST Handler: Dermal and Inhalation ST Post app: adult dermal; child incidental ingestion and dermal IT/ LT Post app: child dermal ( diaper) Trigger pump spray3 10088 105 ( OPP) 0.0208 lb ai/ gal ( 0.249% ai x 8.34 lb/ gal)

Air Deodorization ST Handler: Dermal and Inhalation Post app: adult ( ST) and child ( ST and IT) 1 inhalation 2 Aerosol spray 44446 67 ( OPP) 0.199% a. i. by weight Fogging ST Post app: adult and child inhalation ( vapor) 8 Fogger 70263 3 5 ( OPP) 0.019 lb a. i./ 6000 ft2 ( 0.22% a. i. x 1 gal product/ 6000 ft2 x 8.34 lb/ gal)

Using Treated Plastic/ polymer products ( i. e., toys) ST Post app: child incidental ingestion NA 67869 24 ( OPP salt) 0.34% a. i. by weight of material to be preserved Using Treated Paint ST Handler: Dermal and Inhalation ( aerosol and vapor) 6 ST Post app: adult and child inhalation ( vapor) 7 Paint brush, rollers, airless sprayer 67869 24 ( OPP salt)

and 464 126 ( OPP) 0.56% a. i. by weight of material to be preserved 0.5% a. i. by weight of material to be preserved 20 ST = Short term exposure, IT = Intermediate term exposure 1IT post application exposures for children were assessed because that this product could be used in a commercial day care facility. 2 Since this application rate is for OPP, which has a relatively high vapor pressure, it was necessary to assess post application inhalation exposure to the vapor. OPP salts have a much lower vapor pressure and will not readily volatilize. 3 The aerosol spray was chosen to represent the aerosol foam product and trigger pump spray product because it is expected that they have similar unit exposures. 4 The post app exposure is represented by the post app exposure scenario for air deodorization. 5 Label Reg # 70263 3 can be used in household settings by commercial applicators; therefore, a postapplication scenario was assessed using the % ai from this product. However, the application rate from another label (# 65020 7) for lack of better data. Note: Reg # 65020 7 also can be used in schools. 6 Handler dermal and inhalation ( to the particulates) exposure were assessed for OPP salts using PHED unit exposures. WPEM ( Wall Paint Exposure Model) was also used to assess the vapors of OPP for residential handlers because of the high vapor pressure of OPP. 7 Post application inhalation exposures to the vapor were assessed for only the OPP product because of its high vapor pressure. 8 For the fogging scenario, child post application incidental ingestion or dermal exposures were not assessed because they were assessed for the mopping application. The mopping application has a much higher application rate ( in terms of lb ai/ ft2) than the fogging application. It should also be noted that although the fogging application can occur in child care facilities, the intermediate term duration was not assessed because it was assumed that the fogging application would be used primarily in areas damaged by smoke, fire, floods, or sewage backups and these incidents do not occur on a continuous basis. 97 This label, # 40510 5 states that the product can be used for " housekeeping sanitization" and to " sanitize latrine: buckets, urinals, toilet bowls, walls, shower stalls, garbage cans, and garbage platforms." This is why it is assumed to not be used in daycares. It does not specifically say " commercial and institutional premises."

4.4.1 Residential Handler Exposures The residential handler scenarios described in Table 4.1 were assessed to determine dermal and inhalation exposures. The majority of the scenarios were assessed using CMA data and Equations 1 3 in Section 1.2, " Criteria for Conducting Risk Assessment." However, for handlers using paint, two approaches were used to determine inhalation exposure. CMA data were used to determine inhalation exposure to aerosolized particles of paint ( assessed below). To assess the inhalation exposure to OPP vapor, EPA's Wall Paint Exposure Model ( WPEM) was used ( see Section <IP_ADDRESS>).

The assumptions and factors used for those scenarios in which CMA data were used include:

Unit Exposure Values: Unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the PHED data presented in HED's Residential SOPs ( USEPA, 1997).

  For the mopping scenario, the CMA dermal and inhalation unit exposure values for ungloved mopping were used ( 71.6 mg/ lb a. i. and 2.38 mg/ lb a. i., respectively). These values are based on data collected from six replicates mopping floors and receiving exposure via contact with the mop or with the bucket.   For the wiping scenario, the CMA dermal and inhalation unit exposure values for ungloved wiping were used ( 2,870 mg/ lb a. i. and 67.3 mg/ lb a. i., respectively). These values are based on data collected from six replicates ( dental technicians) who used a finger pump sprayer to apply the product and then wiped the surfaces with a paper towel. 21   For aerosol foam spray, trigger pump and air deodorization scenarios, the PHED dermal and inhalation unit exposure values are 220 mg/ lb a. i. and 2.4 mg/ lb a. i., respectively. The values are based on homeowners applying an aerosol insecticide to baseboards in kitchens and are representative of a handler wearing short pants and a short sleeve shirt, with no gloves.   For the tank type garden sprayer scenario, the PHED dermal and inhalation unit exposure values for a residential handler pouring a pesticide and applying it via a low pressure sprayer. These ungloved unit exposure values ( 100 mg/ lb a. i. for dermal and 0.030 mg/ lb a. i. for inhalation) represent a handler treating low and mid level targets ( generally below the waist) while wearing short pants and a short sleeve shirt, with no gloves.   For the airless sprayer scenario, PHED dermal and inhalation unit exposure values for a residential handler applying a pesticide using an airless sprayer were used. These unit ungloved exposure values ( 79 mg/ lb a. i. for dermal and 0.83 mg/ lb a. i. for inhalation) represent a handler painting a residential bathroom wearing short pants and a short sleeve shirt, with no gloves.   For the brush/ roller scenario, PHED dermal and inhalation unit exposure values for a residential handler applying a pesticide using a paint brush were used. These unit exposure values ( 230 mg/ lb a. i. for dermal and 0.28 mg/ lb a. i. for inhalation) represent a handler wearing short pants and a short sleeve shirt, with no gloves.

Quantity handled/ treated: The quantities handled/ treated were estimated based on information from various sources and assumptions.

  For the mopping scenarios, it is assumed that 1 gallon of diluted solution is used.   For the wiping and trigger pump spray scenarios, it is assumed that 0.5 liter ( 0.13 gal) of diluted solution is used.   For the aerosol foam spray and air deodorization scenarios, it is assumed that one can of product is used. For the aerosol foam spray ( EPA Registration No. 777 27), the product contains a net weight of 14 oz ( 0.875 lbs). For the air deodorization product ( 44446 67), the product contains a net weight of 16.5 oz ( 1.03 lbs).   For the tank type ( low pressure spray) garden sprayer in outdoor hard surface applications, it is assumed that 5 gallons of dilute product will be used.   For the airless sprayer in paint applications, it is assumed that 150 lbs ( approximately 15 gallons) of treated paint will be used. This is based on the coverage of 200 ft2/ gallon and a house size of 40 x 30 x 20 ft ( surface area of 2,800 ft2).   For the brush/ roller in paint applications, it is assumed that 20 lbs ( approximately 2 gallons) of treated paint will be used. This is based on the 90th percentile value of 8 gallons of latex paint used per year divided by the mean frequency of 4 painting events/ year.

Duration of Exposure: The duration of exposure for most homeowner applications of disinfectant/ deodorizing and paint products is believed to be best represented by the shortterm duration ( 1 to 30 days). The reason that short term duration was chosen to be assessed is because the different scenarios ( i. e. methods of application) are assumed to be episodic, not daily. In addition, homeowners are assumed to use different cleaning products with varying actives, not exclusively OPP or OPP Salt treated products.

Results 22 The resulting short term exposures and MOEs for the representative residential handler scenarios are presented in Table 4.2. The calculated MOEs were above the target dermal and inhalation MOE of 100 for all scenarios. Furthermore, all short term inhalation MOEs exceeded 1,000 therefore, a confirmatory inhalation toxicity study is not warranted based on the results of these exposure scenarios.

Table 4.2 Short Term OPP & Salts Residential Handlers Exposures and MOEs Unit Exposure ( mg/ lb ai) Absorbed Daily Dose ( mg/ kg/ day) MOE ( ST)

Exposure Scenario Method of Application Dermala Inhalation Application Rate Quantity Handled/ Treated per day Dermalb Inhalationc Dermal ( Target = 100) d Inhalation ( Target = 100) e Mopping 71.6 2.38 0.126 lb ai/ gallon 1 gallons 0.1289 0.0043 780 23,000 Wiping 2870 67.3 0.126 lb ai/ gallon 0.13 gallons 0.6716 0.0157 150 6,300 Application to indoor hard surfaces Aerosol Foam Spray 220 2.4 0.42 % ai by weight 0.875 lbs 0.0116 0.0001 8,700 7.90x105 Application to outdoor hard surfaces ( i. e. exterior of homes) Tank Type Low Pressure Garden Sprayer 100 0.03 0.00104 lb ai/ gallon 5 gallons 0.01 0.00016 13,000 4.5x107 Application to textiles Trigger Pump Spray 220 2.4 0.0208 lb ai/ gallon 0.13 gallons 0.085 0.0065 12,000 1.10x106 Air deodorization Aerosol Spray 220 2.4 0.199% ai by weight 1.03 lbs 0.0064 7x10 5 16,000 1.4x106 Brush/ roller 230 0.284 0.56% ai by weight 20 lb s ( 2 gal) 0.368 0.0005 270 220,000 Painting Airless sprayer 79 0.83 0.56% ai by weight 150 lbs ( 15 gal) 0.948 0.01 110 10,000 a All dermal unit exposures represent ungloved replicates. The aerosol spray, tank type garden sprayer ( i. e., low pressure sprayer), trigger pump sprayer, brush/ roller, and airless sprayer unit exposures represent short sleeve and short pant replicates. The mopping, wiping, and liquid pour represent long pant and long shirt replicates. b Dermal Daily Dose ( mg/ kg/ day) = [ dermal unit exposure ( mg/ lb ai) * application rate * quantity handled / body weight ( 70 kg). c Inhalation Daily Dose ( mg/ kg/ day) = [ inhalation unit exposure ( mg/ lb ai) * application rate * quantity handled / body weight ( 70 kg). d Dermal MOE = NOAEL ( 100 mg/ kg/ day) / Daily Dose. Target dermal MOE is 100. e Inhalation MOE = NOAEL ( 100 mg/ kg/ day) / Daily Dose. Target inhalation MOE is 100.

<IP_ADDRESS> Residential Painter Inhalation ( vapor) Exposure The residential painter inhalation exposure to aerosolized paint was assessed in the previous section, 4.4.1. In this section, the painter inhalation exposure to chemical vapor from the paint is assessed. AD utilized EPA's Wall Paint Exposure Model ( WPEM) version 3.2 to estimate air concentrations resulting from the use of paint preserved with OPP. WPEM was 23 developed under a contract by Geomet Technologies for EPA OPPT to provide estimates of potential air concentrations and consumer/ worker exposures to chemicals emitted from wall paint which is applied using a roller or a brush. WPEM uses mathematical models developed from small chamber data to estimate the emissions of chemicals from oil based ( alkyd) and latex wall paint. The emission data can then be combined with detailed use, workload and occupancy data ( e. g., amount of time spent in the painted room, etc,) to estimate exposure. Specific input parameters include: the type of paint ( latex or alkyd) being assessed, density of the paint ( default values available), and the chemical weight fraction, molecular weight, and vapor pressure. Detailed information and the executable model can be downloaded from http:// www. epa. gov/ opptintr/ exposure/ docs/ wpem. htm.

For this exposure assessment, the WPEM default scenario for the homeowner painter ( RESDIY) was used. This WPEM default scenario assumes that the homeowner is exposed to the chemical in paint when painting the bedroom of a house. For a detailed description of the default RESDIY scenario, see the WPEM User =

s Guide. The following chemical specific inputs were used in the model:

  OPP's molecular weight ( 170.19 amu) and vapor pressure ( 0.002 mm Hg)   The weight fraction of OPP in paint ( product # 464 126 contains 0.5% OPP)

The model provides several dose measures ( i. e., LADD, ADD), air concentration measures ( i. e., peak, 15 min, 8hr), and a comma separated (. csv) file as outputs. The commaseparated file contains details on time varying concentrations within the modeled building as well as concentrations to which the individual is exposed. This file can be read directly into spreadsheet software ( e. g., Excel) for calculating additional summary statistics. The air concentrations outputted by the model were used by AD to estimate inhalation exposure doses and MOEs. The model results and exposure calculations are summarized in Table 4.3.

Since a homeowner or do it yourself painter typically paints on an intermittent basis ( i. e., once or twice a year), it was necessary to assess exposure for only the short term duration. The inhalation ( vapor) MOE for the short term exposure for the DIY painter is above the target MOE of 100. 24 Table 4.3. Short Term Inhalation ( vapor) Exposure and MOE for Residential Painters Exposure Duration ( hrs) Average Air Conc. ( mg/ m3) a Inhal. Rate ( m3/ hr) b Inhalation Dose ( mg/ kg/ day) c ST Inhal. MOE 3 1.15 1.00 0.0493 2,000 a The average air concentration for 3 hours of exposure ( during the painting activities only) ( see Appendix E, Table for Air Conc for DIY) b Inhalation rate for light activity in the Exposures Factor Handbook ( USEPA, 1997) c Inhalation Dose = Exposure Duration x Air Concentration x Inhalation Rate/ Body Weight ( 70 kg for adults) d Short Term Inhalation MOE = Short Term Inhalation NOAEL ( 100 mg/ kg/ day) / Inhal. Dose where Target MOE = 100 4.4.2 Residential Post application Exposures For the purposes of this screening level assessment, postapplication scenarios have been developed that encompass multiple products, but still represent a high end exposure scenario for all products represented. As shown in Table 4.1, representative postapplication scenarios assessed include contacting treated hard surfaces/ floors ( dermal and incidental oral exposure to children), wearing treated clothing ( dermal exposure to adults and children), wearing treated diapers ( dermal exposure to infants), mouthing treated textiles such as clothing and blankets ( incidental oral exposure to children), and mouthing treated plastic toys ( incidental oral exposure to infants). Additionally, postapplication/ bystander inhalation exposures were assessed for use of the disinfecting/ deodorizing products ( vapor exposure to adults and children) and paints ( vapor exposure to adults and children).

Typically, most products used in a residential setting result in exposures occurring over a short term time duration ( 1 to 30 days). This assumption is supplemented with the idea that the different scenarios ( i. e. methods of application) are episodic, not daily. In addition, homeowners are assumed to use different cleaning products with varying actives, not exclusively OPP or OPP Salt treated products. If the products are used on a routine basis ( i. e., once a week) and the active ingredient has a long indoor half life, exposures may occur over an intermediate term time duration ( 30 days   6 months). At this time, AD does not have residue dissipation data or reliable use pattern data, including the frequency and duration of use of antimicrobial products in the residential setting. AD does not believe that the use patterns of many residential products result in intermediate term exposure. However, AD does believe that intermediate term exposure to children may occur in day care centers where disinfecting products are used more frequently. Additionally, AD also believes that exposures will occur on a continuous basis for infants wearing treated diapers therefore, short, intermediate and long term ( greater than 6 months) exposures were necessary to assess for this scenario.

<IP_ADDRESS> Hard Surface/ Floor Cleaners Dermal Exposure to Children from Treated Floors Exposure Calculations There is the potential for dermal exposure to toddlers crawling on hard floors after mopping with OPP and OPP salts products. Exposures and MOEs were calculated for 25 children contacting treated hard surface floors in residential homes ( short term exposure) and in commercial daycare centers ( intermediate term exposure). To determine toddler exposure to floor residues ( mopping), the following equation was used:

PDD = AR x DTF x DRF x CF1 x CF2 x SA BW where, PDD = Potential daily dose; AR = Application Rate ( lb/ ft2); DTF = Dermal transfer factor ( fraction, unitless); DRF = Disinfectant fraction remaining on floor ( unitless); CF1 = Conversion factor ( 4.54x105 mg/ lb); CF2 = Conversion factor ( 10.8 ft2/ m2); SA = Surface area of the body which is in contact with floor ( m2); and BW = Body weight ( kg)

Assumptions   Toddlers ( 3 years old) were used to represent the 1 to 6 year old age group. A body surface area of 0.657 m2 and a body weight of 15 kg was been assumed, which are the median values for 3 year olds ( USEPA, 1997).   The labels did not provide information on the volume of disinfectant to be used for cleaning surfaces such as floors. It was assumed that the diluted treatment solution is applied at a rate of 1 gallon per 1,000 sq. ft. The maximum application rate on the product labels for application to hard surfaces is 0.126 lb ai/ gal ( see Table 4.1) for a residential setting and 0.0183 lb ai/ gal ( see Table 6.1) in an institutional setting ( i. e. daycare center). Therefore, the application rates used in the postapplication scenarios were 0.000126 lb ai/ ft2 and 0.0000183 lb ai/ ft2.   No transferable residue data were available that could be used to estimate the transfer of OPP and salts from the floor to skin. Therefore, it is assumed that 10% of the deposition rate is available for dermal transfer ( USEPA, 2000, and 2001).   No data could be found regarding the quantity of solution residue left on the floor after treatment. As a conservative measure, it has been assumed that 25% of the cleaner remains after the final mopping.   It was assumed that the exposed toddler plays regularly on the treated floor. In a residential home, a short term exposure duration is most likely since homeowners are expected to clean the floor only intermittently. In a commercial daycare center, an intermediate term exposure duration is likely since it is expected that the floors are cleaned on a routine basis.

Results The calculations of the short and intermediate term dermal doses and MOEs are shown in Table 4.4. The dermal MOEs for the residential settings ( short term MOE) and institutional settings ( intermediate term MOE) are above the target MOE of 100. 26 Table 4.4. Short and Intermediate term Post application Dermal Exposures and MOEs for Children Contacting Treated Floors Exposure Scenario Application Rate ( lb ai/ sq ft) Product remaining after mopping Percent Trans. Residue Body Area in contact with floor ( m2) Absorbed potential daily dosea ( mg/ kg/ day) Dermal MOEb Hard surfaces  residential setting 1.26x10 4 25% 10% 0.657 0.674 150 ( ST)

Hard surfaces  daycare center 1.83x10 5 25% 10% 0.657 0.0421 930 ( IT)

a Absorbed Potential Daily Dose( mg/ kg/ day) = [( Application rate, lb ai/ ft2)*( conversion factor, 454 g/ lb)* ( conversion factor, 1,000 mg/ g) * ( conversion factor, 1 ft2/ 0.093 m2) * ( product remaining after mopping, 25%) * ( dermal transfer factor, 10%) * ( body surface area in contact with floor, 0.657 m2) * ( dermal absorption , 0.43 for IT exposure and not applicable for ST exposures) ] / ( body weight, 15 kg) b Dermal MOE = NOAEL ( mg/ kg/ day) / Absorbed Potential Daily Dose ( mg/ kg/ day) [ Where short term dermal NOAEL = 100 mg/ kg/ day and intermediate term dermal NOAEL = 39 mg/ kg/ day]. Target MOE = 100.

Child Incidental Ingestion Exposure to Treated Floors Exposure Calculations In addition to dermal exposure, toddlers crawling on treated hard floors will also be exposed to OPP and OPP salts residues via incidental oral exposure through hand to mouth activity. To calculate incidental ingestion exposure to these chemicals due to hand to mouth transfer, the methodologies established in the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA 2000 and, 2001) were used. These use assumptions that are similar to those used in calculating dermal exposures for toddlers crawling on treated hard floors. Exposures were calculated for children contacting treated floors in residential homes and in commercial day care centers using the following equations for hand to mouth transfer of pesticide residues to toddlers:

PDD = SR x DTF x SA x EF x ET x SE x CF1 BW where: PDD = Potential daily dose ( mg/ kg/ day); SR = Indoor surface residue ( µ g/ cm2); DTF = Dermal transfer factor ( unitless fraction); SA = Surface area of the hands that contact both the treated area, and the individuals mouth ( cm2/ event); FQ = Frequency of hand to mouth events ( events/ hr); SE = Saliva extraction efficiency ( unitless fraction); ET = Exposure Time ( 4 hrs/ day); CF1 = Unit conversion factor ( 0.001 mg/ µ g); and BW = Body weight ( 15 kg)

And 27 SR= AR x DRF x CF2 x CF3 where: SR = Surface residue ( µ g/ cm2); AR = Application rate ( lb ai/ ft2); DRF = Disinfection fraction remaining on floor ( unitless); CF2 = Unit conversion factor ( 4.54x108 µ g/ lb); and CF3 = Unit conversion factor ( 1.08x10 3 ft2/ cm2)

Assumptions   Toddlers ( 3 years old) were used to represent the 1 to 6 year old age group and are assumed to weigh 15 kg, the median for male and female toddlers ( USEPA, 2000 and 2001).   Based on HED's Residential SOP, it was assumed that the surface area used for each hand to mouth event is 20 cm2. For short term exposures, it is assumed that there were 20 events per hour ( 90th percentile, according to the SOP) and for intermediateterm exposures, it was assumed that there were 9.5 event/ hour ( mean value).   The exposure time was 4 hours a day ( USEPA, 2000 and 2001).   The saliva extraction efficiency was 50% ( USEPA, 2000 and 2001).   The labels did not provide information on the volume of disinfectant to be used for cleaning surfaces such as floors. It was assumed that the diluted treatment solution was applied at a rate of 1 gallon per 1,000 sq. ft. The maximum application rate on the product labels for application to hard surfaces is 0.126 lb ai/ gal ( see Table 4.1) for a residential setting and 0.0183 lb ai/ gal ( see Table 6.1) in an institutional setting ( i. e. daycare center). Therefore, the application rates used in the postapplication scenarios were 0.000126 lb ai/ ft2 and 0.0000183 lb ai/ ft2.   No data could be found regarding the quantity of solution residue left on the floor after treatment. As a conservative measure, it was assumed that 25% of the cleaner remains after the final mopping.   No transferable residue data were available that could be used to estimate the transfer of OPP and salts from the floor to skin. Therefore, it was assumed that 10% of the deposition rate is available for dermal transfer ( USEPA, 2000 and 2001).

Results The calculation of the short and intermediate term oral doses and the oral MOEs are shown in Table 4.5. The oral MOEs are above the target MOE of 100 for residential settings and institutional settings.

For the intermediate term exposures, it was necessary to determine Total MOEs since the toxicity effects are the same for the dermal and oral routes. The intermediate term Total MOE for children contacting treated floors in day care facilities was 820 and is greater than the target MOE of 100. The Total MOE was estimated using the following equation: Total MOE = 1 / (( 1/ MOEdermal) + ( 1/ MOEoral)) where, MOEdermal = 930 and MOEoral = 6,900. 28 Table 4.5. Short and Intermediate term Incidental Oral Post application Exposures and MOEs for Children Contacting Treated Floors Exposure Scenario Appl. Rate ( lb ai/ sq ft) Product remaining after mopping Surface Residuea ( µ g/ cm2) Percent transferable residue Surface area mouthed ( cm2/ event) Exposure Frequency ( events/ hr) Saliva Extraction Factor Exp. Time ( hrs/ day) Absorbed Potential Daily Doseb ( mg/ kg/ day) Oral MOEc Hard surfaces  residential setting 1.26x10 4 25% 15.45 10% 20 20 50% 4 0.0824 1,200 ( ST)

Hard surfaces  daycare center 1.83x10 5 25% 2.24 10% 20 9.5 50% 4 0.0057 6,900 ( IT)

a Surface residue ( µ g/ cm2) = ( application rate, lb ai/ ft2)*( Disinfectant fraction remaining on floor, 0.25)*( conversion factor to convert lb to µ g, 4.54E+ 08 µ g/ lb)*( conversion factor to convert ft2 to cm2, 1.08E 03 ft2/ cm2) b Absorbed Potential Daily Dose ( mg/ kg/ day) = [( Surface residue, µ g/ cm2)*( transferable residue, 0.10)*( exposure time, 4 hrs/ day)*( surface area of hands, 20 cm2/ event)*( frequency of hand to mouth activity, 20 events/ hr, and 9.5 event for intermediate term)*( extraction by saliva, 50 %)*( conversion factor to convert µ g to mg, 0.001 mg/ µ g)]/( body weight, 15 kg) c MOE = NOAEL ( mg/ kg/ day) / absorbed potential daily dose( mg/ kg/ day) [ Where short term oral NOAEL = 100 mg/ kg/ day and intermediate term NOAEL = 39 mg/ kg/ day]. Target MOE = 100.

<IP_ADDRESS> Textiles Dermal Exposure to Adults and Children from Wearing Treated Clothing Exposure Calculations There is the potential for dermal exposure to adults and children from wearing clothing treated with a trigger pump spray product containing OPP or treatment via factory impregnation of the chemical as a preservative. Even as there is anticipated exposure to result from an already preserved textile, the trigger pump use was identified to be the worst case, and ultimately was the one assessed in this document. Though it is likely that the clothing treated with this product would be washed prior to use, the label does not provide specific use instructions pertaining to washing. Therefore, a post application assessment assuming no laundering was conducted as a conservative measure. It should be noted that it was assumed that not all articles of clothing are treated with the OPP products or worn on a continuous basis therefore, only short term duration exposures were assessed for the clothing scenarios.

Potential doses are calculated as follows:

PDD = C x SA x ET x TR x CF1 BW where: PDD = potential daily dose ( mg/ kg/ day); C = concentration on clothing ( mg ai/ cm2); SA = surface area of skin covered by clothing ( cm2/ day); ET = exposure time ( hours/ day); TR = transferable residue from clothing to skin (%); CF1 = conversion factor from hour to day ( 1 day/ 24 hours); and 29 BW = body weight ( kg).

And C = A x WF where: C = Concentration on clothing ( mg ai/ cm2) A = Product absorption rate ( 198 mg/ cm2); and WF = Weight fraction of product (% ai).

Assumptions   There is one product labeled for use on clothing: # 10088 00105 for trigger pump spray. The instructions state: " hold spray opening about 6 to 8 inches away from surface and spray until its [ sic] thoroughly wetted. For proper disinfection, apply at approximately 20 E C, then allow 10 minutes for it to act". Because the label does not state otherwise, it was assumed that the clothing is to be worn after spraying, without any subsequent washing. Because no specific application rate information is available from the label, surrogate data were used. Whatman, Inc. sells " absorbent sinks", reels of absorbent materials for use in laboratories ( Whatman, 2005). One of their products, CF7, is composed of 100% cotton and is 1.9 mm thick. This product has a stated water absorption rate of 198 mg/ cm2. Since 1.9 mm seems a reasonable thickness for clothing, and the product label states that the clothing is to be thoroughly wetted, an application rate of 198 mg product/ cm2 was used for this assessment. Because the product contains 0.249% OPP, this corresponds to an application rate of 0.493 mg a. i./ cm2.   The median surface area of clothing contacting skin for a 3 year old toddler is 5,670 cm2 ( total body surface area minus the head) ( USEPA, 1997a). For adults, the median surface area is 16,900 cm2 ( total body surface area minus the head) ( USEPA, 1997a).   No data were available from which a transfer factor could be estimated. Potential doses were calculated using a conservative transfer factor of 100%, which assumes that all residues are transferable from clothing surfaces to the skin. In cases where the MOEs did not meet the Agency's target MOE, potential doses were also calculated using a less conservative transfer factor of 5%, which is based on the amount of residue assumed to be transferable from carpeted surfaces ( USEPA, 2000 and 2001). In these cases, confirmatory data are needed to support the use of the lower transfer factor.   An exposure time of 16 hours has been used ( waking hours).   Toddlers ( 3 years old) are assumed to weigh 15 kg. This is the mean of the median values for male and female toddlers ( USEPA, 1997). For adults, a body weight of 70 kg has been assumed.

Results The calculations of the short term dermal doses and MOEs for adults and children wearing treated clothing are shown in Table 4.6. The dermal MOEs for children are below the target MOE of 100 using the 100% transfer factor ( MOE < 1) and using the 5% transfer 30 factor ( MOE = 16). For adults, the dermal MOEs are also below the target MOE of 100 using both the 100% transfer factor ( MOE = 1) and the 5% transfer factor ( MOE = 25).

Dermal Exposure to Infants Wearing Treated Cloth Diapers There is the potential for dermal exposure to infants wearing cloth diapers treated with a trigger pump spray product containing OPP. Though it is likely that the diapers treated with this product would be washed prior to use, the label does not provide specific use instructions pertaining to washing. Therefore, a post application assessment assuming no laundering was conducted as a conservative measure. Furthermore, since infants typically wear diapers on a continuous basis, short, intermediate, and long term exposure durations were necessary to assess. The exposures were calculated using the following equations and assumptions:

PDD = C x SA x EF x TR BW where: PDD = potential daily dose ( mg/ kg/ day); C = concentration on clothing ( mg ai/ cm2); SA = surface area of skin covered by the diaper ( cm2/ diaper); EF = exposure frequency ( diapers/ day); TR = transferable residue from diaper to skin (%); BW = body weight ( kg).

And C = A x WF where: C = Concentration on clothing ( mg ai/ cm2) A = Product absorption rate ( 198 mg/ cm2); and WF = Weight fraction of product (% ai).

Assumptions   The application rate of the product is 0.493 mg a. i./ cm2, which is based on the product containing 0.249% a. i. and the diaper having a product absorption rate of 198 mg product / cm2 ( see discussion above).   The median surface area of the body area covered by a diaper is 462 cm2/ diaper. This was calculated for a < 1 year old, assuming that a diaper covers 1/ 3 of the trunk area ( professional judgment) and the trunk area is 35.7% of the body surface area ( USEPA 1997a). The total body surface area was assumed to be 3,925 cm2.   It was assumed that a child < 1 year old wears 8 diapers per day ( Professional judgment).   Potential doses were calculated using a transfer factor of 100 and 5%.   A child under 1 year old was assumed to weigh 10 kg. 31 Results Table 4.6 shows the calculations of the short, intermediate, and long term dermal doses and MOE for infants wearing treated cloth diapers. When using a transfer factor of 100% and 5%, all MOEs were below the target MOE of 100.

Table 4.6. Dermal Post application Exposures and MOEs for Children and Adults Contacting Treated Textiles % a. i. Product absorption rate ( mg/ cm2) Conc. on clothinga ( mg ai/ cm2) Surface area covered by textile ( cm2/ day) Percent transferred Exposure time Potential daily doseb ( mg/ kg/ day) Dermal MOEc Short Term Wearing Treated Clothing  Children 100% 16 ( hours/ day) 124.24 < 1 0.249 198 0.493 5,670 5% 16 ( hours/ day) 6.21 16 Short Term Wearing Treated Clothing   Adults 100% 16 ( hours/ day) 79.34 1 0.249 198 0.493 16,900 5% 16 ( hours/ day) 3.97 25 Wearing Treated Diapers  < 1 year old 100% 8 diapers/ day 182.2 ( ST) 78.35 ( IT/ LT) < 1 ( ST) < 1 ( IT/ LT) 0.249 198 0.493 462 5% 8 diapers/ day 9.11 ( ST) 3.92 ( IT/ LT) 11 ( ST) 10 ( IT/ LT)

a Concentration on clothing ( mg/ cm2) = % active ingredient / 100 * Product absorption rate ( 198 mg/ cm2) b Potential Daily Dose for clothing ( mg/ kg/ day) = [( concentration on clothing, mg/ cm2) * ( surface area of skin covered by clothing, cm2/ day) * ( percent transferable residue from textile) * ( exposure time, hrs/ day) * ( conversion factor, 1 day/ 24 hours)] / ( body weight, kg). Potential Daily Dose for diapers ( mg/ kg/ day) = [( concentration on diapers, mg/ cm2) * ( surface area covered by diaper, cm2/ diaper) * ( exposure frequency, diapers/ day) * ( dermal absorption factor, 0.43 for IT, not applicable for ST) * ( percent transferable residue from diapers)] / ( body weight, kg) c MOE = NOAEL ( mg/ kg/ day) / absorbed potential daily dose [ Where short term dermal NOAEL = 100 mg/ kg/ day and IT/ LT dermal NOAEL = 39 mg/ kg/ day]. Target MOEs = 100.

Incidental Oral Exposure to Children Mouthing Treated Textiles Exposure Calculations There is the potential for incidental oral exposure to children from mouthing textiles treated with a trigger pump spray product containing OPP.

Potential doses are calculated as follows:

PDD = C x SA x SE BW where: 32 PDD = potential daily dose ( mg/ kg/ day) C = concentration on clothing ( mg/ cm2) SE = saliva extraction efficiency (%) SA = Surface area mouthed ( cm2/ day) BW = body weight ( kg)

Assumptions   The concentration of the chemical on clothing was determined using same methodology as discussed in the previous section, post application dermal exposure to textiles.   The surface area of textiles mouthed by children is 20 cm2 ( professional judgment).   The saliva extraction efficiency is 50% ( USEPA, 2000 and 2001).   Toddlers ( 3 years old) are used to represent the 1 to 6 year old age group. For threeyear olds, the median body weight is 15 kg ( USEPA, 1997).

Results Table 4.7 shows the calculation of the oral dose and oral MOE for children mouthing treated textiles. The MOE value is above the target MOE of 100 ( MOE = 300).

Table 4.7. Short term Post application Incidental Oral Exposures and MOEs for Children Contacting Treated Textiles % a. i. Product absorption rate ( mg/ cm2) Concentration on clothinga ( mg/ cm2) Area mouthed ( cm2/ day) Saliva Extraction Factor Potential daily dose ( mg/ kg/ day) Incidental Oral MOEc 0.249 198 0.493 20 50% 0.329 300 a Concentration on clothing ( mg ai/ cm2) = % active ingredient * Product absorption rate ( 198 mg/ cm2) b Potential Daily Dose ( mg/ kg/ day) = ( Concentration on clothing, mg/ cm2) * ( area mouthed, cm2/ day) * ( saliva extraction factor, unitless fraction) / ( body weight, kg). c MOE = NOAEL ( mg/ kg/ day) / absorbed potential daily dose [ Where short term oral NOAEL = 100 mg/ kg/ day]. Target MOE = 100.

<IP_ADDRESS> Plastics ( Toys)

There is the potential for incidental oral exposure to children from mouthing plastic toys impregnated with products containing OPP and OPP salt preservatives.

Oral Exposure to Children from Mouthing Treated Plastic Toys The exposure estimates for children mouthing treated toys are based on the methodology used for Microban Additive " B" assessment ( USEPA 1997b), which assessed risks to 12 month old infants playing with treated toys, and exposure assumptions from HED's Residential SOPs ( USEPA, 2000 and 2001). 33 Exposure Calculations Potential doses are calculated as follows:

PDD = SR x SE x SA BW where: PDD = potential daily dose ( mg/ kg/ day); SR = surface residue ( mg/ cm2); SE = saliva extraction efficiency ( unitless fraction) SA = surface area of toy mouthed ( cm2/ day) BW = body weight of a 12 month old infant ( kg).

And SR = % a. i x W x CF x F SA where: SR = surface residue ( mg a. i./ cm2) % a. i. = fraction active ingredient in toy by total weight ( unitless) W = weight of toy ( g) CF = conversion factor ( 1,000 mg/ g) F = fraction additive available at the surface of the toy ( unitless) SA = surface area of toy ( cm2)

Assumptions   Since chemical specific leaching data were not available, the actual amount of active ingredient at the surface of the toy which is available for mouthing is based on the following assumptions: o the toy is manufactured from ABS or polystyrene plastic; o the diffusion of the active ingredient available at the surface of the toy to the child's mouth is allowed to reach equilibrium; and o no more then 0.5% of the additive is available on the surface of the toy for each mouthing event.   The total surface area of a treated toy is 500 cm2 ( Dang 1997).   The weight of a 500 cm2 toy is 50 g, which is based on data that show a polyethylene highchair sample with a surface area of 12.7 cm2 weighs 1.3072 g ( i. e., 0.1 g/ cm2) ( Dang, 1997).   50% of the surface residue is ingested ( saliva extraction efficiency).   The body weight of a 12 month old infant is 10 kg.   A child mouths 500 cm2 of treated toy surface per day.

Results Table 4.8 presents the calculations of the oral dose and MOE for children mouthing treated toys. The MOE value is above the target MOE of 100 ( MOE = 2400). 34 Table 4.8 Short term Post application Incidental Oral Exposures and MOEs for Infants Mouthing Treated Toys % ai Weight of toy ( g) Percent additive available at surface of the toy (%) Surface area of toy ( cm2) Surface Residue a ( mg ai/ cm2) Saliva Extraction Factor Surface area of toy mouthed ( cm2/ day) Absorbed potential Daily Dose b ( mg/ kg/ day) Incidental Oral MOE c 0.34% 50 0.5% 500 0.0017 50% 500 0.0425 2400 a Surface Reside ( mg ai for a 500 cm2 toy) = (% ai) * ( Weight of toy, 50 g) * ( Conversion factor, 1000 mg/ g) * ( Additive available at surface of toy, 0.5%) / ( Surface area of toy, 500 cm2) b Potential Daily Dose ( mg/ kg/ day) = Surface residue ( 0.0017 mg ai/ cm2) * ( toy area mouthed, 500 cm2/ day) * ( saliva extraction) /( body weight, 15 kg) c MOE = NOAEL ( mg/ kg/ day) / potential daily dose ( mg/ kg/ day) [ Where short term oral NOAEL = 100 mg/ kg/ day]. Target MOE = 100.

<IP_ADDRESS> Air Deodorizers No post application air concentration data have been submitted for OPP products to determine potential vapor inhalation risk. Therefore, the Multi Chamber Concentration and Exposure Model ( MCCEM v1.2) was used to present a screening level estimate of the potential inhalation risk to adults and children. MCCEM estimates average and peak indoor air concentrations of chemicals released from products or materials in houses, apartments, townhouses, or other residences. The data libraries in MCCEM contain information about residential settings. MCCEM estimates inhalation exposures to chemicals, calculated as single day doses, chronic average daily doses, or lifetime average daily doses. It should be noted that all dose estimates are potential doses; they do not account for actual absorption into the body.

Assumptions   The area being deodorized is a bedroom in a generic house. The product is deployed just before bedtime ( i. e., 8 hr exposure while sleeping).   Deodorization occurs instantaneously, so that the entire mass of product is mixed homogeneously with the indoor air as soon the product is deployed. It was assumed that 100% of the product is available as inhalable vapor.   The label for product # 44446 67 states that one can ( 168 g, 0.199% OPP) can be used to deodorize one 6,000 ft3 ( 170 m3) area for 30 days. Based on this rate of use, the amount used in one bedroom ( 35 m3 in the MCCEM generic house) per day is assumed to be 1.15 g ( 168 g x 35 m3 / 170 m3 / 30 days).   The product # 44446 67 can be used in both residential and institutional settings ( i. e., day care facilities). Therefore, short term duration exposures were assessed for adults and children in residential settings since this type of product was assumed to be used on an intermittent basis. However, short and intermediate term duration exposures were assessed for children in day care facilities since this type of product was assumed to be used on a routine basis. 35 Results Details of the MCCEM modeling can be found in Appendix B. Results of the MCCEM calculation are shown in Table 4.9. For both adults and children, the calculated inhalation MOEs are greater than the target MOE of 100. Furthermore, these MOEs are also greater than 1,000 therefore; an additional inhalation toxicity study is not warranted based on the results of this scenario.

Table 4.9. Short and Intermediate Term Post application Inhalation Exposures and MOEs for Adults and Children in Areas Treated with Air Deodorizers Value Parameter Adult Child Rationale House* Generic House ( 2 chambers: 35 m3 bedroom, 373 m3 other rooms) MCCEM default Activity Schedule* In bedroom at start of modeling, out after 8 hours EPA Assumption Concentration of product 0.199% OPP by weight Product label # 44446 67 Quantity in Can 168 g product Product label # 44446 67 Quantity Used per Day 1.15 g product ( 2.54x10 3 lb product) Based on rate of 1 can per 6,000 m3 for 30 days, and a bedroom size of 35 m3 Quantity ai Used per Day 5.06x10 6 lb ai/ day ( 2.30x10 3 g/ day) ( Quantity per day) * ( Concentration)

Concentration in Bedroom after spraying ( Initial Concentration in Bedroom)* 6.56x10 5 g a. i./ m3 ( 65.6 µ g a. i./ m3) ( Quantity ai per day) / ( Bedroom volume)

Body Weight* 70 kg 15 kg Average body weights for adults and young children Inhalation Rate* 11.6 m3/ day 8.88 m3/ day Average resting rate for adults and young children ( USEPA, 1997)

MCCEM Outputs Dose 2.67x10 4 mg/ kg/ day 9.53x10 4 mg/ kg/ day MCCEM Output Inhalation short term MOE 370,000 100,000 NOAEL ( 100 mg/ kg/ day)/ Dose Inhalation intermediate term MOE ( day care facilities) NA 41,000 NOAEL ( 39 mg/ kg/ day)/ Dose * Used as MCCEM input. Default values from MCCEM were used for all inputs not listed in the table above. 36 <IP_ADDRESS> Paints AD utilized EPA's Wall Paint Exposure Model ( WPEM) version 3.2 to estimate air concentrations resulting from the use of paint preserved with OPP. For this exposure assessment, a WPEM default scenarios were used to determine exposure to adults ( RESADULT) and children ( RESCHILD). In these scenarios, an adult and child are located in a non painted part of the house while a bedroom is being painted by a professional painter. For a detailed description of the RESADULT and RESCHILD scenarios, see the WPEM User's Guide. The following chemical specific inputs were used in the model:

  OPP's molecular weight ( 170.19 amu) and vapor pressure ( 0.002 mm Hg)   The weight fraction of OPP in paint ( product # 464 126 contains 0.5% OPP)

The model provides several dose measures ( i. e., LADD, ADD), air concentration measures ( i. e., peak, 15 min, 8hr), and a comma separated (. csv) file as outputs. The commaseparated file contains details on time varying concentrations within the modeled building as well as concentrations to which the individual is exposed. This file can be read directly into spreadsheet software ( e. g., Excel) for calculating additional summary statistics. The air concentrations outputted by the model were used by AD to estimate inhalation exposure doses and MOEs. The model results and exposure calculations are summarized in Table 4.10. It should be noted that the WPEM model moves the occupant throughout the home ( i. e., zone 1 = painted room, zone 2 = non painted room, and outdoors) based on predefined activity schedules. Therefore, the 24 hr average used in this assessment was based on OPP air concentrations found in each zone at the specific time the person is placed within the associated zone ( see Appendix E). Furthermore, although the house dimensions and the painting schedule is identical for both the adult and child scenario, the average air concentrations to which the individuals are exposed are different, due to different schedules of activities followed by the adult and child.

Table 4.10. Short term Post application Inhalation ( vapor) Exposures and MOEs for Adult and Children in Areas Painted with Preserved Paint Exposed Individual 24 hr TWA ( mg/ m3) a Exposure Duration ( hrs/ day) Inhal. Rate ( m3/ hr) b Inhalation Dose ( mg/ kg/ day) c ST Inhal. MOEd Adult 0.98 24 0.5 0.168 600 Child 1.35 24 0.4 0.867 120 a 24 hr Time Weighted Average ( TWA) including the time during and after painting occurs ( see Appendix E) b Inhalation rate for sedentary activity as indicated in the Exposure Factors Handbook ( USEPA, 1997) c Inhalation Dose = Air Conc. TWA * Exposure duration * Inhalation Rate / Body Weight ( 70 kg for adults, 15 kg for children) d Short Term Inhalation MOE = Short Term Inhalation NOAEL ( 100 mg/ kg/ day) / Inhal. Dose Both the child and adult inhalation MOEs are above the target MOE of 100, but below a value of 1,000. Since the MOEs are below 1,000, the Agency may request that a confirmatory inhalation toxicity study be conducted. 37 <IP_ADDRESS> Foggers Post application inhalation exposures were assessed for entry into a room after a fogging application was conducted using MCCEM v1.2.

One product was identified that can be used for fogging in residential settings ( product # 70263 3, 0.22% OPP, 0.0183 lbs a. i./ gal). The label states that the product is for household use in areas damaged by smoke, fire, floods, and sewage backups and also notes that the product can be applied with appropriate fogging equipment. Therefore it was assumed that a professional cleanup operation would actually apply the product in a residential setting, such as a basement. No other information was provided on the label regarding use of the product as a fogger. In the absence of better information, an assessment was performed for residential post application exposures using the OPP concentration from label # 70263 3 ( 0.0183 lb ai/ gal) and the application rate listed on product # 65020 7 ( 1 gallon of product per 6,000 square feet). Note that product # 65020 7 is intended for fogging agricultural premises and was selected for occupational assessment. Because the label for product # 70263 3 did not provide a re entry interval, this assessment was performed using reasonable re entry intervals ( REIs) of 0 and 4 hours. Concentrations of exposed individuals were determined for 2, 8, and 24 hours of exposure. It should be noted that label # 70263 3 can be used in both residential and institutional settings ( i. e., day care facilities). However, since this product ( when used as a fogger) appears to be used specifically for clean up following smoke, fire, floods, and sewage backup damage, it was assumed that it would not be used on a routine basis and only short term duration exposures would occur in both the residential and institutional setting.

Assumptions   The area being fogged is the default 1 chamber generic house ( assuming this is similar to a water damaged basement), as defined by MCCEM ( 408 m3, ACH= 0.18/ hr).   Fogging occurs instantaneously, so that the entire mass of product is mixed homogeneously with the indoor air as soon as fogging commences.   Table 4.11 summarizes the model inputs Table 4.11. MCCEM Model Inputs for Postapplication Exposure to Fogged Houses Value Parameter Adult Child Rationale House Dimensions* 408 m3 ( 14,400 ft3) 1801 ft2 floor area MCCEM 1 chamber generic house, assuming 8 ft high stories Concentration of Fogging Liquid 0.22% a. i. ( OPP) 0.0183 lbs a. i./ gal See Table 6.1.

Use rate 1 gal/ 6000 ft2 Product label # 65020 7 Mass applied to house 0.00549 lbs a. i. ( 2.49 g a. i.) ( Use rate) x ( Concentration) x ( Floor area)

Concentration in house after fogging ( initial concentration at time 0)* 0.00611 g/ m3 Mass / Volume 38 Body Weight* 70 kg 15 kg Average body weights for adults and young children Light Activity Inhalation Rate ( m3/ hr)* 0.5 0.4 Sedentary activity inhalation rates for adults and young children ( USEPA, 1997a)

* Used as MCCEM input. Default values from MCCEM were used for all inputs not listed in the table above.

Results Details of the MCCEM modeling can be found in Appendix B. Based on the model output, inhalation exposures to adults and young children were calculated ( Table 4.12). All of the adult and child inhalation MOEs were above the target MOE of 100. All of the MOEs for children were below 1,000. However, the ST vapor inhalation exposures to adults for a 0 hr REI and a 4 and 24 hour exposure duration along with the ST vapor inhalation exposure to adults for a 4 hr REI and 24 hour exposure duration were below 1,000. Therefore, the based on the results of these scenarios for which the calculated MOEs are below 1,000, the Agency may request that a confirmatory inhalation toxicity study be conducted.

Table 4.12. Short term Post application Inhalation Exposures and MOEs for Adults and Children in Fogged Houses Re Entry Interval ( hrs) Exposure Duration ( hrs/ day) TWA Air Conc. ( mg/ m3) a Inhalation Rate ( m3/ hr) b Inhalation Dose ( mg/ kg/ day) c ST Inhal. MOEd Adults 2 5.25 0.5 0.075 1,300 4 4.45 0.5 0.127 790 0 24 1.43 0.5 0.245 410 2 2.56 0.5 0.037 2,700 4 2.17 0.5 0.062 1,600 4 24 0.695 0.5 0.119 840 Child 2 5.25 0.4 0.280 360 4 4.45 0.4 0.475 210 0 24 1.43 0.4 0.914 110 2 2.56 0.4 0.136 730 4 2.17 0.4 0.231 430 4 24 0.695 0.4 0.445 230 a Air concentrations calculated by MCCEM using inputs described in Table 4.11. Model provided air concentrations at 15 minute intervals. Starting after the REI, the TWA was calculated for each exposure time duration ( See Appendix B). b Inhalation rate is based on sedentary activity of adults and young children ( USEPA, 1997a) c Inhalation Dose = Exposure Duration x TWA x Inhalation Rate / Body Weight ( 70 kg for adults, 15 kg for children) d Short Term Inhalation MOE = Short Term Inhalation NOAEL ( 100 mg/ kg/ day) / Inhal. Dose 39 4.4.3 Data Limitations/ Uncertainties There are several data limitations and uncertainties associated with the residential handler and postapplication exposure assessments which include the following:

  Surrogate dermal and inhalation unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998) ( See Appendix A for summaries of these data sources). Most of the CMA data are of poor quality therefore, AD requests that confirmatory monitoring data be generated to support the values used in these assessments.   The quantities handled/ treated were estimated based on information from various sources, including HED's Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( USEPA 2000, and 2001) and AD standard assumptions, which can be further refined from input from registrants.   The low pressure spray unit exposure data from PHED were used to assess outdoor applications to hard surfaces ( exterior of homes). As the low pressure spray data are representative of treating low to mid level shrubs and the scenario assessed in this document represents treatments above the waist, the unit exposure value may underestimate exposure to the head and the upper body.   The method used to estimate exposure from mouthing treated plastic toys is conservative because it does not account for washing of the toy or depletion of residue after each toy to mouth episode.   The textile exposure methods were very conservative because they assumed that the textiles were saturated with the product, dried, and worn. No laundering was accounted for because the labels did not provide specific use instructions pertaining to washing of the clothing/ diapers.   A confirmatory study is needed to verify the 5% transfer factor for clothing and diapers.   The Wall Paint Exposure Model is designed to estimate indoor air concentrations and associated inhalation exposures for interior applications involving alkyd or latex primer/ paint. The chamber tests on which the emission algorithms are based involve a limited set of chemicals with a correspondingly limited range of properties ( molecular weight and vapor pressure). Further, the emission algorithms are valid only for chemicals that are formulated into alkyd/ latex primers or paints. Actual monitoring data could be used to refine the exposures and risks estimated in this assessment.

5.0 RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION 5.1 Acute and Chronic Dietary Aggregate Risk This is included in the Preliminary Risk Assessment.

5.2 Short and Intermediate Term Aggregate Risk In order for a pesticide registration to continue, it must be shown " that there is reasonable certainty that no harm will result from aggregate exposure to pesticide chemical 40 residue, including all anticipated dietary exposures and other exposures for which there are reliable information." Aggregate exposure is the total exposure to a single chemical ( or its residues) that may occur from dietary ( i. e., food and drinking water), residential, and other non occupational sources, and from all known or plausible exposure routes ( oral, dermal, and inhalation). However, this assessment only addresses non dietary residential aggregate exposures and risks. The PRA of the RED will address the complete aggregate assessment including both dietary and non dietary residential exposures and risks.

In performing aggregate exposure and risk assessments, the Office of Pesticide Programs has published guidance outlining the necessary steps to perform such assessments ( General Principles for Performing Aggregate Exposure and Risk Assessments, November 28, 2001; available at http:// www. epa. gov/ pesticides/ trac/ science/ aggregate. pdf). Steps for deciding whether to perform aggregate exposure and risk assessments are listed, which include: identification of toxicological endpoints for each exposure route and duration; identification of potential exposures for each pathway ( food, water, and/ or residential); reconciliation of durations and pathways of exposure with durations and pathways of health effects; determination of which possible residential exposure scenarios are likely to occur together within a given time frame; determination of magnitude and duration of exposure for all exposure combinations; determination of the appropriate technique ( deterministic or probabilistic) for exposure assessment; and determination of the appropriate risk metric to estimate aggregate risk Short and Intermediate Term Aggregate Exposures and Risks Short and intermediate term aggregate exposures and risks were assessed for adults and children that could be exposed to OPP and OPP salt residues from the use of products in non occupational environments. The following lists summarize all of the non dietary, nonoccupation potential sources of OPP and OPP salt exposures for adults and children:

Adult OPP and OPP salt exposures sources:   Cleaning indoor hard surfaces via mopping, wiping, or spraying   Cleaning outdoor hard surfaces via low pressure sprayer   Applying textile products to clothes and diapers   Applying air deodorizers in residential settings   Applying of OPP preserved paint in residential settings   Wearing treated clothing   Post application exposure to OPP vapors from foggers used in residential settings   Post application exposure to OPP vapors from air deodorizers used in residential settings   Post application exposure to OPP vapors from OPP preserved paint used in residential settings Child OPP and OPP salt exposures sources:   Post application exposures to residues from cleaning products used on hard surfaces ( i. e., floors)   Wearing treated clothing and diapers   Post application exposure to OPP vapors from foggers used in residential settings   Post application exposure to OPP vapors from air deodorizers used in residential settings 41   Post application exposure to OPP vapors from OPP preserved paint used in residential settings   Playing with OPP preserved plastic toys The use patterns of the products and probability of co occurrence must be considered when selecting scenarios for incorporation in the aggregate assessment. In the case of OPP and OPP salts, homeowner painting activities occur only once or twice a year. Furthermore, the use of fogger products occurs on an intermittent basis since they are used as a cleanup after water or smoke damage. Therefore the probability of co occurrence and the potential for exposure to residues from these products on the same day is highly unlikely. However, it is likely that someone could clean the kitchen ( mopping and wiping activities) as well as, use an air deodorizer containing OPP or OPP salts during the same day.

Cleaning activities in a residential setting occur on a short term basis. However, the OPP and salts containing cleaning products are also labeled for use in institutional settings such as day care facilities where cleaning activities can occur on an intermediate term basis. Therefore, children could have exposure to cleaning product residues on a more continuous basis in a day care facility thus; these post application scenarios were included in the intermediate term aggregate assessment. Table 5.1 summarizes the scenarios included in the short and intermediate term aggregate assessments.

Table 5.1: Summary of Exposure Scenarios Included in the Short and Intermediate Term Aggregate Assessments Short term Aggregate Intermediate Term Aggregate Dermal:   Mopping applicator   Wiping applicator   Air deodorizer applicator Adults Oral + Inhalation:   Mopping applicator   Wiping applicator   Air deodorizer applicator   Post app to air deodorizers Dermal + Oral + Inhalation:   No applicable exposures Dermal:   Dermal post app exposure to residues from mopping activities Children Oral + Inhalation:   Inhalation post app exposure to air deodorizer residues   Oral post app exposure to residues from mopping activities Dermal + Oral + Inhalation:   Inhalation post app exposure to air deodorizer residues   Oral post app exposure to residues from mopping activities   Dermal post app exposure to residues from mopping activities It should be reiterated that the adult and child dermal post application exposures to textile OPP residues alone are of concern to the Agency. Incorporation of this scenario in the aggregate assessment would result in risks of concern. Therefore, the textile scenario was not incorporated in the aggregate assessment. If these exposures did not result in risks of 42 concern, then they also would have been included in the aggregate assessments. It should also be noted that the short term aggregate assessment for children did not include a child mouthing plastic toys because this scenario is represented by children under the age of 1 year old whereas, the child aggregate assessment is represented by children 3 years old.

Since the short term dermal toxicity endpoint was based on skin irritation and the oral and inhalation endpoints were based on the same study and toxic effect, the short term dermal exposures were aggregated in a separate analysis from the short term inhalation and oral exposures. However, the intermediate term toxicity endpoints for all of the routes of exposure ( oral, dermal and inhalation) are based on the same study and same toxic effect therefore, all intermediate term routes were aggregated together. The Total MOE method outlined in OPP guidance for aggregate risk assessment ( September 1, 2000, Standard Operating Procedure ( SOP) for Incorporating Screening Level Estimates of Drinking Water Exposure into Aggregate Risk Assessments) was utilized in the assessment. This method was used because the oral, dermal and inhalation endpoints have the same uncertainty factors or target MOEs. The target MOE for all routes of exposure is 100. The general equation used to estimate total or aggregate MOEs is:

Aggregate MOE = 1 / (( 1/ MOEroute 1, scenario 1) + ( 1/ MOEroute1, scenario 2) + ( 1/ MOE route 1, scenario n) + ( 1/ MOEroute 2, scenario 1) + ( 1/ MOEroute 2, scenario 2) + ( 1/ MOEroute 2, scenario n) + ( 1/ MOEroute n, scenario n))

Where, route represents oral, dermal, or inhalation exposures, and scenario represents handler or post app wiping, mopping, etc.

Tables 5.2, 5.3, and 5.4 present the OPP short term dermal exposures, the OPP shortterm oral and inhalation exposures, and the OPP intermediate term exposures used in the aggregate assessment, respectively. Tables 5.5, 5.6, and 5.7 present the resulting MOEs for the short term dermal, short term oral and inhalation, and intermediate term aggregate assessments, respectively. All of the short and intermediate term aggregate MOEs for residential scenarios were above the target MOE of 100.

Table 5.2: Exposures for Short term Dermal Aggregate Assessment Household Cleaning Exposure ( mg/ kg/ day) Routes Applicator Post Application Wipe Mop Air Deodorizers Mop Air Deodorizers Adult Dermal 0.672 0.129 0.0064 NA NA Child Dermal NA NA NA 0.674 NA 43 Table 5.3: Exposures for Short term Oral and Inhalation Aggregate Assessment Household Cleaning Exposure ( mg/ kg/ day) Routes Applicator Post Application Wipe Mop Air Deodorizers Mop Air Deodorizers Adult Oral NA NA NA NA NA Inhalation 0.0157 0.0043 0.0001 NA 2.67E 04 Child Oral NA NA NA 0.0824 NA Inhalation NA NA NA NA 9.5E 04 Table 5.4: Exposures for Intermediate term Aggregate Assessment Exposure Household Cleaning ( mg/ kg/ day) Routes Post application Mop Air Deodorizers Child Oral 0.0057 NA Inhalation NA 9.5E 04 Dermal 0.0421 NA Table 5.5 Short term Dermal Aggregate Risks Household Cleaning Exposure MOEs Routes Applicator Post App Aggregate Wipe Mop Air Deodorizers Mop Air Deodorizers Adult Dermal 150 780 16,000 NA NA 120 a Child Dermal NA NA NA 150 NA 150 a: Aggregate MOE = 1/(( 1/ MOEwipe) + ( 1/ MOEmop) + ( 1/ MOEair deodorizer))

Table 5.6: Short term Oral and Inhalation Aggregate Risks Household Cleaning Exposure MOEs Routes Applicator Post App Aggregate Wipe Mop Air Deodorizers Mop Air Deodorizers Adult Oral NA NA NA NA NA Inhalation 6,300 23,000 670,000 NA 370,000 4900a Child Oral NA NA NA 1,200 NA Inhalation NA NA NA NA 100,000 1200b 44 a: Aggregate MOE = 1/(( 1/ MOEwipe, app inhal) + ( 1/ MOEmop, app inhal) + ( 1/ MOEair deodorizer, app inhal) + ( 1/ MOEair deodorizer, post inhal)) b: Aggregate MOE = 1/(( 1/ MOEmop, post oral) + ( 1/ MOEair deodorizer, post inhal))

Table 5.7: Intermediate term Aggregate Risks Household Cleaning MOEs Exposure Post application Aggregate Routes Mop Air Deodorizers Child Oral 6,800 NA Inhalation NA 41,000 Dermal 930 NA 800a a: Aggregate MOE = 1/(( 1/ MOEmop oral) + ( 1/ MOEmop dermal) + ( 1/ MOEair deodorizer inhal))

6.0 OCCUPATIONAL EXPOSURE ASSESSMENT The exposure scenarios assessed in this document for the representative uses selected by AD are shown in Table 6.1. The table also shows the maximum application rate associated with the representative use and the appropriate EPA Registration number for the product label. For handlers, the representative uses assessed include application to indoor hard surfaces, outdoor hard surfaces, and air deodorization ( aerosol spray). Additionally, handler exposures were assessed for the application of treated paint ( paint brush/ roller and airless sprayer) and mixing and loading of product for fogging applications ( liquid pour of soluble concentrate). It should be noted that for the calculation of application rates in which 8.34 lb a. i./ gal is noted, the product is assumed to have the density of water because no productspecific density is available.

Potential occupational handler exposure can occur in various use sites, which include; agricultural premises, food handling premises, commercial/ institutional/ industrial premises, and medical premises. Additionally, occupational exposure can occur during the preservation of materials that are used for household, institutional, and industrial uses, along with the preservation of wood. The " preservation of materials" refers to the scenario of a worker adding the preservative to the material being treated ( metalworking fluid, paint, textiles, etc.) through either liquid pour or liquid pump methods. Liquid pour refers to transferring the antimicrobial product from a small container to an open vat. Liquid pump refers to transferring the preservative by connecting/ disconnecting a chemical metering pump from a tote or by gravity flow. For the preservation of wood, the procedure for treatment can occur in different ways, such that multiple worker functions were analyzed. Due to the complexity of the wood preservative analysis, the results for handler and postapplication exposures are presented in a separate section, 6.4. 45 Table 6.1. Representative Exposure Scenarios Associated with Occupational Exposures to OPP and OPP Salts Representative Use Method of Application Exposure Scenario Registration # Application Rate Agricultural Premises and Equipment Indoor Hard Surfaces   Low pressure handwand   High Pressure Spray   Mopping   Wiping surfaces   Trigger pump spray IT and ST Handler: dermal and inhalation 70263 3 ( OPP) 0.0183 lb a. i./ gal ( 0.22% a. i. x 8.34 lb/ gal)

Fogger1   Liquid pour of soluble concentrate IT and ST Handler ( mixer/ loader only): dermal and inhalation ST Postapp: inhalation ( vapor) 65020 7 ( OPP) 0.661 lb a. i./ 6000ft2 ( 7.92% a. i. x 1 gal product/ 6000 ft2 x 8.34 lb/ gal)

Food Handling   Low pressure handwand   Mopping   Wiping surfaces2 IT and ST Handler: dermal and inhalation 11725 7 ( OPP) 0.00391 lb a. i./ gal ( 12.0% a. i. x 0.5 oz product/ gal water x 8.34 lb/ gal x 1gal/ 128oz) Indoor Hard Surfaces   Trigger pump spray3 IT and ST Handler: dermal and inhalation 69658 3 ( OPP) 0.0334 lb a. i./ gal ( 0.4% a. i. x 8.34 lb/ gal)

Commercial/ Institutional Premises   Low pressure handwand IT and ST Handler: dermal and inhalation 70263 3 ( OPP) 0.0183 lb a. i./ gal ( 0.22% a. i. x 8.34 lb/ gal)

  Mopping   Wiping surfaces2 IT and ST Handler: dermal and inhalation 40510 5 ( OPP Salt) 7 0.126 lb a. i./ gal ( 8oz. product/ 4 gal water x 97% a. i. x 8.34 lb/ gal x 1 gal/ 128 oz) Indoor Hard Surfaces   Trigger pump spray3 IT and ST Handler: dermal and inhalation 69658 3 ( OPP) 0.0334 lb a. i./ gal ( 0.4% a. i. x 8.34 lb/ gal)

Outdoor hard surfaces   Airless sprayer IT and ST Handler: dermal and inhalation IT and ST 71240 1 ( OPP Salt) 0.00104 lb a. i./ gal ( 0.25% a. i. x 1 quart of product / 5 gal water x 1gal/ 4 quarts x 8.34 lb/ gal) 46 Table 6.1. Representative Exposure Scenarios Associated with Occupational Exposures to OPP and OPP Salts Representative Use Method of Application Exposure Scenario Registration # Application Rate Mixer/ Loader Air Deodorization   Aerosol spray IT and ST Handler: dermal and inhalation 44446 67 ( OPP) 0.199% a. i. by weight Medical Premises   Low pressure handwand IT and ST Handler: dermal and inhalation 70263 3 ( OPP) 0.0183 lb a. i./ gal ( 0.22% a. i. x 8.34 lb/ gal)

  Mopping   Wiping surfaces2 IT and ST Handler: dermal and inhalation 46851 11 ( OPP) 0.0234 lb a. i./ gal ( 9% a. i. x 1/ 32 water dilution x 8.34 lb/ gal) Indoor Hard Surfaces   Trigger pump spray IT and ST Handler: dermal and inhalation 69658 3 ( OPP) 0.0334 lb a. i./ gal ( 0.4% a. i. x 8.34 lb/ gal)

Air Deodorization   Aerosol spray IT and ST Handler: dermal and inhalation 44446 67 ( OPP) 0.199% a. i. by weight Material Preservatives Metalworking fluid ( worker pouring preservative into fluid being treated)   Liquid pour   Liquid pump IT and ST Handler: dermal and inhalation ST and IT/ LT Machinist: dermal and inhalation ( vapor) 67869 24 ( OPP salt)

464 126 ( OPP) 5.66% a. i. by weight of the material to be treated ( 28.3% product by weight of material treated x 20% a. i. in product) 4 1.5% a. i. by weight of the material to be treated ( 1.5% product by weight of material treated x 99.5% a. i. in product)

Paint Preservation of paint   Liquid pour   Liquid pump Professional painter   Brush/ Roller   Airless sprayer IT and ST Handler: dermal and inhalation ST Prof Painter: dermal and inhalation ( aerosol and vapor) 67869 24 ( OPP Salt)

464 126 ( OPP) 0.56% a. i. by weight of the material to be treated ( 2.8% product by weight of material treated x 20% a. i. in product)

0.5% a. i. by weight of the material to be treated ( 0.5% product by weight of material treated x 99.5% a. i. in product) 5 47 Table 6.1. Representative Exposure Scenarios Associated with Occupational Exposures to OPP and OPP Salts Representative Use Method of Application Exposure Scenario Registration # Application Rate Paper pulp   Liquid pump IT and ST Handler: dermal and inhalation 67869 24 ( OPP Salt) 0.34% a. i. by weight of the material to be treated ( 1.7% product by weight of material treated x 20% a. i. in product)

Textiles   Liquid pour   Liquid pump IT and ST Handler: dermal and inhalation ST and IT Industrial bystander: inhalation6 ( vapor) 67869 24 ( OPP salt)

464 126 ( OPP) 5.66% a. i. by weight of the material to be treated ( 28.3% product by weight of material treated x 20% a. i. in product)

5% a. i. by weight of the material to be treated ( 5 % product by weight of material treated x 99.5% a. i. in product)

Wood Preservative ( non pressure treated)   Airless Spray   Dip IT and ST Handler: dermal and inhalation 67869 24 ( OPP salt) 4.52% a. i. in treatment solution ( formulated product is applied at a rate of 22.6% of the weight of the wood treated, and the product contains 20% a. i.)

1 Label for fogging application in Food Handling, Commercial/ Institutional, and Medical Premises ( EPA Reg No. 11725 7) does not provide specific use rate instructions. Therefore the Agricultural Premise fogging scenario represents all fogging scenarios ( EPA Reg No. 65020 7). 2 Wiping surfaces is assumed to be representative of impregnated wipes. 3 The trigger pump scenario also represents the aerosol scenario since the application rate for the trigger pump is higher and the aerosol spray. Also, the unit exposure for aerosol applications is used in the exposure assessment for both the trigger pump and aerosol spray products. 4 Label 67869 24 provides a high application rate for preserving concentrate mineral oil based cooling fluid products; therefore this label was assessed for the handler ( adding the preservative to the concentrated cooling fluid). However, the label that provides an application rate for the non concentrate fluid was selected for the machinist scenario ( Label 464 126). 5 For the professional painter and industrial bystander, the OPP product ( Label 464 126) was assessed over the OPP salt product ( Label 67869 24) because the vapor pressure of OPP is greater and therefore poses a greater inhalation risk. 6 Currently, there is no data for the assessment of industrial bystanders' inhalation exposures. 7 This label, # 40510 5, states that the product can be used for " housekeeping santization" and to " sanitize latrine: buckets, urinals, toilet bowls, walls, shower stalls, garbage cans, and garbage platforms." This is why it is assumed not to be used in daycares. It does not specifically say " commercial and institutional premises."

6.1 Occupational Handler Exposures The occupational handler scenarios included in Table 6.1 were assessed to determine dermal and inhalation exposures. The general assumptions and equations that were used to calculate occupational handler risks are provided in Section 1.2, Criteria for Conducting the Risk Assessment. The majority of the scenarios were assessed using CMA data and Equations 48 1 3. However, for the occupational scenarios in which CMA data were insufficient, other data and methods were applied.

Unit Exposure Values ( UE): Dermal unit exposure values were taken from the proprietary Chemical Manufacturers Association ( CMA) antimicrobial exposure study ( USEPA, 1999: DP Barcode D247642) or from the Pesticide Handler Exposure Database ( USEPA, 1998).

  For the low pressure handwand scenarios, the CMA dermal and inhalation unit exposure values for ungloved use of a low pressure spray were used ( 191 mg/ lb a. i. and 0.681 mg/ lb a. i., respectively). These values are based on data collected from eight replicates in which the applicator hand sprayed carpet using 200 psi, then used a push broom rake to raise the carpet nap   For the high pressure spray scenario, the PHED dermal and inhalation unit exposure values for liquid/ open pour/ high pressure spray ( PHED scenario 35) were used ( single layer of clothing and gloves). The dermal and inhalation unit exposure values are 2.5 mg/ lb a. i. and 0.12 mg/ lb a. i., respectively.   For the mopping scenarios, the CMA dermal and inhalation unit exposure values for ungloved mopping were used ( 71.6 mg/ lb a. i. and 2.38 mg/ lb a. i., respectively). These values are based on data collected from six replicates in which the applicator mopped the floor and received exposure via contact with the mop or with the bucket.   For the wiping scenarios, the CMA dermal and inhalation unit exposure values for ungloved wiping were used ( 2,870 mg/ lb a. i. and 67.3 mg/ lb a. i., respectively). These values are based on data collected from six replicates ( dental technicians) who used a finger pump sprayer to apply the product and then wiped the surfaces with a paper towel   For the aerosol sprays and trigger pump spray scenarios, the PHED dermal and inhalation unit exposure values for aerosol applications ( PHED scenario 10) were used. The dermal unit exposures ( single layer of clothing) are 190 mg/ lb a. i. for ungloved replicates and 81 mg/ lb a. i. for gloved replicates. The inhalation unit exposure is 1.3 mg/ lb a. i.   For the fogging scenarios, it was assumed that most of the exposure to the handler will be due to preparing the fogger, and that the handler leaves the room immediately after fogging commences. Therefore, the available CMA disinfectant liquid pour dermal and inhalation unit exposure values were used. The dermal and inhalation unit exposure values are 36.5 mg/ lb a. i. and 1.89 mg/ lb a. i., respectively. This value is based on data collected from two gloved replicates involving pouring a disinfectant product from a jug into sterilization trays designed for dental instruments, adding water and instruments to the tray, removing the instruments, and discarding the old solution.   For the liquid pour scenarios for materials preservatives, the unit exposure depends on the material being treated. The following CMA unite exposures were available and used for the assessment of the risk associated with the treatment of the specified materials. o Metalworking fluid: CMA metal fluid gloved data. The dermal UE is 0.184 mg/ lb ai and the inhalation UE is 0.00854 mg/ lb ai. The values are based on 8 replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. o Paint and Textiles: CMA preservative gloved data. The dermal UE is 0.135 mg/ lb ai and the inhalation UE is 0.00346 mg/ lb ai. The values are based on 2 replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. 49   For the liquid pump scenarios, the unit exposure depends on the material being treated. The following CMA unite exposures were available and used for the assessment of the risk associated with the treatment of the specified materials. o Metalworking fluid: CMA metal fluid gloved data. The dermal UE is 0.312 mg/ lb a. i. and the inhalation UE is 0.00348 mg/ lb a. i. The values are based on 2 replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. o Paint and Textiles: CMA preservative gloved data. The dermal UE is 0.00629 mg/ lb a. i. and the inhalation UE is 0.000403 mg/ lb a. i. for inhalation. The values are based on two replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. o Pulp and Paper: CMA pulp and paper gloved data. The dermal UE is 0.00454 mg/ lb a. i. and the inhalation UE is 0.000265 mg/ lb a. i. The values are based on 7 replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves.   For roller/ brush scenarios, the occupational PHED dermal and inhalation unit exposure values for paintbrush applications ( PHED scenario 22) were used ( single layer of clothing). The inhalation exposure value is 0.28 mg/ lb a. i. The dermal unit exposures are 180 mg/ lb a. i. for ungloved replicates and 24 mg/ lb a. i. for gloved replicates.   For airless sprayer scenarios, the occupational PHED dermal and inhalation unit exposure values for airless sprayer application ( PHED scenario 23) were used ( single layer of clothing). The inhalation exposure value is 0.83 mg/ lb a. i. The dermal unit exposures are 38 mg/ lb a. i. for ungloved replicates and 14 mg/ lb a. i. for gloved replicates.