UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

			OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

June 28, 2007

MEMORANDUM:

Subject:	Occupational and Residential Exposure Chapter for Copper 8-Quinolinolate (Oxine-Copper) in Support of the Reregistration Eligibility Decision (RED) Document for the Copper Salts (RED Case 4026).

To:		Kathryn Jakob, Chemical Review Manager

		Regulatory Management Branch II

Antimicrobials Division (7510P)

			AND

		Timothy McMahon, PhD., Risk Assessor

		Senior Toxicologist

		Antimicrobials Division (7510P)

From: 		Doreen Aviado, Biologist

		Team Two

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Thru:		Nader Elkassabany, Team Leader

		Team Two

		Risk Assessment and Science Support Branch (RASSB)

		Antimicrobials Division (7510P)

		Norm Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

DP Barcode: 	D337781

							CAS

Chemical Name:			PC Code:	Registry No.: 	Common Names:

Copper, bis(8-quinolinolato-N1,O8)-,	024002		10380-28-6	Copper 8-Quinolinolate;										Oxine-Copper; Oxine-Cu; 									Copper-8

Attached is the revised Occupational and Residential Exposure Chapter for Copper 8-Quinolinolate based on error correction comments in support of the Copper Salts RED (RED Case 4026).

OCCUPATIONAL AND RESIDENTIAL EXPOSURE CHAPTER FOR

COPPER 8-QUINOLINOLATE (OXINE-COPPER) IN SUPPORT OF

THE REREGISTRATION ELIGIBILITY DECISION (RED) DOCUMENT

FOR THE COPPER SALTS

REREGISTRATION CASE 4026

June 28, 2007

Antimicrobials Division

Office of Pesticide Programs

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

TABLE OF CONTENTS

 TOC \f

EXECUTIVE SUMMARY	3

1.0 INTRODUCTION	10

1.1 Purpose	10

1.2 Criteria for Conducting Exposure Assessments	10

1.3 Chemical Identification	12

1.4 Physical/Chemical Properties	13

2.0 USE INFORMATION	14

2.1 Formulation Types and Percent Active Ingredient	14

2.2 Summary of Use Patterns and Formulations	14

3.0 SUMMARY OF TOXICITY DATA	16

3.1 Acute Toxicity	16

3.2 Summary of Toxicity Endpoints	17

3.3 FQPA Considerations	19

4.0 RESIDENTIAL EXPOSURE ASSESSMENT	19

4.1 Summary of Registered Uses	19

4.2 Dietary Exposure	20

4.3 Drinking Water Exposure	20

4.4 Residential Exposure	20

4.4.1 Residential Handler Exposures	21

4.4.2 Residential Post-application Exposure	24

<IP_ADDRESS> Outdoor Hard Surfaces/Remedial Fungistatic Surface Treatments	24

<IP_ADDRESS> Treated Textiles	28

<IP_ADDRESS> Treated Lumber	32

4.4.3 Data Limitations/Uncertainties	37

5.0 RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION	38

5.1 Acute and Chronic Dietary Aggregate Risk	38

5.2 Short and Intermediate Term Aggregate Exposure and Risks	38

6.0 OCCUPATIONAL EXPOSURE ASSESSMENT	39

6.1 Summary of Registered Uses	39

6.2 Occupational Handler Exposures	42

6.3 Occupational Post-application Exposures	45

   6.4 Wood Preservation	48

  HYPERLINK \l "_Toc120347553"  6.4.1 Non-Pressure Treatment Scenarios (Handler and Post-application)	48

   HYPERLINK \l "_Toc120347554"  <IP_ADDRESS> Scenarios Assessed by Worker Function	   PAGEREF _Toc120347554 \h  48

  HYPERLINK \l "_Toc120347559"  6.4.2 Pressure Treatment Scenarios (Handler and Post-Application)	  PAGEREF _Toc120347559 \h  55

6.5 Data Limitations/Uncertainties	58

7.0 REFERENCES	59

APPENDIX A: Summary of CMA and PHED Data	61

APPENDIX B: Calculation of DDAC Exposure Values	63

EXECUTIVE SUMMARY

		This document is the Occupational and Residential Exposure Chapter for the active ingredient, Copper, bis (8-quinolinolato-N1,O8)-, commonly referred to as Copper 8-Quinolinolate or Oxine-Copper, as part of the Reregistration Eligibility Decision (RED) document for the Copper Salts (RED Case 4026).  It addresses the potential risks to humans that result from the antimicrobial uses of products containing this chemical in occupational and residential settings.

		The Office of Pesticide Programs (OPP), Special Review and Reregistration Division (SRRD) issued a drafted preliminary risk assessment for a comprehensive RED on Copper compounds which was posted to the Agency docket January 25, 2006 for public comment (EPA’s Pesticide Docket EPA-HQ-OPP-2005-0558).  This Coppers RED included a qualitative human health assessment of copper-containing pesticides from four copper cases, including: Copper II Compounds (0649), Copper Sulfates (0636), Copper and Oxides (4025), Copper Salts (4026) and certain other coppers.  SRRD had determined that the Cupric ion is the component of toxicological interest, regardless of the source of Copper.  Since Copper (Cu) is a naturally occurring metal efficiently regulated in the human system, and due to the lack of systemic toxicity associated with Copper exposure, no toxicological endpoints were selected for human health risk assessment purposes; therefore only a qualitative assessment was conducted (USEPA, 2006).

		The Antimicrobials Division (AD) determined however that a separate RED document would be developed for the copper salt, Copper 8-Quinolinolate, since the pesticide is used solely as an antimicrobial and all registered products are under the regulatory purview of AD.  Also, endpoints of concern have been identified from the available toxicology database for Oxine-Copper, enabling AD to conduct a formal risk assessment.

	Copper 8-Quinolinolate (a.k.a. Oxine-Copper) is an organometallic compound registered as an antimicrobial fungicide for control of decay, sapstain, mold, rot, mildew and certain wood-boring insects (e.g., termites and powder-post beetles) in various preservative applications.  It is approved for use primarily in industrial/commercial wood preservation (Use Site Category X -wood preservatives) for non-pressure and pressure treatments to control sapstain in freshly cut or debarked lumber, and for protection against mold and decay in unfinished wood and various wood products.  It may also be used as a protective wood coating and water-repellent when applied to new and aged wood.  It is intended for mainly exterior above-ground wood use applications and certain interior structural wood construction, including: millwork, sills/baseboards, siding, wooden components of decks, playsets, fences, outdoor furniture, shingles, structural lumber, plywood, composites and interior boat holds. Treated wood materials may be used in contact with fruit, vegetables and other foodstuffs (indirect food contact) in areas such as greenhouses for greenhouse items, produce picking boxes/containers, mushroom trays and vegetable stakes.

Oxine-Copper is also used industrially for materials preservation (Use Site Category VII - materials preservatives ) as a fungistatic dispersion incorporated into manufactured goods including: paper/paperboard, adhesives, paints and cellulose-based cordage/textiles. Copper 8-quinolinolate is additionally used to control mold and mildew on industrial textiles (mainly military-issued or government-specified) such as cloth and webbing used in military tentage, tarps, canvas, burlap, rope, leather and nets (non-aquatic uses only).  It may be used as a water-repellent coating for textiles as well.  Oxine-Copper is used on hard and porous environmental contact surfaces to remediate mold, mildew, and fungal decay (e.g., outdoor painted surfaces, tile, brick/concrete, glass, metal, plastic, leather, wood, and asphalt shingles).

	The chemical is also used commercially in food handling settings as a surface disinfectant to control potato ring rot in planters, seed handling equipment, seed cutters, storage areas and transportation equipment such as railroad cars and trucks (Use Site Category II- food handling/storage establishments, premises, and equipment).

Oxine-Copper was first registered with the Agency as a pesticide on January 5, 1956.  At present there are 27 active registrations for products containing Copper 8-quinolinolate.  The technical grade active ingredients (TGAIs) are powder concentrates registered to two companies, Tanabe U.S.A., Inc. (96% a.i.) and Osmose, Inc. (96% a.i.).  These are technical chemical source products for use by formulators in manufacturing wood preservative and materials preservative end-use products requiring EPA registration.  An additional product, recently approved in 2006, is registered to James Hardie Building Products, Inc. (98% a.i.) as a manufacturing use product (MUP) powder concentrate, specified as an additive to control mold/mildew on cement and pulp/paper (cellulose fiber) ingredients used to manufacture “backerboard” (a.k.a. fiber-cement board).  The rest of the 24 registrations are end-use products (EPs) as soluble concentrates, emulsifiable concentrates and ready-to use (RTU) formulations.  The formulated end-use products can range from 0.25% to 34.18% active ingredient.

The durations and routes of exposure evaluated in this assessment include: short-term (ST ) (1 to 30 days ) and intermediate-term (IT- 30 days to 6 months) dermal route exposures; and, ST/IT and long-term (LT) (longer than 6 months) inhalation route exposures for occupational scenarios. A dermal end-point for LT exposure was not selected for Oxine-Copper.

Residential (non-occupational) handler scenarios were developed as ST dermal and ST inhalation exposures. Residential post-application scenarios included assessing child ST incidental oral and dermal contact with treated wood, treated articles and environmental surfaces.

 For the dermal and incidental oral exposure routes, a ST/IT (systemic) NOAEL of 200 mg/kg/day was used and for inhalation route exposure, a ST/IT/LT NOAEL of 5 mg/kg/day was selected.  A human dermal absorption factor was not selected since the dermal endpoint was derived from a route-specific study. An inhalation absorption factor of 100% was used (default value, assuming oral and inhalation absorption are equivalent) since an oral endpoint was selected for determining inhalation exposures (USEPA, 2006a).

The uncertainty factor or “target” margin of exposure (MOE) for dermal (occupational/residential) and incidental oral (residential) route exposure is 100. Whereas, the target MOE is 1000 for inhalation exposure scenarios for occupational and residential handlers. 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.

		Based on registered use patterns from product labeling on file with the Agency for Oxine-Copper, 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. The representative scenarios selected by the Antimicrobials Division (AD) for assessment were evaluated using maximum application rates as stated on the product labels.

	To assess the handler risks, AD used surrogate unit exposure data from the following proprietary sources: the Chemical Manufacturers Association (CMA) antimicrobial exposure study, the Pesticide Handlers Exposure Database (PHED), and for non-pressure wood treatments, the proprietary sapstain study (SIG Task Force # 73154) was used “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).  Also, the exposure study sponsored by the American Chemistry Council (2002) entitled “Assessment of Potential Inhalation and Dermal Exposure Associated with Pressure Treatment of Wood with Arsenical Wood Products” (ACC, 2002) was used for occupational pressure treatment scenarios.

	Agency standard values and EPA’s Health Effects Division’s (HED) Standard Operating Procedures (SOPs) for Residential Exposure Assessments (USEPA, 2000 and 2001), were used to estimate post-application/bystander exposures. Additionally, certain chemical-specific wood leaching data on file with the Agency for Oxine-Copper (MRID 436370-01) was used as a source for estimating high-end, maximum residue load for child post-application exposure to treated wood.

Handler Risk Summary

		For the residential handler dermal and inhalation risk assessment, the MOEs were above the target MOE of 100 for dermal in all scenarios assessed, and above the target MOE of 1000 for inhalation in most scenarios except the following:

Inhalation Exposure

Painting (amateur) treated paint, airless sprayer: ST MOE = 278.

		It should be noted that for MOEs below 1,000 the Agency may request a confirmatory inhalation toxicity study to refine the potential risks since the current inhalation endpoint is based on an oral NOAEL.

		For the occupational handler dermal and inhalation risk assessment, the MOEs were above the target MOE of 100 for dermal and above the target MOE of 1000 for inhalation in most scenarios except the following:

Dermal Exposure

The calculated dermal MOEs were all above the target MOE of 100 with the use of glove PPE. Baseline dermal estimates for workers without gloves indicated risk concerns for certain scenarios listed below.

General wood preservative brush applications: ST/IT MOE = 47.

Painting (professional) wood coatings, low pressure sprayer: ST/IT MOE = 35.

Painting (professional) treated paint, airless sprayer: ST/IT MOE = 74.

Paper preservation, liquid pump: ST/IT MOE = 12.

Paint preservation, liquid pour: ST/IT MOE = 14.

Textile preservation, liquid pour: ST/IT MOE = 3.

Inhalation Exposure

Most inhalation MOEs were above the target MOE of 1000, except for the scenarios indicated below.  It should be noted that for MOEs below 1,000 the Agency may request a confirmatory inhalation toxicity study to refine the potential risks since the current inhalation endpoint is based on an oral NOAEL.

General wood preservative brush applications: ST/IT/LT MOE = 758.

Paper preservation, liquid pump: ST/IT/LT MOE = 500.

Painting (professional) treated paint, airless sprayer: ST/IT/LT MOE = 83 / 833 (PPE).

Blender/Sprayer Operator (non-pressure sapstain treatment): ST/IT/LT MOE = 212

Post-application/Bystander Risk Summary

	For the residential postapplication risk assessment, exposures resulting from materials preservative/wood preservative treatments yielded MOEs above the respective Agency targets (i.e., ST Dermal/ST Incidental Oral  MOEs =100; ST Inhalation MOE = 1000) for all scenarios except for the following:

Dermal Exposure

Adult/Child dermal contact with treated textiles: ST MOEs = 4 and 67 (adult); 3 and 50 (child) when residue transfer was assumed as 100% and 5% respectively.

	Except for the post-application scenarios assessed for wood preservatives in Section 6.4, occupational post-application exposures were not assessed and assumed to be negligible.

Aggregate exposure risk summary

		Non-dietary short- and intermediate-term aggregate exposures and risks were not assessed for adults and children exposed to Oxine-Copper residues from the use of products in non-occupational environments.  For Oxine-Copper, the toxicity endpoints for routes of exposure assessed (i.e., incidental oral, dermal and inhalation) were selected from three separate studies, each characterized by different toxicological effects. Therefore, aggregating non-dietary exposure risks was not considered appropriate.

		In addition, since the majority of registered products are for industrial/commercial-use, representative scenarios for residential exposure are limited to adult handlers painting with wood preservative surface coatings/water repellents or treated paint products containing Oxine-Copper as an in-can preservative.  Potential child post-application exposure is limited to contact with residues on mainly in-service treated wood and on environmental outdoor surfaces which may be treated for mold/mildew control by commercial applicators in residential sites. Textile preservation appears to be limited to industrial textiles and government-issued (military specified) treatments for cellulose-based cotton, canvas, tentage/tarps, cordage and paperboard.

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 may request 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 the AD Draft SOP use table.  In certain cases, no standard values were available for some scenarios.  Assumptions for these scenarios were based on AD estimates and could be further refined from input from registrants.

The low pressure spray unit exposure data from PHED were used to assess outdoor applications of wood preservative coatings (exterior of homes).  As the low pressure spray data are representative of treating low to mid level range targets (shrubs/greenhouse benches) and the scenario assessed in this document represents treatments that may also occur above the waist, the unit exposure value may underestimate exposure to the head and the upper body.

The methods used to estimate child and adult exposures to treated textiles are highly conservative and based on approaches from the Residential SOPs (USEPA 2000, and 2001) for contact with porous treated surfaces (clothing, mattresses and carpets). Without data on actual treated textile residues, dissipation or dermal transfer coefficients, these scenarios have a high degree of uncertainty associated with them. The registrants input will assist in refining the MOEs and confirming the Oxine-Copper textile use patterns.

In this assessment, incidental ingestion and dermal exposures to treated wood were estimated using surrogate DDAC data (3 (g/cm2).  The degree of uncertainty (under- or overestimation) associated with using the DDAC hand residue data for dermal and oral exposure from contacting treated lumber are unknown.  The amount of residue measured on the test subjects’ hands is variable and may be influenced by the duration of exposure, how often wood is contacted, and the degree of contact (i.e., do the hand residues from the DDAC study mimic a child’s play activity on decks and playsets?). In comparison, measured wood retention data from a chemical-specific leaching study (MRID 436370-01) were used as a surrogate to represent potential residue load for child contact. The maximum surface retention (surface deposition) measured from lumber spray-treated with Oxine-Copper (27 (g/cm2) was used as a conservative, high-end estimate. There is a high degree of uncertainty associated with this value as well.

Data are not available to assess the levels of Oxine-Copper in soil contaminated from Oxine-Copper-treated wood (e.g., above ground fabricated components of decks or playsets). Because of this data gap, EPA was not able to estimate residential post-application dermal and incidental oral ingestion exposure to soil contaminated with Oxine-Copper residues.  It is assumed that any soil residues attributed to weathering of in-service wood (playsets) will remain near these structures for potential child exposure. [Note: Soil migration study data (MRIDs 429255-03, 429255-04) on file with the Agency for Oxine-Copper indicate that between 88-90% of the applied active remained in 0-6 cm of the tested soil columns, indicating limited leaching and migration from soil matrices (USEPA, 2006c).]

	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 Handlers Exposure Database (USEPA, 1998) (See Appendix A for summaries of these data sources).   Since the CMA data are of poor quality, the Agency may request that confirmatory data be submitted in order to support the occupational scenarios assessed in this document.

The low pressure spray unit exposure data from PHED were used to assess both outdoor environmental surface treatments (materials preservative) and applications of wood coatings/water repellents (wood preservatives).  As the low pressure spray data are representative of treating low to mid level range targets (shrubs/greenhouse benches) and the scenarios assessed in this document represents treatments that may also occur above the waist, the unit exposure value may underestimate exposure to the head and the upper body.

For the wood preservative pressure treatment scenarios, surrogate CCA exposure data were used for lack of chemical-specific exposure data for this use pattern. For the wood preservative non-pressure treatment scenarios, surrogate DDAC exposure data were used for the lack of chemical-specific exposure data.  Limitations and uncertainties associated with the use of these data include:

The assumption was made that exposure patterns for workers at treatment facilities using CCA and DDAC would be similar to exposure patterns for workers at treatment facilities using Oxine-Copper, and therefore the exposures could be used as surrogate data for workers that treat wood with Oxine-Copper based formulations.

For environmental modeling, it was assumed that the leaching process from wood treated with Oxine-Copper would be similar to that of CCA and DDAC. However, due to the lack of robust data for Oxine-Copper -treated wood, it is not possible to verify this assumption.

The quantities handled/treated were estimated based on information from various sources, including Agency standard assumptions, HED’s Standard Operating Procedures (SOPs) for Residential Exposure Assessments (USEPA, 2000 and 2001), and professional judgment based on Agency understanding of industrial practices.  In certain cases, no standard values were available for some scenarios.  Assumptions for these scenarios were based on AD estimates and could be further refined with input from registrants.

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 Oxine-Copper. This information is for use in EPA's development of the stand alone assessment for the copper salt, Copper 8-Quinolinolate, as part of the Reregistration Eligibility Decision document (RED) for Copper Salts (Case 4026).

		The Office of Pesticide Programs (OPP), Special Review and Reregistration Division (SRRD) issued a drafted preliminary risk assessment for a comprehensive RED on Copper compounds which was posted to the Agency docket January 25, 2006 for public comment (EPA’s Pesticide Docket EPA-HQ-OPP-2005-0558).  This Coppers RED included a qualitative human health assessment of copper-containing pesticides from four copper cases, including: Copper II Compounds (0649), Copper Sulfates (0636), Copper and Oxides (4025), Copper Salts (4026) and certain other coppers.  SRRD had determined that the Cupric ion is the component of toxicological interest, regardless of the source of Copper.  Since Copper (Cu) is a naturally occurring metal efficiently regulated in the human system, and due to the lack of systemic toxicity associated with Copper exposure, no toxicological endpoints were selected for human health risk assessment purposes; therefore only a qualitative assessment was conducted (USEPA, 2006).

		The Antimicrobials Division (AD) determined however that a separate RED document would be developed for the copper salt, Copper 8-Quinolinolate, since the pesticide is used solely as an antimicrobial and all registered products are under the regulatory purview of AD.  Also, endpoints of concern have been identified from the available toxicology database for Oxine-Copper, enabling AD to conduct a formal risk assessment.

		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 Copper 8-Quinolinolate (Oxine-Copper), 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 µg) 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)

Where:

E	=	Amount (mg or (g 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 selected for inhalation exposures of all durations; therefore, an absorption factor of 100% was used (default value, assuming oral and inhalation absorption are equivalent).  A dermal absorption factor was not necessary for the short-term and intermediate-term exposures because the 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 this assessment, 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:

The copper salt, Copper 8-Quinolinolate, is a broad spectrum fungicide predominantly used as a wood preservative, a materials preservative, and to a lesser degree as an environmental surface treatment and a disinfectant against potato ring rot. As such, AD has patterned this risk assessment on a series of likely scenarios for use sites believed to be representative of the vast majority of Oxine-Copper use patterns.

Based on the adverse effects for the endpoints, the average body weight of 70 kg was used for an adult (and 15 kg for children in the post-application assessment) as appropriate 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 product labeling were assumed.

		1.3	Chemical Identification

	Copper 8-Quinolinolate is a coordination compound (i.e., a 1:2 coordination complex) between copper and the organic ligand 8-hydroxyquinoline.  Table 1.1 shows chemical identification information for the Oxine-Copper technical grade active ingredient (TGAI).

Chemical Name

Copper, bis (8-quinolinolato-N1,O8)-

Common Name

Copper 8-Quinolinolate/ Oxine-Copper

Chemical Code	024002

CAS Number

10380-28-6

Molecular Formula	C18H12CuN2O2

		1.4	Physical/Chemical Properties

		Table 1.2 shows physical/chemical characteristics that have been reported for Oxine-Copper.  The chemical is stable under normal conditions and considered non-volatile. Due to the low solubility properties of the TGAI in water and solvents, formulated end-use products contain ingredients which provide solubilized forms of Oxine-Copper for use in both water-, oil- and solvent-borne preservative treatment solutions.

Table 1.2.  Physical/Chemical Properties of Oxine-Copper TGAI

Parameter

Copper 8-Quinolinolate

Molecular Weight	                                                     351.851

Color/Odor

Olive Green/Odorless (slightly phenolic)

Physical State

Crystalline powder

Specific Gravity

1.63 g/ml

Stability

Stable under normal conditions. Stable under UV irradiation. It is not flammable, nor oxidizing.

Melting Point

270 o C (decomposes below MP)

Boiling Point

Not determined

Water Solubility

0.7 mg/L at 25 o C (Insoluble)

Solvent Solubility

Insoluble in ethanol and common organic solvents (slightly soluble in pyridine)

Kow	3.14

Vapor Pressure (VP)	Assumed to be non-volatile.  Cannot be calculated even at 270 o C *

* (EPISuite Program estimated the VP of copper-8 as: 6.3 x 10-12  mm Hg)

Source: Certain data presented in Tables 1.1 and 1.2 were taken from an October 27, 2006 Review Memorandum, “Product Chemistry Science Chapter for Copper-8 Quinolinolate or Copper-Oxine” from A. Najm Shamim, PhD., 	Chemist, AD.

2.0	 USE INFORMATION

		2.1	 Formulation Types and Percent Active Ingredient

	The twenty-seven (27) products containing Copper 8-Quinolinolate active ingredient (a.i) are registered as either industrial-use technical chemical source products or formulated end-use products for industrial/commercial and residential use as fungicidal preservatives.   Currently, there are three (3) registered manufacturing-use products (MUPs) in the form of powder concentrates as technical grade active ingredient (TGAI) and formulator-use chemical source products for manufacturing pesticide end-use products (EPs).  The twenty-four (24) formulated EPs containing Oxine-Copper are soluble concentrates, emulsifiable concentrates and  ready-to-use (RTU) solutions. Concentrations of Oxine-Copper in the MUPs are from 96% to 98%.  The remaining EPs contain between 0.25% to 34.18% active ingredient.  The majority of EPs are as solubilized formulations containing 10% Oxine-Copper. There are no inert uses for Copper 8-Quinolinolate.

		2.2	 Summary of Use Patterns and Formulations

	Oxine-Copper has been used for over 50 years as a contact fungicide for the protection of wood and a wide range of materials. As part of the re-registration process for Copper 8-Quinolinolate the Antimicrobials Division (AD) has met with three registrants who manufacture the technical grade active ingredient (TGAI) source products and MUPs to better understand the allowed use patterns supported under this RED case (USEPA, 2006b). When the MUPs and formulated end-use products for this chemical were registered, data to address human exposure were "reserved" (i.e., not imposed).  Therefore, EPA has no chemical-specific worker monitoring study data, nor product use and human activity data, to best characterize use patterns and develop occupational and residential exposure dose estimates.

Osmose, Inc. and Tanabe USA, Inc. hold registrations for the technical grade active ingredient MUPs (96% a.i. powders) from which registered end-use products are formulated for wood preservative and/or materials preservative uses. James Hardie Building Products, Inc. has a niche market MUP (98% a.i. powder) used as an additive in the manufacture of fiber-cement backerboard.  For the rest of the registrant community with active product registrations for Oxine-Copper, the Agency has had to rely on the most current accepted product labeling on file for the numerous other products attributed predominantly to IBC Manufacturing Co. (11 products), Rohm & Haas Co. (8 products), and Kop-Coat, Inc. (3 products).

	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.

Table 2.1. Potential Use Scenarios Based on Copper 8-Quinolinolate Product Use Patterns

Example Use Sites	Scenarios

Use Site Category X -Wood Preservatives

Used in the preservation of wood products against mold, rot, decay and for sapstain control. Also repels termites and other insects. For interior and exterior applications:

Fresh-cut and debarked  lumber, poles, posts, timbers;

Dry lumber, general structural wood, building construction lumber, sub-flooring/framing lumber;

Wood products such as logs (including log home exterior wood protection, poles, timbers, stakes, wood composites, boards,  plywood, fencing, wood shingles, wood siding, millwork, sills/baseboards wood components for decks, playsets, furniture, interior boat holds);

Wood in contact with foodstuffs (indirect-food contact) boxes, bins, beverage cases, mushroom trays, fruit and vegetable produce containers, pallets, nursery and greenhouse trays/flats.  	Application to wood by pressure and non-pressure treatment methods in oil/solvent-borne or water-based solutions.

Industrial/Commercial and Residential:

Non-pressure treatment of above-ground and ground-contact wood and wood products (including indirect food contact wood) through methods such as dipping, conventional spray system, spray box, low pressure spray, low volume spray machine, immersion,  brush, roller coater, and flood.

Surface application of protective coatings and water-repellents to wood via low pressure spray/brush/roller.

Industrial/Commercial:

Pressure treatment of wood and wood products for above-ground uses through methods such as vacuum and empty-cell (AWPA P8 Standard specified for above-ground treated wood uses).  The minimum specified retention (as Oxine-Copper active ingredient) for these applications is 0.32 kg/m3 (0.02 lb/ft3).

Use Site Category VII - Material Preservatives

Used to protect various manufactured end products and treated articles (fungistatic and water repellent treatments) for predominantly commercial/industrial and government-specified uses, as well as institutional and consumer use (residential household, farm and greenhouse)

Industrial/Commercial - Incorporation during manufacture/processing to:

Adhesives/glues; Cement; Paints and Coatings

Paper and paperboard (military-issued shoe counters/shoe boards, Kraft paper, agricultural-use paper)

Textiles (industrial textiles/fabrics, industrial and military-issued cotton, cotton duck, webbing, nets, rope/cordage, twine, canvas and burlap);

	Industrial/Commercial– Impregnation of articles via Brush/Spray/Dip to finished :

Textiles (industrial textiles/fabrics, industrial and military-issued cotton, cotton duck, webbing, nets, rope/cordage, twine, canvas, burlap and leather);

Paper and paperboard (Kraft paper, agricultural-use paper);

Leather

	Industrial/Commercial -Environmental outdoor surface treatments via Brush or Spray for mold and mildew control to:

Painted surfaces, concrete, brick, glass, tile, metal, plastic, wood, (paper)*, (leather)*, textiles and asphalt shingles.

* - Treatments to these materials may indicate potential indoor uses.    Clarification of labeling is needed.

Use Site Category II - Food handling/storage establishments, premises and equipment

Used for indoor hard surface disinfection against Potato Ring Rot on surfaces in food handling/ processing equipment and premises.

Industrial/Commercial – Non-mist Low Pressure Spray applications at Potato processing, storage and transportation facilities:

Potato (seed) Cutters/Handling Equipment/Planters/Storage Equipment

Railroad Boxcars (Feed/Food-full) (Non-residual Contact Treatment)

Railroad cars (Feed/Food-empty)

Trucks (Feed/Food-Full) (Non-residual Contact Treatment).

	From the use patterns shown in Table 2.1, AD selected exposure scenarios representative of the vast majority of uses and those believed to provide potential high-end dermal, inhalation, or incidental oral 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

	The acute toxicity database for this compound is considered complete.  Animal studies conducted with technical grades of Copper 8-Quinolinolate active ingredient show low acute oral toxicity (Toxicity Category IV) and moderate acute dermal toxicity (Toxicity Category III).  Data indicate moderate to severe acute inhalation toxicity (Toxicity Category II), and severe primary eye irritation (Toxicity Category I).  The compound exhibits low potential for dermal irritation (Toxicity Category IV) and is not a dermal sensitizer. The acute toxicity data for Oxine-Copper TGAI are summarized below in Table 3.1.

Table 3.1 Acute Toxicity Profile for Copper 8-Quinolinolate (Oxine-Copper) TGAI

Guideline Number	Study/Test Substance 	MRID	Results	Toxicity Category

870.1100	Acute oral, rat

Oxine-copper, 99.5%	42921501	LD50 > 5000 mg/kg (combined)	IV

870.1200	Acute dermal, rat

Oxine-copper, 99.5%	42921502	LD50 > 2000 mg/kg (combined)

	III

870.1300	Acute inhalation, rat   Oxine-copper 96%

  Whole-body	43611901	LC50  = 0.089 mg/L	II

870.1300

	Acute inhalation, rat

Whole-body	00079231	LC50 = 0.82 mg/L	II

870.1300	Acute inhalation, rat   Oxine-copper 99.7%

Nose-only	41678401	LC50 = 0.15 mg/L	 II

870.2400	Primary Eye Irritation, rabbit

Oxine-copper 98%	41678402	Corneal opacity and conjunctival redness through day 21 post-dose	I

870.2500	Primary Dermal Irritation, , rabbit	42921503	No irritation observed	IV

870.2600	Dermal sensitization, guinea pigs

 Oxine-copper, 99.7%	42921504	Not a dermal sensitizer	N/A

Source:  June 13, 2006 Review Memorandum “Oxine Copper (copper 8-quinolinolate) - Endpoint Selection Report” from T.F. McMahon, Ph.D., Senior Toxicologist, AD (USEPA, 2006a).

	3.2	Summary of Toxicity Endpoints

	On June 8, 2006, toxicity endpoints of concern were selected for Oxine-Copper (Copper 8-Quinolinolate) by Antimicrobials Division toxicologists’ and members of the former Antimicrobials Division Toxicity Endpoint Selection Committee (ADTC) based on submitted dose-response studies conducted with animals.  These dose-response studies conducted with the technical grade active ingredient indicate that Oxine-Copper does not elicit neurotoxic, reproductive or developmental effects. Also, it is not mutagenic, nor is there evidence of carcinogenicity based on available animal studies.

	For the non-dietary exposure assessment presented herein, route-specific toxicity studies were found acceptable for selecting incidental oral and dermal endpoints. However, the inhalation endpoint relied on an oral study and therefore an additional 10x uncertainty factor is applied. The endpoint selection memorandum (USEPA, 2006a) noted a need for a repeated dose inhalation toxicity study with Oxine-Copper to fulfill the current data gap and allow for adequate assessment of risk from inhalation exposures arising from paint and wood preservative uses.   Table 3.2 summarizes the selected toxicological endpoints which are further detailed in the toxicology chapter and preliminary risk assessment developed for this RED (USEPA, 2007).

Table 3.2     SEQ CHAPTER \h \r 1 Summary of Toxicological Doses and Endpoints for Oxine-Copper for Use in Human Risk Assessments

  SEQ CHAPTER \h \r 1 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 =

5 mg/kg/day

	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)

Chronic RfD (cPAD) = 0.05 mg/kg/day	 Subchronic Toxicity in the Dog

MRID 42986802   (99.5% a.i.)

LOAEL = 50mg/kg/day, based on vomiting, decreased total plasma protein and albumin, and reddened mucosa and hyperemia in the stomach and small intestine.

Non-Dietary Risk Assessments

Incidental Oral Short-Term

(1-30 days)

Intermediate-term

(30-days – 6months) 	NOAEL (maternal)  =  200 mg/kg/day

	Target MOE = 100

(UF =10x inter-species extrapolation, 10x intra-species variation)

FQPA SF = 1	Prenatal Developmental Toxicity Study in the Rat   MRID 42986803   (98.5% a.i.)

LOAEL (maternal) = 800 mg/kg/day, based on clinical signs of toxicity and decreased body weight gain in maternal rats.

Dermal

Short-Term (1 to 30 days) and Intermediate-term (30 days- 6 months)

(residential and occupational)	NOAEL (systemic) =

200 mg/kg/day

	Target MOE = 100

(UF = 10x inter-species extrapolation, 10x intra-species variation)

	28-Day Dermal Toxicity Study in the Rat

MRID 42957802   (99.7% a.i.)

LOAEL (systemic)  = 1000 mg/kg/day, based on  necrosis of thymic lymphocytes.

No evidence of dermal irritation from either this study or the acute dermal study

Dermal

Long-Term ( >6 months)

(residential and occupational)	A long-term dermal endpoint is not required for Oxine-copper.

Inhalation (all durations)

(residential and occupational)	NOAEL = 5 mg/kg/day a

	Target MOE = 1000

(UF = 10x inter-species extrapolation, 10x intra-species variation, 10x route extrapolation)	 Subchronic Toxicity in the Dog

MRID 42986802   (99.5% a.i.)

LOAEL = 50mg/kg/day, based on vomiting, decreased total plasma protein and albumin, reddened mucosa and hyperemia in the stomach and small intestine.

Cancer	Oxine-Copper has not been formally classified as to carcinogenicity.

Source: June 13, 2006 Review Memorandum “Oxine Copper (copper 8-quinolinolate) – Endpoint Selection Report” from T.F. McMahon, Ph.D., Senior Toxicologist, AD (USEPA, 2006a).

UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (c = chronic), RfD = reference dose, MOE = margin of exposure.

a 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.  If results are below an MOE of 1,000, a confirmatory inhalation study is warranted.

	3.3	FQPA Considerations

	Neurotoxicity, Reproductive and Developmental Toxicity Study Conclusions:

	There was no evidence to suggest a neurotoxic effect of Oxine-Copper from the available toxicology data on this chemical.  There is one acceptable reproductive toxicity study which showed no evidence of primary reproductive effects.   Also, there was no evidence for a primary developmental effect in either of the two acceptable developmental toxicity studies available for Oxine-Copper done on the rat and rabbit.

	Recommendation for a Developmental Neurotoxicity Study:

	A developmental neurotoxicity study for Oxine-Copper is not needed at this time.

The available data show no neurotoxic effects from administration of the chemical in experimental animal studies.

Hazard-based Recommendation for the FQPA safety factor:

	The ADTC concluded that the special hazard-based FQPA safety factor of 10x can be reduced to 1x.  The available developmental and reproductive toxicity data for Oxine-Copper show no evidence of teratogenicity or reproductive toxicity.  The studies are conducted according to guidelines and show no evidence of increased susceptibility of offspring.  There is no evidence for neurotoxicity of Oxine-Copper.

4.0	RESIDENTIAL EXPOSURE ASSESSMENT

	4.1	Summary of Registered Uses

The majority of registered products are intended for industrial/commercial uses in the preservation of materials/wood during manufacture, or through impregnation and surface treatments against fungicidal decay in non-residential use sites.  However, some end-use products containing Oxine-Copper are for protection of wood found in residential sites as well as residential application of wood coatings and water repellents.  Some are ready-to-use RTU products sold to consumers for home/farm uses to protect outdoor wood surfaces (e.g., fencing, wood siding/shingles/roofs, log homes).

	Also, the Oxine-Copper-treated wood itself is used for fabrication of residential structures (e.g., outdoor above-ground fencing, playsets, decks) and in home renovation (interior sub-flooring and framing lumber).  Material preservation of textiles are intended for mainly industrial/government-specified (i.e., military-issued) end-use applications (USEPA, 2006b).  However, the Agency cannot rule out the possibility of consumers coming in contact with treated textiles (e.g., obtaining Army-grade canvas tents treated with Oxine-Copper). Commercial remediation treatments to outdoor environmental surfaces in residential sites (e.g., brick, concrete and tile) may also contribute to residential post-application exposure.  Table 2.1 presents a summary of all exposure scenarios that may occur from uses in residential settings based on examination of product labels.  Table 4.1 identifies the representative residential exposure scenarios considered for assessment in this document.

	4.2	Dietary Exposure

	The Agency has not set any tolerances for this chemical and certain Oxine-Copper uses in preserved wooden articles (e.g., fruit/vegetable containers) and paper may result in indirect food-contact residues.  However, the U.S. Food and Drug Administration (U.S. FDA) permits use of this preservative as an indirect food additive as cited in 21 CFR Part 176 [Indirect food additives: paper and paperboard components - 176.170 (b) (2)] and in 21 CFR Part 178 [Indirect food additives: adjuvants, production aids, and sanitizers - 178.3800 (b) preservatives for wood].  Any risks pertinent to dietary exposures are discussed separately from this chapter in the Preliminary Risk Assessment for this RED.

	4.3	Drinking Water Exposure

Oxine-Copper is not used for potable water treatment, nor are effluents containing this chemical expected in fresh water environments. Any risks pertinent to drinking water exposures, if applicable, are discussed separately from this chapter in the Preliminary Risk Assessment for this RED.

	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 include treatments to wood surfaces (e.g., water repellents and coatings applied via brush, roller and low-pressure coarse spray). Additionally, handler exposures were assessed for the application of manufactured paint products containing Oxine-Copper as a preservative (paint brush/roller and airless sprayer).

Table 4.1. Representative Uses Associated with Residential Exposure

Representative Use

Exposure Scenario

Application Method

EPA Reg. No.

Maximum Application Rate

Using Wood Preservative Coatings/ Water Repellents 	ST Handler: Adult Dermal and Inhalation	Paint brush,

Roller and Low-pressure coarse sprayer

	1022-514 and 81819-1	0.675% ai ready-to-use (RTU) oil-based exterior coating for log homes, wood roofs, siding, fences, rough sawn lumber, new/old wood. 150-300 sq ft/gal. as one coat application.

Using Treated Paints/Coatings             (in-can preservative)

ST Handler: Adult Dermal and Inhalation

(aerosol particulates)6

Paint brush,

Roller,

Airless sprayer

Commercially-treated article preserved with 2829-136 (e.g., exterior house paint)

Solvent-based paint containing 1.0% ai incorporation to inhibit mold/mildew. (Paint use applications unspecified).

Contact with treated Textiles (i.e., outdoor-use treated tents/tarps, canvas exposed to the elements and prone to decay)

Note: Textiles are not Clothing Apparel, Bedding or Home-goods 	ST Post-application: Adult dermal; Child Incidental oral ingestion and Dermal

	NA	Commercially- treated articles preserved with 2829-42;     2829-49; and 2829-112 	0.7-1.0% ai used to treat canvas fabric

Environmental Outdoor Hard Surface Treatments

(i.e., mold and mildew control treatments to exterior environmental surfaces ) 	ST Post-application: Child incidental oral ingestion and Dermal

NA

Commercial application done

via Brush/Spray at residential sites with

1022-489;

1022-490; and

75675-1

0.1% ai treatment solution used on painted/varnished surfaces, concrete, brick, glass, tile, metals, plastic, wood, (paper)*, (leather)*, textiles and asphalt shingles.

* - Treatments to these materials may indicate potential indoor uses. Clarification of labeling is needed.

Contact with treated Wood products (i.e., outdoor playsets, decks, wood structures)

	ST Post-application: Child incidental oral ingestion and Dermal	NA

Commercially- treated wood preserved with 2829-135 and 2829-136, used for above-ground applications (via pressure and non-pressure methods)

1.0% ai used to treat wood via pressure methods resulting in an active ingredient retention of 0.02 lb/ft3.

Note: Only EPA registered products with specified use directions/use applications are included in this table.

Products listed were selected based on maximum use rates by application method.

ST = Short-term exposure

6 Handler dermal and inhalation (to the particulates) exposure were assessed for Oxine-Copper using PHED unit exposures.

	4.4.1	Residential Handler Exposures

	The residential handler scenarios described in Table 4.1 were assessed to determine dermal and inhalation exposures.  These scenarios were assessed using PHED data and Equations 1-3 in Section 1.2, “Criteria for Conducting Risk Assessment.”  Residential handlers using Oxine-Copper-treated paint (as an in-can preservative) may have inhalation exposures to aerosol particulates during airless spray applications.  Aerosols are not anticipated for the wood coatings applications using a low-pressure sprayer (non-misting).  In the case of Oxine-Copper, the technical-grade chemical has a low vapor pressure (6.3 x 10-12 mm Hg) and therefore it is expected to be non-volatile in end product formulations.

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

Unit Exposure Values: Unit exposure values were taken from the Pesticide Handlers Exposure Database (PHED) data presented in HED’s Residential SOPs (USEPA, 1997). A summary of the PHED database is presented in Appendix A.

For the low pressure sprayer (course spray) scenario, the PHED dermal and inhalation unit exposure values for a residential handler pouring a pesticide and applying it via a low pressure sprayer (handwand) were used.  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. The density of paint is assumed to be 10 lbs/gallon.

For the low pressure sprayer in wood coating applications it is assumed that 50 lbs (approximately 5 gallons) of RTU 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 paint products is believed to be best represented by the short-term duration (1 to 30 days).  The Agency assumes that painting events are episodic, not daily.

Results

	The resulting short-term exposures and MOEs for the representative residential handler scenarios are presented in Table 4.2. The calculated ST MOEs were above the target dermal MOE of 100 for all scenarios.  The high-end scenario developed for airless sprayer yielded a ST inhalation MOE below the target of 1000, as 278, indicating a potential risk concern. Confirmatory inhalation toxicity study data may be required to address this.

Table 4.2 Short-Term Oxine-Copper Residential Handlers Exposures and MOEs

Exposure Scenario

Method of Application

Unit Exposure

(mg/lb ai)

Application Rate

Quantity Handled/ Treated per day

Absorbed Daily Dose (mg/kg/day)

MOE (ST)

Dermala

Inhalationb

Dermalc

Inhalationd

Dermal

(Target = 100)e

Inhalation (Target = 1000)f

Using

Wood Coatings

	Low Pressure Sprayer

100

0.030

0.675% ai by weight

	50 lbs

(5 gal)

0.482

0.00015

415

33,333

Using Treated Paint

Brush/roller

230

0.284

1.0% ai by weight

20 lb s

 (2 gal)

0.657

0.0008

304

6,250

Airless sprayer

79

0.83

1.0% ai by

 weight	150 lbs (15 gal)

1.69

0.018

118

	278

a	All dermal unit exposures represent ungloved replicates. The low pressure sprayer, brush/roller, and airless sprayer unit exposures represent short sleeve and short pant replicates.

b	No respirator used by exposed individual.

c	Dermal Daily Dose (mg/kg/day) = [dermal unit exposure (mg/lb ai) * application rate (0.00675 or 0.01) * quantity handled * dermal absorption factor (NA) / body weight (70 kg).

d	Inhalation Daily Dose (mg/kg/day) = [inhalation unit exposure (mg/lb ai) * application rate (0.00675 or 0.01) * quantity handled * inhalation absorption factor 100% / body weight (70 kg).

e	Dermal MOE = NOAEL (200 mg/kg/day) / Daily Dose. Target dermal MOE is 100.

f 	Inhalation MOE = NOAEL (5 mg/kg/day) / Daily Dose. Target inhalation MOE is 1000.

	4.4.2	Residential Post-application Exposures

 	For the purposes of this screening level assessment, post-application scenarios have been developed to encompass potential high-end exposure from various wood/materials preservative treatments.  As shown in Table 4.1, representative post-application scenarios assessed include child contact with surface residues from Oxine-Copper treated wood (dermal and incidental oral exposure) and residues remaining on treated outdoor hard surfaces (dermal and incidental oral exposure to children).  Scenarios were also developed for contact with  residues on treated textiles such as tents and tarps (dermal exposure to adults and children and incidental oral exposure to children).

	Typically, post-application exposures in residential settings are assumed to occur over a short-term duration (1 to 30 days) as episodic, not daily events.  AD does not believe that the use patterns for Oxine-Copper will result in any intermediate-term residential exposures.

	<IP_ADDRESS>		Outdoor Hard Surfaces/Remedial Fungistatic Surface Treatments

Dermal Exposure to Children from Treated Outdoor Surfaces

Exposure Calculations

	There is the potential for dermal exposure to toddlers crawling on hard outdoor surfaces (e.g., brick/tile or concrete surfaces of walkways/patios) after periodic surface treatments with Oxine-Copper products.  Exposures and MOEs were calculated for children contacting treated hard surfaces in residential sites (short-term exposure).

To determine toddler exposure to surface residues after commercial remediation (via brush/spray), 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	=	Treatment Solution fraction remaining on hard surfaces (unitless);

CF1	=	Conversion factor (4.54x105 mg/lb);

CF2	=	Conversion factor (10.8 ft2/m2);

SA	=	Surface area of the body in contact with treated surface (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, 1997a).

The product labels (for 1022-489, 1022-490 and 75675-1) did not provide information on the volume of product to be used for treating hard-contact surfaces.  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 0.1% ai [1:100 dilution in water of a 10% ai product (1022-489) = 0.1% ai in treatment solution]. Therefore, the water-based application rate of 0.1% ai as a weight fraction (0.001) yields a density of (0.00834 lb ai/gal) assuming the density of water (8.34 lbs/gal).  Therefore, the application rate used in the post-application scenario is 0.00000834 lb ai/ft2.

Labels state “re-inspect annually and retreat as necessary” so treatment  by commercial applicators for mold remediation are assumed to be done at residential sites no more than once a year, twice at most.

No data could be found regarding the quantity of solution residue left on surfaces after treatment. As a conservative measure, it has been assumed that 25% of the applied solution remains after treatment by brush or spray.

No transferable residue data were available that could be used to estimate the transfer of Oxine-Copper from hard surfaces to skin.  Therefore, it is assumed that 10% of the deposition rate is available for dermal transfer (USEPA, 2000, and 2001).

Results

	The calculated short-term dermal exposure dose and MOE is shown in Table 4.3.  The dermal MOE of 4,484 is above the target MOE of 100 and is therefore not of concern.

Table 4.3.  Short-term Post-application Dermal Exposure and MOE for Children Contacting Treated Outdoor Hard Surfaces

Exposure Scenario

Application Rate

(lb ai/sq ft)

Product remaining after treatment

Percent Trans. Residue

Body Area in contact with surface (m2)

Absorbed potential daily dosea (mg/kg/day)	ST

Dermal MOEb

Target = 100

Treated Outdoor Hard surfaces - residential setting

8.34 x10-6

25%

10%

0.657

0.0446

4,484

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 hard surface treatment, 25%) * (dermal transfer factor, 10%) * (body surface area in contact with floor, 0.657 m2) * (dermal absorption , NA) ] / (body weight, 15 kg)

b	Dermal MOE  = NOAEL (mg/kg/day) / Absorbed Potential Daily Dose (mg/kg/day) [Where short-term dermal NOAEL (systemic) = 200 mg/kg/day].  Target MOE = 100.

Child Incidental Ingestion Exposure to Treated Floor Residues

Exposure Calculations

	In addition to dermal exposure, toddlers crawling on treated outdoor hard surfaces will also be exposed to Oxine-Copper residues via incidental oral ingestion through hand-to-mouth activity.  To calculate incidental oral ingestion exposure to this chemical via hand-to-mouth transfer, the methodologies established in the Standard Operating Procedures (SOPs) for Residential Exposure Assessments (USEPA 2000 and, 2001) were used.  These SOPs use assumptions that are similar to those used above in calculating the dermal exposure for toddlers crawling on residential outdoor treated surfaces.  Exposure was calculated 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		=		Treated surface residue (μg/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/µg); and

BW		=		Body weight (15 kg)

And

SR=AR x DRF x CF2 x CF3

where:

SR		=		Surface residue (µg/cm2);

AR		=		Application rate (lb ai/ft2);

DRF		=		Treatment Solution fraction remaining on treated surface (unitless);

CF2		=		Unit conversion factor (4.54x108 µg/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).

The exposure time was 4 hours a day (USEPA, 2000 and 2001).

The saliva extraction efficiency was 50% (USEPA, 2000 and 2001).

The product labels (for 1022-489, 1022-490 and 75675-1) did not provide information on the volume of product to be used for treating hard-contact surfaces.  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 0.1% ai [1:100 dilution in water of a 10% ai product (1022-489) = 0.1% ai in treatment solution]. Therefore, the water-based application rate of 0.1% ai as a weight fraction (0.001) yields a density of (0.00834 lb ai/gal) assuming the density of water (8.34 lbs/gal).  Therefore, the application rate used in the post-application scenario is 0.00000834 lb ai/ft2.

Labels state “re-inspect annually and retreat as necessary” so treatment  by commercial applicators for mold remediation are assumed to be done at residential sites no more than once a year, twice at most.

No data could be found regarding the quantity of solution residue left on surfaces after treatment.  As a conservative measure, it has been assumed that 25% of the applied solution remains after treatment by brush or spray.

No transferable residue data were available that could be used to estimate the transfer of Oxine-Copper from hard surfaces to skin.  Therefore, it was assumed that 10% of the deposition rate is available for dermal transfer (USEPA, 2000 and 2001).

Results

	The calculated short-term incidental oral exposure dose and MOE is shown in Table 4.4.  The oral MOE is 36,765, which is over the target MOE of 100 and therefore not of concern.

Table 4.4.  Short-term Incidental Oral Post-application Exposure and MOE

for Children Contacting Treated Outdoor Hard Surfaces

Exposure Scenario

Appl. Rate

 (lb ai/

sq ft)

Product remaining after treatment

Surface Residuea (µg/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)

ST Oral

MOEc

Target = 100

Treated Outdoor Hard surfaces - residential setting

8.34 x10-6

25%

1.02

10%

20

20

50%

4	0.00544	36,765

a 	Surface residue (µg/cm2) = (application rate, lb ai/ft2)*(product fraction remaining on surface, 0.25)*(conversion factor to convert lb to µg, 4.54E+08 µg/lb)*(conversion factor to convert ft2 to cm2, 1.08E-03 ft2/cm2)

b 	Absorbed Potential Daily Dose  (mg/kg/day) = [(Surface residue, µg/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)*(extraction by saliva, 50 %)*(conversion factor to convert µg to mg, 0.001 mg/µg)]/(body weight, 15 kg)

c 	MOE = NOAEL (mg/kg/day) / absorbed potential daily dose(mg/kg/day) [Where short-term oral NOAEL (maternal) = 200 mg/kg/day].  Target MOE = 100.

	<IP_ADDRESS>		Treated Textiles

Dermal Exposure to Adults and Toddlers from Contacting Treated Textiles (Canvas Tents)

	The Agency assumes that there is the remote potential for dermal exposure to adults and children from contact with fabric (canvas tents) treated for mildew control at military-specified levels of 1.0% Oxine-Copper via factory impregnation. From our understanding of registered use patterns, textiles treated with Oxine-Copper preservatives meet the needs of niche markets for government (military-issued) and industrial textiles.  Registrant input is needed to confirm that residential consumers will have limited contact with Oxine-Copper-treated textiles.

	This post-application assessment assumes the tent is new (i.e., not laundered and not yet exposed to rainfall and outdoor elements) as a conservative measure (i.e., the effect of dislodgeable residues being diminished over time is not quantifiable).  It should be noted that it was assumed that contact with these treated textile articles are infrequent and episodic. Therefore, only short-term duration (1-30 days) exposure was considered.

Exposure Calculations

Potential doses are calculated as follows:

PDD = W x WFai x CF x TF

 	         BW

Where:

PDD		= 	potential daily dose (mg/kg/day);

W		=	weight of treated textile (g/day);

WFai		= 	percent active ingredient in textile (%);

TF		= 	percent transfer;

CF		=	conversion factor (1000 mg/µg); and

BW		=	body weight (kg).

And

W = (SW/SSA) * BSA* CF1

Where:

W	=	weight of treated textile (g/day);

SW 	=	weight of medium-grade canvas cloth (g);

SSA 	= 	surface area of textile (m2);

BSA	=	surface area of body in contact with textile (cm2); and

CF1	=	unit conversion factor (0.0001 m2/cm2).

Assumptions

The product is applied at a rate of 0.01 a.i. weight fraction to the textile (based on maximum application rate of 1% a.i. for registered products (EPA Reg. Nos. 2829-42 and 2829-49).

The median surface area of skin in contact with the textile is 2,955 cm2 for a 3-year-old toddler (as 50% of total surface area of a toddler) (NAFTA guidance per USEPA, 1997a).  For adults, the median surface area is 9,220 cm2 (as 50% of total surface area of an adult) (NAFTA guidance per USEPA, 1997a).

The canvas tent cloth textile is assumed to be medium weight Army Duck Canvas (12 oz/yd2 ) with a density of  408 g/m2.  [This density estimate is based on a weight specification chart from an internet source of exported canvas textile (Bharat Textiles, 2007)].  As a conservative approach it is assumed that adults and children are sleeping inside a treated tent with no bedding between body and tent floor surfaces, wearing short pants/tee-shirt or just undergarments. Also that contact is on one side of the body (i.e., 50% body surface area contacting cloth).  Therefore, the total weight of treated textile in contact with human skin (high-end assumption) per day is equal to the density of the fabric (408 g/m2) times the surface area (2,955 cm2 for toddlers, 9,220 cm2 for adults), or 121 g/day for toddlers, and 376 g/day for adults when adjusted by a conversion factor of 0.0001 m2/cm2.

No data were available from which a transfer factor could be estimated.  Potential doses were calculated using a conservative percent transfer of 100%, which assumes that all residues are transferable from textile 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 percent transfer of 5%, which is based on approaches for 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.

Toddlers (3 years old) are assumed to weigh 15 kg. This is the mean of the median values for male and female toddlers (USEPA, 1997a).  For adults, a body weight of 70 kg has been assumed. (USEPA, 1997a).

Results

	The calculations of the short-term dermal doses and MOEs for adults and toddlers in contact with treated textiles are shown in Table 4.5.  The dermal MOEs for adults and toddlers are all below the target MOE of 100, denoting potential risk concerns.

Table 4.5:  Dermal Post-application Exposures and MOEs for Toddlers and Adults Contacting Treated Textiles

Exposure Scenario	W (weight of treated textile per day)a  (g/day)	WFai

(fraction a.i. in textile)	TF (percent transfer)	PDD (mg/kg/day)b	ST Dermal MOEc   Target = 100

Toddler	121	0.01	100%	81	3

	5%	4	50

Adult	376	0.01	100%	54	4

	5%	3	67

a.	Weight of  treated textile in contact with skin (g/day) = (Density of shirt 408 g/m2) * (surface area of body covered, cm2  as 2,955 cm2 toddler or  9,220 cm2 adult ) *  (0.0001 m2/cm2)

b.	Absorbed Potential Daily Dose (mg/kg/day) = [(weight of treated textile, g/day) * (weight fraction a.i. in treated cloth) * (percent transfer) * (conversion factor, 1000 mg/g)] / (body weight, kg, as 15 toddler or 70 adult).

c. 	Dermal MOE = NOAEL (mg/kg/day) /Absorbed Potential Daily Dose [Where short-term dermal (systemic) NOAEL = 200 mg/kg/day].  Target MOE = 100.

Incidental Oral Exposure to Toddlers Mouthing Treated Textiles (Canvas Tents/Tarps)

	Based on the dermal scenario developed above, there is the potential for incidental oral exposure to toddlers from mouthing textiles (e.g., canvas tents/tarps) treated with Oxine-Copper.

Exposure Calculations

Potential doses are calculated as follows:

PDD = C x SE x SA

	    BW

Where:

PDD	= 	potential daily dose (mg/kg/day);

C 	= 	concentration on Textile (mg/cm2);

SE	=	saliva extraction efficiency (%);

SA 	= 	surface area mouthed (cm2/day); and

BW 	= 	body weight (kg).

And

C = WFai x W x CF1 x CF2

Where:

C		=	concentration on Textile (mg/cm2);

WFai		= 	weight fraction of a.i. in Textile (unitless);

W 		= 	weight of Textile (g/m2);

CF1		=	unit conversion factor (1,000 mg/g); and

CF2		=	unit conversion factor (0.0001 m2/cm2).

Assumptions

The product is applied at a rate of 0.01 a.i. weight fraction to the textile (based on maximum application rate of 1% a.i. for registered products (EPA Reg. Nos. 2829-42 and 2829-49).

The textile is assumed to be medium weight Army Duck Canvas (12 oz/yd2 ) with a density of  408 g/m2.  [This density estimate is based on a weight specification chart from an internet source of exported canvas textile (Bharat Textiles, 2007)].

The saliva extraction efficiency was 50% (USEPA, 2000 and 2001).

The surface area of textile mouthed by toddlers is 20 cm2 (professional judgment).

Toddlers (3 years old) are used to represent the 1 to 6 year old age group.  For three-year olds, the median body weight is 15 kg (USEPA, 1997a).

Results

    Table 4.6 shows the calculation of the oral dose and oral MOE for toddlers mouthing treated textiles. The MOE value is 735 which is above the target MOE of 100 and is not of concern.

Table 4.6:  Incidental Oral Exposures and MOEs for Toddlers Mouthing Treated Textiles (Canvas Tent/Tarp)

Weight of textile (g/m2)	Concentration on textilea

(mg/cm2)	Surface area mouthed (cm2/day)

Saliva extraction efficiency

	Potential daily doseb (mg a.i./kg/day)	Incidental Oral MOEc

408	0.408	20	50%	0.272	735

a.	Concentration on textile (mg/cm2) = (Weight fraction a.i. in clothing, 0.01) * (weight of textile, g/m2) * (1,000 mg/g) * (0.0001 m2/cm2)

b.	Potential Daily Dose (mg/kg/day) = (concentration on textile, mg/cm2) * (surface area mouthed, cm2/day) * (saliva extraction efficiency 0.50) / (body weight, 15 kg).

c 	Oral MOE = NOAEL (mg/kg/day) / Potential Daily Dose [Where short-term incidental oral (maternal) NOAEL = 200 mg/kg/day].  Target MOE = 100.

	<IP_ADDRESS>	Treated Lumber

	Certain Oxine-Copper end-use products are labeled for wood preservative uses in pressure and non-pressure treatments of wood products intended for residential applications.  The Agency is concerned that there are potential post-application exposures to individuals exposed to Oxine-Copper-treated wood in residential settings (home and farm).

The potential outdoor residential post-application exposure pathways considered are outlined below for children.

Dermal contact with Oxine-Copper-treated wood products for above-ground uses [e.g., residential playground equipment (playsets), posts, decks, shingles, fencing, outdoor lumber, etc.];

Incidental ingestion due to hand-to-mouth contact with Oxine-Copper-treated wood products;

Inhalation of wood dusts from fabrication of Oxine-Copper-treated wood products;

Incidental ingestion of soil contaminated with Oxine-Copper;

Dermal contact with soil contaminated with Oxine-Copper (e.g., soil contaminated by treated decks and playsets); and

Inhalation of soil dusts contaminated with Oxine-Copper (e.g., soil contaminated by treated decks and playsets).

Other potential outdoor residential post-application exposure pathways for adults are outlined below:

Dermal contact with wood/wood dusts from construction of decks and playsets;

Incidental ingestion of wood dusts from construction of decks and playground equipment; and,

Inhalation of wood dusts from construction of decks and playsets.

	Currently, there are no study data that can be used to estimate either exposure to adults from inhalation of wood dusts during construction of wood decks or to children exposed to treated wood.  Incidental ingestion exposure for adults is expected to be negligible and dermal contact for adults is expected to be lower than children for crawling on wood decks.  Because children are more likely than adults to contact wood surfaces using playground equipment (playsets), and because children have a higher surface area to body weight ratio, they have been used to represent the maximum exposed individual.

At present, there are no available data to assess the levels of Oxine-Copper residues in soil contaminated from Oxine-Copper-treated wood (above ground fabricated components of decks or playsets).  Because of this data gap, EPA was not able to estimate residential post-application dermal and incidental ingestion exposures to soil contaminated with Oxine-Copper.  In this assessment, incidental ingestion and dermal exposures to children from contact with treated wood were estimated using surrogate data.

Surrogate Data

	No chemical-specific residential post-application studies conforming to Series 875 guidelines were available; however, data from the proprietary study, “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, SIG Task Force #73154) can be used as surrogate data to estimate screening-level exposures for the following pathways: outdoor residential dermal contact with Oxine-Copper-treated wood products used in above-ground applications (e.g., residential playsets, posts, decks, shingles, fencing, outdoor lumber, etc.); and outdoor residential incidental ingestion due to hand-to-mouth contact with pressure-treated wood products.  The DDAC study measured dermal and inhalation exposures for various worker functions/positions for individuals handling DDAC-containing wood preservatives for non-pressure treatment application methods and for individuals that could then come into contact with the preserved wood.

Outdoor Residential Dermal Contact with Oxine-Copper-treated Wood Products

Potential dermal doses are calculated as follows:

PDD = R x SA exposed

	    BW

Where:

PDD	= 	potential daily dose (mg/kg/day);

μg/cm2);

SA exposed=	Skin surface area in contact with treated wood (cm2);

BW	=	Body Weight of a toddler (kg)

The value for R used was based on two surrogate data sources: 1) measured worker residue data for hands that are available in the DDAC study (maximum concentration 3.0 µg/cm2 ); and, 2) a conservative (high-end) surrogate value to represent skin residue concentration (as 27 µg/cm2) taken from a chemical-specific leaching study on Oxine-Copper spray-treated hemlock-fir lumber (MRID 436370-01).

	DDAC Study (MRID 455243-04)

	The DDAC data in Table 4.7 were used to approximate the residues transferred from 	treated wood to skin for contact with Oxine-Copper-treated wood.  No wood-wipe 	sampling data are available.  The data from the following job descriptions in the 	DDAC study were chosen because of the possibility of the contact with dry treated 	wood.

End Stacker - Operates an automated stacking system at the end of the conveyor.  Lumber stacked into loads.

Stickman - Places sticks between stacks of wood manually.  At some mills, this is done automatically by end stacker operator.

Tallyman - Staples information sheet on to wood.  May come in contact with treated lumber. (Note: there were two reps available for tallyman)

Table 4.7.  Hand Residue Data for DDAC for Handling of Dry Wood

Job Description	Total Hand Residue Data (μg/cm2)

End Stacker	1.2

Stickman	0.6

Tallyman	0.8

Tallyman (Maximum Value)	3.0

Average Hand Residue	1.4

	These test subjects handled the dry treated wood from the non-pressure treatments. Of 	the 20 test subjects measured for handling “dry” wood in the DDAC study, 19 had 	detectable hand values (one value non-detect) ranging from 0.04 to 3.0 µg/cm2 	(DDAC study page 104). The highest value (most conservative) (3.0 µg/cm2) 	represents the “Tallyman” that wore no gloves (DDAC study page 189).  This value  was used in the assessment.

	Oxine-Copper Study (MRID 436370-01)

	A non-guideline leaching study is on file with the Agency for this chemical, 	“Leaching of Copper Oxinate (Copper 8-Quinolinolate) From Lumber Spray Treated 	with Maag Sapstain Control Formulations: Lab Project Number: 17930425. 	Unpublished study prepared by Forintek Canada Corp. 24 p.” (Byrne, A.; Minchin, 	D.,1991, MRID 436370-01).  It is unclear if it has been formally reviewed for 	acceptance by EPA in registering the end-use product.  However, since it is cited as 	a data source in an environmental fate transport memorandum written in support of 	Oxine-Copper reregistration (USEPA, 2006c), it is used in this assessment.

	The study included data on the measured wood surface concentration of Oxine-	Copper on hemlock-fir samples which were subjected to spray treatments for sapstain 	control.  Data indicated that a conventional spray system achieved a surface sample 	retention concentration (surface deposition) of 27 µg/cm2 .  	For lack of  wood wipe 	sampling data on Oxine-Copper residues, the 27 µg/cm2 Oxine-Copper retention 	level is assumed to represent a maximum surface residue concentration, as a  surrogate for hand residue load.

SA exposed was determined using the following equation:

SA exposed =  SA total * (X handSA *  X hand,touching+X non-handSA * X non-hand,touching)

Where:

SA total 		=	 total surface area for a 3-year old toddler (cm2)

X handSA		=	fraction of total toddler surface area that is hand (unitless)

X hand,touching	=	fraction of X handSA that contacts treated wood (unitless)

X non-handSA	=	fraction of total toddler surface area that is unclothed, other than hands (i.e., legs, arms, head)

X non-hand,touching	=	fraction of X non-handSA that contacts treated wood (unitless)

The value for SA total used was 6,565 cm2, which is the average surface area for a 3-year old toddler.  The values X handSA and X non-handSA are 0.0607 and 0.548, also based on the average surface area for a 3-year old toddler (USEPA, 1997a).  The values for X hand,touching and X non-hand,touching are 0.74 and 0.158, respectively.  These are the values used in a USEPA model to determine chromated copper arsenate (CCA) exposure on treated playground sets (USEPA, 2005a).

Table 4.8 shows the results of the calculations.  The dermal MOEs are greater than the target MOE of 100 (MOEs = 1156 and 129) and therefore are not of concern.

Table 4.8.  Residential Post-application Dermal Exposures to Oxine-Copper-treated Wood Products

Hand Residue Concentration from DDAC Study (ug/cm2)	Fraction of Hand Touching Residues: Hand, touching	Fraction of Body Surface that is hand: Hand SA	Fraction of Unclothed Body (Non-hand) skin touching residues:

Non-Hand, touching	Fraction of body surface that is unclothed, non-hand (i.e., legs, arms, head):

Non-Hand SA	Total surface area of 3-yr old (cm2):

 SA Total	Surface Area in contact with residues

 (cm2): a

SA Exposed	PDD (mg/kg/day)b	ST Dermal MOEc

Target MOE = 100

3.0	0.74	0.0607	0.158	0.548	6565	863	0.173	1156

Surrogate Hand Residue Concentration

(Maximum Surface Residue) from Oxine-Copper

Spray-treated Lumber

(MRID 436370-01 Study) (µg/cm2)

	1.55	129

27.0

a	SA exposed = (X hand,touching*X handSA+X non-hand,touching*X non-hand,SA)*SA total

b	PDD=[Residue (either 3 μg/cm2  or 27 μg/cm2) x 0.001 mg/ μg x SAexposed]/(Body Weight, 15 kg)

c	MOE  = NOAEL (mg/kg/day) / daily dose (mg/kg/day).  For dermal exposures, the (systemic) NOAEL is 200 	mg/kg/day.  Target MOE = 100.

  SEQ CHAPTER \h \r 1 Outdoor Residential Hand-to-Mouth Contact with Oxine-Copper-treated Wood Products

	The daily hand-to-mouth dose (mg/kg/day) is estimated using the following equation:

Oral Dose t= Handt x Hand SA x SEF x  Frequency x CF1  x  ET 								BW

Where:

	Handt 		=	DDAC highest hand residue detected (i.e.,“Tallyman” working

				with dry wood) (μg/cm2); and Oxine-Copper surface residue  (surrogate hand residue) concentration (μg/cm2),

	Hand SA	=	hand surface area (cm2/event),

SEF		=     	saliva extraction efficiency,

Frequency 	= 	frequency of exposure event (events/hr),

	ET		=	exposure time (hr/day),

	CF1		=	conversion factor (0.001 mg/µg), and

	BW		=	body weight (kg).

The highest hand residue value from the DDAC study (3.0 µg/cm2) was used for this assessment. In comparison, as a high-end surrogate hand residue value, chemical-specific data were also used from a leaching study on Oxine-Copper spray-treated hemlock-fir lumber (MRID 436370-01) which indicated that a conventional spray system achieved a surface sample retention concentration (surface deposition) of 27 µg/cm2 .  In this assessment, the 27 µg/cm2 Oxine-Copper retention level is assumed to represent a maximum surface residue concentration, as a surrogate for hand residue load.

The palmar surface area of 3 fingers of a toddler, 20 cm2, is used to estimate hand-mouthing as opposed to whole hand mouthing (USEPA, 2001 and 2005).

The rate of hand-to-mouth activity for outdoor playing is 7 events per hour based on Freeman et. al (2001) at the 95th percentile.

 The exposure time (ET) is 2 hours and is consistent with the Agency’s CCA assessment for time playing outdoors.  Although the 2 hour duration represents “outdoor” time, it is used as a conservative estimate for playing on decks and playsets.

The saliva extraction factor (SEF) is 50% and is based on the assumption of 50 percent removal efficiency of residues from hands by human saliva (USEPA, 2001 and 2005).

The mean body weight of a child, age 3, is 15 kg.

	The results of the hand-to-mouth estimates are presented in Table 4.9.  The estimated short-term MOEs for the hand-to-mouth exposure are above the target MOE of 100 (MOEs = 7143 and 794) and therefore are not of concern.

Table 4.9: Residential Post-application Incidental Oral Exposures to Oxine-Copper-treated Wood Products

Hand Residue concentration

from DDAC Study (µg/cm2)	Finger

 Surface Area (cm2)	Exposure Frequency for Outdoor Playing (events/hr)  Saliva Extraction Factor	Exposure Time (hrs/day)	Average Daily Oral Dose a (mg/kg/day)	ST Oral MOEb

Target MOE = 100

3.0

	20	7	50%	2	0.028	7143

Surrogate Hand Residue (Maximum Surface Residue)

concentration from Oxine-Copper Spray-treated Lumber

 (MRID 436370-01 Study) (µg/cm2)

27.0

	0.252	794

a	Average Daily Oral Dose (mg/kg/day) = [hand t (either 3 μg/cm2  or 27 μg/cm2 ) x Hand SA (20 cm2) x SEF (50% as 0.50 ) x Frequency (7 events/hr) x Exposure Time (2 hrs/day) x 0.001 mg/μg] / BW (15 kg)

b	MOE  = NOAEL (mg/kg/day) / daily dose (mg/kg/day).  For incidental oral exposures, the ST/IT (maternal) 	NOAEL is 200 mg/kg/day.  Target MOE = 100.

	4.4.3	Data Limitations/Uncertainties

	There are several data limitations and uncertainties associated with the residential handler and post-application exposure assessments.  These 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 may request 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 the AD Draft SOP use table.  In certain cases, no standard values were available for some scenarios.  Assumptions for these scenarios were based on AD estimates and could be further refined from input from registrants.

The low pressure spray unit exposure data from PHED were used to assess outdoor applications of wood preservative coatings (exterior of homes).  As the low pressure spray data are representative of treating low to mid level range targets (shrubs/greenhouse benches) and the scenario assessed in this document represents treatments that may also occur above the waist, the unit exposure value may underestimate exposure to the head and the upper body.

The methods used to estimate child and adult exposures to treated textiles are highly conservative and based on approaches from the Residential SOPs (USEPA 2000, and 2001) for contact with porous treated surfaces (clothing, mattresses and carpets). Without data on actual treated textile residues, dissipation or dermal transfer coefficients, these scenarios have a high degree of uncertainty associated with them. The registrants input will assist in refining the MOEs and confirming the Oxine-Copper textile use patterns.

In this assessment, incidental ingestion and dermal exposures to treated wood were estimated using surrogate DDAC data (3 (g/cm2).  The degree of uncertainty (under- or overestimation) associated with using the DDAC hand residue data for dermal and oral exposure from contacting treated lumber are unknown.  The amount of residue measured on the test subjects’ hands is variable and may be influenced by the duration of exposure, how often wood is contacted, and the degree of contact (i.e., do the hand residues from the DDAC study mimic a child’s play activity on decks and playsets?). In comparison, measured wood retention data from a chemical-specific leaching study (MRID 436370-01) were used as a surrogate to represent potential residue load for child contact. The maximum surface retention (surface deposition) measured from lumber spray-treated with Oxine-Copper (27 (g/cm2) was used as a conservative, high-end estimate. There is a high degree of uncertainty associated with this value as well.

Data are not available to assess the levels of Oxine-Copper in soil contaminated from Oxine-Copper-treated wood (e.g., above ground fabricated components of decks or playsets). Because of this data gap, EPA was not able to estimate residential post-application dermal and incidental oral ingestion exposure to soil contaminated with Oxine-Copper residues.  It is assumed that any soil residues attributed to weathering of in-service wood (playsets) will remain near these structures for potential child exposure. [Note: Soil migration study data (MRIDs 429255-03, 429255-04) on file with the Agency for Oxine-Copper indicate that between 88-90% of the applied active remained in 0-6 cm of the tested soil columns, indicating limited leaching and migration from soil matrices (USEPA, 2006c).]

5.0	RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION

	5.1	Acute and Chronic Dietary Aggregate Risk

	Any risks pertinent to dietary exposures are discussed separately from this chapter in the Preliminary Risk Assessment for this RED.

	5.2	  SEQ CHAPTER \h \r 1 Short- and Intermediate-Term Aggregate Exposures and Risks

		Non-dietary short- and intermediate-term aggregate exposures and risks were not assessed for adults and children exposed to Oxine-Copper residues from the use of products in residential (non-occupational) environments.  For Oxine-Copper, the toxicity endpoints for routes of exposure assessed (i.e., incidental oral, dermal and inhalation) were selected from three separate studies, each characterized by different toxicological effects. Therefore, aggregating non-dietary exposure risks was not considered appropriate.

	The use patterns of the products and probability of co-occurrence must also be considered when selecting potential scenarios for incorporation into aggregate assessments.  In the case of Oxine-Copper, homeowner painting activities occur only once or twice a year.  Any mold remediation done by commercial applicators in residential sites is also expected to be episodic, occurring once or twice a year.  Since textile applications are limited to industrial/government-use items (e.g., webbing/canvas/tarps/tents/cordage/shoe counter paperboard), sensitive adult sub-populations and children are not expected to come in contact with treated materials made into consumer clothing apparel, bedding, blankets, carpets and house-wares.  Therefore the probability of co-occurrence and the potential for exposure to residues from these products on the same day is highly unlikely.

6.0	OCCUPATIONAL EXPOSURE ASSESSMENT

	6.1 	Summary of Registered Uses

	Potential occupational handler exposure can occur in various use sites, which include food handling premises, commercial/industrial premises, and even applications done in residential sites.  The exposure scenarios assessed in this document for the representative uses selected by AD are taken from 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 various materials preservative and wood preservative applications: mixing and loading of product concentrates for materials preservative incorporation into textile/paint/paper matrices (liquid pour/liquid pump of soluble concentrates); application of treated paint (paint brush/roller and airless sprayer) and protective wood coatings (low pressure sprayer); and applications to outdoor hard surfaces for mold remediation (brush/roller and low pressure sprayer).

	The “preservation of materials” refers to the scenario of a worker adding the preservative to the material being treated 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 at treatment plants and lumber mills, the methods for treatment can vary (pressure/non-pressure), such that multiple worker functions were analyzed.  Due to the complexity of the wood preservative analysis, the results for handler and post-application exposures are presented in a separate section, 6.4.

Table 6.1.  Representative Exposure Scenarios Associated with

 Occupational Exposures to Oxine-Copper

Representative Use

Method of Application

Exposure Scenario

EPA Reg. No.

Maximum Application Rate

Wood Preservatives (Use Site Category X)

Non-pressure treatment of wood and wood products in wood treatment facilities

	Handler Worker Functions

Diptank Operators

Blender/spray operators

Chemical operators

Post-Application Worker Functions

Graders

Trim saw operators

Clean-up crews

Construction Workers

ST/IT/LT Handler & Post-application: Dermal and inhalation	3008-91

	Diptank operators and Blender/spray operators:

2.3 % ai water-borne treatment solution used (1:15 v/v dilution of 34.18% ai product)

Chemical operators and all other worker functions:

34.18% ai water-borne product concentrate handled.

Pressure treatment of wood and wood products in wood treatment facilities

	Handler Worker Functions

Treatment assistant

Treatment operator

Post-Application Worker Functions

Tram setter, stacker operator, loader operator, supervisor, test borer, and tallyman	ST/IT/LT Handler & Post-application: Dermal and inhalation 2829-135;

2829-136	1.0 % ai solvent-borne treatment solution used (10% w/w solution of 10% ai product) via vacuum/empty-cell methods

General Preservation of wood in commercial sites (non-pressure treatment applications to wood including indirect food contact wood)

	Brush/Spray and Dip methods employed for this use pattern 	ST/IT Handler: Dermal and Inhalation

	2829-135;

2829-136

	Dip 1.0 % a.i. solvent-based treatment solution (applied at a rate of 10% w/w of 10 % a.i. product)

	1022-489;

75675-1	Brush  3.3% ai water-based treatment solution (1:3dilution of 10% ai product) for ground-contact wood

Wood Preservative Coatings/ Water Repellents

	Paint brush,

Roller and Low-pressure coarse sprayer

	ST/IT Handler: Dermal and Inhalation	1022-504;  1022-514; 81819-1 0.675%-0.8% ai ready-to-use (RTU) water and oil-based exterior coatings for log homes, wood roofs, siding, fences, rough sawn lumber, new/old wood. 150-300 sq ft/gal. as one coat application.

Material Preservatives (Use Site Category VII)

Paints/Coatings

(in-can preservative incorporation)

Preservation of paint

Liquid pour

Liquid pump

Commercial/

Professional painter

Brush/Roller

Airless sprayer

ST/IT/LT Handler: Dermal and Inhalation

ST/IT Prof Painter:

Dermal and Inhalation (aerosol particulate) 6

2829-136

Treated article preserved with 2829-136 (e.g., exterior house paint)

1.0 % a.i. incorporation by volume of the material to be treated (10 % product by volume treated x 10 % a.i. in product) Note: Adhesives are incorporated at 0.1 % ai

[Solvent-based]

Paper and Paperboard

	Liquid pump

(i.e., incorporation at the size press during manufacture of paper and paperboard sheets)

ST/IT/LT Handler: Dermal and Inhalation

2829-112

0.24% a.i. incorporation by weight of the material to be treated (3.2% product by weight of material treated x 7.5% a.i. in product)

[Water-based]

	Brush/Spray and Dip impregnation methods employed for this use pattern

1022-489;

75675-1

	0.4% ai water-based treatment solution impregnation (1:25 dilution of 10% ai products)

Textiles

[Industrial-use and government-specified (e.g., military-issued) cloth/webbing/ropes used for tents/tarps, cotton duck/canvas, paper, paperboard for shoe construction]

Liquid pour

Liquid pump

(i.e., incorporation at the padder during textile processing)

Brush/

ST/IT/LT Handler: Dermal and Inhalation

	2829-42;

2829-49;

2829-112

0.7% ai (industrial-use) to

1.0 % ai (government-use) incorporation by weight of the material to be treated (10 % w/w  of 10 % a.i. products for 2829-42 and 2829-49)

[Solvent- & Water-based]

	Brush/Spray and Dip impregnation methods employed for this use pattern

2829-135;

2829-136;

60061-22

	Mildew inhibitor to cotton duck, canvas, cotton webbing and rope

Dip:

0.2% ai to 1.0 % ai (government-use);

1.0% ai as RTU (60061-22)

[Solvent-based]

Material Preservatives (Use Site Category VII)

Environmental Outdoor Hard Surface Treatments

(i.e., mold and mildew control treatments to exterior environmental surfaces )

Brush/Spray

Tank-type garden sprayer  (i.e., Low pressure sprayer)

ST/IT Handler: Dermal and Inhalation

1022-489;

1022-490;

75675-1

0.1% ai water-based treatment solution (1:100 dilution of 10% ai product; 1:50 dilution of 5% ai product) used on paint/varnish, concrete, brick, glass, tile, metals, plastic, wood, (paper)*, (leather)*, textiles and asphalt shingles.

* - Treatments to these materials may indicate potential indoor uses. Clarification of labeling is needed.

Food Handling/Storage Establishments, Premises and Equipment (Use Site Category II)

Indoor Hard Surfaces Disinfection for Potato Ring Rot

(e.g., potato processing planters, seed handling equipment, seed cutters, storage areas, truck/railcar transportation equipment.)

Spray- Low pressure spray non-mist nozzle 20 psi

ST/IT Handler: Dermal and Inhalation

1022-489;

1022-490; and

75675-1

0.05% ai water-based treatment solution (1:200 dilution of 10% ai product; 1:100 dilution of 5% ai product)

Note: Only EPA registered products with specified use directions/use applications are included in this table.  Products listed were selected based on maximum use rates by application method.

ST = Short-term exposure, IT = Intermediate-term exposure, LT= Long-term exposure.

6 Handler dermal and inhalation  exposure (to aerosol  particulates) were assessed for Oxine-Copper using PHED unit exposures.

	       6.2   Occupational Handler Exposures

	Certain occupational handler scenarios included in Table 6.1 were assessed to determine dermal and inhalation exposures.  If application methods were similar across use patterns, then only those scenarios with maximum application rates were assessed as representative of potential exposure for the other handler scenarios.  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 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 Handlers Exposure Database (USEPA, 1998).

For the liquid pour scenarios for materials preservatives, the unit exposure depends on the material being treated.  The following CMA unit exposures were available and used for the assessment of the risk associated with the treatment of the specified materials.

 Paint and Textiles: CMA preservative gloved data.  The dermal UE is 0.135 mg/lb a.i. and the inhalation UE is 0.00346 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. Since no baseline dermal (unlgoved) unit exposure data are available for preservative uses in paints or textiles, the baseline dermal exposures were evaluated using the cooling tower CMA data (50.3 mg/lb ai).

For the liquid pump scenarios, the unit exposure depends on the material being treated. The following CMA unit exposures were available and used for the assessment of the risk associated with the treatment of the specified materials.

 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.  The values are based on two replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves. Since no baseline dermal (unlgoved) unit exposure data are available for preservative uses in paints or textiles, the baseline dermal exposures were evaluated using the cooling tower CMA data (0.454 mg/lb ai).

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. Since no baseline dermal (unlgoved) unit exposure data are available for preservative uses in adhesives, paint, or textiles, the baseline dermal exposures were evaluated using the cooling tower CMA data (0.454 mg/lb ai). Only closed application methods were assessed for pulp/paper based on industrial practices. Therefore, a liquid pour scenario for preservation of paper/paperboard with Oxine-Copper was not developed.

For the low pressure sprayer (course spray) scenarios, the occupational PHED dermal and inhalation unit exposure values for a handler pouring a pesticide and applying it via a low pressure sprayer (handwand) were used (PHED scenario 32).  The unit exposure values of 100 mg/lb a.i. for ungloved dermal, 0.43 mg/lb a.i. for gloved replicates, and 0.030 mg/lb a.i. for inhalation represent a handler treating low and mid-level targets, generally below the waist (greenhouse benches and shrubs) while wearing a single layer of clothing.

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 the airless sprayer scenario, 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.

Quantity handled/treated: The quantity handled/treated values were estimated based on information from various sources.  The following assumptions were made:

For the liquid pour scenarios, the quantity of the chemical that is handled depends on the material that is being treated.  The following values were used for the different materials:

Paint:  2,000 lbs (approximately 200 gallons, weight based on a density 10 lb a.i./gal) (USEPA, 2005).

Textiles:  10,000 lbs (USEPA, 2005).

For the liquid pump scenarios the quantity that is handled depends on the material that is being treated.  The following values were used for the different materials:

Paint:  10,000 lbs (approximately 1,000 gallons, weight based on a density of 10 lb a.i./gal) (USEPA, 2005).

Textiles:  10,000 lbs (USEPA, 2005).

Paper/Papeboard:  These applications are expected to be similar to textile treatments, but a standard value of 500 tons is used as a high-end assumption (500 tons x 2204.622 lb/ton = 1102311 lbs).

For the low pressure sprayer (course spray) scenarios, it was assumed that 100 lbs (approximately 12 gallons of water-based treatment solution having a density of water 8.34 lb/gal) are used for the outdoor hard surface treatments (Agency assumption); and for the wood coating scenario it was assumed that 500 lbs (approximately 50 gallons of paint with a density of 10 lb/gal) of treated paint are used. (USEPA, 2005).

For the roller/brush painting scenario, it was assumed that 50 lbs (approximately 5 gallons of paint with a density of 10 lb/gal) of treated paint are used (USEPA, 2005).

For the airless sprayer scenario, it was assumed that 500 lbs (approximately 50 gallons of paint with a density of 10 lb/gal) of treated paint are used. (USEPA, 2005).

Duration of Exposure: The MOEs were calculated as ST/IT dermal and ST/IT/LT inhalation based on end-point selection in Table 3.2.  It is assumed however, that occupational handlers will have exposures of short- and intermediate-term durations only.

Exposure Calculations and Results

	The resulting exposures and MOEs for the representative occupational handler scenarios are presented in Table 6.2. The calculated dermal MOEs were all above the target MOE of 100 with the use of glove PPE. Baseline dermal estimates for workers without gloves indicated risk concerns for certain scenarios listed below.   It should be noted that the baseline (ungloved) dermal MOEs for the material preservation of paints, textiles and paper were calculated using unit exposure values (liquid pour/liquid pump) from the cooling tower CMA data set because data for baseline dermal unit exposures were not available for preservative scenarios.

General wood preservative brush applications: ST/IT MOE = 47.

Painting (professional) wood coatings, low pressure sprayer: ST/IT MOE = 35.

Painting (professional) treated paint, airless sprayer: ST/IT MOE = 74.

Paper preservation, liquid pump: ST/IT MOE = 12.

Paint preservation, liquid pour: ST/IT MOE = 14.

Textile preservation, liquid pour: ST/IT MOE = 3.

	Most inhalation MOEs were above the target MOE of 1000, except for the scenarios  indicated below.  It should be noted that for MOEs below 1,000 the Agency may request a confirmatory inhalation toxicity study to refine the potential risks since the current inhalation endpoint is based on an oral NOAEL.

General wood preservative brush applications: ST/IT/LT MOE = 758.

Paper preservation, liquid pump: ST/IT/LT MOE = 500.

Painting (professional) treated paint, airless sprayer: ST/IT/LT MOE = 83 / 833 (PPE).

	6.3  	Occupational Post-application Exposures

	Except for the post-application scenarios assessed for wood preservatives in Section 6.4, occupational post-application exposures are assumed to be negligible.

Table 6.2  Short-, Intermediate-, and Long-Term Risks Associated with Occupational Handlers

Exposure Scenario

Method of Application

Unit Exposure (mg/lb a.i.)	Application Rate (% a.i. by weight)

Quantity Handled/ Treated per day

Absorbed Daily Dose (mg/kg/day)c

MOEd

Baseline Dermala

PPE-Gloves Dermalb

 Inhalation

Baseline Dermala

PPE-

Gloves Dermalb

	Inhalation

Baseline Dermal

 (Target MOE = 100)a

PPE-Gloves Dermal

 (Target MOE = 100) b	Inhalatione

(Target MOE = 1000)

ST/IT

ST/IT	ST/IT/LT

Wood Preservatives (Use Site Category X) *

General Wood Preservative Application by Professionals	Brush	180	24	0.28 0.033	50 lbs	4.24	0.566	0.0066	47	353	758

Application of Wood Coatings by Professionals

Brush/ Roller	180	24

0.28	0.008

50 lbs	1.03	0.137	0.0016	194	1,460	3,125

Low Pressure Sprayer	100	0.43  	0.030	0.008

500 lbs	5.71	0.025	0.0017	35	8,000	2,941

Material Preservatives (Use Site Category VII)

Preservation of  Paper and Paperboard

Liquid Pump	0.454	0.00454	0.000265	0.0024

(500 tons)

1,102,311 lbs	17.16	0.172	0.01	12	1,163	500

	Brush

	180	24	0.28	0.004	50 lbs	0.514	0.069	0.0008	389	2,898	6,250

Preservation of Paint

(in-can preservative)

Liquid Pour

	50.3

0.135

0.00346

0.01

2,000 lbs	14.37	0.039	0.001	14	5,128	5,000

Liquid Pump	0.454

0.00629

0.000403

0.01

10,000 lbs	0.649	0.0089	0.0006	308	22,472	8,333

Preservation of Textiles

Liquid Pour

	50.3

0.135

0.00346

0.01

10,000 lbs	71.86	0.193	0.005	3	1,036	1,000

Liquid Pump	0.454

0.00629

0.000403

0.01

10,000 lbs	0.649 	0.0089 	0.0006	308	22,472	8,333

Material Preservatives (Use Site Category VII)

Application of Treated Paint by Professionals

Brush/ Roller

180

24

0.28

0.01

50 lbs	1.29	0.17	0.002	155	1,176	2,500

Airless Sprayer

38

14

0.83

0.01

500 lbs	2.71	1.0	0.060	74	200	83	833

PPE

Commercial application to outdoor hard surfaces 	Low Pressure Sprayer 100	0.43	0.030	0.001	100 lbs	0.143	0.00061	0.000043	1,399	327,869 116,280

	* Note:  Other Occupational scenarios for Wood Preservatives are assessed separately in Section 6.4.

	ST= Short-term;  IT = intermediate-term, NA= No data available (or not applicable for dermal absorption factor).

	Unit Exposure (UE) Data from CMA for most scenarios. PHED data used for Brush/Roller and Airless Sprayer.

	a	Baseline Dermal:  Long-sleeve shirt, long pants, no gloves. It should be noted that the baseline dermal unit exposures for the preservation of paper, paint and textiles were from the cooling tower CMA data set because baseline (ungloved) dermal unit exposures are not available for the CMA data set on preservatives.

 	b	PPE Dermal with gloves: baseline dermal plus chemical-resistant gloves.  No gloved replicates available for CMA Low Pressure Spray scenario.

	c	Absorbed Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) * absorption factor (NA for dermal; 100% (1.0) for  inhalation) * application rate * quantity treated / Body weight (70 kg).

	d	MOE = NOAEL  (mg/kg/day) / Absorbed Daily Dose [Where ST/IT Dermal NOAEL (systemic)  = 200 mg/kg/day; ST/IT/LT Inhalation NOAEL = 5 mg/kg/day].

	e	For PHED data, a protection factor of 90% can be applied to UE values to represent use of organic vapor respirators as PPE.  Any PHED Baseline inhalation painting scenarios (Brush/Roller or Airless Sprayer) with MOEs below the target of 1000 were also assessed for use of PPE.

	6.4 	Wood Preservation

	Oxine-Copper is used industrially as a stand-alone preservative to control sapstain, and protect against mold/mildew in softwood or hardwood lumber.  It can also protect against insect damage for wood used in mainly above-ground use applications.  Where ground- contact protection is needed, usually higher concentrations of preservative treatment solutions are used and applied via non-pressure methods  Wood treated with Oxine-Copper has a greenish-brown color, and little or no odor.

	Registered uses for Oxine-Copper include several wood preservative treatments as wood surface coatings (e.g., water repellents applied via brush, roller or spray) and impregnation into wood via non-pressure (e.g., non-pressure dipping/immersion) and pressure techniques (vacuum/empty-cell).  The products can be used on many different types of wood including 1) green or fresh cut/debarked lumber, poles, posts, and timbers; 2) manufactured wood products such as logs (including for log home construction), plywood, and particle board (wood composites); 3) dry lumber; and 4) finished wood products such as millwork, shingles, shakes, siding, plywood and structural lumber. The majority of the products are intended for use at wood treatment facilities,

	The exposure scenarios assessed in this document for the representative wood preservation uses selected by AD are shown in Table 6.1.  Section 6.4.1 presents the exposure analysis for the handler and post-application scenarios for non-pressure treatment scenarios and Section 6.4.2 presents the exposure analysis for the handler and post-application scenarios for pressure treatment scenarios.

	6.4.1 	Non-Pressure Treatment Scenarios (Handler and Post-application)

	<IP_ADDRESS>		Scenarios Assessed by Worker Function

	Handler and post-application scenarios that have been identified and assessed using surrogate data.  The proprietary study, “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) identified various worker functions/positions for individuals that handle DDAC-containing wood preservatives for non-pressure treatment application methods and for individuals that could then come into contact with the preserved wood. Representative worker functions/positions identified in the DDAC study are presented below. It was assumed that the workers at facilities using Oxine-Copper wood preservatives, and handling the treated wood are performing similar tasks as those monitored in the DDAC study. This study was sponsored by an industry consortium [Sapstain Industry Group (SIG) Task Force # 73154]; therefore, data compensation issues apply for use of these data as a surrogate source in assessing exposure.

Handler:

Blender/spray operators are workers that add the wood preservative into a blender/sprayer system for composite wood via closed-liquid pumping.

Chemical operators for a spray box system consist of chemical operators, chemical assistants, chemical supervisors, and chemical captains.  These individuals maintain a chemical supply balance and are assigned the task of flushing and cleaning spray nozzles.

Diptank Operators can be in reference to wood being lowered into the treating solution through an automated process (i.e.: elevator diptank, forklift diptank).  This scenario can also occur in a small scale treatment facility in which the worker can manually dip the wood into the treatment solution.

Post-application:

Graders are expected to be positioned right after the spray box sequence, where they grade the dry lumber by hand (i.e. detect faults).  In the DDAC study, graders graded wet lumber; therefore, the exposures to graders using Oxine-Copper are assumed to be the worst-case scenarios.

Trim saw operators operate the hula trim saw and consist of operators and strappers.  In the DDAC study, hula trim saw operators handled dry lumber.

Millwrights repair all conveyer chains and are involved in a general up-keep of the mill.

Clean-up crews perform general cleaning duties at the mill.

Construction workers install treated plywood, oriented strand board, medium density fiberboard, and others.

	In lieu of chemical-specific data available regarding typical exposures to Oxine-Copper as a wood preservative, surrogate data were used to estimate exposure risks. The blender/spray operator position was assessed using CMA unit exposure data and the remaining handler and post-application positions were assessed using data from the DDAC study (Bestari et al., 1999).

Blender/Spray Operators

	Exposures and risks to the blender/spray operators were assessed using Equations 1 through 3 in Section 1.2.  The surrogate unit exposures were taken from the CMA study (USEPA, 1999).  Specifically, the liquid pump preservative unit exposures for gloved workers were used in this assessment.  The dermal unit exposure was 0.00629 mg/lb ai and the inhalation unit exposure was 0.000403 mg/lb ai. These values are based on two replicates where the test subjects were wearing a single layer of clothing and chemical resistant gloves.  The quantity of the wood being treated was derived from other wood preservative estimates (USEPA, 2004) for the amount of wood slurry treated because no chemical specific data were available for Oxine-Copper.  It was assumed that batches of wood   SEQ CHAPTER \h \r 1 slurry are treated in 10,000 gallon tanks, and that eight batches of wood slurry are treated per day (one per hour for an 8-hr work shift).  Additionally, it was assumed that each batch requires 3,000 gallons of preservatives and the remainder volume of the tank consists of wood slurry (7,000 gallons of wood slurry per batch).  Since wood chips have a density of approximately 380 kg/m3 (SIMetric, 2005), the total amount of wood slurry treated per day would be 178,000 lbs (i.e., 8 batches/day * 7,000 gallons/batch * 0.003785 m3/gallon * 380 kg/m3 * 2.2 lb/kg).    SEQ CHAPTER \h \r 1 The assumptions used for batch sizes and the quantity of preservative needed are consistent with an assessment performed previously by the EPA. The Oxine-Copper assessment was conducted based on use-application of a 2.3 % ai solution.  This represents the maximum application rate for both diptank and spray methods for sapstain treatment as per product labeling for EPA Reg. No. 3008-91.  This product is a 34.18 % ai concentrate used to make water-based treatment solutions of up to 2.3% ai [i.e., 1:15 v/v use dilution (0.0666) x 34.18 % ai in product = 2.3 % ai].  Product labeling cites use of eye protection and rubber gloves as PPE.

	Table 6.3 provides the short-, intermediate-, and long-term doses and MOEs for the blender/spray operators adding the preservative to the wood slurry.  The dermal ST/IT MOE was 540 which is above the target MOE of 100 and therefore not of concern.  The inhalation ST/IT/LT MOE was below the Agency target of 1,000, as 212, denoting a potential risk concern.  For inhalation MOEs below 1,000 the Agency may request a confirmatory inhalation toxicity study since the current inhalation endpoint is based on an oral NOAEL.

Table 6.3. Short-, Intermediate-, and Long-term Exposures and MOEs for Wood Preservative Blender/Spray Operators

Exposure Scenario

	Dermal Unit Exposurea

(mg/lb ai)	Inhalation Unit Exposureb

(mg/lb ai)	Application Ratec

(% ai in solution/

day)	Wood Slurry Treatedd

(lb/day)	Absorbed Daily Dosee

(mg/kg/day)	MOEsf

	Dermal	Inhalation	Dermal

ST/IT

Target=100	Inhalation

ST/IT/LT

Target = 1000

Occupational Handler

CMA Liquid Pump	0.00629	0.000403	2.3	178,000	0.37	0.0236	540	212

ST =	Short-term duration; IT =Intermediate-term duration; and LT = long-term.

Dermal unit exposure: Single layer clothing with chemical resistant gloves.

Inhalation unit exposure: Baseline, with no respirator.

c.	The maximum application rate for both diptank and sapstain spray application methods is 2.3% ai solution based on product labeling (3008-91).

d.	Wood slurry treated = (8 batches/day * 7,000 gallons/batch * 0.003785 m3/gallon * 380 kg/m3 * 2.2 lb/kg)

e.	Absorbed Daily Dose = unit exposure (mg/lb ai) x App Rate (% ai/day as 2.3%; the ai weight fraction is 0.023) x Quantity treated (lb/day) x absorption factor (NA for dermal and 100% for inhalation) / BW (70 kg)

f.	MOE = NOAEL (mg/kg/day) / Daily dose [Where ST/IT (systemic) NOAEL = 200 mg/kg/day for dermal and

	ST/ /IT/LT NOAEL = 5 mg/kg/day for inhalation].  Target MOE is 100 for dermal exposure and 1000 for inhalation 	exposure.

Chemical Operators, Graders, Millwrights, Clean-up Crews, and Trim Saw Operators

	Exposures to chemical operators, graders, millwrights, trim saw operators, and clean-up crews were assessed using surrogate data from the DDAC study (Bestari et al., 1999). This study examined individuals’ exposure to DDAC while working with anti-sapstains and performing routine tasks at 11 sawmills/planar mills in Canada.  Dermal and inhalation exposure monitoring data were gathered for each job function of interest using dosimeters and personal sampling tubes.  These sample media were then analyzed for DDAC, and the results were reported in terms of mg DDAC exposure per person per day.  The study reported average daily exposures for workers in various categories.  Exposure data for individuals performing the same job functions were averaged together to determine job specific averages.  Total exposures from 2 trim saw workers, 13 grader workers, 11 chemical operators, 3 millwrights, and 6 clean-up staff were used.

	The individual dermal and inhalation exposures from the DDAC study are presented in Table B-1 in Appendix B.  To determine Oxine-Copper exposures, the average DDAC exposures measured on individuals (in terms of total mg DDAC) were multiplied by a modification factor of 0.427 to account for the difference in percent active ingredient between Oxine-Copper and DDAC (34.18 % Oxine-Copper in the wood preservative product versus 80% DDAC in the comparative wood preservative product). The pound (lb) active ingredient handled by each person or the percent (%) active ingredient in the treatment solution was not provided for these worker functions.

The following equation was used to calculate daily dose for Oxine-Copper:

Daily Dose = DDAC UE x CR x AB

           	         BW

Where

DDAC UE	=	DDAC dermal or inhalation unit exposure (mg/day);

CR		=	Conversion ratio (34.18 % Oxine-Copper / 80% DDAC) ;

AB	=	Absorption factor (NA for dermal, 100% for inhalation); and

BW		=	Body weight (70 kg).

In using this methodology, the following assumptions were made:

DDAC and Oxine-Copper end products will be used in similar quantities.

The procedures for applying both chemicals are similar.

The physical-chemical properties that affect the transport of the chemical are similar. (This assumes similar product densities for the DDAC and Oxine-Copper water-borne solutions).

The limits of detections (LOD) for inhalation residues from   SEQ CHAPTER \h \r 1 chemical operators, graders, mill wrights, and clean-up staff replicates were not provided in the DDAC report.  For lack of better data, it was assumed that the inhalation LODs for these worker positions are equal to the LOD of the diptank operator replicates (5.6 (g).  For all measurements below the air concentration associated with this detection limit, half the detection limit was used.  The dermal LOD for all operators is also 5.6 (g.

In the DDAC study, dermal exposures to hands were measured separately from the rest of the body.  For each replicate, the body dose measurements and hand dose measurements were summed for a total dermal dose.

Air concentrations were reported in the DDAC study. To convert air concentrations ((g/m3) into terms of inhalation unit exposure (mg/day), the air concentrations were multiplied by an inhalation rate of 1.0 m3/hr for light activity (EPA 1997a), sample duration of 8 hrs/day, and a conversion factor of 1 mg/1000 (g.  Table B-1 in Appendix B presents the inhalation and dermal DDAC exposures.

Average DDAC dermal and inhalation exposures were multiplied by a conversion ratio of 0.427 to account for the differences in Oxine-Copper and DDAC concentrations [i.e., (34.18 % Oxine-Copper / 80% DDAC)].

Table 6.4 provides the short-, intermediate-, and long-term doses and MOEs for chemical operators, graders, millwrights, clean-up crews, and trim saw operators.  For all worker functions, the dermal MOEs are above the target MOE of 100 for ST/IT durations assessed.  For all worker functions, the inhalation MOEs are above the target MOE of 1000 for ST/IT/LT durations, and therefore are not of concern. Therefore, a confirmatory inhalation toxicity study is not warranted based on the results of this assessment.

Table 6.4. Short-, Intermediate- and Long-Term Exposures and MOEs for Wood Preservative Chemical Operators, Graders, Trim Saw Operators, and Clean-Up Crews

Exposure Scenarioa

(number of volunteers)	Dermal UEb

(mg/day)	Inhalation UEb

(mg/day)	Conversion Ratioc 	Absorbed Daily Dosesd

(mg/kg/day)	MOEse

Dermal	Inhalation	Dermal

ST/IT

Target = 100	Inhalation

ST/IT/LT

Target = 1000

Occupational Handler

Chemical Operator (n=11)	9.81	0.0281	0.0427	0.060	0.00017	3,333	29,412

Occupational Post-application

Grader (n=13)	3.13	0.0295	0.0427	0.019	0.00018	10,526	27,778

Trim Saw (n=2)	1.38	0.061	0.0427	0.0084	0.00037	23,809	13,513

Millwright (n=3)	12.81	0.057	0.0427	0.078	0.00035	2,564	14,286

Clean-Up (n=6)	55.3	0.60	0.0427	0.337	0.0037	593	1,351

ST = 	Short-term duration; IT = Intermediate-term duration; and LT = long-term

a.	The exposure scenario represents a worker wearing either long-sleeved or short-sleeved shirts, cotton work trousers, and cotton glove dosimeter gloves under chemical resistant gloves. Volunteers were grouped according to tasks they conducted at the mill.

b.	Dermal and inhalation unit exposures are from Bestari et al (1999).  Refer to Table B-1 in Appendix B for the calculation of the dermal and inhalation exposures. Inhalation exposure (mg/day) was calculated using the following equation: air concentration ((g/m3) x inhalation rate (1.0 m3/hr) x sample duration (8 hr/day) x unit conversion (1 mg/1000 (g).  The inhalation rate is from USEPA, 1997a.

c.	Conversion Ratio = 34.18% Oxine-Copper / 80% DDAC