Document ID: EPA-HQ-OPP-2006-0338-0028
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-12-29T05:00Z

DRAFT

Didecyl Dimethyl Ammonium Chloride (DDAC)

Occupational and Residential Exposure Assessment

Office of Pesticide Programs

Antimicrobials Division

U.S. Environmental Protection Agency

1801 South Bell St.

Arlington, VA 22202

Date: August 1, 2006

TABLE OF CONTENTS 

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc125435602"  EXECUTIVE
SUMMARY	  PAGEREF _Toc125435602 \h  3  

  HYPERLINK \l "_Toc125435603"  1.0	 INTRODUCTION	  PAGEREF
_Toc125435603 \h  9  

  HYPERLINK \l "_Toc125435604"  1.1	Purpose	  PAGEREF _Toc125435604 \h 
9  

  HYPERLINK \l "_Toc125435605"  1.2	Criteria for Conducting Exposure
Assessments	  PAGEREF _Toc125435605 \h  9  

  HYPERLINK \l "_Toc125435606"  1.3	Chemical Identification	  PAGEREF
_Toc125435606 \h  11  

  HYPERLINK \l "_Toc125435607"  1.4	Physical/Chemical Properties	 
PAGEREF _Toc125435607 \h  12  

  HYPERLINK \l "_Toc125435608"  2.0	 USE INFORMATION	  PAGEREF
_Toc125435608 \h  12  

  HYPERLINK \l "_Toc125435609"  2.1	 Formulation Types and Percent
Active Ingredient	  PAGEREF _Toc125435609 \h  12  

  HYPERLINK \l "_Toc125435610"  2.2	 Summary of Use Pattern and
Formulations	  PAGEREF _Toc125435610 \h  12  

  HYPERLINK \l "_Toc125435611"  3.0	SUMMARY OF TOXICITY DATA	  PAGEREF
_Toc125435611 \h  13  

  HYPERLINK \l "_Toc125435612"  3.1	Acute Toxicity	  PAGEREF
_Toc125435612 \h  13  

  HYPERLINK \l "_Toc125435613"  3.2	Summary of Toxicity Endpoints	 
PAGEREF _Toc125435613 \h  13  

  HYPERLINK \l "_Toc125435614"  3.3	FQPA Considerations	  PAGEREF
_Toc125435614 \h  15  

  HYPERLINK \l "_Toc125435615"  4.0	RESIDENTIAL EXPOSURE ASSESSMENT	 
PAGEREF _Toc125435615 \h  15  

  HYPERLINK \l "_Toc125435616"  4.1	Summary of Registered Uses	  PAGEREF
_Toc125435616 \h  15  

  HYPERLINK \l "_Toc125435617"  4.2	Residential Exposure	  PAGEREF
_Toc125435617 \h  15  

  HYPERLINK \l "_Toc125435618"  4.2.1	Residential Handler Exposures	 
PAGEREF _Toc125435618 \h  17  

  HYPERLINK \l "_Toc125435619"  4.2.2	Residential Post-application
Exposures	  PAGEREF _Toc125435619 \h  20  

  HYPERLINK \l "_Toc125435620"  4.2.3	Data Limitations/Uncertainties	 
PAGEREF _Toc125435620 \h  36  

  HYPERLINK \l "_Toc125435621"  5.0	RESIDENTIAL AGGREGATE RISK
ASSESSMENT AND CHARACTERIZATION	  PAGEREF _Toc125435621 \h  37  

  HYPERLINK \l "_Toc125435622"  6.0	OCCUPATIONAL EXPOSURE ASSESSMENT	 
PAGEREF _Toc125435622 \h  37  

  HYPERLINK \l "_Toc125435623"  6.1 	Occupational Handler Exposures	 
PAGEREF _Toc125435623 \h  40  

  HYPERLINK \l "_Toc125435624"  6.2  	Occupational Post-application
Exposures	  PAGEREF _Toc125435624 \h  46  

  HYPERLINK \l "_Toc125435625"  6.3 	Wood Preservation	  PAGEREF
_Toc125435625 \h  48  

  HYPERLINK \l "_Toc125435626"  6.3.1 	Non-Pressure Treatment Scenarios
(Handler and Post-application)	  PAGEREF _Toc125435626 \h  48  

  HYPERLINK \l "_Toc125435627"  6.3.2	Pressure Treatment Scenarios
(Handler and Post-Application)	  PAGEREF _Toc125435627 \h  53  

  HYPERLINK \l "_Toc125435628"  6.4	Data Limitations/Uncertainties	 
PAGEREF _Toc125435628 \h  55  

  HYPERLINK \l "_Toc125435629"  7.0	REFERENCES	  PAGEREF _Toc125435629
\h  57  

  HYPERLINK \l "_Toc125435630"  APPENDIX A: Master DDAC Label	  PAGEREF
_Toc125435630 \h  59  

  HYPERLINK \l "_Toc125435631"  APPENDIX B: Summary of CMA and PHED Data
  PAGEREF _Toc125435631 \h  72  

  HYPERLINK \l "_Toc125435632"  APPENDIX C: Input/Output from
Residential MCCEM Modeling	  PAGEREF _Toc125435632 \h  75  

  HYPERLINK \l "_Toc125435633"  APPENDIX D: Input/Output from
Occupational MCCEM Modeling	  PAGEREF _Toc125435633 \h  87  

  HYPERLINK \l "_Toc125435634"  APPENDIX E:  Calculation of DDAC Unit
Exposure Values	  PAGEREF _Toc125435634 \h  96  

 

EXECUTIVE SUMMARY 

	This document is the Occupational and Residential Exposure Chapter of
the Reregistration Eligibility Decision (RED) document for the Group I
Quat Cluster. It addresses the potential risks to humans that result
from the use of chemicals in this group in occupational and residential
settings.  Group I Quat Cluster is a group of structurally similar
quaternary ammonium compounds (“quats”) that are characterized by
having a positively charged nitrogen covalently bonded to two alkyl
group substituents (at least one C8 or longer) and two methyl
substituents.  In finished form, these quats are salts with the
positively charged nitrogen (cation) balanced by a negatively charged
molecule (anion).  The anion for the quats in this cluster is chloride
or bromide. In this document, the Group I Quat Cluster will be referred
to as DDAC (didecyl dimethyl ammonium chloride).

	DDAC is the active ingredient in numerous types of products.  The
products are mainly disinfectants and deodorants that are used in
agricultural, food handling, commercial/ institutional/industrial,
residential and public access, and medical settings (Use Site Categories
I, II, III, IV, and V respectively). Examples of registered uses for
DDAC in these settings include application to indoor and outdoor hard
surfaces (e.g., walls, floors, tables, toilets, and fixtures), eating
utensils, laundry, carpets, agricultural tools and vehicles, egg shells,
shoes, milking equipment and udders, humidifiers, medical instruments,
human remains, ultrasonic tanks, reverse osmosis units, and water
storage tanks. There are also DDAC-containing products that are used in
residential and commercial swimming pools (Use Site Category XI), in
aquatic areas (Use Site Category XII) such as decorative ponds and
decorative fountains, and in industrial process and water systems (Use
Site Category VIII) such as re-circulating cooling water systems,
drilling muds and packer fluids, oil well injection and wastewater
systems. Additionally, DDAC-containing products are used for wood
preservation (Use Site Category X) through non-pressure and
pressure-treatment methods.  There are registered uses for fogging in
occupational settings.  Products containing DDAC are formulated as
liquid ready-to-use, soluble concentrate, pressurized liquid, and water
soluble packaging. The percentage of DDAC in the various end-use
products ranges from 0.08% to 80% as reported in the Master Label
spreadsheet (Appendix A).  Residential products such as EPA Reg. No.
10324-69 range up to 50% DDAC for swimming pools and spas.

 is a localized skin irritation, a skin concentration (μg/cm2) of
exposure, rather then a dose (mg/kg/day) was used to assess the dermal
risk concerns.  No body weight is needed for the dermal irritation
endpoint, since no systemic dose is calculated.  Since the toxicological
endpoint for inhalation is female-specific, a body weight of 60
kilograms is used in the assessment.  This represents the body weight of
an adult female. They Agency’s level of concern (LOC) for occupational
and residential DDAC inhalation and oral exposures is 100 (i.e., a
margin of exposure (MOE) less than 100 exceeds the level of concern).
The level of concern is based on 10x for interspecies extrapolation and
10x for intraspecies variation.  The level of concern for the dermal
route of exposure using dermal irritation as an endpoint is a target MOE
of 10 (i.e., 3x for interspecies extrapolation and 3x for intraspecies
variation).

	The dermal and inhalation margins of exposure were not combined for the
DDAC risk assessment because the toxicity endpoints for the dermal and
inhalation routes of exposure are based on different toxicological
effects. No cancer endpoint was identified; therefore, cancer risks are
not assessed.

		This occupational and residential assessment was based on examination
of product labels describing uses for the product.  There are many
end-use products that contain DDAC; therefore, only labels on the Master
Label developed by AD and the registrants were reviewed. It has been
determined that exposure to handlers can occur in a variety of
occupational and residential environments.  Additionally,
post-application 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.  The representative scenarios are believed to
represent high-end uses resulting in dermal, inhalation, and incidental
oral exposures.

To assess most handler risks, AD used surrogate unit exposure data from
the Chemical Manufacturers Association (CMA) antimicrobial exposure
study and the Pesticide Handlers Exposure Database (PHED). 
Postapplication/bystander exposures were assessed using EPA’s Health
Effects Division’s (HED) Standard Operating Procedures (SOPs) for
Residential Exposure Assessment, MCCEM (Multi- Chamber Concentration and
Exposure Model), and Swim Model. Additionally, handler and
post-application exposures resulting from wood preservation activities
were assessed using surrogate data from the studies 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) and “Assessment of
Potential Inhalation and Dermal Exposure Associated with Pressure
Treatment of Wood with Arsenical Wood Products” (ACC, 2002a).  

Residential Handler Risk Summary

Dermal

		For the residential handler dermal exposure and risk assessment,
dermal risks were calculated by comparing residues on the surface of the
skin to the short-term dermal irritation endpoints.  Residues on the
surface of the skin (dermal irritation exposure) were determined using
hand unit exposures from CMA and/or PHED adjusted for the surface area
of the hand (mg/lb ai/cm2), application rates, and use amounts. The
dermal MOEs were below the target MOE of 10 only for the carpet spray
application and at the maximum application rate for the mopping and
wiping. 

Inhalation

		For the residential handler inhalation assessment, the inhalation
risks were calculated by comparing the daily doses to the short-term
inhalation endpoint.  The inhalation MOEs were above the target MOE of
100 for all scenarios.

Residential Post-Application/Bystander Risk Summary

Dermal

	The residential post-application dermal risks were assessed by
comparing the surface residue on the skin (dermal skin irritation
exposure) to the short-term dermal endpoint. It was assumed that during
the exposure period the skin repeatedly contacts the treated surface
until a steady-state concentration of residues is achieved on the skin. 
For residential scenarios, the post-application dermal MOEs were above
the target MOE of 10 for the laundered clothing (assuming 1% residue
transfer) and hard surface and carpet dermal contact but below the
target MOE for the following:

Wearing clothes treated with a fabric spray: ST dermal MOE =  less than
or equal to 1 using a 100% clothing to skin transfer factor and the MOE
is 8 using a 5% clothing to skin transfer factor.

There are no wipe data available to assess the children’s dermal
contact to treated decks and/or play sets.  Based on hand measurements
of workers at the treatment plants, dermal MOEs range from 3 to 13 with
considerable uncertainties, and therefore, a wipe study is warranted.  

Inhalation

		For the residential post-application inhalation exposure and risk
assessment, the MOEs were below the target MOE of 100 for the following
scenario: 

Humidifier: ST/IT 8-hr Inhalation MOE = 27 for adults and 8 for
children; ST/IT 24-hr Inhalation MOE = 11 for adults and 5 for children

Incidental Oral

For the residential post-application incidental oral assessment, the
MOEs were above the target MOE of 100 for all scenarios. 

Occupational Handler Risk Summary

Dermal

DDAC dermal irritation exposures and risks were not estimated for
occupational handler exposures.  Instead, dermal irritation exposures
and risks will be mitigated using default personal protective equipment
requirements based on the toxicity of the end-use product.  To minimize
dermal  exposures, the minimum PPE required for mixers, loaders, and
others exposed to end-use products containing concentrations of DDAC
that result in classification of category I, II, or III for skin 
irritation potential will be long-sleeve shirt, long pants, shoes,
socks, chemical-resistant gloves, and chemical-resistant apron.  Once
diluted, if the concentration of DDAC in the diluted solution would
result in classification of toxicity category IV for skin irritation
potential, then the chemical-resistant gloves and chemical-resistant
apron can be eliminated for applicators and others exposed to the
dilute. Note that chemical-resistant eyewear will be required if the
end-use product is classified as category I or II for eye irritation
potential. 

Inhalation

	For the occupational handler inhalation exposure and risk assessment,
the MOEs were above the target MOE of 100 for all scenarios.

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

Small process water systems, liquid pour: ST/IT Inhalation MOE = 130

Agricultural fogging, mixing and loading: ST/IT Inhalation MOE = 110

Medical premises, mopping: ST/IT Inhalation MOE = 280

Wood Preservation (non-pressure treatment), blender/sprayer: ST/IT/LT
Inhalation MOE = 280

Occupational Post-Application/Bystander Risk Summary

Dermal

	Dermal irritation exposures are assumed to be negligible for all
post-application occupational scenarios, except those associated with
wood preservation. As with occupational handlers, dermal irritation
exposures and risks from post-application activities in a wood
preservation treatment facility will be mitigated using default personal
protective equipment requirements based on the toxicity of the end-use
product.  For construction workers handling treated wood the MOEs range
from 3 to 13 shortly after application.  

Inhalation

	For the occupational inhalation post-application exposure and risk
assessment, the MOEs were above the target MOE of 100 for all scenarios
except for the following scenarios listed below.

Fogging in a food processing plant:  The 8-hr MOE from 2 to 10 hours (2
hour re-entry interval) = 8.

A confirmatory inhalation toxicity study may be warranted because the
inhalation MOE was below 1,000 (additional 10x uncertainty factor is
considered because of the lack of an inhalation route-specific
toxicological endpoint) for the following scenarios:

Fogging in a hatchery:	 The 8-hr MOE from 0 to 8 hours (entering
immediately after fogging) = 120.

Non-pressure treatment wood preservation, clean-up worker: ST/IT/LT
Inhalation MOE = 990

Data Limitations and Uncertainties:

	There are a number of uncertainties associated with this assessment and
these have been reiterated from Sections 4.2.3 (residential) and 6.4
(occupational) respectively.

	The data limitations and uncertainties associated with the residential
handler and post-application 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 B for summaries of
these data sources). Most of the CMA data are of poor quality therefore,
AD requests that confirmatory monitoring data be generated to support
the values used in these assessments.  

The quantities handled/treated were estimated based on information from
various sources, including HED’s Standard Operating Procedures (SOPs)
for Residential Exposure Assessments (USEPA 2000 and 2001).  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. 

Some labels for products which can be used by homeowners in residential
settings, as well as by workers in occupational settings, indicate that
low pressure sprayers can be used for application of the disinfectant to
hard, non-porous surfaces such as floors and walls. A low pressure spray
scenario was not assessed for the residential scenario because it is not
a typical cleaning method for homeowners.

In this assessment, incidental ingestion and dermal exposures to treated
wood were estimated using DDAC data from an occupational exposure study.
 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 are 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?).  A wipe study on
treated wood is needed to refine these estimates.  

Available data to assess the levels of DDAC in soil contaminated with
DDAC-treated wood do not exist at this time.  In addition, leaching data
were also not available.  Because of this data gap, EPA was not able to
accurately predict dermal and incidental ingestion residential
post-application exposures to soil contaminated with DDAC-treated wood.

The data limitations and uncertainties associated with the occupational
handler and post-application exposure assessments include:

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handler Exposure Database (USEPA, 1998) (See Appendix B for summaries of
these data sources).   Since the CMA data are of poor quality, the
Agency requests that confirmatory data be submitted to support the
occupational scenarios assessed in this document.

  SEQ CHAPTER \h \r 1 Unit exposures are not available for some of the
specific scenarios that are prescribed for DDAC, including open loading
into oil-well/field environments 

The CMA data used for oil-well uses are based on open pouring of a
material preservative.  Although these data are only represented by 2
replicates each, the exposure values are similar to open loading of
pesticides in PHED. Furthermore, there are no representative unit
exposure data for chemical metering into secondary recovery oil
operations.  Since the volume of water being treated in secondary
recovery operations is so large, the available CMA data can not be
reliably extrapolated because they are based on activities that handle
much lower volumes and possibly different techniques.  Therefore, it was
assumed that if the open pour handling activities for the other oil well
operations resulted in MOEs that are not of concern, then the MOEs for
the closed system chemical metering into secondary recovery operations
would also be not of concern.  AD requests that confirmatory data be
conducted to show that this is accurate.

For the wood preservative pressure treatment scenarios, CCA exposure
data were used for lack of DDAC-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 would be similar to exposure patterns for workers
at treatment facilities using DDAC, and therefore the exposures could be
used as surrogate data for workers that treat wood with DDAC. 

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

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 personal
communication with experts.  In particular,   SEQ CHAPTER \h \r 1 the
use information for oil-well uses and cooling water tower uses are based
on personal communication with biocide manufacturers for these types of
uses.  The individuals contacted have experience in these operations and
their estimates are believed to be the best available without
undertaking a statistical survey of the uses.  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 percent active ingredient in solution for the pressure treatment of
lumber needs to be refined by the registrant.  The labels only provided
a retention rate.  For this assessment, the application rate on the
master label was used, which is the same as the application rate for
non-pressure treatment of lumber. 

1.0	 INTRODUCTION tc \l1 "1.0	 INTRODUCTION 

		1.1	Purpose  tc \l2 "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 DDAC. This information is for
use in EPA's development of the DDAC Reregistration Eligibility Decision
(RED) document. 

		1.2	Criteria for Conducting Exposure Assessments tc \l2 "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 DDAC, both criteria are met. Toxicological
endpoints were selected for short- and intermediate-term dermal,
inhalation, and incidental oral exposures to DDAC.  There is a
significant potential for exposure in a variety of occupational and
residential settings.  Therefore, risk assessments are required for
occupational and residential handlers as well as for occupational and
residential postapplication exposures that can occur as a result of DDAC
use.

In this document, handler 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 (1 mg = 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 and inhalation handler exposures are
estimated for each applicable handler task with the application rate,
quantity treated/handled in a day, and the applicable inhalation unit
exposure using the following formula:

Daily Inhalation Exposure:	E = UE x AR x AT					(Eq. 1a)

Where:  

E	=	Amount (mg ai/day) inhaled that is available for inhalation
absorption;

UE	=	Hand 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 Dermal Skin Irritation Exposure:	E = UEhand/SAhand x AR x AT		(Eq.
1b)

Where:  

E	=	Amount (mg ai/cm2) deposited on the surface of the skin;

UEhand	=	Unit exposure value (mg ai/lb ai) derived from August 1998 PHED
data or from 1992 CMA data;

SAhand	=	Surface area of two hands (820 cm2);

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 inhalation dose is calculated by normalizing the daily
exposure by body weight and adjusting, if necessary, with an appropriate
absorption factor.  An absorption factor of 100% was used for inhalation
exposures.  A daily dose is not calculated for dermal exposures, because
the dermal endpoint selected is based on irritation effects, not
systemic effects. Daily dose was calculated using the following formula:

Daily Dose:	ADD = E x ABS							(Eq. 2)

			   BW						

Where:

ADD 		= 	Average daily dose or the absorbed dose received from exposure
to a chemical in a given scenario (mg active ingredient/kg body
weight/day);

E 		=	Amount (mg ai/day) 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 risks for each applicable
handler scenario are calculated using a Margin of Exposure (MOE).  This
is the ratio of the daily inhalation dose or dermal exposure to the
toxicological endpoint of concern.  

Margins of Exposure (inhalation):	MOE = NOAEL or LOAEL			(Eq. 3a)

							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	= 	Systemic toxicity level where no observed adverse
effects (NOAEL) or where the lowest observed adverse effects (LOAEL)
occurred in the study (mg ai/kg body weight/day); and

ADD 			= 	Average daily inhalation dose in a given scenario (mg ai/kg
body weight/day).

Margins of Exposure (dermal):	MOE = NOAEL or LOAEL			(Eq. 3b)

							E

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	= 	Irritation toxicity level where no observed adverse
effects (NOAEL) or where the lowest observed adverse effects (LOAEL)
occurred in the study ((g/cm2); and

E 			= 	Dermal skin irritation exposure in a given scenario ((g/cm2).

	In addition to the target MOEs presented in Table 3.2 that were used
for the analysis, a series of assumptions and exposure factors served as
the basis for completing the handler risk assessment. Each general
assumption and factor for both residential and occupational assessments
is detailed below.  Assumptions specific to the use site category are
listed in each separate section of this document.  The general
assumptions and factors include:

DDAC products are widely used and have a large number of use patterns
that are difficult to completely capture in this document.  As such, AD
has patterned this risk assessment on a series of likely representative
scenarios for each use site that are believed by AD to represent the
vast majority of DDAC uses.

Based on the adverse effects for the endpoints, the average body weight
of a female adult handler (60 kg) was used for the inhalation risk
assessment.  

Exposure factors used to calculate daily exposures to handlers were
based on applicable data, if available.  When appropriate data were
lacking, values from a scenario deemed similar were used. 

The maximum application rates allowed by labels were assumed. 	

		1.3	Chemical Identification tc \l2 "1.3	Chemical Identification 

	The Group I Quat Cluster (DDAC) is a group of structurally similar
quaternary ammonium compounds (“quats”) that are characterized by
having a positively charged nitrogen covalently bonded to two alkyl
group substituents (at least one C8 or longer) and two methyl
substituents.  In finished form, these quats are salts with the
positively charged nitrogen (cation) balanced by a negatively charged
molecule (anion).  The anion for the quats in this cluster is chloride
or bromide.

	Currently, there are 5 active ingredients identified by the Agency that
are registered and included in Case Number 350.  Table 1.1 below
provides the common chemical name, active ingredient code, CAS number,
and chemical structure.  

 	R1 = C8 (variable %)

 	R = C12 (5%)

       C14 (90%)

       C16 (5%)

69173	68607-28-3	Oxydiethylenebis (alkyl*) dimethyl ammonium chloride

R=C12 (40%)

      C14 (50%)

      C16  (10%)

		1.4	Physical/Chemical Properties tc \l2 "1.4	Physical/Chemical
Properties 

		Table 1.2 shows physical/chemical characteristics that have been
reported for DDAC.

Table 1.2.  Physical/Chemical Properties of DDAC

Parameter	

DDAC

Molecular Weight	362.08

Density	0.9216 g/cm3 at 25 C

Boiling Point	NA

Water Solubility	Completely soluble

Vapor Pressure	2.33E-11 mmHg

2.0	 USE INFORMATION tc \l1 "2.0	 USE INFORMATION 

		2.1	 Formulation Types and Percent Active Ingredient tc \l2 "2.1	
Formulation Types and Percent Active Ingredient 

		The products containing DDAC as the active ingredient (a.i) are
formulated as liquid ready-to-use, soluble concentrate, pressurized
liquid, and water soluble packaging. Concentrations of DDAC in these
products range from 0.08% to 80% as reported on the Master Label
spreadsheet (Appendix A).  

		2.2	 Summary of Use Pattern and Formulations

	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
Appendix A. Based on a review of product labels, DDAC is the active
ingredient in products used in the following use site categories: I ( 
SEQ CHAPTER \h \r 1 Agricultural premises and equipment), II (  SEQ
CHAPTER \h \r 1 Food handling/storage establishments premises and
equipment), III (  SEQ CHAPTER \h \r 1 Commercial, institutional and
industrial premises and equipment), IV (  SEQ CHAPTER \h \r 1
Residential and public access premises), V (  SEQ CHAPTER \h \r 1
Medical premises and equipment), VIII (  SEQ CHAPTER \h \r 1 Industrial
processes and water systems), X (  SEQ CHAPTER \h \r 1 Wood
preservatives), XI (Swimming pools), and XII (Aquatic Areas).

	From the scenarios in Appendix A, AD selected representative exposure
scenarios to assess the labeled uses of DDAC in this document.  These
scenarios were selected to be representative of the vast majority of
uses and are believed to provide high-end degrees of dermal, inhalation,
or incidental ingestion exposure.  The representative scenarios assessed
in this document are shown in Table 4.1 (residential) and Table 6.1
(occupational).

3.0	SUMMARY OF TOXICITY DATA tc \l1 "3.0	SUMMARY OF TOXICITY CONCERNS
RELATING TO EXPOSURE 

	3.1	Acute Toxicity

 tc \l2 "3.1	Acute Toxicity 

The acute toxicity data for DDAC are summarized below in Table 3.1
(USEPA, 2006).

Table 3.1   Acute Toxicity Profile for DDAC

Guideline Number	Study Type/ Test substance (% a.i.)	MRID Number/
Citation	Results	Toxicity Category

870.1100

(§81-1)	Acute oral, rat

(Purity 65%)	MRID 41394404	  SEQ CHAPTER \h \r 1 LD50 =262 mg/kg
(combined)	II

870.1100

(§81-1)	Acute oral, rat

(Purity 80%)	MRID 42296101	  SEQ CHAPTER \h \r 1 LD50 =238 mg/kg
(combined)	II

870.1200

(§81-2)	Acute dermal, rabbit

(Purity 65%)	MRID 42053801	  SEQ CHAPTER \h \r 1 LD50 =2930 mg/kg
(combined)	III

870.1300

(§81-3)	Acute inhalation, rat

 (Purity not reported)	MRID 00145074

TRID 455201010	  SEQ CHAPTER \h \r 1 LC50 = 0.07 mg/L (combined)	II

870.2400

(§81-4)	Primary eye irritation, rabbit (Purity 80% a.i.)	MRID 42161602	
 SEQ CHAPTER \h \r 1 Corrosive.	I

870.2500

(§81-5)	Primary dermal irritation, rabbit (Purity 80%)	MRID 42161601
Corrosive.	I

870.2600

(§81-6)	Dermal sensitization, guinea pigs (Purity 80%)	MRID 46367601
Not a sensitizer.	NA

3.2	Summary of Toxicity Endpoints tc \l2 "3.2	Summary of Toxicity
Concerns Relating to Exposures 

	Table 3.2 summarizes the toxicological endpoints for DDAC (USEPA,
2006).  The specific MRID numbers for toxicity studies are referenced in
USEPA 2006 and not repeated in this document.

  SEQ CHAPTER \h \r 1 

Table 3.2  Summary of Toxicological Endpoints for DDAC

Exposure

Scenario	Dose Used in Risk Assessment

(mg/kg/day)	Target MOE/UF,

Special FQPA SF

for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(Females 13-50)	NOAEL(developmental) = 10 mg/kg/day

	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)
Prenatal Developmental Toxicity - Rat

MRID 41886701

LOAEL = 20 mg/kg/day based on increased incidence of skeletal
variations.

	Acute RfD = 0.1 mg/kg/day (for Females age 13-50)

Acute Dietary

(general population)	An acute dietary endpoint was not identified in the
data base.  This risk assessment is not required

Chronic Dietary

(general population)

	NOAEL = 10

mg/kg/day	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation
Chronic Toxicity Study - Dog

MRID 41970401

LOAEL = 20 mg/kg/day based on increased incidence of clinical signs in
males and females and decreased total cholesterol levels in females. 

	Chronic RfD = 0.1 mg/kg/day

Dermal, Short-Term (technical a.i.)

 

NOAEL = 2 

UF = 100Based on increased dermal clinical and gross findings

Rat 90-day Dermal Study

MRID 413059-01

Non-Dietary Exposures

Incidental Oral

Short-Term	NOAEL

(developmental) = 10 mg/kg/day

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

FQPA SF = 1

	Prenatal Developmental Toxicity - Rat

MRID 41886701

LOAEL = 20 mg/kg/day based on increased incidence of skeletal
variations.

Incidental Oral

Intermediate-Term	NOAEL  = 10 mg/kg/day

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

FQPA SF = 1	Chronic Toxicity Study - Dog

MRID 41970401

LOAEL = 20 mg/kg/day based on increased incidence of clinical signs in
males and females and decreased total cholesterol levels in females. 

Dermal, Short-term (formulated product, 0.13% a.i.)	No endpoint
identified.  No dermal or systemic effects identified in the 21-day
dermal toxicity study (MRID 45656601) up to and including the limit dose
of 1000 mg/kg/day

Dermal, Short-term 	NOAEL(dermal) = 2 mg ai/kg/day

(8 µg ai/cm2)a	Target MOE = 10 (3x inter-species extrapolation, 3x
intra-species variation)

	90-day Dermal Toxicity - Rat

MRID 41305901

LOAEL = 6 mg ai/kg/day based on increased clinical and gross findings
(erythema, edema, exfoliation, excoriation, and ulceration)

Dermal, Intermediate- and Long-term 	No appropriate endpoint identified.

Inhalation, Short-Term

	NOAEL b  = 10 mg/kg/day

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

FQPA SF = 1	Prenatal Developmental Toxicity - Rat

MRID 41886701

LOAEL = 20 mg/kg/day based on increased incidence of skeletal
variations.

 Inhalation, Intermediate- and Long-Term

	NOAEL b = 10

mg/kg/day	Target MOE = 100 (10x inter-species extrapolation, 10x
intra-species variation)

FQPA SF = 1	Chronic Toxicity Study - Dog

MRID 41970401

LOAEL = 20 mg/kg/day based on increased incidence of clinical signs in
males and females and decreased total cholesterol levels in females. 

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 (a = acute, c = chronic), RfD =
reference dose, MOE = margin of exposure, LOC = Level of concern, NA =
Not Applicable.

a  Short-term dermal endpoint = (2 mg/kg rat x 0.2 kg rat x 1000 ug/mg)
/ 50 cm2  area of rat dosed = 8 µg/cm2.

b An additional uncertainty factor of 10x is used for route
extrapolation from an oral endpoint to determine if a confirmatory study
is warranted.  

	3.3	FQPA Considerations 

The Agency (USEPA, 2006) decided that the FQPA safety factor be removed
for DDAC, based upon the existence of a complete developmental and
reproductive toxicity database and the lack of evidence for increased
susceptibility in these data.  

4.0	RESIDENTIAL EXPOSURE ASSESSMENT  tc \l1 "4.0	RESIDENTIAL EXPOSURE
ASSESSMENT 

	4.1	Summary of Registered Uses tc \l2 "4.1	Summary of Registered Uses 

	Products containing DDAC can be used as general cleaners,
disinfectants, and deodorizers. These products are primarily for use on
indoor surfaces such as hard floors, carpets, walls, bathroom fixtures,
trash cans, toilet bowls, and household contents.  Additionally, other
uses in the home include liquid laundry deodorizers that are added to
the final rinse of the wash cycle, algaecide/bacteriocides that are
added to portable humidifiers and swimming pools, and deodorizers that
are sprayed on fabric.  Residents may also be exposed to items that have
been treated with DDAC in occupational settings, such as dimensional
lumber for decks and play sets. Appendix A presents a summary of all
exposure scenarios that may occur in residential settings based on
examination of product labels.  Table 4.1 identifies the representative
exposure scenarios assessed in this document.

	4.2	Residential Exposure tc \l2 "4.4	Residential Exposure/Risk Pathway 

	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.  It should
be noted that for the calculation of application rates in which the
density of the product is noted as 8.34 lb/gal, the product is assumed
to have the density of water because no product-specific density is
available. Handler exposures were assessed for the application of DDAC
to indoor hard surfaces, carpets, humidifiers, and swimming pools. 
Post-application exposures were assessed for dermal and/or oral contact
with treated surfaces including hard floors, carpets, textiles, lumber,
and pool water. Post-application/bystander inhalation exposures were
assessed for the humidifier use.  DDAC has a low vapor pressure, and
therefore, inhalation exposure is to the aerosol generation.

Table 4.1. Representative Uses Associated with Residential Exposure

Representative Use	Application Method	Exposure Scenario	Example
Registration #	Application Rate

Indoor Hard Surfaces	Mopping

Wiping

Trigger pump spray	ST Handler: adult dermala and inhalation

ST Post-app: child incidental ingestion and dermal	10324-134

10324-80

	0.0200 lb a.i./gal 

(2 oz product/gal water x 15.36% a.i. x 8.34 lb/gal x 1 gal/128 oz)

0.0043 lb ai/gal

(3.3% ai x 8.34 lb/gal x 2 oz/gal x 1 gal/128 oz)

Carpets 	Low pressure spray	ST Handler:  adult dermal and inhalation

ST Post-app: child incidental ingestion and dermal	10324-81

	0.0088 lb ai/gal

(4.5% ai x 8.34 lb/gal x 3 oz/gal x 1 gal/128 oz)

Swimming pool	Liquid pour 	ST Handler:

adult dermala and inhalation 

ST Post-app:  ingestion (child and adult)	10324-69 and

1839-133

	HANDLERS

Heavy algae:

0.000017 lb ai/gal (3 ppm)

(50.0% x 5.25 oz/10,000 gal x 8.34 lb/gal x 1 gal/128 oz)

Winterizing:

0.0000167 lb ai/gal

(10.0% x 128 oz/50,000 gal x 8.34 lb/gal x 1 gal/128 oz)

POST-APPLICATION

Heavy algae:

0.0000488 lb ai/gal (6 ppm)

(50.0% x 15 oz/10,000 gal x 8.34 lb/gal x 1 gal/128 oz) 

Contacting Preserved Wood	NAa	ST Post-app: child incidental ingestion
and dermal	6836-212	NA

Wearing clothing and diapers treated during final rinse cycle of wash
NAb	ST Post-app: adult dermal; child incidental ingestion and dermal 
1677-109	0.000733 lb ai/lbs dry fabric

(50.0% x 2.25 oz/100 lbs dry fabric x 8.34 lb/gal x 1 gal/128 oz)

Wearing clothing treated with fabric spray	NA	ST Post-app: adult dermal;
child incidental ingestion and dermal	3573-69	0.011 lb ai/gal

(0.13% ai x 8.34 lb/gal)

Humidifier	Liquid pour	ST Handler:

adult dermala and inhalation 

ST Post-app: child and adult inhalation	10324-80	0.0043 lb ai/gal

(3.3% ai x 8.34 lb/gal x 2 oz/gal x 1 gal/128 oz)

Note:  The dermal risks are based on the short-term dermal endpoint
(i.e., rat study) regardless of the percent active ingredient in the
product.

a	The handlers scenarios were not assessed because the products can only
be used by occupational handlers.

b	Handler exposures for application to laundry are represented by the
application to humidifiers.

		4.2.1	Residential Handler Exposures

	The residential handler scenarios described in Table 4.1 were assessed
to determine dermal and inhalation exposures.  The scenarios were
assessed using PHED and CMA data and the equations in Section 1.2,
“Criteria for Conducting Risk Assessment.”  A summary of the PHED
and CMA data sets are presented in Appendix B.

Unit Exposure Values: Unit exposure values were taken from the PHED data
presented in HED’s Residential SOPs (USEPA, 1997) and from the CMA
data from the EPA memorandum Evaluation of Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study (USEPA, 1999).

    

For the mopping scenario, the CMA dermal (hand) and inhalation unit
exposure values for ungloved mopping were used (52 mg/lb a.i. and 2.38
mg/lb a.i., respectively).  After normalization for the surface area of
the hand (820 cm2), the dermal unit exposure value is 0.063 mg/lb
a.i/cm2. These values are based on data collected from six replicates
mopping floors and receiving exposure via contact with the mop or with
the bucket.  

For the wiping scenario, the CMA dermal (hand) and inhalation unit
exposure values for ungloved wiping were used (1,100 mg/lb a.i. and 67.3
mg/lb a.i., respectively). After normalization for the surface area of
the hand (820 cm2), the dermal unit exposure value is 1.34 mg/lb
a.i/cm2. These values are based on data collected from six replicates
(dental technicians) who used a finger pump sprayer to apply the product
and then wiped the surfaces with a paper towel.

For trigger pump scenarios, the PHED dermal (hand) and inhalation unit
exposure values are 106 mg/lb a.i. and 2.4 mg/lb a.i., respectively. 
After normalization for the surface area of the hand (820 cm2), the
dermal unit exposure value is 0.129 mg/lb a.i/cm2. The values are based
on homeowners applying an insecticide packaged in an aerosol can to
baseboards in kitchens and are representative of a handler wearing short
pants and a short sleeve shirt, with no gloves.

For low pressure handwand, the CMA dermal (hand) and inhalation unit
exposure values for ungloved use of a low pressure spray are 132 and
0.681 mg/lb a.i., respectively.  After normalization for the surface
area of the hand (820 cm2), the dermal unit exposure value is 0.161
mg/lb a.i/cm2. The values are based on data collected from eight
replicates who hand sprayed carpet using 200 psi, then used a push broom
rake to raise the carpet nap.

For liquid pour in swimming pool and humidifier scenarios, the cooling
tower CMA data for liquid pour was used for dermal exposures.  This set
of data was used because no other CMA data sets represent ungloved
replicates pouring liquid.  The dermal hand unit exposure value is 0.196
mg/lb a.i. After normalization for the surface area of the hand (820
cm2), the dermal unit exposure value is 0.000239 mg/lb a.i/cm2. For
inhalation exposures, the CMA preservative data were used for swimming
pool exposures.  The inhalation unit exposure is 0.00346 mg/lb a.i. and
is based on 2 replicates.   SEQ CHAPTER \h \r 1 Although this unit
exposure is based on minimal replicates, the exposure value is similar
to the one found in PHED for a similar scenarios.  For the humidifier
tank scenario, CMA data for liquid pour of disinfectants were used. The
inhalation unit exposure value is 1.89 mg/lb a.i. The value is based on
data collected from two gloved replicates involving pouring a
disinfectant product from a jug into sterilization trays designed for
dental instruments, adding water and instruments to the tray, removing
the instruments, and discarding the old solution.

Quantity handled/treated: The quantities handled/treated were estimated
based on information from various sources, including the Antimicrobial
Division’s estimates. 

For mopping scenarios, it is assumed that 1 gallon of diluted solution
is used.

For wiping and trigger pump spray scenarios, it is assumed that 0.5
liter (0.13 gal) of diluted solution is used.

For low pressure hand wand, it was assumed that 2 gallons are used in
all indoor applications.

For liquid pour in swimming pool scenario, it was assumed that a
residential pool contains 20,000 gallons of water.

For liquid pour in humidifier scenario, it was assumed that a humidifier
with a 11 gallon tank would be treated, based on Holmes Model#
HM4600-U-11. This humidifier releases 11 gallons/1,700 ft2/24 hours
(http://www.holmesproducts.com/estore/product.aspx?CatalogId=3&CategoryI
d=1120&ProductId=582). 

Duration of Exposure: The duration of exposure for most homeowner
exposures is believed to be best represented by the short-term duration
(1 to 30 days).  The reason that short term duration was chosen to be
assessed is because the different handler and post-application scenarios
are assumed to be episodic, not daily.  In addition, homeowners are
assumed to use different products with varying activities, not
exclusively DDAC treated products.

Results

	The resulting short-term exposures and MOEs for the representative
residential handler scenarios are presented in Tables 4.2 (inhalation)
and 4.3 (dermal). The calculated inhalation MOEs are above the target
MOE of 100 for all scenarios, and therefore, are not of concern. The
calculated dermal MOEs are above the target MOE of 10 for all scenarios
except for carpet applications and at the maximum application rate for
mopping and wiping.  A confirmatory inhalation toxicity study may be
warranted because inhalation MOE was below 1,000 for the wiping scenario
(MOE = 820). 

 

Table 4.2 DDAC Short-Term Residential Handler Inhalation Exposures and
MOEs

Exposure Scenario

Application Method	Application Method	Application Ratea (lb ai/gallon)
Quantity Handled/ Treated per dayb (gallons)	

Unit Exposure

(mg/lb a.i.)	Absorbed Daily Dose (mg/kg/day) c	MOE d 

(Target MOE = 100)

Application to indoor hard surfaces	Mopping	0.020	1	2.38	0.00079	13,000

	Wiping	0.020	0.13	67.3	0.0029	3,400

	Trigger Spray	0.020	0.13	2.4	0.00010	96,000

Application to Carpets	Low Pressure Spray	0.0088	2	0.681	0.012	50,000

Application to Swimming Pools	Liquid Pour	0.000017	20,000	0.00346
0.00002	510,000

Application to Humidifiers	Liquid Pour	0.0043	11	1.89	0.0015	6,700

a	Application rates are the maximum application rates determined from
EPA registered labels for DDAC.

b	Amount handled per day values are estimates or label instructions.	

c	Absorbed Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x
application rate (lb ai/gal) x quantity treated (gal/day) x absorption
factor (1.0 for  inhalation)]/ Body weight (60 kg for inhalation).

d	MOE = NOAEL / Absorbed Daily Dose.  [Where short-term NOAEL = 10
mg/kg/day for inhalation]. Target MOE = 100.

Table 4.3 DDAC Short-Term Residential Handler Dermal Risks

Exposure Scenario	Application Method	Application Ratea 

(lb ai/gal)	Quantity Handled/ Treated per dayb (gallon)	Hand Unit
Exposure Adjusted for Surface Area

(mg/lb ai/cm2)c	

Dermal Skin Irritation Exposure d

((g/cm2)	MOE e

(Target MOE = 10)

Application to indoor hard surfaces	Mopping	0.0043	1	0.063	0.273	29

0.02

	1.27	6

	Wiping	0.0043	0.13	1.341	0.750	11

0.02

	3.49	2

	Trigger Spray	0.0043	0.13	0.129	0.072	110

0.02

	0.34	24

Application to Carpets	Low Pressure Spray	0.0088	2	0.161	2.832	3

Humidifier	Liquid Pour	0.0043	11	0.000239	0.011	710

Application to swimming pools	Liquid Pour	0.000017	20,000	0.000239	0.08
98

a	Application rates are the maximum application rates determined from
EPA registered labels for DDAC.

b	Amount handled per day values are estimates or label instructions.

c	Unit Exposure (mg/lb ai/cm2) = Hand unit exposure from PHED or CMA
(mg/lb ai) / surface area of hand (820 cm2).

d	Dermal Skin Irritation Exposure (μg/lb ai/cm2) = Unit Exposure (mg/lb
ai/cm2) x Application Rate (lb ai/gal) x Quantity Treated (gal/day) x
1,000 μg/mg

e 	MOE = NOAEL (μg/cm2)/ Dermal Skin Irritation Exposure (μg/cm2). 
[Where short-term dermal NOAEL = 8 µg/cm2]. Target MOE = 10.

 		4.2.2	Residential Post-application Exposures tc \l3 "4.4.2
Postapplication Exposure 

 	For the purposes of this screening level assessment, post-application
scenarios have been developed that encompass multiple products, but
still represent a high end exposure scenario for all products
represented. As shown in Table 4.1, representative post-application
scenarios assessed include crawling on treated hard surfaces, carpets,
and treated lumber such as decks/play sets (dermal and incidental oral
exposure to children), wearing treated clothing from wash treatment and
from spray treatment (dermal exposure to adults and children and
incidental oral exposure to children), using portable humidifiers (adult
and child inhalation exposure), and swimming in treated pools (adult and
child incidental ingestion). 

Since no toxicological endpoint of concern was identified for dermal
systemic adverse effects, post-application dermal risks were assessed
using the toxicological endpoint of concern for dermal irritation.  The
residential post-application dermal risks were assessed by comparing the
surface residue on the skin (dermal skin irritation exposure) to the
short-term dermal irritation endpoint. It was assumed that during the
exposure period, the skin repeatedly contacts the treated surface until
a steady-state concentration of residues is achieved on the skin.

			4.2.2.1 Hard Surface Floor and Carpets tc "4.4.2.1		Hard
Surface/Floor " \l 4   

Dermal Exposure to Children from Treated Hard Floors and Carpets

Exposure Calculations

There is the potential for dermal exposure to toddlers crawling on hard
floors and carpets after mopping or cleaning with DDAC. Risks were
calculated for children contacting treated floors in residential homes.
To determine toddler exposure to floor residues, the following equation
was used: 

E = AR x DTF x DRF x CF1 X CF2						(Eq. 4)				

Where:

	

μg/cm2);

	AR	=	Application rate (lb/ft2);

	DTF	=	Dermal transfer factor (fraction, unitless);

	DRF	=	Disinfectant fraction remaining on floor (unitless);

	CF1	=	Conversion factor (4.54x108 μg/lb);

	CF2	=	Conversion factor (0.00108 ft2/cm2);

	

Assumptions

				

Due to limited data, a number of conservative assumptions have been
made:

No transferable residue data were available that could be used to
estimate the transfer of DDAC from the floor to skin.  Therefore, it is
assumed that 10% of the deposition rate is available for dermal transfer
from hard floors and 5% of the deposition rate is available for dermal
transfer from carpets (USEPA, 2000 and 2001).

No data could be found regarding the quantity of solution residue left
on the floor after treatment.  As a conservative measure, it has been
assumed that 25% of the cleaning solution remains on the floor after the
final cleaning/mopping.

For mopping on hard floors, the labels did not provide information on
the volume of disinfectant to be used for cleaning floors.  It was
assumed that the diluted treatment solution was applied at a rate of 1
gallon per 1,000 sq. ft. The maximum application rate on the product
labels for application to hard surfaces is 0.020 lb ai/gal (see Table
4.1) for a residential setting. Therefore, the application rate used in
the post-application hard floor scenarios was 0.000020 lb ai/ft2.  For
carpets, the labels stated that 1 gallon of diluted treatment solution
should be applied at a rate of 1 gallon per 300 to 500 sq. ft for rotary
floor machines.  Using a rate of 1 gallon solution per 300 sq. ft. and a
maximum application rate of 0.0088 lb ai/gal (see Table 4.1), the
application rate used in the post-application carpet scenarios was
0.0000293 lb ai/ft2.

It was assumed that the exposed toddler plays regularly on the treated
floor.  In a residential home, short-term exposure duration is most
likely since homeowners are expected to clean the floor only
intermittently.  

Results

The calculation of the short-term dermal doses and MOEs are shown in
Table 4.4.  The dermal MOEs are above the target MOE of 10 (MOE = 33 for
hard surfaces and 45 for carpets), and therefore, are not of concern.

Table 4.4.  DDAC Short-term Dermal Risks Associated with
Post-application Exposure from a Treated Hard Surface Floor and Carpet

Exposure Scenario	Application Rate

(lb ai/sq ft)	Product remaining after applying	Percent Transfer Residue
Dermal skin irritation exposure a (µg/cm2)	MOE

Hard surface	0.000020	25%	10%	0.245	33

Carpet	0.0000293	25%	5%	0.180	45

a 	Dermal skin irritation exposure (µg/cm2) = (Application rate,
lb/ft2) x (conversion factor, 4.54 E8 µg/lb) x (conversion factor,
0.00108 ft2 /cm2) x (product remaining after mopping, 25%) x (dermal
transfer factor, 10% for hard surface and 5% for carpets)

b. 	MOE  = NOAEL (µg/cm2) / Surface Residue on skin (µg/cm2). 
Short-term dermal NOAEL is 8 µg/cm2.  Target MOE = 10.

Child Incidental Ingestion Exposure to Treated Hard Floors and Carpets

Exposure Calculations

In addition to dermal exposure, toddlers crawling on treated hard floors
will also be exposed to DDAC via incidental oral exposure through
hand-to-mouth activity.  To calculate incidental ingestion exposure to
these chemicals due to hand-to-mouth transfer, the scenarios established
in the Standard Operating Procedures (SOPs) for Residential Exposure
Assessments (USEPA 2000 and 2001) were used.  These scenarios use
assumptions are similar to those used in calculating exposures due to
dermal contact of DDAC from toddlers crawling on treated floors.  Risks
were calculated for children contacting treated floors in residential
homes and in commercial day care centers.  Typically the day care center
scenario is assessed as the intermediate-term duration because the
frequency of cleaning is assumed to be greater than that of the
residential setting.  However, for DDAC, the short- and
intermediate-term incidental oral endpoints are identical.  The
following equations were used to determine risks from hand-to-mouth
transfer of pesticide residues to toddlers:

PDRnorm= SR x DTF x SA x FQ x ET x SE x CF1					(Eq. 5)	

                                         BW

Where:

	PDRnorm	=	Potential dose rate (mg/kg/day);

	SR		=	Indoor 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 (hrs/day);

	CF1		=	Unit conversion factor (0.001 mg/(g); and

	BW		=	Body weight (kg)

SR=AR x DRF x CF2 x CF3								

Where:

	SR		=		Surface residue on floor (µg/cm2);

	AR		=		Application rate (lb ai/ft2);

	DRF		=		Disinfectant fraction remaining on floor (25%);

	CF2		=		Unit conversion factor (4.54x108 µg/lb); and

	CF3		=		Unit conversion factor (0.00108 ft2/cm2)

Assumptions

Due to limited data, a number of conservative assumptions have been
made: 

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 the SOP, it is assumed that the surface area used for each
hand-to-mouth event is 20 cm2, and that there are 20 events per hour for
short-term exposures (90th percentile (USEPA 2000 and 2001)). 

For hard floors, the exposure time is 4 hours/day, based on the time
spent in the kitchen and bathroom for adults. For carpets, the exposure
time is 8 hours/day based on the total amount of time spent indoors for
young children and subtracting the amount of time spent sleeping,
eating, and bathing (USEPA 2000 and 2001).  

The saliva extraction efficiency is 50% (USEPA 2000 and 2001)

No data could be found regarding the quantity of solution residue left
on the floor after treatment.  As a conservative measure, it has been
assumed that 25% of the cleaning solution remains after the final
mopping or cleaning.

No transferable residue data were available that could be used to
estimate the transfer of DDAC from the floor to skin.  Therefore, it was
assumed that 10% of the deposition rate is available for dermal transfer
from hard floors and 5% of the deposition rate is available for dermal
transfer from carpets (USEPA 2000 and 2001).

Results

The calculation of the short-term oral doses and MOEs are shown in Table
4.5.  The oral MOEs are above the target MOE of 100 (MOE = 760 for hard
floors and 520 for carpets).  Note: The short-term duration is
protective of the intermediate-term exposures at a day care facility
because the toxicity data are identical.

Table 4.5.  DDAC Short-term Incidental Oral Risks Associated with
Post-application Exposure from a Treated Hard Surface Floor and Carpet

Exposure Scenario	Appl. Rate

(lb ai/

sq ft)	Percent transferable residue	Product remaining after applying
Surface area mouthed (cm2/

event)	Exposure Frequency (events/hr)	Saliva Extraction Factor	Exposure
Time (hrs/day)	Surface Residue on floora (µg/cm2)	Potential Dose Rateb
(mg/kg

/day)	Incidental Oral MOEc

Hard Surface	0.000020	10%	25%	20	20	50%	4	2.45	0.013	760

Carpet	0.0000293	5%	25%	20	20	50%	8	3.60	0.019	520

a 	Surface residue on floor (µg/cm2) = (application rate, lb ai/ft2) x
(Disinfectant fraction remaining on floor, 25%) x (conversion factor to
convert lb to µg, 4.54E+08 µg/lb) x (conversion factor to convert ft2
to cm2, 1.08E-03 ft2/cm2)

μg to mg, 0.001 mg/µg)]/(body weight, 15 kg)

c 	MOE = NOAEL (mg/kg/day) / potential dose rate (mg/kg/day) [Where oral
NOAEL = 10 mg/kg/day for short-term].  Target MOE = 100.	

		4.2.2.2	Textiles

Dermal Exposure to Laundered Clothing-Adult and Child

Exposure Calculations

Some DDAC fabric softener/sanitizing products are added to the final
rinse cycle water to provide self-sanitizing and bacteriostatic activity
against odor-causing organisms.  To determine dermal skin irritation
exposure to treated clothing, the guidance provided in Human and
Environmental Risk Assessment (HERA) Guidance Document (2003, 2005) was
used.  The following equation, modified from the basic equation provided
in HERA (2003), is used to calculate dermal exposure:

Dermal Skin Irritation Exposure (μg/cm2) = AR x F x FD x F1 x F2 x CF1	
(Eq. 6)						

Where:

	AR	=	Application rate in mg a.i./mg weight of fabric;

	F	=	Weight fraction of the chemical left on the clothing after the
final spin;

	FD	=	Fabric density (mg/cm2); 

	F1	=	Weight fraction transferred from clothing to skin;

	F2	=	Weight fraction remaining on skin; and

	CF1	=	Conversion factor, 1,000 μg/mg.

Assumptions 

 

The application rate is 0.000733 mg a.i/mg weight of fabric, based on
product label # 1677-109.

In HERA (2003), it was determined that 2.5% of the chemical in the
laundry detergent remains after the final rinse cycle.  It is assumed
that a washing machine containing laundry, detergent, and water would
go through an agitation period, and then spin dry, then refill with
fresh water for rinsing, agitate, and then spin dry again.  Assuming
that the fraction of chemical removed during each spin dry cycle is the
same, then:

 

Mf / Mi = Xspin2 = 0.025	(Eq. 7)

Where:

	Mf	=	Mass of chemical remaining on clothing after the final rinse,

	Mi	=	Mass of chemical originally added to laundry machine, and

	Xspin	=	Fraction of chemical remaining after each spin cycle.

The quantity Xspin is squared because the laundry and the detergent
undergo two spin cycles. For assessment of fabric softener/sanitizer,
the fraction of chemical remaining will be equivalent to Xspin, since
the fabric softener/sanitizer, which is applied during the rinse cycle,
will only undergo one spin cycle.  Taking the square root of both sides
of Equation 7 gives an Xspin value of 0.158, or 15.8%.  

The fabric density is 10 mg/cm2, which is the value provided in HERA
(2003) for mixed cotton and synthetics.

No leaching data were available that could be used to estimate a flux
rate of the chemical from clothing.  Exposures were calculated using a
conservative transfer factor of 100%, which assumes that all residues
are transferable from clothing surfaces to the skin, and using HERA’s
value of 1% transfer (HERA, 2003).

No dissipation data were available; therefore, the amount of DDAC
remaining on the skin is assumed to be 100 percent.

Results

The resulting short-term dermal exposures and MOEs are presented in
Table 4.6.  The dermal MOE was above the target MOE of 10 assuming the
1% transfer, and therefore, not of concern.  A confirmatory study to
determine the percent transfer is warranted as the MOE estimated
assuming 100% transfer is of concern.     

1% = 0.0116 μg/cm2

100% = 1.16 μg/cm2	Eq. 6

Dermal NOAEL	4 μg/cm2	Dermal endpoint selected

Dermal Short-term  MOEb	1% = 690

100% = 7	Eq. 3b (Target MOE = 10)

a	Dermal Exposure (μg/cm2) =(Application rate, 0.000733 mg a.i/mg
weight of fabric) x  (residue left after spin cycle, 15.8%) x (fabric
density, 10 mg/cm2) x (weight fraction transferred from clothing to
skin) x (weight fraction remaining on skin) x  (conversion factor, 1000
μg/mg)

b 	MOE = NOAEL (μg/cm2) / dermal exposure (μg/cm2) [Where short-term
dermal NOAEL = 8 μg/cm2].  Target MOE = 10.

Incidental Oral Exposure to Laundered Clothing-Adult and Child

Exposure Calculations

Oral exposure associated with toddlers mouthing clothing was assessed
using an equation similar to that used for assessing dermal exposure to
laundered clothing:

Oral Exposure (mg/kg/day) = AR x F x FD x Smouthed x SE				(Eq. 8)

					       BW

Where:

AR	=	Application rate in mg a.i./mg weight of fabric;

F	=	Weight fraction of the chemical left on the clothing after the final
spin;

FD	=	Fabric density (mg/cm2);

Smouthed	=	Surface area of fabric that is mouthed (cm2);

SE	=	Saliva extraction factor; and

BW	=	Body weight (kg).  

Assumptions 

The surface area of fabric mouthed is 100 cm2 (HERA, 2003).

The saliva extraction factor is 50% (USEPA 2000 and 2001).

Assumptions regarding fabric density and weight fraction of chemical
left after final spin are identical to those used for the assessment of
dermal exposure to laundered clothing.  

Results

The resulting short-term oral exposure and MOE are presented in Table
4.7.  The oral MOE was above the target MOE of 100.   

Table 4.7. DDAC Short-term Incidental Oral Postapplication Exposure and
MOE for Contacting Laundered Clothing –  Child

Parameter	Value	Rational

Application rate	0.000733 mg a.i/mg weight of  fabric	See Table 4.1

Weight fraction of residue remaining after final spin	15.8%	HERA 2005

Fabric density	10 mg/cm2	Mixed cotton and synthetics (HERA 2003)

Surface area of clothing available for mouthing	100 cm2	HERA 2003

Saliva Extraction Factor	50%	USEPA 2000 and 2001

Body weight	15 kg	EPA 1997, median body weight

Oral Exposurea	0.00386 mg/kg/day	Eq. 8

Oral NOAEL	10 mg/kg/day	Oral endpoint selected

Short-, intermediate-term  MOEb	2,600	Eq. 3

a	Oral Exposure  (mg/kg/day) = (Application rate, 0.000733 mg a.i/mg
weight of fabric) x (residue left after spin cycle, 15.8%) x (fabric
density, 10 mg/cm2) x (surface area mouthed, 100 cm2) x (Saliva
extraction factor, 50%) / (body weight, kg)

b 	MOE = NOAEL (mg/kg/day) / potential daily dose (mg/kg/day) [Where
short-term oral NOAEL = 10 mg/kg/day].  Target MOE = 100.

Dermal Exposure to Clothing Treated with Fabric Spray

Exposure Calculations

	There is the potential for dermal exposure to children wearing clothing
treated with a trigger-pump spray product containing antimicrobials. 
The product label (3573-69) indicates to spray fabric until damp and to
allow surface to dry before use. The dermal skin irritation exposure is
calculated using following equation and assumptions:

μg/cm2); and

C 	= 	Concentration on clothing (μg ai/cm2).

TR	=	Transferable residue from clothing to skin (%);

C = A x WF x CF	

Where:

C	=	Concentration on clothing (μg ai/cm2);

A 	= 	Fabric density x percent moisture content of fabric (16 mg/cm2); 

WF 	=	Weight fraction of product (% ai); and

CF	=	Conversion factor (1,000 μg/mg).

Assumptions 

An application rate of 16 mg product/cm2 is assumed based on a 10 mg/cm2
fabric density of mixed cotton and synthetics and a moisture content of
60% from laundered fabric that has been spun dry (HERA 2005).  The
moisture content of clothing after laundering is assumed to be an
overestimate for a spray-on product (i.e., assumes that the fabric is
sprayed to a similar amount of moisture as that from fabric spun dry in
a laundry machine).

If data are not available from which a transfer factor could be
estimated, potential doses are calculated using a conservative transfer
factor of 100%, which assumes that all residues are transferable from
clothing surfaces.  Potential doses can also be calculated using a less
conservative transfer factor of 5%, which is based on the amount of
residue assumed to be transferable from carpeted surfaces (USEPA, 2001)
but confirmatory data will be requested to support this assumption.

Results

The resulting short-term dermal exposure and MOE are presented in Table
4.8.  The dermal MOEs were below the target MOE of 10 for both the 100%
and 5% transfer factors (MOE is 8 when assuming a 5% transfer of
residues from clothing to skin). 

  

Table 4.8.  DDAC Short-term Dermal Risks Associated with
Post-application Exposure from a Clothing Treated with a Fabric Spray

Weight fraction of product (%ai)	Moisture Content of Fabric (mg/cm2);
Concentration of Clothing (µg/cm2)	Percent Transfer Residue	Dermal skin
irritation exposure a (µg/cm2)	MOE (Target MOE = 100)

0.13	16	20.8	100%	20.8	<1

	5%	1.04	8

a	Concentration on clothing (µg/cm2) = % active ingredient / 100 *
Clothing absorption rate (16 mg/cm2)* conversion factor (1,000 µg/mg)

b	Dermal Skin Irritation Exposure (µg/cm2) = (concentration on
clothing, µg/cm2) * (percent transferable residue from textile).

 c 	MOE = NOAEL (µg/cm2) / Dermal Skin Irritation Exposure (µg/cm2) 
[Where short-term dermal NOAEL = 8 µg/cm2.  Target MOEs = 10.

Incidental Oral Exposure to Children Mouthing Clothing Treated with
Fabric Spray

Exposure Calculations 

	There is the potential for incidental oral exposure to children from
mouthing textiles treated with a trigger-pump spray product containing
DDAC.

Potential doses are calculated as follows:

PDD = C x SA x SE									(Eq. 10)

	      BW							

where: 

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

C 	= 	concentration on clothing (mg/cm2)

SE	=	saliva extraction efficiency (%) 

SA 	= 	Surface area mouthed (cm2/day)

BW 	= 	body weight (kg)

Assumptions

The concentration of the chemical on clothing was determined using same
methodology as discussed in the previous section, post-application
dermal exposure to textiles.

The surface area of textiles mouthed by children is 100 cm2 (HERA 2003).

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

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

Results

    Table 4.9 shows the calculation of the oral dose and oral MOE for
children mouthing treated textiles. The MOE value is above the target
MOE of 100 (MOE = 150).

Table 4.9.  Short-term Post-application Incidental Oral Exposures and
MOEs for Children Contacting Clothing Treated with a Fabric Spray

% a.i.	

Moisture Content of Fabric (mg/cm2)	

Concentration on clothinga (mg/cm2)	

Area mouthed (cm2/day) 	

Saliva Extraction Factor	

Potential daily dose (mg/kg/day)	

Incidental Oral MOEc

0.13	

16	

0.0208	

100	

50%	

0.069	

150

a	Concentration on clothing (mg ai/cm2) = % active ingredient/100 *
Product absorption rate (16 mg/cm2)

b	Potential Daily Dose (mg/kg/day) = (Concentration on clothing, mg/cm2)
* (area mouthed, cm2/day) * (saliva extraction factor, unitless
fraction) / (body weight, 15 kg).

c 	MOE = NOAEL (mg/kg/day) / absorbed potential daily dose [Where
short-term oral NOAEL = 10 mg/kg/day].  Target MOE = 100.

			4.2.2.3		Treated Lumber		

Scenarios

	The Agency is concerned that there are potential residential
post-application exposure to children and adults exposed to DDAC treated
wood.  The potential outdoor residential post-application exposure
pathways considered are outlined below:

Children

•	Dermal contact with DDAC-treated wood products (e.g., residential
playground equipment and decks);

•	Incidental ingestion due to hand-to-mouth contact with DDAC-treated
wood products;

•	Incidental ingestion of soil contaminated with DDAC;

•	Dermal contact with soil contaminated with DDAC (e.g., soil
contaminated by treated decks and playground equipment); and

Adults

•	Dermal contact with wood from construction of decks and playground
equipment;

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

	Currently, there are no study data that can be used to estimate either
exposure to adults 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/playing on wood decks.  Because
children exhibit a more intense play contact on surfaces and have a
higher surface area to body weight ratio, they would generally be
considered to represent the maximum exposed individual.  

Available data to assess the levels of DDAC in soil contaminated with
DDAC-treated wood do not exist at this time.  Because of this data gap,
EPA was not able to estimate dermal and incidental ingestion residential
post-application exposures to soil contaminated with DDAC-treated wood. 
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) can be
used as surrogate data to estimate screening-level exposures for the
following pathways: outdoor residential dermal contact with DDAC-treated
wood products (e.g., residential playground equipment and decks); 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 DDAC-treated Wood Products

	Potential risks resulting from children’s dermal contact with DDAC
pressure treated wood are assessed using the range of worker residue
data for hands available in the DDAC antisapstain study.  Hand sampling
was performed in this study using cotton gloves as dosimeters.  The data
in Table 4.10 were used to approximate the residues transferred from
treated wood to skin.  No other data are available (e.g., no surface
wood wipe data).  The data from the job descriptions presented below
from the DDAC study were chosen because of the worker contact with dry
treated lumber.  Each job function is represented by one test subject
performing an 8-hour work shift. The range of concentrations on the
hands (0.6 to 3.0 μg/cm2) of workers handling dry lumber shortly after
treatment with an antisapstain (i.e., surface spray, not pressure
treatment) was assumed to be the dermal skin irritation exposure of
children playing on pressure treated structures.  The results from Table
4.10 indicate that the dermal MOEs range from above to below the target
MOE of 10 (i.e., MOEs range from 3 up to 13).  Considerable
uncertainties in the assessment (e.g., 8-hour work shift, surface spray
applications, and test subjects monitored shortly after application)
require a confirmatory surface wipe study on pressure treated wood to
refine the skin concentration/exposure for children playing on treated
structures.

End Stacker - Operates an automated stacking system at the end of the
conveyor.  Lumber stacked into loads.  Monitoring was performed over an
8-hour work shift.  Gloves were worn as indicated on page 196 of the
DDAC study.

Stickman - Places sticks between stacks of wood manually.  At some
mills, this is done automatically by end stacker operator. Monitoring
was performed over an 8-hour work shift.  Gloves were not worn as
indicated on page 192 of the DDAC study.

Tallyman - Staples information sheet on to wood.  May come in contact
with treated lumber. (Note: there were two reps available for tallyman).
 Monitoring was performed over an 8-hour work shift.  Gloves were not
worn as indicated on pages 193 and 207 of the DDAC study.

Total Hand Residue Data (μg/cm2) (data page 104 of the DDAC study
report)

End Stacker	1.2

Stickman	0.6

Tallyman	0.8

Tallyman	3.0

Dermal Skin Irritation Exposurea (μg/cm2)	 Range 0.6 to 3.0

MOEb (Target MOE =10)	Range 3 up to 13

a	Dermal Skin Irritation Exposurea (μg/cm2)= range from 0.6 to 3.0
μg/cm2  (hand residues)

b	MOE  = NOAEL (μg/cm2) / dermal skin irritation exposure (μg/cm2). 
Dermal NOAEL is 8 μg/cm2.  Target MOE = 10.

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

	Potential risks from a child’s hand-to-mouth activities are also
assessed using worker residue data for hands that are available in the
DDAC study. The most appropriate hand values to estimate potential
residues of a child playing on treated decks/playground structures are
for the “dry” strata test subjects (as defined above).  These test
subjects handled the dry treated wood from the non pressure treatments. 
The highest value (most conservative) of 3.0 µg/cm2 represents the
“Tallyman” that wore no gloves (DDAC study page 189).  

	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 		(Eq. 11)

					BW

Where:

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

				with dry wood (μg/cm2)),

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

SEF		=     	saliva extraction factor (unitless),

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

	ET		=	exposure time (hr/day), 

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

	BW		=	body weight (kg).

	In addition to the hand residue value from the DDAC study, the
following inputs are used in the hand-to-mouth estimate:

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).

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 0.5 and is based on the assumption
of 50 percent removal efficiency of residues from hands by human saliva
(USEPA 2001).

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

	The results of the hand-to-mouth estimates are presented in Table 4.11.
 The estimated short-term MOE for the hand-to-mouth exposure is above
the target MOE of 100 (MOE = 360) and is not of concern.  Because the
dermal and oral endpoints represent different toxicological effects, an
aggregate of the dermal (discussed above) and oral MOEs are not
appropriate. 

Table 4.11: Residential Post-application Incidental Oral Exposures with
DDAC-treated Wood Product

Hand 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)
Incidental Oral MOEb (Target MOE = 100)

3.0	20	7	0.5	2	0.028	360

a	Average Daily Oral Dose (mg/kg/day) = [handt (3 μg/cm2 ) x Hand SA
(20 cm2) x SEF (0.5) 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 oral, NOAEL is
10 mg/kg/day.  Target MOE = 100.

			

4.2.2.4	Swimming Pools 

There are post-application exposures associated with use of DDAC
products in swimming pools and spas.  For swimming pools, only
incidental oral exposures are assessed in this document.  Dermal and
inhalation exposures are expected to be negligible due to the low
concentration of DDAC in pool water and the low vapor pressure of DDAC. 
Because the amount of exposure will most likely be greater for swimming
pools than for spas, swimming pool scenarios were evaluated to represent
the high-end exposures associated with use of DDAC in pools and spas.  

	The SWIMODEL 3.0 was developed by EPA as a screening tool to conduct
exposure assessments of pesticides found in swimming pools and spas
(Versar, 2003). The SWIMODEL uses well-accepted screening exposure
assessment equations to calculate the total worst-case exposure for
swimmers expressed as a mass-based intake value (mg/event). The model
focuses on potential chemical intakes only and does not take into
account metabolism or excretion of the chemical of concern.  Detailed
information and the downloadable executable file are available at
http://www.epa.gov/oppad001/swimodel.htm.  For this assessment, the
actual model was not used, however, the same equations as provided in
the SWIMODEL User's Manual (version 3.0) were used in a spreadsheet
format to estimate post application incidental oral and inhalation
exposures for use of DDAC in swimming pools.  

	It should be noted that this exposure assessment identifies short-term
(1-30 days) and intermediate-term (1-6 months) noncancer exposure doses
based on the reported toxicology endpoints for DDAC.  Because of the
shorter exposure durations of these toxicological endpoints,
conservative event-based exposure assumptions are used to calculate
upper bound daily dose estimates.  The noncancer doses are not amortized
over a lifetime.  

Post-application Incidental Ingestion Exposure through Swimming Pool Use
 tc "4.4.2.2	Postapplication Ingestion through Swimming Pool Use " \l 4 

	The following equation was used to calculate incidental ingestion
doses:

PDR = Cw x IR x ET 							(Eq. 12)	

       BW								

Where:

		PDR	= 	Potential dose rate (mg/kg/day);

	Cw	=	Chemical concentration in pool water (mg/L);

	IR	=	Ingestion rate of pool water (L/hr);

	ET	=	Exposure time (hrs/day); and

	BW	=	Body weight (kg).

Assumptions

For short-term exposures, it was assumed that the concentration in water
after shock treatment is 6.00 ppm (6.0 mg DDAC/L).  This concentration
is based on the application of 7.5 oz to the pool skimmers/lines per day
(regardless of the pool volume) for two consecutive days to treat heavy
algae contamination as per label 10324-69.  Thus the pool concentration
would be 15 oz (for two days of treatment) per pool.  EPA uses a 20,000
gallon pool volume for the assessment.  It is likely that the DDAC
concentration in water would decrease after the 24 to 48 hour waiting
period specified in the label but AD does not have data to indicate the
dissipation of DDAC in pool water.

The ingestion rate is based on the value used in EPA’s Residential
SOPs (USEPA 2000) and an EPA pilot study as discussed in ACC’s swimmer
survey (ACC, 2002b).  

Exposure time for non-competitive swimmers is based on the summary
statistics from the National Human Activity Pattern Survey (NHAPS)
(USEPA, 1996) whereas competitive swimmer exposure time data are based
on the Agency’s review of the American Chemistry Council (ACC) study
(ACC, 2002b).  

The assumed body weight is 60 kg for adults, 48 kg for children (age
11-14 years), and 30 kg for children (age 7-10 years).  

Table 4.12. Parameters for Swimming Ingestion Exposure and Dose Estimate

Population	Adult	Child 7-10 yrs	Child 11-14 yrs

Type of Swimmer	Competitive	Non- Competitive	Competitive	Non-
Competitive	Competitive	Non- Competitive

Cw (mg/L) –

Short term exposure	6.0	6.0	6.0	6.0	6.0	6.0

IR (L/hr)	0.0125	0.0125	0.05	0.05	0.025	0.05

ET(hr/day)	3	2a	1	3a	2	2.6a

BW(kg)	60	60	30	30	48	48

a	90th percentile values

	Short-term MOE values were calculated for ingestion of swimming pool
water and are presented in Table 4.13.  The calculations for short-term
incidental ingestion of DDAC indicate no risk concern for the
non-competitive or competitive swimming pool scenarios (i.e., MOE>100).

Table 4.13.  Short-Term Ingestion Dose and MOE for Residential Swimming
Post-Application

Use Type	Scenario Description	Ingestion Dose (mg/kg/day)	Ingestion MOE a

Swimming Pool	Adult, Competitive	0.0038	2,700

	Adult, Non-Competitive	0.0025	4,000

	Child (7-10 yrs), Competitive	0.0100	1,000

	Child (7-10 yrs), Non-Competitive	0.030	330

	Child (11-14 yrs), Competitive	0.0063	1,600

	Child (11-14 yrs), Non-Competitive	0.0163	620

aMOE = NOAEL (mg/kg/day)/ Ingestion Dose (mg/kg/day).  Short-term Oral
NOAEL = 10 mg/kg/day. Target MOE = 100

4.2.2.5	Humidifiers 

Inhalation Exposures for Portable Humidifiers - Adult and Child

	

Inhalation exposures to DDAC used in portable humidifiers may also
occur.  To determine potential inhalation risk, the Multi-Chamber
Concentration and Exposure Model (MCCEM v1.2) was used to provide a
screening-level estimate of potential inhalation risk to adults and
children.  MCCEM estimates average and peak indoor air concentrations of
chemicals released from products or materials in houses, apartments,
townhouses, or other residences.  It estimates inhalation exposures to
chemicals, calculated as single day doses, chronic average daily doses,
or lifetime average daily doses.  All dose estimates calculated by MCEMM
are potential doses; they do not account for actual absorption into the
body.

Assumptions

The entire house is being humidified; therefore, a single chamber model
was run.

A person is exposed to the release for either 8-hours a day or 24-hours
a day.

The inhalation rates for the 8-hour exposure period are based on the
sedentary activities (  SEQ CHAPTER \h \r 1 0.5  SEQ CHAPTER \h \r 1 
m3/hr for adults and 0.4 m3/hr   SEQ CHAPTER \h \r 1 for children).  The
inhalation rates for the 24-hour exposure period are based on the
chronic inhalation rates (13.3 m3/day for adults and 8.3 m3/day for
children) (USEPA 1997). 

For the 8-hr exposure duration assessment, the MOE was calculated using
concentrations from 0 to 8 hours after the humidifier was turned on. For
the 24-hr exposure assessment, it was assumed that the humidifier had
already been running for the previous day; therefore, the concentrations
from 24 to 48 hours after the fogger was turned on were used. 

Release of the product occurs at a steady state throughout the day
(constant emission rate from one source).

The label indicated that 2 oz of product should be used per gallon. The
label did not provide information on the quantity of solution that is
released per hour.  A release rate of 11 gallons/1,700 ft2/24 hours was
used in this assessment based on the Holmes Model# HM4600U.
(http://www.holmesproducts.com/estore/product.aspx?CatalogId=3&CategoryI
d=1120&ProductId=582). It was assumed that 11 gallons of the dilute
solution would be released into the generic MCCEM house (approximately
1,800 ft2 assuming 8 ft ceilings) over a 24-hour period. Based on an
application rate of 0.0043 lb ai/gal, approximately 0.895 g ai/hr would
be emitted into the house. 

It was assumed that 100% of the product is inhalable (e.g., assumes all
particulates emitted are less then 100 microns and that the filter
within the humidifier does not bind any of the DDAC).

Results

	The resulting short- and intermediate-term inhalation exposure and MOE
for the representative post-application inhalation scenarios are
presented in Table 4.14 and 4.15.  The 8-hr and the 24-hr MOEs for
children and adults are below the target MOE of 100.

Table 4.14. Short- and Intermediate-term Post-application Exposures and
MOEs for Adults and Children in Houses Being Humidified (8-hr Exposure
Duration)

Parameter	Value	Rationale

	Adult	Child

	Housea	Generic House (1-chamber)	A portable humidifier that humidifies
the entire house

Activity Schedule	Average concentration starting at 0  hour through 8
hours	EPA Assumption

Air Exchange Rate	0.18/hr	MCCEM default

Application Rate	0.0043 lb ai/gal	Chemical specific product label

Quantity Dilute Used	11 gallons/24 hours	Holmes Model# HM4600-U

Emission Ratea	0.895 gram ai/hr	Application rate (lb ai/gal) * Use
amount (gal/hr) * CF (g/lb)

Body Weighta	60 kg	15 kg	Average body weights for adults and young
children

Inhalation Ratea	12 m3/day

(0.5 m3/hr)

	9.6 m3/day

(0.4 m3/hr)	Sedentary rate for adults and young children (USEPA, 1997)

MCCEM Outputs

Average Concentration over 8-hrs (mg/m3)	5.59	5.59	Average of
MCCEM-calculated air concentrations from 0 to 8 hrs

Dose (mg/kg/day)	0.373	1.19	Average Conc. * 8 hrs * Inhal. Rate / BW

Inhalation short- and intermediate-term MOEb	27	8	NOAEL (10 mg/kg/day) /
Dose

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

b 	MOE = NOAEL (mg/kg/day) / daily dose (mg/kg/day) [Where short-,
intermediate-term inhalation NOAEL = 10 mg/kg/day].  Target MOE = 100.

		

Table 4.15. Short- and Intermediate-term Post-application Exposures and
MOEs for Adults and Children in Houses Being Humidified (24-hr Exposure
Duration)

Parameter	Value	Rationale

	Adult	Child

	Housea	Generic House (1-chamber)	A portable humidifier that humidifies
the entire house

Activity Schedule	Average concentration starting at 24 hour through 48
hours	EPA Assumption

Air Exchange Rate	0.18/hr	MCCEM default

Application Rate	0.0043 lb ai/gal	Chemical specific product label

Quantity Dilute Used	11 gallons/24 hours	Holmes Portable Humidifier
Model# HM1285

Emission Ratea	0.895 gram ai/hr	Application rate (lb ai/gal) * Use
amount (gal/hr) * CF (g/lb)

Body Weighta	60 kg	15 kg	Average body weights for adults and young
children

Inhalation Ratea	13.3 m3/day	8.3 m3/day	Chronic rate for adults and
young children (USEPA, 1997)

MCCEM Outputs

Average Concentration over 24 hrs (mg/m3)	12.2	12.2	Average of
MCCEM-calculated air concentrations from 24 to 48 hrs

Dose (mg/kg/day)	0.90	2.24	Average Conc. * 24 hrs * Inhal. Rate / BW

Inhalation short-, intermediate-term MOEb	11	5	NOAEL (10 mg/kg/day) /
Dose

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

b 	MOE = NOAEL (mg/kg/day) / potential daily dose (mg/kg/day) [Where
short-, intermediate-term inhalation NOAEL = 10 mg/kg/day].  Target MOE
= 100.

		

			4.2.3	Data Limitations/Uncertainties tc \l3 "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 B for summaries of
these data sources). Most of the CMA data are of poor quality,
therefore, AD requests that confirmatory monitoring data be generated to
support the values used in these assessments.  

The quantities handled/treated were estimated based on information from
various sources, including HED’s Standard Operating Procedures (SOPs)
for Residential Exposure Assessments (USEPA 2000 and 2001).  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. 

Some labels for products which can be used by homeowners in residential
settings, as well as by workers in occupational settings, indicate that
low pressure sprayers can be used for application of the disinfectant to
hard, non-porous surfaces such as floors and walls. A residential low
pressure spray scenario was not assessed for the residential scenario
because it is not a typical cleaning method for homeowners.

At this time, the Agency does not have exposure data to assess oral
exposures to children and adults from using treated mouthpieces and
reeds; therefore, the Agency is requesting   SEQ CHAPTER \h \r 1 residue
data from treated mouthpieces and reeds.

In this assessment, incidental ingestion and dermal exposures to treated
wood were estimated using DDAC data from the occupational exposure
study.  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 are 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?).  

Available data to assess the levels of DDAC in soil contaminated with
DDAC-treated wood do not exist at this time.  In addition, leaching data
were also not available. Because of this data gap, EPA was not able to
estimate dermal and incidental ingestion residential post-application
exposures to soil contaminated with DDAC-treated wood.

5.0	RESIDENTIAL AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION – To be
determined in the risk assessment. tc \l1 "5.0	RESIDENTIAL AGGREGATE
RISK ASSESSMENTS AND RISK CHARACTERIZATION 

6.0	OCCUPATIONAL EXPOSURE ASSESSMENT tc \l1 "6.0	OCCUPATIONAL EXPOSURE
AND RISK 

	The exposure scenarios assessed in this document for the representative
uses selected by AD are shown in Table 6.1. The table also shows the
maximum application rate associated with the representative use and the
appropriate EPA Registration number for the product label.  It should be
noted that for the calculation of application rates in which 8.34 lb
a.i./gal is noted, the product is assumed to have the density of water
because no product-specific density is available.  Appendix A presents a
summary of all exposure scenarios that may occur in occupational
settings based on examination of product labels.  

	Potential occupational handler exposure can occur in various use sites,
which include: agricultural premises, industrial processes and water
systems, food handling premises, commercial/institutional/industrial
premises, medical premises, swimming pools, and aquatic areas. 
Additionally, occupational exposure can occur during the preservation of
wood. For the preservation of wood, the procedure for treatment can
occur in different ways, such that multiple worker functions were
analyzed. Due to the complexity of the wood preservative analysis, the
results for handler and post-application exposures are presented
separately in Section 6.3.

Table 6.1.  Representative Exposure Scenarios Associated with
Occupational Exposures to DDAC

Representative Use	Method of Application	Exposure Scenario	Registration
#	Application Rate

Agricultural Premises (Use Category I)

General Disinfectant for Hard Surfaces, Equipment, Vehicles	Low pressure
handwand

High Pressure Spray

Wiping surface

Trigger pump spray

Mopping	ST/IT Handler: Inhalation

	10324-81	0.0094 lb ai/gal

(4.5% a.i. x  3.2 fl. oz/gal water x 1 gal/128 fl. oz x 8.34 lb/gal
Florist use)

Deodorize garbage cans 4.25 oz/gal or 0.013 lb ai/gal

Typical rate 0.78 oz/gal or 0.0023 lb ai/gal

Fogger

	Liquid pour	ST/IT Handler (mix/load only): Inhalation

ST Post-application: inhalation 	10324-81	0.22 lb ai/gal

(4.5% a.i. x  74.8 fl. oz/gal water x 1 gal/128 fl. oz x 8.34 lb/gal)

Food Handling (Use Category II)

Indoor Hard Surfaces (including dishes, utensils, equipment)	Low
pressure handwand

Mop

Wipe

Trigger pump sprayer

	ST/IT Handler: inhalation	10324-134

	0.0200 lb a.i./gal 

(2 oz product/gal water x 15.36% a.i. x 8.34 lb/gal x 1 gal/128 oz)

	Flood

Immersion

Circulation

(Liquid pour)	ST/IT Handler: inhalation	1839-173

	0.00196 lb ai/gal

(4.5% a.i. x 0.78 oz product/ gal water x 8.34 lb/gal x 1gal/128oz)

Fogger	Liquid pour	ST Post-application:

Inhalation	10324-80	0.0065 lb ai/gal

(3.3% ai x 8.34 lb ai/gal x 3 oz/gal x 1 gal/128 oz)

Commercial/Industrial/Institutional Premises (Use Category III)

Indoor Hard Surfaces	Low pressure handwand

Mop

Wipe

Trigger pump sprayer	ST/IT Handler: inhalation	10324-134	0.0200 lb
a.i./gal 

(2 oz product/gal water x 15.36% a.i. x 8.34 lb/gal x 1 gal/128 oz)

	Liquid pour	ST/IT Handler:

inhalation	10324-80

	0.0043 lb a.i./gal

(2 oz /gal water x 3.3% a.i. x 8.34 lb/gal x 1 gal/128 oz)

Carpets	Truck mounted extraction machines

(Liquid pour)	ST/IT Handler:

Inhalation	1839-167	0.102 lb ai/gal

(13.02% a.i. x12 oz product/gal water x 8.34 lb/gal x 1gal/128oz)

Medical Premises (Use Category V)

Indoor Hard Surfaces

	Mop	ST/IT Handler: inhalation	10324-134	0.0200 lb a.i./gal 

(2 oz product/gal water x 15.36% a.i. x 8.34 lb/gal x 1 gal/128 oz)

  SEQ CHAPTER \h \r 1 Industrial processes and water systems (Use
Category VIII)

Oil field operations - drilling mud and packing fluidsa	Liquid Pour

	ST/IT Handler: Inhalation

	1839-179	1.50 lb ai/gal product

(18% a.i. x 8.34 lb/gal product) 

Small process water systems (i.e., evaporative condensers, water
scrubbing, wastewater treatment, pasteurizers, auxiliary service water,
recirculation cooling water) 	Liquid Pour	ST/IT Handler: Inhalation
1839-129	4.17 lb ai/gal product

(50% ai x 8.34 lb ai/gal)

	Metered pump

	ST/IT Handler: Inhalation	10707-46	Maximum

0.0015 lb ai/gal or 1,000 ppm

(18%ai x 8.34 lb ai/gal x 1,000 gal/1,000,000 gal)

Maintenance

0.00015 lb ai/gal or 100 ppm

(18%ai x 8.34 lb ai/gal x 100 gal/1,000,000 gal)

Once-through Cooling Water Systems (i.e. power plants)	Metered pump	ST
Handler: Inhalation	6836-235	Slug dose (ST):  

4.89 E-5 lb ai/gal

(50% ai x 8.34 lb/gal x 1.5 fl. oz/ 1,000 gal water x 1 gal/128 fl. oz)

 

Wood Preservation (Use 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: inhalation

ST/IT/LT Post-application: dermal and inhalation

	6836-212	Diptank operators and blender/spray operators:

3% ai solution

All other worker functions:

80% ai in product 

 

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: inhalation

ST/IT/LT Post-application: dermal inhalation

	6836-212	3% aib  

Swimming Pools (Use Category XI)c

Swimming pools/Spas

	Liquid pour 	ST/IT Handler:

inhalation 

	10324-69

1839-133	Maintenance (IT/LT):

0.00000417 lb ai/gal

(10.0% x 1 quart/50,000 gal x 8.34 lb/gal x 1 gal/4 quarts) 

Heavy algae (ST):

0.000017 lb ai/gal

(50.0% x 5.25 oz/10,000 gal x 8.34 lb/gal x 1 gal/128 oz)

a	  SEQ CHAPTER \h \r 1 For the secondary recovery application, the
biocide is meter pumped into the produced water before it is re-injected
into the formation or well.  Since the biocide is added via metering
pump (continuous or batch) in the secondary recovery systems, the
drilling rig worker handling the biocide via open pouring is expected to
have a higher exposure than the secondary recovery worker. 
Additionally, the current CMA data are not representative of handling
the large volume assumed in this scenario.

b	The application rate for pressure treated wood preservation is based
on the master label.  The actual label only provides a retention rate.

c	The swimming pool scenario also represents the decorative
pond/fountain scenario in the aquatic area use site category because the
application rates are very similar.

	6.1 	Occupational Handler Exposures

	The occupational handler scenarios included in Table 6.1 were assessed
to determine inhalation exposures.  The general assumptions and
equations that were used to calculate occupational handler inhalation
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. 

DDAC dermal irritation exposures and risks were not estimated for
occupational handler exposures.  Instead, dermal irritation exposures
and risks will be mitigated using default personal protective equipment
requirements based on the toxicity of the end-use product.  To minimize
dermal  exposures, the minimum PPE required for mixers, loaders, and
others exposed to end-use products containing concentrations of DDAC
that result in classification of category I, II, or III for skin
irritation potential will be long-sleeve shirt, long pants, shoes,
socks, chemical-resistant gloves, and chemical-resistant apron.  Once
diluted, if the concentration of DDAC in the diluted solution would
result in classification of toxicity category IV for skin irritation
potential, then the chemical-resistant gloves and chemical-resistant
apron can be eliminated for applicators and others exposed to the
dilute. Note that chemical-resistant eyewear will be required if the
end-use product is classified as category I or II for eye irritation
potential. 

	

Unit Exposure Values (UE):  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).  

For the liquid pour 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.	

Swimming pools, carpets, and oilfield operations (drilling muds and
packer fluids): CMA preservative data (gloved).  The inhalation unit
exposure is 0.00346 mg/lb a.i. and is based on 2 replicates.   SEQ
CHAPTER \h \r 1 Although this unit exposure is based on minimal
replicates, the exposure value is similar to the one found in PHED for a
similar scenarios.

Indoor hard surfaces (immersion, flooding, circulation and liquid pour)
in Use Site Categories II and III: The inhalation unit exposure value
for disinfectant liquid pour (1.89 mg/lb a.i.) was used.

Small process water systems: CMA cooling tower data (gloved). The
inhalation unit exposure is 0.450 mg/lb a.i. and is based on 5
replicates.

For the mopping scenarios, the CMA inhalation unit exposure value for
ungloved mopping was used (2.38 mg/lb a.i.).  This value is based on
data collected from six replicates in which the applicator mopped the
floor and received exposure via contact with the mop or with the bucket.

For the wiping scenarios, the CMA inhalation unit exposure value for
ungloved wiping was used (67.3 mg/lb a.i.).  This value is based on data
collected from six replicates (dental technicians) who used a finger
pump sprayer to apply the product and then wiped the surfaces with a
paper towel

For the low pressure handwand scenario, the CMA inhalation unit exposure
value for low pressure spray was used (0.681 mg/lb a.i.).  This value is
based on data collected from eight replicates in which the applicator
hand sprayed carpet using 200 psi, then used a push broom rake to raise
the carpet nap

For the trigger pump spray scenarios, the PHED inhalation unit exposure
value for aerosol applications (PHED scenario 10) was used. The
inhalation unit exposure is 1.3 mg/lb a.i.

For the liquid/metering 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.

Small process water systems: CMA cooling tower data. The inhalation unit
exposure is 0.00432 mg/lb a.i. and is based on 4 replicates.

Once-through cooling water systems:  CMA pulp and paper gloved data were
used. The inhalation unit exposure is 0.000265 mg/lb a.i. The value is
based on 7 replicates where the test subjects were wearing a single
layer of clothing and chemical resistant gloves. This unit exposure was
used for the once through cooling water system because no representative
data exists for the volume of water treated in power plant facilities.

For the high-pressure/high volume spray and medium pressure spray
scenarios, the PHED inhalation unit exposure value for liquid/open
pour/high pressure spray (PHED scenario 35) was used (0.12 mg/lb a.i.).

For airless sprayer scenarios, the occupational PHED inhalation unit
exposure value for airless sprayer application (PHED scenario 23) was
used. The inhalation exposure value is 0.83 mg/lb a.i. 

For the fogging, ULV/mist sprayer and automated system scenarios, it was
assumed that most of the exposure to the handler will be due to
preparing the fogger, and that the handler leaves the room immediately
after fogging commences.  Therefore, the available CMA disinfectant
liquid pour inhalation unit exposure value was used.  The inhalation
unit exposure value is 1.89 mg/lb a.i., respectively. This value is
based on data collected from two gloved replicates involving pouring a
disinfectant product from a jug into sterilization trays designed for
dental instruments, adding water and instruments to the tray, removing
the instruments, and discarding the old solution.

For the brush/roller scenario, the occupational PHED inhalation unit
exposure value for paintbrush applications was used (single layer of
clothing). The inhalation exposure value is 0.28 mg/lb a.i. 

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:

Swimming pools: 200,000 gallons. 

Indoor hard surfaces (immersion, flooding, circulation, and liquid
pour): 2 gallons.

Carpets:  32 gallons, based on label 1839-81 (solution is metered at 4
gallons per hour, assuming an 8-hour shift).

Oil field operations (drilling muds and packer fluids):   SEQ CHAPTER \h
\r 1 The following use information was used to estimate the amount of ai
handled per day during oil-well activities.  Biocide is typically added
directly to drilling rig mud tanks via open pouring. Over a 3 to 6 week
period, while a 13,000 ft well is being drilled, 1 to 2 drums (1 drum =
42 gallons) of biocide may be used if microbiological problems are
encountered.  Therefore, the short-term exposure assessment used 5.6
gallons for the amount of biocide handled per day by the drilling rig
worker [i.e., (2 drums x 42 gal/drum) / (5 days/week x 3 weeks) = 5.6
gal/day].  The intermediate-term exposure assessment used 2.8 gallons
for the amount of biocide handled per day by the drilling rig worker
[i.e., (2 drums x 42 gal/drum) / (5 days/week x 6 weeks) = 2.8 gal/day].
  SEQ CHAPTER \h \r 1 Although crew changes may occur in drilling rig
operations, typically a designated customer representative is
responsible for the biocide feeding.  Therefore, one person would be
involved with the biocide application activities on a daily basis.

Small process water systems:   SEQ CHAPTER \h \r 1  Workers in small
systems could manually pour up to 5 to 10 gallons of biocide into the
system, but larger systems would utilize chemical pumps in order to save
time and labor expense.  However, for DDAC the application rate is low
(16 oz product/1000 gallons of water), and therefore, the maximum amount
used for closed systems is assumed for open pour.  Therefore, AD assumed
that workers handle 2.5 gallons of biocide per day when making open pour
applications.  

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

Small process water systems:   SEQ CHAPTER \h \r 1 AD has assumed that
20,000 gallons of water are treated daily when chemical pump
applications are made.

Once-through cooling water systems: AD has assumed that between
5,900,000 and 153,000,000 gallons of water are treated per day.  This
range is based on the average of 7Q10 values from 12 low flow streams
(100 MGD) and 6 high flow streams (1,000 MGD). The streams chosen for
the averages were used in the ADBAC Ecological Risk Assessment and are
assumed to be representative of the DDAC use as well.  (Versar, 2005).
The 7Q10 flow rate is a flow rate that, once every ten years, a stream
is expected to be below for seven consecutive days. It was assumed to be
the normal cooling water flow rate.  This value was chosen because it is
assumed that electric plants would need to have a steady supply of
cooling water, and the 7Q10 flow reflects a rate that could be
maintained continuously by the power plant.  This is not a conservative
assumption, since electric plants may use more cooling water under
normal conditions, though at a greater risk of running out of usable
water.  For lack of better data, however, these values were used.

For the mopping scenarios, it was assumed that two gallons of solution
are used in the agricultural, food handling, and
commercial/institutional/industrial settings and 45 gallons are used in
the medical setting.  The medical setting use amount is based on a
janitor cleans approximately 28 hospital rooms a day and changing the
cleaning water every three rooms (Helwig 2003).  

For the wiping and trigger pump spray scenarios, it was assumed that 1
liter or 0.26 gallons were used.

For the fogging scenario in the agricultural use site category, it was
assumed that 150,000 ft3 is treated, based on the estimated dimensions
of a poultry barn (300 ft x 50 ft x 10 ft). As the label directions only
state to fog for one minute on maximum output per 4,000 ft3 and does not
provide the amount of treatment solution to use per cubic foot, AD
assumed that the maximum fogger output is 0.42 gallons/min (25 gal/hr). 
This value is the maximum output for the Mistermax fogger which is used
to dispense fungicides, insecticides, germicides and disinfectants as
wettable powders, emulsifiable concentrates, flowables or liquids in a
variety of applications such as greenhouses, warehouses, food processing
plants, and swine/poultry houses (http://bugsource.com/mistermax.html). 

For the low-pressure handwand scenario, it was assumed that 40 gallons
of solution are used in agricultural scenarios (USEPA 2001) and 2
gallons are used in all other applications.	

For the high-pressure spray scenario, it was assumed that 40 gallons of
solution are used. 

Duration of Exposure: The MOEs were calculated for the short- and
intermediate-term durations for occupational handlers using the
appropriate endpoints in Table 3.2. 

  

Exposure Calculations and Results

	The resulting inhalation exposures and MOEs for the representative
occupational handler scenarios are presented in Table 6.2. The
calculated MOEs were above the target MOE of 100 for all scenarios. 

Once-through cooling water, metering pump: Using the average flow rate
for high flow streams (153 MGD) the ST Inhalation MOE = 91 however,
using the average flow rate for low flow streams (5.9 MGD) the ST
Inhalation MOE = 2,300.

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

Small process water systems, liquid pour: ST/IT Inhalation MOE = 130

Agricultural fogging, mixing and loading: ST/IT Inhalation MOE = 110

Medical premises, mopping: ST/IT Inhalation MOE = 280

Wood Preservation (non-pressure treatment), blender/sprayer: ST/IT/LT
Inhalation MOE = 280

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

Exposure Scenario	

Method of Application	

Inhalation Unit Exposure

(mg/lb a.i.) 	Application Rate	Quantity Handled/ Treated per day	

Inhalation  Daily Dose (mg/kg/day)a	

Inhalation 

MOEb, c 

(Target MOE = 100)

Agricultural Premises and Equipment (Use Site Category I)

Application to hard surfaces, equipment, and vehicles 	Mop	2.38	0.0094
lb ai/gal	2 gallons	0.0075	13,000

	High pressure/high volume spray	0.12	0.0094 lb ai/gal	40 gallons
0.00075	13,000

	Low pressure handwand	0.681	0.0094 lb ai/gal	40 gallons	0.0043	2,300

	Trigger pump sprayer	1.3	0.0094 lb ai/gal	0.26 gallons	0.000052	190,000

	Wipe	67.3	0.0094 lb ai/gal	0.26 gallons	0.0027	3,600

Fogging (mix/load only)	Liquid pour	1.89	1.88E-05 lb/ft3	150,000 ft3
0.089	110

  SEQ CHAPTER \h \r 1 Food Handling/Storage Establishments Premises And
Equipment	 (Use Site Category II)

Application to indoor hard surfaces	Low pressure handwand	0.681	0.0200
lb ai/gal	2 gallons	0.00045	22,000

	Mop	2.38	0.0200 lb ai/gal	2 gallons	0.0016	6,300

	Wipe	67.3	0.0200 lb ai/gal	0.26 gallons	0.0058	1,700

	Trigger pump sprayer	1.3	0.0200 lb ai/gal	0.26 gallons	0.00011	89,000

	Immersion, Flooding, Circulation	1.89	0.00196 lb ai/gal	2 gallons
0.00012	81,000

  SEQ CHAPTER \h \r 1 Commercial, Institutional and Industrial Premises
and Equipment (Use Site Category III )

Application to indoor hard surfaces	Low pressure handwand	0.681	0.0200
lb ai/gal	2 gallons	0.00045	22,000

	Mop	2.38	0.0200 lb ai/gal	2 gallons	0.0016	6,300

	Wipe	67.3	0.0200 lb ai/gal	0.26 gallons	0.0058	1,700

	Trigger pump sprayer	1.3	0.0200 lb ai/gal	0.26 gallons	0.00011	89,000

	Liquid pour	1.89	0.0043 lb ai/gal	2 gallons	0.00027	37,000

Application to carpets	Liquid pour	0.00346	0.102 lb ai/gal	32 gallons
0.00019	53,000

Medical Premises and Equipment (Use Site Category V)

Application to hard surfaces	Mop	2.38	0.0200 lb ai/gal	45 gallons	0.036
280

Industrial Processes and Water Systems (Use Site Category VIII)

Small process water systems: Recirculation cooling tower	Liquid pour
0.45	4.17 lb ai/gal product	2.5 gallons	0.078	130

	Metering pump	 0.00432	Initial Dose (ST): 1.50E-03lb ai/gal water
20,000 gallons	0.0022	ST = 4,600

	Maintenance Dose (IT): 1.50E-04lb ai/gal water	20,000 gallons	0.00022
IT =46,000

Oil field operations - drilling mud and packing fluids	Liquid pour
0.00346	1.50 lb ai/gal product	5.6 gallons	0.00048	ST = 21,000

2.8 gallons	0.00024	IT = 41,000

Once-through Cooling Water System - Power plant	Metering pump 	0.000265
Slug Dose (ST): 4.89E-5 lb ai/gal water	5,900,000 gallons	0.0013	ST=2300

	Initial Dose (ST): 4.89 E-5 lb ia/gal water	153,000,000	0.033	ST=91

Swimming Pools (Use Category X)d

Application to swimming pools	Liquid pour	0.00346	Heavy algae Dose (ST):

0.000017 lb ai/gal	200,000 gallons	0.00020	ST= 15,000

	Maintenance Dose (IT/LT):

0.00000417 lb ai/gal	200,000 gallons	0.000048	IT=210,000

	ST = short-term,  IT = intermediate-term, LT = long-term, N/A= No data
available

a	Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x absorption
factor (1.0 for inhalation) x application rate x quantity treated / Body
weight (60 kg for inhalation).

	b	MOE = NOAEL  (mg/kg/day) / Absorbed Daily Dose [Where NOAEL = 10
mg/kg/day for all inhalation exposure durations].  Target MOE = 100.

	c	The MOEs refer to short-term and intermediate-term duration unless
indicated otherwise.

	d.	The swimming pool scenario also represents the decorative
pond/fountain scenario in the aquatic area use site category because the
application rates are very similar.

		6.2  	Occupational Post-application Exposures

	Except for the post-application scenarios assessed for fogging and wood
preservatives in Section 6.3, occupational post-application exposures
are assumed to be negligible.

Fogging (Food Processing Plant and Hatchery) 

	Post-application inhalation exposures only were assessed for entry into
a building (hatchery and food processing plant) after a fogging
application, because dermal post application is presumed to be
negligible.  The inhalation exposure assessment was conducted using the
Multi-Chamber Concentration and Exposure Model (MCCEM v1.2).   MCCEM
estimates average and peak indoor air concentrations of chemicals
released from products or materials in houses, apartments, townhouses,
or other residences. Although the data libraries contained in MCCEM are
limited to residential settings, the model can be used to assess other
indoor environments.  MCCEM has the capability to estimate inhalation
exposures to chemicals, calculated as single day doses, chronic average
daily doses, or lifetime average daily doses. (All dose estimates are
potential doses; they do not account for actual absorption into the
body.)

	The product, EPA Reg # 10324-80 (3.3% ai) with a maximum application
rate of 0.0065 lb ai/gal, was assessed for fogging use in a food
processing plant. The label states to fog one quart of the diluted
product per 1,000 cubic feet. All labels which can be used for fogging
in food processing areas indicate that all personnel must vacate the
room during fogging and for a minimum of 2 hours after fogging.
Therefore, exposure was calculated for a person entering the food
processing plant 2 hours after all the applied fogger has been deployed.

	The product, EPA Reg # 10324-108 (13.02% ai) with a maximum application
rate of 0.181 lb ai/gal, was assessed for fogging use in hatcheries and
incubators. After fogging, the label states that the building should be
well ventilated and not to enter until 2 hours after fogging, unless
wearing a self-contained respirator and long pants/long sleeves.  The
remaining labels for fogging use in hatchery rooms and incubator
indicate re-entry intervals of 0 to 2 hours. Therefore, exposure was
calculated for a person entering the building immediately after all the
applied fogger has been deployed and 2 hours after all the applied
fogger has been deployed

	Assumptions used to calculate inputs for MCCEM and the calculated
exposure values are presented in Table 6.3 for food processing plants
and in Table 6.4 for hatcheries.  The following assumptions were made:

The area being fogged is a one-chamber barn with dimensions of 300 ft x
50 ft x10 ft (AD standard assumption).

For the food processing plant, the air exchange rate is 0.18 per hour
(MCCEM default based on a residential homes at the 10th%tile estimate
for all regions, USEPA 1997, page 17-11 and 17-12) .  For a hatchery,
the air exchange rate is 4 per hour based on the rate for a poultry barn
(Jacobson, 2005).

Fogging occurs instantaneously, so that the entire mass of product is
mixed homogeneously with the indoor air as soon as fogging commences.  

It is assumed that all of the aerosols are inhalable and/or respirable.

Table 6.3.  Short and Intermediate Term Inhalation Risks Associated with
Post-application Exposure to DDAC After Fogging a Food Processing Plant

Parametera	Value	Rationale

Dimensions	300x50x10 ft,

15,000 ft2 floor area,

150,000 ft3 (4,248 m3)

volume	EPA Assumption

Air Changes per Hour (ACH)*	0.18/hr	MCCEM default

(10th%tile estimate for all regions, USEPA 1997, page 17-11 and 17-12)

Activity Pattern*	8-hr average concentration starting at expiration of
2-hr REI	Based on product(s re-entry interval (10324-80)

Concentration of Fogging Liquid	0.0065 lb ai/gal	Product Label (See
Table 6.1)

Use rate	1 quart/1,000 ft3	Product label

Amount applied to room	0.0258 g ai/m3	(Use rate) x (Concentration)

Body Weight	60 kg	EPA Assumption

Inhalation Rate	1.0 m3/hr	NAFTA Light Activity for Adults (USEPA, 1997)

MCCEM Output

Average Concentration over 8-hrs (mg/m3)	2-hr re-entry: 9.74	Average of
MCCEM-calculated air concentrations from Hour 2 to Hour 10 for 2-hr REI

8-hr Dose (mg/kg/day)	2-hr re-entry: 1.30	Average Conc. * 8 hrs * Inhal.
Rate / BW

8-hr short-term MOE	2-hr re-entry: 7	NOAEL (10 mg/kg/day) / Dose

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

Table 6.4.  Short and Intermediate Term Inhalation Risks Associated with
Post-application Exposure to DDAC After Fogging a Hatchery

Parameter	Value	Rationale

Barn Dimensions*	300x50x10 ft,

15,000 ft2 floor area,

150,000 ft3 (4,248 m3)

volume	EPA Assumption

Air Changes per Hour (ACH)*	4/hr	Jacobson, 2005

Activity Pattern*	8-hr average concentration starting at expiration of
0-hr re-entry interval and 2-hr re-entry interval	Based on product(s
re-entry interval 

Application Rate of Fogging Liquid	0.181 lb ai/gal.

(Note: Max rate 0.22 lb ai/gal)	Product Label (See Table 6.1)

Use rate	0.42 gal/4,000 ft3	Product label states to fog 1 min/4,000 ft3.
 Output of 0.42 gal/min from   HYPERLINK
"http://bugsource.com/mistermax.html" 
http://bugsource.com/mistermax.html 

Mass applied to barn	0.301 g ai/m3	(application rate) x (use rate)

Body Weight	60 kg	EPA Assumption

Inhalation Rate	1.0 m3/hr	NAFTA Light Activity for Adults (USEPA, 1997)

MCCEM Output

Average Concentration over 8-hrs (mg/m3)	0-hr Re-entry: 0.62

2-hr Re-entry: 0.0114	Average of MCCEM-calculated air concentrations
from Hour 0 to Hour 8 for 0-hr re-entry and Hour 2 to Hour 10 for 2-hr
re-entry

8-hr Dose (mg/kg/day)	0-hr Re-entry: 0.083

2-hr Re-entry: 0.0015	Average Conc. * 8 hrs * Inhal. Rate / BW

8-hr short-term MOE	0-hr Re-entry: 120

2-hr Re-entry: 6,600	NOAEL (10 mg/kg/day) / Dose

	A detailed report is presented in Appendix D, including hourly air
concentrations.  Based on MCCEM output, 8-hr MOE values were calculated.
 The MOE for fogging in the food processing plant (2-hr re-entry
interval) was below the target MOE of 100 (MOE = 8).  For fogging in
hatcheries, the 8-hr MOE immediately following release and after a 2 hr
re-entry were above the target MOE of 100 (MOE = 120 and 6,600,
respectively). Because the 8-hr MOE for entering a hatchery immediately
after fogging is below 1,000, the Agency may request a confirmatory
inhalation toxicity study.   The risks of concern for the food
processing plant are attributed to the low air changes per hour assumed
(i.e., 0.18 ACH) in the assessment.  For the poultry barn, ventilation
rate was obtained from Jacobson (2005).  The assessment for food
processing plants could be refined if a more accurate ventilation rate
could be obtained.

	

6.3 	Wood Preservation

	DDAC is used in products that are intended to preserve wood through
both non-pressure treatment methods and pressure treatment methods.  The
exposure scenarios assessed in this document for the representative wood
preservation uses selected by AD are shown in Table 6.1. Section 6.3.1
presents the exposure analysis for the handler and post-application
scenarios for non-pressure treatment scenarios and Section 6.3.2
presents the exposure analysis for the handler and post-application
scenarios for pressure treatment scenarios. 

	Dermal irritation exposures from post-application activities in the
wood preservation treatment facility will be mitigated using default
personal protective equipment requirements based on the toxicity of the
end-use product.  Therefore, only inhalation exposures and risks are
presented.

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

	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. The worker
functions/positions identified in the DDAC study are presented below.  

Handler:

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

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 smaller scale
treatment facility in which the worker can manually dip the wood into
the treatment solution.

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 along with flushing and
cleaning spray nozzles. 

Post-application: 

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

Millwrights repair all conveyer chains and general up-keep of the mill. 

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

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. 

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

	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

	The inhalation exposures and risks to the composite wood 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, 1999b). 
Specifically, the liquid pump preservative unit exposures were used in
this assessment.  The inhalation unit exposure is 0.000403 mg/lb ai.
These values are based on two replicates.  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 DDAC.  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 (8
batches/day x 7,000 gallons/batch x 0.003785 m3/gallon x 380 kg/m3 x 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 (USEPA 2003). The DDAC assessment was
conducted using an application rate of 3% ai solution. 

Table 6.5 provides the inhalation doses and MOEs for the workers adding
the preservative to the wood slurry.  The inhalation MOE is above the
target MOE of 100 for short-, intermediate-, and long-term inhalation
exposures (MOE = 280). However, the MOE is below 1,000; therefore, the
Agency may request a confirmatory inhalation toxicity study.

Table 6.5.  Short-, Intermediate-, and Long-Term Inhalation Exposures
and MOEs for Blender/Spray Operator

Exposure Scenario

	Inhalation Unit Exposurea

(mg/lb ai)	Application Rate

(% ai in solution/

day)	Wood Slurry Treatedb

(lb/day)	Daily Dosec (mg/kg/day)	ST/IT/LT 

MOEd 

(Target MOE = 100)

Occupational Handler

Blender/spray operator	0.000403	3	178,000	0.036	280

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

Inhalation unit exposure: Baseline.	

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

c.	Daily Dose = unit exposure (mg/lb ai) x App Rate (% ai/day) x
Quantity treated (lb/day) x absorption factor (100% for inhalation) / BW
(60 kg)

d.	MOE = NOAEL (mg/kg/day)/ Daily dose [Where ST/IT/LT NOAEL = 10
mg/kg/day for inhalation. Target MOE = 100.

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

	The inhalation exposures to chemical operators, graders, millwrights,
trim saw operators, and clean-up crews were assessed using the exposure
data from the DDAC study (Bestari et al., 1999). The DDAC study examined
individuals( exposure to DDAC while working with antisapstains and
performing routine tasks at 11 sawmills/planar mills in Canada. 
Inhalation exposure monitoring data were gathered for each job function
of interest using dosimeters and personal sampling tubes.  Dosimeters
and personal air sampling tubes were analyzed for DDAC.  Exposure data
for individuals performing the same job functions were averaged together
to determine job specific averages.  Monitoring was conducted using 2
trim saw workers, 13 grader workers, 11 chemical operators, 3
millwrights, and 6 clean-up staff.

	The individual inhalation exposures from the DDAC study are presented
in Table E-1 in Appendix E.  The study was conducted using a product
containing 80% DDAC; therefore, the exposures do not need to be modified
to account for any differences in percent active ingredient. The lb ai
handled by each person or the % ai in the treatment solution were not
provided for these worker functions in the DDAC study. 

The following equation was used to calculate daily dose for DDAC: 

Daily Dose = DDAC UE x AB							(Eq. 13)

           	         BW

Where:

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

	AB		=	Absorption factor (100% inhalation); and

	BW		=	Body weight (60 kg).

In using this methodology, the following assumptions were made:

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

The procedures for applying both chemicals are similar. 

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
μg).  For all measurements below the air concentration associated with
this detection limit, half the detection limit was used. 

Air concentrations were reported in the DDAC study. To convert air
concentrations (μg/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 (USEPA,1997), a sample duration of 8 hrs/day,
and a conversion factor of 1 mg/1000 µg.  Table D-1 in Appendix D
presents the inhalation exposures.

Table 6.6 provides the short-, intermediate-, and long-term inhalation
doses and MOEs for chemical operators, graders, millwrights, clean-up
crews, and trim saw operators.  The inhalation MOEs are above the target
MOE of 100 for all worker functions. Any dermal irritation exposures
from post-application activities will be mitigated using default
personal protective equipment requirements based on the toxicity of the
end-use product.  

It should be noted that although the target inhalation MOE is 100, the
MOE for the clean-crew workers is below 1,000; therefore, the Agency may
request a confirmatory inhalation toxicity study.

  

Wood Preservation (non-pressure treatment), clean-up crew: ST/IT/LT
Inhalation MOE = 990

Table 6.6. Short-, Intermediate, and Long-Term Inhalation Exposures and
MOEs for Wood Preservative Chemical Operators, Graders, Trim Saw
Operators, and Clean-Up Crews (Handler and Post-application Activities)

Exposure Scenarioa 

(number of volunteers)	Inhalation UEb 

(mg/day)	Conversion Ratioc	Daily Dosed

(mg/kg/day)	MOEe (Target MOE = 100)

Occupational Handlers

Chemical Operator (n=11)	0.0281	NA	0.000468	21,000

Occupational Post-Application

Grader (n=13)	0.0295	NA	0.000491	20,000

Trim Saw (n=2)	0.061	NA	0.00101	9,900

Millwright (n=3)	0.057	NA	0.00095	11,000

Clean-Up (n=6)	0.60	NA	0.0101	990

ST = 	Short-term duration, IT = Intermediate-term duration, LT =
Long-term duration

a.	The exposure scenario represents a worker wearing 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.

Inhalation exposure (mg/day) was calculated using the following
equation: Air concentration (μg/m3) x Inhalation rate (1.0 m3/hr) x
Sample duration (8 hr/day) x Unit conversion (1 mg/1000 μg).  The
inhalation rate is from USEPA, 1997.

c.	A conversion ratio is not needed because the maximum % active
ingredient in the product is the same as the % active ingredient in the
DDAC study.  

d.	Daily dose (mg/kg/day) = exposure (mg/day) x  absorption factor (100%
for inhalation)/body weight (60 kg). 

e.			MOE = NOAEL (mg/kg/day)/ Daily dose [Where inhalation NOAEL = 10
mg/kg/day]. Target MOE = 100.

Diptank Operators

	Exposures to diptank operators were also assessed using the data from
the DDAC study (Bestari et al., 1999). The diptank scenario assessment
was conducted differently than for the other job functions because the
concentration of DDAC in the diptank solution was provided.  The
exposure data for diptank operators were converted into (unit exposures(
in terms of mg a.i. for each 1% of concentration of the product. The
calculation of the inhalation unit exposure (0.046 mg/1% solution,
respectively) is presented in Table E-2 in Appendix E.  The air
concentrations presented in the DDAC study were converted to unit
exposures using an inhalation rate of 1.0 m3/hr (light activity) (USEPA,
1997) and a sample duration of 8 hrs/day.

The following equations are used to estimate inhalation handler
exposure: 

Daily Dose = DDAC UE x AI x AB 							(Eq. 14)

		BW

Where:

	DDAC UE	=	DDAC inhalation unit exposure (mg/ 1% in solution);

	AI		=	Percent active ingredient (3% ai in solution/day);

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

	BW		=	Body weight (60 kg).

	Table 6.7 provides the short-, intermediate- and long-term inhalation
dose and MOEs for diptank operators. The inhalation MOE is above the
target MOE of 100 and, therefore, is not of concern.

Table 6.7.  Short-, Intermediate-, and Long-Term Inhalation Exposures
and MOEs for Diptank Operator (Handler Activity)

Exposure Scenarioa

(number of replicates)	Inhalation Unit Exposureb

(mg DDAC/1% solution)	App Rate

(% a.i. in solution/ day)	Daily Dosec

(mg/kg/day)	MOEd

Occupational Handler

Dipping, with gloves (n=7)	0.046	3	0.0023	4,300

a 	The exposure scenario represents a worker not wearing a respirator.

b	Inhalation unit exposures are from DDAC study (MRID 455243-04). Refer
to Table E-2 in Appendix E for inhalation unit exposure calculations.
Inhalation exposure (mg) was calculated using the following equation:
Air concentration (mg/m3) x Inhalation rate (1.0 m3/hr) x Sample
Duration (8 hr).  The inhalation rate is from USEPA, 1997.

c	Daily dose (mg/kg/day) = unit exposure (mg/1% ai solution) x percent
active ingredient in solution  (3% ai) x absorption factor (100% for
inhalation) / body weight (60 kg).

d			MOE = NOAEL (mg/kg/day) / Daily dose [Where inhalation NOAEL = 10
mg/kg/day. Target MOE = 100.

Construction workers

	Potential risks resulting from construction worker dermal contact with
DDAC-treated wood are assessed in the same manner as potential risks
resulting from children’s dermal contact with DDAC-treated playsets
and decks (Section 4.2.2.3). The risks were calculated using a range of
worker residue data for hands available in the DDAC exposure study for
contacting dry lumber. Hand residue data from the end stacker, stickman,
and tallyman workers were used because of the contact with dry treated
wood. The range of hand residue values from these data (0.6 up to 3
ug/cm2) was assumed to be the dermal skin irritation exposure. As shown
in Table 4.10, the dermal MOEs range from 3 to 13.  

6.3.2	Pressure Treatment Scenarios (Handler and Post-Application)

	

	DDAC may be used to treat wood and wood products using pressurized
application methods such as double vacuum. According to the product
labels, the maximum retention rate is 0.6 lb/ft3. An application rate
was not provided on the product labels; therefore, an application rate
of 3% ai solution was used in this assessment, based on the master
label. DDAC-specific exposure data are not available for assessment of
pressure treatment exposure.  Therefore, the assessment relies on
surrogate chromated copper arsenate (CCA) data (ACC, 2002b) and was
based on the approach used in a previous exposure assessment (USEPA
2003).  

Surrogate Unit Exposure Data

	

	Inhalation exposures for pressure treatment uses are derived from
information in the exposure study 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, 2002b).  In this study, a treatment solution of CCA
was approximately 0.5 percent.  The CCA study is the best pressure
treatment data available for a water based solution to estimate exposure
to DDAC.  

mall (5 ≤ n ≤ 15).  

	The measured CCA inhalation exposure values were normalized by the
treatment solution concentration used at each of the 3 facilities (i.e.,
unit exposure reported as µg arsenic/ppm treatment solution).  The
normalization by treatment solution concentration was performed to
extrapolate the measured exposures in the CCA study (monitored at ~0.5%
ai solution) to the maximum DDAC treatment solution concentration (1% ai
solution).  Table 6.8 presents the inhalation unit exposure values
normalized to the treatment solution concentration in ppm for (1) all
sites, (2) treatment operator (TA handler), (3) treatment assistant (TA
handler), and (4) all post-application job functions (TS, SO, LO, S, TB,
TM).  

Exposure Calculations

The following equation was used to estimate inhalation handler exposure:

Daily Dose = UE x AI x AB 							(Eq. 15)

	   BW

Where:

	UE	=	Unit exposure (mg As/ppm);

	AI	=	Percent active ingredient (3% ai in solution);

	AB	=	Absorption factor (100% inhalation); and

	BW	=	Body weight (60 kg).

Results

	The estimated inhalation exposures and risks for DDAC are presented in
Table 6.9.  The calculated inhalation MOEs are above the target MOE of
100 for all scenarios. All inhalation MOEs also exceed 1,000, therefore,
a confirmatory inhalation toxicity study is not warranted based on the
results of these exposure scenarios. 

μg As/m3/ppm)	Inhalation Unit Exposurec

(μg As/ppm)

	%	ppma

	All sites - All Data

(n = 64)	0.438 to 0.595	4,380 to 5,950	Average ± std	0.00013 ± 0.00023
0.00104

	Median	0.00013	0.00104

	90th percentile	0.00077	0.00617

	Maximum	0.0011	0.00882

All sites - Handler Treatment Operator

(n = 15)	0.438 to 0.595	4,380 to 5,950	Average ± std	0.00032 ± 0.00038
0.00257

	Median	0.00013	0.00104

	90th percentile	0.00092	0.00737

	Maximum	0.0011	0.00882

All sites - Handler Treatment Assistant

(n = 10)	0.438 to 0.595	4,380 to 5,950	Average ± std	0.0001 ± 0.00004
0.000802

	Median	0.00013	0.00104

	90th percentile	0.00013	0.00104

	Maximum	0.00014	0.00112

All sites – Post-application: All job functions (TS, SO, LO, S, TB,
TM)

(n = 39)	--	--	Average ± std	0.00020 ± 0.00025	0.00160

	Median	0.00013	0.00104

	90th percentile	0.00050	0.00401

	Maximum	0.0011	0.00882

	a.	ppm = (% treatment solution) * (10,000).

	b.	Air concentration was calculated as μg collected per sample per ppm
/ (480 min per day x 2 L/min).

	c.	Inhalation unit exposure = air concentration (μg As/m3/ppm) x
breathing rate for light activities (0.0167 m3/min) x sample duration
(480 min).

Table 6.9.  Short-, Intermediate-, and Long-Term Inhalation Exposures
and MOEs for Pressure Treatment Handler and Post-application Scenarios

Exposure Scenario	Inhalation Unit Exposurea

(μg As/ppm) 	Application Rate 

(% ai solution)	Absorbed Daily Dosesb 

(mg/kg/day)	Inhalation MOEsc

(Target MOE = 100)

Occupational Handler

Treatment Operator (TO)	0.00257	3	0.0013	7,800

Treatment Assistant (TA)	0.000802	3	0.00040	25,000

Occupational Post-application

All (Tram setter, stacker operator, loader operator, supervisor, test
borer, and tallyman) 	0.00160	3	0.00080	13,000

a. 	Unit exposure values taken from CCA study and are shown in Table
6.11.

 (μg As/ppm) x [% DDAC in solution (3) x 10,000 (parts per million
conversion)] x (0.001 mg/μg) x absorption factor (100% for inhalation)
/ Body weight (60 kg).

c.			MOE = NOAEL (mg/kg/day) / Daily dose [Where inhalation NOAEL = 10
mg/kg/day for all durations. Target MOE = 100.

	

6.4	Data Limitations/Uncertainties tc \l2 "6.3	Data
Limitations/Uncertainties 

	There are several data limitations and uncertainties associated with
the occupational handler and post-application exposure assessments. 
These include:

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study (USEPA, 1999: DP Barcode D247642) or from the Pesticide
Handler Exposure Database (USEPA, 1998) (See Appendix B for summaries of
these data sources).   Since the CMA data are of poor quality, the
Agency requests that confirmatory data be submitted to support the
occupational scenarios assessed in this document.

  SEQ CHAPTER \h \r 1 Unit exposures are not available for some of the
specific scenarios that are prescribed for DDAC including open loading
into oil-well/field environments 

The CMA data used for oil-well uses are based on open pouring of a
material preservative.  Although these data are only represented by 2
replicates each, the exposure values are similar to open loading of
pesticides in PHED. Furthermore, there are no representative unit
exposure data for chemical metering into secondary recovery oil
operations.  Since the volume of water being treated in secondary
recovery operations is so large, the available CMA data can not be
reliably extrapolated because they are based on activities that handle
much lower volumes and possibly different techniques.  Therefore, it was
assumed that if the open pour handling activities for the other oil well
operations resulted in MOEs that are not of concern, then the MOEs for
the closed system chemical metering into secondary recovery operations
would also be not of concern.  AD requests that confirmatory data be
conducted to show that this is accurate.

For the wood preservative pressure treatment scenarios, CCA exposure
data were used for lack of DDAC-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 DDAC, and therefore the exposures
could be used as surrogate data for workers that treat wood with DDAC. 

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

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 personal
communication with experts.  In particular,   SEQ CHAPTER \h \r 1 the
use information for oil-well uses and cooling water tower uses are based
on personal communication with biocide manufacturers for these types of
uses.  The individuals contacted have experience in these operations and
their estimates are believed to be the best available without
undertaking a statistical survey of the uses.  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 percent active ingredient in solution for the pressure treatment of
lumber needs to be refined by the registrant.  The labels only provided
a retention rate.  For this assessment, the application rate on the
master label was used, which is the same as the application rate for
non-pressure treatment of lumber. 

7.0	REFERENCES tc \l1 "7.0	REFERENCES 

American Chemistry Council (ACC). 2002a.  Assessment of Potential
Inhalation and Dermal Exposure Associated With Pressure Treatment of
Wood with Arsenical Wood Products.  MRID 4550211-01.

American Chemistry Council (ACC). 2002b.  An Analysis of the Training
Patterns and Practices of Competitive Swimmers.  Prepared by Richard
Reiss.  Sciences International, Inc. Alexandria, Virginia.  December 9,
2002.

  SEQ CHAPTER \h \r 1 Bestari KT, Macey K, Soloman KR, Tower N. 1999. 
Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl
Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber
(Phase III). MRID 455243-04.

  SEQ CHAPTER \h \r 1 CEC, 2001.  Residential Manual for Compliance with
California’s 2001 Energy Efficiency Standards. 
http://www.energy.ca.gov/title24/residential_manual/index.html, viewed
January 2005.

DOE.  1997.  Energy Information Administration: Profile of Commercial
Buildings in 1995. 
http://www.eia.doe.gov/emeu/cbecs/char95/profile.html

  SEQ CHAPTER \h \r 1 Freeman, N , Jimenez M, Reed KJ,Gurunathan S,
Edwards RD, Roy A, Adgate JL, Pellizzari ED, Quackenboss J, Sexton K,
Lioy PJ, 2001.  Quantitative analysis of chilren’s microactivity
patterns:  The Minnesota Children’s Pesticide Exposure Study.  Journal
of Exposure Analysis and Environmental Epidemiology.  11(6): 501-509.

Helwig, D. (2003) Personal Communication between D. Helwig (Johnson
Diversy, Inc) and K. Riley (Versar, Inc.), November 11, 2003.

HERA, 2003.  Human and Environmental Risk Assessment, Guidance Document
Methodology, April 22, 2002
(http://www.heraproject.com/files/Guidancedocument.pdf).

HERA, 2005.  Human and Environmental Risk Assessment, Guidance Document
Methodology, February 2005 (http://www.heraproject.com).

MCCEM V 1.2  The Multi-Chamber Concentration and Exposure Model (MCCEM)
Model Version 1.2. Prepared for the US EPA Office of Pollution
Prevention and Toxics. Prepared by Versar, Inc. and Wilkes Technologies,
LLC.

Jacobson, Larry. 2005.  Professor and Extension Engineer at University
of Minnesota.

SIMetric. 2005.    HYPERLINK
"http://www.simetric.co.uk/si_materials.htm" 
http://www.simetric.co.uk/si_materials.htm   Last viewed November 9,
2005.

USEPA.  Undated.  RISK.  Version 1.9.27.  Developed by Dr. Les Sparks of
USEPA/NRMRL/ APPCD.

USEPA. 1996.  Office of Research and Development, Descriptive Statistics
Tables from a Detailed Analysis of the National Human Activity Pattern
(NHAPS) Data; EPA/600/R-96/148, July 1996.   Data Collection Period
October 1992 - September 1994 . 

USEPA.  1997.  Exposure Factors Handbook. Volume I-II.  Office of
Research and Development.  Washington, D.C.  EPA/600/P-95/002Fa. August
1997.

USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure
from the Pesticide Handler Exposure Database Version 1.1.   Washington,
DC:  U.S. Environmental Protection Agency.

  SEQ CHAPTER \h \r 1 USEPA. 1999.  Evaluation of Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study (Amended on 8
December 1992).  Memorandum from Siroos Mostaghimi, PH.D., USEPA to
Julie Fairfax, USEPA. Dated November, 4 1999.  DP Barcode D247642.

USEPA.  2000.  Residential SOPs.  EPA Office of Pesticide Programs(Human
Health Effects Division. Dated April 5, 2000.

USEPA.  2001.  HED Science Advisory Council for Exposure. Policy Update,
November 12.  Recommended Revisions to the Standard Operating Procedures
(SOPs) for Residential Exposure Assessment, February 22, 2001. 

 

USEPA. 2003.  Assessment of the Proposed Bardac Wood Preservative
Pressure Treatment Use.  Memorandum from Tim Leighton and Siroos
Mostaghimi.  February 11, 2003.

USEPA. 2004.  Occupational and Residential Exposure Assessment for
Carboquat WP-50.  Memorandum from Siroos Mostaghimi, USEPA to Welma
Noble, USEPA.   Dated November 4, 2004. DP Barcodes D303714 and D303938.

USEPA. 2006.  Didecyl dimethyl benzyl ammonium chloride (DDAC) –
Report of the Antimicrobials Division Toxicity Endpoint Committee (ADTC)
and the Hazard Identification Assessment Review Committee (HIARC). 
January 9, 2006.



APPENDIX A: Master DDAC Label



EPA Reg Number used for Max. Appl. Rate	Use Site	Treatment Site/Surfaces
Method of Application	Notes	Freq of Application

Industrial processes and water systems

1839-129	Industrial Recirc Water Systems 	Cooling Towers (including
evaporative condensers, dairy sweetwater systems, cooling canals,
pasteurizers, tunnel coolers and warmers)	Pour/metered	1839-129 (50% ai)
	Weekly

10707-46	cooling water, disposal water, oil field operations	 	slug
treatment	 	 

1839-151	Oil Field water flood or salt water disposal	oil field water
disposal systems	pour/metered	1839-151	As needed

1839-179	Oil Field	injection and wastewater	continuous injection	Blend
with ADBAC	As needed

1839-179	Oil Field	injection and wastewater	batch treatment	Blend with
ADBAC	As needed

1839-179	Oil Field	packer fluids	 	Blend with ADBAC	As needed

1839-179	Oil Field	drilling muds	 	Blend with ADBAC	As needed

Swimming Pools

10324-69	Swimming Pool 	 	pour	 	Once               weekly

1839-133	Outside Spas/Whirlpools/Hot Tub Bath	 	pour	 	Weekly

Aquatic Areas

499-482	greenhouse/nurseries, golf courses, recreational parks,
amusement parks, universities, cemeteries	decorative fountains,
decorative pools, ponds, water displays, standing waters	dribble, spray
ring	Blend with ADBAC	As needed

499-482	greenhouse/nurseries	irrigation system, watering lines, drip
lines, emitters, watering nozzles, and hoses	immersing or running thru
system	Blend with ADBAC	As needed

 Wood Treatment	 	 	 	 	 

6836-212	Pressure Treatment	 	 	3% ai soln	As needed

6836-212	Double vacuum	 	 	3% ai soln	As needed

6836-212	Dip/Spray surface treatment	 	 	3% ai soln	As needed

Agricultural Premises and Equipment

 

10324-80	hatcheries, swine/poultry/turkey farms, egg receiving area, egg
holding area, setter room, tray dumping area, chick holding room,
poultry buildings, dressing plants, farrowing barns and areas,  blocks,
creep areas,  chick holding area, hatchery room, chick processing area,
and chick loading area	toilets, urinals, portable toilets, floors,
walls, ceilings, feed racks, mangers, troughs, automatic
feeders/fountains/waterers, other feeding and watering appliances,
halters, ropes and other types of equipment used in handling and
restraining animals, as well as forks, shovels, and scrapers used for
removing litter and manure, blocks, chutes, incubators, hatchers, 
glazed porcelain, glazed ceramic tile,  glass	mop, wipe, spray,
immersion	 	As needed

10324-81	hatchery rooms	 	fogging 	Blend with ADBAC	As needed

10324-81	incubators and hatchers	 	fogging 	Blend with ADBAC	Every 12
hrs

10324-108	Mushroom Farm	breezeways and track alleys before spawning,
inside and outside walls of mushroom houses, lofts, floors, storage
sheds and casing rings	mop, wipe	Blend with ADBAC	As needed

1839-167	Mushroom Farm	breezeways and track alleys before spawning,
inside and outside walls of mushroom houses, lofts, floors, storage
sheds and casing rings	cloth, mop, sponge, spray, immersion	Blend with
ADBAC	As needed

1839-167	Mushroom Farm	waterproof footwear	immersion (shoe bath)	Blend
with ADBAC	As needed

1839-167	Citrus Farm	trucks, vehicles, equipment, trailers, field
harvesting equipment, cargo area, wheels, tires, under carriage, hood,
roof, fenders	spray, dip, brush	Citrus canker, Blend with ADBAC	As
needed

10324-117	Animal housing facilities	boots and shoes	immersion	Blend with
ADBAC	As needed

1839-167	Florists/flower shops, greenhouses, shippers, packing areas
flower buckets, coolers, floors and walls of coolers, design and packing
benches, garbage pails	Mop/wipe, cloth, brush, sponge, sprayer	Blend
with ADBAC	As needed

 	 

499-482	greenhouse/ nursuries	work tables, benches, pots, flats,knives,
pruning tools, floors, plant containers, carts, transplant trays,
hanging baskets, tray/ pot holders, water collectors, walkways, windows
immersion, spray, brush	Blend with ADBAC	As needed

48815-1	farms	fish aquariums, tanks, fish handling equipment, nets,
seines, traps, filter boxes, pumps, air diffusers, shipping boxes,
feeding equipment, floors, countertops, raceways, garbage pails, other
hard nonporous surfaces, holding tanks, lavatories.	immersion, brush,
mop or cloth

As needed

Residential and Public Access Premises

10324-134	Homes	floors, walls, windows, toilets, bathtubs,  shower
stalls, shower door/curtain, sinks, mirrors, restroom fixtures,
cabinets, tables, chairs, desks, bed frames, doorknobs, garbage
cans/pails,  outdoor furniture, telephones, glazed porcelain, glazed
ceramic tile,  glass, Countertops (kitchen/food prep);  Internal
(external) surfaces of appliances (refrigerator, microwave, freezer);
stovetop; table surfaces;  sinks, shelves, racks	mop, wipe, (cloth),
spray	Disinfect        Heavy Duty Cleaning	As needed

1839-175	Home 	floors, walls, metal surfaces, stainless steel, glazed
porcelain, glazed ceramic tile, shower stalls, bathtubs, cabinets,
plastic surfaces	RTU wipe/spray	Blend with ADBAC	As needed

10324-108	homes	Carpets	Rotary Floor Machine	Blend with ADBAC	300-500 sq
ft/gal

3573-69	home	Furniture upholstery, window treatments, clothing, plush
toys,  shoes/sneakers, children mattresses, pet bed, sports
bag/equipment, carpet 	Spray (fabric sanitizer)	 	As Needed

3573-69	homes, mobile home, car, campgrounds, trailer, camper, boat
floors, walls, toilets, urinals, bathrooms, bathtubs, sinks,
countertops, shower doors/curtains, toilet seats, shower stalls, tables,
chairs, shelves, telephones, cabinets, desks, bed springs, door knobs,
linen carts, hampers, exercise equipment,cat litter boxes, bidets,
diaper changing tables, toys, high chairs, fountains,  synthetic marbel,
vinyl, linoleum , sealed granite, glazed porcelain, microwave oven
exteriors, marlite, plastic, outdoor furniture, laundry hampers, 	spray
(disinfect)	potable rinse for chidren toys and food contact	 

 10324-117	Homes	cooking utensils; coolers/ice chest; cups; cutlery;
dishes; eating utensils; glassware	Immersion	Blend with ADBAC	As needed

1836-167	campgrounds, playgrounds, Public facilites, mobile homes, cars,
campers, trailers, trucks	floors, walls, toilets, urinals, bathrooms,
bathtubs, sinks, countertops, shower doors/curtains, toilet seats,
shower stalls, tables, chairs, shelves, telephones, cabinets, desks, bed
springs, door knobs, linen carts, hampers, exercise equipment,
automobile/truck interiors, garbage cans/pails, fixtures, metal,
stainless steel. glazed porcelain, glazed ceramic tile, plastic,
granite, marble, chrome, vinyl, glass, enameled surfaces, painted wood
work, Formica, vinyl and plastic upholstery, chrome plated fixtures
cloth, mop, sponge, spray	Blend with ADBAC	As needed

10324-117	homes	water softners and reverse osmosis units	pour	 	As
needed

6718-24	homes	bedframes, tables, sinks, walls, countertops, chairs,
other hard nonporous surfaces	cloth, mop, spray	 	As needed

1839-178	homes	counters, stovetops, sinks, outside microwaves,
refrigerator exteriors, walls, appliances, finished wood, cabinets,
floors, exterior toilet bowl surfaces, trash cans, tubs, shower walls,
bathrooms, door knobs, closets, phones, car interiors, computers, hand
rails, switch plates, door frames, urinals, desks, cribs, changing
tables, patio furniture, dining room surfaces	RTU wipe/spray	Blend with
ADBAC	As needed

48815-1	homes	fish aquariums, tanks, fish handling equipment, nets,
seines, traps, filter boxes, pumps, air diffusers, shipping boxes,
feeding equipment, floors, countertops, raceways, garbage pails, other
hard nonporous surfaces, holding tanks, lavatories.	immersion, brush,
mop or cloth

As needed

10324-80	homes	humidifier	pour

As needed

Medical Premises and Equipment

1839-167	Hospitals, Health Care facilities, Medical/Dental offices,
Nursing homes, operating rooms, patient care facilities, clinics,
isolation wards, medical research facilities, autopsy rooms, ICU areas,
recovery anesthesia, emergency rooms, X-ray cat labs, newborn nurseries,
orthopedics, respiratory therapy, acute care institutions, alternate
care institutions, healthcare institutions, Funeral Homes, mortuaries
floors, walls, toilets, urinals, lavatories, bathrooms, bathing areas,
bathtubs, sinks, sink tops, shower stalls, shower doors/curtains,
mirrors, ultrasonic bath, whirlpools, foot baths, countertops, cabinets,
tables, chairs, desks, hospital beds, bed springs, bed frames, traction
devices, MRI, CAT, examining tables, scales, paddles, wheelchairs,
lifts, door knobs, wheel chairs, telephones, garbage pails/cans,
fixtures, metal, stainless steel. glazed porcelain, glazed ceramic tile,
plastic, granite, marble, chrome, vinyl, glass, enameled surfaces,
painted wood work, 	Wipe, mop, (cloth), swab, brush, spray	Blend with
ADBAC	As needed

 10324-81	Nurseries	Floors, walls, countertops (non-kitchen), sinks
(bathroom), toilets, external surfaces of appliances	mop, wipe (cloth)
Blend with ADBAC	As needed

1839-175	Medical Institutions, Hospitals, and Nursing Homes	floors,
walls, metal surfaces, stainless steel, glazed porcelain, glazed ceramic
tile, shower stalls, bathtubs, cabinets, plastic surfaces	RTU wipe/spray
Blend with ADBAC	As needed

10324-134	hospitals, medical/dental offices, nursing homes	floors,
walls, windows, toilets, bathtubs,  shower stalls, shower door/curtain,
sinks, mirrors, restroom fixtures, cabinets, tables, chairs, desks, bed
frames, doorknobs, garbage cans/pails,   telephones, glass, glazed
porcelain, glazed ceramic tile, table surfaces;  sinks, shelves, racks
mop, wipe, (cloth), spray	Disinfect        Heavy Duty Cleaning	As needed

1839-167	 nursing homes and hospitals	floors, walls, windows, toilets,
bathtubs,  shower stalls, shower door/curtain, sinks, mirrors, restroom
fixtures, cabinets, tables, chairs, desks, bed frames, doorknobs,
garbage cans/pails,  telephones, glass, glazed porcelain, glazed ceramic
tile,  enameled surfaces, countertops (kitchen/food prep);  Internal
external surfaces of appliances (refrigerator, microwave, freezer);
stovetop, shelves, racks	portable extraction units, truck mounted
extraction machines, rotary floor machines, metered, spray	Blend with
ADBAC	As needed

6718-24	hospitals, nursing homes	bedframes, tables, sinks, walls,
countertops, chairs, other hard nonporous surfaces	cloth, mop, spray	 
As needed

1839-178	 hospitals, day-care facilities, sick rooms	counters,
stovetops, sinks, outside microwaves, refrigerator exteriors, walls,
appliances, finished wood, cabinets, floors, exterior toilet bowl
surfaces, trash cans, tubs, shower walls, bathrooms, door knobs,
closets, phones, car interiors, computers, hand rails, switch plates,
door frames, urinals, desks, cribs, changing tables	RTU wipe	Blend with
ADBAC	As needed

1839-173	Morgues and Funeral homes	human remains	sponge, wash cloth,
soft brush	Blend with ADBAC	As needed

Commercial, Institutional, and Industrial premises and equipment

10324-134	Athletic/recreational facilities, exercise facilities,
schools, colleges, dressing rooms, transportation terminals, 
institutions	floors, walls, windows, toilets, bathtubs,  shower stalls,
shower door/curtain, sinks, mirrors, restroom fixtures, cabinets,
tables, chairs, desks, bed frames, doorknobs, garbage cans/pails, 
outdoor furniture, telephones, glass, glazed porcelain, glazed ceramic
tile, chrome plated intakes, enameled surfaces, countertops
(kitchen/food prep);  Internal (external) surfaces of appliances
(refrigerator, microwave, freezer); stovetop; table surfaces;  sinks,
shelves, racks	mop, wipe, (cloth), spray	Disinfect        Heavy Duty
Cleaning	As needed

1839-167	Athletic/recreational facilities, exercise facilites, locker
rooms, dressing rooms, schools, colleges, transportation terminals, 
floors, walls, toilets, urinals, bathrooms, bathtubs, sinks,
countertops, shower doors/curtains, toilet seats, shower stalls, tables,
chairs, shelves, telephones, cabinets, desks, bed springs, door knobs, 
garbage cans/pails, fixtures, metal, stainless steel. glazed porcelain,
glazed ceramic tile, plastic, granite, marble, chrome, vinyl, glass,
enameled surfaces, painted wood work, 	cloth, mop, sponge, spray	Blend
with ADBAC	As needed

1839-167	motels, hotels, schools	carpets	portable extraction units,
truck mounted extraction machines, rotary floor machines, metered, spray
Cleaning Claim     Blend with ADBAC	As needed

1839-175	Hotels and schools	floors, walls, metal surfaces, stainless
steel, glazed porcelain, glazed ceramic tile, shower stalls, bathtubs,
cabinets, plastic surfaces	RTU wipe/spray	Blend with ADBAC	As needed

6836-78	Barber and Beauty Salons	Barber/ Beauty Instruments and Tools
immersion	Blend with ADBAC	As needed

1839-178	Barber and Beauty Salons, Health clubs, hotels, motels,
emergency vehicles, transportation terminals, correctional facilities,
factories, 	counters, sinks, walls,  finished wood, cabinets, floors,
exterior toilet bowl surfaces, trash cans, tubs, shower walls,
bathrooms, door knobs, closets, phones, car interiors, computers, hand
rails, switch plates, door frames, urinals, desks, 	RTU wipe	Blend with
ADBAC	As needed

1839-167	commercial florists	flower buckets, coolers, floors and walls
of coolers, design and packing benches, garbage pails	cloth, mop,
sponge, spray	Blend with ADBAC	As needed

3573-69	Hotels, dorms, convenience stores, recreational centers,
offices, motels, 	floors, walls, toilets, urinals, bathrooms, bathtubs,
sinks, countertops, shower doors/curtains, toilet seats, shower stalls,
tables, chairs, shelves, telephones, cabinets, desks, bed springs, door
knobs, linen carts, hampers, exercise equipment, bidets, fountains, 
synthetic marble, vinyl, linoleum , sealed granite, glazed porcelain,
microwave oven exteriors, marlite, plastic, outdoor furniture, laundry
hampers, 	spray (disinfect)	potable rinse for chidren's toys and food
contact surfaces	 

1677-109	Commercial and institutional laundry mats	clothing	pour at
final rinse or sour to washweel	per 100lbs fabric dry wt	2wk protect 3wk
protect 30dy protect

6718-24	industry and schools	bedframes, tables, sinks, walls,
countertops, chairs, other hard nonporous surfaces	cloth, mop, spray	 
As needed

48815-1	Schools, Institutional, and Industrial	fish aquariums, tanks,
fish handling equipment, nets, seines, traps, filter boxes, pumps, air
diffusers, shipping boxes, feeding equipment, floors, countertops,
raceways, garbage pails, other hard nonporous surfaces, holding tanks,
lavatories.	immersion, brush, mop or cloth

As needed

10324-80

humidifiers	pour

As needed

Food Handling/Storage Establishments premises and equipment

1839-152	Restaurants, food service establishments, food processing
plants/facilities, beverage processing plants,  Bars,  Cafeterias, 
Convenience stores, supermarkets, Dairies, Egg Processing plants, 
Federally inspected meat and poultry plants ,  Food Handling areas, 
Food preparation areas,  Food storage areas,  Institutional kitchens,  
USDA inspected food processing facilities, breweries, fast food
operations	floors, walls, countertops, appliances (microwaves,
refrigerators, stove tops, freezers, coolers), chairs, tables, shelves,
picnic tables, outdoor furniture, racks, carts, telephones, door knobs,
storage areas, potato storage areas, food storage areas, garbage storage
areas, cutting boards, tanks, exhaust fans, refrigerator bins,
refrigerated storage/display equipment, coils and drain pans of air
conditioning/refrigeration equipment, heat pumps, storage tanks,
coolers, ice chests, garbage cans/pails	cloth, mop, spray, flood,
immersion, 	 	As needed

1839-175	Restaurants	floors, walls, tables, shelves, garbage disposal
areas, metal surfaces, stainless steel, glazed porcelain, glazed ceramic
tile, shower stalls, bathtubs, cabinets, plastic surfaces	RTU spray/wipe
Blend with ADBAC	As needed

10324-81	Dairies and Food Processing Facilities 	floors, walls, metal
surfaces, stainless steel, glazed porcelain, glazed ceramic tile, shower
stalls, bathtubs, cabinets, plastic surfaces	fogging	Blend with ADBAC	As
needed

10324-134	bottling and beverage plants, breweries, tobacco,  egg
processing plants, meat/poultry processing plants, rendering plants,
fishery/milk/citrus/wine/ice cream/ potato processing plants,
restaurants	floors, walls, tables, shelves, garbage cans, garbage
disposal areas, glazed porcelain, glazed ceramic tile, glass	mop, wipe,
(cloth), spray	 	As needed

1839-178	Restaurants	counters, stovetops, sinks, outside microwaves,
refrigerators exteriors, walls, appliances, finished wood, cabinets,
floors, exterior toilet bowl surfaces, trash cans, tubs, shower walls,
bathrooms, door knobs, closets, phones, computers, hand rails, switch
plates, door frames, urinals, desks, dining room surfaces	RTU wipe	Blend
with ADBAC	As needed

10324-117	bottling and beverage plants, breweries, tobacco,  egg
processing plants, meat/poultry processing plants, rendering plants,
fishery/milk/citrus/wine/ice cream/ potato processing plants,
restaurants	ice machines, water coolers, counters, tables, food
processing equipment, food utensils, dairy equipment, dishes,
silverware, eating utensils, glasses, sinks, counters,
refrigerated/storage display equipment	spray, wipe, sponge, immersion	 
As needed

10324-117	bottling and beverage plants, breweries, tobacco,  egg
processing plants, meat/poultry processing plants, rendering plants,
fishery/milk/citrus/wine/ice cream/ potato processing plants, 	water
softners and reverse osmosis units	pour	 	As needed

10324-117	bottling and beverage plants, breweries, tobacco,  egg
processing plants, meat/poultry processing plants, rendering plants,
fishery/milk/citrus/wine/ice cream/ potato processing plants, 	boots and
shoes	immersion	Blend with ADBAC	As needed

1839-173	dairies, beverage, and food processing plants	floors, walls,
countertops, appliances (microwaves, refrigerators, stove tops,
freezers, coolers), chairs, tables, shelves,  racks, carts, telephones,
door knobs, storage areas, potato storage areas, food storage areas,
garbage storage areas, cutting boards, tanks, exhaust fans, refrigerator
bins, refrigerated storage/display equipment, storage tanks, coolers,
ice chests, garbage cans/pails	fogging	Blend with ADBAC	As needed

Clean/Deodorization

1839-167	Water/Smoke restoration (institutional, industrial, hospital)
carpets, carpet cushion, sub floors, drywall, trim, farm lumber,
tackless strip and paneling	Pour, brush, spray	Blend with ADBAC	As
needed

1839-167	Sewer backup/river flood cleanup,  (clean water source)
carpets, carpet cushion, sub floors, drywall, trim, farm lumber,
tackless strip and paneling	spray	Blend with ADBAC	As needed

1839-167	garbage storage areas, pet areas, garbage bins & cans	 	 
Blend with ADBAC	As needed

  

71814-1	hospitals	Medical waste	pour	blend w/ ADBAC	Poured into machine



APPENDIX B: Summary of CMA and PHED Data

 tc \l1 "APPENDIX A: Summary of CMA data and PHED Chemical
Manufacturers Association (CMA) Data:

In response to an EPA Data Call-In Notice, a study was undertaken by the
Institute of Agricultural Medicine and Occupational Health of The
University of Iowa under contract to the Chemical Manufacturers
Association.  In order to meet the requirements of Subdivision U of the
Pesticide Assessment Guidelines (superseded by  Series 875.1000-875.1600
of the Pesticide Assessment Guidelines), handler exposure data are
required from the chemical manufacturer specifically registering the
antimicrobial pesticide.   The applicator exposure study must comply
with the assessment guidelines for (Applicator Exposure Monitoring( in
Subdivision U and the (Occupational and Residential Exposure Test
Guidelines( in Series 875.  For this purpose, CMA submitted a study on
28 February, 1990, entitled "Antimicrobial Exposure Assessment Study
(amended on December 8, 1992)" which was conducted by William Popendorf,
et al.  It was evaluated and accepted by Occupational and Residential
Exposure Branch (OREB) of Health Effect Division (HED), Office of
Pesticides Program (OPP) of EPA in 1990.  The purpose of this CMA study
was to characterize exposure to antimicrobial chemicals in order to
support pesticide reregistrations (CMA, 1992).  The unit exposures
presented in the most recent EPA evaluation of the CMA database (USEPA,
1999b) were used in this assessment.

The Agency determined that the CMA study had fulfilled the basic
requirements of Subdivision U - Applicator Exposure Monitoring.  The
advantages of CMA data over other (surrogate data sets( is that the
chemicals and the job functions of mixer/loader/applicator were defined
based on common application methods used for antimicrobial pesticides. 
A few of the deficiencies in the CMA data are noted below:

The inhalation concentrations were typically below the detection limits,
so the unit exposures for the inhalation exposure route could not be
accurately calculated. 

QA/QC problems including lack of either/or field fortification,
laboratory recoveries, and storage stability information.

Data have an insufficient amount of replicates.

The Pesticide Handlers Exposure Database (PHED):

The Pesticide Handlers Exposure Database (PHED) has been developed by a
Task Force consisting of representatives from Health Canada, the U.S.
Environmental Protection Agency (EPA), and the American Crop Protection
Association (ACPA).  PHED provides generic pesticide worker (i.e.,
mixer/loader and applicator) exposure estimates.  The dermal and
inhalation exposure estimates generated by PHED are based on actual
field monitoring data, which are reported generically (i.e., chemical
specific names not reported) in PHED.  It has been the Agency(s policy
to use (surrogate( or (generic( exposure data for pesticide applicators
in certain circumstances because it is believed that the physical
parameters (e.g., packaging type) or application technique (e.g.,
aerosol can), not the chemical properties of the pesticide, attribute to
exposure levels. [Note: Vapor pressures for the chemicals in PHED are in
the range of E-5 to E-7 mm Hg.]  Chemical specific properties are
accounted for by correcting the exposure data for study specific field
and laboratory recovery values as specified by the PHED grading
criteria.

PHED handler exposure data are generally provided on a normalized basis
for use in exposure assessments.  The most common method for normalizing
exposure is by pounds of active ingredient (ai) handled per replicate
(i.e., exposure in mg per replicate is divided by the amount of ai
handled in that particular replicate).  These unit exposures are
expressed as mg/lb ai handled.  This normalization method presumes that
dermal and inhalation exposures are linear based on the amount of active
ingredient handled.	



APPENDIX C: Input/Output from Residential MCCEM Modeling

Humidifier

         MCCEM SUMMARY REPORT

  TITLE:    Humidifier - 8hrs - Adult

  RUN         Day  Hour  Min      Length   Days  Hours  Min    
Reporting

  TIME  Start: 0    0     0       of Run:   2     0      0     
Interval: 60 minutes

 

  HOUSE   Type: Generic house      State: NA                  Code:
GN001

        Season: SUMMER             Zones: 2      Infiltration Rate: 0.18
ACH

  EMISSIONS   Source   Zone   Type              Details

              ¯¯¯¯¯¯   ¯¯¯¯   ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯  
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

                1       1     Constant          Emission Rate = 0.895 
g/hr

                2                               

                3                               

                4                               

  SINKS  Sink  Zone  Model          Details

         ¯¯¯¯  ¯¯¯¯  ¯¯¯¯¯¯¯¯¯¯¯¯¯ 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

          1                        

          2                        

          3                        

          4                        

          5                        

          6                        

 

  ACTIVITIES    Primary Activity Pattern is used on days: 1,2,3,4,5,6,7

  OVERRIDE ACTIVITIES:  YES

  DOSE

  Events/yr:    Yrs of Use:    Weight(kg): 60   Length of Life(yrs):  

  MONTE CARLO: NO          Number of Trials:  1          Seed No:   
Random

  OPTIONS  Single Chamber:  YES          Saturation Concentration
(mg/m³):  NONE      Output Concentration Units: mg/m³

  Initial Concentrations          Units:  mg/m³

      Zone 1:  0      Zone 2: 0      Zone 3: 0      Zone 4: 0     
Outdoors: 0

 
________________________________________________________________________
____

  RESULTS

 ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯¯

  LADD:  0.011809  mg/(kg day)

  LADC:  0.059043  mg/m³

  ADD:   0.011809  mg/(kg day)

  ADC:  0.059043  mg/m³

  Single Event Dose:  258.79  mg

  Peak Concentration:  12.191  mg/m³

  APDR:  2.4298  mg/(kg day)

  Time when APDR occurred:  1.9587  days

  Average Inhalation Rate:  12  m³/day

 
________________________________________________________________________
____

MCCEM SUMMARY REPORT

  TITLE:    Humidifier - 8hrs - Child

  RUN         Day  Hour  Min      Length   Days  Hours  Min    
Reporting

  TIME  Start: 0    0     0       of Run:   2     0      0     
Interval: 60 minutes

  HOUSE   Type: Generic house      State: NA                  Code:
GN001

        Season: SUMMER             Zones: 2      Infiltration Rate: 0.18
ACH

  EMISSIONS   Source   Zone   Type              Details

              ¯¯¯¯¯¯   ¯¯¯¯   ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯  
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

                1       1     Constant          Emission Rate = 0.895 
g/hr

                2                               

                3                               

                4                               

  SINKS  Sink  Zone  Model          Details

         ¯¯¯¯  ¯¯¯¯  ¯¯¯¯¯¯¯¯¯¯¯¯¯ 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

          1                        

          2                        

          3                        

          4                        

          5                        

          6                        

  ACTIVITIES    Primary Activity Pattern is used on days: 1,2,3,4,5,6,7

  OVERRIDE ACTIVITIES:  YES

  DOSE

  Events/yr:    Yrs of Use:    Weight(kg): 15   Length of Life(yrs):  

  MONTE CARLO: NO          Number of Trials:  1          Seed No:   
Random

  OPTIONS  Single Chamber:  YES          Saturation Concentration
(mg/m³):  NONE      Output Concentration Units: mg/m³

  Initial Concentrations          Units:  mg/m³

      Zone 1:  0      Zone 2: 0      Zone 3: 0      Zone 4: 0     
Outdoors: 0

 
________________________________________________________________________
____

  RESULTS

 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯

  LADD:  0.037787  mg/(kg day)

  LADC:  0.059043  mg/m³

  ADD:   0.037787  mg/(kg day)

  ADC:  0.059043  mg/m³

  Single Event Dose:  207.03  mg

  Peak Concentration:  12.191  mg/m³

  APDR:  7.7754  mg/(kg day)

  Time when APDR occurred:  1.9587  days

  Average Inhalation Rate:  9.6  m³/day

 
________________________________________________________________________
____

Humidifier - 8hrs

Time (days)	Time (hrs)	Conc Outdoors (mg/m³)	Conc Zone 1 (mg/m³)
Conc@Person(mg/m³)

0	0	0	0	0

0.0416667	1	7.59E-59	2.00763	2.00763

0.0833334	2	2.87E-58	3.68471	3.68471

0.125	3	6.10E-58	5.08566	5.08566

0.166667	4	1.03E-57	6.25594	6.25594

0.208334	5	1.52E-57	7.23354	7.23354

0.25	6	2.09E-57	8.05018	8.05018

0.291667	7	2.70E-57	8.73237	8.73237

0.333334	8	3.36E-57	9.30223	9.30223

0.375	9	4.07E-57	9.77826	9.77826

0.416667	10	4.80E-57	10.1759	10.1759

0.458334	11	5.56E-57	10.5081	10.5081

0.5	12	6.34E-57	10.7856	10.7856

0.541667	13	7.14E-57	11.0174	11.0174

0.583334	14	7.96E-57	11.211	11.211

0.625	15	8.78E-57	11.3728	11.3728

0.666667	16	9.62E-57	11.5079	11.5079

0.708334	17	1.05E-56	11.6208	11.6208

0.750001	18	1.13E-56	11.7151	11.7151

0.791667	19	1.22E-56	11.7938	11.7938

0.833334	20	1.31E-56	11.8596	11.8596

0.875001	21	1.39E-56	11.9146	11.9146

0.916667	22	1.48E-56	11.9605	11.9605

0.958334	23	1.57E-56	11.9989	11.9989

1	24	1.66E-56	12.0309	12.0309

1.04167	25	1.75E-56	12.0577	12.0577

1.08333	26	1.83E-56	12.08	12.08

1.125	27	1.92E-56	12.0987	12.0987

1.16667	28	2.01E-56	12.1143	12.1143

1.20833	29	2.10E-56	12.1273	12.1273

1.25	30	2.19E-56	12.1382	12.1382

1.29167	31	2.28E-56	12.1473	12.1473

1.33333	32	2.37E-56	12.1549	12.1549

1.375	33	2.46E-56	12.1613	12.1613

1.41667	34	2.55E-56	12.1666	12.1666

1.45833	35	2.64E-56	12.171	12.171

1.5	36	2.73E-56	12.1747	12.1747

1.54167	37	2.81E-56	12.1778	12.1778

1.58333	38	2.90E-56	12.1804	12.1804

1.625	39	2.99E-56	12.1825	12.1825

1.66667	40	3.08E-56	12.1843	12.1843

1.70833	41	3.17E-56	12.1858	12.1858

1.75	42	3.26E-56	12.1871	12.1871

1.79167	43	3.35E-56	12.1881	12.1881

1.83333	44	3.44E-56	12.189	12.189

1.875	45	3.53E-56	12.1897	12.1897

1.91667	46	3.62E-56	12.1904	12.1904

1.95833	47	3.71E-56	12.1909	12.1909

2	48	3.80E-56	12.1883	12.1883

Adults

8 hr exposure duration concentration (0 to 8 hr)	5.59

Time (hr)	8

Body Weight (kg)	60

Inhalation (m3/hr)	0.50

Dose (mg/kg/day)	0.373

NOAEL (mg/kg/day)	10

MOE	27

Children

8 hr exposure duration concentration (0 to 8 hr)	5.59

Time (hr)	8

Body Weight (kg)	15

Inhalation (m3/hr)	0.40

Dose (mg/kg/day)	1.19

NOAEL (mg/kg/day)	10

MOE	8.4

MCCEM SUMMARY REPORT

 TITLE:    Humidifier - 24hrs - Adult

 RUN         Day  Hour  Min      Length   Days  Hours  Min     Reporting

  TIME  Start: 0    0     0       of Run:   2     0      0     
Interval: 60 minutes

  HOUSE   Type: Generic house      State: NA                  Code:
GN001

        Season: SUMMER             Zones: 2      Infiltration Rate: 0.18
ACH

  EMISSIONS   Source   Zone   Type              Details

              ¯¯¯¯¯¯   ¯¯¯¯   ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯  
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

                1       1     Constant          Emission Rate = 0.895 
g/hr

                2                               

                3                               

                4                               

  SINKS  Sink  Zone  Model          Details

         ¯¯¯¯  ¯¯¯¯  ¯¯¯¯¯¯¯¯¯¯¯¯¯ 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

          1                        

          2                        

          3                        

          4                        

          5                        

          6                        

  ACTIVITIES    Primary Activity Pattern is used on days: 1,2,3,4,5,6,7

  OVERRIDE ACTIVITIES:  YES

  DOSE

  Events/yr:    Yrs of Use:    Weight(kg): 60   Length of Life(yrs):  

  MONTE CARLO: NO          Number of Trials:  1          Seed No:   
Random

  OPTIONS  Single Chamber:  YES          Saturation Concentration
(mg/m³):  NONE      Output Concentration Units: mg/m³

  Initial Concentrations          Units:  mg/m³

      Zone 1:  0      Zone 2: 0      Zone 3: 0      Zone 4: 0     
Outdoors: 0

 
________________________________________________________________________
____

  RESULTS

 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯

  LADD:  0.013088  mg/(kg day)

  LADC:  0.059043  mg/m³

  ADD:   0.013088  mg/(kg day)

  ADC:  0.059043  mg/m³

  Single Event Dose:  286.82  mg

  Peak Concentration:  12.191  mg/m³

  APDR:  2.6931  mg/(kg day)

  Time when APDR occurred:  1.9587  days

  Average Inhalation Rate:  13.3  m³/day

 _______________________________________________________________________
_____

MCCEM SUMMARY REPORT

  TITLE:    Humidifier - 24hrs - Child

  RUN         Day  Hour  Min      Length   Days  Hours  Min    
Reporting

  TIME  Start: 0    0     0       of Run:   2     0      0     
Interval: 60 minutes

  HOUSE   Type: Generic house      State: NA                  Code:
GN001

        Season: SUMMER             Zones: 2      Infiltration Rate: 0.18
ACH

  EMISSIONS   Source   Zone   Type              Details

              ¯¯¯¯¯¯   ¯¯¯¯   ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯  
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

                1       1     Constant          Emission Rate = 0.895 
g/hr

                2                               

                3                               

                4                               

  SINKS  Sink  Zone  Model          Details

         ¯¯¯¯  ¯¯¯¯  ¯¯¯¯¯¯¯¯¯¯¯¯¯ 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

          1                        

          2                        

          3                        

          4                        

          5                        

          6                        

  ACTIVITIES    Primary Activity Pattern is used on days: 1,2,3,4,5,6,7

  OVERRIDE ACTIVITIES:  YES

  DOSE

  Events/yr:    Yrs of Use:    Weight(kg): 15   Length of Life(yrs):  

  MONTE CARLO: NO          Number of Trials:  1          Seed No:   
Random

  OPTIONS  Single Chamber:  YES          Saturation Concentration
(mg/m³):  NONE      Output Concentration Units: mg/m³

  Initial Concentrations          Units:  mg/m³

      Zone 1:  0      Zone 2: 0      Zone 3: 0      Zone 4: 0     
Outdoors: 0

 
________________________________________________________________________
____

  RESULTS

 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯

  LADD:  0.03267  mg/(kg day)

  LADC:  0.059043  mg/m³

  ADD:   0.03267  mg/(kg day)

  ADC:  0.059043  mg/m³

  Single Event Dose:  178.99  mg

  Peak Concentration:  12.191  mg/m³

  APDR:  6.7225  mg/(kg day)

  Time when APDR occurred:  1.9587  days

  Average Inhalation Rate:  8.3  m³/day

 
________________________________________________________________________
____



Humidifier - 24hrs

Time (days)	Time (hrs)	Conc Outdoors (mg/m³)	Conc Zone 1 (mg/m³)
Conc@Person(mg/m³)

0	0	0	0	0

0.041667	1	7.59E-59	2.00763	2.00763

0.083333	2	2.87E-58	3.68471	3.68471

0.125	3	6.10E-58	5.08566	5.08566

0.166667	4	1.03E-57	6.25594	6.25594

0.208334	5	1.52E-57	7.23354	7.23354

0.25	6	2.09E-57	8.05018	8.05018

0.291667	7	2.70E-57	8.73237	8.73237

0.333334	8	3.36E-57	9.30223	9.30223

0.375	9	4.07E-57	9.77826	9.77826

0.416667	10	4.80E-57	10.1759	10.1759

0.458334	11	5.56E-57	10.5081	10.5081

0.5	12	6.34E-57	10.7856	10.7856

0.541667	13	7.14E-57	11.0174	11.0174

0.583334	14	7.96E-57	11.211	11.211

0.625	15	8.78E-57	11.3728	11.3728

0.666667	16	9.62E-57	11.5079	11.5079

0.708334	17	1.05E-56	11.6208	11.6208

0.750001	18	1.13E-56	11.7151	11.7151

0.791667	19	1.22E-56	11.7938	11.7938

0.833334	20	1.31E-56	11.8596	11.8596

0.875001	21	1.39E-56	11.9146	11.9146

0.916667	22	1.48E-56	11.9605	11.9605

0.958334	23	1.57E-56	11.9989	11.9989

1	24	1.66E-56	12.0309	12.0309

1.04167	25	1.75E-56	12.0577	12.0577

1.08333	26	1.83E-56	12.08	12.08

1.125	27	1.92E-56	12.0987	12.0987

1.16667	28	2.01E-56	12.1143	12.1143

1.20833	29	2.10E-56	12.1273	12.1273

1.25	30	2.19E-56	12.1382	12.1382

1.29167	31	2.28E-56	12.1473	12.1473

1.33333	32	2.37E-56	12.1549	12.1549

1.375	33	2.46E-56	12.1613	12.1613

1.41667	34	2.55E-56	12.1666	12.1666

1.45833	35	2.64E-56	12.171	12.171

1.5	36	2.73E-56	12.1747	12.1747

1.54167	37	2.81E-56	12.1778	12.1778

1.58333	38	2.90E-56	12.1804	12.1804

1.625	39	2.99E-56	12.1825	12.1825

1.66667	40	3.08E-56	12.1843	12.1843

1.70833	41	3.17E-56	12.1858	12.1858

1.75	42	3.26E-56	12.1871	12.1871

1.79167	43	3.35E-56	12.1881	12.1881

1.83333	44	3.44E-56	12.189	12.189

1.875	45	3.53E-56	12.1897	12.1897

1.91667	46	3.62E-56	12.1904	12.1904

1.95833	47	3.71E-56	12.1909	12.1909

2	48	3.80E-56	12.1883	12.1883

Adult

24 hr exposure duration concentration (24 to 48 hr)	12.2

Time (hr)	8

Body Weight (kg)	60

Inhalation (m3/hr)	0.55

Dose (mg/kg/day)	0.90

NOAEL (mg/kg/day)	10

MOE	11.1

Child

24 hr exposure duration concentration (24 to 48 hr)	12.2

Time (hr)	8

Body Weight (kg)	15

Inhalation (m3/hr)	0.36

Dose (mg/kg/day)	2.32

NOAEL (mg/kg/day)	10

MOE	4.3



APPENDIX D: Input/Output from Occupational MCCEM Modeling 

Food Processing Plant and Hatchery MCCEM SUMMARY REPORT

  TITLE:    Food Processing

  RUN         Day  Hour  Min      Length   Days  Hours  Min    
Reporting

  TIME  Start: 0    0     0       of Run:   2     0      0     
Interval: 60 minutes

 

  HOUSE   Type: Hypothetical house    State: NA                  Code:
HY06

        Season: NA                 Zones: 1      Infiltration Rate: 0.18
ACH

  EMISSIONS   Source   Zone   Type              Details

              ¯¯¯¯¯¯   ¯¯¯¯   ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯  
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

                1                               

                2                               

                3                               

                4                               

 

  SINKS  Sink  Zone  Model          Details

         ¯¯¯¯  ¯¯¯¯  ¯¯¯¯¯¯¯¯¯¯¯¯¯ 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯

          1                        

          2                        

          3                        

          4                        

          5                        

          6                        

 

  ACTIVITIES    Primary Activity Pattern is used on days: 1,2,3,4,5,6,7

  OVERRIDE ACTIVITIES:  YES

  DOSE

  Events/yr:    Yrs of Use:    Weight(kg): 60   Length of Life(yrs):  

  MONTE CARLO: NO          Number of Trials:  1          Seed No:   
Random

  OPTIONS  Single Chamber:  YES          Saturation Concentration
(mg/m³):  NONE      Output Concentration Units: mg/m³

  Initial Concentrations          Units:  g/m³

      Zone 1:  0.0258      Zone 2: 0      Zone 3: 0      Zone 4: 0     
Outdoors: 0

 
________________________________________________________________________
____

  RESULTS

 
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
¯¯¯¯

  LADD:  0.0065343  mg/(kg day)

  LADC:  0.016336  mg/m³

  ADD:   0.0065344  mg/(kg day)

  ADC:  0.016336  mg/m³

  Single Event Dose:  143.2  mg

  Peak Concentration:  25.761  mg/m³

  APDR:  2.3554  mg/(kg day)

  Time when APDR occurred:  1.0003  days

  Average Inhalation Rate:  24  m³/day

 
________________________________________________________________________
____

Food Processing

Time (days)	Time (hrs)	Conc Outdoors (mg/m³)	Conc Zone 1 (mg/m³)
Conc@Person(mg/m³)

0	0	0	25.8	0

0.0416667	1	6.38E-55	21.55	21.55

0.0833334	2	1.17E-54	18	18

0.125	3	1.61E-54	15.0349	15.0349

0.166667	4	1.99E-54	12.5582	12.5582

0.208334	5	2.30E-54	10.4895	10.4895

0.25	6	2.56E-54	8.76156	8.76156

0.291667	7	2.77E-54	7.31827	7.31827

0.333334	8	2.95E-54	6.11273	6.11273

0.375	9	3.10E-54	5.10578	5.10578

0.416667	10	3.23E-54	4.26471	4.26471

0.458334	11	3.34E-54	3.56218	3.56218

0.5	12	3.42E-54	2.97538	2.97538

0.541667	13	3.50E-54	2.48525	2.48525

0.583334	14	3.56E-54	2.07585	2.07585

0.625	15	3.61E-54	1.7339	1.7339

0.666667	16	3.65E-54	1.44827	1.44827

0.708334	17	3.69E-54	1.2097	1.2097

0.750001	18	3.72E-54	1.01043	1.01043

0.791667	19	3.74E-54	0.843979	0.843979

0.833334	20	3.76E-54	0.70495	0.70495

0.875001	21	3.78E-54	0.588824	0.588824

0.916667	22	3.80E-54	0.491827	0.491827

0.958334	23	3.81E-54	0.410808	0.410808

1	24	3.82E-54	0.343136	0.343136

1.04167	25	3.83E-54	0.286611	0.286611

1.08333	26	3.83E-54	0.239398	0.239398

1.125	27	3.84E-54	0.199962	0.199962

1.16667	28	3.84E-54	0.167022	0.167022

1.20833	29	3.85E-54	0.139509	0.139509

1.25	30	3.85E-54	0.116527	0.116527

1.29167	31	3.86E-54	0.0973318	0.0973318

1.33333	32	3.86E-54	0.0812983	0.0812983

1.375	33	3.86E-54	0.067906	0.067906

1.41667	34	3.86E-54	0.0567199	0.0567199

1.45833	35	3.86E-54	0.0473764	0.0473764

1.5	36	3.86E-54	0.0395721	0.0395721

1.54167	37	3.87E-54	0.0330534	0.0330534

1.58333	38	3.87E-54	0.0276085	0.0276085

1.625	39	3.87E-54	0.0230606	0.0230606

1.66667	40	3.87E-54	0.0192618	0.0192618

1.70833	41	3.87E-54	0.0160888	0.0160888

1.75	42	3.87E-54	0.0134385	0.0134385

1.79167	43	3.87E-54	0.0112248	0.0112248

1.83333	44	3.87E-54	0.0093757	0.0093757

1.875	45	3.87E-54	0.0078313	0.0078313

1.91667	46	3.87E-54	0.0065412	0.0065412

1.95833	47	3.87E-54	0.0054637	0.0054637

2	48	3.87E-54	0.0045637	0.0045637

2-hr Reentry Interval

8 hr exposure duration concentration (2 to 10 hr)	9.74

Time (hr)	8

Body Weight (kg)	60

Inhalation (m3/hr)	1.25

Dose (mg/kg/day)	1.62

NOAEL (mg/kg/day)	10

MOE	             6.2 

MCCEM SUMMARY REPORT

  TITLE:    Hatchery

  RUN         Day  Hour  Min      Length   Days  Hours  Min    
Reporting

  TIME  Start: 0    0     0       of Run:   2     0      0     
Interval: 60 minutes

 

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1,2,3,4,5,6,7

  OVERRIDE ACTIVITIES:  YES

  DOSE

  Events/yr:    Yrs of Use:    Weight(kg): 60   Length of Life(yrs):  

  MONTE CARLO: NO          Number of Trials:  1          Seed No:   
Random

  OPTIONS  Single Chamber:  YES          Saturation Concentration
(mg/m³):  NONE      Output Concentration Units: mg/m³

  Initial Concentrations          Units:  g/m³

      Zone 1:  0.301      Zone 2: 0      Zone 3: 0      Zone 4: 0     
Outdoors: 0

 
________________________________________________________________________
___

  RESULTS 
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  LADD:  0.0033768  mg/(kg day)

  LADC:  0.008442  mg/m³

  ADD:   0.0033768  mg/(kg day)

  ADC:  0.008442  mg/m³

  Single Event Dose:  74.003  mg

  Peak Concentration:  291.13  mg/m³

  APDR:  1.2334  mg/(kg day)

  Time when APDR occurred:  0.41701  days

  Average Inhalation Rate:  24  m³/day

________________________________________________________________________
___

Hatchery

Time (days)	Time (hrs)	Conc Outdoors (mg/m³)	Conc Zone 1 (mg/m³)
Conc@Person(mg/m³)

0	0	0	301	0

0.041667	1	4.43E-53	5.51299	5.51299

0.083333	2	4.51E-53	0.100974	0.100974

0.125	3	4.51E-53	0.001849	0.001849

0.166667	4	4.52E-53	3.39E-05	3.39E-05

0.208334	5	4.52E-53	6.20E-07	6.20E-07

0.25	6	4.52E-53	1.14E-08	1.14E-08

0.291667	7	4.52E-53	2.08E-10	2.08E-10

0.333334	8	4.52E-53	3.81E-12	3.81E-12

0.375	9	4.52E-53	6.98E-14	6.98E-14

0.416667	10	4.52E-53	1.28E-15	1.28E-15

0.458334	11	4.52E-53	2.34E-17	2.34E-17

0.5	12	4.52E-53	4.29E-19	4.29E-19

0.541667	13	4.52E-53	7.86E-21	7.86E-21

0.583334	14	4.52E-53	1.44E-22	1.44E-22

0.625	15	4.52E-53	2.64E-24	2.64E-24

0.666667	16	4.52E-53	4.83E-26	4.83E-26

0.708334	17	4.52E-53	8.84E-28	8.84E-28

0.750001	18	4.52E-53	1.62E-29	1.62E-29

0.791667	19	4.52E-53	2.97E-31	2.97E-31

0.833334	20	4.52E-53	5.43E-33	5.43E-33

0.875001	21	4.52E-53	9.95E-35	9.95E-35

0.916667	22	4.52E-53	1.82E-36	1.82E-36

0.958334	23	4.52E-53	3.34E-38	3.34E-38

1	24	4.52E-53	6.11E-40	6.11E-40

1.04167	25	4.52E-53	1.12E-41	1.12E-41

1.08333	26	4.52E-53	2.05E-43	2.05E-43

1.125	27	4.52E-53	3.76E-45	3.76E-45

1.16667	28	4.52E-53	6.88E-47	6.88E-47

1.20833	29	4.52E-53	1.26E-48	1.26E-48

1.25	30	4.52E-53	2.31E-50	2.31E-50

1.29167	31	4.52E-53	4.68E-52	4.68E-52

1.33333	32	4.52E-53	5.29E-53	5.29E-53

1.375	33	4.52E-53	4.53E-53	4.53E-53

1.41667	34	4.52E-53	4.52E-53	4.52E-53

1.45833	35	4.52E-53	4.52E-53	4.52E-53

1.5	36	4.52E-53	4.52E-53	4.52E-53

1.54167	37	4.52E-53	4.52E-53	4.52E-53

1.58333	38	4.52E-53	4.52E-53	4.52E-53

1.625	39	4.52E-53	4.52E-53	4.52E-53

1.66667	40	4.52E-53	4.52E-53	4.52E-53

1.70833	41	4.52E-53	4.52E-53	4.52E-53

1.75	42	4.52E-53	4.52E-53	4.52E-53

1.79167	43	4.52E-53	4.52E-53	4.52E-53

1.83333	44	4.52E-53	4.52E-53	4.52E-53

1.875	45	4.52E-53	4.52E-53	4.52E-53

1.91667	46	4.52E-53	4.52E-53	4.52E-53

1.95833	47	4.52E-53	4.52E-53	4.52E-53

2	48	4.52E-53	4.52E-53	4.52E-53

0 hr Re-entry Interval

8 hr exposure duration concentration (0 to 8 hr)	0.62

Time (hr)	8

Body Weight (kg)	60

Inhalation (m3/hr)	1.00

Dose (mg/kg/day)	0.083

NOAEL (mg/kg/day)	10

MOE	120

2-hr Reentry Interval

8 hr exposure duration concentration (2 to 10 hr)	0.0114

Time (hr)	8

Body Weight (kg)	60

Inhalation (m3/hr)	1.00

Dose (mg/kg/day)	0.0015

NOAEL (mg/kg/day)	10

MOE	6,562





APPENDIX E:  Calculation of DDAC Unit Exposure Values

Table E-1:  DDAC Dermal and Inhalation Exposure Values for Chemical
Operators, Graders, Millwrights, Clean-up Crews, and Trim Saw Operatorsa

Replicate Number	Chemical Operator	Grader	Trim Saw Operator	Millwright
Cleanup Crew

	Dermal	Inhalation	Dermal	Inhalation	Dermal	Inhalation	Dermal	Inhalation
Dermal	Inhalation

	Potential exposure (mg)	Air Concentrationb,c ((g/m3)	Potential
exposured (mg)	Potential exposure (mg)	Air Concentrationb,c ((g/m3)
Potential exposured (mg)	Potential exposure (mg)	Air Concentrationb,c
((g/m3)	Potential exposured (mg)	Potential exposure (mg)	Air
Concentrationb,c ((g/m3)	Potential exposured (mg)	Potential exposure
(mg)	Air Concentrationb,c ((g/m3)	Potential exposured (mg)

1	3.5	10.1	0.0808	3.05	2.90	0.0232	0.78	2.83	0.0227	1.31	2.92	0.0233
68.3	2.99145	0.0239

2	6.11	2.80	0.0224	7.47	2.93	0.0234	1.98	12.3	0.0984	29.08	2.83	0.0226
0.720	2.78840	0.0223

3	6.07	2.79	0.0223	1.09	2.91	0.0233

8.03	15.6	0.1248	166	30.3	0.2424

4	46.37	2.82	0.0226	10.51	3.00	0.0240

	95.2	412	3.2960

5	0.94	2.93	0.0235	0.61	2.82	0.0226

	1.20	2.83585	0.0227

6	22.15	2.83	0.0227	0.98	2.85	0.0228

	0.260	2.80989	0.0225

7	21.45	2.77	0.0222	2.63	2.91	0.0233

	8	0.22	2.73	0.0218	5.23	2.85	0.0228

	9	0.44	2.77	0.0222	0.19	13.20	0.1056

	10	0.33	3.14	0.0251	1.47	2.89	0.0231

	11	0.29	2.88	0.0230	2.38	2.85	0.0228

	12

4.09	2.81	0.0225

	13

1.03	2.94	0.0235

	Arithmetic Mean	9.81	3.51	0.0281	3.13	3.68	0.0295	1.38	7.57	0.061	12.8
7.12	0.057	55.3	75.6	0.60

Minimum	0.22	2.73	0.0218	0.19	2.81	0.0225	0.78	2.83	0.0227	1.31	2.83
0.0226	0.260	2.79	0.0223

Maximum	46.4	10.1	0.081	10.51	13.2	0.106	1.98	12.3	0.098	29.1	15.6	0.125
166	412	3.30

a.	“Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III)” is the study that values were obtained from for
this table (Bestari et al., 1999, MRID 455243-04).

b.	The inhalation LOD was not provided for chemical operators, graders,
trim saw operators, millwrights, or the clean-up crew.  Therefore, the
LOD provided for the diptank operator (5.6 (g) was used for these
positions.  Residues less than the LOD were adjusted to 1/2 LOD.

c.	The inhalation limit of detection was converted to (g/m3 using the
following equation: air concentration ((g/m3) = 5.6 (g/ [average flow
rate (L/min) * sampling duration (480 min) * 1000 L/m3.  Data was
obtained from Bestari et al (1999).

d.	DDAC air concentrations were converted to inhalation exposure using
the following equation: Air concentration ((g/m3) x inhalation rate (1.0
m3/hr) x Conversion factor (1 mg/1000 (g) x sample duration (8 hours/day



Table E-2:  Normalization of DDAC Dermal and Inhalation Exposure Values
for Diptank Operatorsa

Worker ID	Mill number	Sample Time (min)	DDAC

Conc. in

Diptank

(%)	Gloves	Dermal Body Exposureb (mg)	Hand Exposureb (mg)	Total Dermal
Exposure (mg)	Normalized Total Dermal Unit Exposurec

(mg/ 1 % solution)	Air Conc.d (mg/m3)	Inhalation Exposuree (mg)
Normalized Inhalation Unit Exposurec

(mg /1% solution)

M7P1A	7	480	0.64	Rubber	0.5	3.44	3.94	6.16	0.003	0.024	0.0375

M7P1B	7	480	0.64	Rubber	0.32	2.02	2.34	3.66	0.003	0.024	0.0375

M8P4A	8	408	0.42	Rubber	0.04f	1.34	1.38	3.29	0.003	0.024	0.057

M8P4B	8	480	0.42	Rubber	0.04f	0.5	0.54	1.29	0.003	0.024	0.057

M8P7	8	480	0.42	Cotton	0.03	0.04	0.07	0.17	0.003	0.024	0.057

M11P9A	11	395	0.63	Leather	0.15	3.33	3.48	5.52	0.003	0.024	0.0381

M11P9B	11	480	0.63	Leather	0.1	0.45	0.55	0.87	0.003	0.024	0.0381

Arithmetic Mean	0.17	1.59	1.76	2.99	0.0030	0.0240	0.046

Standard Deviation	0.18	1.39	1.53	2.32	0.0000	0.0000	0.0103

Median	0.10	1.34	1.38	3.29	0.0030	0.0240	0.0381

Geometric Mean	0.10	0.83	0.99	1.86	0.0030	0.0240	0.045

90%tile	0.39	3.37	3.66	5.78	0.0030	0.0240	0.057

Maximum	0.50	3.44	3.94	6.16	0.0030	0.0240	0.057

 a.	“Measurement and Assessment of Dermal and Inhalation Exposures to
Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut
Lumber (Phase III)” is the study that values were obtained from for
this table (Bestari et al., 1999, MRID 455243-04).

b.	DDAC concentration that was detected in the monitoring study (MRID
#455243-04).

c.	Normalization of DDAC data for percent ai treatment.  Normalized Unit
Exposure (mg/1% ai solution) = Exposure (mg DDAC) / concentration in
diptank solution (% DDAC)

d.	All inhalation residues were <LOD (5.6 g or 0.0056 mg/m3). 1/2 LOD
was used in all calculations (0.003 mg/m3). Air Concentration (mg/m3) =
5.6 g / (~2 L/min flow rate x ~480 min) x 1000 L/m3 conversion x
0.001 g/mg = 0.003 mg/m3

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@

ༀ킄ᄂやㇽĤ葞ː葠ﴰကtion (8 hours/day).

f.	Residues were <LOD for dermal samples M8P4A, M8P4B.  Sample size of
~11,231 cm2 x <0.007 ug/cm2 = LOD of 0.079 mg.  1/2 LOD reported (i.e.,
0.04 mg)

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