UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

  OFFICE OF PREVENTION, PESTICIDES 

                                                                        
                                				AND TOXIC SUBSTANCES

February 20, 2008

MEMORANDUM

SUBJECT: 	Risk Assessment and Science Support Branch’s (RASSB’s)
Review of Petition Submission to Amend 27 CFR § 178.1010 (b)41 and
(c)36, and 40 CFR § 180.940 for Steramine 1G Tablets.

FROM:		Sherrie L. Kinard, Chemist, Team 1

Risk Assessment and Science Support Branch

Antimicrobials Division (7510P)

THROUGH:  Norm Cook, Branch Chief

Risk Assessment and Science Support Branch

Antimicrobials Division (7510P)

TO:			Dennis Edwards, Branch Chief

				Regulatory Management Branch I

Antimicrobials Division (7510P)

Chemical:		N-alkyl (C12-14) dimethyl benzyl ammonium chloride (ADBAC
compounds)

PC Code:		069105

CAS #:	1225-02-9 and 8001-54-5

DP Barcodes:	  D340428 and D340759

 I.	INTRODUCTION AND BACKGROUND

	1.	Introduction

A petition has been submitted to the Agency which requests that the 40
CFR § 180.940 (a) be amended to increase the end use solution
concentration permitted for the quaternary sanitizer, ADBAC.  The
proposed amendment requests that the tolerance exemption for ADBAC be
increased from 200 ppm to 400 ppm when it is used as an active
ingredient in food-contact surface sanitizing products.   Approval of
this petition to increase the tolerance exemption level from 200 ppm to
400 ppm will eliminate restrictions placed on this product and allow its
usage throughout the USA along with those quaternary sanitizers that are
approved under 21 CFR 178.1010 for use up to 400 ppm level.  The label
being considered for this tolerance exemption increase is currently
registered with the Agency (EPA registration number 1561-11) at a use
rate of 200 ppm.  Supplementary to the review of the proposed tolerance
exemption increase, the residential and occupational risks associated
with the labeled uses were also evaluated.   A proposed RED was
completed for the ADBAC quaternary ammonium chloride chemicals for uses
in food handling establishments, food processing establishments, and
bottling/packaging establishments.  Additionally, data that has been
collected by and reported by the Quats Residue Group (QRG) Joint Venture
and Consumer Specialty Products Association (CSPA) have been considered
for this review.  

	2.	Petition

	Edwards-Councilor CO., Inc. has submitted this petition which requests
that the Agency amend 40 CFR § 180.940 (a) by increasing the end-use
concentration of the quaternary ammonium compound n-alkyl (C12-16)
dimethylbenzylammonium chloride in the sanitizing solution from 200 to
400 ppm of active ingredient (a.i.).  The use sites covered under §
180.940 (a) are:  food-contact surfaces in public eating places, dairy
processing equipment, and food-processing equipment and utensils.

Section F of the petition reads as follows:

Pesticide Chemical	CAS Reg. No.	Limits

Quaternary Ammonium Compounds n-alkyl (C14-16) benzyldimethyl ammonium
chloride, average molecular weight (in amu) 351-380	1225-02-9 in 21 CFR

and

8001-54-5 in 40 CFR	When ready for use, the end-use concentration of the
n-alkyl benzyldimethyl ammonium chloride is not to exceed 400 ppm of the
sanitizing solution in food handling establishments.

Note:  Pending approval of this petition, the 8001-54-5 in 40 CFR should
read, “When ready for use, the end-use concentration of all quaternary
chemicals in the solution is not to exceed 400 ppm of active quaternary
compound.

		2.1. Reference ADBAC Label and Chemical Identity

	The registrant has submitted a reference product label:  STERAMINE™
1-G TABLETS (EPA Reg. No. 1561-11), which contains the following product
ingredients:

n-alkyl dimethyl benzyl ammonium chloride 	50% a.i.

	The alkyl (C14, 95%; C12, 3%; C16, 2%) dimethyl benzyl ammonium
chloride (ADBAC) compounds comprise 50% of the formulation. The alkyl
groups contain 12 to 16 carbons and not more than 1% each of the groups
with 8 to 10 carbon atoms, in or on all foods, when residues are the
result of the lawful application of a registered pesticide containing
not more than 400 ppm of the n-alkyl benzyldimethyl ammonium chloride as
a sanitizing solution in food handling establishments.  The alkyl benzyl
quaternary compound falls into cluster 2 of PR Notice 88-2.

	

	

		2.2. Proposed ADBAC Uses and Rates

	The representative product label claims uses as a multi-purpose
sanitizer and claims that the product “kills HIV-1 (AIDS Virus) when
used as directed for sanitizing.”   The label states that the uses for
this product are intended for institutional and commercial sites only. 
The sanitizer maximum application rate for food contact surfaces is
currently 1 tablet per 1 gallon of water which results in the diluted
solution concentrations of 200 ppm total a.i.; however, pending approval
of this petition, the maximum application rate for food contact surfaces
will be 1 to 2 tablets per 1 gallon of water resulting in diluted
solution concentrations of 200 to 400 ppm total a.i..  Also pending
approval of this petition for a tolerance exemption increase, the
following “statement of compliance” will be added to the label:

™ sanitizing solutions of 200 to 400 ppm concentration may be safely
used on food processing equipment, utensils, and other food contact
articles and surface as specified under 40 CFR 180.940 of the U.S.
Environmental Protection Agency.”

		2.3. Residue Analytical Method (860.1340) and Residue Data (860.1500)

	The registrant did not submit an analytical method (860.1340). 
However, the use is regulated as an exemption from the requirement of a
tolerance and an analytical method is not required.  Also, no residue
data (860.1500) were submitted.  These ammonium compounds presently have
clearances under 40 CFR CFR § 180.940 (a) at lower application rates.

II.	RASSB Comments and Conclusions

		RASSB has performed an evaluation of ADBAC at the proposed increase in
n-alkyl benzyldimethyl ammonium chloride residues from 200 ppm total
a.i. to 400 ppm total a.i. which is not covered by existing tolerance
exemptions under 40 CFR § 180.940 (a).  

The proposed petition results in an increase in potential ADBAC residues
in food-contact settings.  The petition proposes an increase to the
tolerance exemption level from 200 ppm to 400 ppm and also an increase
in the maximum application rate to 200 to 400 ppm.  

		It is noted that in the proposed RED for ADBAC (see Public Docket
under EPA-HQ-OPP-2006-0339) the rate of 200 ppm a.i. is evaluated for
food-contact settings.  Essentially, the ADBAC petition’s proposed use
rate has not been evaluated under the ADBAC RED.  Considering this,
RASSB has completed the following evaluation of the proposed ADBAC
petition using surface residues resulting from an application of 0.0033
lbs a.i./gal (400 ppm a.i).  The findings are as follows:

Dietary: 			No risks of concern resulting from an increase in potential
residues in food-contact settings.

Drinking Water:  	A drinking water assessment is not warranted based on
the uses proposed on this label; however, the drinking water assessment
that was performed in the ADBAC RED was used to aggregate risks from
this proposed use with those currently allowed on other labels.  The
drinking water assessment demonstrated no risks of concern.

Residential: 		No risks of concern resulting from an increase in
potential residues in food-contact settings.

Aggregate: 		No risks of concern resulting from an increase in potential
residues in food-contact settings.

Occupational: 		No risks of concern.

		1. Toxicology

	In assessing the proposed petition, RASSB used appropriate
toxicological end-points, which are taken from the ADBAC RED (see Public
Docket under EPA-HQ-OPP-2006-0339):

Table 1.  Summary of Toxicological Endpoints for ADBAC

Exposure

Scenario	Dose Used in Risk Assessment

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

Special FQPA SF

for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(general population; females 13+)	An acute dietary endpoint was not
identified in the data base.  This risk assessment is not required.

Chronic Dietary	

NOAEL =44 mg/kg/day

	FQPA SF = 1

UF = 100 (10x inter-species extrapolation, 10x intra-species variation)
Chronic toxicity/carcinogenicity –rat MRID 41947501

LOAEL = 88 mg/kg/day, based on decreased body weight and weight gain  



Chronic RfD = 0.44 mg/kg/day

Incidental Oral (Short-term)	NOAEL = 10 mg/kg/day

	FQPA SF = 1

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

MRID 42351501

LOAEL = 30 mg/kg/day, based on decreased body weight and food
consumption 

Incidental Oral (Intermediate-term)	NOAEL = 10 mg/kg/day

	FQPA SF = 1

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

MRID 42351501

LOAEL = 30 mg/kg/day, based on decreased body weight and food
consumption

Short-term

Dermal 	NOAEL= 20 mg a.i./kg/day

(333 µg/cm2)a	FQPA SF = 1

UF = 10 (3x inter-species extrapolation, 3x intra-species variation)
21-day dermal toxicity- guinea pigs MRID 41105801

LOAEL = 40 mg a.i./kg/day, based on denuded non-vascularized epidermal
layer 

Short-term dermal 	NOAEL = 20 mg ai/kg/day

 (80 µg ai/cm2) b	UF = 10 (3x inter-species extrapolation, 3x
intra-species variation)	21-day dermal toxicity in rats MRID 41499601

20 mg ai/kg/day is the highest dose tested before irritation became
significant at day 43.

Short-term Dermal (technical grade a.i.)

	No endpoint identified from the available data on dermal irritation.
Dermal irritation in the 90-day dermal toxicity study was not evident
until day 43 (MRID 41499601).  

Long-term Dermal (TGAI)	No appropriate endpoint identified.  No systemic
effects observed up to 20 mg/kg/day, highest dose of technical grade
that could be tested without irritation effects.

Inhalationc

(Any time point)	NOAEL= 3 mg/kg/day

MOE = 100c

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

Note:  an additional 10x is used for route extrapolation to determine if
a confirmatory study is needed	Developmental Toxicity – rabbit, MRID
42392801

LOAEL = 9 mg/kg/day, based on clinical signs of toxicity in maternal
rabbits

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no
observed adverse effect level, LOAEL = lowest observed adverse effect
level, RfD = reference dose, MOE = margin of exposure, LOC = Level of
concern, NA = Not Applicable.

a  Formulated-based dermal endpoint = (20 mg a.i./kg guinea pig x 0.43
kg guinea pig x 1000 ug/mg) / 25.8cm2  area of guinea pig dosed = 333
µg ai/cm2 .

b  TGAI-based dermal endpoint = (20 mg ai/kg rat x 0.2 kg rat x 1000
ug/mg) / 50cm2  area of rat dosed = 80 µg ai/cm2  .

c  SEQ CHAPTER \h \r 1 aAn additional uncertainty factor of 10x is
applied for use of an oral endpoint for route-to-route extrapolation to
determine if a confirmatory inhalation toxicity study is warranted.

2. Endocrine Disruption

	  SEQ CHAPTER \h \r 1 EPA is required under the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) “may
have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.”  Following recommendations of its
Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA
determined that there was a scientific basis for including, as part of
the program, the androgen and thyroid hormone systems, in addition to
the estrogen hormone system.  EPA also adopted EDSTAC’s recommendation
that the Program include evaluations of potential effects in wildlife. 
For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an
effect in humans, FFDCA authority to require the wildlife evaluations. 
As the science develops and resources allow, screening of additional
hormone systems may be added to the Endocrine Disruptor Screening
Program (EDSP).

		3. Dietary Assessment

	In the absence of data for residues of ADBAC on treated food contact
surfaces, the Agency estimated residue levels that may occur in food
from the application rates on food contact surfaces.  In addition, the
food processing and dairy equipment uses of ADBAC have also been
addressed. 

Utensils

To calculate the Estimated Daily Intake (EDI) for dietary exposures
resulting from sanitizing utensils, a number of assumptions were made
based on the FDA guidelines (FDA, 2003).  

When a surface is treated with a disinfectant, a quantity of the
disinfectant remains on the surface (Residual Solution).  The FDA
recommended worst-case concentration for this quantity is 1 mg of
solution per square centimeter of treated surface area.  In the absence
of any other data, this value has been used.

The FDA suggests that, as a worst-case scenario, all food that an
individual consumes will come into contact with 4,000 cm2 of sanitized
non-porous food-contact surfaces.  This contact area represents all the
surface area from silverware, china, and glass used by a person who
regularly eats three meals per day at an institutional or public
facility.   

The value for the amount of active material present on food contact
surfaces that is expected to migrate to is based on the standard
assumption of 100%.  This is a conservative estimate assumes that 100%
of the residues available on the surface will be transferred to the food
and subsequently ingested.

The body weights used for this assessment are: adult man = 70 kg; adult
woman = 60 kg, and an infant = 10 kg (USEPA, 1997).  

The above assumptions and the following equations were used to calculate
EDI and Dietary Daily Dose (DDD):

EDI (mg/p/day) = AR x RS x SA x F x 10-6	 			(1)

DDD (mg/kg/day) = EDI/BW 						(2)



Table 2:  Input Parameters for Utensil Sanitization

Parameter	Value	Rationale

Residual Solution on Surface (RS)	1 mg/cm2	FDA worst-case assumption

Area of Treated Surface (SA)	4,000 cm2	100% FDA worst case assumption

ADBAC concentration in diluted Solution (AR)	400 ppm	Diluted Solution
concentration, based on maximum concentration in Stearamine 1-G Tablets.

Fraction Transferred(F)	100%	Standard Assumption

Body Weight (kg) (BW)

Adult man =

Adult woman =

Child =	70

60

10	EPA, 1997



The calculated dietary risks resulting from utensil contact are provided
below.  These risks are not of concern since the % PAD values are less
than 100%.

Table 3:  Calculated EDIs and PADs for Chronic Indirect Dietary
Exposures from Utensils

Population	Utensils

	EDI (mg/p/d)a	DDD (mg/kg/d)b	% PADc

Adult males	1.60	0.023	5.2

Adult females

0.027	6.1

Children

0.16	36.4

a.	EDI (mg/p/day) = AR x RS x SA x F x 10-6

b.	DDD (mg/kg/day) = EDI (mg/p/day) / BW (kg)

c.	% PAD = exposure (DDD) /(cPAD, both 0.44 mg/kg/day) x 100. 

3.2. 	Countertops

To calculate the Estimated Daily Intake (EDI) from treated countertops,
the Indirect Dietary Residue Exposure Model (IDREAM) (Exponent 2006)
along with the new residue data that has been submitted by QRG and CSPA
were utilized.  There are currently two levels of refinement for
assessing dietary exposure to antimicrobial pesticide products on
countertops and for purposes of this assessment; a Tier 2 approach was
used.  

A Tier 1 assessment is a two-dimensional approach using default
assumptions based on AD’s current standard operating procedures (SOP),
which are considered to be conservative.  These assessments assume 1
mg/cm2 of product residue on countertops and that 100% of the residues
are transferred from the 2000 cm2 of countertop into the food consumed
by each individual daily.  A Tier 1 estimate would be made as follows:

1 mg/ cm2 × 1000 ppm active concentration = 0.001 mg a.i./ cm2

0.001 mg a.i./ cm2  × (2000) × 100% ÷ (15 or 60 or 70 kg bw) =
exposure in mg/kg/d

A Tier 2 assessment is a three-dimensional approach which is still
conservative, yet provides a refined exposure estimate compared to that
from a Tier 1.  For Tier 2 assessment, potential residues are estimated
in foods that are prepared on treated countertops.  Tier 2 uses food
consumption and preparation patterns as well as data and assumptions
that are not chemical specific.  Foods ingredients are separated into
nine categories based on food preparation, food physical properties, and
the potential, or likelihood of contact with treated countertops.  The
nine categories are liquids, fruit, bread, cheese, vegetable, meat,
purees (e.g., pudding, oatmeal), pieces (foods normally consumed in
small pieces), and powders (foods normally used in powder/granular
forms).  Assumed countertop residues are converted to estimated residues
contacting the countertops using a translation factor for each food
category, and default residue transfer efficiency for a representative
food.  Therefore, IDREAM™ combines estimated countertop residues for
surface treatment products, CSFII consumption data, food-specific
conversion factors that relate the surface area contacting a countertop
to the corresponding weight of the food item, and the transfer
efficiency of residues from countertops to food.  Conservative
assumptions for these analyses include: all disinfectants registered
uses to clean kitchen countertops and subsequently prepare foods on
those countertops; all foods prepared contact the treated countertop
with maximum active ingredient residues and that residues do not
diminish over time; there is a 100% likelihood of contact to account for
both commercial and residential scenarios; all commercial and households
use the same disinfectant product; all foods are prepared and consumed;
all foods are prepared on the countertops, and no reduction of residues
in food result from cooking or other preparation processes.  Tier 2
estimates are calculated as follows:

Ingestion (mg/kg/d) = CSR (mg/ cm2) × [CSA (cm2) ÷ FW (g)] × LC (%)
× RT (%)× ConR (g/kg bw/d)

Where:  

	CSR:	Countertop surface residue (mg/ cm2)

	CSA:  	Contact Surface area from CSFII (cm2)

	FW:  	Weight of a piece/serving of food from CSFII (g)

	LC:  	Likelihood of contact (%)

	RTE:  	Residue transfer efficiency (%)

IDREAM™ such to incorporate the new data that has been generated and
submitted by QRG and CSPA.  The residue values provided by these
constituents were generated by collecting data on the residual levels of
ADBAC found on three food types: apple, bread, and bologna.  The value
for the amount of active material present on food contact surfaces that
is expected to migrate to is based on the information that is provided
in MRID #468707-03. Study to Demonstrate Transferability Equivalence
Among Quats and Measure Food Surrogate Transfer Efficiency.  Three food
types were sampled n this study; bologna, apple, and bread, with bologna
yielding the highest average percent transfer rate.  The residue data
from QRG and CSPA are reported in Table 4.

The detailed IDREAM output tables are provided in Appendix A.  All of
the calculated indirect dietary exposures are not of a concern. 

Table 4. Food categories and QRG data utilized with IDREAM parameters

Food Category as Identified in IDREAM™	QRGa food equivalence	Residue
Transfer Efficiency



(%)

Liquid	NA	100

Fruit	Apple	39

Bread	Bread	0.86

Cheese	Bologna	47

Vegetable	Apple	39

Meat	Bologna	47

Purees	Apple	39

Pieces	Bread	0.86

Powders	Bread	0.86



Table 5:  Calculated DDDs and PADs for Chronic Indirect Dietary
Exposures 

Exposure Group	Countertops

	DDD (mg/kg/d)	% cPADa

Adult males (13+)	0.00059	0.13

Adult females (13-49)	0.00055	0.12

Children (1-2)	0.0019	0.43

a.	DDD (mg/kg/day) was provided from the IDREAM model

b.	% PAD = exposure (DDD) /(cPAD, 0.44 mg/kg/day) x 100. 

	3.3.	Food Processing/Dairy Equipment  

ADBAC may also be used as a sanitizer or disinfectant in for food
processing equipment as well as dairy equipment.  The sanitization of
food processing and dairy equipment permits product contact with the
interior of equipment.  FDA utilizes the milk truck model (described in
the FDA document, “Sanitizing Solutions: Chemistry Guidelines for Food
Additive Petitions”, pages 9-10) (FDA 2003) for these types of uses
and this was performed in order to estimate residues that could transfer
from treated surfaces to food such as milk.  The risks calculated for
these uses are not of a concern.

This guidance states on page 9, “For applications limited to use of
the food sanitizer on food processing equipment and utensils, the Agency
has determined that estimates of sanitary exposure from use in dairy
processing plants significantly exceed estimates based on other uses
with food processing equipment and utensils.  Depending on the available
safety data, the petitioner may either submit a petition for the broader
use of its sanitizer on ‘food processing equipment and utensils
including dairy processing plants’ or for the more limited use on
‘food processing equipment and utensils excepting use in dairy
processing plants.’”

Although in practice, consideration of all of the components of a milk
handling system should be included as sources of sanitizer residue in
milk, for purposes of this assessment, the Agency assumes the sanitized
tank truck which transports the milk is the primary source of residue. 
It is conservatively assumed that the milk undergoes no additional
dilution prior to reaching the consumer.   The calculation of the
estimated daily intake (EDI) of residual sanitizer solution in milk from
use in a dairy processing plant utilized the following equation and
assumptions:

EDI = SA x CT x R x AR x CF1 x CF2 x CF3

EDI:	Estimated Daily Intake (µg /L milk)

SA:	Internal surface area of 413 ft2 is calculated for the tank (413
ft2/truck).

CT:	Assuming a cylindrical model for the tank truck, it is assumed to
have a 4,000 gal capacity (1 truck/4,000 gallons).

R:		When a surface is treated with a disinfectant, a quantity of the
disinfectant remains on the surface.  The FDA recommended worst-case
concentration for this quantity is 1 mg of solution per square
centimeter of treated surface area.  In the absence of data, this value
has been used.

AR:	Application rate based on label direction to use an undiluted
product, which contains 0.005% silver (or 50 ppm)

CF1:	Conversion factor (929 cm2/1 ft2)

CF2:	Conversion factor (0.264 gal/1L)

CF3:	Conversion factor (1000ug = 1mg)

Table 3.   Estimated Dietary Consumption of Adults and Children from the
use of ADBAC in Dairy Processing Plants

Exposure Scenario	

Application Rate (% a.i.)

	Estimated Daily Intake

(µg /L milk) a	Adult dietary consumption (µg/day)b	Child dietary
consumption (µg/day)c	Total Dietary Dose (mg/kg/day)d	c% PAD
(mg/kg/day)e

Food processing equipment	0.004	1.13 	0.15	0.38	Male: 2.1 x 10-6	4.8 x
10-4





	Female: 2.5 x 10-6	5.7 x 10-4





	Child: 3.8 x 10-5	9.0 x 10-3



a  Estimated Daily Intake (ug/L milk) = 413ft2/ truck x 1truck/4000gal x
1mg/cm2 x (0.004%) x 929cm2/ft2 x 0.264gal/1L x  1,000µg/1mg = 1.13µg
/L milk ~ 1.13 ppb.

b  If an adult (male or female) were to consume 125g of food per day,
assumed to be containing 1.13 µg/L of ADBAC, utilizing the following
equation: 125g/day x kg/1000g x 1.13µg/L x L/0.96kg, then the person
would ingest 0.15µg of ADBAC per day.

c  If an child were to consume 320g of food per day, assumed to be
containing 1.13µg/L of ADBAC, utilizing the following equation:
320g/day x kg/1000g x 1.13µg/L x L/0.96kg, then the child would ingest
0.38µg of ADBAC per day. 

d  Dietary exposure (mg/kg/day) = Dietary Consumption (mg/day) / Body
weight (Where male body weight is 70 kg, female is 60 kg and children is
10 kg and a conversion factor of 1,000ug = 1mg is applied).

e  % PAD (population adjusted dose) = exposure (total dietary dose)/
PAD) x 100.  The PAD is assumed to be equivalent to the chronic dietary
RfD value of 0.44mg/kg/day.  

Combined Dietary Exposures and Risks

Combined exposures were calculated for the use of ADBAC in food handling
establishments, and risks were not of concern.  ADBAC treatments of food
processing equipment and dairy equipment are considered to be negligible
and were not included in the combined dietary assessment.  Therefore,
the combined dietary assessment includes utensils and countertop dietary
exposures only.  The combined dietary exposures from indirect food
exposure are not of concern.

Table 9:  Cumulative DDDs and PADs for Chronic Indirect Dietary
Exposures

Exposure Group	Countertops and Utensils

	DDD (mg/kg/d)	% cPADa

Adult males (13+)	0.024	5.4

Adult females (13-69)	0.028	6.4

Children (1-2)	0.16	36.4

a.	Aggregate DDD = Utensil DDD + Countertop DDD

b.	% PAD = exposure (DDD) /(cPAD, 0.44 mg/kg/day) x 100. 

3.5. 	Drinking Water Assessment  tc "5.4	Drinking Water Exposures and
Risks " \l 2 

	A drinking water assessment is not warranted based on the uses proposed
on this label.  The indoor hard surface applications are anticipated to
result in minimal, if any, runoff of silver into the groundwater. 
However, ADBAC is also used as an outdoor pesticide on nursery
ornamentals, turf, and for mosquito control in ponds and puddles and as
an algaecide in decorative pools.  Therefore, for the purposes of this
assessment, the labeled turf and nursery uses for ADBAC were included in
the aggregate dietary assessment.  Details of these assessments may be
found in the ADBAC RED (see Public Docket under EPA-HQ-OPP-2006-0339).

	An acute oral toxicological endpoint was not established for ADBAC. 
Therefore, only the chronic drinking water exposure was calculated.  The
adult chronic drinking water dose is 0.009 mg/kg/day (i.e., average EDWC
331 ug/L x 2 L/day consumption x 1/70 kg BW).  The children chronic
drinking water dose is 0.022 mg/kg/day (i.e., average EDWC 331 ug/L x 1
L/day consumption x 1/15 kg BW). There are no drinking water concerns
with ADBAC as the concentrations are much lower than the level of
concern.

Table 10. Tier I Estimated Drinking Water Concentrations (EDWCs) Based
on Aerial Application of ADBAC on Nursery Ornamentals

Drinking Water Source (Model)	Use rate (lbs ai/A/year)	EDWC (ppb)

Surface water (FIRST)

Acute (peak)

Chronic (annual average)	906	

13,129

331

Groundwater (SCIGROW)	906	5.4



4. Residential Exposure/Risk Pathway

	There are no residential uses associated with this petition; however,
since the request is also for an increase in the tolerance exemption,
certain residential uses were assessed.  The exposure scenarios assessed
in this document for the representative antimicrobial uses selected by
the Agency to represent the residential risks include:

Indoor hard surfaces (e.g., mopping, wiping, trigger pump sprays).

Exposure Data and Assumptions

	The residential handler scenarios were assessed to determine dermal and
inhalation exposures.  Surrogate dermal and inhalation 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).  Specific surrogate data used in
determining the dermal and inhalation exposures are reported below:

    

For the mopping and wiping, the CMA data were used; and

For trigger pump scenarios the PHED data were used.

The quantities handled/treated for the handler scenarios were estimated
based on information from various sources, including Antimicrobial
Division 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.

As with the antimicrobial use, homeowners are assumed to complete
elements of an application (mix/load/apply) without the use of personal
protective equipment. 

	Post-application scenarios have been developed that encompass multiple
products, but still represent a high end exposure scenario for all
products represented.  Representative post-application scenarios
assessed include crawling on treated hard surfaces.  Data sources and
methodologies include the HED Residential SOPs (USEPA 2000, 2001), Human
and Environmental Risk Assessment (HERA) Guidance Document (2003 and
2005), Pesticide Handlers Exposure Database (PHED), and Outdoor
Residential Exposure Task Force (ORETF) studies.

Since no toxicological endpoint of concern was identified for dermal
systemic adverse effects, both the handler and the post-application
dermal risks were assessed using the short-term toxicological endpoint
for dermal irritation.  The duration of exposure for most homeowner
handler 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.  

		4.1. 	Risk Characterization of Antimicrobial Uses

	A summary of the residential handler inhalation risks are presented in
Table 11.  Although the inhalation endpoint represents short,
intermediate, and long-term durations, the exposure duration of most
homeowner applications of cleaning products is believed to be best
represented by the short-term duration.  The inhalation toxicological
endpoint is based on an oral study because a route-specific inhalation
study is not available.  The calculated inhalation MOEs are above the
target MOE of 100.  The dermal MOEs are presented in Table 12.  The
dermal MOEs are above the target MOE of 10.

Table 11. Short-term Residential Handler Inhalation Exposures and MOEs

Exposure Scenario

Application Method	Application Method	Application Ratea	Quantity
Handled/

Treated per dayb	Unit Exposure 

(mg/lb ai)c	MOE d 

(Target MOE = 100)

Application to indoor hard surfaces	Mopping	0.0033 lb ai/gal	1 gallon
2.38	23,000

	Wiping	0.0033 lb ai/gal	0.13 gallon	67.3	6,200

	Trigger Spray	0.0033 lb ai/gal	0.13 gallon	2.4	170,000

a	Application rates used for mopping, wiping, and trigger spray are the
equal to the proposed application rate of 400 ppm of ADBAC.  

b	Amount handled per day values are AD standards.

c	Unit Exposure (mg/lb ai) = Unit Exposure from PHED or CMA (mg/lb ai).

d	MOE = NOAEL / Absorbed Daily Dose.  [Where short-term NOAEL = 3
mg/kg/day for inhalation]. Target MOE = 100.

Table 12.  ADBAC Short-term Residential Handler Dermal Risks

Exposure Scenario	Application Method	Application Ratea 	Quantity
Handled/ Treated per dayb	Hand Unit Exposure Adjusted for Surface Area

(mg/lb ai/cm2)c	

Dermal Skin Irritation Exposure d

(µg/cm2)	MOE e

(Target MOE = 10)

Application to indoor hard surfaces	Mopping	0.0033 lb ai/gal	1 gallon
0.063	0.208	1,600

	Wiping	0.0033 lb ai/gal	0.13 gallon	1.341	0.575	580

	Trigger Spray	0.0033 lb ai/gal	0.13 gallon	0.129	0.055	6,100

a	Application rates used for mopping, wiping, and trigger spray are the
equal to the proposed application rate of 400 ppm of ADBAC.  For all
other methods, application rates are the maximum application rates
determined from EPA registered labels for ADBAC.

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

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

μg/mg

e 	MOE = NOAEL (µg /cm2)/ Surface Residue on Skin (µg/cm2).  [Where
short-term dermal formulated-based NOAEL = 333 µg/cm2]. Target MOE =
10.

	

	A summary of the residential post application risks are presented in
Table 13.  Although the inhalation endpoint represents short,
intermediate, and long-term durations, the exposure duration of most
homeowner applications of cleaning products is believed to be best
represented by the short-term duration.  The inhalation toxicological
endpoint is based on an oral study because a route-specific inhalation
study is not available.  The calculated dermal and incidental oral MOEs
are above the target MOE of 10 and 100, respectively. The inhalation
MOEs are above the target MOE of 100 for both scenarios.

Table 13.  Short-term Residential Post Application Risks for Children.

Exposure Scenario	Dermal MOE	Incidental Ingestion MOE	Inhalation MOE

Child playing on floora	1,100	610	NA

Child playing on carpeta	1,200	330	NA

NA = not assessed because negligible exposure is assumed by that route
for the exposure for the scenario of concern.

a.	These exposures are not resulting from the proposed use associated
with this petition; however, are included in the aggregate.  For details
on the assessment for uses resulting in these exposures, please refer to
the ADBAC RED. 

		 tc \l2 "4.4	Residential Exposure/Risk Pathway 5. Aggregate Assessment

	In order for a pesticide registration to continue, it must be shown
that the use does not result in “unreasonable adverse effects on the
environment”. Section 2 (bb) of FIFRA defines this term to include
“a human dietary risk from residues that result from a use of a
pesticide in or on any food inconsistent with standard under section
408...” of FFDCA.  Consequently, even though no pesticide tolerances
have been established for ADBAC, the standards of FQPA must still be
met, including “that there is reasonable certainty that no harm will
result from aggregate exposure to pesticide chemical residue, including
all anticipated dietary exposures and other exposures for which there
are reliable information.”   Aggregate exposure is the total exposure
to a single chemical (or its residues) that may occur from dietary
(i.e., food and drinking water), residential, and other non-occupational
sources, and from all known or plausible exposure routes (oral, dermal,
and inhalation).  Aggregate risk assessment were conducted for
short-term (1-30 days), intermediate-term (1-6 months) and chronic
(several months to lifetime) exposures.  An acute endpoint was not
identified for ADBAC, and therefore, an acute aggregate dietary
assessment was not necessary.

	In performing aggregate exposure and risk assessments, the Office of
Pesticide Programs has published guidance outlining the necessary steps
to perform such assessments (General Principles for Performing Aggregate
Exposure and Risk Assessments, November 28, 2001; available at
http://www.epa.gov/pesticides/trac/science/aggregate.pdf).  Steps for
deciding whether to perform aggregate exposure and risk assessments are
listed, which include: identification of toxicological endpoints for
each exposure route and duration; identification of potential exposures
for each pathway (food, water, and/or residential);  reconciliation of
durations and pathways of exposure with durations and pathways of health
effects; determination of which possible residential exposure scenarios
are likely to occur together within a given time frame; determination of
magnitude and duration of exposure for all exposure combinations;
determination of the appropriate technique (deterministic or
probabilistic) for exposure assessment; and determination of the
appropriate risk metric to estimate aggregate risk.

5.1. Acute and Chronic Aggregate Dietary Risks tc "6.1	Acute and
Chronic Aggregate Risks " \l 2 

	An acute toxicological endpoint was not identified for ADBAC. 
Therefore, an acute aggregate risk assessment was not conducted.  The
chronic aggregate risk assessment includes dietary and drinking water
exposures.  Chronic dietary risk estimates from indirect food uses are
presented in Section 3.3.  Drinking water exposure estimates are
presented in Section 3.5.  Table 14 presents a summary of these
exposures, including the combined dietary exposures (i.e., all indirect
food contact exposures), as well as a total dietary aggregate exposure
estimate (i.e., drinking water plus indirect dietary exposures).  Based
on the results of the chronic aggregate assessment, the %cPAD for adults
and children are 5.0% and 22.0%, respectively.  Therefore, the chronic
dietary risks are not of concern (i.e., less then 100 % of cPAD).

Table 14.  ADBAC Chronic Aggregate Exposures and Risks (cPAD)

Exposure Routes	Chronic Dietary Exposures (mg/kg/day)

	Countertop Dietary  Exposuresa	Utensil Dietary Exposuresa	Drinking
Water Exposures 	Aggregate Dietary Exposuresb	% cPADc

(MOE)c

Adultsd

Oral Ingestion	0.00059	0.027	0.009	0.037	8.4

(1,200)

Childrene

Oral Ingestion	0.0019	0.16	0.022	0.18	40.9

(240)

a 	Dietary (countertops and utensil food contact) exposures are
presented in Tables 3 and 5.

b 	Aggregate Dietary Exposures = indirect dietary + drinking water
exposures.

c 		%cPAD (percent chronic population adjusted dose) = (aggregate
exposures / cPAD) x 100.  Where cPAD = NOAEL 44 mg/kg/day ÷ 100x
uncertainty factor = 0.44 mg/kg/day.  MOE = NOAEL of 44 mg/kg/day ÷
aggregate dietary exposures mg/kg/day.

d 	Adult population used is the highest exposed adult population, adult
females 13-69 years of age.

e 	Children population used is the highest exposed children population,
children 1-2 years of age. 

 		5.2. Short and Intermediate-term Aggregate Exposures and Risks  tc
"6.2	Short- and Intermediate-Term Aggregate Exposures and Risks " \l 2 

	Short and intermediate-term aggregate exposures and risks were assessed
for adults and children that could be exposed to ADBAC residues from the
use of products in non-occupational environments.  The short and
intermediate-term aggregate risks account for pesticide exposures from
the diet, drinking water, and residential uses.  The following list
summarizes all of the potential sources of ADBAC exposures for adults
and children related to the label and increased tolerance exemption
considered for this petition.

Adult ADBAC exposure sources:

handling of cleaning products containing ADBAC as an a.i. during wiping,
mopping, and spraying activities;

and, eating food having ADBAC residues from indirect food contact.

	

Child ADBAC exposure sources:

post-application exposures to cleaning product residues containing ADBAC
that are used on hard surfaces (e.g, floors);

and, eating food having ADBAC residues from indirect food contact. 

	The use patterns of the products and probability of co-occurrence must
be considered when selecting scenarios for incorporation in the
aggregate assessment.  Table 15 summarizes the scenarios from this
petition included in the short and intermediate-term aggregate
assessments.

	Short-term (ST) Aggregate

Adults	chronic dietary (indirect)

handling cleaning products (wipe + trigger pump spray) 

Children	chronic dietary – (indirect)

post-application to cleaning product on carpets (dermal and oral) from
the ADBAC RED



The chronic dietary exposures were used in both the short and
intermediate-term aggregate assessment because chronic dietary exposures
occur nearly every day (as opposed to acute dietary exposures occurring
on a one-time basis).  Therefore, short or intermediate-term non-dietary
exposures have a high probability to co-occur with the chronic dietary
intake.  

	

	Since the ADBAC toxicity endpoints for the oral, dermal, and inhalation
routes of exposure are based on different toxic effects, these three
routes of exposure are not aggregated together.  Instead, the aggregate
assessment is based solely on the co-occurrence of the same route of
exposures.  Aggregate risks were calculated using the total MOE approach
outlined in OPP guidance for aggregate risk assessment (August 1, 1999,
Updated “Interim Guidance for Incorporating Drinking Water Exposure
into Aggregate Risk Assessments”).  The aggregate MOE for adults is
2,000 for oral, 480 for dermal with a target MOE of 10, and 2,000 for
inhalation with a target MOE of 100.  These aggregate MOEs demonstrate
risks that are not of concern for adults.  For children, the aggregate
risk estimate for each of the routes of exposure are above the target
MOE of 100 for oral and inhalation, and a target MOE of 10 for dermal
(MOE=454 for the oral route, 1,200 for the dermal route, and no
co-occurrence for the inhalation route); and thus, are not of concern.



Table 16.  Short and Intermediate-term Aggregate Risk (MOE) Assessment

Exposure Routes	Chronic Dietary 

MOE	Cleaning Product MOEs(Adult Applicators & Children Playing)
Route-Specific Aggregate MOE

Adults

Oral Ingestion	1,200	NA	1,200

Dermal 

	NA	1,600 (mop)	580 (wipe)	6,100 (spray)	480

Inhalation	NA	27,000

(mop)	7,300 (wipe)	200,000 (spray)	2,000

Children

Oral Ingestion	240	 330	140

Dermal

(ST only)	NA	1,200	1,200

Inhalation	NA	NA	NA

Aggregate MOE = 1/((1/MOEsame route) + (1/MOE same route) + etc)

6. Cumulative Exposure and Risk

		Another standard of section 408 of the FFDCA which must be considered
in making an unreasonable adverse effect determination is that the
Agency considers "available information” concerning the cumulative
effects of a particular pesticide's residues and "other substances that
have a common mechanism of toxicity.” 

		Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a
common mechanism of toxicity finding as to ADBAC and any other
substances and ADBAC does not appear to produce a toxic metabolite
produced by other substances.  For the purposes of this tolerance
action, therefore, EPA has not assumed that ADBAC has a common mechanism
of toxicity with other substances.  For information regarding EPA’s
efforts to determine which chemicals have a common mechanism of toxicity
and to evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA’s Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA’s website at  
HYPERLINK "http://www.epa.gov/pesticides/cumulative/" 
http://www.epa.gov/pesticides/cumulative/ .

7. Occupational Exposure Assessment tc \l1 "6.0	OCCUPATIONAL EXPOSURE
AND RISK 

	Potential occupational handler exposure can occur in food handling
premises, dairy processing premises, and in food processing premises.  

7.1. Occupational Handler Exposures

ADBAC 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 those exposed to end-use
products containing concentrations of ADBAC 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 ADBAC 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 exposures and risks were presented based on the oral
toxicity endpoint (i.e., route-specific inhalation study not available).
 The surrogate 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).   The specific inhalation unit exposures and
quantity of ADBAC handled are provided in the Occupational and
Residential Exposure chapter for ADBAC.

	

The inhalation MOEs were calculated for the short and intermediate-term
durations for occupational handlers using the oral endpoint. 

 Risk Characterization for Antimicroibal Uses

	The resulting inhalation exposures and MOEs for the representative
occupational handler scenarios are presented in Table 17. The calculated
MOEs were above the target MOE of 100 for all scenarios, except those
listed below. 

Table 17. 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 a	Quantity Handled/ Treated per day
Inhalation  Daily Dose (mg/kg/day) b	Inhalation 

MOEc,d 

(Target MOE = 100)



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

Application to indoor hard surfaces (including dishes, utensils,
equipment)	Low pressure hand wand	0.681	0.0033 lb ai/gal	2 gallons
0.00007	40,000

	Mop	2.38	0.0033 lb ai/gal	2 gallons	0.0003	11,000

	Wipe	67.3	0.0033 lb ai/gal	0.26 gallons	0.0010	3,100

	Trigger pump sprayer	1.3	0.0033 lb ai/gal	0.26 gallons	0.00002	160,000

	Immersion, Flooding, Circulation	1.89	0.0033 lb ai/gal	2 gallons	0.0002
14,000

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

a	Application rate used is the proposed application rate of 400 ppm of
ADBAC.  

b	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).

	c	MOE = NOAEL  (mg/kg/day) / Absorbed Daily Dose [Where NOAEL = 3
mg/kg/day for all inhalation exposure durations].  Target MOE = 100.

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

7.2. Occupational Post-application Exposures

	The occupational post-application dermal and inhalation exposures are
assumed to be negligible for the use sites listed under 40 CFR §
180.940 (a).  The use sites covered under 40 CFR § 180.940 (a) are: 
food-contact surfaces in public eating places, dairy processing
equipment, and food-processing equipment and utensils.

8.  Conclusions

	

In conclusion, the above represents RASSB’s evaluation of the proposed
petition for the increased application rate and tolerance exemption from
200 ppm to 400 ppm for ADBAC.  There appear to be no dietary,
residential, or occupational risks of concern resulting from an increase
in the tolerance exemption or from an increase in the end use solution
concentration permitted for the quaternary sanitizer, ADBAC, to
food-contact surfaces in public eating places, dairy processing
equipment, and food-processing equipment and utensils.  

	If there are questions on the above, please contact RASSB.

Appendix A

IDREAM Inputs and Results:

IDREAM Tier 2 - Incidental Ingestion Exposure





Subject active ingredient	400 ppm ADBAC





	Product residue	1	mg/cm²

In-use active conc (%)	0.040%

	Active surface residue	0.0004	mg/cm²









CHRONIC ASSESSMENT







Subpopulation	Tier 2 Chronic Exposure (mg/kg/d)	%cPAD

Children 1-2	0.00189	0.429

Children 3-5	0.00150	0.341

Adults 13+	0.00059	0.134

Females 13-49	0.00055	0.125



TIER 2 MODEL - Children aged 1-2

Active ingredient:	400 ppm ADBAC

	modified to match the first section of the children 1-2 years old and
includes the quat residue data for the % residue transfer, as well as
100% likelihood

CHRONIC EXPOSURE ASSESSMENT







Food Category	Contact Surface Area	Weight of Serving/ Piece	Likelihood
of Contact	Residue Transfer Efficiency	Residue Translation Factor	Quat
Surface Residue	Residue in Food	Mean Food Consumption Rate	Ingestion
Exposure

	(cm²)	(g)	(%)	(%)	(cm²/g)	(mg/cm²)	(mg/g)	(g/kg bw)	(mg/kg/d)

Liquid	250	240	0%	100%	0	0.0004	0	70.80	0

Solid	 	 

 	 	 	 	 	 

Fruit	28	97	100%	39%	0.11	0.0004	0.000045	6.30	0.00028

Bread	94	56	100%	0.86%	0.01	0.0004	0.000006	8.77	0.00005

Cheese	65	49	100%	47%	0.62	0.0004	0.000249	1.05	0.00026

Vegetable	34	99	100%	39%	0.13	0.0004	0.000054	6.39	0.00034

Meat	103	138	100%	47%	0.35	0.0004	0.000140	5.11	0.00072

Purees	46	107	100%	39%	0.17	0.0004	0.000067	3.17	0.00021

Pieces	0.8	1.2	100%	0.86%	0.01	0.0004	0.000002	1.27	0.00000

Powders	123	30	100%	0.86%	0.04	0.0004	0.000014	1.32	0.00002

 	 	 

	 	Total Ingestion Exposure:	0.00189





TIER 2 MODEL - Children aged 3-5

Active ingredient:	400 ppm ADBAC

	modified to match the first section of the children 3-5 years old and
includes the quat residue data for the % residue transfer, as well as
100% likelihood

CHRONIC EXPOSURE ASSESSMENT







Food Category	Contact Surface Area	Weight of Serving/ Piece	Likelihood
of Contact	Residue Transfer Efficiency	Residue Translation Factor	Quat
Surface Residue	Residue in Food	Mean Food Consumption Rate	Ingestion
Exposure

	(cm²)	(g)	(%)	(%)	(cm²/g)	(mg/cm²)	(mg/g)	(g/kg bw)	(mg/kg/d)

Liquid	250	240	0%	100%	0	0.0004	 	50.07	0

Solid	 	 	 	 	 	 	 	 	 

Fruit	28	97	100%	39%	0.113	0.0004	0.000045	3.59	0.00016

Bread	94	56	100%	0.86%	0.014	0.0004	0.000006	4.17	0.00002

Cheese	65	49	100%	47%	0.623	0.0004	0.000249	0.89	0.00022

Vegetable	34	99	100%	39%	0.134	0.0004	0.000054	2.80	0.00015

Meat	103	138	100%	47%	0.351	0.0004	0.000140	4.88	0.00068

Purees	46	107	100%	39%	0.168	0.0004	0.000067	3.19	0.00021

Pieces	0.8	1.2	100%	0.86%	0.006	0.0004	0.000002	9.22	0.00002

Powders	123	30	100%	0.86%	0.035	0.0004	0.000014	1.65	0.00002

 	 	 	 	 	 	Total Ingestion Exposure:	0.00150



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 	 	 	 	 	 	Total Ingestion Exposure:	0.00059





TIER 2 MODEL – Females aged 13-49

Active ingredient:	400 ppm ADBAC

	modified to match the first section of the females 13-49 years old and
includes the quat residue data for the % residue transfer, as well as
100% likelihood

CHRONIC EXPOSURE ASSESSMENT







Food Category	Contact Surface Area	Weight of Serving/ Piece	Likelihood
of Contact	Residue Transfer Efficiency	Residue Translation Factor	Quat
Surface Residue	Residue in Food	Mean Food Consumption Rate	Ingestion
Exposure

	(cm²)	(g)	(%)	(%)	(cm²/g)	(mg/cm²)	(mg/g)	(g/kg bw)	(mg/kg/d)

Liquid	250	240	0%	100%	0	0.0004	0	19.94	0

Solid	 	 	 	 	 	 	 	 	 

Fruit	28	97	100%	39%	0.113	0.0004	0.000045	0.89	0.00004

Bread	94	56	100%	0.86%	0.014	0.0004	0.000006	1.30	0.00001

Cheese	65	49	100%	47%	0.623	0.0004	0.000249	0.30	0.00007

Vegetable	34	99	100%	39%	0.134	0.0004	0.000054	1.72	0.00009

Meat	103	138	100%	47%	0.351	0.0004	0.000140	1.87	0.00026

Purees	46	107	100%	39%	0.168	0.0004	0.000067	0.84	0.00006

Pieces	0.8	1.2	100%	0.86%	0.006	0.0004	0.000002	2.78	0.00001

Powders	123	30	100%	0.86%	0.035	0.0004	0.000014	0.64	0.00001

 	 	 	 	 	 	Total Ingestion Exposure:	0.00055



  Note:  for a full discussion of toxicology, exposure, etc. the reader
should consult with the RED science chapters available in the Public
Docket for ADBAC under EPA-HQ-OPP-2006-0339.

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