![](media/image1.png){width="0.78125in" height="0.78125in"}

**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460**

**OFFICE OF PREVENTION, PESTICIDES**

**AND TOXIC SUBSTANCES**

**February 20, 2008**

**[MEMORANDUM]{.underline}**

**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 (C~12-14~) 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]{.underline}**

**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 (C~12-16~)
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:]{.mark}

+-----------------------+-----------------------+-----------------------+
| **[Pesticide          | **[CAS Reg.           | **[                   |
| Ch                    | No.]{.underline}**    | Limits]{.underline}** |
| emical]{.underline}** |                       |                       |
+-----------------------+-----------------------+-----------------------+
| Quaternary Ammonium   | 1225-02-9 in 21 CFR   | When ready for use,   |
| Compounds n-alkyl     |                       | the end-use           |
| (C~14-16~)            | and                   | concentration of the  |
| benzyldimethyl        |                       | n-alkyl               |
| ammonium chloride,    | 8001-54-5 in 40 CFR   | benzyldimethyl        |
| average molecular     |                       | ammonium chloride is  |
| weight (in amu)       |                       | not to exceed 400 ppm |
| 351-380               |                       | 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 (C~14~, 95%; C~12~, 3%; C~16~, 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:

"Steramine™ 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]{.underline}**[^1]

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.

[]{.mark}

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:]{.underline} No risks of concern resulting from an increase in
potential residues in food-contact settings.

[]{.mark}

[Drinking Water:]{.underline} 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.

[]{.mark}

[Residential:]{.underline} No risks of concern resulting from an
increase in potential residues in food-contact settings.

[]{.mark}

[Aggregate:]{.underline} No risks of concern resulting from an increase
in potential residues in food-contact settings.

[]{.mark}

[Occupational:]{.underline} 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 |          |                     |                       |
| Tox        |          |                     |                       |
| icological |          |                     |                       |
| Endpoints  |          |                     |                       |
| for        |          |                     |                       |
| ADBAC**    |          |                     |                       |
+============+==========+=====================+=======================+
| Exposure   | Dose     | Target MOE or UF,   | Study and             |
|            | Used in  |                     | Toxicological Effects |
| Scenario   | Risk     | Special FQPA SF     |                       |
|            | As       |                     |                       |
|            | sessment | for Risk Assessment |                       |
|            |          |                     |                       |
|            | (mg      |                     |                       |
|            | /kg/day) |                     |                       |
+------------+----------+---------------------+-----------------------+
| Acute      | An acute |                     |                       |
| Dietary    | dietary  |                     |                       |
|            | endpoint |                     |                       |
| (general   | was not  |                     |                       |
| p          | id       |                     |                       |
| opulation; | entified |                     |                       |
| females    | in the   |                     |                       |
| 13+)       | data     |                     |                       |
|            | base.    |                     |                       |
|            | This     |                     |                       |
|            | risk     |                     |                       |
|            | as       |                     |                       |
|            | sessment |                     |                       |
|            | is not   |                     |                       |
|            | r        |                     |                       |
|            | equired. |                     |                       |
+------------+----------+---------------------+-----------------------+
| Chronic    | NOAEL    | FQPA SF = 1         | Chronic               |
| Dietary    | =44      |                     | tox                   |
|            | m        | UF = 100 (10x       | icity/carcinogenicity |
|            | g/kg/day | inter-species       | --rat MRID 41947501   |
|            |          | extrapolation, 10x  |                       |
|            |          | intra-species       | LOAEL = 88 mg/kg/day, |
|            |          | variation)          | based on decreased    |
|            |          |                     | body weight and       |
|            |          |                     | weight gain           |
+------------+----------+---------------------+-----------------------+
|            |          | > **Chronic RfD =** |                       |
|            |          | > 0.44 mg/kg/day    |                       |
+------------+----------+---------------------+-----------------------+
| Incidental | NOAEL =  | FQPA SF = 1         | Developmental         |
| Oral       | 10       |                     | Toxicity -- Rat,      |
| (S         | m        | UF = 100 (10x       |                       |
| hort-term) | g/kg/day | inter-species       | MRID 42351501         |
|            |          | extrapolation, 10x  |                       |
|            |          | intra-species       | LOAEL = 30 mg/kg/day, |
|            |          | variation)          | based on decreased    |
|            |          |                     | body weight and food  |
|            |          |                     | consumption           |
+------------+----------+---------------------+-----------------------+
| Incidental | NOAEL =  | FQPA SF = 1         | Developmental         |
| Oral       | 10       |                     | Toxicity -- Rat,      |
| (Intermed  | m        | UF = 100 (10x       |                       |
| iate-term) | g/kg/day | inter-species       | MRID 42351501         |
|            |          | extrapolation, 10x  |                       |
|            |          | intra-species       | LOAEL = 30 mg/kg/day, |
|            |          | variation)          | based on decreased    |
|            |          |                     | body weight and food  |
|            |          |                     | consumption           |
+------------+----------+---------------------+-----------------------+
| Short-term | NOAEL=   | FQPA SF = 1         | 21-day dermal         |
|            | 20 mg    |                     | toxicity- guinea pigs |
| Dermal     | a.i      | UF = 10 (3x         | MRID 41105801         |
|            | ./kg/day | inter-species       |                       |
|            |          | extrapolation, 3x   | LOAEL = 40 mg         |
|            | (333     | intra-species       | a.i./kg/day, based on |
|            | µg       | variation)          | denuded               |
|            | /cm^2^)a |                     | non-vascularized      |
|            |          |                     | epidermal layer       |
+------------+----------+---------------------+-----------------------+
| Short-term | NOAEL =  | UF = 10 (3x         | 21-day dermal         |
| dermal     | 20 mg    | inter-species       | toxicity in rats MRID |
|            | a        | extrapolation, 3x   | 41499601              |
|            | i/kg/day | intra-species       |                       |
|            |          | variation)          | 20 mg ai/kg/day is    |
|            | (80 µg   |                     | the highest dose      |
|            | a        |                     | tested before         |
|            | i/cm^2^) |                     | irritation became     |
|            | b        |                     | significant at day    |
|            |          |                     | 43.                   |
+------------+----------+---------------------+-----------------------+
| Short-term | No       |                     |                       |
| Dermal     | endpoint |                     |                       |
| (technical | id       |                     |                       |
| grade      | entified |                     |                       |
| a.i.)      | from the |                     |                       |
|            | a        |                     |                       |
|            | vailable |                     |                       |
|            | data on  |                     |                       |
|            | dermal   |                     |                       |
|            | irr      |                     |                       |
|            | itation. |                     |                       |
|            | Dermal   |                     |                       |
|            | ir       |                     |                       |
|            | ritation |                     |                       |
|            | in the   |                     |                       |
|            | 90-day   |                     |                       |
|            | dermal   |                     |                       |
|            | toxicity |                     |                       |
|            | study    |                     |                       |
|            | was not  |                     |                       |
|            | evident  |                     |                       |
|            | until    |                     |                       |
|            | day 43   |                     |                       |
|            | (MRID    |                     |                       |
|            | 41       |                     |                       |
|            | 499601). |                     |                       |
+------------+----------+---------------------+-----------------------+
| Long-term  | No       |                     |                       |
| Dermal     | app      |                     |                       |
| (TGAI)     | ropriate |                     |                       |
|            | endpoint |                     |                       |
|            | ide      |                     |                       |
|            | ntified. |                     |                       |
|            | No       |                     |                       |
|            | systemic |                     |                       |
|            | effects  |                     |                       |
|            | observed |                     |                       |
|            | up to 20 |                     |                       |
|            | mg       |                     |                       |
|            | /kg/day, |                     |                       |
|            | highest  |                     |                       |
|            | dose of  |                     |                       |
|            | t        |                     |                       |
|            | echnical |                     |                       |
|            | grade    |                     |                       |
|            | that     |                     |                       |
|            | could be |                     |                       |
|            | tested   |                     |                       |
|            | without  |                     |                       |
|            | ir       |                     |                       |
|            | ritation |                     |                       |
|            | effects. |                     |                       |
+------------+----------+---------------------+-----------------------+
| Inh        | NOAEL= 3 | UF = 100 (10x       | Developmental         |
| alation^c^ | m        | inter-species       | Toxicity -- rabbit,   |
|            | g/kg/day | extrapolation, 10x  | MRID 42392801         |
| (Any time  |          | intra-species       |                       |
| point)     | MOE =    | variation)          | LOAEL = 9 mg/kg/day,  |
|            | 100^c^   |                     | based on clinical     |
|            |          | Note: an additional | signs of toxicity in  |
|            |          | 10x is used for     | maternal rabbits      |
|            |          | route extrapolation |                       |
|            |          | to determine if a   |                       |
|            |          | confirmatory study  |                       |
|            |          | is needed           |                       |
+------------+----------+---------------------+-----------------------+

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) / 25.8cm^2^ area of guinea pig dosed = 333 µg
ai/cm^2^ .

b TGAI-based dermal endpoint = (20 mg ai/kg rat x 0.2 kg rat x 1000
ug/mg) / 50cm^2^ area of rat dosed = 80 µg ai/cm^2^ .

c^a^An 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

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.

1.  **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).

1.  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.

2.  The FDA suggests that, as a worst-case scenario, all food that an
    individual consumes will come into contact with 4,000 cm^2^ 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.

3.  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.

4.  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   |                             |                       |
| S             |                             |                       |
| anitization** |                             |                       |
+---------------+-----------------------------+-----------------------+
| **Parameter** | **Value**                   | **Rationale**         |
+---------------+-----------------------------+-----------------------+
| Residual      | 1 mg/cm^2^                  | FDA worst-case        |
| Solution on   |                             | assumption            |
| Surface (RS)  |                             |                       |
+---------------+-----------------------------+-----------------------+
| Area of       | 4,000 cm^2^                 | 100% FDA worst case   |
| Treated       |                             | assumption            |
| Surface (SA)  |                             |                       |
+---------------+-----------------------------+-----------------------+
| ADBAC         | 400 ppm                     | Diluted Solution      |
| concentration |                             | concentration, based  |
| in diluted    |                             | on maximum            |
| Solution (AR) |                             | concentration in      |
|               |                             | Stearamine 1-G        |
|               |                             | Tablets.              |
+---------------+-----------------------------+-----------------------+
| Fraction      | 100%                        | Standard Assumption   |
| T             |                             |                       |
| ransferred(F) |                             |                       |
+---------------+-----------------------------+-----------------------+
| Body Weight   | 70                          | EPA, 1997             |
| (kg) (BW)     |                             |                       |
|               | 60                          |                       |
| Adult man =   |                             |                       |
|               | 10                          |                       |
| Adult woman = |                             |                       |
|               |                             |                       |
| Child =       |                             |                       |
+---------------+-----------------------------+-----------------------+

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           **DDD               **% PAD^c^**
                   (mg/p/d)^a^**   (mg/kg/d)^b^**      

  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/cm^2^ of product residue on countertops and that 100% of the residues
are transferred from the 2000 cm^2^ of countertop into the food consumed
by each individual daily. A Tier 1 estimate would be made as follows:

1 mg/ cm^2^ × 1000 ppm active concentration = 0.001 mg a.i./ cm^2^

0.001 mg a.i./ cm^2^ × (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/ cm^2^) × \[CSA (cm^2^) ÷ FW (g)\] × LC
(%) × RT (%)× ConR (g/kg bw/d)

Where:

CSR: Countertop surface residue (mg/ cm^2^)

CSA: Contact Surface area from CSFII (cm^2^)

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

LC: Likelihood of contact (%)

RTE: Residue transfer efficiency (%)

ConR: Consumption rate of food from CSFII (g/kg bw/d)

The amounts of residue transferred to food are dependent on food types.
This parameter was modified in 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]{.underline}. 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        **QRG^a^ food       **Residue Transfer
  Identified in IDREAM™**   equivalence**       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)**       **% cPAD^a^**

  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 ft^2^ is calculated for the tank (413
> ft^2^/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 cm^2^/1 ft^2^)
>
> CF2: Conversion factor (0.264 gal/1L)
>
> CF3: Conversion factor (1000ug = 1mg)

+--------+-------+-------+--------+--------+-----------+------------+
| *      |       |       |        |        |           |            |
| *Table |       |       |        |        |           |            |
| 3.     |       |       |        |        |           |            |
| Est    |       |       |        |        |           |            |
| imated |       |       |        |        |           |            |
| D      |       |       |        |        |           |            |
| ietary |       |       |        |        |           |            |
| Consu  |       |       |        |        |           |            |
| mption |       |       |        |        |           |            |
| of     |       |       |        |        |           |            |
| Adults |       |       |        |        |           |            |
| and    |       |       |        |        |           |            |
| Ch     |       |       |        |        |           |            |
| ildren |       |       |        |        |           |            |
| from   |       |       |        |        |           |            |
| the    |       |       |        |        |           |            |
| use of |       |       |        |        |           |            |
| ADBAC  |       |       |        |        |           |            |
| in     |       |       |        |        |           |            |
| Dairy  |       |       |        |        |           |            |
| Proc   |       |       |        |        |           |            |
| essing |       |       |        |        |           |            |
| Pl     |       |       |        |        |           |            |
| ants** |       |       |        |        |           |            |
+========+=======+=======+========+========+===========+============+
| Ex     | A     | Esti  | Adult  | Child  | Total     | c% PAD     |
| posure | pplic | mated | d      | d      | Dietary   | (mg/       |
| Sc     | ation | Daily | ietary | ietary | Dose      | kg/day)^e^ |
| enario | Rate  | I     | consu  | consu  | (mg/k     |            |
|        | (%    | ntake | mption | mption | g/day)^d^ |            |
|        | a.i.) |       | (µg/d  | (µg/d  |           |            |
|        |       | (µg   | ay)^b^ | ay)^c^ |           |            |
|        |       | /L    |        |        |           |            |
|        |       | milk) |        |        |           |            |
|        |       | ^a^   |        |        |           |            |
+--------+-------+-------+--------+--------+-----------+------------+
| Food   | 0.004 | 1.13  | 0.15   | 0.38   | Male: 2.1 | 4.8 x      |
| proc   |       |       |        |        | x 10^-6^  | 10^-4^     |
| essing |       |       |        |        |           |            |
| equ    |       |       |        |        |           |            |
| ipment |       |       |        |        |           |            |
+--------+-------+-------+--------+--------+-----------+------------+
|        |       |       |        |        | Female:   | 5.7 x      |
|        |       |       |        |        | 2.5 x     | 10^-4^     |
|        |       |       |        |        | 10^-6^    |            |
+--------+-------+-------+--------+--------+-----------+------------+
|        |       |       |        |        | Child:    | 9.0 x      |
|        |       |       |        |        | 3.8 x     | 10^-3^     |
|        |       |       |        |        | 10^-5^    |            |
+--------+-------+-------+--------+--------+-----------+------------+

a Estimated Daily Intake (ug/L milk) = 413ft^2^/ truck x 1truck/4000gal
x 1mg/cm^2^ x (0.004%) x 929cm^2^/ft^2^ 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.

4.  **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)**       **% cPAD^a^**

  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**

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        | Use rate (lbs       | EDWC (ppb)      |
| (Model)                      | ai/A/year)          |                 |
+------------------------------+---------------------+-----------------+
| Surface water (FIRST)        | 906                 | 13,129          |
|                              |                     |                 |
| Acute (peak)                 |                     | 331             |
|                              |                     |                 |
| Chronic (annual average)     |                     |                 |
+------------------------------+---------------------+-----------------+
| 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]{.underline}

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.

```{=html}
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```
-   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 |           |          |          |        |           |
| R          |           |          |          |        |           |
| esidential |           |          |          |        |           |
| Handler    |           |          |          |        |           |
| Inhalation |           |          |          |        |           |
| Exposures  |           |          |          |        |           |
| and MOEs** |           |          |          |        |           |
+------------+-----------+----------+----------+--------+-----------+
| Exposure   | Ap        | App      | Quantity | Unit   | MOE ^d^   |
| Scenario   | plication | lication | Handled/ | Ex     |           |
|            | Method    | Rate^a^  |          | posure | (Target   |
| A          |           |          | Treated  |        | MOE =     |
| pplication |           |          | per      | (mg/lb | 100)      |
| Method     |           |          | day^b^   | ai)^c^ |           |
+------------+-----------+----------+----------+--------+-----------+
| A          | Mopping   | 0.0033   | 1 gallon | 2.38   | 23,000    |
| pplication |           | lb       |          |        |           |
| to indoor  |           | ai/gal   |          |        |           |
| hard       |           |          |          |        |           |
| surfaces   |           |          |          |        |           |
+------------+-----------+----------+----------+--------+-----------+
|            | Wiping    | 0.0033   | 0.13     | 67.3   | 6,200     |
|            |           | lb       | gallon   |        |           |
|            |           | ai/gal   |          |        |           |
+------------+-----------+----------+----------+--------+-----------+
|            | Trigger   | 0.0033   | 0.13     | 2.4    | 170,000   |
|            | Spray     | lb       | gallon   |        |           |
|            |           | ai/gal   |          |        |           |
+------------+-----------+----------+----------+--------+-----------+

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 |        |         |          |       |       |         |
| R          |        |         |          |       |       |         |
| esidential |        |         |          |       |       |         |
| Handler    |        |         |          |       |       |         |
| Dermal     |        |         |          |       |       |         |
| Risks**    |        |         |          |       |       |         |
+============+========+=========+==========+=======+=======+=========+
| Exposure   | Appli  | Appl    | Quantity | Hand  | D     | MOE ^e^ |
| Scenario   | cation | ication | Handled/ | Unit  | ermal |         |
|            | Method | Rate^a^ | Treated  | Exp   | Skin  | (Target |
|            |        |         | per      | osure | Irrit | MOE =   |
|            |        |         | day^b^   | Adj   | ation | 10)     |
|            |        |         |          | usted | Exp   |         |
|            |        |         |          | for   | osure |         |
|            |        |         |          | Su    | ^d^   |         |
|            |        |         |          | rface |       |         |
|            |        |         |          | Area  | (µg/c |         |
|            |        |         |          |       | m^2^) |         |
|            |        |         |          | (     |       |         |
|            |        |         |          | mg/lb |       |         |
|            |        |         |          | ai    |       |         |
|            |        |         |          | /cm^2 |       |         |
|            |        |         |          | ^)^c^ |       |         |
+------------+--------+---------+----------+-------+-------+---------+
| A          | M      | 0.0033  | 1 gallon | 0.063 | 0.208 | 1,600   |
| pplication | opping | lb      |          |       |       |         |
| to indoor  |        | ai/gal  |          |       |       |         |
| hard       |        |         |          |       |       |         |
| surfaces   |        |         |          |       |       |         |
+------------+--------+---------+----------+-------+-------+---------+
|            | Wiping | 0.0033  | 0.13     | 1.341 | 0.575 | 580     |
|            |        | lb      | gallon   |       |       |         |
|            |        | ai/gal  |          |       |       |         |
+------------+--------+---------+----------+-------+-------+---------+
|            | T      | 0.0033  | 0.13     | 0.129 | 0.055 | 6,100   |
|            | rigger | lb      | gallon   |       |       |         |
|            | Spray  | ai/gal  |          |       |       |         |
+------------+--------+---------+----------+-------+-------+---------+

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/cm^2^) = Unit Exposure from PHED or CMA (mg/lb
ai) / surface area of hand (820 cm^2^).

d Dermal Skin Irritation Exposure (µg /lb ai/cm^2^) = Unit Exposure
(mg/lb ai/cm^2^) x Application Rate (lb ai/gal) x Quantity Treated
(gal/day) x 1,000 μg/mg

e MOE = NOAEL (µg /cm^2^)/ Surface Residue on Skin (µg/cm^2^). \[Where
short-term dermal formulated-based NOAEL = 333 µg/cm^2^\]. 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  Inhalation MOE
                                      MOE                   

  Child playing on        1,100       610                   NA
  floor^a^                                                  

  Child playing on        1,200       330                   NA
  carpet^a^                                                 
  ------------------------------------------------------------------------

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.

**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

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 |         |         |         |         |
|                    | Ex      |         |         |         |         |
|                    | posures |         |         |         |         |
|                    | (mg/    |         |         |         |         |
|                    | kg/day) |         |         |         |         |
+--------------------+---------+---------+---------+---------+---------+
|                    | Cou     | Utensil | D       | Ag      | \%      |
|                    | ntertop | Dietary | rinking | gregate | cPAD^c^ |
|                    | Dietary | Expos   | Water   | Dietary |         |
|                    | Expos   | ures^a^ | Ex      | Expos   | (       |
|                    | ures^a^ |         | posures | ures^b^ | MOE)^c^ |
+--------------------+---------+---------+---------+---------+---------+
| ***Adults***^d^    |         |         |         |         |         |
+--------------------+---------+---------+---------+---------+---------+
| Oral Ingestion     | 0.00059 | 0.027   | 0.009   | 0.037   | 8.4     |
|                    |         |         |         |         |         |
|                    |         |         |         |         | (1,200) |
+--------------------+---------+---------+---------+---------+---------+
| ***Children***^e^  |         |         |         |         |         |
+--------------------+---------+---------+---------+---------+---------+
| 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 

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      |                 |     |     |     |                |
| Int            |                 |     |     |     |                |
| ermediate-term |                 |     |     |     |                |
| Aggregate Risk |                 |     |     |     |                |
| (MOE)          |                 |     |     |     |                |
| Assessment**   |                 |     |     |     |                |
+================+=================+=====+=====+=====+================+
| Exposure       | Chronic Dietary | Cl  |     |     | Route-Specific |
| Routes         |                 | ean |     |     | Aggregate MOE  |
|                | MOE             | ing |     |     |                |
|                |                 | P   |     |     |                |
|                |                 | rod |     |     |                |
|                |                 | uct |     |     |                |
|                |                 | M   |     |     |                |
|                |                 | OEs |     |     |                |
|                |                 | (Ad |     |     |                |
|                |                 | ult |     |     |                |
|                |                 | Ap  |     |     |                |
|                |                 | pli |     |     |                |
|                |                 | cat |     |     |                |
|                |                 | ors |     |     |                |
|                |                 | &   |     |     |                |
|                |                 | Ch  |     |     |                |
|                |                 | ild |     |     |                |
|                |                 | ren |     |     |                |
|                |                 | Pl  |     |     |                |
|                |                 | ayi |     |     |                |
|                |                 | ng) |     |     |                |
+----------------+-----------------+-----+-----+-----+----------------+
| ***Adults***   |                 |     |     |     |                |
+----------------+-----------------+-----+-----+-----+----------------+
| Oral Ingestion | 1,200           | NA  |     |     | 1,200          |
+----------------+-----------------+-----+-----+-----+----------------+
| Dermal         | NA              | 1,  | 580 | 6,  | 480            |
|                |                 | 600 | (wi | 100 |                |
|                |                 | (m  | pe) | (   |                |
|                |                 | op) |     | spr |                |
|                |                 |     |     | ay) |                |
+----------------+-----------------+-----+-----+-----+----------------+
| Inhalation     | NA              | 27, | 7,  | 2   | 2,000          |
|                |                 | 000 | 300 | 00, |                |
|                |                 |     | (wi | 000 |                |
|                |                 | (m  | pe) | (   |                |
|                |                 | op) |     | spr |                |
|                |                 |     |     | ay) |                |
+----------------+-----------------+-----+-----+-----+----------------+
| ***Children*** |                 |     |     |     |                |
+----------------+-----------------+-----+-----+-----+----------------+
| Oral Ingestion | 240             | 330 |     |     | 140            |
+----------------+-----------------+-----+-----+-----+----------------+
| Dermal         | NA              | 1,  |     |     | 1,200          |
|                |                 | 200 |     |     |                |
| (ST only)      |                 |     |     |     |                |
+----------------+-----------------+-----+-----+-----+----------------+
| Inhalation     | NA              | NA  |     |     | NA             |
+----------------+-----------------+-----+-----+-----+----------------+

Aggregate MOE = 1/((1/MOE~same\ 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
<http://www.epa.gov/pesticides/cumulative/>.

**7. Occupational Exposure Assessment**

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]{.underline}

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 ,      |           |     |         |        |       |       |
| I            |           |     |         |        |       |       |
| ntermediate, |           |     |         |        |       |       |
| and          |           |     |         |        |       |       |
| Long-term    |           |     |         |        |       |       |
| Inhalation   |           |     |         |        |       |       |
| Risks        |           |     |         |        |       |       |
| Associated   |           |     |         |        |       |       |
| with         |           |     |         |        |       |       |
| Occupational |           |     |         |        |       |       |
| Handlers**   |           |     |         |        |       |       |
+==============+===========+=====+=========+========+=======+=======+
| Exposure     | Method of | I   | Appl    | Qu     | Inhal | Inhal |
| Scenario     | Ap        | nha | ication | antity | ation | ation |
|              | plication | lat | Rate    | Ha     | Daily |       |
|              |           | ion | ^a^     | ndled/ | Dose  | MOE   |
|              |           | U   |         | T      | (     | ^c,d^ |
|              |           | nit |         | reated | mg/kg |       |
|              |           | Ex  |         | per    | /day) | (T    |
|              |           | pos |         | day    | ^b^   | arget |
|              |           | ure |         |        |       | MOE = |
|              |           |     |         |        |       | 100)  |
|              |           | (mg |         |        |       |       |
|              |           | /lb |         |        |       |       |
|              |           | a.  |         |        |       |       |
|              |           | i.) |         |        |       |       |
+--------------+-----------+-----+---------+--------+-------+-------+
| **Food       |           |     |         |        |       |       |
| Hand         |           |     |         |        |       |       |
| ling/Storage |           |     |         |        |       |       |
| Es           |           |     |         |        |       |       |
| tablishments |           |     |         |        |       |       |
| Premises And |           |     |         |        |       |       |
| Equipment    |           |     |         |        |       |       |
| (Use Site    |           |     |         |        |       |       |
| Category     |           |     |         |        |       |       |
| II)**        |           |     |         |        |       |       |
+--------------+-----------+-----+---------+--------+-------+-------+
| Application  | Low       | 0.  | 0.0033  | 2      | 0.    | 4     |
| to indoor    | pressure  | 681 | lb      | g      | 00007 | 0,000 |
| hard         | hand wand |     | ai/gal  | allons |       |       |
| surfaces     |           |     |         |        |       |       |
| (including   |           |     |         |        |       |       |
| dishes,      |           |     |         |        |       |       |
| utensils,    |           |     |         |        |       |       |
| equipment)   |           |     |         |        |       |       |
+--------------+-----------+-----+---------+--------+-------+-------+
|              | Mop       | 2   | 0.0033  | 2      | 0     | 1     |
|              |           | .38 | lb      | g      | .0003 | 1,000 |
|              |           |     | ai/gal  | allons |       |       |
+--------------+-----------+-----+---------+--------+-------+-------+
|              | Wipe      | 6   | 0.0033  | 0.26   | 0     | 3,100 |
|              |           | 7.3 | lb      | g      | .0010 |       |
|              |           |     | ai/gal  | allons |       |       |
+--------------+-----------+-----+---------+--------+-------+-------+
|              | Trigger   | 1.3 | 0.0033  | 0.26   | 0.    | 16    |
|              | pump      |     | lb      | g      | 00002 | 0,000 |
|              | sprayer   |     | ai/gal  | allons |       |       |
+--------------+-----------+-----+---------+--------+-------+-------+
|              | I         | 1   | 0.0033  | 2      | 0     | 1     |
|              | mmersion, | .89 | lb      | g      | .0002 | 4,000 |
|              | Flooding, |     | ai/gal  | allons |       |       |
|              | Ci        |     |         |        |       |       |
|              | rculation |     |         |        |       |       |
+--------------+-----------+-----+---------+--------+-------+-------+

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       **%cPAD**
                                      Exposure (mg/kg/d)**   

  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                                                                          **Active        **400 ppm                 
  MODEL -                                                                           ingredient:**   ADBAC**                   
  Children aged                                                                                                               
  1-2**                                                                                                                       

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

                 (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                                   0.00189
                                                                                    Ingestion                                 
                                                                                    Exposure:**                               
  -------------- ----------- ---------- -------------- -------------- ------------- --------------- ----------- ------------- -------------

  -------------- ----------- ---------- -------------- -------------- ------------- --------------- ----------- ------------- -------------
  **TIER 2                                                                          **Active        **400 ppm                 
  MODEL -                                                                           ingredient:**   ADBAC**                   
  Children aged                                                                                                               
  3-5**                                                                                                                       

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

                 (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                                   0.00150
                                                                                    Ingestion                                 
                                                                                    Exposure:**                               
  -------------- ----------- ---------- -------------- -------------- ------------- --------------- ----------- ------------- -------------

  -------------- ----------- ---------- -------------- -------------- ------------- --------------- ----------- ------------- -------------
  **TIER 2 MODEL                                                                    **Active        **400 ppm                 
  -- Adults aged                                                                    ingredient:**   ADBAC**                   
  13+**                                                                                                                       

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

  **CHRONIC                                                                                                                   
  EXPOSURE                                                                                                                    
  ASSESSMENT**                                                                                                                

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

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

  Liquid         250         240        0%             100%           0             0.0004          0           20.24         0

  Solid                                                                                                                        

  Fruit          28          97         100%           39%            0.113         0.0004          0.000045    0.94          0.00004

  Bread          94          56         100%           0.86%          0.014         0.0004          0.000006    1.40          0.00001

  Cheese         65          49         100%           47%            0.623         0.0004          0.000249    0.29          0.00007

  Vegetable      34          99         100%           39%            0.134         0.0004          0.000054    1.87          0.00010

  Meat           103         138        100%           47%            0.351         0.0004          0.000140    2.10          0.00029

  Purees         46          107        100%           39%            0.168         0.0004          0.000067    0.83          0.00006

  Pieces         0.8         1.2        100%           0.86%          0.006         0.0004          0.000002    2.72          0.00001

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

                                                                                    **Total                                   0.00059
                                                                                    Ingestion                                 
                                                                                    Exposure:**                               
  -------------- ----------- ---------- -------------- -------------- ------------- --------------- ----------- ------------- -------------

  -------------- ----------- ---------- -------------- -------------- ------------- --------------- ----------- ------------- -------------
  **TIER 2 MODEL                                                                    **Active        **400 ppm                 
  -- Females                                                                        ingredient:**   ADBAC**                   
  aged 13-49**                                                                                                                

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

                 (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                                   0.00055
                                                                                    Ingestion                                 
                                                                                    Exposure:**                               
  -------------- ----------- ---------- -------------- -------------- ------------- --------------- ----------- ------------- -------------

[^1]: 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.