### MEMORANDUM Jan 20,, 2006

SUBECT; Dietary Risk Assessment for Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) for Reregistration Eligibility Decision (RED) Process

From: A. Najm Shamim, Ph.D, Chemist

Regulatory Management Brnach II

Antimicrobials Division (7510C)

To: Jacqueline Campbell-McFarlane, CRM for ADBAC RED

Regulatory Management Branch I

Antimicrobials Division (7510C)

Thru: Mark Hartman, Chief

Regulatory Management Branch II

Antimicrobials Division (7510C)

### 

### 

### 

### Executive Summary

Alkyl benzyl ammonium chloride (ADBAC) can be used as a disinfectant or
sanitizer on counter tops, utensils, appliances, tables, refrigerators,
on animal premises and/or farms, and in mushroom premises. The use of
antimicrobial on food or feed contact surfaces, agricultural
commodities, in animal premises and poultry premises including
hatcheries and application to food-grade eggs may result in pesticide
residues in human food. Residues from treated surfaces, such as food
utensils, countertops, equipment, and appliances can migrate to food
coming into contact with the treated and rinsed surfaces and can be
ingested by humans.

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. Dietary exposures
from general agricultural premise use, poultry hatcheries, mushroom
houses and hydroponic uses are expected to be much lower than the
dietary exposures resulting from the surface disinfectant and sanitizing
uses; therefore, these uses were not assessed.

To estimate the Estimated Daily Intake (EDI) to treated surfaces, an FDA
(FDA, 2003) model was used in lieu of residue data. The maximum
application rate for ADBAC in food handling establishments from the
various labeled ready-to-use products is 0.0017 *a.i* pounds per gallon
of treatment solution. The EDI calculations presented in this assessment
assumes that food can contact 2,000 cm^2^ or 4,000 cm^2^ (50% and 100%
of the FDA worst case scenario) of treated surfaces, and that 10% of the
pesticide migrate to food, based on the Agency Residential SOPs. The use
of the 10% transfer rate, instead of the use of a 100% transfer rate
that is used in the FDA Sanitizer Solution Guidelines, requires the
submission of confirmatory data to establish the reliability of the use
of the10% transfer rate. These daily estimates were conservatively used
to assess both acute and chronic dietary risks. None of the calculated %
aPad or % cPad values exceeded 100%.

The maximum application rate for ADBAC for bottling/packing of food is
0.0103 lbs a.i per gallons of treatment solution. EDI values were
calculated using an approach similar to that used for treated
food-contact surfaces and food utensils. Exposure was assumed to occur
through the ingestion of three food products that might be packaged with
treated material: milk, egg products, and beverages (alcoholic and
non-alcoholic). None of the calculated % aPad or % cPad values exceeded
100%.

### Dietary Toxicity

The acute or chronic Population Adjusted Dose (aPAD or cPAD) is
presented in Table 1. The cPAD is 0.44 mg/kg/day ( Antimicrobials ADTC
(End Point Selection Committee )) Memo by Tim McMahon

# Table 1: ADBAC Dietary Toxicity

+--------+---------------+-----------------+--------------------------+
| Ex     | Dose Used in  | Target MOE/ UF, | Study and Toxicological  |
| posure | Risk          |                 | Effects                  |
|        | Assessment    | Special FQPA SF |                          |
| Sc     |               |                 |                          |
| enario | (mg/kg/day)   | for Risk        |                          |
|        |               | Assessment      |                          |
+========+===============+=================+==========================+
|        |               |                 |                          |
+--------+---------------+-----------------+--------------------------+
|        |               |                 |                          |
+--------+---------------+-----------------+--------------------------+
| C      | **NOAEL** =   | **FQPA SF** = 1 | Chronic                  |
| hronic | 44 mg/kg/day  |                 | Toxicity/Carcinogenicity |
| D      |               | **UF** = 100    | -Rat                     |
| ietary | (See          | (10x            |                          |
|        | Incidental    | inter-species   | MRID 41947501            |
|        | Oral,         | extrapolation,  |                          |
|        | Short-term    | 10x             | **LOAEL** = 30 mg/kg/day |
|        | dose and      | intra-species   | based on *clinical sign* |
|        | endpoint      | variation)      | and decreased body       |
|        | selection)    |                 | weight gain              |
+--------+---------------+-----------------+--------------------------+
|        |               | > **cPAD =**    |                          |
|        |               | > 0.44          |                          |
|        |               | > mg/kg/day     |                          |
+--------+---------------+-----------------+--------------------------+

a\. cPAD or aPAD= the RfD/FQPA SF (acute RFD and FQPA for aPAD and
chronic RFD and FQPA SF for the cPAD)

### Use Information

Twelve ADBAC products were identified that have uses that could lead to
incidental ingestion. These uses/products are presented in Table 2. The
labels with the maximum-listed application rate for each use are
presented in bold.

# Table 2: Use Site Categories and Application Rates

+----------------------+--------------+----------------+--------------+
| Use Site             | Product      | Method of      | Application  |
|                      | Label        | Application    | Rates (lb    |
|                      | (            |                | a.i./gal)    |
|                      | Registration |                |              |
|                      | No.)         |                |              |
+======================+==============+================+==============+
| Egg handling         | 10324-108    | Fogger         | 0            |
| equipment and rooms: |              |                | .0005-0.0938 |
| Incubator and        | 10324-111    |                |              |
| hatchers             |              |                |              |
|                      | 10324-117    |                |              |
|                      |              |                |              |
|                      | 10324-80     |                |              |
|                      |              |                |              |
|                      | 10324-81     |                |              |
|                      |              |                |              |
|                      | **1839-155** |                |              |
|                      |              |                |              |
|                      | 1839-173     |                |              |
|                      |              |                |              |
|                      | **1839-81**  |                |              |
|                      |              |                |              |
|                      | **1839-86**  |                |              |
+----------------------+--------------+----------------+--------------+
| Hatchery: hatchery,  | 10324-108    | Mop, cloth,    | 0            |
| settlers, trays,     |              | sponge, hand   | .0009-0.0065 |
| racks, carts, sexing | *            | pump trigger   |              |
| tables, delivery     | *10324-111** | sprayer, or    |              |
| trucks, and other    |              | low pressure   |              |
| hard surfaces        | 10324-117    | coarse sprayer |              |
|                      |              |                |              |
|                      | 10324-140    |                |              |
|                      |              |                |              |
|                      | 10324-80     |                |              |
|                      |              |                |              |
|                      | 10324-81     |                |              |
|                      |              |                |              |
|                      | 1839-155     |                |              |
|                      |              |                |              |
|                      | 1839-173     |                |              |
|                      |              |                |              |
|                      | 1839-81      |                |              |
|                      |              |                |              |
|                      | 1839-86      |                |              |
+----------------------+--------------+----------------+--------------+
| Egg packing plants:  | **1839-86**  | Immersion, low | 0            |
| food grade eggs      |              | pressure       | .0005-0.0016 |
|                      | 1839-173     | coarse         |              |
|                      |              | sprayer, or    |              |
|                      | **1839-155** | swabs          |              |
|                      |              |                |              |
|                      | 10324-81     |                |              |
|                      |              |                |              |
|                      | 10324-117    |                |              |
|                      |              |                |              |
|                      | *            |                |              |
|                      | *10324-111** |                |              |
+----------------------+--------------+----------------+--------------+
| Food handling        | **1839-81**  | Immersion, low | 0            |
| establishments:      |              | pressure       | .0013-0.0017 |
| utensils and         | 1839-173     | coarse         |              |
| equipment            |              | sprayer, or    |              |
|                      | 10324-81     | swabs          |              |
|                      |              |                |              |
|                      | 10324-117    |                |              |
|                      |              |                |              |
|                      | 10324-111    |                |              |
+----------------------+--------------+----------------+--------------+
| Food handling        | 1839-86      | Mop, cloth,    | 0            |
| establishments:      |              | sponge, hand   | .0013-0.0071 |
| countertops,         | 1839-81      | pump trigger   |              |
| appliances, and      |              | sprayer, or    |              |
| tables               | 1839-155     | low pressure   |              |
|                      |              | coarse sprayer |              |
|                      | 10324-81     |                |              |
|                      |              |                |              |
|                      | 10324-140    |                |              |
|                      |              |                |              |
|                      | 10324-117    |                |              |
|                      |              |                |              |
|                      | 10324-108    |                |              |
|                      |              |                |              |
|                      | 1839-173     |                |              |
|                      |              |                |              |
|                      | **10324-80** |                |              |
|                      |              |                |              |
|                      | 10324-111    |                |              |
+----------------------+--------------+----------------+--------------+
| Food processing      | 10324-81     | Mop, cloth,    | 0            |
| plants: (poultry,    |              | sponge, hand   | .0013-0.0065 |
| meat, fish, tobacco  | 10324-117    | pump trigger   |              |
| etc.): hard surfaces |              | sprayer, or    |              |
| and equipment,       | 10324-108    | low pressure   |              |
| including utensils,  |              | coarse sprayer |              |
| dishes, silverware,  | 10324-140    |                |              |
| glasses, sink tops,  |              |                |              |
| countertops,         | 10324-80     |                |              |
| refrigerated         |              |                |              |
| storage, display     | 1839-173     |                |              |
| equipment, storage   |              |                |              |
| shelves, appliances, | 1839-86      |                |              |
| conveyers            |              |                |              |
| (fruits/vegetables   | 1839-155     |                |              |
| or meat/poultry)     |              |                |              |
| etc.                 | 1839-81      |                |              |
|                      |              |                |              |
|                      | 1839-51      |                |              |
|                      |              |                |              |
|                      | 10324-80     |                |              |
|                      |              |                |              |
|                      | *            |                |              |
|                      | *10324-111** |                |              |
+----------------------+--------------+----------------+--------------+
| Food                 | 1839-173     | Fogger, mop,   | 0            |
| Bottling/Packaging:  |              | cloth, sponge, | .0009-0.0103 |
| food contact surface | 10324-81     | hand pump      |              |
| sanitizer (i.e.      |              | trigger        |              |
| bottle sanitizing,   | 10324-117    | sprayer, low   |              |
| beer storage tanks,  |              | pressure       |              |
| and beverage         | 10324-108    | coarse         |              |
| dispensing unit)     |              | sprayer,       |              |
|                      | 10324-80     | liquid pour -- |              |
|                      |              | mechan         |              |
|                      | 1839-86      | ical/automated |              |
|                      |              | systems, or    |              |
|                      | 1839-155     | circulation    |              |
|                      |              |                |              |
|                      | 10324-111    |                |              |
|                      |              |                |              |
|                      | **1839-81**  |                |              |
|                      |              |                |              |
|                      | 10324-140    |                |              |
+----------------------+--------------+----------------+--------------+
| Mushroom facilities  | 10324-81     | Mop, cloth,    | 0            |
|                      |              | sponge, hand   | .0015-0.0057 |
|                      | 10324-117    | trigger        |              |
|                      |              | sprayer, or    |              |
|                      | 10324-108    | coarse spray   |              |
|                      |              | device         |              |
|                      | 1839-86      |                |              |
|                      |              |                |              |
|                      | 1839-155     |                |              |
|                      |              |                |              |
|                      | **10324-80** |                |              |
+----------------------+--------------+----------------+--------------+
| Farm (poultry,       | 1839-173     | Mop, cloth,    | 0            |
| swine, dairy)        |              | sponge, hand   | .0005-0.0063 |
| premises and cows    | 10324-81     | pump trigger   |              |
| (utters, flanks, and |              | sprayer, low   |              |
| teats)               | 10324-117    | pressure       |              |
|                      |              | coarse         |              |
|                      | 1839-86      | sprayer, or    |              |
|                      |              | towels         |              |
|                      | 1839-155     |                |              |
|                      |              |                |              |
|                      | 10324-111    |                |              |
|                      |              |                |              |
|                      | *            |                |              |
|                      | *10324-140** |                |              |
|                      |              |                |              |
|                      | 10324-108    |                |              |
|                      |              |                |              |
|                      | 10324-80     |                |              |
|                      |              |                |              |
|                      | 1839-81      |                |              |
+----------------------+--------------+----------------+--------------+
| Potato Storage:      | 10324-117    | Mop, cloth,    | 0            |
| potato rinse and     |              | sponge, hand   | .0009-0.0065 |
| humidification       | 1839-86      | pump trigger   |              |
|                      |              | sprayer, or    |              |
|                      | 1839-155     | low pressure   |              |
|                      |              | coarse sprayer |              |
|                      | *            |                |              |
|                      | *10324-111** |                |              |
+----------------------+--------------+----------------+--------------+

**3. Quantitative Dietary assessment**

**3.1 Egg handling equipment, Agricultural Premise Use, and Poultry
Hatcheries**

ADBAC products may be used on egg shells in both poultry hatcheries and
food grade-eggs. Although it is possible that some of
sanitizer/disinfectant chemicals may penetrate the egg shells, at this
time the Agency believes that the amount of the chemical transferred
into food is likely to be minimal. Dietary exposures from general
agricultural premise use, poultry hatcheries, mushroom houses and
hydroponic uses are expected to be much lower than the dietary exposures
resulting from the surface disinfectant and sanitizing uses; therefore,
these uses were not assessed.

**3.2 Food Handling Establishments and Food Processing Plants**

To calculate the EDI associated with use of an ADBAC product as a food
utensil sanitizer in food handling establishments, a number of
assumptions have been 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.  It is assumed that 10% of the active material present on food
    contact surfaces will migrate.

4.  The body weights used for this assessment are: adult man = 70 kg;
    adult woman = 60 kg, and 3-yr old toddler = 15 kg (USEPA, 1997).

For use of an ADBAC product as a counter top disinfectant in food
handling establishments, the same assumptions as listed above were used,
and one additional assumption was added:

1.  The amount of counter top surface area that comes in contact with
    food should be much smaller than the amount of food utensil area
    that comes into contact with food. As a conservative estimate, it is
    assumed that 50% of the FDA value, or 2,000 cm^2^ of treated counter
    top surface area, comes into contact with an individual's food per
    day.

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) = AR x RS x SA x F x 10^-6^/BW (2)

Where:

AR = Application rate (ppm)

RS = Residual solution (mg/cm^2^)

> SA = Surface area of the treated surface which comes into contact with
> food (cm^2^)

F = Fraction of the pesticide transferred or migrated to food (unitless)

> BW = Body weight (kg)

The input parameters listed in Table 4 and equations 1 and 2 were used
to calculate the output parameters listed in Table 5.

Table *3*: Input Parameters for Food Handling Establishments and Food
Processing Plants Hard Surface Sanitizer

+---------------+---------------+-------------+-----------------------+
| **Parameter** | **Value**     |             | **Rationale**         |
+---------------+---------------+-------------+-----------------------+
|               | **Food        | **C         |                       |
|               | Utensil**     | ountertop** |                       |
+---------------+---------------+-------------+-----------------------+
| Residual      | 1 mg/cm^2^    |             | FDA worst-case        |
| Solution on   |               |             | assumption            |
| Surface       |               |             |                       |
+---------------+---------------+-------------+-----------------------+
| Area of       | 4,000 cm^2^   | 2,000 cm^2^ | 100% and 50% of FDA   |
| Treated       |               |             | worst-case assumption |
| Surface       |               |             | for food utensils     |
+---------------+---------------+-------------+-----------------------+
| ADBAC         | 0.0017 lb     | 0.0071 lb   | Diluted Solution      |
| concentration | a.i./gal or   | a.i./gal or | concentration, based  |
| in diluted    | *200* ppm     | 850 ppm     | on maximum            |
| Solution^a^   |               |             | concentration.        |
+---------------+---------------+-------------+-----------------------+
| Fraction      | 10%           |             | EPA Assumption        |
| Transferred   |               |             |                       |
+---------------+---------------+-------------+-----------------------+
| Body Weight   | > 70          |             | EPA, 1997             |
| (kg)          | >             |             |                       |
|               | > 60          |             |                       |
| Adult man =   |               |             |                       |
|               | 15            |             |                       |
| Adult woman = |               |             |                       |
|               |               |             |                       |
| Child =       |               |             |                       |
+---------------+---------------+-------------+-----------------------+

a\. Maximum application rates for food utensils were from product label
1839-81for Utensils and product label 10324-80 for counter-tops.

Table *4*: Calculated EDIs, aPAD, and cPAD for Utensils and Countertops

  ------------ -------------- ----------- ---- --------- ----------------- ----------- ----- --------- --------------- ----------- ---- ---------
  **Exposure   **Utensils**                              **Countertops**                               **Aggregate**                    
  Group**                                                                                                                               

               EDI (mg/p/d)   DDD              \%        EDI (mg/p/d)      DDD               \%        EDI (mg/p/d)    DDD              \%
                              (mg/kg/d)        cPAD^a^                     (mg/kg/d)         cPAD^a^                   (mg/kg/d)        cPAD^a^

  Adult males  0.0815         0.00116          0.265     0.170             0.00243           0.552     0.252           0.00359          0.817

  Adult        0.0815         0.00136          0.309     0.170             0.00284           0.645     0.252           0.00419          0.953
  females                                                                                                                               

  Children     0.0815         0.00543          1.23      0.170             0.0113            2.58      0.252           0.0168           3.81
  ------------ -------------- ----------- ---- --------- ----------------- ----------- ----- --------- --------------- ----------- ---- ---------

a.  \% PAD = exposure (DDD) /(aPAD or cPAD) x 100.

For ADBAC treatments of food processing plants, the application rates
are similar to food handling establishments presented above, and hence
the exposure, EDIs, DDDs, and % aPAD and cPADs are also similar.

4.  **Food Bottling/Packaging**

ADBAC may also be used as a sanitizer or disinfectant in processing
equipments, utensils in dairies, breweries, canning operations, meat and
vegetable processing plants. In assessing this use, the following
assumptions were made, based on USEPA (2005):

1.  The ADBAC concentration in the treatment solution is 0.0103 lb
    a.i./gal, or 123 ppm (0.000123 wt/wt)

2.  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.

3.  For the fraction of pesticide that migrates from the residue to the
    food (*F* in equations 3 and 4), a transfer rate of 100% was used
    instead of 10% because the food is in contact with the treated
    surfaces for potentially very long periods of time.

4.  For a given person, the grams of food per surface area of container
    were as follows (g/cm^2^):

    a.  Milk (dairy): 6.6

    b.  Egg/mayonnaise: 64.0

    c.  Beer, beverages: 150

5.  The daily intake rates for an adult (g/person/day) were as follows:

    a.  Beverages, alcoholic/beer: 182

    b.  Beverages, non-alcoholic: 240

    c.  Egg products: 9.0

    d.  Milk: 124

6.  A child will consume a smaller quantity of calories in a given day.
    To account for differences between intake values among children and
    adults a calorie intake modification factor of 0.64 was applied to
    the EDI for a child. Recommended energy allowances measured in
    kilocalories per body weight for different age groups and genders
    were taken from the National Research Council's Recommended Energy
    Allowances. The values are based on the resting energy expenditure
    and the energy required for light to moderate levels of activity, as
    determined by the World Health Organization (USAID, 2005). The
    calculation of the factor is presented in Table 6 below.

> 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 DIR x MSA^-1^ x F x 10^-6^ x CMF (3)
>
> DDD (mg/kg/day) = AR x RS x DIR x MSA^-1^ x F x 10^-6^ x CMF/BW (4)

Where:

AR = Application rate (ppm)

RS = Residual solution (mg/cm^2^)

> MSA = Mass-surface area ratio (the treated surface that comes into
> contact with food) (g/cm^2^)
>
> DIR = Daily intake rate of food in a given day (g/p/day)

F = Fraction of the pesticide transferred or migrated to food (unitless)

> BW = Body weight (kg)
>
> CMF = Calorie intake modification factor (100% adults; 64.4% Children)

Assumptions 1-4, inputs from Table 6 and 7, and equations 3 and 4 were
used to calculate the dietary rates and doses presented in Table 8.

**Table *5***: Toddler (3-yr old) and Adult Calorie Intake Comparison

+-----------------------+-------------+-------------+---+----------------+
| **Group (Age)**       | **Body      | **K         | * |                |
|                       | Weight      | ilocalories | * |                |
|                       | (kg)**      | per kg^a^** | K |                |
|                       |             |             | i |                |
|                       |             |             | l |                |
|                       |             |             | o |                |
|                       |             |             | c |                |
|                       |             |             | a |                |
|                       |             |             | l |                |
|                       |             |             | o |                |
|                       |             |             | r |                |
|                       |             |             | i |                |
|                       |             |             | e |                |
|                       |             |             | s |                |
|                       |             |             | ^ |                |
|                       |             |             | b |                |
|                       |             |             | ^ |                |
|                       |             |             | * |                |
|                       |             |             | * |                |
+-----------------------+-------------+-------------+---+----------------+
| Child (1-3)           | 15.0        | 102         | 1 |                |
|                       |             |             | , |                |
|                       |             |             | 5 |                |
|                       |             |             | 3 |                |
|                       |             |             | 0 |                |
+-----------------------+-------------+-------------+---+----------------+
| Female (25-50)        | 60.0        | 36.0        | 2 |                |
|                       |             |             | , |                |
|                       |             |             | 1 |                |
|                       |             |             | 6 |                |
|                       |             |             | 0 |                |
+-----------------------+-------------+-------------+---+----------------+
| Male (25-50)          | 70.0        | 37.0        | 2 |                |
|                       |             |             | , |                |
|                       |             |             | 5 |                |
|                       |             |             | 9 |                |
|                       |             |             | 0 |                |
+-----------------------+-------------+-------------+---+----------------+
| **Output**            |             |             |   |                |
+-----------------------+-------------+-------------+---+----------------+
| ##### Child Modifica  |             |             |   | 0.644          |
| tion Factor (CMF)^c^  |             |             |   |                |
+-----------------------+-------------+-------------+---+----------------+

a.  USAID, 2005

b.  Kilocalories = Kcal/Kg x BW

c.  CMF = Kcal-child ÷ \[(Kcal-female + Kcal-male)/2\]

Table *6*: Input Parameters for Food Bottling/Packaging Hard Surface
Sanitizer

+-------------------+---------------+-------+-------------------------+
| **Parameter**     | ##### Input   |       | **Rational**            |
+-------------------+---------------+-------+-------------------------+
| Food mass/surface | Milk          | 6.6   | USEPA, 2005             |
| (g/cm^2^)         |               |       |                         |
|                   |               |       |                         |
+-------------------+---------------+-------+-------------------------+
|                   | E             | 64    |                         |
|                   | gg/Mayonnaise |       |                         |
+-------------------+---------------+-------+-------------------------+
|                   | Beer,         | 150   |                         |
|                   | beverages     |       |                         |
+-------------------+---------------+-------+-------------------------+
| Intake rates      | Milk          | 124   | USEPA, 2005             |
| (g/p/d)           |               |       |                         |
|                   |               |       |                         |
|                   |               |       |                         |
|                   |               |       |                         |
|                   |               |       |                         |
|                   |               |       |                         |
+-------------------+---------------+-------+-------------------------+
|                   | Egg products  | 9     |                         |
+-------------------+---------------+-------+-------------------------+
|                   | Beer,         | 182   |                         |
|                   | beverages     |       |                         |
+-------------------+---------------+-------+-------------------------+
|                   | Beverages/    | 240   |                         |
|                   | nonalcoholic  |       |                         |
+-------------------+---------------+-------+-------------------------+
| Fraction          | 100%          |       | FDA worst case          |
| Transferred       |               |       | assumption              |
+-------------------+---------------+-------+-------------------------+
| Residual Solution | 1 mg/cm^2^    |       | FDA worst case          |
| on Surface        |               |       | assumption              |
+-------------------+---------------+-------+-------------------------+
| Quantity ADBAC    | 0.0103 lb ai  |       | Diluted solution        |
|                   | or 1234 ppm   |       | concentration, based on |
|                   |               |       | maximum concentration.  |
+-------------------+---------------+-------+-------------------------+
| Body Weight (kg)  |               |       |                         |
|                   |               |       |                         |
| Adult man =       | 70            |       |  USEPA, 1997            |
|                   |               |       |                         |
| Adult woman =     | 60            |       |                         |
|                   |               |       |                         |
| Child =           | 15            |       |                         |
+-------------------+---------------+-------+-------------------------+

a\. Maximum application rates for food utensils were from product labels
1839-173, 10324-81, and 10324-117.

**Table *7***: Calculated EDIs, aPAD, and cPAD for Representative Dairy
and Beverage Consumption

  ---------------- ------------- ------------- ------------- -------------
  **Food Type**    **Exposure    **EDI         **DDD         **% cPAD**
                   Group**       (mg/p/d)**    (mg/kg/d)**   

  Milk             Adult Male    0.0232        3.31x10^-4^   0.0753

                   Adult Female                3.86x10^-4^   0.0878

                   Child^a^      0.0149        9.96x10^-4^   0.226

  Egg product      Adult Male    2.14x10^-7^   3.06x10^-9^   7.00x10^-7^

                   Adult Female                3.57x10^-9^   8.00x10^-7^

                   Child ^a^     1.38x10^-7^   9.20x10^-9^   2.00x10^-6^

  Beverages,       Adult Male    0.118         0.00169       0.385
  non-alcoholic                                              

                   Adult Female                0.00197       0.449

                   Child^a^      0.0763        0.00509       1.16

  Beverages,       Adult Male    0.00150       2.14x10^-5^   0.00490
  alcoholic, beer                                            

                   Adult Female                2.50x10^-5^   0.00570
  ---------------- ------------- ------------- ------------- -------------

a\. Child EDI values are multiplied by a modification factor of 0.64

**4.0 References**

FDA. 2003. "Sanitizing Solutions: Chemistry Guidelines for Food Additive
Petitions."

Last accessed June 9, 2003.

USAID. 2005. "ANNEX III: Recommended Energy Allowance Tables." November
2005.
<http://www.usaid.gov/our_work/humanitarian_assistance/ffp/crg/annex-3.htm>.
Last viewed January 23, 2006.

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

USEPA. 2005. Dietary Assessment of Chlorine Dioxide, Sodium Chlorite
From Their Use As Indirect Food Contact Sanitizers/Disinfectants (Hard
Surface Sanitizers). Memorandum from Najm Shamim, USEPA to Melba Morrow
and Jennifer Slotnick, USEPA. Dates August 15, 2005.

Versar. 2006. ADBAC Occupational and Residential Exposure Assessment.
Memorandum from Adria Diaz/Karie Riley/Kelly McAloon, Versar, Inc., to
Laura Bailey, USEPA dated January 16, 2006.