**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, DC 20460**

OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES

![](media/image1.png)

Feb.12, 2008

MEMORANDUM

Subject: Dietary Risk Assessment for HHT (Grotan) for the RED Process

From: A. Najm Shamim, PhD., Chemist

Regulatory Management Branch II

Antimicrobials division (7510P)

To: William Hazel, Risk Assessor for HHT (Grotan) RED

Risk Assessment and Science Support Branch

> Antimicrobials Division (7510P)
>
> And
>
> Lance Wormell, CRM for HHT (Grotan) RED
>
> Regulatory Management Branch II
>
> Antimicrobials Division (7510P)

Thru: Mark Hartman, Chief

Regulatory Management Branch II

Antimicrobials Division (7510P)

DP Barcode: (346239)

**EXECUTIVE SUMMARY**

**As pursuant to the Agency policy AD has carried out the dietary risk
assessment from the AD use patterns which present the indirect food
contact scenarios. AD has conducted the risk assessment of those use
patterns which triggered the possibility of indirect food migration from
adhesives, cutting boards, and counter tops uses. All % aPADs and %
cPADs for adults and children for HHT (Grotan) uses fall well below
Agency's level of concern.**

**[DIETARY RISK ASSESSMENT FROM INDIRECT FOOD USES OF HHT
(GROTAN)]{.underline}**

**Background:**

AD's label search has shown that HHT (Grotan) is used in many scenarios
which trigger risk assessment for the indirect food contact purposes.
The following table lists the use patterns, and application rates of HHT
(Grotan).

Table I

  ------------------------ --------------------- -----------------------------
  **Product Name/EPA       **Use Scenario**      **Application Rates**
  Reg#**                                         

  SURCIDE-P 68868-1        Dish detergents,      0.05-0.20% (add 0.4-1.8
                           all-purpose cleaners, pints/100 gallons of product
                           hard surface          
                           cleaners, printing    
                           inks                  

  NIPACIDE TBX/49403-32    Adhesives             0.1-0.2%, based on the total
                                                 weight of the finished
                                                 product

  NIPACIDE BK/49403-16     Emulsions, adhesives, 0.1-0.3% (1,000-3,000 ppm)
                           inks                  

  NIPACIDE TABX/49403-32   Adhesives, emulsions, 0.1-0.2%, based on the total
                           natural and synthetic weight of the finished
                           thickener, aqueous    product
                           slurries              

  ONYXIDE 200/1839-99      Adhesives, emulsions, 0.1-0.3% (1,000-3,000 ppm)
                           inks                  

  PROXEL TN                Adhesives, ink and    Adhesives: 0.10-0.20%;
  Preservative/1258-1248   dyes, aqueous mineral Slurries:0.01-0.20%; Inks and
                           slurries              dyes:0.025-0.15% (based on
                                                 total weight of product)

  TRIADINE 3/1258-1071     Coating and           Addition up to 1500 ppm of
                           emulsions, adhesives, this product (0.15 lbs. of
                           sealants              this product/100 lbs. of
                                                 formulation

  TRIADINE 10/1258-990     Adhesives, sealants,  Adhesives and sealants: (0.15
                           inks                  lbs. of this product/100 lbs.
                                                 of formulation; 0.5 lbs.
                                                 product/100 lbs. of ink
  ------------------------ --------------------- -----------------------------

**RESIDUE CHEMISTRY**

All uses of HHT (Grotan) are nonagricultural, and no residue chemistry
data based on Agency's Residue Chemistry Guidelines (OPPTS GLN 860.xxx)
were submitted nor the Agency asked for it. Therefore, The Agency has
used available methods to estimate HHT (Grotan) residues on food due to
migration of this chemical, when this chemical comes in to contact with
food-contact paper. In this regard Food and Drug Administration has
developed guidelines to estimate residues in food due to migration into
food.

Antimicrobials Division in the recent REDs has included the scenarios
like: paper/pulp, paperboard, adhesives, counter tops, cutting boards,
as a source of indirect food contacts surfaces and a cause of migration
of pesticides into foods. For all scenarios' AD has heavily used FDA
methodology for calculating the estimated daily intakes (EDI), and daily
dietary doses (DDD). In turn, we calculate the % a-and cPADs for the US
populations to determine if there are any exceedences. Agency has
decided that FDA methodology will be considered a tier-I assessment
(screening level) where it is assumed that the transfer of the pesticide
to the food is 100%. If there are no risk concerns, it is so reported.
If, however any dietary risks arise, then tier-II, which is QRG method
called IDREAM will be used. In the present case, no dietary risks are
observed at the tier-I level.

**Detailed Discussion:**

1)  **Adhesive Use of HHT (Grotan)**

As a matter of policy, AD has assessed adhesive use as an indirect food
use. Since it is likely that adhesives may end up in the food packaging
materials, and this may result in the migration of the pesticide into
the food indirectly. For the indirect food dietary assessment, AD has
adopted Food & Drug Administration (FDA) methodology. For adhesive use,
FDA has provided guidance for dietary estimation that a maximum of 7 ppb
of a pesticide is likely to migrate from the food packaging materials
into the food. (FDA guidance document states: " if the adhesive is
either separated from food by a functional barrier, or the quantity of
adhesive that contacts aqueous and fatty food is limited to the trace
amounts at seams and edges, then the migration levels for the substances
generally will be assumed to be no greater than 50 ppb, and if a CF
factor (consumption factor) of 0.14 is taken in to account for
adhesives, it gives a dietary concentration of 7 ppb." (FDA, 2007) The
quantity of 7 ppb can be used to calculate the Estimated Daily Intake
(EDI), Daily Dietary Dose (DDD), and using the acute and dietary end
points from toxicity data, one calculates the overall risks to general
and subgroups of populations ( % aPAD, and % cPAD).

For the present case: FDA's assumptions are: 1) Maximum migration of HHT
(Grotan) into food from adhesive use = 7 ppb = 7µg/g; 2) Maximum adult
food intake = 3000 g; 3) Maximum food intake for a child = 1500 g.

In general, % PAD = DDD/% a PAD or % cPAD.

Table II gives estimates of % cPAD for adhesive use of HHT (Grotan)

> Table II

Dietary Exposure of HHT (Grotan) from Adhesive Use

+-------+------+---------------+--------------+---------+------------+
| **    | *    | **Estimated   | **Daily      | **%     | **% cPAD** |
| Use** | *Die | Daily Intake  | Dietary Dose | aPAD**  |            |
|       | tary | (EDI)         | (DDD)        |         | **( cPAD = |
|       | C    | µg/p/day**    | mg/kg/day**  | *       | 0.50       |
|       | onc. |               |              | *(aPAD= | mg/kg/d)** |
|       | (pp  |               |              | 0.50    |            |
|       | b)** |               |              | mg/     |            |
|       |      |               |              | kg/d)** |            |
+=======+======+===============+==============+=========+============+
| Adh   | 7    | Adult:        | Adult: 21 µg | Adult:  | Adult:     |
| esive |      | .007µg/g x    | x (1 mg/1000 | 0.00    | 0.0003     |
|       |      | 3000g = **21  | µg)/70       | 03/0.50 | mg/kg/day  |
|       |      | µg/p/day**    | kg/day =     | x 100)  | ∕0.5       |
|       |      |               | **0.003      | =       | mg/kg/day  |
|       |      | Child: .007   | mg/kg/day**  | **      | x100 =     |
|       |      | µg/g x 1500 g |              | 0.06%** | **0.06%**  |
|       |      | = **10.5      | Child:       |         |            |
|       |      | µg/p/day**    | 10.5µg (1    | Child:  | Child:     |
|       |      |               | mg/1000 µg)  | 0.000   | 0.0007     |
|       |      |               | /15kg/day =  | 7/0.500 | mg/kg/day  |
|       |      |               | **0.0007     | =       | ∕ 0.5      |
|       |      |               | mg/kg/day**  | **      | mg/kg/day  |
|       |      |               |              | 0.14%** | x 100 =    |
|       |      |               |              |         | 0.1**4 %** |
+-------+------+---------------+--------------+---------+------------+

These calculations assume that the adhesive use is 100% of the chemical
produced, which is not a likely scenario. The actual % cPAD is going to
be much lower than the estimated one The Agency has no chronic dietary
concerns from the use of HHT (Grotan) in adhesives.

2)  **Counter Tops and Cutting Boards:**

Table III lists the input parameters and explanations for EDI, DDD, %
aPAD and % cPAD for HHT (Grotan) use on counter tops, and cutting board.

Table III

  --------------- ------------------------------- ----------------------------
  **Parameter**   **Comment**                     **Value/Units**

  AR              Application Rate, usually       ppm or µg
                  highest application rate is     
                  used                            

  RS              Residual solution               1 mg/cm^2^ , adapted from
                                                  FDA methodology

  SA              Treated surface area which      Cm^2^ ; assumed to be 2000
                  comes into contact with food    cm^2^ for counter tops and
                                                  cutting boards

  F               \% fraction of the active       No units; normally Agency
                                                  has used 10%., worst case
                                                  scenario 100/100, 100%.
                                                  (used worst case)

  BW              Body Weight                     Adult: 70 kg; child: 15 kg

  EDI             Estimated Daily Intake          = AR \* RS \* SA \* F

  DDD             Daily Dietary Dose              = EDI/BW

  aPAD            Acute dietary end points        For HHT (Grotan): 0.30
                                                  mg/kg/day

  cPAD            Chronic Dietary end point       For HHT (Grotan): 0.30
                                                  mg/kg/day

  \% aPAD         Ratio of DDD and aPAD           \% population affected
                                                  (acute)

  \% cPAD         Ratio of DDD and cPAD           \% population affected
  --------------- ------------------------------- ----------------------------

Table IV provides the summary of calculations and results for EDI, DDD,
% aPAD, and % cPAD; based on: a) maximum application rate = .2%; aPAD =
0.50 mg/kg/day and cPAD = 0.50 g/day; fraction % = 10%; and maximum
surface area food is exposed to the pesticide = 2000 cm^2^

Table IV

+----------+-----------------------------------------------------------+
| **Par    | **Calculations/Results**                                  |
| ameter** |                                                           |
+----------+-----------------------------------------------------------+
| EDI      | AR \* RS\* SA \* F; = 3,000 µg/1000 mg (ppm) \* 1         |
|          | mg/cm^2^ \* 100/100 \* 2000 cm^2^ = **6000 µg**           |
+----------+-----------------------------------------------------------+
| DDD      | **Adult**: EDI/70 kg/day = 6000µg/70 = **85.7             |
|          | µg/kg/day**; **Child**: EDI/15 kg/day = 6000µg/15 kg/day  |
|          | = **400 µg/kg/day**                                       |
+----------+-----------------------------------------------------------+
| \% aPAD  | DDD/ aPAD x 100 ; **Adult**: 0.0857 mg/kg/day/ 0.5        |
|          | mg/kg/day **= 17%**                                       |
|          |                                                           |
|          | **Child:** 0.4 mg/kg/day/0.50 mg/kg/day x 100 **=80**%    |
+----------+-----------------------------------------------------------+
| \% cPAD  | **Adult:** 0.0857 mg/kg/day/0.5 mg/kg/day = **17.0%;      |
|          | Child =** 0.40 mg/kg/day/0.50 mg/kg/day = **80.0%**       |
+----------+-----------------------------------------------------------+

All results are well below a level of concern. These results are very
conservative and the likelihood of exposure from counter tops and
cutting board use on a regular basis of 7/24/year is minimum. In
addition use of surface area of 2000 cm^2^ of 7/24/year is also not
likely. The Agency believes the actual exposure from counter tops and
cutting boards will be much lower than the results shown here.

**3) Inks and Dyes:**

The Agency does not have a model to work with. It is estimated that
exposure from inks will be very low. The Agency does nit see any dietary
concerns fro use of HHT (Grotan) with inks.

**Conclusions**:

None of the indirect food contact scenarios appear to exceed Agency's
level of concern at the screening level (tier-I)

> BIBLIOGRAPHY

1.  FDA, 2007, A Guidance For Industry: Preparations of Food Contact
    Notifications and Food Additive Petitions for Food Contact
    Substances, Chemistry Recommendations. Final Guidance, 2007
    [http://www.cfsan.fda.gov](http://www.cfsan.fda.gov/)

2.  FDA, 2003. Sanitizing Solutions: Chemistry Guidance for Food
    Additive Petitions, January 2003.
    [Http://www.cfsan.fda.gov](http://www.cfsan.fda.gov/)