UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

			

 

MEMORANDUM								June 28, 2007

SUBJECT: 	DIETARY EXPOSURE ASSESSMENT OF COPPER-8 QUINOLINOATE USE OF
INDIRECT FOOD CONTACT SURFACES 

From:	A. Najm Shamim, PhD., Chemist

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

To:	Tim McMahon, PhD, Senior Toxicologist and Risk Assessor for Copper-8
Quinolinoate RED

	Risk Assessment and Science Support Branch

	Antimicrobials Division (7510P)

				And

	Kathryn Jakob, CRM for Copper-8 Quinolinoate RED

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

Thru:	Mark Hartman, Chief

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

Executive Summary:

Antimicrobials Division has assessed the exposure and risk assessment of
copper-8 quinoloate for its uses in pulp/paper and adhesives. AD does
such assessments routinely even if the label language indicates a
caution for the chemical not to be used for wrappings or exposing
adhesives to foods. These use scenarios have been addressed in the past
by AD for previous REDs. AD employs FDA methodology for indirect
migration of pesticides into foods.  

AD has determined that % aPAD and or % cPAD for copper-8 quinoloate uses
in pulp/paper (% aPAD and cPAD less than one percent for adults and
children) and adhesives (% cPAD less than one percent for adults and a
little over one percent for children) pose no dietary concerns for US
populations..

Discussion:

AD’s label reviews have shown that copper -8-quinolinoate has the
following use patterns/use sites. Some of which may require  indirect
food contact dietary exposure assessments.:  Sapstain use, wood in
contact with fruits and vegetables like mushroom trays etc.; paper
products, cardboard, adhesives, conveyor belts, Kraft paper, paperboard,
 plastics, potato. We will follow the same methodology for this RED
also. 

	

FDA METHODOLOGY FOR DETERMINING ESTIMATED DAILY INTAKE (EDI) OF A
PESTICIDE USE IN A FOOD CONTACT PAPER .

For the determination of the amount of a pesticide migrating into food
when the food is in contact with the treated paper, FDA makes the
following assumptions:

					Table I			

Parameter	Assumption/Value

1.Paper slurry, prior to entering paper manufacturing machine	1%: 99%
water, 1% pulp

2.Concentration of slurries entering driers	33% pulp, 67% water

3.Standard paper wt.	50 mg/in2

4.Finished paper	8% water, 92% pulp

5. Mass of food in contact with surface area of treated paper	10 g/in2

6. Consumption factor (CF)*	0.10

7. Daily  average food intake (adult)	3000 g

8. Daily average food intake (child)	1500 g



Notes: *FDA1,2,3 Method makes a number of assumptions for calculating
migration of active (in this case copper-8-quinolinoate)) from food
contact surfaces (paper): 1. Food contact surface (paper) can be a one
time use/day or a repeat use material; 2. Consumption factor (CF) or
fraction of daily food which comes in to contact with the packaging
surface (paper). CF represents the actual weight of food that comes into
contact with the paper to the weight of all food packaged with paper; 3.
The CF varies from one type of packaging (type of paper) to the other
(type of paper). FDA methodology of migration of active assumes a 100%
migration to the food commodities (This represents a worst case
scenario).

Note:	Label search indicates that copper-8-quinolinoate is used in pulp
and paper in more than one formulation. : 1)PQ-56 (EPA Reg#: 1022-489);
2)  PQ-57 (EPA Reg#: 1022-490); 3) Cunilate 2174-NO ( EPA Reg#:
2829-44); 4) Cunilate 2002 (EPA Reg#: 707-302); 5) Cu-8 (EPA Reg#:
10827-5). In all applications for pulp and paper maximum active is 10%
and in all application dilutions are made. The minimum dilution is 0.5%
active or 0.5 lb of active per 1000 lbs of paper. This also translates
into 1.0 lbs active per 2000 lbs.  A short ton = 2000 lbs.   We use this
rate of applications to determine the exposure of this active to food
through indirect contact with paper. 

1 lb active /2000 lb of finished paper = 454 active  mg/kg of  finished
paper

 But the paper slurry is 1% ; 454 mg x 01 = 4.5  active mg/kg of
finished paper = ~ 5 ppm of active in the paper slurry= Application Rate

Application  rate x % water / % pulp = 5 ppm  = 5µg/g pulp slurry x
0.67g water/0.33.g pulp = 10 µ g of active/g pulp.

Consumption Factor (CF) = 0.10

	Likely amount of Cu-8  migrating into food:

⁄ mass of pulp x 0.92 g pulp∕ g of paper x 0.05 g ∕ in2 x 1 in2
∕ 10 g food = 0.046µ g of Cu-8 ∕ g food

Since the Consumption factor for paper, based on FDA’s methodology is
0.10

The actual amount of Cu-8 in daily diet will be:

0.046µg of Cu-8 ∕ g food x 0.10 = 0.0046 µg ∕ g food

Estimated Daily Intake (EDI) of Cu-8 for an adult:

0.0046µg of Cu-8 ∕ g food x 3000 g food =13.8µg of Cu-8/person/day

Estimated Daily Intake (EDI) of Cu-8 for a child:

0.0046µg of Cu-8 ∕ g food x 1500 g food = 6.9 µg of Cu-8 /person/
day

AD’s End Points Selection Committee (A Memo by Tim McMahon, June 13,
2006) determined that: cPAD (chronic RfD) for Copper-8 quinolinoate is
0.05 mg/kg/day.

In Table II estimations are given for % cPAD

				Table II

		

∕ 0.05 mg/kg/day x 100

= 0.3%

	Child: 6.9 µg 	Child: 6.9µg/70 kg/day = 0.0046 mg/kg/day	Child:
0.0046 mg/kg/day ∕ 0.05 mg/kg/day = 0.9% 



The calculations of % cPAD show that there are no chronic dietary
concerns from the migration of Cu-8 form paper to food. No acute dietary
end points exist, and therefore, Agency does not have any acute exposure
from the use of Cu-8 by migration into foods.

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. 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
Copper-8 Quinolinoate 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 III gives estimates of % cPAD for adhesive use of Copper-8
Quinoloate

.

. 

					Table III					

Use	Dietary Conc. (ppb)	Estimated Daily Intake (EDI) µg/p/day	Daily
Dietary Dose (DDD) mg/kg/day

 

	% aPAD	% cPAD

( cPAD) = o.05 mg/kg/day

Adhesive	7	Adult: 7µg/g x 3000g = 21 µg/p/day

Child: 7 µg/g x 1500 g = 10.5 µg/p/day	Adult: 21 µg/70 kg/day =
0.0003 mg/kg/day

Child: 10.5 µg/15kg/day = 0.0007 mg/kg/day	Adult: no data. No concerns.

Child: no data. No concerns.	Adult:  0.0003 mg/kg/day ∕ 0.05 mg/kg/day
x100 = 0.6%

Child: 0.0007 mg/kg/day ∕ 0.05 mg/kg/day x 100  = 1.4 %

	

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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 Copper-8 Quinoloate in adhesives.

Another scenario which may likely pose some concerns is the use of
copper-8 treated wooden trays which are used to store or transfer foods.
No data, laboratory or monitoring, were submitted. It is therefore a
data gap for the dietary risk assessment for copper-8.

					BIBLIOGRAPHY

Food and Drug Administration (FDA), 2003, “Guidance for Industry:
Preparation of food Contact Notifications and food Additive Petitions
for Food contact Substances: Chemistry Recommendations, Final
Guidance”

FDA, 2003,   HYPERLINK "http://www.cfsan.fda.gov/~opa2pmmne.html" 
http://www.cfsan.fda.gov/~opa2pmmne.html 

FDA, 2003, “Sanitizing solutions: Chemistry Guidelines for Food
Additive Petitions, January 1993.   HYPERLINK "http://www"  http://www .
Cfsan.fda.gov/~dms/opa-cg3a.html.

AD’s End Point Selection Memo by  Tim McMahon, June 13, 2006

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