UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

			OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

 								

MEMORANDUM							September 30, 2007

SUBJECT:	Dietary Risk Assessment (Indirect Food Contact) Uses in Paper
Manufacturing Process of 
Poly[(oxyethylene)(dimethylimino)ethylene(dimethylimino) ethylene
dichloride] [Busan 77]

From:	A. Najm Shamim, PhD., Chemist

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

To:	Talia Lindheimer, Risk Assessor for Busan 77

	Risk Assessment and Science Support Branch

	Antimicrobials Division (7510P)

			And

	ShaRon Carlisle, CRM for Busan 77 RED Process

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

Thru:	Diane Isbell,  Team leader,

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

		And

	

	Mark Hartman, Chief

	Regulatory Management Branch II

	Antimicrobials Division (7510P)

DP Barcode:	

			EXECUTIVE SUMMARY

	For completion of the RED process, the Antimicrobials Division is
required to complete a risk assessment for the indoor uses of Busan 77;
for possible indirect food contact scenarios like paper manufacturing
processes.

There are no risk dietary concerns for Busan 77 uses at this time.

DIETARY RISK ASSESSMENT OF  BUSAN 77 FROM INDRIECT FOOD CONTACT SURFACES

Background:

AD’s label search has shown that Busan 77 is used for paper 
manufacturing processes. The process consisted of first treating a
certain amount starch which is then added to the chemicals used for
paper manufacturing process. This could entail a possible migration of
Busan 77 to the food indirectly. Two labels: Bio/TEC 112 (EPA Reg#
55137-1) and Bioguard Algae All 60 (EPA Reg# 5185-339) indicated
possible use as outlined above in the paper manufacturing process.  A
third label (Reg#: 1448-42) indicates that Busan 77 is used in paper and
pulp manufacturing process but not as a primary microbiocide. Also the
rate of application is set at 10 ppm.  AD has conducted dietary risk
assessments on various REDs for application rates in the range of 1000
to 1200 ppm levels.  In all such application rates AD did not find any
dietary risks to any set of population groups.  

	RESIDUE CHEMISTRY

All uses of Busan 77 are nonagricultural, and no residue chemistry data
based on Agency’s Residue Chemistry Guidelines (OPPTS GLN 860) were
submitted nor the Agency asked for it. Food and Drug Administration has
developed guidelines to estimate residues in food due to migration into
food.1, 2   EPA uses this methodology for dietary risk assessments

The registrants have recently communicated to the Agency (Memo by
Buckman Laboratories to ShaRon Carlisle, CRM for Busan 77) that Buckman
no longer supports the use of Busan 77 on treating starch which in turn
is used for paper manufacturing processes (which result in indirect
migration of Busan 77 into food).

Conclusions:

Since  indoor uses of Busan 77   in treating starch and using this
treated starch into the paper and manufacturing processes have been
canceled and   one application of Busan 77 at a level of 10 ppm into
paper and pulp manufacturing process is very low. AD has conducted
dietary assessment for other REDs at application rates of 1000 to 1200
ppm and have found no dietary risk for all sets of US Populations. AD
considers that an application rate of 10 ppm will not trigger any
dietary concerns.

The Agency, therefore has no dietary concerns for Busan 77 indoor uses
at this time

					BIBLIOGRAPHY

FDA, 2003, A Guidance For Industry: Preparations of food Contact
Notifications and Food Additive Petitions for Food Contact Substances,
Chemistry Recommendations. Final Guidance, April 2003.   HYPERLINK
"http://www.cfsan.fda.gov"  http://www.cfsan.fda.gov 

FDA, 2003.  Sanitizing  Solutions: Chemistry Guidance for Food Additive
Petitions, January 2003.   HYPERLINK "Http://www.cfsan.fda.gov" 
Http://www.cfsan.fda.gov 

					

			

			

				

 

