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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000646

Date: August 2, 2006

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

Subject: FCN No. 646 - Copolymer of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid

Notifier: DuPont Chemical Solutions Enterprise
Jackson Laboratories, Chamber Works
Deepwater, NJ 08023

To: Division of Food Contact Notifications (HFS-275)
Attention: Paul Honigfort, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

The above referenced notification contains two proposed uses for the food contact substance (FCS), as an oil and grease resistant treatment for paper and paperboard, one for prior to sheet forming, and one for use at the size press. The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(i) for the proposed use of the FCS as an oil and grease resistant treatment for paper and paperboard for use at the size press.

We have reviewed the claims of categorical exclusion and have concluded that categorical exclusion is warranted for the proposed use at the size press. The claim of categorical exclusion cites the section under which categorical exclusion is warranted, 21 CFR 25.32(i), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

The notifier submitted an environmental assessment (EA for the proposed use of the FCS when it is employed prior to sheet forming. The EA was required because as much as 12% of the FCS will not be incorporated into the finished food packaging but will instead remain with the white water, which will eventually be discharged to a wastewater treatment plant.

We have reviewed the EA and have prepared a Finding of No Significant Impact (FONSI) for the proposed use of the FCS as an oil and grease resistant treatment for paper and paperboard when employed prior to sheet formation (attached). After this notification becomes effective, this FONSI and the notifier's environmental assessment (in PDF, 1.09Mb), dated May 30, 2006, may be made available to the public and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

Please let us know if there is any change in the identity or use of the food-contact substance.

Annette M. McCarthy, Ph.D.

Attachment



 

Finding of No Significant Impact

A food contact notification (FCN No. 646), submitted by DuPont Chemical Solutions Laboratory, to provide for the safe use of a copolymer of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid for use as an oil and grease resistant treatment for paper and paperboard employed prior to the sheet forming operation.

The Environmental Review Group has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in an environmental assessment (in PDF, 1.09Mb) dated December May 30, 2006.

Prepared by __________________________________________Date: August 2, 2006
Annette M. McCarthy, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: August 2, 2006
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.