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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000349

Date: October 16, 2003

 

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

 

Subject: FCN No. 349 - Polyester-polyurethane resin-acid dianhydride adhesive in laminate structures for use at retort temperatures

 

Notifier: Dainippon Ink and Chemicals, Inc.
Sakashita, Itabashi-ku
Tokyo, Japan

 

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

 

 

This memorandum and finding of no significant impact (FONSI) supersede the August 27, 2001, memorandum from Annette McCarthy to Kenneth McAdams.

 

The notifier submitted FCN 349 with a claim of categorical exclusion under 21 CFR 25.32(i). The use level in the initial submission exceeded the five percent-by-weight required for the claim of categorical exclusion to be warranted. We informed the notifier of this fact and requested that the notifier submit an environmental assessment (EA). The notifier chose to accept a limitation that restricted use of the food contact substance to not greater than 5 percent-by-weight in order to qualify for the exclusion. Our review determined that the categorical exclusion was warranted under these use conditions, and we finalized a categorical exclusion memorandum dated August 27, 2003. However, prior to the effective date, the notifier requested that the limitation be removed. Since the use level exceeds the 5 percent-by-weight limitation required for the requested categorical exclusion, we requested that the notifier submit an EA as required under 21 CFR 25.20(i).

 

The notifier has submitted an EA dated September 29, 2003, and we have prepared a Finding of No Significant Impact (FONSI). When FCN 349 becomes effective, the attached FONSI and the notifier's EA, dated September 29, 2003, may be made available to the public.

 

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

 

 

 

Annette M. McCarthy, Ph.D.

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 349), submitted by Dainippon Ink and Chemicals, Inc., to provide for the safe use of polyester-polyurethane resin-dianhydride adhesive in laminate structures for use at retort temperatures.

 

 

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 dated September 29, 2003.

 

 

 

Prepared by_______________________________________ Date: October 16, 2003
Annette 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: October 16, 2003
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