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CFSAN/Office of Food Additive Safety
February 15, 2008
| Date: | February 15, 2008 |
| From: | Supervisor, Environmental Review Team (ERT) Office of Food Additive Safety (HFS-246) |
| Subject: | FCN No. 802 - Benzoic acid, 2-hydroxy-, monosodium salt used as a component of an adjuvant solution mixture to control or eliminate microbial contamination. |
| Notifier: | FMC Corporation c/o Keller and Heckman, LLP Washington, D.C., USA |
| To: | Division of Food Contact Notifications (HFS-275) Attention: Julie Mayer, M.F.S. |
The food contact substance for this notification is benzoic acid, 2-hydroxy, monosodium salt (sodium salicylate) to be used as a component of an adjuvant solution mixed with a peroxyacetic acid solution intended to reduce or eliminate microbial contamination in polymeric food-contact packaging. Attached are the Finding of No Significant Impact (FONSI) and, by reference, our supplement to the environmental assessment (EA) for FCN 634 by the same notifier and available at http://www.cfsan.fda.gov/~rdb/opa-envt.html. When this notification becomes effective, the FONSI and the notifier's EA, dated December 31, 2007, 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.
Layla I. Batarseh, Ph.D.
Attachment:
Finding of No Significant Impact
A food contact notification (FCN No. 802), submitted by FMC Corporation, to provide for the safe use of benzoic acid, 2-hydroxy, monosodium salt as a component of an adjuvant solution mixed with a peroxyacetic acid solution to reduce or eliminate microbial contamination in sterilizing polymeric food-contact packaging.
The Environmental Review Team 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 the notification, including an environmental assessment, dated December 31, 2007, and our supplement to the environmental record of the notifier's effective FCN 634.
Prepared by __________________________________________Date: February 15, 2008
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
