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CFSAN/Office of Food Additive Safety
August 29, 2007
| Date: | August 29, 2007 |
| From: | Chemist, Environmental Review Team (ERT) Office of Food Additive Safety (HFS-246) |
| Subject: | FCN No. 725 - (1,1'-biphenyl)-4,4'-diol, polymer with 1,1'-sulfonylbis(4-chlorobenzene), for use as a resin in the manufacture of food contact articles. |
| Notifier: | BASF Aktiengesellschaft KS/KS-E100 D-67056 Ludwigshafen, Germany |
| To: | Division of Food Contact Notifications (HFS-275) Attention: Vivian Gilliam Through: Layla I. Batarseh, Ph.D., Supervisor, ERT |
Attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 725. After this notification becomes effective, this FONSI and the notifier's EA, dated February 5, 2007, may be made available to the public in response to a FOIA request, and we will post redacted copies of 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.
William H. Lamont
Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 725
A food contact notification (FCN No. 725), submitted by BASF Aktiengesellschaft to provide for the safe use of (1,1'-biphenyl)-4,4'-diol, polymer with 1,1'-sulfonylbis(4-chlorobenzene), for use as a resin in the manufacture of food contact articles.
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 an environmental assessment (EA), dated February 5, 2007, and a confidential section, dated June 6, 2007, to the notification and on our supplement to the environmental record for FCN 725.
Prepared by__________________________________________Date: August 29, 2007
William H. Lamont, Chemist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by__________________________________________Date: August 29, 2007
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
This document incorporates by reference the notifier's environmental assessment (EA), dated February 5, 2007.
The purpose of this supplement is to discuss briefly economic factors, which were not presented in the EA or in a confidential section pertinent to the EA, that govern the potential for environmental impact posed by the use and disposal from use of the food contact substance (FCS). Consideration of economic factors in our analysis of the potential for environmental impact was important to support a finding of no significant impact (FONSI) and was needed to ensure the completeness of the environmental record.
Our finding was based partly on the notifier's strategic business projection for specific production of the FCS. We believe that the intended use of the FCS as a fungible replacement for other competitive, single use, food packaging materials is economically restrained primarily by cost and secondarily by production capacity. A significant diversion of the notifier's annual manufacturing capacity of 12,000 metric tons (year 2007 expected maximum capacity) for production of similar polymeric resins from engineering and industrial demands to single use packaging applications for the FCS would likely generate a higher price. Expansion of the manufacturing capacity to accommodate the additional demand for the FCS would not be expected to lower the already high intrinsic production cost of the resin. We believe that single use food contact containers fabricated from the FCS would be more expensive than glass containers and much more expensive than food packaging commodity plastics. Consequently, we expect that economic impediments to any major use of the FCS as single use packaging material operate in commerce on its supply and demand to limit severely its potential for environmental impact.
Prepared by ___________________________________________ Date: August 29, 2007
William H. Lamont, Chemist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
