Environmental Decision Memo for Food Contact Notification No. 000717
|Date:||June 5, 2007|
|From:||Supervisor, Environmental Review Team (ERT)|
Office of Food Additive Safety (HFS-246)
|Subject:||FCN No. 717 - Formaldehyde polymer with 1-naphthalenol for use as an anti-scaling or release agent in the production of ethylene-vinyl acetate food-contact copolymers|
|Notifier:||Akzo Nobel Polymer Chemicals|
Chicago, IL 60607
|To:||Division of Food Contact Notifications (HFS-275)|
Attention: Mark A Hepp, Ph.D.
Attached are the Finding of No Significant Impact (FONSI) and our Supplement to the notifier's Environmental Assessment (EA) for FCN 717. When this notification becomes effective, the following documents 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* after the notification becomes effective:
- This FONSI;
- The notifier's EA (in PDF, 446Kb), dated March 23, 2007; and
- Our supplement to the record for FCN 717.
The environmental record for FCN 717 includes by reference the environmental record for FAP 3B4380, which is available on the FDA Dockets; hence our decision to make the EA (in PDF, 785Kb), dated May 24, 1995, and the FONSI, dated December 8, 1995, for FAP 3B4380 publicly available on the same page on the internet as the record for FCN 717.
Please let us know if there is any change in the identity or use of the food-contact substance.
Layla I. Batarseh, Ph.D.
Finding of No Significant Impact
A food contact notification (FCN No. 717), submitted by Akzo Nobel Polymer Chemicals, LLC, to provide for the safe use of formaldehyde polymer with 1-naphthalenol as an anti-scaling or release agent, applied to the internal parts of reactors employed in the production of ethylene-vinyl acetate food-contact copolymers
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 (in PDF, 446Kb) dated March 23, 2007, which included by reference the environmental record for FAP 3B4380, and on information contained in our supplement to the record.
Prepared by:__________________________________________Date: June 05, 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
Supplement to the Environmental Record
for Food Contact Notification No. 717
This document incorporates by reference the notifier's environmental assessment (EA) (in PDF, 446Kb) dated March 23, 2007, and the EA and FONSI for FAP 3B4380
The purpose of this supplement is to ensure the accuracy of the environmental record. Comments of the Environmental Review Team to supplement specific format items in the EA are provided below.
Format Item 5: Identification of Substance that is the Subject of the Proposed Action.
A more detailed description of the FCS is presented in the EA for FAP 3B4380.
Format Item 6. Introductions of Substances into the environment as a result of use and disposal: The intended use of this FCS is the same as the regulated use in FAP 3B4380. We believe that the application of the FCS in this FCN is very similar to that in FAP 3B4380 and, therefore, we believe that the environmental introductions, fate, and effects of substances introduced into the environment is substantially the same as those discussed in FAP 3B4380.
Market volume: The market volume for the proposed use, provided in a confidential section of the FCN, is an extremely small fraction of the total market volume of the subject FCS used as a nonfunctional component of food-packaging material in the USA. Therefore, the incremental increase in the environmental introductions of the FCS is very small and is not expected to cause any significant impact on organisms in the environment.
*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.