Environmental Decision Memo for Food Contact Notification No. 000752
|Date:||August 13, 2007|
|From:||Supervisor, Environmental Review Team (ERT)|
Office of Food Additive Safety (HFS-246)
|Subject:||FCN No. 752 - Formaldehyde polymer with 1-naphthalenol for use as an anti-scaling or release agent in the production of ethylene-vinyl chloride food-contact copolymers (EVC)|
|Notifier:||Akso Nobel Chemicals|
Chicago, IL 60607
|To:||Division of Food Contact Notifications (HFS-275)|
Attention: Anna Shanklin, Ph.D.
Attached are the Finding of No Significant Impact (FONSI) and our Supplement to the notifier's Environmental Assessment (EA) for FCN 752. When this notification becomes effective, the following documents may be made available to the public under a FOIA request and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html* after the notification becomes effective:
1. This FONSI;
2. The notifier's EA, dated July 12, 2007; and
3. Our supplement to the record for FCN 752.
The environmental record for FCN 752 references FCN 717 and the environmental record for FAP 3B4380, which is available on the FDA Dockets; hence our decision to make the EA, 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.
The EA contains an estimate of the market volume for the proposed use; we consider this information confidential and it must be redacted from the EA when it is made available to the public under a FOIA request and when we post it on the internet.
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. 752), 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 chloride food-contact copolymers (EVC)
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 dated July 12, 2007, which included by reference the environmental record for FAP 3B4380, and on information contained in our supplement to the record.
Prepared by: _____________________________________ Date: August 13, 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. 752
This document incorporates by reference the notifier's environmental assessment (EA) dated July 12, 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 FCN 717 and FAP 3B4380. We believe that the application of the FCS in this FCN is very similar to that in FCN 717 and FAP 3B4380 and, therefore, we believe that the environmental introductions, fate, and effects of substances introduced into the environment are substantially the same as those discussed in these regulated uses.
*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.