Food

Environmental Decision Memo for Food Contact Notification No. 000688

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: March 7, 2007

From: Chemist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)

Subject: FCN No. 688 - N-ethyl-N-hydroxy- ethanamine (CAS Reg. No. 3710-84-7).

Notifier: Arkema Inc.
2000 Market Street
Philadelphia, PA 19103

To: Division of Food Contact Notifications (HFS-275)
Attention: Elizabeth R. Sánchez, Ph.D.Through: Layla I. Batarseh, Ph.D., Supervisor, ERT

Attached is the Finding of No Significant Impact (FONSI) for FCN 688. After this notification becomes effective, this FONSI and the notifier's environmental assessment (in PDF, 412Kb), dated February 16, 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.*

In the environmental assessment (EA), a discussion about a chemical mechanism for oxygen scavenger reactions was incorrectly described in its details. Consequently, a summary reaction derived from the mechanism was not correctly formulated. However, the discussion of chemical mechanism was not essential to conclusions about the introduction of substances into the environment. Nonetheless, the summary reaction was actually reported correctly elsewhere in the EA. That correctly stated reaction was critical and supported conclusions relevant to the introduction of substances into the environment.

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

William H. Lamont

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 688), submitted by Arkema Inc., to provide for the safe use of N-ethyl-N-hydroxy- ethanamine (CAS Reg. No. 3710-84-7) as a polymerization regulator in the polymerization of vinyl chloride homopolymers and copolymers used in contact with food.

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) (in PDF, 412Kb), dated February 16, 2007.

Prepared by__________________________________________Date: March 7, 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: March 7, 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


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Ingredients and Packaging section under the Food topic of www.fda.gov.

Page Last Updated: 12/24/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.