• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 000442

Date: August 9, 2004

 

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

 

Subject: FCN No. 442 - Alcohol ethoxylate for use as a component of a mixture intended for use as a thickener for hand sanitizers for food contact use

 

Notifier: Noveon, Inc.
9911 Brecksville Road
Cleveland, OH 44141-3247

 

To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

 

Attached are the Finding of No Significant Impact (FONSI) and our Supplement to the Environ-mental Assessment (EA) for FCN 442. When this notification becomes effective, the following documents may be made available to the public:

1. This FONSI;
2. The notifier's revised EA, dated July 26, 2004; and
3. Our Supplement to the Environmental Assessment for FCN 442.

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

 

 

 

Annette M. McCarthy, Ph.D.

 

2 Attachments

 





Finding of No Significant Impact

A food contact notification (FCN No. 442), submitted by Noveon, Inc., to provide for the safe use of alcohol ethoxylate where the alcohol contains from 12 to 22 carbon atoms and the ethoxylate chain contains from 4 to 20 repeating ethoxylate units as a component of a mixture intended for use as a component of a thickener for hand sanitizers used in food service establishments.

 

 

The Environmental Review Group 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 a revised environmental assessment dated July 26, 2004, and on our Supplement to the Environmental Assessment for FCN 442.

 

 

 

Prepared by________________________________________ Date: August 9, 2004
Annette M. McCarthy, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

 

Approved by________________________________________ Date: August 9, 2004
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 





Supplement to the Environmental Information
for Food Contact Notification No. 442

This document incorporates by reference the notifier's environmental assessment (EA) dated July 26, 2004.

 

Format Item 6. Introduction of Substances into the Environment

The notifier indicated under format items 6 and 8 that the Carbopol. polymers do not biodegrade, inhibit waste treatment bacteria, or pass through wastewater treatment to the environment, but instead are removed with the biomass. The information provided does not indicate if the studies were conducted using a polymer that contained the subject food contact substance (FCS) and, therefore, we can not depend on these studies to determine the fate of the FCS in sewage treatment plants.

Studies have shown that, in general, sewage treatment plants typically remove 82%, and as much as 93%, of the alcohol ethoxylate compounds that enter the plant. This is due to significant adsorption that occurs in the sewage sludge. Anaerobic biodegradability laboratory tests have resulted in the classification of alcohol ethoxylates as "well biodegradable." As a class they are generally considered to be non-toxic.

Based on the above information we agree with Noveon, Inc.'s conclusion that the major route of introduction of the FCS into the environment will be the result of land application of biosolids from sewage treatment plants and that, based on the predicted environmental exposure concentration, no adverse environmental effects are expected.