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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000751

Date:September 11, 2007
From:Chemist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 751 - 2-Propenoic acid, homopolymer, sodium salt, for use to control the formation of mineral scale during evaporation of beet or cane sugar juice.
Notifier:Alco Chemical
909 Mueller Avenue
Chattanooga, TN 37406
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 notifier's environmental assessment (EA) for FCN 751. When this notification becomes effective, these documents and the notifier's EA, dated July 24, 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. 751


 

Finding of No Significant Impact

A food contact notification (FCN No. 751), submitted by Alco Chemical, to provide for the safe use of 2-propenoic acid, homopolymer, sodium salt (with a weight average molecular weight of 2300 to 5700 Daltons and a weight average molecular weight to number average molecular weight ratio of not more than 6.3) for controlling the formation of mineral scale during evaporation of beet or cane sugar juice.

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 July 24, 2007, and our supplement to the environmental record for FCN 751.

Prepared by __________________________________________Date: September 11, 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: September 11, 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. 751

This document incorporates by reference the notifier's environmental assessment (EA) dated July 24, 2007.

The purpose of this supplement is to provide information and discussion focused upon aspects of the EA requiring additional explanation that clarify why we believe that significantly adverse impacts on the environment following disposal of the food contact substance (FCS) are very unlikely.

The food contact substance (FCS) is used at sugar production sites, which in the United States are chiefly located in agricultural regions suited to the cultivation of sugarcane and sugar beets. (To some extent, raw sugar may be refined at industrial locations distant from the agricultural regions that are the sources for its initial milling.)

The FCS is water soluble and is used during the evaporative stages of concentrating clarified sugar juice. The sugar juice, concentrated by evaporation into a thickened juice, is subsequently separated by industrial crystallization into sugar crystals and liquid molasses. Any technical differences in sugar sources and processing operations do not present unique effects requiring special environmental considerations pertaining to the use of the FCS.

Consequently, by virtue of its solubility and molecular weight, the FCS is anticipated to remain in the molasses by-product, which is a waste product from the perspective of sugar producers. Little, if any, of the FCS, its products, or its impurities is expected to enter the environment via discharges (wastewater effluents, gaseous emissions, and solid wastes) from sugar processing facilities.

As discussed in the EA, the agency has previously assessed the potential for environmental impact posed by the eventual disposal of related substances substantially alike to the FCS as a component of industrial and feed molasses and has found no significant impact. The FCS is expected to compete with essentially similar chemical substances already used for the same purpose. The agency is not aware of any new information pertaining to environmental risks specific to the FCS of this notification that would lead to a conclusion contrary to previous environmental decisions, based upon the same considerations, involving closely related chemical substances for similar uses and subsequent disposal from uses. Therefore, we do not anticipate that the FCS of this notification, as a fungible substance, will exacerbate any deleterious effects, if any, due to its inclusion in molasses used industrially to produce pharmaceuticals, yeasts, or (bio)chemicals.

Prepared by ___________________________________________ Date: September 11, 2007
William H Lamont, Chemist
Environmental Review Team
Office of Food Additive Safety


*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.