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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000554

Date: January 19, 2006

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

Subject: FCN No. 554 - 2-Propenoic acid, homopolymer, sodium salt, to control mineral scale during evaporation of beet or cane sugar juice in the production of sugar.

Notifier: Ciba Specialty Chemicals Corp.
540 White Plains Road
Tarrytown, NY 10591

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

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 554. The food contact substance is 2-propenoic acid, homopolymer, sodium salt, with weight average molecular weight of 2300 to 5700 Daltons and weight average molecular weight to number average molecular weight ratio of not more than 6.3. When this notification becomes effective, these documents and the notifier's EA, dated December 13, 2005, 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.*

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

William H. Lamont

2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Assessment for Food Contact Notification No. 554





Finding of No Significant Impact

A food contact notification (FCN No. 554), submitted by Ciba Specialty Chemicals Corporation, 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) to control mineral scale during evaporation of beet or cane sugar juice in the production of sugar.

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 an environmental assessment (EA), dated December 13 2005, and our supplement to that EA.

Prepared by __________________________________________Date: January 19, 2006
William H. Lamont, Chemist
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: January 19, 2006
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. 554

This document incorporates by reference the notifier's environmental assessment (EA) dated December 13, 2005.

The purpose of this supplement is to provide additional information and discussion specifically focused upon the route of introduction of the food contact substance (FCS) into the environment. The FCS is similar in identity and function to sodium polyacrylate regulated under 21 CFR 173.73.

The notifier incorporated, by electronic reference, Attachment A to the EA. The source for Attachment A, "Sugarcane Processing.pdf," was Supplement C, June 1997, Chapter 9, "Food and Agricultural Industries," Section 10, "Confectionary Products," Subsection 1, "Sugar Processing," of US Environmental Protection Agency, Compilation of Air Pollutant Emission Factors, Fifth Ed., Vol. 1: Stationary Point and Area Sources, EPA AP-42, US Government Printing Office, SN 055-000-00500-1, Washington, DC, January 1995. Attachment A is publicly available and may be currently obtained at http://www.epa.gov/ttn/chief/ap42/ch09/final/c9s10-1a.pdf.

The notifier also incorporated, by electronic reference, Attachment B to the EA. Attachment B, "11-Sugar.ppt," submitted in a Microsoft PowerPoint electronic format, was a Ciba presentation describing the use and mechanism of the FCS as an inhibitor for scale formation. Attachment B included a sub attachment, entitled "Sugar.doc," describing sugarcane processing, which was derived from copyrighted material in the Encylopaedia Brittannica, 1996, under the entry "Food Processing." We obtained permission from Ciba on December 12, 2005, to use some of Ciba's own information in Attachment B in this supplement. Otherwise, because Attachment B is not in a text format and chiefly because of copyright issues involving the sub-attachment, we are not making Attachment B publicly available, but instead we are summarizing information only to an extent necessary to discuss our environmental decision.

The notifier described in Attachment B the mode of action for the FCS as a scale inhibitor during the process of evaporating sugar juice to form concentrated sugar syrup. In Attachment B, the notifier further disclosed that the FCS is eventually depleted from the sugar syrup by its deposition with the scale. The scale containing the FCS can be removed as waste, the management of which complies with environmental regulations governing disposal in landfills as declared by the notifier in the EA.

The notifier did not provide data or information to support the claim that the FCS is entirely removed in scale deposits and subsequently could be managed as solid waste. We believe that the FCS would not be co deposited in anything other than adventitious amounts with scale forming constituents of the sugar juice. Instead, we believe that formation of a colloidal suspension is likely, and virtually all the FCS is expected to remain in solution or suspension in aqueous phases of by products removed after separation of sugar by industrial crystallization.

In our environmental decision for FAP 3A 3699, which resulted in regulation of a similar sodium polyacrylate at 21 CFR 173.731, we concluded that sodium polyacrylate will "...become a component of the aqueous phase of the molasses produced during sugar processing and refining." We specifically expected that disposal from use of sodium polyacrylate would not occur in discharged waste products generated at sugar processing locations. The basis of our opinion rested upon conclusions from experimental data provided in FAP 3A 1019 submitted by Dow Chemical Company2. Analytical studies using carbon 14 radioisotope tracer experiments performed between December 1959 and April 1960 reported the distribution of residual acrylamide acrylate resin in cane sugar and in by products of cane sugar manufacture. Consequently, based on the tracer experiments reported in FAP 3A 1019, we concluded that sodium polyacrylate would also be similarly distributed with respect to the use proposed in FAP 3A 3699.

Because the FCS is chemically identical to the additive considered in FAP 3A 3699 and the proposed use is functionally identical, we conclude that the route of introduction of the proposed FCS into the environment will be identical to that considered in our environmental decision for the additive of FAP 3A 3699. Moreover, we believe that the analysis of environmental introduction, fate, and effects of the FCS considered in FAP 3A 3699 is still applicable to FCN 554. Also, based on information in the notification and EA that the FCS is a direct replacement for sodium polyacrylate already regulated under an applicable food additive regulation at 21 CFR 173.73, we believe that a reasonable expectation exists that any additional increase, if any at all, in the amount of the substance introduced as a result of the proposed use of the FCS will be very small. Consequently, no significant impact on resources and energy following disposal from use of the FCS is anticipated because such use of resources and energy will be virtually unchanged. Thus, we conclude that an action to permit use of the FCS does not individually or cumulatively have a significant effect on the human environment.

Prepared by ___________________________________________ Date: January 19, 2006
William H Lamont, Chemist
Environmental Review Group
Division of Chemistry Research and Environmental Review


(1)FAP 3A 3699 was submitted by Calgon Corporation and resulted in regulation of sodium polyacrylate to control mineral scale during the evaporation of beet sugar juice or cane sugar juice in the production of sugar, Federal Register, 53, 39465 (October, 7, 1988)

(2)A regulation, which is currently amended at 21 CFR 173.5, prescribing the conditions of use of acrylamide acrylic acid resin in the clarification of beet sugar and cane juice sugar was originally issued as a result of FAP 3A 1019, Federal Register, 28, 12747 (November 30, 1963).


*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.