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Environmental Decision Memo for Food Contact Notification No. 000326

Date: June 3, 2003

 

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

 

Subject: FCN No. 326 - N-(2-hydroxyethyl)octadecanamide (SMEA) for use as a processing aid in rinse-aid products used in the final rinse water of commercial dishwashing machines

 

Notifier: Ecolab, Inc.
370 Wabasha Street
St. Paul, MN 55102-1390

 

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

 

 

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's revised environmental assessment (EA) for FCN 326. 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 April 25, 2003; and
3. Our supplement to the revised EA for FCN 326.

 

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

 

 

 

John Dennison

 

2 Attachments

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 326), submitted by Ecolab, Inc., to provide for the safe use of N-(2-hydroxyethyl)octadecanamide (SMEA) as a processing aid in rinse-aid products in the final rinse water of commercial dishwashing machines.

 

 

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 (EA) dated April 25, 2003, and on our supplement to that EA.

 

 

 

Prepared by___________________________________________ Date: June 3, 2003
John Dennison., Environmental 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: June 3, 2003
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. 326

This document incorporates by reference the notifier's revised environmental assessment (EA) dated April 25, 2003.

 

Under Format Item 8 of the revised EA (April 25, 2003), the notifier stated that the impact from the use of SMEA in rinse aids will be minimal based on the low levels at which the substance may be introduced into the environment. The notifier did partially support such a conclusion by providing some ecotoxicity data under Format Item 7, for closely related substances or hydrolysis products, and by calculating the EIC under Format Item 6(b) and the EEC under Format Item 7.

It is not always true that a low level at which a substance is introduced into the environment means low ecotoxicity of the substance, especially if the substance does not biodegrade, but rather accumulates in the environment. Consequently, we have prepared this supplement to the EA to discuss further the environmental fate and effects of this FCS (SMEA). We estimated ecotoxicity endpoints using structure-activity relationships (SAR) for the FCS.

Structure-Activity Relationship Analysis

The chemical formula for SMEA is C20H41NO2 (M.W. = 327.56 Daltons). We have conducted environmental fate and ecotoxicity analysis for SMEA, using EPI SuiteTM (v3.10) SAR predication models . Based on the predicated data, we have arrived at the following conclusions:

1. The FCS has a relatively high octanol-water partition coefficient and low water solubility, resulting in its removal from water.

2. The SMEA is expected to undergo primary biodegradation quickly, within days, as indicated by the probability of linear biodegradation model of 1.07 and non-linear model of 0.98, where values of over 0.5 indicate fast biodegradation.

3. Acute and chronic toxicities of SMEA are not expected to occur at the worst-case estimates of the environmental concentrations of the substance, 8.7 ppt., as shown under Format Item 7 of the revised EA.

Conclusion

Based on the small introduction of SMEA to aquatic environments, little potential to accumulate in the environment, and its rapid degradation, we believe that there would be no potential for significant adverse environmental impacts due to the expected release of SMEA into the environment as proposed in FCN 326.

 

 

 

Prepared by_____________________________________________ Date: June 3, 2003
John Dennison, Environmental 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