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Environmental Decision Memo for Food Contact Notification No. 000370

Date: October 27, 2003

 

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

 

Subject: FCN No. 370 - Dibutyl sebacate as a dispersing agent for pigments used as colorants in all polymers

 

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

 

To: Division of Food Contact Notifications (HFS-275)
Attention: William J. Trotter, Ph.D.
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 370. When this notification becomes effective, these documents and the notifier's EA, dated October 3, 2003, may be made available to the public:

 

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

 

 

 

Tong Zhou, Ph.D.

 

2 Attachments

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 370), submitted by Ciba Speciality Chemicals Corporation, to provide for the safe use of dibutyl sebacate as a dispersing agent for pigments used as colorants in all polymers.

 

 

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 October 3, 2003, and on our supplement to that EA.

 

 

 

Prepared by___________________________________________ Date: October 27, 2003
Tong Zhou, 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: October 27, 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. 370

This document incorporates by reference the notifier's environmental assessment (EA) dated October 3, 2003.

 

Background

 

Under Format Item 6.b. of the EA, the notifier, Ciba Specialty Chemicals Corporation, indicated that there is little or no introduction of the food contact substance (FCS), dibutyl sebacate, as a result of its use, since a scrubber will capture the FCS that is lost during the spray-drying step. The notifier stated under Format Item 4 ("Location of disposal") that the wastewater in the scrubber goes directly to a wastewater treatment plant, where the FCS is biologically degraded. However, the notifier did not fully discuss the environmental introductions, fate, and effects of the FCS as a result of its disposal. In addition, the notifier did not explain clearly why there is essentially no effect on the use of natural resources and energy under Format Item 9 ("Use of resources and energy"). Consequently, we have prepared this supplement to the EA to 1) discuss further the environmental exposure, fate, and effects of this FCS, and 2) discuss effects on the use of resources and energy as a result of the proposed use of the subject FCS.

1. Introduction and Fate of Substances in the Environment

As mentioned above, a scrubber will capture the lost FCS and the wastewater in the scrubber will go to a wastewater treatment plant. Because the FCS is not volatile (Vp = 4.69 x 10-6 mmHg at 25°C) and is insoluble in water (water solubility = 40 mg/L at 20°C), we anticipate that almost all of the FCS will partition in sludge of on-site wastewater treatment plants. Moreover, structure activity relationships (SARs) analysis predicts that the FCS is readily degradable, and will undergo primary biodegradation in days. Literature search confirmed that dibutyl sebacate can be broken down by environmental bacteria and fungi (Klausmeier, 1986 ; Klausmeier and Jones, 1960 ; Klausmeier and Osmon, 1976 , ATSDR, 1995 ). Therefore, we expect that only very small quantities, if any, of the FCS will be discharged into the effluent of wastewater treatment plants, or directly into the environment. In addition, we expect that the FCS biodegradation products are non-toxic short chain alkanes as a result of primary biodegradation process.

2. Environmental Effects of Released Substances

Because, as discussed above, only very small quantities, if any, of the FCS is expected to be introduced into the environment, and because we expect the FCS to biodegrade to non-toxic products, we have no concerns for environmental effects of the FCS.

3. Use of Resources and Energy

Because the market volume for the proposed use is expected to be small, we do not believe that there will be a significant increase in the amount of resources and energy used as a result of the proposed use of FCS.

Conclusion

Because the FCS is readily degradable and virtually no significant introduction of the FCS to aquatic environments is expected, we believe that there would be no potential for significant adverse impacts on the environment as a result of the proposed use. Furthermore, because the market volume of the FCS is expected to be small, we believe that there will be essentially no effect on the use of natural resources and energy as a result of the proposed use.

 

 

Prepared by___________________________________________ Date: October 27, 2003
Tong Zhou, 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