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Environmental Decision Memo for Food Contact Notification No. 000436

Date: September 28, 2004

 

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

 

Subject: FCN No. 436 - 1,4-Dioxa-8-azaspiro[4.5]decane, 7,7,9,9-tetramethyl- for use as a catalyst in the manufacture of pulp used to manufacture food-contact paper

 

Notifier: Degussa Corporation
379 Interpace Parkway
Parsippany, NJ 07054

 

To: Division of Food Contact Notifications (HFS-275)
Attention: Ken A. McAdam, 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 436. When this notification becomes effective, these documents and the notifier's revised EA, received on August 10, 2004 and dated July 23, 2004, 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. 436), submitted by Degussa Corporation, to provide for the safe use of 1,4-dioxa-8-azaspiro[4.5]decane, 7,7,9,9-tetramethyl-, as a catalyst in the manufacture of pulp used to manufacture food-contact paper.

 

 

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), received on August 10, 2004 and dated July 23, 2004, and our supplement to that EA.

 

 

 

Prepared by____________________________________Date: September 28, 2004
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: September 28, 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. 436

This document incorporates by reference the notifier's environmental assessment (EA) received on August 10, 2004 and dated July 23, 2004.

This supplement provides further discussion on the environmental introduction, fate, and effects of the food-contact substance (FCS) and its associated products as a result of the use and disposal of the FCS.

Introduction of the FCS into the Environment

Under this format item on page 2 of the EA, the notifier stated, "During the use of the FCS other species are generated. Species that have been determined analytically under laboratory conditions include TAA EGK (the FCS), TAA EGK nitroxide, Triacetoneamine (TAA), and TAA nitroxide. . . It is not expected that any of the species other than the FCS will be present in wastewater once the pulp bleaching process is complete and the pulp prepared for dewatering."

We agree with the notifier's assertion that TAA EGK nitroxide and TAA nitroxide would not be present in the wastewater during pulp manufacture, because these substances are unstable free radical intermediates and were not detected in finished dry pulp.

We expect TAA to be present in the wastewater from the paper mill, because (1) it is not a free radical, (2) it was measured in finished pulp, and (3) it is water soluble. However, we believe only very small amounts would be present in the wastewater and thus very small amounts would be introduced into the environment. Below are the calculations of the environmental introduction concentration (EIC) for TAA based on the most conservative assumptions.

Assuming that 95% of the FCS added at 200 ppm (lab level) in the headbox was contained in the waste stream with a distribution of 2% of TAA, and the actual expected use level in commercial manufacture is about two-third (2/3) of the lab level, the TAA anticipated in the waste stream would be 2.3 ppm (200 ppm x 2/3 x 95% x 2% = 2.53 ppm).

Assuming 90% removal via on-site wastewater treatment, the maximum amount of TAA in paper mill effluent would be 0.253 ppm (2.53 ppm x [1 - 90%] = 0.253 ppm).

Environmental Fate and Effects of the Released FCS

We estimate the expected environmental concentration (EEC) for TAA to be 0.0127 ppm (0.253 ppm ) 20 = 0.0127 ppm = 12.7 ppb), assuming zero loss due to any depletion mechanisms (such as adsorption, biodegradation, hydrolysis and photolysis) and a river dilution factor of 20-fold. Based on the predicated data from EPI Suite (v3.11) structure-activity relationships (SAR) prediction models, we conclude that (1) TAA has little potential to bioaccummulate because of its low predicated values of Kow (LogKow = 0.43) and bioconcentration factor (BCF = 3.16), (2) TAA will undergo primary biodegradation in weeks, and (3) acute and chronic toxicity are not expected to occur at the environmental concentrations estimated for the substance, since the lowest predicated toxicity endpoint is 4.45 ppm (96-hr chronic toxicity for green algae) is more than two orders of magnitude higher than the worst-case estimated EEC of 0.0127 ppm.

With regard to the environmental introduction of the FCS, the notifier stated, ". . . the aqueous environmental exposure will be less than 1 ppm when introduced into the environment via surface waters." The notifier also indicated that the FCS has a high affinity for absorption onto solids (Koc > 2,500) and 15 times more of the FCS would be found on soil than in water. Yet, the notifier did not discuss the expected environmental concentration (EEC) in sediments of an aquatic environment. We expect that some of the FCS introduced into the aquatic environment may end up in sediments. However, we expect that the EEC in sediments would be very small in running waters, where the FCS introduced into the aquatic environment may precipitate and distribute heterogenously in the sediment. Furthermore, based on the n-octanol/water partition coefficient (Kow) provided by the notifier (Kow = 8.49, Log Kow = 0.93), we expect that the FCS has a very low potential to bioaccumulate in living organisms.

We also note that government of Canada requires pulp and paper mills to conduct environmental effects monitoring studies on effluent under Pulp and Paper Effluent Regulations.

Conclusion

Based on the discussion in this supplement and in the EA, we have no concern about potential releases of this FCS and its associate products to the environment as a result of the proposed use of the FCS.

 

Prepared by__________________________________ Date: September 28, 2004
Tong Zhou, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review