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U.S. Department of Health and Human Services


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Environmental Decision Memo for Food Contact Notification No. 000206

This document incorporates by reference the notifier's environmental assessment (EA) dated February 12, 2002.


In the EA, the notifier indicated that there may be continual releases of the FCS to aquatic environments. Appropriate acute aquatic toxicity data were provided for the food-contact substance (FCS); however, no environmental fate data, or bioaccumulation data and chronic toxicity data were provided. The notifier also indicated in an email dated March 15, 2002 that it did not have such data for the FCS. In addition, the notifier did not address potential introductions of the FCS to terrestrial environments through land application of waste water treatment plant sludges. Consequently, we prepared this supplement to the EA to provide additional discussions related to the environmental exposure, environmental fate and environmental effects of the FCS.

Introduction of Substances into the Environment as a Result of Use/Disposal

The notifier stated on page 5 of the EA that solid wastes or sludges recovered from the waste water "are expected to be disposed of by means of either landfilling at suitable sites or by incineration, with the ash from the incinerator being disposed of via landfill." The notifier also stated under the footnote 3 on page 5 of the EA, "the sole plant that currently intends to use the product in the wet end does not dispose of solid wastes by" soil application of sludges.

We determined that 1) the paper industry in the United States produces approximately four million tons of sludge each year, of which 69% is landfilled and 29% is incinerated; and 2) only very small number of pulp and paper mills land apply the sludges from waste water treatment plants. Therefore, environmental introduction of the FCS through land application of sludges is negligible.

Fate of Emitted Substances in the Environment

No environmental fate data, i.e., degradation data and depletion data, were available. However, we believe that the main part, or backbone, of the copolymer is fairly stable and does not break down easily.

Environmental Effects of Released Substances

No bioaccumulation data or chronic toxicity data were available. However, we anticipate that the FCS has little potential to bioaccummulate because it is an extremely big molecule (M.W. = 6 x 105 to 2.3 x 106 Daltons) and is not expected to be absorbed by any living organisms. Therefore, we do not anticipate chronic toxicity of this FCS to occur at levels comparable to concentrations anticipated in the environment.


Based on the minimal introduction of the FCS to aquatic and terrestrial environments, and the lack of bioavailability of the FCS to living organisms, we have no concern about potential releases of this FCS to the environment as a result of the use requested in FCN No. 206.




Prepared by___________________________________________ Date: April 19, 2002
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