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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000311

Date: February 28, 2003

 

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

 

Subject: FCN No. 311 - Fluorinated copolymer as an oil and grease resistant treatment for paper and paperboard

 

Notifier: DuPont Chemical Solutions Enterprise
Deepwater, NJ 08023

 

To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: Kelly Randolph, D.V.M., M..P.H.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

 

 

Attached is the Finding of No Significant Impact (FONSI) and our supplement to the notifier=s Environmental Assessment for FCN 311. When this notification becomes effective, the following documents may be available to the public:

 

1. This FONSI;
2. The notifier's Environmental Assessment, dated February 3, 2003; and
3. Our supplement to the notifier's Environmental Assessment.

 

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
1. Finding of No Significant Impact for FCN 311
2. Supplement to the notifier's Environmental Assessment

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 311), submitted by DuPont Chemical Solutions Enterprise, to provide for the safe use of copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate as an oil or grease resistant treatment for paper and paperboard intended for single service use in microwave heat-susceptor packaging intended to contact all food types.

 

 

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

 

 

 

Prepared by___________________________________________ Date: February 28, 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: February 28, 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. 311

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

 

The notifier, DuPont Chemical Solutions Enterprise, indicated in the EA that there may be continual releases of the food contact substance (FCS) to aquatic environments. Appropriate acute aquatic toxicity data were provided for the FCS; however, no data were provided on environmental fate, bioaccumulation or chronic toxicity.

This FCS also was the subject of an effective food contact notification, FCN No. 206, from DuPont Chemical Solutions Enterprise. In an email dated March 15, 2002, regarding FCN 206, the notifier said 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 sludge from waste water treatment plants. Consequently, we have prepared this supplement to the EA to discuss further 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 7 of the EA that filtered solids 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 footnote 3 on page 7 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 a very small number of pulp and paper mills land apply the sludge from their waste water treatment plants. Therefore, environmental introduction of the FCS through land application of sludge would be 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 biologically available to organisms in the environment. Therefore, we do not anticipate chronic toxicity of this FCS to occur at levels comparable to concentrations anticipated in the environment.

Conclusion

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. 311.

 

 

 

Prepared by_______________________________________ Date: February 28, 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