Food

Environmental Decision Memo for Food Contact Notification No. 000206

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: April 19, 2002

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

Subject: FCN No. 206 - Fluorinated copolymer as an oil and grease-resistant treatment in paper and paperboard

Notifier: DuPont Chemical Solutions Enterprise
Deepwater, NJ 08023

To: Division of Food Contact Substance Notification Review (HFS-275)
Attention: Julius Smith, Ph.D.
Through: Paul C. DeLeo, Ph.D., Environmental Scientist, ERG

Attached is the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for this premarket notification. When this notification becomes effective, the following documents may be available to the public:

  1. this FONSI;
  2. the notifier's EA, dated February 12, 2002; and
  3. our supplement to the EA.

Please let us know if there is any change in the identity or use of the food-contact substance that would be inconsistent with the identity and use described in the FONSI.

Tong Zhou, Ph.D.

Attachments

  1. FONSI
  2. Supplement to the notifier's EA

Finding of No Significant Impact

A food contact notification (FCN No. 206), submitted by DuPont Chemical Solutions Enterprise, to provide for the safe use of a copolymer of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate as an oil and grease-resistant treatment for paper and paperboard intended for food-contact use.

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 12, 2002, and in our supplement to that EA.

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

Approved by____________________________________________ Date: April 19, 2002
Paul C. DeLeo, Ph.D., Environmental Scientist
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. 206

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.

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. 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

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