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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000890

 

Date:June 18, 2009
From:Acting Supervisor, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 890 – Hydrocarbons, C6-20, polymer, hydrogenated for use in polypropylene (PP) film to improve transparency and ethylene vinyl acetate (EVA) film to improve adhesive strength.
Notifier:Idemitsu Kosan Company, Ltd.
3-1-1 Marunouchi, Chiyoda-ku
Tokyo 100-8321, Japan
To:Division of Food Contact Notifications (HFS-275)
Attention: Helen Lee, Ph.D.
 

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 890. After this notification becomes effective, the FONSI, our supplement, and the notifier's redacted EA, dated January 21, 2009, may be made available to the public, and we will post them on the internet where they can be accessed within the Food Ingredients and Packaging key topic under the Food link of www.fda.gov.

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

 

William H Lamont

 

Attachment:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 890


Finding of No Significant Impact

A food contact notification (FCN No. 890), submitted by Idemitsu Kosan Company, Ltd., to provide for the safe use of hydrocarbons, C6-20, polymer, hydrogenated, for use as a miscible additive at a concentration not exceeding 20 percent by weight in polypropylene film to improve optical properties and as a tackifying resinous component of adhesive systems applied to ethylene vinyl acetate film to improve adhesion for heat sealed packaging at a concentration not to exceed 25 percent by weight of the finished film.

The Environmental Review Team 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 in the notification, including an environmental assessment, dated January 21, 2009, submitted by the notifier and other information known to the agency.

 

Prepared by __________________________________________Date: June 18, 2009
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Record for Food Contact Notification No. 890

This document incorporates by reference the notifier's environmental assessment (EA), dated January 21, 2009.

The purposes of this supplement are to ensure the accuracy and completeness of the environmental record by clarifying some information in the EA and to assist the public in understanding the agency’s basis for preparing a finding of no significant impact (FONSI) for the proposed use.

The EA is marked "Confidential" in the title line on the first page. The EA itself is not confidential, but the EA contained, in topic 6.b, specially marked information declared by the notifier to be confidential business information, which was used to support that topic's discussion. The notifier's explicitly declared confidential information is protected from public release, and thus only that specially marked information is excluded from being publically released in the EA.

In topic 6.b, the EA contained a characterization about the chemical composition of the food contact substance (FCS). The notifier stated that oxygen is an elemental component of the FCS and, furthermore, the combustion of articles using the FCS will produce sulfur dioxide. We clarify the discussion in the EA by noting particularly that the FCS is a saturated hydrocarbon, which, by definition, constrains the elemental composition only to hydrogen and carbon. Therefore, other chemical elements, such as oxygen and sulfur, do not define the composition of the FCS itself and, if present, are adventitious or trivial inclusions from concomitant impurities, residues, or other sources. Consequently, we believe that oxygen and sulfur, if present in impurities or residues concomitant with the FCS, do not pose a prominent introduction of combustion emissions into the environment and will not cause or threaten to cause violation of environmental air quality regulations controlling such combustion emissions.

Topic 10 of the EA was intended clearly to be about mitigation measures in the event that adverse environmental effects had been identified. No adverse effects were identified, and no mitigation measures needed to be discussed. The text of topic 10 was virtually repetitious with that found in topic 9. We believe that the duplication of the title for topic 10, "Use of resources and energy," with the properly titled topic 9 and the virtual repetition of the text contained in the two topics were unintended and did not present an impediment to forming the agency's final environmental decision—a FONSI.

 

Prepared by __________________________________________Date: June 18, 2009
William H. Lamont, Chemist
Acting Supervisor, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration