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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000770

Date: October 31, 2007
From: Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject: FCN No. 770 - 1,4 -bis(2-ethylhexyl) benzenedicarboxylate for use as plasticizer in vinyl chloride polymer formulations and as components of food-contact articles
Notifier: Eastman Chemical Company
100 North Eastman Road
Kingsport, TN 37662
To: Division of Food Contact Notifications (HFS-275)
Attention: Mark Hepp, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT



The above referenced notification contains four proposed uses for the food contact substance (FCS). The intended uses are:

  1. at a level not to exceed 35 percent by weight of finished plasticized vinyl chloride polymer formulations used in repeated-use food contact applications at temperatures no greater than 100°C;
  2. as a component of a paper or paperboard, or coatings for such paper and paperboard intended for use in contact with dry foods with no free surface fats or oil in compliance with 21 CFR 176.180 Components of Paper and paperboard in contact with dry food;
  3. as a component of adhesives complying with the provisions of 21 CFR 175.105 Adhesives; and,
  4. as a component of pressure sensitive adhesives complying with the provisions of 21 CFR 175.125 Pressure-sensitive adhesives.

The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(j) for use (1) and discussed uses (2), (3), and (4) in an environmental assessment (EA).

We have reviewed the claim of categorical exclusion and have concluded that categorical exclusion is warranted for the proposed use of the FCS in food-contact articles intended for repeated use or as a component of permanent or semi-permanent equipment. The claim of categorical exclusion cites the section under which categorical exclusion is warranted, 21 CFR 25.32(j), states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.

The EA was required for use (2) when the FCS is used as a component of paper and paperboard, and for uses (3) and (4) because these uses do not qualify for a claim of categorical exclusion from the need to prepare an EA. Components of coatings, as in use (2), qualify for a categorical exclusion under 25.32(i). However, a claim of categorical exclusion was not submitted for this use, which was discussed in the EA.

Attached is the Finding of No Significant Impact (FONSI) for FCN 770. When this notification becomes effective, the FONSI and the notifier's EA (in PDF, 326Kb), dated September 12, 2007, may be made available to the public in response to a Freedom of Information Act request and we will post redacted copies of them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

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

Katrina E. White, Ph.D.

Attachment:
Finding of No Significant Impact


Finding of No Significant Impact

A food contact notification (FCN No. 770), submitted by Eastman Chemical Company, to provide for the safe use of 1,4-bis(2-ethylhexyl) benzenedicarboxylate for use as plasticizer in vinyl chloride polymer formulations and as components of food-contact articles.

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 submitted by the notifier in the notification, including an environmental assessment (in PDF, 326Kb), dated September 12, 2007.

Prepared by__________________________________________Date: October 31, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by__________________________________________Date: October 31, 2007
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.