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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000597

Date: February 13, 2006

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

Subject: FCN No. 597 - 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate for use as a plasticizer for repeat-use vinyl chloride polymers, including gloves and for use as a component of coatings.

Notifier: Eastman Chemical Co.
PO Box 551, B-54D
Kingsport, TN 37662

To: Division of Food Contact Notifications (HFS-275)
Attention: Helen Lee, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

The above referenced notification contains two proposed uses for the food contact substance (FCS), one as a plasticizer for repeat-use vinyl chloride polymers that may contact food, including vinyl chloride polymer-based gloves used in processing food, and one as a component of coatings for paper and paperboard intended to contact dry food. The notifier submitted a claim of categorical exclusion under 21 CFR 25.32(i) for the proposed use of the FCS as a component of coatings for paper and paperboard, a claim of categorical exclusion under 21 CFR 25.32(j) for the proposed use as a plasticizer for repeat-use vinyl chloride polymers that may contact food and an environmental assessment for its proposed use as a plasticizer in vinyl chloride polymer-based gloves used in processing food.

We have reviewed the claims of categorical exclusion and have concluded that categorical exclusion is warranted for the proposed use as a coating and as a plasticizer in repeated use applications. The claims of categorical exclusion cite the sections under which categorical exclusion are warranted, 21 CFR 25.32(i) and (j), state compliance with the categorical exclusion criteria, and state that no extraordinary circumstances exist that require the submission of an environmental assessment.

We have prepared a Finding of No Significant Impact (FONSI) for the proposed use of the FCS as a plasticizer in disposable gloves (attached). After this notification becomes effective, this FONSI and the notifier's environmental assessment, dated December 29, 2005, may be made available to the public and we will post 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.

Annette M. McCarthy, Ph.D.

Attachment


 

Finding of No Significant Impact

A food contact notification (FCN No. 597), submitted by Eastman Chemical Company, to provide for the safe use of 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate as a plasticizer for repeat-use vinyl chloride polymers that may contact food, including vinyl chloride polymer-based gloves used in processing food, and as a component of coatings for paper and paperboard intended to contact dry food.

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 dated December 29, 2005.

Prepared by __________________________________________Date: February 13, 2006
Annette M. McCarthy, 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 13, 2006
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


*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.