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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000561

Date: December 5, 2005

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

Subject: FCN No. 561 - A mixture containing peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene- 1,1-diphosphonic acid and water

Notifier: FMC Corporation
1735 Market Street
Philadelphia, PA 19103

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

Attached are the Finding of No Significant Impact (FONSI) and our Supplement to the notifier's Environmental Assessment (EA) for FCN 561. When this notification becomes effective, the following documents 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* after the notification becomes effective:

  1. This FONSI;
  2. The notifier's EA, dated October 21, 2005; and
  3. Our supplement to the record for FCN 561.

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. 561), submitted by FMC Corporation, Chemical Products Group, to provide for the safe use of a mixture containing peroxyacetic acid, hydrogen peroxide, acetic acid, 1-hydroxyethylidene-1,1-diphosphonic acid and water to ensure the sterility of surfaces of polymeric food packaging..

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 October 21, 2005, and via e-mail on December 2, 2005, and on information submitted by the notifier and contained in our supplement to the record.

Prepared by __________________________________________Date: December 5, 2005
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: December 5, 2005
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. 561

This document incorporates by reference the notifier's environmental assessment (EA) dated October 21, 2005, and information submitted in an e-mail message on December 2, 2005.

Estimate of HEDP Released

The FCS is used to insure the sterility of surfaces of polymeric food packaging. The FCS is sprayed on the polymer and then rinsed with sterile water. The treatment solution and sterile water rinse run into drains and enter the food processing plant wastewater treatment facility where it is collected and treated before being sent to a publicly-owned treatment works.

In the confidential attachment to the EA, the notifier lists the flow rate of steam in units of kg/hr. When performing their calculations, the notifier lists the flow rate of steam in units of L/hr. In an email dated December 2, 2005, the notifier stated that "As the flow consists primarily of water, which has a density of 1 g/mL (i.e., 1 kg/L), measurements in units of kg/hr are equivalent to measurements in L/hr, i.e., the values are the same."

The notifier states in the EA that the highest HEDP concentration that will be released to the environment is 18 ppb. This number is based on the maximum amount of the FCS that is expected to be used on any bottle. In order for the packaging to be sterile at the time of use, we would expect both the bottle and the cap to be sprayed at the same time. Therefore, the highest HEDP concentration that is expected to be released to the environment would actually be the sum of the amount of the FCS applied to the bottle and to the cap. This results in a release of HEDP to the environment of 19.5 ppb. Based on the available toxicity data, we do not anticipate any adverse effects from the increased release of HEDP.


*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.