• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 000359

Date: November 21, 2003

 

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

 

Subject: FCN No. 359 - Benzoic acid, 2,4-dihydroxy-, polymer with formaldehyde and 1-napthalenol, sodium salt for use as an anti-fouling agent in the production of PVC

 

Notifier: 3V, Inc.
PO Box 2810
Georgetown, SC 29442

 

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

 

 

The notifier originally submitted an environmental assessment (EA) containing, as attachments, confidential documents submitted to the Environmental Protection Agency to satisfy the requirements of the Toxic Substance Control Act. We informed the notifier that the EA should not contain confidential information. The notifier submitted a revised EA, dated October 2003, containing information not considered confidential but that was contained within a confidential section of the notification. Since the information in the revised EA is still labeled as confidential in the FCN, FDA's Office of Chief Council is investigating the confidential status of the revised EA. Please do not release the EA to the public without consulting the Environmental Review Group first.

 

We have prepared the Finding of No Significant Impact (FONSI) for FCN 359. When this notification becomes effective, only this FONSI may be made available to the public.

 

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

 

 

 

Annette M. McCarthy, Ph.D.

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 359), submitted by 3V, Inc., to provide for the safe use of benzoic acid, 2,4-dihydroxy-, polymer with formaldehyde and 1-napthalenol, sodium salt for use as an anti-fouling agent for autoclaves used for the polymerization of PVC intended for food contact.

 

 

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 2003.

 

 

 

Prepared by _______________________________________ Date: November 21, 2003
Annette 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: November 21, 2003
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