• 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. 001156

 

February 29, 2012
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams, Ph.D.
 
Subject: FCN No. 1156 – 2-Propenoic acid, butyl ester, polymer with ethene as the basic polymer in the manufacture of single- and repeat-use food-contact articles having a maximum thickness of 210 µm.
 
Notifier: LyondellBasell Industries
 
For the requested repeat-use applications, we have reviewed the claim of categorical exclusion for the above referenced notification and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the section, 21 CFR 25.32 (j), under which the categorical exclusion is warranted, states compliance with the categorical exclusion criteria, and states that no extraordinary circumstances exist that require the submission of an environmental assessment.
 
For the single-use applications, attached is the Finding of No Significant Impact (FONSI) for FCN 1156. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 4, 2012, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.
 
Please let us know if there is any change in the identity or use of the food-contact substance.
 
 
Leah D. Proffitt
 
 
 
Attachment:         Finding of No Significant Impact
       


 

FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1156), submitted by LyondellBasell Industries to provide for the safe use of 2-Propenoic acid, butyl ester, polymer with ethene as the basic polymer in the manufacture of single-use food-contact articles having a maximum thickness of 210 µm.
 
The Office of Food Additive Safety 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 January 4, 2012.
 
Prepared by     __________________________________________Date: February 29, 2012
Leah D. Proffitt
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
 
 
Approved by   __________________________________________Date: February 29, 2012
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration