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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001375

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: January 9, 2014
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN 1375- Petroleum distillates (C3-6, piperylene-rich; CAS Reg. No. 68477-35-0) polymers and copolymers with one or more of the following: isobutylene (CAS Reg. No. 115-11-7), styrene (CAS Reg. No. 100-42-5), and alpha-methylstyrene (CAS Reg. No. 98-83-5) as a component of pressure sensitive adhesives (PSAs) subject to the use limitations under 21 CFR 175.125.
Notifier: Eastman Chemical Company
 
To: Vivian Gilliam, Division of Food Contact Notifications (HFS-275)
Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____
 
The notifier submitted claim of categorical exclusion under 21 CFR 25.32(j) for the proposed use of the FCS as a component of a food contact article intended for repeated use. An EA was submitted for the remaining uses of the FCS as a component of articles that are not considered repeat use.
 
We have reviewed the claim of a categorical exclusion and have concluded that categorical exclusion is warranted. The claim of categorical exclusion cites the sections, 21 CFR 25.32(j), under which 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.
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1375. After this notification becomes effective, copies of this FONSI and the notifier’s environmental assessment, dated October 30, 2013, 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.
 
Talia A. Lindheimer
 
Attachment:         Finding of No Significant Impact
 
File:    FCN No. 1375 

FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1375), submitted by The Eastman Chemical Company, to provide for the safe use of petroleum distillates (C3-6, piperylene-rich; CAS Reg. No. 68477-35-0) polymers and copolymers with one or more of the following: isobutylene (CAS Reg. No. 115-11-7), styrene (CAS Reg. No. 100-42-5), and alpha-methylstyrene (CAS Reg. No. 98-83-5) as a component of pressure-sensitive adhesives (PSA) used in contact with food and subject to the use limitations listed in 21 CFR 175.125.
 
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 (EA), dated October 30, 2013, as summarized below.
 
The Food Contact Substance (FCS) will be used as or added to Pressure Sensitive Adhesives (PSAs) to be used with the foods listed in the PSA regulations found at 21 CFR 175.125. These types of PSAs will include direct application to the surfaces of fruits and vegetables. The stickers are not intended to be used jointly with plastic wraps or food packaging papers, such that the FCS containing articles are not expected to be recovered for recycling. The PSAs are expected to be disposed of only via conventional trash disposal and primarily by incineration or sanitary landfills. The FCS is intended to either compete with PSAs already on the market or be used in conjunction with the previously authorized PSAs. No increase in the overall use of PSAs is expected as a result of the authorization of the FCS.
 
When properly disposed into landfills operating in compliance with EPA regulations in 40 CFR Part 258 governing landfills, significant releases of the FCS to the environment would not be expected.   Furthermore, according to confidential market volume information as provided in Attachment 11 to the EA, the disposal of the FCS will not significantly alter emissions from municipal solid waste combustors or threaten a violation of 40 CFR Part 60, which regulate MSW combustion units.   As minimal release is expected, no significant environmental impacts are expected as a result of the proposed action. 
 
No extraordinary circumstances have been identified, which would otherwise indicate a significant environmental impact, as a result of the use and post-consumer disposal of these items.
 
Prepared by     __________________________________________Date: January 9, 2014
Talia A. Lindheimer
Biologist
Office of Food Additive Safety          
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by   __________________________________________Date: January 9, 2014
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