Environmental Decision Memo for Food Contact Notification No. 1657
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: May 12, 2016
From: Biologist, Environmental Review Team, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: Food Contact Notification (FCN) 1657 – Use of cyclopentene, polymer with 1-butene, (2E)-2-butene, (2Z)-2-butene, 2-methyl-1-propene, and 1,3-pentadiene [CAS Reg. No. 220543-67-9] as a component of pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes.
Notifier: Keller and Heckman LLP on behalf of ZEON Corporation
To: Vanee Komoloprasert, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Team Supervisor, Office of Food Additive Safety, HFS-255
Attached is the Finding of No Significant Impact (FONSI) for food-contact notification (FCN) 1657.
After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated March 8, 2016, 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 (FCS).
Mariellen Pfeil
Attachment: Finding of No Significant Impact
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1657), submitted by Keller and Heckman LLP on behalf of ZEON Corporation, to provide for the safe use of cyclopentene, polymer with 1-butene, (2E)-2-butene, (2Z)-2-butene, 2-methyl-1-propene, and 1,3-pentadiene as a component of pressure-sensitive adhesives used as the food-contact surface of labels and/or tapes.
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, an environmental impact statement will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated March 8, 2016 with an EA addendum containing confidential market volume data and a greenhouse gas emissions (GHG) analysis. The EA is incorporated by reference in this Finding of No Significant Impact, and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.
The FCS is intended to provide tackifying properties to the adhesive formulations that are intended for use as the food-contact surface of labels and/or tapes. These final materials will be widely distributed across the country, and therefore disposed of nationwide.
Post-consumer disposal of the articles which contain the FCS will be to landfills or municipal solid waste combustion facilities complying with 40 CFR Parts 258 and 60, respectively. No significant effect on the concentrations of and exposures to any substances in air, water or soil are anticipated. The FCS has low water solubility so is not likely to leach. The FCS is comprised of carbon and hydrogen so will not significantly alter the emissions from properly operating municipal solid waste combustors, and incineration of the FCS will not cause these combustors to threaten a violation of applicable emissions laws and regulations at 40 CFR Part 60 and/or relevant state and local laws. Based upon an analysis using market volume information provided in the confidential attachment to the EA, the expected CO2-e emissions fall below the CEQ threshold for quantitative disclosure.
In manufacturing label adhesives, formulators can vary the composition of the various adhesive components to produce adhesives that do not cause interference with the repulping processes in paper recycling. Further, adhesive labels manufactured with the FCS will be directly applied to food and are not expected to be recovered for recycling. Therefore, impacts to recycling are not anticipated.
The FCS is manufactured from raw materials that are already produced for various uses. It is intended to replace similar adhesives (such as those permitted under 21 CFR 175.125) currently used in food-contact applications. Impacts to the use of energy and resources are not anticipated s. Thus, the use of the FCS as proposed is not reasonably expected to result in environmental impacts requiring mitigation measures.
No potential adverse environmental effects are identified that would necessitate alternative actions to those proposed. The alternative of not approving the notified action would result in the continued use of the materials that the subject FCS would otherwise replace; such action would have no environmental impact.
As evaluated in the EA, the use of the FCS as described in FCN 1657, will not significantly affect the human environment. Therefore, an environmental impact statement will not be prepared.
Prepared by __________________________________________Date: Digitally signed 05-12-2016
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________ Date: Digitally signed 05-18-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration