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Environmental Decision Memo for Food Contact Notification No. 1637

Environmental Decision Memo for Food Contact Notification No. 1637

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: March 10, 2016

From: Biologist, Environmental Review Team, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: Food Contact Notification (FCN) 1637 - Butanoic acid, 3-oxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester [CAS Reg. No. 21282-97-3] for use as a monomer in the production of polymers to be used in adhesives, except for use in contact with infant formula and breast milk.

Notifier: Steptoe & Johnson, LLP on behalf of Eastman Chemical Company

To: Kelly Randolph, D.V.M, M.P.H., 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) 1637. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated February 3, 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. 1637), submitted by Steptoe & Johnson, LLP on behalf of Eastman Chemical Company, to provide for the safe use of Butanoic acid, 3-oxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester (CAS Reg. No. 21282-97-3) for use as a monomer in the production of polymers to be used in adhesives, except for use in contact with infant formula and breast milk.

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 February 3, 2016, as summarized below.

The FCS is intended modify the physical properties and thus improve the use versatility of resins utilized as adhesives. The FCS will be sold to manufacturers who produce food-contact materials, and 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 waste combustion (MWC) 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. Finished adhesives containing the FCS are expected to be highly cross-linked and of high molecular weight, and are not volatile or likely to leach. The FCS is comprised of carbon, hydrogen and oxygen only so will not significantly alter the emissions from properly operating MWC units, and incineration of the FCS will not cause municipal waste 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 of greenhouse gas emissions using market volume information that is provided in the confidential attachment to the EA, the expected total carbon dioxide equivalent (CO2-e) emissions fall below the Council on Environmental Quality’s 25,000 metric ton annual CO2-e emission threshold for quantitative disclosure.

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 175.105) currently used in food packaging applications. Thus energy and resource impacts are not anticipated.

No potential adverse environmental effects were identified that would necessitate alternative actions to that proposed in the FCN. If the proposed action is not approved, the result would be the continued use of the currently marketed commodity chemicals that the subject FCS would replace. Such action would have no environmental impact.

Therefore, FDA has found that the proposed use of the FCS as described in the food contact notification does not present significant environmental impacts, and an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: Digitally signed 04-04-2016
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________ Date: Digitally signed 04-04-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration