Food

Environmental Decision Memo for Food Contact Notification No. 1382

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 23, 2014

From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN No. 1382 – Oxirane, 2-ethyl, polymer with 2-methyloxirane, monododecyl ether as characterized in the notification, as a lubricant with incidental food contact, consistent with 21 CFR 178.3570.

Notifier: The Dow Chemical Company

To: Vanee Komolprasert, P.E., Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Mariellen Pfeil, Environmental Reviewer, Office of Food Additive Safety, HFS-255____

Attached is the Finding of No Significant Impact (FONSI) for FCN 1382. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 16, 2014, 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. 1382), submitted by The Dow Chemical Company, to provide for the safe use of oxirane, 2-ethyl, polymer with 2-methyloxirane, monododecyl ether as characterized in the notification, as a lubricant with incidental food contact, consistent with 21 CFR 178.3570.

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 in an environmental assessment submitted by the notifier, dated January 16, 2014, as summarized below.

The action requested in this notification is to permit the use of "OSP Lubricants" as a lubricant with incidental food contact or a component of such lubricants under 21 CFR 178.3570.

The subject substance offers several technical properties that make it useful in lubricants. In particular, the FCS is compatible with mineral oils and synthetic hydrocarbon base oils. In addition, the FCS has high viscosity index values, low pour points and excellent film-forming benefits.

Use and disposal of final food-contact items are expected to occur according to established patterns, with disposal reflecting EPA’s 2011 Municipal Solid Waste (MSW) statistics: 53.6% land disposed, 11.7% combusted, and 34.7% recovered for recycling and composting. Land disposal and combustion are governed by 40 CFR Parts 258 and 60, respectively, in addition to state and local laws. Therefore, no environmental releases in violation of those laws are expected.

Lubricants made with the FCS are expected to substitute for other lubricants currently on the market, all of which are managed and collected as used oil, and recovered for their energy value. Finally, lubricants made from the FCS will find limited if any application in beverage bottling; thus, no impact on recycling programs is expected as a result of the use of the FCS.

Prepared by __________________________________________Date: January 23, 2014
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: January 23, 2014
Robert I. Merker, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 

Page Last Updated: 07/01/2014
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