Food

Environmental Decision Memo for Food Contact Notification No. 001409

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:  February 27, 2014

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

Subject:  FCN No. 1409 – Ethylene/propylene copolymers (CAS Reg. No. 9010-79-1) polymerized in the presence of propylene homopolymer (CAS Reg. No. 9003-07-0) complying with 21 CFR 177.1520(c) Item 1.1, to produce an inseparable blend of the two polymers.  The FCS is intended for use as a basic polymer used in the production of articles intended to contact food.
Notifier:  Propilco S.A.

To:  Paul Honigfort, Ph.D., Division of Food Contact Notifications (HFS-275)
Through:  Leah Proffitt, Environmental Reviewer, Office of Food Additive Safety, HFS-255____

Attached is the Finding of No Significant Impact (FONSI) for FCN 1409. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated December 18, 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.

Mariellen Pfeil

Attachment: Finding of No Significant Impact


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1409), submitted by Propilco S.A., to provide for the safe use of ethylene/propylene copolymers polymerized in the presence of propylene homopolymer complying with 21 CFR 177.1520(c) Item 1.1, to produce an inseparable blend of the two polymers intended for use as a basic polymer used in the production of articles intended to contact food.

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, dated December 18, 2013 as summarized below.

The FCS is expected to be wholly incorporated into finished food packaging materials and remain in them through use and disposal by the consumer.  Thus, no significant environmental release is expected.

Introduction of the FCS into the environment is expected to occur via land disposal and waste combustion, with approximately 82% being landfilled and 18% incinerated, according to 2011 EPA figures referenced in the EA1,2. Due to EPA's regulations governing landfills at 40 CFR Part 258, only very small amounts of the FCS or its components are expected to enter the environment.  Furthermore, no violations of federal, state or local emissions laws are expected as a result of disposal by permitted solid waste incineration facilities, due to regulations at 40 CFR Parts 60.  There are no extraordinary circumstances surrounding manufacture, use, or disposal of the FCS.

Similarly, the replacement of other polymers by the FCS is not expected to adversely affect the use of energy and resources, as the manufacture and use of the FCS will consume comparable resources as those substances it is intended to replace.  The copolymers that are the subject of this FCN are substitutional for other polypropylene copolymers currently authorized for use and will therefore, not impact current or future recycling programs for these materials.

Prepared by __________________________________________
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________
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


1Municipal Solid Waste in the United States: 2011 Facts and Figures, EPA530-R-13-001, U.S. Environmental Protection Agency, www.epa.gov, May 2013

2The distribution of disposal patterns is re-calculated from the EPA report based on only the percent land disposed and combusted: % Combusted = 11.7% combusted ÷ (11.7% combusted + 54.3% land disposed) = 17.7% combusted. % Land-disposed = 54.3% land-disposed ÷ (11.7% combusted + 54.3% land disposed) = 82.3% land-disposed.
 

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