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Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1819

Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1819

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: October 24, 2017

To: Sharon Koh-Fallet, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Mariellen Pfeil, Acting Environmental Supervisor, Office of Food Additive Safety, HFS-255

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

Subject: Finding of No Significant Impact for food-contact notification (FCN) 1819 for a mixture of 1-decene, polymer with sulfur dioxide (CAS Reg. No. 33990-98-6); 1,3-propanediamine, N1-(9Z)-9-octadecen-1-yl-, polymer with 2-(chloromethyl) oxirane (CAS Reg. No. 1010121-89-7); and dodecylbenzenesulfonic acid (CAS Reg. No. 27176-87-0).

Notifier: Innospec Ltd.

Attached is the Finding of No Significant Impact (FONSI) for FCN 1819 for use of a mixture of 1-decene, polymer with sulfur dioxide (CAS Reg. No. 33990-98-6); 1,3-propanediamine, N1-(9Z)-9-octadecen-1-yl-, polymer with 2-(chloromethyl) oxirane (CAS Reg. No. 1010121-89-7); and dodecylbenzenesulfonic acid (CAS Reg. No. 27176-87-0), as an antistatic agent in polyethylene and polypropylene polymers and copolymers except for use in contact with infant formula and human milk, at use levels not to exceed 20 parts per million (ppm) in polyethylene and polypropylene polymers and copolymers intended to be used in contact with all food types under all Conditions of Use.

After this notification becomes effective, copies of this FONSI, Environmental Assessment (EA) Revision Sheet, and the notifier's EA, dated July 7, 2017, may be made available to the public. We will post digital transcriptions of the FONSI, EA revision sheet and the EA 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

Attachments:
Finding of No Significant Impact
EA Revision Sheet


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1819), submitted by Innospec Ltd., to provide for the safe use of a mixture of 1-decene, polymer with sulfur dioxide (CAS Reg. No. 33990-98-6); 1,3-propanediamine, N1-(9Z)-9-octadecen-1-yl-, polymer with 2-(chloromethyl) oxirane (CAS Reg. No. 1010121-89-7); and dodecylbenzenesulfonic acid (CAS Reg. No. 27176-87-0), as an antistatic agent in polyethylene and polypropylene polymers and copolymers except for use in contact with infant formula and human milk, at use levels not to exceed 20 parts per million (ppm) in polyethylene and polypropylene polymers and copolymers intended to be used in contact with all food types under all Conditions of Use.

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 prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated July 7, 2017. 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 improves the yield from the polymerization process and results in increased throughput rates. Items containing the FCS are expected to be land disposed or combusted proportionately with disposal patterns described in U.S. Environmental Protection Agency’s (EPA) report “Advancing Sustainable Materials Management: Facts and Figures 2014.” Since the FCS is intended to be used with polyolefins, recycling is also expected to occur in proportion to national figures reflected in the EPA report. Discarded items will go to landfills or municipal solid waste (MSW) combustion facilities complying with 40 CFR Parts 258 and 60, respectively. The FCS will not significantly alter the emissions from properly operating MSW combustion facilities, and incineration of the FCS will not cause these facilities to threaten a violation of applicable emissions laws and regulations at 40 CFR Part 60 and/or relevant state and local laws. Market volume information provided in a confidential attachment to the EA demonstrates that the FCS will comprise a very small portion of MSW, compared to overall MSW generated; this comparison uses EPA’s 2014 MSW statistics.

According to information in a confidential attachment to the EA, total annual emissions of greenhouse gases (GHG), including nitrous oxide (N2O), represented as CO2-equivalent (CO2-e) in metric tons (mT), are well below the 25,000 mT GHG reporting threshold described in 40 CFR 98.2. Therefore, no significant impacts are expected from incineration of the FCS at MSW combustion facilities.

Use of the FCS in as an antistatic agent in polyethylene and polypropylene polymers and copolymers is not expected to result in a net increase in the use of energy and resources, because the raw materials used in the manufacture of the FCS are already in wide use in other industrial applications.

No significant environmental impacts are expected from use and disposal of the FCS; therefore, mitigation measures have not been identified. The alternative of not allowing the FCN to become effective would be the continued use of the materials that the subject FCS would otherwise replace; such action would have no environmental impact.

Consequently, we find that use of the FCS as an antistatic agent in polyethylene and polypropylene polymers and copolymers, as described in FCN 1819, will not cause significant adverse impacts on the human environment. Therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 10-24-2017
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 10-24-2017
Mariellen Pfeil
Acting Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


U.S. Food and Drug Administration

Revision Sheet for the July 7, 2017 EA for FCN 1819

Dated: October 24, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of July 7, 2017 for food contact notification (FCN) 1819 concluded that the action will not constitute a significant impact. This revision is issued to make a minor change and update of an editorial nature that should be acknowledged, while not making any substantive changes to the EA. This revision does not impact our Finding of No Significant Impact (FONSI) and is as follows:

1) In introducing their discussion of GHG emissions expected from combustion of products containing the FCS [in EA Item 6 (on EA page 4, paragraph 2)], the notifier mentions the August 1, 2016 final GHG guidance issued by the Council on Environmental Quality (CEQ). However, an Executive Order issued by the White House on March 28, 2017, rescinded the final guidance (see EO 13783, Section 3(c); available at https://www.gpo.gov/fdsys/pkg/FR-2017-03-31/pdf/2017-06576.pdf). Therefore, the EA is revised to remove reference to this guidance; e.g., to delete the following text and the associated footnote:

On August 1, 2016, the Council on Environmental Quality (CEQ) issued final guidance4 to agencies regarding addressing GHG emissions and climate change impacts in NEPA documents. This guidance is “intended to help Federal agencies ensure their analysis of potential GHG emissions and effects of climate change in an EA or EIS is commensurate with the extent of the effects of the proposed action” (CEQ, 2016 p. 3).

As the notifier provides adequate context for the impact assessment of GHG emissions, no further analysis is required.

2) In EA Item 11 (on EA page 6), the notifier states:

Considering the excellent properties of the FCS for use in food-contact applications, the fact that its constituents are not expected to enter the environment in more than minute quantities upon use and disposal of finished food-contact articles, and the absence of any significant environmental impact which would result from its use, the establishment of an effective FCN to permit the use of the subject polymer as described herein is environmentally safe in every respect.

An adequate EA is one that provides sufficient evidence for an agency to prepare a Finding of No Significant Impact or an Environmental Impact Statement. Thus, the standard for review is presence or absence of significant environmental impacts, not whether an action is “environmentally safe in every respect.” As this statement is not applicable to the given analysis, the EA is revised to delete this statement.

3) In EA Item 14 (on EA page 7) the EA is revised to delete reference 4 as it is no longer applicable to the EA (see above Revision 1).