Date: October 31, 2017

To: Kenneth McAdams, Consumer Safety Officer, Division of Food Contact Notification (HFS-275)
Through: Mariellen Pfeil, Biologist, Acting Environmental Team Lead, Office of Food Additive Safety (HFS-255)

From: Physical Scientist, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: Finding of No Significant Impact (FONSI) for Food Contact Substance Notification (FCN) 1824: Use of poly-1-butene polymers (CAS Reg. No. 9003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7) as the basic polymer in the production of articles intended to contact food, including infant formula and human milk.

Notifier: LyondellBasell Industries

Attached is the FONSI for FCN 1824.

After this FCN becomes effective, copies of this FONSI, and the notifier's environmental assessment (EA), dated August 2, 2017, may be made available to the public. We will post digital transcriptions of the FONSI, 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.

Antonetta Thompson-Wood

Attachment: FONSI

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN) 1824, submitted by LyondellBasell Industries to provide for the safe use of Poly-1-butene polymers (CAS Reg. No. 9003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7) as the basic polymer in the production of articles intended to contact food, including infant formula and human milk.

The Office of Food Additive Safety has determined that allowing FCN 1824 to become effective will not significantly affect the quality of the human environment and, therefore, an environmental impact statement (EIS) will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated August 2, 2017. The EA is incorporated by reference in this Finding of No Significant Impact (FONSI), and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.

The FCS will contain no more than 7.5 percent of polymer units derived from ethylene and may be used in contact with all types of food under FDA Conditions of Use A through H. The density of the FCS will range from 0.87-0.93 g/cm3. The melt index will range from 0.1 - 3000. The intrinsic viscosity will not exceed 3.2 dl/g. Additives permitted for use in butene polymers complying with 21 CFR 177.1570 or in olefin polymers complying with 21 CFR 177.1520(c), items 3.1 and 3.2 may also be used in the FCS, provided that the limitations and specifications on the use of the additives are met. The FCS polymers may be used in repeat-use articles (excluding baby bottle nipples) intended to contact infant formula and human milk.

Impacts to the Environment as a Result of Use and Disposal

The FCS will be sold to formulators engaged in the production of food-contact articles. Post-consumer disposal of the articles which contain the FCS will be to landfills or municipal solid waste (MSW) combustors complying with 40 CFR Parts 258 and 60, respectively. Recycling is not anticipated. No significant effect on the concentrations of and exposures to any substances in air, water or soil are anticipated. Due to EPA’s regulations governing landfills at 40 CFR Part 258, leaching into the environment of the FCS or its components as a result of land disposal of articles manufactured with the FCS is not anticipated. The FCS is comprised of carbon and hydrogen, and will not significantly alter the emissions from properly operating MSW combustion facilities. Further, incineration of the FCS will not cause municipal waste combustors to threaten a violation of applicable emissions laws and regulations at 40 CFR Parts 60, regulations for mandatory emissions reporting at 40 CFR 98, and/or relevant state and local laws. Based upon an analysis using market volume information provided in the confidential attachment to the EA there are no significant impacts with respect to greenhouse gas emissions resulting from incineration of materials containing the FCS. Thus, the use of the FCS as proposed is not reasonably expected to result in significant environmental impacts.

Use of Resources and Energy

The FCS will replace similar materials now on the market for use in food-contact applications. Use of the FCS will consume energy and resources in amounts comparable to the manufacture and use of these other polymers. As such, replacement by the FCS is not expected to have any significant impact on the use of energy and resources.

Mitigation Measures

No significant environmental impacts are expected to result from the use and disposal of food-contact materials fabricated from the FCS. Therefore, mitigation measures are not required.

Alternatives to the Proposed Action

No significant environmental impacts were identified in the EA that would necessitate alternative actions for the proposed use in this Food Contact Notification. If the proposed action is not approved, the result would be the continued use of the materials that the FCS would replace. Such action would have no significant environmental impacts.

As evaluated in the EA, the proposed use of the FCS as described in FCN 1824 is not expected to significantly affect the human environment; therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 10-31-2017
Antonetta Thompson-Wood
Physical Scientist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 11-02-2017
Mariellen Pfeil
Biologist, Acting Environmental Team Lead, Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration