Environmental Decision Memo for Food Contact Notification No. 1820
Date: October 30, 2017
To: Jessica Urbelis, Ph.D., Consumer Safety Officer, Division of Food Contact Notifications, HFS-275
Through: Mariellen Pfeil, Biologist / Acting Lead, Environmental Review Team, Office of Food Additive Safety (HFS-255)
From: Staff Fellow, Environmental Review Team, Division of Biotechnology and GRAS Notice Review, HFS-255
Subject: Finding of No Significant Impact for Food Contact Notification 1820 (Styrene-isobutylene-styrene (SIS) block copolymer. CAS name: 2-methylprop-1-ene, styrene CAS No. 9011-12-5)
Notifier: Kaneka North America LLC
Attached is the Finding of No Significant Impact (FONSI) for Food Contact Substance Notification (FCN) 1820, which is for the use Styrene-isobutylene-styrene (SIS) block copolymer as a component of blended polymers that will be used in the manufacture of single-use food-contact articles.
After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 28, 2017, 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.
Denis Wafula
Attachment: Finding of No Significant Impact
FINDING OF NO SIGNIFICANT IMPACT
Proposed Action: Food Contact Substance (FCS) Notification (FCN) 1820, submitted by Kaneka North America LLC for the use of Styrene-isobutylene-styrene (SIS) block copolymer (CAS No. 9011-12-5) as a component of blended polymers that will be used in the manufacture of single-use food-contact articles for use in food packaging applications in contact with all food types under Conditions of Use A through H and J.
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 be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated August 28, 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 is intended to be used as a component of blends with other polymers such e.g. polyethylene and polypropylene. Finished 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 solid waste (MSW) combustors complying with 40 CFR Parts 258 and 60, respectively or recycled. 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 so it 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.
The notifier intends to produce the FCS in a facility located in Pasadena, Texas. This facility is operated in compliance with all applicable environmental laws and regulations and already produces similar SIS copolymers for non-food uses. Therefore, the proposed action will use existing facilities and processes and any waste material produced will be disposed in the same manner currently used for similar polymers. The notifier will not fabricate finished food-contact material but will market the FCS to manufacturers who will use it at their facilities. It is reasonably expected that these facilities are currently producing food-contact materials for similar applications and operate in compliance with all applicable environmental laws and regulations. Any waste material (eg plant scraps) from the manufacture of food contact articles containing the FCS is expected to be disposed as part of the manufacturer’s non-hazardous solid waste. Because the intended for uses of the FCS will replace other copolymers, significant impacts to the use of energy and resources are not anticipated.
No potential adverse environmental effects are identified that would necessitate alternative actions to those proposed. The alternative of not approving the notified action would result in the continued use of the materials that the subject FCS would otherwise replace; such action would have no significant environmental impacts. Because no significant impacts were identified, mitigation measures are not required.
As evaluated in the EA, the use of the FCS as described in FCN 1820 will not significantly affect the human environment. Therefore, an environmental impact statement will not be prepared.
Prepared by __________________________________________Date: digitally signed 10-30-2017
Denis Wafula
Staff Fellow
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________Date: digitally signed 10-30-2017
Mariellen Pfeil
Acting Environmental Team Lead
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration