Environmental Decision Memo for Food Contact Notification No. 001390

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. 1390 – Benzene, ethenyl-, polymer with 1,3-butadiene, hydrogenated [CAS Reg. No. 66070-58-4]. The FCS is intended for use in blends with other polymers in food-contact articles.

Notifier: Kuraray Co., Ltd., Kuraray America, Inc., and Kuraray Europe GmbH

To: Hui Chen Chang, 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 1390. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 13, 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

File: FCN No. 1390


A food-contact notification (FCN No. 1390), submitted by Kuraray Co., Ltd., Kuraray America, Inc., and Kuraray Europe GmbH, to provide for the safe use of Benzene, ethenyl-, polymer with 1,3-butadiene, hydrogenated [CAS Reg. No. 66070-58-4], intended for use in blends with other polymers in food-contact articles.

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 by the notifier in an environmental assessment (EA), dated Nov. 13, 2013.

The FCS is intended for use in contact with food types III, IV-A, V, VII-A and IX under Conditions of Use A through H as described in Tables 1 and 2 of FDA Food Types & Conditions of Use for Food Contact Substances. Not for use in contact with food for infants 0-6 months of age or its ingredients.

Styrene (ethenylbenzene) hydrogenated butadiene polymers similar to the FCS for use in the manufacture of food-contact articles are the subject of numerous effective Food Contact Notifications (FCNs 28, 63, 321, 350, 650j, 679, 720, 821, 1184, and 1228). The environmental introduction, fate, and effects of the FCS have been discussed in detail in the EAs and internal memoranda of the Environmental Review Team. All the environmental decisions for use as a basic polymer in food-contact articles are FONSIs.

There are additional FCNs citing use of styrene non-hydrogenated butadiene polymers in food-contact films and coatings (FCN 522 and 711), food-contact articles (FCN 124 and 627), can-end cements (FCN 69), and latex binders in paper and paperboard (FCN 845). All are EA/FONSIs. Polymers similar to the FCS are also authorized under 21 CFR 177.1810(3)(i) – styrene block polymers with 1,3-butadiene, hydrogenated, for use as articles or as components of articles that contact food of Types I, II, IV-B, VI, VII-B, and VIII, and 21 CFR 177.1810(3)(ii) – styrene block polymers with 1,3-butadiene, hydrogenated, for use at levels not to exceed 42.4 percent by weight as a component of closures with sealing gaskets that would contact food of Types III, IV-A, V, VII-A, VIII, and IX to include those requested in the current notification.

This FCN does not propose the use of a new food-contact material, but proposes an expansion in the permitted conditions of use for a cleared polymer for use in food-contact applications where the package is used in contact with fatty foods. With regard to this, effective FCN 1184 authorizes use of similar styrene block polymers with 2-methyl-1,3-butadiene and 1,3-butadiene, hydrogenated as the basic resin in food-contact articles used in contact with all types of food (i.e., food types I through IX) under Conditions of Use A through H. Moreover, the FCS is essentially identical and substitutional to the polymer that is cleared for fatty food-contact under FCN 679. Consequently, the proposed use of the FCS is not expected to open significant new markets for styrene-based polymers in the area of food-contact articles.

The hydrogenated block copolymer will be manufactured by the notifier at their production facilities located in Ibaraki, Japan and Pasadena, Texas, U.S.A. The notifier does not manufacture finished food-contact articles containing the FCS; rather, they will sell resin to compounders or to processors that are involved in the manufacture of food-contact articles. Thus, the copolymer is expected to be used by producers at a number of different production sites throughout the United States. No significant environmental release is expected upon the use of the FCS to fabricate food packaging articles, as it will be incorporated into the finished food-contact article and is expected to remain in that article through use and disposal. Any waste materials generated in this process, e.g., plant scraps, are expected to be disposed of as part of the packaging manufacturer’s overall nonhazardous solid waste in accordance with established procedures.

Uses of the FCS in the subject notification are identical and substitutional to the uses already-authorized under existing effective FCNs for similar food contact substances. Essentially all of the FCS is expected to remain with the food contact materials throughout the use and disposal by the consumer.

Food-contact articles produced with the FCS will be utilized in patterns corresponding to the national population density and will be widely distributed across the country. Thus, it is anticipated that disposal of the food-contact articles containing the FCS will occur nationwide; with the material being land disposed, combusted, or recycled in accordance with U.S. municipal solid waste disposition data generated by the U.S. Environmental Protection Agency which in 2010 estimated that 54.3% of municipal solid waste generally was land disposed, 11.7% was combusted, and 34.0% was recovered for recycling [1]. Articles manufactured with the FCS may not be recycled to as high an extent as other recyclable materials (i.e., glass bottles or jars, aluminum cans, polyethylene terephthalate (PET) bottles for carbonated beverages, or high-density polyethylene (HDPE) milk jugs) included in the statistic. Thus, if the 34% recovered for recycling is excluded, and it is assumed all FCS-containing materials are land-disposed or combusted, it may be estimated that about 18% of the materials will be combusted, and about 82% deposited in land disposal sites [2].

The subject hydrogenated block copolymer is prepared from only carbon and hydrogen containing materials. No toxic combustion products are expected as a result of incineration of the polymers in municipal waste combustors operating in compliance with applicable emission laws and regulations (i.e., 40 CFR Part 60 and/or relevant state and local laws). Additionally, only extremely small amounts, if any, of the polymer’s constituents are expected to enter the environment as a result of the U.S. EPA regulatory compliant (40 CFR Part 258) landfill disposal of food-contact articles.

As the identity and uses of the FCS in the subject notification are identical, or nearly so, and substitutive to the uses of the FCS in the already-approved methods no new or significantly different chemical releases resulting from the use of the FCS are expected.

The potential for environmental impacts associated with the proposed action resulting from the manufacture and use of the FCS is also substitutional to currently authorized materials and therefore is not significant. Additionally, the use of this alternative product will have no impact on the use of resources and energy.

Food contact articles containing the FCS are expected to be disposed of according to the same patterns when they are used in place of the currently used articles. Thus, there will be no impact on current or future landfilling, combustion, or recycling programs.

No potential adverse environmental effects have been identified which would necessitate mitigation measures or alternative actions to that proposed.

No extraordinary circumstances have been identified, which would otherwise indicate a significant environmental impact, as a result of the use of the FCS.


Prepared by __________________________________________Date: ____________
Mariellen Pfeil
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: ____________
Robert I. Merker
Supervisory Consumer Safety Officer
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] U.S. Environmental Protection Agency. Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2010. EPA-530-F-11-005, November, 2011, Washington DC. The percentages noted above are based on municipal solid waste, excluding waste recovered for composting.

[2] The distribution of disposal may be re-calculated based on land-disposal and combustion percentages from the EPA report as follows. Percent Combusted = 11.7% combusted ÷ (11.7% combusted + 54.3% land disposed) = 17.7% combusted. Percent Land-disposed = 54.3% land-disposed ÷ (11.7% combusted + 54.3% land disposed) = 82.3% land-disposed.

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