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Environmental Decision Memo for Food Contact Notification No. 1636

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 19, 2016

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

Subject: FCN No. 1636 – Acrylonitrile-methyl methacrylate-trimethylolpropane trimethacrylate copolymer (CAS Reg. No. 57192-88-6) as a component of agglomerated cork stoppers used as closures for alcoholic beverage bottles

Notifier: Akzo Nobel Pulp and Performance Chemicals AB, Expancel

To: Kenneth McAdams, Division of Food Contact Notifications (HFS-275)
Through: Suzanne Hill, Environmental Team Supervisor, Office of Food Additive Safety, HFS 255

Attached is the Finding of No Significant Impact (FONSI) for FCN 1636. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 15, 2016 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.

Antonetta Thompson-Wood

Attachment: Finding of No Significant Impact


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1636), submitted by Akzo Nobel Pulp and Performance Chemicals AB, Expancel to provide for the safe use of Acrylonitrile-methyl methacrylate-trimethylolpropane trimethacrylate copolymer (CAS Reg. No. 57192-88-6) as a component of agglomerated cork stoppers used as closures for alcoholic beverage bottles.

The Office of Food Additive Safety has determined that allowing this food contact notification (FCN) 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, dated January 15, 2016, as summarized below.

The action requested in this notification is to permit the use of a copolymer of acrylonitrile-methyl methacrylate-trimethylolpropane trimethacrylate copolymer, (CAS Reg. No. 57192-88-6), at a level not to exceed 10 weight percent of the stoppers used as closures for bottles intended to hold beverages containing up to 50 percent alcohol by volume.

Introduction of Substances into the Environment as a Result of Use
Closures containing the FCS will be utilized in patterns corresponding to the national population density and will be widely distributed across the country. The only substances that may be expected to be released to the environment upon the use and disposal of food packaging materials fabricated with the subject polymer consist of extremely small quantities of combustion products.

In these applications, the FCS (i.e., a polymer) is expected to be entirely incorporated into and remain with the finished food-contact article/closure. Any waste materials generated in this process, e.g., plant scraps, are expected to be disposed of as part of the food-contact article manufacturer’s overall nonhazardous solid waste in accordance with established procedures. Disposal by the ultimate consumer of closures containing the subject food-contact substance will be by conventional rubbish disposal and, hence, primarily by sanitary landfill or incineration. Therefore, the analysis in the EA focused on impacts to air and land.

Impacts to Air and Land
There are no environmental releases expected to water or land upon the use of the subject food-contact substance to fabricate bottle closures.

The FCS consists of carbon, oxygen, nitrogen, and hydrogen. Combustion of the FCS may produce carbon dioxide and nitrous oxide. Based on confidential market volume information and greenhouse gas (GHG) emissions calculations provided in a confidential attachment to the EA, the FCS will make up a very small portion of the total municipal solid waste (MSW) currently combusted. The FCS will also not exceed the Council on Environmental Quality’s (CEQ) annual 25,000 metric ton CO2 equivalent GHG/year threshold for GHG emissions above which warrants quantitative disclosure. The FCS will also not significantly alter emissions from properly operating solid waste combustors, or cause MSW waste combustors to threaten a violation of applicable emission laws and regulations (40 CFR 60). Therefore, use of the FCS is not expected to have an adverse effect on air quality.

Only extremely small amounts, if any, of the FCS constituents are expected to enter the environment as a result of the landfill disposal of food-contact articles, in light of the Environmental Protection Agency’s (EPA) regulations governing municipal solid waste landfills. EPA’s regulations require new municipal solid-waste landfill units and lateral expansions of existing units to have composite liners and leachate collection systems to prevent leachate from entering ground and surface water, and to have ground-water monitoring systems (40 CFR 258).

Use of Resources and Energy
Use of the FCS is anticipated to have no net increase in the use of energy or resources as the FCS will be competing with and/or replacing closures or similar articles already on the market for use in food-contact applications. Such action would have no environmental impact.

Food-contact materials produced using the FCS is expected to be disposed of according to the same patterns when they are used in place of current materials. Therefore, there will be no impact on current or future recycling programs.

Alternatives to the Proposed Action
No potential adverse environmental effects were identified in the EA that would require evaluation of reasonable alternatives for the proposed use in this FCN. If the proposed action is not approved, the result would be the continued use of materials which the proposed FCS would otherwise replace. Such action would have no environmental impact.

As evaluated in the EA, the proposed use of the FCS to provide improved compressibility in stoppers composed of cork granules, as well as reduced weight, improved elasticity, and density control in stoppers made from synthetic materials, is not expected to have a significant environmental impact and an environmental impact statement is not required

Prepared by __________________________________________Date: digitally signed 02-20-2016
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 02-23-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration