Food

Environmental Decision Memo for Food Contact Notification No. 000042

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: April 19, 2000

From: Team Leader, Chemistry and Environmental Review Team
Scientific Support Branch (HFS-207)

Subject: Subject: FCN No. 000042 - A Superabsorbent Polymer for Use as a Fluid Absorbent in Food-Contact Material.

Notifier: Stockhausen, Inc.
2401 Doyle Street
Greensboro, NC 27406

To: Division of Petition Control (HFS-215)
Attention: Vivian Gilliam

Attached is the Finding of No Significant Impact (FONSI) for this premarket notification. The following environmental documents should be made publicly available when this notification becomes effective:

  1. The FONSI
  2. The environmental assessment (EA) dated January 18, 2000
  3. Document entitled, "Supplement to the Environmental Assessment for Premarket Notification No. 000042"

The EA for this notification incorporates the EA for FAP 2B4323, dated February 3, 1997, in its entirety. The EA for FAP 2B4323 is already publicly available because it was sent to the Dockets Management Branch (Docket No. 92F-0368) after that petition was filed, as noted in the Federal Register of October 28, 1992.

Layla I. Batarseh, Ph.D.


Finding of No Significant Impact

A Premarket Notification (FCN No. 000042), submitted by Stockhausen, Inc., to provide for the safe use of a grafted copolymer of crosslinked polyacrylic acid sodium salt polymer with polyvinyl alcohol for use as fluid absorbent in food-contact materials used in the packaging of red meat which is either refrigerated or frozen until use.

The Chemistry and Environmental Review Team 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 petitioner in an environmental assessment (EA) dated January 18, 2000, and on information submitted in the EA for Food Additive Petition (FAP) 2B4323, dated February 3, 1997. The information in the referenced EA is still accurate and it is applicable in its entirety to this notification.

Prepared by __________________________________________Date: April 19, 2000
Layla I. Batarseh, Team Leader
Chemistry and Environmental Review Team
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Information for Food Contact Notification No. 42

This document incorporates by reference the environmental assessment (EA) contained in the subject premarket notification and in the EA for FAP 2B4323. The subject chemical, grafted copolymer of crosslinked polyacrylic acid sodium salt polymer with polyvinyl alcohol, is intended for use in as fluid absorbent in food-contact materials used in the packaging of red meat which is either refrigerated or frozen until use. The notifier states that, as a result of disposal of food-packaging material containing the subject additive:

1. Only very small amounts of the soluble components migrate into landfill leachate and that 20% of that will degrade within 39 weeks (1). The notifier also states that further calculations are difficult to make because data about the typical amount of leachates out of a landfill and their subsequent dispersion into ground and/or surface waters are not available. We agree with the petitioner. In addition, we estimate that only very small amounts of the subject additive, its soluble components, its degradation products or its impurities, if any at all, are expected to enter the environment as a result of landfill disposal of food-packaging materials containing the subject additive based on the Environmental Protection Agency's regulations governing municipal solid waste landfills (2).

2. No environmental effects are expected in the incineration operations or the composition of exhaust gases because there are no combustible products in the subject additive. We agree with the notifier's conclusion but we do not agree that there are "... no combustible products in the subject additive." The substance is combustible and will produce combustion products; however, we do not expect a significant impact on the environment as a result of combustion because the subject copolymer is composed of carbon, hydrogen, sodium, and oxygen, elements commonly found in municipal solid waste (3). The complete combustion of the subject copolymer will produce only carbon dioxide, water, and sodium salts. Because the market volume of the subject copolymer is a small fraction of the municipal solid waste generated and disposed of in the United States, adding the additive to waste that is combusted will not alter significantly the emissions from municipal waste combustors.

Prepared by: _____________________________________________ Date: April 19, 2000
Layla I. Batarseh, Leader
Chemistry and Environmental Review Team
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

(1) Attachment V in the EA for FAP 2B4323, date February 3, 1997 (see Format Item 6.E.1).

(2) The Environmental Protection Agency's regulations require new municipal solid waste landfills and lateral expansions of existing landfills 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 Part 258). Although owners and operators of existing active municipal solid waste landfills that were constructed before October 9, 1993, are not required to retrofit liners and leachate collection systems, they are required to monitor groundwater and to take corrective action as appropriate.

(3) Municipal Waste Combustors - Background Information for Proposed Guidelines for Existing Facilities, EPA- 450/3-89-27e, United States Environmental Protection Agency, Office of Air Quality Planning and Standards, Research Triangle Park, NC 27711; August 1989; Table 2.2-1. Although sodium in not listed in Table 2.2-1 of this reference, it is well known to be a very commonly found element.


 

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