Food

Environmental Decision Memo for Food Contact Notification No. 000054

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: May 25, 2000

From: Program Specialist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)

Subject: Premarket Notification FCN No. 000054 - alpha-Sulfo-omega-dodecyloxy)poly(oxyethylene), sodium salt for use in coatings for paper and paperboard

Notifier: Cognis Corporation
c/o Keller and Heckman
Washington, DC 20001

To: Division of Petition Control (HFS-215)
Attention: Vivian Gilliam
Through: Team Leader, ERT

Attached is our Finding of No Significant Impact (FONSI) for the above cited Premarket Notification. Please make public the following documents when the notification becomes effective:

  1. This FONSI.
  2. The revised Environmental Assessment (EA) dated October 4, 1996.
  3. Appendix H of the May 9, 1996, EA, which contains ecological evaluation and test reports.
  4. Appendix H of the October 4, 1996, EA, which contains Material Safety Data Sheets for acetaldehyde, ethylene oxide, and 1,4-dioxane.

Please let us know if there is any change in the identity or use of the food contact substance that would be inconsistent with the identity and use described in the FONSI.

Sylvia G. Matson


Finding of No Significant Impact

A Premarket Notification (FCN No. 000054), submitted by Cognis Corporation, previously Henkel Corporation, for the safe use of alpha-sulfo omega (dodecyloxy)poly(oxyethylene) sodium salt (CAS Reg. No. 9004 82 4) as an emulsifier in the production of acrylic and modified acrylic polymers and vinyl acetate copolymers used as pigment binders in coatings for paper and paperboard that contact aqueous and fatty foods.

The 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 an environmental assessment (EA) submitted by Henkel Corporation in a food additive petition (FAP 6B4506), which was converted to Premarket Notification FCN No. 000054, and on the following analysis:

1. Only a very small amount of the food contact substance (FCS) is expected to enter the environment as a result of landfill disposal of food-packaging materials containing the FCS. This finding is based on the following:

  1. The market volume of the FCS, provided in a confidential section of FCN No. 000054;
  2. The percentage of the estimated market volume of the FCS that will be disposed of in landfills; and
  3. The Environmental Protection Agency's (EPA) regulations governing municipal solid waste landfills.

2. Incineration of food packaging containing the FCS may produce sulfur oxides. We estimate that the amount of sulfur entering the municipal solid waste stream as a result of allowing this notification to become effective will be an extremely small fraction of the amount of sulfur present in municipal solid waste that is incinerated. This estimate is based on the following:

  1. EPA's projections of municipal solid waste combustion for the years 2000 and 2005,2
  2. The notifier's estimated yearly market volume for the FCS, provided in a confidential section of the premarket notification,
  3. EPA's estimate of the amount of sulfur in unprocessed municipal solid waste, and
  4. The percentage of sulfur in the FCS.

Therefore, we expect no significant increase in incinerator emissions of sulfur oxides as a result of allowing this notification to become effective.

Prepared by: ____________________________________________ Date: May 24, 2000
Sylvia G. Matson, Program Specialist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by: ____________________________________________ Date: May 25, 2000
Buzz L. Hoffmann, Ph.D., Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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