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Environmental Decision Memo for Food Contact Notification No. 000507

Date: July 11, 2005

 

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

 

Subject: FCN No. 507 - Organosiloxane as a defoaming agent in the pulping of lignocellulosic materials that will be used in the manufacture of paper and paperboard

Dow Corning Corporation
2200 W. Salzburg Road
Midland, MI 48686-0994

Division of Food Contact Notifications (HFS-275)
Attention: Kelly Randolph, D.V.M., M.P.H.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

 

 

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 507. When this notification becomes effective, these documents and the notifier's revised EA, dated May 11, 2005, may be made available to the public.

 

Please let us know if there is any change in the identity or use of the food-contact substance.

 

 

 

Tong Zhou, Ph.D.

 

2 Attachments

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 507), submitted by Dow Corning Corporation, to provide for the safe use of siloxanes and silicones, di-Me, 3-hydroxypropyl Me, ethers with polyoxyethylene mono-Me ether and polyoxypropylene mono-Me ether as a defoaming agent in the pulping of lignocellulosic materials that will be used in the manufacture of paper and paperboard.

 

 

The Environmental Review Group 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 a revised environmental assessment (EA), dated May 11, 2005, and our supplement to that EA.

 

 

Prepared by __________________________________________Date: July 11, 2005
Tong Zhou, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 

Approved by __________________________________________Date: July 11, 2005
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

 

 





Supplement to the Environmental Information
for Food Contact Notification No. 507

This document incorporates by reference the notifier's revised environmental assessment (EA) dated May 11, 2005.

 

1. Format Item 4: The notifier stated under Format Item 4.c., ". . . 98% of the PEMS product will be disposed off along with the black liquor and another 98% will be disposed of with the white liquor at the paper mill. Therefore, 99.96% of the PEMS product will be disposed of at the paper mill." We do not agree with this statement. This statement also contradicts the notifier's descriptions that we agree with regarding black liquor under Format Item 6.b., which states that it is a common practice for paper mills to recycle black liquor in the commonly used Kraft pulping process; recycling black liquor is one way to maximize chemical recovery and to minimize the amount of chemical waste in plant effluent.

2. Format Item 6: The notifier stated under Format Item 6.b.i, ". . . it is estimated over 97% of the material that is sent to the wastewater treatment plant will stay with the sludge. This sludge from the paper mills will be either land filled, incinerated or land applied."

 

We believe that disposal of the sludge containing the FCS in landfills will not have an adverse impact on the environment. We expect only very low levels of the FCS to leach from the wastewater treatment plant sludge in landfills. Moreover, even if a very small amount of the FCS migrates from the sludge in landfills, we expect extremely low quantities to actually enter the environment; this finding is based on the regulations of the Environmental Protection Agency (EPA) governing municipal solid waste landfills. Landfilling sludge from paper mills is also governed by individual state's regulations.

 

We believe that incineration of the sludge containing the FCS is not expected to have adverse impacts on the environment. The FCS contains carbon, hydrogen, oxygen and silicone; proper incineration of the FCS will generate carbon dioxide, silica dioxide and water. Based on the annual market volume estimate provided by the notifier, we estimate that the FCS would be an extremely small fraction of municipal solid waste that would incinerated and would not result in a notable increase in air emissions from all other sources; silica compounds are prevalent in the environment.

 

We believe that land application of the sludge will not have a significantly adverse impact on the environment. We estimate that environmental introduction of the FCS through land application of sludge would be very low; in addition, only a very small percentage of paper mills in the Unite States land apply their sludge.

 

Prepared by ___________________________________________ Date: July 11, 2005
Tong Zhou, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review