Environmental Decision Memo for Food Contact Notification No. 001261

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the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

Date: March 20, 2013

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

Subject: FCN No. 1261 – Tannins, ammonium salt, intended for use as a coagulant for the clarification/flocculation of influent water used in the pulp and paper manufacturing process.

Notifier: Buckman Laboratories, Inc.

To: Thomas Zebovitz, Ph.D., Division of Food Contact Notifications (HFS-275)

Through: Annette M. McCarthy, Ph.D, Senior Science and Policy Staff____

Attached is the Finding of No Significant Impact (FONSI) for FCN 1261. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated March 18, 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.

Leah D. Proffitt

Attachment:         Finding of No Significant Impact


A food-contact notification (FCN No. 1261), submitted by Buckman Laboratories, Inc., to provide for the safe use of tannins, ammonium salt, as a coagulant for the clarification/flocculation of influent water used in the pulp and paper manufacturing process.

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, dated March 18, 2013 as summarized below.

The FCS will be added to influent water used in the pulp and paper manufacturing process. The purposed of the FCS is to act as a coagulant or flocculation aid to remove suspended particles, decrease microbial growth, prevent product contamination and decrease corrosion and clogging of pulp and paper manufacturing equipment. The FCS functions as a coagulant or flocculation aid by acting as a substrate for particles to adhere and precipitate out of the whitewater. As such the FCS is expected to be found primarily in sludge. 

To estimate average sludge production at pulp and paper manufacturing facilities, sludge generation across three types of mills was averaged (Attachment 3 of the EA) as 131 kg sludge per ton of paper. According to industry data provided with the EA (Attachment 7), 14% of all paper manufactured in the US is used for food contact purposes. Given that 1 kg of FCS is used per ton of paper made, each ton of sludge is estimated to contain 0.7% of FCS (1 kg FCS ÷ 131 kg sludge/paper ton = 0.007 = 0.7%).   It is conservatively assumed that all 14% food-contact paper uses the FCS as an influent water clarifier. However, rather than multiplying 0.7% by 14%--or 0.007 x 0.14--the calculations in the EA show 0.7 multiplied by 0.14. The end result of 0.01 or 0.1% is the same, but the decimal error in the EA is noted. When the calculation is done using the appropriate values the correct result is 0.01.  It is this value of 0.1% of sludge containing the FCS which was used to estimate potential environmental impacts. 

According to the Bryant study (Attachment5 of the EA), 87% of mills use river water, the remainder using treated municipal or well water. Municipal or well water is not expected to be treated with coagulant or flocculation aids due to the lower prevalence of suspended particles. As only 87% of water used in pulp and paper manufacture would require the use of a coagulant or flocculation aid, we can conservatively assume a worst case scenario that an equivalent 87% of the sludge would contain the FCS. When doing so the amount of total pulp and papermaking sludge that would be contain the FCS would be .0087% (0.001 x 0.87).

As demonstrated by the Scott study (Attachment of the EA), the majority of sludge (90%) is expected to be landfilled (69%) or incinerated (21%). Although not cited in the EA, due to EPA regulations in 40 CFR Part 258 governing landfills, and 40 CFR Part 60 regulating MSW combustion units, significant releases of the FCS to the environment would not be expected when properly disposed of according to these regulations,. As minimal release is expected, no significant environmental impacts are expected as a result of the proposed action.

Prepared by     __________________________________________Date: March 20, 2013
Leah D. Proffitt
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by   __________________________________________Date: March 20, 2013
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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