Food

Environmental Decision Memo for Food Contact Notification No. 1380

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See also Environmental Decisions.


Date: February 14, 2014

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

Subject: FCN No. 1380 – The reaction products of paraformaldehyde (CAS Reg. No. 30525-89-4) and ethylene glycol (CAS Reg. No. 107-21-1), as a stabilizer for aqueous biocides used to preserve filler or other additive mixtures or coating solutions for use in uncoated or clay-coated paper and paperboard.

Notifier: Troy Corporation

To: Paul Honigfort, Ph.D., Division of Food Contact Notifications, HFS-275

Through: Mariellen Pfeil, Environmental Reviewer, Office of Food Additive Safety, HFS-255____

Attached is the Finding of No Significant Impact (FONSI) for FCN 1380. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated January 15, 2014, 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


FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1380), submitted by Troy Corporation, to provide for the safe use of the reaction products of paraformaldehyde (CAS Reg. No. 30525-89-4) and ethylene glycol (CAS Reg. No. 107-21-1), as a stabilizer for aqueous biocides used to preserve filler or other additive mixtures or coating solutions for use in uncoated or clay-coated paper and paperboard.

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 in an environmental assessment, dated January 15, 2014, as summarized below.

The Food-Contact Substance (FCS) is intended to be used as a stabilizer for biocides used to preserve filler or additive mixtures in the wet end of production of food-contact paper and paperboard, at a use level of up to 150 parts-per-million (ppm). In addition, the FCS will be used as a stabilizer for biocides used to preserve paper coating solutions at levels up to 75 ppm. Commercial biocides formulated with the FCS have been shown to more fully retain their activity during storage and transport, thereby providing significant improvements in efficacy compared to biocides formulated without the FCS.

Upon addition to water, the FCS hydrolyzes completely to ethylene glycol and formaldehyde as follows:

C4H10O4 → 2CH2O (formaldehyde) 49% + HOC2H4OH (ethylene glycol) 51%

In addition, ethylene glycol may also be present as a residual impurity in the FCS at up to 6%, thereby yielding a total amount of 57% ethylene glycol.

Incineration offinished food-contact paper will not cause municipal solid waste (MSW) combustors to threaten a violation of 40 CFR Part 60, or other relevant state and local laws, as the combustion products are carbon dioxide and water in amounts that would not have significant impacts on the operation of solid waste combustors. Furthermore, due to EPA regulations at 40 CFR Part 258, land disposal to MSW landfills is not expected to cause any release to the environment.

The primary route of environmental exposure from use of the FCS in filler additives at the wet end of papermaking is the discharge of FCS hydrolysis products—i.e. formaldehyde and ethylene glycol—with paper mill waste water. Use of the FCS to preserve coating solutions is not expected to result in aquatic releases since coating solutions are applied directly to paper. Thus, FCS hydrolysis products will remain with the finished food-contact paper at trace levels, and will be discarded by the consumer as solid waste.

The calculation of environmental introduction concentrations (EIC) and effective environmental concentrations (EEC) is based on the following assumptions:

  • The FCS is intended to be used at 150 ppm in the filler or additive slurry.1
  • A typical mineral slurry contains on the order of 70% solids, and therefore the amount of FCS on a dry weight basis is 214 ppm (150 ppm/70%).2
  • Finished paper contains on average 15% filler3, and therefore the amount of FCS per weight of the paper is estimated at 32 ppm FCS (15% of 214 ppm).
  • A representative paper mill employing the FCS will produce about 500 tons of treated paper per day, therefore amounting to 14,400 g FCS/daily.4
  • Approximately 10,000 gallons of water will be used per ton of paper, totaling 5,000,000 gallons/day(or 1.9 x 1010g ; assuming 1 lb = 453 g, and the density of water at 8.34 lb/gal).
  • No reductions of the amount of FCS based on wastewater treatment or recycling or any other losses that may naturally occur.
  • Maximum concentration of FCS in discharge water: 14,400 g FCS ÷ 1.9 x 1010 g water = 7.6 x 10-7 g FCS/g water = 760 parts per billion (ppb).

Therefore, given the percent-partitioning of hydrolysis products, the following EICs are calculated:

760 ppb FCS x 57% = 434 ppb ethylene glycol

760 ppb FCS x 41% = 370 ppb formaldehyde

The ecotoxicity endpoints for these chemicals are reported at 6.7mg/L (96 hr LC50, Morone saxatilis) for formaldehyde, and in excess of 10,000 mg/L (48 hr LC50, immobilization, Daphnia magna) for ethylene glycol.  EECs are estimated by applying a ten-fold dilution factor to the EICs calculated above, for a result of 43.4 ppb for ethylene glycol, and 37 ppb for formaldehyde. Therefore, given these large margins of safety, we conclude that use of the FCS will not result in significant environmental impacts.

Prepared by __________________________________________Date: see electronic signature
Leah D. Proffitt
Biologist
Office of Food Additive Safety 
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 

Approved by __________________________________________Date: see electronic signature
Robert I. Merker, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


1 This "filler or additive slurry"; in this assumption is the biocide, which is then added to the paper itself. The maximum concentration of the FCS in the biocide (filler) is 150ppm.

2 When the water in the filler solution is driven off the remaining solids will be more concentrated.

3 The actual application rate of the filler to the paper can vary, such that 15% is assumed to be representative.

4 FCS per day = (32 x 10-6 g-FCS/g-paper)(4.5 x 108 g-paper) = 14,400 g-FCS.

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