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Date: April 30, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: FCN No. 1272 – Diallyldimethylammonium chloride (DADMAC) polymer with acrylamide, reaction product with glyoxal, produced by copolymerizing from 20 to 90 weight percent of acrylamide and 10 to 80 weight percent of diallyldimethylammonium chloride, which is then cross-linked with not more than 30 weight percent of glyoxal (Trade name Fennorez [CAS No. 32555-39-8]). The FCS is intended for use as a drainage aid or as a dry and wet strength additive added prior to the sheet-forming operation in the manufacture of food-contact paper and paperboard at concentrations not to exceed 2.0% by wt. of the dry fibers in the finished paper and paperboard and is intended for single-use applications in contact with all food types (I – IX) under Conditions of Use A through H.
Notifier: Kemira Chemicals, Inc.
To: Kelly Randolph, 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 1272. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated April 8, 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.
Attachment: Finding of No Significant Impact
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1272), submitted by Kemira Chemicals, Inc., to provide for the safe use of diallyldimethylammonium chloride (DADMAC) polymer with acrylamide, reaction product with glyoxal, produced by copolymerizing from 20 to 90 weight percent of acrylamide and 10 to 80 weight percent of diallyldimethylammonium chloride, which is then cross-linked with not more than 30 weight percent of glyoxal, intended for use as a drainage aid or as a dry and wet strength additive added prior to the sheet-forming operation in the manufacture of food-contact paper and paperboard at concentrations not to exceed 2.0% by wt. of the dry fibers in the finished paper and paperboard and is intended for single-use applications in contact with all food types (I – IX) under Conditions of Use A through H.
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 (EA), dated April 8, 2013, and information discussed below.
The EA references information provided only in attachments to the notification. The following attachments are hereby incorporated as attachments to the EA:
- Attachment 1: Identity and FCS Characterization. Food Contact Notification # 001272, dated 02-19-2013, Kemira Chemicals, Inc.
- Attachment 2: Molecular Weight Distribution. Food Contact Notification # 001272, dated 02-19-2013, Kemira Chemicals, Inc.
- Confidential Attachment 29: Free Glyoxal Measurements and Environmental Calculations for Related Substances. Food Contact Notification # 001272, dated 02-19-2013, Kemira Chemicals, Inc.
Fate and Effects of FCS Copolymer
The active (solids) component of the FCS is greater than that of currently marketed products resulting in the use of approximately one third less product formulation to produce an equivalent volume of paper. Once incorporated into paper, the FCS is stable under the conditions of use and no significant degradation is expected. Because the intended use of the FCS is intended to replace that cleared in prior effective food contact notifications, and will require a lower volume of FCS formulation, no new exposure to the FCS is expected.
Articles containing the FCS are expected to replace, and be disposed of at a rate equivalent to, products with similar use profiles already on the market. The use and disposal of the FCS is not expected to threaten violation of applicable laws and regulations (e.g. U.S. EPA 40 CFR parts 60 and 258).
To assess the potential impacts of the disposal of finished paper and paperboard, we reviewed statistics from EPA’s 2011 MSW Report. According to this report, of the 71.3 million tons of paper and paperboard generated in 2010, 44.6 million tons (62.5%) were recovered for recycling or composting. The remaining 26.7 million tons (37.5%) were either combusted or land disposed.
Incineration of food contact articles containing the FCS release carbon dioxide, water, and nitrogen oxides. Given that the FCS is intended to replace similar currently marketed products, and that lower volumes of FCS will be required per ton paper, increase of releases to the environment from incineration are not expected presuming disposal in accordance with U.S. EPA regulations in 40 CFR parts 60. Similarly, inputs are not expected to alter emissions in 40 CFR 268 compliant MSW land disposal facilities. While specific market volume data are unknown, we agree that increases above current volumes are not expected for the reasons stated.
Paper processing wastewater effluents are typically recycled and undergo continuous treatment processes, including settling, coagulation, flocculation and biodegradation. Any FCS copolymer residues present in wastewater that do not biodegrade tend to absorb to solids in the wastewater and settle as sludge. Environmental inputs from these processes are not anticipated when performed in accordance with U.S. EPA NPDES permitting authorizations.
Fate and Effects of Residual Monomers
When added at the dry-end of paper processing, the residual monomers are expected to be substantive to the paper such that roughly 100% of the FCS and all components is expected to remain with the paper through use and disposal by consumers as described above.
When added to the whitewater at the wet-end of paper processing, the unpolymerized (residual) monomers in the FCS formulation, which equal greater than 5% by weight of the FCS, are not substantive to the paper and are expected to be lost to the environment. The potential for environmental impact is predominantly from release of these monomers, specifically the excess glyoxal polymer cross-linking agent and to a lesser extent acrylamide and DADMAC. Because the intended use of the FCS is intended to replace that cleared in currently-marketed similar products, no new exposure to the FCS is expected. Additionally, the formulation contains a greater ratio active (solids) component of the FCS resulting in lower volumes of the FCS formulation being required in paper and paperboard processing.
Because of the high water solubility of glyoxal, close to 100% of the residual, unbound glyoxal is expected to be lost in the white water during paper processing. This is also the case with any residual, unbound acrylamide and DADMAC. Environmental introduction concentrations (EICs), and estimated environmental concentrations (EECs) for the glyoxal cross-linking agent, and the FCS monomers acrylamide and DADMAC applied at the maximum usage rate were calculated in the EA. These calculations contain errors. Namely the EIC calculated for glyoxal assumes that 70% of glyoxal degrades prior to release to the environment. There is insufficient information to support this assumption. Therefore, the EIC is being recalculated assuming that 100% of the glyoxal is released to the environment. Additionally, the EECs for all residual monomers were calculated assuming a 20-fold dilution factor. The supporting evidence given for this assumption pre-date 1991 and are outdated. This value is not representative of current practices, as understood by FDA. FDA recommends that a 10-fold dilution factor be used. The EECs were recalculated using this value. No EIC or EEC values were calculated for the FCS copolymer as approximately 100% is expected to remain with the paper and, therefore, it will not be released to the environment with the whitewater. The EIC and EEC values are provided in Table 1.
* = EIC / 200 ppm x 100
|Monomers||EIC (% of added*)||EEC|
|Glyoxal||13.0 ppm (6.5%)||1.3 ppm|
|DADMAC||2.3 ppm (1.2%)||0.23 ppm|
|Acrylamide||0.8 ppb (0.0004%)||0.08 ppb|
The U.S. EPA hazard evaluation for environmental toxicity and fate for ‘low’ acute aquatic toxicity is LC50 / EC50 > 100 ppm, and for ‘low’ chronic aquatic toxicity is LC50 / EC50 > 10 ppm. The calculated EEC concentrations for the stated residues are at least a factor of 10 lower than these tolerance values. Ecotoxicity data for aquatic species were evaluated and the calculated EEC values are at least two orders of magnitude lower than the toxicity for the most sensitive listed species as provided in Table 2.
|Monomers||Toxicity||Endpoint / Species|
|Glyoxal||> 134 ppm||16-hr. EC50 Pseudomonas putida|
|DADMAC||> 33.3 ppm||96-hr. LC50 blue-green algae|
|Acrylamide||78 ppm||96-hr. LC50 mysid shrimp|
No significant environmental impacts are predicted as a result of the proposed use. The FCS is intended to compete with and replace other similar products already on the market. Due to the more concentrated nature of the FCS copolymer, reduced levels of some impurities would result from a switch from currently authorized products to this FCS. No significant effects have been identified as a result of disposal of products containing the FCS. EECs for the residual monomers entering the environment through process whitewater are sufficiently below ecotoxicity endpoints, such that no impacts have been identified.
Prepared by __________________________________________Date: April 30, 2013
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________Date: April 30, 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
 U.S. Environmental Protection Agency. Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2010. EPA-530-F-011-005, November 2011, Washington, DC.
 The maximum concentration of the FCS (max. 2%wt. dry pulp) in the aqueous phase of the wet-end of paper processing (1% pulp consistency) = 0.02 x 1% = 0.02% = 200 ppm.
 U.S. EPA design for the Environment Program Alternatives Assessment Criteria for Hazard Evaluation, August 2011