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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001368

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: December 16, 2013
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1368 – 2-Propenoic acid, homopolymer, sodium salt; Sodium polyacrylate; [CAS Reg. No. 9003-04-7]; intended for use to control the formation of mineral scale during evaporation of beet or cane sugar juice at levels not to exceed 3.6 mg/kg (ppm) of active sodium polyacrylate to the sugar juice liquor.  
Notifier: Kemira Chemicals, Inc.
 
To: Paul Honigfort, 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 1368. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated August 7, 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.
 
Mariellen Pfeil
 
Attachment:    Finding of No Significant Impact
 
             File:     FCN No. 1368

FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1368), submitted by Kemira Chemicals, Inc., to provide for the safe use of 2-propenoic acid, homopolymer, sodium salt; sodium polyacrylate [CAS Reg. No. 9003-04-7], intended for use to control the formation of mineral scale during evaporation of beet or cane sugar juice at levels not to exceed 3.6 mg/kg (ppm) of active sodium polyacrylate in the sugar juice liquor.
 
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 August 7, 2013, and other data as incorporated by reference in the EA. 
 
The food contact substance (FCS) is intended for use in compliance with 21 CFR 173.73, polymers of acrylic acid hydrolyzed with aqueous sodium hydroxide, with the exception of subparagraphs (a)(1), weight average molecular weight (wt.ave mw) of 3000 to 7000 Daltons (Da), instead of 2000 to 2300 Da, and (a)(2), weight average molecular weight to number average molecular weight ratio (polydispersity index) of ≤ 3.0, instead of ≤ 1.3. 
 
Data provided in the EA have adequately described introduction of the FCS into the environment as a result of manufacture, use, and disposal from use. There is sufficient evidence supporting that the assumptions and discussion of the use in the most recent effective food contact notification (FCN) (FCN 1110), and incorporated by reference into this EA, the partitioning of the FCS into the molasses fraction, and final distribution into animal feed are still appropriate. The Environmental Introduction Concentrations (EIC) and Expected Environmental Concentration (EECs) would be 2.8 times lower than those cited in incorporated by reference from FCN 1110[1] due to the lower use rate in the current FCN (3.6 ppm vs. 10 ppm). The calculated EECs for the FCS are therefore:
Animal
EECsoil
(mg FCS/kg soil)
Beef Cattle
0.13
Dairy Cattle
0.65
Pigs
0.57
Poultry(broilers)
1.25
 
The EA adequately describes the fate of the FCS in terrestrial soils and provides data on polycarboxylate fate in soil[2]. These data show that the FCS does not move into ground water, nor does it bioaccumulate.
 
Ecotoxicity data for polycarboxylates are provided in the EA. There is no expected environmental risk to terrestrial organisms based upon comparison of the calculated EECs to the earthworm (Eisenia foetida foetida) lethal concentration for 50% of the population (LC50) acute toxicity endpoint (> 1,000 ppm), or to corn, soybean, wheat or grass seed growth inhibition (no inhibition of growth at 225 ppm highest tested concentration). The EA incorporates data given in FCN 1150[3] pertaining to aquatic ecotoxicity. LC50 and Effects Concentration for 50% of the population (EC50) concentrations are greater than 100 ppm for all tested species. Any aquatic introduction resulting from run-off or percolation would be a further dilution of the soil applied EECs. Therefore, there is also no expected environmental risk to aquatic organisms from the use of the FCS.
 
The use of the FCS is substitutional to existing antiscalant materials used in sugar processing. No additional uses of energy or resources are anticipated.
No potential adverse environmental effects have been identified which would necessitate mitigation measures or alternative actions to that proposed. 
 
Prepared by          __________________________________________Date: ____________
Mariellen Pfeil
Biologist
Office of Food Additive Safety           
Center for Food Safety and Applied Nutrition
Food and Drug Administration
 
Approved by          __________________________________________Date: ____________
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
 


[1] FCN 1110 EA dated 01-19-2012
[2] ECETOC, 1993, Joint Assessment of Commodity Chemicals No. 23, Polycarboxylate Polymers as used in Detergents, European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels, Belgium.
[3] FCN 1150 EA dated 02-13-2012