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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 001388

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: January 23, 2014
 
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
 
Subject: FCN No. 1388 – Cross-linked 2-propenoic acid, homopolymer, sodium salt (2:1) [CAS Reg. No. 9003-04-7]. The FCS is intended for use as a fluid absorbent with food contact materials.
 
Notifier: McAirlaid’s, Inc.
 
To: Elizabeth Furukawa, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Leah Proffitt, Environmental Reviewer, Office of Food Additive Safety (HFS-255) ____
 
Attached is the Finding of No Significant Impact (FONSI) for FCN 1388. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated November 12, 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. 1388
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1388), submitted by McAirlaid’s, Inc., to provide for the safe use of cross-linked 2-propenoic acid, homopolymer, sodium salt (2:1) [CAS Reg. No. 9003-04-7], intended for use as a fluid absorbent with food contact materials.
 
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 Nov. 12, 2013.
 
The food contact substance (FCS) is intended for use in contact with poultry, red meat, fish and seafood, fruits and vegetables under Conditions of Use E through G as described in Table 2 of FDA Food Types & Conditions of Use for Food Contact Substances. It is not for use in contact with food for infants 0-6 months of age or its ingredients. [1]
 
The FCS belongs to a group of polyacrylate substances that have been examined extensively with respect to their environmental impacts. All environmental decisions for use of the FCS as a fluid absorbent component of food-contact pads are FONSIs.
 
This FCN has been submitted as a ‘me-too’ alternative to currently authorized FCNs 427, 653, and 957 for the same FCS and use. As the identity and uses of the FCS in the subject notification are identical and substitutive to the uses of the FCS in the already-approved methods no new or significantly different chemical releases resulting from the use of the FCS are expected.
 
The potential for environmental impacts associated with the proposed action resulting from the manufacture and use of the FCS is also substitutional to currently authorized materials and therefore is not significant. Additionally, the use of this alternative product will have no impact on the use of resources and energy.
 
 
Superabsorbent pads containing cross-linked sodium polyacrylate are expected to be disposed of according to the same patterns when they are used in place of the currently used pads with or without superabsorbent materials. Thus, there will be no impact on current or future landfilling, combustion, or recycling programs.
 
 
No potential adverse environmental effects have been identified which would necessitate mitigation measures or alternative actions to that proposed.
 
 
No extraordinary circumstances have been identified, which would otherwise indicate a significant environmental impact, as a result of the use of the FCS.
 
 
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: ____________
Robert I. Merker
Supervisory Consumer Safety Officer
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1] The notification does not identify any specific infant food contact uses for the FCS and FDA did not address the safety of such potential uses. Therefore, a limitation against such use will be included in the Limitations section of the web listing for this FCN should it become effective.