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CFSAN/Office of Food Additive Safety
January 17, 2007
Date: January 17, 2007
From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)
Subject: FCN No. 673 -D,L-Aspartic acid, N-(1,2-dicarboxyethyl)-, tetrasodium salt for use as a stabilizer for bleach used in the manufacture of paper and paperboard
Notifier: LANXESS Deutschland GmbH
D-51369 Leverkusen
GERMANY
To: Division of Food Contact Notifications (HFS-275)
Attention: Julius Smith
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG
Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 673. After this notification becomes effective, this FONSI, our supplement, and the notifier's environmental assessment (in PDF*, 548Kb), dated September 26, 2006, may be made available to the public and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.
Please let us know if there is any change in the identity or use of the food-contact substance.
Annette M. McCarthy, Ph.D.
Attachment
A food contact notification (FCN No. 673), submitted by LANXESS Deutschland GmbH, to provide for the safe use of D,L-Aspartic acid, N-(1,2-dicarboxyethyl)-, tetrasodium salt as a stabilizer for bleach used in the manufacture of paper and paperboard intended to contact all foods under all conditions of use at a level not to exceed 0.18% as active ingredient by weight of the dry pulp.
The Environmental Review Group 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 (in PDF*, 548Kb) dated September 26, 2006, and on our supplement to the environmental record.
Prepared by__________________________________________Date: January 17, 2007
Annette M. McCarthy, Ph.D., Environmental Toxicologist
Environmental Safety Team
Office of New Animal Drug Applications
Center for Veterinary Medicine
Food and Drug Administration
Approved by__________________________________________Date: January 17, 2007
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
This document incorporates by reference the notifier's environmental assessment (EA) (in PDF*, 548Kb) dated September 26, 2006, and in a letter from the notifier dated November 20, 2006.
The purpose of this supplement is to ensure the accuracy and completion of the environmental record to assist the public in understanding the agency's basis for preparing a finding of no significant impact.
Item 8. Environmental Effects of Released Substances:
Under Format Item 8, the table incorrectly lists the 72 hour NOEC for algal growth inhibition as ≥ 91.5 mg/L. In the study reports submitted November 20, 2006, the NOEC is listed as being 22.8 mg/L. Effects are being seen at levels lower than the stated NOEC. The EC50 for algal growth inhibition estimated for measurements of total biomass is 19 mg/L.
The same table also lists the 21 day NOEC for Daphnia magna reproduction as 11.7 mg/L. It is important to recognize that the highest test concentrations used in the study was 10.0 mg/L. The NOEC value that is listed in the table is estimated based on total organic carbon determinations.
The expected environmental concentration (EEC) of Na-IDS in the receiving water is estimated as 0.85 mg/L based on a standard, conservative, 10-fold dilution from the expected introduction concentration (EIC). The revised acute toxicity values are still substantially higher than the EEC for the Na-IDS. No adverse environmental effects are anticipated.
Prepared by _________________________________________ Date: January 17, 2007
Annette M. McCarthy, Ph.D., Environmental Toxicologist
/ Environmental Safety Team
Center for Veterinary Medicine
*PDF Readers are available for free from the Adobe Acrobat web site.
