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CFSAN/Office of Food Additive Safety
July 26, 2007
| Date: | July 26, 2007 |
| From: | Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246) |
| Subject: | FCN No. 739 - An aqueous solution of sodium chlorite and chlorine dioxide for use as an antimicrobial agent in poultry processing waters |
| Notifier: | Bio-Cide International, Inc.
2845 Broce Drive Norman, OK 73072 |
| To: | Division of Food Contact Notifications (HFS-275)
Attention: Kenneth McAdams Through: Layla I. Batarseh, Ph.D., Supervisor, ERT |
Attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 739. When this notification becomes effective, the FONSI and the notifier's revised environmental assessment (in PDF*, 886Kb), dated June 25, 2007, may be made available to the public in response to a Freedom of Information Act request and we will post redacted copies of 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.
Katrina E. White, Ph.D.
Two Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 739
A food contact notification (FCN No. 739), submitted by Bio-Cide International, Inc., to provide for the safe use of an aqueous solution of sodium chlorite and chlorine dioxide for use as an antimicrobial agent in poultry processing waters, as a component of a spray, dip, prechiller solution, or chiller solution.
The Environmental Review Team 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 the notification, including a revised environmental assessment (in PDF*, 886Kb), dated June 25, 2007, and our supplement to the environmental record for FCN 739.
Prepared by__________________________________________Date: July 26, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by__________________________________________Date: July 26, 2007
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF*, 886Kb), dated June 25, 2007.
The purpose of this supplement is to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency's basis for preparing a finding of no significant impact (FONSI).
Clarification of Information in the EA
Under Format Item 6, the EA indicates that the Chemical Abstracts Service Registry Number (CAS Reg. No.) for sodium bicarbonate is 144-58-8. However, the correct CAS Reg. No. is 144-55-8 (1).
Mitigation Measures
The mitigation measures discussed in the environmental assessment helped support the finding of no significant impact for this food contact notification. The mitigation measures are based on the requirements of the United States Environmental Protection Agency (EPA) and described in the "Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023)" (2). The EPA determined that, "chlorine dioxide and sodium chlorite are eligible for reregistration provided that: (i) additional data that the Agency intends to require confirm this decision; and (ii) the risk mitigation measures outlined in this document are adopted, and (iii) label amendments are made to reflect these measures" (2). The risk mitigation measures and label amendments are listed and clearly identified in the RED and include requiring the following statement on the label in the ecological effects language:
"This product is toxic to fish, aquatic invertebrates, oysters, and shrimp. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans or other waters unless in accordance with the requirements of a National Pollution Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA"(2).
Under Format Item 10, the EA stated that the required language would be included on the label for the food contact substance. This will help to mitigate any possible adverse environmental effects.
Literature Cited
ChemIDplus Lite, United States National Library of Medicine. http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp (accessed July 26, 2007).
Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023); EPA 738-R-06-007; U.S. Environmental Protection Agency; Prevention, Pesticides and Toxic Substances: Washington D.C., Aug, 2006. http://www.epa.gov/oppsrrd1/REDs/chlorine_dioxide_red.pdf (accessed Jan. 25, 2007).
Prepared by__________________________________________Date: July 26, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
*PDF Readers are available for free from the Adobe Acrobat web site.
