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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000450

Date: October 18 2004

 

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

 

Subject; FCN No. 450 - An aqueous solution of sodium chlorite and chlorine dioxide for use as an antimicrobial agent in the processing of red meat and meat products

 

Notifier: Bio-cide International, Inc.
2845 Broce Drive
Norman, OK 73072

 

To: Division of Food Contact Notifications (HFS-275)
Attention: Mark A. Hepp, Ph.D.
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 450. When this notification becomes effective, these documents and the notifier's revised EA, dated August 27, 2004, may be made available to the public.

 

Please let us know if there is any change in the identity or use of the food-contact substance.

 

 

 

Tong Zhou, Ph.D.

 

2 Attachments

 





Finding of No Significant Impact

A food contact notification (FCN No. 450), submitted by Bio-cide International, Inc., to provide for the safe use of an aqueous solution of sodium chlorite and chlorine dioxide containing up to 1200 mg/kg sodium chlorite and up to 30 mg/kg chlorine dioxide as an antimicrobial agent for use in the processing of red meat, red meat parts, and organs, and on processed, comminuted, and formed meat products as a component of a dip or a spray

 

 

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 (EA), dated August 27, 2004, and our supplement to that EA.

 

 

 

Prepared by______________________________________Date: October 18, 2004
Tong Zhou, Ph.D., Environmental Toxicologist
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

 

 

 

Approved by___________________________________Date: October 18, 2004
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

 





Supplement to the Environmental Information
for Food Contact Notification No. 450

This document incorporates by reference the notifier's environmental assessment (EA) dated August 27, 2004.

 

The purpose of this supplement is to clarify inaccuracies in the notifier's EA.

 

1. Under Format Item 4 ("Description of the proposed action") of the EA, the notifier stated, "The proposed additive is produced by mixing an aqueous solution of sodium chlorite with any generally regarded as safe (GRAS) acid to achieve a pH in the range of 2.2 to 3.0 and then further diluting this solution with a pH elevating agent such that the resultant sodium chlorite concentration is between 300 and 1,200 ppm, and the pH of the solution is between 5.0 and 7.5." After thorough review of the information submitted in the FCN, the agency decided that the subject food contact substance (FCS) is actually an aqueous solution of sodium chlorite (NaClO2) and chlorine dioxide (ClO2), containing up to 1200 mg/kg sodium chlorite and up to 30 mg/kg chlorine dioxide.

2. Under Format Item 5 of the EA, the notifier stated, "The sodium chlorite products are diluted with water to an intermediate solution with a sodium chlorite concentration in the range of about 0.5% to 3.5%." The correct concentration for the concentrated precursor solution is in the range of 0.5 to 3.35%, as indicated under Intended Use on page 7 of FDA Form 3480 of the FCN.

3. Under Format Item 6.B. ("Emission substances from the use of the Food Contact Substance") of the EA, the notifier incorporated by reference the EAs for three petitions (FAPs 7A4532, FAP 9A4692, and FAP 0A4724) to discuss the potential for air and water releases and their effects on on-site wastewater treatment plants and on publicly owned treatment works (POTWs). In these EAs, the levels of dissolved chlorine dioxide that are typically generated with the acidified sodium chlorite solution (the food additive) will not exceed 1 to 2 mg/liter; i.e., 1 to 2 ppm. Based on the 2 ppm generated within the acidified sodium chlorite solution, the EA for FAP 0A4724 estimated the concentration of chlorine dioxide to be 0.02 ppm in the plant effluent or 2.6 ppb in an average POTW influent.

These estimated environmental introduction concentration of chlorine dioxide are not applicable to the subject FCN, because the concentration of chlorine dioxide in the FCS can reach up to 30 ppm, which is 15 times higher than what was described in the three referenced EAs. It is reasonable to expect the concentration of chlorine dioxide in the plant effluent or in an average POTW influent as a result of the proposed action to be 15 times higher than what was estimated in the EA for FAP 0A4724; i.e., 0.3 ppm (0.02 ppm x 15 = 0.3 ppm) in the plant effluent or 39 ppb (2.6 ppb x 15 = 39 ppb) in an average POTW influent for the subject FCN.

However, since chlorine dioxide is highly reactive, we expect that it will readily react with the organic matter and microorganisms on the meat surfaces and will be reduced to chlorite, chloride, and chlorate. Furthermore, because oxychlorine species (chlorite, chlorate and chlorine dioxide) readily react with the organic matter and microorganisms in water and soil (sediments) and will undergo ultimate degradation into chloride ion, we anticipate that the expected environmental concentrations for these oxychlorine species will be very small and thus will be of no environmental concern.

 

Prepared by___________________________________ Date: October 18, 2004
Tong Zhou, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review