• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 000668

Date: December 6, 2006

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

Subject: FCN No. 668 - Chlorine dioxide for use as an antimicrobial agent.

Notifier: Drew Industrial Division. &
Ashland Specialty Chemical Co.
Boonton, NJ 07005

To: Division of Food Contact Notifications (HFS-275)
Attention: Kenneth A. McAdams
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's revised environmental assessment (EA) for FCN 668. When this notification becomes effective, these documents and the notifier's revised EA (in PDF, 7.6MB), dated November 13, 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.

Katrina E. White, Ph.D.

2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 668



 



 

Finding of No Significant Impact

A food contact notification (FCN No. 668), submitted by Drew Industrial Division & Ashland Specialty Chemical Company, to provide for the safe use of chlorine dioxide for use as an antimicrobial agent to be applied to red meat (including meat parts and organs), raw agricultural commodities, processed, comminuted or formed meat products, seafood, and processed fruits and vegetables.

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 the notification, including a revised environmental assessment (in PDF, 7.6MB), dated November 13, 2006, and our supplement to the environmental record.

Prepared by__________________________________________Date: December 6, 2006
Katrina E. White, 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: December 6, 2006
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group/Supervisor
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 Record
for Food Contact Notification No. 668

This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF, 7.6MB), dated November 13, 2006.

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).

Basis of FONSI

The United States Environmental Protection Agency (EPA) recently published the "Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023)"(1). The RED gives a comprehensive review of the use of chlorine dioxide as an antimicrobial and this review is applicable to the proposed use in this food-contact notification (FCN) and also helps to support this FONSI. The risk assessment was conducted for the "once-through cooling tower use of chlorine dioxide/sodium chlorite...because out of all the uses of these chemicals, it is the one expected to have the most potential for environmental exposure." (2). The risk assessment found that,

"Acute risk is anticipated for aquatic organisms from the use of chlorine dioxide/sodium chlorite in once-through cooling towers. At the highest doses on current labels (25 ppm), there is risk to freshwater and marine/estuarine fish and invertebrates and aquatic plants, and at the lowest doses there is risk only to freshwater invertebrates. To mitigate this risk, the maximum application rate for this use pattern must be reduced from 25 ppm to 5 ppm for intermittent applications" (1).1
"Chronic risk to aquatic organisms cannot be assessed at this time due to the lack of chronic toxicity endpoints for fish and aquatic invertebrates. When the required aquatic chronic toxicity testing described above is submitted, chronic risk to these organisms will be assessed. All other exposure and risk estimates are below the Agency's level of concern" (1).

As stated by EPA, "The generic database supporting the reregistration of chlorine dioxide and sodium chlorite has been reviewed and determined to be substantially complete" (1). 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" (1). 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"(1).

The risk mitigation measures and label requirements identified in the RED will also be required for use of chlorine dioxide as an antimicrobial in food processing facilities and will help to mitigate any adverse environmental impact from the proposed uses.

The EPA risk assessment included some of the uses requested in FCN 668. However, use of chlorine dioxide in FCN 668 in meat processing and seafood processing were not specifically listed in the RED (1). The environmental review group (ERG) believes that the environmental exposures from these uses will be similar to or less than those evaluated in the RED. Additionally, the FDA recently reviewed use of sodium chlorite and chlorine dioxide in poultry processing, fruit and vegetable processing, and for red meat and meat processing in FCNs 450, 644, and 645 (3-8). These reviews all indicate that the expected environmental concentrations will be lower than the lowest toxicity endpoints currently available due to the chemical degradation of chlorine dioxide, chlorite, and chlorate into chloride (1,3,5-12).2

Comments by ERG on the Revised EA

Item 6. Introduction of Substances into the Environment.

The EA states on page 4, "All of these methods are well-established and have been previously reviewed by FDA. Accordingly, there are not extraordinary circumstances that apply to the manufacture of chlorine dioxide, as described herein." ERG agrees with the notifier that there are no extraordinary circumstances regarding the manufacture of the materials used to produce chlorine dioxide. We also agree that the methods of generation of chlorine dioxide are well-established and have been previously reviewed by the FDA for different uses than requested in this notification. However, 1) this notification requested use applications not previously reviewed for all methods of generation used in this notification, and 2) new information on the environmental toxicity of chlorite, a substance used in some production methods of chlorine dioxide and a degradation product of chlorine dioxide, became available between the time the previous uses were approved and the time this FCN was submitted. Therefore, as with all FCNs, the environmental introduction from the proposed use applications must be reviewed for their environmental impact, especially in regards to the new information available. Additionally, different methods of generation of chlorine dioxide will result in different environmental introductions of chloride, chlorite, chlorate, and sodium (10,12).3 For instances where the production site of the FCS is also its use site, the environmental introductions resulting from production and use of the FCS should be considered in the EA. ERG advises that the use application that results in the most conservative or highest environmental introductions be evaluated.

The EA states on page 4, "the releases of chlorine dioxide, chlorite, and the sodium ion are anticipated to be less than those already approved under 21 CFR §173.325 (Acidified Sodium Chlorite Solutions)." We agree with this statement. However, new environmental toxicity endpoints have been identified that were not available when the EAs for the identified uses were completed. This information must be considered in the EA for this and subsequent approvals of food-contact substances. A finding of no significant impact cannot be based on previous approval when new information relevant to the assessment is available.

The EA assumed that approximately 50% of the total water discharged from a food-processing facility is treated with chlorine dioxide. ERG notes that the references support this assumption for fruit and vegetable processing facilities, it is not supported for the uses in red meat and seafood (13).

The EA did not consider terrestrial introductions into the environment. ERG knows that food-processing facilities commonly apply wastewater to land (14). ERG agrees with the statement published by the EPA on terrestrial environmental risk assessment, "The rapid degradation of the chemicals, coupled with the generally low toxicity of chlorine dioxide and sodium chlorite to birds and mammals, make risk to these organisms unlikely. The very limited data available to assess the phytotoxicity of chlorine dioxide/sodium chlorite make it difficult to determine the risk to terrestrial/semi-aquatic plants" (1). Rapid degradation of the chemicals is also expected to prevent toxicity in soil dwelling organisms such as earthworms.

Item 8. Environmental Effects of Released Substances.

The EA states on page 9, "An evaluation of the ecotoxicity data on chlorite was conducted by a research group associated with the University of Maryland. The group proposed an acute ecological risk criteria (ERC) or water quality criteria (WQC) of 0.135 ppm for the chlorite ion (see Appendix 5). This value takes into account the large different in chloride toxicity between fish and aquatic invertebrates. US EPA's Office of Water essentially concurred with this proposal (See Appendix 6)." Appendix 5 is a copy of a reference titled, "Derivation of acute ecolgocial risk criteria for chlorite in freshwater ecosystems" (15). Appendix 6 is a letter from the EPA to the American Chemistry Council dated March 11, 2002. The letter states, "The information available suggests that their benchmark concentration would be adequate to protect aquatic life uses, particularly in situations where the discharge of chlorite is brief and infrequent." A comment requesting the use of the 0.135 ppm toxicity endpoint was also submitted by the American Chemistry Council to the Antimicrobial Division (AD) of the EPA as a comment to the chlorine dioxide risk assessment. The EPA stated that the study, "uses a different method of risk assessment than AD uses and the results are therefore not applicable to our risk assessment" (16). ERG notes that it is not FDAs practice to omit toxicity endpoints based on them being much lower than other measured values.

Literature Cited

  1. Reregistration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023); EPA 738-R-06-007; US Environmental Protection Agency; Office of Pesticide Programs: Washington DC, August 2006.
  2. Angle, G. Chlorine Dioxide: Environmental Hazard and Risk Assessment; Docket Document ID Number EPA-HQ-OPP-2006-0328-0020; US Environmental Protection Agency; Office of Pesticide Programs: Washington, DC, July 13, 2006.
  3. Zhou, T. Supplement to the Environmental Information for Food Contact Notification No. 450; US Food & Drug Administration; Office of Food Additive Safety: Washington, DC, October 18, 2004. http://www.cfsan.fda.gov/~rdb/fnsi0450.html* (accessed November 24, 2006).
  4. Ringo, J. P. Environmental Assessment for Food Contact Notification No. 450; US Food & Drug Administration; Office of Food Additive Safety: Washington, DC, August 27, 2004. http://www.cfsan.fda.gov/~acrobat2/fnea0450.pdf* (accessed November 24, 2006).
  5. White, K. Supplement to the Environmental Record for Food Contact Notification No. 645*; US Food & Drug Administration; Office of Food Additive Safety: Washington, DC, September 5, 2006.
  6. Heger, E. A. Environmental Assessment for Food Contact Notification No. 645*; US Food & Drug Administration; Office of Food Additive Safety: Washington, DC, August 18, 2006.
  7. McCarthy, A. M. Finding of No Significant Impact for Food Contact Notification No. 644*; US Food & Drug Administration; Office of Food Additive Safety: Washington, DC, August 28, 2006.
  8. Simmons, R. A.; Heger, E. A.; Doyle, T. M. Environmental Assessment for Food Contact Notification No. 644*; US Food & Drug Administration; Office of Food Additive Safety: Washington, DC, August 17, 2006.
  9. Korn, C.; Andrews, R. C.; Escobar, M. D. Development of chlorine dioxide-related by-product models for drinking water treatment. Water Research 2002, 36, 330-342.
  10. 10. Veschetti, E.; Cittadini, B.; Maresca, G.; Citti, G.; Ottaviani, M. Inorganic by-products in waters disinfected with chlorine dioxide. Microchemical Journal 2005, 79, 165-170.
  11. Lee, Y.; Kim, H.; Lee, U. Formation of chlorite and chlorate form chlorine dioxide with Han River water. Korean J Chem Eng 2004, 21 (3), 647-653.
  12. Deshwal, B. R.; Lee, H. K. Manufacture of chlorine dioxide from sodium chlorite: Process chemistry. Jour of Industrial & Engineering Chemistry 2005, 11 (1), 125-136.
  13. Clean technologies in U.S. industries: Focus on Food Processing, United States Asia Environmental Partnership; Civil Engineering Research Foundation. www.p2pays.org/ref/09/08853.htm (accessed November 24, 2006).
  14. Regulation of Food Processing Waste Discharges to Land; California Environmental Protection Agency; Central Valley Regional Water Quality Control Board: 06. http://www.waterboards.ca.gov/centralvalley/available_documents/waste_to_land/FoodProcessingInfoItem/StaffRpt.pdf (accessed November 24, 2006).
  15. Fisher, D. J.; Burton, D. T.; Yonkos, L. T.; Turley, S. D.; Ziegler, G. P.; Turley, B. S. Derivation of acute ecological risk criteria for chlorite in freshwater ecosystems. Water Research 2003, 37, 4359-4368.
  16. Morrow, M. Memorandum: Chlorine Dioxide, Sodium Chlorite and Sodium Chlorate (Antimicrobial Uses): EPA response to Error Correction Comments on AD's Risk Assessment; Docket ID Number EPA-HQ-OPP-2006-0328-0012; US EPA; Office of Prevention, Pesticides, and Toxic Substances: Washington, DC, April 10, 2006.

Prepared by __________________________________________Date: December 6, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review


1 Parts per million is abbreviated by ppm.

2 The lowest toxicity endpoint currently available for chlorite is the 48 hour median effects concentration of 0.027 parts per million for Daphnia magna (2).

3 Appendix 1 of amended EA for food-contact notification 668.


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.