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CFSAN/Office of Food Additive Safety
February 18, 2007
| Date: | February 18, 2007 |
| From: | Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246) |
| Subject: | FCN No. 692 - Hypochlorous acid for use as an antimicrobial agent in a solution for the re-hydrating of fresh fruits and vegetables, including leafy green vegetables. |
| Notifier: | Sterilox Food Safety/Div. of PuriCore,
Malvern, PA 19355 |
| To: | Division of Food Contact Notifications (HFS-275)
Attention: Julie N. Mayer, M.F.S. 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 692. When this notification becomes effective, these documents and the notifier's revised environmental assessment (in PDF*, 100Kb), dated January 22, 2007, may be made available to the public in response to a FOIA 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.
2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 692
A food contact notification (FCN No. 692), submitted by Sterilox Food Safety/Div. of PuriCore., to provide for the safe use of hypochlorous acid, for use as an antimicrobial agent in a solution for the re-hydrating of fresh fruits and vegetables, including leafy green vegetables.
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*, 100Kb), dated January 22, 2007, and our supplement to the environmental record for FCN 692.
Prepared by__________________________________________Date: February 18, 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: February 18, 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*, 100Kb), dated January 22, 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).
National Recommended Water Quality Criteria for Chlorine
The United States Environmental Protection Agency (EPA) has established national recommended water quality criteria for chlorine for the protection of aquatic life and human health. The EPA determined the Criteria Maximum Concentration and Criterion Continuous Concentration and defines them as,
"The Criteria Maximum Concentration (CMC) is an estimate of the highest concentration of a material in surface water to which an aquatic community can be exposed briefly without resulting in an unacceptable effect. The Criterion Continuous Concentration (CCC) is an estimate of the highest concentration of a material in surface water to which an aquatic community can be exposed indefinitely without resulting in an unacceptable effect." (1)
The CMC for chlorine in freshwater is 19 micrograms per liter and the CCC is 11 micrograms per liter (1). The CMC in saltwater is 13 micrograms per liter and the CCC is 7.5 micrograms per liter (1). Expected environmental concentrations are expected to be below these concentrations because of dilution in publicly owned treatment works and conversion to chloride (2).
Environmental Toxicity Endpoints for Chlorite and Chlorate
The EA provides environmental toxicity endpoints for free available chlorine but not chlorite, chorate, and trihalomethanes. We have provided a summary of relevant aquatic toxicity endpoints for chlorite and chlorate in Tables 1 and 2. Chronic toxicity endpoints were not available. Terrestrial exposure is not expected to occur for use in retail food service establishments and available endpoints were not included in the Tables. Toxicity endpoints for trihalomethanes were not provided as they have not been specifically identified. However, we do not expect significant amounts of trihalomethanes to be produced.
| Species | LC50 or EC50 (mg/L) | NOEC (mg/L) |
|---|---|---|
| Freshwater Fish | 50.6 - 420 | 32 - 216 |
| Freshwater Invertebrates | 0.027 - 1.4 | 0.003 - 0.4 |
| Estuarine/Marine Fish | 75 | 13.9 |
| Estuarine/Marine Invertebrates | 0.576 - 21.4 | 14.3 |
| Aquatic Plants | 1.32 | < 0.62 |
| a The substance tested was sodium chlorite with approximately 80% active ingredient. | ||
| b All data from: Chlorine Dioxide: Final Risk Assessment Case 4023; Docket ID No. EPA-HQ-OPP-2006-0328; U.S. Environmental Protection Agency, Antimicrobials Division: Washington D.C., Aug 2, 2006. | ||
| Species | LC50 or EC50 (mg/L) | NOEC (mg/L) |
|---|---|---|
| Freshwater Fish | 7.3 - 1100 | 600 - 1000 |
| Freshwater Invertebrates | 2100 - 4100 | 52 - 1000 |
| Aquatic Plants | 133 - 444 | 50 - 3137 |
| a All data from: Anderson, B.; Hetrick, J. A.; Nelson, H. Environmental Fate and Ecological Risk Assessment for the Reregistration of Sodium Chlorate as an Active Ingredient in Terrestrial Food/Feed and Non-food/Non-feed Uses. Reregistration Case Number 4049; Docket ID No. EPA-HQ-OPP-2005-0507; U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances: Washington, D.C., Jan 31, 2005. | ||
Definitions of Abbreviations Used in Tables
The Median Effective Concentration (EC50) is the concentration that causes a specified effect in 50% of the organisms tested.
The Median Lethal Concentration (LC50) is a statistically estimated concentration that is expected to be lethal to 50% of organisms tested.
The No Observable Effect Concentration (NOEC) is the highest concentration that did not produce and effect.
Error in EA
The EA provides references under Item 8. The report numbers for the documents written by J. C. Calandra are incorrect. The correct report numbers are Report No. 13 IBT J2119 and Report No. 1 IBT J2118.
Literature Cited
1. Current National Recommended Water Quality Criteria, http://www.epa.gov/waterscience/criteria/wqcriteria.html (accessed Feb. 13, 2007).
2. Anderson, B.; Hetrick, J. A.; Nelson, H. Environmental Fate and Ecological Risk Assessment for the Reregistration of Sodium Chlorate as an Active Ingredient in Terrestrial Food/Feed and Non-food/Non-feed Uses. Reregistration Case Number 4049; Docket ID No. EPA-HQ-OPP-2005-0507; U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances: Washington, D.C., Jan 31, 2005.
3. Chlorine Dioxide: Final Risk Assessment Case 4023; Docket ID No. EPA-HQ-OPP-2006-0328; U.S. Environmental Protection Agency, Antimicrobials Division: Washington D.C., Aug 2, 2006.
Prepared by __________________________________________Date: February 18, 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.
