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See also Environmental Decisions.

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Date: April 12, 2016

From: Biologist, Environmental Team, Division of Biotechnology and GRAS Notice Review (HFS-255)

Subject: FCN No. 1634 – Chlorine dioxide (CAS No. 10049-04-4), REPLACES FCN 1400, as an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables, including raw agricultural commodities (RAC).

Notifier: Clordisys Solutions, Inc.

To: Hui Chen A. Chang, Ph.D., Division of Food Contact Notifications (HFS-275)

Through: Suzanne Hill, Environmental Supervisor, Office of Food Additive Safety, HFS-255

Attached is the Finding of No Significant Impact (FONSI) for food-contact notification (FCN) 1634. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated February 23, 2016, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website. A revision sheet making a minor technical change to the EA is appended to this FONSI.

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

Leah D. Proffitt

Attachments: Finding of No Significant Impact
EA Revision Sheet

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1634), replacing FCN 1400, submitted by Clordisys Solutions, Inc., to provide for the safe use of a solution of chlorine dioxide as an antimicrobial agent in water used in poultry processing and to wash fruits and vegetables, including raw agricultural commodities (RAC). The FCS will be used in an amount not to exceed 3 ppm residual chlorine dioxide as determined by Method 4500-Cl02-D, modified for use with the Hach Spectrophotometer, or equivalent. The FCS will be generated by the reaction between chlorine gas and a solid matrix of sodium chlorite. When used on RAC, the FCS will be applied as a spray or dip in the preparing, packaging or holding of food for commercial purposes, consistent with the FD&C Act section 201(q)(1)(B)(i), but not applied for use under 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II) or (q)(I)(B)(i)(III) of the FD&C Act. Treatment of fruits and vegetables, including raw agricultural commodities, shall be followed by a potable water rinse, blanching, cooking, or canning.

The Office of Food Additive Safety has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and, therefore, an environmental impact statement will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment, dated February 23, 2016, as summarized below.

The FCS is intended to inhibit the growth of undesirable or pathogenic microorganisms, and will be applied to water used in poultry processing, and to wash fruits and vegetables, including raw agricultural commodities (RAC). The FCS will be applied at a maximum level of 10 ppm to ensure a residual chlorine level of not greater than 3 ppm.

The FCS is expected to reduce to chlorite, chlorate, and chloride. Chlorine dioxide is expected to convert to chlorite and chlorate at a ratio of 70:15, with the remaining 15% constituting minor reaction products.^[1]

Treatment of the process water containing chlorine dioxide at the on-site wastewater treatment facility or publicly-owned treatment works (POTW) is expected to degrade and remove 99% of chlorite.^[2] It is assumed, worst case, that all chlorite and chlorate is converted to chloride.^[3] Therefore, assuming that approximately 50% of total water used at RAC processing facilities^[4], and 43% of total water at poultry processing plants^[5] is treated with ClO2, and applying a dilution factor (DF) of 10 to account for post-treatment discharge to surface waters^[6], the maximum expected environmental concentrations (EECs) for chlorite, chlorate and chloride are as follows:

According to published environmental toxicity endpoints for chlorite^[7], chlorate^[8] and chloride^[9], the EECs for all three ions are below ecotoxicity endpoints. The chlorite EECs of 0.0030 – 0.0035 ppm do not exceed the lowest endpoint of 0.027-0.39 ppm (Daphnia magna). The chlorate EECs of 0.064 – 0.075 ppm do not exceed the lowest toxicity endpoint of 7.3 ppm (Brown trout). The chloride EECs of 0.067 – 0.078 ppm do not exceed the lowest toxicity endpoint of 200 – 36,400 ppm (aquatic plants). The use of ClO2 produced using the method described in the FCN is expected to replace existing generation methods; therefore no increased use of energy or resources is anticipated. Any air releases are not expected to exceed 0.04 ppm, which is below the acute inhalation LC50 for rats of 105 ppm. Chlorite and chlorate are expected to convert to chloride which dissociates in water to chloride ion (Cl-). The lowest terrestrial endpoint for Cl- is 300 ppm for terrestrial plants^[10], which is three orders of magnitude higher than the highest EEC for chloride (0.0785 ppm). Therefore, no adverse impacts to terrestrial organisms are expected. Mitigation is not required since no adverse environmental impacts were identified.

We find that the proposed use of chloride dioxide as an antimicrobial solution used in water in poultry processing and to wash fruits and vegetables, including raw agricultural commodities, will not significantly affect the human environment, and therefore, an environmental impact statement will not be prepared for FCN No. 1634.

Prepared by __________________________________________Date: Digitally signed 04-12-2016
Leah D. Proffitt
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: Digitally signed 04-12-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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^[1] Lee, Yoon-jin, Hea-tae Kim, and Un-gi Lee. (2004). Formation of Chlorite and Chlorate from Chlorine Dioxide with Han River Water. Korean J. Chem. Eng., 21(3): 647-653; available at http://link.springer.com/article/10.1007%2FBF02705500

^[2] Toxicological Profile for Chlorine Dioxide and Chlorite. Sep. 2004. U.S. Department Of Health And Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry.

^[3] i.e. EEC chloride = EEC Chlorite + EEC Chlorate

^[4] Food Processing Environmental Assistance Center at http://www.fpeac.org/fruit/fruitveg.html

^[5] J. K. Northcutt and D. R. Jones: A Survey of Water Use and Common Industry Practices in Commercial Broiler Processing Facilities; 2004 Journal of Applied Poultry Research; available at http://naldc.nal.usda.gov/download/38935/PDF. This study describes 7 main uses of water in poultry facilities, of which 3 (carcass washing, chilling, and movement) would be treated with ClO2. Each use has been given equal weight: 3/7*100 = 43%

^[6] Rapaport, Robert A., 1988. Prediction of consumer product chemical concentrations as a function of publically owned treatment works treatment type and riverine dilution. Environmental Toxicology and Chemistry 7(2), 107-115. Found online at: http://onlinelibrary.wiley.com/doi/10.1002/etc.5620070204/abstract

^[7] 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; available at http://www.regulations.gov in EPA Docket No. EPA-HQ-OPP-2006-0328 (under “Supporting Documents”)

^[8] 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; available at http://www.regulations.gov in EPA Docket No. EPA-HQ-OPP-2005-0507 (under “Supporting Documents”)

^[9] Siegel, Lori. Hazard Identification for Human and Ecological Effects of Sodium Chloride Road Salt. (6 Jul. 2007). State of New Hampshire, Department of Environmental Services; available at http://trid.trb.org/view.aspx?id=1316825

^[10] Ibid.

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U.S. Food and Drug Administration
Revision Sheet for the February 23, 2016 Environmental Assessment for Food Contact Notification 1634
Dated: April 12, 2016

The U.S. Food and Drug Administration (FDA), in its review of the Environmental Assessment (EA) of February 23, 2016 for Food Contact Notification (FCN) 1634, concluded that the action will not constitute a significant environmental impact. This revision is issued to make a minor change and update of a technical or editorial nature to the EA that should be acknowledged, while not making any substantive changes to the EA. This revision does not impact our Finding of No Significant Impact (FONSI).

The revision applies to the calculation of the aquatic expected environmental concentration (EEC) for chlorate at fruit and vegetable and raw agricultural commodity processing facilities. The revision is as follows:

The EA contains the following calculation on page 26 for the aquatic EEC for chlorate:

1.5 * 0.5 * (1/10) = 0.15 ppm

The corrected calculation and result should be 0.075 ppm, as follows:

1.5 ppm * 0.5 * 0.1 = 0.075 ppm

As the corrected EEC result is less than the EEC result in the EA, impacts to aquatic organisms would be even less than presented in the EA. Therefore, this minor correction does not affect our FONSI for FCN No 1634.