Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.

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Date: October 19, 2016

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

Subject: FCN No. 1700 – Monochloramine (CAS Reg. No. 10599-90-3).

Notifier: Buckman Laboratories, Inc.

To: Thomas Zebovitz, Ph.D., Consumer Safety Officer, Div. 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) 1700.

After this notification becomes effective, copies of this FONSI, the notifier's environmental assessment (EA), dated July 12, 2016 may be made available to the public. We will post digital transcriptions of the FONSI and the EA on the agency's public website.

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

Mariellen Pfeil

Attachment: Finding of No Significant Impact

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FINDING OF NO SIGNIFICANT IMPACT

A food-contact notification (FCN No. 1700), submitted by Buckman Laboratories, Inc. to provide for the safe use of monochloramine as an antimicrobial agent in process water used in poultry processing, including primary and secondary processing of whole or cut poultry.

The Office of Food Additive Safety has determined that allowing this food contact notification (FCN) 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 EA dated July 12, 2016. The EA is incorporated by reference in this Finding of No Significant Impact, and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.

The food contact substance (FCS) is intended for use as an antimicrobial agent in process water used in poultry processing, including primary and secondary processing of whole or cut poultry. The FCS will be used in an amount not to exceed 50 ppm. The FCS will be generated by the reaction between ammonia and sodium hypochlorite using the oxamine generation process. The FCS is intended for use in poultry processing facilities throughout the United States. The need for the FCS is to provide an alternative to antimicrobials currently used in poultry processing plants.

Introduction of Substances into the Environment as a Result of Use
It is expected that wastewater from an on-site wastewater treatment facility will discharge to a publically-owned treatment works (POTW) or, if in possession of a National Pollutant Discharge Elimination System (NPDES) permit, directly to surface waters. Wastewater effluents may also be land applied.

Confidential trial facility data which sampled influent going to an on-site wastewater treatment facility tested for the presence of the FCS show no detectable residues of the FCS with a limit of detection of 0.04 ppm. Therefore, environmental release of the FCS is not expected. Partitioning to wastewater treatment sludge therefore also is not anticipated. As discussed in the EA, the FCS components that may be present in wastewater effluents are chloride (Cl-), ammonia (NH3), sodium (Na+) and sulfate (SO4=) ions, as these are the degradation products of the FCS. Therefore, aquatic expected environmental concentrations (EECs) were calculated for these constituents. The aquatic EECs are 0.95 ppm chloride, 0.45 ppm ammonia, 0.62 ppm sodium, and 1.27 ppm sulfate. Additionally, a worst case aquatic EEC that assumes no degradation of the FCS was calculated to be 1.37 ppm. In all instances, these EECs do not exceed lowest ecotoxicity endpoints, U.S. EPA drinking water quality criteria or published agricultural irrigation guidelines.

Use of Resources and Energy
The FCS will be used in place of other, currently regulated/authorized chlorinated antimicrobials and therefore, will not impact energy or resources.

Alternatives to the Proposed Action
No potential adverse environmental effects were identified in the EA that would require evaluation of reasonable alternatives for the proposed use in this FCN. If the proposed action is not approved, the result would be the continued use of the currently marketed antimicrobial agents that the subject FCS would replace. Such action would not have a significant environmental impact.

As evaluated in the EA, the proposed use of the FCS as an antimicrobial agent for use in the processing of poultry is not expected to have a significant environmental impact; therefore, an environmental impact statement will not be prepared for FCN 1700.

Prepared by ____________________________________________Date: digitally signed 10-19-2016
Mariellen Pfeil
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by ____________________________________________Date: digitally signed 10-19-2016
Suzanne Hill
Environmental Team Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration