Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1659

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FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food-contact notification (FCN) No. 1659, submitted by Ecolab, Inc., for use of the food-contact substance (FCS) 2-Pyridinethiol-1-oxide, sodium salt (CAS Reg. Nos. 15922-78-8; 3811-73-2) as a preservative for a rinse aid used on food preparation, storage, and eating utensils in commercial facilities such as restaurants, delis, cafeterias, bars, residential dining facilities, and medical institutions. Application will be by machine ware washing, (i.e., sprayed onto plates, cups, silverware, pots, and pans as a last step in the washing process, no water rinse afterwards) at a concentration not to exceed 3 ppm in the final rinse water.

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 (EA), dated June 15, 2016. The EA is incorporated by reference in this Finding of No Significant Impact (FONSI), and is briefly summarized below. The EA was prepared in accordance with 21 CFR 25.40.

The FCS is a preservative for rinse aids, which may remain in commercial dishwashing machines (warm and wet environments) for extended periods of time. The notifier does not intend to manufacture the FCS, but uses it in their rinse aid products. There are no extraordinary circumstances associated with the manufacture of the FCS or the rinse aid products. The evaluation in the EA focuses on the use and disposal of the FCS.

The FCS will be used nationwide in food-handling facilities and the rinse water containing the FCS will be disposed of via wastewater sent to Publicly Owned Treatment Works (POTWs). Environmental exposure was estimated using the Environmental Protection Agency’s (EPA) Exposure and Fate Assessment Screening Tool (E-FAST) model and FDA guidance. EPA E-FAST was used to estimate potential aquatic exposure (0.19 µg FCS/L water) and FDA guidance was used to estimate potential terrestrial exposure (when sewage from POTWs is land applied, 0.71 mg FCS/kg soil). These environmental exposure estimates were lower than relevant toxicity endpoints (looking across the data for sodium, zinc and copper pyrithione, the lowest aquatic endpoint identified is a no observed effects concentration (NOEC) of 0.31 µg zinc pyrithione/L water in Skeletonema costatum; and the lowest relevant terrestrial endpoint identified is a NOEC of 250 mg FCS/kg soil in Folsomia candida). Additionally, based on the use pattern and chemical properties of the FCS, the FCS is not expected to reach air. Therefore, we anticipate no significant impact to the environment.

As indicated in the EA, we do not expect a net increase in the use of energy and resources from the use of the FCS, nor do we expect adverse environmental effects, which would necessitate alternative actions to that proposed in this FCN. The alternative of not approving the action proposed herein would result in the continued use of the materials which the FCS would otherwise replace; such action would have no environmental impact. Furthermore, as the use and disposal of the FCS is not expected to result in significant adverse environmental impacts; mitigation measures are not identified.

As evaluated in the EA, the use of the FCS, as described in FCN 1659, as a preservative for rinse aids used in commercial dishwashing machines, will not significantly affect the quality of the human environment; therefore, an environmental impact statement will not be prepared.

Prepared by __________________________________________Date: digitally signed 09-12-2016
Sarah C. Winfield
Biologist
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: digitally signed 09-12-2016
Suzanne Hill
Environmental Supervisor
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

U.S. FOOD AND DRUG ADMINISTRATION
REVISION SHEET FOR THE JUNE 15, 2016 EA FOR FCN 1659

Date: September 12, 2016

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of June 15, 2016 for food contact notification (FCN) 1659 concluded that the action will not constitute a significant impact. The revision is issued to make a minor change and update of an editorial nature 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 is necessary to correct two endpoints incorrectly reported in Table 1 under Item 8 b. Aquatic Toxicity:

The endpoint for Ciona intestinalis was incorrectly reported as an EC50 of 108 instead of 95 nM. We estimate 95 nM to be equivalent to about 30 µg /L (ECHA, 2005, footnote 37 of the EA)
The endpoint for Skeletonema costatum was incorrectly reported as 1.3 µg /L instead of 1.2 µg /L for the 120 hour EC50 (Arch Chemicals, 2004, footnote 38 of the EA)

FINDING OF NO SIGNIFICANT IMPACT

U.S. FOOD AND DRUG ADMINISTRATION REVISION SHEET FOR THE JUNE 15, 2016 EA FOR FCN 1659

U.S. FOOD AND DRUG ADMINISTRATION
REVISION SHEET FOR THE JUNE 15, 2016 EA FOR FCN 1659