Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1764

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FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food Contact Substance (FCS) Notification (FCN) 1764, submitted by Selective Micro Technologies, LLC for use as an antimicrobial agent used to fumigate fruits and vegetables, including raw agricultural commodities. The FCS will be applied only in unlit areas and shall not exceed 3 ppm residual in the air. The treatment of fruits and vegetables will be followed by air flush or by blanching, cooking, or canning. In raw agricultural commodities, the FCS will be applied in the preparing, packing, or holding of the food for commercial purposes, consistent with the FD&C Act section 201(q)(l)(B)(i) but not applied for use under 201(q)(l)(B)(i)(I), (q)(l)(B)(i)(II), or (q)(I)(B)(i)(III). The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.

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 (EIS) will not be prepared. This finding is based on information submitted by the notifier in an environmental assessment (EA), dated April 4, 2017. The EA was prepared in accordance with 21 CFR 25.40. The EA is incorporated by reference in this Finding of No Significant Impact (FONSI), and is briefly summarized below.

The FCS is intended for use as an antimicrobial agent used to fumigate fruits and vegetables, including raw agricultural commodities at a level not to exceed 3 ppm residual in the air. Manufacture of the FCS is not expected to result in adverse environmental impact. During application, the FCS is in solution; the solution is then agitated to release the FCS as a gas into the application area. After application, the treatment area may be vented and any remaining FCS could be released to ambient air; also, the vessel that contains the solution of water and FCS will be disposed of, and may contain residual FCS. Lastly, the FCS is administered in a microreactor (a type of container) that is disposed of as trash after use. Therefore, the EA considers the potential environmental impact of these three exposure pathways.

The majority of the 3 ppm FCS concentration in the treatment area will be consumed when the FCS reacts with organic matter on the surface of fruits and vegetables, so when the treatment area is vented, very little of the FCS is expected to be released to the atmosphere (and any released FCS will be rapidly diluted). Also, the FCS is an unstable gas, and expected to immediately decompose to oxygen and chlorine when released. As oxygen is an abundant gas in the atmosphere, any oxygen contributed via use of the FCS will not be discernable and will not have a significant impact on the environment. Chlorine, on the other hand, is not an abundant gas in the atmosphere and is considered a Hazardous Air Pollutant by the U.S. Environmental Protection Agency (EPA). However, chlorine is expected to rapidly degrade to the chloride ion, and fall within or below background levels of chloride in the environment. Therefore, the venting of any remaining FCS to the atmosphere is not expected to significantly impact the environment.

The second exposure pathway involves disposal of the used solution of water and FCS. The EA explains that per the label, the vessel of water and FCS must be diluted to no more than 0.25 ppm FCS before release as wastewater. The FCS will degrade to chlorite, chlorate (at a ratio of 70:15) and chloride in water. The EA conservatively estimates environmental introduction concentrations (EICs) where 70% of the remaining FCS degrades to chlorite, 15% degrades to chlorate and, ultimately, 100% degrades to chloride. The resulting EICs for chlorite, chlorate and chloride, when adjusted for molecular weight, are 0.175, 0.0464 and 0.13 ppm, respectively. These EICs are expected to be diluted by at least 10-fold by the receiving water body, resulting in environmental exposure concentrations (EECs) as follows:

Chemical	EEC (ppm or mg/L)
Chlorite	0.0175
Chlorate	0.00464
Chloride	0.013

Comparing these EECs to the lowest aquatic ecotoxicity endpoint identified (an effect concentration, EC50 of 0.027 ppm in Daphnia magna) illustrates that there will be no significant environmental impact from the disposal of the used solution of water and FCS via wastewater.

Lastly, the used microreactor that administers the FCS will be disposed of as trash (and will not be recycled). Consequently, the used microreactors are expected to be primarily land disposed (80.4%) and secondarily, incinerated (19.6%) based on disposal trends for municipal solid waste (MSW), as reported by the EPA. Because of EPA’s regulations governing landfills (40 CFR Part 258) and the marginal amount of waste that would be landfilled (as disclosed in a confidential attachment to the EA), the microreactors are not expected to result in substances introduced to land or water when disposed via landfill. Similarly, when combusted, the EA explains there is nothing to suggest the disposed microreactors would threaten a violation of 40 CFR 60, the regulations governing MSW combustion facilities (based on the composition of the microcreactors and their contents; as well as the marginal amount of waste the disposed microreactors comprise compared to all combusted MSW). The EA also considered the impact of greenhouse gas (GHG) emissions in a confidential attachment. According to information in the confidential attachment to the EA, total annual emissions of GHGs represented as carbon dioxide-equivalents (CO2-e) in metric tons (mT), are well below the 25,000 mT GHG EPA mandatory reporting threshold described in 40 CFR 98.2. Therefore, no significant impacts are expected from incineration of the FCS at MSW combustion facilities. Therefore, the disposal of used microreactors as MSW is not expected to significantly impact the environment. In sum, we do not expect a significant impact to the environment from the use of the FCS as specified in FCN 1764.

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 antimicrobial materials which the FCS would otherwise replace; such action would have no new significant 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 1764, as an antimicrobial agent used to fumigate fruits and vegetables, including raw agricultural commodities at a level not to exceed 3 ppm residual in the air, will not significantly affect the quality of the human environment; therefore, an EIS will not be prepared.

Prepared by __________________________________________Date: digitally signed 07-19-2017
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 07-19-2017
Mariellen Pfeil
Biologist / Acting Lead, Environmental Review Team
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 April 4, 2017 EA for FCN 1764

Dated: July 19, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of April 4, 2017 for Food Contact Notification (FCN) 1764 concluded that the action will not constitute a significant environmental 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 explain the following:

Under Item 8 of the EA, on page 13, the EA does not provide the complete mathematical units conversion of ppm to μg/g. Therefore, the fully described mathematical conversion is shown below:

3 ppm ClO₂ = 3 μg ClO₂/1 g ClO₂ * 1 mg ClO₂/1000 μg ClO₂ * 67.45 g ClO₂/mol ClO₂ * mol ClO₂/24.45 L = 8.28x10^-3 mg/L ClO₂