Environmental Decision Memo and EA Revision Sheet for Food Contact Notification No. 1739

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FINDING OF NO SIGNIFICANT IMPACT

Proposed Action: Food Contact Substance (FCS) Notification (FCN) 1739, submitted by the Dow Chemical Company, for use of benzene, diethenyl-, polymer with ethenylbenzene and ethenylethylbenzene, chloromethylated (CAS Reg. No. 69011-14-9) as a resin to remove organic substances from aqueous and acidic food types I, II, and VI, excluding bottled water and alcoholic beverages containing over 30% alcohol, as described in Table 1.^[1] The finished resin is intended for repeated use in the processing of food at stream temperatures not to exceed 40°C. The finished resin should be treated with water to remove the process solvent in accordance with good manufacturing practice (GMP). 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 March 13, 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 used as an ion-exchange resin to remove organic substances from aqueous and acidic food streams. 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. Manufacture of the FCS is not expected to result in significant environmental impact. Once the FCS is manufactured, the FCS ion-exchange resin will be used to filter substances from the following three food streams:

Aqueous food streams such as juice (filtering polyphenols for subsequent re-use in other food applications)
Citrus juice (filtering out liminoids such as limonin and naringin)
Beer and other alcohol (filtering esters from recovered ethanol, so the ethanol can be re-used)

When the FCS is used as a filter, the FCS is not expected to be introduced into the environment – however – the substances filtered from the food streams and the solvents used to wash the FCS (so it can be used again) may enter the environment. Therefore, the EA considers the potential for the filtered substances and solvent washes to enter and impact the environment.

Filtering aqueous food streams (juice) to recover polyphenols
No substances are expected to enter the environment when the FCS ion-exchange resin is used to filter polyphenols from juice or other aqueous food streams. The polyphenols are eluted out of the filter using ethanol. The recovered polyphenols are re-used in other food applications and the ethanol is recovered for re-use as well.

Filtering citrus juice to remove liminoids
When the FCS ion-exchange resin filters liminoids from citrus juice, sodium hydroxide is used to wash the liminoids from the FCS ion-exchange resin so it can be used again. The mixture of sodium hydroxide and liminoids is considered waste and may reach the environment. Although sodium hydroxide is part of this wastewater, the concentration is not estimated because sodium hydroxide will decompose in water; although it has the potential to impact the pH – pH will be managed to comply with a facility's National Pollutant Discharge Elimination System (NPDES) permit or as corrosive waste under the Resource Conservation Recovery Act (RCRA) and therefore the use of sodium hydroxide in relation to FCN 1739 is not expected to impact the environment.

Therefore, this use of the FCS focuses on the environmental introduction concentration (EIC) of liminoids, which is calculated as follows:

The FCS would filter 126,000 L citrus juice before being washed
Citrus juice contains no more than 700 ppm liminoids
40% of the liminoid content is filtered out by the FCS ion-exchange resin
Therefore the FCS ion-exchange resin would contain 35.3 kg liminoids before being washed: 126,000 L citrus juice x (1 kg/1 L) x (700 parts liminoid/1,000,000 parts citrus juice) x (0.4) = 35.3 kg liminoid
The 35.3 kg liminoid is washed off of the FCS ion-exchange resin with 16,200 L of water/sodium hydroxide solution, resulting in a concentration of 2179 parts per million (ppm) liminoid waste solution: 35.3 kg / 16,200 L = 2179 ppm

This concentration is expected to be diluted to 304 ppm as the solution is discarded along with other water used in the food processing facility (at least an additional 100,000 L of water are expected to be discarded per day). Wastewater from a citrus processing facility is expected to be treated for biological oxygen demand (BOD) before reaching the environment. BOD treatment will result in liminoids partitioning to the air (followed by rapid degradation and dissipation) and adsorbing to sediment or suspended organic matter (followed by aerobic degradation).^[2] Therefore, following BOD treatment the concentration will be at least halved, resulting in an EIC of 150 ppm when discharged to surface water.

When this wastewater is discharged to surface water, the wastewater mixes with the surface water and the EIC will be diluted at least 10-fold to 15 ppm. Furthermore, the half-life of limonene is a few hours, resulting in an estimated environmental concentration (EEC) of 8 ppm. The aquatic liminoid EEC of 8 ppm is lower than the lowest aquatic endpoint (an EC50 for aquatic plants, blue-green algae, 9.353 mg/L or 9.353 ppm) therefore, no significant impact to the aquatic environment is expected when liminoid containing wastewater is discharged to surface water.

Liminoid containing wastewater may also be used as irrigation water. When used as irrigation water, the liminoid content will partition to the air and rapidly degrade, and will adsorb to the soil and also degrade. Furthermore, the EA explains that irrigation is a controlled irrigation limited to the root zone of trees (via drip irrigation). Therefore, based on the expected degradation and the limited reach of irrigation, no significant environmental impact is expected when liminoid containing wastewater is reclaimed as irrigation water.

Lastly, if the citrus processing wastewater is discarded to a Publicly Owned Treatment Works (POTW) there is the potential for the liminoid content to partition to sewage sludge at the POTW and become a part of biosolids. Since biosolids can be applied to land, the EA considered whether there may be environmental impact via this exposure pathway. However, since biosolids are conditioned, and since limonene is expected to degrade rapidly under aerobic conditions, liminoids are not expected to reach the environment via biosolids.

Filtering ethanol from the beer waste stream to remove esters
When the FCS ion-exchange resin filters ethyl esters from ethanol (recovered in breweries or other alcohol production facilities), water is used to wash the ethyl esters from the FCS ion-exchange resin so the FCS can be used again. Based on the professional expertise of Dow Chemical Company, the resulting concentration of ethyl esters in water would be 16 ppm. This EIC of 16 ppm is 5-fold lower than the most sensitive endpoint identified (a Lowest Observed Effect Concentration of 80 mg/L in blue-green algae); furthermore, based on the fate information of representative ethyl esters these substances are expected to degrade rapidly. Consequently, no significant impact to the environment is expected from the use of the FCS ion-exchange resin filtering ethyl esters from ethanol.

Disposal of the FCS resin
After repeated use (expected lifetime of 5 to 7 years), the FCS ion-exchange resin is disposed as regular municipal solid waste (MSW). The discarded FCS will either reach a landfill or a MSW combustion facility. Because of EPA’s regulations governing landfills (40 CFR Part 258) and the marginal amount of the FCS that would be landfilled (as disclosed in a confidential attachment to the EA), the FCS is not expected to be introduced to land or water when disposed via landfill. Similarly, when combusted, the EA explains there is nothing to suggest the FCS would threaten a violation of 40 CFR 60, the regulations governing MSW combustion facilities. This analysis is based on the composition of the FCS and the marginal amount of FCS compared to all combusted MSW. The EA also considered the impact of greenhouse gas (GHG) emissions resulting from combustion of the FCS resin and provided an analysis in the confidential attachment. Total annual emissions of GHGs represented as carbon dioxide-equivalents (CO2-e) in metric tons (mT), are well below the 25,000 mT GHG reporting threshold described in 40 CFR 98.2. Therefore, no significant environmental impacts are expected from incineration of the FCS at MSW combustion facilities. In sum, we do not expect a significant impact to the environment from the use of the FCS as specified in FCN 1739.

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 1739, as an ion-exchange resin to remove organic substances from aqueous and acidic food streams, will not significantly affect the quality of the human environment; therefore, an EIS will not be prepared.

Prepared by __________________________________________Date: digitally signed 06-14-2017
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 06-14-2017
Mariellen Pfeil
Biologist / Acting Lead, Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] https://www.fda.gov/food/ingredientspackaginglabeling/packagingfcs/foodtypesconditionsofuse/default.htm, accessed 6/5/17

[2] The fate information for liminoids is mainly based on data for limonene, and considered representative for liminoids.

U.S. Food and Drug Administration
Revision Sheet for the March 13, 2017 EA for FCN 1739

Dated: June 14, 2017

U.S. Food and Drug Administration (FDA) in its review of the Environmental Assessment (EA) of March 13, 2017 for Food Contact Substance (FCS) Notification (FCN) 1739 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 the following in the EA:

On page 7 of the EA, footnote 34, the environmental introduction concentration (EIC) of esters is diluted by 100,000 L, and reduced from 16 ppm to 0.4 ppm. The EA does not provide a reference to support the dilution by 100,000 L, however, the EA does demonstrate that an EIC of 16 ppm will not significantly impact the environment. Consequently, we ask the reader to disregard the dilution calculation outlined in footnote 34 on page 7.
On page 10 of the EA, footnote 46 says "Id., p. 7" and refers the reader to the previous footnote which cites the U.S. Environmental Protection Agency's (EPA) ecological risk assessment of d-limonene. This is a typographical error – the information in the sentence that refers the reader to footnote 46 is from the following reference, which is listed under Item 14 of the EA: World Health Organization, Concise International Chemical Assessment Document 5, Limonene, 1998
On page 11 of the EA, footnote 51 says "Id., p. 3", footnote 52 says "Id." and footnote 53 says "Id., p. 14." These footnotes refer the reader to the reference cited in footnote 50, the Organization for Economic Cooperation and Development Screening Information Data Set (OECD SIDS) Initial Assessment of Isobutyl acetate. This is a typographical error – the information in the sentences that refer the reader to footnotes 51-53 is from the following reference, which is listed under Item 14 of the EA: U.S. EPA, d-Limonene: Ecological Risk Assessment for Registration Review, Docket No. EPA-HQ-OPP-2010-0673 (December 5, 2014)
On page 11 and 12 the EA estimates an application for limonene if wastewater from the citrus processing facility is used to irrigate nearby citrus groves. We ask the reader to disregard this application rate. Our FONSI relies on the fate profile of limonene outlined in the EA. The EA explains limonene is expected to volatize to air and then rapidly break down or adsorb to soil and biodegrade. Furthermore, the reference cited in footnote 66 explains that most irrigation in citrus groves is via drip irrigation systems. This method of irrigation would limit the ability of limonene to reach habitat. The fate profile of liminoids coupled with the method indicate no environmental impact is expected when liminoid containing wastewater from citrus processing facilities is used as irrigation water.

Despite these inaccurate statements, the EA demonstrates no significant impact on the environment.

FINDING OF NO SIGNIFICANT IMPACT

U.S. Food and Drug Administration Revision Sheet for the March 13, 2017 EA for FCN 1739

U.S. Food and Drug Administration
Revision Sheet for the March 13, 2017 EA for FCN 1739