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Environmental Decision Memo for Food Contact Notification No. 000876

Date:June 22, 2009
From:Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 876 - Phosphonic acid, (1-methyl-ethenyl)-, homopolymer, sodium salt (PIPPA), as a boiler water additive.
Notifier:GE Infrastructure Water & Process Technologies
4636 Somerton Road
Trevose, PA 19053
To:Division of Food Contact Notifications (HFS-275)
Attention: Anita Chang, Ph.D.
Through: William H. Lamont, Acting Supervisor, ERT

Attached is the Finding of No Significant Impact (FONSI) for FCN 876. After this notification becomes effective, this FONSI and the notifier's environmental assessment, dated March 9, 2009, may be made available to the public, and we will post them on the internet where they can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.

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

 

Ron C. Hardman

Attachment:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 876


Finding of No Significant Impact

A food contact notification (FCN No. 876), submitted by GE Infrastructure Water & Process Technologies, to provide for the safe use of phosphonic acid, (1-methyl-ethenyl)-, homopolymer, sodium salt (PIPPA), as an anti-scalant boiler water additive at a maximum concentration of 25 ppm active material in boiler water used to prepare steam that will contact food.

The Environmental Review Team has determined that allowing this notification 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 in the notification, including an environmental assessment, dated March 9, 2009, submitted by the notifier and other information known to the agency.

Prepared by __________________________________________Date: June 22, 2009
Ron C. Hardman, Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: June 22, 2009
William H. Lamont, Acting Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Record for Food Contact Notification No. 876

This document incorporates by reference the notifier's environmental assessment (EA), dated March 9, 2009.

The purposes of this supplement are to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency’s basis for preparing a finding of no significant impact (FONSI) for the proposed use.

Overview: The notifier expected that disposal of the food-contact substance (FCS) primarily affected the aquatic environment. Also, the notifier expected that the intensities of introduction, fate, and effect of the disposed FCS critically depended upon two salient factors specifically identified as the extents to which the FCS can be degraded and can be diluted in wastewater. These expectations served to establish a basis for discussion and analysis in the assessment. In principle, we accept such a basis for this EA.

However, the EA contained some inaccurately characterized technical information about wastewater discharges that required clarification for better understanding of the basis for assessment. Also, minor discrepancies existed in computations to obtain the expected environmental concentration (EEC) of the FCS emitted into the environment. Corrected computations can better help to support the accuracy and completeness of conclusions in the EA about the potential impacts on the environment and biota, although those conclusions presented in the EA were not altered qualitatively by such corrections.

(As an aside, note that two special abbreviations were used in the EA. The notifier's name was denoted with "dba," which means "doing business as." The commercial delivery of the FCS in bulk was described for an on-site type of storage denoted as "POF," which means "point of feed" for a system using the FCS.)

Introduction of Product into the Environment (Item 6): Data presented elsewhere in the notification demonstrated that the FCS may be subject to dephosphorylation under the physico-chemical conditions of a boiler system. Consonant with prior conclusions in an EA for FAP 9B4114 for the same FCS, we believe that the concentrations expected for the notified use of the FCS in boilers are not anticipated to pose a significant environmental impact on the aquatic environment from emissions of phosphate decomposition products derived from a fraction of the FCS that may not survive boiler conditions and that becomes dephosphorylated.

The notifier discussed in the EA four, different, food processing scenarios that necessarily involved dilution of the FCS after its disposal from use. All scenarios commonly shared two distinct operational factors prompting unavoidable dilutions.

  • The notifier reasoned, on the basis of experience with different boiler systems, that the FCS released from boiler discharges ("blowdown") would be diluted—prior to any treatment—to different extents into the collected wastewater effluents of facilities utilizing steam generation for their processes.
  • The notifier also reasoned, on the basis of environmental obligations, that collected wastewaters would be subject to treatment imposed by discharge permits so that the treated FCS would be diluted again when ultimately discharged into receiving surface waters of the environment.

For each of these scenarios, the notifier assumed dilution conditions for food-processing wastewaters containing the FCS that depended partly on a range of wastewater treatment plant discharge capacities varying from 1.0 to 10 million gallons per day. The notifier selected that range of daily flow rates assuming an interpretation that the "flow range represents approximately 55% of all treatment facilities in operation in 2004," based on data contained in the Clean Watersheds Needs Survey (CWNS).1 The implicit intent was to select a range that could serve as a sufficiently protective basis supporting calculated EECs for the four food-processing scenarios in a rural setting. However, we note particularly that, in fact, the notifier's selection did not represent 55% of all treatment facilities but encompassed 17% of treatment facilities. Notwithstanding the misinterpretation, the notifier computed EECs for which the dilutions, despite some minor computational errors, varied between 730- (wet corn milling plant) to 27,800-fold (cereal processing plant), excluding an assumed 25% degradation fate for the FCS.

Environmental Effects of Released Substances (Item 8): The least dilution effect, 730-fold, attenuating the emission of the FCS into the aquatic environment was found for conditions ascribed to the scenario for a wet corn milling plant located in the Mississippi watershed. The notifier did not recognize a numerical error—a misplaced decimal—in computations characterizing discharge conditions for a wet corn milling plant. Therefore, the notifier based conclusions about the intensity of environmental impact posed by discharge of the FCS on another scenario, which was thought to be the "worst case," involving a potato processing plant for which the combined dilution effect, exclusive of a 25% degradation fate, was 6,950 under assumed operating conditions.

(Another numerical error was found in the scenario for processing fruit and vegetables. However, the error, in an intermediate step of the calculation, was simply typographic. The error was not carried into the final computed result for the EEC.)

We understand that industrial statistics vary widely for operational practices using water. The scenarios about four, different, food-processing operations demonstrate, at least qualitatively, that expected variance. As stated by the notifier in the EA, the agency typically uses a default dilution effect of ten-fold whenever industrial statistics are not available about wastewater discharges in receiving surface waters of the environment.

Given a concentration of 25 ppm for the FCS in boiler blowdown discharges and ignoring any degradation fate, we may, in this case, simply apply the agency's default ten-fold dilution effect to estimate a dilution-based EEC of 2.5 ppm FCS in the aquatic environment. (Applying a factor of 75% to account for the FCS surviving degradation, the fat-adjusted EEC becomes 1.9 ppm.) The eco-toxic data provided in the EA show by comparison that the toxic effects, if any, posed by the EEC is two orders of magnitude below the lowest (most conservative) no observed effect concentration (NOEC) for Daphnia magna (625 ppm). As discussed in the EA, the no observed adverse effect level (NOAEL) of 2.3 ppm for Selenastrum was attributed to effects other than toxicity. Nevertheless, we do not anticipate significant adverse environmental impacts as a result of use and disposal from use of the FCS because we expect the actual EEC to be very much less than the default dilution-based EEC of 2.5 ppm given that dilution, as demonstrated in the four scenarios, in the natural environment is reasonably expected to be a factor, at least, ten times greater than the agency's default ten-fold dilution effect. Also, based on the notifier's confidential projected market volume for the annual use of the FCS, we conclude that the actual EEC will likely be orders of magnitude less than the most sensitive threshold for toxicity or other effects disclosed in the EA, and potential impacts on the environment and biota posed by introduction, fate, and effect of the concentration of the disposed FCS are not likely to be significant.

Prepared by __________________________________________Date: June 22, 2009
Ron C. Hardman, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety


1United States Environmental Protection Agency, Clean Watersheds Needs Survey 2004 Report to Congress, Office of Wastewater Management, Washington, DC, (January 2008).