Environmental Decision Memo for Food Contact Notification No. 000625

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.

Date: August 21, 2006

From: Environmental Toxicologist, Environmental Review Group (ERG)
Division of Chemistry Research and Environmental Review (HFS-246)

Subject: FCN No. 625 - A mixture of peroxyacetic acid, hydrogen peroxide, and 1- hydroxyethylidine-1,1-diphosphonic acid, with or without an adjuvant system composed of a mixture of dimethyl esters.

Notifier: Ecolab, Inc.
c/o Exponent
Washington, DC, USA

To: Division of Food Contact Notifications (HFS-275)
Attention: Mark Hepp, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERG

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 625. The food contact substance is a mixture of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1,1-diphosphonic acid, with or without an adjuvant system composed of a mixture of dimethyl sebacate (up to 20%), dimethyl succinate (up to 0.8%), dimethyl adipate (68-76%), and dimethyl glutarate (4-12%). When this notification becomes effective, these documents and the notifier's revised EA (in PDF), dated June 19, 2006, may be made available to the public, and we will post them on the internet at*

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

Katrina E. White, Ph.D.

2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 625

Finding of No Significant Impact

A food contact notification (FCN No. 625), submitted by Ecolab, Inc., to provide for the safe use of a mixture of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidine-1,1-diphosphonic acid, with or without an adjuvant system composed of a mixture of dimethyl sebacate (up to 20%), dimethyl succinate (up to 0.8%), dimethyl adipate (68-76%) and dimethyl glutarate (4-12%) as an antimicrobial in the sterilization of polymeric packaging.

The Environmental Review Group 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 submitted by the notifier in the notification, including a revised environmental assessment (in PDF), dated June 19, 2006, and our supplement to the environmental record.

Prepared by __________________________________________Date: August 21, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: August 21, 2006
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Supplement to the Environmental Information for Food Contact Notification No. 625

This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF), dated June 19, 2006.

The purpose of this supplement is to ensure the accuracy and completion 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.

Item 7. Introduction of Substances into the Environment.

The EA used an assumption that wastewater resulting from use of the food contact substance (FCS) would be diluted by 1.0 million gallons per day (mgd or 3.79 x 106 L/day) to calculate environmental introduction concentrations (EICs) and expected environmental concentrations (EECs). This assumption was based on the weighted average of typical daily flow at publicly owned treatment works (POTWs) in operation in 2000, as presented in the Clean Watersheds Needs Survey (CWNS) 2000, Table C-3 (1). Table 1 displays the data from Table C-3, with columns added to show the percent facilities and percent flow in each flow range.

Table 1. Number of treatment facilities by flow range.
Treatment Facilities in Operation in 2000a,b
a California, Colorado, New York, and South Dakota did not have the resources to complete the updating of these data.
b Results presented in this table for Amercian Samoa, Guam, Northern Mariana Islands, Puerto Rico, Virgin Islands,
and Wyoming are from the 1996 survey because these States and Territories did not participate in the CWNS 2000.
c Flow data for these facilities were unavailable.
Existing Flow Range
Number of
Total Existing Flow
Percent of Total
Percent of Total
0.001 to 0.100 6583 290 40.50 0.83
0.101 to 1.000 6462 2339 39.75 6.70
1.001 to 10.000 2665 8325 16.39 23.86
10.001 to 100.000 487 12741 3.00 36.51
100.001 and greater 46 11201 0.28 32.10
Otherc 12 -- -- --
Total 16255 34899 100 100

Ninety-two percent of the total volume of flow occurred at POTWs with greater than 1.0 mgd flow. However, the daily flow at 80.25 percent of POTWs was 1.0 mgd and below. Based on the CWNS data, ERG does not consider the EA's assumption conservative because 1) the flow in many POTWs is often much less than 1.0 mgd, 2) there is a large variation in flow at POTWs, and 3) industrial wastewater can contribute to a large percentage of the total flow in an individual POTW. This consideration is supported by the following references.

  • Chapter 3 of the CWNS states, "It is noteworthy that 90 percent or more of the facilities in five states (Alaska, Kansas, Nebraska, North Dakota, and West Virginia) serve small communities. Moreover, in 10 additional States small community facilities constitute 80 - 90 percent of the publicly owned facilities" (page 12 - 13) (1). The survey also indicates that small communities serve a population less than 10,000 and have a flow less than 1.0 mgd, resulting in the assumed flow of 1.0 mgd being at the highest flow range for 80 - 90% of POTWs in 15 states.
  • The large variation in flow rate at different POTWs, as shown in Table 1, indicates that an average value will vastly overestimate dilution in some cases while underestimating dilution in others.
  • Much of the food processing industry is located in rural areas in which the water treatment systems are designed to serve small populations. As a result, one food processing plant can have a significant impact on water quality in POTWs and surface waters (2,3). For example, in a study published in 1979, new dairy plants were often located in suburban areas in cities with a population under 50,000, some distance from any major waste treatment facility, and with the average waste load equivalent to a population of about 55,000 (3).
  • Dairy processing plants, as well as other food processing plants, can release wastewater treated at on-site wastewater treatment plants directly to surface water (3,4).1 For example, in 1979, more than 5000 dairy plants discharged, "53 billion gallons of wastewater each year - about 31 billion gallons into municipal treatment plants, and 22 billion gallons directly into water bodies." If wastewater is not going to be released into a POTW, dilution based on flow in a POTW should not be considered in the calculations of EICs or EECs because POTW dilution will not be applicable to these cases.

Due to use of the assumption of dilution in 1.0 mgd flow in POTWs to calculate EECs in the EA, the Environmental Review Group (ERG) calculated alternative conservative EECs without considering dilution with POTW flow. ERG's calculated EECs should not be considered typical EECs as many of the assumptions were conservative.2

Calculation of Conservative EECs.

The calculations of the conservative EECs were based on the following assumptions.

  • Seventy-five percent of industrial wastewater will be treated with the FCS mixture. There is uncertainty with this assumption because these numbers vary from plant to plant, references with estimates on water use were published several years ago, and water use in the food processing industry is changing due to an emphasis on reducing water use and wastewater in food processing plants. However, based on a literature survey, ERG is confident that this assumption overestimates the percent of wastewater that is treated in most food processing plants expected to use the FCS and thus, is appropriate for a conservative estimate (2,3,6-8).
  • Concentrations will be diluted by a factor of 10 upon release into surface waters. This factor has traditionally been used by ERG.3

Approximate EECs in surface waters, based on dilution and degradation or sorption, are shown in Table 2.

Table 2. Summary of expected environmental concentrations (EECs) as a result of the proposed use.
Component EEC based on
dilution (mg/L)
EEC based on dilution and
degradation or sorption
Dimethyl succinate (DMSu, C6H10O4) 0.71 0.07
Dimethyl glutarate (DMG, C7H12O4) 7.13 0.71
Dimethyl adipate (DMA, C8H14O4) 64.13 6.41
Dimethyl sebacate (DMS, C12H22O4) 17.81 1.76
1-hydroxyethyylidine-1,1-diphosphonic acid
(HEDP, C2H8O7P2)
23.18 4.64

The concentrations that still exceed lowest toxicity endpoints after dilution include dimethyl adipate (DMA), dimethyl sebacate (DMS), and 1-hydroxyethylidine-1, 1-diphosphonic acid (HEDP). Greater than 90% adsorption of HEDP was measured at wastewater treatment plants (11). As the wastewater will go to an onsite-wastewater treatment plant or a POTW, ERG assumed that 80% of the HEDP is removed from the water via adsorption prior to release into surface waters (11,12).4 This results in a conservative EEC of 4.64 mg/L HEDP. As stated in the EA, dimethyl esters are readily biodegradable and are expected to be almost fully degraded with wastewater treatment. The biodegradation rates in the EA were measured in non adapted industrial sludge and indicate complete biodegradation in days to weeks. Biodegradation rates of days to weeks do not support complete degradation prior to release from the wastewater treatment plants as the residence time of water in the treatment plant can be less than weeks. However, industrial and municipal sewage sludge will be adapted and ERG expects the degradation rate to be faster then weeks. In addition, rapid biodegradation is expected in water due to ester hydrolysis facilitated by microorganisms. This is supported by model estimates provided by the Environmental Protection Agency (EPA) that predicted complete hydrolysis within hours in sewage treatment and by results using the EPI Suite (v3.12) program which predicted removal rates greater than 90% in wastewater treatment for all of the dimethyl esters in the FCS. Based on the assumption that 90% of dimethyl esters will degrade in the wastewater treatment plant or with sewage treatment, the predicted EECs are: 0.07 mg/L DMSu, 0.71 mg/L DMG, 6.41 mg/L DMA, and 1.76 mg/L DMS (Table 2).

Item 8. Fate of Substances Released into the Environment.

The EA provided a table of physicochemical properties for DMS and stated that the properties were representative of C4-C12 dimethyl esters. The physicochemical properties of C4 - C12 dimethyl esters are variable and the properties of one dimethyl ester are not applicable to all. A table of the physicochemical properties and environmental fate predictions for the distribution in different environmental media are shown in Table 3.

Table 3. Physicochemical properties and environmental fate of the C4-C12 dimethyl esters and HEDP.

Physicochemical Propertiesa
Compound Water Solubility
Vapor Pressure
(mm Hg)
Henry's Law Constant
Log Kow Boiling Point
(deg C)
Melting Point
(deg C)
Dimethyl succinate 25000 0.41 6.43E-08 0.35 196.4 19
Dimethyl glutarate 59000 0.18 6.43E-07 0.62 214 -42.5
Dimethyl adipate 6000 0.06 2.31E-06 1.03 115 10.3
Dimethyl sebacate 120 0.01 3.03E-06 3.35 -- --
Percent Distribution in Environmental Mediab
a All physicochemical properties were obtained from the Syracuse Research Corporation PhysProp Database available at:
b Dimethyl ester data were obtained from High Production Volume (HPV) Challenge Program: Robust Summaries & ; Test
Plans published for the dibasic esters and aliphatic esters categories. Available at: HEDP data were estimated using EPI Suite v3.12.
Compound Air Water Soil Sediment
Dimethyl succinate 4.67 48.2 47.1 0.08
Dimethyl glutarate 6.25 51.1 42.6 0.09
Dimethyl adipate 4.13 50.7 45.1 0.09
Dimethyl sebacate 2.5 36.7 60.1 0.7
HEDP <0.01 46.4 53.6 0.09

Item 9. Environmental Effects of Released Substances.

Dimethyl Esters: Aquatic Toxicity

To fully understand toxicity data, it is important to evaluate the source of the data. The EA summarized ecotoxicity data published in the High Production Volume (HPV) Chemical Challenge Program for the dimethyl esters and aliphatic esters (13,14). Most of the summarized values were calculated or estimated based on accepted models that use structure activity relationships and all data for DMS were estimated (Table 4) (13,14). Estimated toxicity data based on models should be compared to measured values to evaluate their accuracy. Measured acute median lethal concentrations (LC50)5 for fish ranged from 18 - 122 mg/L and are assumed to be representative of the dibasic esters (DMSu, DMG, and DMA) as a group. Toxicity tends to increase as molecular weight increases for these dimethyl esters and ecotoxicity endpoints for dimethyl sebacate are expected to be lower than endpoints for the other dimethyl esters (13). The lowest acute toxicity endpoint for the dimethyl esters for fish was 18 mg/L. A chronic median effects concentration (EC50)6 was estimated to be 6.44 mg/L (10).

Acute toxicity endpoints for Daphnia magna were measured using a dibasic ester mixture (DMSu, DMA, and DMG) and 48-hr LC50s were reported of 136 mg/L and 112-150 mg/L (13). We agree with EPA's comments on the HPV robust summaries regarding the invertebrate data, stating:

"The submitted data are only for the mixture, DBE, and are inconsistent with the predicted values for the other category chemicals. EPA therefore believes that the results of the DBE studies cannot be extrapolated to the single chemicals of the category and considers that this endpoint has not been adequately addressed. Furthermore, tests were performed on a mixture containing as little as 10% DMA, the member expected to be the most toxic, and thus the estimated value for DMA (497 mg/L vs. the measured value of 136 mg/L for DBE) appears to underestimate significantly the true toxicity. Measured data for DMA are needed to clarify the situation and help interpret the DBE data. Therefore, EPA recommends that the submitter conduct a daphnia toxicity study on DMA and use the results of this study for read-across purposes"(15).

No toxicity tests have been conducted on aquatic plants or algae. ERG also agrees with EPA that the estimated values using ECOSAR for algae are of limited value "because no measured analog data are available that are consistent with SAR results" (15). EPA recommended an algal toxicity study using DMA to represent the category (15). Finally, we note that no chronic toxicity studies were conducted on aquatic species.

Despite the above comments regarding the need for more data to support the ecotoxicity assumptions for the dimethyl esters, ERG believes that the available information is adequate to support a FONSI because of the high biodegradation of this class of compounds and the fact that calculated conservative EECs are lower than any measured or estimated ecotoxicity endpoints (Table 5). ERG agrees with the conclusions in the EA that DMSu, DMG, DMA, and DMS will almost fully degrade in wastewater treatment plants prior to release into the environment.

Table 4. Summary of aquatic toxicity data for C4-C12 dimethyl esters.a
a All data from the High Production Volume Chemical Challenge Program for the dimethyl esters and aliphatic esters, references 13 and 14.
Compound Test Organism Species Endpoint mg/L Source
Dimethyl Succinate Fish Brachydanio renio 96-hr LC50 50-100 Unknown
Invertebrate Daphnia Magna 48-hr LC50 3317.276 Calculated using SAR model
Algae Chlorophyta 96-hr LC50 11.917 Calculated using ECOSAR
Dimethyl Glutarate Fish Lepomis macrochirus 96-hr LC50 30.9 Measured by Dupont
Invertebrate Daphnia Magna 48-hr LC50 1275 Calculated using ECOSAR
Algae Chlorophyta 96-hr LC50 7.186 Calculated using ECOSAR
Dimethyl Adipate Fish   LC50 25.7 Calculated by Matthiessen, P. et al. (1993). Mar. Poll. Bull., 26(2):90-95.
Fish Carpus carpio 43-hr LC50 89-122 Loeb, H.A. et al. (1963). U.S. fish Wildl. Serv. Sp. Sci. Rep.-Fish No. 471, Washington, DC (Aquire/AQ 0002965)
Fish   Lowest Chronic EC50 6.44 Calculated by Matthiessen, P. et al. (1993). Mar. Poll. Bull., 26(2):90-95.
Invertebrate Daphnia magna 48-hr LC50 497 Calculated using ECOSAR
Algae Chlorophyta 96-hr EC50 4.351 Calculated using ECOSAR
Dibasic Ester Mixture Fish Pimephales promelas 96-hr LC50 18-24 Measured by Dupont
Invertebrate Daphnia magna 48-hr LC50 136 Measured by Dupont
Table 5. Comparison of conservative expected environmental concentrations (EEC) to the lowest measured acute toxicity endpoints.
Compound   EEC (mg/L)     Lowest Measured  
Acute Toxicity
Endpoint (mg/L)
Dimethyl succinate         0.07 50
Dimethyl glutarate 0.71 30.9
Dimethyl adipate 6.41 89
Dimethyl sebacate 1.76 --
HEDP 4.64 10

HEDP: Aquatic Toxicity

The aquatic toxicity data for HEDP in the EA did not reflect the available data for this compound or give a good description of the relevant environmental concerns. Comprehensive environmental risk assessments for HEDP were recently published by Jarworska et al. (2002) and by the Human & ; Environmental Risk Assessment (HERA) group on ingredients of household cleaning products (11,12). These documents serve as a good reference on this subject. Acute toxicity endpoints ranged from 0.74 - 2180 mg/L (Table 6) (11, 12). Chronic no observable effects concentrations (NOECs) are also shown in Table 6. The 14 day NOEC for Onchorhynchus mykiss was between 60 - 180 mg/L and the 28 day NOEC for Daphnia magna was 10 mg/L (12).7

HEDP is a strong chelating agent and can result in adverse effects on environmental organisms by complexation of essential nutrients (11). For strong chelating agents, it is suggested that two types of NOECs be determined: an intrinsic NOEC (NOECi) measured with excess nutrients available and an NOEC measured to protect from the chelating effects in natural waters (NOECc) (12). A realistic NOECc should be determined by testing in natural waters, by predicting metal speciation and algal trace element requirements, and/or using metal speciation modeling programs (12). However, ERG believes that excess nutrients are expected to be present in industrial wastewater as eutrophication is a well known phenomenon seen in industrial wastewaters from food processing facilities (3,16,17).

The lowest toxicity endpoints published for algae, Selenastrum capricornutm, Daphnia magna, and Crassostrea virginica are believed to be the result of the chelation effect and not the intrinsic toxicity of HEDP (12). These values are not relevant when excess nutrients are present as expected in food processing wastewaters (16,17).8 This leaves the lowest aquatic toxicity endpoint published by Jaworska et al. at 10 mg/L which is higher than the very conservative EEC of 4.64 mg/L calculated by ERG. This is the basis of the FONSI for HEDP in relation to intrinsic aquatic toxicity.

Table 6. Environmental toxicity data for HEDP.a
aAll data from: Jaworska, J.; Van Genderen-Takken, H.; Hanstveit, A.; van de Plassche, E.; Feijtel, T.
Chemosphere. 2002, 47 655-665. HERA. Human & Environmental Risk Assessment on Ingredients
of European Household Cleaning Products: Phosphonates (Draft), (accessed Jul 2006).
Species Endpoint (mg/L)
Lepomis macrochirus 96 hour LC50 868
Oncorhynchus mykiss 96 hour LC50 360
Cyprinodon variegatus 96 hour LC50 2180
Ictalurus punctatus 96 hour LC50 695
Leuciscus idus melanatus 48 hour LC50 207-350
Daphnia magna 24-48 hour EC50 165-500
Palaemonetes pugio 96 hour EC50 1770
Crassostrea virginica 96 hour EC50 89
Selenastrum capricornutum 96 hour EC50 3
Selenastrum capricornutum 96 hour NOEC 1.3
Algae 96 hour NOEC 0.74
Chlorella vulgaris 48 hour NOEC ≥100
Pseudomonas putida 30 minute NOEC 1000
Oncorhynchus mykiss 14 day NOEC 60-180
Daphnia magna 28 day NOEC 10 - <12.5
Algae 14 day NOEC 13

Eutrophication is a process whereby water bodies, such as lakes, rivers, and streams, receive excess nutrients that stimulate excessive growth of algae and other plant material. This enhanced plant growth can result in low dissolved oxygen, fish kills, and a depletion of desirable flora and fauna. The relevance of this environmental issue is reflected in reports from the EPA which state, "As much as half of the Nation's waters surveyed by states and tribes do not support aquatic life because of excess nutrients" (17). The main cause of eutrophication in lakes and streams are high levels of nitrogen and phosphorus and phosphates usually originate from municipal or industrial effluents (16,17). Primary industrial point source contributions of phosphorus include dairy, meat, and vegetable processing facilities, indicating that excess phosphates in food processing effluent is a relevant environmental issue (18). HEDP contains phosphorus and has the potential to contribute to eutrophication.9 In 1998, permissible discharge levels for industries ranged from 0.1 - 0.5 mg/L total phosphorus and a goal of 1 mg/L total phosphorus was set in a phosphorus management plan for POTWs in the Upper Mississippi River Basin (16,18). ERG expects the proposed use of the FCS to contribute a small percentage of the total phosphorus load in the wastewater (19).10 However, dairy processing effluent released to POTWs and surface waters is typically treated to reduce total phosphorus prior to discharge (3). The FCS will be used with a product currently registered as a pesticide with the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The label requires that the permitting authority of the National Pollutant Discharge Elimination System (NPDES) or the local sewage treatment plant authority be notified prior to the product being discharged into natural waters or POTWs. The label will also apply to FDA-regulated uses and will help to mitigate any adverse effects from the proposed use of the FCS.

Literature Cited

  1. US EPA Clean Watersheds Needs Survey 2000: Report to Congress; EPA-832-R-03-001; 2003.
  2. United States Asia Environmental Partnership; Civil Engineering Research Foundation. Clean technologies in U.S. industries: Focus on Food Processing. (accessed Jul 2006).
  3. Carawan, R. E.; Chambers, J. V.; Zall, R. R.; Wilkowske, R. H. Dairy Processing: Water and Wastewater Management; Extension Report No. AM-18b; 1979. North Carolina Agricultural Extension Service. (accessed Jul 2006).
  4. Bough, W. A.; McJimsey, E.; Clark-Thomas, D. Operating Costs of Dairy Pretreatment vs. POTW Facilities and the Establishment of a Waste Minimization Program, Mid-AmericaDairymen, Inc. (accessed Jul 2006).
  5. US EPA Reregistration Eligibility Decision: Peroxy Compounds. Case 4072. EPA-738-F-93-026.; 1993.
  6. Carawan, R. E.; Jones, V. A.; Hansen, A. P. Journal of Dairy Science. 1979, 62 (8), 1238-1241.
  7. Carawan, R. E.; Chambers, J. V.; Zall, R. R. Fruit and Vegetable Water and Wastewater Management, Extension Report No AM-18e. North Carolina Agricultural Extension Service. (accessed Jun 2006).
  8. Coca-Cola HBC. Social Responsibility Report 2004, (accessed Jul 2006).
  9. Cleland, J.; Rodriquez, M.; Huang, M.; Wrenn, B.; ICF Consulting Background Research Related to Aquatic Expected Exposure Concentrations from Poultry First Processing, Draft Memorandum, FDA Contract No. 233-00-2450, WA No. 314, Task 2; 2003.
  10. Matthiessen, P.; Thain, J. E.; Law, R. J.; Fileman, T. W. Marine Pollution Bulletin. 1993, 26 (2), 90-95.
  11. HERA. Human & Environmental Risk Assessment on Ingredients of European Household Cleaning Products: Phosphonates (Draft), (accessed Jul 2006).
  12. Jaworska, J.; Van Genderen-Takken, H.; Hanstveit, A.; van de Plassche, E.; Feijtel, T. Chemosphere. 2002, 47 655-665.
  13. Synthetic Organic Chemical Manufacturers Association Dibasic Esters Group. High Production Volume Robust Summaries and Test Plans: Dibasic Esters, US EPA. (accessed Jul 2006).
  14. American Chemistry Council's Aliphatic Esters Panel High Production Volume (HPV) Chemical Challenge Program: Test Plan of Aliphatic Esters Category; AR201-13466A; 201, U.S. EPA. (accessed Jul 2006).
  15. Hernandez, O. Robust Summaries & Test Plans: Dibasic Esters; EPA Comments. (accessed Jul 2006).
  16. Anirudhan, T. S.; Noeline, B. F.; Manohar, D. M. Environmental Science and Technology. 2006, 40 2740-2745.
  17. US EPA. Fact Sheet: Ecoregional Nutrient Criteria, EPA-822-F-02-008. (accessed Jul 2006).
  18. Minnesota Technical Assistance Program. Final Report. Pollution Prevention for Industrial Wastewater Discharges in the Upper Mississippi River Basin Using City-wide Inventories. Grant No. 03-025. Funding Period June 2003 to May 2005., University of Minnesota. (accessed Jul 2006).
  19. PCA Consultants Ltd. Technical Pollution Prevention Guide for the Dairy Processing Operations in the Lower Fraser Basin. DOE FRAP 1996-11, Environment Canada. (accessed Jul 2006).

Prepared by __________________________________________Date: August 21, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review

1 The FCS is expected to be used in the production of low acid foods to be packaged in aseptic packaging. The low acid foods produced were described on page 7 of Form 3480 as "certain milk, milk-based fluids, dairy-based creams and substitutes" indicating that the FCS is likely to be used at dairy processing plants.

2 These assumptions and calculations should not be adopted for future notifications unless they are applicable to the proposed use and substance.

3 ERG has examined dilution factors (DF) at poultry first processing plants and found that 71% of facilities had DFs greater than 100 and 96 percent had a DF of 20 or greater (9,10). A DF of 10 for all food processing facilities is assumed to be a conservative DF for the majority of food processing facilities.

4 This assumption was used by the Human & Environmental Risk Assessment group and in a risk assessment conducted for phosphonates in the Netherlands (11,12).

5 A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals.

6 A statistically derived concentration of a substance that can be expected to cause a specified effect in 50% of test animals.

7 A chronic NOEC of 0.1 mg/L for reproductive effects in Daphnia magna was published but is inconsistent with other toxicity data for the phosphonates and Jaworska suggested that the value is due to the depletion of micronutrients by HEDP rather than its intrinsic toxicity (11). No systemic toxicity was found below 10 mg/L and Jaworska et al. used 10 mg/L to represent the chronic NOEC for Daphnia magna (12).

8 Wastewater of dairy processing facilities is characterized by high total phosphorus levels and high biological oxygen demand (BOD), reflecting the presence of excess nutrients (18,19). However, it may contain low levels of nitrogen (19).

9 The FONSI and "Supplement to the Environmental Information Available for Food Contact Notification 140" reviewed the use of HEDP in meat processing facilities and discussed the possible contribution of HEDP to total phosphorus and thus eutrophication. It was found that the total phosphorus resulting from the use of HEDP was a small portion of total phosphorus levels found in wastewater of meat processing facilities.

10 Typical total phosphorus in dairy effluent ranged from 9 - 210 mg/L and the primary sources of phosphorus were milk, detergents, and sanitizers (page 35) (19). (4).

*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Ingredients and Packaging section under the Food topic of

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