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Environmental Decision Memo for Food Contact Notification No. 000641

Date: August 16, 2006

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

Subject: FCN No. 641 - Equilibrium Mixture of Peroxyacetic Acid and Hydrogen Peroxide for Use in Lactose Process Water.

Notifier: Enviro Tech Chemical Services, Inc.
500 Winmoore Way
Modesto, CA, 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 641. When this notification becomes effective, these documents and the notifier's revised EA (in PDF), dated July 27, 2006, may be made available to the public, and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

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. 641



 



 

Finding of No Significant Impact

A food contact notification (FCN No. 641), submitted by Enviro Tech Chemical Services, Inc., to provide for the safe use of an equilibrium mixture of peroxyacetic acid and hydrogen peroxide for use in lactose process water.

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 July 27, 2006, and our supplement to the environmental record.

Prepared by __________________________________________Date: August 16, 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 16, 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. 641

This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF), dated July 27, 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). Comments by the environmental review group (ERG) on specific items in the EA are provided.

Item 4. Description of the Proposed Action.

The use level of the components of the food-contact substance (FCS) are at a maximum level of 30 mg/L peroxyacetic acid, 140 mg/L hydrogen peroxide, and 3.2 mg/L 1-hydroxyethylidine-1, 1-diphosphonic acid (HEDP) in the lactase process water. The FCS will be used in food-processing facilities throughout the United States. The treatment solution will ultimately run into drains and enter the food processing plant water treatment facility, where it is collected and treated, along with other process water, by the facility prior to it being discharged to a publicly-owned treatment works (POTW), to surface waters, or applied to land (1,2). Additionally, a small amount of HEDP will be incorporated into the lactose as stated in the EA.

Item 6. Introduction of Substances into the Environment.

The EA states, "The stabilizer in the formulation HEDP would be diluted many thousands of times by wt. with the balance of the food plant wastewater and would result in a HEDP concentration in excess of parts per billion quantities, which would not present an environmental concern."1 ERG agrees that the FCS will be diluted with wastewater from other operations in the dairy-processing plant. However, the amount of dilution will depend on the amount of wastewater treated with HEDP versus the amount of wastewater not treated with HEDP. ERG believes that HEDP will be used in sanitizers and detergents used in other areas of dairy processing plants and that the EA's estimate of dilution is high (3).

ERG calculated the expected HEDP concentration in effluent discharged from the on-site wastewater treatment facility using conservative assumptions. ERG assumed that all wastewater is treated and that 80% of the HEDP is removed from the water via adsorption (4,5).2, 3 The effluent concentration is then 0.64 mg/L HEDP for discharge from the on-site wastewater treatment facility. Additionally, ERG assumed effluent concentrations will be diluted by a factor of 10 in surface waters.4 The expected environmental concentration (EEC) in surface waters is then 0.064 mg/L HEDP. This EEC is considered the highest EEC for introduction to surface waters and therefore an EEC for introduction to surface waters via a POTW was not calculated.5

Item 7. Fate of Emitted Substances in the Environment.

The EA states, "the half-life of hydrogen peroxide in ground water, taken from wells in a shallow sand and gravel aquafier at 11-32 meters below ground level was < 1 hr.6 The reference used in the EA to support this half-life did not report a half life for hydrogen peroxide in ground water (7).

The EA states, "Degradation has also been shown in several test soils at rates similar to biodegradable linear alkylbenzene sulfonate." No reference was given for this statement. ERG does not agree with this statement, the extrapolated half-life for HEDP in soil is 373 days and the half-life for linear alkylbenzene sulfonates in sludge applied to soil is 5-30 days (4,8).

Item 8. Environmental Effects of Released Substances.

HEDP

Aquatic Environment

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 (4,5). These documents serve as a good reference on this subject. Acute toxicity endpoints ranged from 0.74 - 2180 mg/L (Table 1) (4,5). Chronic no observable effects concentrations (NOECs) are also available. 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 (5).7

HEDP is a strong chelating agent and can result in adverse effects on environmental organisms by complexation of essential nutrients (4). 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) (5). 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 (5). However, 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 (9-11).

Table 1. Environmental toxicity data for HEDP.a
SpeciesEndpoint(mg/L)
Lepomis macrochirus96 hour LC50868
Oncorhynchus mykiss96 hour LC50360
Cyprinodon variegatus96 hour LC502180
Ictalurus punctatus96 hour LC50695
Leuciscus idus melanatus48 hour LC50207-350
Daphnia magna24-48 hour EC50165-500
Palaemonetes pugio96 hour EC501770
Crassostrea virginica96 hour EC5089
Selenastrum capricornutum96 hour EC503
Selenastrum capricornutum96 hour NOEC1.3
Algae96 hour NOEC0.74
Chlorella vulgaris48 hour NOEC≥100
Pseudomonas putida30 minute NOEC1000
Oncorhynchus mykiss14 day NOEC60-180
Daphnia magna28 day NOEC10 - <12.5
Algae14 day NOEC13
a All data from Jaworska et al. (2002) and the HERA risk assessment, references 4 and 5.
b The median lethal concentration (LC50) is a statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. The median effects concentration (EC50) is a statistically derived concentration of a substance that can be expected to cause a specified effect in 50% of test animals.

The lowest toxicity endpoints published for algae, Selenastrum capricornutm, Daphnia magna, and Crassostrea virginica are the result of the chelation effect and not the intrinsic toxicity of HEDP (5). These values are not relevant when excess nutrients are present as expected in food processing wastewaters (10).8 This leaves the lowest aquatic toxicity endpoint published by Jaworska et al. at 10 mg/L, which is higher than the conservative EEC of 0.064 mg/L calculated by ERG. This is the basis of the FONSI for HEDP in relation to intrinsic aquatic toxicity.

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 Environmental Protection Agency (EPA) stating that, "As much as half of the Nation's waters surveyed by states and tribes do not support aquatic life because of excess nutrients" (10). 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 (9,10). 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 (12). 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 (9,12,13). ERG expects the proposed use of the FCS to contribute to a small percentage of total phosphorus load in wastewater (3).10 However, food processing effluent released to POTWs and surface waters is typically treated to reduce total phosphorus prior to discharge (11).

Terrestrial Environment

HEDP in effluent discharged to land is not expected to have any adverse environmental impact. The effluent concentration of 0.64 mg/L is expected to result in soil concentrations lower than terrestrial toxicity endpoints available for plants, earthworms, and birds (4). The NOEC for soil dwelling organisms was 1000 mg/kg soil dry weight and this includes plants and earthworms (4). The 14 day median lethal dose (LD50) for birds was greater than 284 mg/kg body weight (4).11 Application of the wastewater to land will result in phosphorus concentrations in soil that are a small fraction of total phosphorus concentrations currently found in the environment and used in fertilizers (13,14).12 Runoff of phosphorus into groundwater or surface waters depends on the management practices and site specific factors. When best management practices developed by the EPA are followed, ERG believes that land application of wastewater will reduce use of water by recycling water for irrigation and the cost of treatment of wastewater.13

Item 10. Mitigation Measures.

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 Pollution Discharge 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. Central Valley Regional Water Quality Control Board. Regulation of Food Processing Waste Discharges to Land, California Environmental Protection Agency. http://www.waterboards.ca.gov/centralvalley/available_documents/waste_to_land/FoodProcessingInfoItem/StaffRpt.pdf (accessed Aug 2006).

2. Wisconsin Department of Natural Resources. Food Processing Business Sector Fact Sheet, http://dnr.wi.gov/org/caer/cea/assistance/foodprocessing/info.htm#wastewater (accessed Jul 2006).

3. PCA Consultants Ltd. Technical Pollution Prevention Guide for the Dairy Processing Operations in the Lower Fraser Basin. DOE FRAP 1996-11, Environment Canada. http://www.p2pays.org/ref/04/03995.pdf (accessed Jul 2006).

4. HERA. Human & Environmental Risk Assessment on Ingredients of European Household Cleaning Products: Phosphonates (Draft), http://www.heraproject.com/files/30-F-04-%20HERA%20Phosphonates%20Full%20web%20wd.pdf (accessed Jul 2006).

5. Jaworska, J.; Van Genderen-Takken, H.; Hanstveit, A.; van de Plassche, E.; Feijtel, T. Chemosphere. 2002, 47 655-665.

6. 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.

7. Holm, T. R.; George, G. K.; Barcelona, M. J. Analytical Chemistry. 1987, 59 (4), 582-586.

8. WHO Task Group on Environmental Health Criteria for Linear Alkylbenzene Sulfonates and Related Compounds, World Health Organization. http://www.inchem.org/documents/ehc/ehc/ehc169.htm#SectionNumber:1.4 (accessed Aug 2006).

9. Anirudhan, T. S.; Noeline, B. F.; Manohar, D. M. Environmental Science and Technology. 2006, 40 2740-2745.

10. US EPA. Fact Sheet: Ecoregional Nutrient Criteria EPA-822-F-02-008, http://www.epa.gov/waterscience/criteria/nutrient/ecoregions/jan03frnfs.pdf (accessed Jul 2006).

11. Carawan, R. E.; Chambers, J. V.; Zall, R. R.; Wilkowske, R. H. Dairy Processing: Water and Wastewater Management, North Carolina Agricultural Extension Service. http://www.p2pays.org/ref/01/00458.pdf .

12. 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. http://mntap.umn.edu/POTW/McKnight05.pdf (accessed Jul 2006).

13. Litke, D. W. Review of Phosphorus Control Measures in the United States and Their Effects on Water Quality: Water-Resources Investigations Report 99-4007; U.S. Geological Survey: Denver, Colorado, 1999.

14. Sharpley, A.; Sheffield, R. Lesson 34: Phosphorus Management for Agriculture and the Environment, Livestock and Poultry Environmental Stewardship Curriculum. http://www.lpes.org/Lessons/Lesson34/34_Phosphorus_Management.html (accessed Aug 2006).

15. Wortman, C. S.; Helmers, M.; Mallarino, A.; Barden, C.; Devlin, D.; Pierzynski, G.; Lory, J.; Massey, R.; Holz, J.; Shapiro, C.; Kovar, J. Agricultural Phosphorus Management and Water Quality; Agreement No. 2004-51130-02249; Heartland Regional Water Coordination Initiative; USDA: 2005.

Prepared by __________________________________________Date: August 16, 2006
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Group
Division of Chemistry Research and Environmental Review


1 The abbreviation wt. stands for weight.

2 The portion of wastewater treated with HEDP in food-processing facilities will be lower than 100%.

3 The adsorption assumption was used by the Human and Environmental Risk Assessment (HERA) group and in a risk assessment conducted for phosphonates in the Netherlands (4,5).

4 FDA 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 (6). A DF of 10 for all food processing facilities is assumed to be a conservative DF for the majority of food processing facilities.

5 Effluent discharged to a POTW will be diluted with other sources of water entering the POTW and additional adsorption of HEDP will occur, resulting in a lower EEC.

6 The abbreviation hr stands for hour.

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 (4). 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 (5).

8 Wastewater of food processing facilities is characterized by high total phosphorus levels and high biological oxygen demand (BOD), reflecting the presence of excess nutrients (3,12).

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 31-35) (3).

11 The median lethal dose (LD50) is a statistically derived dose of a substance that can be expected to cause death in 50% of test animals.

12 Typical phosphorus concentrations in soil range from 12 - 1000 parts per million (ppm) total phosphorus (14,15). Environmental threshold soil test phosphorus values, developed to prevent soil phosphorus from becoming high enough to result in unacceptable phosphorus enrichment of agricultural runoff, ranged from 75 - 200 ppm in eight states (14). The application rate of 0.64 ppm used for land application is minor compared to 75 - 200 ppm and thus will not result in adverse environmental effects.

13 Information on EPA's best management practices is available at: http://www.epa.gov/ebtpages/envibestmanagementpractices.html.


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