• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

Environmental Decision Memo for Food Contact Notification No. 000634

Date: August 21, 2006

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

Subject: FCN No. 634 - Benzoic acid, 2-hydroxy, monosodium salt used as a component of an adjuvant solution mixture used in sterilizing polymeric food-contact packaging.

Notifier: FMC Corporation
c/o Keller and Heckman, LLP
Washington, D.C., USA

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

The food contact substance for this notification is benzoic acid, 2-hydroxy, monosodium salt to be used as a component of an adjuvant solution mixed with a peroxyacetic acid solution intended for use in sterilizing polymeric food-contact packaging. Attached are the Finding of No Significant Impact (FONSI) and our supplement to the notifier's environmental assessment (EA) for FCN 634. When this notification becomes effective, these documents and the notifier's revised EA (in PDF, 550Kb), dated June 9, 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. 634



 



 

Finding of No Significant Impact

A food contact notification (FCN No. 634), submitted by FMC Corporation, to provide for the safe use of benzoic acid, 2-hydroxy, monosodium salt as a component of an adjuvant solution mixed with a peroxyacetic acid solution intended for use in sterilizing polymeric food-contact 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, 550Kb), dated June 9, 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. 634

This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF, 550Kb) dated June 9, 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 EA states, the food-contact substance (FCS) "...is for use in food processing facilities throughout the United States...The treatment solution and sterile water rinse ultimately runs into drains, and enters 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 sent to a publicly-owned treatment works (POTW)." ERG agrees that many food-processing facilities will discharge wastewater to a POTW. However, some food-processing facilities discharge wastewater over land or directly into surface waters after treatment at on-site waste treatment facilities (1,2).

Item 6. Introduction of Substances into the Environment.

6.b. Introduction of substances into the environmental as a result of use/disposal.

ERG calculated expected environmental concentrations (EECs) for sodium salicylate and 1-hydroxyethylidine-1, 1-diphosphonic acid (HEDP) without dilution in a POTW as some food processing facilities do not discharge effluent to a POTW.

ERG assumed that the only dilution at the food processing plant is from the water used to rinse the FCS off the polymeric food packaging. This conservative assumption was used in the EA. ERG also used specific assumptions for different compounds, supported and listed below.

  • Greater than 90% adsorption of HEDP was measured at wastewater treatment plants (3). As the wastewater will go to an onsite-wastewater treatment plant or a POTW, ERG conservatively assumed that 80% of the HEDP is removed from the water via adsorption (3,4).1
  • Based on the predictions of the Environmental Protection Agency's (EPA) EPI Suite (v 3.12), ERG assumed that 75% of sodium salicylate would be removed in wastewater treatment via biodegradation.
  • Concentrations will be diluted by a factor of 10 in surface waters. This factor has traditionally been used by the ERG.2

ERG's calculated EECs are shown in Table 1.

Table 1. Conservative expected environmental concentrations (EEC) in effluent discharged to land and surface waters.
CompoundEEC for Land
Application (mg/L)
EEC for Surface
Waters (mg/L)
Sodium Salicylate
363.81
36.38
HEDP
62.18
6.22

6.b.i. pH Control

The EA indicates that use of the FCS "may have a slight impact on the pH of the water at the facility." ERG agrees that use of the FCS may influence the pH of the wastewater as the pH of the FCS is low (7). The EA states, "...all of the process water will go to an on-site wastewater treatment facility prior to release to the POTW...This allows the facility to comply with any discharge requirements established by the POTW for the facility and to meet the statutory requirement that discharges to POTWs may not be less than a pH of 5." In addition to pH requirements for discharge to POTWs, any effluent discharged to natural waters and POTWs will require a National Pollutant Discharge Elimination System (NPDES) permit and will have restrictions on the pH of the effluent. 3

Item 7. Fate of Emitted Substances in the Environment.

b. Peroxyacetic acid Mixture.

The EA states, "However, given the maximum level estimated to be released, 2.6 ppm, we would not expect that phosphate released from HEDP would result in measurable increases in phosphate in water receiving treated effluent."4 HEDP contains phosphorus and ERG expects use of the FCS to contribute a small percentage of total phosphorus load in the wastewater (8). See comments under Item 8.

The EA also states, "Sulfate has a secondary MCL of 500 ppm..." This is incorrect. The EPA's secondary maximum contaminant level (MCL) for sulfate in drinking water is 250 mg/L (9). 5

Item 8. Environmental Effects of Released Substances.

Sodium Salicylate

Aquatic Environment

The EA states, "The estimated 96-hour EC50 value for algae is 97,500 mg/L."6 This endpoint was estimated by ECOSAR and is much higher than values measured for aquatic plants. The no observable effects concentration (NOEC) for change in biomass in Lemna minor was 60 mg/L (10).

The EA states, "The 48-hour EC50 for Daphnia magna is approximately 1450 mg/L." This value was based on a study published in 1946 (11). In 1989, an acute EC10 of 304 mg/L sodium salicylate was published for Daphnia magna and an EC0 of 80 mg/L (10). ERG estimates the lowest acute NOEC in the aquatic environment is 60 mg/L, based on data for Lemna minor. Information on the aquatic chronic toxicity of sodium salicylate was not available.

The conservative EEC calculated for surface water is 36.68 mg/L and is approximately half of the lowest acute endpoint of 60 mg/L. Therefore, ERG does not expect any adverse effects in aquatic organisms due to use of the sodium salicylate in the FCS in food processing facilities. 7

Terrestrial Environment

Sodium salicylate in effluent discharged to land is not expected to have any adverse environmental impact. The half life in soil was estimated by EPI Suite v 3.12 to be 720 hours and salicylic acid was readily biodegradable in soils and activated sludge (12).8 ERG expects sodium salicylate to be further degraded and diluted with application to soils. Limited data on the toxicity of sodium salicylate to terrestrial organisms is available. However, the concentration expected in soil resulting from use of the FCS will be below all terrestrial toxicity endpoints published in the ECOTOX database and no terrestrial toxicity is expected as a result of the proposed use.9

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 (3,4). These documents serve as a good reference on this subject. Acute toxicity endpoints ranged from 0.74 - 2180 mg/L (Table 2) (4). Chronic NOEC 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 (4).10

HEDP is a strong chelating agent and can result in adverse effects on environmental organisms by complexation of essential nutrients (3). 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) (4). 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 (4). 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 (14-16).

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 (4). These values are not relevant when excess nutrients are present as expected in food processing wastewaters (14,16).11 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 6.22 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 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" (14). 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 (14,16). 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 (17). HEDP contains phosphorus and has the potential to contribute to eutrophication.12 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 (16,17). ERG expects the proposed use of the FCS to contribute to a small percentage of total phosphorus load in wastewater (8).13 However, food processing effluent released to POTWs and surface waters is typically treated to reduce total phosphorus prior to discharge (15).

Table 2. Environmental toxicity data for HEDP.a
Species
Endpointb
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
Oncorhychus mykiss
14 day NOEC
60-180
Daphnia magna
28 day NOEC
10-<12.5
Algae
14 day NOEC
13
a All data from the following references.
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), http://www.heraproject.com/files/30-F-04-%20HERA%20Phosphonates%20Full%20web%20wd.pdf (accessed Jul 2006).

Terrestrial Environment

HEDP in effluent discharged to land is not expected to have any adverse environmental impact. The effluent concentration of 62.18 mg/L is expected to result in soil concentrations lower than terrestrial toxicity endpoints available for plants, earthworms, and birds (3). The NOEC for soil dwelling organisms was 1000 mg/kg soil dry weight and this includes plants and earthworms (3). The 14 day median lethal dose (LD50) for birds was greater than 284 mg/kg body weight (3).14 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 (19, 20).15 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 reduce the cost of treatment of wastewater.16

Sulfates

The concentration of sulfates in effluent discharged to land is not expected to result in an adverse environmental impact as sulfates are commonly found in soils, used in fertilizers, and the effluent concentration due to use of the FCS is below levels commonly found in the environment (7,18).17

Item 10. Mitigation Measures.

The main concern with the use of sulfuric acid for aquatic toxicity is the lowering of the pH (7). This will be mitigated by the fact that 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 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. 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).

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

5. 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.

6. Matthiessen, P.; Thain, J. E.; Law, R. J.; Fileman, T. W. Marine Pollution Bulletin. 1993, 26 (2), 90-95.

7. US EPA Reregistration Eligibility Decision: Mineral Acids, List D, Case 4064, EPA-738-F-93-025; 1993.

8. 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).

9. US EPA Secondary Drinking Water Regulations: Guidance for Nuisance Chemicals, EPA810/K-92-001; 1992.

10. Wang, W. H.; Lay, J. P. Ecotoxicology and Environmental Safety. 1989, 17 308-316.

11. Anderson, B. G. Sewage Works. 1946, 18 82-87.

12. Hazardous Substances Data Bank. Environmental Fate/Exposure Summary for Salicylic Acid, National Library of Medicine. http://www.toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~ZrtgrM:1 .

13. US EPA. ECOTOX Database, http://cfpub.epa.gov/ecotox/quick_query.htm (accessed Jul 2006).

14. 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).

15. 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 .

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

17. 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).

18. Hazardous Substances Data Bank. Sulfuric Acid, http://www.toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~jSIs5P:1.


 

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


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

2 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 (5,6). A DF of 10 for all food processing facilities is assumed to be a conservative DF for the majority of food processing facilities.

3 The FIFRA label for the product used with the FCS requires an NPDES permit prior to discharge to natural waters or POTWs. Additionally, pesticides containing the mineral acids (including sulfuric acid) require an NPDES statement on the FIFRA label (7).

4 Parts per million is abbreviated by ppm.

5 Parts per million (ppm) has units of mg/L.

6 The effects concentration (EC) is a statistically derived concentration of a substance that can be expected to cause a specified effect in a specified percentage of test animals. An EC50 would result in the effect in 50% of the test animals and an EC10 would result in the effect in 10% of test animals.

7 This is further supported by the conservative nature of the EEC calculations and other environmental influences on bioavailability. For example, further dilutions and degradation is expected at the food-processing facility, in POTWs, and in surface waters. Additionally, bioavailability for this compounds will decrease in the presence of organic matter (10).

8 Salicylic acid exists as the salicylate ion above a pH of 5. Greater than 90% of salicylic acid degraded in four days of acclimation during the Zahn-Wellens screening method (12).

9 The ECOTOX database reported no response of the house mouse at 1600 mg/kg and 500 mg/kg for bread wheat (13).

10 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 (3). 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 (4).

11 Wastewater of food processing facilities is characterized by high total phosphorus levels and high biological oxygen demand (BOD), reflecting the presence of excess nutrients (8,17).

12 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.

13 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) (8).

14 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.

15 Typical phosphorus concentrations in soil range from 12 - 1000 parts per million (ppm) total phosphorus (20, 21). 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 (20).

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

17 The conservative EEC for sulfuric acid in effluent discharged from a food-processing facility is 343.97 mg/L.


*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.