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Environmental Decision Memo for Food Contact Notification No. 000728

Date:July 17, 2007
From:Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 728 - Peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidene-1,1-diphosphonic acid to treat food-contact surfaces of polymeric food packaging to attain commercial sterility
Notifier:FMC Corporation
1735 Market Street
Philadelphia, PA 19103
To:Division of Food Contact Notifications (HFS-275)
Attention: Mark Hepp, Ph.D.
Through: Layla I. Batarseh, Ph.D., Supervisor, ERT


 

Attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 728. When this notification becomes effective, the FONSI and the notifier's revised environmental assessment (in PDF, 469Kb), dated May 15, 2007, may be made available to the public in response to a Freedom of Information Act request and we will post redacted copies of them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

The supplement to the environmental record contains confidential business information that should not be released to the public. A redacted copy of the document may still serve to inform the public and we will make it available on the internet.

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
Confidential Supplement to the Environmental Record for Food Contact Notification No. 728


 

Finding of No Significant Impact

A food contact notification (FCN No. 728), submitted by FMC Corporation, to provide for the safe use of peroxyacetic acid, hydrogen peroxide, and 1-hydroxyethylidene-1,1-diphosphonic acid for use as a part of the process to treat food-contact surfaces of polymeric food packaging to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for by Title 21 CFR Part 113.

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 submitted by the notifier in the notification, including a revised environmental assessment (in PDF, 469Kb), dated May 15, 2007, and our supplement to the environmental record for FCN 728.

Prepared by__________________________________________Date: July 17, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by__________________________________________Date: July 17, 2007
Layla I. Batarseh, Ph.D., 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. 728

Note: Material that is not releasable under the Freedom of Information Act (FOIA) has been redacted/deleted from this electronic version of the document. Deletions are marked by a barred out area or hash marks.

This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF, 469Kb), dated May 15, 2007.

The purpose of this supplement is 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).

Clarification of Information in the EA
 

  • The EA states under Item 5, "The maximum concentrations of these components are provided in Attachment 5 ("Confidential Environmental Information")." The intended use and limitations/specifications of food contact notifications are not considered confidential business information. We have included them here to give the maximum concentrations of substances that are not considered confidential business information.

    Intended Use
    The FCS will be used as a part of the process to treat food-contact surfaces of polymeric food packaging to attain commercial sterility at least equivalent to that attainable by thermal processing for metal containers as provided for by Title 21 CFR Part 113.

    Limitations/Specifications
    The maximum concentration of 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) in the food-contact substance solution will not exceed one percent of the solution. After application of the solution to the food packaging, the solution is rinsed from the package surface with sterile water. If the packaging surface is a film, the solution may be mechanically stripped in accordance with good manufacturing practice rather than rinsed from the food-contact surface. If the excess solution is to be mechanically stripped rather than rinsed, the concentration of the food-contact substance in the treatment bath must be reduced 37.5 fold (e.g. from 15% to 4,000 parts per million peroxyacetic acid), maintained at that dilution during operations, and drained and recharged with fresh solution when the total volume of the food-contact substance added as makeup reaches 90% of the volume of the solution bath reservoir.

  • The EA indicated under Item 1, 5, and 6, that FCN 728 was originally filed on March 28, 2007. We received FCN 728 on April 3, 2007.
  • The EA employed a decomposition reduction factor in estimating the environmental concentrations of HEDP in sludge removed from waste water treatment plants (WWTP). We do not agree that degradation of HEDP is expected. This is supported by the following excerpt from Jaworska et al. (1).

    "Little or no biodegradation of HEDP and ATMP has been observed in standard simulation tests of aerobic wastewater treatment plants or in standard OECD ready or inherent biodegradability tests (Steber and Wierich, 1986, 1987; Gledhill and Feijtel, 1992). The conditions applied in these investigations involve phosphate-rich environments that may suppress any of the biological mechanisms able to degrade phosphonates (Daughton et al, 1979; Steber and Wierich, 1987; Schowanek and Verstraete, 1990a). For this reason, biodegradation in biological wastewater treatment plants is not expected (Egli, 1988). Most of the removal of phosphonates actually observed in wastewater treatment plants can therefore be attributed to adsorption to sludge (Gledhill and Feijtel, 1992; Fischer, 1993). Steber and Wierich (1986, 1987) found no degradation of HEDP and ATMP in anaerobic digesters. Therefore, for exposure calculations no biodegradation in a sewage treatment plant (STP) is assumed in this study." (1)
  • Biodegradation and decomposition of HEDP are not expected to occur in food processing wastewater treatment plants which often contain high levels of phosphates (2-4). The estimated environmental concentrations from introduction of sludge into the environment of 2194 mg/kg in sludge and 55 mg/kg in soil are based on decomposition and/or removal mechanisms that are not fully supported. Therefore, we estimated the concentration of HEDP in soil assuming that HEDP accumulated in sludge over a | | | | 1 and that no degradation of HEDP occurred. The calculations are provided below.
  • The EA states under Item 8, "Biodegradation study results for HEDP are variable. Zahn-Wellens dissolved organic carbon testing indicated removal of 33% of HEDP after 28 days; modified OECD screening theoretical carbon dioxide evolution was 2% after 70 days; modified SCAS dissolved organic carbon removed 90%; and closed bottle BOD30/COD was 5%." A source to verify this information was not provided. These endpoints were reported in a risk assessment published by the Human and Environmental Risk Assessment Project and in a material safety data sheet (MSDS) (5,6).
  • The EA states under Item 8, "The NOEC for soil dwelling organisms was 1000 mg/kg soil dry weight and this includes plants and earthworms." However, the source of this information was not provided. We summarized toxicity endpoints relevant to soil dwelling organisms in Table 1.
Table 1. Terrestrial toxicity data for HEDP.a
Common Name (Species)Endpointmg/kg dry weight
Red worm
(Eisenia foetida)
14 day NOEC>1000
Oats
(Avena sativa)
14 day NOEC>960
a All data from:
Draft Human and Environmental Risk Assessment on Ingredients of European Household Cleaning Products: Phosphonates; Human and Environmental Risk Assessment Initiative: Jun 9, 2004. http://www.heraproject.com/RiskAssessment.cfm (accessed Jan. 23, 2007).

Environmental Concentration of HEDP in Soil

Sludge produced in a food processing wastewater treatment plant using the FCS may be disposed of in a landfill or amended into soil (7,8). We estimated the soil concentration of HEDP due to land application of sludge assuming that HEDP accumulated in sludge over a | | | | 2 and that no degradation of HEDP occurred.

HEDP Concentration in Bottle Rinsing Effluent
HEDP in Effluent Produced from Bottle Rinsing
Maximum HEDP Concentration x Average FCS flow of Bottle Rinse3 / Average Total Flow of Bottle Rinse per Hour4 = 10,000 mg/L x | | | | L x (Hours/| | | | L) = | | | | mg/L HEDP

| | | | Contribution of HEDP to Sludge from Bottle Rinsing
HEDP Concentration in Bottle Rinsing Effluent x Percent HEDP Adsorbed to Sludge5 x Average Total Flow of Bottle Rinse per Hour6 x 1 kg/106 mg Conversion Factor x 24 hours/day Conversion Factor x | | | | Conversion Factor = | | | | mg/L x 0.80 x | | | | L/hr x kg/106 mg x | | | | = | | | | kg/| | | |

| | | | Contribution of HEDP to Sludge from Sterilant Bath
Concentration HEDP in Bath on 10th Day7 x Percent HEDP Adsorbed to Sludge8 x Volume of Effluent in Bath9 x Rate per Day that Tank is drained10 x | | | | Conversion Factor x 1 kg/106 mg Conversion Factor = | | | | mg/L x 0.80 x | | | | L/tank x tank/10 days x | | | | x kg/106 mg = | | | | kg HEDP/| | | |

Total HEDP to Sludge per | | | |
| | | | Contribution of HEDP to Sludge from Bottle Rinsing + | | | | Contribution of HEDP to Sludge from Sterilant Bath = | | | | kg + | | | | kg = | | | | kg HEDP

Estimated Concentration of HEDP in Sludge
Total HEDP to Sludge per | | | | / Total Sludge Produced per | | | |11 = | | | | kg HEDP / | | | | kg sludge x 106 mg/kg = | | | | mg/kg

Estimated Environmental Concentration in Soil Amended with Sludge
Estimated Concentration of HEDP in Sludge x Dilution Factor12 = | | | | mg/kg x | | | | = 225 mg/kg HEDP in Soil

The estimated environmental concentration of HEDP in soil of 225 mg/kg is below the estimated soil toxicity endpoint of 960 mg/kg dry weight for soil dwelling organisms. Therefore, we do not expect a significant environmental impact due to land application of food processing sludge.

Literature Cited

  1. Jaworska, J.; Van Genderen-Takken, H.; Hanstveit, A.; van de Plassche, E.; Feijtel, T. Environmental risk assessment of phosphonates, used in domestic laundry and cleaning agents in the Netherlands. Chemosphere 2002, 47, 655-665.
  2. Pollution Prevention for Industrial Wastewater Dischargers in the Upper Mississippi River Basin Using City-wide Inventories; Grant No. 03-025; U.S. Environmental Protection Agency; Minnesota Pollution Control Agency: Minneapolis, MN, Jul 30, 2005. http://mntap.umn.edu/potw/mcknight05.pdf (accessed July 13, 2007).
  3. Clean Technologies in U.S. Industries: Focus on Food Processing, http://www.owr.ehnr.state.nc.us/ref/09/08853.htm#EXECUTIVE%20SUMMARY (accessed May 8, 2007).
  4. Food Processing Business Sector Fact Sheet; Wisconsin Department of Natural Resources: Jul 27, 2006. http://dnr.wi.gov/org/caer/cea/assistance/foodprocessing/info.htm#wastewater (accessed Jan. 23, 2007).
  5. Draft Human and Environmental Risk Assessment on Ingredients of European Household Cleaning Products: Phosphonates; Human and Environmental Risk Assessment Initiative: Jun 9, 2004. http://www.heraproject.com/RiskAssessment.cfm (accessed Jan. 23, 2007).
  6. Material Safety Data Sheet: 1-Hydroxyethylidene-1, 1-Diphosphonic Acid (HEDP); Gulbrandsen Technologies: Feb 1, 2002. http://www.gulbrandsen.com/pdf/HEDPmsds.PDF (accessed July 12, 2007).
  7. Multimedia Environmental Compliance for Food Processors; EPA 305-B-99-005; U.S. Environmental Protection Agency: Washington, D.C., Mar, 1999. http://www.epa.gov/Compliance/resources/publications/assistance/sectors/multifood.pdf (accessed July 16, 2007).
  8. Hang, Y. D. Management and utilization of food processing wastes. Journal of Food Science 2004, 69 (3), 104-107.
  9. Harrass, M. C.; Erikson, C. E.; Nowell, L. H. Role of plant bioassays in FDA review: Scenarios for terrestrial exposures. In Plants for Toxicity Assessment: Second Volume, ASTM Special Technical Publication, no. 1115 ed.; Gursuch, J. W., Lower, W. R., Wang, W., Lewis, M. A., Eds.; American Society for Testing and Materials: Philadelphia, 1991; pp 12-28.

Prepared by__________________________________________Date: July 17, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety


1The notifier indicated that sludge would be removed on an | | | | basis on Page 15 of Attachment 5.

2See Footnote 1.

3The average FCS flow of bottle rinse is reported as | | | | L in the Table on Page 13 of Attachment 5.

4The average total flow of the bottle rinse is reported as | | | | L/hour in the Table on Page 13 of Attachment 5.

5Two risk assessments for HEDP assumed that 80% of HEDP adsorbed to sludge in wastewater treatment plants (11,12).

6See Footnote 4.

7The HEDP concentration in the sterilant bath is reported as | | | | mg/L on Page 14 of Attachment 5.

8 See Footnote 5.

9The volume of the sterilant bath is reported as | | | | L on Page 14 of Attachment 5.

10The notifier indicated on Page 4 of Attachment 1 that tanks are typically drained every | | | | days. However, a conservative assumption of draining the tank every 10 days was assumed in the chemistry calculations of this notification and was also assumed for the environmental calculations.

11The total sludge produced per | | | | is reported as approximately | | | | kg on Page 16 of Attachment 5.

12The land application dilution factor was calculated using the methods described in Harrass et al. (9).


*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.