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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000879

 

Date:May 8, 2009
From:Environmental Scientist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246)
Subject:FCN No. 879 – An aqueous solution of peroxyacetic acid, hydrogen peroxide, acetic acid and (optional) sulfuric acid for use as an antimicrobial agent in commercial process and storage of cheese whey.
Notifier:Enviro Tech Chemical Services, Inc.
500 Winmoore Way,
Modesto, CA 95358
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 notifier's environmental assessment (EA) for FCN 879. After this notification becomes effective, these documents and the notifier's environmental assessment, dated January 7, 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.

 

Hoshing W. Chang, Ph.D.

Attachment:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 879


Finding of No Significant Impact

A food contact notification (FCN No. 879), submitted by Enviro Tech Chemical Services, Inc., to provide for the safe use of an aqueous solution of peroxyacetic acid, hydrogen peroxide, acetic acid and (optional) sulfuric acid for use in commercial process and storage of cheese whey.

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 January 7, 2009, submitted by the notifier and on our supplement to the environmental record.

Prepared by __________________________________________Date: May 8, 2009
Hoshing W. Chang, Ph. D.
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by __________________________________________Date: May 8, 2009
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. 879

This document incorporates by reference the notifier's environmental assessment (EA), dated January 7, 2009.

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). The Environmental Review Team (ERT) provides below comments on specific items in the EA.

Item 4 Description of Proposed Action:

The notifier states maximum at-use concentrations of the FCS components are 15 ppm peroxyacetic acid (PAA) and 60 ppm hydrogen peroxide (HP). However, maximum at-use concentrations described in the rest of the FCN are 15 ppm PAA, 67 ppm HP. Since HP is a very unstable and easily degraded chemical compound [1], ERT believes the difference in the amount of degradation products based on at-use levels of 60 ppm or 67 ppm is not significant.

In addition, the EA lacks information regarding “locations of use/disposal”, which is important to help the public understand the potential environmental exposure locations. We found that as of 2002, there were 211 establishments manufacturing dry, condensed, and evaporated dairy product, including plants processing dry and modified dry whey products. Those establishments spread widely in US. The top five states, where the establishments are located, are Wisconsin (27 establishments), Illinois (11 establishments), Pennsylvania (11 establishments), New York (10 establishments), Michigan (10 establishments), and Utah (9 establishments)[2].

Item 5 Identification of Substance

The FCS is made by blending acetic acid, hydrogen peroxide, and reverse-osmosis water. The EA omits the word “water” in the description.

Item 6 Introduction of the FCS into the Environment:

ERT agrees that the amount of the FCS retained in the Whey Protein Concentrate is minimal and that the FCS is easily decomposed during the process to manufacture the Whey Protein Isolate. Therefore, there is no introduction of the FCS into the environment as a result of use.

Discussion on different environmental introduction routes after use: A great amount of the FCS will remain in the liquid part of whey (permeate) after use. The EA lacks discussion on environmental introduction routes of the FCS after use/disposal. We describe below the three possible environmental introduction routes of the FCS after use:

  • Decomposition in the further process to manufacture lactose: In the Chemistry section of the notification, not in the EA, the notifier mentioned manufactures of lactose from permeate. During the process of manufacture of lactose, which involves evaporation by heat, the FCS will be decomposed. The safe use of a similar FCS was the subject of effective FCN641, which had an EA and a FONSI. FCN641 is for use of an equilibrium mixture of at maximum level of PAA (30 ppm), HP (140 ppm), and HEDP (3.2 ppm) in lactose process water.
  • Discharge to either publicly-owned treatment works (POTWs) or an on-site wastewater treatment facility: If the permeate is discharged to the on-site wastewater treatment plants or POTWs, PAA and HP are anticipated to be decomposed readily [1;3].
  • Direct discharge into the aquatic environment after use: Dairy processing plants, as well as other food processing plants, can release wastewater directly to surface water [4]. 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”[4]. Even though portions of the FCS may be discharged into the aquatic environment after use, we believe that the components of the FCS or their degradation products will be diluted in the whey-producing plants to very low levels that are not of concern in the environment.

Clarification on expected introduction concentration (EIC) as a result of use of the FCS: The EA lacks the calculations on how the EICs are estimates; instead, the notifier uses the maximum at-use concentrations as an estimate of EICs of PAA and HA. ERT believes that this is a very conservative estimation and agrees with it.

Disregard Outline 6d: ERT believes that the discussion under Outline 6d is inadequate and only partially correct. Furthermore, the concerns on accidental spills of the FCS are included in the direct discharge of the FCS into the environment after use (see below). Therefore, ERT disregarded this section when making the environmental decision.

Item 7 Fate of Emitted Substances in the Environment:

Clarification on dilution factor (DF): The notifier estimated the expected environmental concentration (EEC) using a DF of 50, based on the watershed survey on poultry processing plants. ERT disagrees with this DF. The DF at poultry plants does not represent the DF at other food-processing plants. The geographic distributions and the processes occurring in whey and poultry processing plants are different; therefore, unless supported by actual numbers, the Agency continues to use a DF 10 for food-processing plants.

Item 8 Environmental Effects of Released Substances

  • Discharge into the environment through discharge into either publicly-owned treatment works (POTWs) or an on-site wastewater treatment facility: The FCS will degrade in the on-site wastewater treatment plant and in POTWs. Subsequently, the degradation products of PAA and H2O2 will be introduced into the environment. Studies have shown that PAA and HP treated wastewater effluents or surface waters used for drinking water contains no toxic or mutagenic products [5]. Therefore, ERT believes the FCS or its degradation products will not pose environmental treats after direct discharge into the environment from POTWs or from on-site wastewater treatment plant.
  • Direct discharge into the environment after use: ERT does not believe the environmental effects of the FCS from direct disposal to surface water are of concern because the FCS components or their degradation products will be diluted in the whey-producing plants to very low level and will be further diluted at least 10 times in the environment. Furthermore, PAA and HP are easily decomposed in the environment. For example, the half-life of 95 ppm PAA is 48 hour at pH 7 [3], and the decomposition of HA in water take minutes or several hours depending on the mineral contents and microbial populations in the adjacent environment [1]. Therefore, in the instance of direct deposal, the FCS will decompose before reaching the surface water.
    Our conclusion that neither direct nor indirect discharge of wastewater containing the FCS, its components, or degradation products would result in a significant impact on organisms in the environment is based on our knowledge of and experience with the environmental fate and effects of these substances.

Discussion on the environmental effects of the FCS on terrestrial environment:

ERT considers that the FCS has no adverse effect on the terrestrial environment because it degrades rapidly in soil [1;3]. Nevertheless, ERT believes that the discussion under Outline 8b is inadequate, contains errors, and only partially correct. ERT disregarded this section when making the environmental decision.


Bibliography

 

[1] ECETOC, Joint Assessment of Commodity Chemicals No. 22 Hydrogen Peroxide (CAS No. 7722-84-1) European Centre for Ecotoxicology and Toxicology of Chemicals, 1993.

 

[2] US Census Bureau, "Census of Manufacture," 2008.

 

[3] ECETOC, Peracetic Acid (CAS No. 79-21-0) and Its Equilibrium Solutions, JACC No. 40 European Centre for Ecotoxicology and Toxicology of Chemicals, 2001.

 

[4] R. E. Carawan, J. V. Chambers, R. R. Zall, and R. H. Wilkowske, "Dairy Processing: Water and Wastewater Management," North Carolina Agricultural Extension Service, Extension Report No. AM-18b, 1979.

 

[5] M. Kitis, "Disinfection of Wastewater with Peracetic Acid: a Review," Environmental International, vol. 30, pp. 47-55, 2004.