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Date: May 13, 2013
From: Biologist, Regulatory Team 2, Division of Biotechnology and GRAS Notice Review (HFS-255)
Subject: FCN No. 1278 – An aqueous mixture of catalase (CASRN: 9001-05-2), glycerol (CASRN: 56-81-5), sodium citrate dihydrate (CASRN: 6132-04-3), sodium formate (CASRN: 141-53-7), and 1,2-benzisothiazolin-3-one (CASRN: 2634-33-5); Trade name: ES-3000; intended for use as an adjuvant to peroxyacetic acid antimicrobial solutions for use in commercial sterilization of aseptic filling systems and packaging prior to filling.
Notifier: Ecolab, Inc., 370 North Wabasha St., EUC-9, St. Paul, MN 55102
To: Thomas Zebovitz, Ph.D., Division of Food Contact Notifications (HFS-275)
Through: Annette M. McCarthy, Ph.D., Senior Science and Policy Staff____
Attached is the Finding of No Significant Impact (FONSI) for FCN 1278. After this notification becomes effective, copies of this FONSI and the notifier's environmental assessment, dated February 28, 2013, may be made available to the public. We will post digital transcriptions of the FONSI and the environmental assessment on the agency's public website.
Please let us know if there is any change in the identity or use of the food-contact substance.
Attachment: Finding of No Significant Impact
FINDING OF NO SIGNIFICANT IMPACT
A food-contact notification (FCN No. 1278), submitted by Ecolab, Inc., to provide for the safe use of an aqueous mixture of catalase (CASRN: 9001-05-2), glycerol (CASRN: 56-81-5), sodium citrate dihydrate (CASRN: 6132-04-3), sodium formate (CASRN: 141-53-7), and 1,2-benzisothiazolin-3-one (CASRN: 2634-33-5), intended for use as an additive to peroxyacetic acid antimicrobial solutions for use in commercial sterilization of aseptic filling systems and packaging prior to filling
The Office of Food Additive Safety 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 an environmental assessment (EA), dated February 28, 2013, and confidential business information attached to the EA. The following additional information, provided in the food-contact notification (FCN) are incorporated by reference.
- Part I: General Information, Section C – FCS Supplier Letter; FCN1278, Ecolab, Inc., dated 03-05-2013
- Part II: Chemistry, Section F – Migration; FCN1278, Ecolab, Inc., dated 03-05-2013
The FCS is intended for single use application not to exceed 13 ppm catalase in mixtures applied to polymeric food packaging containers (e.g., bottles and closures) for liquid and semi-solid “flowable” foods. Following the application of the FCS, the surfaces of the polymeric food packaging will be drained, rinsed with sterile water, and drained again. The FCS/antimicrobial solution mixture is intended for use on aseptic filling lines; not hot-fill or canning lines. The intended technical effect of the FCS is hydrogen peroxide removal from the antimicrobial mixture. Removal of peroxide enhances the efficacy of commercial sterilization of aseptic systems, packaging, and equipment.
Introduction of Substances into the Environment:
Only minor environmental introductions are expected from FCS manufacturing and distribution facilities. Introduction of FCS substances into the environment are expected to occur primarily via use in beverage processing and packaging facilities. After the treatment solution is applied to the food packaging and allowed to drain, a sterile water rinse is applied to the food packaging. The treatment solution and sterile water rinse ultimately run into drains, and enter the food packaging plant waste water treatment facility, where it is collected and treated by the facility prior to it being sent to a publicly owned treatment works (POTWs). The waste liquids may also be discharged directly to POTWs. Because of the high water solubility of the FCS, close to 100% of the FCS components are expected to be lost in the processing water.
No significant concentrations of the FCS are expected to remain with the food packaging material through use and disposal by the consumer. Therefore, significant environmental introduction from any FCS components as a result of the disposal of the food packaging material are not expected.
Environmental introduction concentrations (EICs), and estimated environmental concentrations (EECs) for catalase, glycerol, sodium citrate dehydrate, sodium formate, and 1,2-benzisothiazolin-3-one applied at the maximum usage rate were calculated. These calculations are based upon a number of estimates described below, including domestic water use and average POTW inflow and outflow rates, and mirror the calculation methods utilized in several related effective food contact notifications.
- A given beverage processing facility uses no more than 2.5 kg/day of the FCS.
- 100% of the amount used per day is ultimately discharged into the wastewater.
- An average flow rate for POTW of 1.0 million gallon per day (mgd).
- Per capita domestic use of water is approximately 100 gallons per day. Assuming a small city with a population of 10,000, the total daily inflow into the POTW is: 10,000 × 100 gal/person/day = 1x106 gal/day (1 mgd) = 3.8 x106 L/day (Solley, Pierce et al. 1995).
- Commercial use inflow to a POTW estimated at 25% of total daily POTW flow rate (Wetzel and Murphy, 1986)
- POTW inflow attributable to a single beverage-processing facility estimated at 50% of total commercial use inflow: 50% x 25% x 1 mgd = 125,000 g/day = 475,000 L/day.
- The components of the FCS were not degraded in any on-site or POTW wastewater treatment facility, and
- The level of each component in the wastewater discharge from the plant will not be diluted upon entering the POTW.
The following equations were used to calculated the EICs and EECs:
EIC = g component released from beverage processing facility/day x 1000 mg/g
475,000 L beverage facility outflow/day
EEC = EIC x beverage facility outflow (475,000 L/day)
total daily POTW inflow (3.8E6 L/day)
The EIC and EEC values are provided in Table 1.
|FCS Component||EIC (ppm)||EEC (ppm)|
Sodium citrate dehydrate
Fate and Effects of Released Substances:
Treatment of wastewater by POTWs are expected to reduce water concentrations of the FCS components. These include sedimentation, aerobic or anaerobic treatment, filtration, and chemical disinfection. Further degradation via other physical, chemical and biological processes are likely. Aquatic biodegradability data show that glycerol, sodium citrate dehydrate, and sodium formate are readily degraded in days, and 1,2-benzisothiazolin-3-one is ultimately degraded in weeks. No degradation data for catalase is available. However, catalase is a ubiquitous compound in animals and plants. Environmental introductions from this use are not expected to result in any noticeable increase in environmental concentrations.
The U.S. EPA hazard evaluation for environmental toxicity and fate for ‘low’ acute aquatic toxicity is LC50 / EC50 > 100 ppm, and for ‘low’ chronic aquatic toxicity is LC50 / EC50 > 10 ppm. The calculated EEC concentrations for the stated residues are at least two orders of magnitude lower than these tolerance values.
The ecotoxicity data for aquatic species were evaluated for the remaining FCS components and compared to the calculated EEC values. Acute toxicity is deemed the most applicable aquatic endpoint given that all the FCS components quickly biodegrade in aqueous environments; thus, not persisting and negating a risk for a chronic aquatic hazard. The EECs are at least three orders of magnitude lower than the toxicity for the most sensitive listed species as provided in Table 2.
|FCS Component||Lowest Toxicity||Endpoint / Species|
|Catalase||no data given|
|Glycerol||855 – 11,000 ppm||96-hr. LC50 Cyprinodon variegatus|
|Sodium citrate dehydrate||5,600 – 10,000 ppm||48-hr. EC50 Daphnia magna|
|Sodium formate||807 ppm||72-hr. EC50 Pseudokirchnerell subcapitata|
|1,2-Benzisothiazolin-3-one||0.15 ppm||72-hr. EC50 unstated aquatic plant species|
With respect to catalase, the ecotoxicity of this component is expected to be low as it is an enzyme and would be expected to degrade to peptides and amino acids. Such compounds are prevalent in the environment and are not expected to result in any adverse effects.
There is a large variation in flow among POTWs and industrial wastewater can contribute a large percentage of the total flow in an individual POTW. If the daily flow rate from a POTW were estimated as 0.1 mgd, EEC values would still provide a sufficient margin of safety such that no adverse impacts would be expected on any aquatic species. Therefore if non-conservative assumptions were used in the calculation to determine the EICs, and subsequently the EECs no significant impact would be anticipated.
Additionally, an estimate of the FCS mixture ecotoxicity was calculated utilizing the an additivity formula (see below) based on the combined toxicity of the ingredients. These estimates are presented in Table 3.
Acute Toxicity of FCS Mixture(Organism) = Ʃ[%wt. componentx ÷ ecotox endpt. componentx](x = 1 to n)
|Organism||FCS Mixture Acute Toxicity (ppm)|
|Fish||LC50 2,366 – 4,838|
|Aquatic invertebrates||EC50 2,654|
|Aquatic plants||EC50 483|
In general, an LC50 in the part per thousand range, such as those calculated, suggests a low aquatic hazard.
Use of resources and energy:
The FCS is intended to enhance the efficacy of sterilants used in beverage processing facilities and to result in a net decrease in the level of sterilants used at such facilities. Energy and resources will be consumed in amounts comparable to or less than what is already in practice, as the FCS is intended to be used in place of, and at the same rate, as the catalase enzyme adjuvant previously cleared and currently marketed. This is due, in part, to the higher concentration of catalase in the current FCS, resulting in the use of approximately one third less product formulation to obtain the treatment concentration.
Articles containing the FCS are expected to replace, and be disposed of at a rate equivalent to, products with similar use profiles already on the market. The use and disposal of the FCS is not expected to threaten violation of applicable laws and regulations (e.g. U.S. EPA 40 CFR parts 60 and 258).
Mitigation Measures / Alternatives to the Proposed Action:
No potential adverse environmental effects have been identified which would necessitate mitigation measures or alternative actions to that proposed in this notification.
Prepared by __________________________________________Date: May 13, 2013
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by __________________________________________Date: May 13, 2013
Annette M. McCarthy, Ph.D.
Senior Science and Policy Staff
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
See Table I-2, Clean Watersheds Needs Survey 2008 Report to Congress, available at http://water.epa.gov/scitech/datait/databases/cwns/upload/cwns2008rtc.pdf
 Solley, W. B., R. R. Pierce, et al. (1995). Estimated use of water in the United States in 1995. U.S. Geological Survey Circular 1200, U.S. Geological Survey.
Wetzel, E.D. and S.B. Murphy (1986). “Interferences at Publicly Owned Treatment Works.” A technical report prepared by the Montgomery Consulting Engineer, Inc. for the Environmental Protection Agency. Report number PB-90-108853/XAB
 U.S. EPA design for the Environment Program Alternatives Assessment Criteria for Hazard Evaluation, August 2011