Food

Environmental Decision Memo for Food Contact Notification No. 000163

Return to inventory listing: Inventory of Environmental Impact Decisions for Food Contact Substance Notifications or
the Inventory of Effective Food Contact Substance Notifications.

See also Environmental Decisions.


Date: September 27, 2001

From: Environmental Scientist, Environmental Review Group
Division of Chemistry Research and Environmental Review

Subject: FCN No. 163 - A mixture of polyethylene glycol (400) monooleate and polyethylene glycol (400) dioleate

Notifier: Lonza Inc.
17-17 Route 208
Fair Lawn, NJ 07410

To: Division of Food Contact Substance Notification Review
Attention: William Trotter, Ph.D.
Through: Supervisor, Environmental Group

Attached is the Finding of No Significant Impact (FONSI) for this premarket notification. When the notification becomes effective, you may make the following environmental documents available to the public:

1. the attached FONSI;
2. the notifier's Environmental Assessment (EA), dated June 6, 2001;
3. the notifier's amendment to the EA, dated July 17, 2001; and
4. the Environmental Review Group's supplement to the EA, dated September 27, 2001.

Please let us know if there is any change in the identity or use of the food-contact substance.

Paul C. DeLeo, Ph.D.


Finding of No Significant Impact

A premarket notification (FCN No. 163), submitted by Lonza Inc., to provide for the safe use of a mixture of polyethylene glycol (400) monooleate and polyethylene glycol (400) dioleate as an anti-corrosive agent in the steam header and steam lines of boiler systems where the steam will contact food.

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 an Environmental Assessment dated June 6, 2001, and an amendment to the EA dated July 17, 2001. In addition, the Environmental Review Group prepared a supplement to the EA which is dated September 27, 2001.

Prepared by:________________________________________ Date: September 27, 2001
Paul C. DeLeo, Ph.D., Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center of Food Safety and Applied Nutrition
Food and Drug Administration

Approved by:________________________________________ Date: September 27, 2001
Jeanette Glover Glew, Acting Supervisor
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center of Food Safety and Applied Nutrition
Food and Drug Administration


Supplement to the Environmental Information for Food Contact Notification No. 163

September 27, 2001

This document incorporates by reference the notifier's Environmental Assessment (EA) dated June 6, 2001 and an amendment to the EA dated July 17, 2001. In addition, the notifier incorporated by reference the environmental assessment prepared by BetzDearborn for its Food Contact Notification (FCN) 97 dated July 24, 2000.

The notifier provided no environmental fate or effects data for polyethylene glycol (400) dioleate (PEG-DO) in the initial environmental assessment dated June 6, 2001. PEG-DO is a constituent of the subject food contact substance (FCS) PEGOSPERSE 400 MO. In an amendment to the EA dated July 17, 2001, the notifier indicated that it had no environmental fate or effects data on PEG-DO and could not identify relevant data in the published literature. This supplement to the EA for FCN 163 provides additional discussion related to the environmental exposure, fate and effects of PEG-DO.

Environmental Exposure Assessment

We estimated the environmental exposure to PEG-DO using the information provided in both EAs. The expected introduction concentration (EIC) was calculated to be 0.1 5g/L using the concentration of PEG-DO in boiler water determined by the notifier (0.44 ppm) and the assumptions for introduction in the EA for FCN 97 (p. 39):

4 boilers H 10,000 lb/hr H 24 hr H 5% blowdown H 0.000044% PEG-DO = 0.0211 lb/day
= 10 g/day PEG-DO

Assuming dilution by a wastewater treatment plant processing 109 L/day , the EIC is 0.1 5g/L.

Environmental Fate Assessment

No environmental fate data were available for PEG-DO; however, we expect a high log Kow, low solubility and high sorption coefficient because of the characteristics of the compound. Subsequently, we expect PEG-DO to be immobilized on solid media (soil, sediment, etc.). There is a large body of literature regarding the biodegradation of fatty acids including oleates and derivatives. We anticipate that any available PEG-DO will biodegrade rapidly.

Environmental Effects Assessment

The notifier used the Environmental Protection Agency's (EPA's) ECOSAR model in an attempt to estimate the aquatic toxicity of PEG-DO. The notifier noted that the model gives estimates for ethoxylates (such as PEG-DO) but they are limited to smaller molecules with alkyl groups of C8-C18; PEG-DO has an alkyl group of C36. We attempted to estimate the aquatic toxicity of PEG-DO using the SMILES notation structure in ECOSAR (via EPIWIN ). However, the model indicated that Log Kow values greater than 5.0 exceeded the limit where it could provide reliable results; a Log Kow of 13.5 was predicted for PEG-DO by EPIWIN. Given the dependence of ecotoxicity results from Quantitative Structure Activity Relationship (QSAR) models on Log Kow values, we compared estimates from other models. An interactive website maintained by the University of Lausanne, Switzerland allows the estimation of Log Kow (also referred to as Log P) using five models: ALOGPS , IA logP , ClogP , KOWWIN , and XLOGP . When the Log Kow of PEG-DO was estimated using the SMILES notation structure in the five models, the results varied by 12 orders of magnitude. For the five models, results were 9.28, 4.56, 16.9, 13.5 and 12.1, respectively. Subsequently, we concluded that QSAR modeling would not provide reliable data to assess the environmental fate and effects of PEG-DO.

Mammalian toxicological studies showed that PEG-DO was virtually non-toxic. However, there is not necessarily any correlation between mammalian toxicology studies and aquatic or terrestrial toxicological studies. Nonetheless, there were no data available which indicated that PEG-DO had any significant negative environmental effects.

Other Data Relevant to the Environmental Assessment

PEG-DO is used as an inert ingredient in pesticide products, and EPA has determined that it qualifies to be listed on List 4B for inert ingredients for which "their current use patterns in pesticide products will not adversely affect public health and the environment." Since pesticides are applied directly to the environment and since this compound is likely to be present in quantities much greater than the EIC for the subject use, EPA's conclusion about the environmental safety of the compound appears to have been made under a much greater environmental exposure scenario. EPA's listing of PEG-DO on List 4B was likely a result of "conformance with the criteria given in the polymer exemption rule (40 CFR 723.250)."

Conclusion

We have no concern about releases of PEG-DO to the environment as a result of the requested use of the subject FCS, because there is low environmental exposure, low availability in the environment and a lack of evidence regarding significant environmental toxicity for PEG-DO.

Prepared by: _________________________________________ Date: September 27, 2001
Paul C. DeLeo, Ph.D., Environmental Scientist
Environmental Review Group
Division of Chemistry Research and Environmental Review
Office of Food Additive Safety
Center of Food Safety and Applied Nutrition
Food and Drug Administration

Page Last Updated: 12/16/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.