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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000388

Date: April 1, 2004

 

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

 

Subject: FCN No. 388 - A mixture of potassium alkyl phosphate salts for use as a finish component on poly(phenyleneterephthalamide) resins

 

Notifier: E.I. du Pont de Nemours and Co., Inc.
5401 Jefferson Davis Highway
Richmond, VA 23234

 

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

 

 

Attached are the Finding of No Significant Impact (FONSI) and our Supplement to the notifier's Environmental Assessment (EA) for FCN 388. When this notification becomes effective, the following documents may be made available to the public:

 

1. This FONSI;
2. The notifier's revised EA, dated December 8, 2003; and
3. Our Supplement to the notifier's EA.

 

NOTE: Do not release the Confidential Attachment to our Supplement; it contains confidential business information that is protected from disclosure.

 

 

 

Tong Zhou, Ph.D.

 

2 Attachments

 

 





Finding of No Significant Impact

A food contact notification (FCN No. 388), submitted by E. I. du Pont de Nemours and Company, Inc., to provide for the safe use of a mixture of potassium stearyl phosphate, polyoxyethylene lauryl ether phosphate potassium salt, and polyoxyethylene tridecyl ether phosphate potassium salt for use as a finish component on poly (phenyleneterephthalamide) resins cleared in 21 C.F.R. §177.1632 for repeated-use applications at a level not to exceed 1% by weight of the base polymer in contact with all types of 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 (EA) dated December 8, 2003, and on our supplement to that EA.

 

 

 

Prepared by ___________________________________________ Date: April 1, 2004
Tong Zhou, 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: April 1, 2004
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. 388

This document incorporates by reference the notifier's environmental assessment (EA) dated December 8, 2003.

 

Background

 

The notifier, E.I. du Pont de Nemours and Company, Inc., originally claimed categorical exclusion from the requirement to prepare an EA under 21 CFR 25.32(j), because the finished food contact articles, such as gloves, aprons and sleeves, are repeat-use articles. This exclusion requires that almost all of the market volume of the food contact substance (FCS) become a component of and remain with the food-contact articles through use and disposal by consumers. Because most of the market volume of the subject FCS is lost into the environment as a result of its use and disposal at the textile facility, we told the notifier that categorical exclusion under 21 CFR 25.32(j) would not apply to the requested use. The notifier submitted an EA, dated November 14, 2003, which we found to be inadequate. Subsequently, the notifier submitted a revised EA, dated December 8, 2003.

We have prepared this supplement to the revised EA to discuss further the environmental introduction, fate, and effects of the FCS as a result of its use and disposal.

 

Format Item 5. Identification of Substances that are the Subject of the Proposed Action

 

Under Section A.5 of FDA Form 3480, the notifier stated that the FCS is an aqueous mixture of anionic surfactants and contains a blend of potassium alkyl phosphate salts. All three structures for the FCS are monoalkyl. We know that most phosphate-based anionic surfactants are mixtures of majority of mono alkyl, or majority of dialkyl, or 50 monoalkyl to 50 dialkyl. We further understand that monoalkyl phosphate anionic surfactants are rare and expensive to make because it is expensive to separate the monalkyl from the dialkyl via purification; thus, it is not surprising that the projected market volume for this FCS is very small, as shown in the confidential submission to the FCN. We know that the FCS is in fact being used as a fiber lubricant.

 

Format Item 6. Introduction of Substances into the Environment

 

The notifier, E.I. du Pont de Nemours and Company, Inc., indicated under Format Items 4 and 6 of the EA that the expected routes of environmental introduction from the use of the FCS are in the use of the aramid fibers that contain the finish in the manufacturing of fabric and garments at textile manufacturing facilities or during use of the garments at food processing facilities. In a letter dated December 8, 2003, the notifier stated, ". . .because there may be instances in which the finish is not removed completely from the fiber prior to its transfer to a food processing facility, we have included that potential avenue of environmental release as well." Furthermore, the notifier estimated a single environmental introduction concentration (EIC) applied to wastewater effluent from both the textile manufacturing facility and the food processing facility, assuming commercial washing machines were used to scour or wash the fabric or articles and that the textile facility discharges approximately 380,000 gallons of wastewater per day to publicly-owned treatment works (POTWs).

 

We have consulted with the EPA scientists (Dr. Vince Nabholz and Dr. Eric Jackson ) with regard to the potential route of environmental introduction of anionic surfactants, in general, that are used in lubricants. They told us that it is a general industry practice to remove all of the fiber lubricant before the article is dyed because the lubricant will interfere with dye uptake. At least 99%, if not all, of the anionic surfactant will be washed off into the wastewater prior to the dyeing process, and definitely before the fiber is converted to final articles. The wastewater from the textile facility will be discharged directly into the environment after on-site wastewater treatment, or indirectly to POTWs.

 

Based on the above information, we believe that the major route where the FCS will be introduced into the environmental is at the textile facility and not at the food processing facility where the articles are used to contact food. We found that nearly 6000 establishments are engaged in the manufacture of textile products; approximately 35% to 50% are engaged in wet processing (dyeing, finishing, printing and coating). At least 90% of the wet processing textile facilities are indirect dischargers who discharge wastewater to POTWs; the remaining are direct dischargers who treat their wastewater on-site before discharging the effluent to a receiving water body. Based on the most conservative assumptions, we calculated the concentration of the subject FCS in the effluent discharged from the wet processing textile facility to be 3.61 ppm for direct discharge and 18.52 ppm for indirect discharge, as detailed in the confidential attachment to this supplement.

 

For indirect discharge, assuming that a POTW generates 1 to 10 millions of gallons of wastewater per day, the concentration of the FCS in the POTW effluent to the receiving waters would be between 0.252 ppm and 2.52 ppm.

 

In a confidential section of the FCN, the notifier provided data on the ultimate biodegradation potential for the K-7749 Finish containing the FCS, using the 7-day/28-day Zahn-Wellens test. On page 5 of the EA under Format Item 7, the notifier stated that these studies indicated that at least 84% of the FCS is degraded (and/or adsorbed). However, the actual data showed 96% bioelimination (degradation and/or adsorbed) after 3 days of incubation and 97% bioelimination after 6 days of incubation. The speed and completeness of the removal shown in this DOC (dissolved organic carbon) removal test suggest that this material is easily biodegraded by non-adapted bacteria. Based on these data, we calculated the biodegradability for the K-7749 Finish in the Zahn-Wellens test to be about 95% at day 6. We also have concluded that the FCS very likely will undergo ultimate biodegradation in a matter of days under aerobic environment. We expect that the biodegradability data for the K-7749 Finish containing the FCS also apply to the biodegradability of the FCS. Therefore, we expect that only extremely small quantities, if any, of the FCS will persist in the environment.

 

Using 95% biodegradability as a conservative estimate and assuming that all of the FCS partitioned in the water phase during the wastewater treatment process, we estimated the EIC in the effluent to the receiving waters to be 181 ppb for direct discharge and 126 ppb for indirect discharge.

 

Format Item 7. Fate of Emitted Substances in the Environment

 

Assuming a river dilution factor of 20-fold, we estimated the expected environmental concentration (EEC) for the FCS in receiving waters to be 9.05 ppb for direct discharge, and 6.30 ppb for indirect discharge. These estimates are based on the most conservative assumption that all the market volume of the FCS will be used and discharged one time, which is an unlikely scenario. We also believe that the FCS will continue to biodegrade in the environment. We predict that, in reality, the concentration of FCS in receiving waters will be much lower than the above estimates.

 

Format Item 8. Environmental Effects of Released Substances

 

The notifier commented on the environmental effects of the FCS at the end of EA Format Item 7. Based solely on an estimated EEC of 0.36 ppm, the notifier stated, ". . .we respectfully submit that there is no reasonable expectation of a significant impact on the concentration of any substance in the environment due to the proposed use of the FCS. . . ." We believe that the comments are not justified absent any eco-toxicity data.

Under Format Item 8, the notifier stated that no eco-toxicity data are available for the FCS. Therefore, we used eco-toxicity data on mixtures of mono and dialkyl phosphate that we believe are structurally similar to the FCS to predict the environmental effects of the FCS (Table 1). The lowest predicted acute toxicity value (0.72 ppm) is about 80-fold higher than the highest EEC estimated (9.05 ppb) based on the most conservative assumptions.

 

Because, as we discussed under Format Item 7, only extremely small quantities of the FCS are expected to be introduced into the environment, and because the estimated EEC (based on the most conservative assumptions) is much lower than the lowest estimated acute toxicity value, we believe that there will be no significant environmental effects from introduction of the FCS into the environment.

 

 

 

Table 1. Aquatic acute toxicity for mixtures of mono and dialkyl phosphates

Test organism, eco-toxicity test potassium stearyl phosphate polyoxyethylene lauryl ether phosphate potassium salt polyoxyethylene tridecyl ether phosphate potassium salt
Fish,
96-hr LC50
>28 mg/L (H32)
≥78 mg/L (H150)
≥3 mg/L
≥30.0 mg/L
= 9.4 mg/L (geometric mean)
= 2.8 mg/L
Daphnia,
48-hr EC50
≥3.0 mg/L (H)
>780 mg/L (H160)
≥10.0 mg/L = 2.8 mg/L
Algae,
96-hr EC50
= 4.9 mg/L (H15)
= 4.4 mg/L (H15)
= 47.0 mg/L (H159)
≥60 mg/L (H≤24) = 0.72 mg/L (H≤24)

 

H refers to hardness of dilution water.

 

The notifier did not discuss the potential eutrophication due to the release of the FCS, which contains phosphate, into the aquatic environment. We do not believe that the amount of phosphate released would contribute significantly to the potential eutrophication of the receiving waters, because (1) the projected market volume for the FCS is very low; (2) advanced wastewater treatment would remove most of the phosphorous; and (3) the amount of phosphorous released from the proposed use of the FCS is much less than the amount released from non-point sources such as animal wastes and fertilizers used for crops.