Environmental Decision Memo for Food Contact Notification No. 000009

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Date: March 2, 2000

From: Environmental Chemist, Environmental Review Team (ERT)
Division of Product Manufacture and Use (HFS-246)

Subject: Premarket Notification FCN No. 000009 for PEN/PET Copolymers with > 50% PEN

Notifier: Shell Chemicals Company
Akron, Ohio

To: Division of Product Policy (HFS-206)
Attention: Hortense Macon
Through: Team Leader, ERT (HFS-246)

Attached are the Finding of No Significant Impact (FONSI) and a Supplemental Environmental Assessment (EA) for this notification. When this notification becomes effective, these two documents should be made available to the public. The notifier's most recent EA is already publicly available because you sent it to the Dockets Management Branch in September 1999.

As you likely remember, there were comments on the original EA for the petition (FAP 5B4451) from which this notification was converted. Our draft letters to the commentors that were attached to our memorandum to you on FCN No. 000008 addressed these comments, since the commentors included both FAP 5B4450 and FAP 5B4451 in their letters. Thus, sending out those letters will handle the comments on this action.

Please let us know if there is any change in the identity or use of the food-contact substance that would be inconsistent with the identity and use described in the FONSI.

Elizabeth Ann Cox

2 Attachments

Finding of No Significant Impact

A Premarket Notification (FCN No. 000009), submitted by Shell Chemicals Company, to provide for the safe use in contact with food of poly (oxy-1,2-ethanediyloxycarbonyl)-2,6-naphthalenediylcarbonyl) homopolymer and copolymers with ethylene terephthalate in which the finished copolymers may contain up to 50 weight percent of the polymer units derived from ethylene terephthalate.

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 action was originally requested in Food Additive Petition (FAP) 5B4451, as announced in the June 20, 1995, Federal Register (60 FR 32159). The food contact use in the premarket notification is identical to the use requested in FAP 5B4451. Therefore, the information presented in the environmental assessment (EA) for FAP 5B4451 is applicable to this notification. This finding is based on the information in that EA, which, in turn, relies extensively on the EA prepared for FAP 5B4450, a petition for very similar copolymers, which was also converted to a premarket notification, FCN No. 000008. This finding is also based on the supplement to the EAs for FCN No. 000008 and for this notification prepared by the Environmental Review Team. Further, as is noted in the EA for FAP 5B4451 (page VII-2), the analyses provided to the agency for FAP 5B4450 and FAP 5B4451 considered issues associated with these two actions separately and jointly. Thus, the cumulative effects of naphthalate-containing polyesters have been considered. The EAs for FAP 5B4451 and for FAP 5B4450 are displayed at the Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, under Docket Numbers 95F-0129 and 95F-0130, respectively.

Prepared by ________________________________ Date: March 2, 2000
Elizabeth Ann Cox, Environmental Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by________________________________ Date: March 2, 2000
Buzz L. Hoffmann, Ph.D., Team Leader
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Supplement to the Environmental Information
for Food Contact Notification Nos. 8 & 9

This document incorporates by reference the Environmental Assessments (EAs) for Food Additive Petitions (FAPs) 5B4450 and 5B4451. The EA for FAP 5B4450 is dated Dec. 20, 1994, Revised 4 Nov. 1998, 10 May 1999 with editorial changes 4 August 1999, and the EA for FAP 5B4451 is dated December 28, 1994, Revised August 26, 1999. These EAs are displayed at the Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, under Docket No. 95F-0130 for FAP 5B4450 and Docket No. 95F-0129 for FAP 5B4451. As explained in the Findings of No Significant Impact for FCN Nos. 000008 and 0000009, Food Additive Petitions 5B4450 and 5B4451 were converted to premarket notifications, and the EAs for these petitions are applicable to the corresponding notifications.

1. Tab 14 of the EA for FAP 5B4450 contains the non-confidential summary of a study performed by Amoco, entitled, Amoco Study of Compatibility of Naphthalate-containing Polyesters with Fibers derived from recycled PET. The summary draws several conclusions based on this study. One of these conclusions is that the naphthalate content tested (6%) did not adversely impact the resulting fiber's physical properties. We (in this document "we" refers to FDA personnel) reviewed the confidential study report and found that, while the data presented for fibers derived from recycled PET containing naphthalate were very similar to the data for fibers from recycled PET without added naphthalate, the study provided no information on the variation expected for the properties tested. Thus, we find no basis in this study to agree or disagree with the statement in Tab 14 of no adverse impacts on the physical properties of fibers. Subsequent studies, e.g., a study by Wellman Inc, entitled, Polyethylene Naphthalate (PEN): A Recyclability Study - Effects of PEN on the Processing, Physical Properties and Disperse Dyeability of Recycle PET Fibers that was submitted to Dockets 95F-0129 and 95F-0130 in November 1996, have shown that a range of PEN levels, including 6%, in recycled PET do not affect the physical properties of fibers. Thus, it was not necessary for the Amoco study to be repeated to determine the expected variation in the properties tested.

2. One comment FDA received on the original EAs for FAPs 5B4450 and 5B4451 questioned the potential for environmental impacts as a result of replacing refillable/reusable glass beer bottles with plastic bottles. The commentor did not estimate the quantities of refillable beer containers that could potentially be affected when FDA takes this action. Nor did the commentor provide any basis for concluding that the long established use of refillable beer bottles would be affected by new plastic beer bottles. The comment did include the following citation: "EPA 1997 at 96." We interpret this citation to mean page 96 of the Environmental Protection Agency's (EPA) document entitled Characterization of Municipal Solid Waste in the United States: 1997 Update, EPA530-R-98-007, May 1998, internet address: We note that the discussion of refillable beer containers occurs on page 95 of the cited EPA document in a section on the management of municipal solid waste by source reduction. This EPA document says, "Glass bottles are a prime example of reuse of a container for its original purpose. Refillable glass beer and soft drink bottles can be collected, washed, and refilled for use again. Some years ago large numbers of refillable glass soft drink bottles were used, but these have largely been replaced by single-use glass bottles, plastic bottles, and aluminum cans. Considerable numbers of beer bottles are collected for refilling, often by restaurants and taverns, where the bottles can easily be collected and returned by the distributor. The Glass Packaging Institute estimates that refillable glass bottles achieve a rate of 8 trips (refillings) per bottle." To the extent that PET/PEN copolymer beer bottles replace refillable glass bottles, there is potential for adverse impacts such as increased atmospheric emissions, increased waterborne wastes, an increase in the volume of solid waste, and increased consumption of energy. Therefore, because the EAs for FAP 5B4450 and FAP 5B4451 do not discuss the potential for environmental impacts resulting from the replacement of refillable/reusable beer containers, we are addressing this issue in this supplement to those EAs.

The Beer Institute collects and publishes information on how beer is sold, i.e., the percentages of beer as sold in various containers and draft-style. These data for 1982 through 1997 are presented in the table below.

The data in the table show that the percentage of beer in refillables has gradually declined since 1982, although this percentage appears to level out periodically, including in the most recent years reported.

We understand that refillable glass beer bottles are mainly used on-premises (in bars, restaurants, hotels, etc.) and that this use has been established for a long time. We believe that decisions to modify current on-premises refillable beer container systems are very unlikely to be based on the availability of a new plastic container. Instead, we believe that these decisions are based on other factors pertaining to these systems, such as 1) product image (glass packaging is said to provide a premium image), 2) consumer preference (some believe that consumers will be reluctant to accept beer in plastic containers; this is likely to be especially true for the beer drinker accustomed to beer in refillable glass containers), 3) convenience (it may be more convenient to use refillable bottles than to constantly order new containers for packaging beer and to deal with the additional solid waste that would result from single use bottles), 4) economics (it may be less expensive to use refillable bottles than to use nonrefillable bottles), and 5) support for source reduction strategies (source reduction includes the reusing of glass bottles and source reduction is the top component of EPA's tiered integrated waste management strategy). Nonrefillable glass and aluminum containers have been available as beer containers for many years and could have essentially eliminated the refillable glass beer market. Yet, a small, relatively stable refillable glass beer market persists. We have no information showing that PET/PEN copolymer bottles would be more likely to replace refillable glass beer containers than would other nonrefillable containers. Therefore, we conclude that any penetration of the refillable glass beer market would be very small and would not have significant effects on the environment.

How Beer Is Sold

Year% metal cans% one-way bottles% refillable bottles% draught

Prepared by: ________________Date: _________________
Elizabeth Ann Cox, Environmental Chemist
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

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