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U.S. Department of Health and Human Services

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Environmental Decision Memo for Food Contact Notification No. 000044

Date: May 24, 2000

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

Subject: Premarket Notification FCN No. 000044 - Nylon MXD-6 Modified PET for Food Contact Use

Notifier: Toyobo Co., Ltd.
c/o Center for Regulatory Services
Reston, Virginia 22091

To: Division of Petition Control (HFS-215)
Attention: Mark A. Hepp, Ph.D.

Attached is a revised Finding of No Significant Impact (FONSI) for this premarket notification. This FONSI supersedes the FONSI dated July 30, 1996, that was prepared for Food Additive Petition 0B4204. When the July 30, 1996, FONSI was prepared, we were concerned that the market volume for PET/Nylon MXD-6 blends might be substantially larger than the very small market volume predicted by the petitioner for the specific uses requested in the petition, and that such a large market volume might have a detrimental affect on PET recycling. We based our concern on the following:

  1. Information we had about packaging materials that are similar to PET/MXD-6;
  2. The fact that once a food additive regulation is promulgated, any company in the world may produce the subject additive for use in the United States in accordance with the regulation; and
  3. Information about PVC showing that the presence of even small amounts (20 ppm) of PVC in the PET recycling stream will significantly degrade PET.

The July 30, 1996, FONSI concluded that there would be no significant adverse effects on PET recycling, provided that the food additive regulation contained mitigating instructions that bottles made of PET/Nylon MXD-6 must be identified as not being appropriate for recycling as a specific resin, i.e., they can be recycled only with commingled plastics. Based on an internal agency review of the July 30, 1996, FONSI, we determined that this mitigation did not adequately address the potential environmental effects that may result if Nylon MXD-6 enters the PET recycling stream and is not compatible with PET recycling. Based on this internal review we continued our in-depth analysis of this issue.

On February 7, 2000, the petitioner requested that FAP 0B4204 be converted to a premarket notification. Since an effective notification only applies to the manufacturer of the food contact substance, only Toyobo Co., Ltd. can produce and market Nylon MXD-6 for the intended use as a modifier for polyethylene terephthalate (PET) polymers. Consequently, based on information in Toyobo's April 15, 1996, environmental assessment (EA), and on our experience with the existing regulation in 21 CFR 177.1630(e)(4)(v), we now believe that the petitioner's very small market volume estimate for the United States (| | | | | | | | | | of PET/Nylon MXD-6) is realistic for the notified use and may even be an overestimate. In the petition that led to the existing regulation in §177.1630(e)(4)(v), Toyobo Co., Ltd. estimated a market volume of | | | | | | | | | | | | | | | | | | | | | | | | for PET/Nylon MXD-6 containers for use in the United States, primarily in packaging carbonated beverages and beer. Although this use was regulated on July 24, 1985 (50 FR 30146), Toyobo's EA states that there is "no current usage of PET/Nylon MXD-6 blends in the United States," and PET/Nylon MXD-6 articles are "manufactured only in Japan." Because the petitioner's estimated market volume for PET/Nylon MXD-6 blend containers is substantially less than the market volumes we had previously estimated, we have determined that the proposed action will not have a significant effect on resource use, including potential impacts on recycling and energy use. Therefore, we no longer believe that an in-depth analysis of larger market volumes on resource use is needed.

We have also attached a supplement to the EA that 1) corrects certain information in Toyobo's April 15, 1996 EA, 2) contains an analysis of the notifier's recycling data referred to in footnote 1, and 3) contains an analysis of the introduction of substances at landfill and combustion sites where the finished packaging will be disposed. The confidential energy information referred to in item 4 of the supplement to the EA may be found in the Confidential Waste Management and Energy Analysis for FAP 0B4204 that was attached to the July 31, 1996, memorandum prepared by Dr. Kristina Paquette.

When this notification becomes effective, the following documents may be made available to the public:

  1. Our revised FONSI;
  2. Toyobo's revised EA for FAP 0B4204 dated April 15, 1996 (plus pages 9-50 of the EA dated December 2, 1995 );
  3. The supplement to the EA;
  4. Mr. Begley's memorandum dated November 18, 1997, provided that it does not contain confidential information.

Buzz L. Hoffmann, Ph.D.



 



 

 

Finding of No Significant Impact

A Premarket notification (FCN No. 000044) submitted by Toyobo Co., Ltd. for the use of hexanedioic acid polymer with 1,3-benzenedimethanamine (Nylon MXD-6) as a modifier for polyethylene terephthalate intended for food-contact applications.

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) 0B4204, as announced in the June 27, 1990 Federal Register (55 FR 26264). The food contact use requested in the premarket notification is identical to the use requested in FAP 0B4204. Therefore, the information presented in the environmental assessment (EA) for FAP 0B4204, prepared using the format described in FDA's previous regulations under 21 CFR 25.31a(a), is applicable to this notification. This finding of no significant impact is based on that EA and on the attached supplement to the notifier's environmental assessment.

Approved by: ___________________________________________ Date: May 24, 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 No. 44 (Formerly FAP 0B4204)

May 24, 2000

This document incorporates by reference the Toyobo Co., Ltd. environmental assessment (EA) dated April 15, 1996, and its attachments.

1. Introductions of Substances at Landfill Sites

The amount, if any, of monomers, oligomers, and other non-volatile extractives introduced into the environment from the landfill disposal of food-packaging materials made from a blend of polyethylene terephthalate (PET) and Nylon MXD-6 is expected to be extremely low. This finding is based on 1) the very small yearly market volume estimated for PET/ Nylon MXD-6 blend containers (| | | | | | | | | | ); 2) the amount of substances extracted from PET/Nylon MXD-6 containers;1 and 3) EPA's regulations governing municipal solid waste landfills.2

2. Introductions of Substances at Incineration Sites

Based on information in the notifier's April 15, 1996, EA, we expect very little recycling of PET/Nylon MXD-6 blend containers. Therefore, after use by consumers, about 24% of PET/Nylon MXD-6 containers will be disposed of by incineration.3 Under EA Format Item 6 is a table showing the combustion products of Nylon MXD-6, Nylon 6, and Nylon 66. In the analysis that follows, we have considered the potential for adverse environmental impact resulting from introductions of Nylon MXD-6 combustion products.

a. The Nylon MXD-6 modified PET contains nitrogen, which upon incineration will form nitrogen oxides; these gases have the potential to cause environmental effects by contributing to acid precipitation. However, based on the molecular formula of the food contact substance (FCS) and on the projected market volume for PET/Nylon MXD-6 blend containers (| | | | | | | | | | | | | | | | |), we have determined that allowing this notification be become effective will result in a very small increase in the amount of nitrogen entering the municipal solid waste (MSW) stream. This amount of nitrogen would contribute only a very small fraction of the total nitrogen oxides produced from all anthropogenic sources in the U.S. and Canada, estimated to be 18.6 million metric tons in 1985.4

b. The table included in the notifier's EA indicates that methane, ethylene, acetylene, benzene, and hydrogen cyanide are measurable combustion products of Nylon MXD-6 at a furnace temperature of 700° C (1292° F) and an air flow rate of 500 ml/minute. When the values given in this table are applied to the projected market volume, the total expected emissions of these substances are negligible and will not be environmentally significant.

c. Under Format Item 6 of the EA, the notifier stated that the combustion products of Nylon MXD-6 are similar to those of Nylon 6 and Nylon 66. According to the table of combustion products provided in the EA, Nylon MXD-6 combustion results in significantly lower amounts of all the organic compounds listed except benzene.

3. Recycling

As noted above, we expect that PET/Nylon MXD blend containers will be recycled only to a very small extent and then only with commingled plastics. However, some PET/Nylon MXD blend containers will inadvertently enter the PET recycling stream. The Toyobo Company Ltd., provided confidential data to support its claim that Nylon MXD-6 is compatible with PET recycling up to a level of 4 percent. These data were reviewed by an FDA scientist who concluded, "...a 4 % level of Nylon MXD-6 in PET did not affect the physical properties of PET for the specific tests listed." This scientist noted, however, that the data do not show "...the PET contaminated with Nylon MXD-6 can be solid-stated to increase the intrinsic viscosity to an equivalent value of virgin material." Therefore, the data do not support a conclusion that Nylon MXD-6 at a level of 4 percent is compatible with the recycling of PET for a specific end use. However, given the very small market volume projected by Toyobo Company Ltd. for the proposed applications of PET/Nylon MXD-6 blend containers (| | | | | | | | | | | | | | | | | PET/Nylon MXD-6), we expect the level of Nylon MXD-6 in the PET recycling streams will be substantially less than 4 percent, on the order of a very small fraction of 1 percent.5 Therefore, we conclude that the presence of Nylon MXD-6 in the PET recycling streams as a result of allowing this notification to become effective will not disrupt these reycling streams or have any adverse environmental effects.

The EA (Format Item 9) stated, "...since Toyobo cannot control the manufacture and use of blended bottles by others in the U.S., it is proposed that the regulation issued in approval of this petition included the instructions that bottles made by the blended resins must be identified as not being appropriate for recycling as a specific resin." This statement was made when the proposed use of PET/Nylon MXD-6 was the subject of FAP 0B4204. Under the petition system, anyone may produce a food additive for use in the United States in accordance with the applicable regulation. The situation under the premarket notification system is different: If FCN No. 000044 becomes effective, only Toyobo Company Ltd. may produce and market PET/Nylon MXD-6 for the proposed use. We believe that the very small market volume of PET/Nylon MXD-6 containers for the specific uses requested by Toyobo Co., Ltd. will not disrupt the PET recycling streams or have any adverse environmental effects. Therefore, we do not believe that any mitigations are necessary with respect to PET recycling.

4. Energy and Resources

Given the very small yearly market volume projected for PET/Nylon MXD-6 containers (| | | | | | | | | | ), we do not expect significant effects on energy and resource use. Based on confidential information available to the agency, we determined the amount of energy that would be required to produce, transport, package, and fill containers made of PET/Nylon MXD-6 for the proposed uses. Because we expect that PET/Nylon MXD-6 containers will replace primarily glass containers, we compared the energy estimated for PET/Nylon MXD-6 containers with that required by the glass containers that would be replaced by PET/Nylon MXD-6. The energy requirements for glass containers were obtained from the 1989 NAPCOR Report.6

Using the 1995 energy projections given in the NAPCOR report for non-returnable glass containers, we determined that the production of PET/Nylon MXD-6 would result in a small energy increase (< 10%). According to Franklin Associates, who authored the EPA Municipal Solid Waste Report,5 and the NAPCOR Report,6 less than 10 percent differences in energy values between packaging materials have consistently been shown to be insignificant, i.e., one cannot distinguish between the energy requirements for two products whose energy difference falls within this range.7,8 We therefore conclude that the energy differences between PET/Nylon MXD-6 and glass containers are insignificant.

Preparers:

___________________________________________ Date: May 24, 2000
Kristina E. Paquette, Ph.D., Chemist
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

___________________________________________ Date: May 24, 2000
Layla I. Batarseh, Ph.D., Toxicologist
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Approved by: ___________________________________________ Date: May 24, 2000
Buzz L. Hoffmann, Ph.D.
Environmental Review Team
Division of Product Manufacture and Use
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
Food and Drug Administration