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Environmental Decision Memo for Food Contact Notification No. 000547

Date: January 19, 2006

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

Subject: FCN No. 547 - Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) for use in food contact applications.

Notifier: Futura Polymers
c/o Keller & Heckman, LLP
Washington, DC 20001

To: Division of Food Contact Notifications (HFS-275)
Attention: Vivian Gilliam
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 547. When this notification becomes effective, these documents and the notifier's EA, dated October 27, 2005, may be made available to the public, and we will post them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.*

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

William H. Lamont

2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Assessment for Food Contact Notification No. 547





Finding of No Significant Impact

A food contact notification (FCN No. 547), submitted by Futura Polymers, to provide for the safe use of polyethylene terephthalate copolyesters (diethylene glycol - isophthalate modified) containing a total of up to 16 mole percent of total diethylene glycol and isophthalate units, with the diethylene glycol content expressed as a mole percent of the total glycol units and the isophthalate content expressed as a mole percent of the total isophthalate/terephthalate units, for fabrication of films or articles intended to 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 (EA), dated October 27, 2005, and our supplement to that EA.

Prepared by __________________________________________Date: January 19, 2006
William H. Lamont, Chemist
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: January 19, 2006
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. 547

This document incorporates by reference the notifier's environmental assessment (EA) dated October 27, 2005.

The purposes of this supplement are (1) to discuss and provide information and clarification of statements made in the EA that, otherwise, may be a source of potential misunderstandings, (2) to correct minor discrepancies, and (3) to discuss why we believe that recycling of disposed articles fabricated from the food contact substance (FCS) is unlikely to impact to any significant extent the recycling stream of polyethylene terephthalate (PET).

The notifier referred to effective food contact notification (FCN) Nos. 4, 85, 280, and 376 as forming a basis to support various conclusions developed in the EA. The EA for this FCN claimed that the proposed FCS is chemically identical to PET polymers already permitted for use under the cited FCNs. To clarify environmental issues, information from the EAs for the cited FCNs, as well as information from other appropriate public sources, is reviewed and summarized in this supplement about specific aspects of the chemical composition that has relevance in determining the environmental decision.

1. Relevance of effective notifications 4, 85, 280, and 375 to FCN 547

The FCS is a modified polyethylene terephthalate (PET) polymer. Commercial PET is often deliberately modified to yield advantageous thermal, mechanical, or other technical properties and to gain economic efficiencies for processing. Other diols to replace ethylene glycol (EG) and other dicarboxylates to replace terephthalate (TP) have been used in copolymerization reactions as modifiers in PET. In this regard, the PET polymers that are the subject of this notification are modified with a diol component, which is diethylene glycol (DEG), and a dicarboxylate component, which is isophthalate (IP), both of which typically are randomly distributed in the resulting polymeric chain forming the polyester's structure.

Apart from economic considerations, incorporating DEG or IP comodifiers to any extent in PET to induce specific properties is not technically limited. The properties of the modified PET are a function of the content of each or both comodifiers, which may generally be varied as desired.1

In this FCN, the subject PET is specifically limited to a maximum total content of 12 or 16 mole percent of DEG and IP comodifiers,2 depending upon conditions of use.

We agree with statements asserted by the notifier that the proposed FCS is substantially identical, in kind, to PET copolyesters considered in FCNs 4, 85, and 376 for similar conditions of use. The limitation imposed on the composition of the FCS encompasses limitations accepted for modified PET polyesters that are the subjects of FCNs 4, 85, and 376. The FCS differs only in degree from the PET copolyesters described in FCNs 4, 85, and 376 with respect to content of the modifying components. The composition range of DEG and IP comonomers as modifiers for PET is limited in FCN 85 and 376 to a total combined maximum of 10 mole percent. The composition range of IP modifier for PET specified in FCN 4 is 3 to 17 weight percent, which when supplemented by 21 CFR 177.1630(e)(4)(i)(a) and (b) allows the range to extend from 0 to 23 weight percent of IP polymeric units as a result of three prior petitions.3 Therefore, the combined composition range of IP (0 - 23 mole percent) and DEG (implicitly a nominal 0 mole percent)4 for FCN 4 encompasses the limitation proposed for the FCS of FCN 547. In effect, the only new aspect of the proposal concerns the DEG content.

The polymer of FCN 280 is a modified PET that uses a combination of 1,4 cyclohexanedimethanol (CHDM) and DEG comonomers. The specification for the composition range of the modified PET that is the subject of FCN 280, as it relates only to DEG, limits DEG as a modifier to a maximum of 12 mole percent of the total glycol. However, an additional limitation on DEG is imposed by limiting the sum of CHDM and DEG to 35 mole percent of the total glycol. No IP modifier is declared present in the PET polyester of FCN 280. The EA of FCN 547 focused on the DEG and implicitly the IP contents of the PET polyester for FCN 280 and suggested that the FCS that is the subject of FCN 547 is similar to the modified PET described in FCN 280. We do not agree with this suggestion. The substantial presence of CHDM modifier is pertinent. Our conclusion is that the modified PET of FCN 280 is substantially different chemically, in kind, from the FCS of FCN 547. As a modifier, the CHDM imparts thermal and mechanical properties to PET different from those induced by DEG and IP; consequently, FCN 280 is not relevant to the environmental considerations discussed in the EA for FCN 547.5

2. Environmental consequences arising from disposal of food packaging material fabricated from the FCS

Because the EA disclosed that some articles fabricated from the proposed FCS were expected to be recycled, the primary environmental issue involved an examination of the potential impact from such articles upon recycled PET. The major use for recycled PET (> 50%) is the manufacturing of fiber for carpets and textiles.6 The quality of fibers is affected, in part, by thermal, mechanical, and processing properties of recycled PET.7

The Coalition on PET Safety, the notifier for FCN 85, identified in their EA that "...the only concern presented by the inclusion of high-comonomer PET in the general recycle stream would be the possibility that there will be increased variability in the composition of post consumer PET that might affect the properties and use of resins containing significant amounts of the 'new PET copolyesters.'" Because it is desirable that fiber be available in a variety of colors, these colors obtained by various dyeing techniques, the Coalition stated that:

"...dying [sic] consistency is affected by smaller changes in composition than are needed to affect other critical properties. That is, variations in fiber depth becomes [sic] a marketing liability long before the recycled resin will fail to meet physical property specifications. For example, inconsistency of dye uptake will easily result in unacceptable variations in the color of products such as carpet fiber and textiles."

Based on test results reported in a separate section of FCN 85 for dye uptake, the Coalition on PET Safety demonstrated "...that the proposed use of PET copolyesters containing a total of up to 10 mole % of DEG and IP units will have no significant adverse impact on current or future recycling programs for post consumer PET." Moreover, the Coalition asserted in FCN 85 that the impact of PET copolyesters containing high concentrations of comonomers upon recycling programs for PET was expected to be virtually non-existent because "...the high comonomer (>6%) product is expected...to account for no more than 1% of the total market for food-contact PET." In fact, "[t]he maximum expected comonomer level is 8%; the typical ratio of DEG to IP will be close to 1."

Our environmental decision for FCN 85, expressed in a Finding of No Significant Impact (FONSI), accepted a limitation of 10 mole-percent for the total concentration of DEG and IP polymeric units.8 The FONSI for FCN 85 was based partly on testing data provided to show experimentally that physical properties of recycled PET were not significantly affected and partly on an analysis of confidential market volume information provided to show that a very small market demand, less than 1%, existed for the sale of recyclable PET containing more than 6 mole percent of DEG and IP modifiers. We have no other information since then that alters the validity of the assumptions, data, and conclusions presented in FCN 85 on this topic.

We believe that FCN 85 established that recycled PET could sustain inclusion of 10 weight percent of articles fabricated from PET containing a total maximum of 10 mole percent of modifiers. FCN 85 fixed the upper bound for modifiers, but it did not fix any specific manner to achieve the upper bound. Therefore, an equivalent mathematical restatement of the original finding in FCN 85 can be computed, thereby avoiding the need for new data or extrapolating old data, of which the latter action cannot provide a justifiable basis for this FONSI.

The quantitative finding of FCN 85 was that a maximum of 1 mole percent of comodifiers could be additionally incorporated into recycled PET without impact.9 Therefore, we conclude that articles fabricated from an FCS containing a maximum total of 16 mole percent of modifiers is equivalent to the finding in FCN 85 only if the proportion of the proposed FCS included in recycling does not exceed 6.25 weight percent.10 We interpret this result to mean that if the demand for PET containing less than 16 mole percent modifiers is not greater than 6.25 weight percent of potentially recycled PET, then such modified PET is not anticipated to impact the recycling of "unmodified" PET.

On the basis of confidential market volume information submitted by the notifier to support the EA, we conclude that the market penetration of the subject substance will be limited to meet the experimentally supported limitation level of modifiers in PET. We also believe that there will be no significant incremental increase in the market volume of existing PET with the modified PET as a result of allowing this notification to become effective because the subject PET, modified with up to 16 mole percent modifiers, will replace already approved PET modified with 10 mole percent of modifiers.

3. Summary

Food contact articles fabricated from the subject PET copolyesters are expected to be recycled in combination with other PET food contact articles. The subject PET copolyesters will compete with other PET copolyesters that are already regulated under an applicable food additive regulation (i.e., 21 CFR 177.1315 and 177.1630) or effective food contact notification (e.g., FCN Nos. 4, 85, and 376). The FCS polymers that are the subject of this notification do not substantively differ chemically from other related regulated PET copolyesters. Therefore, containers fabricated from the FCS are expected to be marked with the same PET identification recycling code that is used for other PET containers currently produced. Consequently, PET containers fabricated from the FCS will be included in the same post consumer collection stream as other similar poly(ethylene terephthalate) based bottles and will be processed and utilized in the same appropriate recycle markets. Thus, the proposed use of the FCS in articles collected for recycling is not expected to affect adversely the properties of recyclable post consumer PET or to impart any other significant impact on resources and energy following disposal from use of such articles.

Furthermore, impacts on recycling due to the specific use of the FCS in food-contact films will not be significant because recycling of food-contact films, if any, in the United States is currently very limited. Future recycling of food-contact films is not likely because of the difficulty of cleaning films that have residual food adhering to them and because food-contact films are frequently made from diverse materials that are not specifically identified on the finished packaging material. Thus, action to permit use of the FCS in the manufacture of food contact films has no potential to significantly affect existing recycling programs.

We note finally that in Item 6 of the EA, footnote 1 should correctly read: "U.S. Environmental Protection Agency. Municipal Solid Waste in the United States: 2001 Facts and Figures. EPA530-R-03-011, October 2003, Washington, DC." Although we are aware that more recent data in this series are available,11 which update data from footnote 1, the updated data for 2003 do not alter the principal discussion and conclusions given in Item 6 of the EA.

 

 

Prepared by ___________________________________________ Date: January 19, 2006
William H Lamont, Chemist
Environmental Review Group
Division of Chemistry Research and Environmental Review


1 For examples, see SW Lee, M Ree, CE Park, YK Jung, C-S Park, YS Jin, and DC Bae, Polymer, 40, 7137-7146 (1999), "Synthesis and non isothermal crystallization behaviors of poly(ethylene isophthalate-co-terephthalate)s." and SW Lee, B Lee, and M Ree, Macromol. Chem. Phys., 201, 453-463 (2000), "Poly(ethylene-co-ethyleneoxyethylene terephthalate)s: synthesis and non isothermal crystallization behavior."

2 In the EA, the content limitation for the DEG and IP comodifiers is incompletely described. The content specification for DEG is expressed as a mole percent of total glycolic polymeric units in which the total comprises the moles of DEG and EG units in the finished polymer. Similarly, the content specification for IP is expressed as a mole percent of total phthalic polymeric units in which the moles of TP and IP units compose the total in the finished polymer. The composition of the polymer is defined algebraically by a set of four simultaneous equations, which express the four physicochemical bases for the finished polymer:

  1. DEG + EG + IP + TP = 100, wherein the sum of the weights of each component is arbitrarily set equal to 100 units of weight to express the conservation of mass,
  2. (DEG/104) + (EG/60) = (IP/132) + (TP/132), wherein the total moles of glycolic polymeric units equal the total moles of phthalic polymeric units to express the stoichiometric reaction constraint that glycolic and phthalic components react in a 1:1 molar ratio to form the product,
  3. (DEG/104)/[(DEG/104) + (EG)/60] = (mole percent DEG)/100, wherein, depending upon conditions of use, 0 ≤ (mole percent DEG) ≤ 12 or 16 to express the condition of chemical constraint set by the specification for the mole fraction of DEG, and
  4. (IP/132)/[(IP/132) + (TP/132)] = (mole percent IP)/100, wherein, depending upon conditions of use, (mole percent IP) = (12 or 16) - (mole percent DEG) to express the condition of chemical constraint set by the specification for the mole fraction of IP.

3 Food Additive Petition (FAP) 0B2567 was submitted by Minnesota Mining & Manufacturing seeking approval of 17 to 23 weight percent IP content (37 FR 6469, March 30, 1972). American Enka submitted FAP 5B3871 seeking approval of 0 to 2 weight percent (50 FR 35367, September 4, 1985), which was later expanded by Goodyear Tire & Rubber Co. in their submission of FAP 5B3884 seeking approval of 0 to 3 weight percent (52 FR 32917, September 1, 1987).

4 FCN 4 did not address DEG content. However, FCN 85 established that commercial PET is likely to contain some small quantity of DEG polymeric units. Formation of DEG and its incorporation into PET is an important side reaction, which is a fact that has been long known, e.g., one early quantitative case is Toyo Rayon Co. Ltd., JP68013074-B (JP, 43-013074, B), June 3, 1968, "Production method of a polyester condensation polymerization series [poriesuteru kei jushukugo no seizo ho]."

5 Moreover, because the anticipated uses of the FCS of FCN 547 differ with respect to recycling from the uses of the modified PET of FCN 280, we believe that these incongruous uses establish FCN 280 as an inapplicable basis of comparison for FCN 547. The economics of CHDM modifiers incorporated into PET are a limitation. The notifier for FCN 280 specifically stated that its FCS was additionally modified with CHDM to enable the fabrication of shrink wrap film, blister packaging, and thermoformed tubs, all of which, as types of food packaging materials, "...are not recovered for recycling to a significant extent...."

6 American Plastic Council, 2004 National Post-Consumer Plastics Recycling Report, RW Beck, Inc., 1300 Wilson Blvd., Arlington, VA 22209, November 21, 2005

7 WS Murdoch, US Patent 6545061, April 8, 2003, "Recycling of polyethylene terephthalate with regeneration of acetic acid."

8 An inventory of environmental impact decisions for effective food contact substance notifications may be found at http://www.cfsan.fda.gov/~rdb/opa-envt.html for review.

9 We compute the finding as follows: (10 weight units modified PET/100 weight units recycled PET) x 10 mole percent upper bound limitation = 1 mole percent upper bound limitation).

10 We compute the limitation as follows: (10 weight percent FCS included in recycling as tested in FCN 85) x (10 mole percent accepted in FCN 85 as the maximum concentration comodifiers/16 mole percent proposed in FCN 547 as the maximum concentration comodifiers) = 6.25 weight percent FCS containing 16 mole percent maximum concentration comodifiers that can be tolerated in recycling.

11 U.S. Environmental Protection Agency. Municipal Solid Waste Generation, Recycling, and Disposal in the United States: Facts and Figures for 2003. EPA530-F-05-003, April 2005, Washington, DC.


*The FDA web links cited in this article are now out of date. The new FDA websites can be accessed from the Food Ingredients and Packaging section under the Food topic of www.fda.gov.