FDA RECYCLING CONCERNS THWART PEN THRUST

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NEWARK, N.J. — The Food and Drug Administration is holding back U.S. commercialization of polyethylene naphthalate resin because of recycling-related concerns.

FDA, leery of PET and PEN's compatibility in the recycling stream, may require bottles made from PEN to be distinctly identified from PET.

``The resolution of the questions of materials labeling and recycling protection — something heretofore outside the scope of FDA's activity — added about five years to the time it took for the PEN clearance,'' industry lawyer Jerome Heckman said.

Two pending petitions that seek clearances for PET/PEN copolymers and blends also may be subjected to the same type of delay, Heckman told attendees of Polyester Packaging: ``The Critical Path Ahead,'' held May 28-30 in Newark. Heckman is a senior partner with Keller & Heckman in Washington, and counsel to the Society of the Plastics Industry Inc., also based in Washington.

FDA officials did not return telephone calls seeking comment.

Heckman cited a Wellman Inc. report indicating that PEN in the PET recycling stream adversely affects the ability to dye fibers used in carpet and textiles, a primary outlet for recycled PET.

The concern for Shrewsbury, N.J.-based Wellman, a huge recycler of PET, stems from technological problems in a dispersive method of textile dyeing, according to Heckman. Wellman also asserts that PEN-content resins and packaging are highly fluorescent at low levels of concentration and the fluorescence is carried over to fiber.

Both Houston-based Shell Chemical Co., which makes Hipertuf-brand food- and beverage-grade PEN resins, and Amoco Chemical Co., which makes a monomer for PEN, have conducted PEN recycling tests. Bob Minney, manager of recycled programs for Shell's polyester business, said his firm's tests show no negative results on processability or physical properties.

``We've received a couple of reports on the dyeability issue and the results vary,'' Minney said by telephone from his Akron, Ohio, office. ``Trials are being done by a third party. We should have the results in a couple of months.

``The fluorescence seems to be Wellman-specific,'' Minney added. ``They're the only merchant fiber supplier to the carpet industry. The others are fully integrated.''

Another provision in clearing PEN for packaging applications might be requiring ``distinctive labeling to assure that bottles made from the new copolymer or blend will be separately recycled at a comparable rate to the containers they displace,'' Heckman said.

``PEN homopolymer is well worth getting back in the recycling stream [to] use it again in the same application,'' he said.

``We have a unique problem where PET and its cousins are concerned. The materials are so good that they have commanded a new kind of FDA attention that has nothing to do with public health or safety in the conventional FDA sense,'' Heckman said.

In Europe and Australia, PEN is not encountering such obstacles, as witnessed by new PEN packaging applications there. In Australia, Coca-Cola Co. is test-marketing a 12-ounce PET/PEN contour bottle, according to Michael Gage, consulting packaging engineer for Atlanta-based Coke.

``We've had a petition before the FDA for two years,'' said Gage, who also spoke at the packaging conference. ``We'll get this into the [United States] market when FDA approves it.'' He added that the FDA is not moving on the petition because of recycling and environmental issues.

Coke expects to release market research information on the success of its Australian venture next month, he said.

On the European front, Swiss retail giant Migros is marketing hot-filled PET/PEN half-liter bottles of Sports+Fit beverages. The bottles, containing 8-10 percent naphthalate, are blow molded from a PET/PEN copolymer made by Hoechst Trevira GmbH & Co.

Domestically, the biggest roadblock for further FDA approval of PET/PEN copolymers and blends are all environmental-related, Minney said.

``The FDA can hold us up as long as they want,'' he noted. ``It'll be interesting to see what the face of PET will look like in a year or two.''