SPI FOOD-PACKAGING PROPOSAL RIDING ON FAST-PACED FDA BILL

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WASHINGTON — A Society of the Plastics Industry Inc. proposal that would overhaul some food packaging rules has been attached to a fast-moving piece of legislation in Congress, and appears to have good prospects on Capitol Hill.

The provision, which essentially would allow new food-contact substances to be used automatically unless the Food and Drug Administration says no, has been attached to legislation renewing a very popular prescription drug- approval program at the FDA.

The FDA supports the food-contact proposal, and it appeared to pass its first legislative hurdle at a June 11 hearing of the Senate Labor and Human Resources Committee. The provision was attached June 5. The legislation renews the Prescription Drug User Fee Act, a program that has cut approval times for new drugs. The program must be renewed before Aug. 1 or layoff notices will be sent to 600 FDA employees.

The food-contact provision, known as pre-market notification, would allow a firm to begin using a food-contact substance 120 days after notifying the FDA. The company must document that the substance is safe, and the FDA can turn down the application.

A Senate Labor Committee spokesman said the SPI-FDA measure is not likely to be opposed.

Other provisions of the bill important to plastics firms, however, are dividing Washington. Several Democratic senators at the hearing opposed the bill's dramatic expansion of third-party review of medical devices, as did Health and Human Services Secretary Donna Shalala in a June 11 letter.

The bill from Labor Committee Chairman James Jeffords, R-Vt., would allow third-party approval of all devices except for Class III devices, which are among the most complicated, said Jeff Kimbell, executive director of the Medical Device Manufacturers Association in Washington.