WASHINGTON — A key plastics industry proposal to slash the time it takes to approve new food packaging from two years to four months has survived an unexpected challenge from an influential member of Congress.
That opposition came from Rep. Thomas Bliley (R-Va.), chairman of the House Commerce Committee, who temporarily pulled the provision out of Food and Drug Administration reform legislation because he objected to the user fees that the industry would have to pay for speedy approval.
The fees prompted opposition from the Grocery Manufacturers Association, which argued they are a ``hidden tax.''
But Bliley and other Commerce Committee members agreed Sept. 25 to put the proposal back in FDA legislation — minus the user fees.
The fees may return when negotiators for the House and Senate meet to hash out differences in their versions of FDA legislation. FDA supports the provision, as long as it has the fees.
The Senate passed its own FDA reform plan a day earlier that includes the fees, and an aide from Rep. Bart Stupak (D-Mich.), a supporter of the pre-market notification provision, said the fees are supported by the highest-ranking Democrat on the House Commerce Committee, Rep. John Dingell (D-Mich.).
The full House still must consider the plan adopted by the Commerce Committee.
The pre-market notification provision is a legislative priority of the Washington-based Society of the Plastics Industry Inc.
Instead of seeking FDA approval for new packaging materials, the provision would allow companies to market their products within 120 days of notifying the FDA, as long as the agency does not object. FDA still can choose to put a new material through full review.
The quick process would apply to all food packaging, from water bottles to plastic wrap.
SPI General Counsel Jerry Heckman said in a prepared statement that the provision will ``have a major impact on new-product development, not only on the 25 percent of the plastics industry that is engaged in supplying packaging, but on the many other segments of the industry'' that must be able to say their products comply with FDA regulations.
Most new materials used in packaging now take two to four years to get FDA approval, he said.
The plastics industry supports user fees to maintain FDA support for the plan. SPI and FDA negotiators made the deal last year.
Heckman said he was hopeful the legislation will pass with the user fees. Fee amounts have not been set but Heckman said they probably will not be more than $2,000 per application.
The Senate ended weeks of maneuvering around its own FDA reform legislation, voting 98-2 Sept. 24 to adopt a bill that, among other things, expands third-party approval procedures for medical devices.
The medical device industry has supported such reforms to clear up backlogs, but FDA and some congressional Democrats have argued for more cautious reforms to avoid endangering the public.
