The Society of the Plastics Industry Inc. has proposed changes in the way the Food and Drug Administration regulates food packaging. Although no actual legislation has been written, the Washington-based trade association submitted testimony last month to the House subcommittee on Human Resources and Intergovernmental Relations. The testimony seeks to establish a separate statutory treatment that would expedite FDA clearance of packaging materials used in direct contact with food.
Jerome Heckman, SPI general counsel, said the group seeks to break bureaucratic logjams that can cause huge expenses and years of delay in FDA's clearance process.
``Suppose a company wants to use a certain resin for food packaging, but in order to make it useful in the packaging, anti-fog additives are needed,'' Heckman said. ``The company must file a food additive petition with FDA. This petition requires certain data, and then rule making by the agency. Obtaining clearance can require as much as two to four years from the time it is filed, even though all the substances may already have been tested in other applications and shown to have minimal risk.
``Packaging materials are considered indirect food additives, and are subject to the same rule-making process as direct food additives, even though indirect additives may not migrate into foods, or may do so in infinitesimal and harmless amounts,'' Heckman said.
He added that separate treatment at FDA for food packaging is warranted because the potential for use and ingestion of packaging substances differs dramatically from those directly or deliberately added to food.
In testimony before the subcommittee, Heckman proposed a system in which packaging companies would give pre-market notification of their intent to use certain materials, accompanied by data required under the old system.
The company would gain auto-matic clearance to use the materials within 90 days after notification, unless FDA concludes that the food-contact substance may pose risks to human health, or that more data should be gathered.
``In many cases a package maker may decide not to make the product because they know that the clearance may take such a long time, the product will be obsolete, or the expense and delay will damage business,'' Heckman said. ``Even a threshold petition, which establishes the thresholds for migration of chemicals from a material, can take six to eight months.''
He said the plan is consistent with the Clinton administration and Congress' desire to streamline government and eliminate excessive regulations.
``There are so many of these things,'' said Steven Ziller, vice president for scientific and technical affairs for the Grocery Manufacturers Association, a Washington-based trade group that also testified before the com-mittee.
``Some of these are so routine, and the FDA already has experience with the combinations of materials, that it should be possible simply to notify them.''
Ziller said the notification process still would provide the same or similar documentation as the present system, and would allow FDA to ask for further proof if it saw fit.
``We would be on the road to prioritizing and using resources on the basis of risk instead of being bound to a system that exalts form over substance where insignificant risks are concerned,'' he said.