Some of the most wonderful innovations have happened in the most trivial-seeming areas. Thanks to new and innovative food packaging - particularly plastic packaging - we have more, healthier, and longer-lasting food. But the Food and Drug Administration is needlessly burdening the packaging industry and discouraging innovation.
Since Congress passed the 1958 Food Additive Amendments to the 1937 Food, Drug, and Cosmetic Act, food packaging has been regulated as a ``food additive'' because according to the second law of thermodynamics, all substances diffuse over time. Given enough time, everything that's inside your Coke bottle will eventually become part of the Coke, and vice versa.
It's easy to understand FDA regulation of drugs, medical devices or direct food additives. The link between food packaging regulation and safety, though, is tenuous. And the burden on plastic packaging makers is substantial. FDA is required to deal with food additive petitions within 90 days, with a possible 90-day ex-tension. But, of the 105 petitions approved between 1990-94, 15 percent were pending for under a year. Another 30 percent were pending for up to two years. Al-most 30 percent were pending for over three years. And of these 105, only eight related to major packaging components. The rest were generally less than 1 percent of the package with incidental food contact.
In July, FDA unveiled a ``threshold of regulation'' policy which said: We know packaging components migrate to food, but if you can show that your component will become less than one two-billionth of people's diets, you're OK. This is a good step. But still, according to the Society of the Plastics Industry Inc.'s general counsel Jerry Heckman, the system ``is archaic ... unnecessarily demanding'' and ``inefficient in the use of manpower and other scarce resources.'' According to former FDA general counsel Pe-ter Barton Hutt, indirect additives need ``a completely separate and different pro-cess, with far less government involvement.''
Heckman suggests a "pre-market notification'' system under which the manufacturer submits data to FDA; if FDA says nothing in 90 days, the indirect additive is automatically approved.
The idea isn't new. For 15 years, it was used for medical device clearance, and is still used for food additives when manufacturers want the FDA to affirm an additive is ``generally recognized as safe.'' The FDA can still spend six years looking at a product, but if it does, the product will have been on the market nearly six years. Does this increase risk? In theory, shorter review times might make FDA overlook safety problems it otherwise would have caught. But no agency can eradicate all risks; if FDA tried, it wouldn't approve anything.
Before 1958, there was never any dramatic health-threatening incident like thalidomide in food packaging. No government or responsible authority in the United States had ever raised serious concerns about food packaging safety. Since, there has not been a single FDA case aimed at condemning or seizing food because of hazardous packaging.
What's more, market forces already do a good job of regulating packaging. In most cases, problems are signaled by a food taste or odor problem. No manufacturer would use (because few consumers would buy) such a package. Unwieldy, bureaucratic regimes are bad enough; they're doubly wrong when they serve no good public purpose. Let's hope that whatever Congress comes up with, its FDA reform package will include package reform.
Volokh is an assistant policy analyst at the Reason Foundation, a public policy think tank based in Los Angeles.
