Policy Study

The FDA vs. Recycling

Has Food Packaging Law Gone Too Far?

Executive Summary

Since 1958, the Food and Drug Administration (FDA) has regulated the components of food packaging as “indirect food additives.” The FDA doesn’t have any special regulations for food packaging made with recycled materials. This means that any recycled material can be used as long as it’s “suitably pure.”

But no one knows how pure “suitably pure” is. This is a problem for packagers who use recycled material. Recycled paper and plastic come from many different, unknown sources, and are more likely to contain “contaminants” than virgin materials. This doesn’t mean they’re necessarily unsafe, but it does mean they’re less “pure.” So a standard that’s too strict discriminates against recycled packaging.

To clarify things, the FDA issues informal “non-objection letters” to let packagers know that particular recycled content applications are O.K. Non-objection letters aren’t required by law, but many packagers who use recycled material consider them a must. In July 1995, the FDA finalized its “threshold of regulation policy,” announcing that it would exempt some substances from regulation as food additives. To qualify, the substance musn’t be carcinogenic, and should have an expected dietary concentration of less than 0.5 parts per billion. This policy is now being applied to non-objection letter requests. It has simplified the process, but because of the FDA’s backlog, the process is still lengthy and expensive. Getting a non-objection letter can take half a year and cost hundreds of thousands of dollars.

The FDA continues to be too restrictive in its food packaging regulations, and discourages new packaging applications, especially recycled-content packaging. Every non-objection letter request now requires an environmental assessment, which will add an extra few months of delay. Also, the FDA uses conservative risk assessment methods. It assumes the worst for any chemical, regardless of whether any migration of contaminants between the packaging and the food has been detected. When many studies have been done on a chemical, FDA uses the most pessimistic one, and extrapolates the results to humans in the most conservative ways. The new policy may actually tighten FDA standards. And the FDA gives itself blanket permission to sidestep its rules.

The FDA should:

  • adopt reasonable risk assessment methods;
  • act less arbitrarily by encouraging procedural certainty; and
  • cut down on the delays in issuing non-objection letters by adopting a pre-market notification system and/or by farming out its approval system to approved, independent, competing labs.

We don’t want to force food into recycled packages-that might not be safe. But we shouldn’t discourage safe and profitable recycling. No one knows what “proper levels” are for recycled plastics in food packaging, but we do know that the more of a drag the FDA is, the longer it’ll take recycled material use to grow to desired levels, whatever they are. Add to that the burden of misguided state regulations-like California’s Proposition 65, which was designed to protect public health but which has unintended perverse effects-and it’s small wonder that recycled materials aren’t being used much in food packaging. Prop. 65 was adopted in 1986 by voter initiative and was intended to improve health by informing consumers of products with carcinogens and reproductive toxins. But it has unintended effects. Because Prop. 65 also uses conservative risk assessment, violations of Prop. 65 don’t necessarily correspond to actual risks. This means manufacturers spend a lot of money testing their products for tiny quantities of chemicals, and then spend a lot of money reformulating their products to not contain these chemicals- but we don’t get any safer.

Again, such a state of affairs threatens recycled materials, which are more likely to have low levels of “bad” chemicals. At first, FDA-approved products were exempt from Prop. 65, but this “safe harbor” for food and drugs was rescinded in 1994. Now, packagers can find that while the FDA says their products are safe, the state of California doesn’t. Because recycled paperboard, for instance, tends to have more contaminants than virgin paperboard, Prop. 65 may impede the use of recycled paperboard packaging.

Protecting health is important, but health isn’t served by exaggerating risk and arbitrarily enforcing regulations. There are many forms of recycling that make economic sense and don’t require a government mandate. But they are being discouraged by superfluous health regulations that don’t protect people’s health. If food additive regulations are properly eased, both the food packaging industry and the environment will benefit.

“I hate a man who swallows [his food], affecting not to know what he is eating. I suspect his taste in other matters.”

-Charles Lamb, “Grace before Meat,” Essays of Elia

“Why it’s the Uneeda Biscuit made the trouble. Uneeda, Uneeda, put the crackers in the package, in the package, The Uneeda Biscuit in an airtight, sanitary package, Made the cracker barrel obsolete, obsolete.” “Obsolete, obsolete, obsolete.”

-Meredith Willson, “Rock Island,” The Music Man