🚀 go-pugleaf

The Reason Foundation has just published two new recycling studies by me. 
Here's the executive summary of the first one; the next one follows in
another message.  Both are parts of a series of papers called "Recycling
and Deregulation: Opportunities for Market Development"; the description
of the series follows in yet a third message.  If you're interested, call
the Reason Foundation at 310-391-2245 to find out how to get these papers. 

Reason Foundation
Policy Study No. 196

THE FDA VS. RECYCLING:
Has Food Packaging Law Gone Too Far?

(Part 1 of a Series on Recycling and Deregulation: Opportunities for 
Market Development)

by Alexander Volokh

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 mustn'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 contaminnats 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.

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