Farewell to the Delaney Amendment

Over centuries we have written innumerable laws to protect ourselves from each other's foolishness, negligence, incompetence, or evil. Few of those laws forbid anything absolutely. Murder we can get away with, in self-defense or insanity. We can build on floodplains, if we really want to. The law is strict about robbing banks, but there are plenty of legal ways to rob the public treasury. Most environmental laws allow us to poison people just a bit, as long as we claim to create an economic benefit in the process.

But there were until recently two laws that said flatly No, this you cannot do. One was the Endangered Species Act, which didn't let you push a creature into extinction. The other was the "Delaney amendment," which forbade you from adding to foods anything that might cause cancer.

Hated by industry but loved by the public, these laws withstood steady attack by lobbyists, until recently. In this column I won't go into the many ways Congress sweeps aside the Endangered Species Act. What I want to do is mark the passing of the Delaney amendment.

The Delaney clause, named after Congressman James Delaney of New York and tacked onto the Federal Food, Drugs, and Cosmetic Act in 1958, said, "the Secretary [of the Food and Drug Administration] shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals." Not any. Zero.

From the beginning this dictum conflicted with another law, the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA), passed in 1947. FIFRA could not allow the concept of zero. Pesticides must by their nature and purpose be spread around in large quantities. FIFRA assumed that we can administer a dose lethal to the pest but harmless to the applicator and to anyone who might encounter pesticide-tainted air, soil, water, or food.

Delaney assumed that the only safe dose is zero.

Congress papered over that inconsistency by saying that pesticide residues are not food additives. Under FIFRA the Agriculture Department (and later EPA) was supposed to set safe levels of pesticide residues in apples or tomatoes. Therefore the Food and Drug Administration (where Delaney resided) shouldn't have to worry about them.

Congress did realize a problem, however, with processed foods. Suppose apples are made into juice, or tomatoes are boiled down into paste. Processing could concentrate pesticides into higher amounts than the (assumed safe) raw food tolerances. So, in one of those strange things that bureaucracies do, Congress specified that in any processed food, if a pesticide becomes concentrated beyond its permitted level in the raw food, then suddenly it becomes a food additive. If it is a carcinogen (which at least 75 pesticides are), it falls under the Delaney zero. So a pesticide may be permitted at 7 parts per million in the apple, but if it goes up to 8 parts per million in the sauce, then the sauce cannot be sold.

You can see why pesticide makers and farmers and food processors did not like this law. Predictably, they found many ways around it.

They pressed regulators to set high permissible pesticide levels in raw foods, so processed foods wouldn't exceed them and trigger Delaney. They made sure regulating agencies were weakly administered and poorly funded so that, for instance, they never compiled good data on how much concentration actually happens during food processing. They got into a snarl about how much residue can be detected by laboratory instruments. No lab method can prove a concentration of zero, so the FDA decided that a test was good enough if it could find enough pesticide to cause, say, one cancer in a million people.

So much for the standard of zero.

Over the years hard-fought cases moved policy concerning chemicals in our foods farther away from zero. Diethylstilbestrol in animal feeds was permitted at first under the assumption that it didn't pass into milk or meat; later it was forbidden, as better lab tests found it there. Saccharine was to be banned but under public protest was allowed to stay on the market. Carcinogens that move from plastic packaging into foods were allowed, as long as the risk is "trivial."

What evolved was a sloppy policy, based not on zero risk, but on an unclear balance between assumed risk and assumed benefit. The huge uncertainties behind this policy are thoroughly described in a new book by John Wargo, called Our Children's Toxic Legacy (Yale University Press).

Wargo sums up the conclusions of a National Academy of Sciences study that tried to assess thirty years of the Delaney clause: "... confusing and contradictory legal standards, a virtual nightmare of inadequate data, ... and the absence of any strategic plan for managing or reducing levels of risk.... Clearly, neither the EPA nor the academy knew the extent of carcinogenic risks from pesticides in foods."

The current Congress and president were just the combination needed to do away at last with the Delaney clause. It expired quietly this summer, when the president signed the "Food Quality Protection Act of 1996." Its demise was a symbolic victory for industry, which had actually won the war against zero tolerance long ago.

It's probably just as well that the clear, brave language of Delaney no longer stands to deceive us into thinking that our food supply is risk-free. How much risk there really is, no one knows. How much there will be in the future depends on the new food safety law, and, we must hope, even better ones to come.