This year marks the 30th anniversary of the Delaney Clause, one of the most costly, insidious and scientifically bereft pieces of legislation passed by Congress. The clause demands that the Food and Drug Administration ban from the food supply any chemical that has been shown to cause cancer in laboratory animals.
Although the Delaney Clause applies specifically to food additives, it established the foundation for future regulatory actions, culminating most recently in the passage of California's dangerous toxics measure, Proposition 65.
Those testifying in favor of the clause in 1958 probably would be distraught to learn that now, after three decades of bans imposed literally "at the drop of a rat," our regulators are taking some baby steps into the world of science and cautiously rejecting the notion that a lab animal is a full-fledged surrogate for humans.
Case in point: Recently officials of the EPA downgraded their earlier estimates of risks of pesticides and other environmental chemicals, noting that the evaluation of cancer risk, derived from animal extrapolation, was based on "simplistic" assumptions that "now strain credibility." The EPA candidly acknowledges that the agency's about-face was "driven by the state of research."
Freely translated, this means that our regulators are beginning to take note of the scientific literature rejecting the infallibility of the laboratory animal test and the way animal tests have been misused by toxic terrorists who have led us to believe that there is a toxin on every plate and carcinogen in every cup.
The odds of cancer in laboratory animal tests have always been stacked in favor of "the Big C." Animals known to be extremely sensitive to particular chemicals are chosen and the highest non-lethal dose of a chemical is used.
This situation bears little resemblance to human exposure. Furthermore, only experiments indicating a cancer-induced response are considered noteworthy, all others being dismissed as "we didn't find cancer yet ."
But further, the reliance on the animal model to test synthetic substances like food additives, pesticides, occupational chemicals, cosmetics and more is and always was completely inconsistent with the reality of the carcinogenicity and toxicity of naturally occuring chemicals (the safrole in table pepper, the hydrazines in mushroom, the ethyl carbamate in baked goods) and life-saving drugs. (Penicillin, for instance, is lethal to guinea pigs and hamsters. The anesthetic fluoroxene, used safely in humans for years, is lethal to dogs, cats and rabbits.)
Perhaps most important, the enthusiasm for animal tests overlooks the most basic toxicological premise: The dose makes the poison. It doesn't take a Ph.D in the sciences to grasp the fact that rodent exposure to the saccharin equivalent of 1,800 bottles of soda pop a day doesn't relate well to our daily ingestion of a few glasses of the stuff.
Praise be to the EPA for entering the scientific realm. But one wonders: While our federal regulatory nannies were "protecting" us from pesticides like EDB, aldrin and dieldrin, from food colors like Red Dye No. 2, and from trace levels of dioxin in the soil--all because these substances caused cancer in a laboratory animal experiment--how many Americans died from real but preventable causes of cancer because they were distracted by the trivial pursuit of the "carcinogen of the week," continuing to puff away on cigarettes even as they rejected their muffin mix and maraschino cherries.