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The Delaney amendment and its consequences on the american regulation Prof. Fred S. Singer

Delaney Clause --Linchpin of the Environmental Policy Edifice S. Fred Singer Director, Science & Environmental Policy Project Arlington, Virginia A bright day may be dawning in the United States after several dark decades of environmental policies based on unsubstantiated and skewed science. After all, the acid rain legislation passed in 1990 simply ignored the results of the 10-year scientific study that the US Congress itself had authorized and financed. The current worldwide phase-out of chlorofluorocarbons and other useful chemicals is a hasty operation based more on theoretical fears of ozone depletion and skin cancer than on sound observations. And the Climate Convention signed with great fanfare at the Rio de Janeiro "Earth Summit" last June depicts a future global warming as the greatest threat to the planet, in spite of absence of support- ing data. It is encouraging therefore to find that an icon which has lasted 35 years and wasted billions of dollars is about to fall. We are talking here about the so-called Delaney Clause, more properly Section 409 of the Food, Drug and Cosmetic Act, passed into law by the U.S. Congress in 1958. It bans any food additive, including the presence of pesticide residues, if they have caused cancer in laboratory animals in tests where massive amounts were adminis- tered. In essence, it says that there is no safe dose, no threshold below which health effects can be neglected. To put it more dramatically: "One molecule can kill." No matter how small the exposure to a potentially cancer-causing chemical, it must be regarded as unacceptable as a food additive. But what is zero? When the Delaney Clause became law, instruments were not very sensitive; 50 parts per million would have been considered zero. But in the past few decades technology has advanced to the point where for some chemicals concentrations as much as a billion times smaller can be detected. Clearly the meaning of "zero" has changed in a way that could not have been foreseen by the author of the legislation. The application of the Delaney Clause has caused a great deal of mischief in the United States, and indeed throughout the world. In 1959, the U.S. Department of Health, Education, and Welfare halted cranberry sales because of pesticide residues; thirty years later,jU in 1989, the Alar scare decimated much of the U.S. apple-growingo industry. In between, we have had the ill-considered ban on DDT "-which permitted a resurgence of malaria with an annual death toll worldwide, of about 2 million. The scare about chemical wastes le to the Love Canal debacle in New York State and the evacuation o,. IQ

the town of Times Beach, Missouri--all of which has now been admitted to be an expensive, $100 million mistake. Billions have been wasted to satisfy Superfund legislation, mostly on legal fees and litigation rather than cleanup. There have also been scares about radon and asbestos in buildings, with programs in the hundred-billion dollar range for remediation, without evidence that it would do any good. In 1990, the U.S. Congress passed the Clean Air Act amendments that included the requirement for multi-billion (per year) controls of "air toxics" to levels where a 70-year exposure to outdoor air would cause no more than 1 chance in a million of cancer--when indoor air presented a much greater problem. All the while, the generally accepted 1981 study by British epidemiologists Sir Richard Doll and Richard Peto showed that about 98 percent of all cancers were due to smoking, alcohol consummation, and poor diet, and perhaps 2 percent to environmental factors. The Delaney Clause contradicts, clearly, our long experience with toxic substances in food and drinking water, where a safety factor of 100, i.e., an exposure to one percent of the toxic dose, has been found to be adequate. More importantly, we now understand that the scientific base for animal testing itself is faulty. When rats are given the maximum tolerated dose (MTD) of chemicals they develop tumors because even quite harmless substances cause cell damage that stimulates tumor production. Aside from~the question whether rat tests can be applied to other species, like humans, one cannot extrapolate from such massive doses to chronic exposures at much lower doses, where the defense mechanisms of the body have an opportunity to counter tumor production. There have been instances where a ban was rescinded. In 1977, the U.S. Food and Drug Administration banned the sweetener saccharin after tests at MTD levels produced cases of bladder cancer in rats. To get an equivalent exposure, humans would have had to drink some 5000 cans of saccharin-sweetened soda per day for most of their lives. Popular demand forced congressional action and the ban was replaced by a warning label. Other scientific studies further emphasize the lack of realism of the law. Bruce Ames and his coworkers have demonstrated that natural pesticides exist in food at levels that are some 10,000 times greater than the pesticides residues found in some processed foods that were subject to being banned by the Delaney law. The U.S.National Academy of Sciences in its 1987 report "Regulating~, Pesticides in Food: The Delaney Paradox" recommended replacing theN Delaney standard of zero risk with a standard of "negligible risk," 6T; H-}l f'}1P PY.I- Ct"_. vAll]iP_ to be determined later. If this standard i s, r11 ~ ~

set at a lifetime cancer risk of 1 in a million, it would raise the existing risk of 0.25 to 0.250001-- hardly a cancer epidemic. But it is a legal, administrative matter that will finally kill the Delaney Clause and the unrealistic and unscientific zero-risk standard it prescribes. The Federal Insecticide, Fungicide, and Rodenticide Act, the law governing the use of pesticides on farms, does allow trace amounts of pesticides in food, even if the particular compound causes cancer in test animals--clearly in conflict with Delaney. Long-established drinking water standards are also in conflict with the Delaney Clause. It would seem then that the government should adopt a new policy, relaxing the Delaney Clause, that would allow pesticide residues in all food, including processed food, at such minimal levels. But when the U.S. Environmental Protection Agency tried to put such a policy into effect in 1988, it was sued by the Natural Resources Defense Council, an activist environmental organization, notorious for promoting the Alar scare. In 1992, the Ninth Circuit Court of Appeals in San Francisco ruled in favor of the NRDC on the basis of the Delaney Clause. EPA therefore had no choice but to follow the law and limit or totally ban 35 compounds, many of them~ basic pesticides used in agriculture. It is at this point that the new EPA administrator, Carol M. Browner, announced that perhaps changes in federal law might be required. Such an action by Congress would be both unprecedented and far-reaching. It would mark the first time that an existing environmental policy has been changed because of better scientific evidence. And such action on chemical cancer risk would have corollary effects on the issues of cancer risk from~asbestos and radon. Most important, it would force re-examination of the scientific basis for the Superfund legislation. Like a house of cards, other insubstantial and unsubstantiated policies might collapse. We might even see a domino theory in action--with more attention paid to science rather than emotion when developing policies dealing with air pollution and acid rain, and with putative stratospheric ozone depletion and global warming. Presented at seminar organized by the International Center for Scientific Ecology, Paris, May 10!, 1993.