Government
Environmentalists fight for Delaney clause New Jersey Congressman holds press conference to point up health risks if the amendment is bypassed to placate saccharin backers
"Let's make no mistake about it. The saccharin decision, consciously or not, has proved a powerful weapon in the hands of the people who would like to eliminate the Delaney clause once and for all. To much of the public, the saccharin decision seems [to be] one more example of the capricious workings of the bureaucracy." Rep. Andrew Maguire (D.-N.J.) summed it up pretty well as he opened his press conference last week at the Capitol. Timed suspiciously close to the start of the Food & Drug Administration hearings on the agency's proposed ban on saccharin, Congressional anticancer crusaders and environmentalists were staging a counterattack. Their target: efforts by other members of Congress to modify the now-famous Delaney clause in the 1958 Food, Drug & Cosmetic Act amendments. Maguire declares that the Delaney clause "may be the best piece of anticancer legislation on the books. It says that you cannot use as a food additive any substance that causes cancer in animals. There are a lot of people in this country who would be delighted to waive that rule." Maguire's home state has one of the highest rates of cancer mortality in the U.S. Backing up Maguire were environ-
Maguire: people are going to die 16
C&ENMay23, 1977
mental and health advocate Ralph Nader, and three federal scientists: Dr. Umberto Saffiotti, director of experimental pathology at the National Cancer Institute; Dr. Joseph K. Waggoner, director of field studies for the National Institute for Occupational Safety & Health; and Dr. Robert Hoover of the bureau of epidemiology at NCI. The three scientists quickly cautioned that they were appearing for themselves and not for their agencies. Also scheduled to attend were Rep. James J. Delaney (D.-N.Y.), who authored the clause, and Sen. Gary Hart (D.-Colo.) and Sen. Gaylord Nelson (D.-Wis.). Delaney has been remarkably silent about his handiwork since the storm over saccharin first swept into the capital in March. The reason Maguire called the press conference is that environmentalists are backed into a corner on saccharin. Never before have they found themselves supporting such an unpopular position. Some advocates apparently fear that the saccharin controversy could do irreparable harm to the whole environmental movement since it embodies some basic environmental articles of faith. Not the least of which is that the only safe level of exposure to a carcinogen is no exposure at all—the "one molecule theory." But the proposed saccharin ban also gets to the heart of another controversial issue facing regulators: How well do results from animal experiments translate in terms of human exposure? For example, the Canadian studies FDA invoked for the saccharin ban have been criticized since they used high levels of saccharin—5% in the diet—to produce bladder tumors in rats. Critics point out that this is equivalent to drinking 800 drinks per day for life (FDA's estimate). NCI's Saffiotti warns, however, that "we have to take the results of animal studies very seriously as indications of hazards to people. Every little bit [of a chemical] adds up . . . ." Nader used the occasion to take a swipe at industry, as he is wont to do. He accuses the soft drink industry of deliberately confusing the results of the Canadian study by playing up the 800 cans of diet soda per day. Nader says that as few as two cans of diet drink will cause cancer in people. He also affirms his belief that the Delaney amendment shields FDA from the food industry, and shields the public from "trivialization of carcinogen [regulatory] policies." Nader warns that some Congressional proposals to allow risk/ benefit analyses in dealing with suspected carcinogens simply would not work since
Nader: no saccharin over-the-counter the "ethical preconditions of cost/benefit [analyses] are not considered by economists who are dominated by corporate interests." Nader, in fact, would not even allow saccharin to be sold as an over-thecounter drug as FDA proposed to mollify critics. Government researchers Hoover and Waggoner both criticize epidemiological studies which have shown that saccharin apparently does not produce an increased risk of bladder cancer in human populations—such as diabetics—who regularly have used the compound for years. Hoover says that the widely publicized studies, such as those conducted in the U.K., were defective since they studied only small groups of people, all of whom were adults. He also suggests that diabetics as a group also smoke fewer cigarettes than the general population, minimizing one major cause of bladder cancer. NIOSH's Waggoner points out that epidemiological studies aren't as simple as they might seem. For example, he notes that trichloroethylene has been shown to produce cancer in experimental animals, yet epidemiologists can't find enough chemical plant workers to see if the same holds true for people. Warns Waggoner, "We can no longer permit the 'Let's wait and see' game to continue." Maguire also lashed out at some of his colleagues in Congress. Referring to the facetious bill introduced by Indiana Democrat Andrew Jacobs ("Warning: The Canadians have determined that saccharin may be hazardous to your rat's health"), Maguire says this "is the height of know-nothingism." The conference concluded with Maguire's admonition that "if we continue to use saccharin in this country, people are going to die as a result." Chris Murray, C&EN Washington
