The Politics of Cancer Testing

Michael Fumento  ·  the American Spectator  ·  Cancer

"It’s sweet and it doesn’t have any of that stuff they spray on apples." - George Bush, on why he drinks carrot juice.

"The most potent cancer-causing agent in our food supply is a substance sprayed on apples to keep them on the trees longer and make them look better." Those were the first words heard by 50 million viewers of a segment of CBS’s 60 Minutes on February 26, 1989. And there was panic in the streets:

Monster in the basket?

In the Los Angeles school district, cafeteria workers in over 500 schools yanked apples, applesauce, and apple pie from lunch counters and deleted them from their menus. From New York to Chicago to even Taiwan stockboys and store managers pulled apple products off their shelves and threw out their fresh apples.

A New York mother called the state police to intercept her child’s school bus to remove the killer fruit from the child’s lunchbox. The wholesale price of Washington Red Delicious apples fell by half. Shipments declined precipitously, costing orchards a fortune and throwing produce markets into chaos.

In some parts of the country, the sale of apple juice came to a virtual halt. Industry economists estimated immediate losses to apple growers alone at between $61 million and $140 million. In the months that followed, a number of orchards, most of them small and family-owned, collapsed and underwent foreclosure.

This was the Great Apple Scare of 1989, the result of one of the slickest hype campaigns in recent American history. The immediate target was Alar, the trade name for daminozide, a growth regulator used to promote uniform ripening of red apples and to improve the fruit’s appearance. This chemical, which had been used for twenty-one years with no observable ill effects, and which in fact had been specifically tested and allowed to remain on the market by the EPA, was suddenly tried, convicted, and sentenced to death by the media.

The larger target was chemical pesticides in general, which many environmental extremists believe must be banned through legislation if possible, through a smear campaign if necessary. Such a ban would make our food supply less safe - and far more costly.

Meanwhile, Alar, though still legal, is no longer in use.

An Apple a Day?

Developed by Uniroyal, Alar is sprayed on varieties of red apples and Golden Delicious. It has also been used on some vegetables, especially peanuts. Both 60 Minutes and the Natural Resources Defense Council (NRDC), the litigation group that planned the anti-Alar campaign, downplayed the practicality of Alar, treating it as though it were little more than a food dye.

The chief advantage of Alar was to allow an entire orchard to be harvested just once instead of periodically over six weeks as individual fruits ripen. To marketers, it offered more uniformly shaped and colored fruit, and could extend the usual six-to-eight-month shelf life of apples to about a year. Alar could double the volume of fruit produced during the first seven years of planting. Even after that initial period, by keeping the fruit on the tree and off the ground, the chemical saved some apple growers as much as 25 percent of their crop a year. By preserving the fruit after picking, it allowed consumers to have fresh red apples all year long.

In 1966, Uniroyal submitted rat-feeding studies to the U.S. Department of Agriculture (USDA), then in charge of pesticide regulation. The rats had developed no tumors and the pesticide was approved, although the test would not meet today’s standards.

When Alar is broken down in processing for applesauce or juice, it forms unsymmetrical 1,1-dimethylhydrazine (UDMH), which - and this really set off 60 Minutes reporter Ed Bradley - is a variant of hydrazine, which is used as a rocket fuel. Of course, you would need to eat a few million jars of applesauce to achieve lift-off.

In 1985, the EPA released a draft document looking at four tests performed in the 1970s and one in 1984, and found Alar "is a clear carcinogen in that it induces a highly significant increase in the incidence of blood-vascular tumors which are normally found at very low incidence in Swiss mice." If you receive a press packet from NRDC, as I did in January, you get this information along with a breakdown of the results of the early studies. The press packet doesn’t mention that after the September 1985 EPA audit, a new EPA review found that:

Each of these [1970s) studies, however, has been examined by the Agency and the FIFRA [Federal Insecticide, Fungicide and Rodenticide Act] Scientific Advisory Panel, and has been found not to provide an adequate basis for regulatory action at this time... some of these studies yielded unequivocal results and... other studies have serious flaws or shortcomings in the test methodology and documentation.

Specifically, in some studies the dose of Alar delivered was so large as to directly kill many of the animals, through toxicity (direct posioning), not carcinogenicity (the causing of cancer). This is referred to as exceeding the "maximum tolerated dose, or MTD. A subsequent reexamination of the slides of the test animal tissues and organs suggested that tumor incidence was lower than reported. In the UDMH studies, UDMH was allowed to remain in the water long enough for most of it to break down into different chemicals; the animals were acknowledged to have suffered previously "from severe degenerative diseases"; and, again, the maximum tolerated dose may have been exceeded.

The EPA left Alar and UDMH in the question-mark category, listing them as "possible carcinogens." It also lowered its estimate of potential cancers from UDMH from between 1,000 and 10,000 per million to 45 per million. It should strike the attentive reader at this point that if something is no more than a "possible carcinogen" then assigning a death rate to it is problematic to say the least. More on this later.

But with the NRDC and its allies breathing down its neck, the EPA later proposed accelerating the process that would force the cancellation of food uses of Alar, pending further study. It also classified Alar as a probable human carcinogen.

The last tests on Alar performed prior to the scare were reported by the International Research and Development Corporation in August 1988 and involved rats and mice fed at numerous dosage levels. Both studies concluded that there were no carcinogenic effects related to the administration of Alar.

Dr. Christine Chaisson of Technical Assessment Systems, Inc., a former EPA researcher and present consultant to the EPA, Uniroyal, and other groups, found in an independent review of all the Alar studies that "the weight of the evidence clearly favors classification of daminozide as non-carcinogenic." Although the comprehensive "Chronology for Daminozide" in the NRDC’s packet ends with January 1989, it omits the 1988 study. [Author’s note: The final UDMH mouse study, released this past February, reported that "the test substance did not induce any unusual or unexpected tumors, but did appear to increase the incidence rates for two common tumors of the lungs and blood vessels," but further indications were that "the MTD was exceeded in both high and low dose animals."]

In January 1989, under constant pressure again from the NRDC and others, EPA Acting Administrator John Moore issued a statement finding an "Inescapable and direct correlation" between exposure to UDMH and "the development of life-threatening tumors" and he accelerated its special review.

On February 1, 1989, about four weeks before the 60 Minutes broadcast easily enough time for CBS to cancel the segment - the EPA released a three-page statement detailing the results of laboratory animal studies on Alar and UDMH to date. The statement reported that:

(1) "Although biological trends were noted in the mouse study, tests at 10,000 ppm for two years with the parent compound [Alar, as opposed to UDMH] were statistically negative for cancer response."

(2) "The cancer response in the current UDMH data is seen only in one species at a relatively high dose . . ."

(3) "Mutagenicity data for UDMH are equivocal to negative." This refers to, among others, a test developed by Bruce Ames, chairman of the biochemistry department at the University of California, Berkeley. It tests a chemical to determine if it causes mutations in bacterial DNA, an indicator of chemicals that cause cancer in lab animals.

(4) "Mice in the ’high dose’ study are dying early." The agency said it believed that the death of these mice was due to the tumors, but it "may nonetheless be argued that the deaths were the result of excessive toxicity, which may compromise the outcome of the study." In other words, the mice might have been poisoned.

Somehow, out of all this, 60 Minutes was able to arrive at the conclusion that Alar - not even UDMH but Alar - is the "most potent cancer-causing agent in our food supply."

The NRDC to the Rescue

In 1987, the NRDC, along with Ralph Nader’s Public Citizen group and other organizations, filed suit against the EPA to force it to outlaw Alar. Founded in 1970, the NRDC is the litigation arm of the environmentalist movement, but does not normally conduct scientific studies itself. With about 100,000 members, it is one of the most powerful and well-funded of the nations environmental lobbies, and in 1985 was rated the most influential by congressional and EPA staff members.

Yet the Alar case was one NRDC could not win. In late 1988, a Washington State appeals court threw the case out, claiming NRDC lacked standing to make the challenge. So NRDC decided to bypass the EPA and the courts with a study called "Intolerable Risk: Pesticides in Our Children’s Food."

Orchestrating the NRDC campaign was Fenton Communications, a public relations firm led by one David Fenton, who had earlier done work for the Sandinistas, Grenada under Maurice Bishop, and the Peoples Republic of Angola. The NRDC contracted to pay Fenton a minimum of $180,000 a year plus expenses to carry out an "information strategy," including contacts with "influential editors, reporters, producers, anchormen, columnists and news media executives in the United States." Fenton was so pleased with these operations he released a document boasting that practically the entire U.S. media were his minions.

Fenton has explained how he divided the Alar campaign into two sections in hopes that the media would treat them as separate stories because ". . . more repetition of NRDC’s message was guaranteed." Story one was NRDC’s "Intolerable Risk" study. Story two, set for one week after the release of story one, had popular actress Meryl Streep announcing the formation of Mothers and Others for Pesticide Limits.

By agreement, 60 Minutes was allowed to break the "Intolerable Risk" story, allowing NRDC to bypass the scientifically accepted method of peer review. Then-FDA Commissioner Frank Young stated, "This is one of the worst instances of where statements were made without the benefit of scientific review." Follow-up interviews were arranged months in advance with major women’s magazines such as Family Circle, Woman’s Day, and Redbook, usually bearing titles like Redbook’s "The Foods That Are Poisoning Your Child."

Appearance dates were scheduled for the Donahue show, ABC’s Home show, and double appearances on NBC’s Today Show. From here the story snowballed, with MacNeil/Lehrer, the New York Times, and the Washington Post doing follow-up stories (although the Post later did a critical one), as did all three evening network news shows.

But dupery didn’t account for all of the favorable media reaction. At a conference sponsored by the Smithsonian Institution in September, "Global Environment: Are We Overreacting?" Charles Alexander declared to a round of applause: "As the science editor of Time, I would freely admit that on this issue we have crossed the boundary from news reporting to advocacy." NBC reporter Andrea Mitchell agreed, saying "clearly the networks have made that decision now, where you’d have to call it advocacy."

But Washington Post Executive Editor Ben Bradlee warned, "As soon as you say, ’To hell with the news, I’m no longer interested in news, I’m interested in causes,’ you’ve got a whole kooky constituency to respond to . . . " To which Wall Street Journal editorial writer David Brooks, who may have been the only reporter in the country who felt the public had a right to hear about the conference, sardonically noted, "Mr. Bradlee is right. Probably a lot of ’kooks’ believe in objective journalism."

Congress called a special hearing, at. which Streep and others urged that Uniroyal immediately pull Alar off the market so consumers could be sure apples were completely safe. "What’s a mother to do?" she asked. Rep. Gerry Sikorski (D-Minn.), who had also appeared on the Alar edition of 60 Minutes, charged that the EPA "is turning American parents into the malevolent stepmother in Snow White, handing out enticingly red but fatal apples to our children." Some environmentalist groups began calling grocery store chains and threatening pickets if they didn’t pull all apples and apple products from their shelves.

As is often the case during scares, industry helped cut its own throat. Those companies judged "unacceptable" by Consumer Reports announced immediate measures to stop using Alar-treated apples, while those that scored well on the survey sought to capitalize on it.

For example, BeechNut Nutrition Corp., fresh from its prosecution for having sold phony apple juice, was so happy with its score on the test that it sent out two press advisories alerting the media to the survey even before Consumer Reports released it, with one of the advisories stating that the corporation’s president would "be available for interviews about what the study findings mean for mothers of infants and for the safety of the nation’s food supply generally."

Luxury and health-oriented stores got in on the act, even before the NRDC scare, by selling apples they declared to be "Alar-free." Alas, surveys done by newspapers in several metropolitan areas revealed that many stores, including the Safeway chain, were not selling Alar-free apples when they specifically claimed they were. These stores got the best of both worlds profiting from both Alar and the fear of it.

Although both the EPA and the American Council on Science and Health, an organization that frequently rebuts pesticide alarms, moved quickly to counter the NRDC effort, the mainstream press for the most part gave them short shrift or ignored them altogether. As Fenton concluded on the success of his media campaign: "There are other ways to raise public awareness for the purpose of moving the Congress and policy makers." Indeed.

Of Mice and Men

The word "carcinogen" in the NRDC report, or indeed in any reference to UDMH or Alar, is based exclusively on animal studies in which massive doses of chemicals are dumped into the animal’s body. In the case of Alar, a human would have to ingest the equivalent of 28,000 apples a day for life to duplicate the dosage. Such studies make a huge number of assumptions, of which two are particularly important: first, that enough is known about the mechanisms of cancer to permit lab animals to serve as stand-ins for human beings; second, that the results of testing animals with massive doses can be extrapolated to predict cancer in humans ingesting comparatively tiny ones.

Both assumptions are accepted by the media and by the scientists whom the media regularly tap. Yet they are not accepted by all scientists, and are often pooh-poohed by the general public, which seems prejudiced against being compared with rodentia and has trouble interpolating from, say, tens of thousands of diet colas a day to one a day. Such prejudices were passed off as the musings of the ignorant masses until, at least, the publication of Edith Efron’s landmark The Apocalyptics in 1984. Despite efforts to treat her as an irresponsible radical, by 1987 Efron and her thesis were sitting on the cover of Cancer Research, the official scientific journal of the American Association of Cancer Research.

Efron provided data for the intuitive belief that something is wrong with pumping a rodent full of chemicals to a point near death and seeing if any adverse reactions take place, starting out by showing that even the scientific community didn’t believe it, at least at first. In 1977, John Higginson, founding director of the International Agency for Research on Cancer (IARC), said: "There is no rational biological method of extrapolating from animals to man."

"Don’t let the tie fool you; a rodent is not a little human - unless the human’s damned ugly!"

Yet, just one year later, Lorenzo Tomatis of IARC announced, "In the presence of appropriate experimental carcinogenicity data and in the absence of adequate human data, it is reasonable to regard chemicals for which there is strong evidence of carcinogenicity as if they were carcinogenic to humans."

What had happened? Efron states, "There were no masons given for this change in policy except the avowed desire to be ’more useful’ to ’national and international authorities.’"

In 1976, David Rall, director of the National Institute of Environmental Health Sciences, told Lesley Stahl of CBS on the special "The Politics of Cancer," "Mice and rats predict very well for human cancer." To back this up, he added:

If you don’t accept the mouse and the rat data, you only have one alternative, and that’s letting the human population be exposed for about 25 years, and if in fact the compound was carcinogenic you can have a small epidemic of chemical carcinogeneses in man after that 25 years. So I think there’s no alternative, We have to view the mouse and rat data as predictive for man.

If that is the best Rall could do, we may as well throw dice for each chemical or perhaps, following Judge Learned Hand’s famous statement, merely "hang" every tenth chemical. And that is exactly what can happen.

The Rall statement is representative of a scientific community that called the use of lab animals legitimate not on evidence, but because they wanted something concrete with which to begin indicting chemicals. Also in 1976, NRDC published an article titled, "Is Cancer the Price of Technological Advancement?" In it, the NRDC dismissed nature as a significant contributor to the human cancer rate. It was "the ’chemical revolution’ of the past 50 years" that was the primary cause, but, without some sort of test, none of the apocalyptics could wage war against this onslaught of chemical death.

The cornerstone of the apocalyptics’ thesis is that cancer rates in America are going up and that the reason is synthetic chemicals. Irving Selikoff, whose study of shipyard workers was crucial in establishing risk of high-level exposures of asbestos, predicted that "millions may die in the future of industrially caused cancer."

The assertion was that the vast majority - as much as 90 percent - of cancer deaths were attributable to the synthetic products of the chemical industry which developed after World War 1. This extreme view seems to have been abandoned, quite possibly as a direct result of Efron’s work, but it remains "common knowledge," that many cancer cases do result from such mass poisoning.

The MTD thesis has two major weaknesses. First, as stated, there is no reason to think that what causes cancer in a rodent will necessarily cause cancer in a human. Frequently, what causes cancer in rats doesn’t in mice, and vice versa. If one chemical has different effects on two closely related species, clearly its effect on either of them is of limited usefulness in evaluating the risk to so different a species as humans and one that has a much longer lifespan. Such differences between lab animals are common.

Dr. Lois Swirsky Gold

EBDC, a water-soluble fungicide manufactured by Du Pont and currently the victim of a regulatory crackdown by EPA, was found to cause birth defects in rats at massive doses but not in mice, hamsters, and rabbits. Of 392 chemicals in Ames colleague Dr. Lois Gold’s database of animal cancer tests, almost one-fourth were positive in mice and negative in rats or vice versa. Conversely, important human carcinogens may not be detected in standard tests of rodents, as was the case for a long time for both tobacco smoke and alcohol, the two largest identified causes of neoplastic (tumor-caused) death in the United States.

For these reasons, the standard protocol for carcinogenesis at the National Toxicology Program requires experiments in both sexes of two species, and so does a joint committee of the United Nations Food and Agricultural Organization and the World Health Organization. The Office of Science and Technology Policy has noted that if a sufficient number of tests are conducted, at least one will produce statistically significant results "simply as a result of random variation," and not too long ago recommended that scientists "view the outcome of any single test as potentially the result of chance variation."

Laboratory mice have a high spontaneous incidence of pulmonary tumors, leading many scientists to question the legitimacy of relying only on mouse data. Further, there is no reason to think that if massive doses of a chemical cause tumors in lab animals, then comparatively tiny doses will necessarily have a similar effect on some humans. MTD advocates say that since we can’t test 240 million lab animals (that is, one for every American) at doses to which human beings are normally subjected, we must test a considerably smaller number of animals at considerably higher doses.

The assumption that massive doses predict carcinogenically for even tiny doses is known as the "no threshold" theory, which says that the harm from a substance at high levels will cause harm at lower levels; the risk declines but never becomes nil. As with asbestos (discussed at length in my October 1989 The American Spectator article, "The Asbestos Rip-Off"), the chemical apocalyptics have simply said that since no one knows where the threshold should be placed, none should be recognized.

In the area of toxicity, the "no threshold" theory doesn’t hold at all. The principle in toxicity is Dosis sola facit venenum - only the dose makes the poison. Thus, that which has no effect at one level (say, vitamin A) may be medicinal at a higher level and a deadly poison at a higher level still. Some chemicals which we normally regard as poisonous, such as arsenic, are actually therapeutic at low levels, while others that we generally regard as therapeutic, such as the heart medicine digitalis, are in fact deadly if consumed at the levels at which they normally exist in nature.

By the Occupational Safety and Health Administration’s (OSHA) own admission, acute drug toxicity, radiation or drug control of some tumors, and the gastrointestinal-radiation syndrome all have dose-response curves that show thresholds. One sticky wicket in extrapolating from massive doses is that some animal carcinogens, including nickel and chromium, selenium, nitrites, and even salt, are essential to human health. Further, everything puts out radiation. (One wag suggested that various senators be arrested as "felons" for urinating in states that forbid the storage of radioactive waste.)

One way to get the maximum mileage out of the no-threshold theory, or indeed to eliminate the possibility of setting a threshold, could be termed the "moving threshold principle." This says that because different metabolisms utilize chemicals differently, thresholds differ from person to person. Hence, no single threshold exists for humans and, since "a prudent policy of cancer prevention requires protection of the most sensitive individuals in the population, " as NCI’s Umberto Saffiotti puts it, anything proven carcinogenic in any animal must be assumed to be carcinogenic for some human somewhere at even the lowest level.

FDA policy toward carcinogens is ostensibly guided by the Delaney Clause, a 47-word statement passed as part of the Food Additives Amendment of 1958, which specifies: "No additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal." Under EPA regulations, the clause is applied to processed foods but not to fresh fruits and vegetables. With the latter, an "action level" is established that allows one part or less per million, also known as "negligible risk." With processed foods, the rule, at least in theory, is absolute. No parts per anything is allowed.

When the Delaney Clause was passed, fifty parts per million was considered the practical equivalent of zero. Today, scientists are measuring in parts per trillion and working on ways to measure in parts per quadrillion and even smaller. Thus, levels of allegedly carcinogenic chemicals which were ignored not too many years ago are now used to ban chemicals.

In order to paint apple producers as villains, 60 Minutes used a 1989 Consumers Union survey showing Alar residues (not UDMH) in two-thirds of thirty-two apple juice products that ostensibly no longer contained the chemical. Consumers Union said its testing had found traces where another survey had not because it was now using a test that detected 0.01 to 0.02 parts per million, instead of the old one that could only find 0.5 to 1.0 ppm, a fifty-fold increase in sensitivity. The test was so sensitive that quite possibly it was picking up residue from spraying that occurred in a growing season prior to when the farmer stopped using the chemical. Extended to its ultimate conclusion, increasingly sensitive testing will find molecules of virtually anything in virtually everything. As explained in one pharmacology paper, printed in The Apocalyptics:

...if a pint of water is poured into the sea and allowed to mix completely with all the water on the surface of the earth, ovar 5,000 molecules of the original sample will be present in any pint taken subsequently. The general conclusion to be drawn from these calculations is that nothing is completely uncontaminated by anything else.

The Delaney Clause, if applied literally and indefinitely, will eventually prohibit the consumption of anything that contains additives.

The Natural Carcinogen Cover-Up?

Bruce Ames

At one time, Dr. Bruce Ames was one of Efron’s key apocalyptics and a prime exponent of the "one molecule" method. He is a recipient of the most prestigious award for cancer research, the General Motors Cancer Research Foundation Prize, of the highest award in environmental achievement, the Tyler Prize, is a member of the National Academy of Sciences, and has served on the National Cancer Institute board of directors. John Tierney, writing in Hippocrates Magazine in 1988, stated, "It was his laboratory procedure, the Ames [Mutagenic] Test, that alerted scientists and consumers to the dangers of hundreds of synthetic chemicals. He provided the evidence and occasionally, the rhetoric-that got things banned. He was a scientific hero of the environmental movement. "

Ames began to think about natural carcinogens and wrote Efron, who herself had discovered a mass of natural carcinogen literature in 1978, "Somehow, the theoreticians, the regulators, and the apocalyptic movement itself had misplaced them. The natural carcinogens were sitting there quietly in the literature on carcinogenesis, along with the synthetics. The only difference was that they had not been publicized." Ames decided to publicize those findings and the apocalyptics dropped him faster than an car of corn treated with DDT.

The apocalyptics had acknowledged the existence of a limited number of natural carcinogens, but a very limited number. Rachel Carson listed a few in Silent Spring, eg., ultraviolet rays, radioactive rocks, and arsenic. This dearth of natural carcinogens she attributed to evolutionary processes that allowed man’s physiology to co-exist with nature.

Most recently, Robert Bazell brought up this theory in the _New Republic, _where he noted approvingly the view that naturally occurring rodent carcinogens "probably don’t present any threat because humans have been eating these foods for thousands of years, and if there is a danger we have evolved a way to resist it." When I talked to NRDC Senior Attorney Al Meyerhoff, he gave me the same line, albeit pointing out that his expertise is in law and not the science aspects.

Gold, Ames, and others built a database of chemicals tested in lab animals and found that, even among natural chemicals, about half caused tumors in lab animals. These included chemicals found in table pepper, mushrooms, peanut butter, tea, and bread. One hundred thirty-seven volatile natural chemicals have already been found in apple juice, of which only five have been tested for carcinogenicity. Three of these have been found to be carcinogenic in rats. Now the apocalyptics were in a dilemma. By the same standard by which they were convicting synthetic chemicals as potentially lethal, the natural ones were proving just as bad.

As Ames and Gold point out, many foods have been introduced into our diets only in the last few hundred years, including such staples as coffee, tomatoes, and potatoes. Alcohol, aflatoxin, asbestos, radioactive rocks, and ultraviolet light have been around for several thousand years or since the earth’s beginning and have proved carcinogenic in man.

Many of the common heavy metals, such as cadmium, lead, nickel, beryllium, chromiurn, seleniuni, and arsenic, have been reported to be animal carcinogens. Finally, the evolutionary theory is valid only if cancer develops and kills before the reproductive period is complete. In fact, environmentally induced cancer often takes decades to manifest, itself and in those cases in which there is solid evidence as to the cause, eg., tobacco and asbestos, it almost always strikes those past normal child-bearing years, hence would have no effect on evolutionary development.

Discussion of natural animal carcinogens undercuts the apocalyptics’ approach to risk. Plants produce toxins which protect them against fungi, insects, and predators such as man. Many of these natural pesticides have been discovered, and most species of plant contain a few dozen. Of the natural toxins tested in animals, one half (25 of 50) have proved carcinogenic in MTD testing of lab animals, says Ames, as compared to 58 percent for synthetic chemicals.

It is probable, says Ames, that almost every plant product in the supermarket contains natural animal carcinogens. Among those already identified as such are: bananas, broccoli, brussels sprouts, cabbage, carrots, celery, cocoa, grapefruit juice, honeydew melon, mushrooms, mustard, orange juice, peaches, black pepper, raspberries, turnips and apples, sans Alar. To worry about a substance present in apple juice in such small quantities that it can only be measured with the most advanced instruments seems fatuous indeed.

A few years ago, the American Cancer Society ran a series of commercials in which actors and actresses mocked the notion that "everything causes cancer." Yet, if the results of mass-dose testing of laboratory animals are to be interpreted as applying to humans, they could prove that everything does cause cancer. Indeed, the FDA was scared that the public would discover natural carcinogens, as evidenced by one FDA statement that Efron found buried in the middle of a long opinion on reportedly carcinogenic hair dyes, which read:

Indeed, a requirement for warnings on all foods that may contain an inherent carcinogenic ingredient or a carcinogenic contaminant (in contrast to a deliberately added carcinogenic substance) would apply to many, perhaps most, foods in a supermarket. Such warnings would be so numerous they would confuse the public, would not promote informed consumer decision-making, and would not advance the public health.

In order to establish a priority rating system for carcinogens similar to that already established for toxicity, Ames and Co. have set up what they call a HERP (human exposure dose/rodent potency dose) index, which rates the degree of carcinogenesis of various chemicals based on the degree to which they have caused tumors in lab animals.

Ames calls his rating system not a risk assessment but "an index of possible hazard," noting that assigning a risk per million for any chemical is impossible, that the best one can do is compare one risk to the next. Thus, a liter of tap water is rated 0.001 on the scale because it contains the rodent carcinogen chloroform. A 12-ounce bottle of beer is rated at 2.8 because it contains 18 milliliters of ethyl alcohol; conventional home air, which contains the animal carcinogen formaldehyde, is rated 0.6 per 14 hours of breathing; while the same amount of breathing in a mobile home will pull in enough formaldehyde to incur a rating of 2.1. EDB a grain fumigant banned by EPA in 1984, has a rating of .0004.

During the Alar scare, Ames and Lois Gold noted in a letter to Science that the UDMH in a six-ounce glass of apple juice has a HERP level of 0.0017 percent, less than one-tenth that of either a single raw mushroom a day or a single peanut butter sandwich.

It is one of the great ironies of the synthetic chemical phobia that some varieties of edible plants which have been bred to be naturally pest-resistant have ended up being withdrawn from the market because of acute toxicity to humans. Such was the case with one variety of potato. A specially bred pestresistant type of celery proved so toxic as to cause rashes on the hands of handlers, and upon analysis was found to have 6,200 parts per billion (ppb) of carcinogenic psoralens instead of the 800 ppb present in normal celery. Thus, there is a trade-off between natural pesticides and manmade ones-unless, of course, one doesn’t mind losing anywhere from 10 to 100 percent of ones crop to insects, weeds, and predators.

Ames estimates 99.9 percent of all pesticides are natural. We are ingesting about 1,000 times more natural than synthetic pesticides. It is reassuring, however, that many layers of general defenses in humans protect against toxins without distinguishing whether they are synthetic or natural. The apocalyptics have essentially grandfathered all natural animal carcinogens while slamming the door in the face of the synthesized ones.

Turncoat Ames has become a real thorn in the apocalyptics’ side. As a result of an apple industry backlash against CBS’s first Alar show, CBS did another show and interviewed Ames. Indeed, it spent the entire Ames portion trying to discredit him. At one point, reporter Ed Bradley said, "Dr. [William] Lijinksy disputes Ames’s claim that 99.9 percent of all carcinogens come from natural foods." Such a claim would have been bizarre Bradley, who presumably had read Ames’s articles, must have known that in several of them he states, as have many others, that about 30 percent of human cancer cases are attributable to smoking alone.

At another point Ames says that compounds in celery and broccoli have been found to be carcinogenic. Bradley replies:

He believes further tests show he’s right. But for now, the national toxicology survey lists just 148 substances, and the compounds in celery and broccoli aren’t among them. One compound that is is the one produced by Alar.

Bradley was wrong. An April 1989 status report by the National Toxicology Program of the Public Health Service lists both allyl isothiocynanate and 8-methoxypsoralen as carcinogens, the former as "positive’ in male rats with the latter showing "clear evidence for carcinogenicity" in male rats. The first is found in broccoli, the second in celery. This material also appeared in Ames and Co.’s 1987 Science article which Ames claims to have sent to producer David Gelber but which, in any case, it was Gelber’s duty to read.

The Profits of Doom

Bradley began the 60 Minutes Alar follow-up by attacking the credibility of Elizabeth Whelan, president of the American Council on Science and Health (ACSH), whom it invited onto the show to dispute NRDC`s Alar claims. "You get a lot of money from the chemical industry. A lot of people who’ve looked at your contributors’ list accuse you of being little more than a hired hand for the companies that make chemicals and pesticides."

Never mind that Bradley could have gotten any number of experts from outside the chemical industry to say what Whelan did. His point was that those defending synthetic chemicals are always operating out of profit motive, while the NRDC and its ilk operate out of the goodness of their hearts. But Science editor Daniel Koshland, Jr. writes:

It’s time to recognize that public interest groups have conflicts of interest, just as do business groups, even though their public positions are [straightforward.] Businesses prefer to be out of the limelight; public interest groups like to be in it. Because they are selling products in the marketplace, businesses downplay discussions of hazard. Because public interest groups acquire members by publicity, they emphasize hazards... Businesses today have product liability and can incur legal damages if they place a dangerous product on the market. Public interest groups have no such constraints at the moment; it may be time to develop appropriate ones so that victims of irresponsible information have redress.

Imagine a prosecutor telling a jury, "Pay no attention to the defense attorney; after all, he’s being paid by the defendant!" As both ACSH and NRDC make a living by pushing a set view, the responsible reporter takes both sides with a grain of salt, as would a responsible juror. Problem is, most of the media jurors convict the chemical companies and their lobbyists before the trial even starts.

As to NRDC, Fenton stated "NRDC repaid itself manyfold in tremendous media exposure... _and substantial, immediate revenue for future pesticide _work. . . " [emphasis added]. Included in revenues was a book about pesticides that sold 90,000 copies in a few months’ time through a 900 number on the Donahue show. If it’s true that ACSH gets ten percent of its money from pesticide companies like Uniroyal, it’s also true that NRDC gets 100 percent of its money by convincing donors that chemical companies like Uniroyal are poisoning the environment.

Calculated Risk Factor

Just what is the risk of getting cancer from Alar? It depends on who’s making the estimate and probably how he felt when he got out of bed that morning. NRDC calculated that some 4,700 to 6,000 preschool children, out of a population of 22 million, will eventually get cancer from exposure to Alar in just the first six years of life. That translates into a risk of 240 per million of population.

As it happens, NRDC’s "new data!’ was EPA’s old data, that from before 1985 which had been rejected. But NRDC attorney Janet Hathaway says this was the "best data available." Which it was, of course, for them. In addition, NRDC built in the most conservative "safety factors" imaginable concerning intake and effect. EPA’s new figures had calculated a risk to infants, from exposure for just eighteen months, of nine in one million, which is twenty-five times lower than the NRDC estimate. Why did NRDC accept the higher figures which the originator claimed were no good?

To state that Alar and UDMH are human carcinogens is simply presumptuous. To state even that UDMH is an animal carcinogen may be false, All we know is that it may be a carcinogen in some animals when fed in massive doses. We can further state that there is no proof that any pesticide created by man causes cancer in humans when ingested. It is all theory and conjecture, nothing more. All of the above estimates are sheer guesses, like guessing the weight of an unknown number of marbles in a jar when one hasn’t even an idea of how much each marble weighs.

According to a 1980 OSHA report, saccharin "shows a range of variation of more than five million-fold in estimates of human risk, although an the estimates were derived from the same set of experimental data on rats . . ." In fact, if the data had taken into account that the results of MTD testing of rats may not apply to humans, the variance would, have been infinite.

The most we can say about the risk of getting human cancer from Alar is that there is some upper limit. That is, not everyone exposed to Alar gets cancer. Beyond that, it is all guesses. But this isn’t what Congress, the regulators, and a large segment of the public want to hear. They are hungry for statistics and estimates and often care little about how they were generated, or even who generated them.

Will "Cell Death" Be the Death of MTD Testing?

Why doesn’t everyone get cancer by age 30? One possibility is the existence of anti-carcinogens. It has been known for some time that some chemicals appear to act as neutralizers to carcinogens. Another reason for non-extinction of the human race is the "balance’ between the activation and detoxification of both natural and industrial carcinogens.

Some studies have found that certain combinations of carcinogens are less carcinogenic than the same ones ingested individually. Of course, both the effectiveness of anti-carcinogens and of the balance of carcinogens would be completely overridden by doses that are perhaps millions of times higher than an animal could expect to ingest under normal conditions. If, say, there were something in asparagus, broccoli, and oranges that cancelled out the carcinogenic effect of UDMH, it would take a lot of asparagus, broccoli, and oranges to cancel out the equivalent of 28,000 apples a day.

But perhaps the most fascinating answer to the puzzle of MTD in lab animals lies in the research area that explores cell death. According to this line of thought, toxicity and carcinogenicity, formerly separate and distinct, are confused in MTD testing.

In MTD testing, dosage may be so high that some organ may become sufficiently poisoned not to kill the animal outright but to cause massive new cell replication to replace the cells that have been killed off. For example, massive doses of saccharin overwhelm the natural defenses of rats, causing their bladders to lose many cells which have to be replaced; chloroform does the same with rat liver cells. From there, there are two possible effects, explains Dr. Byron Butterworth of the Chemical Industry Institute of Toxicology, an independent research group (which receives industry funding) at Research Triangle Park, North Carolina:

First, there is a chance for errors - mutations - to show up whenever cells divide and replicate DNA. The more you necessitate this, the better the odds of a mutation am Second, cancer is not just the presence of mutated cells but their growth and expansion. The massive killing of good cells forces the cancerous ones to rapidly reproduce to try to fill the gap.

As evidence for this, Butterworth notes that the same chemicals which cause cancerous tumors at MTD levels usually cause no tumors at lower levels, even though they may still be many times higher than anyone could possibly ingest in a lifetime. This was the case with Alar and UDMH, in which neither caused tumors in lab animals below the MTD range. According to Ames, "If you drop the test level to one-half of MTD, you lose two-thirds of carcinogens."

"Half of [the chemicals] we call carcinogenic really arent," says Butterworth. "They will not produce cancer at levels in which they are ingested in real life." Butterworth is not unaware of what this implies for policy. "Our public cancer policy is dramatically off target and we’re scaring people to death," he says.

The famed Oxford epidemiologist Richard Peto, who evaluates mouse tests for the IARC, stated a similar thesis a decade earlier:

...any chemical which causes proliferation or necrosis in any organ that is subject to spontaneous cancers is likely to modify the onset rate of tumors in that organ, and since the aim of most animal experiments is to study a dose which is nearly, but not quite, sufficient to cause significant weight loss or mortality within three months, it is not surprising that so many chemicals at such doses can cause cancers in animals

Concludes Ames:

It seems likely, therefore, that a high percentage of all chemicals, both manmade and natural, will cause cell proliferation at the [MTD level] and be classified as carcinogens, but most of these may be acting as promoters and therefore may not be of interest at doses much below the toxic dose.

Where, then, does the failure of the MTD test model leave us? One alternative is the testing of lab animals at lower doses, although this still allows the problem of extrapolating from mouse to man. Another is the Ames mutagenicity test. Finally, there is epidemiology, which faces the intractable problem of taking many years to yield results.

Ultimately, however, the removal of the MTD model itself may be the best thing ever to happen to carcinogen testing. So long as the emperor is convinced he is wearing clothes, he has no reason to get dressed. Public acceptance that MTD testing cannot do the job could provide the impetus to develop testing procedures that truly work to protect the public. To do this we must redirect more research into the basic science of what causes cancer.

The Wages of Crying Wolf

Perspective is deadly to the apocalyptics. In blasting Koshland’s_ Science_ editorial, Dr. Edward Groth of the Consumers Union came out boldly and declared:

The scientific facts (estimates of how big the risk is, with all their inherent uncertainties) are just part of what the public knows about Alar. The policy choices - both the personal and the public kind - depend on far more than facts.... [They are] heavily influenced by moral dimensions of the risk. And there you have it. For all the talk about facts and studies and science, what it really comes down to is a moral or quasi-religious dimension. So what if UDMH only causes cancer in mice and not rats? Ban Alar. So what if by the same or even stricter standards more than a score of natural chemicals have been found to be carcinogenic and have not been banned? Ban Alar. So what if, even assuming UDMH to be a human carcinogen, it’s highly possible that its benefits outweigh its risks? Ban Alar.

"Damned DDT! Where are the evironmentalists when you need them?"

In the 1960s, Sri Lanka stopped spraying its mosquitoes with DDT as a result of the warnings in Silent Spring. The incidence of malaria jumped from nearly zero to 2.5 million cases and 10,000 deaths before the country began spraying again. Woodsman, spare that mosquito. As to Alar specifically, Ames and Gold assert that apples falling to the ground prematurely allow the growth of molds which could possibly pose a greater risk to human health than anybody’s estimate of the carcinogenic effect of Alar. NRDC’s absolutism, however, would not have allowed a balancing of actual sickness and death versus theoretical.

And where does this leave NRDC? For now, sitting pretty. Its media campaign was a brilliantly executed end run around the court system, the legislature, and-most importantly-scientific peer review. It scored a touchdown of terror. The first to suffer were the stores, then the apple growers, then Uniroyal. Uniroyal and the stores will get by, as will most of the apple growers. The ultimate victims are those for whom the NRDC claims to be an advocate, the consumers.

Fenton boasted to the leftist magazine Propaganda Review that because of the Alar scare, "Lines started forming in health food stores. The sales of organic produce soared. All of which we were very happy about." It’s easy for well-off people like David Fenton or the attorneys of the NRDC to pay "natural food store’ prices for their staples, but what about the marginal poor who cannot qualify for food stamps or the poor who refuse to use them? As the environmental writer for the Los Angeles Times noted, "While the NRDC has 30 lawyers and 20 scientists, it has no economist to weigh the costs of an environmental reform against its benefits."

In late October, Janet Hathaway, in response to a Bush Administration pesticide monitoring plan, stated, "Allowing the EPA to condone continued use of a chemical whenever the benefits outweigh the risks is absolutely anathema to the environmental community."

Even when the benefits outweigh the risks? Apparently.