HEADLINES:
HOW THEY LIE, PART 6: THE TRUE STORY OF ALAR, PART 4
In late February, 1989, Natural Resources Defense Council (NRDC), a mainstream environmental organization, published a lengthy report on pesticides endangering children's health.[1] The CBS TV news show, "60 Minutes," publicized NRDC's findings February 26, 1989. Most of the "60 Minutes" show was spent describing the government's pesticide-regulation process, which was incapable of keeping industrial carcinogens (cancer-causing chemicals) out of the nation's food supply. However, the opening images of "60 Minutes" highlighted an apple overlaid by a skull and crossbones while a voice described the threat from Alar, and that is what stuck in peoples' minds. To this day, most people think the "60 Minutes" show was all about Alar on apples. In reality, the show was about government failure to protect the food supply from cancer-causing industrial chemicals --a problem that still has not been resolved.
Back in 1989, Alar offered an excellent example of failed regulation. By 1989, high doses of Alar (or its contaminant and breakdown byproduct, UDMH) had been shown to cause cancer in male and female mice, male and female hamsters, and male rats. The International Agency for Research on Cancer had labeled UDMH a "possible" carcinogen in humans and the U.S. government's National Toxicology Program had labeled UDMH a "probable" human carcinogen, as had the Carcinogen Assessment Group within U.S. Environmental Protection Agency [EPA]. (See REHW #530, #531, #532.) The acting chief of the EPA, John A. Moore, had said on February 1, 1989, "There is an inescapable and direct correlation between exposure to UDMH and the development of life-threatening tumors in mice."[2] Yet Alar/UDMH was still legal for apples.
Government officials did not miss the point of the "60 Minutes" program, and they moved quickly to defend their record. On March 16, 1989, Frank E. Young, chief of the Food and Drug Administration (FDA), issued a press release[3] which offered a joint statement by FDA, EPA and USDA [U.S. Department of Agriculture], reassuring the public that apples were safe. The press release made several key points:
1. A recent progress report of [Uniroyal's] ongoing studies shows that a breakdown product of Alar [UDMH] causes certain kinds of tumors in mice.
2. FDA monitors apples and often finds no Alar, or amounts of Alar that are less than the allowable limit.
3. Only 5% of the U.S. apple crop was treated with Alar in 1988.
In sum, the government's assurances boiled down to this: yes, Alar/UDMH causes cancer in animals but Alar isn't used on most apples, so apples and apple products are safe.
As it turned out, this attempt to reassure the public backfired. In May, 1989, CONSUMER REPORTS (CR) magazine published an independent analysis of Alar on apples purchased in the New York area and reported finding Alar residues on 55% of them.[4] Edward Groth of Consumers Union subsequently revealed that FDA itself has found Alar on 38% of the apples it had tested in 1988.[5] Furthermore, CR revealed that the FDA was using antiquated and insensitive laboratory techniques which could not measure Alar below 500 parts per billion (ppb). As CONSUMER REPORTS said, "Looking for daminozide [Alar] in apple juice with PAM II [the test method used by FDA] is like trying to catch speeders with a radar gun that doesn't work for speeds under 100 mph." [FDA subsequently adopted the more sensitive test method recommended by CONSUMER REPORTS.] After CR reported its independent Alar measurements, several state governments and news organizations conducted surveys of their own and reported finding Alar on 22% to 79% of red apples all across the country.[6] On average, it appears, about half of all red apples for sale in 1989 had been sprayed with Alar, not 5%. It was clear that FDA, EPA and USDA were badly misinformed or were lying.
The apple industry, too, began distributing false information about Alar. The industry paid more than a million dollars to Hill & Knowlton, a large PR firm, to design and run ads saying that you would have to eat a box-car-load of apples each day to be harmed by Alar.
The rationale behind such an argument is that laboratory animals were exposed to high doses of Alar and UDMH, to see if high doses would produce cancers. For humans to be exposed to equivalent high doses, they would have to eat a box-car-load of apples each day. However, this is a dishonest representation of the science involved.
Just because high doses cause cancer in animals, it does not mean that ONLY high doses cause cancer in animals. Among public health authorities in the U.S., the assumption is that cancer-causing chemicals follow a linear dose-response curve: if 10 milligrams of a substance causes 4 cancers in 10,000 people, then 5 milligrams will cause two cancers in 10,000 people and 2.5 milligrams will cause one cancer in 10,000 people. However, it is also true that 2.5 milligrams will also cause 2 cancers in 20,000 people and 4 cancers in 40,000 people. Under this linear dose-response assumption, exposing a large population (such as half of all the people who eat red apples) to a carcinogen like Alar/UDMH will cause cancer in some of them, even though none of them received a high dose.
High doses are used in animals studies because only 20 to 200 animals are used in any experiment. This is so because it is expensive to maintain large populations of animals under experimental conditions. If a certain dose of a cancer-causing chemical were sufficient to cause cancer in one out of every 10,000 animals, testing that same dose on 200 animals would not reveal any effect. (A chemical that caused cancer in one among every 10,000 exposed people would create a real public health calamity; if all 250 million Americans were exposed to such a chemical, it would cause 25,000 cancers. This would be a public health disaster by anyone's reckoning.) Therefore, to try to detect carcinogens that might affect only one in 10,000, or one in 100,000 animals (or people), yet not test more than about 200 animals (for cost reasons), high doses must be used to see if any effect can be observed. This approach may not satisfy everyone, but no one has yet suggested a better alternative.
Therefore, there are good reasons for testing high doses on animals, and there is no good reason for saying that people have to be exposed to the same high doses for them to be endangered. The argument, "You would have to eat a box-card-load of apples every day to be endangered by Alar" is specious, false, not valid, untrue.
John Rice of the International Apple Institute admitted in a public forum in June, 1989, that the "boxcar" ads were a dishonest representation of the science of Alar and cancer, but he justified the dishonesty by saying that the "60 Minutes" use of an apple with a skull and crossbones was dishonest, too.[7] (The "boxcar" argument was first used by Uniroyal, the manufacturer of Alar, in 1985 and it was as dishonest then as it was in 1989.[8])
Another common argument from the apple industry, and from scientists who spend their lives pooh-poohing the threats from farm chemicals (such as Bruce Ames and Lois Gold[9]), was this: mice were given such high doses of Alar and UDMH that they were poisoned, so it's not fair to claim that Alar or UDMH causes cancer at lower doses. In technical jargon, the mice were given Alar at levels that exceeded their "maximum tolerated dose" or MTD. Today, in modern cancer tests, typically a group of animals is given a dose just below the MTD, another group is given half the MTD and a third group is given zero. The original studies by Bela Toth in 1973 and 1977 (see REHW #529) gave all the mice only one dose --23.3 milligrams of UDMH per kilogram of body weight per day (mg/kg per day). This dose did exceed the MTD and some of the animals suffered liver damage. However, this dose also produced rare cancers of the blood vessels in 42 out of 50 mice, providing an important clue to the characteristics of UDMH.
When EPA finally forced Uniroyal to conduct new studies of UDMH in mice in the period 1987-1991, mice were given 13 mg/kg per day and 7.3 mg/kg per day. Even Bruce Ames and Lois Gold had to admit that 7.3 mg/kg per day did not approach the MTD,[10] yet this amount of UDMH caused cancer in 31 out of 67 mice (46%) and the 13 mg/kg per day dose caused cancer in 67% of the exposed mice.[11] Despite whatever shortcomings the Toth studies may have had, Toth's 1973 and 1977 findings were corroborated by Uniroyal's studies, using up-to-date protocols. Alar/UDMH DOES cause cancer and no prudent parent would want his or her infants or children to eat or drink such a substance. Even if Bruce Ames were correct when he asserts that the vast majority of cancer-causing chemicals in our food are naturally-occurring --an assertion that has many problems of its own --who in their right mind would expose their infant or child to an ADDITIONAL, unnecessary, human-created danger from Alar/UDMH if they could avoid it?
In November of 1989, Uniroyal voluntarily took Alar off the market in the U.S. in response to public anger. The public was no doubt angry at being lied to repeatedly by government, Uniroyal, grocery stores, and the apple growers' association. Uniroyal recalled existing supplies of Alar, then repackaged and re-labeled them B-Nine, for use on flowers. (Alar and B-Nine are separate Uniroyal products with identical chemical composition.) A Material Safety Data Sheet (MSDS) for B-Nine issued by Uniroyal in 1990 said "no evidence of carcinogenicity."[12]
In 1992, based on the Uniroyal studies, EPA reduced its estimate of the cancer danger from Alar/UDMH by half, to about 23 cancers per one million people exposed for a lifetime.[13] However, in 1993, the National Academy of Sciences told EPA that it should be multiplying by another safety factor of 10 when calculating the hazards of chemicals to children because children are more sensitive than adults.[14] If we follow the National Academy of Science's advice, the latest assessment of the Alar hazard would be 23 x 10 = 230 cancers per million children exposed. Given the uncertainties surrounding any such assessment, this is not different from NRDC's 1989 estimate of the hazard, which was 240 cancers per million children exposed. And that is where the science of Alar stands today.
--Peter Montague
Alar, the apple pesticide, has become a symbol of environmental protection gone wrong. In this series, we are examining the historical record to find the truth about the "Alar scare" of 1989, which is often cited today as a "hoax," an example of chemical hazards wildly exaggerated by environmentalists and by consumer protection extremists.
Last week we reported incorrectly that the International Agency for Research on Cancer (IARC) in Lyon, France, in 1982 declared UDMH a "PROBABLE human carcinogen." (UDMH is a contaminant in, and breakdown byproduct of, Alar.) In fact in 1974,[1] in 1982,[2] and again in 1987,[3] the IARC declared UDMH a "POSSIBLE human carcinogen." In 1974, the IARC made the flat statement, "1,1-Dimethylhydrazine (UDMH) is carcinogenic in mice after oral administration." (pg. 141). However in 1974 and again in 1982 and 1987, the IARC had no data --zero --on the carcinogenicity of UDMH or Alar in humans. Many workers during those years were being exposed to UDMH and to Alar/UDMH but no one studied their health. Uniroyal claimed to have studied its workers and found no evidence of harm, but to this day the company has refused to release the data.[4]
In early 1987, the NEW YORK TIMES reported that, responding to a six-month-long campaign by Ralph Nader, six supermarket chains and nine food manufacturers were refusing to sell or process apples treated with daminozide, the generic name for Alar. The supermarkets were Safeway, A.&P., Giant, Kroger, Grand Union and Farmer Jack's. The manufacturers were Gerber, Heinz, Beech-Nut, Welch, Duffy-Mott, Seneca Foods, Vacu-Dry, Quaker Oats and Martinelli.[5]
However, in early 1988, the TIMES reported that an independent laboratory in Oakland, California had tested apples sold in Safeway stores and had found Alar present.[6]
In January, 1989, EPA received preliminary results from mouse studies Uniroyal to undertake in 1987, under pressure from EPA. EPA Acting Administrator John A. Moore announced February 1 that EPA had decided to speed up the process that would PROPOSE removing Alar from the nation's food supply. Making the announcement by press release February 1, 1989, EPA said Uniroyal's studies of Alar and UDMH were showing that UDMH clearly caused cancer in mice and Alar probably did. Mr. Moore said, "There is an inescapable and direct correlation between exposure to UDMH and the development of life-threatening tumors in mice."[7] Because Alar contains UDMH as a contaminant, and because Alar breaks down into UDMH when heated, or when metabolized in the human stomach, EPA had decided to propose banning Alar/UDMH.
Mr. Moore also said that, based on the Uniroyal studies, EPA had calculated the hazard of cancer among people exposed to UDMH in Alar for a lifetime; he said the hazard was 45 per million, which is 45 times as high as the one-in-a-million hazard EPA considers "negligible."
However, in making his February 1 announcement, Mr. Moore also announced that EPA was extending Uniroyal's license for Alar on apples for another 18 months, to June, 1990.
Therefore, as we enter February, 1989, when the "Alar scare" will officially begin, any member of the public following this story now knows that:
** Uniroyal claims to have data from studies of its workers showing that exposure to Alar is safe, but the company refuses to release any data to back up its claims. (Earlier, Uniroyal had released data showing that Alar did not cause birth defects, but it turned out that those data had been produced by Industrial Bio-Test [IBT] laboratories and were found to be invalid.[8] In late 1983, three IBT executives were jailed for conducting hundreds of fraudulent pesticide-and-health studies for several major corporations.[9])
** Several large supermarket chains had taken a pledge not to purchase apples treated with Alar, but some grocery stores had been caught cheating.
** EPA says Alar/UDMH will most likely cause cancer in 45 out of every million people exposed to it for a lifetime --a hazard 45 times as high as any the agency considers acceptable --yet in the same breath the agency has extended Alar's license for use on apples for at least another 18 months.
Against this unreassuring background, on February 26 and 27, 1989, the Natural Resources Defense Council (NRDC) and the CBS TV news show, 60 Minutes, released the findings of NRDC's two-year study, INTOLERABLE RISK: PESTICIDES IN OUR CHILDREN'S FOOD.[10] NRDC's study made three points:
(1) The cancer hazards to children from pesticides were much higher than government officials said they were because children have quite a different diet from adults (and are very likely more sensitive to carcinogens than adults are);
(2) Many pesticides are known to affect the central nervous system and children are more likely to suffer these effects than adults are;
(3) The government's process for getting hazardous pesticides out of the food supply is too cumbersome and slow to protect public health.
CBS News chose to highlight one aspect of the NRDC report: the cancer hazard to children from one pesticide: Alar on apples. CBS displayed a skull and cross bones on an apple and told its viewers that Alar was a dangerous carcinogen. In response, some school boards pulled apples from their school menus, and apple sales plummeted in February and didn't recover until May.[11]
The NRDC report was not just about Alar; it was not even mainly about Alar. By stressing Alar in the first few minutes of its 60 Minutes program, CBS News skewed coverage of the NRDC report to a point where people today think that NRDC wrote only about Alar. For example, the NRDC report made concluded that some 3 million U.S. children regularly eat combinations of brain-damaging pesticides at exposure levels greater than allowable EPA standards. This important aspect of the NRDC study disappeared from view in the flurry over Alar.
Because this is a history of Alar, we too will focus on that aspect of NRDC's report.
NRDC's report said that, among 22 million U.S. pre-school children, 4700 to 6000 would eventually get cancer from exposure to Alar/UDMH. This translates into about 250 cancers per million children. Naturally, if exposure continued, this cancer hazard would continue to develop at this rate into the future.
Two groups responded immediately and negatively to NRDC's assessment of the Alar hazard to children: the government (EPA, the Food and Drug Administration, and the U.S. Department of Agriculture), and Uniroyal and the apple growers. Extremist libertarian journalists and consultants to the chemical industry piled on later to create the enduring mythology of the "Alar scare."
The government was clearly stung by the NRDC report, and EPA acting chief John A. Moore counter-attacked quickly.[12] He made 4 points:
1. Mr. Moore said EPA's assessment of the Alar hazard was "severely at odds" with NRDC's assessment. He said NRDC's hazard estimates are "up to 100 times higher than EPA's estimates."
2. He went on to assure the public that EPA's risk assessment techniques are based on "highly conservative assumptions."
3. He said EPA's calculations "allow us to ensure that no particular group--such as infants and children--receives exposure that is likely to cause unreasonable risks."
4. NRDC's report was "gravely misleading" because it "relied on data that had been rejected in scientific peer review, along with food consumption data of unproven validity."
It turns out that none of these points is valid. Here is new information relevant to Mr. Moore's 4 points in reverse order:
4. In its risk assessments of Alar, EPA relied on food consumption data gathered by USDA in 1977. NRDC used food consumption data gathered by USDA in 1985. The more current data was based on a smaller sample, but was still the best estimate of food consumption by Americans available in 1989. The more recent data, which NRDC used, showed that daily fruit consumption by pre-schoolers had increased 30% since 1977. The 1985 data were more suitable for Alar risk assessments than the 1977 data.[13]
3. In 1989, EPA was not taking any specific steps to assure that infants and children were protected from pesticides --a point the National Academy of Sciences made again and again in a book-length study published in 1993.[14] In 1989, EPA risk estimates treated children as if they were adults even though Mr. Moore himself said, "EPA is also concerned about the possibility that children and infants may be more sensitive to toxic effects of pesticide residues in their diets than are adults."[12] EPA may have been concerned, but it did not act on that concern.
2. EPA's risk assessment techniques are not necessarily conservative. In December, 1988, a U.S. government statistician examined a database of 1212 laboratory animal experiments on 308 chemicals and concluded that EPA's cancer risk assessment technique "is not conservative when applied in the usual way to animal data."[15]
1. EPA on February 1, 1989, calculated the hazard of Alar to adults to be 45 in a million. NRDC estimated the hazard to children to be 250 in a million. NRDC's estimate was not anywhere near 100 times greater than EPA's. As risk assessments go, their estimates were remarkably similar.
NRDC did use an EPA cancer potency number which the Science Advisory Panel (SAP) had said shouldn't be relied upon. (See REHW #530, #531.) However, EPA's own Cancer Assessment Group in 1987 had developed the potency number, a year AFTER the SAP had said it shouldn't be done. If it was good enough for EPA, why shouldn't it be good enough for NRDC? That cancer potency factor was the best data available at the time NRDC used it and, as we shall see when we continue this series, new data from Uniroyal's own studies reveal that NRDC wasn't far off the mark. However the Libertarian science-fiction attacks on NRDC and on EPA were soon to begin in earnest.
--Peter Montague
