1
Consequently, the FDA committee recommended that foods irradiated at doses below 100,000 rads be considered safe for 1iiinalr consumption without the requirement of toxicological testing
U.S. Food and Drug Administration
Final Rule, April 18, 1986
Given the weight of the research reviewed in the last chapter, how did the FDA come to approve of food irradiation for American consumers? As noted in Chapter One, it took a truly awesome bit of scientific sleight of hand.
The FDA has a long history of such sleights of hand. In 1968 and 1969, the Ralph Nader Study Group issued two separate reports indicting the FDA for deceiving and endangering the American public. The reports were eventually turned into a landmark book by James Turner, The Chemical Feast, published in 1970.
The Chemical Feast detailed the extensive conflicts of interest that had, and have, characterized the FDA's relationships with industry. For example, from 1953 to 1960, Henry Welch, the director of the FDA's Antibiotics Division, edited two private drug journals. Both were financially supported by antibiotic manufacturers such as Upjohn, Smith Kline & Franch, and Abbott Laboratories. Welch was also half-owner of these journals. In that seven-year period, he reportedly made over a quarter of a million dollars in profits.
Tales such as this made The Chemical Feast a controversial best seller. Time magazine noted that the book "may well be the most devastating critique of a U.S. Government Agency ever issued."2 The New York Times book reviewer David Rosenbaum said the FDA was portrayed as:
A tool of the food industry, controlled by political pressures and unable and unwilling to protect the consumer. The food standards and regulations of the agency, the report said read like a catalog of favors to special interest groups.3
Criticisms of the FDA have not been confined to consumer advocacy groups like Nader's Raiders. In 1970, FDA Commissioner and former Harvard University Professor Herbert Ley, Jr., Ph.D., and six other FDA officials issued a scathing forty-six-page report of the FDA's shortcomings. Among Dr. Ley's criticisms were that:
morale was low throughout the agency.
incentive was missing to protect consumers.
the pharmaceutical industry had been applying constant pressure on Ley to overturn FDA decisions that prevent the marketing of certain drugs because they are inferior to other drugs or are therapeutically useless.
Dr. Ley's report was more than a mere tirade of criticisms and finger-pointing. It also made forty-five recommendations for correcting these problems. What was the reply of the Department of Health, Education, and Welfare? As reported in The New York Times on January 4, 1970:
HEW has done little to implement the report's suggestions, except to oust the man who set up the panel in the first place, Dr. Ley, Jr., and two of his top aides.4
After Dr. Ley was removed from office, he issued numerous warnings about the FDA's failure to do its job to protect the public. Thanks in part to his efforts, scrutiny of the FDA by Congress became more intense for a time. But the scrutiny had little effect.
For example, in 1971, when Peter B. Hutt was appointed general counsel for the FDA, he was found to have wide associations with the food industry-including having served as counsel for several food manufacturers in proceedings before the FDA. Mr. Hutt's predecessor as head lawyer for the FDA went on to become president of the Institute of Shortening and Edible Oils. This same association listed Hutt as a former client.
Such blatant conflicts of interest prompted Representative Benjamin S. Rosenthal (D-NY) to declare, "The time has come to draw the line against this in-and-out incestuousness of government and industry. Is there no end to the carousel?"5 Referring to Mr. Hutt, Representative Rosenthal complained, "It looks like a game of musical chairs. He has represented every food and drug client imaginable. He is going to have to disqualify himself from 75 percent of the cases coming before the FDA in the next few years."6
Despite such objections, the FDA's incestuous relationship with industry continued, surfacing once again in August 1989, when it was revealed that former employees of the generic drug division had pleaded guilty to accepting thousands of dollars in illegal payments from drug manufacturers in exchange for processing the companies' drug applications more quickly.7
Today, the problem of accuracy in nutritional labelling has become a national issue, prompting cover stories in Time and Newsweek magazines, and dozens of editorials in newspapers across the country. Yet the FDA assures the public that not only is food irradiation safe, but its labelling requirements are also complete and its existing regulatory mechanisms are sufficient to protect the public. Given the FDA's track record, such assurances seem hollow at best-particularly when one examines the basis of the FDA's decisions regarding food irradiation.
TILE PROCESS OF ELIMINATION
The evaluation of food irradiation has always been an unusual proposition, since it is the process of food irradiation, rather than the food or its contents, that was deemed an additive in 1958.
Under the FDA's normal guidelines, additives must pass a hundredfold safety rule. In other words, additives are tested at 100 times the level proposed for human consumption. This means that if only 1 milligram of a particular additive is being proposed for human use, 100 milligrams or more will be fed to a lab animal. This protocol is meant to allow for the inevitable uncertainties of extrapolating data gathered from work with lab animals to the real world of humans.
In the case of food irradiation, however, food itself is being examined. The FDA decided that it would not be feasible to give 100 times the normal amount of food to a lab rat, and therefore discarded any animal studies on the impact of irradiated foods.
There are definite flaws in this rationale. Given the fact that the molecular changes in irradiated foods are directly dose-related, wouldn't it have made more sense to increase the dosage of radiation applied to the food rather than the quantity of food consumed? Indeed, given the fact that the American people will be eating irradiated foods over a lifetime (as opposed to the weeks or months of an experimental situation), wouldn't it be logical to impose an even higher safety rule than the standard hundredfold? Apparently neither of these possibilities occurred to -the FDA.
Before making the great leap of faith to dismiss all animal studies, the FDA had to perform its "review" of the existing research. To begin, the FDA set up an internal task force, the Bureau of Foods Irradiated Food Committee (BFIC), to review the agency's policy on food irradiation. The BFIC then set up criteria that studies would have to meet in order to be considered scientifically valid. These new standards were established in 1980 "because of the need to analyze carefully the food additive data, including irradiation."8
Using the new standards, the task force reviewed 441 studies (including those discussed in the last chapter) and accepted 266 for further review. The FDA then further narrowed its criteria for acceptance and chose 69 studies to review in depth. Of these, the FDA reported that 32 showed adverse effects, while 37 suggested safety. At this point, therefore, 46 percent of the studies the FDA had reviewed in detail indicated dangers in irradiated food.
Then, without specifying exactly why each study was rejected, the FDA declared that 64 of the 69 studies were in fact scientifically "deficient" and would not be considered. Instead, the FDA would focus on 5 studies, all of which fell within the "suggested safety" category, to determine its final ruling on food irradiation. As reported in the Federal Register in 1986, "Only 5 of the 441 studies reviewed . . . were considered by agency reviewers to be properly conducted, fully adequate by 1980 toxicological standards, and able to stand alone in the support of safety."9
The following are the 5 studies that were able to "stand alone in the support of safety":
"Toxicology Studies in Rats Fed a Diet Containing 15 Percent Irradiated Kent Mangoes" was a technical report that was funded and carried out under the government's food irradiation research program.10
Funded by the Office of the Surgeon General of the U.S. Army and carried out in the early 1960s at the University of Miami, the second study was published in Toxicology and Applied Pharmacology under the title, "Chronic Toxicity Studies on Irradiated Beef Stew and Evaporated Milk." Neither of these foods was, nor is, approved for irradiation.11
Published in a German scientific journal, the third study was conducted in the early 1970s at an institute in Karlsruhe devoted to radiation technology and was titled, "On the Wholesomeness of High Concentrations of Free Radicals in Irradiated Foods."12
The fourth study was published in Food arid Cosmetics Toxicology in 1964 and concerned the reproductive performance of rats fed gamma-irradiated wheat. Conducted in the early 1960s, the research was carried out under the auspices of yet another radiation technology group.13
The final research study cited by the FDA was actually a series of studies carried out by a French research group in the late 1970s.14
Despite the FDA's apparent satisfaction with these studies, other scientists have reviewed the same works and have arrived at markedly different conclusions. Donald Louria, M.D., chairman of the Department of Preventive Medicine and Community Health at the University of Medicine and Dentistry in New Jersey, submitted the second and fourth studies to several epidemiologists and statisticians within his department. None of them had an interest in food irradiation. Their methodological and statistical review found "multiple unacceptable defects,"15 including:
Defects that could not have occurred by chance, related to the method by which researchers determined if their results were "significant."
Failure to document statistical methods used.
Use of improper controls.
Unsound conclusions based on the data presented.
These defects have important ramifications. A closer review of these two studies revealed that several of their findings actually indicated the dangers of irradiated foods, rather than the safety. But because of the statistical methods used, the researchers deemed the findings "insignificant." For example, one study found a substantial increase in the stillbirth rate in rats fed food that had been treated with 200,000 rads. When this finding was reevaluated by the statisticians, they found that there was less than a 2 in 10,000 probability that the increase in stillbirths was due to chance rather than the consumption of irradiated food.16
In the other study, which was done with dogs over a two-year period, five of the sixteen dogs fed irradiated food showed physical abnormalities, including enlarged lymph nodes and enlarged spleens. Only one of the eight control-group animals showed some abnormality.17
Dr. Louria also took a look at the other studies cited by the FDA and found similar problems. In the German study, rats that had been fed irradiated foods for one year:
. . . had a decrement in weight and they had increased mortality within 28 days of births among the litters. To overcome this abnormality found at 1 year, the authors fed large amounts of vitamins [emphasis added] and documented that the birth abnormalities and the increased death rate and abnormal weights related to depletion of vitamins, particularly vitamin E in the food.18
In the series of French studies endorsed by the FDA, the bulk of the research was done using foods that had been irradiated with less than 50,000 rads-considerably less than the doses authorized by the FDA.
Apparently, the FDA realized it was standing on weak ground. Rather than relying on animal feeding studies, the FDA abruptly switched gears and chose to base its final decision on a theoretical estimate of the number of unique radiolytic products (URPs) formed by irradiation, and on the relative danger of these substances. As FDA Commissioner Frank E. Young, Ph.D., explained in his 1987 statement before the Subcommittee on Health and the Environment:
Animal testing is simply too insensitive to show an effect from irradiation of food at low doses, and, thus, would not contribute additional information to the evaluation of the safety of such uses.19
Despite this alleged "insensitivity," Dr. Young then went on to state that "agency scientists saw no consistent patterns or trends of adverse effects that might be attributable to exposure to food irradiated at low dose levels."20 He then backpedaled once again:
Thus, while annual [sic] feeding studies were consistent with a finding that the process is safe, it should be remembered that the FDA did not rely on any of the reports of animal feeding studies as the basis for its regulations [emphasis added]. Rather, we relied primarily on data we had on the effect of radiolytic products.21
To say that animal feeding studies are "insensitive," and that existent studies "show no consistent patterns or trends of adverse effects," flies in the face of all reason and of the numerous studies examined thus far. Mice hearts bursting open are not signs of insensitivity. Indeed, the existing literature shows a remarkably consistent pattern of tumors, stillbirths, congenital malformations, and chromosomal abnormalities in animals (including humans) who consume irradiated foods.
THE PROBLEM OF RADIOLYTIC PRODUCTS
A far more logical approach to the food irradiation problem would have been to analyze the URPs produced by irradiation. We have already seen that irradiation produces several known toxins and carcinogens. The BFIC, after reviewing the radiation chemistry literature, concluded that the irradiation of food at 100,000 rads would generate approximately thirty parts per million of radiolytic products. Of these, approximately 10 percent would be URPs.
The BFIC therefore concluded that URPs would consist of only three parts per million in a given piece of irradiated food. Since more than ten different URPs are likely to be formed by irradiation, the concentration of a single one of them would "probably" be less than one part per million.22
Based on this assumption, the FDA said that current toxicity tests are "not sensitive enough" to determine the potential toxicity of URPs at such low levels unless "the radiolytic products are far more potent than experience in the radiation chemistry of foods and toxicology would suggest."23 So, citing no studies on the effects of either radiolytic products or URPs, the FDA made its final pronouncement:
Because the potential concentration of URPs in irradiated food is low, BFIC concluded that food irradiation at doses not exceeding 100,000 rads is wholesome and safe for human consumption, even where the food that is irradiated may constitute a substantial portion of the diet .... Consequently, the committee recommended that foods irradiated at doses below 100,000 rads be considered safe for human consumption without the requirement of toxicological testing.24
In one fell swoop, the FDA ruled not only that animal feeding studies are irrelevant, but also that toxicological testing is unnecessary. Since radiation changes only a small percentage of the total chemicals in a given food, the FDA deemed these changes irrelevant to human safety. The FDA then explained how it determined that considerably higher dosages are safe for use on special foods such as herbs, spices, seeds, and teas:
The committee further concluded that a food (e.g. nutmeg) that comprises only a small part of the human diet (i.e. no more than 0.01 percent of the diet) and that is irradiated at doses up to 5 million rads would necessarily contribute far fewer radiolytic products to the daily diet-approximately 20 times less than a food representing a significant fraction of the diet (e.g. 10 percent) irradiated at 100,000 rads. Consequently, BFIC recommended that foods comprising no more than 0.01 percent of the daily diet and irradiated at 5 million rads also be considered safe for human consumption without toxicological testing.25
Basically, the FDA ruled that because radiation changes only a small percentage of the total chemicals in food, these changes are irrelevant to safety. But food goes through very significant changes when it is irradiated. DNA, which is the largest molecule in nature, is always disrupted by the randomly striking gamma rays, stopping cell division. Without cell division, food does not undergo the normal processes of ripening and decay. The expanded shelf life of food is a direct result of the devastation of the food's DNA.
This fact alone casts doubt on the FDA's assertions that the chemical changes in irradiated food are irrelevant. But DNA isn't the only chemical in food that is altered by irradiation. As Dr. Tritsch explained in his testimony before Congress, when a food is irradiated, approximately 6 out of every 10 million chemical bonds are broken. As an example, lie said that a quarter of a pint of water contains around 1025 bonds-or 10 followed by 25 zeros. (Water is a particularly relevant substance, since it constitutes about 80 percent of many foods.) If 6 out of every 10 million of these bonds are broken, a total of 101$ bonds is destroyed. In other words, says Dr. Tritsch, a million trillion highly reactive molecules would be produced in a quarter pint of irradiated water. Although the percentage may seem small, the actual number. of molecules is huge.26
Furthermore, in concentrating almost exclusively on the potential toxicity of unique radiolytic products, the FDA ignored the toxicity of known radiolytic products, including formaldehyde and benzene. The fact that these chemicals are not "unique" does not guarantee their safety. Indeed, the dangers of these chemicals are quite well known.
As discussed previously, exposure to formaldehyde has been known to cause pneumonia, pulmonary edema, and death. It is a known carcinogen in animals and is considered a likely cancer-causing agent in humans. Chronic exposure to benzene, meanwhile, has been associated with increased incidence of leukemia27 and general problems in the formation and development of various blood cells and components of blood. (As you may recall, abnormal blood cells associated with leukemia were found in children in the Indian study.)
The FDA's stand on both forms of radiolytic products has been widely criticized. One of the many scientists who remain unconvinced by the FDA's rationale is Homer W. Ibser, Ph.D., professor of physics at California State University at Sacramento. Dr. Ibser has noted that "the fact that URPs are present in irradiated foods in small concentrations is not particularly reassuring if single exotic molecules may be capable of causing carcinogenic chromosomal aberrations."28
Dr. Ibser's observation once again raises the question of why the FDA chose to ignore its own hundredfold rule when considering the problem of radiolytic products. Why not isolate them and subject them to standard toxicological testing under the hundredfold safety rule? As we saw in the previous chapter, when Russian researchers isolated just one class of URPs the orthoquinones -- and injected them into living lab rats, they observed immunological suppression like that found after direct radiation exposure. Despite this existing evidence of the danger of at least one class of URPs, and despite the FDA's own standards for toxicological evaluations, the FDA chose to dismiss the potential dangers of radiolytic products as inconsequential.
Furthermore, the final FDA ruling makes no mention of the possibly synergistic effects of mixing radiolytic products. The lethal power of many toxins increases geometrically when the toxins are mixed with other toxic products. For instance, massive poisoning occurs when malathion and certain other organic phosphates are administered simultaneously. This poisoning is fifty times more severe than one would predict by simply adding the relative toxicities of the two poisons. This means that only one-hundredth of the lethal dose of each compound will be fatal if the two are combined.29
Certain chemicals, such as the pesticide DDT, accumulate in the fatty tissues of the body. These storehouses magnify the effect of daily intake, so that an intake as little as one-tenth of one part per million will result in a total storage of ten to fifteen parts per million (an increase of more than a hundredfold). While these levels may still seem small, they can be deadly. DDT, for example, is known to disrupt an essential enzyme in the heart muscle, and as little as five parts per million has been known to cause necrosis of liver cells. Chlordane and dieldrin, which are close chemical relatives of DDT, cause the same effects at two and a half parts per million.30
Let us assume that the FDA is right and that no URP will exceed one part per million. 1f some of these products accumulate in fatty tissues (and no research has yet been performed on this issue), then these stored deposits could easily bring the level up to one hundred parts per million. If this URP is of a similar toxicity to chlordane, then it has reached a level forty times that necessary to destroy liver cells. If it is similar to DDT, then it has reached thirty-three times the level necessary to disrupt the heart. Remember that food irradiation by its nature includes random molecular and atomic events. No one will ever conclusively know all the possible chemicals that will be created.
We have entered a chemical no-man's land. Not one bite is safe.
THE FDA ON THE OFFENSIVE
In its report in the Federal Register, the FDA dismissed the majority of the feeding studies done on irradiated foods without specifically citing their "deficiencies." It was later forced to justify several of its dismissals. Within one month of its announcement of the omnibus ruling, which allowed irradiation of fruits and vegetables, and the specific ruling, which allowed irradiation of pork, the FDA had received more than 300 objections-245 against the omnibus ruling and 59 against the pork ruling.31 Many of these requested an additional hearing on the issue of food irradiation-all of which were denied by the FDA because "no evidence was submitted in support of these objections, they raise no factual issues for resolutions, and, therefore, do not justify a hearing."32
One of the primary objectors to the FDA rulings was the Health and Energy Institute (HEI), which submitted extensive criticisms of the FDA's rationale and research analysis. The FDA addressed these criticisms in the Federal Register in December 1988. Although the FDA refused to grant HEI a hearing on the grounds of an existing rule that "a hearing will not be granted on the basis of mere allegations of general descriptions,"33 it presented a detailed defense of its dismissal of some critical research findings.
Foremost among this research was the Indian study on children fed irradiated wheat. In criticizing this study, the FDA cited a report submitted to the World Health Organization (WHO) by a committee of Indian scientists who had evaluated the NIN research and found it deficient. This committee faulted the study on methodological and statistical grounds, noting that the number of children (and cells) evaluated was too small to draw any significant conclusion, and that the methodology was flawed.
Other proponents of food irradiation have also sought to discredit the NIN findings. According to Martin Welt, Ph.D., former president of Radiation Technology, a major United States food irradiation company, and convicted violator of the Atomic Energy Act, "The Indian authorities at the Institute where the work was conducted have essentially refuted the concerns raised in the published study."34 Welt says lie received this information when he chaired a panel discussion on food irradiation where the same source also informed the panel that "the study in question may very well have been fraudulent. "35
Closer investigation of these claims revealed that the supposed "committee" was in reality two scientists who had been asked to evaluate the study by the Bhabba Atomic Research Center (BARC), which was seeking approval to irradiate food and was citing results different from those found by the NIN researchers. The criticisms were in a confidential unpublished report to the Ministry of Health and Family Planning in India, and were subsequently refuted, in detail, by the NIN researchers, who also provided additional independent evaluations supporting their work.36
Despite the FDA's-and Dr. Welt's-assertions, the NIN researchers never refuted nor denied their findings in any way. Indeed, they vigorously defended the validity and significance of the work. In testimony before Congress, Dr. B.S. Nariasinga Rao, director of the National Institute of Nutrition, adamantly rejected all criticisms of the NIN study. These "unjustified allegations," said Dr. Rao, "almost amount to libel."37 As for the study itself, particularly the small number of children involved, Dr. Rao noted:
We did not anticipate any adverse effects of feeding irradiated wheat to these children. However, as soon as some abnormality was observed in these malnourished children . . . we terminated the study for ethical reasons .... We could not repeat such studies just for the sake of scientific curiosity, since we knew that some abnormality [polyploidy] would result.
These, I presume, are inspired allegations about the research finding of NIN which is known world over for its important contributions in the field of nutrition. We strongly refute these motivated allegations, which cast aspersion on the scientific integrity of the institute.38
When Dr. Tritsch testified before Congress, he addressed the controversy surrounding this research and the ethical and scientific holes in the logic of those who dismissed the results.
Proponents of food irradiation have attempted to dismiss this study since only five individuals were involved, but mercifully no one has repeated this with greater numbers of children, especially since equivalent results were found when irradiated wheat was fed to monkeys and rats [emphasis added]. In both these studies, polyploidy was seen after several weeks of feeding and returned to normal after feeding irradiated wheat was stopped .... I would be hard put to find a group of better studies to demonstrate the mutagenic properties of irradiated wheat.39
The FDA also reviewed the Russian study that found kidney damage in rats fed irradiated foods. Its criticisms hinged on two basic points. First, the FDA said, the Russian researchers "may not have been familiar with common progressive nephrosis of the rat kidney . . . [the kidney changes reported are] generally consistent with kidney disease commonly seen in aged laboratory rats."40 In other words, Levina and Ivanov had mistakenly chosen older rats to feed the irradiated food to, and younger rats to serve as the control group. Second, a review of eleven other studies in which rats were fed irradiated foods did not show similar results.
The first of these criticisms assumes a rather insulting level of naiveté and inexperience on the part of the researchers and completely disregards the fact that the authors clearly stated that experiments were carried out on 240 rats of both sexes used at the age of one month.41 Indeed, assumption of errors this blatant would call into question all scientific studies currently in print!
In their review of other research on rats fed irradiated foods, the FDA disregarded the data from Raltech that showed kidney damage in mice fed irradiated food and looked at none of the studies that prompted Levina and Ivanov to undertake their research in the first place-the twelve studies they said indicated that "the prolonged ingestion of food consisting even in part of irradiated products can lead to definite functional and structural disturbances."42 Two of the eleven studies reviewed were among the five animal studies deemed "acceptable" by the FDA in its final rule. Of the other nine, five were conducted under the auspices of the International Atomic Energy Agency (IAEA) or other groups dedicated to promoting the use of nuclear technology.
In defending its final ruling, the FDA also had to deal with the problem of some earlier research findings of its own. In its Recommendations for Evaluating the Safety of Foods (Final Report), the FDA itself noted that "chronic feeding studies in the past which have substituted up to 35 percent of the normal [lab animal] diet with specific irradiated foods, e.g., beef, chicken, potatoes, onion, and papaya . . . had to be terminated because of premature mortality acid/or morbidity [emphasis added].43 In other words, the research could not be completed because the experimental animals got sick or died.
How could the FDA ignore these apparently lethal effects of eating an even partially irradiated diet? Later in the same report, the FDA confidently attributes the finding to dietary imbalance, noting that "the portion of the diet substituted, 35 percent, did not provide the full complement of nutrients required."44 But if an unbalanced diet was the problem, why did the control animals, who ate an identical non-irradiated diet, live and remain healthy? A possible explanation, says nutritionist Jeff Reinhardt of the Marin Clinic of Preventative Medicine and Health Education, in San Rafael, California, is that irradiated food contains toxic byproducts caused by irradiation, and that crucial nutrients are being depleted or destroyed.45
Prior FDA research had also documented increased aflatoxin production in irradiated foods. The FDA sought to refute this finding by citing three studies that allegedly failed to show such increased toxin production. Contrary to the FDA's assertions, however, two of the three studies are not at odds with the research indicating increased aflatoxins after irradiation. One of the studies, published in 1973 in Poultry Science, went so far as to conclude that:
Toxic aspergilli appear to be induced to produce significantly large amounts of aflatoxin B, when exposed to radiation .... Since cobalt radiation is currently sanctioned by the United States Department of Agriculture for irradiation of wheat, the induced production of aflatoxins by irradiated toxinogenic strains of fungi could be of public health significance [emphasis added].46
The FDA's evaluation of the research on food irradiation has striking parallels to its handling of the cyclamate issue in the 1960s. Cyclamates had been on the market-and in the food supply-for sixteen years when two Japanese scientists reported that cyclamates create a chemical called cyclohexylamine in humans.47 In November 1968, it was reported that an FDA cell biology research chief had found that cyclohexylamine could "break a significant portion of chromosomes in both in vivo and in vitro studies."48 A high-ranking FDA official was quoted as saying, "It's a big one. This is potentially one of the biggest things we've had around here for a long time. "49 The unnamed official's prediction proved to be correct, but it took another year for the FDA to act on cyclamates. Indeed, for most of 1968 and well into 1969, key FDA officials (including Commissioner Herbert Ley) studiously ignored the evidence of the health risks of cyclamates.
In March 1968, Jacqueline Verret, Ph.D., an FDA biochemist, made a presentation at a high-level seminar. She reported a strong relationship between cyclamates injected into chicken eggs and deformities of the embryos taken from the eggs. In April 1969, Dr. Verret's supervisor, concerned about the FDA's inaction on the matter, carried two deformed chicken embryos into Dr. Ley's office. Dr. Verret's mid-year report had indicated that cyclamates had teratogenic effects, such as wings growing out of the wrong side of the body, a leg rotated in the socket, and extreme spinal curvature. Neither the report nor the deformed embryos seemed to impress Dr. Ley. In The Chemical Feast, author James Turner says that Dr. Ley claimed that he did not understand their significance.50
As we saw earlier in this chapter, Dr. Ley later became one of the FDA's most vocal critics-a frankness that eventually cost him his job. Some twenty years after the cyclamate controversy, a review of the studies the FDA used in approving cyclamates revealed the true extent of the FDA's failure. The studies showed "a highly suspicious frequency of lung tumors,"51 as well as drastic increases in other tumor activity. Of the less than 100 rats the FDA tested, 6 had rare ovarian, kidney, or uterine tumors. These tumors normally occur approximately once in every 10,000 cases. The incidence in the test animals was therefore more than 600 times the normal incidence All of this data was clearly noted in the lab sheets on which the FDA based its conclusion of safety. Given the preponderance of evidence documenting the dangers of irradiated foods, it appears that the FDA is continuing this tradition of turning a blind eye to crucial data.
Despite the blanket assurances currently being issued by the FDA, a close examination of its actions thus far indicates that this "watchdog of public health" has shown an appalling disregard for the documented dangers of consuming irradiated foods. In recognition of this, Senator George Mitchell introduced the Food Irradiation Safety and Labelling Act in February 1987. A central point of the act, which was originally introduced in Congress by California Representative Douglas Bosco-as House Resolution 956-is the mandating of a two-year study by the National Academy of Sciences of food irradiation, "including the environmental and health issues associated with irradiation facilities."52
The act died aborning. House Resolution 956 never made it out of committee. Bosco has since been voted out of office, and Mitchell, now the Senate majority leader, has no plans to reintroduce it.
In his testimony before the U.S. House of Representatives in June 1987, in a hearing on the above bill, Dr. Louria persuasively expressed the crying need for proper investigation of food irradiation. He said, "Until every food is individually tested at various conditions of storage, cooking, freezing, and thawing, and at various radiation dosages, it would seem to me to be virtually unthinkable to approve food irradiation for general use."53
Department of Health and Human Services, Food and Drug Administration: Irradiation in the production, processing, and handling of food: Final Rule. Federal Register April 18, 1986 (21 CFR Part 179Part 111), 51(75): 13,377.
Editorial Staff: Up against the wall, FDA! Time April 20, 1970: 18.
Rosenbaum, DE: FDA called tool of food industry. The New York Times April 9, 1970:17.
Lyons, R: Trouble over drubs on the market. The New York Times January 4, 1970: IV 5.
Morris, JD: Assurances given by FDA counsel. The New York Times September 18, 1971.
Morris, JD: FDA appointee to face hearing. The New York Times September 12, 1971.
Andrews, EL: U.S. examines top 30 generic drugs. Daytona Bench News Journal August 17, 1989: 7C.
Young, FE: Statement before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce (I louse of Representatives) on House Resolution 956-June 19, 1987. U.S. Government Printing Office, Washington, D.C., 1988: 24.
Department of Health and Human Services, Food and Drug Administration: op cit: 13,384.
Elias, PS: Toxicology studies in rats fed a diet containing 15 percent irradiated Kent mangoes. Technical Report IFIP-R-58 1981.
Radomski, JL, Deichmann, WB, et al: Chronic toxicity studies on irradiated beef stew and evaporated milk. Toxicology and Applied Pharmacology 1965; 7:113-121.
Renner, HW and Reichelt, D: On the wholesomeness of high concentrations of free radicals in irradiated foods (translated from the German). Zentralblatt für Veterinarmedizin Reihe B (Berlin) 1973; 20: 64860.
Hickman, R, McLean, DLA, and Ley, FJ: Rat feeding studies on wheat treated with gamma-radiation: 1. Reproduction. Food & Cosmetics Toxicology 1964; 2(15): 1521.
Coquet, B, et al: Etudes
chez la souris concernant le toxicite, I'influence sur la
reproduction, la mutagenecite et la pouvoir teratogenic du riz irradie
incorpore dans la nourriture. Final Report IFIP-R-40, 1976.
Coquet, B, et al: Oignons irradies:
Etudes de toxicite et de reproduction chez le rat. IFREB Report in WHO
Irradiated Onion Monograph, 1980.
Coquet, B, et al: Legumes irradies:
Essais de toxicite et de reproduction chez le rat. Technical Report in
WHO Irradiated Legumes Monograph, 1980.
Louria, DB: Statement before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce (f louse of Representatives) on House Resolution 956-June 19, 1987. U.S. Government Printing Office, Washington, D.C., 1988: 89-94.
Ibid: 89.
Ibid: 90.
Ibid.
Young, FE: Statement before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce (House of Representatives) on House Resolution 956-June 19, 1987. U.S. Government Printing Office, Washington, D.C., 1988: 27-48. (42)
Ibid.
Ibid.
Department of Health and Human Services, Food and Drug Administration: op cit: 13,378.
Ibid.
Ibid.
Ibid.
Tritsch, GL: Statement before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce (House of Representatives) on House Resolution 956-June 19, 1987. U.S. Government Printing Office, Washington, D.C., 1988: 97.
Arena, JM and Drew, RH: Poisoning, 5th edition. Charles Thomas Publishers, New York, 1986: 314.
MacFayden, JT: Immortal Shrimp. Harrowsmith January/ February 1986: 50.
Carson, R: Silent Spring. Houghton Mifflin Co., Boston, 1962:38.
Ibid: 29.
Department of Health and Human Services, Food and Drug Administration: Irradiation in the production, processing, and handling of food: Final Rule. Denial of request for hearing and response to objection. Federal Register December 30, 1988 (21 CFR Part 179-Part III); 53(251): 53,176.
Ibid.
Ibid: 53,181.
Welt, M: Letter submitted in testimony of the Health and Energy Institute at the hearing on food irradiation by the House Agriculture Subcommittee on Department Operations, Research and Foreign Agriculture (House of Representatives)-November 18, 1985.
Ibid.
Rao, BSN: Letter submitted in testimony of the Health and Energy Institute at the hearing on food irradiation by the House Agriculture Subcommittee on Department Operations, Research and Foreign Agriculture (House of Representatives)-November 18, 1985.
Ibid.
Ibid.
Tritsch, GL: Statement before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce (House of Representatives) on House Resolution 956-June 19, 1987. U.S. Government Printing Office, Washington, D.C., 1988: 100.
Department of Health and Human Services, Food and Drug Administration: op cit: 13,386.
Levina, AI and Ivanov, AE: Pathomorphology of the kidneys in rats after prolonged ingestion of irradiated foods. Bulletin of Experimental Biological Medicine February 1978:236-238.(236)
Ibid.
Brunetti, AP, et al: Recommendations for Evaluating the Safety of Irradiated Foods (final report prepared for the Director, Bureau of Foods, Food and Drug Administration). Department of Health and Human Services, Food and Drug Administration, Washington, D.C., July 1980: IV-1.
Ibid.
Reinhart, J: Personal communication.
Applegate, KL and Chipley, JR: Increased aflatoxin production by Aspergillus flavus via cobalt irradiation. Poultry Science 1973; 52: 1492-1496. (1496)
Turner, JS: The Chemical Feast. Grossman Publishers, New York, 1970: 12-13.
Ibid.
Ibid.
Ibid.
Mintz, M: Bittersweet saga: The rise and fall of cyclamates. The Washington Post October 16, 1969:16. (Cited in Turner, T: The Chemical Feast, Grossman Publishers, New York, 1970: 6.)
House Resolution 956: A Bill to Prohibit the Implementation of Certain Regulations of the Secretary of Health and Human Services and the Secretary of Agriculture Respecting Irradiated Foods, to Amend the Federal Drug and Cosmetic Act to Prescribe Labels for Irradiated Food, and for Other Purposes. In: A Hearing Before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce (House of Representatives) on House Resolution 956-June 19, 1987. U.S. Government Printing Office, Washington, D.C., 1988:18-19.
Louria, DB: op cit: 90.
On to Chapter 4 - Euphemisms and Evasions
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