Banned

by Frederick Rowe Davis

  Even Arnold J. Lehman, director of the Division of Pharmacology at the FDA, could not clarify the risks associated with parathion. Lehman was present during the early days of the hearings, perhaps while he waited to be called to testify. Repeatedly, congressmen called on him to address aspects of chemistry and toxicology. During Lehman’s formal testimony, Kleinfeld asked him to describe parathion and its use as an insecticide. Lehman responded: “From my own standpoint, having the interest of the consumer in mind, parathion is probably a safer insecticide than DDT.”94 When Kleinfeld asked if he knew of reports of fatal poisonings, Lehman reported that there had been nine fatal cases of poisoning with parathion. Thomas G. Abernathy (Mississippi) focused the line of inquiry to whether parathion was harmful to a crop and to consumers after eating the crop. Lehman responded definitively: “I think I can answer the question. Parathion is a liquid. It penetrates the skin. It is very poisonous. Very small amounts will produce fatal poisoning.”95 Nevertheless, when Abernathy pressed the point and asked again if parathion could be used on crops, Lehman replied: “I think that it is safe for use.”96 Again Abernathy asked if any damage would result to the consumer in eating a crop on which parathion was used. Lehman responded: “No. There is no evidence that I know of.”97 At that point, Miller noted that he had asked his wife what she used on ants in their home, and he discovered some parathion sprays. He refocused Abernathy’s question: “Do you think that [it’s] harmful in spraying, as women do, all over the country, to get rid of insects. Is there danger in using parathion?” Lehman answered, “There is.” He added a facetious comment: “I hope Mrs. Miller is an expert in the use of insecticides”98 Miller noted that she was not and took the discussion off the record. When testimony resumed, they did not return to the toxicity of parathion. Lehman did not clarify why he believed that a highly toxic chemical like parathion was safe for use on crops and safe for people who ate the foods produced from such crops. Based on his publications, Lehman believed that parathion’s rapid decomposition would protect crops and consumers alike (see chapter 4).

  In order to sort out the different views on the toxicity of insecticides, Kleinfeld sometimes introduced previous testimony into his questions. In the case of chlordane, a chlorinated hydrocarbon like DDT, Kleinfeld cited Lehman’s testimony in which he had testified that chlordane was at least “four times as toxic as DDT.”99 Lehman called chlordane “one of the most toxic of insecticides we have to deal with.”100 Chlordane, in Lehman’s opinion, had no place in the food industry where the possibility of contamination existed. Nor was the chemical appropriate as a household spray or in floor waxes. When Kleinfeld asked Bishopp for the recommended uses of chlordane according to the USDA, Bishopp read a lengthy statement by Ralph Heal, technical director of the National Pest Control Association. Heal argued that the pesticide control industry had used chlordane extensively and that only one employee had shown a sensitivity or allergic reaction in one particularly large firm with more than one hundred employees who spent roughly half their time applying chlordane. Such a record contrasted even with one of their least toxic insecticides, pyrethrum, to which 14 percent of employees developed an allergic response. Bishopp’s response to Kleinfeld offers a glimpse of the considerable extent to which USDA had become co-opted by the chemical companies. Historian Pete Daniel has extensively documented regulatory capture of the USDA, specifically the agency’s clearinghouse for pesticide approval, the Agriculture Research Service, by the pesticide manufacturers (see below).101 Bishopp’s statement, however, represents an early example of capture and a frank acknowledgment of industry ties.

  It is unclear the extent to which Bishopp’s views prevailed among growers and, significantly, producers of food. One clear statement of dissent came from Dr. L. G. Cox representing Beech-Nut Packing Company. In his prepared statement, Cox noted the problems that Beech-Nut faced with the advent of synthetic insecticides like DDT. As early as 1947, Beech-Nut management undertook an extensive and expensive research program on pesticides residues. As a result of this research, Beech-Nut adopted a “near zero tolerance level” in baby foods. Citing the research of Fitzhugh and Lehman and the recommendations of the American Medical Association, among others, Cox noted that producing baby food necessitated caution: “Since we are manufacturers of baby food, we have had to take into account all those factors—prenatal, environmental, physiological, and structural—which may cause a baby to react to food residues in a manner different from the adult.”102 Such a statement reflects a sophisticated understanding of environmental exposures and dose-response. Cox’s statement suggests that infants were particularly vulnerable to environmental exposures. Acting on this concern, Beech-Nut adopted precautionary measures to ensure the safety of their products. Of particular concern was the lack of adequate analytical methods of residue analysis. Cox noted that Beech-Nut had good analytical methods for DDT, DDD, BHC, parathion, methoxychlor, and a few other insecticides not in general use. However, satisfactory analytical methods were lacking for chlordane, toxaphene, aldrin, dieldrin, and heptachlor. In light of this situation, Beech-Nut established an elaborate field survey program through its agricultural purchasing department, which the company enforced through a growers’ contract prohibiting the use of certain insecticides. Cox cited Lehman’s opinion that chlordane had no place in the food industry, in sharp contrast to Bishopp’s recommendations on behalf of the USDA.

  Contamination of crops with pesticides of known and indeterminate toxicity represented just one of the serious problems that Beech-Nut confronted. Certain pesticides corrupted the flavor of foods. BHC posed particular problems, and Cox cited separate cases in which the company rejected squash, peaches, celery, spinach, sweet potatoes, apples, and peanuts. The problem of off-flavors was particularly acute in peanuts. Beech-Nut researchers noted a degree of off-flavor in peanut butter containing 2 ppm of BHC after a five-month shelf life. Chlordane and lindane also caused off-flavoring.103

  Costs of research and quality control, procurement, processing losses, and equipment had amounted to an average of more than $110,000 per year for the five previous years. Such costs inspired seven specific recommendations, including evidence of adequate toxicological testing, development of suitable pesticides residue analysis, information on the approximate range of residues on produce, guidelines for removing pesticide residues, a requirement that the FDA establish and publish a tentative tolerance in the Federal Register within ninety days following registration, FDA sample analysis following the publication of the tolerance, and a requirement that if tolerances were exceeded after a ninety-day warning period, the tentative tolerances would be made official and seizure proceedings instituted.104 If anything, Cox’s statement on behalf of Beech-Nut revealed that one food producer desperately sought oversight of the new chemicals that had proliferated on farms across America.105 Moreover, Cox revealed that Beech-Nut’s in-house scientific group had a sophisticated awareness of environmental exposures and the particular vulnerability of infants, which drove them to advocate precaution with respect to residues of the new insecticides. In both respects, Beech-Nut seems to have been quite progressive in its outlook and its willingness to underwrite precaution. Unfortunately, Beech-Nut’s precautionary approach to the new insecticides, as presented by Cox, seems to have been a single exception to the general incorporation of pesticides by food producers and distributors in America.

  After hearing and questioning expert witnesses from industry, USDA, FDA, PHS, and other organizations, members of Congress could track several themes. Again and again, they heard that synthetic insecticides enabled farmers to produce crops and thus feed a growing nation. Scientific opinion on the risks of the new insecticides varied widely. On one hand, some scientists could point to specific problems with DDT and other chlorinated hydrocarbons, such as the development of resistance in certain insects and transfer of DDT from cows to calves, which led to advisories against its use in dairy barns. On the other, specific cases of poisoning in human
s were rare. Toxicological analysis focused on symptoms of acute poisoning, but the chronic toxicity of DDT remained shrouded in scientific uncertainty. Notably, the leading authority on environmental cancer argued that not enough time had passed to determine if chlorinated hydrocarbons caused cancer in humans. The considerable toxicity of organic phosphates, however, provided a much sharper image of risk. Even as the BEPQ assistant chief questioned whether the tolerance for parathion should be 2 ppm or lower, he left no doubt that it was one of the most toxic chemicals known to mankind. Yet, unlike persistent chlorinated hydrocarbons, it metabolized quickly in the environment. Scientific uncertainty and sharp distinctions between science and policy provided few clear pathways for further regulation and often left members of Congress confused and exasperated. Nevertheless, political scientist Christopher Bosso has argued that the hearings established two major points for those seeking legislative reform: “(1) food and chemical industries did not have consumer health as their primary orientation, and (2) the FDA had no mechanism for knowing beforehand which chemicals reached the consumer, and with what effects.”106 As chairman of the committee, Delaney concluded the hearings with his observation that committee members on the whole supported premarket testing of food additives and strengthening of FDA regulatory power.

  In the aftermath of the Delaney Hearings, Congress passed two major amendments to the FFDCA. The first was adopted by Congress in 1954 and it became known as the Miller Amendment (§ 408), named for Miller himself. As we have seen, certain legislators and regulators worried that feeding a growing American population required chemical insecticides, while others were concerned about the potential risks that these chemicals, particularly chlorinated hydrocarbons and organophosphates, posed to consumers. The Miller Amendment addressed public health concerns by allowing registration only if manufacturers presented data that demonstrated residue levels on food crops posed no danger to public health. This stipulation granted the FDA the authority to set tolerances for each pesticide and crop, specifically raw agricultural commodities, such as fresh fruits, vegetables, or milk.107 Yet the amendment limited FDA’s regulatory jurisdiction to pesticides used on foods; non-food uses remained under the USDA, even in cases where pesticides could contaminate the environment and eventually produce exposures in foodstuffs. Historian John Perkins argued that the Miller Amendment legitimated the use of insecticides by establishing “insignificant” legal doses. According to Bosso, “Congress thus assured the public that, while residues might remain in or on food, the levels were not sufficiently toxic to warrant concern.”108 Under this amendment, the FDA needed to weigh the benefits of insecticides against the risk. This state of affairs prompted environmental scientist John Wargo to argue, “This dual standard, necessitating the protection of both public and economic health, has become the essence of the nation’s pesticide control strategy, as structured by FIFRA and FFDCA.”109

  In 1958 Congress approved the insertion of the Delaney Clause, which stated: “No additive shall be deemed safe if it is found to induce cancer when ingested by man or animal,” within the general safety clause of the FFDCA (§ 409).110 The Delaney Clause effectively prohibited the FDA, which set food tolerances, from approving any food additive shown to induce cancer in animals or humans. If a food additive (for example, an insecticide) caused cancer, the policy prohibited registration or set the tolerance for approved uses to zero, in effect banning the food additive. The regulatory power of this clause was not lost on legislators who supported the farm bloc: the FDA must ban any suspected carcinogen. Wargo has noted that in passing this legislation, Congress worried that this “zero risk” standard conflicted with the risk-benefit standard that balanced potential risks (toxic residues) with potential benefits (enhanced crop production).111 According to the environmental historian Nancy Langston, the Delaney Clause had the potential to be revolutionary by stipulating that “any substance known to cause cancer in test animals could not be added to food in any quantity whatsoever.”112 Thus, in Langston’s view, the Delaney Clause was a formal, legal expression of precaution, but its focus on carcinogens distracted attention from other hazards.

  The first application of the Delaney Clause followed shortly after President Dwight D. Eisenhower signed it into law in November 1958.113 Barely one year later, HEW Secretary Arthur S. Flemming invoked the clause to advise consumers not to buy cranberries, much to the consternation of growers who objected to the negative publicity so close to Thanksgiving (when 70 percent of cranberry sales occur). Flemming noted that some cranberry products on the market had been contaminated with aminotriazole, an herbicide with USDA approval. In 1957 the FDA issued a warning that aminotriazole left unsafe residues on fruit, and it seized and froze contaminated berries for further analysis. Tests for carcinogenicity took two years and they revealed that aminotriazole caused tumors in rats. These findings precipitated Flemming’s announcement and one of the first cases of something approaching mass hysteria as some states banned cranberries or urged caution. Growers and the USDA attacked Flemming and the FDA, arguing that they had not been consulted nor given adequate notice of the announcement. Desperate countermeasures to reestablish consumer confidence included televised broadcasts of Vice President Nixon and other public figures eating generous portions of cranberry sauce during their Thanksgiving feasts. Despite such efforts, cranberry sales plummeted, and losses to the industry rose to a staggering fifteen to twenty million dollars during 1959 (growers found not to be at fault later recovered ten million dollars in indemnity payments from the USDA). Despite the rather conflicted results of the first application of the Delaney Clause, the hearings and resulting legislation served as a crucial (albeit partial) step in the regulation of chemical pesticides.

  As we have seen, Congress, in the passage of FIFRA and the prolonged discussions of risks associated with chemical pesticides during the Delaney Hearings, had already begun to evaluate the testimony of toxicologists both in and out of government. Scientific uncertainty and lack of familiarity with the long-term effects of the newer insecticides stymied legislators’ efforts to draw general conclusions regarding risks associated with insecticides. Legislators were asking the questions that needed to be asked, but concrete answers remained elusive as the opinions of experts from the USDA, the FDA, industry, and academia diverged widely. Particularly unclear were the long-term risks associated with DDT and other chlorinated hydrocarbons. Certain target insects developed resistance to DDT, and evidence of transfer from cow to calf prompted USDA advisories regarding the use of DDT in dairy barns as early as 1949. One expert after another acknowledged the dangers of acute poisoning yet wondered about chronic toxicity. Evidence of risk to humans in particular remained murky. Even the nation’s leading pro-environmental cancer authority argued that not enough time had passed to determine the tumor-producing potential of DDT in humans. There was no question as to the toxicity and substantial risk of organophosphates, but many believed that their rapid decay offset risks. In striking contrast to most growers and food producers, officials at Beech-Nut Foods adopted a precautionary approach and tested for pesticide residues in its foods.

  Despite the uncertainty about pesticides, Congress revised existing legislation to address potential risks. The Miller Amendment restricted residues in foods and empowered the FDA to establish tolerances for foodstuffs. Seeking to minimize the risk of cancer through pesticides, Congress approved the Delaney Clause, stipulating that the FDA set the tolerance for any carcinogenic food additive to zero and effectively prohibiting FDA from registering any food additive shown to be carcinogenic (including pesticides). The first test of the new legislation came when the FDA advised consumers not to purchase cranberries after some cranberry products revealed contamination by aminotriazole. As the market for cranberries collapsed in the midst of mounting consumer panic, the president and vice president attempted to allay fears and growers defended their product. The cranberry scare brought the problems of chemical food additives and the new legisla
tion to national attention.

  CHAPTER 6

  Rereading Silent Spring

  By the late 1950s, toxicologists at the Tox Lab, the FDA, and elsewhere were working to establish toxicology as an independent discipline through courses, textbooks, a professional society, and a scholarly journal. Most Americans had little access to scientific research or the debates in the halls of government. As in the past, it again fell to popular science writers to bridge the gap between scientists, policy makers, and the public. Notable among them was Rachel Carson, whose Silent Spring quickly became a bestseller. Silent Spring alerted Americans to the hazards of insecticides, but it also inspired renewed interest within government even at the executive level. President John F. Kennedy called for further study through the President’s Scientific Advisory Committee, which recommended that Congress review interagency coordination. During the resulting hearings, Congress called on now-familiar witnesses to clarify risks associated with pesticides. Where testimony revealed obvious deficiencies in existing legislation, Congress took decisive action, but the strands of pesticide risk and benefit remained entangled in a Gordian knot.

  In August 1958, Kenneth DuBois sought to expand the research and teaching program in toxicology at the University of Chicago. The Toxicity Laboratory had been renamed the U.S. Air Force Radiation Laboratory in 1953, and all funding ($90,000) was dedicated to radiation research. This research extended well beyond Geiling’s work on radioisotopes in pharmacology. For example, Doull later recalled that one of his first tasks under the new contract was to collaborate with two other researchers to establish a screening program for radio-protective agents. Critically, the research group obtained LD50s for mice on several thousand agents. As Doull remembered: “The resulting large data base of acute toxicity data in male mice has subsequently proven to be of more lasting value than the few radio-protectors we found.”1