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Is It Safe?

BPA and the Struggle to Define the Safety of Chemicals

Sarah A. Vogel (Author)

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Paperback, 324 pages
ISBN: 9780520273580
December 2012
$29.95, £19.95
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We are all just a little bit plastic. Traces of bisphenol A or BPA, a chemical used in plastics production, are widely detected in our bodies and environment. Is this chemical, and its presence in the human body, safe? What is meant by safety? Who defines it, and according to what information? Is It Safe? narrates how the meaning of the safety of industrial chemicals has been historically produced by breakthroughs in environmental health research, which in turn trigger contests among trade associations, lawyers, politicians, and citizen activists to set new regulatory standards. Drawing on archival research and extensive interviews, author Sarah Vogel explores the roots of the contemporary debate over the safety of BPA, and the concerns presented by its estrogen-like effects even at low doses. Ultimately, she contends that science alone cannot resolve the political and economic conflicts at play in the definition of safety. To strike a sustainable balance between the interests of commerce and public health requires recognition that powerful interests will always try to shape the criteria for defining safety, and that the agenda for environmental health research should be protected from capture by any single interest group.
List of Illustrations
List of Abbreviations
Measurements
Preface
Acknowledgments
Introduction
1. Plastic Food
2. The “Toxicity Crisis” of the 1960s and 1970s
3. Regulatory Toxicity Testing and Environmental Estrogens
4. Endocrine Disruption: New Science, New Risks
5. The Low-Dose Debate
6. Battles over Bisphenol A
Epilogue
Notes
Index
Sarah Vogel is Managing Director of the Health program at the Environmental Defense Fund

Chapter 1

Plastic Food

Babies are not just little adults. This simple observation explains why the Beech-Nut Company, a manufacturer of baby foods, voluntarily chose to conduct safety tests of pesticide residues in its products. According to a company representative, its tests considered "prenatal, environmental, physiological, and structural [factors]-which may cause a baby to react to food residues in a manner different from the adult." As a reason for Beech-Nut's tests, the representative pointed to the pesticide DDT and evidence that its "estrogen-like" qualities negatively affected sexual development in young animals. Given the vulnerabilities of babies, the company established a near-zero tolerance for DDT in its products. These statements sound contemporary, but they were made more than fifty years ago at a congressional hearing on the risks of industrial chemicals in the food supply. The company bore the costs of and responsibilities for testing; in the early 1950s, the federal government required no premarket safety testing for the hundreds of new chemicals transforming food production in America of the sort that was required for new drugs.

Beech-Nut and other U.S. private food producers were essentially managing the potential risks of human exposure to hundreds of new industrial chemicals without any roadmap or rules. This came at a high price, at least for Beech-Nut, which spent thousands of dollars developing and conducting tests. The company was in a bind. On the one hand, consumers were demanding greater assurance of the safety of baby food, while on the other hand, the company's competitors found Beech-Nut's actions "hysterical." And so in the early 1950s, a Beech-Nut representative came before members of Congress to ask that the government fix this problem by setting tolerance limits or safety standards for all pesticides.

By the early 1950s, innovations from the Second World War, such as DDT and new plastic products such as Saran Wrap, were rapidly entering commercial markets. The speed and scope of commercial use of pesticides and plastics, specifically those derived from an abundant and cheap supply of petroleum, brought tremendous change to the American economy and environment. The petrochemical industry-the integration of the petroleum and chemical industry-had become the critical building block of a booming consumer economy. It promised abundance, ease, and prosperity, but it also introduced unprecedented hazards into the environment and into the human body.

A decade before Rachel Carson's Silent Spring (1962) popularized the dangers of pesticides, a small but vocal collection of consumers, scientists, and sympathetic politicians raised serious concerns about the long-term health impacts of pesticides, plastics, dyes, and many other classes of petrochemicals (derivatives of oil created when making gasoline) increasingly making their way into the American food supply. Over the course of the 1950s, Congress debated the need and, by the end of the decade, the scope of reforms to the 1938 Federal Food, Drug and Cosmetics Act to address new chemical hazards. The questions that emerged in these legislative debates considered how the state would manage and mitigate the seemingly inevitable risks of the new petrochemical age. What defined a chemical's safety if use and exposure were integral aspects of an advanced technological society? Answering this question shaped the political and scientific contours of debates in chemical policy for the next half century.

The Petrochemical Revolution

The 1950s marked the beginning of an unprecedented economic boom in the United States. The stable provision of cheap oil provided the foundation for this economic and material transformation. Securing a cheap and reliable oil supply required several elements: exploration of and investment in domestic reserves, government pricing controls-supported by administrations from Theodore Roosevelt to Jimmy Carter-and development of stable relations with oil-producing countries. In The Prize, a history of oil, Daniel Yergin argues that by the 1950s a new "petroleum world order" had emerged that secured a steady supply of cheap oil to the burgeoning American consumer economy. As world oil prices fell, domestic consumption grew rapidly-from 5.8 million barrels per day in 1949 to 16.4 million per day in 1972.

With the end of gasoline rationing in 1945, American drivers hit the road. Americans owned twenty-six million cars by the end of the war, and only five years later that number had nearly doubled. As the cold war heated up, the federal government continued to expand military contracts that had driven production during the war, thereby allowing the military to maintain its position as a major purchaser of U.S. goods and services. The expansion of the defense industry created new jobs, and government policies kept inflation and prices low, in particular the price of gasoline. In 1956, Eisenhower signed the Federal Highway Act, which allocated millions of dollars to the expansion of the interstate highway system. Cheap and available gasoline, cars, and highways spurred the development of suburban communities, many of which were financially supported by the government through the Veterans Administration (U.S. Department of Veterans Affairs) and the Federal Housing Administration's loans and tax incentives, developed to meet housing needs for returning soldiers and their families.

In the 1950s and 1960s, the petrochemical industry experienced a growth rate "two and a half times that of the gross national product." Although some petrochemicals were produced from coal and petroleum during the interwar period, it was the investments and expansion of the major U.S. petroleum companies in the 1940s and 1950s that transformed the industry. As Peter Spitz remarks in a business history of petrochemicals, "Regardless of the fact that Europe's chemical industry was for a long time more advanced than that in the United States, the future of organic chemicals was going to be related to petroleum, not coal, as soon as companies such as Union Carbide, Standard Oil (New Jersey), Shell, and Dow turned their attention to the production of petrochemicals." The vast supply of petroleum generated a cheap and ready source of petrochemicals. Chemical companies and oil producers began investing in value-added products made from petrochemicals, such as plastics, pharmaceuticals, and pesticides, and started to generate markets for these new products. In this way, supply drove demand and created new markets for goods. For example, large-scale direct foreign investments in agriculture in the 1960s created much-needed markets for Jersey Standard's pesticides.

Consumer markets for plastics and pesticides emerged almost overnight. The new suburban garage or kitchen was a veritable chemistry lab, full of new plastic surfaces, new poisons, and new cleaning products. Most notorious, of course, was DDT, used during the Second World War for mosquito control in the Pacific and Mediterranean regions to protect American soldiers against typhus, malaria, and yellow fever. After the war, the pesticide became commercially available to local governments, communities, residents, and farmers, who liberally sprayed DDT in residential neighborhoods and households to control for mosquitoes and other "pests." Many other pesticides, such as endrin, aldrin, and lindane, developed for war efforts, were rapidly introduced into large-scale agricultural production with the promise of raising crops yields and lowering food prices.

New plastics appeared on store shelves: the oven bag, a plastic bag that could be used to cook food at high temperatures; Saran Wrap, developed by Dow Chemical Company, as well as Reynold's polyethylene plastic films, created during the war and used commercially to encase precut meats and hold lunches for the on-the-go modern worker; plastic baby bottles for those long car trips; and Teflon pans that simplified cooking and cleaning. Plastic resins developed during the war to replace scarce tin as a preservative lining in cans (tinless cans) came into widespread use in the packaging of motor oil and food by the 1950s.

By-products of these new products were chemical residues, which began to be found in food and milk supplies by the late 1940s. Low levels of DDT and other pesticides were detected in food and milk; DES, the synthetic estrogen given to animals to increase meat production, appeared in edible tissue; and chemical compounds used in plastic wraps and packaging migrated into cheese, meat, and other foods. The risks of chemical exposure were no longer confined to the industrial workplace or the war front. They appeared in homes and on the dinner table. As traces of pesticides and plastics were contaminating air, water, and soil, the issue of the safety of chemicals in food captured political attention in the early 1950s.

Chemicals in Food in the 1950s

From 1950 to 1952, the House of Representatives formed a committee to investigate the impact of chemicals in food and held a series of hearings on the topic, led by Congressman James Delaney. A young liberal from the Queens District Attorney's office in New York with strong ties to the labor movement, Delaney first took his seat in Congress in 1944. Delaney's awareness about chemicals in the food supply began with DDT. Not long after the war, a fellow congressman told Delaney the following story. The congressman (whose name Delaney did not disclose) decided to spray his midwestern lakeshore property with DDT. Several days later, being an avid fisherman, he went out on the lake, only to find a disturbing number of dead fish floating in the water. Delaney found the story deeply unsettling and shared it with the Speaker of the House, Sam Rayburn (D-TX). If DDT could kill the fish in a large lake, what were the risks to Americans' health, given that people were eating food sprayed with the pesticide, and given that the pesticide was showing up in cows' milk? Rayburn agreed to have Congress look into the issue. In 1950, he initiated the Select Committee to Investigate Chemicals in Food Production and appointed Delaney as its chair.B

As it turned out, Delaney's involvement proved to be critical. For the next several decades, he embraced issues related to chemical safety and the need for greater governmental oversight of chemical production. He championed new regulations in food and ultimately helped to pass what became his crowning achievement in public office: the 1958 Federal Food, Drug and Cosmetics Act, or the Food Additives Act. The act expanded federal oversight of chemicals in food and included a short clause, memorialized as the Delaney clause, that prohibited carcinogenic, or cancer-causing, chemicals from the food supply. Delaney spent much of his career defending this clause, which, as soon as it was passed into law, became a source of contentious ideological and scientific debate about the meaning of chemical safety.

What troubled Congressman Delaney in the early 1950s was the tremendous lack of understanding about what new chemicals entering the food supply were doing to public health and the agricultural environment. At the time of the hearings, chemicals were known to inadvertently contaminate food as they leached from new plastics used in food packaging, as pesticide spraying left residue on crops, or, in the case of DES, as the chemical migrated into animals' edible tissue. Chemical preservatives, coloring, and emulsifiers were also increasingly being intentionally added to foods to enhance their color and texture as well as to extend their shelf life. The scope of Delaney's hearing considered all manmade chemicals in food-whether their presence was intentional or unintentional. In 1952, Delaney's committee reported that the FDA listed 704 chemicals in use in food production, of which 428 were considered "safe."

The paramount problem, Delaney asserted in an article in American Magazine, was the profound inadequacy of existing food law-"a tragic legal joker that permits us to become a nation of 150,000,000 guinea pigs guilelessly testing out chemicals that should have been tested adequately before they reached our kitchen shelves."While his rhetoric was aimed at waking up the public, or perhaps frightening the housewife in order to build political support for reform, his fundamental premise was sound. The FDA had only very limited authority under the 1938 Federal Food, Drug and Cosmetics Act (an amendment of the nation's first food safety law, the 1906 Pure Food and Drug Act) to set tolerance levels on "unavoidable poisonous substances," which included lead arsenate and Paris green, two inorganic pesticides. In the intervening years, the number of pesticides, preservatives, additives (including feed additives), and chemicals used in food packaging had exploded, as had their production levels, and there existed no requirement for testing these substances' safety before they came onto the market.

Food safety was an issue for which Delaney could find political support from his constituency in Long Island. It was a middle-class, consumer issue, and at the height of the cold war, when fear of nuclear war and the spread of communism strongly influenced foreign and domestic policies, it was also a politically moderate issue. Moreover, drawing consumer attention to "poisons" in the food supply did not collide with more politically sensitive issues of worker health and safety or, by association, the labor unions. Food safety was about consumer safety, and it affected congressmen and Long Island housewives alike. The target for legislative reform was the 1938 Federal Food, Drug and Cosmetics Act.

In 1906, rising concerns about food quality in the wake of reports about the unchecked adulteration of foods by substances of unknown risks or benefits had precipitated passage of the Progressive-era Pure Food and Drug Act. Publication of Upton Sinclair's The Jungle in 1905, which described in vivid detail the horrendous working conditions in the meatpacking industry, generated considerable public attention to the problem and the political motivation for the passage of the law. While the book was a strong critique of industrial capitalism, the Pure Food and Drug Act dealt with the safety of food per se, not the working conditions of industrial factories. The law prohibited foods with "any added poisonous or other added deleterious ingredient which may render such article injurious to health" and placed the burden of proving a substance was poisonous on a government agency: the Bureau of Chemistry, within the U.S. Department of Agriculture. This authority was later transferred to the Food, Drug and Insecticide Administration, created in 1927 and renamed the Food and Drug Administration in 1931.

The first amendment to the law, the Federal Food, Drug and Cosmetics Act, which was passed as part of New Deal reforms in 1938, expanded the power of the FDA to regulate labeling on food, cosmetics, and drugs and to seize dangerous products. The political impetus for the bill's passage was the tragic case of Dr. Massengill's Elixir Sulfanilamide, a liquid form of a sulfa drug that contained a toxic solvent, which reportedly killed over hundred people. "The policy tragedy of elixir sulfanilamide," as Daniel Carpenter explains, "established the basic lesson that undergirds gatekeeping power in American pharmaceutical policy. In the absence of a regulatory sentry at the border between drug development and market, this lesson says, people will be harmed, and massively so."

As it related to the FDA's oversight of food safety, the 1938 law upheld the absolute restriction of poisons from the food supply, permitted the agency to develop lists of approved ingredients, and provided authority for seizure of unsafe foods. The law also extended regulatory authority over medical devices and cosmetics and required premarket approval for drug safety. The New Deal policy held that in the absence of regulatory oversight the market would not act alone to protect the public's health. The burden of demonstrating that a substance presented a "reasonable possibility of harm to consumers" fell onto the agency itself, not the regulated industry. The 1938 law did not give the FDA the authority to require that a company notify the agency when it planned to use a new additive. Nor did it require that industry undertake toxicity testing. With the deluge of new petrochemicals in the late 1940s and 1950s, the agency was quickly overburdened. It could not require that companies provide it with any information, but at the same time it bore the heavy burden of ensuring that chemicals on the market would not harm consumers.

When Delaney's committee took up the issue of food safety in the early 1950s, they framed the problem very broadly and considered the potential impacts of chemicals in food on nutrition, soil quality, and animal and human health. The hearing's original mandate was to evaluate the "nature, extent, and effect of the use of chemicals, compounds, and synthetics in the production, processing, preparation, and packaging of food products" and their effects on the health of the nation and the agricultural economy. Further, the committee was to determine the "nature, extent, and effect" of fertilizers on soil, vegetation grown on that soil, animals eating that vegetation, the quality and quantity of food produced on such soil, and the health of the public. In other words, Congress was to consider the environmental and health impacts of a petrochemical-based agricultural system. Yet after eight years of resistance and debate, the 1958 reform of the food law ultimately provided for the continued expansion of a highly industrialized food production system intimately dependent upon and integrated with petrochemical production.

In the process of determining how regulatory authority would or would not be expanded, Congress debated some fundamental political questions that would shape chemical debates for the next half century: Was exposure to pesticides such as DDT, or feed additives such as DES, or compounds in plastic wraps that leached into foods an acceptable risk to the general public? Was it necessary and unavoidable? How would the state, the legislature, and the responsible regulatory agency, in this case the FDA, protect public health while simultaneously supporting a national economy increasingly integrated with the petrochemical industry? Who bore the burden of determining safety and risk? How would safety be defined and determined? Did some chemicals present too great a risk to be permitted into American food, or could any industrial chemical be considered safe if it were present in small doses?

When Congress met to evaluate the safety of chemicals in food in 1950, it heard from many sectors of society, including scientists, nutritionists, agriculturalists, representatives of the FDA and the U.S. Public Health Service, pure food activists, and representatives of the National Canners Association, the Grocery Manufacturers of America, the Manufacturing Chemists' Association (MCA), and the National Agricultural Chemicals Association. The MCA, which represented U.S. chemical producers, together with the food and pesticide trade associations, delivered a resolute and unified message to the committee: any reform of the food laws or extension of the FDA's oversight of chemical safety was unnecessary. According to the chemical trade association, the 1938 Federal Food, Drug and Cosmetics Act sufficiently protected the public's health. In the early 1950s, regulatory reform was an unwelcome prospect for the food and chemical industries, which were just developing new commercial markets for pesticides, preservatives, and packaging products. The industry trade association representatives asserted to members of Congress that these new chemicals didn't represent significant or novel risks to the public's health.

After all, "life has always been full of risk," quipped Dr. Robert Kehoe, director of the Kettering Laboratory at the University of Cincinnati, a research institution funded by the leaded-gasoline manufacturer Ethyl Corporation. From the 1920s to the 1950s, Kehoe's research on lead had provided the toxicological reasoning that supported the industry's position that lead exposure could be safe. Relying on the same logic first used to defend the introduction of lead into gasoline in the 1920s, Kehoe reassured Congress that all chemical hazards could be safe. Sure, DDT could be found in milk, he remarked, but like lead, the pesticide did not present a risk to humans at the low levels to which humans were exposed. These chemicals were new and synthetically produced, but that did not necessarily make them more harmful than the chemicals all around us every day. Even natural chemicals were dangerous at high levels. Further, he argued, since pesticides were necessary to produce cheap food, some level of risk was inevitable and unavoidable. The key was "to get that concentration which is without harm and which, if it has benefit, will provide benefit without the effect of harm." The risk of chemical exposures was just part of modern life and the trade-off for the benefits such compounds brought to society and, of course, to their producing companies. The solution to this problem, he told members of Congress, would be found, not in regulatory mechanisms to limit chemicals, but rather in expanded research to ensure their safe use. In other words, science would determine the levels at which humans could be safely exposed to all chemical hazards.

Charles W. Crawford, commissioner of the FDA from 1951 to 1954, strongly disagreed with the industry's confidence in the existing law. He had worked for the regulatory agency for thirty-four years and knew well the limits of the law given recent changes in food production. While the 1938 Food, Drug and Cosmetics Act theoretically restricted poisonous substances from the food supply, he argued, it provided no sufficient definition of or process to determine the safety of chemicals. Indeed, the lack of any safety standards in the 1938 law had been a major disappointment for some Progressive reformers at the time. The assistant secretary of agriculture under President Franklin D. Roosevelt, former Columbia University professor Rex Tugwell, who fought to lower pesticide tolerance levels and restrict dangerous chemicals from cosmetics, considered the 1938 law "disgraceful" because it set no standards, no penalties for fraud, and no restrictions on dangerous products and because it required testing only for drugs. The failure of the existing law was precisely why some companies, such as Beech-Nut, were forced to establish safety standards for themselves. Testifying before Congress in 1950, Commissioner Crawford roundly supported the requirement of premarket safety testing for all chemicals added to food, either directly, as in the case of preservatives and dyes, or indirectly, as in the case of chemicals that inadvertently contaminated food, such as compounds that leached out of resin in plastic packaging.

Determining what was safe was not as simple as Kehoe's argument that one must find the concentration where benefits outweigh risks. Awareness of the complexity of chemical risks was implicit in the Beech-Nut representative's concern for the potential long-term reproductive effects of pesticides in children. If one followed Kehoe's simple logic, a chemical's safety need not be based on who was exposed or how the chemical behaved. All toxic chemicals were presumed to function similarly in the complex process of human life and development, regardless of when exposure occurred. However, as the example of the estrogenic effects of DDT made clear in the 1950s, not all chemicals behaved similarly or simply. Most importantly, toxicity and carcinogenicity were not the same phenomenon.

Dr. Wilhelm Hueper, director of the Environmental Cancer Section of the National Cancer Institute (NCI), explained to members of Congress the difference between toxic chemicals and chemicals that cause cancer. Some compounds demonstrate very little toxicity, in that only very high doses of them result in death, but they are nonetheless highly carcinogenic. In other words, a chemical at a certain concentration might not cause immediate mortality, but over the long term it could cause cancer. To say that a chemical is nontoxic or has low toxicity, therefore, does not necessarily translate into noncarcinogenicity. Toxicity and carcinogenicity, Hueper argued, are not interchangeable categories, but rather separate biological processes. This distinction, according to Hueper, had been demonstrated in studies of reproductive cancers from DES exposure, as well as the carcinogenic effects of beta-naphthylamine. Both substances demonstrated low toxicity and carcinogenicity. Hueper stated that chemical safety tests should require consideration of the complexity of carcinogenicity, because of cancer's long latency period and evidence of carcinogens' effects on the young via maternal exposure. He recommended to Congress "that the uncontrolled use of any known or suspected agent with carcinogenic properties is not advisable."

Hueper's testimony before Congress, like his long research career, was highly controversial. A leader in the field of chemical carcinogens, Hueper was appointed as the first and, as it turned out, the only director of the NCI's Environmental Cancer Section in 1948. (The NCI was established in 1937 as part of the National Institutes of Health [NIH].) He had been fired from his position as chief pathologist at the DuPont Company in 1937 after he reported bladder cancers in workers exposed to the company's naphthylamine dye. For years, the company attempted to discredit Hueper's reputation, and it barred him from publishing or presenting any of his research findings from the company's lab. Dr. G.H. Gehrmann, a DuPont scientist, sent false charges to the Federal Bureau of Investigation (FBI) that Hueper had been a member of the Nazi Party. (Hueper had come to the United States from Germany in the 1930s.) Undeterred, Hueper published the first extensive review of chemical carcinogens in the workplace, Occupational Tumors and Allied Diseases, in 1942. Rachel Carson drew heavily from that text in her research for Silent Spring and spoke with Hueper several times while writing the book. In Silent Spring, she repeats Hueper's warning that exposure to carcinogens during pregnancy can result in cancers in the young.

Hueper served as director of the NCI's Environmental Cancer Section until 1964, but his tenure was plagued by persistent efforts to restrict his work, travel, and presentations, including testimony before Congress regarding the safety of chemicals in the food supply in the 1950s. In a twenty-page memo to the director of the NCI in 1959, he detailed attempts to discredit and slander his research and reputation, including efforts by senior staff at the FDA to block his testimony at the food additive hearings in the late 1950s by threatening to revoke his promotion. In 1958, Leroy Edgar Burney, U.S. surgeon general, denied the publication of a lengthy paper written by Hueper on the health hazards of food additives in consumer products, deeming it "unsuitable" at a time when Congress was debating reform of the food law. Dr. John Harvey, deputy commissioner of the FDA, told a Washington newspaper that Hueper's paper would raise unnecessary alarm in the public.

While Hueper's views on chemical carcinogens were unpopular and Hueper himself a controversial man, he was not alone in his concerns. His colleague Dr. William Smith, a former professor of industrial medicine at New York University (NYU) and chair of the International Union against Cancer, also came before Congress in the 1950s to explain the risks of chemical carcinogens. Like Hueper, Smith allegedly had lost his job at NYU because of his research on chemical hazards in the workplace. Smith informed members of Congress that pressure from the chemical industry had successfully halted research programs on environmental cancer at the NCI as well as at NYU. Industry pressure, Smith alleged, stymied research on chemical carcinogens by reducing available funding and eroding institutional and reputational support for the few researchers in the field. The NCI and NYU denied such accusations, but Hueper defended them.

The International Union against Cancer was an affiliation of cancer organizations from fifty nations, among them the U.S. Public Health Service. The organization first took up the issue of chemicals in food in 1939, but the outbreak of the Second World War delayed its activities until 1950, when the union reconvened and established a "unified position against cancer-causing chemicals in food." Four years later, well aware of the efforts to reform the food law in the United States, the union held its fifth meeting to discuss the problem of what it called "irreversible" toxic chemicals: those chemicals for which the union assumed no threshold of safe exposure existed, namely cancer-causing compounds or carcinogens. In 1956, the union issued a statement that called on all nations to restrict carcinogens from the food supply.

Carcinogens in Food

Of particular concern to both Hueper and Smith was the use of the potent synthetic estrogen DES in livestock. DES was the first synthetic (nonsteroidal) form of estrogen, developed by the British biochemist Edward Charles Dodds in the mid-1930s and commercialized in the early 1940s to treat numerous female "problems": menstruation difficulties, menopause symptoms, nausea during pregnancy, prevention of miscarriages. The drug also found use as a feed additive in poultry and livestock, as it increased the animals' weight and thus meat production.

Estrogen was first isolated in the late 1920s. The isolation and identification of hormones, which were then called internal secretions, including estrogen, testosterone, and insulin, were believed to hold great promise for the treatment of chronic diseases. The most promising discovery was insulin in the early 1920s: the hormone could bring diabetic patients back from the brink of death. Moreover, the ability to produce synthetic forms of insulin expanded medical treatment for hundreds. In the hopes of finding more wonder drugs, Edward Doisy, a biochemist who participated in the research to isolate insulin, worked to isolate estrogen with a fellow colleague, Edgar Allen, a biologist studying estrus, or menstrual cycles, in mice, at Washington University School of Medicine in St. Louis. They succeeded in 1929.

While estrogen had been studied by researchers as an elixir of youth and fertility and as a chemical messenger of femininity (as well as masculinity) as early as the mid-nineteenth century, its chemical isolation provided a pathway for developing cheaper, synthetic forms of the hormone, like DES, and increasing the market for the drug. The emerging market for estrogens involved the treatment of female reproductive issues, such as menopause, menstrual irregularities, miscarriage, and female behavior associated with menstruation (premenstrual syndrome), which were increasingly medicalized in the early twentieth century.

Edward Charles Dodds studied and then taught in the small biochemistry department at the University of London Middlesex Medical School in the 1920s and 1930s. He became fascinated with estrogen and its powerful ability to cause cells to proliferate. He presciently noted, "It is justifiable to say that hitherto no body has been isolated with such a powerful action upon the growth of cells, and it will not be surprising if this and similar bodies start a new era in the investigation of cell growth, and possibly of malignant disease." Dodds began his work in search of a less expensive synthetic form of the hormone in the late 1920s.

Contrary to the prevailing paradigm in hormone research at the time, Dodds and several of his colleagues believed that many chemical structures were capable of estrogenic activity. His research sought to identify the structure that provided the ultimate source of estrogen's activity. He did this by testing a number of compounds with chemical structures similar to that of natural estrogen. To test whether the chemical compounds exhibited estrogenic properties, Dodds removed the ovaries-the source of estrogen-of rodents and then exposed the animals to the various compounds. Removing the ovaries stopped estrus in the animals. Dodds identified a chemical as estrogenic if it induced estrus or caused the cornification of vaginal cells (the cells turned to harder tissue). The stronger the estrogen, the lower the concentration needed to elicit any of these responses.

Dodds tested a number of chemicals throughout the 1930s, including polycyclic aromatic compounds, identified as chemical carcinogens by his colleague James Cook, and fifteen derivatives of diphenyl and diphenyl methane (compounds with two phenol rings). Among the derivatives tested was BPA. In a 1936 paper, published in Nature, Dodds reported BPA's positive estrogenic response. Two years later, he published a paper that identified what he believed was the "mother-substance" of all estrogenic compounds: DES. The highly active estrogenicity of DES (only a low dose was needed to induce estrus in ovarectomized rodents), its purported low toxicity, and the fact that it was fully active when given orally to humans made it an ideal therapeutic drug, Dodds argued in the early 1950s.

DES and Premarin, a mixture of natural estrogens, were the first drugs reviewed by the FDA after the passage of the 1938 Federal Food, Drug and Cosmetics Act. The approval process for Premarin was fairly simple and uncontested, given that a number of natural estrogens were already on the market. DES, on the other hand, was a novel drug with unproven therapeutic uses and high estrogenic potency. In Toxic Bodies, historian Nancy Langston provides a detailed account of the FDA's approval of DES in the 1940s despite concerns about its potential carcinogenicity and reproductive toxicity. Research on DES in the 1930s demonstrated reproductive toxicity in laboratory animals and generally raised ongoing questions about the carcinogenicity of estrogen, whether natural or synthetic. Further, DES's therapeutic possibilities were unclear and undemonstrated, with reported side effects in women, such as nausea and vomiting. The FDA initially instructed drug companies to withdraw their applications for DES's drug approval. Yet deference to physicians, who largely supported the drug, combined with coordinated political pressure from industry, contributed to the drug's final approval in 1941. Langston explores a number of additional reasons for the agency's decision, including recognition by the FDA that some of its skepticism about the drug's safety was based "on evidence that could not be defended in court and therefore could not stand up against political pressure."

Hueper and Smith were particularly concerned with the public's exposure to the low levels of DES used to increased meat production in poultry and other livestock. The FDA allowed the use of DES in poultry in 1947 despite evidence of its residues in edible portions of meat, and use continued in the 1950s even after reports of reproductive effects in male restaurant workers and minks that consumed chicken heads (where the DES was implanted). In 1954, researchers at Iowa State College identified DES's ability to dramatically increase weight gain in cattle, and, although the FDA ultimately banned its use in poultry in 1959 due to its persistent detection in tissue, the FDA allowed its continued use in cattle until the end of the 1970s, given ongoing affirmations by producers that no DES was detectable in meat. Indeed, Eli Lilly and Company, a producer of DES for human treatment, successfully obtained agency approval for DES use in cattle because it demonstrated that no amount could be detected in the edible tissue of animals.

In 1956, Smith, along with Granville F. Knight, Martin Coda (the president and vice president, respectively, of the American Academy of Nutrition), and Rigoberto Iglesias, a physician and researcher from Chile, presented a paper on the dangers of DES at an FDA meeting on medicated feeds. They declared that DES was "known to induce cancer" and listed a number of reproductive pathologies associated with very low doses of DES-levels at which "the effective dose approaches the infinitesimal." They conjectured that the "administration of estrogens, among which diethylstilbestrol is one of the most potent, has led to a wide range of pathological changes in human beings and in animals. In mice, rats or guinea pigs, estrogens can induce polyps, fibroids and cancers of the uterus, cancers of the cervix, cancers of the breast, hyperplasia of prostatic stroma and of endometrium, tumors of the testicle and hypophysis, and lymphosarcomas." Such carcinogenic effects, according to these scientists, not only could occur at extremely low doses but also could result from continuous exposure. They wrote: "Most important, it hasbeen learned from animal work that intermittent injection of very large doses of estrogens is far less effective in inducing tumors than is a continuing exposure to an extremely minute dose. This phenomenon has been repeatedly observed by one of us (R.I.) [Rigoberto Iglesias] in experiments conducted over a period of nearly twenty years. It is a continuing exposure to extremely minute doses that is to be feared from the introduction of estrogens into the food supply."

Such concerns were a minority view at this meeting of regulatory agencies and industry representatives. Speakers from Lilly, Pfizer, and the Department of Agriculture questioned the legitimacy of such damaging DES research by highlighting common exposure to natural estrogens. Naturally occurring estrogens are present in foods and the human body, which meant, the speakers argued, that they don't necessarily present any harm. Moreover, the fact that DES had some adverse effects in one species didn't necessarily mean they would occur in humans. (Such efforts to minimize or generate uncertainty about any potential risk of synthetic or environmental estrogens would become a common tactic in attempts to challenge the validity of endocrine disruption forty years later.) For drug companies and meat producers in the mid-1950s, the benefits of increasing meat supply and thus making larger profits were far too great to worry about long-term exposure to minute amounts of the drug. President Eisenhower sent a message to the meeting, calling "the extensive and increasing use of medicated feeds supplied by a great and growing industry ... a boon to small scale as well as large producers of livestock," to the benefit of all.

For Smith and his colleagues, the fact that human exposure to carcinogens in the food supply mirrored the conditions of their experiments-low doses and continuous exposures-raised serious concern about the wisdom of widespread use of DES in food production. Fueling their alarm was the long latency period of cancer, which meant that effects of exposure to these chemicals wouldn't be detected for decades to come; by that point, the adverse effects would manifest and prevention would be too late. Smith and Hueper also worried about the recognized vulnerability of the young. As Hueper explained to Congress, "The newborn appears more sensitive to small doses of carcinogenic chemicals [than the adult]."

Hueper's concerns about low levels of chemical carcinogens also grew out of his research on several new plastics increasingly being used to package food. During Delaney's hearings, members of Congress heard about the expanding prevalence of new plastic containers and wraps. Many of these plastics could contaminate food because they leached chemical components of their polymers (i.e., complex chemical compounds composed of repeating molecular structures, which include proteins, DNA, carbohydrates, and plastics). Don Irish, a representative from Dow Chemical Company, confirmed before Congress that "in many types of plastics there are small amounts of ingredients which can be extracted" and thus released into food, making it necessary in these cases, he asserted, to determine their level of safety. In response to known leaching from plastics wraps, the Department of Agriculture, in the early 1950s, sought to require safety testing by the food industry. The government demanded that the tests examine health effects over a long duration of use, whereas the food industry contended that short-duration tests were sufficient. Expanding regulatory oversight of substances used in plastics packaging was not a welcome possibility for manufacturers of chemicals or plastics. Regulatory oversight was a new barrier to potential markets for plastics and extensive testing introduced new costs to business. Yet given emerging evidence of the carcinogenic effects of several plastics, there was reason to be concerned.

Barred from doing occupational research by officials at the NIH, Hueper conducted several experimental studies of plastics using rodents. In 1956, he published a study that reported carcinogenic responses in rats exposed to polyvinylpyrrolidone (PVP), a polymer used for diverse purposes, including as an adhesive and emulsifier (a substance that combines two other substances that would not otherwise mix). The following year, another researcher reproduced Hueper's findings, further substantiating PVP's carcinogenicity.

Not all research on plastics began with an intentional design. Some resulted from moments of serendipity in the research laboratory as plastics expanded into new markets. Plastic wraps, like plastic containers in the 1980s and 1990s, were commonly used in the kitchen, as well as scientific laboratories, by the 1950s. In the early 1950s, while conducting a study of a hypertension drug in rats, Dr. Bernard Oppenheimer, a cardiologist, and Dr. Enid Oppenheimer, a physiologist (along with their colleague Arthur Purdy Stout), researchers at the College of Physicians and Surgeons at Columbia University, wrapped rat kidneys in plastic film to induce high blood pressure in the animals. After several years, the Columbia researchers observed that seven of these same rats had developed malignant tumors at the sites where their kidneys were encased in the film and that the cancer had metastasized to other organs. The researchers also found that tumors could be induced if they imbedded plastic film in the abdominal wall of rats. These findings, the researchers remarked, led them to investigate which chemicals might be causing the tumors. In Cancer Research in 1955, the researchers described the very high rate of malignant tumors that developed over several years in rats exposed to a number of plastics, including polyvinyl chloride (PVC), Saran Wrap, polyethylene, Dacron, cellophane, and Teflon. With funding from the NCI, the Oppenheimer team began a series of investigations into plastic films and the monomers added to plastics as stabilizers, plasticizers, and catalysts.

News of these findings received national attention. "The discovery by Dr. Oppenheimer and his associates is important because it indicates that there [are] probably scores of plastics that can generate tumors," the New York Times reported in 1952. News that hundreds of chemicals were making their way into food without any testing provided fodder for reform. If Hueper, Smith, and his colleagues' concerns were credible, the presence of carcinogens even at low levels could present a serious long-term public health risk. Such scientific reasoning lent legitimacy to Delaney's support for regulatory oversight of all chemicals used in food processing, production, and packaging. Delaney's committee drew up a long list of chemicals that should be subjected to regulatory oversight, including pesticides, insecticides, growth regulators, preservatives, and mold inhibitors, as well as chemicals used in plastic packaging, including resins and plasticizers used in tin-can coatings (i.e., phenol-formaldehyde resins and phthalates), for which there was little toxicological information. The committee's report brought the issue to national attention, and for the next six years Congress considered efforts to reform the Food, Drug and Cosmetics Act. A first step in this process was the Miller Amendment to the act, passed in 1954, which established tolerance levels for pesticide residues in food. Delaney considered the amendment to be only a partial response to his committee's full recommendation: the premarket testing of all chemicals, not just pesticides, contaminating food.

Regulating Chemicals in the Food Supply

Delaney's hearings in the early 1950s galvanized a nascent consumer movement. In 1955, a small consumer health advocacy group, the National Health Federation, formed to apply direct pressure on Congress to reform food legislation. It initiated a letter-writing campaign aimed at members of Congress calling for reform; dozens of letters poured into Delaney's office from citizens across the country, encouraging the congressman to initiate additional hearings on food safety. The letters frequently included a request for a copy of the 1950-52 hearings. Indeed, the Government Printing Office received so many requests that it had to print additional copies of the hearings.

In 1956, Gloria Swanson, an Academy Award-winning actress, a fashion icon of the 1920s and 1930s and an avid health food advocate, addressed a gathering of congressmen's wives in Washington on the need for food law reform. (Unlike today, most congressmen moved their entire families to Washington during their terms.) Delaney recalled that immediately after Swanson's address members of Congress approached him in the halls to inform him that their wives insisted that they support his legislation. After nearly losing his seat because of what he considered to be industry pressure, Delaney returned to Capitol Hill in 1956 and initiated a second round of hearings to discuss a number of new reform bills.

In response to increased public and political pressure, the chemical industry's strategy shifted significantly in the mid-1950s. Its initial opposition to reform, voiced at Delaney's first hearings, gave way to industry-sponsored legislation. After Delaney's committee released its recommendations for premarket testing of all chemicals in food production in 1952, the chemical trade association MCA hired its first public relations firm, Hill and Knowlton, and registered for the first time as a lobbying organization. By the early 1950s, the chemical industry, according to MCA president George Merck, had yet to spend even two hundred thousand dollars on public relations. This was in stark contrast to the steel and petroleum industries, which at the time each spent around two million dollars a year. In a discussion of this new public relations push, Merck, chairman of Merck and Company, "enjoined the chemical industry to associate themselves with 'science' in the public mind." He explained, "[The] public has been taught to be interested in science; moreover, they have come to respect the scientist. The industry would do well to identify itself to the public as the organizational mechanism through which the contributions of science are made available for everyday use." In other words, the trade association should speak for science in order to instill public trust in the industry and in the safety and benefits of its products.

The struggle to manage and directly influence the legislative reform process was the chemical and plastics trade associations' first significant battle in the decades before major environmental and occupational safety and health laws were passed. It was in the 1950s that the MCA began transforming into the organization that the leading lawyer for the plastics industry, Jerome Heckman, would later call a "quasi-public institution": one that speaks for science and advises on the direction and implementation of regulatory laws.

Perhaps the greatest threat to industry trade representatives in negotiations over food legislation was the position of the International Union against Cancer on carcinogens. In a lengthy letter to Delaney in 1957, Smith stressed the special dangers of carcinogens and recommended additional legislative language to address these risks. "Responsible bodies of experts," including the International Union against Cancer, Smith wrote, "have clearly stated that safe doses cannot yet be established with certainty for carcinogens." Smith explained that in his own work with laboratory animals he had induced cancerous tumors with "single, very small, doses" of known carcinogens. Working with the chemical urethane, Smith continued, he had induced lung tumors by exposing female rats during their pregnancies. Without knowledge of the safe dose of carcinogens, and given the consensus among international experts that small doses could induce cancer, Smith forcefully argued against allowing carcinogens into the food supply. There is "no moral justification," Smith wrote, "for obliging the consumer, many of whom are children, with life expectancies serving the long latent period of carcinogens, to accept such needless risks." For him the problem was simple: the risks were too high-small doses of carcinogens could cause cancer, and these hazards were in the food supply-and carcinogens' benefits were questionable. Given the grave risks of carcinogenic substances, Smith recommended that the following statement be included in the new law: "The Secretary shall in no case approve for use in food any substance found to induce cancer in man or in tests upon animals." According to Smith, some chemicals should be considered unacceptable regardless of the concentration at which they are present in the food-that is, they should be considered unsafe per se.

Faced with inevitable reform of the food law and demands to restrict all carcinogens from the food supply, the chemical and plastics trade associations changed tactics, and by 1957 sought to develop and promote legislation that would provide "the most comprehensive exemption provision possible." If reform was coming, the industry trade associations wanted to ensure that it would be the reform least burdensome to business. This meant arguing for the absolute necessity of hundreds of chemicals, including chemical carcinogens, in food production and limiting federal oversight and regulation of these compounds, while at the same time providing the legal security of federally sanctioned safety standards.

Defining Safety in the Food Additives Act

The shift in industry support for food reform may also be attributed to the new leadership at the FDA, Commissioner George Larrick, who began his long career at the FDA in 1923 as a food and drug inspector and served as commissioner after Charles Crawford, from 1954 to 1962. According to the 1938 Food, Drug and Cosmetic Act, all poisonous substances were to be absolutely restricted from food. Such an antiquated approach to chemicals, Larrick told members of Congress, failed to account for profound changes in food production since 1938. Risks of exposure were inevitable and unavoidable aspects of modern life. Therefore, any attempt to absolutely restrict chemicals, he contended, was naive and impractical. His position was welcome news to industry. Defining chemical hazards as poisons per se that must be banned from food was an impossible position from industry's perspective.

During Larrick's tenure, the FDA's budget increased tenfold, followed by expansions in facilities, laboratories, and regulatory oversight. In Larrick, the drug and chemical industries found a commissioner who shared their policy positions, or at least could be influenced to do so. As Daniel Carpenter remarks in his history of drug policy at the FDA, "Larrick is portrayed alternatively as a bumble or an industry sop. Images abound of drug company officials walking unimpeded through the agency's corridors, setting up informal residence and hounding medical reviewers."

When asked by Congressman Joseph O'Hara (R-MN), who worked with the MCA to introduce a food reform bill, whether he believed that food manufacturers were concerned with protecting the public interest, Larrick answered, "Yes." This new attitude toward industry, O'Hara remarked, provided "great relief." Reversal of the 1938 "strict policy of the law against poisons in our food" could be done safely, Larrick explained, sounding not unlike Robert Kehoe in the early 1950s, by minimizing public exposure to chemical hazards. In this way, the purported benefits of chemicals could be reaped while protecting public health.

Lawrence Coleman of the MCA echoed Larrick's articulation of chemical safety. "We must divorce from our thinking and from the administration of the food laws," Coleman contended in the hearings, "the idea that 'poisonous' or 'deleterious' are absolute concepts; that a food additive can be denominated a poison without reference to the quantity ingested by a human being." Poison, he argued, was a "relative concept." In other words, "Dosage is key" to determining safety.

The notion that a chemical's toxicity was relative to its dose followed the legal principle of de minimus non curat lex, or "the law does not concern itself with trifles." That is, at the very low concentrations where toxic effects declined, the law might not apply. A de minimus approach to chemical hazards contrasted directly with the concept of a chemical hazard or poison per se, as articulated in the 1938 law. Under a de minimus interpretation, a chemical could be safely permitted in food when the risks were minimal. This shift in the legal framework of food law was essential for industry support of reform.

And, indeed, the final version of the food reform legislation, the 1958 Federal Food, Drug and Cosmetics Act, or the Food Additive Act, included a regulatory framework quite favorable to the chemical trade association. While the law did require premarket testing for all chemicals in food, as called for by Delaney's committee, it also included a number of loopholes for excluding chemicals from regulatory oversight. These included those compounds in use before the amended law, chemicals regarded as safe, and those below any detectable level in food. Such exemptions are evident in the definition of a "food additive" under the 1958 food law.

The law defines a food additive as "any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food." The phrase "may reasonably be expected" provided for regulation that followed the de minimus standard. In other words, a chemical had to "reasonably be" present in food to be deemed a food additive. Substances that were "generally recognized, among experts ... to be safe under the conditions of its intended use" would be exempted. This "generally recognized as safe" clause in the law, which became known as the GRAS standard, grandfathered in hundreds of chemicals used before 1958 as prima facie safe, requiring no testing and marking a tremendous victory for industry.

The 1958 law also included a judicial review clause, which the chemical industry strongly supported. Judicial review provided a legal process through which FDA decisions and actions could be challenged in the courts. In the 1950s, the judicial review process established a procedural check on the administrative authority of regulatory agencies. (Twenty years later, environmental organizations began to successfully use this system of checks and balances to push for regulatory oversight and stronger safety standards.)

Legal authority for the judicial review clause had been only recently established under the Administrative Procedures Act (APA), passed by Congress in 1946. Under the APA, the courts are required to review any regulatory action to determine whether it conforms to the original statute and if it is "arbitrary, capricious, an abuse of discretion or otherwise not in accordance with the law." In 1951, the Supreme Court ruled, in Universal Camera Corporation v. National Labor Relations Board, that the APA directed the courts to take greater responsibility in determining the "reasonableness" and "fairness" of regulatory decisions. The Universal decision ruled that in evaluating "reasonableness" the courts must consider the "weight of the evidence," including "whatever in the record fairly detracts from the weight of the evidence."

Support of judicial review came from the American Bar Association and conservative political leaders seeking to place checks on the expanded regulatory authority promulgated by New Deal legislation. And, indeed, the FDA recognized judicial review as a threat to its expert opinion and autonomy. William Goodrich, assistant general counsel of the FDA, came before members of Congress during a food reform hearing to vehemently oppose such a provision. Throwing open expert opinion and agency decision making to the courts, Goodrich argued, ultimately would shift the burden of proof from the industries to the FDA. In court, the agency would have to prove the lack of safety, as opposed to industry having to prove safety. Defining safety, Goodrich contended, should not be "a popularity contest before the judge. It is not a question of demeanor or veracity.... It is an informed, understanding study of a scientific experiment. I don't believe that juries or judges ... are competent to pass on that kind of question."

Goodrich made a subtle point worth highlighting as the courts today play increasingly powerful roles as arbiters of scientific disputes in regulations. The regulated industry welcomed the burden of testing, or determining safety, as a form of self-regulation. While this shifting of the burden of testing from the FDA to industry was necessary and welcomed by the agency, providing industry with the legal means to challenge a scientific decision by the agency effectively moved the task of demonstrating lack of safety or a need for regulatory action back to the FDA. In this way, industry effectively controlled safety determination through either self-regulation or the courts. The result, from Goodrich's perspective, was a significant undermining of agency expertise and authority. His concerns were prescient. In the years to come, efforts by the FDA and later the EPA to set regulatory safety standards were chronically stalled and delayed by lengthy judicial reviews.

Finally, industry and probusiness legislators also successfully defeated the FDA's demand that producers define the "functional value" of a food additive, a requirement supported by Larrick. This would have created regulatory oversight of the benefits of a chemical and its impact on nutrition. A food additive would then need to be both safe and beneficial. At the time, the FDA lacked the authority to demand safety and effectiveness of drugs, a provision that would come in 1962 with the Kefauver-Harris Amendment. Conservative lawmakers viewed such a provision as an affront to the free market. In questioning the commissioner, Congressman Martin Dies (D-TX) questioned whether, in a "free enterprise" society, the government should make decisions about what consumers consider beneficial to their lives: "The best criteria is whether the public is willing to buy the product. They are the final arbiters," not the FDA, Dies argued to Larrick.

From the perspective of the affected industries, the GRAS clause, the reversal of the FDA's policy to absolutely restrict chemicals as "poisons," the inclusion of the judicial review process, and the cutting of the functional value clause added up to a very favorable law. Safety would be determined according to dose, and the "reasonableness" of the standard established could be challenged in court if necessary. Industry might have claimed a wholesale victory, save for one clause that created an exception for carcinogens.

In the final negotiations on the bill, Delaney lost considerable ground to industry demands and FDA concessions, and Smith condemned the FDA for its failure to support Delaney's bill: "I am told ... that FDA prepared that bill with the knowledge and approval of food industries." He went on to decry the bill's failure to address carcinogens. The absence of Smith's language on carcinogens in the final version of the bill provoked Delaney to stall its passage until Larrick agreed to meet with the congressmen to discuss a possible compromise. After a closed-door negotiation with the FDA, the agency agreed to support inclusion of the following passage: "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 animals." This language became known as the Delaney clause, the anticancer clause, or the zero-tolerance clause. It opened the door for a per seruling on those chemicals deemed carcinogenic and established a legal trigger to ban substances. The prevailing question for industry trade lawyers upon the passage of the 1958 Food, Drug and Cosmetics Act was how the FDA would interpret the Delaney clause. It quickly became a significant thorn in the side of the chemical industry and its lawyers, who would work for decades to minimize its impact and ultimately to remove it from parts of the law.

The obvious problem for the chemical trade association was that chemical carcinogens-DES, plastics, and some pesticides-were used in food production. For example, in February 1957, the MCA's Plastics Committee discussed a number of recently published papers, including the Oppenheimers' work, on the carcinogenic effects of plastic films in food packaging. "The Committee reviewed recent allegations that some plastic materials and specifically polyethylene might promote cancerous growth. In recognition of the importance of plastic materials in food handling and the damaging effect of such irresponsible claims, the Committee asked for the advice of the MCA's Chemicals in Foods Committee as to what should be done, if anything." A review of the literature on toxicity of plastics was sponsored by the B.F. Goodrich Company. The report, presented at the Industrial Hygiene Conference in 1959, cleared many plastics as safe for human use. In summaries of nylon, polyethylene, and vinyl resins, the B.F. Goodrich researchers referenced the work of the Oppenheimers and Hueper, yet concluded that all these plastics were "nontoxic," making no mention of carcinogenicity.

Implementing the Food Additives Act

One lawyer in particular played an essential role in implementing the new food law: Jerome Heckman (see the introduction), a lawyer for the Society of the Plastics Industry (SPI), the trade association of the plastics industry. Heckman effectively guided those in the chemical industry affected by the new law through the loopholes of the regulations and skillfully interpreted the Delaney clause. In the process, he built a global law firm with leading expertise in food law.

A 1952 graduate of Georgetown Law School, Heckman took his first job with the law firm Dow, Lohnen and Albertson, with an interest in radio communications. In one of Heckman's first cases, he represented George Russell, a prominent businessman who owned several radio and television stations and the leading newspaper in Seattle, and who was "active in the lumber industry." Russell had developed a company that manufactured equipment for laminating "wood shreds together with glue by passing the combination through a wave guide where radio energy" melted the glue. The company faced a serious obstacle in using the technology because the FCC restricted many uses of radio frequencies. Working with Russell, Heckman became an expert in the technology and made recommendations to the FCC that resulted in rulings in the client's favor. As it turned out, the plastics industry also used this technology and was similarly concerned about the FCC rules. This brought the SPI's executive vice president to Dow, Lohnen and Albertson and subsequently to Heckman, who worked on the trade association's FCC case. The SPI ultimately retained Heckman, still a young but accomplished associate. Heckman became the SPI's general counsel, a position he holds to this day at his law firm, Keller and Heckman. Heckman's success in keeping markets open for the plastics industry earned him godlike status at the trade association and a place in the Plastics Hall of Fame.

In the years immediately following passage of the food law, Heckman worked with the FDA and SPI to implement the law in a way that would best support his clients' interests. In his regular meetings with the FDA in the late 1950s and early 1960s, Heckman ascertained the agency's position on the Delaney clause. He recognized that any public argument against the need to protect Americans from carcinogens was an impossible one for the industry to make. As Heckman later remarked, "How do you argue against that?!" What Heckman sought and received from the agency was the assurance that the FDA was not planning to enforce the Delaney clause as a per se standard. The carcinogen clause, Heckman informed industry leaders, would be interpreted in accordance with the concept that risk was relative to dose. No carcinogens allowed in food, therefore, would be interpreted, not as absolute, theoretical zero, but as no detectable amount. If the agency were to have interpreted the clause as a restriction on carcinogens per se (i.e., theoretical zero),it would have led to the banning of nearly everything, Heckman noted many years later.

He also worked to secure legal exemptions for those chemicals in the GRAS category and those in "prior use." The GRAS category included over two hundred chemicals that were considered safe by "experts qualified by scientific training" and thus would not require additional safety testing. The second exemption, prior use, included those substances that had been sanctioned by the FDA before 1958. This category included nearly every major plastic product in use before 1958, including vinyl chloride.

For those chemicals that still needed FDA approval, Heckman worked with the agency to establish a mutually agreed-upon process to submit information necessary for market approval (i.e., petitions) to the agency. An important aspect was minimization of requirements for submitting toxicological and migration data to the FDA. Petitions, according to Heckman, needed to follow a standard procedure that would protect the collective industry, as opposed to providing a single manufacturer with a competitive edge. Inconsistency in detection limits used by producers and differences in migration levels demanded standardization of methodologies. For example, the agency reported to the industry that polyethylene was found in fatty foods up to 100 parts per million (ppm), whereas the prior sanctioned use had allowed only 1 to 2 ppm. Polyethylene and polystyrene manufacturers, organized by the SPI, responded by developing standardized methods to detect migration and to determine how a petition would be written and submitted to the FDA.

Speaking before the SPI's Food Packaging Materials Committee, Heckman informed producers that petitions did not require the submission of any toxicological data, on the basis of the "fact that most of the chemical substances involved are either prior sanctioned, or generally recognized as safe, or that toxicity data has previously been submitted in filing with Food and Drug by individual companies." Manufacturers should provide methods for determining migration levels but did not need to file specific analytical data. The presumption was that all producers would meet the standard and, effectively, self-regulate. According to Heckman, during this period the FDA shifted away from demanding analytical data on migration and sought to simplify the process by requiring that petitions include only a description of testing methods used to determine migration.

Heckman assured the Food Packaging Materials Committee that the FDA "recognizes the fact that the Food Additives Amendment of 1958 was not only not drafted with incidental additives [indirect food additives such as plastic monomers that migrate into food] in mind, but ... is ... inept as a statutory device to regulate food packaging materials." This was because the "analytical methods to determine the amount of incidental additive migration into food are, as a practical matter, impossible to develop." In other words, according to Heckman and some officials at the FDA, plastic packaging was effectively exempted from regulatory oversight by prior use or because of the assumption that chemicals that migrated from plastics into food did so at levels either below or barely above detectable levels and thus presented an insignificant risk to public health. What you can't see won't hurt you. "Whatever the lawyers may think of this evolution," Heckman concluded, "and the degree to which the treatment afforded packaging materials complies with the statutory mandate, and regardless of how the scientific world will accept the new FDA attitude, we are sure that the salesmen among you will be pleased." In the end, Heckman reassured plastics producers, "Packaging is not a threat to the public health."

In the decade after the passage of the 1958 Federal Food, Drug and Cosmetics Act, or the Food Additives Act, the chemical, plastics, and food industry trade associations worked diligently to pull the teeth from the Delaney clause by ensuring that it did not provide legal precedent for a per se interpretation of a hazard. In 1962, the FDA passed the DES proviso, which permitted use of the synthetic estrogen, despite evidence of its carcinogenicity, in livestock provided that no detectable residue could be found in human food. A chemical, therefore, would not be banned simply because it was used in food production per se and found to be carcinogenic. There needed to be quantitative evidence of its presence, which meant that the definition of a food additive and its "safe" use would be tied to changes in analytical chemistry. This generated a considerable problem for the producers of DES and other suspected carcinogens, however, because as methods changed and detection thresholds fell, a chemical's safety theoretically could come into question and the chemical could be subject to a ban.

Industry ideally sought to harmonize the process of setting safety standards for carcinogens and noncarcinogens in a way that upheld the assumption that, at some small concentration, all risks, as Kehoe had remarked in the early 1950s, were manageable and acceptable. Such an approach would stabilize the process of defining safety. Lost in this framework of risk was any distinction between carcinogenicity and toxicity as articulated by men such as Smith and Hueper, who argued that a carcinogen can be low in toxicity but of significant concern when exposure occurs over a lifetime and in the very young.

When public interest groups sought to force the FDA to actively use the Delaney clause to pull carcinogens from the market in the 1970s, they relied on evidence of carcinogenic effects from high-dose studies on adult animals. Their goal at the time was to enforce a per se interpretation of the Delaney clause and ban a few high-profile carcinogens from the food supply. This resulted in a distorted notion that public interest groups sought to ban anything that caused even a single rat to die of cancer. Similar contentions that public fears about carcinogens were wildly disproportionate to their true risks pointed to the fact that in order to replicate animal studies, humans would need to consume large amounts of chemicals, when in fact human exposures were very low. Arguments for keeping carcinogens out of the food supply came to be viewed as anathema to progress. Exposure to pesticides, plastics, and preservatives was described as negligible and as a necessary side effect of modern society. Consideration of the risks of chronic low-level exposures in the young, and thus the added variable of time, subsequently found no place in debates over interpretation of the Delaney clause or the definition of safety. The normative assumptions that "life is full of risks" and that, if risk is managed well, a "little bit can't hurt" would form the logical framework used to evaluate and define chemical safety for decades to come.

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