|
A Broken Record How the FDA Legalized ¾ A special report by Public Citizen’s and the Cancer Prevention Coalition Executive Summary This past May—almost 45 years to the day after a U.S. Army general proudly showed members of Congress a picture of a beef tenderloin that had undergone "radiation sterilization"—irradiated meat went on public sale in the United States. Today, somewhere in Iowa or Florida or North Dakota, someone is biting into a hamburger that has been irradiated with the equivalent of 150 million chest x-rays—and maybe sprinkling it with spices that have been "treated" with the equivalent of 1 billion chest x-rays. Has the U.S. Food and Drug Administration done its job to ensure that this food—food that has been exposed to deadly radioactive material or electrons fired nearly to the speed of light—is safe for human consumption? Unfortunately, for the American consumer, the answer is ‘No.’ In the most in-depth investigation ever conducted into the FDA’s oversight of food irradiation, these disturbing facts have come to light:
In short, the FDA has legalized high-dose radiation "treatments" of fruit, vegetables, beef, pork, lamb, eggs and spices—all without certifying that any of the scientific studies they used to justify these decisions met modern standards. In this report, we attempt to answer the questions "Who?" "What?" "Where?" and "How?" One questions remains: "Why?" Food Irradiation: Roots and Reasons From efforts by the Atomic Energy Commission to fulfill the promise of President Eisenhower’s "Atoms for Peace" program, to efforts by the Energy Department to find markets for radioactive waste generated by nuclear bomb facilities and power plants… From efforts by the food industry to rid their products of pathogens and extend their global reach by increasing shelf-life, to efforts by the weapons industry to find new applications for "Star Wars" technology… The history of food irradiation is a long one and, like the technology itself, there is far more to it than meets the eye. In the mid-1960s, after more than a decade of research, the U.S. Army sent a few thousand pounds of irradiated bacon to military personnel in Vietnam. In 1968, however, the Food and Drug Administration (FDA) revoked the Army’s irradiation permit after reviewing previously unreleased Army records indicating that lab animals fed irradiated food suffered premature death, cancer, reproductive dysfunction and other problems.1 A Congress member remarked after learning of the previously hidden Army documents, "We were guinea pigs."2 Meanwhile, international interest in the technology had grown enough to prevent food irradiation from joining atomic locomotives and airplanes, nuclear-powered pacemakers and wristwatches, and plutonium-heated long johns in the ash bin of history. During a meeting in Rome in 1964, officials from the United Nations and International Atomic Energy Agency resolved to "influence legislation in various countries" and "facilitate international acceptance of the process."3 During the 1970s, pressure mounted on DOE officials to solve their radioactive waste problems at two nuclear bomb factories—Hanford in Washington and Savannah River in South Carolina. Food irradiation rose to the top of the list of solutions. "I frankly would like to see us use everything," a DOE official told a congressional committee in 1983, "including the squeal, if you want to refer to pork, we possibly can."4 In 1979 FDA toxicology director Hubert Blumenthal—while serving on the international committee that sought to "influence" national legislation—called for the creation of the FDA’s Irradiated Food Committee (IFC). Based on a theoretical calculation of how many new chemicals are formed in irradiated food, the panel recommended no further testing for food irradiated at low levels and for food comprising a small percentage of the typical American’s diet.5 The panel recommended animal testing for high-level irradiation,6 but the battery of tests was far less comprehensive than the battery normally used by the FDA.7 Two years later, a second FDA panel reviewed 409 toxicology studies on irradiated food and labeled all but five of them "deficient."8 Though none of the five studies met FDA standards, they formed the foundation of FDA rulings to legalize the irradiation of spices in 1983;9 pork in 1985;10 fruit, vegetables and spices in 1986;11 poultry in 1990;12 beef and lamb in 1997;13 and eggs this past July.14 (See "Food Irradiation Timeline," Appendix I.) New Chemicals Never Studied Before legalizing a food additive for human consumption, the FDA is required by federal regulations to establish at least a 100-fold safety factor for humans. This is achieved by determining the highest level at which laboratory animals are unharmed by a proposed additive—the "highest no-adverse effect level"—and then dividing that level by 100.15 In the case of irradiated food, the "additive" is comprised of new chemical compounds called unique radiolytic products (URPs) formed in food when it is exposed to radiation. In 1977 the first in-depth analysis of the radiolytic products formed in irradiated food was released. Working under an Army contract, the Federation of American Societies of Experimental Biology (FASEB) of Bethesda, Md., measured the concentrations of 65 chemical compounds in irradiated beef and found that 55 either did not occur naturally in beef, did not occur naturally in any food, or increased in concentration when exposed to radiation. FASEB scientists, for example, measured a 650 percent increase in the concentration of benzene—a "known human carcinogen" according to the U.S. Environmental Protection Agency.16 (See Chart 2.) FASEB scientists became among the first to publicly acknowledge the unlikelihood of identifying every new chemical formed in irradiated food: "The possible presence of undetected substances can never be excluded."17 Despite these uncertainties, the FDA’s Irradiated Food Committee did not recommend further experiments for foods irradiated at low levels or for foods that comprise a very small portion of the typical American’s diet. The IFC also stated, without presenting specific evidence, that any URPs formed in irradiated food likely would not cause health problems in humans because the chemicals likely would be similar to chemicals in non-irradiated food. The IFC also did not discuss the formation of radiolytic products (unique or otherwise) in poultry, pork, fruit, vegetables, eggs and other classes of food for which the FDA subsequently legalized irradiation. Furthermore, the IFC report included little or no discussion about establishing a 100-fold safety factor for humans by determining the highest no-adverse effect level for lab animals; how—or even whether—researchers should identify or quantify radiolytic products; or whether the testing of radiolytic products generated in one class of food could be used to demonstrate the safety of other classes of irradiated food. Most significantly, the IFC prescribed a series of experiments far more limited than those detailed in the FDA’s published guidelines, which required five short-term mutagenicity studies, two-year carcinogenicity tests on two rodent species, one-year toxicity tests on one rodent and one non-rodent species, and a multigeneration reproduction/teratology test on rodents.18 A review of FDA documents reveals that the agency neither fulfilled its own testing requirements, nor determined the highest no-adverse effect level for lab animals or 100-fold safety factor for humans when the agency legalized the irradiation of pork in 1985; fruit, vegetables and spices in 1986; poultry in 1990; red meat in 1997; and fresh shell eggs in July of this year. Additionally, the agency failed to fulfill the specific IFC requirement that foods irradiated at doses above 100,000 rads and comprising more than 0.01% of the typical American’s diet be used in tests in which "the concentration of radiolytic products is maximized." (emphasis in original).19 The agency, in fact, has failed to specifically address the issue of radiolytic products in its three most recent food irradiation rulings—poultry in 1990, beef in 1997, and eggs this past July. Flaws in the FDA’s Key Studies On April 18, 1986, the FDA approved what would become known as the "Omnibus Rule," which legalized the irradiation of fruit and vegetables, and tripled the maximum irradiation dose for spices.20 Then-FDA Commissioner Frank Young wrote in the Federal Register that five studies endorsed by the agency’s blue-ribbon Irradiated Foods Task Group (IFTG) "were considered by agency reviewers to be properly conducted, fully adequate by 1980 toxicological standards, and able to stand alone in the support of safety. The reports of these…studies indicate no adverse effects from the irradiated foods fed to test animals."21 Listed in the Federal Register’s footnotes, however, were seven studies—including a 1972 German study that the IFTG had actually declared "deficient" four years earlier. Internal FDA documents that perhaps could explain this discrepancy were either missing from agency files during a recent inspection, or have yet to be produced by FDA officials in response to a formal request under the U.S. Freedom of Information Act. Beyond this as yet unexplained discrepancy, an analysis of the seven studies reveals numerous flaws that profoundly question not only the adequacy of the studies, but the credibility of the FDA officials who relied on them to legitimize their decisions to approve irradiated food for human consumption:
Perhaps most alarming, none of the seven FDA studies included short-term experiments to gauge the carcinogenic and mutagenic potential of irradiated food. This failure is of notable concern in light of research presented to Congress in 1968 (some of which was funded by the government) that revealed severe chromosomal damage to human white blood cells;22 a doubling of mutations in fruit flies;23 and "significantly" impaired cell division of plants grown in an irradiated environment.24 Then-FDA Associate Commissioner Daniel Banes warned Congress members: "Our knowledge 8 or 10 years ago about the teratogenic effect of drugs—for example, thalidomide and its effects on the embryo—was sketchy. In fact, it was practically nonexistent. The questions we ask now about the effects of drugs on the reproductive process and on metabolic systems and the biochemistry of the body are far more subtle and far more advanced. I submit, sir, that the same situation obtains with respect to irradiated food."25 Major FDA Rulings Based on ‘Deficient’ Science When the FDA approved its "Omnibus Rule" in the Federal Register of April 18, 1986, the agency listed a study conducted by two German scientists as being among the seven studies endorsed by the FDA’s Irradiated Foods Task Group (IFTG).26 Four years earlier, however, IFTG Chair Marcia van Gemert wrote that the study, conducted in Germany in 1972, was scientifically "deficient." Ironically, van Gemert further wrote that the study, despite its shortcomings, actually "claimed to show adverse effects of irradiated food."27 Though the most notable example, the German study was but one of 29 "deficient" studies used by FDA officials to establish the soundness of their Omnibus Rule. Spanning a 14-year period beginning with that ruling, FDA officials have cited 79 "deficient" studies in 107 different instances when legalizing irradiation for various classes of food. (See Chart 3 and Appendix II.) As for studies the FDA has relied upon to legalize irradiation that were conducted after the IFTG finished its work in 1982, the agency has not publicly certified that any of them comply with modern scientific standards. In what would become a common occurrence in the years since the 1986 ruling, FDA officials made no mention in the Omnibus Rule that they were relying on studies labeled "deficient" by the agency’s own Irradiated Foods Task Force. FDA officials, in another oft-repeated occurrence, also did not explain how studies once considered of poor quality could become adequate for the purposes of legalizing irradiated food. The pattern continued in 1987, when FDA officials rejected requests for a public hearing on the Omnibus Rule by citing 10 IFTG-rejected studies, nine of which—including the German study—previously had been listed when the Omnibus Rule was approved a year earlier.28 In 1988, FDA officials rejected additional requests for a public hearing on the Omnibus Rule by citing nine "deficient" studies, including two by the German researchers.29 In 1990, the FDA relied on 10 "deficient" studies in legalizing the irradiation of poultry.30 Among them was a "deficient" Canadian study that lacked certain histopathological examinations, leading an FDA staffer to write in an internal memo that "there is a fair to good chance" of tumors going undiscovered when only cursory exams are performed.31 Marking the first such occurrence, internal FDA memos reveal that staff members raised concerns about the "deficient" studies, but did nothing to keep them from being used to legalize the irradiation of poultry. (See Appendix V, studies #218, #265, #353.) In 1997, FDA officials cited 46 "deficient" studies—the highest number to date—in legalizing the irradiation of beef, pork, lamb and horse meat.32 Most notably, however, the FDA relied on five studies that the agency’s Irradiated Foods Task Group had not only labeled "deficient," but which the panel specifically stated, ironically, "claimed to show adverse effects of irradiated food"33 In the FDA’s latest major ruling, agency officials this past July legalized the irradiation of fresh shell eggs.34 In doing so, the FDA relied on three studies that the Irradiated Foods Task Group had labeled "deficient." An FDA staffer acknowledged that the studies were "deficient," but made little or no effort to explain how they could be used to legitimize a finding that irradiated eggs are safe to eat.35 (See Appendix VI.) Congress Not Given the Whole Truth At the 10 congressional hearings devoted to food irradiation since 1955, Congress members put direct questions about the safety, effectiveness, and technological and economic feasibility of food irradiation to officials with the FDA, Army, AEC, Department of Energy, and other federal agencies. Though Congress members expected direct answers, they didn’t always get them. In 1966, Rep. Melvin Price, chair of a key subcommittee of the Joint Committee on Atomic Energy, asked Edward Josephson, head of the Army’s food irradiation lab in Natick, Massachusetts, to discuss "what you consider to be the vital and most important" challenges faced by the program.36 Josephson made no mention of the health problems suffered by lab animals fed irradiated food in Army experiments.37 As history would soon show, Josephson knew about these problems. Two years later, Josephson was back in front of Price’s subcommittee. The hearing was held shortly after the FDA revoked the Army’s permit to serve irradiated bacon to military personnel and suggested that the Army withdraw its application to irradiate ham. FDA officials took action after they examined previously unreleased raw data from experiments conducted by Army researchers and others that revealed serious health problems in lab animals that ate irradiated food, including premature death and cancer. Rep. Chet Holifield did not react favorably to the notion that Congress had not been given the complete picture: "I am greatly disturbed by this line of testimony. It is a complete repudiation of what this committee has been told by what we thought were expert people, expert testimony from scientists that had conducted these experiments."38 Despite the revelation of health problems suffered by lab animals, Josephson told subcommittee members, "If there were any reservations as to the safety of irradiation processing, the program would surely not have been carried through to its present state of development."39 The resistance on the part of federal officials to acknowledge to Congress that irradiated food might not be safe for human consumption would continue on-and-off for the next two decades. In the spring of 1970, a high-ranking AEC official told a House Appropriations subcommittee, "We have not seen adverse factors which would suggest that radiation-processed food is unsafe."40 The AEC official made this statement despite the fact that his agency withdrew an application to irradiate strawberries in 1967 after rats fed irradiated peaches developed "significant numbers of tumors"41 ; and the fact that AEC-funded research found in 1965 that fruit flies grown on irradiated food experienced a twofold increase in mutations.42 Less-than-forthcoming congressional testimony by FDA officials continued into the 1980s—a critical time in history, as the agency began a series of rulings that enabled the introduction of irradiated food to the retail grocery market on a mass scale. In 1987 Rep. Douglas Bosco (D-CA) introduced the Food Irradiation Safety and Labeling Requirement Act, which would have blocked the most recent irradiation rulings from taking effect. Then-FDA Commissioner Frank Young glossed over the reasons that the agency revoked the Army’s permit to irradiate bacon. Young made no mention of the roles of the Army and AEC, made no mention of the serious health problems experienced by lab animals that ate irradiated food, and made no mention of the AEC’s withdrawal of applications to irradiate strawberries, oranges and lemons. The Present Coupled with rulings already on the books, pending before the FDA and USDA are petitions and proposed rules that, if approved by the agencies, would result in the legalization of irradiation for nearly every class of food—perhaps within a year. Among the most significant proposals pending before the FDA and USDA, most of which the government is reviewing on an "expedited" basis:
If every petition and proposed rule before the FDA and USDA is approved, more than 90 percent of the typical American’s diet will be eligible for irradiation.49 Such penetration, however, was not envisioned during the 1950s, 1960s and 1970s, when researchers and policymakers made their decisions based on the notion that irradiated food would not soon comprise a large portion of the typical American’s diet. The FDA’s Irradiated Food Committee, for instance, stated in 1980: "A rough estimate...suggests that 10% of the total diet may consist of irradiated food in the near future."50 Our Recommendations The U.S. Food and Drug Administration has repeatedly and consistently failed to abide by federal regulations and the agency’s own policies regarding the regulation of food irradiation. Because of these failings, detailed in this report, the Department of Health and Human Services should take immediate action to: (1) Revoke all food irradiation permits issued by the FDA since 1983. (2) Establish a joint committee with the U.S. Department of Agriculture to encourage the implementation of sustainable farming, ranching, and food production and transportation practices that will reduce the incidence of food-borne disease—including but not limited to slowing down slaughterlines and restoring the integrity of carcass-by-carcass meat inspection. (3) Conduct an Inspector General’s investigation of the FDA’s role in regulating food irradiation since the FDA revoked the Army’s permit to irradiate bacon on August 15, 1968. (4) Forestall, until the completion of (5) through (8), the approval of all petitions and proposed rules related to food irradiation. (5) Appoint an independent panel—comprised of no members who have had involvement with the FDA’s food irradiation program—to oversee a testing regime in accordance with the current scientific protocols. (6) Appoint an independent panel—comprised of no members who have had involvement with the FDA’s food irradiation program—to investigate the agency’s role in regulating food irradiation since the FDA revoked the Army’s permit to irradiate bacon on August 15, 1968. (7) Compile a complete index of all organizations and facilities engaged in the practice of food irradiation in the United States, including the types and quantities of food that have been irradiated since the organizations and facilities began operation. (8) Compile a complete index of all groups and facilities engaged in the production, distribution, transportation, marketing, wholesaling and/or retailing of irradiated food in the U.S. Additionally, complete investigations into the FDA’s role in regulating food irradiation since the agency revoked the Army’s permit to irradiate bacon on August 15, 1968, should be undertaken by the appropriate committees of Congress. |