My conclusion: we have only one food supply for pets, people, and farm animals, and it is global. In researching the book, I uncovered a long history of fraudulent use of melamine in fish and animal feed, as well as in pet food in modern China. In Pet Food Politics Pet Food Politics, I argued that safety problems with pet food must be addressed immediately. Otherwise, we must expect similar problems with human food. Hence the book's subtitle, The Chihuahua in the Coal Mine The Chihuahua in the Coal Mine.
Nonetheless, even I was taken aback when melamine turned up in Chinese infant formula and caused at least 300,000 illnesses, 50,000 hospitalizations, and six deaths. Chinese manufacturers so commonly used melamine as an adulterant that investigators discovered the chemical in a vast array of milk drinks, coffee drinks, crackers, cookies, and chocolates distributed throughout Asia and elsewhere.30 The pet food and infant formula scandals induced the Chinese government to punish perpetrators, sometimes with death sentences, and to enact new food safety laws. Pet food companies initiated routine testing for melamine. The usual calls for regulation followed. Yet two years later, a government review of the FDA's handling of the pet food recalls merely suggested that the agency consider seeking legislative action to give it more effective methods for dealing with recalls.31 2007: Ground Beef Products ( E. coli E. coli O157:H7) O157:H7). This particular recall focused attention on the devastation to affected individuals. It resulted in a $100 million lawsuit filed against Cargill on behalf of an affected young dancer, Stephanie Smith, whose travails were covered extensively by the New York Times New York Times and other media. But it also focused attention on the meat industry's resistance to pathogen testing as well as to its cozy relationships with USDA inspectors. and other media. But it also focused attention on the meat industry's resistance to pathogen testing as well as to its cozy relationships with USDA inspectors.
As explained in chapter 1 chapter 1, hamburger is typically made from trimmings from multiple animals (sometime hundreds) slaughtered in any number of states. To ensure safety, companies ought to test for pathogens but have little incentive to do so. If they test and find pathogens, they land in "a regulatory situation." As a company official explained to the New York Times: New York Times: "One, I have to tell the government, and two, the government will trace it back to them [the slaughterhouse]. So we don't do that." The USDA, in turn, uses a "restrained approach" to regulation. A USDA official said his agency has the power to require pathogen testing but does not use it. Why not? Because the USDA also takes the companies' needs into consideration: "I have to look at the entire industry, not just what is best for public health." "One, I have to tell the government, and two, the government will trace it back to them [the slaughterhouse]. So we don't do that." The USDA, in turn, uses a "restrained approach" to regulation. A USDA official said his agency has the power to require pathogen testing but does not use it. Why not? Because the USDA also takes the companies' needs into consideration: "I have to look at the entire industry, not just what is best for public health."32 2008: Ground Beef (Mad Cow Disease). Sometimes, ground beef induces revulsion as well as illness. The "largest to date" recall record set by pet foods did not last long. In February 2008, the Hallmark/Westland Beef Packing Company recalled more than 143 million pounds of raw and frozen beef products produced over a two-year period. An employee of the Humane Society infiltrated the plant and secretly filmed a video ("WARNING: Contains graphic footage") displaying the slaughter of "downer" cows for food as well as other violations of USDA rules.33 Older, nonambulatory cattle are at risk for mad cow disease, or BSE (discussed in chapter 8 chapter 8). The USDA secretary said, "It is extremely unlikely that these animals were at risk for BSE because of the multiple safeguards; however, this action is necessary because plant procedures violated USDA regulations." A particular source of concern was that Hallmark/Westland produced ground meat for federal school meals. Although BSE had never been found in U.S. cows, the incident demonstrated links between inhumane treatment of animals and public health.34 It also highlighted inadequacies in the USDA's meat inspection system. Insiders complained that inspectors who cite slaughterhouse violations get in trouble with the USDA and are told not to record violations. Representative George Miller (Dem-CA) said the recall "raises alarming questions about the U.S. Department of Agriculture's ability to monitor the safety of meat that is being shipped to our nation's schools. It is outrageous that it took a non-governmental organization to shed light on the egregious abuses that were happening right under the USDA's nose. . . . [The USDA] still can't tell us exactly which schools may have received this tainted meat, or how much of it has already been consumed or reprocessed into other foods."35 Lawsuits followed. Legislation did not. Lawsuits followed. Legislation did not.
2008: Peppers, not Tomatoes (Salmonella). This outbreak demonstrated how entire industries can be damaged in the search for a source of foodborne illness. On May 22, 2008, the New Mexico Health Department notified the CDC that several people had been infected with (Salmonella). This outbreak demonstrated how entire industries can be damaged in the search for a source of foodborne illness. On May 22, 2008, the New Mexico Health Department notified the CDC that several people had been infected with Salmonella Salmonella Saintpaul. Some cases clustered in the Navajo Nation and investigations by the Indian Health Service suggested tomatoes as the likely source. The FDA warned residents of New Mexico and Texas not to eat local raw tomatoes and soon expanded the warning nationally. Restaurant chains stopped serving tomatoes, consumers stopped buying them, and tomato growers lost $200 million in sales. Saintpaul. Some cases clustered in the Navajo Nation and investigations by the Indian Health Service suggested tomatoes as the likely source. The FDA warned residents of New Mexico and Texas not to eat local raw tomatoes and soon expanded the warning nationally. Restaurant chains stopped serving tomatoes, consumers stopped buying them, and tomato growers lost $200 million in sales.36 To verify the source, the CDC conducted seven epidemiologic and environmental investigations, none easy to interpret. Salsa and guacamole were mentioned frequently by people who became ill; these foods contained tomatoes and either raw jalapeno or Serrano peppers. CDC investigators found the outbreak strain in peppers from Mexico. But they continued to consider tomatoes as a possible source until the end of June and did not lift the tomato warning until July 17. By that time, the domestic tomato industry had been virtually destroyed. Also destroyed was a good deal of public confidence in the safety of fresh produce and in government oversight.37 Federal officials explained their error: "Local, state, tribal, and federal response capacity often is strained during large and complex outbreaks. . . . This can cause delays."38 Perhaps, but an analysis of the events by the Pew Charitable Trusts came to tougher conclusions. It questioned why safety officials from two federal and three state agencies insisted that tomatoes were the vector and spoke publicly "with significant variations in facts and messages." It said officials should have learned from previous recalls and charged that despite repeated calls for action, "the establishment of mandatory, enforceable safety standards for the growing, harvesting, processing, and distribution of fresh fruits and vegetables has not happened." Perhaps, but an analysis of the events by the Pew Charitable Trusts came to tougher conclusions. It questioned why safety officials from two federal and three state agencies insisted that tomatoes were the vector and spoke publicly "with significant variations in facts and messages." It said officials should have learned from previous recalls and charged that despite repeated calls for action, "the establishment of mandatory, enforceable safety standards for the growing, harvesting, processing, and distribution of fresh fruits and vegetables has not happened."39 2009: Peanut Butter (Salmonella). Late in 2008, the CDC became aware of clusters of illness caused by (Salmonella). Late in 2008, the CDC became aware of clusters of illness caused by Salmonella Salmonella Typhimurium in young and old people in schools or long-term care facilities. In interviews, 86 percent said they had eaten chicken and 77 percent said they had eaten peanut butter. Because frequencies in the general population are 85 percent for eating chicken and 59 percent for eating peanut butter, peanut butter seemed the more likely source. In January 2009, King Nut Companies, a distributor of peanut butter manufactured by the Peanut Corporation of America (PCA), recalled five-pound tubs of the PCA product. Typhimurium in young and old people in schools or long-term care facilities. In interviews, 86 percent said they had eaten chicken and 77 percent said they had eaten peanut butter. Because frequencies in the general population are 85 percent for eating chicken and 59 percent for eating peanut butter, peanut butter seemed the more likely source. In January 2009, King Nut Companies, a distributor of peanut butter manufactured by the Peanut Corporation of America (PCA), recalled five-pound tubs of the PCA product.40 Because peanuts destined for peanut butter are roasted, the contamination must have occurred after after processing. The plant shipped two kinds of peanut butter: bulk intended for institutions, and ingredients intended for food processors. Samples of both were found to contain the outbreak strain. Eventually, companies recalled nearly four thousand food products containing peanut butter, among them crackers, frozen chicken, emergency disaster rations, and pet foods-so many that the FDA produced an online "widget" to keep track of them. processing. The plant shipped two kinds of peanut butter: bulk intended for institutions, and ingredients intended for food processors. Samples of both were found to contain the outbreak strain. Eventually, companies recalled nearly four thousand food products containing peanut butter, among them crackers, frozen chicken, emergency disaster rations, and pet foods-so many that the FDA produced an online "widget" to keep track of them.
The politics of this particular incident were especially telling. Investigations revealed that the PCA plant knowingly shipped peanut butter contaminated with Salmonella Salmonella. When tests came back positive, PCA retested the samples. The company operated under GMPs, not HACCP. It had been inspected recently, evidently rather casually.41 PCA was involved with regulatory agencies in one other way: the company produced peanuts for export. For reasons of history (see chapter 1 chapter 1), the USDA is responsible for the safety of exported peanuts that might contain aflatoxin. Under pressure from peanut producers, the 2002 Farm Bill specifically exempted the USDA's Peanut Standards Board from conflict-of-interest rules. This exemption permitted the head of PCA to be appointed to that board in 2008 for a term ending in 2011 (he resigned in the wake of the recall). PCA soon filed for bankruptcy, thereby avoiding claims and lawsuits.
Oddly, PCA's plants in Texas and Georgia had organic certification; the organic inspector had issued violation notices but had no authority to close the plants. The FDA asked one recipient of PCA peanuts, WestCo Fruit and Nut Co., to voluntarily recall its products; WestCo refused. The FDA had to serve the company with a warrant and eventually seize the products. This took weeks. In March, the FDA issued after-the-fact advice to the peanut industry-voluntary and nonbinding, of course-about how to produce peanuts safely.42 Given the casual safety practices of food industries and the overall regulatory vacuum, the satirical newspaper Given the casual safety practices of food industries and the overall regulatory vacuum, the satirical newspaper The Onion The Onion proposed a creative solution to the proposed a creative solution to the Salmonella Salmonella problem. It is shown in problem. It is shown in figure 31 figure 31.
[image]
FIGURE 31. "FDA Approves Salmonello's." Reprinted with permission of The Onion The Onion. Copyright 2009 by Onion, Inc., www.theonion.com.
This particular recall induced President Obama to signal that his administration intended to take food safety more seriously. In reference to his then seven-year-old daughter, he said: "At bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter. That's what Sasha eats for lunch, probably three times a week, and you know I don't want to have to worry about whether she is going to get sick as a consequence of having her lunch."43 The new leadership of the FDA also commented on the implications of the peanut butter recalls: "From our vantage point, the recent salmonella outbreak linked to contaminated peanut butter represented far more than a sanitation problem at one troubled facility. It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls. And it exposed the failure of scores of food manufacturers to adequately monitor the safety of ingredients purchased from this facility."44 2009: Pistachios (Salmonella). Late in March 2009, the FDA announced that Setton Pistachios was voluntarily recalling about a million pounds of nuts. The FDA learned about the (Salmonella). Late in March 2009, the FDA announced that Setton Pistachios was voluntarily recalling about a million pounds of nuts. The FDA learned about the Salmonella Salmonella problem from Kraft Foods, which sells a pistachio trail mix. Kraft obtained the mix from a small nut company in Illinois, Georgia's Nut, which evidently uses a HACCP plan; the company routinely tests for problem from Kraft Foods, which sells a pistachio trail mix. Kraft obtained the mix from a small nut company in Illinois, Georgia's Nut, which evidently uses a HACCP plan; the company routinely tests for Salmonella Salmonella and found it in Setton pistachios. Georgia Nut recalled its products and notified Kraft. Kraft informed the FDA and issued its own recall-just the way the food safety system is supposed to work. and found it in Setton pistachios. Georgia Nut recalled its products and notified Kraft. Kraft informed the FDA and issued its own recall-just the way the food safety system is supposed to work.45 Other aspects worked less well. Although its packing plant had passed recent inspections with relatively minor violations, Setton knew it had Salmonella Salmonella problems. When tests came back positive, Setton reheated the nuts but shipped them out without testing to confirm that the bacteria had been killed. The reheated pistachios often were processed on lines used for raw, potentially contaminated nuts. Setton also had a surprising method for handling the recalled nuts: it repackaged them and shipped them out. Other pistachio companies reacted to these revelations by establishing a Web site listing products that had not been recalled. problems. When tests came back positive, Setton reheated the nuts but shipped them out without testing to confirm that the bacteria had been killed. The reheated pistachios often were processed on lines used for raw, potentially contaminated nuts. Setton also had a surprising method for handling the recalled nuts: it repackaged them and shipped them out. Other pistachio companies reacted to these revelations by establishing a Web site listing products that had not been recalled.46 In this instance, the FDA asked for voluntary recalls before anyone became ill, suggesting that the new management team was serious about prevention. The FDA warned food companies that it expected them to follow voluntary GMPs, explained how to do recalls, and issued guidance to pistachio growers about avoiding contaminants. But without congressional authority to force recalls and stop shipments of potentially contaminated products, the FDA could do little more.47 2009: Nestle's Toll House Cookie Dough (E. coli (E. coli O157:H7) O157:H7). This outbreak demonstrated the inadequacy of warning labels and the compelling need for preventive controls. Cookie dough is not supposed to be eaten raw; it is intended to be baked. Packages are labeled with warnings, usually along the lines of "Bake before enjoying" or, as Nestle's post-recall packages now say, "Do not consume raw cookie dough." But let's be honest: raw cookie dough is irresistibly delicious. A Consumer Reports Consumer Reports survey found that 39 percent of respondents admitted to eating dough when they make cookies; surely this underestimates the true percentage. survey found that 39 percent of respondents admitted to eating dough when they make cookies; surely this underestimates the true percentage.48 Companies know that customers eat raw dough. Nestle said it took special precautions as a result, and investigators were able to identify only minor violations at the plant. Although they found E. coli E. coli O157:H7 in one dough sample, it was not the outbreak strain. Investigations linked cases of illness to eating the Nestle dough, but "conclusions could not be made with regard to the root cause of the contamination." The recall cost Nestle more than $30 million. O157:H7 in one dough sample, it was not the outbreak strain. Investigations linked cases of illness to eating the Nestle dough, but "conclusions could not be made with regard to the root cause of the contamination." The recall cost Nestle more than $30 million.49 To people who became ill after eating raw cookie dough, unsolved mysteries and corporate costs hardly matter. Bill Marler, the lawyer mentioned earlier, describes another client: "I spent most of last week being supportive, but feeling helpless, as a client who ate E. coli E. coli O157:H7tainted Nestle Toll House Cookie Dough, may well be slowly dying after spending over 100 days in the hospital (still there), losing her large intestine and gall bladder, and spending weeks on dialysis. It is crazy that people think a foodborne illness is a 'tummy ache.' " O157:H7tainted Nestle Toll House Cookie Dough, may well be slowly dying after spending over 100 days in the hospital (still there), losing her large intestine and gall bladder, and spending weeks on dialysis. It is crazy that people think a foodborne illness is a 'tummy ache.' "50 2009: Ground Beef (Antibiotic-Resistant Salmonella Salmonella). Throughout the summer of 2009, Colorado health officials were dealing with cases of Salmonella Salmonella infections caused by eating ground beef. The most serious were caused by a strain of infections caused by eating ground beef. The most serious were caused by a strain of Salmonella Salmonella Newport highly resistant to a wide range of common antibiotics. Investigators traced the illnesses to ground beef produced by Beef Packers, Inc., a subsidiary of Cargill. The nearly 826,000-pound recall was especially complicated because the company repackaged the meat into small retail-size units. The USDA's list of receiving retailers fills twenty-four pages. Newport highly resistant to a wide range of common antibiotics. Investigators traced the illnesses to ground beef produced by Beef Packers, Inc., a subsidiary of Cargill. The nearly 826,000-pound recall was especially complicated because the company repackaged the meat into small retail-size units. The USDA's list of receiving retailers fills twenty-four pages.51 Beyond generic food safety, this incident raised concerns about additional public health issues: humane treatment of animals, the safety of school meals, and antibiotic resistance in food pathogens. A year earlier, USDA investigators had observed workers at this plant using cattle prods to render animals unconscious so they could be dragged into the slaughterhouse. Use of cattle prods is legal; dragging unconscious and potentially contaminated animals is not. Cargill said "the animals balked because there were too many auditors present that day."52 Even if true, a statement like this is unlikely to reassure anyone that the meat is safe. Even if true, a statement like this is unlikely to reassure anyone that the meat is safe.
Beef Packers is a major supplier of meat to the USDA's school lunch program. The recall covered meat sent to retailers, not schools. Investigative reporters for USA Today USA Today discovered that while the recall was in progress, the USDA bought 450,000 pounds of ground beef produced by Beef Packers during the dates covered by the recall and sent several lots to schools. The USDA knew that Beef Packers had a history of positive discovered that while the recall was in progress, the USDA bought 450,000 pounds of ground beef produced by Beef Packers during the dates covered by the recall and sent several lots to schools. The USDA knew that Beef Packers had a history of positive Salmonella Salmonella tests, but did not disclose that information. An official told tests, but did not disclose that information. An official told USA Today USA Today that if it did, it "would discourage companies from contracting to supply product for the National School Lunch Program and hamper our ability to provide safe and nutritious foods to American school children. that if it did, it "would discourage companies from contracting to supply product for the National School Lunch Program and hamper our ability to provide safe and nutritious foods to American school children.53 As for antibiotic resistance: in this instance, the USDA was faced with a new possibility. Could the agency consider antibiotic-resistant Salmonella Salmonella to be an adulterant, thereby making the meat subject to immediate recall? In August, an official announced to a meat industry conference that the USDA still considered to be an adulterant, thereby making the meat subject to immediate recall? In August, an official announced to a meat industry conference that the USDA still considered E. coli E. coli O157:H7 to be an adulterant and was considering other such controls, some of them involving O157:H7 to be an adulterant and was considering other such controls, some of them involving Salmonella Salmonella. This was a warning that the new administration at the USDA-if not its inspectors-also intended to take foodborne illness more seriously.54 The multiple antibiotic resistance of this Salmonella Salmonella strain raised particular alarms. As discussed in strain raised particular alarms. As discussed in chapters 1 chapters 1 and and 6 6, most antibiotics in the United States are fed to farm animals for nontherapeutic purposes, a practice that selects for antibiotic-resistant bacteria. This problem was the focus of a Pew Commission investigation (in which I participated), which recommended immediate reduction in the use of nontherapeutic antibiotics in animal agriculture.55 Congress considered legislation, but the meat industry opposed it. The American Meat Institute said restrictions on antibiotic use "will jeopardize the industry's ability to protect animal health, animal welfare and the food supply." A coalition of twenty meat producer organizations wrote the White House that antibiotics were vital to livestock and poultry production, and restrictions "are not supported by any conclusive scientific evidence." The American Veterinary Medical Association also opposed restrictions. The Pew report, it said, "contains significant flaws and major deviations from both science and reality. These missteps lead to dangerous and under-informed recommendations about the nature of our food system-and shocking recommendations for interventions that are scarcely commensurate with risk."56 Despite the evident importance of antibiotics to human health, self-interest politics makes this issue-as well as the others discussed here-difficult to resolve. Despite the evident importance of antibiotics to human health, self-interest politics makes this issue-as well as the others discussed here-difficult to resolve.
Taken together, these incidents ought to have provided all the evidence Congress might need to enact food safety legislation. Collectively, they demonstrate that without such legislation, food companies are likely to continue to cut safety corners, lobby against having to produce food safely, and collude with federal agencies to overlook safety hazards-regardless of threats to public health. And because animal wastes (USDA-regulated) are the ultimate source of pathogens on leafy greens and raw cookie dough (FDA-regulated), these incidents also argue for regulation by one agency, not two.
TOWARD A MORE EFFECTIVE FOOD SAFETY SYSTEM.
In 2004, Tommy Thompson announced his resignation as secretary of health and human services with these now famous words: "I, for the life of me, cannot understand why terrorists have not attacked our food supply because it is so easy to do." Fears of bioterrorism induced Congress to require the FDA to implement rules about registration and import shipments, but that was all.57 You might think, as I do, that the surest way to prevent food bioterrorism would be to enact a comprehensive food safety system. Such a system would not only protect against microbial biohazards, but also those that might be posed by old and new technologies such as mercury in fish from coal-burning power plants, the cloning of food animals, genetic modification of animals and fish, chemicals leaching from plastics, and nanotechnology.
You also might think that the recent spate of outbreaks and recalls would have induced Congress to take action. In 2007, Michael Taylor told Congress, "The sad truth is that we have no system for managing multi-state foodborne illness outbreaks. . . . Congress must act to solve this problem." How? By enacting what food safety advocates in and out of government had been recommending for years: a single food agency responsible for overseeing mandatory HACCP (or its euphemistic equivalent, "preventive controls") for all foods, from farm to table.58 With Congress unwilling to take on this challenge, the alternative is to try a stepwise approach, beginning with fixing the FDA. In the wake of the 2007 pet food recalls, the FDA's Science Board released a scathing report on the agency's lack of scientific and financial resources. It pointed out that from 1988 to 2007, Congress had enacted 123 statutes that increased the FDA's regulatory responsibilities but granted few additional resources. The FDA issued a Food Protection Plan attempting to set forth priorities but almost everything it suggested would require new legislation. Even so, critics of the plan such as Michael Taylor pointed out that it failed to treat food safety as a farm-to-table problem or to hold the food industry responsible and accountable.59 At the time he made these statements, Taylor was a professor at George Washington University. Because of his previous connection to Monsanto, antibiotechnology advocates considered him the prime example of how the revolving door favors corporate over public interests. In 2009, despite such concerns, he was reappointed to the FDA with responsibility for implementing whatever food safety legislation Congress chose to enact. Congress was considering bills aimed at fixing the FDA. Because of Taylor's work in the mid-1990s, the USDA's rules did not need much fixing; they mostly needed to be enforced.
In the interim, the FDA did what it could to unblock regulations put on hold by the previous administration. In 2009, it implemented rules for shell eggs first proposed in 2004, issued guidance (still voluntary) for melons, tomatoes, and leafy greens, and speeded up its warning systems. It also showed hopeful signs of collaborating with the USDA on common food safety problems. The USDA does not usually deal with the safety of leafy greens, for example, but large growers asked the USDA to establish a marketing agreement to "facilitate the practical application" of the FDA voluntary guidance. Producers who signed on to the agreement would be obliged to follow GMPs. This might appear to be real progress, but never underestimate politics. Small growers strongly opposed the marketing agreement on the grounds that adhering to GMPs puts them at a competitive disadvantage.60 Overall, safety practices remain voluntary as of early 2010. For mandatory food safety, Congress would have to act. As this book goes to press, creating a food safety system that unites the functions of the FDA and the USDA seems politically unfeasible. Instead, Congress seems likely to pass legislation designed to strengthen the FDA. The bills authorize the FDA to require science-based (HACCP-like) safety standards for all foods from farm to table, and to demand recalls, retain contaminated products, and conduct other long-awaited enforcement measures. As might be expected, these bills were vigorously opposed by industrial food producers. But they also were opposed by producers of local, organic, and sustainable foods who, understandably, wanted regulations more appropriate to their smaller scale of operations.61 No matter how these issues resolve, the proposed legislation falls far short of what is needed. The many industry critics of a unified food safety system argue that a single agency and mandatory requirements will not end foodborne illness; as long as humans prepare food, accidents will happen. Yes, but the single agency idea is worth pursuing because neither the separate agencies nor voluntary actions by food companies have been able to prevent more frequent and deadly outbreaks. We only have one food system, and it makes sense to put one agency in charge of it. At issue is how to achieve an effective food safety system. For this, we need a much higher level of public dread and outrage. It is time for food safety to join the food revolution.
APPENDIX.
THE SCIENCE OF PLANT BIOTECHNOLOGY.
IN WRITING THIS BOOK, I TRIED TO MAKE THE SCIENTIFIC ISSUES accessible to general readers, omitting technical details but retaining accuracy. The purpose of this appendix is to provide a bit more information about the underlying science of food biotechnology. Although it is not necessary to know very much about this science in order to understand its political implications, a grasp of fundamental concepts, approaches, and interpretations can help bridge the gap between science-based and value-based approaches to evaluating risk. At the very least, this information helps to explain why some scientists have difficulty understanding public distrust of genetically engineered foods. accessible to general readers, omitting technical details but retaining accuracy. The purpose of this appendix is to provide a bit more information about the underlying science of food biotechnology. Although it is not necessary to know very much about this science in order to understand its political implications, a grasp of fundamental concepts, approaches, and interpretations can help bridge the gap between science-based and value-based approaches to evaluating risk. At the very least, this information helps to explain why some scientists have difficulty understanding public distrust of genetically engineered foods.
Science has much to teach us about the biological and physical worlds we inhabit, and its methods and approaches are useful tools for investigating such matters. The basic concepts are not difficult to understand, but the methods-and especially the vocabulary-can be intimidating. Here, I extend the discussion of plant biotechnology given in chapter 5 chapter 5 and offer further details, still nontechnical, about the methods used to introduce new genes into plants, particularly those for synthesis of beta-carotene in Golden Rice. Let's begin with a brief overview of basic biological principles having to do with DNA and its functions in bacteria and plants. and offer further details, still nontechnical, about the methods used to introduce new genes into plants, particularly those for synthesis of beta-carotene in Golden Rice. Let's begin with a brief overview of basic biological principles having to do with DNA and its functions in bacteria and plants.
A (VERY) QUICK REMINDER ABOUT DNA, GENES, AND PROTEINS.
DNA (deoxyribonucleic acid) is the principal determinant of the genetic characteristics of most living organisms: humans, animals, plants, bacteria, and many viruses. One of its functions is to specify the structure of proteins. The details of the processes through which DNA reproduces itself and carries out its functions appear immensely complicated-always a good sign that they are incompletely understood. They are also abstract. DNA and proteins are submicroscopic; their actions must be inferred. Furthermore, scientists (like specialists in any field) typically describe molecular actions in a vocabulary impenetrable to the uninitiated.1 Fortunately, we need to use only a few of the most familiar terms: DNA and its subunits (DNA bases, of which there are 4), and protein and its subunits (amino acids, of which there are 20). Fortunately, we need to use only a few of the most familiar terms: DNA and its subunits (DNA bases, of which there are 4), and protein and its subunits (amino acids, of which there are 20).2 No matter what organism it comes from, DNA is composed of just four subunits-the DNA bases. These differ in size and shape and are arranged on the DNA molecule like beads on a string. The sequence sequence of stringing constitutes a four-letter code that contains the genetic information of the cells that make up body organs and tissues. To summarize the basic details: of stringing constitutes a four-letter code that contains the genetic information of the cells that make up body organs and tissues. To summarize the basic details: * Sequences of DNA bases (DNA segments) arranged in a specified order constitute genes.* Some gene DNA sequences specify the structure of proteins.* Other DNA sequences specify the structure of molecules that signal where genes begin and end.* Gene DNA sequences specify the order in which amino acids link to make specific proteins; a sequence of three DNA bases specifies 1 of the 20 amino acids (this is the genetic code genetic code).* Proteins are composed of various combinations of the 20 different amino acids linked in a specific order defined by the gene DNA sequence.* Proteins do the work of cells, muscles, and other organs as structural components, signals, or enzymes.* Enzymes catalyze biochemical reactions in the body.* The structure of DNA is helical; its two strands are twisted around each other in a double helix.* Proteins differ from one another in structure; they fold into specific three-dimensional shapes that depend on the sequence of their amino acids (and other components that may be introduced during or after protein synthesis).* The structure of a protein determines its function.
These biological features operate in the same way in most organisms. Differences among species depend on the specific order of base sequences in their DNA and, therefore, in the sequence of amino acids in their proteins. When scientists extract genes from bacteria, they are taking segments of DNA that contain the same DNA bases that are already in plants-just arranged in a different sequence. The commonality of DNA bases among organisms is the main reason why many scientists are perplexed by public anxieties about genetic engineering; DNA is DNA-its base subunits are the same-no matter where it comes from or where it goes.
MORE ABOUT MAKING RICE GOLDEN: PLASMIDS.
As noted in chapter 5 chapter 5, the genetic engineering of beta-carotene into rice represents an extraordinary technical achievement. The "foreign" genes must be identified and reproduced, inserted into the plant's DNA, and made to function in the plant and reproduce in its seeds. How all of this is accomplished is quite remarkable, as the methods take advantage of the unique and rather bizarre properties of a species of common soil bacteria, Agrobacterium tumifaciens Agrobacterium tumifaciens. Table 17 Table 17 outlines the use of this system to put genes for beta-carotene into rice; it describes the outlines the use of this system to put genes for beta-carotene into rice; it describes the less less complicated of the two approaches used for this purpose. complicated of the two approaches used for this purpose.3,4 Agrobacteria can infect a variety of plants that have been scratched, torn, or "wounded" in some way. At the wound site, the bacteria induce the plant to form swellings-crown galls-a form of plant cancer. The bacteria do not actually penetrate into the plant's tissues. Instead, they attach to the wound site and transfer a special piece of their DNA into the plant. This piece, called transfer-DNA (T-DNA), contains genes and DNA base sequences that enable it to enter the plant cells, find the plant's DNA, integrate into it, and specify the production of proteins that cause plant cells to make crown galls. Why might can infect a variety of plants that have been scratched, torn, or "wounded" in some way. At the wound site, the bacteria induce the plant to form swellings-crown galls-a form of plant cancer. The bacteria do not actually penetrate into the plant's tissues. Instead, they attach to the wound site and transfer a special piece of their DNA into the plant. This piece, called transfer-DNA (T-DNA), contains genes and DNA base sequences that enable it to enter the plant cells, find the plant's DNA, integrate into it, and specify the production of proteins that cause plant cells to make crown galls. Why might Agrobacterium Agrobacterium do this? The most likely explanation is that the T-DNA also contains genes that cause crown galls to produce unusual amino acid derivatives called opines. Opines are not normally made by plants and do nothing for them. Instead, they serve as a preferential food for do this? The most likely explanation is that the T-DNA also contains genes that cause crown galls to produce unusual amino acid derivatives called opines. Opines are not normally made by plants and do nothing for them. Instead, they serve as a preferential food for Agrobacteria Agrobacteria, giving them a competitive edge in the ecological world of soil bacteria.
What makes Agrobacterium tumifaciens Agrobacterium tumifaciens uniquely qualified to transfer genes from other organisms to plants is that the T-DNA is not really part of its own DNA. Instead, the T-DNA is carried on a small, entirely separate, circular piece of DNA called a uniquely qualified to transfer genes from other organisms to plants is that the T-DNA is not really part of its own DNA. Instead, the T-DNA is carried on a small, entirely separate, circular piece of DNA called a plasmid plasmid. Most bacteria contain plasmids (but without T-DNA). Plasmids are self-replicating, which means that they contain genes that specify their own reproductive functions; they multiply independently of the bacterial chromosome-the structure that contains the bacteria's DNA.
Typically, plasmids carry genes for traits that are useful-but not essential-for bacterial growth or reproduction. Agrobacterium tumifaciens Agrobacterium tumifaciens plasmids, for example, carry T-DNA and its genes for crown gall. Other bacteria contain plasmids with genes for a variety of functions highly germane to issues discussed in this book: the ability to fix atmospheric nitrogen, synthesize the plasmids, for example, carry T-DNA and its genes for crown gall. Other bacteria contain plasmids with genes for a variety of functions highly germane to issues discussed in this book: the ability to fix atmospheric nitrogen, synthesize the Bacillus thuringiensis Bacillus thuringiensis ( (Bt) toxin, produce pathogenic toxins (E. coli O157:H7 and O157:H7 and Bacillus anthracis Bacillus anthracis), resist certain antibiotics, and-most important-infect other bacteria. Plasmid genes for these last two characteristics, for example, are often responsible for the widespread dissemination of resistance to antibiotics within a bacterial species, and from one kind of bacteria to another.
Agrobacterium plasmids are unique in containing T-DNA. On these plasmids, the T-DNA is flanked by DNA base sequences that mark its borders. As the T-DNA enters the plant, any DNA that lies between its border regions will be transferred into the plant's cells, regardless of where that DNA came from. plasmids are unique in containing T-DNA. On these plasmids, the T-DNA is flanked by DNA base sequences that mark its borders. As the T-DNA enters the plant, any DNA that lies between its border regions will be transferred into the plant's cells, regardless of where that DNA came from. Agrobacterium Agrobacterium plasmids, therefore, solve a major technical problem: how to get desirable genes from bacteria or other foreign sources inserted into the cells of food plants. plasmids, therefore, solve a major technical problem: how to get desirable genes from bacteria or other foreign sources inserted into the cells of food plants.
Plant biotechnologists select the genes they want from any organism, get rid of unwanted T-DNA genes responsible for crown gall and opines, insert desired genes and regulatory DNA sequences between the T-DNA border regions, and use the Agrobacterium Agrobacterium system to inject the newly constructed T-DNA into plant cells. This system does not work efficiently, and only a rare plant accepts the T-DNA. To identify the successful transfers, scientists add marker genes to the T-DNA, usually for resistance to antibiotics. The constructed plasmid-with the original genes for infectivity (but with crown gall functions removed), and the desired genes, regulatory elements, and markers inserted into the T-DNA-is called a system to inject the newly constructed T-DNA into plant cells. This system does not work efficiently, and only a rare plant accepts the T-DNA. To identify the successful transfers, scientists add marker genes to the T-DNA, usually for resistance to antibiotics. The constructed plasmid-with the original genes for infectivity (but with crown gall functions removed), and the desired genes, regulatory elements, and markers inserted into the T-DNA-is called a transmission vector transmission vector. When the system works, the bacteria containing the vector attach to the plant and actively transfer the T-DNA to the plant's cells. Once in the plant, the T-DNA genes and sequences integrate into the plant's DNA; the integrated genes specify the production of the desired proteins; the proteins move to the appropriate places in the plant's cells; and the plant displays the new characteristic.5 TABLE 17. Highlights of one of the methods used to genetically engineer beta-carotene into Golden Rice Highlights of one of the methods used to genetically engineer beta-carotene into Golden Rice*
Obtain the starting vector Obtain a previously constructed Agrobacterium Agrobacterium plasmid vector containing a transfer-DNA (T-DNA) from which the gene segments for crown gall and opines have been removed. plasmid vector containing a transfer-DNA (T-DNA) from which the gene segments for crown gall and opines have been removed.
Construct the transfer-DNA Using enzymes that split and reattach DNA at specific points, introduce into the T-DNA, one step at a time (not necessarily in this order): * The daffodil gene for one enzyme in the pathway for making beta-carotene * The gene from bacteria that specifies the other missing enzymes in the beta-carotene pathway * Genes from peas and bacteria for proteins that will transport the new enzymes to the rice endosperm * A marker gene for resistance to the antibiotic hygromycin (which blocks protein synthesis in rice and other plants) * Regulatory DNA segments from cauliflower mosaic virus * DNA segments that mark places where genes are to be inserted and removed * Marker genes for resistance to other antibiotics * DNA regulatory segments that enable the new genes to function in rice endosperm Construct the new plasmid vector Insert the plasmid with its new T-DNA "construct" into Agrobacterium Agrobacterium by mixing them together in the presence of an electric current (electroporation), a process that makes the bacteria more permeable. by mixing them together in the presence of an electric current (electroporation), a process that makes the bacteria more permeable.
Prepare rice embryos for growth in tissue culture Grow rice plants until they just set seeds; collect the immature seeds.
Remove the embryos from the seeds, and grow them in tissue culture (a medium containing nutrients and plant hormones).
Remove the sheath (plant material) that surrounds the embryos to make them more permeable; continue growing them in tissue culture.
Transfer plasmid T-DNA into rice embryos Collect the unsheathed rice embryos growing in tissue culture and immerse them in a suspension of Agrobacterium Agrobacterium containing the beta-carotene T-DNA plasmid vector. containing the beta-carotene T-DNA plasmid vector.
Grow the vector-treated embryos in tissue culture.
Select the rare rice embryos able to accept the plasmid T-DNA Add the antibiotic hygromycin to the growth medium, and continue growing the rice embryos; only those with the T-DNA containing the gene for resistance to hygromycin survive.
Test the surviving rice embryos to make sure they contain the genes for beta-carotene.
Grow the successfully transformed embryos in a rooting medium; grow the plants to maturity in a greenhouse; allow the plants to set seeds to maturity.
Harvest the rice seeds, and test them for beta-carotene. The rice grains that contain beta-carotene are yellow (hence: Golden Rice).
SOURCE: Ye X, et al. Ye X, et al. Science Science 2000;287:303305. 2000;287:303305.*Refer to figure 13 figure 13, page 156 page 156.
But that is not all. Constructing T-DNA sequences with foreign genes that actually function in plants requires the action of numerous enzymes that break DNA molecules at specific sites ("restriction" enzymes), enzymes that reattach split pieces (ligases), and a great many steps carried out in a specific order. For the system to work in rice, for example, the scientists also must successfully grow rice cells in tissue culture (an artificial medium containing nutrients and growth factors), infect the rice cells, grow them back into rice plants, and have the rice breed true under greenhouse conditions. Each one of these steps presents its own set of technical difficulties. Thus, genetic engineering requires a "feel" for how to make all of the steps work, which transforms the technology into an art as well as a science. The artistic aspects add to the difficulty of explaining the science to nonspecialists.
BRIDGING THE GAP.
At issue is what is to be done to bridge the gap in knowledge and outlook between scientists and nonscientists. In a preliminary draft of this appendix (now much revised), I argued that scientists must work harder to explain their methods, approaches, and findings to the public, and that the public must take responsibility for demanding such explanations. One of the scientists who commented on that draft said that if I am asking people to demand explanations, I must also insist that they listen listen to the explanations, and with an open mind. He also mentioned that people like me who attempt to provide understandable explanations of science have a responsibility to ensure that the explanations are reasonably complete. I have tried to do this but have also tried to explain the ways in which science is political and inextricably linked to its social context and consequences. to the explanations, and with an open mind. He also mentioned that people like me who attempt to provide understandable explanations of science have a responsibility to ensure that the explanations are reasonably complete. I have tried to do this but have also tried to explain the ways in which science is political and inextricably linked to its social context and consequences.
NOTES.
This section contains reference citations along with occasional notes. Citations follow the spare, unpunctuated "Vancouver" style used by most biological science journals, as described in JAMA JAMA 1993;269:22822286 (translation: 1993;269:22822286 (translation: Journal of the American Medical Association Journal of the American Medical Association, 1993, volume 269, pages 2282 to 2286). Sometimes, issue numbers follow the volume in parentheses. Thus, Food Technology Food Technology 1991;45(5):248253 refers to an article published in the fifth (in this case, May) issue. As is customary in this style, text citations sometimes appear out of numerical order; these are space-saving cross-references to material cited earlier in the 1991;45(5):248253 refers to an article published in the fifth (in this case, May) issue. As is customary in this style, text citations sometimes appear out of numerical order; these are space-saving cross-references to material cited earlier in the same same chapter. Also to save space, references to multiple quotations or facts in a paragraph are listed in order under one note at its end; references to U.S. government reports omit their place and publisher (Washington, DC: U.S. Government Printing Office); and citations to articles in professional journals signed by multiple authors list only the first three followed by et al. Except as otherwise noted, documents obtained from Internet sources were available at the cited addresses in February 2010. chapter. Also to save space, references to multiple quotations or facts in a paragraph are listed in order under one note at its end; references to U.S. government reports omit their place and publisher (Washington, DC: U.S. Government Printing Office); and citations to articles in professional journals signed by multiple authors list only the first three followed by et al. Except as otherwise noted, documents obtained from Internet sources were available at the cited addresses in February 2010.
For clarity, most references give the full name of organizations, government agencies, and the titles of journals and publications, but certain frequently used terms are abbreviated as follows: Am American APHIS.
Animal and Plant Health Inspection Service (of USDA) CDC.
Centers for Disease Control and Prevention (of DHHS) CFSAN.
Center for Food Safety and Applied Nutrition (of FDA) CNI.
Community Nutrition Institute CSPI.
Center for Science in the Public Interest DHHS.
U.S. Department of Health and Human Services EPA.
Environmental Protection Agency ERS.
Economic Research Service (of USDA) FCN.
Food Chemical News FDA.
Food and Drug Administration (of DHHS) FIFRA.
Federal Insecticide, Fungicide and Rodenticide Act FR.
Federal Register FSIS.
Food Safety and Inspection Service (of USDA) GAO.
General Accounting Office (of Congress) (since 2004, the Government Accountability Office) J.
Journal, Journal of, Journal of the JAMA.
Journal of the American Medical Association MMWR.
Morbidity and Mortality Weekly Report (of CDC) (of CDC) NEJM.
New England Journal of Medicine NYT.
New York Times OTA.
Office of Technology Assessment (formerly of Congress, now defunct) Suppl Supplement USDA.
U.S. Department of Agriculture WSJ.
Wall Street Journal
INTRODUCTION: FOOD SAFETY IS POLITICAL.
1. Kaufman M. Biotech critics cite unapproved corn in taco shells. Washington Post Washington Post, September 18, 2000:A2. Freese B. The StarLink Affair The StarLink Affair. Washington, DC: Friends of the Earth, July 2001, at www.foodallergyangel.com/documents/GMO/StarlinkReport.pdf. Food Traceability Report. StarLink: Lessons Learned Food Traceability Report. StarLink: Lessons Learned. Washington, DC: FCN Publishing, 2001. Taylor MR, Tick JS. The StarLink Case: Issues for the Future The StarLink Case: Issues for the Future. Washington, DC: Pew Initiative on Food and Biotechnology, October 2001, at www.pewtrusts.org/our_work_report_detail.aspx?id=33384. Goldberg RA. Aventis CropScience and StarLink Corn Aventis CropScience and StarLink Corn. Boston: Harvard Business School (Case N9-902-411), November 5, 2001.2. Lambert B, Buysse L, Decock C, et al. A Bacillus thuringiensis Bacillus thuringiensis insecticidal crystal protein with a high activity against members of the family Noctuidae. insecticidal crystal protein with a high activity against members of the family Noctuidae. Applied and Environmental Microbiology Applied and Environmental Microbiology 1996;62:8086. 1996;62:8086.3. O'Reilly B. Reaping a biotech blunder. Fortune Fortune, February 19, 2001:156164.4. EPA. Assessment of scientific information concerning StarLink corn Cry9C Bt Bt corn plant-pesticide; notice. corn plant-pesticide; notice. FR FR 65:6524665251, October 31, 2000. This notice gives a particularly clear account of how corn gets commingled in grain elevators and dry mills (corn meal and flour) and wet mills (corn starch, sweeteners, protein, fiber, and alcohol). 65:6524665251, October 31, 2000. This notice gives a particularly clear account of how corn gets commingled in grain elevators and dry mills (corn meal and flour) and wet mills (corn starch, sweeteners, protein, fiber, and alcohol).5. EPA. Allergenicity assessment of Cry9C Bt Bt corn plant pesticide. corn plant pesticide. FR FR 64:7145271453, December 21, 1999. EPA. 64:7145271453, December 21, 1999. EPA. FIFRA Scientific Advisory Panel Meeting, November 28, 2000 FIFRA Scientific Advisory Panel Meeting, November 28, 2000 (SAP Report No. 2000-06), at (SAP Report No. 2000-06), at www.epa.gov/scipoly/SAP/meetings/2000/112800_mtg.htm.6. FDA. FDA Evaluation of Consumer Complaints Linked to Foods Allegedly Containing StarLink FDA Evaluation of Consumer Complaints Linked to Foods Allegedly Containing StarLinko Corn Corn, June 13, 2001, at www.epa.gov/scipoly/SAP/meetings/2001/july/fda.pdf. CDC. Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn, June 11, 2001, at www.cdc.gov/nceh/ehhe/cry9creport/pdfs/cry9creport.pdf.7. EPA. FIFRA Scientific Advisory Panel Meeting, July 1718, 2001 FIFRA Scientific Advisory Panel Meeting, July 1718, 2001 (SAP Report No. 2001-09), at (SAP Report No. 2001-09), at www.epa.gov/scipoly/sap/meetings/2001/071701_mtg.htm.8. Kaufman M. Biotech corn fuels a recall. Washington Post Washington Post, September 23, 2000:A1,A6. Pollack A. Aventis gives up license to sell bioengineered corn. NYT NYT, October 13, 2000:C5.9. Kaufman M. Biotech grain is in 430 million bushels of corn, firm says. Washington Post Washington Post, March 18, 2001:A8. Lin W, Price GK, Allen E. StarLink: impacts on the U.S. corn market and world trade. In Feed Situation and Outlook Yearbook Feed Situation and Outlook Yearbook (USDA/ERS, FDS-2001), April 2001:4048. Kilman S. Regulators are urged to permit bioengineered corn to be in food. (USDA/ERS, FDS-2001), April 2001:4048. Kilman S. Regulators are urged to permit bioengineered corn to be in food. WSJ WSJ, October 26, 2000:B23.10. Pollack A. Aventis tries a new tack on StarLink corn. NYT NYT, April 24, 2001:C4. Durbin D. Review of EPA Documents Shows Agency Had Knowledge in 1998 of Possible Biotech Contamination (press release). Washington, DC: U.S. Senate, December 1, 2000.11. Barboza D. Gene-altered corn changes dynamics of grain industry. NYT NYT, December 11, 2000:A1,A24.12. Winter G. Taco Bell's core customers seem undaunted by shell scare. NYT NYT, October 3, 2000:C6. Kaufman M. Biotech corn may be in various foods. Washington Post Washington Post, October 19, 2000:A1. Barboza D. Negligence suit is filed over altered corn. NYT NYT, December 4, 2000:C2.13. Pollack A. Kraft recalls taco shells with bioengineered corn. NYT NYT, September 23, 2000:C1,C15.14. Mendelson J, Blackwelder B, Ritchie M, et al. Letter to the Honorable William Jefferson Clinton re: Kraft recall of taco shells and genetically engineered food, September 27, 2000, at http://pirg.org/ge/GE.asp?id2=4785&id3=ge&.15. Aventis battles consumer groups at EPA hearing to decide GE corn's safety. Nutrition Week Nutrition Week, December 1, 2000:12.16. Kaufman M. U.S. will buy back corn seed: firms to be compensated for batches mixed with biotech variety. Washington Post Washington Post, March 8, 2001:A3. Hansen M. Starlink-Cry9C Protein (Consumers Union comments, EPA Docket number OPP-00688), November 28, 2000, at www.consumersunion.org/pub/core_food_safety/002294.html. Lueck S. Aventis is criticized over biotech corn. WSJ WSJ, October 27, 2000:B2.17. Carroll J. Judge will approve settlement on use of StarLink corn. WSJ WSJ, March 7, 2002:A4.18. Institute of Medicine. Ensuring Safe Food: From Production to Consumption Ensuring Safe Food: From Production to Consumption. Washington, DC: National Academy Press, 1998.19. Snow CP. Two Cultures and the Scientific Revolution: The Rede Lecture Two Cultures and the Scientific Revolution: The Rede Lecture. London: Cambridge University Press, 1959.20. Geertz C. Empowering Aristotle (book review). Science Science 2001;293:53. 2001;293:53.21. Handler P. Some comments on risk assessment. In: National Research Council Current Issues and Studies National Research Council Current Issues and Studies (annual report). Washington, DC: National Academy of Sciences, 1979. Cited in Douglas and Wildavsky (note 26):32. (annual report). Washington, DC: National Academy of Sciences, 1979. Cited in Douglas and Wildavsky (note 26):32.22. Groth E. Communicating with consumers about food safety and risk issues. Food Technology Food Technology 1991;45(5):248253. 1991;45(5):248253.23. Massey A. Crops, genes, and evolution. 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Fischler writes: "Si l'on est ce que l'on mange et que l'on ne sait plus ce que l'on mange, sait-on encore ce que l'on est?" Also see, of course: Levi-Strauss C. The Raw and the Cooked The Raw and the Cooked, Vols. 13. Chicago: University of Chicago Press, 19681969.28. Slovic P. The Perception of Risk The Perception of Risk. London: Earthscan, 2000. Lowrance WW. Of Acceptable Risk: Science and the Determination of Safety Of Acceptable Risk: Science and the Determination of Safety. Los Altos, CA: William Kaufmann, 1976. Scherer CW. Strategies for communicating risks to the public. Food Technology Food Technology 1991;45(10):110116. Bennett P, Calman K, eds. 1991;45(10):110116. Bennett P, Calman K, eds. Risk Communication and Public Health Risk Communication and Public Health. New York: Oxford University Press, 1999:319.29. Burros M. Congress moving to revamp rules on food safety: reducing federal role. NYT NYT, July 3, 1995:1,28. Thonney PF, Bisogni CA. Government regulation of food safety: interaction of scientific and societal forces: a scientific status summary. Food Technology Food Technology 1992:46 (1):7380. 1992:46 (1):7380.30. Sandman PM. Risk communication: facing public outrage. EPA J EPA J 1987;13(9):2122. Frewer L. Risk perception, social trust, and public participation in strategic decision making: implications for emerging technologies. 1987;13(9):2122. Frewer L. Risk perception, social trust, and public participation in strategic decision making: implications for emerging technologies. Ambio Ambio (Sweden) 1999;28:569574. (Sweden) 1999;28:569574.31. Commission of the European Communities. Communication from the Commission on the Precautionary Principle Communication from the Commission on the Precautionary Principle. Brussels, February 2, 2000, at http://portal.unesco.org/shs/en/ev.php-URL_ID=6615&URL_DO=DO_PRINT PAGE&URL_SECTION=201.html.32. Foster KR, Vecchia P, Repacholi MH. Science and the precautionary principle. 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PART 1. RESISTING FOOD SAFETY.
1. Mead PS, Slutsker L, Dietz V, et al. Food-related illness and death in the United States. Emerging Infectious Diseases Emerging Infectious Diseases 1999;5:607625. CDC. Preliminary FoodNet data on the incidence of foodborne illnesses-selected sites, United States, 2000. 1999;5:607625. CDC. Preliminary FoodNet data on the incidence of foodborne illnesses-selected sites, United States, 2000. MMWR MMWR 2001;50 (April 6):241246. 2001;50 (April 6):241246.2. Fox N. Spoiled: the Dangerous Truth About a Food Chain Gone Haywire Spoiled: the Dangerous Truth About a Food Chain Gone Haywire. New York: Basic Books, 1997:6667.3. Brown J, Byers T, Thompson K, et al. Nutrition during and after cancer treatment: a guide for informed choices by cancer survivors. CA: Cancer J for Clinicians CA: Cancer J for Clinicians 2001;51(3):153187. 2001;51(3):153187.
CHAPTER 1. THE POLITICS OF FOODBORNE ILLNESS: ISSUES AND ORIGINS.
1. Smith RJ. Institute of Medicine report recommends complete overhaul of food safety laws. Science Science 1979;203:12211224. Although warning labels are no longer required, the role of saccharin in human cancer is still under debate. A 1998 review by the World Cancer Research Fund ( 1979;203:12211224. Although warning labels are no longer required, the role of saccharin in human cancer is still under debate. A 1998 review by the World Cancer Research Fund (Food, Nutrition, and the Prevention of Cancer: A Global Perspective. Washington, DC: American Institute for Cancer Research, 1998:356358) concluded that saccharin "probably has no relationship with the risk of bladder cancer in the amounts obtainable from normal diets." For a more cautious view, see: Corcoran L, Jacobson M. Saccharin: bittersweet. Nutrition Action Healthletter Nutrition Action Healthletter 1998;25(3):1113. My assessment: if saccharin does affect cancer risk, it does so weakly. 1998;25(3):1113. 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Los Angeles: Living Planet Press, 1991.4. Burros M. New urgency fuels effort to improve safety of food. NYT NYT, May 7, 1990:A1,D11.5. Wolf ID. Critical issues in food safety, 19912000. Food Technology Food Technology 1992;46(1):6470. Lynch S, Lin C-TJ. Food safety: meal planners express their concerns. 1992;46(1):6470. Lynch S, Lin C-TJ. Food safety: meal planners express their concerns. FoodReview FoodReview 1994;17(2):1418. Food safety concerns addressed by editors, members of public. 1994;17(2):1418. Food safety concerns addressed by editors, members of public. Illinois Agrinews Illinois Agrinews, October 3, 1997:A14.6. Mead PS, Slutsker L, Dietz V, et al. Food-related illness and death in the United States. Emerging Infectious Diseases Emerging Infectious Diseases 1999;5:607625. 1999;5:607625.7. Chicken: what you don't know can hurt you. Consumer Reports Consumer Reports, March 1998:1218. Dahl E, DeWaal CS. Scrambled Eggs: How a Broken Food Safety System Let Contaminated Eggs Become a National Food Poisoning Epidemic Scrambled Eggs: How a Broken Food Safety System Let Contaminated Eggs Become a National Food Poisoning Epidemic. May 1997. Online: www.cspinet.org/reports/eggs.html.8. Archer DL, Kvenberg JE. Incidence and cost of foodborne diarrheal disease in the United States. J Food Protection J Food Protection 1985;48:887894. Council for Agricultural Science and Technology. 1985;48:887894. Council for Agricultural Science and Technology. Foodborne Pathogens: Risks and Consequences Foodborne Pathogens: Risks and Consequences. Ames, IA, September 1994.9. CDC. Incidence of foodborne illnesses-FoodNet, 1997. JAMA JAMA 1998;280: 16511652. GAO. 1998;280: 16511652. GAO. Food Safety: Information on Foodborne Illnesses Food Safety: Information on Foodborne Illnesses (GAO/RCED-96-96), May 8, 1996. (GAO/RCED-96-96), May 8, 1996.10. Institute of Medicine. Ensuring Safe Food: From Production to Consumption Ensuring Safe Food: From Production to Consumption. Washington, DC: National Academy Press, 1998. Its appendix B reviews the history of changes in federal food safety responsibilities.11. CDC. Preliminary FoodNet data on the incidence of foodborne illnesses-selected sites, United States, 2001. MMWR MMWR 2002;51 (April 19):325329. 2002;51 (April 19):325329.12. Roberts T, van Ravenswaay E. The economics of food safety. National Food Review National Food Review 1989;12(3):18. Buzby JC, Roberts T. ERS estimates U.S. foodborne disease costs. 1989;12(3):18. Buzby JC, Roberts T. ERS estimates U.S. foodborne disease costs. FoodReview FoodReview 1995;18(3):3742. Buzby JC, Roberts T, Lin C-TJ, et al. 1995;18(3):3742. Buzby JC, Roberts T, Lin C-TJ, et al. Bacterial Foodborne Disease: Medical Costs and Productivity Losses Bacterial Foodborne Disease: Medical Costs and Productivity Losses. USDA/ERS, August 1996. Buzby JC, Roberts T. ERS updates U.S. foodborne disease costs for seven pathogens. FoodReview FoodReview 1996;19(3):2025. GAO. 1996;19(3):2025. GAO. Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent and Unreliable Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent and Unreliable (GAO/RCED-98-103), April 1998. Buzby JC. Children and microbial foodborne illness. (GAO/RCED-98-103), April 1998. Buzby JC. Children and microbial foodborne illness. FoodReview FoodReview 2001;24(2):3237. 2001;24(2):3237.13. Gilchrist A. Foodborne Disease & Food Safety Foodborne Disease & Food Safety. Chicago: American Medical Association, 1981.14. DeWaal CS, Barlow K, Alderton L, et al. Outbreak Alert! Closing the Gaps in Our Federal Food Safety Net Outbreak Alert! Closing the Gaps in Our Federal Food Safety Net. Washington, DC: CSPI, October 2001. DeWaal CS, Dahl E. Dine at Your Own Risk Dine at Your Own Risk. CSPI, November 1996.15. Linnan MJ, Mascola L, Lou XD, et al. Epidemic listeriosis associated with Mexican-style cheese. NEJM NEJM 1988;319:823828. 1988;319:823828.16. Buchanan RL, Doyle MP. Foodborne disease significance of Escherichia coli Escherichia coli O157:H7 and other enterohemorrhagic O157:H7 and other enterohemorrhagic E. coli. Food Technology E. coli. Food Technology 1997;51(10): 6976. The numbers and letters distinguish the strain of 1997;51(10): 6976. The numbers and letters distinguish the strain of E. coli E. coli. The letter O O refers to a somatic antigen (protein on the bacterial body that elicits an immune response), and refers to a somatic antigen (protein on the bacterial body that elicits an immune response), and H H refers to an antigen on the bacterial flagella. (The variant is pronounced as it is spelled: E co-lie O one five seven H seven.) Grabowski EF. The hemolyticuremic syndrome-toxin, thrombin, and thrombosis. refers to an antigen on the bacterial flagella. (The variant is pronounced as it is spelled: E co-lie O one five seven H seven.) Grabowski EF. The hemolyticuremic syndrome-toxin, thrombin, and thrombosis. NEJM NEJM 2002;346:5861. 2002;346:5861.17. Gansheroff LJ, O'Brien AD. Escherichia coli Escherichia coli O157:H7 in beef cattle presented for slaughter in the U.S.: higher prevalence rates than previously estimated. O157:H7 in beef cattle presented for slaughter in the U.S.: higher prevalence rates than previously estimated. Proceedings of the National Academy of Sciences Proceedings of the National Academy of Sciences 2000;97:29592961. Mead PS, Griffin PM. 2000;97:29592961. Mead PS, Griffin PM. Escherichia coli Escherichia coli O157:H7. O157:H7. Lancet Lancet 1998;352:12071212. 1998;352:12071212.18. CDC reports E. coli E. coli cases exceed previous estimates. cases exceed previous estimates. Nutrition Week Nutrition Week, December 11, 1998:3,6. Marks S, Roberts T. E. coli E. coli O157:H7 ranks as the fourth most costly foodborne disease. O157:H7 ranks as the fourth most costly foodborne disease. FoodReview FoodReview 1993;16(3):5159. 1993;16(3):5159.19. MacDonald JM, Ollinger ME, Nelson KE, et al. Consolidation in U.S. Meatpacking Consolidation in U.S. Meatpacking (Agricultural Economic Report No. 785). USDA/ERS, February 2000. Heffernan W. (Agricultural Economic Report No. 785). USDA/ERS, February 2000. Heffernan W. Consolidation in the Food and Agriculture System: Report to the National Farmers Union Consolidation in the Food and Agriculture System: Report to the National Farmers Union. Columbia: University of Missouri, February 5, 1999. GAO. Dairy Industry: Information on Milk Prices and Changing Market Structure Dairy Industry: Information on Milk Prices and Changing Market Structure (GAO-01-561), June 2001. (GAO-01-561), June 2001.20. Tyson Foods. Tyson and IBP Agree on Merger Terms (press release), June 27, 2001, at www.accessmylibrary.com/coms2/summary_028626709621_ITM.21. Sierra Club. The Rap Sheet on Animal Factories The Rap Sheet on Animal Factories, August 2002. Online: www.sierraclub.org.22. Goodman PS. An unsavory byproduct: runoff and nutrient pollution. Washington Post Washington Post, August 1, 1999:A1. Five additional articles in this series followed on August 2 and 3.23. Armstrong GL, Hollingsworth J, Morris JG. Emerging foodborne pathogens: Escherichia coli Escherichia coli O157:H7 as a model of entry of a new pathogen into the food supply of the developed world. O157:H7 as a model of entry of a new pathogen into the food supply of the developed world. Epidemiologic Reviews Epidemiologic Reviews 1996;18:2951. 1996;18:2951.24. Hennessy TW, Hedberg CW, Slutsker L, et al. A national outbreak of Salmonella enteritidis Salmonella enteritidis infections from ice cream. infections from ice cream. NEJM NEJM 1996;334:12811286. 1996;334:12811286.25. Levy SB, FitzGerald GB, Macone AB. Changes in intestinal flora of farm personnel after introduction of a tetracycline-supplemented feed on a farm. NEJM NEJM 1976;295:583588. An entertaining (and accurate) source, far ahead of its time, is Schell O. 1976;295:583588. An entertaining (and accurate) source, far ahead of its time, is Schell O. Modern Meat: Antibiotics, Hormones, and the Pharmaceutical Farm Modern Meat: Antibiotics, Hormones, and the Pharmaceutical Farm. New York: Random House, 1984.26. Burros M. F.D.A. proposal on meat safety draws criticism. NYT NYT, June 8, 1983:C1. Wright K. The policy response: in limbo. Science Science 1990;249:24. 1990;249:24.27. National Research Council. The Use of Drugs in Food Animals: Benefits and Risks The Use of Drugs in Food Animals: Benefits and Risks. Washington, DC: National Academy Press, 1999:9.28. Leonard R. Drugs as feed additives increase risk to health. Nutrition Week Nutrition Week, August 7, 1998:45. For the science behind these arguments, see: Smith KE, Besser JM, Hedberg CW, et al. Quinolone-resistant Campylobacter jejuni Campylobacter jejuni infections in Minnesota, 19921998. infections in Minnesota, 19921998. NEJM NEJM 1999;340:15251532. Witte W. Medical consequences of antibiotic use in agriculture. 1999;340:15251532. Witte W. Medical consequences of antibiotic use in agriculture. Science Science 1998;279:996997. Levy SB. Private arsenals and public peril. 1998;279:996997. Levy SB. Private arsenals and public peril. NEJM NEJM 1998;338:13751378. 1998;338:13751378.29. Federal policy statements: FDA. Guidance for Industry. Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals Guidance for Industry. Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals, December 13, 1999, at www.fda.gov/OHRMS/DOCKETS/98fr/122399d.txt. GAO. Food Safety: The Agricultural Use of Antibiotics and Its Implications for Human Health Food Safety: The Agricultural Use of Antibiotics and Its Implications for Human Health (GAO/RCED-99-74), April 1999. CDC. (GAO/RCED-99-74), April 1999. CDC. Draft Draft-A Public Health Action Plan to Combat Antimicrobial Resistance, June 2000, at www.cdc.gov/drugresistance/actionplan/aractionplan.pdf. Three papers in the October 18, 2001, NEJM NEJM describe the supermarket findings (2001;345:11471166), as does an accompanying editorial: Gorbach S. Antimicrobial use in animal feed-time to stop. describe the supermarket findings (2001;345:11471166), as does an accompanying editorial: Gorbach S. Antimicrobial use in animal feed-time to stop. NEJM NEJM 2001;345:12021203. 2001;345:12021203.30. Mellon M, Benbrook C, Benbrook KL. Hogging It! Estimates of Antimicrobial Abuse in Livestock Hogging It! Estimates of Antimicrobial Abuse in Livestock. Washington, DC: Union of Concerned Scientists, 2001. Barza M, Gorbach S, DeVincent SJ, eds. The need to improve antimicrobial use in agriculture: ecological and human health consequences. Clinical Infectious Diseases Clinical Infectious Diseases 2002;34 Suppl 3:71143. Osvath R. Bill would phase out fluoroquinolones, other antibiotics. 2002;34 Suppl 3:71143. Osvath R. Bill would phase out fluoroquinolones, other antibiotics. FCN FCN, March 4, 2002:67.31. Brody JE. Studies find resistant bacteria in meats. NYT NYT, October 18, 2001:A12.32. Ferber D. Livestock feed ban preserves drugs' power. Science Science 2002;295:27. Burros M. Poultry industry quietly cuts back on antibiotic use. 2002;295:27. Burros M. Poultry industry quietly cuts back on antibiotic use. NYT NYT, February 10, 2002:A1,A26.33. Couzin J. Cattle diet linked to bacterial growth. Science Science 1998;281:15781579. Diez-Gonzalez F, Callaway TR, Kizoulis MG, et al. Grain feeding and the dissemination of acid-resistant 1998;281:15781579. Diez-Gonzalez F, Callaway TR, Kizoulis MG, et al. Grain feeding and the dissemination of acid-resistant Escherichia coli Escherichia coli from cattle. from cattle. Science Science 1998;281: 16661668. Beers A. Feed supplement can reduce 1998;281: 16661668. Beers A. Feed supplement can reduce E. coli E. coli shedding, study shows. shedding, study shows. FCN FCN, April 29, 2002:15. Crump JA, Sulka AC, Langer AJ, et al. An outbreak of Escherichia coli Escherichia coli O157:H7 infections among visitors to a dairy farm. O157:H7 infections among visitors to a dairy farm. NEJM NEJM 2002;347:555560. 2002;347:555560.34. Friedland WH. The new globalization: the case of fresh produce. In: Bonnano A, Busch L, Friedland WH, et al., eds. From Columbus to ConAgra: The Globalization of Agriculture and Food From Columbus to ConAgra: The Globalization of Agriculture and Food. Lawrence: University Press of Kansas, 1994:210231. For statistics on food imports, see: USDA/ERS. Vegetables and Specialties Yearbook Vegetables and Specialties Yearbook, at http://usda.mannlib.cornell.edu/MannUsda/viewTaxonomy.do?taxonomyID=6.35. Burros M. Salad bars: how clean are they? NYT NYT, August 25, 1999:F1,F9.36. Holler T. The iron rule in Omaha's jungle. Social Policy Social Policy 2002;32(4):2127. Schlosser E. 2002;32(4):2127. Schlosser E. Fast Food Nation Fast Food Nation. New York: Houghton Mifflin, 2001.37. Morris JG, Potter M. Emergence of new pathogens as a function of changes in host susceptibility. Emerging Infectious Diseases Emerging Infectious Diseases 1997;3:335344. 1997;3:335344.38. Hearn L. Haceldama. Cincinnati Commercial Cincinnati Commercial, September 5, 1875. Reprinted in: Cott J. Wandering Ghost: The Odyssey of Lafcadio Hearn Wandering Ghost: The Odyssey of Lafcadio Hearn. New York: Alfred A. Knopf, 1991:6169. Cott defines haceldama haceldama as a New Testament word meaning "field of blood." as a New Testament word meaning "field of blood."39. Smith MS, Roth DM. Chronological Landmarks in American Agriculture Chronological Landmarks in American Agriculture (Agricultural Information Bulletin No. 425). USDA/ERS, November 1990. Brady RP, Cooper RM, Silverman RS, eds. (Agricultural Information Bulletin No. 425). USDA/ERS, November 1990. Brady RP, Cooper RM, Silverman RS, eds. Fundamentals of Law and Regulation: An In-Depth Look at Foods, Veterinary Medicines, and Cosmetics Fundamentals of Law and Regulation: An In-Depth Look at Foods, Veterinary Medicines, and Cosmetics. Washington, DC: Food and Drug Law Institute, 1997.40. Goodwin LS. The Pure Food, Drink, and Drug Crusaders, 18791914 The Pure Food, Drink, and Drug Crusaders, 18791914. Jefferson, NC: McFarland, 1999. Coppin CA, High J. The Politics of Purity: Harvey Washington Wiley and the Origins of Federal Food Policy The Politics of Purity: Harvey Washington Wiley and the Origins of Federal Food Policy. Ann Arbor: University of Michigan Press, 1999. The authors argue that Wiley's interests in promoting pure food legislation had more to do with self-interest in expanding his bureau than with public health.41. Sinclair U. The Jungle The Jungle, 1906 (Bantam Classic edition, 1981). The introduction by Morris Dickstein explains the genesis of the book. The five quotations are from pages 135, 275, 135, 99, and 36, respectively.42. Congress immediately amended the 1906 Meat Inspection Act (the Beveridge Amendment) and reenacted it as the Meat Inspection Act of 1907. This book uses 1906 as the relevant date.43. National Research Council. Meat and Poultry Inspection: The Scientific Basis of the Nation's Program Meat and Poultry Inspection: The Scientific Basis of the Nation's Program. Washington, DC: National Academy Press, 1985.44. Congressional Record Congressional Record-Senate, June 30, 1906:97919792 (Vol. 40, Part 10, 59th Congress, 1st Session). CDC. Achievements in public health, 19001999: safer and healthier foods. MMWR MMWR 1999;48(40):905913. 1999;48(40):905913.45. Congressional Record Congressional Record-House, June 29, 1906:97359740 (Vol. 40, Part 10, 59th Congress, 1st Session).46. Wiley HW. 1001 Tests of Foods, Beverages and Toilet Accessories Good and Otherwise: Why They Are So 1001 Tests of Foods, Beverages and Toilet Accessories Good and Otherwise: Why They Are So. New York: Hearst's International Library, 1914:ixxix.47. Robinson RA. Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food Food Safety and Security: Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001. (GAO-02-47T), October 10, 2001.48. GAO. Food Safety and Quality: Who Does What in the Federal Government Food Safety and Quality: Who Does What in the Federal Government (GAO/RCED-91-19A and GAO/RCED-91-19B), December 1990. (GAO/RCED-91-19A and GAO/RCED-91-19B), December 1990.49. GAO. Food Safety and Quality: Uniform, Risk-based Inspection System Needed to Ensure Safe Food Supply Food Safety and Quality: Uniform, Risk-based Inspection System Needed to Ensure Safe Food Supply (GAO/RCED-92-152), June 1992. (GAO/RCED-92-152), June 1992.50. GAO. Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg Safety Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg Safety (GAO/RCED-99-184), July 1999. Baumler AJ, Hargis BM, Tsolis RM. Tracing the origins of (GAO/RCED-99-184), July 1999. Baumler AJ, Hargis BM, Tsolis RM. Tracing the origins of Salmonella Salmonella outbreaks. outbreaks. Science Science 2000;287:5052. 2000;287:5052.51. National Research Council. Poultry Inspection: The Basis for a Risk-Assessment Approach Poultry Inspection: The Basis for a Risk-Assessment Approach. Washington, DC: National Academy Press, 1987. USDA/FSIS. Enhanced poultry inspection: proposed rule. FR FR 59:3563935657, July 13, 1994. GAO. 59:3563935657, July 13, 1994. GAO. Food Safety: Weaknesses in Meat and Poultry Inspection Pilot Should Be Addressed before Implementation Food Safety: Weaknesses in Meat and Poultry Inspection Pilot Should Be Addressed before Implementation (GAO-02-59), December 2001. (GAO-02-59), December 2001.52. Putnam J, Allshouse J. Imports' share of U.S. diet rises in late 1990s. FoodReview FoodReview 2001;24(3):1522. FDA, USDA, EPA, CDC. 2001;24(3):1522. FDA, USDA, EPA, CDC. Food Safety from Farm to Table: A National Food Safety Initiative: Report to the President Food Safety from Farm to Table: A National Food Safety Initiative: Report to the President, May 1997. Online: vm.cfsan.fda.gov/~dms/fsreport.html.
CHAPTER 2. RESISTING MEAT AND POULTRY REGULATION, 19741994 1. Morgan D. Trying to lead the USDA through a thicket of politics. Washington Post Washington Post, July 5, 1978:A8.2. Foreman CT. Unequal protection, unfair competition: the cause and effect of different standards for food safety and nutrition (speech). Washington, DC: Consumer Federation of America's Consumer Assembly, March 1991 (revised June 10, 1991).3. Jacobson M. Nutrition Scoreboard Nutrition Scoreboard. New York: Avon Books, 1974. Sarasohn J. Ex-USDA chief Glickman joins Akins group. Washington Post Washington Post, February 8, 2001:A21.4. Center for Public Integrity. Safety Last: The Politics of E. coli and Other Food-Borne Killers Safety Last: The Politics of E. coli and Other Food-Borne Killers. Washington, DC, 1998. Quotation: 52. Also see: Food Safety and Government Regulation of Coliform Bacteria Food Safety and Government Regulation of Coliform Bacteria. Hearing before the Subcommittee on Agricultural Research, Conservation, Forestry, and General Legislation. 103rd Congress, 1st Session, February 5, 1993:6970. Mulkern AC. Is USDA too close to meat industry? Denver Post Denver Post, August 11, 2002:A1.5. American Public Health Association et al American Public Health Association et al. v. Earl Butz, Secretary of Department of Agriculture et al Earl Butz, Secretary of Department of Agriculture et al. 511 F. 2d 331 (DC Circuit Court of Appeals), December 19, 1974.6. Gilchrist A. Foodborne Disease & Food Safety Foodborne Disease & Food Safety. Chicago: American Medical Association, 1981:9598.7. Sugarman C. The road to food safety? How the government's new rules will (and won't) protect your dinner. Washington Post Washington Post, October 29, 1997:E1,E11. Lachance PA. Development of stored food and water systems. Environmental Biology and Medicine Environmental Biology and Medicine 1971;1:205228. I am indebted to George Pillsbury and James Behnke for explaining this history. 1971;1:205228. I am indebted to George Pillsbury and James Behnke for explaining this history.8. USDA/FSIS. Pathogen reduction: Hazard Analysis Critical Control Point (HACCP) systems: final rule with request for comments. FR FR 61:3880638989, July 25, 1996. 61:3880638989, July 25, 1996.9. USDA/FSIS. Generic HACCP models and guidance materials available for review and comment. FR FR 61:3205332054, June 12, 1997. 61:3205332054, June 12, 1997.10. National Research Council. Meat and Poultry Inspection: The Scientific Basis of the Nation's Program Meat and Poultry Inspection: The Scientific Basis of the Nation's Program. Washington, DC: National Academy Press, 1985:159.11. National Research Council. An Evaluation of the Role of Microbiological Criteria for Food and Food Ingredients An Evaluation of the Role of Microbiological Criteria for Food and Food Ingredients. Washington, DC: National Academy Press, 1985.12. USDA's "Discretionary Inspection" Plan for Meat and Poultry Processing Plants USDA's "Discretionary Inspection" Plan for Meat and Poultry Processing Plants. House of Representative Committee on Government Operations. Hearing before the Human Resources and Intergovernmental Relations Subcommittee. 101st Congress, 1st Session, April 11, 1989. Quotations: Carol Tucker Foreman, 5960; Delmer Jones, 4; Thomas Devine, 66.13. National Advisory Committee on Microbiological Criteria for Foods. Hazard Analysis and Critical Control Point System Hazard Analysis and Critical Control Point System. Washington, DC: USDA and FDA, March 20, 1992. Waites WM, Arbuthnott JP. Foodborne illness: an overview. Lancet Lancet 1990;336:722725. 1990;336:722725.14. GAO. Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to Ensure Safe Food Supply Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to Ensure Safe Food Supply (GAO/RCED-92-152), June 1992. USDA/FSIS. Streamlined inspection system: cattle and staffing standards. (GAO/RCED-92-152), June 1992. USDA/FSIS. Streamlined inspection system: cattle and staffing standards. FR FR 53:4826248275, November 30, 1988. 53:4826248275, November 30, 1988.15. Crutchfield S. Food safety at a glance. FoodReview FoodReview 1998;21(3):3435. 1998;21(3):3435.16. Committee on Evaluation of USDA Streamlined Inspection System for Cattle (SIS-C). Cattle Inspection Cattle Inspection. Washington, DC: National Academy Press, 1990:4.17. CDC. Update: Multistate outbreak of Escherichia coli Escherichia coli O157:H7 infections from hamburgers-Western United States, 199293. O157:H7 infections from hamburgers-Western United States, 199293. JAMA JAMA 1993;269:21942196. Bell BP, Goldoft M, Griffin PM, et al. A multistate outbreak of 1993;269:21942196. Bell BP, Goldoft M, Griffin PM, et al. A multistate outbreak of Escherichia coli Escherichia coli O157:H7associated bloody diarrhea and hemolytic uremic syndrome from hamburgers: the Washington experience. O157:H7associated bloody diarrhea and hemolytic uremic syndrome from hamburgers: the Washington experience. JAMA JAMA 1994;272:13491353. 1994;272:13491353.18. Egan T. Tainted hamburger raises doubts on meat safety. NYT NYT, January 27, 1993:A10.19. Tolchin M. Clinton orders hiring of 160 meat inspectors. NYT NYT, February 12, 1993:A23.20. Nugent RJ. Statement on Food Safety and Government Regulation of Coliform Bacteria Statement on Food Safety and Government Regulation of Coliform Bacteria. Hearing before the Subcommittee on Agricultural Research, Conservation, Forestry, and General Legislation of the Committee on Agriculture, Nutrition, and Forestry. 103rd Congress, 1st Session :34, February 5, 1993. Mr. Nugent was president of Jack in the Box (headquarters: San Diego, CA).21. Pollack A. A battle-scarred burger warrior. NYT NYT, October 3, 1999:A2. Schneider K. Clinton proposes to change the way meat is inspected. NYT NYT, March 17, 1993:A1,A18.22. Modernizing meat inspections (editorial). NYT NYT, April 2, 1993:A32.23. Altman LK. Lessons are sought in outbreak of illness from tainted meat. NYT NYT, February 9, 1993:C3. Sullivan A. Machines speed testing of food for bacteria. WSJ WSJ, July 15, 1996:B1.24. Wachsmuth IK. Escherichia coli Escherichia coli O157:H7-harbinger of change in food safety and tradition in the industrialized world. O157:H7-harbinger of change in food safety and tradition in the industrialized world. Food Technology Food Technology 1997;51(10):26. 1997;51(10):26.25. Burros M. Agriculture dept. policy blamed for tainted food. NYT NYT, March 3, 1993:C1,C4.26. Quoted in Fox N. Spoiled: The Dangerous Truth About a Food Chain Gone Haywire Spoiled: The Dangerous Truth About a Food Chain Gone Haywire. New York: Basic Books, 1997:25657. Later quotation: 245.27. Beyond Beef, USDA agree on meat handling labels. Nutrition Week Nutrition Week, May 7, 1993:3.28. Burros M. U.S. intends to require label on meat's cooking. NYT NYT, May 6, 1993:A18.29. Burros M. Agriculture dept. unveils cooking labels for meat. NYT NYT, August 12, 1993:A18. Most safety labeling on meat is postponed. NYT NYT, October 10, 1993:25. DeWaal C. Remarks to the Association of Food Journalists, Washington, DC, September 7, 1997.30. Sugarman C. Court blocks safety labels on meat products. Washington Post Washington Post, October 15, 1993:A11.31. Egan T. A year later, raw meat still lacks labels. NYT NYT, December 20, 1993:A1,D10.32. Baquet D, Johnston D. U.S. expanding scope in review of gifts to Agriculture secretary. NYT NYT, August 7, 1994:A1,A24. Johnston D. Agriculture chief quits as scrutiny of conduct grows. NYT NYT, October 4, 1994:A1,A16.33. Greenhouse L. High court voids theory used to press independent counsel's cases over gifts to Espy. NYT NYT, April 28, 1999:A26.34. Burros M. Agriculture dept. scraps poultry bacteria plan. NYT NYT, October 27, 1994:A20.35. Van Natta D, Lacey M. Access proved vital in last-minute race for Clinton pardons. NYT NYT, February 25, 2001:A1,A14.36. Cross HR. Testimony before Senate Agriculture Committee, February 5, 1993. Quoted in: Foreman CT. Hearing statement before the House Committee on Science, Space and Technology, Subcommittee on Technology, Environment and Aviation Hearing statement before the House Committee on Science, Space and Technology, Subcommittee on Technology, Environment and Aviation, 103rd Congress, 2nd Session, May 5, 1994:5.37. Taylor MR. Change and opportunity: harnessing innovation to improve the safety of the food supply (speech). American Meat Institute annual convention, San Francisco, CA, September 29, 1994.38. Beers A. FSIS expands E. coli E. coli O157:H7 adulteration policy. O157:H7 adulteration policy. FCN FCN, January 18, 1999:3,17,18.39. American Meat Institute. Meat and supermarket industries say USDA "misleading consumers" (press release). Washington, DC, November 1, 1994.40. Donnelly J. As E. coli E. coli sampling commences, lobbyists throw down gauntlet. sampling commences, lobbyists throw down gauntlet. Food & Drink Daily Food & Drink Daily, October 25, 1994.41. Food industry opposes food safety initiative. Nutrition Week Nutrition Week, November 4, 1994:7.42. The meat industry's bad beef (editorial). NYT NYT, November 20, 1994:A14.43. Judge upholds USDA program to test meat. Archived: The Victoria Advocate The Victoria Advocate, December 14, 1994 at http://news.google.com/newspapers?nid=861&dat=19941214&id=sTMKAAAAIBAJ&sjid= MUsDAAAAIBAJ&pg=4778,2876108. Texas Food Industry Association, et al Texas Food Industry Association, et al. v. Mike Espy, et al Mike Espy, et al., 870 F. Supp. 143 (W.D. Tex. 1994).44. Pratt, S. Some unsavory questions for meat industry group. Chicago Tribune Chicago Tribune, November 3, 1994:1,10.45. Heersink M. Memo to Safe Food Coalition (leaflet). November 2, 1994. Mary Heersink was a founder of Safe Tables Our Priority (STOP). Her son survived infection with E. coli E. coli O157:H7. O157:H7.46. USDA/FSIS. HACCP-based meat and poultry inspection concepts. FR FR 62:3155331562, June 10, 1997. Ingersoll B. Meat industry spurred to revise policies. 62:3155331562, June 10, 1997. Ingersoll B. Meat industry spurred to revise policies. WSJ WSJ, August 27, 1997:A3.
CHAPTER 3. ATTEMPTING CONTROL OF FOOD PATHOGENS, 19942002 1. DeWaal CS, Barlow K, Alderton L, et al. Outbreak Alert! Closing the Gaps in Our Federal Food Safety Net Outbreak Alert! Closing the Gaps in Our Federal Food Safety Net. Washington, DC: CSPI, October 2001. FDA. Development of Hazard Analysis Critical Control Points for the food industry: request for comments. FR FR 59:3988839896, August 4, 1994. Quote: 3988939890. See: 59:3988839896, August 4, 1994. Quote: 3988939890. See: www.fda.gov/Food/FoodSafety/HazardAnalysis CriticalControlPointsHACCP/default.htm.2. FDA/CFSAN. Second Interim Report of Observations and Comments: Hazard Analysis and Critical Control Point (HACCP) Pilot Program for Selected Food Manufacturers. HACCP: A State-of-the-Art Approach to Food Safety Second Interim Report of Observations and Comments: Hazard Analysis and Critical Control Point (HACCP) Pilot Program for Selected Food Manufacturers. HACCP: A State-of-the-Art Approach to Food Safety (FDA Backgrounder). FDA/CFSAN, August 1999, at (FDA Backgrounder). FDA/CFSAN, August 1999, at http://vm.cfsan.fda.gov/~comm/haccpoth.html.3. FDA. New egg safety steps announced, safe-handling labels and refrigeration will be required. HHS News HHS News, July 1, 1999. Also see: FDA. Procedures for the safe and sanitary processing and importing of fish and fishery products; final rule. FR FR 60:6509565202, December 18, 1995. FDA. Consumers advised of risks associated with raw sprouts. 60:6509565202, December 18, 1995. FDA. Consumers advised of risks associated with raw sprouts. HHS News HHS News, July 9, 1999.4. GAO. Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect Consumers Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect Consumers (GAO-01-204), January 2001. GAO. (GAO-01-204), January 2001. GAO. Food Safety: Federal Oversight of Shellfish Safety Needs Improvement Food Safety: Federal Oversight of Shellfish Safety Needs Improvement (GA)-0-702), July 2001. Abboud L. Bad fish slips through FDA's safety net. (GA)-0-702), July 2001. Abboud L. Bad fish slips through FDA's safety net. WSJ WSJ, October 9, 2002: D1,D2.5. USDA/FSIS. Pathogen Reduction: Hazard Analysis Critical Control Point (HACCP) systems: proposed rule. FR FR 60:67746889, February 3, 1995. USDA/FSIS. Final rule with request for comments. 60:67746889, February 3, 1995. USDA/FSIS. Final rule with request for comments. FR FR 61:3880638989, July 25, 1996. USDA documents on food safety are online at: 61:3880638989, July 25, 1996. USDA documents on food safety are online at: www.fsis.usda.gov.6. U.S. Meat and Poultry Inspection Issues U.S. Meat and Poultry Inspection Issues. Joint hearings before the Subcommittee on Department Operations and Nutrition and the Subcommittee on Livestock. 103rd Congress, 2nd Session, April 19, 1994. Statement of Bruce Tompkin, vice president, Product Safety, Armour Swift-Eckrich: 114.7. American Meat Institute. Meat and Supermarket Industries Say USDA "Misleading Consumers" (press release). Washington, DC, November 1, 1994. Foreman CT. Statement (press conference), National Press Club, Washington DC, May 30, 1995.8. Schulte B. Inspection changes for meat assailed. Philadelphia Inquirer Philadelphia Inquirer, June 16, 1995:A3. Meat and Poultry Processors Use "Bare-Knuckled Tactics" to Delay Food Safety Reforms (press release). CSPI, June 22, 1995.9. Morgan D. Industry finds a way around budget cutters: House Appropriations Panel proves friendlier to corporate subsidies. Washington Post Washington Post, June 26, 1995:A1.10. Jouzaitis C. Food safety regulations face challenge. Chicago Tribune Chicago Tribune, July 10, 1995:A1. Cushman JH. Narrow defeat for a measure on bad meat. NYT NYT, July 13, 1995:B9. Burros M. Congress moving to revamp rules on food safety: reducing federal role. NYT NYT, July 3, 1995:1,28. The Dole bill was S. 343, 104th Congress.11. The Republican assault on meat safety (editorial). NYT NYT, June 22, 1995:A26. Jacobson MJ, DeWaal CS. GOP rhetoric masks an attack on overdue clean-meat rules. San Francisco Examiner San Francisco Examiner, June 27, 1995:A15.12. Rogers D. House panel slows food-safety rules, maintains ban on offshore oil drilling. WSJ WSJ, June 28, 1995:A4.13. Herbert B. Let them eat poison. NYT NYT, July 3, 1995:21.14. Meat safety rules back on track-USDA's Glickman (news release). Reuters News Service Reuters News Service, July 19, 1995.15. Meat Industry Agenda Fails Again (press release). Washington, DC: S.T.O.P. (Safe Tables Our Priority), July 20, 1995.16. Jouzaitis C. Rollback of meat testing stalls in House. Chicago Tribune Chicago Tribune, July 20, 1995:3. DeWaal C. Remarks before the Association of Food Journalists Convention (speech). Washington, DC, September 7, 1997.17. USDA/FSIS. Generic HACCP models and guidance materials available for review and comment. FR FR 61:3205332054, June 12, 1997. 61:3205332054, June 12, 1997.18. Burros M. Plan for food safety panel is criticized. NYT NYT, April 1, 1996:A14.19. Ingersoll B. Meat inspectors omit duties as work grows. WSJ WSJ, May 23, 1996:B1,B6. Center for Public Integrity. Safety Last: The Politics of Safety Last: The Politics of E. coli E. coli and Other Food-Borne Killers and Other Food-Borne Killers. Washington, DC, 1998.20. GAO. Food Safety: New Initiatives Would Fundamentally Alter the Existing System Food Safety: New Initiatives Would Fundamentally Alter the Existing System (GAO-RCED-96-81), March 1996. (GAO-RCED-96-81), March 1996.21. Purdum TS. Meat inspections facing overhaul, first in 90 years. NYT NYT, July 7, 1996:A1,A11.22. Buzby JC, Crutchfield SR. USDA modernizes meat and poultry inspection. FoodReview FoodReview 1997;20(1):1417. Crutchfield S, Buzby JC, Roberts T, et al. 1997;20(1):1417. Crutchfield S, Buzby JC, Roberts T, et al. An Economic Assessment of Food Safety Regulations: The New Approach to Meat and Poultry Inspection An Economic Assessment of Food Safety Regulations: The New Approach to Meat and Poultry Inspection (Agricultural Economic Report No. 755), USDA/ERS, July 1997. (Agricultural Economic Report No. 755), USDA/ERS, July 1997.23. Belluck P. Juice-poisoning case brings guilty plea and a huge fine. NYT NYT, July 24, 1998:A12.24. Questions of pasteurization raised after E. coli E. coli is traced to juice. is traced to juice. NYT NYT, November 4, 1996:A17.25. Drew C, Belluck P. Deadly bacteria a new threat to fruit and produce in the U.S. NYT NYT, January 4, 1998:1,14. Clay T, Goldberg R. Odwalla, Inc Odwalla, Inc (case study). Boston: Harvard Business School, November 5, 1997:30. (case study). Boston: Harvard Business School, November 5, 1997:30.26. Belluck P. Accord is reached in food-poisoning case: juice maker's multimillion-dollar settlement may be a landmark. NYT NYT, May 27, 1998:A16.27. Coca-Cola will buy Odwalla, maker of fruit drinks. NYT NYT, October 31, 2001:C4. Odwalla provides ongoing financial reports on its Web site: www.odwalla.com.28. Food labeling: warning and notice statement; labeling of juice products: final rule. FR FR 63:3703037056, July 8, 1998. The term "5-logs" means 5 logarithmic units, indicating a 100,000-fold reduction. FDA deemed a reduction of this size to indicate that there would be no significant microbiological hazard during the shelf life of the product. 63:3703037056, July 8, 1998. The term "5-logs" means 5 logarithmic units, indicating a 100,000-fold reduction. FDA deemed a reduction of this size to indicate that there would be no significant microbiological hazard during the shelf life of the product.29. Richards B. Odwalla's woes are a lesson for natural-food industry: FDA seeks tighter quality controls as E. coli E. coli outbreak raises concerns. outbreak raises concerns. WSJ WSJ, November 4, 1996:B4.30. FDA. Hazard Analysis and Critical Control Point (HACCP); procedures for the safe and sanitary processing and importing of juice: final rule. FR FR 66:61376202, January 19, 2001. 66:61376202, January 19, 2001.31. USDA/FSIS. Generic E. coli E. coli testing for sheep, goats, equine, ducks, geese, and guineas: proposed rule. testing for sheep, goats, equine, ducks, geese, and guineas: proposed rule. FR FR 62:5930559310, November 3, 1997. 62:5930559310, November 3, 1997.32. Morganthau T. E. coli E. coli alert. alert. Newsweek Newsweek, September 1, 1997:2632.33. Stout D. 5 million hamburger patties may be tainted, US warns. NYT NYT, August 16, 1997:1,7. Janofsky M. 25 million pounds of beef is recalled. NYT NYT, August 22, 1997:A1,A18.34. Belluck P. The tangled trail that led to a beef recall. NYT NYT, August 24, 1997:1,24.35. Burger King. A letter to our customers about hamburgers, food safety and flame broiling. NYT NYT, August 25, 1997:A11. Whelan EM. Safe meat: there is a better way (editorial). WSJ WSJ, August 26, 1997:16.36. Ingersoll B. Meat industry spurred to revise policies. WSJ WSJ, August 27, 1997:A3.37. Drew C. Search widens to find source of tainted beef. NYT NYT, September 11, 1997. Belluck P. U.S. indicts producer of contaminated beef. NYT NYT, December 17, 1998:A24. FSIS to review food recalls. Nutrition Week Nutrition Week, April 8, 2002:1. USDA/FSIS. Recall Information at www.fsis.usda.gov/FSIS_Recalls/index.asp.38. Becker E. 19 million pounds of meat recalled after 19 fall ill. NYT NYT, July 20, 2002:A1,A9. Winter G. Democrats say slow meat recall threatened consumers. NYT NYT, July 27, 2002:A9. Burros M. Federal audit faults department's meat and poultry inspection system. NYT NYT, July 10, 2002:A15. GAO. Meat and Poultry: Better USDA Oversight and Enforcement of Safety Rules Needed to Reduce Risk of Foodborne Illnesses Meat and Poultry: Better USDA Oversight and Enforcement of Safety Rules Needed to Reduce Risk of Foodborne Illnesses (GAO-02-292), August 2002. (GAO-02-292), August 2002.39. Leonard RE. Hudson Foods, Inc: a risk management disaster. Nutrition Week Nutrition Week, August 29, 1997:45.40. Grey J. U.S. seeks new power to regulate meat safety. NYT NYT, October 9, 1997:A28.41. Sugarman C. Building a safer burger. Washington Post Washington Post, September 3, 1997:E1,E1042. Armstrong GL, Hollingsworth J, Morris JG. Emerging foodborne pathogens: Escherichia coli Escherichia coli O157:H7 as a model of entry of a new pathogen into the food supply of the developed world. O157:H7 as a model of entry of a new pathogen into the food supply of the developed world. Epidemiologic Reviews Epidemiologic Reviews 1996;18(1):2951. Gansheroff LJ, O'Brien AD. 1996;18(1):2951. Gansheroff LJ, O'Brien AD. Escherichia coli Escherichia coli O157:H7 in beef cattle presented for slaughter in the U.S.: higher prevalence rates than previously estimated. O157:H7 in beef cattle presented for slaughter in the U.S.: higher prevalence rates than previously estimated. Proceedings of the National Academy of Sciences Proceedings of the National Academy of Sciences 2000;97:29592961. 2000;97:29592961.43. USDA/FSIS. Beef products contaminated with Escherichia coli Escherichia coli O157:H7. O157:H7. FR FR 64:28032805, January 19, 1999. 64:28032805, January 19, 1999.44. Beers A. FSIS expands E. coli E. coli O157:H7 adulteration policy. O157:H7 adulteration policy. FCN FCN, January 18, 1999:3,17,18.45. Glickman D. Letter to Rosemary Mucklow, executive director, National Meat Association, USDA, January 28, 1999. Copies of this letter circulated widely through electronic mail. See: Meat Industry Internet Newsservice. Glickman cancels speech after meat group's comment, January 29, 1999. Online: www.spcnet work.com/mii/1999/990176.htm.46. USDA/FSIS. E. coli 0157:H7 contamination of beef products. FR FR 67:6232562334, October 7, 2002. 67:6232562334, October 7, 2002.47. Burros M. New U.S. standards for meat are snared in a court fight. NYT NYT, December 4, 1999:A11. Ingersoll B. USDA is set to present new evidence Supreme Beef failed to meet standards. WSJ WSJ, December 10, 1999:A6.48. Meat trade groups support Supreme Beef in lawsuit. Food Regulation Weekly Food Regulation Weekly, January 10, 2000:89. Burros M. Judge gives meat plant a reprieve from closing. NYT NYT, December 11, 1999:A12.49. Burros M. Ground beef is recalled for E. coli. NYT E. coli. NYT, December 26, 1999:A14.50. A threat to meat inspection (editorial). NYT NYT, May 26, 2000:A18.51. Supreme Beef refuses USDA request to halt production. Food Regulation Weekly Food Regulation Weekly, June 19, 2000:1213.52. Beers A. Supreme Beef prepares to battle USDA in court over performance standards. FCN FCN, November 27, 2000:34. USDA takes aim at Supreme Beef in latest round. FCN FCN, March 19, 2001:1819.53. Supreme Beef Processors, Inc Supreme Beef Processors, Inc. v. USDA USDA, 275 F. 3d432 (5th Cir. 2001).54. Murphy D. Commentary: Salmonella Ruling-Can USDA's Loss Be Turned into Industry's Gain? Meat Marketing & Technology Meat Marketing & Technology, December 14, 2001. Online: www.meatingplace.com (but no longer available). (but no longer available).55. A threat to meat inspection (editorial). NYT NYT, December 26, 2001: A28.56. Murano E. Ensuring meat safety (letter). NYT NYT, January 2, 2002:A14. Ms. Murano was USDA undersecretary for food safety.57. Movement on meat safety (editorial). NYT NYT, February 9, 2002:A18.58. Beers A. USDA won't appeal Supreme ruling, may seek regulatory changes. FCN FCN, February 18, 2002:1,24. More legal challenges to Salmonella Salmonella standard? standard? FCN FCN, June 17, 2002:1,13.59. Bills seek to restore power for federal Salmonella Salmonella tests. tests. NYT NYT, March 15, 2002:A12. Beers A. Harkin bill gets tougher on pathogen contamination. FCN FCN, March 18, 2002:1,17,18.60. USDA/FSIS. HACCP-based meat and poultry inspection concepts. FR FR 62:3155331562, June 10, 1997. USDA/FSIS. 62:3155331562, June 10, 1997. USDA/FSIS. Backgrounder: HACCP-Based Inspection Models Backgrounder: HACCP-Based Inspection Models, July 1998.61. American Federation of Government Employees American Federation of Government Employees v. v. Glickman Glickman, 215 F.3d 7 (D.C. Cir. 2000).62. HACCP appears to be in jeopardy as court rules against inspection system. Nutrition Week Nutrition Week, July 7, 2000:12.63. American Federation of Government Employees American Federation of Government Employees v. v. Glickman Glickman, 127 F. Supp. 2d 243 (D.D.C. 2001). Beers A. Union once again appeals HIMP ruling. FCN FCN, February 19, 2001:4.64. GAO. Food Safety: Weaknesses in Meat and Poultry Inspection Pilot Should Be Addressed before Implementation Food Safety: Weaknesses in Meat and Poultry Inspection Pilot Should Be Addressed before Implementation (GAO-02-59), December 2001. Quotations: 5,3334. (GAO-02-59), December 2001. Quotations: 5,3334.65. USDA/FSIS. An Overview of the HACCP-Based Inspection Models Project An Overview of the HACCP-Based Inspection Models Project (backgrounder), January 2002. (backgrounder), January 2002.66. Beers A. Appeals court sides with USDA on HIMP-for now. FCN FCN, April 8, 2002:1,13,14. Beers A. New HIMP data shows previously unrevealed problems. FCN FCN, June 10, 2002:1,20,21.67. Schlosser E. Fast Food Nation Fast Food Nation. New York: Houghton Mifflin, 2001.68. The West County Times West County Times (Contra Costa, CA) tracked this story: Lyons C, Holbrook D. Three killed at sausage factory. (June 22, 2000:A1,A16). Marshall S, Jokelson A, Holbrook D, et al. State says plant is unlicensed. (June 23, 2000:A1,A16.) A grand jury indicted Mr. Alexander for murder in September 2000. He was tried, given a death sentence, but died in prison in 2005. (Contra Costa, CA) tracked this story: Lyons C, Holbrook D. Three killed at sausage factory. (June 22, 2000:A1,A16). Marshall S, Jokelson A, Holbrook D, et al. State says plant is unlicensed. (June 23, 2000:A1,A16.) A grand jury indicted Mr. Alexander for murder in September 2000. He was tried, given a death sentence, but died in prison in 2005.69. Anderson B. Beefed-up authority eyed for state inspectors. West County Times West County Times, June 30, 2000:A4. Association of Technical and Supervisory Professionals calls for Billy's resignation. FCN FCN, July 31, 2000:45. USDA officials call for end to workplace violence. The Food Safety Educator The Food Safety Educator (USDA/FSIS) 2000;5(3):2. (USDA/FSIS) 2000;5(3):2.70. Hazelkorn B. Inspector abuse: how bad is it? MeatNews.com No. 381, July 19, 2000. Eye for an eye: abusive inspectors (No 477, October 11, 2000). Why we can't just get along (No. 510, November 8, 2000). It's all about communication (No. 740, January 30, 2001). Online: www.meatnews.com/index.cfm?fuseaction=Article&artNum=381 (477, 510, 740). No longer available. (477, 510, 740). No longer available.71. Beers A. Number of reported workplace violence incidents increasing, USDA data shows. FCN FCN, May 20, 2002:2223. USDA expands scope of workplace violence directive. FCN FCN, June 24, 2002:2829.72. Milbank Memorial Fund. Conflict and Violence in the Food Safety Workplace: A Report on Meetings Conflict and Violence in the Food Safety Workplace: A Report on Meetings, September 2000, at www.milbank.org/0107 foodsafety.html. foodsafety.html.
CHAPTER 4. ACHIEVING SAFE FOOD: ALTERNATIVES.
1. USDA. U.S. Imports of Agricultural, Fish, and Forestry Products, All Countries, 2000 U.S. Imports of Agricultural, Fish, and Forestry Products, All Countries, 2000, at www.fao.org/docrep/008/y7867e/y7867e00.htm. Friedland WH. The new globalization: the case of fresh produce. In: Bonnano A, Busch L, Friedland, WH, et al., eds. From Columbus to ConAgra: The Globalization of Agriculture and Food From Columbus to ConAgra: The Globalization of Agriculture and Food. Lawrence: University Press of Kansas, 1994:210231.2. GAO. Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent and Unreliable Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent and Unreliable (GAO/RCED-98-103), April 1998. Wasik JF. How safe is your produce? (GAO/RCED-98-103), April 1998. Wasik JF. How safe is your produce? Consumers Digest Consumers Digest, September/October 1998:6166.3. Chazan G. Moscow lets U.S. poultry back in. NYT NYT, April 15, 2002:A13.4. GAO. U.S. Agricultural Exports: Strong Growth Likely but U.S. Export Assistance Programs' Contribution Uncertain U.S. Agricultural Exports: Strong Growth Likely but U.S. Export Assistance Programs' Contribution Uncertain (GAO/NSIAD-97-260), September 1997. (GAO/NSIAD-97-260), September 1997.5. FAO and WHO. Understanding the Codex Alimentarius Understanding the Codex Alimentarius. Rome, 2006, at ftp://ftp.fao.org/codex/Publications/understanding/Understanding_EN.pdf.6. Avery N, Drake M, Lang T. Cracking the Codex: An Analysis of Who Sets World Food Standards Cracking the Codex: An Analysis of Who Sets World Food Standards. London: National Food Alliance, 1993.7. Gerth J, Weiner T. Imports swamp U.S. food-safety efforts. NYT NYT, September 29, 1997:A1,A10.8. Daniels RW. Home food safety. Food Technology Food Technology 1998;52(2):5456. 1998;52(2):5456.9. DHHS. Healthy People 2000: National Health Promotion and Disease Prevention Objectives Healthy People 2000: National Health Promotion and Disease Prevention Objectives (conference edition), 1990:339341. DHHS. (conference edition), 1990:339341. DHHS. Promoting Health, Preventing Disease: Objectives for the Nation Promoting Health, Preventing Disease: Objectives for the Nation, 1980:58.10. DHHS. Healthy People 2010: Understanding and Improving Health Healthy People 2010: Understanding and Improving Health (conference edition, Vol. 1), 2000:10-1 to 10-17. (conference edition, Vol. 1), 2000:10-1 to 10-17.11. Glickman D (USDA Secretary), Shalala D (DHHS Secretary). "Dear Colleague" letter on Partnership for Food Safety Education letterhead, September 1997.12. Mokhiber R, Weissman R. Which way, CFA Which way, CFA? Focus on the Corporation, June 8, 2000, at www.mail-archive.com/[email protected]/msg44112.html.13. Partnership for Food Safety Education. Fight BAC! A National Public Education Campaign to Reduce the Risk of Foodborne Illness Fight BAC! A National Public Education Campaign to Reduce the Risk of Foodborne Illness, 1998. Online: www.fightbac.org.14. USDA/FSIS. Backgrounder: Food Safety Education: Making a Difference in Improving Public Health Backgrounder: Food Safety Education: Making a Difference in Improving Public Health, October 1998.15. American Dietetic Association and ConAgra Foundation. Home Food Safety . . . It's in Your Hands Home Food Safety . . . It's in Your Hands. Chicago, IL, 2000.16. Barboza D. Meatpackers' profits hinge on pool of immigrant labor. NYT NYT, December 21, 2001:A26. Tyson Foods indicted in plan to smuggle illegal workers. NYT NYT, December 20, 2001:A1,A32.17. Osterholm MT. No magic bullet: more inspectors is fine and dandy. But don't kid yourself: government can't "solve" the problem of food safety. Newsweek Newsweek, September 1, 1997:33. At the time, Mr. Osterholm was chief of epidemiology, Minnesota Department of Health.18. Olson DG. Irradiation of food. Food Technology Food Technology 1998;52(1):5662. 1998;52(1):5662. Radiation Pasteurization of Food Radiation Pasteurization of Food (Issue paper No. 7). Ames, IA: Council for Agricultural Science and Technology, April 1996. GAO. (Issue paper No. 7). Ames, IA: Council for Agricultural Science and Technology, April 1996. GAO. Food Irradiation: Available Research Indicates That Benefits Outweigh Risks Food Irradiation: Available Research Indicates That Benefits Outweigh Risks (GAO/RCED-00-217), August 2000. (GAO/RCED-00-217), August 2000.19. Morrison RM. Food irradiation still faces hurdles. FoodReview FoodReview 1992;15(2):1115. 1992;15(2):1115.20. USDA. Fruits and vegetables from Hawaii: proposed rule. FR FR 67:3593235936, May 22, 2002. 67:3593235936, May 22, 2002.21. Meat industry pushes irradiation. Illinois Agrinews Illinois Agrinews, November 21, 1997:C3. Grey J. U.S. seeks new power to regulate meat safety. NYT NYT, October 9, 1997:A28.22. Whelan EM. Safe meat: there is a better way (editorial). WSJ WSJ, August 26, 1997:16.23. Produce Marketing Association. Fact Sheet: Irradiation. Newark, DE, November 1997. The association's mission is to "create a favorable, responsible environment that advances the marketing" of fresh fruits, vegetables, and flowers sold by its 2,500 members. O'Connor T. FDA approves irradiation for beef. Illinois Agrinews Illinois Agrinews, December 12, 1997:C3. Mr. O'Connor was executive vice president of the Illinois Beef Forum, a trade association for the state beef industry.24. Food and Drug Modernization Act of 1997, Public Law 105-115, 105th Congress, 1st Session, November 21, 1997, 111 Stat. 2296. Section 306: Disclosure of irradiation. Section 307: Irradiation petition.25. FDA. Irradiation in the production, processing, and handling of food. FR FR 62:6410764121, December 3, 1997. Kolata G. Irradiating red meat approved as a means to kill deadly germs. 62:6410764121, December 3, 1997. Kolata G. Irradiating red meat approved as a means to kill deadly germs. NYT NYT, December 3, 1997:A1,A33.26. Leonard RE. 1997: the year of living dangerously. Nutrition Week Nutrition Week, February 6, 1998:45. Chicken: what you don't know can hurt you. Consumer Reports Consumer Reports, March 1998:1218.27. Farm Security and Rural Investment Act of 2002. Public Law 107-171, 107th Congress, 2nd Session, May 13, 2002. 116 Stat. 134. Liddle AJ. DQ field tests irradiated burgers as farm bill relaxes labeling law. Nation's Restaurant News Nation's Restaurant News, May 20, 2002:3,234.28. Kolata G, Drew C. Long quest for safer food revisits radiation method. NYT NYT, December 4, 1997:A1,A24.29. Frenzen PD, Majchrowicz A, Buzby JC, et al. Consumer acceptance of irradiated meat and poultry products. Issues in Food Safety Economics Issues in Food Safety Economics (Agriculture Information Bulletin No. 757), USDA/ERS, August 2000. (Agriculture Information Bulletin No. 757), USDA/ERS, August 2000.30. Consumers' Views on Food Irradiation Consumers' Views on Food Irradiation. Washington, DC: Food Marketing Institute and Grocery Manufacturers of America, 1998. These are trade organizations for grocery retailers, wholesalers, and food and beverage product companies.31. Expert Panel on Food Safety and Nutrition. Irradiation of food. Food Technology Food Technology 1998;52:5662. Morrison RM, Buzby JC, Lin C-TJ. Irradiating ground beef to enhance food safety. 1998;52:5662. Morrison RM, Buzby JC, Lin C-TJ. Irradiating ground beef to enhance food safety. FoodReview FoodReview 1997;20(1):3337. Buzby JC, Morrison RM. Food irradiation-an update. 1997;20(1):3337. Buzby JC, Morrison RM. Food irradiation-an update. FoodReview FoodReview 1999;22(3):2122. 1999;22(3):2122.32. Fulmer M. Hum of interest builds around irradiated food. Los Angeles Times Los Angeles Times, November 20, 2001:C1.33. Leonard R. Food safety mismanagement puts consumer health at risk. Nutrition Week Nutrition Week, April 16, 1999:45.34. DeWaal CS, Barlow K, Alderton L, et al. Outbreak Alert! Closing the Gaps in Our Federal Food-Safety Net Outbreak Alert! Closing the Gaps in Our Federal Food-Safety Net. Washington, DC: CSPI, October 2001.35. Headrick ML, Korangy S, Bean NH, et al. The epidemiology of raw milkassociated foodborne disease outbreaks reported in the United States, 1973 through 1992. Am J Public Health Am J Public Health 1998;88:12191221. CDC. Outbreak of 1998;88:12191221. CDC. Outbreak of Listeriosis Listeriosis associated with homemade Mexican-style cheese-North Carolina, October 2000January 2001. associated with homemade Mexican-style cheese-North Carolina, October 2000January 2001. MMWR MMWR 2001;50:560562. Cody SH, Abbott SL, Marfin AA, et al. Two outbreaks of multidrug-resistant 2001;50:560562. Cody SH, Abbott SL, Marfin AA, et al. Two outbreaks of multidrug-resistant Salmonella Salmonella serotype typhimurium DT104 infections linked to raw-milk cheese in Northern California. serotype typhimurium DT104 infections linked to raw-milk cheese in Northern California. JAMA JAMA 1999;281:18051810. Villar RG, Macek MD, Simons S, et al. Investigation of multidrug-resistant 1999;281:18051810. Villar RG, Macek MD, Simons S, et al. Investigation of multidrug-resistant Salmonella Salmonella serotype typhimurium DT104 infections linked to raw-milk cheese in Washington State. serotype typhimurium DT104 infections linked to raw-milk cheese in Washington State. JAMA JAMA 1999;281:18111816. 1999;281:18111816.36. Keene WE. Lessons from investigations of foodborne disease outbreaks. JAMA JAMA 1999;281:18451847. 1999;281:18451847.37. Wakin DJ. New scrutiny of cheese offends refined palates. NYT NYT, July 14, 2000:B1,B9.38. American Cheese Society. Platform of the American Cheese Society Regarding Mandatory Pasteurization (flyer). Distributed at the National Association for the Specialty Food Trade Fancy Food Show, New York, July 1114, 1999. The society, which promotes American-made specialty cheeses, is headquartered in Louisville, Kentucky. Online: www.cheesesociety.org.39. USDA/FSIS. Pathogen reduction: Hazard Analysis Critical Control Point (HACCP) systems: proposed rule. FR FR 60:67746889, February 3, 1995. 60:67746889, February 3, 1995.40. Sara Lee pleads guilty to selling adulterated meat from Michigan plant. Detroit Free Press Detroit Free Press, June 23, 2001, at www.accessmylibrary.com/coms2/summary_02868343460_ITM. USDA/FSIS. Owners of Texas Firm Sentenced for Selling Adulterated Meat Products (press release), January 2, 2002.41. Steinhauer J. Number of victims of E. coli E. coli poisoning in upstate New York grows to nearly 300. poisoning in upstate New York grows to nearly 300. NYT NYT, September 9, 1999:B5. Barstow D. A wholesome tradition tainted: E. coli E. coli takes terrible toll on families and fair's future. takes terrible toll on families and fair's future. NYT NYT, September 20, 1999:B1,B6.42. Institute of Medicine. Ensuring Safe Food: From Production to Consumption Ensuring Safe Food: From Production to Consumption. Washington, DC: National Academy Press, 1998. Quotations: vvi, 1213.43. Food Marketing Institute. Long-Range Priorities for Food Safety Long-Range Priorities for Food Safety (adopted by the FMI Board of Directors). Washington, DC, October 28, 1988. Also see: (adopted by the FMI Board of Directors). Washington, DC, October 28, 1988. Also see: White House Conference on Food, Nutrition, and Health, Final Report White House Conference on Food, Nutrition, and Health, Final Report, 1970:129141. Smith RJ. Institute of Medicine report recommends complete overhaul of food safety laws. Science Science 1979;203:12211224. Institute of Food Technologists. Guiding principles for optimum food safety oversight and regulation in the United States. 1979;203:12211224. Institute of Food Technologists. Guiding principles for optimum food safety oversight and regulation in the United States. Food Technology Food Technology 1998;52(5):30,50,52. 1998;52(5):30,50,52.44. GAO. Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to Ensure Safe Food Supply Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to Ensure Safe Food Supply (GAO/RCED-92-152), June 1992:6. (GAO/RCED-92-152), June 1992:6.45. Harman JW. Food Safety: A Unified, Risk-Based System Needed to Enhance Food Safety Food Safety: A Unified, Risk-Based System Needed to Enhance Food Safety (GAO/T-RCED-94-71), November 4, 1993. (GAO/T-RCED-94-71), November 4, 1993.46. Dyckman LJ. Food Safety: U.S. Needs a Single Agency to Administer a Unified, Risk-Based Inspection System Food Safety: U.S. Needs a Single Agency to Administer a Unified, Risk-Based Inspection System (GAO/T-RCED-99-256), August 4, 1999. (GAO/T-RCED-99-256), August 4, 1999.47. Kessler DA (FDA Commissioner). Memorandum to the Secretary of DHHS. Washington, DC: DHHS, March 12, 1993.48. Burros M. Clinton to battle foodborne illness. NYT NYT, January 25, 1997:A1,A7. Marwick C. Putting money where the U.S. mouth is: initiative on food safety gets under way. JAMA JAMA 1997;277:13401342. 1997;277:13401342.49. FDA, EPA, CDC. Food Safety from Farm to Table: A National Food Safety Initiative: Report to the President Food Safety from Farm to Table: A National Food Safety Initiative: Report to the President. FDA/EPA/CDC, May 1997, at www.foodsafety.gov/~dms/fsreport.html.50. Broder JM. Clinton to seek additional money for food safety. NYT NYT, December 28, 1997:A1,A17.51. Burros M. President to push for food safety: seeks more money, and power to tighten import controls. NYT NYT, July 4, 1998:A1,A9.52. GAO. Food Safety: Opportunities to Redirect Federal Resources and Funds Can Enhance Effectiveness Food Safety: Opportunities to Redirect Federal Resources and Funds Can Enhance Effectiveness (GAO/RCED-98-224), August 1998. (GAO/RCED-98-224), August 1998.53. Leonard R. Food safety proposals may be a health hazard. Nutrition Week Nutrition Week, August 28, 1998:45.54. Molotsky I. Clinton to appoint council to oversee safety of food. NYT NYT, August 25, 1998:A15. In response to NAS report Clinton appoints a food safety council; no czar. Nutrition Week Nutrition Week, August 28, 1998:1,6.55. USDA, DHHS, EPA. President's national food safety initiative. FR FR 63:4592245923, August 27, 1998. 63:4592245923, August 27, 1998.56. DHHS, USDA. Backgrounder: 2000 President's Food Safety Initiative Backgrounder: 2000 President's Food Safety Initiative. DHHS/USDA, February 25, 1999. Federal food safety documents are available online: www.foodsafety.gov. Endicott RC. 46th annual report: 100 leading national advertisers. Advertising Age Advertising Age, September 24, 2001:S1S26.57. Draft food safety strategic plan offers no surprises. Food Regulation Weekly Food Regulation Weekly, January 17, 2000:67.58. Food Safety Council strategic plan will get "real," Levitt promises. Food Regulation Weekly Food Regulation Weekly, February 14, 2000:11.59. USDA/FSIS. Performance standards for the production of processed meat and poultry products; proposed rule. FR FR 66:1258912636, February 27, 2001. Bush administration blocks proposed rule on 66:1258912636, February 27, 2001. Bush administration blocks proposed rule on Listeria Listeria testing. testing. Nutrition Week Nutrition Week, January 26, 2001:12. USDA released proposed Listeria Listeria rule from chokehold. rule from chokehold. Nutrition Week Nutrition Week, February 23, 2001:6. Burros M. New meat-testing regulation wins backing of White House. NYT NYT, February 27, 2001:A21.60. Burros M. U.S. proposed end to testing for Salmonella Salmonella in school beef. in school beef. NYT NYT, April 5, 2001:A1,A14. Becker E. Agriculture chief disavows plan to eliminate test on school beef. NYT NYT, April 6, 2001:A1,A19. Beers A. USDA reinstates Salmonella Salmonella testing of school-lunch beef. testing of school-lunch beef. FCN FCN, April 9, 2001:34.61. Jackson D. School lunches: illness on menu, and Jackson D, Dougherty G. Meat from troubled plants sold to U.S. lunch program. Chicago Tribune Chicago Tribune, December 9, 2001:C1,C17.62. GAO. Food Safety: Continued Vigilance Needed to Ensure Safety of School Meals Food Safety: Continued Vigilance Needed to Ensure Safety of School Meals (GAO-02-669T), April 30, 2002. (GAO-02-669T), April 30, 2002.63. Taylor MR. Reforming food safety: a model for the future. Food Technology Food Technology 2002;56(5):190194. 2002;56(5):190194.64. Weber W. The road ahead for the European Food Authority. Lancet Lancet 2001;358:650. 2001;358:650.65. GAO. Food Safety: Experiences of Four Countries in Consolidating Their Food Safety Systems Food Safety: Experiences of Four Countries in Consolidating Their Food Safety Systems (GAO/RCED-99-80), April 1999. (GAO/RCED-99-80), April 1999.
PART 2. SAFETY AS A SURROGATE: THE IRONIC POLITICS OF FOOD BIOTECHNOLOGY.
Some parts of these chapters are drawn from articles published previously and are used with their publishers' permission: Nestle, M. Allergies to transgenic foods-questions of policy, NEJM NEJM 1996;334:726728 (Massachusetts Medical Society); Food biotechnology: labeling will benefit industry as well as consumers, 1996;334:726728 (Massachusetts Medical Society); Food biotechnology: labeling will benefit industry as well as consumers, Nutrition Today Nutrition Today 1998;33(1):612 (Lippincott Williams & Wilkins); Food biotechnology: politics and policy implications. In: Kiple KF, Ornelas-Kiple CK, eds. 1998;33(1):612 (Lippincott Williams & Wilkins); Food biotechnology: politics and policy implications. In: Kiple KF, Ornelas-Kiple CK, eds. The Cambridge World History of Food and Nutrition The Cambridge World History of Food and Nutrition, Vol. II. Cambridge: Cambridge University Press, 2000:16431662; Agricultural biotechnology, policy, nutrition. In: Murray TH, Mehlman MJ, eds. Encyclopedia of Ethical, Legal, & Policy Issues in Biotechnology Encyclopedia of Ethical, Legal, & Policy Issues in Biotechnology. New York: John Wiley & Sons, 2000:6676.
1. Agricultural Biotechnology: The Road to Improved Nutrition & Increased Production? (conference). Boston, MA: Tufts University School of Nutrition Science and Policy, November 12, 2001.2. For the origin of Frankenfoods Frankenfoods, see Safire W. On language. NYT Magazine NYT Magazine, August 13, 2000:23. Mr. Safire notes that biotechnophobes needed a frightening metaphor, "and the Franken-prefix did the trick." He credits the term to this letter from Paul Lewis, an English professor at Boston University: "Ever since Mary Shelley's baron rolled his improved human out of the lab, scientists have been bringing just such good things [genetically modified tomatoes] to life. If they want to sell us Frankenfood, perhaps it's time to gather the villagers, light some torches, and head to the castle" (NYT, June 16, 1992:A24).3. Gaull GE, Goldberg RA, eds. New Technologies and the Future of Food and Nutrition New Technologies and the Future of Food and Nutrition. New York: John Wiley & Sons, 1991.4. Fraley R. Sustaining the food supply. Bio/Technology Bio/Technology 1992;10:4043. 1992;10:4043.5. I am indebted to my NYU colleague Dorothy Nelkin for her discussion of these ideas. See: Nelkin D. Selling Science: How the Press Covers Science and Technology Selling Science: How the Press Covers Science and Technology. San Francisco: W.H. Freeman, 1995.
CHAPTER 5. PEDDLING DREAMS: PROMISES VERSUS REALITY.
1. GAO. Genetically Modified Foods: Experts View Regimen of Safety Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced Genetically Modified Foods: Experts View Regimen of Safety Tests as Adequate, but FDA's Evaluation Process Could Be Enhanced. (GAO-02-566), May 2002. Greenpeace. How to Avoid Genetically Engineered Food: True Food Shopping List How to Avoid Genetically Engineered Food: True Food Shopping List. Washington, DC, October 2000.2. Mann CC. Crop scientists seek a new revolution. Science Science 1999;285:310314. 1999;285:310314.3. Gaull GE, Goldberg RA, eds. New Technologies and the Future of Food and Nutrition New Technologies and the Future of Food and Nutrition. New York: John Wiley & Sons, 1990:97,150. Angell PS. Playing God in the garden (letter). NYT Magazine NYT Magazine, November 15, 1998:26.4. Feldbaum CB. The Transfer of Agricultural Biotechnology to Developing Countries: A Series of Case Studies The Transfer of Agricultural Biotechnology to Developing Countries: A Series of Case Studies. Washington, DC: Biotechnology Industry Organization, 1996.5. Conversion of potatoes (cheap) into potato chips (more expensive, higher profit) is an example of adding value, as is the addition of vitamins to sugar-coated cereals.6. Ollinger M, Pope L. Plant Biotechnology: Out of the Laboratory and into the Field Plant Biotechnology: Out of the Laboratory and into the Field (Agricultural Economic Report No. 697), USDA, 1995. Leary W. Cornucopia of new foods is seen as policy on engineering is eased. (Agricultural Economic Report No. 697), USDA, 1995. Leary W. Cornucopia of new foods is seen as policy on engineering is eased. NYT NYT, May 27, 1992:A1. Brownlee S. Dollars for DNA: biotech seems near to living up to its hype. US News & World Report US News & World Report, May 25, 1998:48,50. Agricultural biotechnology. Nature Biotechnology Nature Biotechnology 2000;18(suppl):IT59IT61. 2000;18(suppl):IT59IT61.7. Vidal J. Special report: GM food debate. Guardian Guardian (London), August 28, 2001. The planting figures may be conservative; Monsanto alone claimed 103 million acres in 2000. (London), August 28, 2001. The planting figures may be conservative; Monsanto alone claimed 103 million acres in 2000.8. A group called Syracuse Cultural Workers produces a t-shirt satirizing the original Monsanto slogan as Lies, Death, Profits Lies, Death, Profits, at http://syracuseculturalworkers.com/aboutus.9. Monsanto. 2000 Annual Report 2000 Annual Report. Online: www.monsanto.com. Pharmacia divested its 84% stake in Monsanto in 2002.10. Enriquez J, Goldberg R. Gene Research, the Mapping of Life, and the Global Economy Gene Research, the Mapping of Life, and the Global Economy (case study). Boston: Harvard Business School, October 16, 1998. (case study). Boston: Harvard Business School, October 16, 1998.11. Caswell MF, Fuglie KO, Klotz CA. Agricultural Biotechnology: An Economic Perspective Agricultural Biotechnology: An Economic Perspective (Agricultural Economic Report No. 687). USDA, 1994. Pennisi E. A bonanza for plant genomics. (Agricultural Economic Report No. 687). USDA, 1994. Pennisi E. A bonanza for plant genomics. Science Science 1998;282:652654. 1998;282:652654.12. Bokanga M. Biotechnology and cassava processing in Africa. Food Technology Food Technology 1995;49:8690. Knorr D. Improving food biotechnology resources and strategies in developing countries. 1995;49:8690. Knorr D. Improving food biotechnology resources and strategies in developing countries. Food Technology Food Technology 1995;49:9193. Messer E. Sources of institutional funding for agrobiotechnology for developing countries. 1995;49:9193. Messer E. Sources of institutional funding for agrobiotechnology for developing countries. Advanced Technology Assessment Systems Advanced Technology Assessment Systems 1992;9:371378. 1992;9:371378.13. Beachy R. Transferring genes. In: Burke WS, ed. Symbol, substance, science: the societal issues of food biotechnology Symbol, substance, science: the societal issues of food biotechnology (proceedings of a conference, July 2829, 1993). Research Triangle Park, NC: USDA Office of Agricultural Biotechnology and North Carolina Biotechnology Center, 1993:4551,61. Beachy RN. Facing fear of biotechnology. (proceedings of a conference, July 2829, 1993). Research Triangle Park, NC: USDA Office of Agricultural Biotechnology and North Carolina Biotechnology Center, 1993:4551,61. Beachy RN. Facing fear of biotechnology. Science Science 1999;285:335. Dr. Beachy is now president of the Donald Danforth Plant Science Center in St. Louis, MO. Although the center is listed on the Monsanto Web site as a partner, Dr. Beachy says he has not been funded by Monsanto since 1991 (see letters to the editor: 1999;285:335. Dr. Beachy is now president of the Donald Danforth Plant Science Center in St. Louis, MO. Although the center is listed on the Monsanto Web site as a partner, Dr. Beachy says he has not been funded by Monsanto since 1991 (see letters to the editor: Science Science 1999;285:1489). 1999;285:1489).14. Sommer A, West KP. Vitamin A Deficiency: Health, Survival, and Vision Vitamin A Deficiency: Health, Survival, and Vision. New York: Oxford University Press, 1996. Sommer A. Vitamin A Deficiency and Its Consequences: A Field Guide to Detection and Control Vitamin A Deficiency and Its Consequences: A Field Guide to Detection and Control. 3rd ed. Geneva: World Health Organization, 1995.15. Yoon CK. Stalked by deadly virus, papaya lives to breed again. NYT NYT, July 20, 1999:F3.16. Hamilton JO. Biotech: an industry crowded with players faces an ugly reckoning. Business Week Business Week, September 26, 1994:8492.17. Wambugu F. Biotechnology: protesters don't grasp Africa's need. Los Angeles Times Los Angeles Times, November 11, 2001:M1. Wambugu FM. Modifying Africa: How Biotechnology Can Benefit the Poor and Hungry, A Case Study from Kenya Modifying Africa: How Biotechnology Can Benefit the Poor and Hungry, A Case Study from Kenya, Nairobi, 2001.18. Monsanto. Meeting the World's Needs with Fewer Resources (press release). St. Louis, MO, 1996. Council for Biotechnology Information. Biotechnology and the Developing World (leaflet). The council's public relations materials appear online at www.whybiotech.com.19. Ye X, Al-Babili S, Kloti A, et al. Engineering the provitamin A (-carotene) biosynthetic pathway into (carotenoid-free) rice endosperm. Science Science 2000;287: 303305. Heldt H-W. 2000;287: 303305. Heldt H-W. Plant Biochemistry and Molecular Biology Plant Biochemistry and Molecular Biology. Oxford: Oxford University Press, 1997.20. Dary O, Mora JO. Food fortification to reduce vitamin A deficiency: International Vitamin A Consultative Group recommendations. J Nutrition J Nutrition 2002; 132:2927S2933S. 2002; 132:2927S2933S.21. Normile D. Rockefeller to end network after 15 years of success. Science Science 1999;286:14681469. Christensen J. Golden Rice in a grenade-proof greenhouse. 1999;286:14681469. Christensen J. Golden Rice in a grenade-proof greenhouse. NYT NYT, November 21, 2000:F1,F5. Normile D. Monsanto donates its share of Golden Rice. Science Science 2000;289:843-845. The scientists describe the patent and legal issues in: Beyer P, Al-Babili S, Ye S, et al. Golden Rice: introducing the -carotene biosynthesis pathway into rice endosperm by genetic engineering to defeat vitamin A deficiency. 2000;289:843-845. The scientists describe the patent and legal issues in: Beyer P, Al-Babili S, Ye S, et al. Golden Rice: introducing the -carotene biosynthesis pathway into rice endosperm by genetic engineering to defeat vitamin A deficiency. J Nutrition J Nutrition 2002;132:506S510S. 2002;132:506S510S.22. Nash JM. Grains of hope. Time Time, July 31, 2000:3946.23. Potrykus I. Nutritionally enhanced rice to compete [sic] malnutrition disorders of the poor (handout). From Agricultural Biotechnology: The Road to Improved Nutrition and Increased Production? (conference), Boston, Tufts University School of Nutrition Science and Policy, November 2, 2001.24. Potrykus I. Golden Rice and beyond. Plant Physiology Plant Physiology 2001;125:11571161. 2001;125:11571161.25. Greenpeace. Background information: the false promise of genetically engineered rice, February 2001. Haerlin B. GE rice is fool's gold, February 9, 2001. Khoo M. Greenpeace demands false biotech advertising be removed from TV, February 9, 2001, at www.greenpeace.org/usa.26. The Potrykus group said the rice contained 1.6 micrograms (g) beta-carotene per gram (g), but thought 2 g/g realistic. The U.S. standard for vitamin A is 300 g per day for children aged one to three years, 700 g for adult women, and 900 g for adult men. At a conversion rate of 12 g beta-carotene to 1 g vitamin A, the beta-carotene standard is 3,600 (12 300) g for young children; 8,400 (12 700) g for women; and 10,800 (12 900) g for men. If Golden Rice contains 2 g per g beta-carotene, the amounts are halved. Children would need to eat 1,800 g rice (4 lb); women 4,200 g (9 lb); and men 5,400 g (12 lb) a day to meet the U.S. standard for vitamin A. Rice is cooked in twice its volume of added water (example: 1 cup raw rice plus 2 cups water to yield 3 cups cooked rice). Therefore, the amounts of cooked cooked rice are 12, 27, and 36 lb per day, respectively. Lower conversion ratios reduce these amounts. rice are 12, 27, and 36 lb per day, respectively. Lower conversion ratios reduce these amounts.27. Institute of Medicine. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: National Academy Press, 2001:65126.28. Potrykus I. "Genetically engineered 'Golden Rice' is fool's gold": response from Prof. Ingo Potrykus. Ag BioTech InfoNet, February 10, 1001. Online: www.biotech-info.net/IP_response.html.29. Conway G. Grain of hope. Guardian Guardian (London), March 21, 2001. Online: (London), March 21, 2001. Online: www.guardian.co.uk.30. Olson JA. Carotenoids. In: Shils ME, Olson JA, Shike M, et al., eds. Modern Nutrition in Health and Disease Modern Nutrition in Health and Disease, 9th ed. Philadelphia: Lippincott Williams & Wilkins, 1998:525541. Also: Torun B, Chew F. Protein-Energy Malnutrition Protein-Energy Malnutrition (1998:963988). (1998:963988).31. Nestle M. Genetically engineered "golden" rice unlikely to overcome vitamin A deficiency (letter). J Am Dietetic Association J Am Dietetic Association 2001;101:289290. This letter points out that beta-carotene itself raises questions. Food sources of beta-carotene protect against cancer and heart disease, but supplements do not and may be harmful or beneficial depending on circumstances. The health effects of adding this single nutrient to rice endosperm are uncertain. 2001;101:289290. This letter points out that beta-carotene itself raises questions. Food sources of beta-carotene protect against cancer and heart disease, but supplements do not and may be harmful or beneficial depending on circumstances. The health effects of adding this single nutrient to rice endosperm are uncertain.32. Filteau SM, Tomkins AM. Promoting vitamin A status in low-income countries. Lancet Lancet 1999;353;14581460. Summer A, Davidson FR, Ramakrishnan U, et al. Twenty-five years of progress in controlling vitamin A deficiency: looking to the future. Proceedings of the XX International Vitamin A Consultative Group Meeting, Hanoi, Vietnam, February 1215, 2001. 1999;353;14581460. Summer A, Davidson FR, Ramakrishnan U, et al. Twenty-five years of progress in controlling vitamin A deficiency: looking to the future. Proceedings of the XX International Vitamin A Consultative Group Meeting, Hanoi, Vietnam, February 1215, 2001. J Nutrition J Nutrition 2002;132(9 suppl):2843S2990S. 2002;132(9 suppl):2843S2990S.33. Potrykus I. Golden Rice and the Greenpeace dilemma. Ag BioTech InfoNet, February 15, 2001. Online: www.biotech-info.net/2_IP_response.html.
CHAPTER 6. RISKS AND BENEFITS: WHO DECIDES?.
1. Pew Initiative on Food and Biotechnology. Public Sentiment about Genetically Modified Food Public Sentiment about Genetically Modified Food, June 2123, 2001, at www.pewtrusts.org/news_room_detail.aspx?id=32822. The survey included 1,231 adults.2. International Food Information Council. U.S. Consumer Attitudes toward Food Biotechnology U.S. Consumer Attitudes toward Food Biotechnology, November 2001. Wirthlin Group Quorum conducted five surveys from 1997 to 2001; Cogent Research conducted the September 2001 telephone survey of about 1,000 adults.3. OTA. New Developments in Biotechnology: Public Perceptions of Biotechnology New Developments in Biotechnology: Public Perceptions of Biotechnology (OTA-BP-BA-45), 1987. Also see: Zimmerman L, Kendall P, Stone M, et al. Consumer knowledge and concern about biotechnology and food safety. (OTA-BP-BA-45), 1987. Also see: Zimmerman L, Kendall P, Stone M, et al. Consumer knowledge and concern about biotechnology and food safety. Food Technology Food Technology 1994;48:7177. Wie SH, Strohbehn CH, Hsu CHC. Iowa dietitians' attitudes toward and knowledge of genetically engineered and irradiated foods. 1994;48:7177. Wie SH, Strohbehn CH, Hsu CHC. Iowa dietitians' attitudes toward and knowledge of genetically engineered and irradiated foods. J Am Dietetic Association J Am Dietetic Association 1998;98:13311333. 1998;98:13311333. Genetically Modified Foods: Are You Afraid of Eating Them? Genetically Modified Foods: Are You Afraid of Eating Them? (Poll, December 1999). (Poll, December 1999).4. Hoban TJ. Consumer acceptance of biotechnology: an international perspective. Nature Biotechnology Nature Biotechnology 1997;15:232234. Aerni P. Public attitudes towards agricultural biotechnology in developing countries: a comparison between Mexico and the Philippines. Cambridge, MA: Center for International Development, Harvard University, October 1, 2001, at 1997;15:232234. Aerni P. Public attitudes towards agricultural biotechnology in developing countries: a comparison between Mexico and the Philippines. Cambridge, MA: Center for International Development, Harvard University, October 1, 2001, at www.inai.org.ar/ogm/Public%20Attitudes%20towards%20Agricultural%20Biotechnology%20in%20developing%20countires.pdf.5. Barling D, de Vriend H, Cornelese JA, et al. The social aspects of food biotechnology: a European view. Environmental Toxicology and Pharmacology Environmental Toxicology and Pharmacology 1999;7:8593. Frewer L. Public perceptions of genetically modified foods in Europe. 1999;7:8593. Frewer L. Public perceptions of genetically modified foods in Europe. J Commercial Biotechnology J Commercial Biotechnology 1999;6:108115. Thompson PB. 1999;6:108115. Thompson PB. Food Biotechnology in Ethical Perspective Food Biotechnology in Ethical Perspective. London: Blackie Academic & Professional, 1997.6. HRH, the Prince of Wales. Seeds of disaster. Daily Telegraph Daily Telegraph (London), June 8, 1998. Reprinted in (London), June 8, 1998. Reprinted in Ecologist Ecologist 1998;28(5):252253. 1998;28(5):252253.7. Smith G, Gruner P. "Scaremonger" but Charles is right to call for debate. Evening Standard Evening Standard (London), June 8, 1998:4. (London), June 8, 1998:4.8. Thavis J. Vatican experts OK plant, animal genetic engineering. St. Louis Review St. Louis Review, October 22, 1999:E1. Lyman E. Pope expresses opposition to GMOs: cites need for "the respect of nature." Bureau of National Affairs, No. 221, November 15, 2000, at http://online.sfsu.edu/~rone/GEessays/PopeGMO.htm.9. Genetically modified food: food for thought. Economist Economist, June 19, 1999: 1921.10. Frederickson DS. The Recombinant DNA Controversy: A Memoir: Science, Politics, and the Public Interest 19741981 The Recombinant DNA Controversy: A Memoir: Science, Politics, and the Public Interest 19741981. Washington, DC: American Society for Microbiology, 2001. For another view, see: Krimsky S. Genetic Alchemy: The Social History of the Recombinant DNA Controversy Genetic Alchemy: The Social History of the Recombinant DNA Controversy. Cambridge, MA: MIT Press, 1994.11. Commoner B. Unraveling the DNA myth: the spurious foundation of genetic engineering. Harper's Harper's, February 2002:3947.12. Fuchs RL, Astwood JD. Allergenicity assessment of foods derived from genetically modified plants. Food Technology Food Technology 1996;50(2):8388. Metcalfe DD, Fuchs RL, Townsend R, et al., eds. Allergenicity of foods produced by genetic modification. 1996;50(2):8388. Metcalfe DD, Fuchs RL, Townsend R, et al., eds. Allergenicity of foods produced by genetic modification. Critical Reviews in Food Science and Nutrition Critical Reviews in Food Science and Nutrition 1996;36(suppl): S1S186. 1996;36(suppl): S1S186.13. Consumer & Biotechnology Foundation. Genetically Modified Foods and Allergenicity: Safety Aspects and Consumer Information Genetically Modified Foods and Allergenicity: Safety Aspects and Consumer Information (workshop proceedings), May 2829, 1999. Den Haag. (workshop proceedings), May 2829, 1999. Den Haag. The Netherlands: Stichting Consument en Biotechnologie The Netherlands: Stichting Consument en Biotechnologie, 1999.14. Buchanan BB. Genetic engineering and the allergy issue. Plant Physiology Plant Physiology 2001;126:57. 2001;126:57.15. Burks AW, Fuchs RL. Assessment of the endogenous allergens in glyphosate-tolerant and commercial soybean varieties. J Allergy and Clinical Immunology J Allergy and Clinical Immunology 1995;96:10081110. 1995;96:10081110.16. Winslow R. Allergen is inadvertently transferred to soybean in bioengineering test. WSJ WSJ, March 14, 1996:B6.17. Nordlee JA, Taylor SL, Townsend JA, et al. Identification of a Brazil-nut allergen in transgenic soybeans. NEJM NEJM 1996;334:688692. 1996;334:688692.18. FDA. Statement of policy: foods derived from new plant varieties. FR FR 57:2298422986, May 29, 1992. 57:2298422986, May 29, 1992.19. FDA. Food labeling: food derived from new plant varieties. FR FR 58:2583725841, April 28, 1993. BIO favors limited notification on biotech food 3-year sunset. 58:2583725841, April 28, 1993. BIO favors limited notification on biotech food 3-year sunset. FCN FCN, May 16, 1994:78.20. EPA. FIFRA Scientific Advisory Panel Meeting, November 28, 2000 FIFRA Scientific Advisory Panel Meeting, November 28, 2000 (SAP Report No. 2000-06), December 1, 2000. EPA Scientific Advisory Panel (SAP) reports are online at: (SAP Report No. 2000-06), December 1, 2000. EPA Scientific Advisory Panel (SAP) reports are online at: www.epa.gov/scipoly/sap [Note: search by date]. [Note: search by date].21. Nestor EW, Roberts CE, Pearsall NN, et al. Microbiology: A Human Perspective Microbiology: A Human Perspective. 2nd ed. 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FR FR 59:2670026711, May 23, 1994. The kanamycin (neomycin) resistance gene specifies the enzyme, aminoglycoside 3'-phosphotransferase II. 59:2670026711, May 23, 1994. The kanamycin (neomycin) resistance gene specifies the enzyme, aminoglycoside 3'-phosphotransferase II.24. FDA. Guidance for industry: use of antibiotic-resistance marker genes in transgenic plants: draft guidance. September 4, 1998. FDA documents on antibiotic resistance are available at http://vm.cfsan.fda.gov/~dms/opa-armg.html.25. FDA Task Force on Antimicrobial Resistance. Key Recommendations and Report Key Recommendations and Report. FDA, December 2000. FDA. HHS releases action plan to combat antimicrobial resistance (press release). January 18, 2001.26. Goldburg R, Rissler J, Shand H, et al. Biotechnology's Bitter Harvest: Herbicide-Tolerant Crops and the Threat to Sustainable Agriculture Biotechnology's Bitter Harvest: Herbicide-Tolerant Crops and the Threat to Sustainable Agriculture. 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