Safe Food: Bacteria, Biotechnology, And Bioterrorism Part 6

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 subt.i.tle, 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 relations.h.i.+ps 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 relations.h.i.+ps with USDA inspectors.

As explained in chapter 1 chapter 1, hamburger is typically made from tr.i.m.m.i.n.gs 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 s.h.i.+pped 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 cl.u.s.tered 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 cl.u.s.tered 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 a.n.a.lysis 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 a.n.a.lysis 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 b.u.t.ter (Salmonella). Late in 2008, the CDC became aware of cl.u.s.ters of illness caused by (Salmonella). Late in 2008, the CDC became aware of cl.u.s.ters 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 b.u.t.ter. Because frequencies in the general population are 85 percent for eating chicken and 59 percent for eating peanut b.u.t.ter, peanut b.u.t.ter seemed the more likely source. In January 2009, King Nut Companies, a distributor of peanut b.u.t.ter 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 b.u.t.ter. Because frequencies in the general population are 85 percent for eating chicken and 59 percent for eating peanut b.u.t.ter, peanut b.u.t.ter seemed the more likely source. In January 2009, King Nut Companies, a distributor of peanut b.u.t.ter manufactured by the Peanut Corporation of America (PCA), recalled five-pound tubs of the PCA product.40 Because peanuts destined for peanut b.u.t.ter are roasted, the contamination must have occurred after after processing. The plant s.h.i.+pped two kinds of peanut b.u.t.ter: bulk intended for inst.i.tutions, 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 b.u.t.ter, 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 s.h.i.+pped two kinds of peanut b.u.t.ter: bulk intended for inst.i.tutions, 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 b.u.t.ter, 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 s.h.i.+pped peanut b.u.t.ter 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 b.u.t.ter. 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 leaders.h.i.+p of the FDA also commented on the implications of the peanut b.u.t.ter recalls: "From our vantage point, the recent salmonella outbreak linked to contaminated peanut b.u.t.ter 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 pa.s.sed recent inspections with relatively minor violations, Setton knew it had Salmonella Salmonella problems. When tests came back positive, Setton reheated the nuts but s.h.i.+pped 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 s.h.i.+pped them out. Other pistachio companies reacted to these revelations by establis.h.i.+ng a Web site listing products that had not been recalled. problems. When tests came back positive, Setton reheated the nuts but s.h.i.+pped 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 s.h.i.+pped them out. Other pistachio companies reacted to these revelations by establis.h.i.+ng 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 s.h.i.+pments 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 rea.s.sure anyone that the meat is safe. Even if true, a statement like this is unlikely to rea.s.sure 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 partic.i.p.ated), 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 Inst.i.tute 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 a.s.sociation 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 s.h.i.+pments, 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 Was.h.i.+ngton 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 sh.e.l.l 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 compet.i.tive 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 pa.s.s 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 princ.i.p.al 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 const.i.tutes 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 const.i.tutes 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 const.i.tute 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 compet.i.tive 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 a.s.sociation Journal of the American Medical a.s.sociation, 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 s.p.a.ce-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 s.p.a.ce-saving cross-references to material cited earlier in the same same chapter. Also to save s.p.a.ce, 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 (Was.h.i.+ngton, 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, doc.u.ments obtained from Internet sources were available at the cited addresses in February 2010. chapter. Also to save s.p.a.ce, 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 (Was.h.i.+ngton, 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, doc.u.ments 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 t.i.tles 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 Inst.i.tute 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 a.s.sociation MMWR.

Morbidity and Mortality Weekly Report (of CDC) (of CDC) NEJM.

New England Journal of Medicine NYT.

New York Times OTA.

Office of Technology a.s.sessment (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 sh.e.l.ls. Was.h.i.+ngton Post Was.h.i.+ngton Post, September 18, 2000:A2. Freese B. The StarLink Affair The StarLink Affair. Was.h.i.+ngton, DC: Friends of the Earth, July 2001, at www.foodallergyangel.com/doc.u.ments/GMO/StarlinkReport.pdf. Food Traceability Report. StarLink: Lessons Learned Food Traceability Report. StarLink: Lessons Learned. Was.h.i.+ngton, DC: FCN Publis.h.i.+ng, 2001. Taylor MR, Tick JS. The StarLink Case: Issues for the Future The StarLink Case: Issues for the Future. Was.h.i.+ngton, 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, Dec.o.c.k 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. a.s.sessment 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 a.s.sessment 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 a.s.sociated with Potential Exposure to Genetically Modified Corn Investigation of Human Health Effects a.s.sociated 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. Was.h.i.+ngton Post Was.h.i.+ngton 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. Was.h.i.+ngton Post Was.h.i.+ngton 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 Doc.u.ments Shows Agency Had Knowledge in 1998 of Possible Biotech Contamination (press release). Was.h.i.+ngton, 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 sh.e.l.l scare. NYT NYT, October 3, 2000:C6. Kaufman M. Biotech corn may be in various foods. Was.h.i.+ngton Post Was.h.i.+ngton 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 sh.e.l.ls 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 sh.e.l.ls 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. Was.h.i.+ngton Post Was.h.i.+ngton 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. Inst.i.tute of Medicine. Ensuring Safe Food: From Production to Consumption Ensuring Safe Food: From Production to Consumption. Was.h.i.+ngton, 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 a.s.sessment. In: National Research Council Current Issues and Studies National Research Council Current Issues and Studies (annual report). Was.h.i.+ngton, DC: National Academy of Sciences, 1979. Cited in Douglas and Wildavsky (note 26):32. (annual report). Was.h.i.+ngton, 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. Ma.s.sey A. Crops, genes, and evolution. Gastronomica Gastronomica 2001;1(3):2129. 2001;1(3):2129.24. DHHS. Determining Risks to Health: Federal Policy and Practice Determining Risks to Health: Federal Policy and Practice. Dover, MA: Auburn House, 1986.25. DHHS. Healthy People 2010 Healthy People 2010, Vol 1, January 2000. Online: www.health.gov/healthypeople/.26. Douglas M, Wildavsky A. Risk and Culture: An Essay on the Selection of Technical and Environmental Dangers Risk and Culture: An Essay on the Selection of Technical and Environmental Dangers. Berkeley: University of California Press, 1982. Quotation: 73,8081.27. Fischler C. Raison et deraison dans la perception des risques alimentaires. Cahiers de Nutrition et de Dietetique Cahiers de Nutrition et de Dietetique 1998;33:297300. 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. 1998;33:297300. 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 partic.i.p.ation in strategic decision making: implications for emerging technologies. 1987;13(9):2122. Frewer L. Risk perception, social trust, and public partic.i.p.ation 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. Science Science 2000;288:979981. Groth E. 2000;288:979981. Groth E. Science, Precaution and Food Safety: How Can We Do Better? Science, Precaution and Food Safety: How Can We Do Better? (discussion paper for the US Codex Delegation), February 2000, at (discussion paper for the US Codex Delegation), February 2000, at www.consumersunion.org/food/codexcpi200.htm.33. Montague P. The precautionary principle. Rachel's Environment & Health Weekly Rachel's Environment & Health Weekly, 586, February 19, 1998, at www.seismo.unr.edu/htdocs/academic/ ANDERSON/Papers/Precaution/Montague_PrecautionaryPrinciple.pdf.34. The EU-U.S. Biotechnology Consultative Forum: Final Report The EU-U.S. Biotechnology Consultative Forum: Final Report. Brussels, December 2000, at http://europa.eu/rapid/pressReleasesAction.do?reference=IP/00/1484&format=HTML&aged=0&language=EN&guiLanguage=en.35. Whelan EM. Our "stolen future" and the precautionary principle. Priorities for Health Priorities for Health 1996;8(3), at 1996;8(3), at www.acsh.org/healthissues/newsID.712/health issue_detail.asp. Also see: Paarlberg RL. The Politics of Precaution: Genetically Modified Foods in Developing Countries The Politics of Precaution: Genetically Modified Foods in Developing Countries. Baltimore: Johns Hopkins University Press, 2001.

PART 1. RESISTING FOOD SAFETY.

1. Mead PS, s.l.u.tsker 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. Inst.i.tute 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. Was.h.i.+ngton, DC: American Inst.i.tute for Cancer Research, 1998:356358) concluded that saccharin "probably has no relations.h.i.+p 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 a.s.sessment: if saccharin does affect cancer risk, it does so weakly. 1998;25(3):1113. My a.s.sessment: if saccharin does affect cancer risk, it does so weakly.2. Kessler DA. Food safety: revising the statute. Science Science 1984;223:10341040. Kramer CS, Penner KP. Food safety: consumers report their concerns. 1984;223:10341040. Kramer CS, Penner KP. Food safety: consumers report their concerns. National Food Review National Food Review 1986;9(spring):2124. Stevens WK. Officials call microbes most urgent food threat. 1986;9(spring):2124. Stevens WK. Officials call microbes mo