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  2. 2. Center for Science in the Public Interest (CSPI) is a non-profit organization based in Washington, DC. Since 1971, CSPI has been working to improve the public’s health, largely through its work on nutrition and food-safety issues. CSPI is supported primarily by the 900,000 subscribers to its Nutrition Action Healthletter and by foundation grants. The FDA Top Ten /Report was researched and written by Sarah Klein, Jacqlyn Witmer, Amanda Tian, and Caroline Smith DeWaal. We gratefully acknowledge the assistance of Ezequiel Zylberberg in preparing this report.
  3. 3. THE TEN RISKIEST FOODS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION 1875 Connecticut Ave NW, Suite 300 In recent years, U.S. consumers 40 percent of all foodborne involved); illnesses need to be Washington, DC 20009 Phone (202) 332-9110 have faced foodborne-illness outbreaks linked to FDA-regulated investigated by state health officials www.cspinet.org outbreak after outbreak linked to foods since 1990, as tracked by the in order to be identified as part contaminated food. A complex, Center for Science in the Public of an outbreak; states often lack globalized food system, archaic Interest (CSPI) using data from the the resources to conduct thorough food-safety laws, and the rise of Centers for Disease Control and investigations to identify the food large-scale production and processing Prevention (CDC) and elsewhere. involved; and finally, outbreaks that have combined to create a perfect Over 1500 separate, definable are investigated must be reported storm of unsafe food. Unfortunately, outbreaks were linked to the FDA to CDC. the hazards now come from all areas Top Ten, with almost 50,000 illnesses of the food supply: not only high-risk reported, ranging from temporary Thus, the outbreaks included here products, like meat and dairy, but gastrointestinal distress to long-term represent only the tip of the iceberg also the must-eat components of a disability and death. of foodborne illness. In fact, in healthy diet, like fruits and vegetables. 1999, the CDC estimated that for While this data represents the best each case of salmonellosis that is This report identifies the top ten data available from the CDC, the clinically diagnosed and reported riskiest foods regulated by the Food hurdles to accurate outbreak tracking to health officials, another 38 cases and Drug Administration (FDA) (the are many: people rarely see a doctor were unreported.1 All told, unsafe “FDA Top Ten”), the agency responsible to treat foodborne illness; those who food causes tens of millions of for all produce, seafood, shell eggs, do are often treated without the lab illnesses, hundreds of thousands and dairy products. Together, these testing needed to document the of hospitalizations, and thousands of ten foods alone account for nearly cause of the illness (the pathogen deaths every year in the United States.
  4. 4. 2 The Riskiest Foods Regulated by the U.S. Food and Drug Administration – Findings 1875 Connecticut Ave NW, Suite 300 Washington, DC 20009 Phone (202) 332-9110 www.cspinet.org MANY OF THE FDA TOP TEN 1 LEAFY GREENS: 363 outbreaks involving 13,568 reported cases of illness ARE, UNFORTUNATELY, SOME OF THE MOST HEALTHY 2 EGGS: 352 outbreaks involving 11,163 reported cases of illness AND POPULAR FOODS 3 TUNA: 268 outbreaks involving 2341 reported cases of illness CONSUMED IN THE U.S. 4 OYSTERS: 132 outbreaks involving 3409 reported cases of illness AND WHILE SOME ARE ALREADY CONSIDERED 5 POTATOES: 108 outbreaks involving 3659 reported cases of illness “HIGH-RISK” FOODS, OTHERS 6 CHEESE: 83 outbreaks involving 2761 reported cases of illness ARE SURPRISING. THE FDA 7 ICE CREAM: 74 outbreaks involving 2594 reported cases of illness TOP TEN RISKIEST FOODS 8 TOMATOES: 31 outbreaks involving 3292 reported cases of illness REGULATED BY FDA ARE: 9 SPROUTS: 31 outbreaks involving 2022 reported cases of illness 10 BERRIES: 25 outbreaks involving 3397 reported cases of illness Illnesses caused by these ten foods may be as minor as stomach cramps and diarrhea for a day or two, or as serious as kidney failure or death. Notably, pathogens most commonly associated with meat and poultry—such as Salmonella2 and E. coli O157:H73—also have been repeatedly linked to these food items. In fact, Salmonella was identified as the cause in 33 percent of the outbreaks from the FDA Top Ten. Other pathogens causing the outbreaks associated with these foods include Campylobacter, Scombrotoxin, Norovirus, and Vibrio.4
  5. 5. The Riskiest Foods Regulated by the 3 U.S. Food and Drug Administration – The FDA Top Ten in detail 1875 Connecticut Ave NW, Suite 300 Washington, DC 20009 Phone (202) 332-9110 LEAFY GREENS Can salad and accounts for 10 percent of all elementary to college—tended to www.cspinet.org really make you sick? While nutritionists outbreaks in leafy greens. Another be quite large—averaging 89 reported shudder at the thought, it is sadly pathogen appearing frequently in illnesses per outbreak—though the case that nutritious greens can leafy greens is Norovirus, which is luckily infrequent. also be highly contaminated with commonly spread by the unwashed pathogens. Overall, CSPI identified hands of an ill handler or consumer. Leafy greens can become initially 363 separate outbreaks linked to This pathogen was linked to 64 percent contaminated on the farm through leafy greens, making them the number of the outbreaks in leafy greens. contact with wild animals, manure, one entry in the FDA Top Ten. Salads Salmonella was responsible for contaminated water, or poor handling and other food items containing nearly 10 percent of the outbreaks. practices during harvest. Once they leafy greens—iceberg lettuce, romaine are contaminated, leafy greens can lettuce, leaf lettuce, butter lettuce, Outbreaks from leafy greens occur support, grow, and spread pathogens baby leaf lettuce (immature lettuce anywhere these popular food items until consumed. Chlorine washes or leafy greens), escarole, endive, are consumed. Contamination may and other post-harvest treatments spring mix, spinach, cabbage, kale, be present from production and can help reduce cross contamination arugula or chard 5 —account for processing, or may occur through between lots, but they don’t make 24 percent of all of the outbreaks improper handling and preparation, contaminated products truly safe to LEAFY GREENS linked to the FDA Top Ten. Those such as inadequate handwashing eat. In fact, bacteria can inhabit the outbreaks sickened over 13,568 and cross-contamination of cutting washing systems used in making people who were reported to have boards and other equipment. In pre-washed bagged lettuce, become ill—almost 30 percent of restaurants, any of these problems transferring dangerous bacteria all the reported illnesses caused in only a single food item can affect from one contaminated lot to the by the FDA Top Ten. multiple patrons. For example, an next, with the potential of effecting outbreak of E. coli O157:H7 in 2006 a full day’s production. In 2006, leafy greens hit the national began at Taco John’s, a popular radar screen as a high-risk food when Iowa eatery. Over 80 people were bagged spinach contaminated with sickened—including two who developed E. coli O157:H7 caused several deaths potentially deadly hemolytic uremic SHELL EGGS Often described and hundreds of illnesses. That same syndrome—from contaminated iceberg as a perfect breakfast food, shell eggs year, deadly E. coli O157:H7 appeared lettuce from California’s Central Valley. are unfortunately among the worst of in two other outbreaks linked to leafy Overall, restaurant outbreaks accounted the FDA Top Ten. Overall, CSPI found greens. Though produce companies for almost 240 outbreaks from leafy 352 outbreaks linked to shell eggs and have voluntarily increased their greens. Private homes accounted egg products.6 The overwhelming vigilance, E. coli O157:H7 is still for another 24 outbreaks. Notably, majority of illnesses from eggs are cropping up in these products, outbreaks in school settings—from associated with Salmonella, which SHELL EGGS
  6. 6. 4 The Riskiest Foods Regulated by the U.S. Food and Drug Administration – The FDA Top Ten in detail 1875 Connecticut Ave NW, Suite 300 Washington, DC 20009 Phone (202) 332-9110 www.cspinet.org sickened over 11,000 people whose Notably, the largest egg outbreaks Notably, scombroid illnesses illnesses were reported from 1990 occurred in prisons, with an average frequently involve fresh product. to 2006. of 143 people reported sick in each These products are subject to HAACP outbreak. Catered events also had (Hazard Analysis Critical Control Most types of Salmonella live in the large outbreaks, averaging almost 60 Points), a safety system in which hazards intestinal tracts of animals and birds people reported to have been sickened. are identified and steps taken to and are transmitted to humans when control them. As a naturally-occurring animal feces contaminate a food toxin, scombrotoxin is foreseeable item of animal origin (such as eggs). and should be properly addressed Regulations for cleaning and inspecting TUNA While a step down from leafy by HAACP. Tuna’s appearance in the eggs were implemented in the 1970s greens and eggs, tuna was linked to FDA Top Ten suggests that FDA’s and have reduced salmonellosis 268 outbreaks in the FDA Top Ten.8 Some seafood program needs to more caused by external fecal contamination consumers may be familiar with warnings effectively address this hazard. of egg shells. However, Salmonella about tuna and methylmercury, but enteritidis, the most prevalent type the pathogens that show up in the In addition to scombrotoxin, of Salmonella in eggs today, infects outbreak data are rarely discussed Norovirus and Salmonella caused TUNA the ovaries of otherwise healthy hens when it comes to this fish. illnesses related to tuna consumption, and contaminates the eggs before affecting nearly 1000 people. Over the shells are formed. Notably, final Scombroid, the illness caused by 65 percent of outbreaks linked to regulations that require the adoption scombrotoxin, was by far the most tuna occurred in restaurants. of controls aimed at minimizing common cause of illness related Salmonella enteriditis in egg production to tuna dishes, affecting over 2300 were issued in July 2009 (and will people who were reported to have become effective in 2010 or 2012, been sickened, according to CSPI’s OYSTERS Often considered an depending on producer size),7 after Outbreak Alert! database. Fresh expensive delicacy, oysters can ruin over a decade of inaction by the fish decay quickly after being caught more than just a gourmet dinner. federal government. and, if stored above 60˚ F, begin Though they comprise a trivial part to release natural toxins that are of the American diet, tainted oysters Half of all egg outbreaks occurred dangerous for humans. Adequate are the fourth entry in the FDA Top from restaurants and other food refrigeration and handling can Ten, responsible for almost 2000 establishments. While proper egg slow this spoilage, but the toxin reported illnesses. Not surprisingly, handling and cooking should destroy cannot be destroyed by cooking, the majority of outbreaks from most pathogens, serving eggs raw freezing, smoking, curing, or canning. oysters occurred in restaurants. or “runny,” or leaving egg dishes Symptoms of scombroid poisoning OYSTERS at improper holding temperatures can include skin flushing, headaches, Illnesses from oysters occur primarily (such as on a breakfast buffet) can abdominal cramps, nausea, diarrhea, from two sources: Norovirus and Vibrio. allow the bacteria to multiply. palpitations, and loss of vision. Although Norovirus in other foods
  7. 7. 5 1875 Connecticut Ave NW, Suite 300 Washington, DC 20009 Phone (202) 332-9110 is usually associated with improper 3600 consumers reported to have CHEESE A perennial favorite www.cspinet.org handling during harvest or preparation, been sickened by spuds since 1990. among consumers for its variety and oysters can actually be harvested versatility—hard, soft, mild, sharp, from waters contaminated with Potatoes are grown in the soil, melted and sliced—cheese products Norovirus. When served raw or but they are always cooked before were linked to 83 outbreaks that undercooked, those oysters consuming. Outbreaks are linked sickened thousands of consumers can cause gastroenteritis, an to dishes, like potato salad, that can since 1990, making it number six of inflammation of the stomach contain many ingredients and also a the FDA Top Ten.9 Salmonella was and small or large intestines. broad range of pathogens. Salmonella the most common hazard among is most common, associated with cheese products. The most dangerous of the two almost 30 percent of potato outbreaks. pathogens found in oysters is Vibrio. E. coli also appears in the potato Cheese can become contaminated This hazard is a type of bacterium category, accounting for 6 potato with pathogens during the initial in the same family as cholera. The outbreaks. Normally found in animal phases of production (curdling, most common strains in the U.S. are feces, the presence of Salmonella molding, and salting), or later during V. vulnificus and V. parahaemolyticus, and E. coli in potato dishes could processing. Most cheeses are now both of which can cause severe indicate cross contamination from made with pasteurized milk, lowering POTATOES disease. In immuno-compromised the raw to the cooked ingredients the risk of contamination with milk- persons, particularly those with chronic or possibly from raw meat or poultry borne pathogens. However, as recently liver disease, V. vulnificus can infect during handling and preparation. as August 2009, California officials the bloodstream, causing a severe warned consumers about eating and life-threatening illness Shigella and Listeria monocytogenes Latin American-style cheeses (such characterized by fever and chills, also appear in outbreaks associated as queso fresco, queso oaxaca, decreased blood pressure (septic with potatoes. Shigella is easily and others), which may be made shock), and blistering skin lesions. transmitted from an infected person by unlicensed manufacturers using V. vulnificus bloodstream infections, to a food product, and thus may unpasteurized milk that could called septicemia, are fatal about indicate improper handling during contain harmful bacteria. 50 percent of the time. food preparation. Listeria is a stubborn bacterium that can live on deli counters Pregnant women should be particularly and in other kitchen areas, and is often cautious about consumption of soft associated with cold deli salads. cheeses (such as feta, Brie, Camembert, POTATOES One of America’s blue-veined, and Mexican-style cheese), most popular and versatile food More than 40 percent of potato which can carry Listeria. Listeriosis items appears in the middle of the outbreaks were linked to foods can cause miscarriage, often without FDA Top Ten list. Potatoes, often in prepared in restaurants and food the mother experiencing any symptoms. CHEESE the form of potato salad, were linked establishments (including grocery Linked to at least four outbreaks to 108 outbreaks, with more than stores and delis). from cheese since 1990, listeriosis
  8. 8. 6 The Riskiest Foods Regulated by the U.S. Food and Drug Administration – The FDA Top Ten in detail 1875 Connecticut Ave NW, Suite 300 Washington, DC 20009 Phone (202) 332-9110 www.cspinet.org is vastly underreported, since overt popular ice cream manufacturer large multistate outbreaks of symptoms of infection can be mild in used the same truck to haul raw, Salmonella, sickening hundreds of those who are not particularly at risk. unpasteurized eggs and pasteurized people across the country. Although Those most at risk include people ice cream premix. Contaminated with tomatoes may have been wrongly who are immunocompromised by Salmonella en route to the plant, the implicated in a sweeping 2008 pregnancy, as well as by another premix was not pasteurized again outbreak (later linked to fresh underlying health condition or before being incorporated into jalapeno and serrano peppers), treatments like chemotherapy. For ice cream products. The result: tomatoes have caused at least 31 the elderly, however, Listeria can cause thousands of people sickened identified outbreaks since 1990. severe illnesses, with high rates of in 41 states. hospitalization and death. For high- The most common hazard associated risk consumers, foods likely to carry Soft ice cream can be a particular with tomatoes is Salmonella, which Listeria, like soft cheeses and deli hazard to pregnant women and accounted for over half of the salads, should be avoided or heated others who are more susceptible reported outbreaks. Salmonella can before consuming. to listeriosis. A particularly hardy enter tomato plants through roots bacterium, Listeria can survive on or flowers and can enter the tomato ICE CREAM Outbreaks from cheese products metal surfaces—such as the interior fruit through small cracks in the skin, occur most frequently in private homes. of soft ice cream machines—and the stem scar, or the plant itself. may contaminate batch after batch Once inside, destruction of Salmonella of products. without cooking the tomato is very difficult. Norovirus was the second ICE CREAM Can your favorite Almost half of all ice-cream outbreaks most common hazard. cold treat really make you sick? contained in CSPI’s database occurred Unfortunately, numerous outbreaks in private homes. This is most likely Restaurants were responsible for documented in the Outbreak Alert! due to the use of undercooked eggs 70 percent of all illnesses associated database show that these scoops in homemade ice cream. with tomatoes. can occasionally carry a load of dangerous bacteria. Whether served with sprinkles or jimmies, in a cone or a cup, frozen treats TOMATOES Reds, rounds, SPROUTS The germinating form have caused nearly 75 outbreaks Romas, and grapes: a favorite of seeds and beans, sprouts have from hazards like Salmonella and addition to salads, tomatoes have become a common food item in Staphylcoccus since 1990. unfortunately been repeatedly grocery stores, salad bars, and Asian linked to foodborne illness. In dishes. As the popularity of sprouts TOMATOES The largest ice-cream outbreak in 2005 and 2006, for example, increases, however, so does the history occurred in 1994, when a tomatoes were implicated in four potential for sprout-related illnesses.
  9. 9. 7 1875 Connecticut Ave NW, Suite 300 Washington, DC 20009 Phone (202) 332-9110 Raw and lightly cooked sprouts Notably, FDA has been encouraged Cyclospora in berries. The resulting www.cspinet.org have been recognized as a source to mandate consumer warning labels infection is a parasitic illness of the of foodborne illness in the U.S. since for sprouts. These labels would warn intestines, which can cause severe the 1990s. Since 1999, CDC and FDA high-risk consumers about the dangers diarrhea, dehydration, and stomach have recommended that persons at of raw sprout consumption. While cramps. Importantly, the illness does high risk for complications of infection it requires similar warnings for other not resolve itself without antibiotics, with Salmonella and E. coli O157:H7, high-risk foods (such as unpasteurized thus requiring a trip to the doctor. such as the elderly, young children, juice and raw oysters), FDA has not and those with compromised immune moved forward to mandate sprout systems, not eat raw sprouts. Although warnings. FDA has provided guidance to sprout producers to enhance the safety of sprout products, these commodities are still causing problems. Number BERRIES The last entry on the nine of the FDA Top Ten, sprouts FDA Top Ten list may also be the have been linked to at least 31 sweetest. Strawberries, raspberries, outbreaks since 1990. blackberries, and other berry products SPROUTS have caused 25 outbreaks with more The most likely source of sprout than 3300 illnesses since 1990. contamination is the seeds that are used to grow the sprouts. Seeds may In 1997, over 2.6 million pounds of become contaminated in the field contaminated strawberries were or during storage, and the warm and recalled after thousands of students humid conditions required to grow across several states reported sprouts are ideal for the rapid growth illnesses from eating frozen strawberries of bacteria. Improper handling and poor in their school lunches. Hepatitis A hygiene in sprout production have also was the culprit, and contamination caused some sprout-related outbreaks may have occurred through an infected of foodborne illness in the past. worker at a farm in Baja California, Mexico. That same year, raspberries Many different serotypes (strains) imported from Guatemala and Chile of Salmonella have been implicated were implicated in an outbreak of in sprout outbreaks, as has E. coli. Cyclospora across five states. Twenty-five of the reported outbreaks since 1990 have been linked to Most of these illnesses, affecting BERRIES Salmonella, and six others to E. coli. 2700 consumers, were caused by
  10. 10. The Riskiest Foods Regulated by the 8 U.S. Food and Drug Administration – Conclusion & Methodology 1875 Connecticut Ave NW, Suite 300 Washington, DC 20009 Phone (202) 332-9110 www.cspinet.org CONCLUSION Reported the Food Safety Enhancement Act, or more people have consumed the outbreaks from the Top Ten riskiest on July 30, 2009. The Senate now same contaminated food and come foods in this report represent the tip needs to pass S. 510, the FDA Food down with the same illness. Also, each of the iceberg. Millions of consumers Safety Modernization Act. And outbreak must have an identified are being made ill, hundreds of Congress should complete its critical food vehicle and pathogen and thousands hospitalized and thousands work on food safety legislation before must have occurred in the U.S. or are dying each year from preventable the end of this year. Two years ago, its territories. Excluded from the foodborne illnesses. Unfortunately, Congress expressed its commitment CSPI database are sporadic cases of FDA is saddled with outdated laws, to adopt a modern regulatory oversight foodborne illness (individual illnesses and lacks the authority, tools and program and fund it adequately to not linked to an outbreak); outbreaks resources to fight unsafe food. fulfill its mission in the Food and with no identifiable etiology (i.e., no Congress is working on legislation Drug Administration Amendments known bacterial or other cause of that makes much-needed changes Act of 2007. It is time to move forward disease); those not known to have to bring our food safety system into with strong public health oriented been triggered by a specific food; the 21st century. legislation to reduce foodborne and waterborne outbreaks. The illnesses and outbreaks by focusing majority of outbreaks reported to Legislation currently being considered on prevention, not reaction. CDC do not have both an identified in Congress would create a modern food and an identified pathogen. food safety program at FDA. It would In the years analyzed for this report, ensure that food processors design 56 percent to 73 percent of all and implement food safety plans, METHODOLOGY CSPI outbreaks reported to CDC have provide specific safety standards food maintains a database of foodborne no known etiology or food vehicle, growers would have to meet, and illness outbreaks, compiled largely and are therefore not included in require FDA to visit high-risk plants from the CDC annual outbreak line CSPI’s database. every 12 months or less, and most other listings. Additional outbreak data are facilities every 3-4 years. The bills also obtained from scientific articles, federal For this report, CSPI analyzed only put new safeguards in place for imported government publications, state health those foodborne illness outbreaks foods, making importers ensure that department postings, and newspaper that have been definitively linked foreign food meets the same high reports verified by public health to FDA-regulated products between safety standards as domestically officials; data from these additional 1990 and 2006. grown and processed food. sources constitute about 5 percent of the database. These bills strive to give consumers farm-to-fork protection. But Congress Outbreaks are only included in the needs to take action. The House of CSPI database if they meet the CDC’s Representatives passed H.R. 2749, definition of an outbreak: when two
  11. 11. The Riskiest Foods Regulated by the U.S. Food and Drug Administration – Endnotes 1 Mead P, Slutsker L, Dietz V. Food-Related Illness and Death in the United States. Centers for Disease Control and Prevention, Emerging Infectious Diseases, Vol. 5, No. 5, 1999. 2 Salmonella bacteria are found worldwide in warm- and cold-blooded animals, in humans, and in nonliving habitats. They cause illnesses, such as typhoid fever, paratyphoid fever, and the foodborne illness salmonellosis in humans, and are associated with disease in some animal species. Salmonella typhimurium and Salmonella enteritidis are the most common in the United States. 3 Escherichia coli (abbreviated as E. coli) are a large and diverse group of bacteria. E. coli O157:H7 is found in the guts of ruminant animals, including cattle, goats, sheep, deer, and elk. Infection with E. coli O157:H7 can cause severe stomach cramps, diarrhea, and vomiting. Around 5–10% of those who are diagnosed with a “Shiga toxin-producing E. coli” infection develop a life-threatening complication known as hemolytic uremic syndrome (HUS). 4 Vibrio bacteria—which occur naturally in warm salt water—belong to the same family of illnesses as cholera. The two most common Vibrio strains in the United States are Vibrio vulnificus and Vibrio parahaemolyticus. 5 Leafy greens do not include herbs such as cilantro and parsley. 6 While FDA regulates shell eggs, USDA has jurisdiction over egg products such as liquid and powdered eggs, many of which are pasteurized. 7 See 74 FR 33030 (July 9, 2009). 8 CDC does not distinguish between foodborne-illness outbreaks from fresh tuna versus canned tuna products. 9 CDC does not distinguish between types of cheeses (e.g. cheeses made with raw milk and those that are aged or fresh).
  12. 12. 10 9 8 7 6 5 4 3 2 1 1875 Connecticut Ave NW, Suite 300 Washington, DC 20009 Phone (202) 332-9110 www.cspinet.org