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THE TEN RISKIEST FOODS

REGULATED BY THE

U.S. FOOD AND DRUG ADMINISTRATION

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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.

1875 Connecticut Ave NW, Suite 300Washington, DC 20009Phone (202) 332-9110

www.cspinet.org

THE TEN RISKIEST FOODSREGULATED BY THEU.S. FOOD AND DRUG ADMINISTRATION

In recent years, U.S. consumershave faced foodborne-illnessoutbreak after outbreak linked tocontaminated food. A complex,globalized food system, archaicfood-safety laws, and the rise oflarge-scale production and processinghave combined to create a perfectstorm of unsafe food. Unfortunately,the hazards now come from all areasof the food supply: not only high-riskproducts, like meat and dairy, butalso the must-eat components of ahealthy diet, like fruits and vegetables.

This report identifies the top tenriskiest foods regulated by the Foodand Drug Administration (FDA) (the“FDATop Ten”), the agency responsiblefor all produce, seafood, shell eggs,and dairy products. Together, theseten foods alone account for nearly

40 percent of all foodborneoutbreaks linked to FDA-regulatedfoods since 1990, as tracked by theCenter for Science in the PublicInterest (CSPI) using data from theCenters for Disease Control andPrevention (CDC) and elsewhere.Over 1500 separate, definableoutbreaks were linked to the FDATop Ten, with almost 50,000 illnessesreported, ranging from temporarygastrointestinal distress to long-termdisability and death.

While this data represents the bestdata available from the CDC, thehurdles to accurate outbreak trackingare many: people rarely see a doctorto treat foodborne illness; those whodo are often treated without the labtesting needed to document thecause of the illness (the pathogen

involved); illnesses need to beinvestigated by state health officialsin order to be identified as partof an outbreak; states often lackthe resources to conduct thoroughinvestigations to identify the foodinvolved; and finally, outbreaks thatare investigated must be reportedto CDC.

Thus, the outbreaks included hererepresent only the tip of the icebergof foodborne illness. In fact, in1999, the CDC estimated that foreach case of salmonellosis that isclinically diagnosed and reportedto health officials, another 38 caseswere unreported.1 All told, unsafefood causes tens of millions ofillnesses, hundreds of thousandsof hospitalizations, and thousands ofdeaths every year in the United States.

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The Riskiest Foods Regulated by theU.S. Food and Drug Administration – Findings

2

MANY OF THE FDA TOP TEN

ARE, UNFORTUNATELY, SOME

OF THE MOST HEALTHY

AND POPULAR FOODS

CONSUMED IN THE U.S.

AND WHILE SOME ARE

ALREADY CONSIDERED

“HIGH-RISK” FOODS, OTHERS

ARE SURPRISING. THE FDA

TOP TEN RISKIEST FOODS

REGULATED BY FDA ARE:

LEAFY GREENS: 363 outbreaks involving 13,568 reported cases of illness

EGGS: 352 outbreaks involving 11,163 reported cases of illness

TUNA: 268 outbreaks involving 2341 reported cases of illness

OYSTERS: 132 outbreaks involving 3409 reported cases of illness

POTATOES: 108 outbreaks involving 3659 reported cases of illness

CHEESE: 83 outbreaks involving 2761 reported cases of illness

ICE CREAM: 74 outbreaks involving 2594 reported cases of illness

TOMATOES: 31 outbreaks involving 3292 reported cases of illness

SPROUTS: 31 outbreaks involving 2022 reported cases of illness

BERRIES: 25 outbreaks involving 3397 reported cases of illness


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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

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LEAFY GREENS Can saladreally make you sick? While nutritionistsshudder at the thought, it is sadlythe case that nutritious greens canalso be highly contaminated withpathogens. Overall, CSPI identified363 separate outbreaks linked toleafy greens, making them the numberone entry in the FDA Top Ten. Saladsand other food items containingleafy greens—iceberg lettuce, romainelettuce, leaf lettuce, butter lettuce,baby leaf lettuce (immature lettuceor leafy greens), escarole, endive,spring mix, spinach, cabbage, kale,arugula or chard5—account for24 percent of all of the outbreakslinked to the FDA Top Ten. Thoseoutbreaks sickened over 13,568people who were reported to havebecome ill—almost 30 percent ofall the reported illnesses causedby the FDA Top Ten.

In 2006, leafy greens hit the nationalradar screen as a high-risk food whenbagged spinach contaminated withE. coli O157:H7 caused several deathsand hundreds of illnesses. That sameyear, deadly E. coli O157:H7 appearedin two other outbreaks linked to leafygreens. Though produce companieshave voluntarily increased theirvigilance, E. coli O157:H7 is stillcropping up in these products,

and accounts for 10 percent of alloutbreaks in leafy greens. Anotherpathogen appearing frequently inleafy greens is Norovirus, which iscommonly spread by the unwashedhands of an ill handler or consumer.This pathogen was linked to 64 percentof the outbreaks in leafy greens.Salmonella was responsible fornearly 10 percent of the outbreaks.

Outbreaks from leafy greens occuranywhere these popular food itemsare consumed. Contamination maybe present from production andprocessing, or may occur throughimproper handling and preparation,such as inadequate handwashingand cross-contamination of cuttingboards and other equipment. Inrestaurants, any of these problemsin only a single food item can affectmultiple patrons. For example, anoutbreak of E. coli O157:H7 in 2006began at Taco John’s, a popularIowa eatery. Over 80 people weresickened—including twowhodevelopedpotentially deadly hemolytic uremicsyndrome—from contaminated iceberglettuce from California’s Central Valley.Overall, restaurant outbreaks accountedfor almost 240 outbreaks from leafygreens. Private homes accountedfor another 24 outbreaks. Notably,outbreaks in school settings—from

elementary to college—tended tobe quite large—averaging 89 reportedillnesses per outbreak—thoughluckily infrequent.

Leafy greens can become initiallycontaminated on the farm throughcontact with wild animals, manure,contaminated water, or poor handlingpractices during harvest. Once theyare contaminated, leafy greens cansupport, grow, and spread pathogensuntil consumed. Chlorine washesand other post-harvest treatmentscan help reduce cross contaminationbetween lots, but they don’t makecontaminated products truly safe toeat. In fact, bacteria can inhabit thewashing systems used in makingpre-washed bagged lettuce,transferring dangerous bacteriafrom one contaminated lot to thenext, with the potential of effectinga full day’s production.

SHELL EGGS Often describedas a perfect breakfast food, shell eggsare unfortunately among the worst ofthe FDA Top Ten. Overall, CSPI found352 outbreaks linked to shell eggs andegg products.6 The overwhelmingmajority of illnesses from eggs areassociated with Salmonella, which


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The Riskiest Foods Regulated by theU.S. Food and Drug Administration – The FDA Top Ten in detail

LEAFY GREENS

SHELL EGGS

Notably, scombroid illnessesfrequently involve fresh product.These products are subject to HAACP(Hazard Analysis Critical ControlPoints), a safety system in which hazardsare identified and steps taken tocontrol them. As a naturally-occurringtoxin, scombrotoxin is foreseeableand should be properly addressedby HAACP. Tuna’s appearance in theFDA Top Ten suggests that FDA’sseafood program needs to moreeffectively address this hazard.

In addition to scombrotoxin,Norovirus and Salmonella causedillnesses related to tuna consumption,affecting nearly 1000 people. Over65 percent of outbreaks linked totuna occurred in restaurants.

OYSTERSOften considered anexpensive delicacy, oysters can ruinmore than just a gourmet dinner.Though they comprise a trivial partof the American diet, tainted oystersare the fourth entry in the FDA TopTen, responsible for almost 2000reported illnesses. Not surprisingly,the majority of outbreaks fromoysters occurred in restaurants.

Illnesses from oysters occur primarilyfrom two sources: Norovirus and Vibrio.Although Norovirus in other foods

Notably, the largest egg outbreaksoccurred in prisons, with an averageof 143 people reported sick in eachoutbreak. Catered events also hadlarge outbreaks, averaging almost 60people reported to have been sickened.

TUNAWhile a step down from leafygreens and eggs, tuna was linked to268outbreaks in theFDATopTen.8 Someconsumersmay be familiar with warningsabout tuna and methylmercury, butthe pathogens that show up in theoutbreak data are rarely discussedwhen it comes to this fish.

Scombroid, the illness caused byscombrotoxin, was by far the mostcommon cause of illness relatedto tuna dishes, affecting over 2300people who were reported to havebeen sickened, according to CSPI’sOutbreak Alert! database. Freshfish decay quickly after being caughtand, if stored above 60˚ F, beginto release natural toxins that aredangerous for humans. Adequaterefrigeration and handling canslow this spoilage, but the toxincannot be destroyed by cooking,freezing, smoking, curing, or canning.Symptoms of scombroid poisoningcan include skin flushing, headaches,abdominal cramps, nausea, diarrhea,palpitations, and loss of vision.

sickened over 11,000 people whoseillnesses were reported from 1990to 2006.

Most types of Salmonella live in theintestinal tracts of animals and birdsand are transmitted to humans whenanimal feces contaminate a fooditem of animal origin (such as eggs).Regulations for cleaning and inspectingeggs were implemented in the 1970sand have reduced salmonellosiscaused by external fecal contaminationof egg shells. However, Salmonellaenteritidis, the most prevalent typeof Salmonella in eggs today, infectsthe ovaries of otherwise healthy hensand contaminates the eggs beforethe shells are formed. Notably, finalregulations that require the adoptionof controls aimed at minimizingSalmonella enteriditis in eggproductionwere issued in July 2009 (and willbecome effective in 2010 or 2012,depending on producer size),7 afterover a decade of inaction by thefederal government.

Half of all egg outbreaks occurredfrom restaurants and other foodestablishments. While proper egghandling and cooking should destroymost pathogens, serving eggs rawor “runny,” or leaving egg dishesat improper holding temperatures(such as on a breakfast buffet) canallow the bacteria to multiply.


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TUNA

OYSTERS

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CHEESE A perennial favoriteamong consumers for its variety andversatility—hard, soft, mild, sharp,melted and sliced—cheese productswere linked to 83 outbreaks thatsickened thousands of consumerssince 1990, making it number six ofthe FDA Top Ten.9 Salmonella wasthe most common hazard amongcheese products.

Cheese can become contaminatedwith pathogens during the initialphases of production (curdling,molding, and salting), or later duringprocessing. Most cheeses are nowmade with pasteurized milk, loweringthe risk of contamination with milk-borne pathogens. However, as recentlyas August 2009, California officialswarned consumers about eatingLatin American-style cheeses (suchas queso fresco, queso oaxaca,and others), which may be madeby unlicensed manufacturers usingunpasteurized milk that couldcontain harmful bacteria.

Pregnant women should be particularlycautious about consumption of softcheeses (such as feta, Brie, Camembert,blue-veined, andMexican-style cheese),which can carry Listeria. Listeriosiscan cause miscarriage, often withoutthe mother experiencing any symptoms.Linked to at least four outbreaksfrom cheese since 1990, listeriosis

3600 consumers reported to havebeen sickened by spuds since 1990.

Potatoes are grown in the soil,but they are always cooked beforeconsuming. Outbreaks are linkedto dishes, like potato salad, that cancontain many ingredients and also abroad range of pathogens. Salmonellais most common, associated withalmost 30 percent of potato outbreaks.E. coli also appears in the potatocategory, accounting for 6 potatooutbreaks. Normally found in animalfeces, the presence of Salmonellaand E. coli in potato dishes couldindicate cross contamination fromthe raw to the cooked ingredientsor possibly from raw meat or poultryduring handling and preparation.

Shigella and Listeria monocytogenesalso appear in outbreaks associatedwith potatoes. Shigella is easilytransmitted from an infected personto a food product, and thus mayindicate improper handling duringfood preparation. Listeria is a stubbornbacterium that can live on deli countersand in other kitchen areas, and is oftenassociated with cold deli salads.

More than 40 percent of potatooutbreaks were linked to foodsprepared in restaurants and foodestablishments (including grocerystores and delis).

is usually associated with improperhandling during harvest or preparation,oysters can actually be harvestedfrom waters contaminated withNorovirus. When served raw orundercooked, those oysterscan cause gastroenteritis, aninflammation of the stomachand small or large intestines.

The most dangerous of the twopathogens found in oysters is Vibrio.This hazard is a type of bacteriumin the same family as cholera. Themost common strains in theU.S. areV. vulnificus and V. parahaemolyticus,both of which can cause severedisease. In immuno-compromisedpersons, particularly those with chronicliver disease, V. vulnificus can infectthe bloodstream, causing a severeand life-threatening illnesscharacterized by fever and chills,decreased blood pressure (septicshock), and blistering skin lesions.V. vulnificus bloodstream infections,called septicemia, are fatal about50 percent of the time.

POTATOES One of America’smost popular and versatile fooditems appears in the middle of theFDA Top Ten list. Potatoes, often inthe form of potato salad, were linkedto 108 outbreaks, with more than


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POTATOES

CHEESE

large multistate outbreaks ofSalmonella, sickening hundreds ofpeople across the country. Althoughtomatoes may have been wronglyimplicated in a sweeping 2008outbreak (later linked to freshjalapeno and serrano peppers),tomatoes have caused at least 31identified outbreaks since 1990.

The most common hazard associatedwith tomatoes is Salmonella, whichaccounted for over half of thereported outbreaks. Salmonella canenter tomato plants through rootsor flowers and can enter the tomatofruit through small cracks in the skin,the stem scar, or the plant itself.Once inside, destruction of Salmonellawithout cooking the tomato is verydifficult. Norovirus was the secondmost common hazard.

Restaurants were responsible for70 percent of all illnesses associatedwith tomatoes.

SPROUTS The germinating formof seeds and beans, sprouts havebecome a common food item ingrocery stores, salad bars, and Asiandishes. As the popularity of sproutsincreases, however, so does thepotential for sprout-related illnesses.

popular ice cream manufacturerused the same truck to haul raw,unpasteurized eggs and pasteurizedice cream premix. Contaminated withSalmonella en route to the plant, thepremix was not pasteurized againbefore being incorporated intoice cream products. The result:thousands of people sickenedin 41 states.

Soft ice cream can be a particularhazard to pregnant women andothers who are more susceptibleto listeriosis. A particularly hardybacterium, Listeria can survive onmetal surfaces—such as the interiorof soft ice cream machines—andmay contaminate batch after batchof products.

Almost half of all ice-cream outbreakscontained in CSPI’s database occurredin private homes. This is most likelydue to the use of undercooked eggsin homemade ice cream.

TOMATOES Reds, rounds,Romas, and grapes: a favoriteaddition to salads, tomatoes haveunfortunately been repeatedlylinked to foodborne illness. In2005 and 2006, for example,tomatoes were implicated in four

is vastly underreported, since overtsymptoms of infection can be mild inthose who are not particularly at risk.Those most at risk include peoplewho are immunocompromised bypregnancy, as well as by anotherunderlying health condition ortreatments like chemotherapy. Fortheelderly, however, Listeria can causesevere illnesses, with high rates ofhospitalization and death. For high-risk consumers, foods likely to carryListeria, like soft cheeses and delisalads, should be avoided or heatedbefore consuming.

Outbreaks from cheese productsoccur most frequently in private homes.

ICE CREAM Can your favoritecold treat really make you sick?Unfortunately, numerous outbreaksdocumented in the Outbreak Alert!database show that these scoopscan occasionally carry a load ofdangerous bacteria. Whetherserved with sprinkles or jimmies,in a cone or a cup, frozen treatshave caused nearly 75 outbreaksfrom hazards like Salmonella andStaphylcoccus since 1990.

The largest ice-cream outbreak inhistory occurred in 1994, when a



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ICE CREAM

TOMATOES

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www.cspinet.orgCyclospora in berries. The resultinginfection is a parasitic illness of theintestines, which can cause severediarrhea, dehydration, and stomachcramps. Importantly, the illness doesnot resolve itself without antibiotics,thus requiring a trip to the doctor.

Notably, FDA has been encouragedto mandate consumer warning labelsfor sprouts. These labels would warnhigh-risk consumers about the dangersof raw sprout consumption. Whileit requires similar warnings for otherhigh-risk foods (such as unpasteurizedjuice and raw oysters), FDA has notmoved forward to mandate sproutwarnings.

BERRIES The last entry on theFDA Top Ten list may also be thesweetest. Strawberries, raspberries,blackberries, and other berry productshave caused 25 outbreaks with morethan 3300 illnesses since 1990.

In 1997, over 2.6 million pounds ofcontaminated strawberries wererecalled after thousands of studentsacross several states reportedillnesses fromeating frozen strawberriesin their school lunches. Hepatitis Awas the culprit, and contaminationmay have occurred through an infectedworker at a farm in Baja California,Mexico. That same year, raspberriesimported from Guatemala and Chilewere implicated in an outbreak ofCyclospora across five states.

Most of these illnesses, affecting2700 consumers, were caused by

Raw and lightly cooked sproutshave been recognized as a sourceof foodborne illness in the U.S. sincethe 1990s. Since 1999, CDC and FDAhave recommended that persons athigh risk for complications of infectionwith Salmonella and E. coli O157:H7,such as the elderly, young children,and those with compromised immunesystems, not eat raw sprouts. AlthoughFDA has provided guidance to sproutproducers to enhance the safety ofsprout products, these commoditiesare still causing problems. Numbernine of the FDA Top Ten, sproutshave been linked to at least 31outbreaks since 1990.

The most likely source of sproutcontamination is the seeds that areused to grow the sprouts. Seeds maybecome contaminated in the fieldor during storage, and the warm andhumid conditions required to growsprouts are ideal for the rapid growthof bacteria. Improper handling andpoorhygiene in sprout production have alsocaused some sprout-related outbreaksof foodborne illness in the past.

Many different serotypes (strains)of Salmonella have been implicatedin sprout outbreaks, as has E. coli.Twenty-five of the reported outbreakssince 1990 have been linked toSalmonella, and six others to E. coli.

BERRIES

SPROUTS

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www.cspinet.org or more people have consumed thesame contaminated food and comedown with the same illness. Also, eachoutbreak must have an identifiedfood vehicle and pathogen andmust have occurred in the U.S. orits territories. Excluded from theCSPI database are sporadic cases offoodborne illness (individual illnessesnot linked to an outbreak); outbreakswith no identifiable etiology (i.e., noknown bacterial or other cause ofdisease); those not known to havebeen triggered by a specific food;and waterborne outbreaks. Themajority of outbreaks reported toCDC do not have both an identifiedfood and an identified pathogen.In the years analyzed for this report,56 percent to 73 percent of alloutbreaks reported to CDC haveno known etiology or food vehicle,and are therefore not included inCSPI’s database.

For this report, CSPI analyzed onlythose foodborne illness outbreaksthat have been definitively linkedto FDA-regulated products between1990 and 2006.

the Food Safety Enhancement Act,on July 30, 2009. The Senate nowneeds to pass S. 510, the FDA FoodSafety Modernization Act. AndCongress should complete its criticalwork on food safety legislation beforethe end of this year. Two years ago,Congress expressed its commitmentto adopt a modern regulatory oversightprogram and fund it adequately tofulfill its mission in the Food andDrug Administration AmendmentsAct of 2007. It is time to move forwardwith strong public health orientedlegislation to reduce foodborneillnesses and outbreaks by focusingon prevention, not reaction.

METHODOLOGY CSPImaintains a database of foodborneillness outbreaks, compiled largelyfrom the CDC annual outbreak linelistings. Additional outbreak data areobtained from scientific articles, federalgovernment publications, state healthdepartment postings, and newspaperreports verified by public healthofficials; data from these additionalsources constitute about 5 percentof the database.

Outbreaks are only included in theCSPI database if they meet the CDC’sdefinition of an outbreak: when two

CONCLUSION Reportedoutbreaks from the Top Ten riskiestfoods in this report represent the tipof the iceberg. Millions of consumersare being made ill, hundreds ofthousands hospitalized and thousandsare dying each year from preventablefoodborne illnesses. Unfortunately,FDA is saddled with outdated laws,and lacks the authority, tools andresources to fight unsafe food.Congress is working on legislationthat makes much-needed changesto bring our food safety system intothe 21st century.

Legislation currently being consideredin Congress would create a modernfood safety program at FDA. It wouldensure that food processors designand implement food safety plans,provide specific safety standards foodgrowers would have to meet, andrequire FDA to visit high-risk plantsevery 12months or less, and most otherfacilities every 3-4 years. The bills alsoput new safeguards inplace for importedfoods, making importers ensure thatforeign food meets the same highsafety standards as domesticallygrown and processed food.

These bills strive to give consumersfarm-to-fork protection. But Congressneeds to take action. The House ofRepresentatives passed H.R. 2749,

The Riskiest Foods Regulated by theU.S. Food and Drug Administration – Conclusion & Methodology

1 Mead P, Slutsker L, Dietz V. Food-Related Illness and Death in the United States. Centers for Disease Control and Prevention, Emerging InfectiousDiseases, 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 astyphoid 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, includingcattle, goats, sheep, deer, and elk. Infection with E. coli O157:H7 can cause severe stomach cramps, diarrhea, and vomiting. Around 5–10% of thosewho 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 strainsin 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).

The Riskiest Foods Regulated by theU.S. Food and Drug Administration – Endnotes


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