1. THE TEN RISKIEST FOODS
REGULATED BY THE
U.S. FOOD AND DRUG ADMINISTRATION
10 9 8 7 6 5 4 3 2 1
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. 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. 2
The Riskiest Foods Regulated by the
U.S. Food and Drug Administration – Findings
1875 Connecticut Ave NW, Suite 300
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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. 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
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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. 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. 5
1875 Connecticut Ave NW, Suite 300
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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. 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. 7
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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. The Riskiest Foods Regulated by the
8
U.S. Food and Drug Administration – Conclusion & Methodology
1875 Connecticut Ave NW, Suite 300
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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. 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).