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February 4, 2019
Foodborne Illnesses and Outbreaks from Fresh Produce
The produce industry continues to be associated with a
ranged from about 30 to 60 per year and sickened from 900
series of foodborne illness outbreaks across multiple U.S.
to nearly 3,000 people annually (1998-2016) (Figure 1).
states and Canada, resulting in hundreds of illnesses and
Leafy greens, a subset of the produce category, accounted
hospitalizations, as well as kidney failure and death in some
for between 20% and 40% of these reported outbreaks and
cases. Many in Congress have expressed concern that
10% to 40% of all produce-related illnesses (1998-2016).
foodborne illness outbreaks are continuing to occur despite
Over this period, single and multistate outbreaks associated
ongoing regulatory oversight by the Food and Drug
with leafy greens ranged from about 10 to 20 per year and
Administration (FDA) and state public health authorities
sickened between 100 and 1,100 annually (Figure 2).
and given the enhanced authorities and resources provided
to food safety officials following the enactment of
Figure 1. Foodborne Illness Outbreaks, All Produce
comprehensive food safety legislation as part of the FDA
Food Safety Modernization Act in 2010 (FSMA, P.L. 111-
353). FSMA req;llllloluired the development and
implementation of produce safety standards for certain
fruits and vegetables, among other regulatory actions.
Foodborne Illnesses Linked to Produce
The Centers for Disease Control and Prevention (CDC)
defines a “foodborne disease outbreak” as occurring when
two or more people get the same illness from the same
contaminated food or drink. Based on previous CDC
outbreak investigations, microbial hazards associated with
fruits and vegetables include pathogenic (disease-causing)
strains of Shiga toxin-producing E. coli (STEC),
Figure 2. Foodborne Illness Outbreaks, Leafy Greens
Salmonella, Norovirus or Norwalk-like virus, and Listeria
monocytogenes. Other produce-related hazards have
involved Vibrio, Shigella, Cryptosporidium, Giardia,
Cyclospora, Toxoplasma gondii, and Hepatitis A virus.
Microbial hazards may be introduced through agricultural
and processing water (used in production or transported via
runoff), soil amendments (such as manure and municipal
biosolids), worker hygiene, field and packing facility
sanitation, and produce transportation and distribution.
During the last three years (2016-2018), FDA, CDC, and
state and local officials have investigated several multistate
outbreaks involving leafy greens, salad mix, sprouts,
Source: CRS from NORS data, https://www.cdc.gov/nors/index.html.
cucumbers, papaya, frozen strawberries, prepared fresh and
Produce includes fruits, nuts (excluding peanuts), vegetables, sprouts,
root crops, and herbs. Leafy greens is a subset of al produce and
frozen vegetables, pre-cut melons, pistachios, and dried
includes al lettuce, greens, and cabbage (excluding sprouts).
coconut. Norovirus, Salmonella, and E. coli are among the
Notes: Includes confirmed and suspected cases across reported
leading cause of illnesses linked to produce. Multiple
single and multistate outbreaks and al attributed causes and settings
foodborne illness and outbreak investigations involved E.
(restaurants and institutions, e.g., schools, hospitals, and prisons).
coli O157:H7 illnesses that were linked to leafy greens. Of
these, one was linked to romaine lettuce grown in
Analysis by the Center for Science in the Public Interest, a
California, and another was linked to romaine lettuce grown
public health advocacy group, indicates that foodborne
in Arizona. Other investigations involved E. coli linked to
illness outbreaks associated with produce were more
leafy greens (not traced back to a common supplier) and
common and sickened more people than any other food
involved Listeria monocytogenes linked to packaged salad.
category. A 2008 United Nations study ranks leafy greens
as the “highest priority” in terms of microbiological hazards
Figure 1 and Figure 2 show reported outbreak and illness
within the fruit and vegetable category. This ranking is
trends for all produce and a subset of produce for leafy
based on the sheer number of outbreaks and the types of
greens based on data from the CDC’s National Outbreak
microbial hazard associated with leafy greens, but it also
Reporting System (NORS). These data indicate the number
reflects the size and scale of production and trade in leafy
of single and multistate outbreaks associated with produce
greens. Other factors include the diversity and complexity
of production of leafy greens and potential for amplification
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Foodborne Illnesses and Outbreaks from Fresh Produce
of foodborne pathogens through the food chain due to
mushrooms, sprouts, peanuts, tree nuts, and herbs. FDA
certain post-harvest activities (e.g., whether packaged in-
estimates that the regulation covers as many as 40,000
field or pre-cut and bagged). Available information tracked
domestic produce farms and nearly 15,000 foreign farms.
by CDC as part of its Foodborne Diseases Active
Foods not covered by regulation include foods that are
Surveillance Network indicate that, across all food groups,
rarely consumed raw (listed at 21 CFR 112.2(a)(1)), foods
infections caused by certain STEC infections have been
that go to commercial processing, foods produced for
decreasing, while the incidence of Salmonella infections
personal consumption, and certain foods identified as low
has not changed significantly. Making such generalizations,
risk. Produce that undergoes certain commercial processing,
however, is often complicated by differences in laboratory
such as bagged salads and leafy greens, are further covered
testing methods and/or differences depending on the strain
by FDA’s rule on preventive controls affecting food
of a microorganism.
facilities (§103). Other FSMA requirements affecting on-
farm activities include facility registration, inspection, and
FDA Standards for Produce Safety
records access. Certain qualified farms and facilities are
FSMA amends the Federal Food, Drug, and Cosmetic Act
exempt from regulation depending on business size, among
(21 U.S.C. §§301 et seq.), which governs foods under
other factors.
FDA’s jurisdiction. Under FSMA, FDA has developed and
Deadlines for complying with FDA’s produce rule are
implemented mandatory food safety and traceability
being phased in over time and vary depending on the crop
requirements for farmers, packers, and processors of
and farm size. In some cases, FDA has granted more time
domestically produced and imported products. Selected
to some farms to implement and comply with certain
provisions that broadly address produce are shown in the
requirements. For example, in September 2017, FDA
text box.
proposed to extend the compliance deadline for agricultural
Selected FSMA Provisions Related to Produce
water testing because of concerns about the feasibility and
cost involved (82 Federal Register 42963). Under the
Inspections of Records (§101)
extension, larger farms have until 2022 to comply with the
Allows FDA to inspect records related to the “manufacture,
rule’s water requirements, while small and very small farms
processing, packing, distribution, receipt, holding, or
importation” of certain food and feed.
have until 2023 and 2024, respectively, to comply.
Registration of Food Facilities (§102)
FSMA also addresses food traceability (§204). Traceability
Requires that food facilities be subject to biennial registration
refers to the ability to fully trace the movement of food and
renewal. Provides that FDA may suspend a facility’s registration
in certain cases.
ingredients through each specific stage of production,
processing, and distribution and to be able to identify the
Hazard Analysis and Risk-Based Preventive Controls
(§103)
origin of food and ingredients when a food or finished
Requires FDA to establish mandatory preventive controls for
product is found to be unsafe. Full traceability often
food facilities except for “small” and “very small” businesses.
requires extensive recordkeeping and/or other types of
Standards for Produce Safety (§105)
traceback mechanisms. FSMA required FDA to establish
Requires FDA to establish mandatory minimum standards for
pilot projects and improve its capacity to effectively and
the safe production and harvesting of fruits and vegetables
rapidly track and trace foods in the event of an outbreak.
except for “small” and “very small” businesses.
FSMA also required FDA to designate high-risk foods that
Targeting of Inspection Resources (§201)
require additional recordkeeping to protect public health.
Requires FDA to identify high-risk facilities, increase the
FDA’s pilot projects were completed in 2012. However,
frequency of inspection of domestic and foreign facilities,
FDA has not yet identified or established enhanced
identify and conduct inspections at ports of entry, and improve
recordkeeping requirements for high-risk foods.
inter-agency coordination and cooperation.
Tracking and Tracing Food, Records (§204)
Considerations for Congress
Requires FDA to establish pilot projects to improve traceability
As foodborne illness outbreaks continue to occur, some
of foods and to establish additional recordkeeping requirements continue to question the effectiveness of FDA’s food safety
for certain “high-risk foods.”
regime. Regarding lapses in produce safety, some advocacy
Surveillance (§205)
groups point to FDA’s repeated delays in fully
Requires CDC to enhance foodborne il ness surveillance
implementing key FSMA produce standards, including
systems and to conduct an assessment of state and local food
postponing compliance with the rule’s water quality testing
safety and defense capacities.
requirements, as a contributing factor. Some groups further
For more information, see CRS Report R43724, Implementation of
blame FDA for not fully implementing FSMA’s traceability
the FDA Food Safety Modernization Act (FSMA, P.L. 111-353).
requirements, especially regarding high-risk foods. Critics
also continue to cite the agency’s low rates of inspection
At the farm production level, FSMA principally affects
and enforcement of FDA-regulated farms and food
produce growers by directing FDA to establish produce
facilities. Others claim that FDA has not been provided
safety standards (§105). FDA finalized its produce safety
with the resources to hire the additional inspectors that are
regulation in 2015 (80 Federal Register 74353). FDA’s
needed to fully implement and adequately enforce the
produce rule addresses certain identified routes of potential
produce standards. Still others point to a possible lack of
contamination, covering water and soil amendments used in
coordination between FDA and state and local authorities,
production, domesticated and wild animal intrusions in
which often bear most of the responsibility for inspecting
production area, worker training and hygiene, and
farms and food facilities within their jurisdictions.
equipment and sanitation practices used in production. The
Renée Johnson, Specialist in Agricultural Policy
regulation covers fruits and vegetables (including mixes),
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Foodborne Illnesses and Outbreaks from Fresh Produce
IF11092
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