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FDA Talk Papers are prepared by the Press Office to guide FDA
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T98-47 Print Media: 202-205-4144
August 31, 1998
Consumer Inquiries: 800-532-4440
INTERIM ADVISORY ON ALFALFA SPROUTS
The Food and Drug Administration is reaffirming health
advisories that persons who are at high risk for severe foodborne
disease should avoid eating raw alfalfa sprouts. This
reaffirmation is an interim measure until such time as
intervention methods are in place to improve the safety of these
products. Persons at high risk include children, the elderly,
and persons with compromised immune systems. Similar advice was
given by the Centers for Disease Control and Prevention (CDC)
after reporting outbreaks of E. Coli O157:H7 in its Morbidity and
Mortality Weekly Report (MMWR) publication in August 1997.
Since 1995, raw sprouts have emerged as a recognized source
of foodborne illness in the United States. FDA's reaffirmation
of this advice follows recent investigation by the state of
California of 3 Salmonella and E. Coli O157 outbreaks associated
with sprouts that affected a total of approximately 60 persons.
The California Department of Health Services has issued a
statewide advisory about the potential risk of illness to
vulnerable populations.
An E. coli O157 infection can lead to hemolytic uremic
syndrome with resultant kidney failure or death in children, and
equally serious complications in the elderly. Salmonella
infections can cause serious illness in children, the elderly and
the immune compromised. Healthy persons infected with these
bacteria experience diarrhea, nausea, abdominal cramping or fever
for several days, but generally the illness is self-limiting.
The International Sprout Growers Association (ISGA) is
taking positive steps to address this problem. For example, the
sprout industry is pursuing the use of calcium hypochlorite at
20,000 parts per million (a 2 percent solution) for soaking of
the seeds prior to germination and growth. This method of
treating seeds has the potential to substantially reduce
microbial contamination of seeds which can be passed on through
the growing sprouts. The Environmental Protection Agency is
expediting evaluation of this procedure. The ISGA is working
with FDA and the California Department of Health Services to
develop and implement a food safety program for sprout
growers.
CDC and FDA have closely monitored the occurrence of
foodborne illness outbreaks associated with sprouts, and FDA has
been working with other agencies and industry to develop a
strategy to enhance the safety of sprouts. Among the steps that
have been taken are these:
- FDA and CDC met with the sprout industry in 1995 to
inform them of recent outbreaks and government concerns about the
safety of sprouts.
- In July 1997, FDA and CDC charged the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF) with
reviewing available data on sprout associated outbreaks, and
providing recommendations on intervention and prevention methods.
(NACMCF is an expert scientific panel which advises the federal
government on food safety matters).
- The industry is also actively working with FDA and
USDA's Agricultural Research Service on other interventions
including irradiation to address the problem.
- FDA has issued a nationwide field assignment to
determine current sprout industry practices during growing,
washing and packaging. Samples of seeds, processing water, and
sprouts are being analyzed microbiologically. Enforcement
actions will be considered as appropriate.
- The California Department of Health Services and FDA's
Pacific Regional Office, in cooperation with the sprout industry,
recently conducted a survey of growers in California.
Information gathered during this survey was used to develop the
current FDA nationwide assignment.
- On September 3-4, 1998, FDA will meet with industry
representatives in Chicago to discuss ongoing cooperative
research toward ensuring the safety of sprouts.
- On September 28 and 29, 1998, FDA will hold a public
meeting on the safety of sprouts to provide a forum for
discussion of the current situation, consumer perspectives,
agricultural practices, the state of the science, and possible
intervention methods.
FDA and other public health agencies will continue to work
with health care professionals in raising awareness about this
potential risk. Consumers who have eaten raw sprouts and are
experiencing severe diarrhea or other extreme symptoms of food
borne infections are advised to consult their health care
providers.
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