FDA ISSUES GUIDANCE TO ENHANCE
SAFETY OF SPROUTS
Washington, D.C. (SafetyAlerts) - The Food and Drug
Administration today issued two guidance documents to enhance the safety of sprouts, a
product that in recent years has been implicated in at least 1,300 cases of foodborne
illness. The guidance advises sprout producers and seed suppliers of steps they should
take to reduce microbial hazards common to sprout production. A companion guide provides
producers with the latest information about testing spent irrigation water, an important
step to ensure the safety of sprouts.
"As a public health agency, FDA is committed
to preventing foodborne illness associated with this product," said Jane E. Henney,
MD, the FDA Commissioner. "We believe these guidances, which are based on sound
science and the cooperation of many groups, represent a major step toward ensuring food
The guides, entitled "Guidance for Industry:
Reducing Microbial Food Safety Hazards for Sprouted Seeds" and "Guidance for
Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout
Production" are the latest of several FDA actions to reduce the risk of foodborne
illness attributed to eating raw sprouts.
In 1997, FDA asked the National Advisory Committee
on Microbiological Criteria for Food (NACMCF) to review the current literature on
outbreaks of sprout-associated foodborne illness, identify the organisms and production
practices of greatest public health concern, set research priorities, and recommend
intervention and prevention strategies. The guidance published today is based largely on
recommendations from the NACMCF report issued last May.
In August 1998, following outbreaks of Salmonella
and E. coli O157 infections attributed to sprouts, FDA issued a health advisory warning
high risk groups not to eat raw alfalfa sprouts. The advisory was reissued last July to
include all raw sprouts and all consumers because of the continued increase in the
incidence of illness attributed to sprouts.
In September 1998, FDA held a public meeting with
industry, consumer groups and academia to discuss further steps to ensure the safety of
sprouts. Although the meeting and other measures improved the food safety awareness within
the industry, sprout- associated foodborne illness outbreaks have continued.
Raw sprouts present unique food safety problems
because conditions under which they are produced -- growing time, temperature, water
activity, pH (a measure of acidity) and nutrients -- are ideal for the rapid growth of
bacteria. If pathogens are present on or in the seed, these conditions are likely to
encourage proliferation. To counter this risk, the FDA guidance recommends seed
disinfection (with solutions such as calcium hypochlorite) combined with microbial testing
of used irrigation water from each batch or production lot to determine whether the
pathogens Salmonella and E. Coli O157:H7 are present.
FDA will closely monitor the safety of sprouts and
the adoption of prevention practices recommended in the guidance, and will consider
enforcement actions against producers who do not have preventive controls in place.
Although FDA solicits public comments, it is
implementing the guidances immediately because of the seriousness of the public health
hazard associated with sprouts. Written comments on the guidance documents should be
submitted by December 13, 1999, to be considered in the preparation of a revised document,
The comments should be identified as Docket No.
99D-4488 and 99D-4489 and submitted to Docket Management Branch (HFA-305), 5630 Fishers
Lane, Room 1061, Rockville, MD 20852.