Answers 10/14/1994 FDA RESPONSE TO SALMONELLA OUTBREAK

T94-49                                         Brad Stone
Oct. 14, 1994                                  (202) 205-4144
   
               FDA RESPONSE TO SALMONELLA OUTBREAK

     FDA has received inquiries concerning recent, numerous
reports of salmonella food poisoning in several areas of the
country, and a subsequent national recall of ice cream products,
except ice cream on a stick items, distributed by Schwan's Sales
Enterprises of Marshall, Minn.  The following information can be
used to answer questions:
     On Oct. 6, FDA was notified by the Minnesota Department of
Health of reports of widespread Salmonella food poisoning
throughout southeastern Minnesota during the previous month. 
Preliminary epidemiological analyses had indicated that these
cases apparently were linked to the consumption of Schwan's ice
cream products.
     FDA immediately began working with Minnesota health
officials, the U.S. Centers for Disease Control and Prevention
and the company on precautionary and corrective measures.  FDA
began laboratory analyses of samples of ice cream collected by
FDA and the state from the homes of affected consumers, and
dispatched investigators to inspect the company's Marshall plant
and collect additional samples that could help confirm the source
of the problem.
     The company has recalled the ice cream products from the
Marshall plant and suspended shipments of new products from that 
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                               Page 2, T94-49, Schwan's Ice Cream
plant until the source of the problem can be identified and
remedied to FDA's satisfaction. 
     The firm made arrangements to have another firm produce ice
cream for them until they can produce ice cream themselves.  This
new product has "plant number 19-114" or "plant number 19-115" on
the label.  
     FDA is continuing its efforts to identify all potential
sources of this problem, and the agency is discussing with
Schwan's what corrective actions are needed before the company
can resume manufacturing and marketing its ice cream from the
Marshall plant.
     The company has agreed to recondition and repasteurize all
existing inventories of ice cream premix, make thorough, multiple
cleanings of its plant and equipment and establish procedures to
ensure that tankers used to transport its ice cream products are
used solely for that purpose.  In addition, the company has
agreed that it will institute rigorous sampling and testing
procedures that will be performed at the beginning of the
production process and again before product lots are released.   
     FDA will ensure that these and other necessary corrective
measures are implemented.  The agency is also monitoring the
company's recall program to ensure that the products in question
are effectively removed from the marketplace.

     To date, the vast majority of cases that have been reported
to the U.S. Centers for Disease Control and Prevention have 
involved people suffering one or two days of the typical symptoms
of the disease -- nausea, vomiting, gastro-intestinal problems,
diarrhea, headaches and fever.  However, Salmonella poisoning can
cause severe illness and even death in infants, the elderly and
individuals with compromised immune systems. 

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