http://www.usda.gov/2009/03/0058.xml
VILSACK ISSUES CONDITIONAL LICENSE FOR VACCINE TO REDUCE E. COLI IN FEEDLOT CATTLE
WASHINGTON, March 13, 2009-Agriculture Secretary Tom Vilsack today announced that the U. S. Department of Agriculture has issued a conditional license to Epitopix, LLC, of Willmar, Minn., for a vaccine to reduce the prevalence of E. coli O157 in feedlot cattle.
"Providing the American people with safe and nutritious food is a top priority for President Obama and the U.S. Department of Agriculture," Vilsack said. "The conditional licensing of this vaccine is an important step toward our goal of improving food safety in this country."
E. coli O157:H7 can cause severe illness and death in humans who consume food tainted with the pathogen. A common path for the pathogen to enter the food supply is when muscle tissue becomes contaminated with E. coli from the intestinal tract of cattle during the slaughtering process. Vaccines to reduce the prevalence and shedding of E. coli pathogens in cattle are one component of a wide-range of options to enhance food safety controls. The department will continue to explore solutions with all stakeholders to better control E. coli O157:H7 and other foodborne pathogens to reduce the incidence of foodborne illness.
USDA's Animal and Plant Health Inspection Service (APHIS) granted the conditional license following the acceptance of data supporting product safety and a reasonable expectation of efficacy. The safety data included the results of studies that evaluated the product under normal conditions, including field safety trials of the size and scope required for full licensure. The company will conduct additional potency and efficacy studies during the one-year period of the condition license.
APHIS issues conditional licenses in the event of an emergency situation, limited market or other special circumstance. The special circumstance in this case is the absence of other licensed veterinary biological products for use in reducing the prevalence and shedding of E. coli O157 in cattle.
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