WASHINGTON – The US General Accountability Office (GAO) recommended the US Department of Agriculture give more specific guidance on license approval requirements for vaccines that could reduce E. coli in cattle before slaughter.
In the agency's report on pre-slaughter interventions aimed at reducing E. coli in cattle, the GAO noted that few manufacturers had submitted applications for pre-slaughter intervention products that target STEC, with the exception being vaccines to reduce O157:H7. USDA oversees licensing and regulation of STEC vaccines. However, USDA's general guidance does not address the challenges animal health companies face when seeking STEC vaccine approval.
For example, under USDA guidance it is unclear about when the agency requires the use of laboratory or field studies to demonstrate efficacy for vaccine license applications.
"Without guidance that gives manufacturers clear and more specific information they need to submit for an acceptable application, the approval process for STEC vaccines could face potential delays," the report stated.
Also, USDA has tests for six other STEC strains that they determined were adulterants in raw ground beef and beef trim. However, confirming positive results may be difficult and time-consuming because certain test components are unavailable commercially for all strains or do not always give clear results, GAO said.
The GAO said some European countries have practices that could be relevant to US efforts to reduce STEC in cattle. For example:
• The European Parliament and the Council of the European Union require certain measures, such as verification of cleanliness by an inspector, to ensure that the cattle going to slaughter are clean. In contrast, USDA assesses the health of cattle but does not inspect for cleanliness.
• At least 12 European Union member countries collected and reported data on STEC in live cattle in 2009. USDA has conducted STEC testing in live cattle, but has not tested since 1999.
• When a person becomes ill from E. coli in Sweden, government officials try to determine the specific farm that sold the contaminated cattle so that other carcasses from the farm can be tested for STEC. USDA does not trace the STEC source back to the farm.
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