Environmental Sampling District Activities Nancy Schmidt Compliance Officer U.S. Food & Drug...

Environmental Sampling

District ActivitiesNancy Schmidt

Compliance OfficerU.S. Food & Drug Administration

Office of Regulatory Affairs Denver District Office

AGENDA

• Current emphasis on environmental sampling (ES)• Triggers for District sampling• Sampling process• Post-Sampling communication

Current Emphasis on ES

• Increased emphasis since 2009 in the food arena based on increased association of certain foods with pathogens and foodborne illness

• Environmental sampling as a tool to identify and control pathogens in the plant

Triggers for District Sampling

• Outbreak related to pathogen traced back to a manufacturing/processing site

• CFSAN surveillance assignment (data gathering)

• Inspectional findings-Routes of contamination-Sanitation practices-Facility

Sampling Process• 3 person team

o Aseptic processo Sanitized apparel and equipment,

disposable shoe coverings, etc.o Swabs or sponges

• Assessment of operations and equipmentoMappingo Zone identification

• Firms encouraged to collect “duplicate” samples

Post-Sampling Communication

• Contact after analysis

• Moving forward to resolve concerns― voluntary corrections

THANK YOU FOR YOUR ATTENTION