1. Environmental Sampling District Activities Nancy Schmidt Compliance Officer U.S. Food & Drug Administration Office of Regulatory Affairs Denver District Office

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

3. 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

4. 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

5. Sampling Process 3 person team o Aseptic process o Sanitized apparel and equipment, disposable shoe coverings, etc. o Swabs or sponges Assessment of operations and equipment o Mapping o Zone identification Firms encouraged to collect “duplicate” samples

21. Post-Sampling Communication Contact after analysis Moving forward to resolve concerns ― voluntary corrections

22. THANK YOU FOR YOUR ATTENTION