Newsworthy Nuggets FSIS FERN Surveillance. Kristi McCallum APHL Annual Meeting June 8, 2016
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1 Newsworthy Nuggets FSIS FERN Surveillance Kristi McCallum APHL Annual Meeting June 8, 2016
2 Background The CDA-BCL has been a USDA FSIS FERN CAP laboratory since 2008 Focused on method development and method validation for detection of bio-threat agents in foods
3 What is FERN?
4 Surveillance Program Design What are you sampling (commodity selection) and analyzing for (agent) Why are you sampling (risk assessment, purpose) Where are you sampling (type of facility, area, etc.) How are you sampling, transporting, testing (resources)
5 FSIS FERN Surveillance The CDA-BCL analyzed 20 FSIS regulated products each month for the grant year FY2014/2015 for a total of 220 samples Staph enterotoxins Salmonella spp. Analyzed four commodity groups per month/five samples from each Deli meat products (sandwich meats, hot dogs) Breaded chicken products (raw and cooked) Deli salads/sandwiches (meat) RTE meats (jerky, salami, pepperoni)
6 FSIS FERN Surveillance Commodities chosen were high-risk and/or RTE Analytes chosen were based on Discussions with public health Agent FERN s mission Lack of data for test performance with certain commodities (matrix performance with assay)
7 Sampling Sample Area 4 Sample Area 8 Sample Area 7 Sample Area 1 Sample Area 6 Sample Area 5 Sample Area 2 Sample Area 3
8 Logistics Retail supermarkets in highly populated areas chosen Samples purchased Wide variety of brands, lot codes, selection not targeted to any brand type Chain of custody a MUST! Transported directly to lab in coolers
9 Methodology FSIS FERN Salmonella qpcr chosen for screening to determine performance of method with wide variety of meat matrices Cultural/Isolation method used official methods AOAC validated method chosen for SE based on previous method comparison studies done at CDA-BCL Be careful when choosing methods make sure they are solid solid aka 70s slang for cool, awesome, trustworthy In other words, validated/verified
10 Timeline of Events 10/14/14 Samples collected at retail grocery store 10/15/14 Samples extracted and analyzed on VIDAS SET2. Sample identified as Positive for SE 10/15/14 Sample tested for SEB using FERN MIC /15/14 Notified FERN and CDPHE of positive sample. CDPHE notified USDA FSIS This was elevated very quickly!
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12 And then 8 months later 6/24/15 Samples collected at retail grocery store 6/25/15 Samples extracted and analyzed on VIDAS SET2. Sample identified as Positive for SE. Sample also tested positive for Salmonella. Notified FERN NPO immediately 6/30/15 Salmonella isolated and confirmed from test sample. Sent to FDA Denver District Lab for serology and PFGE PFGE on Salmonella isolate matched the outbreak strain of Salmonella enteritidis to Aspen Foods products, according to the USDA Food Safety and Inspection Service
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14 Why is this so serious? Enterotoxins are not inactivated by heat (i.e., cooking process) This was a breaded raw chicken product Potential for other pathogens to be present if product is not cooked properly (Salmonella enteritidis also isolated) CDC Select Agent list Who consumes the most chicken nuggets? CHILDREN
15 Outcome 31,689 lbs of chicken products recalled by manufacturer in October 2014 and 20,232 lbs of gluten-free chicken products recalled by manufacturer in July 2015 Photo courtesy
16 Lessons Learned What is important if doing a surveillance program in your agency Have a plan in place of who to contact and have all of the pertinent information ready Make sure you follow the chain-of-command for reporting and be ready for the onslaught of questions and conference calls that follow. Make sure your lab has validated or verified the test method(s) to show it is fit-for-purpose in your lab (this was asked) Have all information about the product, sampling, handling, testing and quality control Chain-of-custody records, sampling, lab storage prior to analysis Lot numbers, dates, product info, photos, etc. Test method used, dates ran, method verification data SOPs and supporting QA/QC documentation Complete and accurate data packet with proper data review following your QA procedures The manufacturer wanted to know and asked if our lab was ISO17025 accredited This was a success story of how accreditation benefitted our laboratory greatly Do not target specific brand names and remember that it is a surveillance program intended to provide useful data to regulatory agencies and other food safety related agencies
17 Thank You! Kristi McCallum Assistant Laboratory Manager Colorado Department of Agriculture Inspection & Consumer Services Division Biochemistry Laboratory
18 Acknowledgements The CDA-BCL would like to thank the following agencies for their continued support and partnership APHL USDA FSIS FERN USDA FSIS FDA Denver District Laboratories
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