Food Safety and Inspection Service ~~ Update ~~
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1 ~~ Update ~~ Farm-To-Fork Continuum 7 th Annual OutbreakNet Conference PulseNet and OutbreakNet: Evolving Connectivity in Food Safety Kristin G. Holt, D.V.M., M.P.H. FSIS Liaison to CDC September 21, 2011 Protecting Public Health through Food Safety and Food Defense
2 FSIS brief overview Presentation Outline FSIS Primary prevention PR/HACCP L. monocytogenes in Ready-to-Eat products Non-O157 STEC policy development FSIS Secondary prevention Consumer outreach Foodborne illness investigations
3 FSIS Mission The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. Protecting Public Health through Food Safety and Food Defense
4 FSIS Workforce ~ 10,000 total personnel - of that number 7,500 are inspection and veterinary personnel The largest single employer of veterinarians 6,100 plants have FSIS personnel present in them every day, as required by Acts Oversee 100 billion pounds of food - about 40% of all domestic food production
5 FSIS Laboratory System Laboratories accredited under ISO In calendar year 2010, FSIS personnel analyzed For presence of E. coli O157:H7 12,550 raw ground beef samples 3,331 raw beef trim and components samples For presence of Salmonella 29,734 raw product samples 1,517 pasteurized egg products samples For presence of Listeria monocytogenes 11,854 ready-to-eat product samples PulseNet member Food Emergency Response Network Network of 157 local, state, and federal food-testing labs Jointly directed by the FSIS and FDA Testing for threat/select agents (chemical, biological, radiological) 5
6 FSIS Organizational Structure
7 Food Safety People and Priorities Secretary of Agriculture Tom Vilsack: There is no more fundamental function of government than protecting consumers from harm. USDA and our partners are working together, more than ever before, to improve and modernize the food safety system based on prevention. Dr. Elisabeth Hagen is sworn in to her new position as Under Secretary for Food Safety, August 20, 2010 Under Secretary for Food Safety Elisabeth Hagen, M.D. 1) Prevention - prevent foodborne illness 2) Tools - have the right tools and data to do the job 3) People - remember the people we are here to protect and empower our people to do the best job possible
8 Primary prevention The Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule Listeria monocytogenes and ready-to-eat (RTE) meat and poultry Non-O157 STEC policy development
9 The Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule Published in July 1996 Moved FSIS toward a preventive, science-based inspection system Empowered the industry to look for and address food safety hazards Sanitation Standard Operating Procedures (SSOP) Pathogen reduction held to performance standards HACCP plan(s) Required that government verify industry s efforts to reduce food safety hazards Food safety and food defense verification procedures daily
10 FSIS Public Health Information System (PHIS) Enhanced FSIS data warehouse 2011 launch Integrate FSIS separate and disparate data systems into one comprehensive data-driven, easy-to-use data-analytics system Powerful decision-making tool that will enable FSIS to protect public health more efficiently, effectively and rapidly On-going efforts to incorporate data along the farm-to-table continuum human data into a predictive analytics module
11 Performance Standards for Young Chicken and Turkey Slaughter Establishments Tougher performance standards for Salmonella New performance standards for Campylobacter Effective starting with FSIS July 2011 verification sample sets Sample set criteria for Salmonella Young chickens 5/51 samples positive Performance standard: original 20%, current 7.5% Turkeys 4/56 positive Performance standard for Campylobacter Young chickens 10.4% Turkeys 0.79% Sample set criteria for Campylobacter Young chickens 8/51 samples positive Turkeys 3/56 positive
12 Performance Standards for Young Chicken and Turkey Slaughter Establishments Establishments that fail to meet our new standards will have their names published and undergo a more intensified inspection by FSIS. FSIS estimates these new standards will prevent a total of about 25,000 illnesses each year. FRN posted at:
13 FSIS Application of Public Health Model Assurance Assessment (Reassessment) Quantitative risk assessments Other scientific assessments Evaluation Policy Development Food data Human data Animal data Environmental data Consumer practices
14 FSIS Regulatory Testing for Lm in RTE Products by Calendar Year (All Years All Random/Risk-based Projects) 5.0% 4.5% 4.61% 4.0% 4.03% Percen nt Positive 3.5% 3.0% 2.5% 2.0% 3.61% 3.44% 2.90% 3.02% 2.91% 2.25% 2.54% 1.91% 1.5% 1.45% 1.32% 1.0% 0.5% 1.03% 0.76% 0.55% 0.64% 0.61% 0.43% 0.42% 0.38% 0.0% Calendar Year
15 Listeria monocytogenes - Attribution Lm prevalence and Lm levels are higher for in store packaged than for manufacturer packaged RTE food Gombas et al., 2003 NAFSS, 2008 > 80% of all listeriosis cases attributed to deli meat are from deli meat sliced and packaged at retail Endrikat et al., 2010 Assessment (Reassessment) Quantitative risk assessments Other scientific assessments Food data Human data Animal data Environmental data Consumer practices
16 Interagency Listeria monocytogenes in Retail Risk Assessment New risk assessment - initiated in 2009 Multi-agency risk assessment - FSIS, FDA, and CDC Collaborators - ARS, UMD, VA Tech, Cornell, EHS-Net Stakeholder participation early in the process and call for additional data on cross-contamination at retail Focus: FDA & FSIS regulated RTE foods Foods that are sliced, prepared and/or packaged in the retail deli environment and consumed in the home (e.g., deli meats, cheeses, deli type salads)
17 Lm in retail Risk Assessment - Data Collection Considerations
18 Six additional STEC - adulterants in non-intact raw beef STEC O26, O45, O103, O111, O121, and O145 Raw, non-intact beef products (e.g., ground beef, hamburger, beef patty products, tenderized steaks) Raw intact components used to manufacture these products (e.g., manufacturing trim) Adulteration within the meaning of 21 U.S.C. 601(m)(1) Unhealthful and unwholesome under 21 U.S.C. 601(m)(3) Federal Register, September 20, sis.usda.gov/oppde/rdad/frpubs/ htm
19 Six additional STEC - adulterants in non-intact raw beef next steps Launch testing program March 5, 2012 Test raw intact components used to manufacture raw, ground beef Testing is in support of FSIS in-plant verification procedures Test ground beef at a later date Survey by FSIS personnel to capture how establishments are addressing STEC Conduct nationwide microbiological baseline survey Review comments to federal register notice 60 day period Review comments to guidance validating commercial test kits Conduct outreach to small and very small establishments
20 FSIS brief overview Presentation Outline FSIS Primary prevention PR/HACCP L. monocytogenes in Ready-to-Eat products Non-O157 STEC policy development FSIS Secondary prevention Consumer outreach Foodborne illness investigations
21 Initiatives Targeting Consumers Food Safe Families In June 2011 USDA, FDA, CDC, and the Ad Council debuted Food Safe Families, the first joint public service campaign to help families prevent foodborne illnesses in the home Links to the video ads are on This campaign used simple messaging, humor, TV air time, and YouTube to remind Americans to clean kitchen surfaces, utensils, hands while preparing food, separate raw meats from other foods by using different cutting boards, cook foods to the correct temperatures, and chill raw and prepared foods promptly. Ask Karen - FSIS 24/7 virtual food safety advisor Launch of smart phone app m.askkaren.gov En Español
22 Alerting consumers during foodborne illness investigations
23 FSIS - Foodborne Illness Investigations (FY10) 25 foodborne illness investigations possibly associated with FSIS-regulated products STEC: O157:H7-8, O157:NM - 1, O26-1 Salmonella - 11, L. monocytogenes - 3, C. perfringens food recalls Multiple investigations involving multiple agencies 12/2009 Multistate Salmonella Montevideo Cluster Ready-To-Eat Italian Sausage Recall 06/2010 Multistate Salmonella Chester Cluster Cheesy Chicken and Rice Frozen Meals Recall
24 CDC-FDA-FSIS Outbreak Investigation Team Orientation Sessions Objective - gain a better understanding of each federal agency and its outbreak response procedures and build relationships to facilitate teamwork Goal improved communication and collaboration during investigations resulting in more successful investigations Participants epidemiologists, investigative and regulatory personnel, and liaisons CDC session - November 2010 FSIS session - Late January early February 2011 FDA session May 2011
25 Chain of custody FSIS Directive 10,000.1 guides FSIS personnel in the evaluation of lab results from non-fsis labs, defined as State and local government laboratories, academic laboratories, and private sector laboratories. Follows a sample through a continuum starting with how the sample was stored and handled prior to collection, how the chain od custody was maintained, through lab result Directive 10,000.1 is referenced in the investigations directive (8080.3). (
26 FSIS Directive 10, section V. Decision Criteria for Accepted NON-FSIS Laboratory Results A. To decide whether to rely on non-fsis laboratory results, FSIS will consider the following questions: 1. Was the sample handled and stored properly prior to collection? 2. Did the party responsible for the sample collection maintain the sample s identity and integrity properly (e.g., through handling and storage) before submitting for testing? Did the party responsible for the sample properly ship it to the laboratory? FSIS will determine whether and how those responsible for maintaining the identity and integrity of the sample did so (e.g., there was an appropriate chain of custody, the sample was not subject to temperature abuse). 3. Did the non-fsis laboratory use a methodology appropriate for the analysis in question? 4. Did the non-fsis laboratory ensure that the results of its analysis are reliable and accurate?
27 Sample collection - caveats Appreciate efforts to collect and test products during outbreak investigations Feel free to call and ask about standards we are looking at regarding sample identity, integrity, and lab methods Backdrop is decisions can be based on lab results with regulatory actions that follow
28 Foodborne Illness Investigations FSIS needs: Continued success of FoodCORE Data shared as close to real-time as possible Chain of custody maintained Alerting state officials Move implication of food vehicle up on the timeline Your needs: Please share them with us
29 Thank you!
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