APPENDIX C
Presentations by Donald Anderson and Matthew Gonzales of FSIS



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APPENDIX C Presentations by Donald Anderson and Matthew Gonzales of FSIS Public Health Risk-Based In-Commerce “Initial” and Follow-up Surveillance Presented to the National Academy of Sciences July 6, 2009 Today’s Topics • Review the “initial surveillance” methodology we are implementing based-- in-part-- on the prior committee’s recommendations • Ask NAS to comment on preliminary ideas for prioritizing follow-up surveillance activities 2 18

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LETTER REPORT 19 In-Commerce System Facility Types - Distributors -Transporters -Warehouses OPEER Investigators -Retailers -Others . ICS Surveillance Tier Initial Surveillance Tier 1. Critical Priority Tier 2. Very Important Priority Tier 3. Important Priority Risk Considerations - Inherent Risk -Consumer Susceptibility -Volume -Food Defense Vulnerability Reports -Jurisdiction Business Types Distributors, 8,262 Transporters, 16,754 Other, 4,275 Warehouses, 23,625 Institutions, 54,621 Retailers, 120,249 Restaurants, 500,000 4

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20 REVIEW OF IN-COMMERCE SURVEILLANCE “Other” Expanded 4-D, 64 Exempt Poultry, 100 Retail Salvage, 162 Custom Slaughter, 170 Renderer, 383 Food Banks, 642 Animal Food, 2,754 5 Tier Results for 13 Business Types Tier 1 (Critical) Tier 2 (Very Important) Tier 3 (Important) y od ge s rs ks s ts rs ns m rs D tr se or 4- an to te re le an va Fo tio ul ut ou or ai us de ur Po B al itu ib et al sp eh C ta en lS od tr m R st pt es an ar is R ai ni Fo In em D W R et Tr A R Ex 6

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LETTER REPORT 21 Previous NAS Review • November 2008 public meeting • March 23 NAS report 7 Risk Considerations • Volume of meat, poultry and egg products handled • Susceptibility to Foodborne Illness of the populations served • Inherent hazards of the products handled and processes engaged in • Food Defense Vulnerability of the operations & • Extent of Surveillance by other Federal, State, or Local authorities 8

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22 REVIEW OF IN-COMMERCE SURVEILLANCE Key NAS Recommendations • Consider a “stepwise” decision process that, in effect, allocates surveillance resources across two tiers instead of three • FSIS should consider absence of surveillance by other jurisdictions to be more important in setting priorities for surveillance than the other risk considerations • Two Flowcharts.ppt 9

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LETTER REPORT 23 Food Safety and Inspection Service (FSIS) Food Methodology for Determining Three Levels of Prioritization for Follow-up Reviews of In- Follow- In- Commerce Businesses Matthew Gonzales FSIS, Office of Program Evaluation, Enforcement and Review (OPEER) In-Commerce Surveillance Activities: Initial and In- Follow-up Surveillance Follow- Methodology outlined in FSIS Directive 8010.1 Methodology • Applicable to both initial surveillance and follow-up follow- Initial Surveillance subject of March 2009 NAS report Initial Businesses chosen for initial surveillance using revised Tier Businesses structure TIER 1 TIER 2 “FOR CAUSE” Transporters Food Banks Institutions Distributors 4-D Retailers Warehouses Retail Salvage Restaurants Renderers Custom Exempt Exempt Poultry Animal Food July 6, 2009 2 July Food Safety and Inpsection Service

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24 REVIEW OF IN-COMMERCE SURVEILLANCE In-Commerce Surveillance Methodology In- Includes activities such as: Includes • Food Safety • Food Defense • Non-Food Safety Consumer Protection Non- • Order Verification • Imported Products Results entered into the In-Commerce System (ICS) In- Results July 6, 2009 3 July Food Safety and Inpsection Service Data is Entered into ICS July 6, 2009 4 July Food Safety and Inpsection Service

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LETTER REPORT 25 Possible Actions Taken in Response to Findings Tier 1 and Tier 2 Follow-up Surveillance Follow- Focus of Next Task Product Control Action Product Initiate Investigation Initiate • Criminal Prosecution • Civil Action • Administrative Action • Recall • Letter of Information • Letter of Warning July 6, 2009 5 July Food Safety and Inpsection Service Possible Actions Taken in Response to Findings “For Cause” Businesses Cause” Initiate Investigation Initiate Follow-up outlined in appropriate surveillance program Follow- • Melamine Testing Significant Incident Response Significant • E. coli O157:H7 Testing Formation of Recall Committee Formation Share information with Federal, State and Local public Share health officials July 6, 2009 6 July Food Safety and Inpsection Service

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26 REVIEW OF IN-COMMERCE SURVEILLANCE DRAFT Risk-Based Initial Surveillance Activities (~ 10% of CID Investigators’ Time) Oversight by Other Regulatory Authorities Minimal Significant Oversight by Oversight by Other Reg. Authorities Other Reg. Authorities Product Volume Inherent Hazard Consumer Susceptibility Food Defense Vulnerability For Cause Tier 2 Tier 1 Surveillance July 6, 2009 7 July Food Safety and Inpsection Service Prioritization of Follow-up Surveillance Follow- at In-Commerce Businesses In- For Cause Tier 2 Tier 1 Surveillance Food Safety Food Safety Finding Finding Product Control Action Product Follow-up as Control Action outlined in Non-Food Safety Consumer appropriate Non-Food Safety Protection Finding surveillance Consumer Protection Food Defense Finding program Finding No Findings Food Defense Finding No Findings High Medium Medium Low Low July 6, 2009 8 July Food Safety and Inpsection Service

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LETTER REPORT 27 Prioritization of Follow-up Surveillance Follow- at In-Commerce Businesses In- Tier Tier 1 Tier 2 Businesses Transporters Food Banks Distributors 4- D Warehouses Retail Salvage Renderers Exempt Poultry Animal Food Initial Surveillance Finding No Findings Low Priority Low Priority Food Defense Finding Medium Priority Low Priority Non-Food Safety Consumer Protection Non- Medium Priority Low Priority Finding Food Safety Finding High Priority Medium Priority Product Control Action High Priority Medium Priority Investigation Initiated As Outlined in FSIS As Outlined in FSIS Directive 8010.2 Directive 8010.2 July 6, 2009 9 July Food Safety and Inpsection Service Food Defense Tier Tier 1 Tier 2 Food Defense Finding Medium Low Priority Priority No regulatory requirements, actions available to FSIS No are limited FSIS has issued guidance to industry FSIS • FSIS Safety and Security Guidelines for the Transportation and Distribution of Meat, Poultry, and Egg Products, June 2005 • FSIS Guide to Developing a Food Defense Plan for Warehouse and Distribution Centers, January 2008 Certain findings would trigger an investigation and/or a Certain significant incident response (e.g. deliberate tampering) July 6, 2009 10 July Food Safety and Inpsection Service

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28 REVIEW OF IN-COMMERCE SURVEILLANCE Non-Food Safety Consumer Protection Non- Tier Tier 1 Tier 2 Non-Food Safety Non- Medium Low Priority Consumer Protection Priority To verify products are not misbranded, economically To adulterated or otherwise unacceptable Not related to food safety Not Certain misbranding can be a food safety concern and Certain would be elevated to a food safety finding Others could trigger an investigation Others July 6, 2009 11 July Food Safety and Inpsection Service Food Safety Tier Tier 1 Tier 2 Food Safety Finding High Priority Medium Priority Includes Includes • Adulteration • Inedible product being diverted to human food • Insanitary conditions • Inadequate hazard controls • Inadequate Recordkeeping Certain findings would trigger an investigation and/or a Certain recall July 6, 2009 12 July Food Safety and Inpsection Service

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LETTER REPORT 29 Product Control Action Tier Tier 1 Tier 2 Product Control Action High Priority Medium Medium Priority Process outlined in FSIS Directive 8410.1, “Detention and Process Seizure” Seizure” Most product control actions result in voluntary action by Most the product owner or custodian, such as voluntary disposal of the product If detained product cannot be disposed of within 20 days, If then FSIS may request an order to seize July 6, 2009 13 July Food Safety and Inpsection Service