Review of the Methodology Proposed by the Food Safety and Inspection Service for Followup Surveillance of In-Commerce Businesses A Letter Report (2009) / Chapter Skim
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Gonzales: At the request of the Food Safety and Inspection Service (FSIS) , the National Academies' Division on Earth and Life Studies established the ad hoc Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service for Followup Surveillance of In-Commerce Businesses.
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FSIS agreed that whether there is oversight by other authorities should be the primary risk consideration and that product volume, inherent hazard, consumer susceptibility, and food-defense vulnerability should be used as secondary risk considerations. FSIS, however, seems to have given equal weight to all secondary risk considerations instead of assigning relative importance to them.
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Finally, it is unclear how FSIS plans to determine the relative proportions of investigators' time that would be spent on initial surveillance and followup surveillance and how priorities would be set for the two activities on a regular basis. That is a key element of in-commerce surveillance, but it was not part of the task assigned to the committee.
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About 90% of CID investigators' time is allocated to emergency responses, outbreak investigations, product recalls, and withdrawal activities; these activities merit higher priority because of their immediate and critical public-health importance. FSIS provides instructions to its compliance officers on how to conduct in-commerce surveillance activities.1 The activities are carried out at in-commerce locations to verify that firms whose businesses involve FSIS-regulated products prepare, store, transport, sell, or offer for sale or transportation such products in compliance with FSIS statutory and regulatory requirements.
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The agenda for the open session in which the task was presented to the committee is given as Appendix B, and copies of the PowerPoint presentations by FSIS staff members to the I-C II committee, showing their proposed approach for followup activities, are in Appendix C Box 1 Specific Request from FSIS FSIS is requesting that the National Academies convene a committee to provide feedback on FSIS' proposed guidance to its Investigators concerning the prioritization of followup surveillance reviews in cases where initial surveillance did not rise to the level of an investigation or enforcement action.
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The I-C I committee also recommended that the CID use an initial period of activity of at least 1 year to collect data, develop collaborations with other jurisdictions, and benchmark where surveillance activities should take place before establishing a specific allocation of time for these activities so that risk ranking may be modified appropriately as specific knowledge and data became available. Food Safety and Inspection Service Response to the Report of the In-Commerce I Committee As illustrated in its draft revision of the I-C I committee's stepwise decision process diagram (Appendix E)
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FSIS, however, seems to have given equal weight to each of the four secondary risk considerations instead of assigning relative importance to them as recommended by the I-C I committee. The I-C I committee's proposed stepwise decision process involved setting two priority levels for FSIS surveillance: high and low.
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OVERVIEW OF FOOD SAFETY AND INSPECTION SERVICE METHODOLOGY FOR IN-COMMERCE SURVEILLANCE (BOTH INITIAL AND FOLLOWUP) FSIS Directive 8010.1, Revision 2, outlines (but does not specifically define)
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are based on the type of establishment and the tier in the ICS; whether the business in question is operating under compliance; surveillance review findings; apparent violations of the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act; whether an investigator initiated a product-control action; and the history of the business's compliance. According to FSIS Directive 8010.1 Revision 2, "Generally, Investigators conduct followup surveillance reviews, when necessary, within a period of 3-, 6- or 12-months." Therefore, according to the directive (8010.1 Revision 2)
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As indicated, a key feature of this important and useful ICS is that it will generate reminders to investigators to conduct followup surveillance and that investigators are instructed to complete the activity within 3 months of the reminder. FOOD SAFETY AND INSPECTION SERVICE PROPOSED FRAMEWORK FOR PRIORITY-SETTING FOR FOLLOWUP SURVEILLANCE OF IN-COMMERCE BUSINESSES In a PowerPoint presentation to the committee, FSIS staff identified five potential findings determined during initial surveillance of in-commerce businesses -- no findings, fooddefense–related deficiencies, non–food-safety consumer-protection issues, food-safety problems, and product-control action needed.
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COMMITTEE RESPONSE TO METHODOLOGY PROPOSED BY THE FOOD SAFETY AND INSPECTION SERVICE FOR FOLLOWUP SURVEILLANCE The proposal that FSIS gave the committee in PowerPoint presentations on July 6, 2009 (Appendix C) seemed incomplete and appeared to lack important information about prioritysetting for followup surveillance, and this limited the committee's capacity to comment on its merits.
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The committee reminds FSIS that not all state and local regulatory agencies have the same resources; the type and extent of surveillance often varies within and between states. State and local resources for food-safety inspections and compliance activities are often subject to budgetary cuts,9 which affect their ability to conduct food safety activities.
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Findings 1. The committee determined that FSIS agreed with the In-Commerce I committee's recommendation that oversight by other regulatory authorities should be the primary risk consideration in determining surveillance activities.
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8. No followup of initial surveillance conducted during for-cause visits is identified; the committee assumes that priority-setting for such followup would follow the same scheme as in Table 1.
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Based on surveillance objectives, type of business, and the risk considerations used by FSIS in determining surveillance priorities, consider carefully the types of data that need to be captured during surveillance and recorded in the ICS because these data will be important in deciding whether to follow up with a second visit or more and will be used to validate and evaluate the impact of surveillance activities in the long run. To the extent possible, quantitative, rather than qualitative, information should be recorded.
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Employees dedicated full-time to surveillance activities could be trained to understand the high-priority businesses where they are most needed. That could facilitate collaboration with other jurisdictions.
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The committee will review and comment on the assumptions, risk factors, and methodology FSIS proposes to use to prioritize followup surveillance at in-commerce business with prior surveillance history. The committee will also review and comment on the agency's proposal for determinants that would indicate the need for followup surveillance and review and comment on the proposed frequency of followup surveillance activities.
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2:00 p.m. FSIS Presentations Donald Anderson and Matthew Gonzales (Office of Program Evaluation, Enforcement and Review, Food Safety Inspection Service, USDA)
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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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Important Priority Risk Considerations - Inherent Risk -Consumer Susceptibility -Volume -Food Defense Vulnerability Reports -Jurisdiction Business Types Transporters, Distributors, 8,262 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 Exempt Poultry, 100 4-D, 64 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)
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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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