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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INTRODUCTION
INTRODUCTION
Pages 3-15
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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 removed four business types -- institutions, retailers, restaurants, and custom exempt -- from the 10% time available for surveillance because the agency believes that they receive significant oversight by other regulatory authorities. The I-C II committee does not believe that the revised FSIS decision process adequately uses the "oversight by other regulatory authorities" risk consideration to rank businesses.
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In-commerce surveillance involves, but is not limited to, activities and observations related to 1. Food safety–CID investigators should verify that meat, poultry, and egg products (hereinafter referred to as products)
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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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Furthermore, some state and local jurisdictions have been unable to perform required food inspections.10 Consequently, it is important for FSIS to develop increased communication and data-sharing with state and local regulatory agencies to improve its understanding of their surveillance activities and to ensure that data collected at the state and local levels can be used. State and local surveillance or inspection capacities should be assessed periodically.
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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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Continue to explore cooperative arrangements with other regulatory agencies to provide assistance in both initial and followup surveillance. If followup surveillance is needed, it may be more efficient and effective for CID investigators to contact federal, state, or local agencies to take over the activity with or without CID involvement.
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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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