SUMMARY

The National Academies issued a report on initial surveillance of in-commerce businesses by the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS). FSIS requested feedback on its proposed process for priority-setting for followup surveillance in cases in which initial surveillance did not lead to an investigation or enforcement action, and this report is a sequel to the first report. To provide context for the current report, the Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service (FSIS) for Followup Surveillance of In-Commerce Businesses summarized and commented on the response by FSIS to the earlier report. 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. As illustrated in the appendices to this report, the committee’s proposed stepwise decision process for priority-setting for surveillance involved setting two priority levels: high and low (or Tiers 1 and 2). With the exception of retail, institutions, restaurants, and custom exempt, in its draft document, FSIS seems not to have set priorities among business types primarily according to oversight by other regulatory authorities inasmuch as it did not change the business types that it had originally placed in Tier 1. When final decisions are made, FSIS should clearly state which of the initial committee’s recommendations will be adopted and the rationale for the decisions.

FSIS Directive 8010.1, Revision 2, outlines procedures for conducting both initial and followup surveillance of in-commerce businesses. However, the directive contains subjective material, and several elements are unclear. The committee recommends that FSIS modify the directive to increase clarity and definition, to the extent possible, and to include more specific guidance about the differences between initial and followup surveillance, types of findings that should result in followup surveillance, and guidelines for determining the period for completion of followup.

A key component of FSIS surveillance of in-commerce businesses is the development and implementation of a computer database known as the In-Commerce System (ICS), which the committee finds is a useful tool. FSIS should consider carefully the types of data that are recorded in the ICS because these data will be important in deciding whether followup surveillance is needed by FSIS or by state or local authorities. To the extent possible, quantitative, rather than qualitative, information should be recorded. FSIS should also consider developing more objective surveillance forms, such as those used by the Food and Drug Administration. The committee believes that additional data collection is an essential component of both initial and followup surveillance for eventual development of the desired risk-based surveillance system.

FSIS is proposing a framework for priority-setting for followup surveillance. The process—which leads to high, medium, or low rankings for findings in each of two tiers for each initial surveillance finding—has not been clearly stated, and at this point there are no written criteria for defining or distinguishing among the rankings. In addition, it is unclear how the rankings were assigned in each of the two tiers and how different priority levels were assigned to a given finding in each tier. As presented to the committee, the proposed framework is not reproducible.



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SUMMARY The National Academies issued a report on initial surveillance of in-commerce businesses by the U.S. Department of Agriculture Food Safety and Inspection Service (FSIS). FSIS requested feedback on its proposed process for priority-setting for followup surveillance in cases in which initial surveillance did not lead to an investigation or enforcement action, and this report is a sequel to the first report. To provide context for the current report, the Committee for the Review of the Methodology Proposed by the Food Safety and Inspection Service (FSIS) for Followup Surveillance of In-Commerce Businesses summarized and commented on the response by FSIS to the earlier report. 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. As illustrated in the appendices to this report, the committee’s proposed stepwise decision process for priority-setting for surveillance involved setting two priority levels: high and low (or Tiers 1 and 2). With the exception of retail, institutions, restaurants, and custom exempt, in its draft document, FSIS seems not to have set priorities among business types primarily according to oversight by other regulatory authorities inasmuch as it did not change the business types that it had originally placed in Tier 1. When final decisions are made, FSIS should clearly state which of the initial committee’s recommendations will be adopted and the rationale for the decisions. FSIS Directive 8010.1, Revision 2, outlines procedures for conducting both initial and followup surveillance of in-commerce businesses. However, the directive contains subjective material, and several elements are unclear. The committee recommends that FSIS modify the directive to increase clarity and definition, to the extent possible, and to include more specific guidance about the differences between initial and followup surveillance, types of findings that should result in followup surveillance, and guidelines for determining the period for completion of followup. A key component of FSIS surveillance of in-commerce businesses is the development and implementation of a computer database known as the In-Commerce System (ICS), which the committee finds is a useful tool. FSIS should consider carefully the types of data that are recorded in the ICS because these data will be important in deciding whether followup surveillance is needed by FSIS or by state or local authorities. To the extent possible, quantitative, rather than qualitative, information should be recorded. FSIS should also consider developing more objective surveillance forms, such as those used by the Food and Drug Administration. The committee believes that additional data collection is an essential component of both initial and followup surveillance for eventual development of the desired risk-based surveillance system. FSIS is proposing a framework for priority-setting for followup surveillance. The process—which leads to high, medium, or low rankings for findings in each of two tiers for each initial surveillance finding—has not been clearly stated, and at this point there are no written criteria for defining or distinguishing among the rankings. In addition, it is unclear how the rankings were assigned in each of the two tiers and how different priority levels were assigned to a given finding in each tier. As presented to the committee, the proposed framework is not reproducible. 1

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2 REVIEW OF IN-COMMERCE SURVEILLANCE Among the committee’s recommendations is a re-evaluation of organizational procedures and structures within FSIS, with one objective being improvement of use of staff time. Currently, approximately 10% of the time of 120 employees is assigned to in-commerce surveillance. One example is to consider whether it would be more efficient and effective to use 100% of the time of 12 employees. Such a change, if feasible, could enhance training and facilitate collaboration with other jurisdictions. 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. As indicated in the In-Commerce I report, this committee re-emphasizes the need to avoid duplicative and redundant inspection efforts, making sure, however, there is adequate surveillance in all situations.