Appendix B
Levels of Inspection

LOI 1 Criteria

LOI 1—Establishment must meet ALL of the criteria below, when applicable:

Establishment has not had a positive Food Safety and Inspection Service (FSIS) Escherichia coli O157:H7 verification result; or if it has, any related Food Safety Assessment (FSA) and follow-up sampling has been completed more than 120 days previously, any related enforcement actions are closed, and establishment meets all other criteria for LOI 1a

Establishment has not had a positive FSIS test result for Listeria monocytogenes in ready-to-eat (RTE) products or a positive L. monocytogenes food contact surface sample; or if it has, any related FSA and follow-up sampling has been completed more than 120 days previously, all related enforcement actions are closed, and establishment meets all other LOI 1 criteriaa

Establishment has not had a positive FSIS test result for Salmonella or E. coli O157:H7 in RTE products; or if it has, any related FSA and follow-up sampling has been completed more than 120 days previously, any related enforcement actions are closed, and establishment meets all other criteria for LOI

Establishment has not shipped adulterated or misbranded product (includes recalls related to human illness); or if it has, any related FSA and follow-up sampling was completed more than 120 days previously, any related enforcement actions are closed, and establishment meets all other criteria for LOI 1



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Appendix B Levels of Inspection LOI 1 Criteria LOI 1—Establishment must meet ALL of the criteria below, when applicable: Establishment has not had a positive Food Safety and Inspection Service (FSIS) Escherichia coli O157:H7 verification result; or if it has, any related Food Safety Assessment (FSA) and follow-up sampling has been completed more than 120 days previously, any related enforcement actions are closed, and establishment meets all other criteria for LOI 1a Establishment has not had a positive FSIS test result for Listeria monocytogenes in ready-to-eat (RTE) products or a positive L. monocytogenes food contact surface sample; or if it has, any related FSA and follow-up sampling has been completed more than 120 days previously, all related enforcement actions are closed, and establishment meets all other LOI 1 criteriaa Establishment has not had a positive FSIS test result for Salmonella or E. coli O157:H7 in RTE products; or if it has, any related FSA and follow-up sampling has been completed more than 120 days previously, any related enforcement actions are closed, and establishment meets all other criteria for LOI Establishment has not shipped adulterated or misbranded product (includes recalls related to human illness); or if it has, any related FSA and follow-up sampling was completed more than 120 days previously, any related enforcement actions are closed, and establishment meets all other criteria for LOI 1 65

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66 APPENDIX B Establishment was below the Salmonella percent positive LOI 1 percentile cut point on most recent sample set, unannounced sampling, or other Salmonella testing programs LOI 1: Establishment has not been cited in the STEPSb database more than once; or if it has, any related FSA and follow-up sampling has been completed more than 120 days previously, any related enforcement actions are closed, and establishment meets all other criteria for LOI 1 Establishment was below the LOI 1 percentile cut point for Salmonella serotypes of human health concern or pulsed field gel electrophoresis (PFGE) matchesc An establishment has not been linked to an outbreak; or if it has, any related FSA and follow-up sampling has been completed more than 120 days previously, any related enforcement actions are closed, and establishment meets all other criteria for LOI 1 An establishment whose public health noncompliance record (NR) rate (over a rolling three-month average) is less than the LOI 1 percentile cut point, when all other indicators suggest the process is in controld a Could be expanded to include other federal, state, local, foreign government, or industry positive samples once data are available and can be analyzed. b System for Tracking E. coli O157:H7 Positive Suppliers. c Future criteria to be implemented when data analysis is complete. d Percentile cut point to be determined via data analysis.

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APPENDIX B 67 LOI 2 Criteria LOI 2—Establishment meets ONE or MORE of the criteria below: Establishment had an FSIS positive test for E. coli O157:H7 in RTE products or ground beef or components, and any related FSA and follow-up sampling has been completed in the previous 120 days and all related enforcement actions are deferred or in abeyance a For an establishment that has had an FSIS positive L. monocytogenes test result in an RTE product or an L. monocytogenes-positive food contact surface sample, any related FSA and follow-up sampling has been completed in the previous 120 days and all related enforcement actions are deferred or in abeyance a For an establishment that has had a positive FSIS test for Salmonella or E. coli O157:H7 in RTE products, any related FSA and follow-up sampling has been completed in the previous 120 days and all related enforcement actions are deferred or in abeyance For an establishment that has shipped adulterated or misbranded product (includes recalls related to human illness), any related FSA and follow- up sampling has been completed in the previous 120 days, and all related enforcement action (e.g., Notice of Intended Enforcement [NOIE]) is deferred or in abeyance Establishment was above the Salmonella percent positive LOI 1 percentile cut point on most recent sample set, unannounced sampling, or other Salmonella testing programs and not in Salmonella Category III For an establishment in the STEPSb database more than once, any related FSA and follow-up sampling has been completed in the previous 120 days, and all related enforcement actions are deferred or in abeyance Establishment was above the LOI 1 percentile cut point for Salmonella serotypes of human health concern or PFGE matchesc For an establishment that was linked to an outbreak, any related FSA and follow-up sampling has been completed in the previous 120 days, and all related enforcement actions are deferred or in abeyance

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68 APPENDIX B An establishment whose public health NR rate (over a rolling three- month average) is greater than the LOI 1 percentile cut point but less than the LOI 3 percentile cut pointd a Could be expanded to include other federal, state, local, foreign government, or industry positive samples once data are available and can be analyzed. b System for Tracking E. coli O157:H7 Positive Suppliers. c Future criteria to be implemented when data analysis is complete. d Percentile cut point to be determined via data analysis.

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APPENDIX B 69 LOI 3 Criteria LOI 3—Establishment must meet ONE or MORE of the criteria below: Establishment has had a FSIS positive test for E. coli O157:H7 in RTE products, or ground beef or componentsa Establishment has had an FSIS positive L. monocytogenes test result in an RTE product or an L. monocytogenes-positive food contact surface samplea Establishment had a FSIS positive test for Salmonella or E. coli O157:H7 in an RTE product Establishment has shipped adulterated or misbranded product or is undergoing enforcement action (e.g., NOIE) that is not the result of an FSA Establishment is in Salmonella Category III Establishment has been in STEPSb database more than once within the previous 120 days Establishment has had repetitive Salmonella serotypes of human health concern or PFGE matchesc Human illness was linked to an FSIS-regulated product from the establishment Establishment has health-related NR rates (over a rolling three-month average) higher than the highest percentile of health-related NR rates (e.g., those citing specified risk material [SRM], insanitary dressing, zero tolerance, residue)d Establishment has sustained structural damage a Could be expanded to include other federal, state, local, foreign government, or industry positive samples once data are available and can be analyzed. b System for Tracking E. coli O157:H7 Positive Suppliers. c Future criteria to be implemented when data analysis is complete. d Percentile cut point to be determined via data analysis.

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Appendix C Acronyms ARS Agricultural Research Service CDC Centers for Disease Control and Prevention CFU colony forming unit EIAO Enforcement Investigations and Analysis Officer FSA Food Safety Assessment FSIS Food Safety and Inspection Service HACCP Hazard Analysis and Critical Control Point HAV hazard assessment verification ICMSF International Commission on Microbiological Specifications for Foods IOM Institute of Medicine IPPS in-plant performance system IVT Intensified Verification Testing LOI level of inspection NACMPI National Advisory Committee on Meat and Poultry Inspection NARMS National Antimicrobial Resistance Monitoring System NOIE Notice of Intended Enforcement NR noncompliance record PCR polymerase chain reaction PFGE pulsed field gel electrophoresis PHRBIS Public Health Risk-Based Inspection System PR/HACCP Pathogen Reduction/Hazard Analysis and Critical Control Point RLm Routine Listeria monocytogenes RTE ready-to-eat SRM specified risk material STEC shiga toxin-producing Escherichia coli 71