Implementation of new FSA procedures in PHIS will be 6-10-15. For FSAs scheduled prior to this date, the EIAO is to record his or her FSA reports using Word versions of the modified tools. Updated tools will be available on the EIAO SharePoint site on 6-1-15.

CHAPTER I – GENERAL

I. PURPOSE

The purpose of this directive is to provide instructions to EIAOs on how to conduct FSAs using a new work methodology, so an EIAO can complete the in-plant portion of most FSAs in 5 to 7 production days. This directive also provides instructions on how to document FSAs using the FSA tools that are a series of questionnaires that an EIAO is to use to gather information. The new work methodology is designed to focus the FSAs on public health risk and to increase consistency in how EIAOs conduct FSAs. For the purposes of this directive, the term “EIAO” also refers to EIAO-trained Public Health Veterinarians (PHVs) when they are conducting EIAO activities. The term “District Office (DO)” includes the District Manager (DM); the Deputy District Manager (DDM); the Supervisory Enforcement, Investigations and Analysis Officer (SEIAO); and the District Case Specialist (DCS).

II. CANCELLATION

FSIS Directive 5100.1, Revision 3, Enforcement, Investigation and Analysis (EIAO) Comprehensive Food Safety Assessment Methodology, 8/23/11

III. SIGNIFICANT CHANGES

1. Establishment of a timeline for the completion of most FSAs from 2 to 4 weeks to 5 to 7 production days;
2. FSAs are to be performed after the EIAO derives results from a Public Health Risk Evaluation (PHRE);
3. The EIAO is to focus on certain processes during the FSA based on the PHRE;
4. Any Routine Listeria monocytogenes (RLm) sampling is to be conducted before the start of an FSA; and
5. The EIAO is to focus on assessing and analyzing the establishment’s food safety system as a whole and is not to only verify whether individual regulatory requirements are in compliance.

IV. BACKGROUND

A. The EIAO is to perform a risk-based, targeted review of establishment food safety systems through the FSA.

B. FSIS has revised the FSA methodology to more effectively utilize resources, so that the in-plant portion of most FSAs can be completed within a 5 to 7 production day timeframe.

C. As a result of these changes, this new methodology will result in more FSAs being routinely performed at establishments that represent the greatest risk.

CHAPTER II – FSA I.

FSA METHODOLOGY OVERVIEW

A. FSAs are performed when the DO determines that one is appropriate based on its analysis of the PHRE, described in FSIS Directive 5100.4, Enforcement Investigations and Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE) Methodology.

B. The purpose of an FSA is to assess and analyze an establishment’s food safety system to verify that the establishment is able to produce safe and wholesome meat or poultry products in accordance with FSIS statutory and regulatory requirements.

C. The EIAO is to use FSA tools (General Tool, Meat Tool, Poultry Tool, Ready-to-Eat (RTE) and Not Ready-to-Eat (NRTE) Tool, and Thermal Processing Tool) within the Public Health Information System (PHIS) (PHIS User Guides are available on the PHIS Intranet site) to record findings and to determine whether:

1. The HACCP system is designed to prevent, reduce, or eliminate the hazards identified in the hazard analysis;
2. The establishment’s decisions in its hazard analysis are appropriately supported, including by the establishment’s validation documents; and
3. The establishment’s sampling and testing programs are designed appropriately and performed under validated conditions, and that the establishment reacts appropriately to sampling results.

D. The purpose of the FSA tools (in PHIS) is to provide the EIAO with a structured framework for conducting the FSA. The EIAO is to analyze the answers to the questions in the tools to reach a logical and supportable recommendation that no action is necessary, that the in-plant team is to issue noncompliance records (NRs), that the DO is to issue a Notice of Intended Enforcement (NOIE) with or without NRs, or that the DO is to issue a Notice of Suspension (NOS). The EIAO is to document his or her findings by responding to the questions in the new FSA tools.

E. In responding to questions in the tools, the EIAO is to focus on documenting vulnerabilities and noncompliance, not making positive editorial findings. In particular, he or she is to summarize the findings that bear most directly on the recommendation that he or she is making at the end of each individual tool with respect to what action, if any, is necessary with respect to the establishment’s HACCP system. The EIAO is to use the decision-making analysis section of the general tool to provide an analysis of the background, applicable sample results, and the observations made throughout the FSA to support the recommendation. The EIAO is to provide a recommendation that is supported by FSIS statutory and regulatory requirements (i.e., the Acts and 9 CFR). The EIAO is to summarize the analysis in an Executive Summary.

F. The EIAO Process Overview and FSA workflow diagrams shown below in Figures 1 and 2 provide a visual depiction of the FSA process, including the performance of FSAs that are part of Incident Investigation Team Reviews (IITs), as described in FSIS Directive 5500.3, Incident Investigation Team Assessment. The EIAO is to follow the work method flow diagrams shown below as he or she navigates this directive.

• See full PDF for Figure 1 Table: EIAO Process Overview
• See full PDF for Figure 2Table: FSA Scheduling Work Flow 

See full PDF for Additional Chapters

• PREPARATION IN ADVANCE OF THE FSA
• ESTABLISHMENT ARRIVAL, ENTRANCE MEETING, and ON-GOING COMMUNICATION
• OVERVIEW OF PERFORMING THE FSA
• SPECIFIC ACTIVITIES AN EIAO IS TO PERFORM DURING THE FSA
• RECOMMENDATIONS, EXECUTIVE SUMMARY, NONCOMPLIANCE, AND REVIEW PROCESS
• EXIT CONFERENCE
• DATA ANALYSIS AND QUESTIONS

See full PDF for Attachment 

• Attachment 1. SUGGESTED FOOD CONTACT SURFACE SITES

Related Information:

• Food Safety Assessment Tools
• Public Health Risk Evaluation (PHRE) and Food Safety Assessment (FSA) Methodology at Egg Products Plants (PDF Only)