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Public Health Risk Evaluation

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Public Health Risk Evaluation (PHRE)

Background

 A decision-making process utilized to

determine if the District Office (DO) needs

to schedule an FSA or take enforcement

action.

 PHRE is a separate activity from the FSA and

will be completed prior to scheduling the

FSA.

 PHRE’s are an internal FSIS Document and is

NOT shared with the establishment. 2

PHRE/ FSA Scheduling

 Office of Planning, Analysis and Risk Management (OPARM) provides a

prioritized list to DO for scheduling FSAs.

 The list is generated based upon available inspection data:

 Public Health Triggers

 Trends in Noncompliance Records/ Public Health Regulations

 Recalls and Outbreaks

 Production of adulterated product = positive FSIS sample results

 Outbreaks

 Date of last FSA

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PHRE/ FSA Scheduling

• The establishment’s inspection data needs to be assessed.

But it’s only one part of the picture – here’s where you

come in to assess the establishment and make a

recommendation.

• Many establishments are on the PHRE list based on

noncompliance with Public Health Regulations (PHR).

•

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PHRE/ FSA Scheduling

• PHR non-compliance rates are calculated for each

establishment monthly, and IPP will get an Early Warning alert

when rates exceed the cut point.

• Establishments with a PHR NR rate exceeding the cut point will

be included in the proposed “for cause” list.

• The list of PHRs is updated annually. https://www.fsis.usda.gov/sciencedata/scientific-reports/public-health-regulations-phr/fsis-data-analysis-and-reporting-5

• PHR Methodology:

• https://www.fsis.usda.gov/science-data/scientific-reports/public-health-regulationsphr

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PHRE/ FSA Scheduling

 FSIS is actively working to better use data generated from

the tasks to drive inspection decisions.

 The list isn’t the only way the Agency identifies

establishments. Districts may schedule for other reasons

including:

 Recommendations from field personnel

 In response to changes in policy based on new or

emerging public health-based information

 Response to emergency incidents.

o See Directive 5500.3, (Jul 19,2006) Incident

Investigation Team

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The PHRE- Directive 5100.4

 PHRE has two parts:

1. A decision process to determine which action to

take.

2. An Assessment Plan, if an FSA is recommended.

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Part 1 –

PHRE

Decision

Part 2–

Assessment

Plan

Part 1-Decision

 There are three possible decisions based on the PHRE

Part 1 –

PHRE

Decision

 The decisions must be documented in the PHRE tool

1. Enforcement can be taken immediately based on the

establishment’s history

2. An FSA should be performed to address vulnerabilities that

can lead to adulterated or misbranded product

3. No issue at the time

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Part 1-Decision Part 1 –

PHRE

Decision

• Utilizing the PHRE Tool, you will:

• Perform a PHRE review and evaluate relevant data. The tool is

designed to help you gather and access the data gathered from all

parts of the Agency (lab data, inspection data, IPP input).

• Document recommendation

• Conduct FSA (5100.1)

• Do not conduct FSA, but take enforcement action (5100.3)

• Do not conduct FSA, do not take enforcement action (5100.4)

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Part 1-Decision-Data Review

 Performing the PHRE Review

 Evaluate PHIS PHRE Report

 Report generated from PHIS

 Past FSAs

 Enforcement Data

 Compliance History

 PHIS Profile Data

 Weekly Meeting MOIs

 Recall Information

 Sampling Results

 STEPs Information

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Part 1-Decision-Data Review

 Performing the PHRE Review

 Investigate and gather data and other background

information

 Use PHIS to generate the PHRE report

 Testing Data from LIMS Direct

 Consumer Complaints from CCMS

 Previous FSAs not in PHIS

 Additional Enforcement Records (AssuranceNet)

 Whole Genome Sequence

 Discuss compliance with:

 FLS, CSI, DDM

Analyze PHRE Data

1. Analyze and identify any trends in sampling results or in

NRs.

2. Evaluate data looking for:

1. Poor or worsening performance

2. Evidence the establishment is not maintaining process control

3. Insanitary conditions

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Part 1-Decision

 Documenting No Action:

 The third outcome is that there is no action at this time. The

rationale and explanation should also be documented on the

PHRE. Support your decision with documentation from the PHRE.

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Part 2- Assessment Plan

 The PHRE, by design, is the first step needed

to formulate the assessment plan. It is

formulated prior to performing an FSA to

help with planning of the FSA.

 PHRE assists the EIAO develop a plan to:

 Ensure the FSA is thorough

 Well organized

 Promotes timeliness

Part 2–

Assessment Plan

for

FSA 14

Part 2- Assessment Plan Contents

• Apparent Violations

• Statement of possible food safety issues found.

• Should contain relevant Statutes, regulations, etc.

• Scope of FSA

• The extent and range of the FSA such as:

• Tools, regulatory issues, food safety issues or other

issues that will be addressed.

• Steps of assessment:

• Steps to gather facts, findings and evidence to explore

apparent/ possible food safety issues. The plan can

change based on in-plant findings during the FSA.

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Objective Check-Up

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1. What is the overall purpose of the PHRE?

Objective Check-Up

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1. What are the two parts of the PHRE?

Objective Check-Up

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1. When is the PHRE tool to be completed.

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PHRE Work Flow

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PHRE Tool

IMPORTANT NOTE:

THE PHRE IS AN INTERNAL DOCUMENT

AND IS NOT TO BE PROVIDED TO

ESTABLISHMENTS

1. Now let’s look at the PHRE Tool

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PHRE Workshop

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