New FSA Tools

1

• New FSA Tools
• EIAO Methodology Industry Walkthrough
• December 18, 2008
• Washington, DC
• William K. Shaw, Jr.
• Senior Food Technologist
• Office of Policy and Program Development
• FSIS, USDA

2
Background

• Project began in February 2007
• Team represents members from OPPD, OPHS, OFO,
  OPEER, OOEET, OFDER
• Pilots took place in Philly and Albany Districts
• The HQ working group conducted FSAs in Alameda,
  Albany and Chicago districts.

3
Goals of New FSA Tools

• Build consistency of data in FSA reports
• Structured process flow for FSAs
• Electronic FSA reports in an analyzable format to
  feed into FSIS data infrastructure improvements
• Streamline background data accessibility for
  EIAOs
• Learn plant practices to develop better guidance
  documents and assess current policies
• More user friendly format which would assist
  plants to improve their food safety systems

4
OIG Recommendations

• Implement an action plan with specific milestone
  dates for capturing the results of food safety
  assessments in appropriate configuration that
  allows for further analysis.
• Determine how the results of food safety
  assessments will be used by FSIS in estimating
  establishment risk.

5
OIG Recommendations

• Develop and implement a criteria for prioritizing
  the scheduling of food safety assessments.
• Develop and implement a system to track changes
  at an establishment over time and determine which
  changes would trigger FSIS to conduct a food
  safety assessment at an establishment prior to
  its periodic evaluation.

6
OIG Recommendations

• Develop and implement procedures to ensure
  sufficient, timely follow-up work is performed in
  response to findings in food safety assessments.
• Data is need in an electronic format to satisfy
  these recommendations

7
What is staying the same?

• EIAOs will still conduct FSAs
• FSAs will be comprehensive and most likely even
  more so
• There will be narrative analysis sections
  supporting decisions but more focused

8
The Most Important New Aspects

• The new FSA will capture the data EIAOs now
  collect in order to do their analysis so FSIS can
  do critical overall program analyses to improve
  public health protection
• Pass/Fail vs. A,B,C,D,F Establishments
• Gives FSIS the opportunity to be more proactive
  than reactive
• Potentially reduce recalls and enforcement
  actions by providing valuable information to
  plants about their food safety systems

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ALL DATA BECOMES RELEVANT IN THIS NEW SYSTEM
BOTH REGULATORY AND NON-REGULATORYAll data
contributes to the larger picture of the plants
food safety system
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Data Supports 2 Functions

• Data used to determine adequacy of food safety
  system (compliance or out of compliance)
• Data used to establish a food safety systems
  risk relative to other establishments

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The Sections
12
5100-1

• Replaces 5000-8
• Contains all the information that 5000-8 captures
  but more data
• Parent Corporation
• Reason for FSA
• Pre-filled background data for verification
• Executive Summary

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03 Category Sections

• 03J Slaughter Meat/Poultry
• 03B Raw Ground Meat/Poultry
• 03C Raw Not Ground Meat/Poultry
• 03D Thermally Processed/Commercially Sterile
• 03E Not Heat Treated-Shelf Stable
• 03F Heat Treated-Shelf Stable
• 03G Fully Cooked-Not Shelf Stable
• 03H Heat Treated-Not Fully Cooked-Not Shelf
  Stable
• 03I Product with Secondary Inhibitors-Not Shelf
  Stable

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Additional Sections

• General Sanitation (SPS/SSOP)
• Dual Jurisdiction
• Food Defense

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FSA Prioritized Scheduling

• Federal/State/Local positive E. coli O157H7
  sample in raw non-intact beef or beef intended
  for non-intact
• Federal/State/Local positive LM, Salmonella, E.
  coli O157H7 in RTE product
• Failed PR/HACCP Set
• At least once every 4 years
• New Establishment
• Shipment of SRM

16
FSA Prioritized Scheduling

• Enforcement action (other than from FSA)
• Outbreak Investigation Link
• Establishment supplier of E. coli O157H7
  positive product more than once in 120 days
• Repetitive Salmonella serotypes of human health
  concern and PFGE matches (future)
• Establishment sustains structural damage from
  natural disaster
• Accumulation of public health related NRs

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Additional Criteria

• District directed FSA scheduling based on events
  on the ground
• Inspector generated with FLS concurrence alert to
  case specialist
• HQ Directed