1. Targeted Food Safety Assessments Barb Masters OFW Law September 2015

2. Targeted Food Safety Assessments FSIS has created a new work method for FSAs The new work method is designed to focus the FSAs on public health risks and to increase consistency in conducting FSAs The EIAO is now expected to complete the in- plant portion in 5 to 7 production days

3. Other Significant Changes FSAs will be performed after a Public Health Risk Assessment (PHRE) to focus on those establishments considered to be at greatest risk, The EIAO will use information from the PHRE to focus on certain processes during the FSA; Routine Listeria monocytogenes (RLm) sampling will be completed before the FSA; and The EIAO is to focus on assessing and analyzing the food safety system as a whole – not whether individual regulatory requirements are in compliance.

4. How are the Targeted FSAs Scheduled? Monthly - Headquarters provides each District Office a prioritized list of establishments for conducting FSAs.prioritized list  Establishments are prioritized based on several “public health risk” criteria.  information in the establishment’s profile, whether the establishment has been associated with an outbreak, whether it recently produced adulterated product, etc.

5. Prioritized List for PHREs Human Illness linked to product IIT to be conducted Class I/II recall Positive STEC Positive Lm or Salmonella in RTE Sole supplier to positive STEC in ground Est. with more than one STEC positive in 120 days PHR noncompliance history Salmonella Cat 3 Salmonella serotypes of public health concern Repeat Salmonella PFGE RRVL CCMS New establishment Instructed by Agency Est. with post-lethality exposed (and no positives)

6. Public Health Risk Evaluation In the past, the DO would review the list and then schedule the FSAs (unless information at the District suggested not necessary). Now, the list is used to schedule a PHRE. The PHRE is used to determine if a FSA will be conducted. A PHRE may also be scheduled by the District.  response to an emergency incident, Salmonella PFGE matches at an establishment, positive sample results or other DO concerns regarding an establishment.

7. What is the PHRE? A decision making tool to determine whether to conduct a FSA. A Paperwork Review -  The EIAO will review the establishment’s historical data (previous FSA, FSIS test results, enforcement data, compliance history, consumer complaints, PHIS profile information, weekly meeting notes, MOIs, and recall information) and correlate with the inspection program personnel assigned to the establishment.

8. PHRE Outcomes The EIAO will recommend to the District Manager: Conducting a targeted FSA; Taking an enforcement action; or Taking no action.

9. PHRE Summary FSAs will continue to be prioritized based on public health concerns and criteria established by the Agency. Prior to conducting any FSAs, the EIAOs will perform a PHRE to make an initial assessment. The PHRE is an internal only document. If an FSA is conducted, the EIAO will provide the “thought process” verbally to the establishment during the entrance meeting.  If the EIAO determines “no action” necessary, this will not be shared with the establishment.

10. Preparing for an FSA FSIS will provide: 1-2 weeks prior notice before the FSA (unless “for cause”) 1 week prior notice for RLm testing

11. Preparing for an FSA New Tools General Tool (All FSAs) Meat Tool, Poultry Tool, Ready-to-Eat (RTE), Not Ready-to-Eat (NRTE) Tool, and Thermal Processing Tool These tools are available for you to use. Recommend having a team use the General and all applicable tools at a regular frequency to review the programs and facility. Are you confident in program design? Are you consistently implementing? ALWAYS make continuous improvements!

12. Preparing for an FSA The results of the PHRE are used to determine the initial scope of the FSA and which of the FSA tools that will be utilized Typically only one additional tool used (unless findings during the FSA suggest another tool should be used) FSIS will review sanitation. If you make multiple products – where do you have most NRs? Which process area is most at risk? Review records for all – look for missing data, errors, etc.  You can make changes bjm BUT you must include the actual date of the change and initial

13. Preparing for an FSA If the EAIO determines to conduct RLm sampling, this is scheduled prior to the start of the FSA. The EIAO will evaluate previous sites that were positive and also sites based on conditions observed at the establishment What actions have you taken to address previous positive sites (yours, FSIS, other regulatory agencies?) Review the facility ---  Broken welds, moisture under floors, peeling paint, cracked seals around doors, saturated insulation, rusty framework….  FIX IT BEFORE THE VISIT!

14. Preparing for an FSA The EIAO is to evaluate the HACCP system and the food safety system as a whole - not to verify compliance with individual regulatory requirements. The HACCP system is defined to include “the hazard analysis, any supporting documentation including prerequisite programs supporting decisions in the hazard analysis, and all HACCP records.”

15. The FSA Visit An establishment should always correct a noncompliance at the time they are notified.  NOTE – THIS DOES NOT NEGATE THE FINDING! The EIAO will include all of their findings as part of the assessment regardless of any corrections taken. If the FSA results in an enforcement action, the establishment will be able to quickly respond to those findings already corrected. Encourage photographs of the correction and these can then be used as part of the response.

16. Preparing for the FSA The EIAO is to randomly select and review records from 13 production days from the preceding 60 days  Additional records can be reviewed if necessary KNOW WHAT IS IN YOUR RECORDS BEFORE THEY REVIEW! Product 8/22/15 Room Temp Time InitialsVerification Pork 39 2:07pmCDR AKL Beef833:09pmCDRAKL Beef 38 4:05pm CDR AKL

17. Product 8/22/15 Room Temp Time InitialsVerification Pork 39 2:07pmCDR AKL Beef 83 BJM 9/10/15 3:09pmCDRAKL Beef 38 4:05pm CDR AKL A recording chart for the room is attached to show the room temperature on 8/22/15 at approximately 3:10 pm was 38°F, not 83°F as recorded. BJM Preparing for an FSA

18. FSA – General Tool The EIAO will consider the establishment’s ability to comply with Sanitation SOP requirements and any affect this has on the establishment’s ability to support decisions in its hazard analysis or to implement its HACCP plan effectively. Beginning in 2016 the EIAO will verify in-plant (execution) validation requirements.validation requirements

19. FSA – Specific Tools While completing specific tools, e.g., the Meat Tool, the EIAO will verify whether the establishment has any sampling programs.  The EIAO will verify the collection of samples during the FSA.  The EIAO will evaluate the design of the written sampling procedures.  The EIAO is to verify sampling methods used are fit for purpose and performed under validated conditions.verify  The EIAO will review data for trends and review corrective actions.

20. FSA Results The EIAO will utilize the Decision Making section of the General Tool to assist in providing support for the recommendation. The support for the recommendation includes: sampling results, PHRE information, in-plant observations, and HACCP design and implementation findings.

21. FSA Results No further action; Issuance of NRs by the in-plant inspection personnel; Recommendation of a Notice of Intended Enforcement Action (NOIE); or Recommendation of Notice of Suspension (NOS).

22. Preparing for an FSA In conclusion –  FSIS using new tools and techniques to better identify “at risk” plants for FSA  FSIS looking in more detail at specific areas while doing the FSA  YOU can still be prepared by knowing the regulations, ensuring your programs are up to date, implementing your programs – and having the documentation to show that you did so!