United States Department of Agriculture Food Safety and Inspection Service. Public Health Information System (PHIS)

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1 Public Health Information System (PHIS) 1

2 PHIS Overview Bill Smith, Assistant Administrator Office of Program Evaluation, Enforcement and Review 2

3 FSIS Inspection and Data Infrastructure Improvements OIG December 2007 audit identified 35 needed improvements to the FSIS data infrastructure. OIG approved FSIS responses to all 35 recommendations. A public health-based, data-driven approach to improving processing and slaughter inspection. The Agency is developing an integrated infrastructure to support a comprehensive, timely and reliable data-driven inspection system. 3

4 OIG Recommendations Develop strong scientific and statistical basis for resource allocation Undertake third party review of Agency programs Prioritize Food Safety Assessments (FSAs) and utilize their findings to inform resource allocation Conduct in-depth review of data systems and develop an integrated data infrastructure Consistently produce data reports to inform decision makers 4

5 PHIS Overview PHIS will automate and replace many of FSIS legacy systems, such as PBIS, RIS and AIIS. It will integrate these separate and disparate systems into one comprehensive data-driven inspection system. It will make results of inspection findings available in real-time. Personnel across the agency will have the tools to make more informed real-time decisions about food safety, food defense and other consumer protections. PHIS will operate through the interaction of 4 components: Domestic inspection, import inspection, export inspection and predictive analytics. 5

6 The Four Components of PHIS 6

7 Domestic Inspection Judith Riggins Deputy Assistant Administrator Office of Field Operations 7

8 Inspection Procedures Basically the same as in the current PBIS system, but with a few changes Inclusion of separate tasks for zero tolerance checks Combining of the HACCP 01 and 02 procedures into HACCP tasks that are more like the current HACCP 02 procedures. 8

9 Inspection Procedures Added procedure called the Hazard Analysis Verification, or HAV, procedure Focus on verifying that the hazard analysis conducted by the plant considered the appropriate hazards when the HACCP plan was developed Instructs inspectors to review the hazard analysis and supporting programs to make determinations about the food safety system as a whole 9

10 Inspection Procedures No additional regulations or requirements have been added on establishments for domestic inspection. 10

11 Documentation of Inspection Procedures Documentation of procedures by the inspector will differ under PHIS: Inspectors will document the specific regulations verified, via a drop down menu, and the findings Inspectors will document additional information for some procedures Inspectors will be able to document a memorandum of interview (MOI) or their notes from meeting with plant management 11

12 PHIS and Import Reinspection Mary Stanley Director, International Policy Division Office of Policy and Program Development Jerry Elliott Director, Import Inspection Division Office of International Affairs 12

13 Import Reinspection Advance Notification of Shipments Electronic certification (ecert) from foreign countries Electronic application by Importer of Record/Broker/Agent Interim solution until interface with ACE/ITDS Enhances Shipment Tracking Alerts when shipments fail-to-present for inspection Automates refused entry disposition decisions and tracking 13

14 Import Reinspection Incorporates all Point of Entry reinspection activities Integrates egg and egg products Automates increased level of inspection Improves targeting appropriate type of inspection to specific products Enables record of inspection results 14

15 Import Reinspection Aligns import and domestic programs Applies same tasks/management for SPS, SSOP, Food Defense Harmonized product classification HACCP process categories; finished product categories Same process for NRs, appeals, MOI, etc. Same process for official import establishment profile Enables OIA use of Resource Management functions 15

16 Import Reinspection Enhanced external communication Direct notification of rejected product to other agencies (e.g. APHIS; CBP) Direct notification to competent authorities in foreign countries Direct communication with Importer of Record/Broker/Agent Foreign Audits: Automates foreign country audit processes Improves linkage between previous audit findings, results at port-of-entry reinspection, and other data used in analysis, planning, and scheduling of foreign country audits 16

17 Export Inspection Rick Harries Director, Export Programs Division Office of International Affairs 17

18 Current Export Certification System Manual Paper-based FSIS inspector verification of requirements Data is not readily available 18

19 PHIS Export Certification System Automates paper based processes , Establishment Approval , Application for Export Certificate , Return of U.S. exported products Ensures certificates reflect importing country requirements Improves use of resources Export certificate application fee proposal 19

20 Export Library in PHIS Automates establishment/product eligibility Export Library Validation Service Automates selection of export certificate statements Provides checklists for requirements that inspectors must verify 20

21 Export Product Lists Provides details about products each establishment exports Used by the Export Library Validation Service (ELVS) Differs from the product category on approved plant lists by: Goes into greater detail than species level Does not specify lists per importing country AMS approves or deny inclusion of product list items in EV programs 21

22 Exporter/Processor Access to PHIS Processors maintain a product list in PHIS which is used by the Export Library Validation Service (ELVS) to determine product eligibility. Exporters can submit export applications: individually through a web-based interface in batches through a computer-to-computer interface. Exporters can manage export applications in PHIS. 22

23 Export Certificates in PHIS Paper certificates printed on security paper USDA/AMS etde (electronic Trade Document Exchange) certificate image ecert developed by UN/CEFACT- certificate data exchange by secure internet protocols. 23

24 e-authorization Bill Smith, Assistant Administrator Office of Program Evaluation, Enforcement and Review 24

25 Electronic Authorization (e-auth) System used by USDA agencies to enable customers to obtain accounts that will allow them to access USDA web applications PHIS Complete an on-line application Local Registration Agents (LRA) to verify application is correct and validate that you are who you say you are Over 14,000 in the US Various forms of identification are acceptable, i.e., passports, government issued ID cards (drivers license) 25

26 Predictive Analytics Dorothy L. Andrews Branch Chief, Field Operation Analysis Branch Office of Data Integration and Food Protection 26

27 What YOU do matters! 27

28 How will Predictive Analytics Support a Data-Driven Approach to Inspections? Domestic Inspection System 28

29 How will Predictive Analytics Support a Data-Driven Approach to Inspections? Import Inspection System 29

30 Real Time Data Mining and Analysis Integrate data streams and provide data reporting and visualization tools PA will also be able to perform real-time data mining and send alerts when irregularities are detected Scheduling rules will be automated to provide quicker response time when reacting to events and performing followup tasks Public health-based prompts to trigger Hazard Analysis Verification (HAV) activities Analysts will be able to carry out spontaneous data analyses using multiple data sources 30

31 PHIS Training Stephanie Wilkins Acting Assistant Administrator, Office of Outreach, Employee Education and Training (OOEET) 31

32 Training approach: PHIS Training Inspectors and supervisors will be trained together Training will have numerous workshops and exercises to reinforce learning Integration of policy and click by click training Throughout, an emphasis on gathering and assessing information, determining compliance/noncompliance, documentation (including MOIs), and enforcement 32

33 PHIS Training Proposed training content: Introduction to PHIS (reasons for PHIS, anticipated public health benefit) Overview of PHIS (Domestic, Export, Import, Predictive Analytics; comparison between PHIS and PBIS) Overview of policy changes (updated directives, tasks, HAV) Click by click in PHIS (by contractor) including a review of Home Page, Plant Profile, Tasks, Task Calendar, Documenting Results Basic Steps of HAV 33

34 PHIS Training Proposed training content (cont d): Hazard analysis exercise (includes a review of the Hazards Control Guide) Verifying the plant s flow chart Verifying the plant s support for Hazard Analysis Verifying the plant s prerequisite programs and control programs related to food safety Review of basic micro principles Exports, eadrs, STEPS, HATS in PHIS 34

35 Training logistics: PHIS Training Training is estimated to take 2 weeks (including travel time) Training evaluation: Pre- and post training will be done as a measure of training effectiveness Outreach to Industry Webinars will be made available for applicants for import and export 35

36 Questions? 36