1. U.S. Department of Health and Human Services Enhancing Public Health and Safety: Food Safety Import and the Shared Establishment Data Service Gary Washington Food Safety Work Group Lead February 7, 2008

2. Discussion Topics Federal Health Architecture Overview Food Safety Work Group Shared Establishment Data Service Next Steps 1

3. Managed by Dept. of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC) Vision: A federal health IT environment that is interoperable with the private sector and supports the President’s Plan, enabling better care, increased efficiency, and improved population health. Federal Health Architecture: OMB Line of Business Initiative 2

4. Food Safety Work Group 3

5. Participating Food Safety Agencies Department of Agriculture –Agricultural Marketing Service* –Animal and Plant Health Inspection Service* –Food Safety and Inspection Service* Department of Commerce –National Oceanic and Atmospheric Administration, National Marine Fisheries Service* Department of Defense –U.S. Army Veterinary Service Department of Health and Human Services –Food and Drug Administration* Department of Homeland Security –Customs and Border Protection* (CBP) Environmental Protection Agency *Involved with import process 4

6. Food Safety Conceptual Overview Legislation, Regulations, Public Health Policies Producer Food Product ► Domestic Food ► Imported Food ► Exported Food Food Processing and Packaging Consumer Transport ► Domestic Private ► Domestic Public ► Export/ Foreign Consumer Government Recalls Labs Research Technical Guidance & Education Monitoring/ Surveillance Threat/Risk Management Inspection/ Enforcement Food Facilities ► Federal (Civil and Defense) ► State and Local ►Foreign Initial Focus Prevention of environmental, accidental and/or intentional contamination of food 5

7. Agencies Collaborated To Develop Food Safety Import Solutions “As-Is” Architecture “To-Be” or Target Architecture Gap Analysis “Transition Approach” Reviewed food safety agencies’ import processes, data, services, and technology Developed baseline products Conducted analysis examining commonalities, differences, and gaps in agency import baseline products Identified opportunities and potential target solutions Developed target architecture products Developed transition approach to move from baseline to target 6

8. Accomplishments First FHA integrated, multi-agency target architecture 31 target solutions to close gaps/risks to public health Multi-agency shared service to better identify establishments (SEDS) New electronic information exchanges between agencies for improved collaboration First FHA products in Federal Transition Framework (FTF) FSWG 7

9. Key Benefits Public health and safety –Provides better visibility/information on potential high-risk products through integrated process –Improves public health outcomes from defined handoffs and shared information –Stops sub-standard and illegal products overseas or at border from earlier identification of issues Food supply security –Reduces opportunities to bypass inspections –Highlights problem importers from shared violations –Enhances decision making through shared data Resource savings and efficiencies –Reduces physical inspections through more robust entity verification and violation sharing –Optimizes resource planning by providing more complete information to agencies, earlier –Leverages inter-agency resources for sampling saving personnel and travel costs 8

10. Food Safety Import and International Trade Data System Program Agency ITDS Plans Agency ITDS CONOPS & Requirements 26 of 31 FS Import Solutions dependent on ITDS and ACE development Automated Commercial Environment (ACE) Submit International Trade Data System (ITDS) Program Food Safety (FS) Import Target Architecture Solutions Incorporate 9

11. Shared Establishment Data Service 10

12. What is SEDS? Target solution conceived by the FHA FSWG Purpose –Create centralized service to provide accurate information on and verify establishments involved in the import supply chain –Provide unique, standard identifier (ID) for establishments –Capture minimal set of establishment violation data from import transactions at central source Key Elements –Standard ID for establishments –Establishment verification performed by commercial service –Shared establishment violation data Establishment: place of business involved in import supply chain (e.g., manufacturer, grower, shipper, importer, etc.) 11

13. SEDS Concept of Operations 12

14. Why SEDS? ― Challenges 13

15. Funding Approach for SEDS Requesting funding from ITDS Program to: –Build ACE-related SEDS components –Procure/integrate commercial service –Note: Currently, ITDS funding does not include maintenance Participating agencies provide funding to: –Modify infrastructure to use SEDS –Clean up data –Obtain any needed licenses Commercial service –Possibly pursue as government-wide license –Will have to determine allocation of costs for licenses; could possibly be some kind of fee for agencies 14

16. Next Steps FHA –Submit FS import final products to Federal Transition Framework –Provide SEDS CONOPS and requirements to SEDS Leadership Team and ITDS Program Agencies –Own and move forward with implementation of target solutions –Incorporate target FS import solutions in agency ITDS CONOPS and requirements set 15

17. Additional Slides 16

18. DRAFT: Food Safety Import Target Solutions Mapped to Agencies (1 of 3) No.Target Solution Type APHISCBPAMSFDAFSISNMFS 1. Transmit updated eligibility information to central source Business process, info exchange XXX 2. Provide establishment certification to U.S./Receive establishment certification information Business process, info exchange XX 3. Transmit establishment certification to central source Business process, info exchange XXX 4.Transmit permit information to central source Business process, info exchange XXX 5. Send certificate to U.S. Government/Receive certificate information Business process, info exchange XX 6.Transmit certificate to central source Business process, info exchange XXX 7.Determine agency jurisdiction Business process XXX 8. Transmit security screening results, advance cargo data, and entry data (if sent) to agency Business process, info exchange XXXXXX 9.Place hold on cargo (message) Info exchange XXXX 17

19. DRAFT: Food Safety Import Target Solutions Mapped to Agencies (2 of 3) No.Target SolutionTypeAPHISCBPAMSFDAFSISNMFS 10.Inspect cargo at foreign port (message) Info exchange X XXXX 11.Transmit no load message Business process, Info exchange XXXX 12.Electronic Entry Submission Info exchange XXXXX 13.Perform edit checks Business process XXXX 14. Reject entry (entry rejection message, automatic message) Business process, info exchange X 15. Transmit security screening results and entry data to agency Business process, info exchange XXXXX 16.Request additional or revised entry data Business process, info exchange XXXXX 17.Transmit inspection notice to central source Info exchange XXXX 18. Transmit inspection notice to importer/broker Business process, info exchange XXXXX 19.Collect sample notification Info exchange XXXXXX 20. Transmit inspection results to central source Business process, info exchange XXXXXX 18

20. DRAFT: Food Safety Import Target Solutions Mapped to Agencies (3 of 3) No.Target SolutionTypeAPHISCBPAMSFDAFSISNMFS 21. Transmit message to central source (cargo disposition message) Business process, info exchange XXXXX 22. Transmit message to importer/broker (cargo disposition message, automatic message) Business process, info exchange X 23.Non-release follow-up request Info exchange XXXX 24.Request inspection Business process, info exchange X 25.Export verification message Info exchange XXXXX 26.Data exchange interfaces Service component XXXX 27. Leverage Customer Service functions of ACE where appropriate Service component XXXXXX 28.Shared Establishment Data Service Service component XXXXX 29. Assess larger $ or criminal penalty for repeat offenders N/A XXXXX 30. Expand interagency efforts to train and leverage resources to collect samples N/A XXXXXX 31.Shipment tracking with tracking technologies Service Components/ Technology 19

21. Key Steps in Moving Target Solutions Toward Implementation Include solutions in Agency architecture/ transition plans Submit solutions to Federal Transition Framework Analyze/ approve requirements Incorporate in agency ITDS requirements & coordinate with ITDS Incorporate requirements into ACE plans and builds Coordinate with OMB Modify agency systems and implement solutions $ FHA coordinates with OMB to move FS import solutions forward ACE Food Safety Agencies FHA Program ITDS Program and CBP Develop business case & request funding 20