1. 1 National Association of State Departments of Agriculture Food Regulation & Nutrition Committee Meeting September 16, 2012 Des Moines, IA Joe Reardon Senior Advisor for Federal-State Relations FDA/Office of Regulatory Affairs Investments in Federal-State Programs to Support an Integrated Food Safety System (IFSS)

2. 2 A National Integrated Food Safety System (IFSS) Jointly developed and implemented inspection and enforcement programs Benefits: –Increased ability to assess potential risks at domestic food facilities –More consistent coverage of these facilities across the entire food supply chain –Greater food surveillance through integration of food facility inspection information –Improved rapid response capacity and efficiency Outcome: Increased public health protection

3. 3 * Did You Know… For new awards issued thus far in FY12, 31 have gone to Departments of Agriculture, totaling over $7.4M. Awards include those for ISO, MFRPS, RRT and Innovative Food Defense

4. 4 Rapid Response Teams (RRT) Multi-year Cooperative Agreement –Awards range from $300,000 - $500,000 Develop Rapid Response Capabilities –RRT Manual (Best Practices) –Metrics Improve Program Infrastructure –MFRPS Implementation Strengthen Federal/State/Local Collaboration –Across programs (health, agriculture, etc) –Across initiatives (IFSS, CDC FoodCORE, etc) * Did You Know 9 RRTs are in Public Health Agencies 10 RRTs are in Departments of Agriculture

5. 5 Rapid Response Teams (Original & Additions from 2012 RFA) Rapid Response Teams (RRTs) Original RRTsNew RRTsOriginal RRTsNew RRTs Southeast RegionCentral Region NC (ATL-DO)GA (ATL-DO)MI (DET-DO)PA (PHI-DO) FL (FLA-DO) TN (NOL-DO)MN (MIN-DO)WV (BLT-DO) MS (NOL-DO)VA (BLT-DO)MD (BLT-DO) Northeast RegionSouthwest Region MA (NWE-DO) NY (NYK-DO) TX (DAL-DO) IA (KAN-DO) RI (NWE-DO)MO (KAN-DO) Pacific RegionSummary: Total: 19 States/14 Districts 2008: 6 States/7 Districts 2009: 3 States/3 Districts 2012: 10 States/7 Districts WA (SEA-DO) N/A CA (LOS-DO & SAN-DO) PAR SWR CER SER NER LOS-DO SAN-DO SEA-DO MIN-DO DET-DO PHI-DO BLT-DO NYK-DO NWE-DO ATL-DO FLA-DO NOL-DO KAN-DO DAL-DO = New RRT State (Under 2012 RFA) = RRT State (Original- Joined 2008/2009) = Department of Agriculture

6. 6 Announcing… The RRT Best Practices Manual is now available upon request to DFSR –Send an email to dfsr@fda.hhs.gov dfsr@fda.hhs.gov A resource for any food regulatory program wishing to improve response capabilities

7. 7 Manufactured Food Regulatory Program Standards (MFRPS) Uniform foundation for the design and management of state programs responsible for regulating food plants Institute a comprehensive quality assurance & standardization program FDA Program-Assessment Validation Audits (PAVAs) conducted at 18, 36 Full program audit conducted at 60 months 41 State Programs (40 States) enrolled in MFRPS)

8. 8 MFRPS Cooperative Agreement RFA issued in late spring, 2012 –Up to $300,000/yr in funding –Up to 5 years of funding –Purpose: to assist State manufactured food regulatory programs to achieve and maintain full conformance with the MFRPS Awards recently issued –26 States –$7.1M in funding per year * Did You Know 16 recipients are in Public Health Agencies 10 recipients are in Departments of Agriculture

9. 9 ISO 17025 Cooperative Agreements RFA issued in late spring, 2012 –Up to $300,000/yr in funding –Up to 5 years of funding –Purpose: To support accreditation of microbiological & chemical analyses performed on behalf of state manufactured food regulatory programs Awards recently issued –31 States –$7.8M in funding per year Pending award –Laboratory Association to support ISO accreditation ($1.5M) * Did You Know 14 recipients are in Public Health Agencies 15 recipients are in Departments of Agriculture 2 recipients are in Universities

10. 10 FY12 Grants & Cooperative Agreements Programs# of Awards* Food Protection Task Forces23 Food Emergency Response Network (FERN)34 Ruminant Feed Ban Support (BSE)11 Rapid Response Teams19 Innovative Food Defense3 Small Conference Grants9 FSMA Emergency Response & Risk Based InspectionsAwards forthcoming Manufactured Food Regulatory Program Standards26 ISO 17025:2005 Laboratory Accreditation31 Voluntary Nat’l Retail Food Regulatory Program StandardsAwards forthcoming Integrated Laboratory System1 Alliances2 Total Funding $44.3M (>200 awards) *Some 2012 awards have not yet been issued

11. 11 FY12 Inspection Contract Programs Program# of Awards Food46 Feed36 Egg8 Tissue Residue21 MQSA44 Medical Device1 Milk ResidueN/A Totals$15.2M (>150 awards)

12. 12 Then & Now: Investment in Federal-State Integration ProgramsFY2009 FundingFY2012 Funding* Contracts (total)$15.5M$15.2M Egg Contract (added FY11)None$320K Grants (total)$17.4M$44.3M MFRPS implementationNone (26 Programs)$11M (41 Programs) ISO (added FY12)None$7.8M RRT (expanded FY12)$4.5M$7.4M FSMA Emergency Response & Risk Based Inspections (added in FY12) None$3.5M Alliances (AFDO and NCSL)None$455K State Cooperative Programs (total)$250K$3.4M Retail Standards Cooperative AgreementNone$2.6M Retail Partnership$250K$500K Dairy & ShellfishNone$250K Total Funding$33.2M$59.54M *2012 awards estimated

13. 13 FDA Division of Federal State Relations 12420 Parklawn Drive, ELEM- 3033, Rockville, MD 20857 301-796-5390 Email: dfsr@fda.hhs.gov DFSR Website: http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm dfsr@fda.hhs.gov http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm