1. Funding Opportunities for State, Local, Tribal and Retail/Manufactured Food Regulatory Programs CASA 2015 Barbara Cassens, Senior Advisor, Acting Director Office of Partnerships, FDA Office of Regulatory Affairs 1

2. Overview ORA Strategic Priorities Where we are now with funding & standards Where we want to be in the future 2

4. 4 GOAL 1: RECRUIT, TRAIN, DEVELOP AND RETAIN A DIVERSE WORLD CLASS WORK FORCE AND PROMOTE AN ORGANIZATIONAL CULTURE OF INTEGRITY, EXCELLENCE, AND COLLABORATION. 1.2: Expand ORA’s training and professional development opportunities. Responsible Office: ORM a. Host a Food and Feed Training meetings to include key external stakeholders. ORA FY 15 Priorities

5. 5 GOAL 3: LEVERAGE AND EXPAND ORA’S PUBLIC HEALTH PARTNERSHIPS. 3.1: Strengthen ORA’s relationships with Federal, State, and Local Public Health Partners. a. Evaluate the utilization of state contracts. b. Maximize the utilization of State Cooperative Agreements and Grants. c. Enhance work planning by capitalizing on ORA-State relationships.

6. 6 d. Advance ORA’s contribution towards the Partnership for Food Protection. e. Facilitate continued progress on FDA’s mutual reliance initiatives, including sharing and utilizing state data. f. Identify training needs and strategies for expanding training to state partners. g. Collaborate with partner associations and alliances. ORA FY 15 Priorities GOAL 3: LEVERAGE AND EXPAND ORA’S PUBLIC HEALTH PARTNERSHIPS. 3.1: Strengthen ORA’s relationships with Federal, State, and Local Public Health Partners. Cont.

7. 7 FSMA Section 205- Surveillance Will enable the development of strategies to leverage and enhance capacities to improve the following (205c1): –Foodborne illness surveillance, outbreak response and containment –Inspections & safety standards –Partnerships & Information sharing (RRT, FERN, MFRPS, AFRPS, Alliance, FoodSHIELD, IFD, Retail, SSCG, FPTF, Funded Workshops, Partnership Funds)

8. 8 FSMA Section 209- Improving the Training of State, Local, Territorial and Tribal Officers Set standards and administer training and education programs for food safety officials (State Contracts, MFRPS, Alliance, ISO/Lab, Retail, Funded Workshops, Risk Factor Study, FoodSHIELD, FPTF) Provide consistency and equivalency among Federal & State Programs (MFRPS, AFRPS, Alliance, ISO/Lab, RRT, FERN, Retail)

9. 9 FSMA Section 210- Enhancing Food Safety Direct investment in the infrastructure of State and local capacities (MFRPS, AFRPS, ISO/Lab Assoc, RRT, FERN, Retail) Eligible entities will be able to: –Build the food safety capacity of the laboratories –Build the infrastructure and capacity of food safety programs (investigations, response, training) Increase capabilities and capacities of State programs

10. Food –2014-2015 = 11,047 –2013-2014 = 11,280 –2012-2013 = 10,873 Feed –2014-2015 = 4,306 –2013-2014 = 5,030 –2012-2013 = 5,224 Tissue Residue –2014-2015 = 312 –2013-2014 = 335 –2012-2013 = 375 MQSA –2014-2015 = 6,923 –2013-2014 = 6,917 –2012-2013 = 6,861 Egg –2014-2015 = 92 –2013-2014 = 55 –2012-2013 = 136 Medical Device –2014-2015 = 20 –2013-2014 = 20 –2012-2013 = 20 10 FY 13-15 Contract Inspections - Summary

11. 11 Programs# of Awards Food Protection Task Forces15 Food Emergency Response Network (FERN)34 Ruminant Feed Ban Support (BSE)11 Rapid Response Teams18 Innovative Food Defense2 Small Science Conference Grants10 FSMA Emergency Response & Risk Based Inspections33 Manufactured Food Regulatory Program Standards37 ISO 17025:2005 Laboratory Accreditation30 Voluntary Nat’l Retail Food Regulatory Program Standards35 Integrated Laboratory System1 Alliances2 Retail Association1 FoodSHIELD1 Farm Survey (NASDA)1 Total Funding$44M FY14 Grants & Cooperative Agreements

12. Integrated Food Safety System (IFSS ) 12 Federal, State, local, tribal, & territorial regulatory & public health partners Working collaboratively across all jurisdictions To provide comprehensive, coordinated coverage of the food supply from farm-to-table Outcome: Prevention of foodborne illness in humans and animals Accomplished, in part, through the Partnership for Food Protection (PFP) “A national IFSS must be built upon mutual reliance and respect among partner agencies, recognizing and understanding each participant’s roles, limitations, and authorities…”

13. 13 The Backbone : Grant and Cooperative Agreements – Standards Supporting Food/Feed Safety Through Capacity Building and Integration with National Program Standards

14. 14 Manufactured Food Regulatory Program Standards (MFRPS) First released in 2007 in response to an HHS OIG report recommending FDA take steps to promote “equivalency” among Federal and State food safety Using MFPRS to support FSMA Section 201 and IFSS: –Regulatory foundation –Training –Inspection and assessment –Compliance and enforcement –Outbreak and response –Laboratory support

15. MFRPS Sustainability Sustainability Plans are now required for States enrolled in the MFRPS Program. States must submit an Exit Strategy of Sustainment (ESS) to FDA for approval in the 5 th year of the cooperative agreement, or sooner if warranted. MFRPS Sustainability recognizes changes in new emerging issues, legal mandates, new scientific research/risk assessments and changes in industry and consumer trends. Primary resource required for State Sustainability: Personnel Recognizing partnerships between FDA-State programs to support the National IFSS. 15

16. Recognition of state challenges/significant events/resources to facilitate FDA’s immediate support/response Original 9 RRT States – Expect 100% implementation by July 2015 By 2017: > 90% State programs at full implementation Promote sustainability, accountability and leverage resources Facilitate mutual reliance and IFSS approach MFRPS Future Direction 16

17. FSMA Preventive Control Rule & MFRPS Challenges/Opportunities FSMA will have a direct effect on States and future changes and implementation of the MFPRS States enrolled in the MFPRS have an advantage with evaluating their current systems and identify necessary changes to meet FSMA –Standard 1 (Regulatory Foundation) - Incorporation of new Rule, e.g., 21 CFR 117 –Standard 2 (Training Program) - Immediate need for phase-in process for States using federal resources Training sources, availability and timeliness –Standard 3 (Inspection Program) – Shift to risk-based, preventive/process control, and component inspections Greater focus on sampling programs and assignments 17

18. ORA/OP/SIS Support for Animal Feed Program Standards (AFRPS) 2 nd Year Goals and Opportunities Cooperative agreement funding Growth with enrollment and implementation (from 12 state programs in FY14 to 24 in FY15) Challenges – Adoption of the Preventive Controls for Animal Food Rule will be a change for the States, e.g., 21 CFR 507 18

19. 19 FDA Retail Food Safety Initiative & the Retail Program Standards Goal : “Create an enhanced local regulatory environment for retail food operations” –Objective 1: “Promote wider implementation…of the FDA Voluntary National Retail Food Regulatory Programs Standards” –Objective 3: “Seek increased multi-year funding for state, local, and tribal food safety programs as part of an integrated food safety system”

20. 20 Retail Program Standards 2,300 (Approx. # of jurisdictions eligible to enroll) 631 (or 27%) (# of enrolled jurisdictions as of Oct 2014) 35 (# of enrolled jurisdictions with OP-administered, multi-year Retail Program Standards Cooperative Agreements in FY15) 149 (# of enrolled jurisdictions receiving funding through cooperative agreement with AFDO in FY15) FDA personnel involved with advancing this initiative: –ORA: Retail Food Specialists, DSCPs, OP, DHRD –CFSAN: Retail Food and Cooperative Program Integration Staff

21. 21 Food Protection Task Force Conference Program Grants Industry FDA Taskforce Grant Academia Law Enforcement Public Health Officials Consumer Groups Current Grantees 15 States & D.C.

22. OR Baseline Funding OPTIONAL Pick List/Menu Options MFRPS Maintenance (Maintenance) Variable funding (see criteria for levels below) Level 1: $XX Level 2: $XX Level 3: $XX Cost matching requirement Levels are based on the number of firms in the state (Active State Inventory) and other relevant factors (may include population, inspection frequency, risk, etc.). Still TBD: Where to draw the thresholds between each level (i.e. what is 1 vs. 2 vs. 3)? Food Protection Task Force (meetings/workshops) Standard rate grant: $XX/year/grantee Available during Development and Maintenance Rapid Response Team (RRT) (Maintenance) Funding scheme for development:$XX/year/grantee Funding scheme for maintenance (transition from development to maintenance after 3 years’ funding): Variable funding (see criteria for levels below) Level 1: $XX Level 2: $XX Level 3: $XX Cost matching requirement Levels are based on foodborne illness outbreak risk or major food/feed emergency. The following factors may be used: # of firms- inventory; # of natural disasters on average; # of recalls from firms in your state; Indicator for rate of food/feed outbreaks (NORS); % high risk population; % population Still TBD: Where to draw the thresholds between each level (i.e. what is 1 vs. 2 vs. 3)? Must Choose: May Choose: MFRPS Implementation (Development) Development rate (Pending availability of funds and acceptable Grantee performance): up to $XX/year/grantee Award base funding tracks (MFRPS) first (if recommended for funding by objective review panel), and then allocate whatever remains of the total program funding to optional pick list/menu options in a prioritized manner based on objective review panel ranking of proposals. Future Funding Approach 22

23. Challenges for the Future FSMA regulations/implementation will be adopted/executed differently by different state agencies Contract inspections will still exist; however, we will need to offer a flexible funding model to accommodate the interests and needs of state regulatory programs 23

24. Future The produce rule is a game changer – to do it right will require the largest inspectional shift and most likely will require a unique funding vehicle (current work with NASDA) States need more time for preventive control regulations outreach and internal training/external education ORA/OP promotes the increased quality of state regulatory programs to improve overall consistency and confidence in the work by these agencies Considerable time and resources needed to adopt preventative Animal Food and Feed Regulations 24

25. Moving forward…Opportunities…. Multiple funding models that account for differences between state programs; transition plan Electronic data collection/sharing between FDA and State programs Define metrics that better measure effectiveness of inspections/value of integration Defining mutual reliance through pilots/models 25

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