FDA’s Rapid Response Teams (RRT) Program Update

1. FDA’s Rapid Response Teams (RRT) ProgramUpdate MFRPS Alliance Meeting Travis Goodman RRT Program Coordinator FDA/Office of Regulatory Affairs/Office of Partnerships March 12, 2014

2. Rapid Response Teams (RRT) • Why RRTs? • White House & Congressional interest in improving response and food safety • Multi-year Cooperative Agreement Program • Awards range from $150,000 - $250,000 • Oversight provided by FDA/ORA Office of Partnerships • Cross-Center RRT Advisory Committee • 18 RRTs (within 14 Districts) are currently funded

3. Updated: January 23, 2014 = Original RRT State (Joined 2008/2009) = New RRT State (Joined 2012) Rapid Response Teams FY13 (2013-2014 Grant Year) NWE-DO DET-DO MIN-DO NYK-DO PHI-DO NER SEA-DO BLT-DO CER ATL-DO SAN-DO NOL-DO FLA-DO LOS-DO SER KAN-DO PAR SWR DAL-DO

4. RRT Program Rationale • Develop and maintain multi-jurisdictional RRTs that operate under ICS/NIMS and Unified Command to support integrated all-hazards prevention, response and recovery efforts for food/feed. • Develop and support wide-spread adoption of best practices. • Strengthen federal/state/local infrastructure through the development of response capabilities in adherence with the preparedness cycle for capability building as per the National Response Framework (plan  organize, train & equip  exercise  evaluate & improve). • Unify and coordinate federal/state/local food/feed emergency response efforts including: • Training, investigations, data sharing, data analysis and communications. • Strengthening the link among epidemiology, lab and environmental health components • Ensure alignment with national priorities, including FSMA, the National Response Framework, Partnership for Food Protection, and Building an Integrated Food Safety System.

5. RRT Cooperative Agreement Milestones, 2013-2014 • New RRTs: RRT Development • RRT Concept Development/Documentation • RRT Concept Assessment • Collaboration • RRT Concept Implementation/Exercise • RRT Concept Incorporation (Sustainability) • Original RRTs: Maintenance of Advanced Capabilities • Mentorship • RRT Capability Data Capture & Assessment • Communication • Post Response & Prevention • RRT Maturity & Maintenance • Sustainability

6. * Did You Know 9 RRT grantees are in Public Health Agencies 9 RRT grantees are in Departments of Agriculture RRT Program Outcomes • Strengthen Federal/State/Local Collaboration • District & State Food Regulatory Program • Across programs within the State • Lab/epi/regulatory • May or may not be multi-agency • Food & Feed Regulatory Programs • May or may not be multi-agency • Local Health Departments • Majority (~75%) of RRT States are decentralized • Across national initiatives. Examples include: • CDC FoodCORE & COEs • Palantir • CIFOR

7. * Did You Know The 2013 Edition of the RRT Manual is available upon request to OP-ORA@fda.hhs.gov RRT Program Outcomes • Development of Rapid Response Capabilities • Multi-disciplinary, multi-jurisdictional communication and coordination • District/State response teams • ICS Implementation (Unified Command) • RRT Best Practices Manual • Capability Assessment Tool • Improve Program Infrastructure • Alignment with the Manufactured Food Regulatory Program Standards • Sustainability of the RRT

8. Developed by Working Groups Multiple States and FDA Reviewed by Many Partners FDA Headquarters and Field Offices State and local agencies Associations (AFDO, NASDA, APHL, NACCHO, ASTHO) Federal Partners (e.g., USDA, DHS) RRTBest Practices Manual 8

9. Working With Other Agencies Federal – State Cooperative Programs Industry Relations Tools for Program Analysis & Improvement: CIFOR Food Emergency Response Plan Communication SOPs ICS Concepts in RRTs RRT Training Tracebacks Joint Inspections & Investigations Environmental Sampling & Records Collection Food Recalls After Action Reviews Metrics RRT Manual Chapters – 2013 Edition

10. Standing Up the New RRTs • Mentorship • Four factors: relationships, agency size, jurisdiction and geographic proximity • Goal: smoother, more efficient team stand-up & development • Development of RRT Capacity Building Process & Mentorship Framework • Transparency & Communications • With States • With ORA Field & HQ components • With other stakeholders

11. Updated September 1, 2013 Rapid Response Teams (RRT) Mentorship Match-Ups NWE-DO DET-DO MIN-DO NYK-DO PHI-DO NER SEA-DO BLT-DO CER ATL-DO SAN-DO NOL-DO FLA-DO LOS-DO SER KAN-DO PAR SWR DAL-DO = Mentor RRT State (Original- Joined 2008/2009) = Mentee RRT State (New- Joined 2012)

12. RRT Capability Assessment Tool • Created and conducted by WIFSS for the original RRTs from 2008-2010 • Separate state and District assessments were conducted • Great for initial baseline assessment • Not ideal for recurring RRT assessment • Did not account for lessons learned or refinement • Created a new Capability Assessment Tool (CAT) • Rolled out in Feb 2013, first set of data received Aug 2013 • Completing the CAT is a yearly milestone for RRTs • Completed revisions to CAT and version 3.0 just launched

13. What’s our Story? • RRT Purpose: Improve the effectiveness of multi-jurisdictional food/feed emergency responses with the ultimate objective of reducing the time from agency notification to implementation of effective control measures. • Four strategies (core RRT functions) to accomplish this purpose: • Demonstrated preparedness/capabilities • Up to date plans/procedures & trained staff • Effective Responses • RRT Activations, Responses & Exercises • Collaboration/Coordination • Multi-agency/jurisdictional; multi-disciplinary (lab/epi/EH, feed); Industry • Process Improvement • National Standards (manufactured food, retail, feed) • AARs

14. What Data Supports our Story? • RRT Characterization Data • Highlights variation among RRTs: structure, activities/areas of focus • Provides context for interpreting other data elements • Achievement Levels • Progress in implementing best practices • Target outcome: a coordinated, documented RRT capability with demonstrated competency and subject to a continuous process improvement program • Metrics • Specific indicators/measures associated with best practices • Key drivers for capability development and maintenance • Baseline Response Data • How often and in what context RRTs are implementing core operational response capabilities • Selected indicators/measures of effectiveness for these responses

15. Selected 2013 CAT ResultsRRT Characterization Data

16. RRT Structure State Food Program State Epi State Lab State Feed Program FDA District Office

17. Typical Hazards Addressed by RRTs

18. Selected 2013 CAT Results Implementation of Best Practices: Achievement Levels & Metrics

19. Training

20. Metrics – Training, Part 1 100% (from the start) of field teams and the program’s RRT food subject matter experts (SMEs) have completed the basic inspection training program described in the Manufactured Food Regulatory Program Standards (MFRPS). (SMEs brought in from other areas for unique responses are excluded for this. However, this is required for those frequently involved in RRT responses.) Bars represent +/- 1σ

21. Metrics – Training, Part 2 RRT conducts a training review every 12 months. An improvement plan is developed for any gaps in meeting the requirements above. (This is intended for non-MFRPS states. MFRPS States would include RRT-specific Training (program training) as a part of the MFRPS review.) 75% of field team staff and 100% of field team leaders have completed advanced courses in epidemiology and foodborne illness investigations including Epi-Ready or the equivalent. (Note: Field team percentage not intended to include staff assigned in surge capacity where they are coming to support the response and carry out specific assigned tasks that are within the scope of their training and routine work (i.e. sampling, etc.)  Bars represent +/- 1σ

22. Metrics – Tracebacks Bars represent +/- 1σ

23. Metrics – AARs Bars represent +/- 1σ

24. Selected 2013 CAT Results Baseline Response Data

25. Source Investigation Further investigation if contamination not at POS Pre-surveillance Surveillance Epi. Investigation Traceback to source completed Illnesses detected by Health Dept.(s) Food contamination Ill persons interviewed Environmental assessment of source(s) completed Food consumption Food Regulatory/EH Program(s) notified Reporting time varies by state and cause of illness Add’l supply chain controls implemented Human illnesses Food implicated Response Improvement Agencies involved depend on jurisdictions Point of Sale EH Investigation After Action Review (AAR) conducted Environmental assessment of source completed Report generated Who notified (Local, State, Federal) and when depends on state and specific circumstances Epidemiology Program(s) notified On-site controls implemented Lessons learned incorporated in preventive measures and response procedures to prevent recurrence of identified problem

27. Conclusions from the 2013 Pilot & Next Steps • Noticeable difference between original and new RRT performance • Demonstrates return on investment • High standard deviations for many data elements • Inconsistency in availability of some data elements • Areas for improvement: CAT Revision Workgroup • Standardization of achievement levels • Standardization of terms • Capturing baseline response data needs to be part of normal business practices for RRTs • Goal: pilot version 2.0 in Spring 2014

28. Other RRT Improvements • Partnerships • Due to RRT program interactions relations between response partners continue to improve • Tracebacks • Traceback training and best practices led to improvements in traceback proficiency • ICS/NIMS • RRTs who participated in the ICS 305 IMT course are more comfortable using ICS

29. RRT Successes • 2011: Salmonella Agona in Papaya (TX RRT) • 2011: E. coli O157:H7 in in-shell Hazelnuts (MI, MN, CA, & WI) • Article on the traceback published in the Journal of Food Protection • 2012: Salmonella in Diamond Petfood (MI) • Resultant large scale recall • 2013: Cyclospora in bagged salad mix and cilantro(IA & TX) • 2 separate, concurrent outbreaks • 2014: Listeria in soft Mexican Cheeses (MD & VA)

30. Developing an RRT in the absence of grant funding • PFP Response and Recall Workgroup • National Capacity Building and Mentorship Program for Rapid Response Teams • 2014 RRT Grant milestone 1: Mentorship • RRTs will actively participate in the RRT Capacity Building & Mentorship Program, to include providing mentorship to at least one 'new' RRT (added to the RRT Program in 2012) as well as non-funded RRTs (as assigned by FDA OP).

32. Thank you! Questions? FDA Office of Partnerships: OP-ORA@fda.hhs.gov Travis Goodman: Travis.Goodman@fda.hhs.gov Lauren Yeung: Lauren.Yeung@fda.hhs.gov