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FDA’s Rapid Response Teams (RRT) Program Update

MFRPS Alliance Meeting

Travis GoodmanRRT Program Coordinator

FDA/Office of Regulatory Affairs/Office of Partnerships

March 12, 2014

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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

Updated: January 23, 2014

= New RRT State (Joined 2012)

= Original RRT State (Joined 2008/2009)

Rapid Response Teams FY13 (2013-2014 Grant Year)

Rapid Response Teams (RRTs)

Original RRTs New RRTs Original RRTs New RRTs

Southeast Region Central Region

NC (ATL-DO) GA (ATL-DO) MI (DET-DO) PA (PHI-DO)

FL (FLA-DO) MS (NOL-DO)MN (MIN-DO) WV (BLT-DO)

VA (BLT-DO) MD (BLT-DO)

Northeast Region Southwest Region

MA (NWE-DO)NY (NYK-DO)

TX (DAL-DO)IA (KAN-DO)

RI (NWE-DO) MO (KAN-DO)

Pacific Region Summary:

• 14 Districts have RRTs

• 1 District has 3 RRTs

• 3 Districts have 2 RRTs

• 10 Districts have 1 RRT

WA (SEA-DO)

N/ACA (LOS-DO & SAN-DO)

PAR

SWR

CER

SER

NER

LOS-DO

SAN-DO

SEA-DO

MIN-DODET-DO

PHI-DO

BLT-DO

NYK-DO

NWE-DO

ATL-DO

FLA-DO

NOL-DO

KAN-DO

DAL-DO

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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.

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 5

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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

* Did You Know9 RRT grantees are in Public Health Agencies

9 RRT grantees are in Departments of Agriculture

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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

* Did You KnowThe 2013 Edition of the RRT Manual is available upon request to OP-ORA@fda.hhs.gov

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• 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)

RRT Best Practices Manual

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RRT Manual Chapters – 2013 Edition

1. Working With Other Agencies

2. Federal – State Cooperative Programs

3. Industry Relations4. Tools for Program Analysis

& Improvement: CIFOR5. Food Emergency

Response Plan6. Communication SOPs7. ICS Concepts in RRTs

8. RRT Training9. Tracebacks10. Joint Inspections &

Investigations11. Environmental

Sampling & Records Collection

12. Food Recalls13. After Action Reviews14. Metrics

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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

Updated September 1, 2013

= Mentee RRT State (New- Joined 2012)

= Mentor RRT State (Original- Joined 2008/2009)

Rapid Response Teams (RRT) Mentorship Match-Ups

RRT Mentorship Match-Ups

Mentor RRTs Mentee RRTs Mentor RRTs Mentee RRTs

Southeast Region Central Region

NC DACS GA DA MI DA PA DA

FL DACS MS DOH VA DACS WV DHHR

Northeast Region Southwest Region

MA DPH RI DOH TX DSHS MO DHSS

Cross-Region Criteria for Selections:

•Relationships

•Size of Agency

•Jurisdiction

•Geographic Proximity

MN DA NY SDAM

WA DA IA DIA

CA DPH MD DHMH

PAR

SWR

CER

SER

NER

LOS-DO

SAN-DO

SEA-DO

MIN-DODET-DO

PHI-DO

BLT-DO

NYK-DO

NWE-DO

ATL-DO

FLA-DO

NOL-DO

KAN-DO

DAL-DO

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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

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

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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

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Selected 2013 CAT ResultsRRT Characterization Data

RRT Structure

State Food Program State Epi State Lab State Feed Program FDA District Office

Typical Hazards Addressed by RRTs

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Selected 2013 CAT Results Implementation of Best Practices:

Achievement Levels & Metrics

TrainingRRT Distribution Lvl Description

25% of Original RRTs70% of New RRTs

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The agency has, within the past 12 months, updated written Training Procedures, updated their assessment of their training program against the Manufactured Foods Regulatory Program Standards (MFRPS), and developed an improvement plan to prioritize future training activities that will move the program towards full compliance.

25% of Original RRTs20% of New RRTs

2Agency personnel have completed MFRPS Level I training within the prescribed timeline established in the Training Procedures and are on track to develop and maintain either intermediate or advanced capacities.

25% of Original RRTs10% of New RRTs

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Agency personnel assigned to RRT activities have completed core response training identified in their Training Procedures consistent with recognized national/multi-jurisdictional guidance (example: RRT Training Guidance). The agency has reassessed their training program, including an assessment of their needs and gaps, within the last 12 months and developed an improvement plan to address any deficiencies identified.

25% of Original RRTs 4 Agency personnel assigned to RRT activities have completed the necessary intermediate response training identified in their Training Procedures consistent with recognized national/multi-jurisdictional guidance (example: RRT Training Guidance).

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Agency personnel assigned to RRT activities have completed the necessary advanced response training identified in their Training Procedures consistent with recognized national/multi-jurisdictional guidance (example: RRT Training Guidance). The agency has reassessed their training program, including an assessment of their needs and gaps, within the last 12 months and developed an improvement plan to address any deficiencies identified.

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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

Metrics – Training, Part 2

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.)

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.)

Bars represent +/- 1σ

Metrics – Tracebacks

Bars represent +/- 1σ

Metrics – AARs

Bars represent +/- 1σ

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Selected 2013 CAT Results Baseline Response Data

Food contamination

Human illnesses

Food consumption

Pre-surveillance

Epidemiology Program(s)

notified

Illnesses detected by

Health Dept.(s)

Surveillance

Who notified (Local, State, Federal) and

when depends on state and

specific circumstances

Ill persons interviewed

Food implicated

Food Regulatory/EH Program(s) notified

Epi. Investigation

Reporting time varies

by state and cause of illness

On-site controls

implemented

Environmental assessment of source

completed

Point of SaleEH Investigation

Traceback to source

completed

Add’l supply chain controls

implemented

Environmental assessment of

source(s) completed

SourceInvestigation

After Action Review (AAR) conducted

Report generated

Lessons learned incorporated in preventive measures and

response procedures to prevent recurrence of identified problem

Response Improvement

Further investigation if contamination

not at POS

Agencies involved

depend on jurisdictions

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Original RRTs New RRTs

n= Average n= Average

Average time from identification of implicated food until boots on the ground (deployed on-site to the facility) at the responsible facility/operation (hours)

4 26.675 1 1

Average time from identification of implicated food to completion of traceback (identification of the source or determination that a source could not be identified) (hours)

3 96.6667 1 48

Average time from the identification of adulterated food item until a consumer advisory is issued (hours)

2 46.25 2 33

Percentage of traceback investigations that successfully result in identification of an implicated food.

2 50% 2 55%

For all incidents where a root cause analysis was initiated, identify the percentage of incidents where a root cause or significant contributing factors were identified in a 12-month period.

3 47% 1 5%

Short of root cause identification, percentage of incidents (out of all incidents where a root cause analysis was initiated) in which at least one contributing factor to the contamination was identified?  

3 67% 1 100%

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

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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 28

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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)

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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).

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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