FDA’s Rapid Response Teams (RRT) Program
Update
MFRPS Alliance Meeting
Travis Goodman
RRT Program Coordinator
FDA/Office of Regulatory Affairs/Office of Partnerships
March 12, 2014
1
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
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Updated: January 23, 2014
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
KAN-DO
SER
Rapid Response Teams (RRTs)
Original RRTs
New RRTs
Southeast Region
PAR
SWR
NC (ATL-DO)
GA (ATL-DO)
FL (FLA-DO)
MS (NOL-DO)
Northeast Region
Original RRTs
Central Region
MI (DET-DO)
PA (PHI-DO)
MN (MIN-DO)
WV (BLT-DO)
VA (BLT-DO)
MD (BLT-DO)
Southwest Region
NY (NYK-DO)
MA (NWE-DO)
Pacific Region
= Original RRT State (Joined 2008/2009)
WA (SEA-DO)
= New RRT State (Joined 2012)
CA (LOS-DO &
SAN-DO)
IA (KAN-DO)
TX (DAL-DO)
RI (NWE-DO)
DAL-DO
New RRTs
N/A
MO (KAN-DO)
Summary:
• 14 Districts have RRTs
• 1 District has 3 RRTs
• 3 Districts have 2 RRTs
• 10 Districts have 1 RRT
RRT Program Rationale
• Develop and maintain multi-jurisdictional RRTs that operate
under ICS/NIMS and Unified Command to support integrated allhazards 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.
4
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
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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
Did You Know
9 RRT grantees are in
Public Health Agencies
9 RRT grantees are in
Departments of Agriculture
– Majority (~75%) of RRT States are decentralized
– Across national initiatives. Examples include:
• CDC FoodCORE & COEs
• Palantir
• CIFOR
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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)
*
Did You Know
The 2013 Edition of the
RRT Manual is available
upon request to
OP-ORA@fda.hhs.gov
– RRT Best Practices Manual
– Capability Assessment Tool
• Improve Program Infrastructure
– Alignment with the Manufactured Food Regulatory Program Standards
– Sustainability of the RRT
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RRT Best Practices Manual
•
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)
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RRT Manual Chapters – 2013 Edition
1. Working With Other
Agencies
2. Federal – State
Cooperative Programs
3. Industry Relations
4. Tools for Program Analysis
& Improvement: CIFOR
5. Food Emergency
Response Plan
6. Communication SOPs
7. ICS Concepts in RRTs
8. RRT Training
9. Tracebacks
10. Joint Inspections &
Investigations
11. Environmental
Sampling & Records
Collection
12. Food Recalls
13. After Action Reviews
14. 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
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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
KAN-DO
SER
RRT Mentorship Match-Ups
Mentor RRTs
Mentee RRTs
Southeast Region
PAR
MI DA
PA DA
FL DACS
MS DOH
VA DACS
WV DHHR
RI DOH
Cross-Region
= Mentor RRT State (Original- Joined 2008/2009)
= Mentee RRT State (New- Joined 2012)
Central Region
GA DA
MA DPH
DAL-DO
Mentee RRTs
NC DACS
Northeast Region
SWR
Mentor RRTs
MN DA
NY SDAM
WA DA
IA DIA
CA DPH
MD DHMH
Southwest Region
TX DSHS
MO DHSS
Criteria for Selections:
•Relationships
•Size of Agency
•Jurisdiction
•Geographic Proximity
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
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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 Results
RRT Characterization Data
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RRT Structure
100%
All RRTs
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
RRT
Member
Steering
Committee
Member
State Food Program
RRT
Member
Steering
Committee
Member
State Epi
RRT
Member
Steering
Committee
Member
State Lab
RRT
Member
Steering
Committee
Member
State Feed Program
RRT
Member
Steering
Committee
Member
FDA District Office
Typical Hazards Addressed by RRTs
100%
All RRTs
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Natural Disasters
Intentional Contamination
Unintentional
Contamination/Outbreaks
Selected 2013 CAT Results
Implementation of Best Practices:
Achievement Levels & Metrics
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Training
RRT Distribution
25% of Original RRTs
70% of New RRTs
25% of Original RRTs
20% of New RRTs
25% of Original RRTs
10% of New RRTs
25% of Original RRTs
Lvl Description
1
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.
2
Agency 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.
3
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.
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).
5
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, 19
within
the last 12 months and developed an improvement plan to address any deficiencies
identified.
Metrics – Training, Part 1
5
Original RRTs
0 = Not Started - - - 3 = Partial - - - 5 = Full
4.5
New RRTs
4
Max - All RRTs
3.5
Min - All RRTs
Avg - All RRTs
3
2.5
2
1.5
1
0.5
0
100% 100%
(from the
start)
of start)
field teams
andteams
the
(from
the
of field
and 100% (within 3 months of assignment to 100% (within 12 months of assignment
program’s RRT food subject matter experts (SMEs)
RRT) of staff in a leading position
to RRT) of Command Staff, General Staff,
the program’s RRT food subject matter
have completed the basic inspection training
experts
(SMEs)
have
completedFood
the basic (Command Staff, General Staff, and Field and Field Team Leads responding to
program
described
in the
Manufactured
inspection
training
program
described
in Team Leads) responding to emergency emergency have completed ICS 300 and
Regulatory
Program
Standards
(MFRPS).
(SMEs
brought in
from
other areas forFood
unique
responses
have completed ICS 100, 200, 700, and
ICS 400.
the
Manufactured
Regulatory
are excluded
for this.
However, (MFRPS).
this is required
for
Program
Standards
(SMEs
800.
Bars represent +/- 1σ
those frequently involved in RRT responses.)
brought in from other areas f
Metrics – Training, Part 2
5
0 = Not Started - - - 3 = Partial - - - 5 = Full
4.5
Original RRTs
New RRTs
4
Max - All RRTs
3.5
Min - All RRTs
3
Avg - All RRTs
2.5
2
1.5
1
0.5
0
RRTconducts
conducts a training
75% of
team
staffstaff
and 100%
field team
75%
offield
field
team
andof100%
of field Each field team when deployed has at RRT
trainingreview
reviewevery
every1212
leaders
have
completed
advanced
courses
in
months.
An improvement
plan plan
is is
team leaders have completed advanced least 1 team member with advanced
months.
An improvement
epidemiology and foodborne illness investigations
developed for
thethe
courses
in epidemiology
and foodborne
training in the activities needed to
developed
forany
anygaps
gapsininmeeting
meeting
including Epi-Ready
or the equivalent.
(Note: Field
requirements above. (This is intended for
illness
investigations
including
Epi-Ready
conduct investigation. For example,
requirements above. (This is intended
team percentage
not intended
to include
staff
states. MFRPS States would
assigned
surge capacity(Note:
where they
areteam
coming seafood HACCP, juice HACCP, sampling, non-MFRPS
or theinequivalent.
Field
for non-MFRPS states. MFRPS States
include RRT-specific Training (program
to support the response and carry out specific
percentage
not
intended
to
include
staff
etc.
would include
training)
as a partRRT-specific
of the MFRPSTraining
review.)
assigned tasks that are within the scope of their
assigned
in
surge
(program
training)
as
a
part
of
the M
Bars represent +/- 1σ
training and routine work (i.e. sampling, etc.)
Metrics – Tracebacks
5
0 = Not Started - - - 3 = Partial - - - 5 = Full
Bars represent +/- 1σ
4.5
4
Original RRTs
New RRTs
Max - All RRTs
3.5
Min - All RRTs
3
Avg - All RRTs
2.5
2
1.5
1
0.5
0
Conducts an annual review of written traceback Includes use of traceback procedure in at least one
procedures.
response or exercise every 12 months.
Metrics – AARs
0 = Not Started - - - 3 = Partial - - - 5 = Full
5
4.5
4
3.5
3
Original RRTs
New RRTs
Max - All RRTs
Min - All RRTs
Avg - All RRTs
2.5
2
1.5
1
0.5
0
Completes an after action meeting with state, local
100% of after action issues related to team
and federal partners (as appropriate) that
performance or skill development are incorporated
participated in a multi-agency response within 45 into improvement plans. If improvement plans are
days of completion of the response investigation. not utilized due to legal or other issues, all action
Bars represent +/- 1σ
issues are incorporated into future trainings.
Selected 2013 CAT Results
Baseline Response Data
24
Pre-surveillance
Epi. Investigation
Source
Investigation
Traceback to
source
completed
Food
contamination
Ill persons
interviewed
Food
consumption
Food Regulatory/EH
Program(s) notified
Environmental
assessment of
source(s) completed
Food
implicated
Add’l supply chain
controls
implemented
Human
illnesses
Reporting
time varies
by state
and cause
of illness
Surveillance
Illnesses
detected by
Health Dept.(s)
Who notified
(Local, State,
Federal) and
when depends
on state and
specific
circumstances
Epidemiology
Program(s)
notified
Agencies
involved
depend on
jurisdictions
Point of Sale
EH Investigation
Environmental
assessment of source
completed
On-site
controls
implemented
Further
investigation if
contamination
not at POS
Response Improvement
After Action Review
(AAR) conducted
Report
generated
Lessons learned incorporated in
preventive measures and
response procedures to prevent
recurrence of identified problem
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%
26
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
27
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
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)
29
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).
30
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
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