The scope of National Level Exercise 2011 was defined
by:
White House guidance
Exercise Overview
The Secretary of Homeland Security’s guidance, as
embodied in the Exercise Directive
The FEMA Administrator’s guidance, in the form of the
Whole Community Approach
Exercise Overview
• Exercise Name– National Level Exercise 2011 (NLE 11)
• Type of Exercise– Operations-based exercise, incorporating elements of
both functional and full-scale exercise
• Exercise Start Date• Exercise Start Date– May 16, 2011
• Exercise End Date– May 19, 2011
• Duration– Four days
Exercise Overview
• Sponsor– U.S. Department of Homeland Security (DHS)/ Federal
Emergency Management Agency
• Program– National Exercise Program
• Mission• Mission– Respond and Recover
• Participation– 15 federal agencies,
– Four FEMA regions,
– White House
– Seven states (participated or were notionally represented in the exercise play)
Exercise Overview
• Capabilities
– Citizen Evacuation and Shelter-in-Place
– Communications
– Critical Resource Distribution and Logistics
– Mass Care (Sheltering, Feeding, and Related Services)– Mass Care (Sheltering, Feeding, and Related Services)
– Emergency Operations Center (EOC) Management
– Emergency Public Information and Warning
– Medical Surge
– Long Term Recovery
Exercise Overview
• FDA Participants
– Three FDA Regions
– ORA Headquarters
– Offices within Office of the Commissioner
– All Centers– All Centers
• Players: Over 200
• Evaluators: 40
Exercise Overview
• Used exercise to test the regional and headquarters’ response and preparatory recovery activities which ensure the efficacy, safety and availability of FDA-regulated products impacted by the catastrophic earthquake.
• With participation at both the headquarters and field levels, the agency was able to assess its
• With participation at both the headquarters and field levels, the agency was able to assess its preparedness for inter-agency and intra-agency response to a catastrophic earthquake.
• Exercise play was intended to test the agency’s ability to initiate response activities within the first 76 hours after an earthquake.
Exercise Overview
NLE 11 was a functional exercise designed to exercise emergency response plans, policies, and procedures as they pertain to a NMSZ earthquake of magnitude 7.7
A functional exercise simulates an emergency in
the most realistic manner possible, short of moving real
people and equipment to an actual site. Players practice
their response to an emergency by responding in a
realistic way to carefully planned and sequenced
messages given to them by simulators.
• Exercise Planning Group
– Office of Crisis Management - Exercise, Planning, and
Evaluation Staff
– Representatives from ORA
– Developed exercise objectives which supported the
Exercise Overview
– Developed exercise objectives which supported the
agency’s participation in the national interagency
exercise as well as our own internal agency exercise
Exercise Overview
• Players: personnel who have an active role in
responding to the simulated emergency
• Controllers: Monitor and control exercise
• Evaluators: Observe the exercise and collect data
to identify issues for the after action report (AAR)
Exercise Overview
• Players received information through multiple forms of communications
– In-person, Phone, Email, Virtual News Network Broadcasts
– Players used the most effective communication method available
– Players used the most effective communication method available
– The initiation of injects occurs from the SimCell
– No player communication were suppose to be sent to nonparticipating entities
– In no instance did exercise communications interfere
with real-world communications
Exercise Overview
• Scenario Type
– Catastrophic earthquake in the new Madrid
Seismic Zone (NMSZ)
– 2011 was the bicentennial anniversary of the
1811 New Madrid earthquake, for which the New 1811 New Madrid earthquake, for which the New
Madrid Seismic Zone (NMSZ) is named
– NLE 2011 was the first NLE to simulate a natural
hazard
• Most seismically active area east of the Rocky Mountains
• Produces 200 earthquakes annually in the M 1.5–4 range
• Largest instrumentally recorded event: M 5 near Marked Tree, AR, in 1976
Red dots represent recorded earthquakes and blue dots represent historic
earthquakes from “felt reports” from residents
Sandy M. Ebersole of the Geological Survey of Alabama
Sandy M. Ebersole of the Geological Survey of AlabamaSandy M. Ebersole of the Geological Survey of Alabama
NLE 11 FDA Objectives
• Test and evaluate FDA’s ability to implement the FDA
Emergency Operations Plan (FDA EOP) to respond to a
catastrophic earthquake, including the establishment of
Incident Command System structures –
• Evaluate the adequacy of the FDA EOP to provide • Evaluate the adequacy of the FDA EOP to provide
guidance for responding to a catastrophic natural
disaster.
• Evaluate how the FDA JIC functions when coordinating
headquarters and field internal and external
communications and public information response
activities.
NLE 11 FDA Objectives
• Demonstrate and evaluate how human resources are
requested and provided for an IMG and IMT
• Assess the agency’s ability to monitor and respond to
issues involving the efficacy, safety and availability of
FDA-regulated products impacted by the earthquake, FDA-regulated products impacted by the earthquake,
including clinical trials.
• Test the agency’s process for managing and responding
to requests from States for assistance with inspectional,
laboratory and technical expertise support through the
FEMA mission assignment process.
NLE 11 FDA Objectives
• Test the agency’s procedures for evaluating FDA
regulated products offered by other countries to ensure
that only medical products determined to be safe and
effective food products determined to be safe are
accepted into the US.
• Identify triggers for the agency to initiate the planning
process for how it will conduct assessments of the
impact of the disaster on FDA-regulated industries
• Evaluate how geospatial information (maps, summary
data, charts, etc.) is used by headquarters and field to
plan response activities during the first 76 hour period
after an earthquake.
Scenario Summary
At 9:00 AM (CDT), on May 16, 2011, the southwestern segment of the New Madrid Seismic Zone (NMSZ) ruptures at a magnitude of 7.7. The ruptured segment is approximately 90miles long from near Ridgley, Tennessee, to near Marked Tree, Arkansas. The released energy is felt as shaking Ridgley, Tennessee, to near Marked Tree, Arkansas. The released energy is felt as shaking throughout the central United States, and two minutes later (9:02 AM CDT), the shaking triggers a second event in the Wabash Valley Seismic Zone (WVSZ) near Mt. Carmel, Illinois at a magnitude of 6.0.Two catastrophic earthquakes within the New Madrid Seismic Zone (Central US).
Scenario Summary
• Significant structural, power, and transportation
infrastructure damage
• Flooding from breached dams/levees
• HazMat releases in land, air, and water
• Contamination from raw sewage• Contamination from raw sewage
Lessons Learned
• Determine if a written delegation of authority for
Incident Commanders is needed when an IMT is
stood up.
• Staff were unclear how the response would be
coordinated using FDA’s ICS structures – IMT & coordinated using FDA’s ICS structures – IMT &
IMG.
• Staff members still need training in incident
command and the use of the agency’s ICS
structures.
• Increased efficiency in coordinating the resources
needed for IMT and IMG should be pursued.
Exercise Play
• The EOC has been activated to responded to the
New Madrid earthquake. At this time, the EOC is
requesting the status of FDA personnel and FDA
assets in the impacted areas.
Exercise Play
• The NOL District offices and all RPs in the NOL
District EXCEPT the Memphis Resident Post (RP)
reported all personnel accounted for, facilities
intact, GOVs operational.
• Due to intermittent communication capacity during • Due to intermittent communication capacity during
the day, SER was unable to establish telephone
communications with the Memphis RP.
• The status of FDA facilities and property at the
Memphis Resident Post could not initially be
determined.
Lessons Learned
• Use of Disaster Evacuation Cards.
– When staff in an affected area are unable to reach
supervisor, they should call Prior Notice Center (PNC)
• 22 NOL-DO personnel called into PNC;
improvement needed and system needs to be improvement needed and system needs to be
tested.
– There is no mechanism for PNC to share that information
with supervisors or IMT
• The rest of the agency doesn’t have a system that
employees can use to report their status
• Need protocol for relocation of RP personnel.
Exercise Play
• TN Department of Health reported there had been
extensive damage to property and most every
water treatment facility and sewage treatment plant
west of the Tennessee River have been knocked
out.out.
– The TN Department of Health requested that a point of
contact for technical assistance in water treatment be
provided
Exercise Play
• TDH coordinated the early stages of evacuation of earthquake victims to shelters in middle and east Tennessee.– Requested two consultants onsite from FDA to provide
technical assistance to their environmental field staff monitoring the preparation, serving, and storage of food monitoring the preparation, serving, and storage of food at their shelters.
• Assistance would be provided through a Mission Assignment; directed State to work through the HHS Incident Response Coordination Team (IRCT) to make the official request for assistance with shelter inspections. [State requested POC]
Lessons Learned
• Must have POC at the HHS Incident Response Coordination Team to provide to the State.– A POC was never received from HHS Secretary’s
Operation Center
• If we deploy personnel to TN, will they be the SER IMT resource or will they integrate within the IRCT?IMT resource or will they integrate within the IRCT?– FDA must establish a protocol
with HHS on interaction during
disasters; update FDA EOP
accordingly.
Exercise Play
• Please provide any available information on
impacts to the healthcare supply chain from the
New Madrid earthquake per the NLE '11 scenario.
• Are there any anticipated impacts on the national
supply chain for critical drugs, biologics, drug supply chain for critical drugs, biologics, drug
products, medical devices, and/or radiological
products?
• Are there any manufacturers of critical products
within the impact zone?
Lessons Learned
Map with Official Establishment Inventory is issued
upon notification of adverse event. For NLE 11,
approx 20,000 firms in the 8 states shown on the
map.
• Need mechanism for identifying critical industries in • Need mechanism for identifying critical industries in an area.
• Official Establishment Inventories must be updated and shared on a routine basis.
• Need field staff to work with Geographic Information Specialists on mapping system.
Exercise Play
• CDER has heard of two news alerts from an
outside source as follows:
– 10,000 lbs of hydrofluoric acid spilled from a pipeline
rupture inside the Memphis ARKEMA (formerly Atofina
Chemicals, Inc.) facility, with runoff into the Tennessee
River. River.
– The National Response Center (NRC) has notified EPA
and FEMA Region 6 of a massive oil spill on the
Mississippi River and farm land bordering the river.
Exercise Play
• Recommendation1. that the emergency response by FDA be a warning not to
consume fish from the affected rivers (subsistence fisher's downstream)
2. discuss closing river to any commercial fisheries with appropriate agency contacts.appropriate agency contacts.
3. in the longer term - consider an ORA assignment (for the oil) depending on the extent of the spill and duration.
4. hydrofluoric acid could have acute effects (fish kill in river and downstream aquaculture facilities) - but based on most of the literature probably won't bioaccumulate.
Lessons Learned
• To assist with ensuring a Request For Information
(RFI) has been officially closed, Center/Office
liaison must consolidate their response then
forward to the IMG
• IMG must receive official position before sending • IMG must receive official position before sending
response to IMT.
• A representative from the Drugs Group, Biologics
Group, Devices Group, Tobacco Group, Food and
Animal Feed Safety Group must be present at the
EOC.
Exercise Play
• ORA issued sampling and limited inspection
assignment of seafood, produce, dairy products
and food processing water for CER, SWR and
SER.
• Identified sampling strategy will also be • Identified sampling strategy will also be
implemented in other impacted areas if
additional oil spills are identified and an expansion
of products could occur.
Lessons Learned
• A good mechanism is needed for assessing
conditions on the ground prior to deploying
personnel.
• The IMT need to work with the Districts/ORA to
ensure that personnel will not be deployed to ensure that personnel will not be deployed to
disaster areas that are unsafe.
• Need reliable mechanism for
assessing damage
on the ground.
Exercise Play
• Telephone service was out for a period of time.
• Email service was down during the incident.
• All IMT members did not have Blackberries.
• Public messaging was needed for states, regulated
industries and the public. industries and the public.
Lessons Learned
• A back up communication system is needed, for instances when formal communications (phones, emails) are down.– Districts had Satellite phones, but service had elapsed.
– Need a list of Satellite phone numbers and POC.
• All members of IMT need Blackberries (BB).• All members of IMT need Blackberries (BB).
• Employees need training on BB pin to pin communications.
• Determine what role the FDA Internal JIC would have in the agency’s use and monitoring of social media during an emergency.
Commit to identifying the personnel who would help
sustain response operations for a sustain response operations for a catastrophic incident over an
extended period of time.
Determine the best way to train a maximum number of agency staff
on how an IMT/IMG and the agency’s EOC function and
operate during a response to a catastrophic event.
To strengthen the agency’s overall state of preparedness, determine how to coordinate
ongoing and future training for personnel from all organizational
components.
Identify the plans, policies, and guidelines that would support guidelines that would support
these expected outcomes.
FDA Internal Joint Information Center
implementation needs to be implementation needs to be practiced.
Clear written procedures are warranted for the coordination and clearance of information to and clearance of information to be transmitted outside the agency.
ACKNOWLEDGEMENT
Office of Crisis Management, Exercise, Planning,
and Evaluation Staff
Theresa Stone
Ada Goldovsky
Christine Kepler
Anthony GarzaAnthony Garza
FDA NLE 2011 Planning Committee
FEMA
Sandy M. Ebersole, Geological Survey of Alabama
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