Lessons from a Major Emergency Lessons from a Major Emergency Response ExerciseResponse Exercise

Exercise Overview

NLE 2011 New Madrid Seismic Zone

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 Overview

MAKE STUFF UP

• 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

EMSe VNN

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

Sandy M. Ebersole of the Geological Survey of Alabama

• 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

Sandy M. Ebersole of the Geological Survey of Alabama

Sandy 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

Scenario Summary

• Affected three FDA Regions

– Central

– Southeast

– Southwest

Incident Management Group (IMG)

27

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.

Use of Social Media

Clearance?

Key Areas of ImprovementKey Areas of Improvement

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

Questions?