Exercise Overview. NLE 2011 New Madrid Seismic Zone

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1 Lessons from a Major Emergency Response Exercise

2 Exercise Overview NLE 2011 New Madrid Seismic Zone

3 Exercise Overview The scope of National Level Exercise 2011 was defined by: White House guidance 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

4 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 May 16, 2011 Exercise End Date May 19, 2011 Duration Four days

5 Exercise Overview Sponsor U.S. Department of Homeland Security (DHS)/ Federal Emergency Management Agency Program National Exercise Program Mission Respond and Recover Participation 15 federal agencies, Four FEMA regions, White House Seven states (participated or were notionally represented in the exercise play)

6 Exercise Overview Capabilities Citizen Evacuation and Shelter-in-Place Communications Critical Resource Distribution and Logistics Mass Care (Sheltering, Feeding, and Related Services) Emergency Operations Center (EOC) Management Emergency Public Information and Warning Medical Surge Long Term Recovery

7 Exercise Overview FDA Participants Three FDA Regions ORA Headquarters Offices within Office of the Commissioner All Centers Players: Over 200 Evaluators: 40

8 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 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.

9 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.

10 Exercise Overview MAKE STUFF UP

11 Exercise Overview Exercise Planning Group Office of Crisis Management - Exercise, Planning, and Evaluation Staff Representatives from ORA Developed exercise objectives which supported the agency s participation in the national interagency exercise as well as our own internal agency exercise

12 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)

13 Exercise Overview Players received information through multiple forms of communications In-person, Phone, , Virtual News Network Broadcasts 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

14 EMSe VNN

15 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 Madrid Seismic Zone (NMSZ) is named NLE 2011 was the first NLE to simulate a natural hazard

16 Sandy M. Ebersole of the Geological Survey of Alabama

17 Most seismically active area east of the Rocky Mountains Produces 200 earthquakes annually in the M 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

18 Sandy M. Ebersole of the Geological Survey of Alabama

19 Sandy M. Ebersole of the Geological Survey of Alabama

20 Sandy M. Ebersole of the Geological Survey of Alabama

21 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 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.

22 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, 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.

23 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.

24 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 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).

25 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

26 Scenario Summary Affected three FDA Regions Central Southeast Southwest

27 Incident Management Group (IMG) 27

28

29 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 & 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.

30 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.

31 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 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.

32 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 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.

33 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. The TN Department of Health requested that a point of contact for technical assistance in water treatment be provided

34 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 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]

35 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? FDA must establish a protocol with HHS on interaction during disasters; update FDA EOP accordingly.

36 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 products, medical devices, and/or radiological products? Are there any manufacturers of critical products within the impact zone?

37

38 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 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.

39

40 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. 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.

41 Exercise Play Recommendation 1. 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. 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.

42 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 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.

43 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.

44 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 disaster areas that are unsafe. Need reliable mechanism for assessing damage on the ground.

45 Exercise Play Telephone service was out for a period of time. service was down during the incident. All IMT members did not have Blackberries. Public messaging was needed for states, regulated industries and the public.

46

47 Lessons Learned A back up communication system is needed, for instances when formal communications (phones, s) 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). 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.

48 Use of Social Media Clearance?

49 Key Areas of Improvement

50 Commit to identifying the personnel who would help sustain response operations for a catastrophic incident over an extended period of time.

51 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.

52 To strengthen the agency s overall state of preparedness, determine how to coordinate ongoing and future training for personnel from all organizational components.

53 Identify the plans, policies, and guidelines that would support these expected outcomes.

54 FDA Internal Joint Information Center implementation needs to be practiced.

55 Clear written procedures are warranted for the coordination and clearance of information to be transmitted outside the agency.

56 ACKNOWLEDGEMENT Office of Crisis Management, Exercise, Planning, and Evaluation Staff Theresa Stone Ada Goldovsky Christine Kepler Anthony Garza FDA NLE 2011 Planning Committee FEMA Sandy M. Ebersole, Geological Survey of Alabama

57 Questions?

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