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U.S. Department of Health and Human Services

Action Step: Phase 2

Action/ Issues Lead Agency/ Supporting Agency
Phase 2: – Incident Response: Activation/Deployment/Initial & Sustained Response
Trigger: When patients present and public health officials conclude that multiple cases of Botulinum Intoxication have occurred warranting the implementation of mitigating strategies
ESF #8 Strategy: Take aggressive actions to assist State, Local, Tribal, or Territorial officials in establishing an effective post-contamination exposure program.
A. Planning and Coordination
1. Confirm clinical cases of botulinum food contamination. EMG / CDC, FDA
2. Consider a Public Health Emergency declaration Sec HHS
3. Consider a notification of a Public Health Emergency of International Concern (PHEIC) to the WHO. For more information see SOC
4. Participate in establishment of U.S. Government executive structure for management of the incident in coordination with DHS.
  • Once ESF #8 has been activated, activate federal response entities e.g. consider activation of NDMS and issue deployment orders for HHS assets to include IRCT and mission assignments for all ESF #8 supporting response activities.
  • Activate EMG and send out Activation Notice to all ESF #8 partners/LNOs establishing watch standing requirements within the Secretary’s Operations Center or alternate location.
EMG / OPDIVs, HHS Agencies, ESF #8 Partners
5. Begin to coordinate response efforts with ESF #8 Partners (DOD, VA, DHS, USDA, DOT, EPA, OSHA, DOJ, ARC, etc), other Federal Partners to provide appropriate LNOs. EMG / OPDIVs, HHS Agencies, ESF #8 Partners
6. Begin monitoring the completion of, assessing the quality of, and providing guidance to fill gaps in botulinum food contamination related public health, medical preparedness, and response operations at the federal and SLTT levels.
  • EMG publishes the SITREP and ICP as required by higher authority.
  • If IRCT was activated and deployed based on credible intelligence, the IRCT will publish the SITREP and IAP as required by the EMG.
EMG / OPDIVs, HHS Agencies, ESF #8 Partners
7. Begin or continue deployment activities of appropriate response assets. EMG / OPDIVs, HHS Agencies, ESF #8 Partners
8. Establish and sustain ongoing communication with ESF #8 partners regarding logistical and operational planning for a response to this event. EMG / OPDIVs, HHS Agencies, ESF #8 Partners

9. EMG request ASH/SG to activate PHS CC.

10. Coordinate with FBI to provide support for any criminal investigation. EMG / OPDIVs, HHS Agencies, ESF #8 Partners

11. Activate NDMS. Recommend convening the (in conjunction with IRCT ) Patient Movement Coordination Cell to review and implement patient movement plans as well as the possible use of Federal Coordinating Centers (FCC) and Patient Reception Areas (PRAs).

EMG / OPDIVs, HHS Agencies, ESF #8 Partners

12. Establish and maintain contact through and with the IRCT/REC/CMO with key SLTT health, healthcare, and community partners (Health Departments, OEM, State Hospital Association, etc.).

EMG / OPDIVs, HHS Agencies

13. IRCT/ESF #8 review and request issuance of Mission Assignments (PSMAs).

EMG / ESF #8 Partners

14. Execute ESF #8 Mission Assignments, Mission Assignment Sub-tasking Requests.

EMG / ESF #8 Partners
15. HHS Incident Response Coordination Team (IRCT).
  • Deploy to designated area
  • Submit situation reports through WebEOC including the following areas
    • Supply and logistics (requirements vs. availability)
    • Bed capacity
    • Critical care capabilities
    • Mental health impacts
    • Public health and medical support needs for at-risk populations
  • Establish liaison with local / State organizations
  • Coordinate with HHS regional personnel
  • Provide federal field management/coordination for deployed ESF #8 and HHS assets
  • Participate in appropriate conference calls / VTCs
  • Track and monitor all ESF #8 and HHS mission requests and personnel.
IRCT / EMG, OPDIVs, HHS Agencies, ESF #8 and other Federal Partners
B. Investigation and Protective Health Measures
16. Maintain situation awareness public health activities ongoing in the affected area.
  • Public Health and Human Surveillance
  • Environmental Surveillance
17. Conduct epidemiological investigation for botulinum toxin food contamination cases in coordination with public health officials to identify the source of contamination. Establish the strains or serotypes of botulinum toxin. EMG / CDC, FDA
18. Consult with FDA to ascertain the regulatory response to the contaminated product and determine the status, current data on safety and efficacy, and availability of products. EMG / OPDIVs, HHS Agencies, ESF #8 and Federal Partners
19. Assess candidate antitoxin(s) for administration under an EUA.
  • Explore the rapid development, EUA submission and issuance, and production of new biological agent antitoxins.
  • Evaluate dose optimization strategies to maximize the use of antitoxin inventory
FDA / OPDIVs, HHS Agencies, ESF #8 and Federal Partners
20. Work with manufacturer to:
  • Authorize the implementation of the antitoxin distribution plan IAW CDC (SNS and Regulatory Affairs)
  • Review or establish a replenishment strategy
  • Provide regulatory guidance to manufacturer for expeditious manufacture and shipment of antitoxin
EMG / OPDIVs, HHS Agencies, CDC, BARDA, FDA, ESF #8 and other Federal Partners
21. Provide guidance and monitor distribution of antitoxin. EMG / OPDIVs, CDC, FDA, ESF #8 and Federal Partners
22. Monitor antitoxin use.
  • Monitor antitoxin distribution. Confirm it follows existing plans for priority groups
  • Monitor reported adverse events associated with antitoxin use
  • Implement protocols and databases for monitoring antitoxin safety, and for tracking antitoxin usage
  • Support data collection efforts on the distribution of federal supplies of antitoxin, and the occurrence of adverse events following administration of antitoxin
  • Implement existing drug monitoring systems to allow population based surveillance for adverse events following the use of antitoxin
  • Use existing drug use monitoring systems to conduct population based surveillance for antitoxin events
CDC / EMG, FDA, OPDIVs, HHS Agencies, ESF #8 and Other Federal Partners.
C. Antitoxin and Ventilator Allocation

23. Consult with FDA/CDC to ascertain the regulatory status, current data on safety and efficacy, and availability of products (in the SNS, vendor inventories, etc.) such as antitoxins appropriate for the treatment of patients who have botulinum food contamination.

24. Assess candidate antitoxins for use.
  • Evaluate dose optimization strategies to maximize the use of antitoxin stocks
25. Work with manufacturer to expedite antitoxin manufacturing. ASPR & EMG / BARDA, FDA, CDC (SNS), Commercial Vendor
26. Provide regulatory guidance to manufacturer for the manufacture and shipment of antitoxin. ASPR / FDA, CDC (Regulatory Affairs), Commercial Vendors

27. Mobilize healthcare partners and request activation of State plans for distributing and administering antitoxins and ventilators.

28. Distribution of antitoxins and ventilators. CDC & EMG / SNS, Commercial Vendors
D. Healthcare and Emergency Response
29. Provide healthcare providers clinical management guidelines for hospitals, long-term care facilities, and outpatient settings.
  • Assess and resolve clinical issues related to antitoxin treatment
  • Distribute clinical management guidelines
    • Need to explore alternative sources of ventilator care e.g. home health, long term vent units, etc.
30. Continue to alert, roster and deploy federal medical and public health personnel.
  • Support hospital augmentation in affected communities to offload low acuity patients from hospitals
  • If needed, use HHS intermittent or temporary hiring authorities to roster and redirect available civilian volunteers to areas most in need
  • Deploy and track federal mortuary assets (DMORT, NDMS, DOD)
EMG / OPDIVs, HHS Agencies, DMORT, NDMS, DOD, ESF #8 and other Federal Partners.
31. Support SLTT use of Emergency Management Assistance Compact
  • (EMAC) to direct available medical and public health personnel to the affected areas.
EMG / OPDIVs, HHS Agencies, ESF #8 and Federal Partners
32. Continue to gather data on bed counts and other critical resources (e.g. ventilators and associated supplies).
  • Contact affected States and Region to determine remaining public health and medical infrastructure and assets (HHS IRCT)
    • Encourage use of Emergency Management Assistance Compact (EMAC) for emergency medical services (EMS), other medical and medical support assets
    • Contact all HHS Regional Emergency Coordinators in non affected regions to determine and coordinate:
      • Deployable medical assets
      • Receiving facilities for patient transport
    • Request receiving facilities to activate surge plans to augment their capacity (e.g., cancel elective surgery, implement early discharge of patients to nursing facilities / home, etc.)
33. If required, deploy medical materiel and pharmaceuticals from the SNS. Prepare to requisition / deploy additional antitoxin. CDC (SNS) / EMG, OPDIVs, HHS Agencies, ESF #8 and Other Federal Partners
34. Encourage the healthcare community to implement protocols related to the allocation of scarce healthcare resources.
  • Protocols that triage patients’ access to hospitalization, intensive care, and ventilators
  • Issue guidance on allocation of federal healthcare assets (personnel, equipment, supplies)
EMG / OPDIVs, HHS Agencies, ESF #8 and other Federal Partners

35. Determine if the Emergency Prescription Assistance Program (EPAP) would be required to provide pharmaceuticals or durable medical equipment in a post-hospitalization or mass care setting.

36. Assess patient transportation plans to move patients to NDMS definitive care facilities. EMG / OPDIVs, HHS Agencies, ESF #8 and Federal Partners
37. Prepare for patient movement requests as required. EMG / OPDIVs, HHS Agencies, ESF #8 and Federal Partners
38. Support / Conduct behavioral health operations. EMG / OPDIVs, HHS Agencies, ESF #8 and Federal Partners

39. Determine need to activate fatality management plans.

E. Communications and Outreach
40. Continue execution of Communications Plan.
  • Open communications with appropriate food industry leaders
  • Provide information on medical and public health response activities
  • Provide anticipatory guidance on how the public health and medical response (including fatality management) will unfold over time
  • Provide regular public updates
  • Provide regular public health updates to Congress, Governors, Mayors, SLTT health departments, local officials, faith based and community organizations, other stakeholders, and the media regularly.
41. Continue execution Media Campaign.
  • Instruct the public on preventive measures
  • Instruct the public on response measures
  • Use various communication methods accessible by the entire population, including at-risk individuals.
  • Prepare and conduct "desk-side briefings" and editorial roundtables with news media decision-makers designed to provide simple and effective public service information as a mitigating strategy

42. If a Joint Information Center (JIC) is established at the SLTT level. Coordinate communications and media activities appropriately with JIC members and approval authorities. 


43. Coordinate communications plan with SLTT Public Information Officers. ASPA to coordinate with the appropriate food production / processing industry leaders.

ASPA / ASPR, EMG, State and local JICs
44. Coordinate press releases with SLTT Public Information Officers. ASPA / ASPR, EMG, State and local JICs

45. Participate in the National Incident Communications Conference Line (NICCL) composed of federal public affairs officers as well as local and State public affairs officers.


46. Participate in coordinated interagency communications campaign.

47. Activate and surge hotline capacity for medical and behavioral health questions. ASPR / EMG, ASPA, CDC, FDA

48. Update appropriate HHS websites (ASPR, CDC, NIH, and FDA).


49. Update the active CDC-INFO telephone line to provide relative information to the public.


50. Assist the Department of State (primary agency) in coordinating international activities related biological incidents and events that pose trans-border threats. Cooperate with DOS, USDA FAS, USTR, WHO and/or foreign Health Ministries to assist in communicating real-time actions taken by the U.S. and U.S. projections of the international consequence of the event (e.g., pharmaceutical supply and distribution).


51. Coordinate with DOS (primary agency) in coordination with foreign States concerning offers of support, gifts, offerings, donations, or other aid. This includes establishing coordination with partner nations to identify the U.S.-validated immediate support in response to an incident.



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  • This page last reviewed: March 20, 2012