national postal model for the delivery of medical countermeasures.pdf

THE DEPARTMENTS OF HEALTH AND HUMAN SERVICES, HOMELAND

SECURITY, DEFENSE, AND JUSTICE

AND THE UNITED STATES POSTAL SERVICE

NATIONAL POSTAL MODEL FOR THE DELIVERY OF MEDICAL

COUNTERMEASURES

A) PURPOSE

To provide one integrated deliverable to address the Presidential requirement cited in Executive Order (EO) 13527, Establishing Federal Capability for the Timely Provision of Medical Countermeasures Following a Biological Attack, Section 2 as follows:

“Sec. 2. United States Postal Service Delivery of Medical Countermeasures.

(a) The U.S. Postal Service has the capacity for rapid residential delivery of medical countermeasures for self administration across all communities in the United States. The Federal Government shall pursue a national U.S. Postal Service medical countermeasures dispensing model to respond to a large-scale biological attack.

(b) The Secretaries of Health and Human Services and Homeland Security, in coordination with the U.S. Postal Service, within 180 days of the date of this order, shall establish a national U.S. Postal Service medical countermeasures dispensing model for U.S. cities to respond to a large-scale biological attack, with anthrax as the primary threat consideration.

(c) In support of the national U.S. Postal Service model, the Secretaries of Homeland Security, Health and Human Services, and Defense, and the Attorney General, in coordination with the U.S. Postal Service, and in consultation with State and local public health, emergency management, and law enforcement officials, within 180 days of the date of this order, shall develop an accompanying plan for supplementing local law enforcement personnel, as necessary and appropriate, with local Federal sworn law enforcement, as well as other appropriate personnel, to escort U.S. Postal workers delivering medical countermeasures.”

President Obama issued this EO on December 30, 2009, directing the establishment of a Federal capability for the timely provision of medical countermeasures (MCM) following a biological attack. Among other instructions, this EO directed the establishment of a national U.S. Postal Service (USPS) model (hereafter referred to as the Postal Model) for residential delivery of MCM following a biological attack as quoted above.

This Postal Model is one potential option that States or Municipalities could consider as a supplemental method for rapid MCM distribution.

The capacity of USPS to deliver self-administrable MCM within one day to every residence in an at-risk geographic area, as defined by the Incident Commander, is a unique response asset. The USPS, in conjunction with the Department of Health and Human Services (HHS) and interested local and State partners, has been working toward a national model since 2004 under the auspices of the Cities Readiness Initiative, or CRI (see section E, 2 below).

The EO calls for a national model to be developed to guide local planning for venue-specific Postal Plans, in cooperation with Federal Departments and Agencies. The model is intended to be replicable in any United States metropolitan area whose jurisdictions are willing to engage in the local pre-event preparations necessary to establish such a capability. The Postal Plan is intended to augment and supplement existing or evolving public health MCM distribution systems, not replace them; therefore it cannot be activated without integration into existing State, Local, Tribal, and Territorial (SLTT) plans. Standing capabilities must be established by each jurisdiction through collaborative planning and deployment processes, as appropriations allow.

For participating jurisdictions, venue-specific Postal Plans created in such an environment ensure coordination of USPS assets with Federal and SLTT emergency response mechanisms.

A Postal Plan will assist in the delivery of antibiotics from the Strategic National Stockpile (SNS), as well as accompanying informational material to be provided from State and/or local public health sources, that will be provided to the general population affected by a life-threatening act of biological terrorism. The model provides the framework for cooperative responsibilities among the contributing Federal organizations and the participating SLTT agencies in both the creation of standing capabilities and in rendering assistance and services to victims of such a catastrophic incident.

B) AUTHORITIES AND REFERENCES

This plan is consistent with all appropriate United States laws, policies, and other related requirements. This plan does not alter existing authorities, nor does it create new authorities. This plan does not supersede existing emergency plans or guidance, nor does it alter or impede the ability of Federal departments and agencies to carry out their specific authorities and statutory responsibilities. It is based upon appropriate legal authorities;

Presidential Executive Orders; Homeland Security Presidential Directives;

and national guidance, policies, and strategies.

Specific authorities include, but are not limited to:

Public Laws (P.L.) and Statutes:

• Defense Production Act of 1950, as amended (50 U.S.C. App. § 2061 et seq.)

• Emergency Federal Law Enforcement Assistance Act (42 U.S.C. § 10501)

• Economy Act (31 U.S.C. §1535)

• The Federal Food Drug and Cosmetic Act (21 U.S.C. § 301 et seq.)

• Federal Tort Claims Act (28 U.S.C. §§ 2671-2680)

• Health Service Programs (5 U.S.C. § 7901)

• Homeland Security Act of 2002 (P.L. 107-296, 116 Stat. 2135 (2002), codified predominately at 6 U.S.C §§ 101-557)

• Insurrection Act (10 U.S.C. §§ 331-335)

• Occupational Safety and Health Act of 1970 (29 U.S.C. § 651, et seq.)

• Post-Katrina Emergency Management Reform Act of 2006 (PKEMRA)

(P.L. 109-295, 120 Stat. 1355 (2006))

• Posse Comitatus Act (18 U.S.C. § 1385)

• The Public Health Service Act (42 U.S.C. § 201 et seq.)

• Pandemic and All-Hazards Preparedness Act (P.L. 109-417, 120 Stat.

2831 (2006))

• The Public Readiness and Emergency Preparedness (PREP) Act (42

U.S.C. §§ 247d-6d, 247d-6e)

• The Robert T. Stafford Disaster Relief and Emergency Assistance Act (42

U.S.C. § 5121, et seq.)

Presidential Directives:

• HSPD-5, Management of Domestic Incidents, February 2003

• HSPD-8, National Preparedness, December 2003

• HSPD-21, Public Health and Medical Preparedness, October 2007 Other References:

• Memorandum of Agreement Among the Departments of Health and

Human Services, Homeland Security, and the United States Postal Service for the Delivery of Antibiotics During a Catastrophic Incident, February 2004

• National Institute for Occupational Safety and Health (NIOSH) Recommendation for the Protection of Postal Mail Carrier Workers delivering Antibiotics door-to-door following an Anthrax Attack, February

• National Preparedness Guidelines, September 2007

• National Response Framework (NRF), January 2008

• National Incident Management System (NIMS), December 2008

• National Infrastructure Protection Plan (NIPP), January 2009

• National Health Security Strategy, December 2009

• Memorandum of Understanding between the Department of Health and

Human Services, Office of the Assistant Secretary for Preparedness and

Response and the United States Postal Service, Office of the Deputy Postmaster General and Chief Operating Officer on the Joint Program for the Development of Postal Capability for Medical Countermeasure Delivery, March 2010

C) FEDERAL STAKEHOLDER EMERGENCY MANAGEMENT

RESPONSIBILITIES

1. Department of Homeland Security (DHS)

The Secretary of Homeland Security is the principal Federal official for domestic incident management. Pursuant to the Homeland Security Act of 2002, the Secretary is responsible for coordinating Federal operations within the United States to prepare for, respond to, and recover from terrorist attacks, major disasters, and other emergencies.

The Secretary shall coordinate the Federal Government's resources utilized in response to or recovery from terrorist attacks, major disasters, or other emergencies if and when any one of the following four conditions applies: (1) a Federal department or agency acting under its own authority has requested the assistance of the Secretary;

(2) the resources of SLTT authorities are overwhelmed, and the appropriate SLTT authorities have requested Federal assistance; (3) more than one Federal department or agency has become substantially involved in responding to the incident; or (4) the President has directed the Secretary to assume responsibility for managing the domestic incident. As it relates to a biological attack or incident, the Secretary is responsible for conducting appropriate threat and risk assessments; developing Federal plans; coordinating the overall Federal response to the incident; developing and implementing policies that facilitate compliance with recommended public health and security measures; providing a common operating picture for all Federal Departments and Agencies; ensuring the integrity of the Nation’s infrastructure, domestic security, and continuity of government; and coordinating communication with the public.

2. Department of Health and Human Services (HHS)

The Secretary of HHS leads all Federal public health and medical responses to public health emergencies and incidents covered by the National Response Framework. The Secretary of HHS, through the Assistant Secretary for Preparedness and Response (ASPR), coordinates national Emergency Support Function (ESF) #8, Health and Medical Services preparedness, response, and recovery actions.

HHS may provide medical and public health assistance following a Stafford Act declaration by the President, but also may provide temporary assistance to States to meet health emergencies in the absence of such a declaration. HHS also conducts day-to-day activities that support an emergency response, such as medical and public health surveillance, control of communicable diseases, development and stockpiling of countermeasures, regulating food and drug safety, providing assistance to children and families, and providing Medicare and Medicaid reimbursement to providers.

3. United States Postal Service (USPS)

The USPS is designated as a support agency to HHS in ESF #8, with responsibility to “assist in the distribution and transportation of medicine and pharmaceuticals to the general public affected by a major disaster or emergency as needed.”

Under Title 39 U.S.C. § 411, the USPS is authorized to furnish property, both real and personal, and personal and non-personal services to Executive agencies, under such terms and conditions, including on a reimbursable basis, as the Postal Service and the head of the agency concerned shall deem appropriate. Frequently the first governmental entity to resume normal operations within a disaster zone, the USPS has undertaken the delivery of Federal Emergency Management Agency (FEMA) informational flyers after destructive natural events, and has agreed to provide situational awareness and transportation capabilities to response authorities under similar circumstances.

4. Department of Justice (DOJ)

DOJ has the lead responsibility for criminal investigation of terrorist acts and terrorist threats. Under HSPD-5, paragraph 8, subject to the National Security Act of 1947 and other applicable law, EO 12333, and Attorney General-approved procedures pursuant to that EO: “The Attorney General has lead responsibility for criminal investigations of terrorist acts or terrorist threats by individuals or groups inside the United States, or directed at United States citizens or institutions abroad, where such acts are within the Federal criminal jurisdiction of the United States, as well as for related intelligence collection activities within the United States. Generally acting through the Federal Bureau of Investigation, the Attorney General, in cooperation with other Federal departments and agencies charged with protecting national security, shall also coordinate the activities of the other members of the law enforcement community to detect, prevent, preempt, and disrupt terrorist attacks against the United States. Following a terrorist threat or an actual incident that falls within the criminal jurisdiction of the United States, the full capabilities of the United States shall be dedicated, consistent with United States law and with activities of other

Federal departments and agencies to protect our national security, to assisting the Attorney General in identifying the perpetrators and bringing them to justice. The Attorney General and the Secretary [of Homeland Security] shall establish appropriate relationships and mechanisms for cooperation and coordination between their two departments.” Following a biological terrorist event, DOJ’s primary response will be directed towards the investigation of the incident and the disruption of future terrorist events.

Under the National Response Framework, DOJ also has the responsibility to assist overwhelmed State and local governments with public safety and security under ESF #13. Generally speaking, ESF #13 provides Federal Public Safety and Security assistance to Federal, State, local, Tribal, and Territorial (FSLTT) law enforcement organizations overwhelmed by the results of an actual or anticipated natural or man-made disaster or an act of terrorism (AOT). DOJ is the ESF #13 Coordinator, and the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) is DOJ's ESF #13 lead coordinating agency (LCA). ESF #13 member departments and agencies include all Federal departments and agencies with law enforcement resources.

Accordingly, ESF #13 has the potential to provide a wide array of Federal law enforcement resources to assist FSLTT departments and agencies overwhelmed by a disaster or AOT.

In addition, the United States Marshals Service has responsibility to coordinate the security of SNS MCM with State and local law enforcement officials during transport from Federal control to State custody in the event of a biological attack.

5. Department of Defense (DoD)

The primary mission of the DoD and its components is national defense. Because of this critical role, resources are committed after approval by the Secretary of Defense or at the direction of the President. Many DoD components and agencies are authorized to respond to save lives, protect property and the environment, and mitigate human suffering under imminently serious conditions, as well as to provide support under their separate established authorities, as appropriate. The provision of defense support is evaluated by its legality, lethality, risk, cost, appropriateness, and impact on readiness.

When Federal military and civilian personnel and resources are authorized to support civil authorities, command of those forces will remain with the Secretary of Defense. DoD elements in the incident area of operations and National Guard forces under the command of a Governor will coordinate closely with response organizations at all levels.

D) CONCEPT OF OPERATIONS

1. Scope of the Problem

In the event of a large-scale outdoor release of an antibiotic-susceptible biohazard, such as B. anthracis, antibiotic prophylaxis will need to be delivered to the potentially exposed population within a short time frame, ideally within 48 hours of exposure, to avert the onset of disease. Scenarios placing large numbers of people at risk for infection could potentially overwhelm the capacity of SLTT authorities to respond via their traditional response modalities within the necessary time frame. Postal Model operations are based on the underlying CRI scenario – initial prophylaxis to the entire population of a large geographic area within 48 hours of the decision to deploy SNS medications.

2. Response Operations

In light of these concerns, the USPS could provide for distribution and delivery of antibiotics to residential addresses in affected metropolitan areas during the initial stages of such an event. The sudden and catastrophic nature of such an event may warrant this departure from normal public health and medical practice. These procedures would be planned for in advance of an event, and would augment, not replace, other local dispensing plans. Local public health Point of Dispensing (POD) locations will also dispense initial starter packs as well as supplemental resupplies of antibiotics in the affected area.

Jurisdictions desiring a fully capable Postal Plan response are required to engage in SLTT planning with the cooperating Federal agencies to prepare venue-specific Postal Plans to ensure coordination across emergency response mechanisms.

The task for the USPS is to deploy USPS carrier volunteers to deliver antibiotics to residents at the outset of a catastrophic incident, using the inherent efficiency of the USPS infrastructure. The Postal Model is intended to provide a quick-strike mechanism to supplement existing dispensing plans that may require additional activation and preparation time to deploy. To achieve the EO’s objective in this regard, and for a number of ancillary funding, recruitment, and training reasons, anything beyond residential MCM delivery falls outside of the approved scope of the Postal Model, including:

• USPS facilities are not available as POD sites.

• USPS employee volunteers will not distribute information sheets and/or antibiotics directly from Post Offices.

• Info sheets will only be delivered by USPS carrier volunteers in conjunction with the delivery of antibiotics to residences, not as a separate function.

• The USPS does not have nor maintain open warehouse space and thus cannot provide warehouse storage of SNS caches.

• USPS trucks cannot be utilized to transport medications or equipment from the State Receipt, Store and Stage (RSS) site, or any intermediate location, to a POD.

• USPS employee volunteers are to be solicited for roles and responsibilities relevant only to the Federally approved residential delivery model, and are not available for use as translators, non-medical staff, or as ad hoc resources at an existing POD.

• Locations such as nursing homes, hotels, universities (e.g., dormitories), or correctional facilities are single-point drop locations, not residential addresses, and therefore would not be a USPS responsibility. In cases where the USPS does not deliver to individual residences on tribal lands, the same exclusion would hold.

• The USPS will not selectively deliver antibiotics and information sheets within a ZIP Code (e.g., only to people with special needs, such as the homebound, or to a subset of routes within a ZIP Code); the decision to activate a Postal Plan will be made at a minimum on a ZIP Code basis. Therefore, deliveries of medication will be made to all residential addresses within a particular five-digit ZIP Code.

• The USPS will not provide route maps and access keys (for mail receptacles and buildings) to allow jurisdictions to execute a plan without USPS assets; nor will USPS carrier volunteers act as route guides for SLTT Public Health volunteers.

By setting these constraints on the Postal Model, the USPS does not intend to be either uncooperative to the authorities responding to such an event or uncaring to the population affected. The rationale is that divergence from the approved scope will debilitate a Postal Plan’s efficacy and delay prompt restoration of postal services, an important step in recovery operations.

In broad terms, the response procedures are as follows:

Activation

In the wake of an emergency that requires rapid distribution of MCM to all residences across all or a substantial portion of a community, Postal

Plan activation will take place in two stages: (1) preliminary notifications and subsequent activation of the local Postal Plan command and control structure, followed by (2) a formal activation when the Secretary of HHS decides to deploy the SNS based on a request from SLTT public health officers.

SLTT public health authorities, prompted by observation of an attack, detection by environmental sensors, or disease index cases, will perform whatever analysis is permitted in the severely shortened timeframe for an effective response within a given metropolitan statistical area (MSA). Those Public Health officials responsible for requesting Centers for Disease Control and Prevention (CDC) SNS assets and activation of the Postal Plan will identify the affected area where initial distribution and delivery of antibiotics to the population at risk will need to take place as soon as possible. SLTT Public Health authorities will then work with local Postal District Operations to identify the ZIP Codes corresponding to the affected area. Using this ZIP Code information, the USPS will confirm the number of residential deliveries where antibiotics will be delivered. Due to the likelihood that a distinct boundary cannot be determined, the entire metro area may be impacted.

Upon a State Governor’s decision to request that SNS assets be released by the CDC and that the Postal Plan be activated for the affected area, notification by SLTT public health authorities will be made to designated local Postal District Operations and Inspection Service contacts. These notifications are needed so the Postal Plan command structure established pre-event in that District can be activated. Some of the following steps are not necessarily performed sequentially. The decision to release the SNS and formally activate the Postal Plan for a capable city will be made by the Secretary of HHS in collaboration with the CDC, in coordination with the Secretary of Homeland Security, and in consultation with the Postmaster General (PMG) of the United States, as follows:

• Public health officials should request Federal assistance during the early stages of a public health emergency to maximize the amount of time available to provide prophylaxis and treatment to the affected population. Once SLTT health officials recognize that a public health emergency may overwhelm local, regional, and State pharmaceutical and medical materiel response assets, they may recommend that the Governor request Federal assistance through DHS or HHS. The Governor contacts the CDC Emergency Operations Center (EOC) and/or the HHS Secretary’s Operations Center (SOC) to request SNS assets, including activation of the Postal Plan. The Governor will submit a clear, concise description of the situation leading to the public health emergency. Whichever operations center receives the Governor’s request will appraise the other operations center immediately.

• The HHS SOC promptly arranges a telephone conference call per established national protocols that will include, but not be limited to, the CDC EOC, FDA EOC, the DHS National Operations Center (NOC), the Federal Bureau of Investigation (FBI) Strategic Intelligence Operations Center (SIOC), the Department of Defense National Military Command Center (NMCC), and appropriate State representative(s). In conjunction with State officials, these Federal agencies will evaluate the Governor’s request by assessing the actual or potential threat and the local resources and planning for dealing with the threat. If the Secretary of HHS concurs that local resources will be insufficient, he or she will order the deployment of SNS assets and, in consultation with the Secretary of Homeland Security, approve activation of the Postal Plan. CDC EOC will relay a projected MCM arrival schedule as soon as the information is available (quantities and timing of transport) to the State public health officials.

• The Secretary of HHS deploys assets as appropriate, including the SNS.

• The Secretary of HHS declares that this emergency justifies the issuance of an Emergency Use Authorization (EUA) (i.e., the emergency use of an unapproved product or an unapproved use of an approved product, based on a determination of a public health emergency by the Secretary of HHS, a determination of a domestic emergency by the Secretary of Homeland Security, or a determination of a military emergency by the Secretary of Defense).

• CDC, ASPR, or other Federal government agency will request an EUA from the Food and Drug Administration (FDA) Commissioner

• The Secretary of HHS, in consultation with the Secretary of

Homeland Security, will formally request that the USPS Postmaster General activate the Postal Plan for the affected city or area. To maintain consistent communication and timely situational awareness, the HHS SOC will notify the United States Postal Inspection Service (USPIS) Watch Desk, or vice versa, both of which are operational on a 24-7 basis, of any potential Postal Plan activation. The ASPR will request that, if a Postal Plan is activated, USPS HQ supply a USPS liaison to the HHS SOC on a 24-7 basis until the completion of Postal Plan activities or when released. In addition, USPS will join ESF #8 calls to discuss current issues and provide situational updates on the Postal Plan activation

• Additional Federal resources may deploy when the President has received and approved a declaration under the Stafford Act.

The decision to deploy SNS assets and to activate that Postal Plan formally will be communicated back to SLTT Public Health authorities;

SLTT Law Enforcement and Emergency Management contacts; and local Postal District Operations and Inspection Service contacts.

All available USPS employee volunteers, previously identified and provisioned with prophylaxis and barrier protection for themselves pre-event (along with the same prophylaxis for their household members), will then be notified, activated, and instructed when to come into their assigned Postal Plan Delivery Units (DU) to pick up medications, unless the State elects to transport the requisite amount of medications via State assets from their Receipt, Staging, and Storage (RSS) sites to USPS facilities, and then make delivery. USPS distribution and delivery functions are expected to be accomplished within 12 hours of receipt of assets from the RSS, as adequate security resources have been made available to meet the timeline (see Security Across Functions below).

The USPS will recruit a greater number of employee volunteers than the number of delivery assignments required during detailed delivery planning to mitigate staffing shortfalls among employee volunteers.

Recovery is possible through reassignment of route segments to allow adequate support by available employee volunteers.

Incident Management

Command and control of the greater response will be accomplished through a unified command structure, run through a city or State EOC.

MCM distribution and delivery using the USPS should be managed under the Operations Section of that unified command. Command and control procedures for Postal Plan activation and execution, developed and established pre-event, will facilitate effective communication flow between dedicated Postal Plan EOCs and partner agency EOCs.

Distribution

USPS employee volunteers will pick up prepackaged medications along with information sheets at the RSS site, unless the information sheets are prepositioned elsewhere, or the State elects to transport the MCM and informational sheets to USPS facilities directly. Required quantities per ZIP Code, thus per distribution vehicle, will be confirmed and communicated to appropriate SLTT public health officials. This inventory will be taken to the USPS DU servicing the particular five-digit ZIP Codes activated for this mission for breakdown by Postal Plan delivery assignment. A five percent excess will be built into each DU allotment to account for address adjustments.

Delivery

A uniform, predetermined quantity of prepackaged medications will be delivered to each residential mail address along with information sheets provided to postal carriers. Delivery does not include Post Office boxes or general delivery to institutions (for example, nursing homes, prisons, or university mailrooms). The USPS will cancel all mail delivery for that day for the affected ZIP Codes and for any other ZIP Codes served by the activated DU. Additionally, retail and processing operations in any activated Postal facility (for example, any DU from which Postal Plan delivery will be staged, USPS District office housing a Postal Plan EOC, or USPS processing facility involved in the Distribution function) will be suspended.

Security Across Functions

To help ensure safe and orderly distribution and delivery, and to provide a measure of confidence to the general public, security escorts for carriers performing the distribution, delivery function functions, or DU perimeter security will be provided primarily by SLTT law enforcement entities as well as other appropriate personnel as previously arranged (see Security Requirements Overview below).

Federal Law Enforcement Officer (FLEO) support may be provided subject to arrangement made during pre-planning (see Annex A below). USPS employee volunteers will provide the services outlined only where it is collectively determined during the pre-event planning process that adequate security measures have been committed. The Postal Plan will not be implemented at the time of response if security is unavailable or inadequate.

Public Information

SLTT health authorities are responsible for providing information and education about their Postal Plans and other methods of distributing

MCM. Local public information officers (PIO) will have the primary responsibility for developing press releases and disseminating recommended public safety and other actions messages. A designated lead PIO at the local level – especially in jurisdictions with multiple municipalities – should be pre-identified during planning and serve as the official release authority for public information. These lead responsibilities should be identified in the jurisdiction’s communication plan and incorporated into the activation of a Joint Information Center (JIC). It is the responsibility of the participating public health authority to provide information related to the Postal Plan to all media sources.

The DHS Office of Public Affairs will coordinate Federal interagency public communications in support of the affected SLTT partners.

Specifically, DHS will coordinate the inclusion of White House Communications, HHS, USPS, and other Federal agencies to provide direct support to local PIO requirements in the affected areas through the National Incident Communications Conference Line (NICCL).

SLTT public health authorities are responsible for requesting activation of an appropriate level JIC associated with the city or State EOC. A web-based virtual JIC may be used to facilitate communication to and among PIOs participating in the incident response. Partner agencies will provide PIOs for the response as necessary. General public messages related to a biological attack must be developed pre-incident and modified as information becomes available. Until USPS carrier volunteers have been notified and activated, information provided to the public about the Postal Plan should be limited to a general announcement about the possibility of home delivery as one of several options for distributing medications in some areas. Operational details, such as affected ZIP Codes and time frame for deliveries, will not be included at this point. Announcement of Postal Plan activation following the notification and activation of USPS carrier volunteers can then include detailed information regarding Postal Plan operations, including information about timing and affected ZIP Codes.

3. Reimbursement and Indemnification

The USPS and other responder departments and agencies, acting in their role as supporting agencies to HHS under ESF #8, will seek reimbursement, through Stafford Act mechanisms, for personnel and non-personnel costs incurred in the distribution and delivery of MCM in response to a biological attack.

Postal workers and others engaged in any aspect of planning for or carrying out duly authorized distribution, dispensing, or direct residential delivery of anthrax countermeasures are immune from liability in accordance with a declaration issued by the Secretary of HHS under the PREP Act (73 Fed. Reg. 58239 (October 6, 2008).

In addition, in instances where the PREP Act would not provide liability immunity, USPS employees providing volunteer services, pursuant to activation under the Postal Model, may have liability immunity under the Federal Tort Claims Act (FTCA) for negligent acts or omissions occurring within the course and scope of their employment for the USPS. In circumstances where the FTCA is deemed applicable, the Federal Government would stand in place of the USPS employee as the sole defendant in an FTCA action. State immunity laws may also provide some protection to USPS employees engaged in distribution of

MCM.

E) CREATING THE CAPABILITY

1. 2004 Memorandum of Agreement (MOA)

On February 18, 2004, the Secretary of HHS, the Secretary of Homeland Security, and the Postmaster General signed an MOA to make resources of the USPS available to help deliver MCM community-wide in response to a biological terrorism incident. This offer of USPS assistance became known as the Postal Plan, also referred to as the Postal Capability, Postal Module, or Postal Option.

Within the scope of the MOA, the USPS was to deliver the same predetermined initial dose of SNS preventive medications and associated local or State public health information sheets to each residential address, by use of USPS carrier volunteers, within ZIP Codes selected by local and/or State Public Health. Additionally, the MOA recognized that both health safety and security provisions must be in place before USPS employee volunteers can perform this task;

the security requirements were subsequently expanded upon by the USPIS, and the health safety requirements were more specifically defined in a NIOSH recommendation elicited by HHS and concurred with by Occupational Safety and Health Administration (OSHA). These tenets have not changed significantly since the MOA was signed, so the Concept of Operations and the requirements necessary to plan and execute an effective Postal Plan response remain largely intact and will carry over into the national model.

2. The Strategic National Stockpile and Cities Readiness Initiative

Public health jurisdictions across the country have the responsibility to develop and maintain the capability to carry out mass antibiotic dispensing and vaccination campaigns, known as mass prophylaxis, tailored to their local populations. To assist in these campaigns, the Federal Government created the SNS, composed of a number of ready-to-deploy “12-hour Push Packages” containing a broad array of items designed to treat a variety of biological agents. The CDC Division of SNS (DSNS) leaders can augment the response with products from SNS Managed Inventory (MI), which can provide larger quantities of medical supplies once specific threats are identified.

At the request of a State governor for SNS assistance, “Push Packages” and/or MI are delivered to State RSS sites for unloading and processing. “Push Package” delivery to RSS sites will occur within 12 hours of the Federal decision to deploy assets. From the RSS site, it is the State/local responsibility to ensure medical supplies are distributed to dispensing centers or treatment facilities.

The CRI is an HHS effort to accelerate the response capacity of those population centers that are considered to be at highest risk for a terrorist attack using a biological weapon (for which MCM are authorized and appropriate).

The CRI program uses the scenario of an outdoor aerosolized release of anthrax as the baseline for planning related to bio-attacks requiring the deployment of post exposure prophylaxis. The goal of these efforts is to provide preventive antibiotics to 100 percent of the potentially exposed population within 48 hours of the decision to deploy. In such an event, HHS, through the CDC DSNS, will promptly provide MCM to help protect the entire affected community.

CRI was initially made available as a grant program to 21 cities in early FY2005. These cities were chosen based on population, threat feasibility, and status as a BioWatch jurisdiction. CDC funding for the pilot group was expanded in FY2006 to include their greater MSA, and 15 other MSAs were also added. In FY2007, 36 more MSAs were added for a total of 72.

3. Postal Model Development Before the EO

In 2004, each of 21 CRI pilot cities received an Executive Briefing and participated in a CDC-sponsored Dispensing Workshop to discuss the concepts and goals of CRI. Postal distribution was one modality discussed.

In 2005, these concepts and goals were reiterated through another CDC-sponsored CRI Workshop; progress to date was reviewed.

Executive Briefings for the next 15 CRI areas followed, and in late

2006, CRI was introduced to 36 more locations. Consistent parameters for the Postal modality, based on the original MOA, have been presented during all CRI Executive Briefings and Workshops.

Initial strategic planning discussions have been held among a subset of the CRI public health departments, their law enforcement counterparts, and USPS Headquarters Program Support (HQPS) within the Office of the Deputy Postmaster General (DPMG). Lessons learned from these interactions have been incorporated into the Model.

USPS and HHS conducted proof-of-concept drills in conjunction with State and local officials (without personal protective equipment, or PPE), in Seattle, Washington, on November 11, 2006, in Philadelphia, Pennsylvania, on June 23-24, 2007, and in Boston, Massachusetts, on September 22-23, 2007. The dates were chosen to approximate CRI-type events where only medications and informational sheets are delivered (no mail delivery). The drills tested the postal delivery function as well as the distribution of medications from a local repository to USPS DU. Lessons learned were incorporated into strategic and tactical planning materials as appropriate. Summary After Action Reports (AAR) were made available through the CDC.

In 2008, HHS and USPS paused all CRI-related postal planning beyond strategic security approval (the step prior to actual deployment in a city; see adoption process below), while a pilot could be conducted in Minneapolis / St. Paul Minnesota. The pilot included a subset of the desired Minneapolis and St. Paul footprint (roughly 25%): 205,000 residences, 14 Post Offices, and 468 normal carrier routes.

Health safety support measures for the USPS employee volunteers were supported by Minnesota Department of Health and Federal Occupational Health personnel to provide antibiotic and PPE, respectively. Antibiotic pre-positioning for USPS employee volunteers and their households required an EUA, issued by the Food and Drug Administration (FDA) in October 2008, and amended in February 2009 (73 Fed. Reg. 62507 (October 21, 2008); 74 Fed. Reg. 30577 (June 26, 2009)). This authorization was informed by a HHS Home Med Kits study in St. Louis, Missouri, which determined that pre-event staging of medication in residences did not result in improper storage or misuse.

The EUA was issued following a determination of a domestic emergency by the Secretary of Homeland Security, and a declaration by the Secretary of HHS that the emergency justified use of doxycycline hyclate tablets accompanied by emergency use information (73 Fed. Reg. 58242 (October 6, 2008)). The Secretary of HHS renewed the emergency declaration (74 Fed. Reg. 51279 (October 6, 2009)) to allow continuation of the EUA. The Secretary of

HHS has the option to renew the declaration annually, as necessary, to continue the EUA.

USPS employee volunteers were screened for antibiotic use by the Minnesota Department of Health through an arrangement with affiliated local public health Medical Reserve Corps members. They were also screened by Federal Occupational Health for N-95 mask use, and underwent N-95 fit-testing. They subsequently received antibiotics and masks. A comprehensive activation and execution plan has been developed and agreed to by the partner agencies involved.

Operational capability has been successfully established in Minnesota.

This capability depends on maintenance of USPS employee volunteers, health safety programs, and distribution and delivery schema.

4. Federal Program Structure Supporting the Postal Model

a. HHS/USPS Joint Program Enterprise (JPE)

HHS and the USPS will cooperate directly on the development of the Postal Plan in participating cities electing to incorporate the postal plan into it into their local plans. The primary objective of this joint enterprise is to develop an operational and sustainable capability in these cities. A 2010 Memorandum of Understanding (MOU) between HHS and USPS sets forth their understanding regarding planned areas of cooperation to develop this capability.

HHS has committed financial resources through an initial interagency agreement (IA) to the USPS to facilitate development of the program, and has agreed to administer the Federal elements of the health safety support program for USPS employee volunteers. HHS and USPS will enter into specific IAs as needed to carry out activities anticipated under this MOU and to support the JPE. Areas of planned cooperation between USPS HQPS and HHS/ASPR/Office of Preparedness and Emergency Operations (OPEO) staff include:

• Coordinating HHS and USPS policies and planning to support the Postal modality’s operational capability and mass prophylaxis activities

• Conducting outreach to and engagement of SLTT authorities

• Tailoring existing models for and with interested municipalities

• Training HHS and USPS personnel to serve as program representatives for each of the participating cities

• Providing guidance to participating SLTT authorities regarding health safety issues

• Evaluating results of exercises and other program deliverables in partnership with SLTT authorities

• Planning and conducting meetings and workshops

HHS/ASPR has been provided appropriated funds in FY 2010 for this specific purpose, which it will use to help develop and begin promulgating the Postal Model through the mechanism of the JPE.

Continuation of both JPE activities and operational capabilities in specific municipalities will depend on a combination of future appropriations and a cost-sharing mechanism between the JPE and municipalities, which is being determined in parallel to the submittal of the Postal Model. Long-term sustainability will require the additional examination of alternative funding sources such as existing and newly developed preparedness grants.

b. Cooperation between the JPE and the Model’s Other

Federal Stakeholders

The JPE is made up of representatives from HHS and USPS.

However, the success of the postal capability will depend on maintaining teamwork between the JPE and other supporting Federal partners. For example, ongoing collaboration on issues such as security requirements is necessary for the postal capability to be a viable option.

The JPE will continue to work in close collaboration with CDC DSNS PPB consultants directly involved in the development and maintenance of venue-specific Postal Plans and the FDA Office of Counterterrorism and Emerging Threats (OCET).

The JPE, in coordination with its Federal partners, will keep the National Security Staff apprised of Postal Model development, deployment of the Postal Model as venue-specific Postal Plans, and improvements made as a result of the on-the-ground planning and exercise experience gained during those deployments.

The DHS Office of Health Affairs (OHA) will represent DHS to the JPE. OHA will serve as the DHS point of contact to provide program continuity to the National Postal Model and its framework.

OHA will participate in all activities required to represent DHS interests to resolve issues related to the national Postal Model as it matures. OHA will provide or arrange for subject matter expertise to advise SLTT jurisdictions who consider adopting the National Postal model for dispensing MCM to affected populations. OHA will provide or arrange for subject matter expert support in areas including, but not limited to: planning, requests for assistance, grant guidance, law enforcement coordination, and technical assistance.

The Special Operations Division within the ATF will represent the DOJ to the JPE, pursuant to the duties outlined in Annex A.

The Office of the Assistant Secretary of Defense for Homeland Defense & Americas' Security Affairs will represent DoD to the JPE, pursuant to the duties outlined in Annex A.

c. Geographic Scope

The Postal Model may be adopted in any United States metropolitan area. The geographical scope of the Postal capability originated with the CRI and the Postal Model still prioritizes CRI cities based on vulnerability and risk. As program funding and resources are finite, the HHS/USPS JPE will prioritize its efforts on CRI metropolitan areas opting to utilize the Postal Model, considering threat, program feasibility, stability, and continuity.

However, if a city that is not within the CRI decides to participate, the JPE will support the development of its postal capability to the fullest extent possible.

If only one metropolitan jurisdiction within a greater MSA engages the JPE, a targeted, city-specific plan will be developed. However, as the USPS operational structure (74 Customer Service Districts in total) overlaps jurisdictional boundaries, the JPE will seek to create a broader MSA-wide plan, as opposed to multiple plans with individual jurisdictions. Additionally, there may be cases where the JPE has to put plans in place with individual States when a MSA crosses State boundaries. The JPE will depend heavily on State health or emergency management authorities to coordinate Postal Plan development among a MSA’s public health / law enforcement / emergency management entities and to develop a phased-by-priority expansion plan.

5. Security Requirements Overview

Coordinated integration of a Postal Plan into comprehensive bio-terror response planning must ensure that security is in place before residential delivery can begin. Security planning is a vital component of any MCM response plan. Security requirements must be factored into both POD-based and postal delivery-based plans. Use of USPS employee volunteers for residential delivery of MCM and public health informational material hinges on establishing adequate security.

As Federal law enforcement entities likely lack the requisite number of locally or regionally based personnel, and given the inherent time constraint for effective MCM distribution using the Postal Model, each participating metropolitan area is expected to provide the appropriate security personnel needed to meet their Postal Plan needs, up to and including direct delivery to the entire residential community. It is envisioned that law enforcement personnel will be utilized for a single 12-hour shift and then released to perform other duties.

a. Role of the U.S. Postal Inspection Service (USPIS)

The USPIS is the Federal law enforcement agency and security arm for the USPS. The USPIS has the lead jurisdictional authority and responsibility for the security of USPS personnel, facilities, and assets.

The USPIS will facilitate Postal Plan security planning and implementation, including support to Federal and SLTT law enforcement to:

• Establish security objectives

• Review the qualifications USPIS considers legitimate and acceptable for potential security personnel

• Identify security resources

• Select city-specific security tactics

• Execute tactical security operations

The primary security objective and minimum security requirements cited below were determined by the USPIS in consultation with Postal Operations.

All locally based USPIS law enforcement personnel will be used to the maximum extent possible during Postal Plan activation;

however, SLTT law enforcement or other appropriate personnel will need to provide the bulk of any numerical security requirement.

b. Primary Security Objective

The primary objective of Postal Plan security is the preservation of the lives of the USPS employee volunteers so that these volunteers may in turn save lives in the affected population through the delivery of prophylaxis.

c. Minimum Security Requirements

If the Postal Model is pursued as a means of antibiotic distribution, security is necessary in three areas, recognizing assignment will be situation dependent upon activation.

Minimum assignment of personnel includes:

• At least two law enforcement or other appropriate personnel at each activated USPS DU

• One law enforcement escort vehicle for each Postal vehicle distributing delivery items from an activated State RSS Warehouse (or other central repository) to activated DUs (unless the State or city elects to perform this distribution function)

• One law enforcement or other appropriate personnel escort for each USPS carrier volunteer making residential deliveries

Note: It is envisioned that most, if not all, of the security escorts for vehicle trips between the RSS warehouse (or other central repository) and activated DU could be reused as residential delivery escorts once distribution duties have been completed.

SLTT law enforcement agencies are responsible to develop a plan, in consultation with and facilitated by the USPIS, which meets these minimum security personnel requirements. This security plan must be periodically reviewed and updated based on residential delivery changes. Local USPIS contacts will provide USPIS personnel data to include in the accounting of available security. The use of private contract security personnel, licensed to carry firearms and having appropriate training, will be considered on a case-by-case basis to augment local law enforcement in a site security role only.

The National Guard, under State Governor’s control, including established CBRNE-Enhanced Response Force Package (CERFP) assets, could be utilized and could be augmented by neighboring State assistance provided via the Emergency Management Assistance Compact (EMAC).

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