The flow chart below provides a summary of the process for Emergency Use Authorization (EUA) issuance.

Description of chart:

Issuance of an EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. First, one of the four following determinations must be in place:

1. The Department of Defense (DoD) Secretary issues a determination of military emergency or significant potential for military emergency
2. The Department of Homeland Security (DHS) Secretary issues a determination of domestic emergency or significant potential for domestic emergency.
3. The Department of Health and Human Services (HHS) Secretary issues a determination of public health emergency or significant potential for public health emergency
4. The DHS Secretary issues a material threat determination

After one of the above four determinations is in place, the HHS Secretary can issue a declaration that circumstances exist to justify issuing the EUA.  This declaration is specific to EUAs and is not linked to other types of emergency declarations.

The FDA Commissioner, in consultation with the HHS Assistant Secretary for Preparedness and Response (ASPR), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), can then issue the EUA, if criteria for issuance under the statute are met.  FDA publishes public notice of each EUA that is issued in the Federal Register.

The last step in the process is termination of declaration and EUA, if appropriate and needed.

STRATEGY FOR PROTECTING AND PREPARING THE HOMELAND AGAINST THREATS OF ELECTROMAGNETIC PULSE AND GEOMAGNETIC DISTURBANCES : Document

“Extreme electromagnetic incidents caused by an intentional electromagnetic pulse (EMP) attack or a naturally occurring geomagnetic disturbance (GMD, also referred to as “space weather”) could damage significant portions of the Nation’s critical infrastructure, including the electrical grid, communications equipment, water and wastewater systems, and transportation modes.

The impacts are likely to cascade, initially compromising one or more critical infrastructure sectors, spilling over into additional sectors, and expanding beyond the initial geographic regions.

EMPs are associated with intentional attacks using high-altitude nuclear detonations, specialized conventional munitions, or non-nuclear directed energy devices. Effects vary in scale from highly local to regional to continental, depending upon the specific characteristics of the weapon and the attack profile. High-altitude electromagnetic pulse attacks (HEMP) using nuclear weapons are of most concern because they may permanently damage or disable large sections of the national electric grid and other critical infrastructure control systems.

Similarly, extreme geomagnetic disturbances associated with solar coronal mass ejections (when plasma from the sun, with its embedded magnetic field, arrives at Earth) may cause widespread and long-lasting damage to electric power systems, satellites, electronic navigation systems, and undersea cables. Essentially, any electronics system that is not protected against extreme EMP or GMD events may be subject to either the direct “shock” of the blast itself or to the damage that is inflicted on the systems and controls upon which they are dependent. For these reasons, the potential severity of both the direct and indirect impacts of an EMP or GMD incident compels our national attention. …..”

Terror Gone Viral 2018 :  Document

“…. Cumulatively, over the 2014 to 2018 period covered by the Terror Gone Viral reports, ISIS has been linked to 243 incidences, averaging five terrorist incidents per month…..”

NBC

NY Daily News

• 3.4 million people are virtually without electrical power
• Food and drinking water remain scarce.
• The Merchant Marine Act of 1920, also known as the Jones Act, requires shipments between ports of the United States to be carried out exclusively by vessels built and operated by Americans.  That prevents Puerto Rico from receiving shipments from foreign countries like Jamaica, even though it may be cheaper and faster than shipping from the continental U.S.

Document:  HomelandSecurity-Haz_Risk_Assess-2013

CPG 201 provides a four-step process for conducting a Threat and Hazard Identification and Risk Assessment. Developing an understanding of its risks from natural, technological, and human-caused threats and hazards, allows a community to make informed decisions about how to manage risk and develop needed capabilities.

DHS

Office of Health Affairs

OHA anticipates the public health impact of biological attacks, chemical releases, pandemics and infectious disease threats, and disasters to help prepare the nation to respond and rebound. Our expertise supports DHS operations, its workforce, and the preparedness of public health and medical communities.

OHA advises DHS leadership about health security issues, guides DHS policies to keep its workforce safe, and coordinates stakeholders at all levels of government to prepare for, respond to, and recover from the public health consequences of national threats and hazards.

OHA helps inform federal, state, and local decision-making about high consequence biological threats with biosurveillance programs that give early warnings for a rapid response to contain and limit the impact.

OHA helps communities nationwide prepare for a chemical or biological attack and build their own capacity to respond and recover.

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