Global & Disaster Medicine

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PHEMCE High-Priority Threats

PHEMCE High-Priority Threats

The PHEMCE will continue to address MCM needs to protect against high-priority threats for which the Secretary of Homeland Security made a determination pose a material threat sufficient to affect national security or PHEMCE leadership determines to have the potential to threaten national health security.

This year, the PHEMCE added three chemical agents (chlorine, phosgene, and vesicants); otherwise, the high-priority threats are unchanged from those listed in the 2016 PHEMCE SIP. The PHEMCE high-priority threats are (in alphabetical order by threat area):

Biological Threats

  • Bacillus anthracis (anthrax)* and
  • Multi-drug resistant B. anthracis (MDR anthrax)*
  • Burkholderia mallei (glanders)* and
  • Burkholderia pseudomallei (melioidosis)*
  • Clostridium botulinum toxin (botulism)*
  • Ebola virus (Ebola hemorrhagic fever)*
  • Emerging infectious diseases4
  • Francisella tularensis (tularemia)*
  • Marburg virus (Marburg hemorrhagic fever)*
  • Pandemic influenza
  • Rickettsia prowazekii (typhus)*
  • Variola virus (smallpox)*
  • Yersinia pestis (plague)*
  • Chemical Threats
  • Acetylcholinesterase inhibitor nerve agents*
  • Chlorine5
  • Cyanide salts (potassium and sodium cyanide)*
  • Hydrogen cyanide*
  • Phosgene5
  • Vesicants*
  • Radiological* and Nuclear* Threats(*) indicates threats identified under the following authorities related to MCMs: (1) emergency use authorities that rely on section 564(b)(1)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); (2) priority review vouchers PRVs) under section 565A of the FD&C Act;6 and, (3) procurements of security countermeasures under section 319F-2 of the PHS Act.

 

4 EIDs continue to remain a high-priority threat for the PHEMCE. The PHEMCE developed a risk assessment framework to assess whether specific emerging pathogens should be included explicitly as a high-priority threat. These pathogens may be included if PHEMCE leadership determines they have the potential to affect national health security.

5 The PHEMCE added additional chemical threat agents to the high-priority threat list after considering multiple factors, including recent reported intentional use of agents as weapons, accidental releases, availability of agents in industry, and health impacts of exposure.

6 It is possible that a drug product meeting the requirements of section 565A (material threat MCM priority review vouchers (PRVs)) also may meet the requirements of section 524 of the FD&C Act (which enables sponsors of certain tropical disease applications to receive PRVs). However, under section 565A(e), the same application is not permitted to receive more than one voucher. U.S. Food & Drug Administration (2017). Tropical Disease Priority Review Voucher Program. https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm534162.htm and U.S. Food & Drug Administration (2017). 21st Century Cures Act: MCM-Related Cures Provisions. https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryand PolicyFramework/ucm566498.htm#prv.


What is the PHEMCE?

The PHEMCE is an interagency coordinating body led by the HHS Assistant Secretary for Preparedness and Response, comprising the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, and interagency partners at the Departments of Defense, Veterans Affairs, Homeland Security, and Agriculture. It coordinates the development, acquisition, stockpiling, and recommendations for use of medical products that we need to effectively respond to a variety of high consequence public health emergencies, whether naturally occurring or intentional.

 

EXECUTIVE SUMMARY

The 2017-2018 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP) describes the priorities that the U.S. Department of Health and Human Services (HHS), in collaboration with its interagency partners, will implement over the next five years. This strategy updates the 2016 PHEMCE SIP and fulfills the annual requirement established by Section 2811(d) of the Public Health Service (PHS) Act, as amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). The annual PHEMCE SIP provides the blueprint the Enterprise will use to enhance national health security through the procurement and effective use of medical countermeasures (MCM). Starting with this iteration of the SIP, the PHEMCE is retitling its SIP to reflect a more forward-focused strategic document by referring to the year the PHEMCE developed it as well as the following year. For example, the PHEMCE developed this SIP in 2017; therefore, it is the 2017-2018 PHEMCE SIP. The PHEMCE examines the SIP goals and objectives annually by taking into consideration the progress achieved and the remaining strategic gaps in MCM preparedness. During the development of the 20172018 PHEMCE SIP, the PHEMCE examined the goals and objectives articulated in the 2016 PHEMCE SIP and determined that no changes were necessary at this time.

The streamlined 2017-2018 PHEMCE SIP provides:

1) a summary of the major recent accomplishments;

2) new activities;

3) updates to the activities from the 2016 PHEMCE SIP; and

4) specific information required annually under PAHPRA reporting mandates.

The 2016 PHEMCE SIP identified priority activities in the near-term (fiscal year (FY) 20172018), mid-term (FY 2019-2020), and long-term (FY 2021 and beyond) timeframes. The PHEMCE maintained these timeframes in the 2017-2018 PHEMCE SIP. The PHEMCE is still pursuing activities detailed in the 2016 PHEMCE SIP unless otherwise noted in this document. All activities described are contingent on available appropriations.

 


Public Health Emergency Medical Countermeasures Enterprise

PHEMC

Public Health Emergency Medical Countermeasures Enterprise

The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) coordinates Federal efforts to enhance chemical, biological, radiological and nuclear threats (CBRN) and emerging infectious diseases (EID) preparedness from a medical countermeasure (MCM) perspective. The PHEMCE is led by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes three primary HHS internal agency partners: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as well as several interagency partners: the Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), the Department of Homeland Security (DHS) and the U.S. Department of Agriculture (USDA).

Compass PHEMCE Strategy and Implementation Plans
The HHS PHEMCE Strategy articulates the strategic direction and will guide policies and decisions for the end-to-end mission of the PHEMCE.  The HHS PHEMCE Implementation Plan identifies priorities across the PHEMCE mission areas.   Learn More >>
Budget PHEMCE Multiyear Budget
The multiyear budget highlights spending plans for the various HHS agencies within the PHEMCE and provides Congress and our external stakeholders with information on funds that have been invested in specific threat areas and future plans for investments in specific threat areas, based on availability of funds.​​ Learn More >>
Manufacturing facility 2010 PHEMCE Review
The vision to combat emerging infectious diseases, pandemics, and bioterrorism is simple: our nation must have the nimble, flexible capability to produce MCMs rapidly in the face of any attack or threat, whether known or unknown, novel or reemerging, natural or intentional.    Learn More >>
Clinician with test tubes. PHEMCE Mission Components
The PHEMCE coordinates medical countermeasure-related efforts within HHS and in cooperation with PHEMCE interagency partners.  This is a complex mission space and many Federal agencies have responsibilities that are critical to its success.  Learn More >>
U.S. Flag PHEMCE Governance
The PHEMCE evolved to address a wider array of challenges, including CBRN threats, pandemic influenza, and emerging infectious diseases.  Under this new paradigm, the PHEMCE is better positioned to address the range of cross-cutting activities that comprise the MCM development process. Learn More >>

An enormous explosion rocked a major natural gas hub in Austria on Tuesday, killing 1 employee, injuring at least 18

NY Times

 

 


Dec. 3, 1984: More than 4,000 people died after a cloud of gas escaped from a pesticide plant operated by a Union Carbide subsidiary in Bhopal, India.


About 5,000 barrels of oil, or about 210,000 gallons, gushed out of the Keystone Pipeline on Thursday in South Dakota

NY Times

 


10/20/1944: Two liquid gas tanks explode in Cleveland, Ohio, killing 130 people

History Channel


Benzene & Mercury: Dangerous health pollutants in the Houston environment after Harvey

NY Times :  “High levels of the carcinogen benzene were detected in a Houston neighborhood close to a Valero Energy refinery, local health officials said Tuesday, heightening concerns over potentially hazardous leaks from oil and gas industry sites damaged by Hurricane Harvey….”

NY Times :  “Public health officials are investigating a case of dangerous liquid mercury that appears to have washed or blown ashore here, east of Houston, in the aftermath of Hurricane Harvey.  Bobby Griffin found the clusters of shiny silver mercury globules scattered across his San Jacinto riverfront property on Tuesday, a few hundred yards from the San Jacinto Waste Pits….”


Arab media and a monitoring group reported that a Syrian chemical weapons production facility was targeted by Israeli military.

BBC

“…..The incident comes a day after UN human rights investigators said they had concluded a Syrian Air Force jet had dropped a bomb containing the nerve agent Sarin on a rebel-held town in April.

At least 83 people were killed in that attack, most of them women and children, according to the investigators……”


the crisis at Crosby has exposed the vulnerability of hundreds of chemical plants in low-lying areas across the U.S. Gulf Coast.

Washington Post

“…..The plant had 19.5 tons of organic peroxides of various strengths, all of them requiring refrigeration to prevent ignition.
But the power went out, and then the floodwaters came and knocked out the plant’s generators. A liquid nitrogen system faltered. In a last-ditch move, the workers transferred the chemicals to nine huge refrigerated trucks, each with its own generator, and moved the vehicles to a remote section of the plant.
That was doomed to fail, too. Six feet of water swamped the trucks, and the final 11 workers gave up. At 2 a.m. Tuesday, they called for a water evacuation and left the plant to its fate…….”

“…..Texas has more than 1,300 chemical plants, a large number of them in low-lying areas near the coast that are vulnerable to flooding. …..”


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