[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
DEFENDING THE HOMELAND FROM BIOTERRORISM: ARE WE PREPARED?
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
EMERGENCY PREPAREDNESS,
RESPONSE, AND RECOVERY
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
FIRST SESSION
__________
OCTOBER 17, 2019
__________
Serial No. 116-42
__________
Printed for the use of the Committee on Homeland Security
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
40-458 PDF WASHINGTON : 2020
COMMITTEE ON HOMELAND SECURITY
Bennie G. Thompson, Mississippi, Chairman
Sheila Jackson Lee, Texas Mike Rogers, Alabama
James R. Langevin, Rhode Island Peter T. King, New York
Cedric L. Richmond, Louisiana Michael T. McCaul, Texas
Donald M. Payne, Jr., New Jersey John Katko, New York
Kathleen M. Rice, New York Mark Walker, North Carolina
J. Luis Correa, California Clay Higgins, Louisiana
Xochitl Torres Small, New Mexico Debbie Lesko, Arizona
Max Rose, New York Mark Green, Tennessee
Lauren Underwood, Illinois Van Taylor, Texas
Elissa Slotkin, Michigan John Joyce, Pennsylvania
Emanuel Cleaver, Missouri Dan Crenshaw, Texas
Al Green, Texas Michael Guest, Mississippi
Yvette D. Clarke, New York Dan Bishop, North Carolina
Dina Titus, Nevada
Bonnie Watson Coleman, New Jersey
Nanette Diaz Barragan, California
Val Butler Demings, Florida
Hope Goins, Staff Director
Chris Vieson, Minority Staff Director
------
SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND RECOVERY
Donald M. Payne Jr., New Jersey, Chairman
Cedric Richmond, Louisiana Peter T. King, New York, Ranking
Max Rose, New York Member
Lauren Underwood, Illinois Dan Crenshaw, Texas
Al Green, Texas Michael Guest, Mississippi
Yvette D. Clarke, New York Dan Bishop, North Carolina
Bennie G. Thompson, Mississippi (ex Mike Rogers, Alabama (ex officio)
officio)
Lauren McClain, Subcommittee Staff Director
Diana Bergwin, Minority Subcommittee Staff Director
C O N T E N T S
----------
Page
Statements
The Honorable Donald M. Payne Jr., a Representative in Congress
From the State of New Jersey, and Chairman, Subcommittee on
Emergency Preparedness, Response, and Recovery:
Oral Statement................................................. 1
Prepared Statement............................................. 3
The Honorable Peter T. King, a Representative in Congress From
the State of New York, and Ranking Member, Subcommittee on
Emergency Preparedness, Response, and Recovery:
Oral Statement................................................. 3
Prepared Statement............................................. 9
The Honorable Bennie G. Thompson, a Representative in Congress
From the State of Mississippi, and Chairman, Committee on
Homeland Security:
Prepared Statement............................................. 10
Witnesses
Ms. Asha M. George, Dr. Ph., Executive Director, Bipartisan
Commission on Biodefense:
Oral Statement................................................. 11
Prepared Statement............................................. 12
Ms. Jennifer L. Rakeman, Assistant Commissioner and Director,
Public Health Laboratory, Department of Health and Mental
Hygiene, New York, New York:
Oral Statement................................................. 16
Prepared Statement............................................. 18
Dr. Umair A. Shah, M.D., M. Ph., Executive Director, Public
Health, Harris County, Texas:
Oral Statement................................................. 21
Prepared Statement............................................. 23
For the Record
The Honorable Peter T. King, a Representative in Congress From
the State of New York, and Ranking Member, Subcommittee on
Emergency Preparedness, Response, and Recovery:
Statement of Roger L. Parrino, Sr.............................. 5
The Honorable Sheila Jackson Lee, a Representative in Congress
From the State of Texas:
Letter From the City of Houston................................ 44
Appendix
Questions From Chairman Donald M. Payne, Jr. for Asha M. George.. 47
Questions From Honorable James R. Langevin for Asha M. George.... 48
Questions From Honorable Lauren Underwood for Asha M. George..... 49
Questions From Chairman Donald M. Payne, Jr. for Jennifer L.
Rakeman........................................................ 50
Questions From Honorable Lauren Underwood for Jennifer L. Rakeman 52
Questions From Honorable Donald M. Payne, Jr. for Umair A. Shah.. 53
Questions From Honorable Lauren Underwood for Umair A. Shah...... 54
DEFENDING THE HOMELAND FROM BIOTERRORISM: ARE WE PREPARED?
----------
Thursday, October 17, 2019
U.S. House of Representatives,
Committee on Homeland Security,
Subcommittee on Emergency Preparedness,
Response, and Recovery,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:15 a.m., in
room 310, Cannon House Office Building, Hon. Donald M. Payne,
Jr. (Chairman of the subcommittee) presiding.
Present: Representatives Payne, Rose, Underwood, Green,
King, Crenshaw, and Guest.
Also present: Representatives Langevin and Jackson Lee.
Mr. Payne. The Subcommittee on Emergency Preparedness,
Response, and Recovery will come to order.
Before we start discussing today's subject matter, I would
like to take a moment to acknowledge the passing of Congressman
Elijah Cummings. Mr. Cummings was a mentor to me on my arrival
here in Congress, as this gentleman next to me was. It is a
very emotional day for quite a few of us. Elijah Cummings was
truly a diplomat and a statesman. Irrespective of what side of
the aisle you sat, he had respect for you. He went through a
lengthy illness. I had an opportunity to speak to him on many
evenings and occasions because we had some of the same health
issues.
But this country has lost a great leader today, and I would
ask if we give a moment of silence in his honor.
[Moment of silence.]
Mr. Payne.
Thank you. I yield to the Ranking Member, Mr. King, for any
statement he would like to make.
Mr. King. Thank you, Mr. Chairman.
I want to join with you in mourning the loss of Elijah
Cummings. He was a true gentleman, a very distinguished person
to work with. Again, he somehow managed to transcend the
politics that too often drags us all down.
So, again, it is a great loss to the country, great loss to
the House of Representatives, and I think all of us are proud
to say that we served with him.
I yield back.
Mr. Payne. Thank you. The subcommittee is meeting today to
receive testimony on ``Defending the Homeland from
Bioterrorism: Are We Prepared?''
Good morning. I want to thank all of you for coming to
today's hearing about the state of bioterrorism preparedness in
the United States. I also want to thank the witnesses for
testifying on this important topic.
Bioterrorism represents a real and persistent threat to
this Nation. Biological weapons are relatively inexpensive,
simple to deliver, and can cause mass casualties. Gram for
gram, they are among the deadliest weapons created by humans.
Even with a small quantity of biological weapons, a terrorist
can cause massive harm to our society.
The Department of Homeland Security's Countering Weapons of
Mass Destruction Office has an important role in strengthening
the Nation's ability to prevent terrorists from using such
weapons of mass destruction.
Formed nearly 2 years ago, the Countering Weapons of Mass
Destruction Office, or CWMD, is the focal point for the
Department's efforts to counter WMD threats.
CWMD was created to centralize and streamline DHS's
countering weapons of mass destruction programs into a single
office that could enhance our defenses, share best practices,
leverage shared resources, and unify command.
However, there have been several recent reports that raise
concerns about CWMD. Even before these reports, our committee
had concerns about the creation of the office. We were
concerned that the reorganization would hurt employee morale,
shortchange biological defense programs, and impact DHS's
ability to carry out its important countering WMD terrorism
mission.
Recently, issues were raised about the technology behind
CWMD's new biodetection system as well as with cuts being made
to several WMD counterterrorism programs. In 2018, the Federal
Employment Morale Viewpoint survey ranked CWMD as the lowest-
scoring office in the Federal Government. Previously, the
office had been ranked in the top 20 percent of the Federal
Government in terms of morale. Such a precipitous decline in
the morale over the course of 2 years is an extremely
concerning trend.
Furthermore, the assistant secretary of CWMD Jim McDonnell,
recently resigned, leaving CWMD without a permanent leader
during this precarious time.
I should also add that, just days ago, Acting Secretary
Kevin McAleenan announced that he was resigning. DHS is
suffering a serious leadership drought and undoubtedly
complicates the Department's ability to execute its mission.
That said, providing oversight to DHS is an important and
timely function of this committee. We must assure that DHS is
adequately executing its mission to protect Americans from
weapons of mass destruction.
Today, we will hear from witnesses who are on the front
line of keeping the Nation safe from bioterrorists. We will
hear their perspectives on the threat posed by bioterrorists,
the state of National bioterrorism preparedness, and what DHS
can do better to protect this Nation from bioterrorists. This
is an important topic, and we need to make sure that we are
doing all we can to protect our Nation from the threat of
bioterrorism.
I would like again to thank the witnesses for participating
in today's hearing. I look forward to learning more about these
topics and to hearing their testimony.
[The statement of Chairman Payne follows:]
Statement of Chairman Donald M. Payne, Jr.
October 17, 2019
I want to thank you all for coming to today's hearing about the
state of bioterrorism preparedness in the United States. I also want to
thank the witnesses for testifying on this important topic.
Bioterrorism represents a real and persistent threat to this Nation.
Biological weapons are relatively inexpensive, simple to deliver, and
can cause mass casualties. Gram for gram, they are amongst the
deadliest weapons created by humans. Even with a small quantity of
biological weapons, a terrorist can cause massive harm to our society.
The Department of Homeland Security's Countering Weapons of Mass
Destruction Office has an important role in strengthening the Nation's
ability to prevent terrorists from using such weapons of mass
destruction. Formed nearly 2 years ago, the Countering Weapons of Mass
Destruction Office (CWMD) is the focal point for the Department's
efforts to counter WMD threats. CWMD was created to centralize and
streamline DHS's countering weapons of mass destruction programs into a
single office that could enhance our defenses, share best practices,
leverage shared resources, and unify command. However, there have been
several recent reports that raise concerns about CWMD. Even before
these reports, our committee had concerns about the creation of the
office. We were concerned that the reorganization would hurt employee
morale, shortchange the biological defense programs, and impact DHS's
ability to carry out its important countering WMD terrorism mission.
Recently, issues were raised about the technology behind CWMD's new
bio-detection system as well as with cuts being made to several WMD
counterterrorism programs. In 2018 the Federal Employment Morale
Viewpoint Survey ranked CWMD as the lowest-scoring office in the
Federal Government. Previously, the office had been ranked in the top
20 percent of the Federal Government in terms of morale. Such a
precipitous decline in morale over the course of 2 years is an
extremely concerning trend. Furthermore, the assistant secretary of
CWMD--Jim McDonnell--recently resigned, leaving CWMD without a
permanent leader during this precarious time.
I should also add that just days ago Acting Secretary Kevin
McAleenan announced that he was resigning. DHS is suffering a serious
leadership drought that undoubtedly complicates the Department's
ability to execute its mission. That said, providing oversight to DHS
is an important and timely function of this committee. We must ensure
that DHS is adequately executing its mission to protection Americans
from weapons of mass destruction. Today, we will hear from witnesses
who are on the front line of keeping this Nation safe from
bioterrorists. We will hear their perspectives on the threat posed by
bioterrorists, the state of National bioterrorism preparedness, and
what DHS can do to better protect this Nation from bioterrorists. This
is an important topic and we need to make sure that we are doing all we
can to protect our Nation from the threat of bioterrorism.
Mr. Payne. With that, I now recognize the Ranking Member of
the subcommittee, the gentleman from New York, Mr. King, for an
opening statement.
Mr. King. Thank you, Mr. Chairman.
As you know, our districts are very close. In fact, we are
basically one terror target, I would say. So, again, thank you
for this hearing. It is very central. It is unfortunate that
the witness for the Port Authority had to cancel at the last
minute because it is literally the Port Authority that connects
our States.
Mr. Payne. Absolutely.
Mr. King. So, anyway, with that, I will read part of my
statement and ask that the entire statement be included in the
record.
Mr. Chairman, since the horrific attacks of September 11,
the terrorist threat against the United States continues to
grow and to evolve. In recent years, the desire to use
nonconventional weapons has increased. Nation-states as well as
terrorists groups, including ISIS, have sought to employ not
only chemical and nuclear materials into their attacks but have
also shown growing interests in using biological warfare.
The President's 2018 National Biodefense Strategy states
that biological threats are, ``among the most serious threats
facing the United States and the international community.'' Not
only can biological weapons sicken, disable, and kill innocent
people on a massive scale, they can also inflict tremendous
economic and social disruption. For example, pathogens directed
against crops to induce crop failure could significantly
cripple our agricultural system.
The Federal Government has recognized the need to enhance
the Nation's abilities to counter against certain terrorist
threats. Following 9/11, several programs were created to
prevent terrorists from using weapons of mass destruction. The
Department of Homeland Security's CWMD office was authorized in
December 2018 to elevate and streamline these efforts.
Unfortunately, recent reports have indicated that the CWMD
office has significantly scaled back or eliminated the specific
programs put in place to help protect the country. According to
these reports, one eliminated practice included the work to
update a formal, strategic, and integrated assessment of
chemical, nuclear, and biological-related risks. This
assessment provided guidance on the purchasing of detection-
related technologies and medications following an attack.
The CWMD office has also been heavily criticized regarding
the BioWatch program, a monitoring system that collects and
tests air samples for biological agents likely to be used in a
bioterrorism attack.
From numerous false alarms and delayed notifications of
lethal pathogens to a questionable roll-out of the second
iteration of the program, Biodetection 21, BD21, it is clear
that the CWMD office needs to do better. The bioterrorism
threat is increasing and should be a priority.
In 2015, I was the House sponsor of the First Responder
Anthrax Preparedness Act, which requires DHS, in coordination
with Health and Human Services, to carry out a pilot program to
provide eligible anthrax vaccines from the strategic National
stockpile to emergency first responders who may be at high risk
of exposure to anthrax should an attack occur.
While this is a step in improving WMD preparedness, there
is a litany of threats beyond anthrax facing DHS and our State
and local partners. It is imperative that our communities and
first responders are well-positioned to detect, protect, and
decontaminate biological warfare agents. As the sophistication
of biological weaponry improves, we must be ready.
I look forward to hearing from our witnesses today on their
perspectives on the growing threat and how well we are
positioned to thwart any attack.
As I mentioned, Mr. Parrino, the director of preparedness
for the Port Authority was supposed to be here today. He cannot
attend, unfortunately. I would ask unanimous consent to insert
his written statement into the record.
[The statement of Mr. Parrino follows:]
Statement of Roger L. Parrino, Sr.
October 17, 2019
introduction to the port authority of new york & new jersey
The Port Authority conceives, builds, operates, and maintains
infrastructure critical to the New York/New Jersey region's
transportation and trade network. These facilities include America's
busiest airport system, including: John F. Kennedy International,
LaGuardia, and Newark Liberty International airports, marine terminals,
and ports, the PATH rail transit system, 6 tunnels and bridges between
New York and New Jersey, the Port Authority Bus Terminal in Manhattan,
and the World Trade Center. For more than 90 years, the Port Authority
has worked to improve the quality of life for the more than 18 million
people who live and work in New York and New Jersey metropolitan
region.
I. Port Authority Transportation Infrastructure
The Port Authority builds, operates, and maintains critical
transportation and trade assets that fall under our 5 lines of
business:
Aviation.--Our aviation assets include 5 airports: John F. Kennedy
International Airport, LaGuardia Airport, Newark Liberty International
Airport, Teterboro Airport and Stewart International Airport. The Port
Authority airports move an estimated 125 million passengers annually.
Rail.--Our rail and surface transportation assets include the:
Trans-Hudson Rail System (PATH). We move an average of 282,000
passengers each weekday.
Tunnels, Bridges, and Terminals.--George Washington Bridge, Bayonne
Bridge, Goethals Bridge, Outerbridge Crossing, the Port Authority Bus
Terminal, George Washington Bridge Bus Station, Journal Square
Transportation Center, Holland Tunnel, and Lincoln Tunnel. Over 115
million vehicles travel over PA's bridges and Tunnels annually.
Ports.--Port Authority also manages ports that transport vital
cargo throughout the New York and New Jersey region. The Port of New
York and New Jersey is the largest on the East Coast and the second-
largest port in the United States and moves over 3.6 million cargo
containers annually.
Commercial Real Estate.--The Port Authority also owns and manages
the 16-acre World Trade Center (WTC) site, home to the iconic One World
Trade Center.
II. Historic Terrorist Target
The Port Authority has experienced multiple terrorist threats which
reflect the ever-changing global terrorist threat--from large-scale,
well-funded organized attacks to self-radicalized self-initiated lone
actors. These acts are an ever-present reminder that we must always
remain vigilant and continue to maintain a strong security posture.
February 26, 1993, vehicle-borne improvised explosive device
(VBIED) detonated below the North Tower of the Word Trade Center. The
1,336 lb. (606 kg) urea-nitrate-hydrogen gas enhanced device killed 6
people and injured over 1,000.
June 1993, less than 4 months after the first World Trade Center
bombing, the FBI infiltrated a terrorist group who were planning on
attacking 6 well-known landmarks in Manhattan. Three of these landmarks
were Port Authority infrastructure: The George Washington Bridge, the
Lincoln Tunnel, and the Holland Tunnel. The planned attacks were to
create chaos in transportation between New Jersey and Manhattan. They
intended to drive VBIEDS into the tunnels, stall the cars in the
middle, and detonate them. The plotters were arrested before the plan
could be carried out.
September 11, 2001, 2 planes were flown into the twin towers of the
World Trade Center as part of a coordinated suicide attack including
the Pentagon and possibly the White House. Almost 3,000 people were
killed including 343 firefighters and 72 law enforcement officers, 37
of which were members of the Port Authority Police Department.
December 11, 2017, improvised explosive device (IED) pipe bomb
partially detonated in a pedestrian tunnel the adjoining the Port
Authority Bus Terminal in Manhattan, injuring 4 people including the
suspect. This event occurred in a passageway roughly 100 feet from the
Port Authority Bus Terminal, a building through which roughly 250,000
commuters traverse daily. It was the courageous acts of our Port
Authority police officers who subdued the suspect.
III. Multi-Layered Approach to Securing Assets and Protecting the
Public
The Port Authority maintains security as a top priority as
evidenced by the investments in resources it makes to that purpose.
Currently, agency-wide, 28 percent of personnel and 22 percent of the
operating budget are allocated to security. Additionally, since 2002,
more than $1.5 billion dollars has been spent on capital security
projects and another $700 million in capital security projects have
been identified for the coming years.
To protect the region's economic stability, the Port Authority's
customers, the general public, employees, and critical infrastructure,
the Office of the Chief Security Officer (OCSO) utilizes a robust
multi-layered security approach which allows for the development,
implementation, and management of programs that preserve life and
property, increase safety and security, and support the Agency's
business objectives by strengthening our resilience and continuity of
operations. With these measures in place--there is no single point of
failure. Our multi-layered approach is explained in detail below.
Intelligence-Led.--The Port Authority Police Department (PAPD)
implements intelligence-led policing to ensure our resources are
effectively deployed to prevent potential threats to our customers,
employees, and facilities. The PAPD has presence in 28 Federal, State,
and local law enforcement task forces, to include: The Federal Bureau
of Investigation Joint Terrorism Task Force (FBI JTTF) in New York and
New Jersey; the New York and New Jersey High-Intensity Drug Trafficking
Areas (HIDTA) taskforce and the New Jersey State Police Regional
Operations Intelligence Center (ROIC) this allows for the immediate
exchange of important, timely, and actionable intelligence for both
sides of the Hudson.
Additionally, we have a dedicated Intelligence Unit that is
responsible for preparing and distributing intelligence bulletins
related to transportation and security, producing daily reports
specific to domestic and global transportation issues, and
participating in the New York Police Department's Lower Manhattan
Security Initiative, which is a key provider of day-to-day actionable
intelligence relative to routine conditions like large events and
demonstrations to current and emerging threats.
These combined resources result in the agile, flexible, effective,
and efficient deployment of security and law enforcement resources that
are responsive to current and developing threats and conditions.
Risk Assessments.--The protection of critical infrastructure is
driven by all-hazards risk assessments which are performed on a regular
basis to better understand changes in threats and vulnerabilities
related to our facilities. Our periodic multi-hazard assessments look
across all agency assets and prioritize our risk so we can guide our
security investments accordingly. This risk-based approach allows for
efficient and effective allocation of human assets and financial
resources.
Police Interdiction Activities.--The PAPD is comprised of over
2,100 uniformed police officers operating across 13 Port Authority
facilities. The department also includes a Criminal Investigations
Bureau, Special Operations Division, which includes an Emergency
Services Unit and a Canine Unit (K-9), and an Aircraft Rescue and
Firefighting component at the Port Authority airports.
Through visible uniformed police presence and in partnership with
other law enforcement agencies, the PAPD suppresses crime and utilizes
counterterrorism measures to thwart potential adversaries seeking to
cause harm or disruption by way of an attack. PAPD also deploys high
visibility patrols (THREAT Teams) and specialized services to enhance
basic patrol functions utilizing intelligence-led policing concepts.
Operational Security Measures and Security Agents.--The Port
Authority implements civilian security programs to supplement our
police department activities and increase the levels of protection at
our facilities. These programs safeguard Port Authority facilities from
threats to physical infrastructure, unauthorized access to restricted
areas, cybersecurity attacks, and breaches of protected security
information. The Port Authority employs over 1,400 unarmed Uniformed
Contract Security Agents to guard our facilities and keep our employees
and customers safe.
Technology.--A critical element of a robust multi-layered approach
is the development and maintenance of advanced technology systems to
support both security and resiliency. Significant investments have been
made in the areas of Closed-Circuit Television (CCTV), access control
systems, and our perimeter intrusion detection system (PIDS). We are
engaged with several Federal agencies to develop and pilot new and
emerging technologies that show promise in addressing the security
challenges of today.
In addition, we have created a new cybersecurity program to better
monitor and respond to suspicious activities occurring on our network,
therefore strengthening our capability to protect our critical
information and industrial control systems. The Port Authority operates
a 24/7 cybersecurity operations center that can receive and respond to
threats to our network and equipment.
Engineered Hardening Solutions.--Since September 11, 2001, we have
made over $1 billion in asset hardening investments. Although faced
with the challenge of retrofitting security features into existing
facilities, we have implemented a multitude of hardening solutions such
as bollard placement, fencing installation, tunnel and guard post
hardening, floating barriers, facade glazing, flood mitigation systems,
and no trespassing signage. Prospectively, these protective measures
are built into new developments or the renovations of existing assets.
Office of Emergency Management.--The Port Authority enhances
resiliency, response, and recovery through our Office of Emergency
Management (OEM). The OEM champions programs that provide the Port
Authority with the resources, support, and capabilities to prepare for,
respond to, recover from, and mitigate against all-hazards. The OEM is
organized into three core mission areas:
Emergency Management.--Supports the Incident Command response
structure at Port Authority during events or incidents.
Additionally, responsible for all-hazard planning and training
for agency personnel and regional partners who will support our
response activities to emergencies at our facilities located in
New York and New Jersey. Through tabletop and full-scale
exercise, over 30,000 Port Authority staff and regional
partners have been trained on such topics as Active Shooter
response, PATH rail emergencies, terror attacks, and other
hazards.
Grant Management.--Administers and manages all Federal and State
Homeland Security Grants that allows us to harden our assets,
invest in technology, initiate new programs, and provide for
enhanced police protective services. This funding source is
essential to help us in continuing the security mission.
Grant programs including but not limited to the Transit Security
Grant Program (TSGP), Urban Area Security Initiative (UASI),
and the Port Security Grant Program have long supported Port
Authority security initiatives, including: Counter Terrorism
Initiative, Police Training and Equipment, WTC Transportation
Hub Security Initiatives, Cybersecurity Programs, Protection of
the PATH Under-River Tunnels, Protection of Columns at the Port
Authority Bus Terminal (PABT), Bollard Protection Initiatives,
Installations of CCTV and Access Control Systems at PATH,
Ports, and the PABT, Maritime Resilience Planning.
Risk Management and Resiliency.--Responsible for coordinating and
implementing the agency-wide all-hazard risk assessment and
oversees the Port Authority Business Continuity program.
These programs are regularly adapted to meet the needs of the Port
Authority with an impact range that stretches from individual employee
preparedness to agency-wide, corporate-level resiliency.
IV. Countering the Chemical, Biological, Radiological (CBR) Threat
The Port Authority recognizes the unique nature of a potential CBR
threat to our region and our critical transportation infrastructure.
The Port Authority has worked with the Department of Homeland
Security (DHS) and Department of Defense (DOD) on developing and
testing some of the most advanced CBR detection and response equipment
used throughout the world today. Additionally, the Port Authority has
prioritized the acquisition of CBR detection and response equipment and
ensure the most advanced levels of training for our police officers.
The Port Authority also actively follows the procedural guidance
and best practices established by the Secure the Cities Program and the
National BioWatch program. These programs provide best practices
related to CBR operational response, and also provide technical
guidance for CBR equipment and operations for post-event response.
Currently, the Port Authority provides a tiered response to
radiological detections. We rely on assistance from our Federal
partners and National laboratories for technical expertise--to confirm
or adjudicate real-world detections of radiological material.
Response assignments for biological events are coordinated through
the New Jersey State and New York City Department of Health and Mental
Hygiene through their respective public health laboratories.
The Port Authority also participates in the National BioWatch which
is an early warning defense program that seeks to prevent acts of bio-
terrorism by strategically placing Portable Sampling Units (PDUs) in
pre-identified areas of high significance. We have several PDUs
strategically placed throughout the Port Authority.
Furthermore, PAPD Emergency Service Unit (ESU) members are trained
as Hazardous Material Technicians; Commercial Vehicle Inspection Unit
(CVI) police officers are trained as Decontamination Operators; and
PAPD patrol members of the service are trained in Gross Decontamination
operations.
V. Training and Exercising for Chemical, Biological, Radiological (CBR)
The PAPD includes a cadre of highly-specialized members called the
Emergency Service Unit (ESU). ESU members receive in-house training for
HazMat certification. In addition to this baseline certification,
members of the PAPD ESU through our partnerships with DHS-FEMA's
National Domestic Preparedness Consortium, are trained in advanced
response techniques via the following programs:
Louisiana State University--National Center for Biomedical
Research and Training (LSU-NCBRT) for Biological Response.
National Nuclear Security Administration for Radiological
Response.
Energetic Materials Research and Testing Center (EMRTC) at
New Mexico Tech for Explosive Response.
The Port Authority also actively participates in Federal, State,
and local exercises related to CBR scenarios; some examples include:
Radiological--Macro-level exercises for city-wide or
regional--Improvised Nuclear Devise attacks.
Radiological--Functional exercises on response to
radiological incidents on Port Authority facilities, that
includes multi-tiered response from local command, Special
Operations, through National reach back.
Biological--Biological Functional exercises on Port
Authority facilities.
CBR--Post-event technical decontamination training.
the importance of collaboration with our federal partners in countering
the chemical, biological, radiological (cbr) threat
The Port Authority understands the importance of maintaining strong
relationships with our Federal partners. The Port Authority has
partnered with the DHS on several initiatives to study and analyze CBR
threats to Port Authority facilities and infrastructure and determine
the optimal placement of CBR detection sensors. Such programs/
initiatives include:
World Trade Center Complex Detection Optimization and
Analysis Project.--This project was completed in 2014. The
project included modeling studies and analysis conducted in
order to optimize the detection of chemical, biological, and
radiological (CBR) threat agents on the World Trade Center
(WTC) campus. This project was led by DHS--National Protection
and Programs Directorate (NPPD), Sandia National Lab, Argonne
National Lab, and Los Alamos National Lab.
Chemical Detection Program--Port Authority.--This is an on-
going project in coordination with Federal partners to test and
install chemical detection technologies at Port Authority
facilities.
PATH--Supported by DHS Science & Technology (S&T).
PABT--Supported by DHS S&T, Transportation Security
Administration (TSA), Argonne National Lab.
WTC--Supported by DHS S&T and Argonne National Lab.
Chem/Bio Advanced Capabilities Test (CBACT).--This is an on-
going project to further advance the study of chemical/
biological dispersion in NYC metro area. The Port Authority
provides infrastructure to install test sensors.
BioDetection 21 (BD21).--This is an on-going project
conducted between the Port Authority and the National BD21
initiative to advance the next generation of biological threat
detection capability. We are also working with DHS-Countering
Weapons of Mass Destruction (CWMD) on performance
characteristics to include in this new capability.
Future CBR Program/Capability/Study.--The Port Authority is
working with the Defense Advanced Research Projects Agency
(DARPA) and DHS's CWMD on developing the next generation of
detection technologies for CBR threats called SIGMA plus. The
SIGMA plus program is a collaboration between our Federal
partners and the Port Authority to research and develop new and
emerging CBR detection technologies in a real-world environment
on some of the Nation's most critical transportation
infrastructure. This builds upon the foundations established
under the SIGMA program. One of the fundamental goals of SIGMA
plus is to recognize efficiencies in CBR detection architecture
and consolidate the detection of CBR threats into a unified
system. The technological development and lessons learned from
SIGMA plus can provide a new state-of-the-art CBR detection
suite for utilization by jurisdictions across the United
States.
All of these partnerships are critical to information sharing
regarding emerging security technologies and have led to the
development and piloting of a variety of programs at Port Authority's
vast array of multi-modal facilities. These research arms of the
Federal Government need adequate funding to support the development and
testing of future technologies which aim to increase the efficiency and
effectiveness of detection devices, screening devices, and police
personal safety devices.
Furthermore, the ability for Federal entities to provide guidance
and recommendations regarding CBR products will greatly aid agency
decision makers in their selection of reliable and proven technologies
and equipment that would best protect the our officers, our
infrastructure and the traveling public.
vi. closing remarks
The Port Authority operates the busiest and most important
transportation infrastructure in the region, as such, we own the
tremendous responsibility of policing and maintaining safety and
security. The Port Authority will continue to enhance its security
programs and systems to stay current and adapt to the ever-changing
threat environment.
I would like to thank the Members of the Subcommittee on Emergency
Preparedness, Response, and Recovery of the House Committee on Homeland
Security for inviting me to testify on behalf of the Port Authority of
New York and New Jersey regarding ``Bioterrorism.''
I would like to thank our Congressional delegation for their
continuing support that allows us to better serve our employees,
customers, the region, and better protect our critical transportation
infrastructure.
Mr. King. With that, I yield back.
[The statement of Ranking Member King follows:]
Statement of Ranking Member Peter T. King
Oct. 17, 2019
Since the horrific attacks of September 11, 2001, the terrorist
threat against the United States continues to grow and evolve. In
recent years, the desire to use non-conventional weapons has increased.
Nation-states, as well as terrorist groups such as ISIS, have sought to
employ not only chemical and nuclear materials into their attacks, but
have also shown growing interest in using biological warfare.
In 2001, we witnessed first-hand the grim reality of bioweapon use
when anthrax powder was delivered through the mail, ultimately killing
5 people, sickening 17, and shutting down much of the Capitol Complex.
In 2014, a laptop reportedly recovered from an ISIS hideout contained
general information on the benefits of using biological weapons and
included instructions on weaponizing the bubonic plague. Earlier this
year, a couple in Germany who bought large quantities of ricin were
charged with plotting Islamist-motivated attacks using a biological
weapon. Additionally, many have speculated on North Korea's rapidly
advancing biological weapons capabilities.
The President's 2018 National Biodefense Strategy States that
biological threats ``are among the most serious threats facing the
United States and the international community.'' Not only can
biological weapons sicken, disable, and kill innocent people on a
massive scale, they can also inflict tremendous economic and social
disruption. For example, fungal plant pathogens directed against crops
to induce crop failure could significantly cripple our agricultural
system.
While advances in science bring faster cures, better medicines, and
improved quality of life, they also bring new security risks. The rapid
evolution of new biological techniques, like the gene editing process,
CRISPR-Cas9, can pose significant threats if used by bad actors. A 2018
ODNI threat assessment stated that biological technologies ``move
easily in the globalized economy, as do personnel with the scientific
expertise to design and use them for legitimate and illegitimate
purposes.''
The Federal Government has recognized the need to enhance the
Nation's abilities to counter against certain terrorist threats.
Following 9/11, several programs were created to prevent terrorism
using weapons of mass destruction. The Department of Homeland
Security's (DHS) Countering Weapons of Mass Destruction Office (CWMD)
was authorized in December, 2018 to elevate and streamline these
efforts. Unfortunately, recent media reports have indicated that the
CWMD office has significantly scaled back or eliminated the specific
programs put in place to help protect the country. According to
reporting, one eliminated practice included work to update a formal,
strategic, and integrated assessment of chemical, nuclear, and
biological-related risks. This assessment provided guidance on the
purchasing of detection-related technologies and medications following
an attack.
The CWMD office has also been heavily criticized regarding the
BioWatch Program--a monitoring system that collects and tests air
samples for biological agents likely to be used in a bioterrorism
attack. From numerous false alarms and delayed notifications of lethal
pathogens, to a questionable roll-out of the second iteration of the
program, Biodetection 21 (BD21), it is clear that the CWMD office needs
to do better. The bioterrorism threat is increasing and should be a
priority.
In 2015, I was the House sponsor of the First Responder Anthrax
Preparedness Act, which requires DHS, in coordination with the
Department of Health and Human Services, to carry out a pilot program
to provide eligible anthrax vaccines from the Strategic National
Stockpile to emergency first responders who may be at high risk of
exposure to anthrax should an attack occur. While this is a good step
in improving WMD preparedness, there are a litany of threats beyond
anthrax facing DHS and our State and local partners.
It is imperative that our communities and first responders are
well-positioned to detect, protect, and decontaminate biological
warfare agents. As the sophistication of biological weaponry improves,
we must be ready. I look forward to hearing from our witnesses on their
perspective on the growing threat and how well we are positioned to
thwart any attack.
Additionally, I ask unanimous consent to insert into the record
written testimony from Mr. Roger Parrino, director of preparedness,
intelligence, and inspections for the Office of the Chief Security
Officer at the Port Authority of New York and New Jersey. Mr. Parrino
was supposed to attend today's proceedings but was unfortunately called
away at the last minute.
Mr. Payne. Thank you, Mr. King. Reminder that other Members
may submit a statement for the record.
[The statement of Chairman Thompson follows:]
Statement of Chairman Bennie G. Thompson
October 17, 2019
I would like to thank the Emergency Preparedness, Response, and
Recovery Subcommittee for holding today's hearing. I want to also thank
the witnesses for joining us to lend their expertise to this important
discussion. Through the years, the Department of Homeland Security has
consistently struggled with its biodetection capabilities. BioWatch,
the Department's biological weapon detection system, was developed in
the wake of the anthrax attack on 2 U.S. Senators that followed the 9/
11 attacks.
Nefarious actors developing and using biological weapons on
American citizens is a huge threat. That is why this committee has led
significant oversight efforts of the Department's challenges with
developing adequate biodetection capabilities, and I am pleased that
this topic continues to be a priority for this subcommittee. Through
our oversight, we have learned that BioWatch has not performed as it
should. Specifically, the operation process of BioWatch is expensive,
detection time is too long, and the system has difficulty
distinguishing between normally-occurring biological agents and those
used by terrorists.
The criticism of BioWatch prompted the Department to develop
Biodetection 21 (BD21), the biodetection apparatus that is intended to
replace BioWatch. BD21 is expected to be deployed within the next few
years, though it is still unclear as to whether it will address the
biodetection capability gaps of its predecessor. We have also heard
concerning reports that highlight the shortcomings of BD21's
technology, like triggers may be less accurate, and handheld equipment
used to investigate warnings prompted by the triggers are not mature
enough to be operational. Further, the Department's Office of
Countering Weapons of Mass Destruction (CWMD) has received criticism
for its limited stakeholder outreach. Considering that State and local
public health officials will be the first to respond in the event of a
biological attack, it is troubling that they do not believe the CWMD
Office has shared enough information on the BD21 technology before
being asked to adopt the new system.
Stakeholders have also indicated that because BD21 trigger
prototypes are likely to have a much higher false positive rate than
BioWatch, it is probable that the expense of the program will increase.
Since 2013, the Department has attempted to reorganize its chemical,
biological, radiological, and nuclear mission spaces, the latest of
which established the CWMD Office in 2017. This office was intended to
elevate the Department's efforts to counter weapons of mass
destruction, but since its establishment there have been serious
operational concerns like low morale and the lack of meaningful
stakeholder engagement.
These concerns were also highlighted in a 2016 Government
Accountability Office report (GAO-16-603). I am interested to hear from
the witnesses about the extent to which the Department engages with
them on biodetection-related concerns associated with the CWMD
reorganization. I also look forward to hearing from the witnesses on
whether the CWMD reorganization has affected the Department's ability
to carry out its biodetection mission. I am interested to hear from our
witnesses about how this change will impact State and local biological
preparedness.
Mr. Payne. I want to welcome our panel of distinguished
witnesses.
Our first witness is Dr. Asha George, who is the executive
director of the Bipartisan Commission on Biodefense. Dr. George
is also a former staffer with the committee, and we are excited
to see her here today. Welcome back.
Next is Dr. Jennifer Rakeman. Dr. Rakeman is the assistant
commissioner and laboratory director at the New York City
Department of Health and Mental Hygiene. Welcome.
Last, we have Dr. Umair Shah, who is the executive director
of Harris County Public Health in Texas and the past president
of the National Association of County and City Health
Officials. Welcome.
Thank you all for being here today. I look forward to
hearing your testimonies on this important topic.
Without objection, the witnesses' full statements will be
inserted into the record.
I now ask each witness to summarize his or her statement
for 5 minutes, beginning with Dr. George.
STATEMENT OF ASHA M. GEORGE, DR. PH., EXECUTIVE DIRECTOR,
BIPARTISAN COMMISSION ON BIODEFENSE
Ms. George. Thank you, Chairman Payne.
Mr. Chairman, Ranking Member King, Mr. Crenshaw, Mr. Guest,
and the other Members of the subcommittee, thank you very much
for having me here today. I appreciate the opportunity to talk
with you. Certainly, as former professional staff of this
committee, I am particularly glad and honored to be here and
recognize the Congressional staff for their hard work to pull
this hearing together.
On behalf of former Senator Joe Lieberman and former
Governor and Secretary of Homeland Security Tom Ridge, who are
the co-chairs for our Commission, I am pleased to be here to
talk about a terrible topic, bioterrorism preparedness and our
ability to defend against biological attacks.
Our other commissioners are former Senate Majority Leader
Tom Daschle, former Representative Jim Greenwood, former
Homeland Security Advisor Ken Wainstein, and former Homeland
Security Advisor and Counterterrorism Advisor Lisa Monaco.
I mention Senator Daschle, of course because 18 years ago
this week was when his office received an anthrax letter in the
Hart Senate Office Building. That letter shut down that
building for 3 months and certainly had a wide-ranging impact
on all of the offices here on the Capitol.
Homeland in particular wound up having to change its
security protocols and continues, I know, to receive the
occasional terrible white powder package or letter. It is still
an issue for Congress, and it is still an issue for the Nation.
In October 2015, we released our first report, a National
Blueprint on Biodefense. That report contained 33
recommendations to cover the span of biological defense
activities. So we address everything from prevention and
deterrence through preparedness, detection, response,
attribution, recovery, and mitigation, so all of it. All of the
Federal departments and a number of our independent agencies
have a role to play and responsibilities for biodefense. We
tried and address as many of them as we could.
One of our recommendations was for a National Biodefense
Strategy. Congress put that in the NDAA for fiscal year 2017,
President Obama signed it, and the Trump administration
released it last year.
Unfortunately, the Federal Government hasn't been able to
get its act together quite yet to implement that strategy. But
it is on its way. At least we have a strategy for them to work
from.
I think it is important to remember that the Nation is not
adequately prepared and has not been adequately prepared for
more than a decade now. The hearings that this committee has
held numerous times demonstrate that.
Worse, current efforts to develop new technology to detect
the threat are insufficient and are going in the wrong
direction. We often talk about the threat--and I know, Chairman
Payne, you are very interested in hearing about the threat. We
have nation-state and terrorist threats to worry about. Russia,
China, North Korea, and Iran are all suspected now of
maintaining their biological weapons programs. Al-Qaeda, ISIL,
and other terrorists organizations continue to be very vocal
about their pursuit of biological weapons and have gone as far
as to put training materials up on the internet to train others
on how to execute such an action.
So we need to do something about this. The threat is still
with us, and it requires an active biodefense program,
particularly by the Department of Homeland Security.
So the Department recognizes this, and nobody disagrees
with this. As you know, we put in place a BioWatch program back
in 2003 of biological detectors throughout the Nation. That
system has not worked particularly well, as many of your
hearings have demonstrated, and so the Department decided to
create a new program called Biodetection 21, BD21.
We are not particularly supportive of that particular
program. We would like to see its goals be achieved to replace
the BioWatch system with much better detectors, but their
approach is flawed. They are not utilizing state-of-the-art
technology to test. They are not using standard acquisition
procedures. Frankly, they are not seeking the input of State
and local folks who are actually going to have to respond to
whatever happens with these.
So, of course, in conclusion, I think there are a number of
solutions, and they don't require tons of money or huge amounts
of new legislation. I would be happy to talk with you about
those further.
[The prepared statement of Ms. George follows:]
Prepared Statement of Asha M. George
October 17, 2019
Chairman Payne, Ranking Member King, and Members of the
subcommittee: Thank you for your invitation to provide the perspective
of the Bipartisan Commission on Biodefense. On behalf of our
Commission--and as a former subcommittee staff director and senior
professional staff for this committee--I am glad to have the
opportunity today to discuss our findings and recommendations with
respect to biological terrorism and National defense against biological
threats.
Our commission assembled in 2014 to examine the biological threat
to the United States and to develop recommendations to address gaps in
National biodefense. Former Senator Joe Lieberman and former Secretary
of Homeland Security and Governor Tom Ridge co-chair the commission,
and are joined by former Senate Majority Leader Tom Daschle, former
Representative Jim Greenwood, former Homeland Security Advisor Ken
Wainstein, and former Homeland Security and Counter Terrorism Advisor
Lisa Monaco. Our commissioners possess many years of experience with
National and homeland security.
In October 2015, the Commission released its first report, A
National Blueprint for Biodefense: Major Reform Needed to Optimize
Efforts. Shortly thereafter, we presented our findings and
recommendations to this committee. We made 33 recommendations with 87
associated short-, medium-, and long-term programmatic, legislative,
and policy action items. If implemented, these would improve Federal
efforts across the spectrum of biodefense activities--prevention,
deterrence, preparedness, detection and surveillance, response,
attribution, recovery, and mitigation.
Since the release of the Blueprint for Biodefense, we have
presented additional findings and recommendations in Defense of Animal
Agriculture (2017), Budget Reform for Biodefense: Integrated Budget
Needed to Increase Return on Investment (2018); and Holding the Line on
Biodefense: State, Local, Tribal, and Territorial Reinforcements Needed
(2018). We also continue to assess Federal implementation of our
recommendations. We issued our first assessment, Biodefense Indicators,
in 2016, 1 year after we released the Blueprint for Biodefense, and
found that events were outpacing Federal efforts to defend the Nation
against biological threats.
Our third recommendation in the Blueprint for Biodefense called for
the development and implementation of a National Biodefense Strategy.
The goal was for the Federal Government to take existing Presidential
directives, public laws, and international treaties, partnerships, and
instruments that address biodefense, as well as all of the many Federal
policy, strategy, and guidance documents that address bits and pieces
of biodefense, and create one comprehensive strategy that subsumes them
all. Required by Congress in the National Defense Authorization Act of
Fiscal Year 2017, signed into law by President Obama, and produced by
the Trump administration in September 2018, the National Biodefense
Strategy now exists to guide defense against biological threats to our
country.
Substantial participation is required by non-Federal partners to
help implement this strategy. State, local, Tribal, and territorial
governments, and non-Governmental stakeholders respond to the immediate
impact of biological events. There is no guarantee that Federal support
will arrive within the first few hours after a biological event occurs.
The Federal Government must greatly strengthen non-Federal capabilities
and capacities by increasing support to them. Collaboration,
coordination, and innovation are all needed--for Government policy,
public and private-sector investments, advancing science and
technology, intelligence activities, and public engagement. We also
need to foster entrepreneurial thinking and develop radically effective
solutions.
We are greatly concerned about intentionally-introduced biological
threats. Four years after the release of our initial report, the Nation
remains unprepared for bioterrorism and biological warfare with
catastrophic consequences. Worse, current efforts to develop needed
technology to detect the threat are insufficient and going in the wrong
direction.
Biodefense is not a new requirement for our country. At one time,
the United States developed both biological weapons and the ability to
defend against them. We collected intelligence on our enemies'
activities (although admittedly, we missed the continued activities of
the Former Soviet Union after we ceased our own offensive biological
weapons program). We rightly feared the specters of horrific diseases
like smallpox and worked hard to eradicate them with vaccines,
antibiotics, and other medicines. But over time, as our public health
and health care systems improved and we decided not to engage in
biological warfare, we reduced our National emphasis on, and fiscal
support for, biodefense.
The biological threat has only increased since the anthrax events
of 2001. We suspect North Korea and other countries of continuing or
creating biological weapons programs. Al-Qaeda, the Islamic State of
Iraq and the Levant, and other terrorist organizations have been quite
vocal about their active pursuit of biological weapons. We are not
alone in expressing our concerns. The United Nations, as well as
France, Germany, the United Kingdom, and other European countries;
Russia; and other nations have also articulated their suspicions and
apprehensions.
Letters containing anthrax spores were received in the Hart Senate
Office Building 18 years ago this week, shutting the building down for
3 months. One of our commissioners, former Senate Majority Leader Tom
Daschle, was the target of one of those letters. More were sent to
other locations. Anthrax killed 5 people, made 17 others sick, reduced
business productivity, and forced us to engage in costly
decontamination, remediation, and treatment after the fact. Clearly,
the Nation was not adequately prepared.
Today, the biological threat has not ebbed. No Federal department
or agency disagrees with this assessment. The Department of State
believes that Russia and North Korea continue activities to develop
biological weapons, and is unsure whether China and Iran have
eliminated their biological warfare programs. Nation-states such as
China and Russia hardly bother to hide their efforts to drive high
biotechnology, much of which is dual-use and could be easily turned to
produce large quantities of biological agents and weapons. China alone
will invest about $12 billion to advance biotechnology innovation from
2015 to 2020. Terrorist organizations continue to place training
materials on-line for conducting biological attacks with anthrax,
botulism, and other biological agents. Ebola was never fully eradicated
and defies control to this day. And the U.S. Army Medical Research
Institute of Infectious Diseases, one of the Nation's most important
laboratories for research on biological agents and deadly diseases for
which we have no cure is currently shut down because it failed to meet
biosafety standards.
The Director of National Intelligence again testified about the
biological threat before Congress this year, expressing the
intelligence community's growing concern about the increasing diversity
of, and ability to develop, traditional and novel biological agents;
ways in which they can be used in attacks; ability to produce
biological weapons; and the risks they pose to economies, militaries,
public health, and agriculture of the United States and the world. The
National Intelligence Council also made similar statements in its
latest Global Trends report, focusing on the risk associated with
synthetic biology and genome editing, and how advances in biotechnology
are making it easier to develop and use biological weapons of mass
destruction.
Given the severity of the threat, the Federal Government has spent,
and continues to spend, millions to develop, improve, and deploy
technology in hopes of rapidly detecting biological attacks. Effective
environmental surveillance should assist with pathogen identification
and provide early warning. Unfortunately, as this committee is well
aware, the equipment designed to detect airborne biological
contaminants do not perform well and have not progressed significantly
since their initial deployments. The Federal Government has also failed
to efficiently and comprehensively integrate and analyze human, animal,
plant, water, and soil surveillance data.
The United States launched the BioWatch biodetection program in
2003, but its potential remains unrealized. As of 2019, BioWatch uses
the same technology (e.g., manual filter collection, laboratory
polymerase chain reaction testing) as it did 6 years ago. The
Department of Homeland Security Office of Countering Weapons of Mass
Destruction oversees the BioWatch program of Nationally-distributed
detectors that sample the air for a select number of pathogens. Non-
Federal public health laboratories then analyze the samples.
Technological limitations of the system include: (1) Reliance on wind
blowing in optimal directions; (2) taking up to 36 hours to provide
notification of the possible presence of a pathogen; (3) inactivation
of specimens, preventing determinations of whether live organisms were
released; and (4) inability to differentiate between normal background
and harmful pathogens. Additionally, Federal agencies involved in
determining what to do with BioWatch-related test results often
disagree as to what course of action should be taken and do not always
consult non-Federal public health and other leaders, even though they
often must make many response decisions.
Late last year, the Department of Homeland Security announced a new
initiative--Biodetection 21 or BD21--to replace existing, inadequate
BioWatch technology. This effort has already seen its share of
problems. The Department is not testing state-of-the-art technology.
The Department has not established requirements for new platforms. The
Department has not sought comprehensive input from relevant
stakeholders. Instead, BD21 is testing old Department of Defense
technology for domestic use, rather than evaluating more current and
advanced Department of Defense candidates. Some of the technology under
evaluation may itself be flawed, lacking sufficient validity and
reliability data. State, local, Tribal, and territorial partners have
been left almost entirely out of the loop. They are unsure if they can
support the system, because no vision for it has been communicated to
them, other Federal partners, and Congress. These characteristics do
not provide a good basis for success.
The Bipartisan Commission on Biodefense supports efforts to
develop, deploy, and maintain effective biodetection technology. We
support efforts to replace poor and nonfunctioning BioWatch technology.
We support Congressional efforts to ensure that the $80 million in
taxpayer funds spent annually on BioWatch is used wisely going forward.
The Department of Homeland Security must engage in good Government
by identifying requirements with non-Federal Governmental
representatives, testing candidates with scientific and organized
processes, and utilizing standard acquisition procedures in awarding
contracts. We continue to recommend that the Department of Defense
transfer more advanced, far-better-performing biodetection technology
to the Department of Homeland Security for domestic testing. We also
recommend that the Department of Homeland Security reengage its Science
and Technology Directorate, as the problem is now, and has always been,
one of basic, applied science. It may also be time to reach back to the
National laboratories that worked on biodetectors in the late 1990's
and which continue to conduct research in this arena for assistance.
Finally, Congress needs to reexamine authorization of, and
appropriations for, this program and that of the National
Biosurveillance Integration System and Center. The biological threat is
increasing, our Nation grows increasingly vulnerable to this threat,
and the catastrophic consequences are far too great to ignore.
Once again, thank you for this opportunity to address biodefense.
We appreciate the committee's interest in our Commission since its
inception. I also thank Hudson Institute, which serves as our fiscal
sponsor, and all of the organizations that support our efforts
financially and otherwise. We look forward to continuing to work with
you to strengthen National biodefense.
Please see our bipartisan report, A National Blueprint for
Biodefense* and our other reports for more details regarding the
following 33 recommendations:
---------------------------------------------------------------------------
* The document has been retained in committee files and is
available at https://biodefensecommission.org/reports/a-national-
blueprint-for-biodefense/.
---------------------------------------------------------------------------
1. Institutionalize biodefense in the Office of the Vice President
of the United States.
2. Establish a Biodefense Coordination Council at the White House,
led by the Vice President.
3. Develop, implement, and update a comprehensive National
biodefense strategy.
4. Unify biodefense budgeting.
5. Determine and establish a clear Congressional agenda to ensure
National biodefense.
6. Improve management of the biological intelligence enterprise.
7. Integrate animal health and One Health approaches into
biodefense strategies.
8. Prioritize and align investments in medical countermeasures
among all Federal stakeholders.
9. Better support and inform decisions based on biological
attribution.
10. Establish a National environmental decontamination and
remediation capacity.
11. Implement an integrated National biosurveillance capability.
12. Empower non-Federal entities to be equal biosurveillance
partners.
13. Optimize the National Biosurveillance Integration System.
14. Improve surveillance of, and planning for, animal and zoonotic
outbreaks.
15. Provide emergency service providers with the resources they
need to keep themselves and their families safe.
16. Redouble efforts to share information with State, local,
Tribal, and territorial partners.
17. Fund the Public Health Emergency Preparedness cooperative
agreement at no less than authorized levels.
18. Establish and utilize a standard process to develop and issue
clinical infection control guidance for biological events.
19. Minimize redirection of Hospital Preparedness Program funds.
20. Provide the financial incentives hospitals need to prepare for
biological events.
21. Establish a biodefense hospital system.
22. Develop and implement a Medical Countermeasure Response
Framework.
23. Allow for forward deployment of Strategic National Stockpile
assets.
24. Harden pathogen and advanced biotechnology information from
cyber attacks.
25. Renew U.S. leadership of the Biological and Toxin Weapons
Convention.
26. Implement military-civilian collaboration for biodefense.
27. Prioritize innovation over incrementalism in medical
countermeasure development.
28. Fully prioritize, fund, and incentivize the medical
countermeasure enterprise.
29. Reform Biomedical Advanced Research and Development Authority
contracting.
30. Incentivize development of rapid point-of-care diagnostics.
31. Develop a 21st Century-worthy environmental detection system.
32. Review and overhaul the Select Agent Program.
33. Lead the way toward establishing a functional and agile global
public health response apparatus.
Mr. Payne. Thank you very much.
I now recognize Dr. Rakeman to summarize her statement for
5 minutes.
STATEMENT OF JENNIFER L. RAKEMAN, ASSISTANT COMMISSIONER AND
DIRECTOR, PUBLIC HEALTH LABORATORY, DEPARTMENT OF HEALTH AND
MENTAL HYGIENE, NEW YORK, NEW YORK
Ms. Rakeman. Thank you.
Good morning, Chairman Payne, Ranking Member King, and
Members of the subcommittee. I am Dr. Jennifer Rakeman,
assistant commissioner and laboratory director of the Public
Health Laboratory at the New York City Department of Health and
Mental Hygiene.
On behalf of Mayor Bill de Blasio and Health Commissioner
Dr. Oxiris Barbot, thank you for the opportunity to testify on
New York City's biothreat detection efforts and on-going work
to prepare for and respond to public health emergencies.
I am here today to discuss the vital role that public
health plays in biothreat detection efforts and how the New
York City Health Department collaborates with city agencies and
coordinates with State and Federal partners to prepare for and
respond to emergencies.
Our Nation's public health and health care infrastructure
play a critical role in protecting people from a range of
hazards, including bioterrorism and infectious diseases. Local
public health departments and their partners are on the front
lines and are often the first to detect and respond to disease
outbreaks.
Core public health infrastructure at the local level
requires state-of-the-art laboratories and electronic
surveillance systems. We also need highly-skilled staff, such
as laboratory leadership, lab bench technologists,
epidemiologists, informatics specialists, and emergency
management and response experts to enable the people and
systems to operate efficiently during emergencies.
What we do every day at the local level is backed by our
partners at the Federal level, such as the Centers for Disease
Control and Prevention and the Department of Homeland Security.
For this system to work, each piece must be appropriately
resourced and engage in on-going transparent communication and
collaboration.
As the largest, most densely-populated city in the United
States, New York City is an international hub for business,
media, and tourism. Consequently, we face a high risk of both
intentionally disseminated and naturally-occurring hazards. A
biological attack or large-scale infectious disease outbreak in
New York City would significantly impact the health, security,
economy, and political stability not only of the city but of
the rest of the country and will have an international impact.
The New York City Public Health Laboratory is a local
laboratory that serves a population larger than that of most
States. It has been central to the New York City response to
the Amerithrax letters in 2001, the H1N1 outbreak in 2009,
Ebola in 2014, Zika in 2016, and the recent unprecedented
measles outbreak in New York.
In addition, the New York City Public Health Lab, in
coordination with the CDC's Laboratory Response Network,
provides local diagnostic testing for emerging and highly-
pathogenic diseases, including Ebola virus disease and Middle
East Respiratory Syndrome coronavirus, or MERS.
Seven days after the 9/11 attacks in 2001, letters tainted
with Bacillus anthracis, which causes anthrax, were sent to
media companies and Congressional offices. The investigation
that followed resulted in a Nation-wide focus on bioterrorism
and identified significant gaps in our ability to protect the
public's health.
In 2003, as a result of this investigation, BioWatch was
created and quickly rolled out to a number of jurisdictions,
including New York City. BioWatch is intended to serve as an
early warning system of a wide-spread attack with one of a
small number of potential biological threat agents.
As the lead scientific agency for the New York City
BioWatch program, the health department is responsible for the
day-to-day technical oversight of the BioWatch laboratory
testing and the development of environmental sampling plans to
be deployed in the event of a BioWatch detection.
While the Public Health Laboratory hosts the BioWatch lab,
neither the PHL, nor the New York City Health Department, has
input regarding the standard operating procedures and testing
reagents used for BioWatch testing. Further, the local
jurisdictions do not have detailed information regarding basic
performance characteristics of the tests to which we are asked
to respond.
However, as the Public Health Lab director, I am
responsible for determining that a BioWatch result is valid and
is a BioWatch actionable result, or BAR, to be reported to
local Federal partners and to determine what response actions
will be taken.
In 2010, after New York City experienced an unacceptable
increase in the number of false positive BioWatch testing
results, the New York City Public Health Lab revised the
testing algorithm to differ from the National BioWatch program
standard to require additional verification to minimize this
threat of a false positive BAR.
New York City has taken a leadership role Nationally in
pushing for a better system that provides reliable results. As
the committee is aware, DHS is proposing to replace BioWatch
with a new system, BD21, the intention of which is to detect a
potential release in near-real time. BD21 will use real-time
detectors of biological anomalies in the field to signal the
initiation of additional sample collection and testing.
A biodetection program is an essential public health tool
for a global city like New York. We understand the need for a
reliable biodetection system and applaud the efforts to improve
upon the current system, both in the timing of detection and
the reliability of the assays.
However, both BioWatch and the proposed BD21 systems fail
to meet even minimum standards that any other test deployed in
a public health laboratory would need to meet.
While we support advancing the current BioWatch program to
take advantage of modern biothreat detection technology, we
have concerns about the deployment of this new program and the
options under evaluation as part of BD21.
Instruments currently deployed for military use, which have
generated regular false alarms, are being considered for
implementation in New York City and throughout the country.
Biothreat detection systems requirements for urban settings
like New York fundamentally differ from the requirements for
those used in military settings.
Mr. Payne. Please wrap up.
Ms. Rakeman. The implications for launching a substantial
response based on a false positive are far-reaching and will
have associated morbidity and mortality.
It is imperative that DHS has an on-going dialog with other
Federal partners, such as CDC and ASPR and, critically, with
local jurisdictions throughout this process.
Chairman Payne and Ranking Member King, thank you once
again for inviting me to testify today. Our concerns regarding
BioWatch, BD21, and the need for a stable investment in public
health preparedness are shared by cities across the Nation.
[The prepared statement of Ms. Rakeman follows:]
Prepared Statement of Jennifer L. Rakeman
October 17, 2019
Good morning Chairman Payne, Ranking Member King, and Members of
the subcommittee. I am Dr. Jennifer Rakeman, assistant commissioner and
laboratory director of the Public Health Laboratory at the New York
City Department of Health and Mental Hygiene (NYC Health Department).
On behalf of Mayor Bill de Blasio and Health Commissioner Dr. Oxiris
Barbot, thank you for the opportunity to testify on New York City's
(NYC) biothreat detection efforts and on-going work to prepare for and
respond to public health emergencies.
public health and emergency preparedness
I am here today to discuss the vital role that public health plays
in biothreat detection efforts and how the NYC Health Department
collaborates with city agencies and coordinates with State and Federal
partners to prepare for and respond to emergencies.
Our Nation's public health and health care infrastructure play a
critical role in protecting people from a range of hazards, including
bioterrorism and infectious diseases. Local public health departments
and their partners are on the front lines and are often the first to
detect and respond to disease outbreaks. What we do every day at the
local level is backed by our partners at the Federal level, such as the
Centers for Disease Control and Prevention (CDC) and the Department of
Homeland Security (DHS). For this system to work, each piece must be
appropriately resourced and engage in on-going transparent
communication and collaboration.
A robust public health infrastructure saves lives and is crucial
for all jurisdictions. Core public health infrastructure at the local
level requires state-of-the-art laboratories and electronic
surveillance systems. We also need highly-skilled staff such as
laboratory leadership, bench technologists, epidemiologists,
informatics specialists, and emergency management and response experts
who enable the people and systems to operate effectively during
emergencies. Core public health infrastructure is essential to detect
and respond to emerging diseases and outbreaks. Without it, we risk the
rapid spread of disease, increased illness, and death. It is therefore
critical to our Nation's security that local health departments receive
the necessary resources to maintain these capabilities.
Public health and health care system readiness noticeably expanded
and improved after 9/11, with an influx of Federal preparedness funding
from the CDC and the Assistant Secretary for Preparedness and Response
(ASPR). Public health departments and health care systems have used
these funds to invest in staff, purchase equipment and instrumentation,
implement critical information technology (IT) systems, and create
response plans. Adequate funding allows operators to train and exercise
these plans to prepare for a broad range of emergencies and maintain a
strong, experienced workforce necessary for a robust response.
new york city context
As the largest, most densely-populated city in the United States,
NYC is an international hub for business, media, and tourism.
Consequently, we face a high risk of both intentionally disseminated
and naturally-occurring hazards. A biological attack or large-scale
infectious disease outbreak in NYC would significantly impact the
health, security, economy, and political stability of not only the
city, but the rest of the country, and will have international impact.
The NYC Public Health Laboratory (PHL) serves a population larger than
that of most States. It has been central to the NYC response to the
Amerithrax letters in 2001, H1N1 outbreak in 2009, Ebola in 2014, Zika
virus in 2016, and the recent, unprecedented measles outbreak. In
addition, the NYC PHL, in coordination with the CDC's Laboratory
Response Network (LRN), provides local diagnostic testing for emerging
and highly pathogenic diseases including Ebola virus disease and Middle
East respiratory syndrome corona virus (MERS-CoV).
Seven days after the 9/11 attacks in 2001, letters tainted with
Bacillus anthracis were sent to media companies and Congressional
offices. The investigation that followed resulted in a Nation-wide
focus on bioterrorism and identified significant gaps in our ability to
protect the public's health. In 2003, as a result of this
investigation, BioWatch was created and quickly rolled out to a number
of jurisdictions, including NYC. BioWatch is intended to serve as an
early warning system of a wide-spread attack with one of a small number
of potential biological threat agents.
As the lead scientific agency for the NYC BioWatch program, the NYC
Health Department is responsible for the day-to-day technical oversight
of BioWatch laboratory testing and is responsible for the development
of environmental sampling plans to be deployed in the event of a
BioWatch detection. While the NYC PHL hosts the BioWatch laboratory,
neither the NYC PHL nor the NYC Health Department has input regarding
the standard operating procedures and testing reagents used for
BioWatch testing. Further, the local jurisdictions do not have detailed
information regarding basic performance characteristics of the tests to
which we are asked to respond. However, as the PHL Laboratory Director,
I am responsible for determining that a BioWatch result is valid and is
a ``BioWatch Actionable Result'' (or BAR) to be reported to local and
Federal partners to determine what response actions will be taken.
In 2010, after NYC experienced an unacceptable increase in the
number of false positive BioWatch testing results, the NYC PHL revised
the testing algorithm to differ from the National BioWatch program
standard to require additional verification to minimize the threat of a
false positive BAR. The same BioWatch reagents and testing standard
operating procedures are used, as required by the BioWatch program, but
part of the test is repeated in the NYC algorithm as a check of the
initial positive result.
cooperation with federal partners
NYC has taken a leadership role Nationally in pushing for a better
system that provides reliable results, and has worked closely with the
CDC, DHS, and other jurisdictions to inform the building of a biothreat
detection architecture with acceptable performance characteristics
required in urban and civilian settings. As the committee is aware, DHS
is proposing to replace BioWatch with a new detection system,
BioDetection 21 (BD21), the intention of which is to detect a potential
release in near real-time. BD21 will use real-time detectors of
``biological anomalies'' in the field to signal the initiation of
additional sample collection and testing. A biodetection program is an
essential public health tool for a global city like NYC. We understand
the need for a reliable biodetection system and applaud the efforts to
improve upon the current system, both in the timing of detection and
the reliability of the assays. However, both BioWatch and the proposed
BD21 systems fail to meet even minimum standards that any other test
deployed in a public health laboratory would need to meet.
While we support advancing the current BioWatch program to take
advantage of modern biothreat detection technology, we have concerns
about the deployment of this new program and the options under
evaluation as part of BD21. Instruments currently deployed for military
use, which have generated regular false alarms, are being considered
for implementation in NYC and throughout the country. Biothreat
detection system requirements for urban settings like NYC fundamentally
differ from the requirements for those used in military settings. The
implications for launching a substantial response based on a false-
positive biothreat detection could have profound economic consequences
and will have associated morbidity and mortality.
DHS has communicated very little about the program and has made it
clear that jurisdictions will need to develop response plans without
any input or consideration to the technology deployed, evaluation
plans, or access to evaluation data. Local public health agencies have
been left out of the conversation and, at best, are receiving very
limited information and no data. Active, on-going collaboration between
local, State, and Federal partners is critical to the development and
deployment of a successful biodetection program. It is imperative that
DHS has an on-going dialog with other Federal partners, such as CDC and
ASPR, and, critically, with State and local jurisdictions throughout
this process. The local end-users must be confident that the system is
based on scientifically-sound principles, that it will be used
appropriately, and that the technology will generate information with
sufficient fidelity for an actionable response. We are grateful for the
subcommittee's interest in this matter.
importance of federal emergency preparedness funding
A strong public health and health care system preparedness and
response infrastructure is an essential component of National security
to any biodetection program. However, significant cuts in Federal
funding have hampered State and local readiness at a time when emerging
diseases are spreading faster than ever before. NYC relies on Federal
funding to prepare for, detect, and respond to public health
emergencies. Over the past 14 years, this funding has been
significantly reduced--including a 34 percent cut to the Public Health
Emergency Preparedness (PHEP) program and 39 percent cut to the
Hospital Preparedness Program (HPP) funding since fiscal year 2005. The
most drastic impact of these cuts has been the significant reduction in
the public health preparedness and response workforce in NYC. If there
are no public health laboratory scientists, epidemiologists,
environmental health specialists, emergency managers, and risk
communication experts to build the local alarm system, and then hear
the alarm and respond when it goes off, we cannot protect the health of
the American public. This critical workforce needs an infrastructure to
enable them to do their work--state-of-the-art public health
laboratories that are flush with instrumentation, reagents, and
supplies, information technology solutions for the analysis of data,
and interoperable electronic systems to share that data are all also
basic necessities for protecting Americans.
Additionally, funding for the CDC Epidemiology and Laboratory
Capacity (ELC) Infection Control and Laboratory BioSafety Officer (BSO)
programs ended in March 2019. These programs provided critical support
for infection control and clinical laboratories at health care
facilities. The BSO network ensured that clinical laboratory staff
across the country were trained to safely handle and test specimens
from patients that may have a highly infectious disease. This program
is critical to ensuring the safety of the health care workforce and to
ensure that all patients are able to receive appropriate life-
sustaining care, and allows NYC and the rest of the country to maintain
these capabilities. This loss of funding threatens to waste years of
investment and relationship-building with critical partners.
In 2014, Congress appropriated funding to prepare public health and
health care systems to respond to cases from the Ebola outbreak in West
Africa that reached the United States and prevent further transmission.
This funding has helped sustain the capacity of 10 Regional Ebola and
Other Special Pathogen Treatment Centers (RESPTC), state-designated
Ebola Treatment Centers (ETCs) as well as front-line hospitals, health
departments, and emergency medical services (EMS). With this funding,
the capability to identify and safely care for patients with viral
hemorrhagic fevers and other high-consequence infectious diseases was
built and maintained. These funds supported joint planning and regional
coordination between public health, health care, EMS, and law
enforcement to rapidly respond, and were critical to the replacement of
aging laboratory equipment and instrumentation, initially purchased
with post-9/11 funding, in public health laboratories. As a result, our
country is substantially more prepared to manage cases of Ebola than
ever before. However, there is no plan to continue funding when it
expires in 2020. Local health departments, public health laboratories,
and health care systems around the country cannot continue to function
on sporadic funding. We cannot wait for the next major public health
emergency to maintain critical infrastructure.
Chairman Payne and Ranking Member King, thank you once again for
inviting me to testify today. Our concerns regarding BioWatch, the BD21
system, and the need for stable investment in public health
preparedness are shared by cities across our Nation. Federal investment
and collaboration is critical to ensuring local government's ability to
stay ahead of emerging threats. I look forward to your questions.
Mr. Payne. Thank you. Thank you very much.
Now, I recognize Dr. Shah to summarize his statement for 5
minutes.
STATEMENT OF UMAIR A. SHAH, M.D., MPH, EXECUTIVE DIRECTOR,
PUBLIC HEALTH, HARRIS COUNTY, TEXAS
Dr. Shah. Good morning, Chairman Payne and Ranking Member
King. It is wonderful to join you both and Members of the
subcommittee today.
I also want to extend greetings to fellow Texans,
Representative Green and Representative Crenshaw. I hope you,
too, will join me in wishing the Houston Astros well against
the New York Yankees.
Mr. King. I object to that remark.
Dr. Shah. I hope that is not considered a partisan
statement.
Thank you for inviting me to testify on this important
topic. I am joined by Michael ``Mac'' McClendon, our director
of the Office of Public Health Preparedness and Response, and
Albert Chang, in our area of policy.
My name is Dr. Umair Shah. I am the executive director of
the Harris County Public Health and the local health authority
of Harris County, Texas, the third-largest county in the United
States. I am also the past president of NACCHO, the National
Association of County and City Health Officials, representing
the Nation's nearly 3,000 local health departments, and its
Texas affiliate, TACCHO, which represents 45 local health
departments across Texas.
I am also an emergency department physician at the Michael
E. DeBakey VA Medical Center in Houston, where I have proudly
cared for our Nation's veterans for the last 20 years.
Today, I am here to testify on local public health's key
role in emergency preparedness and response with respect to
bioterrorism.
I have limited time, so please refer to my full written
testimony. Let me point out, though, that, on the top of page
7, the testimony inadvertently refers to HHS when it should
have instead stated DHS. Please note that correction.
Today, I will touch on 3 main points. One, public health
truly matters, especially at the local level and in
emergencies, yet it is largely invisible.
I refer to this as the #invisibilitycrisis. This
invisibility is a major issue in ensuring adequate capacity for
preparing and responding to a myriad of emergencies. Frankly,
our communities most often do not even know we are working on
their behalf when we are.
No. 2, emergencies occur repeatedly and unexpectedly, and
public health must have strong tools at its disposal to protect
our communities. Biodetection systems are important such tools,
but even they cannot be used in isolation.
No. 3, there is a science and an art to public health, just
as in medicine, and we must have access and availability to as
much information as possible to make decisions. This means that
Federal, State, and local partners must plan together today in
order to protect our communities more effectively tomorrow.
I speak to you as someone who comes from an impacted
community. Since Tropical Storm Allison in 2001, we have
responded to the H1N1 pandemic, West Nile virus, Ebola, Zika,
Hurricanes Katrina, Rita, Ike, Harvey, and just this year a
resurgence of measles, 3 large-scale petrochemical fires,
confirmed vaping cases, and, most recently, Tropical Storm
Imelda. No doubt Harris County has seen it all, but our story
is one of a community of strength and resilience.
Harris County Public Health is part of the Houston/
Galveston Metro Area BioWatch Advisory Committee. The BAC is
one of many such BACs across the country.
In 2003, our community witnessed the Nation's first
BioWatch actionable result, a BAR, when low levels of
Francisella tularensis were detected for three consecutive
days. We eventually confirmed the detection was due to a
naturally-occurring source, but it took time to rule out a
weaponized version.
As many communities, too, have learned, a biodetection
positive is not the same as a public health positive. While
biodetection systems must be robust and accurate, effective,
and efficient, they are still tools within a well-established
public health emergency response system.
We cannot forget, no matter how invisible they may be,
local public health personnel are the quote-unquote, boots on
the ground in ensuring communities are prepared for, protected
from, and resilient to a variety of health threats.
Much of the discussion today is focused on the science of
biodetection. While I agree there is a science to public health
decision making, there is also an art. Despite the technologies
at our disposal, this decision making is based on the expertise
of the individuals and agencies who are part of the process
based on all available data points.
This is why in medicine, we ensure a finding from a
diagnostic test is both confirmed and put into context of the
patient in front of us. Local public health officials take
other factors into consideration, including community concerns
as well as political, economic, and other ramifications for
actions such as canceling large-scale events and how to
respond.
This is why locals must be a part of the equation. We
cannot be brought in at the end. Ultimately, the decision of
how to respond to a biodetection hit must be a shared one
involving local decision makers and responders, front and
center. This means Federal, State, and local partners must work
together as do public health and emergency management, law
enforcement, and health care delivery, all partners alike.
Ultimately, we are all part of the same team, and our
communities expect it.
Let me close by saying I am honored to represent our
amazingly resilient community, as well as the strong, dedicated
public health professionals that give it their all as first
responders in emergencies each and every day, not just at
Harris County Public Health but in the 3,000 such local health
departments across the Nation.
I appreciate again the opportunity to testify today and
look forward to your questions.
Thank you.
[The prepared statement of Dr. Shah follows:]
Prepared Statement of Umair A. Shah
October 17, 2019
I would like to thank Chairman Thompson, Ranking Member Rogers,
Subcommittee Chairman Payne, Ranking Member King, and Members of the
committee for the opportunity to testify today on behalf of local
health departments and public health emergency responders across the
country.
My name is Dr. Umair Shah, and I am the executive director for
Harris County Public Health (HCPH) and the local health authority for
Harris County, Texas. Harris County is the third most populous county
in the United States with 4.7 million people and is home to the
Nation's 4th largest city, Houston. I am a past president and former
board member of NACCHO, the National Association of County and City
Health Officials. NACCHO is the voice of the nearly 3,000 local health
departments (LHDs) across the country. I am also a past president and
current board member of TACCHO, the Texas Association of City and
County Health Officials, which represents approximately 45 LHDs across
Texas.
As background, Harris County is the most culturally diverse and one
of the fastest-growing metropolitan areas in the United States and home
to the world's largest medical complex, the Texas Medical Center, one
of the Nation's busiest ports, the Port of Houston, and 2 of the
Nation's busiest international airports. Our metropolitan area
comprises the largest concentration of petrochemical manufacturing in
the world. HCPH is the county public health agency responsible for
protecting the public's health in the event of wide-spread public
health emergencies within Harris County under the direction of County
Judge Lina Hidalgo, who by State law, is the county's director of
emergency management and leads the Harris County Office of Homeland
Security & Emergency Management (HCOHSEM). In close coordination with
HCOHSEM, HCPH's Office of Public Health Preparedness and Response
(OPHPR) ensures an effective, coordinated public health response to a
variety of emergencies including terrorist attacks, disease outbreaks,
weather-related disasters, to name a few.
In fact, our community has seen its share of emergencies over the
years, including but not limited to Tropical Storm Alison (2001),
Hurricane Katrina sheltering (2005), Hurricane Ike (2008) and more
recently Hurricane Harvey (2017). Coupling these natural disasters with
others such as the Department's 18-month nH1N1 influenza pandemic
response (2008), West Nile virus (WNv) response (2012), Ebola readiness
& ``response'' activities (2014-2015), human rabies death and rabies in
a Harris County dog (2008 and 2015), Zika virus (2016-2017), measles
``resurgence'' (2019), and 3 large-scale chemical fires in 2019 as
well, our community is undoubtedly an impacted community. However, one
thing one must remember about Harris County--and really this goes for
all of Texas--is that it is also an incredibly strong and resilient
community.
In my testimony today, I will focus on 3 main points:
1. We all agree that emergencies occur repeatedly, unexpectedly,
and we must ensure that our communities are prepared for what
lurks behind the next corner. BioWatch and the next generation
of biodetection are important tools in the toolbox for decision
making but are not the only tools. Yet these tools must be
effective which means they must be science-based and must
evolve as the science and threats equally evolve.
2. Public health at all levels of government is vital--indeed we
say that public health truly matters! Public health must be
invested in and capacity built because it is absolutely
critical to protecting our communities even when it is largely
invisible or forgotten (the so-called ``Invisibility Crisis'').
Public health is equally a crucial sector that must be well-
equipped and trained to prevent, protect against, mitigate,
respond to, and recover from all incidents whether small or
catastrophic.
3. There is a science and an art to public health and we must have
access and availability to as much information as possible
especially during a biological attack to make appropriate,
difficult, nuanced decisions on behalf of our community so
sharing of that information is critical. We must continue to
involve all Federal, State, local, and even global partners in
not just response activities but also the planning phase.
protecting our communities
HCPH is part of the Houston/Galveston Metro Area BioWatch Advisory
Committee (BAC) and this BAC makes up 1 of the more than 30 BioWatch
jurisdictions across the country. The National Academy of Medicine
(formerly the Institute of Medicine) and the National Research Council
convened a workshop in 2014 entitled, ``Strategies for Cost-effective
and Flexible Biodetection Systems that Ensure Timely and Accurate
Information for Public Health Officials'' that explored many of the
issues around BioWatch and biodetection systems and needs. I
participated in this workshop that was held 5 years ago--unfortunately
many of those same themes that were inherent then are still of concern
today. Many of the issues and problems with any biodetection system or
the next generation replacement systems will always need to be
addressed in order to ensure the most robust and accurate system and
must be seen as a ``tool'' within a well-established public health
emergency preparedness system. In 2003, our local community had the
first BioWatch hit in the Nation when low levels of Francisella
Tularensis (FT) were detected for 3 days. The detection caught natural-
occurring instances of the bacterium and yet no terrorism was
discovered. Instead it caused a cascade of events and highlighted gaps
that public health helped identify that I will describe within my
testimony.
The CDC Foundation states, ``Public health is the science of
protecting and improving the health of people and their communities.
Overall, public health is concerned with protecting the health of
entire populations. These populations can be as small as a local
neighborhood, or as big as an entire country or region of the world.''
Public health emergency preparedness is truly National health security.
Local health departments play an essential role in ensuring that people
and their communities are prepared for, protected from, and are
resilient to, threats to health that result from a host of disasters
and emergencies. Given that the impact of all disasters is felt locally
first and foremost, local health departments have and will continue to
play a critical part of every community's first response to disasters
in an emergency and in the long-term recovery efforts. Local health
departments regularly host trainings and exercises to prepare their own
staff and health care partners for public health emergencies, to build
consistent and on-going communication between partners, clearly define
response roles, and anticipate challenges before an emergency occurs.
And when disasters strike, local health departments are the ``boots on
the ground'' responding to and helping communities recover.
Much of the discussion around BioWatch is focused on the science of
biodetection. I agree there is a ``science'' to public health decision
making, but I also strongly maintain there is also an ``art'' to public
health decision making. Public health decision making is still based on
the experiences of the individuals and the agencies that are part of
the process and performed in the contextual framework of a summation of
available information. It is what we as clinicians and public health
practitioners do all the time, which is really taking the situational
contexts, the individual nuances, and making that part of our decision-
making process. BioWatch and the next iteration, BioDetection 21
(BD21), should be considered simply as tools--one of many tools that
are available to public health decision makers and needs to be kept in
the context of that paradigm. The sum of all those tools is really how
we go about making sound public health decisions.
As mentioned earlier, our community had the Nation's first BioWatch
Actionable Result (BAR) for tularemia in 2003. Our community has seen
multiple subsequent tularemia detections where HCPH has been notified
by our Houston Health Department partners who operate our region's
Centers for Disease Control & Prevention (CDC) BioWatch Laboratory of a
BAR. This has required considering those detection data, along with
information from disease surveillance and contextual intelligence.
Disease surveillance includes examining zoonotic patterns reported by
local veterinary clinics and the State zoonosis surveillance system as
well as data on human disease patterns that may have been reported by
area hospitals or other health departments to our epidemiologists, or
disease detectives. Contextual information includes details about
environmental patterns and unusual security threats or security
patterns.
While this decision-making process is occurring, response partners
begin mobilizing its crisis risk communication resources and makes sure
that its operational support functions are ready. Local public health
officials also take a number of other factors into consideration
including community concerns as well as political and economic
ramifications for actions such canceling large-scale community events
when making decisions on how to respond to a BAR. Fiscal constraints in
particular have a real impact on the value proposition of biodetection
today. For example, investment in the technologies that enable programs
such as BioWatch may compete with more broad-based public health
investments and capacity building. This could mean decreased
investments in other technologies such as syndromic surveillance and
automated disease reporting systems, not to mention decreased staffing
for surveillance and response as well as other important preparedness-
related activities. These diminished response capabilities in turn make
the decision on how to respond to a BAR even more art than science.
It should be pointed out that a laboratory positive is not the same
as a public health positive, and the issue of false positives is likely
to be a bigger issue with new autonomous detection systems with more
cycles, more tests, and more results on an almost continual basis. A
biodetector that has the capability to signal automatically a BAR or
act as if it has somehow ``confirmed'' that very result without any
human input or additional context (so-called red light/green light) may
be appealing from a technology perspective, but from the public health
perspective such a feature would take away the ability to engage in
nuanced decision making. It is important to remember that the integrity
of public health is critically important. How does the public view
decision makers if we do launch or do not launch a response based on
incorrect or incomplete information? What are the ramifications to a
community if decision makers cancel events or move forward with them
based on inaccurate sensor data systems alone? Our understanding of
what a BAR means locally has even changed over time. Let me provide a
clinical example to drive home this point.
As a clinician, if I had a female patient who walked through the
clinic door and I said to her, ``Ma'am, we have unfortunately found a
spot on your mammogram, and without any additional testing, I am going
to send you immediately for a total mastectomy (i.e., removal of the
entire breast), based on that abnormal spot,'' immediately, my days as
a physician would be numbered. That is the challenge here. What we are
really trying to do is take that spot on a mammogram, figure out what
other diagnostic and contextual information we need to put to the
puzzle, and then figure out what to do with that information. In the
IOM Workshop I referenced, one of my colleagues, Dr. David Persse said,
``Two of the strengths that public health agencies bring to the table
are their versatility and their ability to make decisions even when
sufficient information is not available.'' Dr. Persse is an emergency
medicine physician and the city of Houston's Public Health Authority,
who serves as our local BioWatch Advisory Committee (BAC) chair.
Ultimately the decision of how to respond to the release of a
biological weapon must be a shared one but it must involve local
decision makers front and center. Our communities, our residents,
expect local governance and local decision making, which implies both a
need for transparency and a need for local public health officials to
help in managing the data from a networked system. Local Health
Authorities (LHAs) are responsible for the lives of the people
entrusted to them within their jurisdictions. Local (and State)
officials must be given more input and information from Federal
partners during the planning phase as well as the response phase as
future programs are deployed. Any new technology must make public
health more effective and not make it more difficult for these
officials to make necessary decisions when time is of the essence.
cooperation and information sharing with all partners
From the beginning of BioWatch and the inception of a National
response system after the 9/11 terrorist attacks, a priority has been
placed on the need to form partnerships and acknowledge the role of
local responders and to share information with all partners. This has
been an important and accepted tenet within the program. Anything less
than this is unacceptable, and we must continue this cooperation and
information sharing.
In 2012, President Obama released the National Strategy for
Biosurveillance. He said at that time that this strategy `` . . . calls
for a coordinated approach that brings together Federal, State, local,
and Tribal governments; the private sector; nongovernmental
organizations; and international partners. There exists a strong
foundation of capacity arrayed in a tiered architecture of Federal,
State, local, Tribal, territorial, and private capabilities. We can
strengthen the approach with focused attention on a few core functions
and an increased integration of effort across the Nation. In these
fiscally challenging times, we seek to leverage distributed
capabilities and to add value to independent, individual efforts to
protect the health and safety of the Nation through an effective
National biosurveillance enterprise. (https://
obamawhitehouse.archives.gov/sites/default/files/National_Strategy_for-
_Biosurveillance_July_2012.pdf).
I have spoken in front of Congress previously about the
invisibility crisis of public health. I refer to this in the age of
social media as the so-called ``hashtag Invisibility Crisis''
(#InvisibilityCrisis). Why? Well, despite the significant impact to a
community's overall health and well-being, public health is largely
invisible, under-appreciated, and as a result underfunded. This is
further exacerbated when public health agencies are confused for health
care. Most people operate in their daily lives without noticing that
public health is there working to prevent diseases and address other
concerns. Though the news may cover a measles outbreak, few tell the
countless stories of public health responders who work to ensure the
most vulnerable are vaccinated. Just this year as our Department
confirmed a few cases of measles in our community, each identified case
meant that our epidemiologists had to contact 100 persons for each case
to ensure the protection of our community. The prevention of countless
outbreaks seldom makes the headline. Public health is there day and
night ensuring the health, well-being, and safety of the community. I
say often that public health is like the ``offensive line'' of a
football team--rarely recognized for the success of the football team
but absolutely critical nonetheless.
Whether intentional or not, one of the most import areas where
public health is largely invisible to the public and other partners is
in emergency preparedness and response. Everyone sees and knows the
other first responders, such as police, fire, EMS, and even the
National Guard, but many are unaware of public health's role in
emergency response. All public health staff are trained and are a part
of the National Incident Management System (NIMS) developed by the
Federal Emergency Management Association (FEMA) to respond and prepare
for large and small-scale disasters across the country. Local public
health would respond and distribute antibiotics, vaccines, chemical
antidotes, antitoxins, and other critical medical supplies from the
Strategic National Stockpile (SNS) as the final interface between
Government and its community members.
This ``Invisibility Crisis'' problem has unfortunately led to
funding cuts for public health and public health preparedness at every
level of government at a time where our services are needed more than
ever as we face incredible challenges in our public health sector for
ensure the health, security, and well-being of our communities from a
variety of emergencies. These funding cuts impact preparedness and our
ability to respond to a public health disaster. We know another
hurricane, wildfire, mass-shooting, disease outbreak, or even another
terrorist attack may happen, yet preparedness and resiliency for our
communities is still just not at adequate levels to protect us. We need
a National response strategy that does not react to the latest disaster
but one that is pro-active to build and maintain that necessary
capacity on an on-going basis. All emergency events, including
infectious disease emergencies, are ultimately local. An effective
response that prevents illness and saves lives demands immediate
attention. Local health departments, local health care providers, local
emergency responders, and local government all work together to make
this an every-day reality and are in the best position to exact
immediate action for small- and large-scale events. They must be
trusted partners for our Federal and State agencies and decision
makers.
Local public health departments deal with infectious diseases
daily--our staff of epidemiologists and other key personnel are on-
call, 24 hours a day, 7 days a week, diligently monitoring disease
patterns and looking for irregularities. In fact, the only way to
recognize the unusual is to understand the normal. On a daily basis,
public health staff members work with health care providers to conduct
diseases surveillance activities. We communicate disease patterns and
specific actions that are critical for disease investigation and
disease control to the community. From an epidemiologist's point of
view, you take away the name of the disease, and the response is the
same--early detection of cases, contact investigation and control
measures are all essential. They save lives. At our department, we have
built capacity keeping the ``One Health'' approach in mind as we know
that the intersection of the environment impacts all those who live in
that environment, whether humans, animals, or even insects. This is
vital as many of the agents of bioterrorism and nearly 75 percent of
the newly-emerging infectious disease agents are zoonotic (animal-
related) in nature. (http://www.onehealthinitiative.com/publications/
One%20Health_ASMPoster.pdf)
I applaud Congress and President Trump for passing and signing the
Pandemic and All-Hazards Preparedness and Advancing Innovation Act
(PAHPAI) earlier this year. PAHPAI reauthorizes the Public Health
Emergency Preparedness (PHEP) grant program and the Hospital
Preparedness Program (HPP) to keep our emergency preparedness
infrastructure strong; strengthens the National Health Security
Strategy, including global health security; and authorizes the Public
Health Emergency Medical Countermeasure Enterprise, with a role for
input from stakeholders, including local health departments. These
measures must not just be milestones in time but lead to foundations of
on-going capacity-building that should be maintained and strengthened
over time.
cooperative partnerships
As recently as 2017, National biodefense policy continued to
emphasize cooperation between Federal, State, local, and territorial
partners. Section 1086 of the National Defense Authorization Act for
Fiscal Year 2017 (https://www.Congress.gov/114/plaws/publ328/PLAW-
114publ328.pdf) directs the Department of Defense (DOD), the Department
of Health and Human Services (HHS), the Department of Homeland Security
(DHS), and the Department of Agriculture (DOA) to develop a strategy
for the United States response to biological threats. The National
Biodefense Strategy (https://www.whitehouse.gov/wp-content/uploads/
2018/09/National-Biodefense-Strategy.pdf) was released on September 18,
2018. The strategy lays out a clear pathway and set of objectives to
counter threats effectively from naturally-occurring, accidental, and
deliberate biological events. It is broader than a Federal Government
strategy. It is a call to action for State, local, territorial, and
Tribal (SLTT) entities, other governments, practitioners, physicians,
scientists, educators, and industry.
Moving the responsibility of biodetection and the authority
previously within the U.S. Department of Homeland Security (DHS) Office
of Health Affairs to the Countering Weapons of Mass Destruction Office
is potentially concerning as it is a significant change from the U.S.
history of biodetection in the aftermath of the 9/11 attacks. The
director of the HCPH Office of Public Health Preparedness and Response
(OPHPR), Mr. Michael W. ``Mac'' McClendon--who is with me here today
and I might add along with the rest of our dedicated HCPH staff members
has served admirably to protect our community from a variety of threats
over the years--serves on a DHS Countering Weapons of Mass Destruction
(CWMD) BioDetection 21 (BD21) workgroup.
Earlier this year, locals were briefed on BD21 in Indianapolis at a
closed workshop. I cannot say too much about this meeting except that
we hope the concerns of locals have been heard and that appropriate
steps to address these concerns including the importance of true
partnership and the sharing of information bidirectionally is not
forgotten. We know that problems with BD21 continue to appear in the
press. (https://www.latimes.com/politics/story/2019-08-08/bipartisan-
lawmakers-seek-probe-of-controversial-bio-weapons-defense-system). The
technology is not proven or vetted as of yet and has not been fully
shared with local public health partners. It is hard for us to say more
from a local level since we do not have additional information to base
any such comments on. As per what we have read though, it appears there
are concerns that an environmentally-based detection system could still
have trouble with small pathogen releases in real-time, underground, or
indoor releases, and may not detect previously-unknown organisms such
as naturally-occurring mutant viral strains of genetically-engineered
bacteria. On-going epidemiologic and zoonotic surveillance systems
which rely on collective diagnoses, monitoring of the health and
agriculture sectors looking for aberrant disease patterns, will always
be needed for natural pathogens but have a role in detecting a
terroristic attack as well.
conclusion
Thank you for allowing me to testify today on this very important
topic. I want to restate 3 main points:
1. We all agree that emergencies occur repeatedly, unexpectedly,
and we must ensure that our communities are prepared for what
lurks behind the next corner. BioWatch and the next generation
of biodetection are important tools in the toolbox for decision
making but are not the only tools. Yet these tools must be
effective which means they must be science-based and must
equally evolve as the science and threats evolve. We must
continue to involve all Federal, State, local, and even global
partners. Even the DHS Countering Weapons of Mass Destruction
Office acknowledges that the current BioWatch Program
``involves a large network of stakeholders from public health,
emergency management, law enforcement, laboratory, scientific,
and environmental health organizations around the country who
collaborate to detect and prepare a coordinated response to a
bioterrorism attack.'' (https://www.dhs.gov/biowatch-program)
2. Public health at all levels of government is vital--indeed we
say that public health truly matters! Public health must be
invested in and capacity built because it is absolutely
critical to protecting our communities even when it is largely
invisible or forgotten (the so-called ``Invisibility Crisis'').
Public health is equally a crucial sector that must be well-
equipped and trained to prevent, protect against, mitigate,
respond to, and recover from all incidents whether small or
catastrophic. Public health emergency preparedness is National
health security. Local health departments and local health
authorities should be notified and allowed to verify
independently a suspected sample and use medical and veterinary
surveillance and local intelligence of the community to help
make the call on the threat.
3. There is a science and an art to public health and we must have
access and availability to as much information as possible
especially during a biological attack to make appropriate,
difficult, nuanced decisions on behalf of our community so
sharing of that information is critical. Beyond a certain
point, during a biological catastrophe, everything will depend
on sound public health decision making. Leaders will then have
to do the best they can with the resources they have at their
disposal to ensure the very health, safety, and security of the
communities for whom they are responsible. (https://
biodefensecommission.org/wp-content/uploads/2019/07/Holding-
the-Line-on-Biodefense.pdf)
On behalf of Harris County Public Health, and the nearly 3,000
local health departments across the country, I appreciate again the
opportunity to testify today. We join you in strengthening a public
health system that protects our economic vitality and National
security. Thank you for all you do in building safe, healthy, and
protected communities where we live, learn, work, worship, and play,
across this great Nation of ours.
Mr. Payne. Thank you.
I want to thank all of the witnesses for their testimony. I
will remind each Member that he or she will have 5 minutes to
question the panel.
I will now recognize myself for questions.
Dr. George and Dr. Rakeman, the creation of the Countering
Weapons of Mass Destruction Office was intended to enhance our
defenses against biological terrorists and increase
coordination and cooperation in the WMD mission space. Has
creation of CWMD improved our preparedness for a bioterror
attack?
Ms. George. Mr. Chairman, it has not. That office,
unfortunately, has suffered from changes in the mission and
goals and objectives for it since they started talking about
creating it years ago--8 years ago, as I believe.
When you don't have a vision, the people perish. We know
this. But they seem to have just spun down worse and worse as
the years have gone by, these past 2 years.
You mentioned the morale survey earlier. But in addition,
they just seem not to be able to accomplish any of the things
that they set out to accomplish. BioWatch has not improved.
NBIC has not improved. DNDO is beginning to suffer, and they
have lost a great deal of personnel, specialists that used to
address all of those issues.
So I would say, no, it hasn't done what it was intended to
do.
Mr. Payne. Dr. Rakeman.
Ms. Rakeman. I think also, with the creation of CWMD,
biological agents have been lumped together with radiological
and chemical agents and are being approached in the same
manner, which is an issue. You can't approach biological agents
and detection of biological agents the same way that you can
for radiological and chemical. Radiological and chemical agents
are either there or they are not. Biological agents require
detecting a specific agent in a mix of lots of biology and
biological agents. So approaching them in the same way does not
work well.
Mr. Payne. So can those agents lay dormant for periods of
time?
Ms. Rakeman. Well, it is trying to detect a very specific
agent that you are concerned about in a world where we are
surrounded by bacteria and viruses and things that are good for
us and also bad for us. So being able to pick out a select
agent in that mix is a very different approach than looking for
whether or not sarin gas is present or not, for example.
Mr. Payne. Yes. You know, I have been very critical of the
BioWatch program. Actually, I finally ran across one of the
units at the Democratic Convention. They had one in the parking
lot. I walked by and, oh, finally--I finally saw one, so--but
it has not been the most successful way to do this. It almost
seems antiquated science, you know, from the fifties or
whatever. With all of the advances that we have, it is really
amazing that that is what we are stuck with at this point in
time.
Dr. George and Dr. Shah and Rakeman, all 3, CWMD is
creating a new biodetection system to replace BioWatch--DHS's
current system. This new system is called Biodetection in the
21st Century, or BD21, and it is supposed to address the
shortcomings of BioWatch.
Is the technology behind BD21 mature enough to address the
issue of BioWatch, and how has CWMD worked with local
jurisdictions to develop BD21 and solicit requirements for its
use?
Start with Dr. Shah.
Dr. Shah. Yes, thank you, Mr. Chairman, for that question.
I think the challenge that we have is that we do not have a
lot of information about this new system. So when locals, and
State partners as well--but locals are in particular not a part
of the planning process. We understand that there is sensitive
information here, that we are not going to be able to get
everything shared. But we do believe that there is an
opportunity to work with locals throughout this planning
process. Again, that is how we are going to know better what
the system is, what its limitations are, and certainly how we
are going to be able to respond effectively to it in the
future.
Mr. Payne. Thank you.
Dr. Rakeman.
Ms. Rakeman. I agree with Dr. Shah. We are not confident in
the maturity of the technology that is being deployed. It is
technology that has been used in a military setting, which is
not appropriate for an urban center like New York City or other
cities around the country. It generates a lot of false alarms,
which is a problem.
Locals have not been given really any data and very little
information about the system and have not been pulled into good
conversations about how to develop this process and make it
work.
So, again, it is a technology that is potentially being
pushed on locals without any input. We have to respond.
Mr. Payne. Thank you.
Very quickly, Dr. George.
Ms. George. Mr. Chairman, I would only say just two things.
One is that the system is predicated on the notion that State
and local folks would respond immediately to a trigger. But if
they are supposed to respond, they ought to be included in the
planning for the system in the first place.
The other is that the DOD technology that is being tested
was technology that was rejected by the Department of Defense.
It did not test well in the operational field environment.
While it is good for DHS to try and test anything it can, I
suppose, in the domestic environment, it is not like it started
out with great results, and DHS has been testing it. It is not
mature.
Mr. Payne. Thank you.
I now recognize the gentleman from New York, Mr. King.
Mr. King. Thank you, Mr. Chairman.
Dr. George, just out of curiosity. There is no need to get
specific. You mentioned Senator Daschle. Have his staff members
recovered? Because I remember for several years afterwards,
they were--some of them were still, you know, pretty ill from
that.
Ms. George. Yes, sir, they have recovered. But one of the
things--if Senator Daschle was here, he would tell you this--
that none of the people that were potentially or absolutely
exposed to those letters were ever tracked going forward.
Nobody paid attention to their health, other than their bosses,
like yourself and Senator Daschle. There is no reason for that.
The Department of Defense actually tracks people going
forward if they have been exposed. I think it is a simple thing
for the Department of Homeland Security to do now.
Mr. King. OK. Thank you.
Tell Senator Daschle I wish him the best.
Dr. Rakeman, Chairman Payne and I, our districts are so
close. With the PATH trains and Amtrak, what happens in New
York can happen in Newark, and Newark can happen in New York.
Does the city have the supplies necessary to counter deadly
pathogens?
Ms. Rakeman. So that is something that is a little bit
outside of my area of expertise as a laboratory professional,
so we can get back to you on that.
Mr. King. OK. If you would, yes.
Also, then, I guess, if the city has its own vaccine
stockpiles, or do you have to rely on the Strategic National
Stockpile?
Ms. Rakeman. Again, we will get back to you on that.
Mr. King. OK. To all of the witnesses, do you believe the
Federal Government has successfully leveraged the private
sector to increase bioterrorism defense?
Dr. Shah. So let me just----
Mr. King. Sure.
Dr. Shah. Excuse me. Thank you for that question.
Let me just start by saying that I think there are
opportunities for working with, partnering with, and learning
from private sector. I think there is a lot that we can really
look at with respect to technologies, improving those
technologies, but also in the distribution of medication
supply, stockpiles, et cetera. So I think there are some things
that we can learn better as a Federal Government.
That said, this is an emerging area. This is also an area
that has a number of unknowns that potentially can also be
challenging. So I think the--you know, the proof in the
pudding, if you will, is going to take some time for us to
understand what better private companies might be able to--or
private sector might be able to offer. But I think it is
absolutely critical that the Federal Government does partner
and explore all avenues to protect Americans.
Ms. George. Mr. King, I would say, no, they have not. Of
course, the Department as a whole has struggled with leveraging
and working with the private sector. But in this particular
arena, I would say it is very hard for the private sector to
even be involved if the office itself does not actually issue
requirements for the technology that it is trying to utilize.
They don't know where to connect.
It has been an unnecessary challenge, but I would also say
it is not just about industry. Academia should be involved.
Then you have your sort-of half-and-halfs, like the National
laboratories. They are not involved as much as they could be or
should be.
Mr. King. Dr. Rakeman.
Ms. Rakeman. I would agree with both of my colleagues on
the witness panel here and also add that, again, more
transparency and interaction with even local jurisdictions as
well as industry partners, National partners. All of us are on
the same team. All of us are looking to protect the health of
Americans. If we get all of our heads together, that is going
to give us the best result at the end of the day.
Mr. King. Going back to Dr. George. Parenthetically--and
this goes beyond this particular issue. I know one concern we
have had for years is DHS has not worked with the private
sector, for instance, to the extent that the Defense Department
works with the private sector. In many ways, it should be
mirror images of each other.
So--I guess--assume it is a deficiency, but especially in
this regard. But as you are saying, unless the guidance is
coming, it is hard to make use of the private sector.
With that, Mr. Chairman, I yield back.
Also thank you all for your testimony and your service. We
appreciate it. Good seeing you again.
Mr. Payne. Thank you, sir.
We now recognize the gentlelady from Illinois, Ms.
Underwood.
Ms. Underwood. Thank you, Chairman Payne.
Before being elected to Congress, I was honored to serve as
a senior advisor to the assistant secretary for preparedness
and response at the Department of Health and Human Services,
and while at HHS, I had the opportunity to work on public
health response and recovery efforts involving emerging
infectious diseases, natural disasters, and bioterror threats.
From my time working as a senior advisor to the ASPR and my
work with BARDA, the Biomedical Advanced Research and
Development Authority, I appreciate their evidence-based whole-
of-community approach to planning, response, and recovery
efforts, including in determining which threats to prioritize
for development of medical countermeasures like vaccines,
therapies, and diagnostics. I have seen first-hand how ASPR
coordinates with CDC and local public health agencies on
deployment and education.
After reviewing the testimony, your testimony, for today's
hearing, it seems that there is room for closer coordination
between the Department of Homeland Security, local law
enforcement, and local public health departments.
So my question is for Drs. George and Shah. HHS also plays
a critical role in protecting and promoting public health. As
DHS seeks to protect the country from the threat of
bioterrorism, they should ensure that they are coordinating
with HHS.
In your view, what could be done to strengthen that
coordination?
Ms. George. Well, one thing I would like to mention are the
material threat determinations that DHS is supposed to be
producing and sending over to HHS for them to respond to, with
BARDA's actions and others.
It currently takes the Department of Homeland Security up
to 2 years to produce one of these things, which is way too
slow for the actual threat stream, which means then that BARDA
has to sort-of rush on its own with whatever information it can
get.
So that should work better. If DHS can't produce one of
those determinations in less than 2 years, then we need to come
up with something else. Otherwise, you are going to
automatically have siloed efforts going down the pike.
Ms. Underwood. Thank you so much.
Dr. Shah.
Dr. Shah. Yes. Thank you for that question.
My humble opinion is that a lot more can be done. I have an
incredible amount of respect for Department of Health and Human
Services, ASPR, as well as CDC. They do an incredible job. They
support hospital systems. They certainly support local public
health departments, State public health agency, just an
incredible amount of work that goes in. There seems to be a lot
more of that cooperative agreement, a cooperative
understanding, a sharing of working together with, partnering
with, and really leveraging the expertise and knowledge of
local, States, Tribes, territorial, as well as private-sector
hospitals, et cetera, et cetera, all coming to the table.
That doesn't seem to be happening the same way with DHS. So
I think just the fact that learning from each other and how HHS
is able to share with locals, I think that is an important.
But I do want to also point out that we recognize again, as
I said earlier, that there are sensitivities in a biodetection
program. But there is also a trust that should be engendered
with local public health officials that we also are a part of
that spectrum.
So some--and oftentimes we are then put into the category
of: Well, they are locals, they don't get it, they are not
smart enough, or they are just not--we can't trust them enough
with this sensitive information, and so, therefore, it is just
not shared with us. That is--that is a terrible mistake.
Ms. Underwood. So would you characterize there have been an
improvement since the Countering Weapons of Mass Destruction
Office is now housing the health care aspects at DHS, or would
you say that there has been really dissemination of that
relationship over at DHS?
Dr. Shah. It is difficult to tell. But I will say that we
have noted that there was an earlier meeting, as you saw in my
testimony earlier--meeting in Indianapolis where locals did
share concerns with DHS and CWMD about the sharing of
information, really working together. We are hopeful that that
is going to start to show results. But that was the concern
that was really articulated, is that you have got to work with
Federal partners, Federal agencies across the spectrum, and
also work with State and local agencies. So certainly that is a
perspective.
I think it is also important to say: Look, law enforcement
and security oftentimes have different perspectives. Not that
they are wrong, but different perspectives than health. So we
have to really bring together both parts of the equation in
order to be successful to protect our communities.
Ms. Underwood. Well, one of the things that we are
considering, and certainly with feedback from the office of
CMO, the chief medical officer, is trying to make sure that
they have the authorities that they need in order to do their
important work. It appears that in this reorganization, some of
those authorities have been stripped away or require additional
levels of bureaucracy in order to execute the mission. So, as
you-all may have some ideas or feedback about how sure to
structure that, please be sure to pass that on to our office.
With that, I yield back. Thank you.
Mr. Payne. Thank you.
I now recognize the gentleman from Texas, Mr. Crenshaw.
Mr. Crenshaw. Thank you, Mr. Chairman. Thank you, everyone,
for being here.
I will start with a general question, which is, as we say
in the military, we have the most likely threat and the most
dangerous course of action or threat.
For all 3 of you, what would you perceive to be the answer
to both of those questions? The most likely threat that we
face, I would say, so I guess the easiest way for someone to
attack us, and the most dangerous potentiality that you might
see.
Start with Dr. George.
Ms. George. Mr. Crenshaw, I think the most likely is a
terrorist attack or a small-scale nation-state attack utilizing
biological agents probably already weaponized. I think the most
dangerous course of action----
Mr. Crenshaw. Can you dig into that a little bit more? How
would they do that? So what are our most vulnerable points in
our society, if they were to--you said weaponize a biological
agent. But if you were to take a quick look at our
infrastructure right now, what would you say is the most
vulnerable?
Ms. George. OK. So I am former military, too, so I am going
to answer that question with a military answer.
So you have to look and see what is going on throughout the
Nation right now. As a military person, if we were going to
attack somebody else, we would look for vulnerabilities. But we
would also look to see where are different critical
infrastructure sectors or whatever is the most busy.
So places like New York and other metropolitan areas and
rural areas that are currently struggling with naturally-
occurring diseases are already taken up and responding to some
kind of crisis. If you add in the naturally-occurring disasters
and such, now you have another layer.
So, if you are going to attack with a biological weapon of
any sort, or a biological agent, you are going to go to those
places, which are very obvious on a map and attack there.
In terms of--in terms of weaponizing things, weaponizing a
biological agent is not the most technically difficult thing in
the world to do. It is made even easier when you get your hands
on already-weaponized material from the former Soviet Union and
other places like that. I would suggest to you that getting
their hands on that material or producing it and then bringing
it over here would not be that difficult.
Mr. Crenshaw. OK. You mentioned New York City. Dr. Rakeman,
if you could answer that, you know, what are your
vulnerabilities in New York City? What do you see?
Ms. Rakeman. So I think one thing as a Nation that we need
to be very careful about is maintaining the public health and
health care infrastructure, because that is what we need in
place to be able to detect and respond to any biological
incident, whether it is an intentional attack or a naturally-
occurring outbreak.
So making sure that we have stabilized funding and
infrastructure in place, a laboratory that works and we have
the right instruments and we can get the right reagents and get
a test up and running very quickly in an emergency is really
critical and sort-of keeping that going. We have been in a
place where we sort-of fund our lab and buy new instruments and
things from emergency to emergency rather than having things
ready to go every single moment. We need to be able to do that.
Mr. Crenshaw. Do you have that now?
Ms. Rakeman. So we did get a large influx of money after
Ebola. That helped us actually, in one instance, in the Public
Health Laboratory replace aging biosafety cabinets that were
initially purchased with money that came after 9/11 and the
Anthrax attacks.
Mr. Crenshaw. Dr. Shah.
Dr. Shah. Sure. I actually really like that last answer,
Congressman. What I--and as I said in my testimony, I really
think one of the challenges is that we have this invisibility
crisis, that we are really behind the scenes.
Because we are behind the scenes, oftentimes there isn't
the visibility, which then drives value, and when you have
value, you have validation by either pro-health policies or
pro-health funding. That is not happening.
So what happens is, we are behind the scenes, people don't
see what we are doing, so we don't get that investment that you
get with the bells and whistles of a police car or hospital or
an emergency department physician. You start to really have a
value proposition that goes into, well, public sector, public
health, or even what is happening at local public health
agencies, that is not as critical.
But surveillance systems, epidemiological systems, working
with our hospitals, the technologies, those are
vulnerabilities. So to answer your question, those
vulnerabilities translate to if somebody is really looking at
all of this and then you pepper this with Federal partners not
sharing with local partners, now you have a state of either
not-as-good capacity or you have a state of confusion when you
actually have a release. I think that is our biggest
vulnerability.
Mr. Crenshaw. OK. So, if I understand in summary what you
all are saying, you are not as concerned about whether they
come through the water or they send a sick person through an
airport. You are concerned more about our ability to respond to
any of those events?
Dr. Shah. To detect and respond, that is right.
Ms. George. We are--our Commission is as concerned about
the scenario you just laid out as with the ability to detect.
Mr. Crenshaw. Thank you. I yield back. Thank you, Mr.
Chairman.
Mr. Payne. Thank you. Before I recognize the next Member, I
now ask unanimous consent to allow Congresswoman Sheila Jackson
Lee to sit and question witnesses at today's hearing.
Without objection, so ordered.
I now recognize the gentleman from Texas, Mr. Green.
Mr. Green of Texas. Thank you, Mr. Chairman. Thank the
witnesses for appearing. I am going to acknowledge the presence
of Dr. Shah from Harris County. Greatly appreciate your work
over the years.
Let me start with the concept that we have to embrace of
CWMD, replacing BioWatch with the BD21 system.
The question has to do with the triggers. The triggers that
are proposed, it seems, may not be as sensitive as we would
have them be.
Can you give me some intelligence on how these triggers
will perform, in your estimation, if you have such?
Dr. Shah. Thank you, Congressman. Great seeing you again
today.
I am going to defer the scientific aspects to my
colleagues. But what I would like to say is that one of the
concerns that we had initially with the BD21 was that it seemed
to skip a step when it came to locals being involved in even
knowing that something was happening that was abnormal.
That was a very big concern that, for example, we in
local--and you know our local governance, our Judge Hidalgo,
our emergency management, and our entire structure at the
county, as well as with Mayor White and--Mayor Turner and all
of our colleagues at the city of Houston. There is an
incredible infrastructure of local strength.
What we didn't want to have happen is that in the middle of
something being detected, our Federal Government partners were
finding out first, and we weren't even aware that something was
happening. We are hopeful that that has changed, but that is
one of the big concerns that we had.
Then I will defer to my colleagues on the triggers piece.
Mr. Green of Texas. Thank you.
Ms. Rakeman. I think one of the major concerns we have with
BD21 and our interaction with CWMD and DHS on this project is
that we haven't really been given any information; we have no
data on how the anomaly detection works, how well it performs.
Again, we are being asked to start to think about developing
CONOPS and response plans for this system without knowing
anything about its performance characteristics.
Ms. George. Mr. Green, from what we have been told, there
isn't reliability and validity data on any of the detectors
that are being tested as part of BD21, No. 1.
No. 2, it depends on trying to set some sort of normal
baseline for whatever is going on around those detectors, and
then eventually getting to the point where you could identify
an anomaly.
The problem is, most of these detectors aren't set up for
that sort of thing, No. 1. No. 2, the Department that is trying
to do this, the Department of Homeland Security, hasn't been in
the environmental airborne detection business for that long.
If you are going to look at the background anyplace and
look at things like pollen counts and air quality, you are
going to go to EPA or some other department. So they don't even
have that sort of history--historical background to use with
the system.
Last, I would tell you that we have heard that the BD21
detectors go off at least 1 time a day, wherever these 12 have
been deployed thus far. They go off, but nobody knows what to
do about it because they didn't get in place with a good
concept of operations in the first place or any direction to
the State and locals or any of the other Federal departments
and agencies like the FBI and DOD that might have to respond.
Mr. Green of Texas. Next question. With the current
BioWatch system, have you been privy to an actual testing of
the system where you actually see it function so as to
determine the efficacy?
Ms. George. I have never seen such a test done since its
implementation. The last time I saw BioWatch or BioWatch-
related technology being tested, physically being tested, was
back when the original technology was rolled out for the Salt
Lake City Olympics. One of the National labs actually produced
the BASIS detector. I have not seen since then.
Dr. Shah. What I would just add is that, as you know, 2003,
Houston was the first BioWatch hit in the country. We have
learned a tremendous amount since then. However, I will say,
with the bacterium that was discovered at that time, we were
being told that this is an active intent or terror immediately,
regardless of what was happening, and turned out over time
learning that it was really naturally-occurring bacterium.
That is a big challenge. This is why it is not just the
science of the biodetection. It is the art of public health
coming together and really putting all of that intel together
to make decisions.
Mr. Green of Texas. Thank you very much, Mr. Chairman. I
yield back.
Mr. Payne. Thank you.
I now recognize the gentleman from Mississippi, Mr. Guest.
Mr. Guest. Thank you, Mr. Chairman.
Dr. George, you state in your report that the Bipartisan
Commission on Biodefense in October 2015 presented findings and
recommendations to this committee. You state in the report that
you made 33 recommendations, and then you later, on page 2 of
your report, state that 4 years after the release of the
initial report, the Nation remains unprepared for bioterrorism
and biological warfare with catastrophic consequences.
My question to you is, of those 33 recommendations that
were made some 4-plus years ago, what progress has been made to
make sure that those recommendations are being carried out?
Ms. George. Thank you, Mr. Guest.
Some of our recommendations have been taken up. We had 33
recommendations and 87 associated action items. Of those, I
would say about 17 have been taken up by Congress in various
pieces of legislation, the reauthorization for the Pandemic All
Hazards Preparedness Act, the farm bill, the National Defense
Authorization Act and others.
In terms of actual execution, however, I would tell you
that the third recommendation for a National biodefense
strategy has been completed. The Trump administration released
that last year, and they are in the process of implementing it.
Other activities have been taken up by the Federal Government
itself without legislation or the White House having to push
them to do it.
Strides are being made in terms of biological attribution,
in terms of addressing the one health concept of animal,
environmental, and human health all coming together.
The State Department has taken some forward steps in terms
of addressing the biological weapons convention requirements.
The Judiciary Committee here has been working on strengthening
the law to make the possession of biological agents and working
with biological agents more of a criminal activity.
Mr. Guest. So, from your answer, roughly half of those
recommendations, there has been some action on? Would that be
correct, Dr. George? I think you said 17. Did I get that number
correct?
Ms. George. I would say probably 10 percent.
Mr. Guest. Oh, only 10 percent?
Ms. George. Yes.
Mr. Guest. All right. Of those that have--those
recommendations that we have not yet taken action on, which of
those do we need to give the highest priority to?
Ms. George. Gosh, I think this issue of biodetection
certainly is a high priority. I think that our recommendations
on preparedness for the public health and health care
communities are also high priority.
I believe we need a stratified hospital system so that we
know where to send patients, wherever those patients might find
themselves. We can't assume that everybody who is going to
become ill from a biological agent is conveniently going to be
around the 4 or 5 Ebola treatment centers that we have right
now.
Mr. Guest. Let me ask--you also talk about in your report--
you mention North Korea and Russia, that they continue to
develop biological weapons. You say China will invest, between
2015 and 2020, $12 billion in biological innovations. You also
mention Iran and terrorist organizations.
As it relates to terrorist organizations, you talk about
different biological agents, including anthrax. Where would a
terrorist organization most likely obtain a biological agent?
Would they manufacture those themselves? Would they be obtained
from a country, such as Iran or North Korea? Based upon your
expertise in this area, is it more likely that they will
internally be able to produce a biological agent, or would they
be more likely to partner with North Korea, Iran, China,
Russia, one of the nation-states that currently are producing
and possess biological weapons?
Ms. George. Sir, I think it depends, honestly. It depends
on the terrorist organization and the resources that they have
available to them. If they can, if they have the resources, if
they can get them and they can get the scientific expertise,
they will try and produce them themselves, because that would
just be easier logistically.
Otherwise, you would have to determine whether those
organizations have a relationship with the countries you just
mentioned, or whether they are able to tap into the black
market, and somehow get already weaponized material out of the
former Soviet Union and other countries like that, and bring--
and just already have weaponized material at their disposal.
Mr. Guest. One last question, ma'am. I know my time is
running short.
In previous meetings and reports, the Commission has
highlighted the importance of partnering with the private
sector.
Can you provide examples of how the private sector,
specifically the medical countermeasure manufactures, have
partnered with the U.S. Government and ways in which we can
improve this public/private partnership in which we are working
together to keep the American public safe?
Ms. George. Sir, I think where it has worked best is when
the U.S. Government has been very clear on its requirements, so
that the private sector knows what it is responding to.
A great example would be what happened with Ebola. We had a
very--the industry had a very specific disease it was going
after. It knew where various locations were at. The Department
of Defense, the Department of Health and Human Services, and
others, were very clear on what it is--what it was they were
looking for.
So now you can see today, we don't just have one vaccine,
we have got all kinds of things happening now, because they
knew what they were shooting for.
Mr. Guest. Thank you.
Mr. Chairman, I yield back.
Mr. Payne. Thank you. I now recognize the gentlelady from
Texas, Ms. Jackson Lee.
Oh, I apologize, sir. We will now go to the gentleman from
New York, Mr. Rose. I apologize.
Mr. Rose. Thank you, sir. No need for an apology.
Dr. Rakeman, thank you for your service, first of all, to
New York City.
Are you familiar with the unit at Fort Hamilton Base that
moves to major sites, whether it is the Thanksgiving Day parade
or whatever else it might be, that has biodetection technology?
Ms. Rakeman. I am not. I can get back to you with more
information----
Mr. Rose. OK. Well, this unit does exist, and they do
certainly move from----
Ms. Rakeman. CST unit?
Mr. Rose. What is that?
Ms. Rakeman. CST unit, Civil Support Team?
Mr. Rose. Yep. So my concern is, is that when they are on-
site, they have basically detection technology there, and it
takes about an hour to determine if something is hazardous or
not.
In the event that that CST unit is not on-site, let's say
U.S. Open, whatever other large-scale event in New York City,
what is the time that it takes from identifying whatever it
might be to actually having a confirmation that it is
hazardous?
Ms. Rakeman. So using the BioWatch system, which, in New
York City, can be deployed and is often deployed at big special
events, such as--I am sorry--the New York Yankees games, things
like that, and events like the U.S. Open, we will--the city
will deploy PSUs to those.
Mr. Rose. A PSU is?
Ms. Rakeman. A portable sampling unit, the unit that is on-
site that actually draws in the air sample.
Mr. Rose. They have the same technology as a CST?
Ms. Rakeman. The CST technology is not something that I am
particularly familiar----
Mr. Rose. Dr. George, do you want to add anything to this?
Ms. George. No, sir. It is different technology.
Mr. Rose. How is it different?
Ms. George. I can't tell you that, sir. It is just
different technologies, actual different pieces of equipment.
Mr. Rose. Is it worse? Is it better? Is it--I mean----
Ms. George. I don't have that data, sir. I would have to
talk to DOD.
Mr. Rose. So PSUs, you said, right?
Ms. Rakeman. It is BioWatch testing. So then the filter
would come back the Public Health Laboratory and be tested.
Mr. Rose. So the PSUs don't--can't test it on-site?
Ms. Rakeman. No. No, all BioWatch testing samples----
Mr. Rose. So what do they do then?
Ms. Rakeman. So they are collected by our partners in the
field----
Mr. Rose. OK.
Ms. Rakeman [continuing]. The filters, they come back to
the laboratory, and we process and test those samples at the
laboratory.
So in New York City, depending on where the sampler is--and
if it is a special event, the sampler will be operational for a
period of time, up to 24 hours. It could be less. So an attack
may have occurred 24 hours prior to when the sample is
collected. Then that sample needs to be transported to the
laboratory, processed and tested, and that takes a number of
hours as well.
So the window between when something may have happened and
when we actually have a positive BioWatch actionable result in
the laboratory can be over 24 hours, up to 36 hours.
Mr. Rose. So what is our right now--first of all, is that
OK, 36 hours, in terms of the time line? Is that too long? It
seems to me that that is too long.
Ms. Rakeman. The goal for biodetection, and one of the
goals of the BD21 program, is to shorten that time to
detection. That is something is that we definitely support.
Mr. Rose. What would you like to shorten it to?
Ms. Rakeman. Well, to pick up an attack, to be able to save
lives, hours count. So as short as that window can be, the
better it is.
Mr. Rose. So, Dr. George, what do you think it should be?
Ms. George. You know, sir, the right answer to this is it
should be immediate or near-immediate.
The reason she is saying that it is taking so long is
because those--what is happening with the current BioWatch
system is that it is just a system of filters that is filtering
air and somebody has got to test it. The system itself is not
testing it.
So if you have better handheld detectors that could
identify something quickly and with valid and reliable results,
or you had better detectors or whatever----
Mr. Rose. That technology exists?
Ms. George. Technology exists, but it is--but none of that
technology is perfect yet. So all of it requires gold standard
testing back in a laboratory as of right now.
Dr. Shah. That was a key. The key message is that it is the
confirmatory test. You certainly don't want to launch a
response when you don't have the confirmation.
Ms. Rakeman. The tests deployed need to be good, reliable
tests.
Mr. Rose. But we do have the technology right now for
mobile laboratories, correct?
Dr. Shah. Well, and I will----
Mr. Rose. Does that technology exist?
Dr. Shah. I will defer, but we do--we still--the mobile
does not have the confirmatory component.
Mr. Rose. OK.
Dr. Shah. So it still requires you going back to a public
health laboratory or response network laboratory to actually
confirm.
Mr. Rose. Well, but, right now in New York City, based off
our SOP with the NYPD, obviously we would evacuate a site once
there was any level of confirmation, correct?
Ms. Rakeman. So if we had a full BioWatch actionable result
that we determined--and me, as the laboratory director, is
responsible for determining whether our result is valid, which
is--then the response would happen. That is something that we
partner with NYPD to determine----
Mr. Rose. So right now, if you found something in Grand
Central Station, and I am sure this has happened before, and
you send it to the lab, takes 36 hours. So really, what New
York City policy is right now, is that we find something that
is potentially hazardous, we wait 36 hours before evacuating?
Ms. Rakeman. No. So it might take 36 hours to determine
whether there is a reason to go back and do follow-up sampling,
to determine whether there was a true agent in that facility at
that site.
Mr. Rose. So how long does that take?
Ms. Rakeman. Well, then that can add on more hours.
Mr. Rose. So basically, I am asking, how many hours does it
take for us to find out whether this stuff kills people? Do you
have a number for that?
Ms. Rakeman. I don't have a number for that. We can get
back to you. We would have to talk about the entire system and
work with all of our partners to come up with that number.
Mr. Rose. Who is in charge of that entire system in New
York City?
Ms. Rakeman. There are multiple city agencies that work----
Mr. Rose. There is not one person in charge?
Ms. Rakeman. No.
Mr. Rose. So there is not one person in charge in New York
City right now of managing a biohazard response?
Ms. Rakeman. So there is a public health piece to the
response that the health department is responsible for. There
is a law enforcement response that the law enforcement teams
are responsible for.
Mr. Rose. OK. So we have some interesting questions here,
because I am a simple guy. I just want to know that we can
quickly get people out of large areas by quickly finding out
that there is a hazardous item there.
Mr. Payne. The gentleman's time has expired, and if we can
come to a second go-round, we can get back to that.
Mr. Rose. Thank you.
Mr. Payne. I recognize the gentlelady from Texas, Ms.
Jackson Lee.
Ms. Jackson Lee. Mr. Chairman, let me thank you for your
generosity and kindness for allowing me to sit on a very
important panel for a committee that I have invested my
legislative career, the Homeland Security Committee.
But I want to thank you particularly for your well-suited
leadership on this committee. I look forward to working with
you and being a problem-solver for some of the very issues that
these very fine witnesses are espousing, particularly in the
FEMA overhaul.
One of the things that we are stifled by is the structure
of funding from the Federal Government, the Stafford Act. For
those of us who have experienced disasters, Hurricane Sandy,
you saw it first-hand, your local folk coming out of City
Council--I came out of City Council--your local folk needed
their resources and they knew what they needed to do.
So, my line of questioning will be to these witnesses on
that very order. But as I do so, I would be remiss not to speak
about my friend, Dr. Shah, who has responded to all of the
public requests that I have made dealing with public health.
Let it be very clear that we have worked together on public
matters. I am reminded of the Zika virus and the work and the
promptness and the astuteness that Harris County Health engaged
in. Dr. Shah is a collaborator with the Houston City Health
Department. We worked on Ebola. No, the first case was not in
Houston, it was in Dallas, but we were well recognizing, as the
rest of you were, that we needed to be on point, because Ebola
took to the flight, aviation system, and people were traveling.
We worked on this question that doesn't get you a lot of
fans, and that is about supporting vaccinations. When we were
having a moment in our community wherein people seemingly were
rejecting the value of vaccinations, that is a public health
scenario.
For example, one does not know if those untoward Russian
bots could influence people, let's don't get vaccinated. We
know what will happen. We had a measles outbreak in a number of
places. Then, of course, the idea of gun violence.
So let me make some pithy questions. Yes or no. I want to
get back to Dr. George, and I want to thank her for her
service. I want to thank her for the 2014 report that you
worked on so diligently.
Just give me--has the Government responded to that report
and some of the valuable aspects of it?
Ms. George. Yes.
Ms. Jackson Lee. In its totality or portions thereof?
Ms. George. Portions thereof. I think----
Ms. Jackson Lee. Tell me where we could get in there in a
better way for some of the----
Ms. George. I think where Congress could act would be to
take--take those activities they are halfway through and push
them, show some interest and----
Ms. Jackson Lee. Give me one activity to push through?
Ms. George. Well, I think--BioWatch is the topic of today.
I think BioWatch would be one that could be pushed.
Ms. Jackson Lee. That we need to profoundly try to refine
and define and make it work?
Ms. George. Yes, ma'am.
Ms. Jackson Lee. You also--someone said the BD21 has data
that you haven't discerned whether it is reliable. Is that
accurate?
Ms. George. Correct.
Ms. Jackson Lee. So that is certainly a part of our work
that we really need to encourage and work with the private
sector. We need to refine the reliability of that data?
Ms. George. Correct.
Ms. Jackson Lee. To both--I am going to go to Dr. Shah
first, but let me ensure that Dr. Rakeman--see if my glasses
are working--can ask, in your leadership. But you made a very
important statement that the bells and whistles of public
health are not conspicuous. If you are working on Zika, maybe
the neighborhood of which you may be doing the complementary
mosquitoes spraying, which is another agency, but you work with
them to do what they are supposed to be doing, is not a real
bell and whistle, unless somebody is looking out their window
at about 9 at night.
But there are other aspects of public health that you are
working on, and, therefore, when it comes to funding, you may
not be in the forefront.
Tell me how devastating that is and how we need to change
the Federal construct that you--that we are dealing with so
that public health, particularly in bioterrorism, can be front
and center? Dr. Shah and Dr.----
Dr. Shah. Sure. Thank you, Congresswoman, for your
leadership and your support of public health. We really
appreciate that. Your on-going support is critical to what we
are wanting and trying to achieve in our local community. So
thank you.
I think that the real rub of this is--at the end of the
day, is to ensure that locals are a part of that planning
process. I mean, emergencies happen in local communities, local
governments, local responders, local partners, local community
members who are impacted. We want to make sure--and you
highlighted many of those issues that have occurred in our
community, but also the vast number of emergencies that the
Houston/Harris County and southeast Texas, as well as Texas
throughout has had, in terms of emergencies over the years.
We have to ensure that that experience is respected by our
Federal partners, that it is not that the Federal partners know
it all, and they simply say, You know what? We are going to
tell you exactly how this is going to happen. It should be a
cooperative partnership. That is not always happening, and I
think that is the concern.
Ms. Jackson Lee. Doctor, would you respond?
Thank you, Dr. Shah.
Ms. Rakeman. Thank you. I like Dr. Shah's hashtag of
invisibility crisis. Because that really is something that is
an important aspect of what we do in public health. Our job is
to keep people from getting sick. To sort-of put that on a
banner, puts lights and sirens around that, is very difficult.
So, making sure that State and locals--local governments
are part of the conversation when it comes to things like
funding or programming is very important, because what we do
needs to have infrastructure and that needs to be there always.
We don't know when the next outbreak is going to happen. We
don't know when the next crisis will occur. But if the
infrastructure is not there ahead of time, then we can't
respond.
Ms. Jackson Lee. Let me quickly ask you this:
You heard me talk about the construct, which is Federal,
State, and then maybe--would it be helpful that if we had a
definition of a crisis, an emergency, a natural disaster, a
man-made disaster, that you are getting a direct emergency
infusion of dollars? Would that be helpful to you all as
leaders in your community on health care?
Ms. Rakeman. Yes.
Ms. Jackson Lee. It would be defined to the particular
incident, or the definition of incidents, that would occur that
would be able to direct moneys directly to those local
agencies.
Dr. Rakeman.
Ms. Rakeman. So getting funding to local agencies is very,
very important. Funding that is, particularly for emergencies,
is important and necessary.
What can be hampering is if funding dollars are tied to
specific events and that we can't use them for other things,
because building that infrastructure is important. The same
instrumentation we use in the laboratory to test for a food-
borne outbreak is instrumentation we use to test for Zika or to
test for Ebola.
So having all of that there and being able to spend the
money in the way that makes our work most efficient and makes
us most nimble is really critical.
Ms. Jackson Lee. We would listen to you in how that would
be designed.
Dr. Shah.
Dr. Shah. Yes. As you know, it is not an either/or. It is
not just the emergency funding coming. It is really building
that capacity throughout. So you have higher level of capacity,
and so, you don't have to stretch as much when you have a surge
in an emergency.
But I think as you also know, Congresswoman, there is also
that concern about looking at how Federal agencies really send
those dollars down to local partners, local health departments,
and insuring that it is not just going, for example, to a city
core, but really, it is looking at all of the risk threats and
all of the community members that are potentially in Houston/
Harris County, where you have 2.2 million that are within the
city of Houston, but you have 2.5 million outside the city of
Houston, also looking at a whole-community approach to that
funding.
So I think looking at funding streams and funding formulas
is absolutely critical so that we can get this correct.
Mr. Payne. OK.
Ms. Jackson Lee. I know my time is long spent, Mr.
Chairman.
Thank you to the witnesses.
As I close, may I just have a letter of collaboration from
the city of Houston? May I just extend a question that we can
work on? Part of their issue is being blocked from getting
information because of it being Classified--as Classified or
they are not at that level. So I think this is a very perfect
entity to work on solving some of those structural problems,
funding problems----
Mr. Payne. Yes.
Ms. Jackson Lee [continuing]. So that we can fight this war
of bioterrorism.
Thank you. I yield back, Mr. Chairman, for your courtesies,
thank you.
Mr. Payne. I would like to ask unanimous consent to enter
into the record the Bipartisan Report of the Blue Ribbon Study
Panel of Biodefense from October 2015.*
---------------------------------------------------------------------------
* The information has been retained in committee files and is also
available at https://biodefensecommission.org/reports/a-national-
blueprint-for-biodefense/.
---------------------------------------------------------------------------
I want to thank all of you for your testimony.
Ms. Jackson Lee. I am sorry. Mr. Chairman, did you get this
one, too, the letter that I offered on unanimous consent to
be----
Mr. Payne. Without objection.
[The information referred to follows:]
Letter From the City of Houston
October 17, 2019.
Congresswoman Sheila Jackson Lee (TX-18),
2079 Rayburn HOB, Washington, DC 20515.
Dear Congresswoman Jackson Lee: We are writing to brief you on the
current efforts that the city of Houston (COH) has under way to be
prepared for a Bioterrorism event. We have strong relationships between
the Houston Health Department (HHD), Houston Emergency Medical
Services, HazMat teams, Emergency Management, health care, and law
enforcement agencies, both Federal and local. Our efforts include
drills, surveillance and laboratory capacity.
In October, we will be conducting an exercise to develop our mass
dispensing capability for antibiotics that would be issued in the event
of an anthrax event. That day-long exercise includes multiple Point of
Dispensing sites (PODs) to dispense antibiotics and reassignment of COH
employees to staff the exercise, In 2018, we worked with the U.S.
Postal Service to conduct an anthrax tabletop at the main Houston
postal distribution center.
During the current baseball playoffs for the Houston Astros, COH is
conducting enhanced syndromic surveillance and laboratory testing for
any possible bioterrorism incidents, The effort includes syndromic
surveillance of emergency room complaints and laboratory surveillance
for bioterrorism agents.
We are also aware of the risk that illegal drugs potentially pose
both as a risk to the community and as potential bioterrorism agents.
COH has just competed for and been awarded a Department of Justice
award to implement OD Map, a tool to track opioid overdoses.
Early in 2020, COH units, including public health and the water
department, will partner with the Environmental Protection Agency and
the Houston office of the Federal Bureau of Investigation to describe
water issues in biosecurity. We will explore possible hazards and do a
tabletop exercise assessing COH ability to respond to an incident where
the opioid fentanyl is added to the water supply.
The HHD lab has extensive laboratory testing capacity, including
the ability to conduct rule-out testing for Category A agents. The
laboratory has been quick to adopt emergent testing capabilities,
including for Ebola. Such capacities are developed as part of our
participation in the Laboratory Response Network.
COH is extremely aware of the potential risk of bioterrorism and
has a strong system in place to detect, confirm and respond to such
incidents. We wanted to let you know that we take our responsibility
seriously and make maximum use of Federal dollars.
Sincerely,
Stephen L. Williams,
Director, Houston Health Department.
David E. Persse, MD,
Public Health Authority, Physician Director EMS.
Ms. Jackson Lee. Thank you, Mr. Chairman.
Mr. Payne. I want to thank the witnesses for your valuable
testimony and the Members for their questions.
The Members of the subcommittee may have additional
questions for the witnesses, and we ask that you respond
expeditiously in writing to those questions.
Pursuant to committee Rule VII(D), the hearing record will
be held open for 10 days.
Without objection, hearing no further business, the
subcommittee stands adjourned.
[Whereupon, at 11:34 a.m., the subcommittee was adjourned.]
A P P E N D I X
----------
Questions From Chairman Donald M. Payne, Jr. for Asha M. George
Question 1a. It is my understanding that DoD Civil Support Teams
(CST) teams have biodetection capabilities.
What capabilities do they have and how do they interact with local
public health?
Answer. The commission understands that the National Guard Weapons
of Mass Destruction (WMD)--Civil Support Teams (CSTs) support civil
authorities when a domestic biological event occurs with identification
and assessment of the biological hazard. They utilize an Analytical
Laboratory System (ALS, a standardized mobile laboratory system) to
conduct analysis of biological samples collected from the affected
environment. The ALS also prepares, extracts, analyzes, and stores
environmental samples, using a variety of scientific methods, including
electrochemical luminescence, gas chromatography, mass spectroscopy,
infrared spectroscopy, polarized light microscopy, polymerase chain
reaction, lateral flow immunoassays, high purity germanium gamma
spectroscopy, and fluorescence microscopy.
The commission's understanding is that the National Guard CSTs
interact with the Laboratory Response Network (for biological,
chemical, and radiological threats)--also known as the LRN. Public
health laboratories are members of this Network. In addition, the CSTs
participate in scenario-driven exercises and support large-scale events
at which the public health community is also present. Given the
relationship of the National Guard with their Governors, it seems more
likely that the CSTs would interact with State departments of health
than they would with local public health personnel.
While the CST integrates data from a variety of sources to
determine the extent and severity of a biological hazard, the
commission understands that CST testing throughput capability is
limited to a maximum of 8 samples per day, making the use of LRN
reference laboratories for confirmatory testing critical during events.
Question 1b. How long does it take them to detect a biological
agent?
Answer. The commission does not possess information about how long
it takes for a CST ALS to identify biological agents, but depending on
the type of scientific method used, most identifications take from 4-48
hours. Preliminary, unconfirmed identification takes much less time
than confirmation, which often requires the growth of microorganisms
and subsequent use of gold standard laboratory testing that occurs in
brick-and-mortar laboratories.
Question 1c. How do they confirm the results? If there is a
positive hit in their detection system, what actions do they take?
Answer. The commission has been told that the ALS applies
standardized analyses to screen potentially hazardous samples and
prepare them for safe transport by the appropriate civilian law
enforcement entity to the appropriate LRN reference laboratory for
confirmatory testing and definitive analysis.
The commission understands that while the CST focuses on sending
samples back to the appropriate LRN reference laboratory for
confirmatory testing to support public health decisions, the CST also
works closely with the Federal Bureau of Investigation, local law
enforcement, and public health agencies to support public health and
safety decisions with on-scene hazard analysis and evaluation of the
extent of contamination.
The commission also understand that CSTs may take other actions
after initial detection of a biological agent vary according to the
situation. If a CST has been deployed to support a large-scale public
event, they are part of a larger team (which may include local law
enforcement, hazardous materials specialists, medical, public health,
and Federal law enforcement, among others) and would alert incident
commanders on-site, as well as their own Department of Defense (DOD)
chain-of-command, to the suspected presence of biological agents. If
the CST is deployed alone or as part of military activity, they would
alert their own DOD chain-of-command, which would, in turn, alert
civilian leaders and organizations.
Question 1d. What technology does CST use for biodetection? How
does it compare to BioWatch technology?
Answer. The commission does not know which technology the CSTs are
using to detect biological agents. We understand that a wide variety of
detectors with different capabilities are available to DOD, including
bio-aerosol monitoring and sampling systems, and devices that trigger
on-board or remote samplers to collect real-time samples for subsequent
analysis when a biological threat is present. From what the commission
has been able to tell (without data), all biodetection systems
currently in use by the CSTs, other elements of DOD, other parts of the
Department of Homeland Security, and NASA outperform BioWatch
technology.
Questions From Honorable James R. Langevin for Asha M. George
Question 1. The intelligence community is increasingly concerned
that the technical knowledge and material needed to develop biological
agents is becoming more widely available. Will you please discuss how
advances in synthetic biology and genome editing make it easier to
develop biological weapons? What trends are you seeing in this area?
Answer. The commission understands that next-generation
technologies (e.g., CRISPR-Cas9) have greatly lowered the barrier for
both good and bad actors to experiment with microorganisms. Today,
anyone looking to develop or alter biological agents can feasibly do
so. Directions are readily available for those who know where to look
for them on the Dark Web, and raw biological materials can be
conveniently ordered on-line. The prospect of advances in synthetic
biology being misused becomes even more concerning when considered in
conjunction with the convergence of the cyber- and biological sciences.
Bad actors may seek to penetrate sensitive computer systems at research
institutions or Federal laboratories to obtain data regarding
biological agents and other disease-causing organisms that they could
use to develop biological weapons.
Such developments have increased the number of biological threats
and made it all the more difficult to detect and identify them. While
it is difficult to quantify how much the biological threat has expanded
in recent years, the commission believes that it is a question of when,
not if, synthetic biology and genome editing are used to create deadly
pathogens.
Question 2. As you mentioned in your testimony, the Department of
Homeland Security is using outdated Department of Defense technology in
its transition from BioWatch to BD21. Is it your sense that DHS has
access to the latest DoD technology? Is there another reason DHS is not
using the latest technology in the testing and implementation of BD21?
Answer. The commission understands that Department of Homeland
Security (DHS) BioWatch program has long suffered from a lack of
effective technology. As currently designed and deployed, the system
and its underlying technology simply do not work. BioWatch detectors
cannot accomplish the stated mission of rapidly detecting biological
threats to the public.
The commission understands that the BD21 program has obtained older
Department of Defense (DOD) detection technology (including Government
off-the-shelf technology) for evaluation, instead of more recent
technology available to the private sector and other Federal
departments and agencies. DOD also provided technology for evaluation
by DHS that failed when DOD fielded the technology itself. Although DOD
has transitioned some technology to DHS, these candidates have not
included the latest DOD technology, according to both DHS and DOD. DOD
is not required to provide all of its biodetection technology with DHS.
The DHS Office of Countering Weapons of Mass Destruction (where
responsibility for BioWatch and domestic environmental biodetection
resides) does not appear to the commission to be adhering to a standard
Federal acquisition process. DHS has not issued requirements for BD21
biodetection technology. Industry representatives are at a loss as to
what, if anything, they should provide when responding to DHS calls for
biodetection technology. As a result, much of the private sector is not
providing more advanced biodetection technology to DHS and those
companies that are providing technology are guessing at requirements
and providing technology that is inadequate to meet DHS National
biodetection needs.
The commission understands that other elements of DHS are employing
biodetectors that are not part of BioWatch and also do not appear to be
under consideration by DHS for BD21. The Office of Countering Weapons
of Mass Destruction has not explained why this is the case, but other
parts of DHS believe this is due to the office's poor working
relationship with the Science and Technology Directorate, which was
responsible for identifying and emplacing some of this biodetection
technology.
BioWatch program officials, working in conjunction with the DHS
Science and Technology Directorate and other Federal partners, should
identify the most cutting-edge biological detection technology and test
it for potential use in the program. While DHS has declined to conduct
a full evaluation of detection technology currently available to
Federal departments and agencies, as well as the private sector,
nothing prevents the Department from conducting such an analysis. The
DHS Office of Countering Weapons of Mass Destruction consistently
declines to work with the DHS Science and Technology Directorate in
this regard.
Given the long-standing issues surrounding the technology used for
the BioWatch program, Congressional actions, through oversight and
legislation, may be the best methods by which to ensure that the latest
technology is considered to replace BioWatch detectors. The commission
recommended and continues to recommend that Congress and the
administration terminate the existing BioWatch system and replace it
with technology that can actually detect biological threats, thereby
fulfilling Congressional mandate in this regard. If DHS cannot
accomplish this, the commission recommends that Congress eliminate the
program altogether.
Question 3. Researchers must follow security standards when working
with dangerous pathogens to ensure they are not accessed by people with
malicious intent. Are researchers required to comply with any
cybersecurity standards when storing data on dangerous pathogens that
could have biodefense implications?
Answer. The commission is not aware of any cybersecurity or
cyberbiosecurity standards with which civilian researchers that work
with dangerous pathogens and must store data on dangerous pathogens
with biodefense implications must comply. The commission believes that
the DOD is slightly further ahead in this regard, in that the National
Security Agency has at least developed some mature plans for how
researchers should store and work with this sort of data in a cyber-
secure fashion.
Questions From Honorable Lauren Underwood for Asha M. George
Question 1. Recent reports have suggested that both health
disinformation and misinformation campaigns have promoted vaccine
hesitancy amongst the public. I am concerned that these campaigns could
have long-lasting consequences on public health in this country. Are
you worried that these campaigns will have a negative impact on
domestic preparedness in case of a bioterror attack or naturally-
occurring outbreak?
Answer. The commission supports vaccine uptake by the public as an
effective approach to prevent, deter, and mitigate large-scale
biological outbreaks. Although the Nation's biodefense enterprise often
finds itself focusing on the challenges of research and development for
new vaccine candidates, producing and stockpiling medical
countermeasures are only two elements of biodefense. Public engagement
and education regarding the benefits of vaccination are important
contributors to public health security. The success of ring vaccination
and other response efforts depend upon public trust in public health
and other Governmental institutions. Public disinformation and
misinformation campaigns about vaccines undermine public confidence in
vaccine safety and put the health of the Nation at risk.
Question 2. Credible information is critical to saving lives during
terrorist attacks. How can State and local health officials work to
ensure the correct information is disseminated to the public leading up
to, during, and after a bioterror attack? What can the Federal
Government do to be an effective partner?
Answer. Effectively alerting the public depends upon access to
accurate, actionable information with which to issue alerts. State,
local, Tribal, and territorial governments should leverage their public
health laboratories to confirm the identification and presence of
biological pathogens. Simple, clear messaging to the public regarding
the extent of the threat posed by an outbreak must follow. In the case
of a biological terrorism attack, law enforcement must be brought in as
evidence emerges, so that they can investigate and assist with
messaging. Locations where needed medical countermeasures are available
should also be made clear by the Federal Government.
Unfortunately, the unreliable technology that comprises the Federal
Government's biological detection system, BioWatch, makes the task of
collecting useful data for the purposes of informing the public more
difficult. The Federal Government must replace this technology so that
State, local, Tribal, and territorial partners can better maintain
situational awareness of and during an outbreak. The Department of
Health and Human Services, and Federal law enforcement, can assist with
coordination and messaging for after a biological attack, and provide
guidance on the location of supplies and medical countermeasures.
Question 3. How would you characterize the decision to move the
health aspects of the Department of Homeland Security, including the
Office of Health Affairs and Office of the Chief Medical Officer (CMO),
within the Office of Countering Weapons of Mass Destruction (CWMD)?
Answer. In 2017, the Department of Homeland Security (DHS) decided
to reorganize its weapons of mass destruction programs by combining the
Domestic Nuclear Detection Office with the Office of Health Affairs and
parts of a few other DHS components. The resulting Office of Countering
Weapons of Mass Destruction was charged with leading Department
policies and coordination on matters pertaining to chemical,
biological, nuclear, and radiological threats. This reorganization also
saw the transfer of some of the duties from the Office of Health
Affairs to the Department's Management Directorate, to maintain the
health of the DHS workforce. Other duties deemed to be more
operational, including deploying liaisons to component agencies, were
kept at the Office of Countering Weapons of Mass Destruction. During
the course of this process, the position of the CMO was subsumed and
the political position of Assistant Secretary of Health Affairs was
changed to the Assistant Secretary for Countering Weapons of Mass
Destruction.
An argument could be made that the CMO position and occupational
health matters for the Department's workforce should be located within,
and addressed by, the DHS Management Directorate. However, current
statute (6 USC 597) specifically charges the CMO with some of the same
responsibilities now taken up by the assistant secretary for countering
weapons of mass destruction.
Question 4. Do you believe providing the CMO with contracting
authority will allow for greater operational capabilities?
Answer. No, the commission does not believe that providing the CMO
with contracting authority will allow for greater health care and
public health operational capabilities. The problem is that the
position of the CMO has been subsumed within the Office of Countering
Weapons of Mass Destruction.
Question 5. Can you provide any recommendations for how the
Department of Homeland Security should structure the CMO within DHS?
Answer. I believe that the position of the chief medical officer
(CMO) should be removed from the Office of Countering Weapons of Mass
Destruction. I believe the CMO should retain responsibilities for
serving as principal advisor on medical and public health issues to the
Secretary of Homeland Security, administrator of the Federal Emergency
Management Agency, and all other officials in the Department of
Homeland Security (DHS). The Department's CMO should also retain
responsibility for coordinating medical and public health matters with
Federal, State, local, Tribal, and territorial governments; and the
medical, public health, and emergency medical services communities.
Advisory and coordinating responsibilities should be removed from the
Office of Countering Weapons of Mass Destruction. Additionally, the
head of the DHS occupational health office should report to the under
secretary of the DHS Management Directorate and to the Department's
CMO.
I believe that CMOs should be established in all DHS operational
components. The component CMOs should be managed by their component
heads and not by the Department's CMO. Component CMOs should provide
operational medical support to their own components and this
responsibility should be removed from the Office of Countering Weapons
of Mass Destruction and the Department's CMO. All component CMOs should
report to their component heads and to the Department's CMO.
I do not believe that the Department's CMO needs to be a licensed
physician, as the position is advisory and policy-oriented, and that
this position should not only possess knowledge of medicine and public
health, but they should also have experience with both, beyond the
possession of academic credentials. The CMOs in each of the components
should be licensed health care deliverers (i.e., nurses and other
health care professionals should be considered for these positions) if
the components believe that licensure is necessary.
Questions From Chairman Donald M. Payne, Jr. for Jennifer L. Rakeman
Question 1a. It is my understanding that DoD Civil Support Teams
(CST) have biodetection capabilities. What capabilities do they have
and how do they interact with local public health in NYC?
Answer. We recommend that you contact DoD to discuss their specific
biodetection capabilities.
Question 1b. How long does it take them to detect a biological
agent in NYC?
Answer. The CST utilizes field testing methods that can detect the
DNA of biothreat agents within 2 hours. Note that this type of testing
does not determine viability (i.e. whether the agent is infectious).
Question 1c. How do they confirm the results? If there is a
positive hit in their detection system, what actions do they take?
Answer. The CST would refer samples to the NYC Public Health
Laboratory (NYC PHL) as the local member of the Laboratory Response
Network (LRN). Further characterization of biothreat samples would be
performed by the NYC PHL and/or the CDC and other National laboratories
such as the FBI's National Bioforensic Analysis Center (NBFAC).
Question 1d. What technology does CST use for biodetection? How
does it compare to BioWatch technology?
Answer. We recommend that you contact DoD to discuss their specific
biodetection capabilities. BioWatch testing is performed in a
laboratory setting, including the NYC PHL, and utilizes DoD reagents
from the critical reagent program to screen samples and reagents from
the LRN to verify the presence of biothreat agent DNA.
Question 2. The time between biological agent release and detection
has been described as taking too long. For NYC, how long is it until we
have a confirmed bio event with current technology and processes? What
recommendations would you have to decrease this time?
Answer. Depending on the frequency of sample collection, the
current BioWatch system allows for detection of biothreat agent DNA
between 12 to 36 hours post-release. Note that collection frequency and
timing are determined locally.
As discussed during the hearing, no technology currently exists to
specifically and rapidly detect a wide spectrum of biothreat agents in
the field. Possible means to reduce detection time include:
Increasing frequency of collections for laboratory-based
testing, which would require increased funding to hire
additional field and laboratory staff.
Multiplexing, which is the combining of multiple target
detection reagents into a single reaction mixture; this is
technologically feasible but has not been accomplished to date
for all biothreat agents of interest and may require
sacrificing sensitivity and/or specificity.
Reducing assay specificity, which may increase the false
positive rate.
Note that there are no technologies for field use that are able to
CONFIRM detection and/or viability of agents. Confirmatory and
viability testing must be performed in a laboratory setting.
Question 3. Could you describe the process by which NYC detects,
manages, and recovers from a biological attack?
Answer. NYC uses a multidisciplinary approach to detect, respond
to, and recover from biothreat agents that includes disease
surveillance, laboratory testing, emergency management, life safety,
and law enforcement activities. A biological incident is managed using
a Unified Command Element that is comprised of multiple NYC agencies.
Any related criminal investigations are led by NYPD.
The NYC Health Department is responsible for human and animal
disease surveillance and epidemiology, mass prophylaxis (including
antibiotics and vaccines), laboratory testing, public health orders,
clinical guidance and risk communication, mental health needs
assessment, and service coordination and environmental mitigation.
The NYC Health Department will make a final assessment of the
biological hazard, develop environmental sampling strategies to confirm
and then characterize the incident, adjust zones of contamination and
direct all mitigation efforts, including oversight of the remediation
and clearing spaces for re-occupancy.
In anticipation of this role, the NYC Health Department, with
support from the Environmental Protection Agency (EPA), developed the
NYC Health Department Environmental Response and Remediation Plan for
Biological Incidents. The Plan called for the establishment of a
Technical Working Group, now established, consisting of subject-matter
experts that would provide the NYC Health Department with technical
expertise during environmental remediation operations.
Recovery from a widely disseminated biothreat agent attack would
require a lengthy National effort, involving all levels of government.
Question 4a. There has been a lot of discussion about using field-
deployed detection approaches for assisting in the detection of
biological agents. Do we have the technology for mobile laboratories/
handheld field detection equipment?
Can these technologies have a confirmatory element to it?
Answer. Any field-based test requires a laboratory-based
confirmatory test. Current field detection technologies in use are not
capable of determining the viability of biothreat agents. A rapid
viability PCR-based test (RV-PCR) specifically for the detection of
Bacillus anthracis spores has been developed by EPA for laboratory use,
but it is not widely used or available to LRN public health
laboratories. This method requires culture of spores and cannot be
adapted to field use.
Question 4b. Do you have any concerns about making actionable
public health decisions based upon hand-held field detection equipment
or mobile laboratories?
Answer. Hand-held and mobile laboratory testing for biothreat
agents that is performed by first responders has previously led to
misidentification of suspicious substances in NYC. Mobile data
collection does not yet provide the level of accuracy needed by first
responders and health officials to adequately identify and respond to
potential biological emergencies.
Question 4c. Would your jurisdiction allow the use of such hand-
held devices to confirm a bioterror attack in the field?
Answer. Currently available hand-held technology is not capable of
determining viability and therefore is not considered confirmatory.
Question 4d. Is the technology mature enough and has it been vetted
to be used for this purpose?
Answer. Hand-held technology has not been tested in a manner
similar to clinical assays that have received FDA clearance and CLIA-
waivers and should not be considered for any routine use that may lead
to high regret decisions such as closure of transit hubs or failure to
pursue additional laboratory-based testing. Additionally, there are
serious concerns about the lack of oversight to ensure training and
competency of first responders using hand-held devices and a lack of
laboratory quality systems in place in the first responder community
for maintaining complex detection technology, whether hand-held or in a
mobile lab.
Questions From Honorable Lauren Underwood for Jennifer L. Rakeman
Question 1. Recent reports have suggested that both health
disinformation and misinformation campaigns have promoted vaccine
hesitancy amongst the public. I am concerned that these campaigns could
have long-lasting consequences on public health in this country. Are
you worried that these campaigns will have a negative impact on
domestic preparedness in case of a bioterror attack or naturally-
occurring outbreak?
Answer. The recent measles outbreaks across the United States
highlight the direct impact that misinformation can have on public
health. Vaccine hesitancy is fueled by a small but impactful group of
individuals spreading false information regarding vaccine development,
purported negative health outcomes and other misinformation that seek
to undermine the unequivocal science. Such misinformation can foment
distrust in Government, such as some of the conspiracy theories
surrounding vaccination, and can make it harder for Government agencies
to respond to public health events in impacted communities.
In New York City, we have incredibly strong and versatile systems
in place to respond to disease outbreaks. During the recent measles
outbreak, our surveillance system promptly detected the outbreak and
identified potentially infected individuals; our Public Health
Laboratory rapidly tested specimens; legal mechanisms enabled the
declaration of a public health emergency and vaccination mandate,
exclusion of unvaccinated children from school and day care and
enforcement against noncompliant schools, day cares and individuals;
and our outreach and communications staff harnessed existing
relationships to partner with public and private health care providers,
community leaders and others to provide accurate information, improve
infection control, and rapidly vaccinate thousands of New Yorkers.
In a public health emergency, we may need the public to take rapid
action to save lives. In order to increase cooperation, we need clear
and credible messages and trusted communicators at the local, State,
and Federal level who are able to deliver coordinated information and
instructions to the public. At the same time, we as a Nation need
strategies to combat and halt misinformation. We must remain vigilant
in dispelling misinformation to reduce the risk of another disease
outbreak and improve the effectiveness of Government response in an
emergency.
Question 2. Credible information is critical to saving lives during
terrorist attacks. How can State and local health officials work to
ensure the correct information is disseminated to the public leading up
to, during, and after a bioterror attack? What can the Federal
Government do to be an effective partner?
Answer. Critical to a speedy and effective response is developing
risk communication messaging before an event and sharing at all levels
of government to assure messages are aligned. This work requires close
coordination with disease, environmental, and risk communication
subject-matter experts.
As stated above, we need clear and credible messages and trusted
communicators at the local, State, and Federal level who are able to
deliver coordinated information and instructions to the public. The
Federal Government and its resources are critical to an effective
response, but Federal actions must be driven by local information to
ensure that public messaging and response efforts are consistent and
coordinated across all levels.
Question 3. In addition to risks posed by bioterrorists, naturally-
occurring pandemics also represent a threat to homeland security. Could
you specify the ways in which bioterrorism preparedness dovetails with
pandemic preparedness, and how we can more effectively leverage
synergies from investing in each?
Answer. Local public health departments and their health care
partners are on the front lines and are the first to detect and respond
to public health emergencies. Therefore, it is essential that State and
local health departments, health care partners, and first responders
plan, exercise, and maintain readiness for ``all-hazards'' in close
coordination.
Both public health and health care preparedness capabilities are
developed for all-hazards and are thus designed to be flexible and
responsive to the spectrum of public health threats, including a
bioterrorism incident or a pandemic.
Federal Public Health Emergency Preparedness (PHEP) funding
supports jurisdictions to build and maintain public health preparedness
capabilities, which include:
Maintaining systems to share information between
jurisdictions and health disciplines;
Timely and accurate communication of emergency information
and guidance to the public;
Standing up and coordinating emergency operations based on
National standards; planning for, managing, and dispensing
medical countermeasures;
Implementing non-pharmaceutical interventions; conducting
public health laboratory testing, as well as public health
surveillance and investigatory activities; and
Planning for and building community preparedness and
resiliency.
Likewise, Federal Hospital Preparedness Program (HPP) funding via
the assistant secretary for preparedness and response (ASPR) supports
jurisdictions to build health care preparedness capabilities, which
include:
Effective system-wide coordination between facilities for
planning, mitigation of vulnerabilities and preparedness gaps,
information sharing, and collective resource management;
Systematic plans and procedures to maintain continuity of
health care service delivery; and
Robust and exercised plans to respond to medical surge.
NYC relies on Federal funding to prepare for, detect, and respond
to public health emergencies. Over the past 14 years, this funding has
been significantly reduced--including a 34 percent cut to the Public
Health Emergency Preparedness (PHEP) program and 39 percent cut to the
Hospital Preparedness Program (HPP) funding since fiscal year 2005. The
most drastic impact of these cuts has been the significant reduction in
the public health preparedness and response workforce in NYC.
If there are no public health laboratory scientists,
epidemiologists, environmental health specialists, emergency managers,
and risk communication experts to build the local alarm system, and
then hear the alarm and respond when it goes off, we cannot protect the
health of the American public. This critical workforce needs an
infrastructure to enable them to do their work--state-of-the-art public
health laboratories that are flush with instrumentation, reagents, and
supplies, information technology solutions for the analysis of data,
and interoperable electronic systems to share that data are all also
basic necessities for protecting Americans.
Federal investment and collaboration is critical to ensuring local
government's ability to stay ahead of emerging threats.
Questions From Honorable Donald M. Payne, Jr. for Umair A. Shah
Question 1a. It is my understanding that DoD Civil Support Teams
(CST) teams have biodetection capabilities. What capabilities do they
have and how do they interact with local public health in Houston?
How long does it take them to detect a biological agent in Houston?
Answer. CST does not have any pre-deployed or continuous monitoring
capability in Houston/Harris County. CST would respond at the request
of Houston/Harris County either as part of a special event enhanced
monitoring or for a chemical, biological, radiological, or nuclear
(CBRN) emergency.
Question 1b. How do they confirm the results?
Answer. This question is better answered from the National Guard
Civil Support Team spokesman.
Question 1c. If there is a positive hit in their detection system,
what actions do they take?
Answer. This question is better answered from the National Guard
Civil Support Team spokesman.
Question 1d. What technology does CST use for biodetection? How
does it compare to BioWatch technology?
Answer. This question is better answered from the National Guard
Civil Support Team spokesman.
Question 2. The time between biological agent release and detection
has been described as taking too long. For Houston, how long is it
until we have a confirmed bio event with current technology and
processes? What recommendations would you have to decrease this time?
Answer. Through routine BioWatch environmental monitoring, the time
from release to lab-confirmed detection is estimated at 12-36 hours.
Currently, we do not have practical recommendations to decrease this
time, but it is under study.
Question 3. Could you describe the process by which Houston
detects, manages, and recovers from a biological attack?
Answer. Biological attack detection can be through 5 separate
pathways: (1) Environmental detection via systems like BioWatch or the
USPS Bio-Detection System; (2) Human clinical suspect or confirmed
disease reporting by practitioners and labs; (3) Animal clinical
suspect or confirmed disease reporting by veterinary providers; (4)
Human Syndromic Surveillance of Emergency Department chief complaints;
and (5) overt threats from perpetrators (e.g. letters to media or
Congressional members in 2001). Regardless of the mechanism of initial
detection public health would need to assess the threat and determine
appropriate actions. The management of the threat depends on the agent
and the interventions needed to protect the public.
Question 4a. There has been a lot of discussion about using field-
deployed detection approaches for assisting in the detection of
biological agents. Do we have the technology for mobile laboratories/
hand-held field detection equipment?
Can these technologies have a confirmatory element to it?
Answer. In the case of mobile laboratories, yes, if equipped with
PCR capability.
Question 4b. Do you have any concerns about making actionable
public health decisions based upon hand-held field detection equipment
or mobile laboratories?
Answer. Yes, hand-held field instruments and mobile laboratories
each need to provide their specifications and limitations before we can
assess their creditability for public health decision support.
Confirmatory tests should be done in a controlled LRN laboratory for
verification.
Question 4c. Would your jurisdiction allow the use of such hand-
held devices to confirm a bioterror attack in the field?
Answer. Currently, we rely on our LRN and BioWatch labs for
confirmatory testing. Before we can attribute confirmation testing
capability to a hand-held device we would need to know more about the
actual specifications of the instrument and its reliability--we are not
aware of any current hand-held field instruments that have proven
confirmatory testing capability.
Question 4d. Is the technology mature enough and has it been vetted
to be used for this purpose?
Answer. Testing technology is rapidly emerging. For public health
to feel comfortable relying on new technology for decision support it
needs to be vetted with local public health, the user of the
instruments and the DHS CWMD science and technology group.
Questions From Honorable Lauren Underwood for Umair A. Shah
Question 1. Recent reports have suggested that both health
disinformation and misinformation campaigns have promoted vaccine
hesitancy amongst the public. I am concerned that these campaigns could
have long-lasting consequences on public health in this country. Are
you worried that these campaigns will have a negative impact on
domestic preparedness in case of a bioterror attack or naturally-
occurring outbreak?
Answer. Yes. These campaigns erode the very creditability of public
health and put us in the precarious position of having to re-establish
trust and confidence and developing an effective communications
strategy to counter the misinformation.
Question 2. Credible information is critical to saving lives during
terrorist attacks. How can State and local health officials work to
ensure the correct information is disseminated to the public leading up
to, during, and after a bioterror attack? What can the Federal
Government do to be an effective partner?
Answer. Unity of message for public health is our credibility and
our currency. We coordinate our public information messaging through
the Joint Information Center. Local, State, and Federal partners all
contribute, recognizing that all disasters are local. State and Federal
partners work to support locals.
Question 3. In addition to risks posed by bioterrorists, naturally-
occurring pandemics also represent a threat to homeland security. Could
you specify the ways in which bioterrorism preparedness dovetails with
pandemic preparedness, and how we can more effectively leverage
synergies from investing in each?
Answer. Both bioterrorism incidents and pandemics have the
potential to affect large numbers of people and therefore require
extensive coordinated large-scale responses.
Preparedness similarities:
i. Use of Preparedness Cycle
ii. Education (community & partners)
iii. Relationship building.
Response to both incidents are similar:
i. Strong media/social media campaign
ii. Both require the use of prophylaxis
iii. Both require local unity of effort to include State and
Federal partners.
Question 4. How would you characterize the decision to move the
health aspects of the Department of Homeland Security, including the
Office of Health Affairs and Office of the Chief Medical Officer (CMO),
within the Office of Countering Weapons of Mass Destruction (CWMD)?
Answer. CWMD seems to have a primary focus on protecting the
homeland whereas the OHA focus is more in line with protecting the
public health and coordinating with the health care response during a
major emergency. Merging the CMO in the CWMD may not be the most
effective from a health perspective. The locals do not understand what
the CMO mission is under the new alignment.
Question 5. Do you believe providing the CMO with contracting
authority will allow for greater operational capabilities?
Answer. Not sure, there has been no communication with the local
health departments on the subject. As mentioned before with the CWMD
program, there is a lack of communication.
Question 6. Can you provide any recommendations for how the
Department of Homeland Security should structure the CMO within DHS?
Answer. From the local health department perspective, better define
and publicize the CMO mission, communication paths, determine lines of
reporting within DHS and the CMO authority.