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Report to Congressional Committees:
United States Government Accountability Office:
GAO:
June 2010:
Biosurveillance:
Efforts to Develop a National Biosurveillance Capability Need a
National Strategy and a Designated Leader:
GAO-10-645:
GAO Highlights:
Highlights of GAO-10-645, a report to Congressional Committees.
Why GAO Did This Study:
The U.S. government has a history of employing health surveillance to
help limit malady, loss of life, and economic impact of diseases.
Recent legislation and presidential directives have called for a
robust and integrated biosurveillance capability; that is, the ability
to provide early detection and situational awareness of potentially
catastrophic biological events. The Implementing Recommendations of
the 9/11 Commission Act directed GAO to report on the state of
biosurveillance and resource use in federal, state, local, and tribal
governments. This report is one in a series responding to that
mandate. This report addresses (1) federal efforts that support a
national biosurveillance capability and (2) the extent to which
mechanisms are in place to guide the development of a national
biosurveillance capability. To conduct this work, GAO reviewed federal
biosurveillance programs, plans, and strategies and interviewed agency
officials from components of 12 federal departments with
biosurveillance responsibilities.
What GAO Found:
Federal agencies with biosurveillance responsibilities—including the
Departments of Health and Human Services, Homeland Security, and
Agriculture—have taken or plan to take actions to develop the skilled
personnel, training, equipment, and systems that could support a
national biosurveillance capability. GAO previously reported that as
the threats to national security have evolved over the past decades,
so have the skills needed to prepare for and respond to those threats.
Centers for Disease Control and Prevention (CDC) officials stated that
skilled personnel shortages threaten the capacity to detect
potentially catastrophic biological events as they emerge in humans,
animals, or plants. To address this issue, some federal agencies are
planning or have taken actions to attract and maintain expertise using
fellowships, incentives, and cooperative agreements. Moreover, CDC has
called for the development of a national training and education
framework to articulate professional roles and competencies necessary
for biosurveillance. The Department of Agriculture has also developed
training programs to help ensure that diseases and pests that could
harm plants or animals can be identified. In addition, federal
agencies have taken various actions designed to promote timely
detection and situational awareness by developing (1) information
sharing and analysis mechanisms, (2) laboratory networks to enhance
diagnostic capacity, and (3) equipment and technologies to enhance
early detection and situational awareness.
While national biodefense strategies have been developed to address
biological threats such as pandemic influenza, there is neither a
comprehensive national strategy nor a focal point with the authority
and resources to guide the effort to develop a national
biosurveillance capability. For example, the National Security Council
issued the National Strategy for Countering Biological Threats in
November 2009. While this strategy calls for the development of a
national strategy for situational awareness, it does not meet the need
for a biosurveillance strategy. In addition, this strategy includes
objectives that would be supported by a robust and integrated
biosurveillance capability, such as obtaining timely and accurate
insight on current and emerging risks, but it does not provide a
framework to help identify and prioritize investments in a national
biosurveillance capability. GAO previously reported that complex
interagency efforts, such as developing a robust, integrated, national
biosurveillance capability, could benefit from an effective national
strategy and a focal point with sufficient time, responsibility,
authority, and resources to lead the effort. Efforts to develop a
national biosurveillance capability could benefit from a national
biosurveillance strategy that guides federal agencies and other
stakeholders to systematically identify risks, resources needed to
address those risks, and investment priorities. Further, because the
mission responsibilities and resources needed to develop a
biosurveillance capability are dispersed across a number of federal
agencies, efforts to develop a biosurveillance system could benefit
from a focal point that provides leadership for the interagency
community.
What GAO Recommends:
GAO recommends that the Homeland Security Council direct the National
Security Staff to identify, in consultation with relevant federal
agencies, a focal point to lead the development of a national
biosurveillance strategy to guide the capability’s development.
GAO provided a copy of this draft to the 12 federal departments and
the National Security Staff.
View [hyperlink, http://www.gao.gov/products/GAO-10-645] or key
components. For more information, contact William O. Jenkins, (202)-
512-8777.
[End of section]
Contents:
Letter:
Background:
Federal Agencies Have Taken Actions That Support a National
Biosurveillance Capability:
A National Strategy and a Focal Point Could Help Guide Development of
a National Biosurveillance Capability:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Full Text for Figure 2 Select Worldwide Disease
Occurrences in Recent Decades:
Appendix III: Traditional Monitoring Systems Provide Important but
Limited Contributions to a National Biosurveillance Capability:
Appendix IV: Selected Systems Used in Federal Early Detection and
Situational Awareness Activities:
Appendix V: Comments from the Department of Homeland Security:
Appendix VI: GAO Contacts and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Laboratory Networks That Comprise the ICLN.
Table 2: Departments and Agencies with Which We Met To Discuss
Biosurveillance Roles, Responsibilities, and Programs:
Figures:
Figure 1: Biosurveillance in Brief:
Figure 2: Select Worldwide Disease Occurrences in Recent Decades:
Figure 3: Time Line of Laws and Presidential Directives Related to
Biosurveillance:
Figure 4: Examples of Workforce Involved with Biosurveillance
Activities:
Figure 5: West Nile Virus: A Case Study in the Value of Cross-Domain
Surveillance:
Figure 6: Roles and Responsibilities for Detection across the
Intergovernmental, Cross-Domain Biosurveillance Network:
Figure 7: A National Biosurveillance Strategy Would Support Related
Strategies at the National, Agency, and Nonfederal Levels:
Figure 8: Select Worldwide Disease Occurrences in Recent Decades:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
June 30, 2010:
The Honorable Joseph I. Lieberman:
Chairman:
The Honorable Susan M. Collins:
Ranking Member:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
The Honorable Bennie Thompson:
Chairman:
The Honorable Peter King:
Ranking Member:
Committee on Homeland Security:
House of Representatives:
A catastrophic biological event, such as a terrorist attack with a
weapon of mass destruction or a naturally occurring pandemic, could
cause thousands of casualties or more, weaken the economy, damage
public morale and confidence, and threaten national security. In
January 2010, the bipartisan Commission for the Prevention of Weapons
of Mass Destruction Proliferation and Terrorism, which was established
by the Implementing Recommendations of the 9/11 Commission Act to
address the threat that the proliferation of weapons of mass
destruction poses to the United States, gave the nation a failing
grade in its efforts to enhance capabilities for rapid response to
prevent biological attacks from inflicting mass casualties.[Footnote
1] The commission reported that unless the world community acts, it is
more likely than not that a weapon of mass destruction will be used in
a terrorist attack somewhere in the world by the end of 2013. Further,
the report stated that such a weapon is more likely to be biological
than nuclear.[Footnote 2]
The U.S. government has a long history of employing disease
surveillance activities to help limit malady, loss of life, and
economic impact. Traditional disease surveillance activities involve
trained professionals engaged in monitoring, investigation,
confirmation, and reporting in an effort to further various missions
including, but not limited to, detecting signs of pathogens in humans,
animals, plants, food, and the environment. However, in recent years
experts and practitioners, reacting to an increasing awareness of the
speed and intensity with which a biological weapon of mass destruction
or highly pathogenic strain of emerging infectious disease could
affect the nation, have sought to augment the traditional surveillance
activities with biosurveillance programs and systems. The dual
purposes of biosurveillance are (1) to detect as early as possible a
potentially catastrophic biological event and (2) to enhance
situational awareness--including awareness, comprehension of meaning,
and projection into the near future about events--by improving the
quality of information available to support response and policy
actions in the face of such an event.
Since at least the 1990s, there has been an ongoing and evolving
effort by the federal government in conjunction with its partners to
address the need for a strategic approach to improving disease
surveillance and response. Recognizing the potentially devastating
consequences that could flow from biological events--both natural and
intentional--responsible federal officials and other experts have, in
various formats, called for better integration of multiple disparate
surveillance and related mission activities to help support a strong
national biosurveillance capability. For example, among the federal
government's initiatives to confront the threat of biological events
was a presidential directive that called for the development of a
national, robust, and integrated biosurveillance capability that
provides timely warning and ongoing characterization of catastrophic
biological events, drawing on the systems, resources, and information
from existing human, animal, plant, food, and environmental
surveillance activities.[Footnote 3] Ensuring the development of such
a national biosurveillance capability involves attention to the
resources--personnel, training, equipment, and systems--that underpin
various surveillance efforts across the federal government, as well as
mechanisms to help direct effective and efficient use of those
resources to support the capability.
Many federal departments and agencies pursue missions and manage
programs that might contribute to a national biosurveillance
capability. The Department of Health and Human Services (HHS) is the
federal agency with primary responsibility for disease surveillance--
including food-borne illnesses--in humans. The Department of
Agriculture (USDA) is the primary federal agency with responsibility
for pest and disease surveillance in animals and plants as well as
food-borne illnesses within the agricultural industries. As the agency
with lead responsibility for protecting against and responding to
threats and hazards to the nation, the Department of Homeland Security
(DHS) is concerned with the prevention of bioterrorist attacks as well
as preparing the nation to respond to biological events in order to
minimize human and economic losses. In addition, the Homeland Security
Council was established by executive order in 2001 to serve as a
mechanism for ensuring coordination of homeland security-related
activities of executive departments and agencies and effective
development and implementation of homeland security policies.[Footnote
4] The establishment of the Homeland Security Council was subsequently
codified in statute with the enactment of the Homeland Security Act of
2002.[Footnote 5]
Around the same time that the President issued a directive calling for
a national biosurveillance capability, Congress articulated a similar
goal with respect to a biosurveillance capability in the Implementing
Recommendations of the 9/11 Commission Act of 2007 (9/11 Commission
Act)--to enhance the capability of the federal government to rapidly
identify, characterize, localize, and track biological events of
national concern by integrating and analyzing data relating to human,
animal, plant, food, and environmental surveillance.[Footnote 6] The
9/11 Commission Act also directed us to examine the state of federal,
state, local, and tribal government biosurveillance efforts and the
federal government's use of resources to implement and execute
biosurveillance systems.[Footnote 7] This report responds in part to
that mandate by examining the extent to which a national, robust,
integrated biosurveillance capability has been established.
Specifically, the report examines the following: (1) federal agency
efforts to provide resources--personnel, training, equipment, and
systems--that support a national biosurveillance capability; and (2)
the extent to which mechanisms are in place to guide the development
of a national biosurveillance capability.
In December 2009, in response to the same mandate, we issued work
addressing the efforts of DHS's National Biosurveillance Integration
Center (NBIC), which was established in the 9/11 Commission Act to
enhance federal biosurveillance capabilities.[Footnote 8] We also have
ongoing work on state, local, tribal, and territorial biosurveillance
activities, from which we expect to issue a report in winter 2011.
To address our objectives, we reviewed key legislation and
presidential directives related to biosurveillance, including the
Homeland Security Act of 2002,[Footnote 9] the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002,[Footnote 10]
the Pandemic and All Hazards Preparedness Act of 2006,[Footnote 11]
and Homeland Security Presidential Directives (HSPD) 9, 10, and 21.
[Footnote 12] This report focuses on surveillance efforts for one or
more of the following biosurveillance domains: human health, animal
health, plant health, food, and the environment (specifically, air and
water). It focuses primarily on seven federal departments that have
key roles and responsibilities--based on agency missions, statutory
responsibilities, presidential directives, or programmatic objectives--
for biosurveillance and related mission activities, including
protecting public health, agriculture, and national security. These
departments are the Departments of Agriculture, Defense (DOD),
Homeland Security, Health and Human Services, Interior (DOI), as well
as the Environmental Protection Agency (EPA) and the United States
Postal Service (USPS). To understand how federal agencies have planned
or coordinated their biosurveillance efforts, we reviewed key agency
and interagency documents, including concepts of operation,
surveillance and implementation plans, and biodefense strategies. For
example, we reviewed NBIC's Concept of Operations for the National
Biosurveillance Integration System, agency strategies and plans for
conducting surveillance, and the National Security Council's National
Strategy for Countering Biological Threats. We conducted interviews
with officials and observed operations at federal agencies--
particularly DHS, HHS, and USDA, which have the larger and more direct
mission responsibilities for biosurveillance and related mission
activities--to understand their roles and responsibilities and how
their activities support the national biosurveillance capability. We
also collected and analyzed information on the resources, systems, and
equipment they use; the other governmental and nongovernmental
entities with whom they partner; and the limitations they have
encountered in conducting their biosurveillance missions. We also
reviewed reports published by nongovernmental entities--for example,
the National Academy of Sciences's Institute of Medicine and the
Center for Biosecurity--related to public health, disease detection,
bioterrorism, biodefense, and emergency management. We also reviewed
our prior work on federal surveillance activities, food safety,
intergovernmental and interagency collaboration, and national security
issues. We compared information we collected from agency documents and
officials to our previous work related to national strategies and
focal points for leadership to identify mechanisms that could help
support crosscutting efforts to build and sustain a national
biosurveillance capability.[Footnote 13] More detailed information
about our scope and methods appears in appendix I.
We conducted this work from December 2008 through May 2010 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
Background:
As shown in figure 1, biosurveillance is a concept that emerged in
response to increased concern about biological threats from emerging
infectious diseases and bioterrorism. Biosurveillance is carried out
by and depends on a wide range of dispersed entities. Federal
biosurveillance responsibilities, likewise, are spread across an array
of agencies and provided for in multiple laws and presidential
directives.
Figure 1: Biosurveillance in Brief:
[Refer to PDF for image: illustration]
What is it?
In the biological context, surveillance is the ongoing collection,
analysis, and interpretation of data to help monitor for pathogens in
plants, animals, and humans; food; and the environment. The general
aim of surveillance is to help develop policy, guide mission
priorities, and provide assurance of the prevention and control of
disease. In recent years, as concerns about consequences of a
catastrophic biological attack or emerging infectious diseases grew,
the term biosurveillance became more common in relation to an array of
threats to our national security. Biosurveillance is concerned with
two things: (1) reducing, as much as possible, the time it takes to
recognize and characterize biological events with potentially
catastrophic consequences and (2) providing situational awareness—that
is, information that signals an event might be occurring, information
about what those signals mean, and information about how events will
likely unfold in the near future.
Why is it important?
Although catastrophic events are rare, there are a number of threats
of biological origin with the potential to cause catastrophic
consequences. Since the 1970s, newly emerging diseases have been
identified at the unprecedented rate of one or more per year.
Moreover, terrorism experts have warned that both terrorists and
nations have sought to obtain biological weapons. Finally, the nation’
s food and agriculture systems face threats from natural and
intentional origin that could have devastating consequences in terms
of both health and economic loss.
How is it done?
Biosurveillance requires effective organizational systems, people, and
technologies to ensure the nation’s ability to detect a biological
event with potential for catastrophic consequences and to provide
situational awareness for response that gives decision makers and the
public accurate information about how to prevent, manage, or mitigate
catastrophic consequences. The backbone of biosurveillance is
traditional disease surveillance systems, which help professionals to
recognize unusual disease signals and analyze their meaning, but
generally have inherent limitations that affect the speed with which
their results can be determined, communicated, and acted upon.
Numerous federal, state, local, and private sector entities with
responsibility for monitoring plant, animal, and human health, food,
and the environment have roles to play both in supporting traditional
surveillance activities and in designing systems to focus specifically
on enhancing detection and situational awareness. Because of the vast
array of activities and entities associated with effective
biosurveillance, ongoing interagency and intergovernmental
collaboration is crucial.
Source: GAO analysis of agency data; Art Explosion.
[End of figure]
Social and Economic Conditions Contribute to the Threat of a
Catastrophic Biological Event:
[Side bar:
Epidemiology:
Epidemiology is the study of diseases in populations of humans or
other animals, specifically how, when, and where they occur.
Epidemiologists have an important responsibility in public health
matters. It is their goal to determine what factors are associated
with diseases (risk factors), and what factors may protect people or
animals against disease (protective factors). The science of
epidemiology was first developed to discover and understand possible
causes of contagious diseases like smallpox, typhoid, and polio among
humans. It has expanded to include the study of factors associated
with non-transmissible diseases like cancer and of poisonings caused
by environmental agents.
The Council of State and Territorial Epidemiologists—an organization
of member states and territories representing public health
epidemiologists—provides technical advice and assistance to partner
organizations and to federal public health agencies such as CDC. The
Council supports the use of effective public health surveillance and
good epidemiologic practice through training, capacity building,
developing standards for practice, and advocating for resources and
scientifically based policy.
Source: GAO.
End of side bar]
In an era of rapid transit and global trade, the public health and
agricultural industries, as well as natural ecosystems including
native plants and wildlife, face increased threats of naturally
occurring outbreaks of infectious disease and accidental exposure to
biological threats. According to the World Health Organization (WHO),
infectious diseases are not only spreading faster, they appear to be
emerging more quickly than ever before. Since the 1970s, newly
emerging diseases have been identified at the unprecedented rate of
one or more per year. There are now nearly 40 diseases that were
unknown a generation ago. In addition, during the last 5 years, WHO
has verified more than 1100 epidemic events worldwide. Figure 2 shows
select disease occurrences worldwide in recent decades. Additional
information about the occurrences is available electronically in pop-
up boxes on the map or in print in appendix II. Examples of emerging
infectious disease include Severe Acute Respiratory Syndrome (SARS),
H5N1 influenza (avian flu), and the H1N1 influenza that resulted in a
global pandemic in 2009. The potential impact of these events is not
limited to public health. For example, the avian influenza outbreaks
in Asia and Eastern Europe were reminders that the public health
sector is intrinsically linked to the agriculture, trade, tourism,
economic, and political sectors.
Figure 2: Select Worldwide Disease Occurrences in Recent Decades:
[Refer to PDF for image: illustrated map of the world]
Interactive features: Roll your mouse over the named disease or for
more information on the particular event. Information on the
transmission and symptoms of the disease will also appear:
Salmonella, United States 2008 - outbreak in 43 states and DC; 1,500
persons reported ill with the outbreak strain. The initial
investigations identified tomatoes as the likely source. As the
outbreak continued, additional investigations showed much of the
outbreak was due to jalapeno and Serrano peppers grown and packed in
Mexico and distributed in the United States. The tomato industry
sustained an estimated $100 million or more loss.
Transmission and Symptoms: Transmission to humans usually occurs by
eating foods contaminated with animal feces. Contaminated foods are
often of animal origin, such as beef, poultry, milk, or eggs, but any
food, including vegetables, may become contaminated. Symptoms of
Salmonella develop 12-72 hours after infection and can include
diarrhea, fever, and abdominal cramps. Salmonella can also be
transferred from animal to animal through contact with newly acquired
farm animals, the use of contaminated food and water sources, and
stress and overcrowded conditions of can increase the spread of the
bacteria.
Anthrax, United States 2001 - anthrax was intentionally spread through
the postal system by sending letters with powder containing anthrax to
the U.S. Capitol. Of the 22 infected persons, 5 died. EPA spent
$27million for cleanup of Capitol Hill and the U.S. Postal Service was
appropriated hundreds of millions of dollars to clean up effected
facilities.
Transmission and Symptoms: Symptoms vary depending on the type of
disease. Cutaneous symptoms include a small sore that develops into a
blister, and later becomes a skin ulcer with a black area in the
center. Gastrointestinal symptoms are nausea, loss of appetite, bloody
diarrhea, fever, and bad stomach pain. Inhalation symptoms are like
cold or flu symptoms and can include a sore throat, mild fever and
muscle aches, cough, chest discomfort, shortness of breath, tiredness
and muscle aches. All warm-blooded animals are also susceptible to
anthrax, but cattle, horses, sheep, and goats are most commonly
affected. Anthrax spores that occur naturally in the soil can be
ingested by animals or spread by horse flies which spread the disease
when they fed on infected carcasses.
West Nile Virus, United States 1999 - first detected in New York, 62
cases were reported in 1999 with 7 fatalities. The virus has since
been reported in the lower 48 states. In 2009, 663 cases were reported
with 30 fatalities.
Transmission and Symptoms: The virus is spread by mosquitoes who bite
birds containing the virus and then pass it to humans through bites.
While most people infected do not experience any symptoms, they can
range from mild (e.g., headache, nausea, or rash) to severe (e.g.,
high fever, muscle weakness or paralysis). Birds serve as a reservoir
for this virus; over 170 species have tested positive for WNV in the
U.S. Mortality rates for avian cases are high. Death usually occurs
within 3 weeks of infection. Clinical signs prior to death include
uncoordinated walking, weakness, lethargy, tremors, and head tilt
caused by encephalitis or meningitis. Horses are also susceptible to
infections.
Foot and Mouth Disease (FMD), United Kingdom 2001 - resulted in mass
slaughtering and burial of animals and a loss of about $4 billion.
Transmission and Symptoms: FMD is a highly contagious viral disease
which infects cloven-hoofed animals, such as cattle, swine, and sheep.
Infected animals develop a fever and painful blisters between their
hooves and on their tongue, lips making it difficult to feed. This is
a debilitating disease that leads to severe losses in the production
of milk and meat. Because of its rapid spread and potential economic
losses, producers greatly fear contraction of FMD among their
livestock. FMD is not a threat to people and no human health risks are
associated with the disease.
Severe Acute Respiratory Syndrome (SARS), Worldwide (with highest
concentration in Southeast Asia) 2003 - over 8,000 infected and over
750 deaths. Economic losses due to lack of tourism and consumer
spending in Asia were estimated at $20 billion.
Transmission and Symptoms: SARS seems to spread is by close person-to-
person contact through respiratory droplets produced when an infected
person coughs or sneezes. It can also spread when a person touches a
surface or object contaminated with infectious droplets and then
touches his or her mouth, nose, or eye(s). SARS causes flu-like
symptoms which may progress to pneumonia. Symptoms include fever,
malaise, chills, headache, body ache, coughing, difficulty breathing,
and diarrhea. SARS can infect animals, such as bats, civets, and mice,
and it also infects humans. To date, scientists have not been able to
confirm the origin of SARS in humans. Some public health officials
hypothesize that SARS virus was transmitted from an animal to human
thereby sparking the 2003 outbreak.
H5N1 (commonly known as Avian influenza), Worldwide (spreading from
China to nearly 60 countries) beginning in early 2000s reaching a peak
in 2006. Nearly 500 human cases have been reported, with almost 300
fatalities. H5N1 has also resulted in the death and destruction of
millions of wild and domestic birds throughout Asia, Europe, Africa,
and the Middle East.
Transmission and Symptoms: Influenza A, H5N1 (avian influenza) is a
type of influenza that infects birds and may be transmitted to humans.
Although primarily an avian disease, this virus has also infected
humans—most of whom had close contact with infected poultry. Symptoms
of avian influenza in humans range from typical influenza-like
symptoms to eye infections, pneumonia, acute respiratory distress, and
other severe and life-threatening complications. In bird populations,
avian influenza is highly contagious, transmitted by direct contact
between healthy and infected birds by fecal excretions as well as by
nose, mouth, and eye secretions. Indirect contact can also occur via
contaminated equipment and materials. Clinical signs vary with
pathogenicity of the subtype and disease severity can range from in-
apparent or mild clinical signs (depression, anorexia, fever,
weakness, decreased egg production, neurological signs, edema of the
face and neck, diarrhea, and respiratory signs) to 100 percent
mortality. Serious concerns exist that H5N1 could reach North America
at any time via migrating birds or smuggled imports of diseased birds
and bird products. Health experts are concerned that a pandemic could
occur should highly pathogenic H5N1 (or another subtype), to which
humans have no immunity, develop the capacity to spread easily from
person to person.
H1N1, Worldwide 2009 - identified in Mexico, the virus spread to more
than 213 countries, overseas territories or communities with millions
of confirmed cases, including over 17,700 deaths. The World Health
Organization declared a pandemic in June 2009.
Transmission and Symptoms: H1N1 spreads like other influenza viruses
through person-to-person contact through respiratory droplets produced
when an infected person coughs or sneezes. It can also spread when a
person touches a surface or object contaminated with infectious
droplets and then touches his or her mouth, nose, or eye(s). Symptoms
may include: a fever or feeling feverish/chills, cough, sore throat,
runny or stuffy nose, muscle or body aches, headaches, fatigue,
vomiting, or diarrhea. The 2009 H1N1 has two genes from flu viruses
that normally circulate in pigs in Europe and Asia and bird (avian)
genes and human genes, but is very different from the swine influenza
virus that normally circulates in North American pigs. Swine, however,
are susceptible to infection with the Novel H1N1 2009 Virus.
Sources: GAO analysis; Map Resources (map).
[End of figure]
Due to the rapid and constant movement of people and commodities--such
as animals, plants, and food--biological agents can be carried by
passengers or containers on airplanes and boats and slip across
national borders unnoticed as infectious diseases are transferred from
person to person through close contact with one another. Ecological
changes, such as changes in land use, and the globalization of the
food supply are also associated with the emergence and spread of
infectious disease. Animals also face the threat of infectious
disease, and in some cases diseases--known as zoonotic diseases--can
be transferred between animals and people. Zoonotic diseases represent
at least 65 percent of newly emerging and reemerging infectious
diseases in recent decades. Many important factors contribute to the
proliferation of zoonotic diseases, including the growth of human and
domestic animal populations and the increasingly close physical
proximity within which humans and their domestic animals live with
wild animals.
Some disease agents can also be weaponized and used as weapons of mass
destruction to disrupt economies and endanger human, animal, and plant
health. Since the attacks of September 11, 2001, there has been
concern that another terrorist attack on U.S. soil could involve
biological or other weapons of mass destruction. Groups like the
Center for Counterproliferation Research at the National Defense
University and the Commission on the Prevention of Weapons of Mass
Destruction Proliferation and Terrorism (established by the 9/11
Commission Act) have warned that the biological weapons threat is
real, with evidence that terror groups like Al Qaeda have had active
biological weapons programs in the past and approximately 12 countries
are suspected of seeking biological weapons.
Emerging disease and bioterrorism concerns also surround the nation's
agriculture and food supply, as well. Plant resources in the United
States, including crops, rangelands, and forests, are vulnerable to
endemic, introduced, and emerging pathogens. More than 50,000 plant
diseases occur in the United States, caused by a variety of pathogens.
Increasing globalization and international trade activities create a
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years.
In addition, the United States faces growing food safety challenges
from fresh and processed foods that become contaminated well before
they reach the consumer, leading to outbreaks linked to foods that
have not previously been associated with foodborne illnesses. For
example, according to USDA, leafy greens are the category of produce
most likely to be associated with an outbreak. Recent outbreaks of
foodborne illness have also focused public attention on the increasing
potential for widespread dissemination of contaminated products. For
example, beginning in September 2006, the United States experienced an
outbreak of E. coli 0157:H7 associated with the consumption of tainted
spinach grown in California; this outbreak resulted in 205 victims in
26 states suffering severe disease. Three people died. Widespread
outbreaks of other foodborne illnesses, such as Salmonella, have also
occurred from contaminated peanut butter and tomatoes.[Footnote 14]
We reported in March 2005 that although the United States has never
experienced a terrorist attack against agriculture, it is vulnerable
for a variety of reasons, including the relative ease with which
causative agents of diseases that could affect livestock and crops
could be obtained and disseminated.[Footnote 15] Many of these
diseases are endemic in other parts of the world and can be extracted
from common materials, such as soil. Farms in general are easily
accessible because they are located in rural areas and have minimal
security, especially crop farms. Moreover, the highly concentrated
breeding and rearing practices of our livestock industry may make it a
vulnerable target for terrorists because diseases could spread rapidly
and be difficult to contain. For example, between 80 and 90 percent of
grain-fed beef cattle production is concentrated in less than 5
percent of the nation's feedlots. Therefore, the deliberate
introduction of a highly contagious animal disease in a single feedlot
could have serious economic consequences.[Footnote 16] In addition, a
number of disease causing agents can infect and be spread by wildlife.
According to officials at DOI, it may be difficult to control a novel
pathogen if it is introduced into native wildlife. These officials
noted that the gregarious habits of many wildlife species can enhance
their susceptibility to catastrophic losses from select diseases, and
because of their mobility, there is potential for infectious disease
to spread quickly to new locations and populations.
Finally, pathogens can be carried through or introduced into the
environment, causing damage to health and economies. Drinking water
utilities across the country have long been recognized as potentially
vulnerable to terrorist attacks of various types, including physical
disruption, bioterrorism, chemical contamination, and cyber attack.
[Footnote 17] Damage or destruction by terrorists could disrupt not
only the availability of safe drinking water, but also the delivery of
vital services that depend on these water supplies, such as fire
suppression. People and animals also face the threat of becoming ill
from inhaling certain biological agents, some of which occur naturally
in our environment and some that can be weaponized and intentionally
released to cause catastrophic disruption. Concerns about weaponized
airborne pathogens were amplified by the anthrax attacks conducted
through the mail a month after the September 11, 2001, attacks on the
World Trade Center and the Pentagon.
Laws and Presidential Directives Direct Agencies to Strengthen
Biosurveillance and HSPD-21 Calls for an Integrated National
Biosurveillance Capability:
As figure 3 shows, federal laws and directives call for HHS, USDA,
DHS, and other federal agencies to take action to strengthen
biosurveillance. The most recent of these--Homeland Security
Presidential Directive-21--synthesizes and reiterates actions in other
laws and directives, explicitly calling for a national biosurveillance
capability. In calling for this national capability, HSPD-21 discusses
certain aspects related to the personnel, training, equipment, and
systems needed. For example, among the elements it describes as
necessary for a robust and integrated national capability are enhanced
clinician awareness, stronger laboratory diagnostic capabilities,
integrated biosurveillance data, and an epidemiologic surveillance
system with sufficient flexibility to tailor analyses to new syndromes
and emerging diseases.
Figure 3: Time Line of Laws and Presidential Directives Related to
Biosurveillance:
[Refer to PDF for image: time line]
Date: July 2002;
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002[A]:
* Requires HHS to establish an integrated system of public health
alert communications and surveillance networks between and among
federal, state, and local public health officials, and public and
private health-related laboratories, hospitals, and other health care
facilities.
Date: January 2004;
HSPD-9: Defense of United States Agriculture and Food:
* Directs DOI, USDA, HHS, and EPA to develop—for animals, plants,
wildlife, food, human health, and water—robust, comprehensive, and
fully coordinated surveillance and monitoring systems, including new
tracking systems and integrated laboratory networks that use
standardized protocols and procedures.
* Directs DHS to create a biological threat awareness capacity to
enhance detection and characterization of biological attacks that
integrates and analyzes data on human, animal, and plant health; food;
and water quality.
Date: April 2004;
HSPD-10: Biodefense for the 21st Century:
* States that the federal government is working to develop an
integrated and comprehensive system to rapidly recognize and
characterize the dispersal of biological agents in human and animal
populations, food, water, agriculture, and the environment to permit
the recognition of a biological attack at the earliest possible moment
and permit initiation of a robust response to prevent unnecessary loss
of life, economic losses, and social disruption.
Date: December 2006;
Pandemic and All-Hazards Preparedness Act of 2006[B]:
Requires HHS to establish a near real-time electronic nationwide
public health situational awareness capability through an
interoperable network of systems to share data and information to
enhance early detection of, rapid response to, and management of
potentially catastrophic infectious disease outbreaks and other public
health emergencies.
Date: August 2007;
Implementing Recommendations of the 9/11 Commission Act of 2007[C]:
Requires DHS to establish a center to enhance the ability of the
nation to rapidly identify, characterize, localize, and track a
biological event of national concern by integrating and analyzing data
relating to human health, animal, plant, food, and environmental
monitoring systems.
Date: October 2007;
HSPD-21: Public Health and Medical Preparedness:
States that the United States must develop a nationwide, robust, and
integrated biosurveillance capability, with connections to
international disease surveillance systems, in order to provide timely
warning and situational awareness.
Source: GAO Analysis of Laws and Presidential Directives
[A] Pub. L. No. 107-188, § 103, 116 Stat. 594, 604 (2002) (codified at
42 U.S.C. § 247d-4(b)).
[B] Pub. L. No. 109-417, § 202(2), 120 Stat. 2831, 2845 (2006)
(codified at 42 U.S.C. § 247d-4).
[C] Pub. L. No. 110-53, § 1101, 121 Stat. 266, 375 (2007) (codified at
6 U.S.C. § 195b).
[End of figure]
In the case of biological threats, timely detection of biological
agents is a precursor to effective response; therefore, a national
biosurveillance capability like the one described in HSPD-21 is an
essential tool in the nation's preparedness to confront catastrophic
threats. Capabilities to carry out any broad emergency management
mission--like biosurveillance--are made up of (1) planning, (2)
organization and leadership, (3) personnel, (4) equipment and systems,
(5) training, and (6) measurement/monitoring.
[Side bar:
Situational Awareness:
The term situational awareness is frequently used in the context of
emergency response, and has a number of definitions. Officials at CDC
with key biosurveillance responsibilities subscribe to a definition
that includes three components: (1) awareness that a situation has
occurred (e.g., detection of a biological condition that differs from
the norm), (2) comprehension of its meaning (e.g., characterization of
the nature and scope of a biological event), and (3) projection of its
likely course in the near future (e.g., how its nature and scope will
evolve and the decision implications of that evolution, particularly
whether it may have catastrophic consequences). The projection aspect
of situational awareness, sometimes overlooked in other definitions,
is crucial in the biological context, because of the high degree of
uncertainty and instability as the event unfolds over a period of
time, which is not necessarily encountered in more discrete disaster
events. Source: GAO.
End of side bar]
A national biosurveillance capability like the one described in HSPD-
21 would largely rely on an interagency effort because the mission
activities and accompanying resources that support the capability--
personnel, training, equipment, and systems--are dispersed across a
number of federal agencies. For example, HHS's Centers for Disease
Control and Prevention (CDC) has primary responsibility for human
health and USDA for plant and animal health. Responsibility for
various food sources is split between USDA and HHS's Food and Drug
Administration (FDA). DHS, as the agency with primary responsibility
for securing the homeland, is responsible for coordinating efforts to
prevent, protect against, respond to, and recover from biological
attacks. The resources--personnel, training, equipment, and systems-
that support a national biosurveillance capability reside within the
separate agencies that acquire and maintain them in pursuit of their
missions, which overlap with but are not wholly focused on
biosurveillance.
A national biosurveillance capability also depends upon participation
from state, local, and tribal governments. Few of the resources
required to support the capability are wholly owned by the federal
government. The responsibility and capacity for collecting most
information related to plant, animal and human health, food, and
environmental monitoring resides within state, local, and tribal
governments, or private sector entities--such as hospital and other
private health care providers. In the United States, state and local
public health agencies have the authority and responsibility for
carrying out most public health actions, and the federal government
generally cannot compel state, local and tribal governments, or
private sector entities to provide information or resources to support
federal biosurveillance efforts. Instead, individual federal agencies,
in pursuit of their missions, attempt to build relationships and offer
incentives--like grants--to encourage voluntary cooperation with
specific federal efforts.
[Side bar:
Timeliness of Surveillance:
According to CDC experts, the timeliness of surveillance is measured
by the time between when individuals are first exposed to a disease
agent and the time that public action is taken to address the
outbreak. Given the nature of disease incubation and other factors,
indicators of outbreaks in humans may require days or weeks to become
apparent within the traditional public health infrastructure. For many
diseases, there is no quantifiable benchmark for timely detection.
However, experts agree that recognizing more quickly that a
catastrophic biological event may be imminent can improve the
effectiveness of mitigation measures by orders of magnitude.
Source: GAO.
End of side bar]
In addition, although traditional disease surveillance systems
designed to collect information on the health of humans, animals, and
plants are the backbone of biosurveillance--because they, among other
things, provide mechanisms for ongoing monitoring and specific
information about outbreaks to inform response--they also rely on time-
intensive testing and confirmation practices. The inherent time lag,
combined with limitations arising from reliance on data not owned by
the federal government, presents challenges that limit the promise of
traditional disease surveillance alone to provide the timely detection
and situational awareness that is the goal of a national
biosurveillance capability. For additional information on the
contributions and associated challenges of traditional federal
surveillance activities to monitor for pathogens in plants, animals,
humans, and food see appendix III. For more information on specific
federal programs that can be used to support biosurveillance see
appendix IV.
Federal Agencies Have Taken Actions That Support a National
Biosurveillance Capability:
Federal agencies have taken or are planning some actions to improve
the personnel, training, and systems and equipment that support a
national biosurveillance capability, including, but not limited to,
planning to assess workforce needs, sponsoring recruitment and
training efforts, seeking to facilitate information sharing, and
applying technologies to enhance surveillance.
Federal Agencies Have Taken Actions to Help Ensure Availability of
Personnel to Monitor Human, Animal, and Plant Health Domains for
Biosurveillance Purposes:
Some of the professions that underpin the surveillance mechanism for a
national biosurveillance capability currently face and are expected to
continue to confront workforce challenges--particularly workforce
shortages; however, some federal agencies with key biosurveillance
responsibilities have efforts underway to help confront those
challenges. We reported in September 2009 that as the threats to
national security--which include the threat of bioterrorism and
pandemic outbreak--have evolved over the past decades, so have the
skills needed to prepare for and respond to those threats.[Footnote
18] We also found that like other federal efforts to address modern
national security challenges that require collaboration among multiple
agencies, an effective biosurveillance capability relies on qualified,
well-trained professionals with the right mix of skills and
experience. Figure 4 provides examples of the workforce involved with
detection and situational awareness activities that support
biosurveillance.
Figure 4: Examples of Workforce Involved with Biosurveillance
Activities:
[Refer to PDF for image: illustration]
Public health:
* Hospitals;
* Physicians;
* Clinicians;
* State or local public health officials;
* Pharmacists;
* Laboratories;
* Epidemiologists.
Animal health:
* Veterinarians;
* Wildlife officials;
* Zoo officials;
* Producers;
* Laboratories;
* Epidemiologists.
Plant/forest health:
* Agriculture extension agents;
* Customs and Border Protection and USDA inspection officials;
* Growers;
* Foresters;
* Taxonomists;
* Laboratories.
Source: GAO; Art Explosion.
[End of figure]
[Side bar:
The Institute of Medicine:
The Institute of Medicine is an independent, nonprofit organization
that works outside of government to provide unbiased and authoritative
advice to decision makers and the public.
Established in 1970, the Institute of Medicine is the health arm of
the National Academy of Sciences, which was chartered under President
Abraham Lincoln in 1863. Nearly 150 years later, the National Academy
of Sciences has expanded into what is collectively known as the
National Academies, which comprises the National Academy of Sciences,
the National Academy of Engineering, the National Research Council,
and the Institute of Medicine. Source: GAO. End of side bar]
The public health and health care workforce is expected to continue to
confront shortfalls in the coming years, which could threaten the
federal government's ability to develop a national biosurveillance
capability. According to CDC officials, serious public health and
health care workforce shortages currently exist due to factors such as
the exodus of retiring workers, an insufficient supply of trained
workers, inadequate funding, and uncompetitive salaries and benefits.
In discussing concerns about looming workforce shortages, CDC
officials pointed to a December 2008 Association of Schools of Public
Health estimate that by 2020 the nation will face a shortfall of over
250,000 public health workers.[Footnote 19] CDC officials said that
states and communities nationwide report needing more public health
nurses, informaticians, epidemiologists, laboratory workers,
statisticians, and environmental health experts. Moreover, the
Institute of Medicine stated in 2009 that the unevenness of
organizational and technical capacity at state and local levels across
the public health system weakens the nation's preparedness to detect
and, especially, to respond to and manage the consequences of a major
health emergency.[Footnote 20]
We also reported in February 2009 that the animal health field faces
workforce shortages that could affect the ability of professionals to
be prepared and enabled to detect and warn of biological events.
[Footnote 21] For example, USDA officials have expressed concern about
the future size and skills of the veterinarian workforce, particularly
veterinary pathologists who are integral to the work conducted in
USDA's diagnostic laboratories, including work on diseases that
threaten animal and human health. Further, USDA officials have also
expressed concern about the availability of taxonomists, whose
expertise is critical to characterizing threats and providing warning
of a potentially catastrophic biological event involving plants.
Although the workforce shortages threaten to diminish capacity to
detect signals of potentially catastrophic biological events as they
emerge, some federal agencies are planning or have taken actions to
help mitigate them. In particular, in its National Biosurveillance
Strategy for Human Health, CDC named the biosurveillance workforce as
one of its priority areas.[Footnote 22] To enhance workforce
capability, CDC's strategy calls for assessing the current
biosurveillance workforce capability, identifying and addressing gaps,
ensuring the workforce is competent, developing recruitment and
retention strategies for professionals across diverse fields, and
establishing a national-level governance body for the biosurveillance
workforce across agency boundaries and disciplines. CDC has also taken
actions to help increase the number of public health workers,
including extending service and learning fellowships in epidemiology,
informatics, laboratory, and management.[Footnote 23]
Moreover, with respect to animal and plant workforce, the federal
government is implementing measures to help ensure an adequate
workforce. For example, we reported in February 2009 that USDA has set
a goal of recruiting at all veterinary colleges and universities. In
addition, USDA is using incentives, such as bonuses, to attract and
maintain its veterinarian workforce. [Footnote 24] In addition, USDA
has identified tactics to build the capacity and retain the experience
of taxonomists. USDA is also using cooperative agreements and funding
to enlist taxonomic services from nonfederal institutions to identify
and confirm identifications of exotic plant pests. According to USDA
officials, they have increased the number and variety of these
agreements in recent years, increased availability of professionals
who can help identify threats to plants by nearly 50 percent in the
past 20 years, and created a career ladder to retain experienced and
talented workers. Further, in response to recommendations we made in
February 2009 to address veterinarian shortages, in November 2009, the
Office of Personnel Management established the governmentwide
Veterinary Medical Officer Talent Management Advisory Council.
[Footnote 25] The purpose of the council is to lead the design and
implementation of a governmentwide workforce strategy for federal
veterinary medical workers. The council held its first meeting in
March 2010 and is in the process of gathering workforce data from all
federal agencies with veterinarian medical officers.
Federal Agencies Have Supported or Implemented Training and
Accreditation Programs:
Federal agencies have supported programs to help with workforce
development at the state and local levels that respond partially to
the ongoing challenge of maintaining a trained cadre of professionals
who operate in fields where professional issues, systems, and
technologies continue to evolve over time. Training and accreditation
programs are essential to developing a knowledgeable workforce with
the skills needed to identify potential threats to human, animal, and
plant health. An effective medical response to a biological event
would depend in part on the ability of individual clinicians and other
professionals to identify, accurately diagnose, and effectively treat
diseases, including many that may be uncommon.[Footnote 26] The
opportunity to evaluate signs and symptoms of diseases of concern
relies on trained professionals possessing the knowledge needed to
identify and order the right lab test to confirm a diagnosis. In
addition, detection and warning of a disease threat also relies on
these professionals knowing who to call to report the finding.
One challenge federal officials relayed to us is that because the
concept of biosurveillance is relatively new and has been evolving
over the last decade, there are few if any specialties or
concentrations in biosurveillance within epidemiology or other
programs. They further noted that while some university programs are
beginning to address the issues in their curricula, the general lack
of biosurveillance or cross-domain specialties, curricula, and classes
in these programs limits the feedback loop between academics and
practitioners that helps support innovative solutions.
[Side bar: Can you Detect Bioterrorism?
Imagine you are a busy emergency department doctor. Could you identify
and correctly diagnose a case of smallpox — now believed to be
eradicated as a naturally occurring disease but recognized as a
bioterrorism threat agent? [3 photographs]
A. Smallpox;
B. Chickenpox;
C. Monkeypox.
Source: CDC. End of side bar]
Another training challenge is keeping up with changes in issues,
technologies, and systems. CDC officials told us that public health
workers are always challenged with keeping abreast of developments.
For example, when a new laboratory tool or method is developed, public
health workers must be trained to use them. Epidemiologists also must
be trained and educated about new or emerging health issues,
infections, software, information technology systems, and tools.
Clinicians require continuing education to remain astute. These CDC
officials noted that maintaining expertise in a rapidly changing field
is difficult, yet having professionals with the right expertise is
critical in protecting the public's health, as well as for emergency
preparedness and response. For USDA, the increased risks to animal and
public health from animal diseases have presented challenges because
the expertise needed to identify and respond to the risks of zoonotic
diseases has not been defined.
Further, a DOI official expressed concern about maintaining skills and
expertise of wildlife health professionals. According to this
official, identifying, characterizing, and mitigating threats
involving free ranging fish and wildlife populations call for specific
training and expertise in wildlife epidemiology and wildlife disease
ecology. These officials expressed concern about whether federal
inspectors receive sufficient training or have sufficient resources to
address disease in free-ranging wildlife populations.
Federal agencies have taken actions to help respond to the challenges
arising from evolving fields of study and increased risks of outbreaks
impacting more than one domain. For example, in the National
Biosurveillance Strategy for Human Health, CDC has called for the
development of a national training and education framework to
articulate professional roles and competencies necessary for
biosurveillance. The strategy also noted that in addition to the
traditional public health professions trained in surveillance, there
is a need to recruit professionals from other diverse fields including
informatics and computational sciences to enhance data sharing, as
well as the plant and veterinary sciences to help understand how
diseases flow among humans, animals, and plants. Along these lines,
CDC has developed a public health informatics fellowship program,
which is designed to help address the need for practitioners with a
mastery of sophisticated electronic systems to facilitate
communication and data exchange among public health personnel at the
local, state, and federal levels. Officials at HHS also noted that the
National Institute of Health's National Library of Medicine has funded
18 University-Based Biomedical Informatics Research Training programs,
of which 10 have special Public Health Informatics tracks.
USDA has also developed training programs to ensure their first
detectors are knowledgeable on diseases and pests of significance. For
example, USDA has an accreditation program for veterinarians and views
the cadre of veterinarians it has accredited as the front line of
surveillance for diseases of significance that are not specifically
monitored through a program. These accredited state and federal
veterinary officials--as we reported in 2005, approximately 80 percent
of the veterinary workforce--are dispersed throughout the country and
are trained to observe signs and symptoms of diseases and unusual
occurrences of illness or death in animal populations.[Footnote 27]
According to USDA, the United States depends extensively on accredited
veterinarians for official functions, such as inspecting, testing, and
certifying animal health. For plant surveillance, USDA's National
Plant Diagnostic Network began the National First Detector Training
Program in 2003. The program offers training to aid USDA's
surveillance of plants for pests and diseases. First detectors are
individuals who in the course of their activities are in a position to
notice an unusual plant pest outbreak, a pest of concern, or symptoms
of a pest of concern. The individuals may include growers, nursery
producers, crop consultants, pesticide applicators, and master
gardeners, among others. According to USDA officials, the training
equips participants with the knowledge to detect and report unusual
exotic pest or disease activity, which is key to initiating response
and mitigation activities.
Federal Agencies Have Efforts Underway to Develop Equipment and
Systems to Support Their Biosurveillance Missions:
Our analysis of relevant presidential directives and our discussion
with federal officials with central responsibilities for monitoring
disease and protecting national security indicate that a national
biosurveillance capability depends upon systems and equipment that
enable rapid detection and communication of signals that might
indicate a potentially catastrophic biological event, quick and
effective analysis of those signals, and timely dissemination of high-
quality and actionable information to decision makers.[Footnote 28] In
this vein, federal agencies have taken various actions designed to
promote timely detection and situational awareness by developing (1)
information sharing and analysis mechanisms, (2) laboratory networks
to enhance diagnostic capacity, and (3) equipment and technologies to
enhance early detection and situational awareness.
Information Sharing and Analysis Mechanisms:
Because the data needed to detect an emerging infectious disease or
bioterrorism may come from a variety of sources, the ability to share
and analyze data from multiple sources may help officials better
collaborate to analyze data and quickly recognize the nature of a
disease event and its scope.[Footnote 29] As illustrated in figure 5,
observing related symptoms in human and animal populations, or cross-
domain surveillance, may bring concerns into focus more quickly than
monitoring human symptoms alone. This may be particularly important as
many disease agents have the potential to be weaponized and many of
the recent emerging infectious diseases are zoonotic.[Footnote 30]
Figure 5: West Nile Virus: A Case Study in the Value of Cross-Domain
Surveillance:
[Refer to PDF for image: illustration]
West Nile Virus-—a virus with a 3-15 percent fatality rate that passes
from mosquitoes to birds and humans-—first appeared in the Western
hemisphere in 1999.
Bird to insect:
Insect to bird:
Insect to human:
In reviewing the federal response, we reported that the analysis of
the outbreak continued for weeks as separate investigations of sick
people and of dying birds.[A] Only after the investigations converged,
and after several parties had independently explored other possible
causes, was the link made and the virus correctly identified.
June 1999:
Animal outbreak:
First reports of dying birds;
Human outbreak.
August 1999:
Investigation of bird deaths intensifies;
First human cases reported.
September 1999:
St. Louis encephalitis outbreak announced, mosquito control begins;
Veterinary and Agriculture laboratories isolate virus from mosquitoes
and birds;
Identification of West Nile virus;
Academic researcher invited to help identify virus.
We concluded that the time it took to connect the bird and human
outbreaks signaled a need for better coordination among public and
animal health agencies.
Source: GAO; Art Explosion.
[A] West Nile Virus Outbreak: Lessons for Public Health Preparedness,
GAO/HEHS-00-180 (Washington D.C.: Sept. 11, 2000).
[End of figure]
One example of a federal initiative designed to improve sharing of
biosurveillance information is DHS's National Biosurveillance
Integration Center's (NBIC) Biological Common Operating Picture
(BCOP), a manually updated Google Maps application of current
worldwide biological events being tracked.[Footnote 31] Officials can
view the BCOP on the Homeland Security Information Network.[Footnote
32] The BCOP provides a situational awareness tool for the National
Biosurveillance Integration System (NBIS)--the community of federal
and other stakeholders that have information that can be used to
enhance the safety and security of the United States against potential
biological events of national significance. NBIC supports the BCOP
through a system--the Biosurveillance Common Operating Network (BCON)--
that monitors, tracks, and disseminates available NBIS-partner
information, but relies largely on information from publicly available
sources, such as news articles. One of the primary data sources for
BCON is an international information gathering service called Global
Argus, a federally funded program in partnership with Georgetown
University. The service searches and filters over 13,000 overseas
media sources, in more than 34 languages.
A similar type of initiative underway at some federal agencies
involves developing and maintaining communication tools for
information sharing within specialized disciplines. These
communication tools may include functions that allow users to send and
receive information or view the status of ongoing events. One such
tool is a Web-based forum that provides a secure environment for the
exchange of information on case reports and allows users to request
information or expertise from other users. For example, one such
communication tool developed by CDC, known as Epi-X, provides a secure
Web-based forum for public health officials to post case reports of
conditions and ask other health officials whether they have also seen
cases of the condition. The officials can also discuss similarities in
the cases that may indicate how the disease is spreading and suggest
mitigation measures--for example, product recalls--that could be
implemented. In this way, health officials can leverage both
information and analytical capacity across agencies, levels of
government, and different regions of the country to help support the
early detection and situational awareness goals of biosurveillance.
For example, the forum may help them to more quickly and
comprehensively determine whether diseases seem to be widespread and
what caused them and to discuss treatment options in a secure
environment. For more information on specific communication tools, see
appendix IV.
In addition, we reported in May 2003 that electronic reporting of data
can facilitate data exchange among different databases and allow more
rapid and accurate analysis of information from multiple sources.
[Footnote 33] CDC officials noted that laboratory reports could be
received by CDC in 72 hours if exchanged through an electronic system,
as opposed to the up to 2 weeks it can take for laboratory report hard
copies to be sent through the mail. Further, because it facilitates
data exchange, standardization can help support the vision of
integrated surveillance systems articulated in HSPD-9 and 21.
According to CDC officials, the potential benefits of electronic
reporting of data in a standardized format are striking and can
eliminate the need for analysts to dedicate valuable time to
processing and translating data provided in different formats
expressed using various terminologies. For example, during the 2001
anthrax event, the results of laboratory tests for anthrax were
reported in different formats (e.g., emailed text, mailed hard copy,
as attachments in different software programs), and using different
terminology, such as "Bacillus anthracis," "B. anthracis," and
"Anthrax."[Footnote 34] These variations in report format and language
required analysts at CDC to spend time translating and compiling the
data into information that could inform decision making during the
event.
To support effective and efficient information sharing, some agencies
have efforts underway to promote electronic reporting of information
in a standardized format. For example, CDC's Public Health Information
Network (PHIN) initiative aims to advance the development of
interoperable surveillance and other public health systems at federal,
state, and local levels. The initiative defines data and messaging
standards and provides guidance for public health entities to follow
in building systems that meet compatibility and interoperability
standards for enhanced electronic information sharing. Additionally,
HHS, through initiatives to support nationwide health information
exchange, has defined specific standards that promote the exchange of
biosurveillance information among health care providers and public
health authorities.
Within CDC, several surveillance systems have been developed and
implemented in accordance with PHIN standards to promote electronic
information sharing. One of these is the National Electronic Disease
Surveillance System (NEDSS). A primary goal of NEDSS is the ongoing,
automatic capture and analysis of data that are already available
electronically to minimize the problems of fragmented, disease-
specific surveillance systems. The initiative is intended to promote
efficient and effective data management and information sharing by
eventually consolidating the data collection of CDC's various
programmatic disease surveillance activities in one place. For more
information on programs that support standardization and electronic
data exchange, see appendix IV.
To further enhance and support biosurveillance activities, CDC, DHS
and other federal agencies have developed or taken action to gather
electronic data from syndromic surveillance systems. Syndromic
surveillance uses health-related data collected before diagnosis to
look for signals or clusters of similar illnesses that might indicate
an outbreak. Examples of syndromic surveillance data are prediagnostic
health-related information like patients' chief complaints recorded by
a health care worker at the admissions desk of a hospital emergency
room and information collected on over-the-counter sales of
antidiarrheal medicines that could indicate gastrointestinal disease
outbreaks. We reported in 2004 that because these syndromic systems
monitor symptoms and other signs of disease outbreaks instead of
waiting for clinically confirmed reports or diagnoses of a disease,
some experts believe they can increase the speed with which outbreaks
are identified. However, we also reported in September 2004 and
November 2008 that the ability of syndromic surveillance to more
rapidly detect emerging diseases or bioterror events has not yet been
demonstrated, and questions about its cost-effectiveness arise.
[Footnote 35] An example of a syndromic surveillance system is CDC's
BioSense--another CDC system that was developed and implemented in
accordance with data and message standards defined by the PHIN
initiative. BioSense collects electronic data that are voluntarily
shared by participating state, local, and other federal public health
entities, including data related to infections, injuries, and chronic
diseases. Currently the system collects chief complaint data from 570
hospitals and 1,100 federal clinics, and sales data from over 10,000
pharmacies. Because the data and messages are sent and received in
standardized formats, the data are integrated into the BioSense
system, reducing the need for analysts to manually interpret or
manipulate data and are analyzed by the system to enhance the
nationwide situational awareness capabilities of public health
analysts at CDC.
Even as standardization and data and information-sharing tools
improve, other challenges will likely impede information sharing for
biosurveillance purposes across federal, state, and local levels of
government. We and others have noted that numerous challenges have
impeded efforts to coordinate and collaborate across organizational
boundaries to integrate biosurveillance and other national security
activities.[Footnote 36] Some such challenges are inherently
intergovernmental issues and arise because most of the information
needed for biosurveillance is generated and owned outside of the
federal government. Therefore, there is limited assurance that state
and local governments can or will fully participate in federal
information sharing and standardization initiatives like PHIN. CDC
officials expressed concern about the differing levels of capacity and
willingness among states to participate in data standardization and
electronic information-sharing initiatives.
Moreover, information-sharing challenges also occur among the federal
agencies. As we reported in December 2009, NBIC has faced
collaboration challenges and has been largely unsuccessful in
obtaining from federal partners key resources needed to support data
integration and shared analytical capacity.[Footnote 37] Federal
officials from agencies participating in the National Biosurveillance
Integration System--such as CDC, USDA, and FDA--described challenges
to sharing such information, including concerns about trust and
control over sensitive information before it is vetted and verified.
In addition, NBIC officials told us and we previously reported that
much of the information available to help achieve biosurveillance
goals is unstructured and not readily processed by a computer system;
while, data that are more easily computer processed often lack the
context needed to make appropriate conclusions about whether anomalies
actually signal a potential problem.[Footnote 38]
Laboratory Networks to Enhance Laboratory Diagnostic Capacity:
Over the past decade, the federal government has leveraged and
enhanced its laboratory capabilities, capacity, resources, and
expertise for detecting and warning about biological threat agents by
developing and implementing laboratory networks at the federal, state,
and local level.[Footnote 39] In addition, the federal government led
an effort to establish a consortium of laboratory networks that
further integrates a number of these networks. In June 2005, 10
federal agencies signed a Memorandum of Agreement establishing the
Integrated Consortium of Laboratory Networks (ICLN).[Footnote 40] The
purpose of this consortium is to establish a coordinated and
operational system of laboratory networks that provide timely, high-
quality, and interpretable results for early detection of acts of
terrorism and other events that require integrated laboratory response
capabilities. ICLN's individual laboratory networks focus on detecting
biological threat agents that affect humans, animals, or plants that
contaminate the air, water, or food supply. These laboratory networks
which comprise the ICLN are shown in table 1.
Table 1: Laboratory Networks That Comprise the ICLN.
Laboratory network: HHS/CDC's Laboratory Response Network (LRN);
Members: Over 150 federal, military, state, local, and international
laboratories;
Mission and capabilities: LRN is charged with maintaining an
integrated network of federal, military, state, local, and
international laboratories that can respond to bioterrorism, chemical
terrorism, and other public health emergencies. The biological
component of LRN provides network capacity to test for biological
agents in a variety of formats including clinical specimens, and food
and environmental samples. The laboratories in this component are
classified as either reference, national, or sentinel laboratories,
depending on the types of tests that the laboratory can perform and
how it handles infectious agents.[A]
Laboratory network: USDA's Animal and Plant Health Inspection Service
(APHIS) and the National Institute of Food and Agriculture's (NIFA) b
National Animal Health Laboratory Network (NAHLN);
Members: Fifty-eight NAHLN laboratories in over 40 states; Nine of
these laboratories are also part of the LRN network;
Mission and capabilities: NAHLN is responsible for a functional
national network of existing veterinary diagnosis laboratories to
rapidly and accurately detect and report animal diseases of national
interest. These laboratories include federal, state, and university
laboratories. Federal laboratories include the National Veterinary
Services Laboratory, which serves as in international reference
laboratory and conducts tests and confirms tests for other
laboratories, and the Foreign Animal Disease Diagnostic Laboratory,
which tests for highly contagious diseases such as foot-and-mouth
disease.
Laboratory network: USDA's APHIS and NIFA's National Plant Diagnostic
Network (NPDN);
Members: The NPDN consists of network of five regional hub
laboratories that coordinate plant diagnostic activities in 50 states
and 2 territories;
Mission and capabilities: The NPDN is charged with helping federal,
state, local, university, and private laboratories to rapidly detect
and identify high-consequence pests and pathogens introduced
deliberately or accidentally into commercial and natural ecosystems
and report these pests and pathogens to appropriate decision makers
and responders.
Laboratory network: USDA's Food Safety Inspection Service and HHS's
FDA's Food Emergency Response Network (FERN);
Members: Over 130 FERN laboratories in 50 states. These laboratories
include over 100 microbiological-capable facilities. Membership is
limited to laboratories from public institutions performing regulatory
and diagnostic analytical work;
Mission and capabilities: FERN integrates the nation's food-testing
laboratories at the federal, state, and local levels into a network
that is able to respond to emergencies involving biological, chemical,
or radiological contamination of food. The network also seeks to
strengthen laboratory capacities and capabilities, as well as act as
surge capacity.
Laboratory network: EPA's Environmental Response Laboratory Network
(ERLN);
Members: The ERLN integrates capabilities of existing public sector
labs with accredited private sector labs to support, as needed, large-
scale environmental responses;
Mission and capabilities: The mission of ERLN is to provide federal,
state, and local decision makers with reliable, high-quality
analytical data used to identify chemical, biological, and
radiological contaminants collected in support of response and clean-
up activities. ERLN goals include providing laboratory testing
capability and capacity to meet EPA's responsibilities for
surveillance, response, decontamination, and recovery from incidents
involving release of chemical, biological, or radiological
contaminants; facilitating the coordination of labs capable of
responding efficiently and effectively to incidents;
and establishing relationships and priorities with other federal
laboratory networks through the ICLN;
The ERLN includes the Water Laboratory Alliance, which was developed
in response to HSPD-9's call for nationwide laboratory networks for
water quality. Its purpose is to provide the water/wastewater sector
with an integrated nationwide network of laboratories with the
analytical capability and capacity to support monitoring,
surveillance, and remediation in response to intentional and
unintentional water contamination events involving chemical,
biological, and radiochemical contaminants.
Source: GAO analysis of federal agency data.
[A] Reference laboratories can perform tests to detect and confirm the
presence of a threat agent and ensure a timely response. Sentinel
laboratories are hospital-based facilities that are in direct contact
with the public. If these laboratories detect suspicious specimens,
they forward the suspect samples to reference laboratories. National
laboratories have unique resources to handle highly infectious
diseases and to identify and definitively characterize new strains and
novel agents.
[B] NIFA is the former USDA Cooperative State Research, Education, and
Extension Service (CSREES).
[End of table]
Equipment and Technologies to Enhance Early Detection and Situational
Awareness:
The federal government is developing and implementing equipment and
technologies that can provide additional information to support early
detection and situational awareness. For example, the federal
government is applying diagnostic technologies to help detect and
monitor biological events. Studying disease agents at the molecular
level can provide information for situational awareness. Techniques to
determine and attribute the source of biological events can be
important for both natural and intentional events. In a natural event-
-such as a foodborne illness--it can help speed detection, focus the
investigation, and characterize the extent and severity of disease.
For intentional events, it can provide critical information to help
determine the scope of the attack and contribute to law enforcement
investigations.[Footnote 41] One example of such a system is CDC's
PulseNet, a national network of public health laboratories that
perform DNA "fingerprinting" as a means to help with early
identification of outbreaks of foodborne illness with a common source
and enhance situational awareness during an event. The PulseNet
program provides a tool for participating laboratories to upload and
then compare the genetic "fingerprints" of foodborne pathogens
isolated from samples taken from sick individuals. The network can
identify and label each fingerprint pattern to permit the rapid
comparison of these patterns with others in the PulseNet database.
PulseNet officials told us that this process can take roughly 2 weeks
after receiving a sample. FDA, USDA, CDC, and state public health
officials have access to the PulseNet database. See appendix IV for
more information on foodborne disease monitoring systems and
diagnostic technologies.
[Side bar:
Salmonella Outbreak: Case Study in Food Monitoring:
In November 2008, CDC’s PulseNet staff noted a multistate outbreak of
an unusual strain of salmonella infections which was eventually
attributed to a brand of peanut butter and peanut paste from a single
production facility. It resulted in over 700 confirmed cases of
salmonella infection in 46 states.
On November 10, 2008, CDC PulseNet identified a multistate cluster of
Salmonella Typhimurium infections (13 cases reported in 12 states) and
began monitoring for additional reports of cases with the same DNA
fingerprint. On November 24, 2008, PulseNet identified a second
multistate cluster of cases (27 cases reported in 14 states) and
continued monitoring to identify additional cases.
Based on preliminary information stemming from CDC and states’
epidemiological investigation, and collaborating with USDA and public
health officials, FDA began its investigation to identify the source
of the contaminated peanut butter by inspecting the facility where the
implicated peanut butter was made. Following FDA confirmation that
salmonella was found at their Blakely, GA facility, on January 13,
2009, the company recalled affected products.
{Photograph: Salmonella Typhimurium]
Source: CDC; GAO analysis. End of side bar]
Federal agencies have also developed technologies to detect biological
agents in drinking water and air. Drinking water utilities across the
country have long been recognized as potentially vulnerable to
terrorist attacks of various types, including physical disruption,
bioterrorism, chemical contamination, and cyber attack.[Footnote 42]
People also face the threat of becoming ill from inhaling certain
biological agents--whether naturally occurring or intentionally
weaponized and released to cause disease and disruption. EPA has
developed a system to detect contamination of drinking water and USPS,
DOD, and DHS have developed sensor technologies to detect aerosolized
biological agents in the air. EPA's Water Security Initiative program
developed a contamination warning system to allow local water
utilities to monitor drinking water for contamination by chemical,
biological, and radiological agents. The contamination warning system
has been designed to provide timely detection and appropriate response
to biological events.
[Side bar: Monitoring the Nation’s Water Supply:
According to the EPA, federal oversight of all water utilities, given
the size and complexity of the various systems around the country, is
not feasible. EPA reported in 2009 that nationwide, there were more
than 150,000 public water systems varied greatly in size. Over 125,000
of these water systems served 500 or fewer people. Only 413 systems
served more than 100,000 people each, but these systems, located
primarily in urban areas, accounted for nearly half of the total
population served.
Figure: vertical bar graph]
Population served: less than 500;
Number of systems: 125,125.
Population served: 501-3,300;
Number of systems: 19,126.
Population served: 3,301-10,000;
Number of systems: 5,090.
Population served: 10,001-100,000;
Number of systems: 3,775;
Population served: Greater than 100,000;
Number of systems: 413.
Source: GAO; Art Explosion.
[End of figure]
End of side bar]
The system, however, is not widely distributed. Currently, the Greater
Cincinnati Water Works in Cincinnati, Ohio is the only locality that
has the system fully operating. EPA is assisting local water districts
in four other locations--New York City, San Francisco, Dallas, and
Philadelphia--with implementation the contamination warning system as
part of a five-city pilot project each of which EPA officials stated
is to last for four years and be complete in 2012. Local water
utilities are to implement this system on a voluntary basis and
operate it at their own expense. According to EPA officials, no
contamination warning systems has yet been proven to be effective and
sustainable for drinking water systems, but the Water Security
Initiative is attempting to design, deploy, and test an effective and
sustainable system. For more information on the Water Security
Initiative, see appendix IV.
USPS, DOD, and DHS have developed and implemented technologies to
sample the air and test for specific biological agents.[Footnote 43]
One of these, DHS's Biowatch program, has been implemented in more
than 30 metropolitan areas and tests for the presence of multiple
biological threat agents.[Footnote 44] USPS has deployed an indoor
monitoring system--Biohazard Detection System--at mail distribution
centers nationwide that automatically detects and warns of the
presence of the anthrax organism in the air surrounding mail-sorting
equipment. DOD has also developed indoor and outdoor monitoring
systems to detect airborne chemical, biological, radiological, or
nuclear agents in order to protect military interests.
However, these sensor technologies are limited in their ability to
provide early detection because there are constraints on the speed
with which the diagnostic testing can be performed. For example, DHS'
Biowatch sensor technology depends on air filters which must be
collected and transported to a laboratory for diagnostic testing,
which can take more than a day.[Footnote 45] According to senior
officials from the Office of Health Affairs and the Science and
Technology Directorate at DHS, research and development to eliminate
the need for manual collection of samples is underway, but the science
needed to do so may not yet be fully mature. Additional information on
the USPS, DOD, and DHS biodetection systems can be found in appendix
IV.
A National Strategy and a Focal Point Could Help Guide Development of
a National Biosurveillance Capability:
While some high-level biodefense strategies have been developed, there
is no broad, integrated national strategy that encompasses all
stakeholders with biosurveillance responsibilities that can be used to
guide the systematic identification of risk, assessment of resources
needed to address those risks, and the prioritization and allocation
of investment across the entire biosurveillance enterprise. Further,
while numerous agencies have biosurveillance responsibilities, a
single focal point for this effort has not been established. We have
reported that developing effective national strategies and
establishing a focal point with sufficient time, responsibility,
authority, and resources can help ensure successful implementation of
complex interagency and intergovernmental undertakings, such as
providing a national biosurveillance capability.[Footnote 46]
A National Biosurveillance Strategy Has Not Yet Been Developed:
We reported in 2001 that complex interagency and intergovernmental
efforts--for example developing a robust national biosurveillance
capability--can benefit from developing a national strategy.[Footnote
47] In prior work, we identified elements of an effective national
strategy including (1) identifying the purpose, scope, and particular
national problems and threats the strategy is directed towards; (2)
establishing goals, subordinate objectives and activities, priorities,
milestones, and performance measures; (3) defining costs, benefits,
and resource and investment needs; (4) delineating roles and
responsibilities; and (5) integrating and articulating the
relationship with related strategies' goals, objectives, and
activities.[Footnote 48]
Although broad national strategies for biodefense have been
formulated, there is no national strategy to help guide federal
agencies and their partners' efforts to build and maintain the
national biosurveillance capability. Two national strategies--the
National Security Council's National Strategy for Countering
Biological Threats and HHS's National Health Security Strategy--call
for further development of biosurveillance strategies and plans to
help support their broader biodefense goals. Specifically, the
National Strategy for Countering Biological Threats, which is a high-
level strategy to provide a framework for future federal efforts to
support biological threat preparedness, calls for the development of a
strategy for advancing situational awareness and a plan that
identifies key elements of information to be shared, critical
sensitivities to be protected, and a framework for enabling
information exchange. However, this high-level call for additional
work does not articulate or assign specific roles and
responsibilities; it does not establish specific objectives,
activities, milestones, and performance measures; and it does not
provide a foundation for determining investment priorities to guide
the entire interagency and intergovernmental biosurveillance
enterprise.
HHS's Office of the Assistant Secretary for Preparedness and Response
issued the National Health Security Strategy (NHSS) in December 2009.
The NHSS is designed to achieve two goals: build community resilience
and strengthen and sustain health and emergency response systems. One
of the strategy's 10 strategic objectives is to ensure the nation has
a situational awareness capability. Under this objective, the strategy
and its accompanying interim implementation plan emphasize the need
for situational awareness obtained through epidemiological and animal
disease surveillance as well as monitoring agricultural and food
supplies for contamination. This NHSS goal is similar to the call for
robust and integrated biosurveillance capabilities in HSPD-21;
however, like the National Strategy for Countering Biological Threats,
it does not provide a foundation to clarify roles and
responsibilities; define specific objectives, activities, and
priorities; or guide investment priorities.
USDA and HHS have drafted strategies for carrying out the missions
that support biosurveillance within the animal and human health
domains, but these are not intended to support a robust and integrated
capability across the entire biosurveillance enterprise.[Footnote 49]
USDA has had a strategic plan for the National Animal Health
Surveillance System (NAHSS) since 2005, drafted in part to respond to
HSPD-9's call to develop robust, comprehensive, and fully coordinated
surveillance and monitoring systems to support timely detection and
situational awareness. The plan notes that although consequences of
inadequate surveillance could be catastrophic, resources for
surveillance activities are limited and have to be judiciously and
efficiently allocated. As such, it identifies specific goals and
objectives designed to support surveillance mission activities
including enhancing timely detection and situational awareness--for
example, by encouraging the development and application of new
technologies for early and rapid disease detection and data analysis
related to foreign and emerging animal diseases. However, this
strategy was formulated to help USDA pursue its animal health mission
and neither reflects nor provides guidance to help ensure that
investments of limited resources to support USDA's mission are aligned
with a comprehensive strategy that supports linkages across the
biosurveillance enterprise.
Similarly, in response to the same HSPD-9 concept of robust and fully
coordinated surveillance, which was reiterated and expanded in HSPD-
21, CDC has led the formulation of the National Biosurveillance
Strategy for Human Health and an accompanying Concept Plan for
Implementation. Noting that the challenges and opportunities for
creating a more robust biosurveillance system are substantial and
multidimensional, while resources are limited, the strategy outlines
six priority areas of focus. Among the priority areas are equipment
and systems enhancements to strengthen the way information is used and
shared, as well as strategies for addressing workforce issues by
helping to ensure the availability of well-trained medical and public
health officials. However, this strategy focuses its attention on
human health and does not serve the purpose of providing a unified,
national biosurveillance strategy to guide the whole biosurveillance
enterprise. We spoke with CDC officials responsible for formulating
this strategy about its scope, among other things, and they
acknowledged that it does not fully address key aspects of
biosurveillance outside of human disease. Further, officials from
agencies with key biosurveillance responsibilities, including CDC,
DOD, DOI, and USDA, said that efforts to enhance the national
biosurveillance capability would benefit from a broader strategic
effort that integrated the human health focus with other domains and
relevant mission activities.
An Effective National Strategy Could Help Ensure the Development of a
National Biosurveillance Capability:
Although federal agencies have efforts underway that could provide
support for a robust, integrated biosurveillance capability, many
challenges remain--looming workforce shortages, providing ongoing
training in rapidly evolving fields, information-sharing impediments
among systems developed for various purposes, and constraints on
environmental monitoring systems. These challenges are complex,
inherent to building capabilities that cross mission areas and
agencies, and not easily resolved. Having a strategy in place to guide
development of a national biosurveillance capability could potentially
help agencies address these challenges. A national strategy could
define the scope of the problems to be addressed, and in turn could
lead to specific objectives and activities for tackling those
problems, better allocation and management of resources, clarification
of roles and responsibilities, and, finally, to integration of a
biosurveillance strategy with other related preparedness and response
strategies.
Purpose, Scope and Problems to Be Addressed:
A national strategy could help to clarify the purpose and scope of a
national biosurveillance capability and the specific problems or risks
to be addressed by this capability. While federal agencies have put in
place various monitoring programs and systems in pursuit of their
agency-specific missions, senior officials we interviewed from
agencies with key biosurveillance roles expressed concern that
definitional issues, such as the scope of biosurveillance and the
range of activities that it should include, are unclear. For example,
CDC officials stated that although the National Biosurveillance
Strategy for Human Health provides a framework for biosurveillance
within the human health domain, questions regarding the scope of this
effort remain. Specifically, CDC officials said it is yet to be
determined whether human health biosurveillance efforts should be
limited to pathogens that directly cause illness in humans or also
include events that could indirectly affect the health of humans, such
as an agricultural event that causes mass starvation. Other federal
officials we interviewed from agencies including USDA, EPA, FDA, and
DOD said it was unclear whether the scope of biosurveillance should
extend to any event that affects the health of living organisms--
humans, plants, and animals--or whether biosurveillance should be
limited to detecting and monitoring pathogens that may cause disease.
A national strategy for biosurveillance could allow the federal
government to define and agree on key terms, among other things, that
could help federal agencies clarify the actions needed to meet their
biosurveillance responsibilities.
Goals, Objectives, Activities, and Priorities:
A national strategy could help establish goals, objectives,
activities, priorities, milestones, and performance measures to help
guide the development of a national biosurveillance capability. A
national strategy could further clarify the goals of a national
biosurveillance capability, building upon the decisions made regarding
the scope and purpose of the capability. At the highest level, this
could be a description of the ideal "end-state" of what a robust and
integrated national biosurveillance capability would be, followed by
accountability mechanisms for implementation and ongoing performance
monitoring. Federal agencies, such as CDC and USDA, have developed
some strategic doctrine that outlines agency priorities in pursuit of
their missions, but there is no strategy that outlines national goals,
objectives, and priorities for the entire biosurveillance enterprise
that would guide the larger federal effort. For example, the National
Strategy for Biosurveillance for Human Health, calls for the
development of information that would define objectives and funding
needs to help mitigate looming workforce shortages. A national
strategy could assist in setting priorities, milestones, and desired
results across the biosurveillance enterprise--not only for human or
animal health--while giving implementing parties flexibility to pursue
and achieve those results within a reasonable time frame. In addition,
once objectives and priorities are established, outcome-based
performance measures could provide information to further refine them
over time.
Costs, Benefits, Resources, and Investment Needs:
A national strategy could help assess the costs of a robust,
integrated, national biosurveillance capability and identify potential
benefits of mitigating the problems or risks identified by the
strategies' goals and objectives. Currently, limited information is
available to develop a reliable, enterprisewide assessment of the
costs and benefits of a national biosurveillance capability. According
to the Institute of Medicine, the costs of the broader infectious
disease-surveillance activities in the public health and health care
systems are difficult to determine. The institute reported in 2009
that current budgeting and accounting systems at the local, state, and
federal levels do not usually provide this information, and the
surveillance costs incurred by the private-sector components of the
health care system are even less readily captured.[Footnote 50]
Similarly, the National Biosurveillance Advisory Subcommittee reported
in 2009 that it was unable to establish reliable estimates of the
annual cost of U.S. biosurveillance programs, in part because there is
no budget activity line for federally funded biosurveillance
activities that would allow for tracking total federal spending. The
subcommittee noted that although current appropriations do not appear
to be sufficient for the tasks at hand, additional cost efficiencies
are possible.[Footnote 51]
In addition, a national strategy could help identify the resources
currently being used to support a biosurveillance capability,
additional resources that may be needed, and opportunities for
leveraging resources. CDC and USDA officials have stated that there is
no accurate inventory of resources currently being used to support a
biosurveillance capability or of the sources and types of resource
investments that would be needed in the future to build a national
biosurveillance capability. CDC is developing a National
Biosurveillance Registry for Human Health. This registry is to
identify existing federal, state, local, and international systems
that could support the National Biosurveillance Strategy for Human
Health, as well as determine the need for additional systems.
According to CDC officials, they have begun to work with FDA in this
regard. The CDC officials responsible for the project stated that they
have made progress, but also said the registry is complex and will
take longer than originally envisioned, in part because the project
competes for resources with other projects and duties--including
activities to respond to emerging situations like the 2009 H1N1
pandemic--which has affected its progress. Moreover, although CDC's
registry is an encouraging step, this registry project does not yet
involve all the federal agencies and programs that play a role in
biosurveillance and, thus, will not approach a complete picture of the
entire biosurveillance enterprise for some time. USDA has also
undertaken a separate registry project, known as the U.S. Animal
Health and Productivity Surveillance Inventory, for animal health
surveillance activities as a mechanism to leverage resources. The USDA
project identifies opportunities for efficiencies across programs,
such as allowing animal samples to be simultaneously tested for
multiple diseases thus eliminating the need for different surveillance
programs to undertake multiple sampling campaigns. According to USDA,
the Web-based registry contains approximately 300 animal surveillance
programs, most at the federal level. A national strategy that
identifies the resources associated with the entire biosurveillance
enterprise could help further identify efficiencies and opportunities
for leveraging resources.
Finally, a national strategy could prioritize where those additional
resources and investments should be targeted and guide agencies to
allocate resources accordingly. A national strategy could begin to
address the difficult but critical issues of who pays and how funding
for biosurveillance will be sustained in the future. Federal officials
from agencies with key biosurveillance roles that we interviewed noted
that there are few guarantees that funding for potentially valuable
activities that are not solely devoted to one specific disease
surveillance activity will be sustained. For example, CDC developed a
program designed to integrate human-health disease information from
across the entire agency into daily reports of disease activity to
enhance situational awareness for HHS decision makers, as well as
federal and nonfederal partners. According to CDC officials, this
program was designed as a key supporting activity to achieve the
National Biosurveillance Strategy for Human Health priority of
"Integrated Biosurveillance Information." However, the program was
funded from general funds that compete with other CDC activities for
scarce resources, and the CDC director determined that other
activities were a higher priority. In another example, officials from
USDA's National Surveillance Unit, whose mission is to develop and
enhance national animal health surveillance, noted that one of their
main challenges involves the limitations of funding mechanisms. For
example, these officials told us that the National Surveillance Unit
produces evaluations of surveillance systems in order to make
recommendations for improvements and cost efficiencies. However, the
current funding mechanisms, such as line items and earmarks, make it
difficult to efficiently move the funding stream from a program where
less surveillance is needed to a new disease area that has need for
more intensive testing.
Further, we found in our December 2009 review of NBIC that agencies
were skeptical and confused about the value of providing data for the
center's integration and analysis efforts. Among the specific reasons
federal officials cited for the skepticism was their uncertainty that
the model of biosurveillance integration was the most effective
investment for strengthening the nation's biosurveillance capacities.
In an environment with competing priorities and limited resources, a
strategy could help address these types of challenges where
investments must be carefully weighed and considered and sound
judgments about targeting investments and using the most cost-
effective approaches require information about the cost, benefits, and
risks associated with the whole biosurveillance enterprise.
Clarifying Roles and Responsibilities for Leading, Partnering, and
Supporting:
A national strategy could help delineate and clarify roles and
responsibilities for developing and supporting a national
biosurveillance capability. As figure 6 shows, numerous federal,
state, local, and private sector entities have roles and
responsibilities for monitoring for pathogens in human, animal, plant,
food, and the environment. Federal departments, such as HHS, USDA,
DOI, and DHS, play leading biosurveillance roles for some domains such
as human and animal health, food, and air, but within these domains
also rely on support from state and local authorities or partner with
other federal agencies. In other cases federal departments or agencies
play supporting roles. In particular, agencies with missions that do
not entail health surveillance activities may play a supporting
biosurveillance role on an ongoing or ad hoc basis. For example, as
demonstrated during the 2009-10 H1N1 pandemic, the Department of
Education provided information on school closings which enhanced
situational awareness. In another example, although the National
Weather Service does not have health surveillance responsibilities,
NBIC may at times coordinate with this agency because understanding
weather patterns helps predict the course of some outbreaks.
Figure 6: Roles and Responsibilities for Detection across the
Intergovernmental, Cross-Domain Biosurveillance Network:
[Refer to PDF for image: illustration]
Coordination occurs between agencies surrounding an event:
Water:
HHS:
State Public Health Department;
Local Public Health Department;
Lab;
FD.
Contamination detection system at public water utility.[A]
Air:
DHS:
School and Local Public Health Department;
Local Public Health Department;
Lab;
FD.
DOD:
Lab;
Sensor detection.
USPS:
Sensor detection.
Food:
HHS:
State Public Health Department;
Local Public Health Department;
Lab;
FD.
USDA:
Inspectors provide situational awareness following foodborne outbreak
detection.
Human:
DOD:
Monitors disease to protect military interests.
HHS[B]:
State Public Health Department;
Local Public Health Department;
Lab;
FD.
Animal:
USDA/DOI:
State Agriculture Department;
Local Agriculture Department;
Lab;
FD.
Plant:
USDA:
State Agriculture Department;
Local Agriculture Department;
Lab;
FD.
DHS:
Point of entry inspections.
FD: Refers to first detector which could be any of the professionals
described in figure 4.
Source: GAO analysis of agency information.
[A] This could include the EPA Water Security Initiative program's
contamination warning system being piloted in a few states.
[B] While the Department of Veterans Affairs does not have a primary
biosurveillance mission, it does participate in interagency
biosurveillance activities (e.g., NBIS) and provides health data to
CDC for biosurveillance (e.g., BioSense).
[End of figure]
Clarifying the numerous governmental and private sector entities'
roles and responsibilities for leading, partnering, or supporting
biosurveillance activities could help ensure timely disease detection
and situational awareness across these multiple domains. Clarifying
roles and responsibilities could also help identify gaps or
duplications in biosurveillance coverage within and across domains and
determine whether they should be addressed. For example, in the water
domain, while federal standards for clean drinking water have been
established, monitoring the quality of drinking water itself is a
local responsibility, a decentralized function that relies on public
water utilities. According to EPA, health care practitioners would
likely be the first to detect waterborne pathogens by diagnosing
people who have become sick from drinking tainted water. A strategy
could help determine whether and to what extent local, state, and
federal authorities should partner, lead, or support each other to
monitor drinking water for elements besides those provided for in
federal water quality standards, such as pathogens that could be used
in a bioterror attack.
By mapping out clear roles and responsibilities for leading,
supporting, and partnering across the biosurveillance enterprise, a
national strategy could also help promote better coordination among
federal agencies and their public and private sector partners. As
noted in legislation, presidential directives, and national and agency
strategies, coordination is important because a national
biosurveillance capability relies on the ability of this complex
interagency and intergovernmental network to work together. We and
others have noted that numerous challenges have impeded efforts to
coordinate and collaborate across organizational boundaries to
integrate biosurveillance activities, including lack of clearly
defined roles and responsibilities. As we reported in December 2009,
NBIC, which under the 9/11 Commission Act has statutory responsibility
and authority for coordinating information sharing across agencies,
faced challenges collaborating with its federal partners. These
challenges were at least partially attributable to a lack of clarity
regarding roles, responsibilities, joint strategies, policies, and
procedures for operating across agency boundaries.[Footnote 52]
Integrating National Strategies and Capabilities:
A national strategy could help integrate and articulate how the
national biosurveillance capability would support and be supported by
related biodefense strategies and preparedness capabilities. The final
element of a strategy that could help support a national
biosurveillance capability is the articulation of how the strategy
relates to other strategies' goals, objectives, and activities and
associated implementation plans. Clarifying relationships among
strategies can help support effective and efficient resource use
across a whole range of interrelated activities by helping responsible
parties understand their roles and responsibilities, fostering
effective implementation, and promoting accountability. Although it is
an inherently interagency enterprise facing complex challenges,
biosurveillance, as described in HSPD-10, is but one pillar in a
biodefense architecture. Similarly, as shown in figure 7, a national
biosurveillance capability is a critical element in both the National
Strategy for Countering Biological Threats and the National Health
Security Strategy. Strategies for countering biological threats and
ensuring human health security are in turn a supporting element of the
National Strategy for Countering Weapons of Mass Destruction, which is
a component of the Homeland Security Strategy. Also, strategies for
human and animal health surveillance could draw from and contribute to
a national biosurveillance strategy to help ensure that goals and
objectives are aligned. In addition to this vertical chain of
supporting relationships among strategies, other strategies and plans
like the National Strategy for Pandemic Influenza and strategic and
operational plans for responding to biological emergencies can inform
and be informed by a national surveillance strategy.
Figure 7: A National Biosurveillance Strategy Would Support Related
Strategies at the National, Agency, and Nonfederal Levels:
[Refer to PDF for image: illustration]
Strategies for homeland defense:
National Strategy for Homeland Security:
* National Strategy to Combat Weapons of Mass Destruction;
* National Infrastructure Protection Plan;
* National Response Framework;
* National Strategy for Countering Biological Threats;
* National Health Security Strategy;
* National Strategy for Pandemic Influenza.
National Biosurveillance Strategy:
Strategies and plans for surveillance:
* Food Protection Plan;
* National Biosurveillance Strategy for Human Health;
* Strategic Plan for the National Animal Health Surveillance System.
Collaboration with nonfederal partners.
Source: GAO.
[End of figure]
Moreover, although the scope of our work is confined to federal
domestic biosurveillance efforts, because of the nature of disease and
bioterrorism, as the National Strategy for Combating Weapons of Mass
Destruction notes, cohesive international efforts are important. The
biosurveillance HSPDs each include international surveillance as part
of their call for integrated surveillance systems, and federal
agencies like HHS and USDA support global monitoring efforts as part
of their mission activities. In addition, the NSC's Strategy for
Countering Biological Threats focuses on leading collaborative
initiatives across the international community. Moreover, the United
States is a signatory of the Biological and Toxin Weapons Convention,
which bans the development, production, stockpiling, acquisition,
transfer, and retention of microbial or other biological agents or
toxins that have no justification for peaceful purposes. The 2010
meeting of experts associated with the convention will focus on
biosurveillance and monitoring issues. Clear articulation of mission,
scope, purpose, roles, responsibilities, and priorities for the U.S.
biosurveillance enterprise could also position the United States to be
a more effective leader and partner in international strategies and
initiatives.
Establishing a Focal Point Could Help Ensure the Development and
Implementation of a National Strategy:
We reported in February 2004 that strategies themselves are not
endpoints, but rather, starting points, and, as with any strategic
planning effort, implementation is the key.[Footnote 53] This work
also reported that the ultimate measure of these strategies' value
will be the extent to which they are useful as guidance for policy and
decision makers in allocating resources and priorities. However, for
an undertaking such as developing a national biosurveillance
capability, those policy and decision makers are spread across the
interagency and intergovernmental network. In our work related to
combating terrorism, we reported that an interagency and
intergovernmental undertaking can benefit from the leadership of a
single entity with sufficient time, responsibility, authority, and
resources needed to provide assurance that the federal programs are
based upon a coherent strategy, are well coordinated, and that gaps
and duplication in capabilities are avoided.[Footnote 54]
According to our analysis of requirements in laws and presidential
directives related to biosurveillance, a focal point has not been
established with responsibility and authority for ensuring the
development of a robust, integrated, national biosurveillance
capability. The mission responsibilities and resources needed to
develop a biosurveillance capability are dispersed across a number of
federal agencies, and, according to officials at a number of federal
agencies--CDC, USDA, and DHS--chief among them, agencies have
capabilities that could be leveraged to support a robust, integrated,
national biosurveillance capability. However, our analysis indicates
that no entity has the responsibility, authority, and accountability
for working across agency boundaries to guide and oversee the
development and implementation of a national effort that encompasses
all stakeholders with biosurveillance responsibilities. For example,
CDC has been given the operational lead for developing the vision of
HSPD-21 for a human health biosurveillance capability. However,
according to CDC officials, responsibility for developing a national
biosurveillance capability that includes human as well as animal,
plant, food, and environmental surveillance has not been assigned to a
single entity such as an intergovernmental council, a federal agency,
or an individual official.
Officials in various agencies have taken the lead to fulfill their
agencies' biosurveillance missions, but they lack authority to direct
other agencies with whom they must partner to take specific action.
For example, CDC has undertaken some efforts to coordinate federal
efforts relating to human and zoonotic disease surveillance, but
according to CDC officials, it has limited authority to ensure the
implementation of specific activities at other agencies. According to
CDC officials, an overarching organizational mechanism and clearly
articulated roles and responsibilities across the separate
surveillance programs that serve a range of purposes could help
address common surveillance issues within CDC and across the
biosurveillance enterprise by coordinating communication and
planning.[Footnote 55] Officials from CDC, DOD, DHS, USDA, and HHS
stated that having a focal point would help coordinate federal efforts
to develop a national biosurveillance capability. Because the mission
responsibilities and resources needed to develop a biosurveillance
capability are dispersed across a number of federal agencies, efforts
to establish a national biosurveillance capability could benefit from
designated leadership--a focal point--that provides leadership for the
interagency community.
Conclusions:
The report of the Commission on the Prevention of Weapons of Mass
Destruction Proliferation and Terrorism stated that an attempted
biological attack somewhere in the world is likely is likely within
the next few years and concluded that the nation was unprepared for
such an event. A key component of preparedness is the ability to
detect a dangerous pathogen early and assess its potential spread and
effect. Various federal statutes and presidential directives call for
biosurveillance actions, culminating with HSPD-2's most recent call
for a robust, integrated national biosurveillance system that draws
upon and synthesizes the capabilities of multiple existing systems
across a number of federal departments and agencies. The challenges in
achieving this vision are many and difficult to successfully address,
such as acquiring and retaining staff with sophisticated skills and
melding disparate information and data systems. Biosurveillance must
operate in a complex environment of many players and an evolving
threat. Because a biological incident, originating from nature or
deliberate acts, could emerge through any number of means--plant,
animal, air, and human transmission--it is essential that federal
agencies collaborate to leverage their capabilities and find effective
and efficient solutions and strategies for detection and analysis.
Although efforts like the National Biosurveillance Strategy for Human
Health, USDA's Strategy for the National Animal Health Surveillance
System, and DHS's National Biosurveillance Integration Center are
potentially useful steps in developing a robust, national
biosurveillance capability, they do not provide a unifying framework
and structure for integrating dispersed capabilities and
responsibilities. Further, none of the current players have the
authority to guide and oversee the development and implementation of a
national effort that encompasses all stakeholders with biosurveillance
responsibilities. Without a unifying framework, structure, and an
entity with the authority, resources, time, and responsibility for
guiding its implementation, it will be very difficult to create an
integrated approach to building and sustaining a national
biosurveillance capability as envisioned in HSPD-21.
Recommendations for Executive Action:
In order to help build and maintain a national biosurveillance
capability--an inherently interagency enterprise--we recommend the
Homeland Security Council direct the National Security Staff to, in
coordination with relevant federal agencies, take the following two
actions:
(1) Establish the appropriate leadership mechanism--such as an
interagency council or national biosurveillance director--to provide a
focal point with authority and accountability for developing a
national biosurveillance capability.
(2) Charge this focal point with the responsibility for developing, in
conjunction with relevant federal agencies, a national biosurveillance
strategy that:
* defines the scope and purpose of a national capability;
* provides goals, objectives and activities, priorities, milestones,
and performance measures;
* assesses the costs and benefits associated with supporting and
building the capability and identifies the resource and investment
needs, including investment priorities;
* clarifies roles and responsibilities of leading, partnering, and
supporting a national capability; and:
* articulates how the strategy is integrated with and supports other
related strategies' goals, objectives, and activities.
Agency Comments and Our Evaluation:
We provided a draft of this report for review to the Departments of
Homeland Security (DHS), Health and Human Services (HHS), Agriculture
(USDA), Commerce (DOC), Defense (DOD), Interior (DOI), Justice (DOJ),
State (State), Transportation (DOT), and Veterans Affairs (VA); the
Environmental Protection Agency (EPA); the United States Postal
Service (USPS); and the National Security Council (NSC). DHS provided
written comments on the draft report, which are summarized below and
presented in their entirety in appendix V of this report. DOC, DOD,
DOI, DOJ, HHS, State, DOT, VA, EPA, USDA, USPS, and the NSC did not
provide written comments. We incorporated technical comments from DOC,
DOD, DOI, DOJ, HHS, State, DOT, VA, EPA, USDA, and the USPS where
appropriate.
In written comments, DHS generally concurred with our findings and
recommendations. In particular, DHS noted that it is important to
develop a strategy that encompasses all biological domains. Further,
DHS stated that the department's National Biosurveillance Integration
Center in conjunction with its NBIS partners, have identified
strategic planning gaps and could also be helpful in providing
leadership for the strategic planning effort. DHS also noted that the
statutory responsibilities and expectations assigned to NBIS federal
participants could serve as guideposts for any White House Homeland
Security Council leadership mechanism.
We are sending copies of this report to the Special Assistant to the
President for National Security Affairs; the Attorney General; the
Secretaries of Homeland Security, Health Human and Services,
Agriculture, Commerce, Defense, Interior, State, Transportation, and
Veterans Affairs; the Administrator of the Environmental Protection
Agency; the Postmaster General; and interested congressional
committees. The report is also available at no charge on GAO's Web
site at [hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report please
contact me at (202) 512-8777 or JenkinsWO@gao.gov. Contact points for
our Offices of Congressional Relations and Public Affairs may be found
on the last page of this report. GAO staff who made major
contributions to this report are listed in appendix VI.
Signed by:
William O. Jenkins, Jr.
Director, Homeland Security and Justice Issues:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
The Implementing Recommendations of the 9/11 Commission Act of 2007
required GAO to describe the state of federal, state, local, and
tribal government biosurveillance efforts, the duplication of
biosurveillance efforts, the integration of biosurveillance systems,
and the effective use of resources and expertise at these levels of
governments.[Footnote 56] We are addressing these questions in a
series of three reports. The first of the series, issued in December
2009, focused on the Department of Homeland Security's (DHS) National
Biosurveillance Integration Center (NBIC).[Footnote 57] This report
describes domestic biosurveillance efforts at the federal level; we
did not review efforts by the federal government to create or improve
on international biosurveillance programs. A third report, which we
expect to issue during the Winter of 2011, will describe
biosurveillance efforts at the state, local, tribal, and territorial
levels of government.
Specifically, this report examines the following: (1) federal agency
efforts to provide resources--personnel, training, equipment, and
systems--that support a national biosurveillance capability; and (2)
the extent to which mechanisms are in place to guide development of a
national biosurveillance capability.
To address these objectives, we reviewed key legislation, presidential
directives, and agency-issued policies related to biosurveillance.
Specifically, we reviewed the Homeland Security Act of 2002,[Footnote
58] the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002,[Footnote 59] the Pandemic and All Hazards
Preparedness Act of 2006,[Footnote 60] the Implementing
Recommendations of the 9/11 Commission Act of 2007,[Footnote 61] and
Homeland Security Presidential Directives (HSPD) 5, 7, 8, 9, 10, and
21. These laws and presidential directives task various federal
agencies with specific biosurveillance responsibilities and related
mission activities, describe biosurveillance activities that agencies
are to perform, and define key terms, among other things. To determine
the elements of a capability, we reviewed DHS's Target Capability
List, which specifies that capabilities are made up of the personnel,
training, equipment and systems, planning, and leadership necessary to
accomplish a mission. We consulted our prior reports including reports
on the public health system, emerging infectious diseases, the use of
information technology tools to support homeland security and national
security goals, protection of animal health and the agriculture
sector, food safety and defense, and combating terrorism. See Related
GAO Works for an expansive list.
We used the information in the laws and presidential directives, as
well as previous GAO work, to identify federal departments and
agencies responsible for biosurveillance. We also considered federal
departments and agencies that NBIC had included among its National
Biosurveillance Integration System (NBIS) partners. In addition to
DHS, NBIC has identified 11 NBIS-partner agencies, which it considers
to be part of the NBIS interagency community. Those departments and
agencies are the Departments of Agriculture (USDA), Commerce, Defense
(DOD), Health and Human Services (HHS), Interior, Justice, State,
Transportation, Veterans Affairs, as well as the Environmental
Protection Agency (EPA) and the United States Postal Service (USPS).
We considered interviews we conducted with officials with
responsibilities for participating in the NBIC community, as well as
interviews with officials responsible for a number of other
biosurveillance-related mission activities to inform the findings and
underlying context of this report. Although we conducted interviews at
multiple components of 12 federal departments, we focused on
information collected at 7 federal departments that have key roles and
responsibilities--based on agency mission, statutory responsibilities,
presidential directives, or programmatic objectives-
-for biosurveillance and related mission activities, including
protection of public health, agriculture, and national security. These
departments are USDA, DOD, DHS, HHS, DOI, EPA, and USPS. Further, as
USDA, HHS, and DHS have the larger and more direct mission
responsibilities for biosurveillance and related mission activities,
we focused most heavily on the contributions of their activities to
support a national biosurveillance capability. For the purposes of
this review, we limited our evaluation to domestic biosurveillance
activities and how these domestic activities may contribute to a
national biosurveillance capability. We did not review federal efforts
to enhance international disease surveillance.
Specifically, we met with and reviewed documents from officials in the
agencies shown in table 1.
Table 2: Departments and Agencies with Which We Met To Discuss
Biosurveillance Roles, Responsibilities, and Programs:
Department: United States Department of Agriculture (USDA);
* Component/agency: Animal and Plant Health Inspection Service;
Unit/program:Veterinary Services.
* Component/agency: Animal and Plant Health Inspection Service;
Unit/program: Department: Plant Protection and Quarantine.
* Component/agency: Animal and Plant Health Inspection Service;
Unit/program: Department: Wildlife Services.
* Component/agency: National Institute of Food and Agriculture.
* Component/agency: Forest Service.
* Component/agency: Food Safety and Inspection Service.
Department: Department of Commerce;
* Component/agency: National Oceanic and Atmospheric Administration.
Department: Department of Defense;
* Component/agency: Armed Forces Health Surveillance Center.
* Component/agency: Pentagon Force Protection Agency;
Unit/program: Pentagon Shield/Urban Shield.
* Component/agency: National Center for Medical Intelligence.
Department: Environmental Protection Agency;
* Component/agency: Office of Ground Water and Drinking Water;
Unit/program: Office of Homeland Security and Division of Water
Security.
Department: Department of Health And Human Services;
* Component/agency: Centers for Disease Control and Prevention;
Unit/program: Coordinating Center for Health Information and Service:
National Center for Public Health Informatics.
* Component/agency: Centers for Disease Control and Prevention;
Unit/program: Coordinating Center for Infectious Diseases:.
* Component/agency: Centers for Disease Control and Prevention;
Unit/program: Coordinating Center for Infectious Diseases: National
Center for Preparedness, Detection, and Control of Infectious Diseases.
* Component/agency: Centers for Disease Control and Prevention;
Unit/program: Coordinating Office for Terrorism, Preparedness, and
Emergency Response.
Component/agency: Food and Drug Administration;
Unit/program: Office of Food Protection.
* Component/agency: Food and Drug Administration;
Unit/program: Office of Regulatory Affairs.
* Component/agency: Food and Drug Administration;
Unit/program: Center for Food Safety and Applied Nutrition.
* Component/agency: Indian Health Service.
* Component/agency: National Institutes of Health.
Department: Department of Homeland Security (DHS);
* Component/agency: Customs and Border Protection.
* Component/agency: Federal Emergency Management Agency.
* Component/agency: Office of Health Affairs.
* Component/agency: Science and Technology Directorate.
Department: Department of the Interior;
* Component/agency: U.S. Geological Survey;
Unit/program: National Water Quality Assessment Program.
Component/agency: U.S. Fish and Wildlife Services.
Department: Department of Justice;
* Component/agency: Federal Bureau of Investigation;
Unit/program: WMD Directorate.
Department: Department of State;
* Component/agency: United States Agency for International Development.
Department: United States Postal Service;
* Component/agency: Biohazard Detection System.
Department: Department of Transportation;
* Component/agency: Federal Transit Administration.
Department: Department of Veterans Affairs;
* Component/agency: Assistant Secretary for Operations, Security and
Preparedness.
* Component/agency: Infectious Disease Program Office.
* Component/agency: Office of Public Health and Environmental Hazards.
Source: GAO.
[End of table]
We reviewed publicly available documents, including organizational
charts, mission statements, memoranda of understanding, and program
descriptions from these agencies to identify programs which may
contribute to disease surveillance, early detection of biological
events, or improved situation-specific information during a biological
event. We also reviewed previously assembled lists of biosurveillance
or disease surveillance programs compiled in our prior reports and by
other federal agencies. These include a portfolio of biosurveillance
programs completed by CDC in October 2008 and the U.S. Animal Health
and Productivity Surveillance Inventory assembled by USDA. NBIC has a
biosurveillance mission specified in the Implementing Recommendations
of the 9/11 Commission Act of 2007,[Footnote 62] which requires
interagency coordination across the federal government to detect and
provide warning of biological events of national concern. As such, we
reviewed NBIC operational documents that describe the federal agencies
that participate in NBIC's biosurveillance activities.
To determine the extent to which mechanisms are in place to support a
national biosurveillance capability, we reviewed strategic plans
issued for supporting the nation's biodefense goals--which includes
biosurveillance--for the extent to which these plans incorporated
biosurveillance objectives. These plans included the National Health
Security Strategy, the National Security Council's National Strategy
for Countering Biological Threats, and the National Response
Framework. We also reviewed documents from individual agencies'
efforts to pursue their biosurveillance mission, in order to determine
the extent to which individual agencies efforts may contribute to a
national biosurveillance capability. These documents include: The
National Biosurveillance Strategy for Human Health, NBIC's Concept of
Operations for the National Biosurveillance Integration System, USDA's
National Animal Health Surveillance System strategic plan, and FDA's
Food Protection Plan. We also reviewed reports issued by the National
Academies of Science's Institute of Medicine which analyzed the
existing capacity of the United States to detect and respond to
emerging microbial threats, the limitations of disease surveillance,
and costs and benefits of existing biosurveillance programs. We
reviewed the approach used and the information provided in the
Institute of Medicine studies and found them to be credible for our
purposes.
We met with federal officials who had responsibility for specific
disease surveillance programs or were directly involved in other
federal biosurveillance activities, such as representing the
department as part of NBIC activities or having responsibility for
implementing the department's responsibilities in relevant HSPDs. We
interviewed these officials on the function of the specific disease
surveillance program, including the process of detection, information-
sharing mechanisms, and time frames in which information is generated
and shared. In addition, we interviewed these officials on the degree
to which the federal government has built a national biosurveillance
capability, how specific programs could contribute to a national
capability for early detection or situational awareness of biological
events, the degree to which federal programs are integrated with each
other, and the limitations of these programs in supporting a national
biosurveillance capability. We analyzed this information to determine
how individual agencies' programs could contribute to building the
personnel, training, and equipment and systems needed for a national
biosurveillance capability. We also interviewed agency officials from
programs that have responsibilities for carrying out the relevant
HSPDs to determine the extent to which individual agencies have
created mechanisms for integrating data, information sharing, and
implementing new biosurveillance techniques. We also interviewed these
officials on the limitations individual agencies have in building this
capability and compared it to our previous work on identifying a focal
point. These officials included senior officials with CDC's
Biosurveillance Coordination Unit, HHS's Office of the Assistant
Secretary for Preparedness and Response, DHS's NBIC, USDA's Centers
for Epidemiology and Animal Health, and DOD's National Center for
Medical Intelligence.
In addition, because public health activities are primarily
administered at the state and local levels of government, we met with
representatives from nonprofit and public health professional
organizations that have biodefense or disease surveillance-related
missions, as well as state and local organizations, in order to
further identify federal programs or initiatives that may contribute
to biosurveillance. These include the Association of State and
Territorial Health Officials, the Council of State and Territorial
Health Epidemiologists, and the National Association of County and
City Health Officials. These organizations represent state and local
epidemiologists, public health organizations, and officials involved
in public health at the state and local levels. In particular, the
Council of State and Territorial Health Epidemiologists coordinates
the development of the National Notifiable Disease List. In addition,
we met with experts from research organizations that study biodefense
issues, including the University of Pittsburgh Center for Biosecurity,
the Congressional Research Service, and the National Academies's
Institute of Medicine. These organizations identified biosurveillance
efforts at the federal level, discussed the status of the federal
government's efforts to build a national biosurveillance capability,
and described limitations on the federal government's biosurveillance
efforts and efforts to build a robust and integrated national
biosurveillance capability.
During our review of documents and interviews with knowledgeable
officials, we compiled a list of more than 100 programs from across
the federal government which may be relevant to biosurveillance. We
also asked federal officials to explain how these programs may
contribute to detecting biological events or providing situation-
specific information to decision makers during an ongoing event, and
to identify other programs to consider for inclusion in our study. For
each program identified, we interviewed officials and requested
descriptive information on their program, such as the coverage and
frequency of populations surveyed; diseases on which data are
collected by these biosurveillance efforts and their characteristics;
how data are used to conduct biosurveillance; how information is
reported to support early detection of a biological event or improved
information during an event; the status of these efforts; and costs to
operate these efforts. These programs were included in our catalog
because they may contribute to biosurveillance in one of the following
five ways:
1. Provide information to establish disease baselines, such as
infection rates and geographical distribution of disease outbreaks.
2. Provide opportunities for astute clinicians to detect outbreak
signals, such as collecting syndromic data that, when analyzed, may
indicate an emergent infectious disease.
3. Provide disease-specific information to enhance response; for
instance, data which may be used to identify and trace sources of
detected outbreaks.
4. Represent a surveillance effort designed to shorten the time to
detect disease outbreaks, such as environmental sensors designed to
detect specific biological agents.
5. Provide tools to integrate data or coordinate information sharing;
for instance, communication platforms on which analysts can discuss
biosurveillance issues of concern.
For each agency in our review, we compiled the information on each
program into a standard profile and validated this information with
program officials. We asked these program officials to verify the
accuracy of the information, to add missing information, or make
technical comments, which we incorporated as appropriate. We also
requested officials to identify additional programs for us to consider
including in this review, which we added as appropriate.
These selected efforts do not represent the total universe of
biosurveillance efforts, nor does the catalog represent a
statistically representative sample of federal biosurveillance
efforts. In addition, we did not include programs or initiatives that
are led by state, local, international, or private entities; do not
specifically support biosurveillance activities; or are classified
systems. Some programs or initiatives may be used to support the
nature and purposes of biosurveillance on a case-by-case basis during
a biological event, but may not regularly be used to support
biosurveillance. For example, some systems we identified track weather
patters or map transportation infrastructures, which may be used to
estimate the severity of an outbreak or predict a disease's
epidemiology. These programs are not included in the selected catalog.
Because these efforts are not included in the selected catalog, it
does not represent the total universe of biosurveillance capabilities
nor does it represent a statistically significant sample of
biosurveillance efforts. Finally, we did not evaluate the efficiency
or effectiveness of the biosurveillance efforts that we identify in
the catalog.
We conducted this work from December 2008 through June 2010 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe
that the evidence obtained provides a reasonable basis for our
findings and conclusions based on our audit objectives.
[End of section]
Appendix II: Full Text for Figure 2 Select Worldwide Disease
Occurrences in Recent Decades:
The following information appears as interactive content in the body
of the report when viewed electronically. The content associated with
each point on the map describes a disease event and includes
information on the transmission and symptoms of the disease. The
content appears in print form below in alphabetical order by disease
name.
Figure 8: Select Worldwide Disease Occurrences in Recent Decades:
[Refer to PDF for image: illustrated map of the world]
Interactive features: Roll your mouse over the named disease or for
more information on the particular event. Information on the
transmission and symptoms of the disease will also appear:
Salmonella, United States 2008 - outbreak in 43 states and DC; 1,500
persons reported ill with the outbreak strain. The initial
investigations identified tomatoes as the likely source. As the
outbreak continued, additional investigations showed much of the
outbreak was due to jalapeno and Serrano peppers grown and packed in
Mexico and distributed in the United States. The tomato industry
sustained an estimated $100 million or more loss.
Transmission and Symptoms: Transmission to humans usually occurs by
eating foods contaminated with animal feces. Contaminated foods are
often of animal origin, such as beef, poultry, milk, or eggs, but any
food, including vegetables, may become contaminated. Symptoms of
Salmonella develop 12-72 hours after infection and can include
diarrhea, fever, and abdominal cramps. Salmonella can also be
transferred from animal to animal through contact with newly acquired
farm animals, the use of contaminated food and water sources, and
stress and overcrowded conditions of can increase the spread of the
bacteria. Source: GAO.
Anthrax, United States 2001 - anthrax was intentionally spread through
the postal system by sending letters with powder containing anthrax to
the U.S. Capitol. Of the 22 infected persons, 5 died. EPA spent
$27million for cleanup of Capitol Hill and the U.S. Postal Service was
appropriated hundreds of millions of dollars to clean up effected
facilities.
Transmission and Symptoms: Symptoms vary depending on the type of
disease. Cutaneous symptoms include a small sore that develops into a
blister, and later becomes a skin ulcer with a black area in the
center. Gastrointestinal symptoms are nausea, loss of appetite, bloody
diarrhea, fever, and bad stomach pain. Inhalation symptoms are like
cold or flu symptoms and can include a sore throat, mild fever and
muscle aches, cough, chest discomfort, shortness of breath, tiredness
and muscle aches. All warm-blooded animals are also susceptible to
anthrax, but cattle, horses, sheep, and goats are most commonly
affected. Anthrax spores that occur naturally in the soil can be
ingested by animals or spread by horse flies which spread the disease
when they fed on infected carcasses. Source: EPA.
West Nile Virus, United States 1999 - first detected in New York, 62
cases were reported in 1999 with 7 fatalities. The virus has since
been reported in the lower 48 states. In 2009, 663 cases were reported
with 30 fatalities.
Transmission and Symptoms: The virus is spread by mosquitoes who bite
birds containing the virus and then pass it to humans through bites.
While most people infected do not experience any symptoms, they can
range from mild (e.g., headache, nausea, or rash) to severe (e.g.,
high fever, muscle weakness or paralysis). Birds serve as a reservoir
for this virus; over 170 species have tested positive for WNV in the
U.S. Mortality rates for avian cases are high. Death usually occurs
within 3 weeks of infection. Clinical signs prior to death include
uncoordinated walking, weakness, lethargy, tremors, and head tilt
caused by encephalitis or meningitis. Horses are also susceptible to
infections. Source: CDC; Jim Gathany.
Foot and Mouth Disease (FMD), United Kingdom 2001 - resulted in mass
slaughtering and burial of animals and a loss of about $4 billion.
Transmission and Symptoms: FMD is a highly contagious viral disease
which infects cloven-hoofed animals, such as cattle, swine, and sheep.
Infected animals develop a fever and painful blisters between their
hooves and on their tongue, lips making it difficult to feed. This is
a debilitating disease that leads to severe losses in the production
of milk and meat. Because of its rapid spread and potential economic
losses, producers greatly fear contraction of FMD among their
livestock. FMD is not a threat to people and no human health risks are
associated with the disease. Source: USDA.
Severe Acute Respiratory Syndrome (SARS), Worldwide (with highest
concentration in Southeast Asia) 2003 - over 8,000 infected and over
750 deaths. Economic losses due to lack of tourism and consumer
spending in Asia were estimated at $20 billion.
Transmission and Symptoms: SARS seems to spread is by close person-to-
person contact through respiratory droplets produced when an infected
person coughs or sneezes. It can also spread when a person touches a
surface or object contaminated with infectious droplets and then
touches his or her mouth, nose, or eye(s). SARS causes flu-like
symptoms which may progress to pneumonia. Symptoms include fever,
malaise, chills, headache, body ache, coughing, difficulty breathing,
and diarrhea. SARS can infect animals, such as bats, civets, and mice,
and it also infects humans. To date, scientists have not been able to
confirm the origin of SARS in humans. Some public health officials
hypothesize that SARS virus was transmitted from an animal to human
thereby sparking the 2003 outbreak. Source: CDC.
H5N1 (commonly known as Avian influenza), Worldwide (spreading from
China to nearly 60 countries) beginning in early 2000s reaching a peak
in 2006. Nearly 500 human cases have been reported, with almost 300
fatalities. H5N1 has also resulted in the death and destruction of
millions of wild and domestic birds throughout Asia, Europe, Africa,
and the Middle East.
Transmission and Symptoms: Influenza A, H5N1 (avian influenza) is a
type of influenza that infects birds and may be transmitted to humans.
Although primarily an avian disease, this virus has also infected
humans—most of whom had close contact with infected poultry. Symptoms
of avian influenza in humans range from typical influenza-like
symptoms to eye infections, pneumonia, acute respiratory distress, and
other severe and life-threatening complications. In bird populations,
avian influenza is highly contagious, transmitted by direct contact
between healthy and infected birds by fecal excretions as well as by
nose, mouth, and eye secretions. Indirect contact can also occur via
contaminated equipment and materials. Clinical signs vary with
pathogenicity of the subtype and disease severity can range from in-
apparent or mild clinical signs (depression, anorexia, fever,
weakness, decreased egg production, neurological signs, edema of the
face and neck, diarrhea, and respiratory signs) to 100 percent
mortality. Serious concerns exist that H5N1 could reach North America
at any time via migrating birds or smuggled imports of diseased birds
and bird products. Health experts are concerned that a pandemic could
occur should highly pathogenic H5N1 (or another subtype), to which
humans have no immunity, develop the capacity to spread easily from
person to person. Source: CDC.
H1N1, Worldwide 2009 - identified in Mexico, the virus spread to more
than 213 countries, overseas territories or communities with millions
of confirmed cases, including over 17,700 deaths. The World Health
Organization declared a pandemic in June 2009.
Transmission and Symptoms: H1N1 spreads like other influenza viruses
through person-to-person contact through respiratory droplets produced
when an infected person coughs or sneezes. It can also spread when a
person touches a surface or object contaminated with infectious
droplets and then touches his or her mouth, nose, or eye(s). Symptoms
may include: a fever or feeling feverish/chills, cough, sore throat,
runny or stuffy nose, muscle or body aches, headaches, fatigue,
vomiting, or diarrhea. The 2009 H1N1 has two genes from flu viruses
that normally circulate in pigs in Europe and Asia and bird (avian)
genes and human genes, but is very different from the swine influenza
virus that normally circulates in North American pigs. Swine, however,
are susceptible to infection with the Novel H1N1 2009 Virus. Source:
CDC; Cade Martin.
Sources: GAO analysis; Map Resources (map).
[End of section]
Appendix III: Traditional Monitoring Systems Provide Important but
Limited Contributions to a National Biosurveillance Capability:
[Side bar:
National Notifiable Disease List:
The Council of State and Territorial Epidemiologists, in consultation
with CDC, updates the list of notifiable conditions and national
surveillance case definitions every year. The list includes those
diseases that CDC and state public health officials have identified as
posing a serious public health risk for which case reports would help
inform prevention and control efforts. State public health departments
verify cases of notifiable diseases, monitor disease incidence, and
identify possible outbreaks within their states. States voluntarily
report their notifiable disease data to CDC to support the National
Notifiable Diseases Surveillance System. The agency publishes current
data on notifiable diseases in its Morbidity and Mortality Weekly
Report. Source: GAO. End of side bar]
[Side bar:
CDC’s Influenza Portfolio:
The influenza surveillance system is one of the largest and most
timely surveillance systems at CDC. The system consists of seven
complementary surveillance components. These components include
reports from more than 120 laboratories, 2,000 sentinel health care
providers, vital statistics offices in 122 cities, research and health
care personnel at the Emerging Infections Program and New Vaccine
Surveillance Network sites, and influenza surveillance coordinators
and state epidemiologists from all 50 state health departments and the
New York City and District of Columbia health departments. Influenza
surveillance data collection is based on a reporting week that starts
on Sunday and ends on Saturday of each week. Each surveillance
participant is requested to summarize weekly data and submit them to
CDC by Tuesday afternoon of the following week. The data are then
downloaded, compiled, and analyzed at CDC each Wednesday. The compiled
data are interpreted and checked for anomalies which are resolved
before the report is written and submitted for clearance at CDC. On
Friday, the report is approved, distributed, and posted to the
Internet. CDC collects data year-round and reports on influenza (flu)
activity in the United States each week from October through May.
Source: GAO. End of side bar]
Traditional disease surveillance systems designed to collect
information on the health of humans, animals, and plants support
biosurveillance efforts by recording national health and disease
trends and providing specific information about the scope and
projection of outbreaks to inform response. Traditional systems,
however, rely on time-intensive testing and confirmation practices as
well as data not owned by the federal government, which present
challenges that limit their ability to provide timely detection and
situational awareness.
Monitoring for disease at the national level establishes a baseline
understanding of disease characteristics that enables officials to
recognize anomalous disease occurrences within the United States.
Detecting a signal that warns of a potential or imminent biological
threat of national concern requires the ability to discern whether
disease occurrence is abnormal based on its general characteristics,
as well as where, when, and how severely the disease has historically
occurred. This information is also useful for projecting how an
outbreak may progress during response to a potentially catastrophic
biological event.
The U.S. government has a long history of monitoring human, animal,
and plant health--in some cases for more than a century--to help limit
malady, loss of life, and economic impact. Disease surveillance for
human health at the national level was established to assess the
status of the public's health, develop policy to define public health
priorities, and provide assurance of the prevention and control of
disease. The federal government uses a nationally notifiable disease
List as the foundation of its human health surveillance efforts.
Fifty-seven jurisdictions, including state and local health
departments, voluntarily report cases of certain diseases named on the
list of nationally notifiable diseases to the CDC. CDC uses these
reports from the states to monitor national health trends, formulate
and implement prevention strategies, and evaluate state and federal
disease prevention efforts. In addition to the National Notifiable
Disease Surveillance System, CDC maintains programs aimed at detecting
and preventing specific diseases, such as influenza. (For more
information on specific programs, see appendix IV.) In general, these
programs rely on participating health providers to send case reports
to CDC on a periodic basis. According to CDC, the timeliest of these
disease-specific surveillance programs have participants report the
data weekly. Other programs may send information to the CDC on a
monthly or annual basis. CDC compiles the data, checks for accuracy,
clarifies inconsistencies, and reports national level data at regular
intervals. Information that is collected through the National
Notifiable Disease Surveillance System and other public health
surveillance programs can be applied to determine the scope and
forecast the course of an outbreak to enhance situational awareness to
guide decision makers' response efforts.
[Side bar:
National Animal Health Reporting System:
The National Animal Health Reporting System was designed to provide
data from chief state animal health officials on the presence or
absence of confirmed World Organization for Animal Health reportable
diseases in specific commercial livestock, poultry, and aquaculture
species in the United States. Within a state, data about animal
disease occurrence are gathered from as many verifiable sources as
possible and consolidated into a monthly report submitted to the
National Surveillance Unit, where the information is verified,
summarized, and compiled into a national report. The commodities
currently covered are cattle, sheep, goats, equine, swine, commercial
poultry, and commercial food fish. The system is a joint effort of the
U.S. Animal Health Association, American Association of Veterinary
Laboratory Diagnosticians, and USDA's Animal and Plant Health
Inspection Service. Source: GAO. End of side bar]
Similarly, to help protect the nation's agricultural sector, USDA has
routine reporting systems and disease-specific surveillance programs
for domesticated animals and some wildlife that can provide
information to support the early detection goal of biosurveillance.
Information gathered through these efforts can also help characterize
and project the nature and scope of an outbreak--for example, by
providing the number of infected animals and where they are located--
to enhance situational awareness. For instance, state animal health
officials obtain information on the presence of specific, confirmed
clinical diseases in livestock, poultry, and aquaculture in the United
States from multiple sources--including veterinary laboratories,
public health laboratories, and veterinarians--and report this
information to the USDA's National Animal Health Reporting System (for
more information, see appendix IV). USDA has also developed control
and eradication programs of specific diseases that threaten the health
of animals to reduce the incidence of disease and to provide timely
detection of some foreign animal diseases, resulting in smaller
outbreaks. These programs are carried out in targeted high-risk
populations of various animal and aquaculture species to identify
cases of the disease, stem the spread of disease, and take measures to
ensure certain diseases that are no longer common in the United States
do not reemerge.
In addition, USDA coordinates with state departments of agriculture,
state foresters, universities, and industry partners to conduct pest
detection surveys of agricultural plants and forests annually. By
working with states to identify and prioritize pest threats of
national interest and coordinate pest surveys, USDA's Pest Detection
Program provides nationwide information about the presence of select
plant pests.
According to officials at DOI, currently there is no national
reporting system for diseases of wildlife, making it difficult to
track national trends in wildlife disease. DOI's U.S. Geological
Survey's National Wildlife Health Center is changed with addressing
wildlife disease throughout the U.S. This center provides disease
diagnosis, field investigation, disease management and research, and
training. It also maintains a database on disease findings in wild
animals and on wildlife mortality events.
For foodborne illness, CDC, USDA, and FDA can partner to use their
traditional surveillance activities to enhance situational awareness
during outbreaks. First, CDC identifies an outbreak of foodborne
illnesses based on reports from state and local health care providers.
Then, it works with the other federal partners to characterize the
extent of the illness and identify its source, using a system called
OutbreakNet (see appendix IV for more information). While CDC works
with its external partners to collect additional information about
identified cases--such as characteristics of the people affected, the
types of food consumed, and the possible location of the consumption--
FDA and USDA work with state and local food safety agencies to gather
additional information about the source by conducting inspections and
testing food samples.
Although information provided by traditional surveillance activities
is essential for biosurveillance purposes, the nature of those systems
presents inherent challenges that prevent them from being wholly
sufficient as tools for timely detection and enhanced situational
awareness. We and others have reported that traditional disease
reporting has generally been slow and incomplete, and, therefore, not
well suited to provide early detection and warning of a disease
outbreak or pest infestation.[Footnote 63] For example, federal
agencies collecting data from state, local, and private-sector
entities generally rely on voluntary participation, which limits the
federal government's ability to institute controls at the initial
collection and data entry points to help ensure accuracy,
completeness, or timely reporting. As we reported in 2004, most states
maintain a modified version of the national notifiable disease list
that reflects the public health priorities of the particular state,
but do not consistently reflect CDC's list of notifiable diseases.
Therefore, some local health care providers are not obligated to
report diseases on the national notifiable disease list. For instance,
five states, including Alabama, Nevada, New Hampshire, Oregon, and
Washington do not require local health care providers to report cases
of smallpox--which could be used by terrorists as a biological weapon--
even though CDC requests this information.[Footnote 64]
We also previously reported that state officials have experienced
significant underreporting by health care providers in their efforts
to collect disease data and underreporting can adversely affect public
health efforts by leading to erroneous conclusions about trends in
incidence, risk factors for contracting a disease, appropriate
prevention and control measures, and treatment effectiveness.[Footnote
65] According to the Institute of Medicine, many health care providers
do not fully understand their role in infectious disease surveillance,
including their role as a source of data.[Footnote 66] Furthermore,
despite the existence of state notifiable disease lists and related
laws, some providers may be unaware of basic reporting requirements.
Also posing a challenge to timely detection and situational awareness
is the need for laboratory confirmation. Although mechanisms exist for
reporting suspected cases of disease, traditional public health
systems rely on laboratory-confirmed cases. Laboratory confirmation,
while important to establishing accurate information, adds up to 2
weeks to the reporting process, as results are analyzed and
communicated at the state and local levels before they are reported to
federal health officials. Officials from CDC and USDA attribute this
delay to the inability of labs to communicate test results
electronically.
Timely detection and situational awareness are also problems for
livestock biosurveillance. For example, we reported in 2005 that USDA
does not always use rapid diagnostic tools to test animals at the site
of an outbreak. Although, according to experts, on-site use of rapid
diagnostic tools is critical to speeding diagnosis, containing the
disease, and minimizing the number of animals that need to be
slaughtered, USDA employed them only within selected laboratories. DOD
used rapid diagnostic tools to identify disease agents on the
battlefield, but USDA officials considered the technology to be still
under development.[Footnote 67] A 2002 USDA exercise estimated that,
under the current approach, a foreign animal disease such as Foot and
Mouth Disease would spread rapidly, necessitating the slaughter of
millions of animals and cause staggering financial losses--precisely
the type of high-visibility destruction some experts told us
terrorists seek.[Footnote 68] In response to our recommendation, USDA
is in the process of evaluating the costs and benefits of using
penside rapid diagnostic tools. In addition, we reported that animal
numbers and locations are generally not known, and without a national
animal identification program, surveillance, trace back, and disease
containment is a challenge.[Footnote 69]
[End of section]
Appendix IV: Selected Systems Used in Federal Early Detection and
Situational Awareness Activities:
Below we describe selected systems owned or developed by federal
agencies which may be used to detect or provide enhanced information
about outbreaks relating to human, animal, and plant health, as well
as monitoring food and the environment. This list encompasses
information reported by federal agencies on electronic communications
and surveillance systems as well as networks of laboratories and
health officials engaged in disease surveillance.
Integrated Consortium of Laboratory Networks:
DHS; Science and Technology Directorate;
Domain: Human Health, Animal, Plant, Food, Air, Water.
Description:
The Integrated Consortium of Laboratory Networks is to facilitate the
development and maintenance of a system of laboratory networks that is
built upon established laboratory networks such as the Food Emergency
Response Network; the Laboratory Response Network; the National Animal
Health Laboratory Network; the National Plant Diagnostic Network; the
Environmental Response Laboratory Network; and other emerging networks
within the federal government with responsibilities and authorities
for laboratory preparedness and response. These networks are to
provide timely, high-quality, and interpretable results for the early
detection and effective consequence management of acts of terrorism
and other events requiring an integrated laboratory response. The
Integrated Consortium of Laboratory Networks has created a
capabilities assessment of member network laboratories and established
working groups to address deficiencies identified by member lab
networks. Additionally, the Integrated Consortium of Laboratory
Networks provides a forum for laboratory network representatives to
provide assistance in the event of a biological, chemical, or
radiological contamination emergency;
Primary Users:
Departments of Agriculture, Commerce, Defense, Energy, Health and
Human Services, Homeland Security, Interior, Justice, State, and the
Environmental Protection Agency are ICLN members;
Primary Providers of Data:
Members provide information to leverage expertise;
Status:
In development since 2005 and will be transitioned to the Office of
Health Affairs once operational (currently targeted for fiscal year
2011);
FY 2009 Costs (thousands): $1,500;
Diseases of Concern:
Diseases resulting from an act of terrorism involving a biological or
chemical agent or toxin, radiological contamination, or a naturally
occurring outbreak of an infectious disease that may result in a
national epidemic;
Disease Information:
Laboratory networks have modeled threats posed by chemical,
biological, and radiological agents and are developing the capability
to support characterization, containment, and recovery from such
attacks.
BioWatch:
DHS; Office of Health Affairs (OHA);
Domain: Air;
Description:
The Department of Homeland Security's BioWatch Program is an early
warning system comprised of collectors capable of detecting aerosol
releases of select biological agents, natural and man-made. The
Program develops and disseminates guidance and other documents geared
toward the public health community, which provide information
necessary to prepare for and respond to the detection of an agent of
interest. The program also evaluates state and local implementation of
guidance documents through an active exercise program which serves to
assure that BioWatch coverage areas have the capability to respond to
a detection. According to DHS, the combination of early warning and
rapid public health response can substantially minimize the
potentially catastrophic impact on the population;
Primary Users:
Local public health officials and Department of Homeland Security
officials;
Primary Providers of Data: State and local laboratories conduct
testing on air samples;
Status:
System is operational. BioWatch sensors were first deployed to major
urban areas across the United States in 2003;
FY 2009 Costs (thousands): $116,000;
Diseases of Concern:
Aerosolized biological agents;
Disease Information: DHS has identified scenarios involving the
release of biological materials in urban areas that could result in
significant casualties and economic disruption.
National Biosurveillance Integration Center:
DHS; Office of Health Affairs;
Domain: Human Health, Animal, Plant, Food, Air, Water;
Description:
The Implementing Recommendations of the 9/11 Commission Act (9/11
Commission Act) established, within the Department of Homeland
Security, the National Biosurveillance Integration Center. The center
is tasked with enhancing the capability of the federal government to
rapidly identify, characterize, localize, and track biological events
of national concern by integrating and analyzing data related to human
health, animal, plant, food, and environmental monitoring systems, and
to disseminate alerts if any such events are detected. A central
responsibility is to develop and oversee the National Biosurveillance
Integration System, a federal interagency consortium and information
management concept that was established to integrate and analyze
biosurveillance-relevant information to achieve earlier detection and
enhanced situational awareness;
Primary Users: Federal agencies;
Primary Providers of Data: NBIC has identified the following federal
agencies as potential partners: The Departments of Agriculture,
Commerce, Defense, Education, Energy, Health and Human Services,
Interior, Justice, Labor, State, Transportation, and Veterans Affairs,
as well as the US Postal Service, and the Environmental Protection
Agency. State, Local, Tribal and Territorial Agencies will also be
provided access to information and analysis as well as be allowed to
contribute data;
Status: NBIC has been operational since 2007;
FY 2009 Costs (thousands): $8,000;
Diseases of Concern: Any bio-event involving the intentional use of
biological agents as well as emergent biohazards, such as accidental
release of biological agents or natural disease outbreaks;
Disease Information: A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
Airbase/Port Detector System (Portal Shield):
DOD; Joint Portal Shield;
Domain: Human Health, Air
Description: The Portal Shield sensor system was developed to provide
early warning of biological threats for high-value, fixed-site assets,
such as air bases and port facilities. Portal Shield can detect and
identify up to 10 biological warfare agents simultaneously, within 25
minutes of release;
Primary Users: Military commanders and health personnel at fixed asset
sites (e.g., air bases and port facilities);
Primary Providers of Data: CBRNE operative personnel managing the
system;
Status: System is operational;
FY 2009 Costs (thousands): $22,000
Diseases of Concern: Potential biological warfare agents;
Disease Information; Biological agents could pose a threat to soldiers
on the battlefield.
Electronic Surveillance System for the Early Notification of Community-
based Epidemics (ESSENCE):
DOD; TRICARE Management Activity;
Domain: Human Health;
Description: ESSENCE is used in the early detection of infectious
disease outbreak and provides epidemiological tools that can be used
to investigate disease oubreaks. It utilizes ambulatory data from
hospitals and clinics. Epidemiologists can track, in near real time,
symptoms being reported in a region through a daily feed of reported
data (such as working diagnoses indicated by codes assigned by local
health care staff). ESSENCE uses the daily data downloads, along with
traditional epidemiological analyses that use historical data, for
baseline comparisons in order to improve detection;
Primary Users: Military and veterans' public health and preventive
medicine officials;
Status: System is operational;
FY 2009 Costs (thousands): $2,676;
Diseases of Concern; Infectious diseases affecting humans;
Disease Information; Health surveillance is critical to medical
readiness and force health protection.
Armed Forces Health Surveillance Center:
DOD; US Army Public Health Command (formerly known as US Army Center
for Health Promotion and Preventative Medicine);
Domain: Human Health.
Description; The mission of the Armed Forces Health Surveillance
center is to analyze, interpret, and disseminate information related
to the status, trends, and determinants of the health of the U.S.
military service members and military-associated populations. The
center identifies obstacles to medical readiness by linking various
databases that communicate information relevant to service member
health and fitness. The Armed Forces Health Surveillance Center
maintains the Defense Medical Surveillance System, a database
containing up-to-date and historical data on disease and medical
events as well as longitudinal data on personnel and deployments. The
Defense Medical Surveillance System provides the data supporting the
Department of Defense Serum Repository which as of Spring 2010
includes over 50 million serum specimens drawn from servicemembers
(since the late 1980s) and used to perform longitudinal analyses of
service member health. The system also supports the Defense Medical
Epidemiology Database, an application that provides remote user access
to selected deidentified data (i.e., data with patient identifying
characteristics removed). The Armed Forces Health Surveillance Center
also operates the Global Emerging Infectious Surveillance and Response
System, a program that conducts laboratory-based surveillance for
emerging infectious diseases within the U.S. military and in foreign
civilian populations through leveraging a network of research and
clinical laboratory partners in the United States and overseas;
Primary Users: DOD officials for health surveillance information on
military and military-associated populations;
Primary Providers of Data: The Armed Forces Health Surveillance Center
gathers data from a variety of existing health surveillance sources
maintained by other military units;
Status: System is operational;
FY 2009 Costs (thousands): Defense Medical Surveillance System/DOD
Serum Repository/Defense Medical Epidemiology Database: $6,000; Global
Emerging Infectious Surveillance and Response System: $52,000;
Diseases of Concern; All health threats to U.S. military personnel,
including trauma, psychological stress, environmental hazards, and
infectious diseases. Laboratory network surveillance is focused on
infectious diseases affecting humans, including some animal diseases
that also affect humans, as well as some pathogens that could
contaminate food;
Disease Information; Health surveillance is critical to medical
readiness and Force Health Protection.
Division of Migratory Bird Management"
DOI; Fish and Wildlife Service;
Domain: Animal;
Description; The Division of Migratory Bird Management is largely
responsible for monitoring the health of migratory bird populations
and issuing guidelines for conservation and sustainable harvest. The
Division of Migratory Bird Management program activities are
restricted to sampling migratory bird populations and testing those
populations for indicators of diseases affecting birds or zoonotic
diseases that could affect human populations, such as avian (H5N1)
influenza. The United States Geological Survey laboratory in Madison,
Wisconsin conducts laboratory analysis of submitted samples. The
Division of Migratory Bird Management also collaborates with USDA's
Animal and Plant Health Inspection Service to test bird samples and to
survey bird populations;
Primary Users: Fish and Wildlife and U.S. Department of Agriculture
officials;
Primary Providers of Data: Fish and Wildlife inspectors and inspection
programs active in foreign countries provide information;
Status: System is operational;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Infectious diseases affecting migratory birds;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
Fish and Wildlife Service Inspections:
DOI; Fish and Wildlife Service (FWS);
Domain: Animal;
Description; Fish and Wildlife Service inspectors work with public
health officials and other federal inspectors at ports of entry to
enforce wildlife regulations and ensure compliance with international
wildlife laws as they pertain to wild animal imports. Some inspections
consist of examinations of import paperwork, while others may consist
of physical inspections of the animals being imported to confirm that
the shipment contents match corresponding documents. The decision to
physically inspect a shipment could depend on the type of commodity,
country of origin, or importer history. Random physical inspections
are also conducted;
Primary Users: Fish and Wildlife officials;
Primary Providers of Data: FWS inspectors stationed at ports of entry;
Status: System is operational;
FY 2009 Costs (thousands): $687;
Diseases of Concern; Diseases affecting animal populations are not the
primary focus of the wildlife inspection program; although, if
wildlife inspectors note the presence or suspected presence of
disease, they will notify the appropriate federal agency;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
National Wild Fish Health Survey:
DOI; Fish and Wildlife Service;
Domain: Animal;
Description; The National Wild Fish Health Survey is an ongoing effort
to sample and test wild fish for both specific diseases identified as
key threats and for emerging infectious diseases. Fish samples are
collected by state and tribal governments for testing at one of Fish
and Wildlife Service's nine regional laboratories. A national database
collects and maintains all laboratory test results. Fish and Wildlife
Service inspectors also examine all federal fish hatcheries at least
annually and some are examined biannually. States may also request
testing in the event of a major fish die-off or apparent disease
outbreak;
Primary Users: Incidences of notifiable diseases are reported to
USDA's Animal and Plant Health Inspection Service;
Primary Providers of Data: Data is primarily provided by state and
local wildlife inspectors;
Status: System is operational;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Infectious diseases affecting fish populations;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
Water Security Initiative:
EPA; Office of Ground Water and Drinking Water;
Domain: Water;
Description; The Water Security Initiative addresses the risk of
intentional contamination of drinking water distribution systems by
promoting the voluntary adoption of online water quality monitoring,
sampling and analysis, enhanced security monitoring, consumer
complaint surveillance, public health surveillance, and a consequence
management plan at local water utilities. EPA is implementing the
Water Security Initiative by developing the conceptual design of a
system for detection of and response to a contamination event;
demonstrating the viability of such a system through pilots in five
cities; and developing guidance and outreach to promote voluntary
adoption of drinking water contamination warning systems. EPA has
implemented a pilot drinking water contamination warning system with
the Cincinnati Water Works in Cincinnati, Ohio, and has funded pilots
in San Francisco, New York City, Philadelphia, and Dallas, all of
which are underway;
Primary Users: Local water utilities that implement Water Security
Initiative in their distribution network;
Primary Providers of Data: EPA provides guidance and best practice
standards to facilitate the implementation of a contamination warning
system in a drinking water utility, and local water utilities operate
the system and respond to threats;
Status: System is a pilot;
FY 2009 Costs (thousands): $13,870;
Diseases of Concern; Chemical, biological, and radiological agents
which could be present in drinking water;
Disease Information; Drinking water utilities have been recognized as
being potentially vulnerable to physical disruption, bioterrorism,
chemical contamination, and cyber attack. Damage or destruction of a
water network could disrupt not only the availability of safe drinking
water but also the delivery of vital services that depend on these
water supplies, like fire suppression.
Environmental Response Laboratory Network;
EPA;
Domain: Water;
Description; The Environmental Response Laboratory Network serves as a
national network of labs that can be accessed as needed to support
large scale environmental responses by providing consistent analytical
capabilities, capacities, and quality data in a systematic,
coordinated response;
Primary Users: Federal, state, and local decision makers;
Primary Providers of Data: Contributors to the Environmental Response
Laboratory Network include CDC, DOD, USDA, FDA; state environmental,
agricultural, and public health organizations; and commercial
laboratories;
Status: System can be accessed as needed to support large-scale
environmental responses;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Chemical, biological, and radiological agents
present in air or water that can cause diseases resulting from a large-
scale environmental disaster;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
122 Cities Mortality Reporting System:
HHS; CDC;
Domain: Human Health;
Description; As part of its national influenza surveillance effort,
CDC receives weekly mortality reports from 122 cities and metropolitan
areas in the United States within 2-3 weeks from the date of death.
These reports summarize the total number of deaths occurring in these
cities/areas each week due to pneumonia and influenza. This system
provides CDC with the preliminary information with which to evaluate
the impact of influenza on mortality in the United States and the
severity of the currently circulating virus strains;
Primary Users: CDC epidemiologists;
Primary Providers of Data: 122 cities and metropolitan areas
contribute data to the system;
Status: System is operational;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Pneumonia and influenza;
Disease Information; Influenza viruses are found in human and many
different animals, including ducks, chickens, pigs, whales, horses and
seals. Seasonal Flu is a contagious respiratory illness caused by flu
viruses. It can cause mild to severe illness, and at times can lead to
death. Pneumonia is an infection of the lungs that is usually caused
by bacteria or viruses. Globally, pneumonia causes more deaths than
any other infectious disease, such as AIDS, malaria, or tuberculosis.
However, it can often be prevented with vaccines and can usually be
treated with antibiotics or antiviral drugs.
Arboviral Surveillance System (ArboNet):
HHS; CDC;
Domain: Human Health;
Description; ArboNet is an internet-based national arboviral
surveillance system developed by state health departments and CDC in
2000. ArboNet collects reports of arboviral diseases and other data
from all states and three local districts (New York City, Washington
D.C, and Puerto Rico). Data are reported by local health departments
weekly for routine analysis and dissemination. These data are
summarized periodically in the Morbidity and Mortality Weekly Report
and yearly in the MMWR Summary of Notifiable Diseases;
Primary Users: Public health officials at CDC. esearchers,
pharmaceutical companies, the media, and the general public may access
limited use data sets;
Primary Providers of Data: State and local health departments;
Status: System is operational since 2000;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Arboviruses, such as West Nile Virus,
encephalitis, and yellow fever viruses;
Disease Information; West Nile virus is a mosquito-borne viral disease
that is transmitted to humans through infected mosquitoes. Many people
infected with the virus do not become ill or show symptoms. Symptoms
that do appear may be limited to headache, sore throat, backache, or
fatigue. There is no vaccine for the West Nile virus, and no specific
treatment besides supportive therapies. The disease occurs in Africa,
Eastern Europe, West Asia, and the Middle East. This disease appeared
for the first time in the United States in 1999. Yellow fever is a
mosquito-borne viral disease that occurs in tropical and subtropical
areas. The yellow fever virus is transmitted to humans through a
specific mosquito. Symptoms include fever, muscle pain, headache, loss
of appetite, and nausea. There is no treatment for yellow fever beyond
supportive therapies. A vaccine for yellow fever is available.
BioSense:
HHS; CDC;
Domain: Human Health;
Description; BioSense is a national program intended to improve
capabilities for rapid disease detection, monitoring, and real-time
situation awareness through access to specific health care data from
participating organizations, including more than 500 acute-care
hospitals, commercial laboratories, as well as Department of Defense
and Veterans Affairs health care facilities. BioSense enables local
and state public health departments to share and access data,
providing a more complete picture of potential and actual health
events both locally and across jurisdictional boundaries. Data
received into the system are available simultaneously to state and
local health departments, participating hospitals, and CDC through a
Web-based application. BioSense securely processes, analyzes, and
visualizes data to help characterize and monitor outbreaks and enable
appropriate and timely public health interventions. Based on user
feedback, BioSense is undergoing revision to deemphasize collection of
detailed clinical data from hospitals at CDC and emphasize greater
dependence on collection of data from existing automated surveillance
systems operated by state and local health departments. The BioSense
program also funds applied and developmental projects including
Regional Surveillance collaboratives, state-based health information
exchanges, Centers of Excellence in Public Health Informatics, and
BioSense evaluations;
Primary Users: Public health staff at state and local health
departments, CDC program staff (e.g., influenza, environmental health,
injury), CDC's Emergency Operations Center, International Society for
Disease Surveillance, VA's Office of Public Health and Environmental
Hazards, VA's Infectious Disease Program Office;
Primary Providers of Data: 580 acute-care hospitals; 1,300 DOD and VA
hospitals and health care facilities; 2 large national commercial
laboratories; national retail pharmacy database representing 27,000
retail pharmacies;
Status: BioSense is operational across the current participating
health care facilities, health systems, and health department
surveillance systems. A contract solicitation is underway to support
BioSense redesign to enhance population coverage and stakeholder
engagement;
FY 2009 Costs (thousands): $27,656;
Diseases of Concern; All-hazards (with a focus on infectious diseases)
affecting human health;
Disease Information; The BioSense program monitors 90 concepts
(syndromes and sub-syndromes) that encompass infections, injuries,
chronic diseases, exposures, miscellaneous conditions, and specified
codes, and free-text search terms corresponding to these concepts. In
addition to these health outcome data, patient demographics (age
group, sex), date of diagnosis, and geographic location information is
reported.
Biosurveillance Coordination:
HHS; CDC;
Domain: Human Health, Animal, Plant, Food, Air, Water as it relates to
human health;
Description; The mission of the Biosurveillance Coordination is to
coordinate the development and support the implementation of an
integrated, national biosurveillance plan for human health. The plan,
a requirement outlined in Homeland Security Presidential Directive 21,
includes the capacity to generate timely, comprehensive, and
accessible information with proper context for public health decision
making. Biosurveillance Coordination has developed the National
Biosurveillance Strategy for Human Health and a companion document
titled Concept Plan for Implementation of the National Biosurveillance
Strategy for Human Health. Biosurveillance Coordination has begun to
compile an inventory of biosurveillance systems, tools,
collaboratives, programs, and registries within CDC. More information
about these activities and final documents can be found at [hyperlink,
http://www.cdc.gov/osels/ph_surveillance/bc.html];
Primary Users: Decision makers in federal, state, local, tribal, and
territorial public health agencies;
Primary Providers of Data: Not applicable;
Status: CDC established the BCU in early 2008;
FY 2009 Costs (thousands): $2,400;
Diseases of Concern; All hazards;
Disease Information; Not applicable.
Biosurveillance Indications and Warning Analytic Community (BIWAC):
Collaborative effort among BIWAC partners;
Domain: Human Health, Animal, Plant, Food, Air, Water;
Description; The Mission of the Biosurveillance Indications and
Warning Analytic Community (BIWAC) is to provide a secure, interagency
forum for timely collaborative exchange of critical information
regarding Indications and Warning (I&W) of Biological events that may
threaten U.S. National Interests. The BIWAC will conduct the
collaborative exchange of critical Biosurveillance information through
an encrypted information-sharing portal called "Wildfire," and also
through meetings and teleconferences;
Primary Users: BIWAC partners include the intelligence community and
the Departments of Agriculture, Defense, Health and Human Services,
Homeland Security, and State;
Primary Providers of Data: BIWAC partners contribute data to the
system and share information via an online portal;
Status: System is operational;
FY 2009 Costs (thousands): $801 (with additional in-kind support from
partners);
Diseases of Concern; Diseases of concern to BIWAC members, including
foreign animal and plant diseases and pathogens of national
significance (priority 1 and 2), and zoonotic diseases, particularly
those with pandemic potential;
Disease Information; Not applicable.
Border Infectious Disease Surveillance Project:
HHS; CDC;
Domain: Human Health;
Description; The Border Infectious Disease Surveillance Project serves
as a binational early warning and active syndromic illness and disease
monitoring network operating in the United States (U.S.)-Mexico Border
Region and targets approximately 12 million people. The project
conducts surveillance among residents of border states who visit
participating clinics and hospitals. Using Web-based data entry, the
project provides timely data sharing through data system and Epi-X
notifications dependent on state health department and Mexican
national policies;
Primary Users: State and local public health epidemiologists at the
U.S.-Mexico border;
Primary Providers of Data: Data are contributed by local, state, and
federal public health officials from the United States and Mexico;
Status: The Web-based system has been operational since 2006;
FY 2009 Costs (thousands): $728;
Diseases of Concern; Infectious diseases affecting humans of mutual
interest to the United States and Mexico including syndromes
compatible with bioterrorism agents;
Disease Information; The Border Infectious Disease Surveillance
Project conducts surveillance for viral hepatitis (A,B,C,D,E); fever
and rash syndromes (measles, rubella, dengue, flea-borne typhus, tick-
borne ehrlichiosis); fever and neurologic illness/West Nile Virus;
influenza; undifferentiated fever/dengue/rickettsial disease; severe
acute vesicular rash/varicella; community acquired
pneumonica/Coccioidomycosis; animal rabies; brucellosis; and foodborne
infections such as Salmonella and E.coli 0157:H7.
Early Aberration Reporting System:
HHS; CDC;
Domain: Human Health;
Description; The Early Aberration Reporting System provides a free-to-
end-user analysis tool that allows state and local public health
officials as well as disaster and response agencies and organizations
to quickly detect syndromes that might indicate a public health
emergency and to monitor progression and control. The Early Aberration
Reporting System allows users to add anything that can be counted into
the software, and it will detect trends indicating something out of
the ordinary. The tool may be downloaded from CDC's Web site. Unless a
user initiates a submission, there is no link alerting CDC to
investigate a potential public health emergency, and the user is
responsible for initiating investigation and incident response.
According to CDC, a new version of the system is scheduled for release
in Summer 2010 and a version geared for local disaster management and
monitoring organizations, both domestic and foreign, will be developed
and fielded prior to 2011;
Primary Users: State and local public health officials, federal
government public health officials at other agencies, universities,
and nongovernmental agencies and organizations. This system, or
portions of its software, has been used widely across the United
States, as well as by government entities in Japan, China, New Zealand
and elsewhere;
Primary Providers of Data: Users contribute and may analyze only their
own data. CDC does not currently receive data from the system, and the
data from end users vary according to state regulations and the data-
sharing agreements set up with data reporters;
Status: System is operational;
FY 2009 Costs (thousands): $350;
Diseases of Concern; Diseases affecting humans;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause hundreds of thousands of casualties or
more, weaken the economy, damage public morale and confidence, and
threaten national security. Being able to monitor extent and impact is
valuable for response coordinators.
Early Warning Infectious Disease Surveillance:
HHS; CDC;
Domain: Human Health;
Description; The Early Warning Infectious Disease Program is a
collaboration of state, federal and international partners who are
working to provide rapid and effective laboratory confirmation of
urgent infectious disease case reports in the border regions of the
United States, Canada, and Mexico. Activities include assessing
surveillance and laboratory capacity on each side of the international
border, improving electronic sharing of laboratory information,
maintaining a database of all sentinel/clinical labs, and working to
develop and agree on a list of notifiable conditions. The program was
established in 2003 in order to enhance coordination between the
United States, Canada, and Mexico to provide early warning and cross-
border capability in the event of a disease outbreak;
Primary Users: Not applicable;
Primary Providers of Data: Not applicable;
Status: The program was established in 2003;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Diseases affecting humans;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
Electronic Disease Notification System:
HHS; CDC;
Domain: Human Health;
Description; The Electronic Disease Notification System is an
electronic system used to notify state and local public health
jurisdictions about diseases and disease outbreaks occurring among
refugees and immigrants entering the United States. The system has a
module to track tuberculosis and other quarantinable diseases in
refugees and immigrants. CDC uses the system to electronically notify
health departments of arriving refugees and immigrants with Class A
and Class B quarantinable conditions, provide an electronic
communication system for health departments to notify each other of
persons with tuberculosis conditions who change jurisdictions, and
provide health departments with an electronic system to record and
evaluate the outcome of domestic follow-up examinations;
Primary Users: CDC officials as well as state and local public health
officials;
Primary Providers of Data: Panel Physicians using required Department
of State medical examination forms;
Status: System is operational;
FY 2009 Costs (thousands): $1,183;
Diseases of Concern; Quarantinable Diseases, as defined by executive
order 13295, include cholera, diphtheria, infectious tuberculosis,
plague, smallpox, yellow fever, viral hemorrhagic fevers (such as
Marburg, Ebola and Congo-Crimean disease), SARS (severe acute
respiratory syndrome), and influenza caused by novel or re-emergent
influenza viruses that are causing or have the potential to cause a
pandemic;
Disease Information; Tuberculosis is a bacterial disease that is
usually transmitted by contact with an infected person. People with
healthy immune systems can become infected but not ill. Symptoms
include a bad cough, coughing up blood, pain in the chest, fatigue,
weight loss, fever, and chills. Several drugs can be used to treat
tuberculosis, but the disease is becoming increasingly drug resistant.
Emerging Infections Program (EIP):
HHS; CDC;
Domain: Human Health;
Description; The Emerging Infections Program is a network of CDC and
10 state health departments working with collaborators, including
academic institutions and other federal agencies. The network conducts
active population-based surveillance and research for emerging
infectious diseases of public health importance. Examples of programs
included in the Emerging Infections Program network include Active
Bacteria Core Surveillance (a program conducting laboratory-based
surveillance for bacterial pathogens), FoodNet (a program to monitor
the incidence of foodborne and waterborne diseases), and Influenza
Projects (a program that tracks trends and characterizes outbreaks of
severe influenza);
Primary Users: EIP data collection and surveillance activities are
conducted by participating state health departments;
Primary Providers of Data: Reports generated from EIP data are shared
with public health officials, scientists and policy makers at CDC and
federal agencies, and the public;
Status: System was established in 1995 and is operational;
FY 2009 Costs (thousands): $30,000;
Diseases of Concern; A variety of diseases affecting humans;
Disease Information; Not applicable.
Epidemic Information Exchange, Epi-X:
HHS; CDC;
Domain: Human Health;
Description; Epi-X connects state and local public health officials so
that they can share information about outbreaks and other acute health
events, including those possibly related to bioterrorism. It is
intended to provide epidemiologists and others with a secure, Web-
based platform that can be used to instant emergency notification of
outbreaks and requests for CDC assistance. Epi-X provides tools for
searching, tracking, and reporting on diseases;
Primary Users: CDC epidemiologists, veterinarians, and other relevant
public health professionals;
Primary Providers of Data: Epi-X has over 5,000 users who have the
capability to provide data, including all state epidemiologists and
local health officers from more than 150 major metropolitan cities or
counties that can post data to the system. Epi-X scientific staff are
available 24 hours a day, 7 days a week to post reports and notify
users of urgent health events;
Status: System is operational;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Diseases affecting humans;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
Foodborne Disease Active Surveillance Network (FoodNet):
HHS; CDC;
Domain: Human Health;
Description; As part of CDC's Emerging Infections Program, FoodNet
provides a network for responding to new and emerging foodborne
diseases of national importance, monitoring the burden of foodborne
disease, and identifying the sources of specific foodborne diseases.
It consists of active surveillance and related epidemiological
studies, which help public health officials better understand the
epidemiology of foodborne diseases in the United States. Participating
FoodNet sites may also be employed to coordinate enhanced surveillance
and epidemiologic investigation if a novel foodborne disease threat is
suspected in order to more rapidly identify the source and extent of
the threat;
Primary Users: CDC epidemiologists and public health officials;
Primary Providers of Data: Public health and food safety officials in
the 10 FoodNet sites;
Status: System is operational;
FY 2009 Costs (thousands): $5,900;
Diseases of Concern; Foodborne illnesses;
Disease Information; Foodborne illness harms human health, and
outbreaks undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance, the
2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Global Disease Detection:
HHS; CDC; Domain: Human Health;
Description; The Global Disease Detection program focuses on
gathering, analyzing, and sharing global information to identify and
respond to emerging health threats. The program has three mechanisms
to accomplish this focus: regional centers that are placed around the
world and are concerned with the detection and control of emerging
infectious disease; CDC staff placed overseas to support CDC's
mission; and the Global Disease Detection program operations center,
which serves as the central clearinghouse focused on early detection
of international events to which CDC may be asked to respond;
Primary Users: CDC and other federal government decision makers and
public health subject matter experts;
Primary Providers of Data: Staff in the Global Disease Detection unit;
Status: The program began operating in 2004;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Infectious diseases affecting humans;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
Global Emerging Infections Sentinel Network (GeoSentinel):
HHS; CDC;
Domain: Human Health;
Description; GeoSentinel is a Web-and provider-based sentinel network.
It consists of travel/tropical medical clinics around the world that
participate in surveillance to monitor geographic and temporal trends
in morbidity among travelers and other globally mobile populations.
Passive surveillance and response capabilities are also extended to a
broader network of GeoSentinel Network members;
Primary Users: Physicians in travel/tropical medicine clinics;
Primary Providers of Data: Travel and tropical medical clinics that
are users of the system;
Status: GeoSentinel was established in 1995 and is operational;
FY 2009 Costs (thousands): $685;
Diseases of Concern; Infectious diseases affecting humans;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
Health Alert Network:
HHS; CDC;
Domain: Human Health;
Description; The Health Alert Network is a nationwide system serving
as a platform for the distribution of health alerts, dissemination of
prevention guidelines and other information, distance learning,
national disease surveillance, and electronic laboratory reporting, as
well as for CDC's bioterrorism and related initiatives to strengthen
preparedness at the local and state levels. Among other things, the
Health Alert Network is to provide early warning alerts and to secure
capability to securely transmit surveillance, laboratory, and other
sensitive data;
Primary Users: State public health officials;
Primary Providers of Data: Not available;
Status: System is operational;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Not applicable;
Disease Information; Not applicable.
Influenza Surveillance Portfolio:
HHS; CDC;
Domain: Human Health;
Description; The objective of influenza surveillance is to monitor the
timing, geographic extent, and severity of influenza activity in the
United States and its impact on the U.S. population over time. The
system consists of nine complementary surveillance components, which
include data on laboratory-based data describing the number and
percentage of positive tests from laboratories across the country; the
percentage of doctor visits for flu-like symptoms; the percentage of
deaths reported to be caused by pneumonia and influenza in 122 U.S.
cities; state and territorial epidemiologist reports of influenza
activity; influenza-associated pediatric mortality; and reported
pediatric influenza hospitalizations;
Primary Users: CDC public health officials and the public;
Primary Providers of Data: Data on influenza are contributed by more
than 120 laboratories, more than 2,400 sentinel health care providers,
vital statistics in 122 cities, research and health care personnel at
the Emerging Infections Program and influenza surveillance
coordinators and state epidemiologists for 50 state health
departments, New York City and the District of Columbia;
Status: System is operational;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Influenza affecting humans;
Disease Information; Influenza viruses are found in human and many
different animals, including ducks, chickens, pigs, whales, horses,
and seals. Seasonal flu is a contagious respiratory illness caused by
flu viruses. It can cause mild to severe illness, and at times can
lead to death.
Laboratory Response Network:
HHS; CDC;
Domain: Human Health, Air;
Description; The Laboratory Response Network is an integrated network
of 165 public health and clinical laboratories that provide laboratory
diagnostics and disseminated testing capability for public health
preparedness and response. It ensures that all member laboratories
collectively maintain current biological detection and diagnostic
capabilities, as well as surge capacity for all biological and
chemical agents likely to be used by terrorists. The network is based
on the use of standard protocols and reagents, integrated data
management, and secure communications;
Primary Users: State and local public health officials;
Primary Providers of Data: Members share data with each other;
Status: System is operational;
FY 2009 Costs (thousands): $7,594;
Diseases of Concern; Infectious diseases affecting humans;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
Morbidity and Mortality Weekly Report:
HHS; CDC;
Domain: Human Health;
Description; The Morbidity and Mortality Weekly Report is the nation's
leading public health bulletin and the flagship publication of CDC.
The Morbidity and Mortality Weekly Report includes reports on disease
epidemics, trends, prevention and control of illness, injuries, and
deaths. This information represents the primary manner that state and
local public health officials, the media, and the public are informed
of public health issues from CDC. The Morbidity and Mortality Weekly
Report publishes data from the National Notifiable Disease
Surveillance System each week and in an annual Summary of Notifiable
Diseases. These data are the official statistics, in tabular and
graphic form, for the reported occurrence of nationally notifiable
infectious diseases in the United States;
Primary Users: Physicians and scientists, public health officials,
public information officers, associations, and the general public;
Primary Providers of Data: International and U.S. public health
officials and scientists submit epidemiological and surveillance data
about outbreaks or other health events. Other federal agencies, such
as USDA, FDA, and EPA produce public health information for
publication. The publication is also integrated with the Epi-X and
National Notifiable Diseases Surveillance System, both of which
contribute data for publication;
Status: The Morbidity and Mortality Weekly Report published its first
issue in 1961. The publication is updated weekly and monthly;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Not applicable;
Disease Information; Not applicable.
National Botulism Surveillance:
HHS; CDC;
Domain: Human Health;
Description; The National Botulism Surveillance System compiles
information on botulism cases that occur in the United States. CDC
provides clinical, epidemiological, and laboratory consultation and
testing services for suspected botulism cases 24 hours a day and is
the only source for antitoxin in the US. CDC alerts other federal
agencies concerning botulism outbreaks associated with commercially
produced and distributed food products. Also, CDC conducts a yearly
survey of state and territorial epidemiologists and of state public
health laboratory directors to identify and compile all botulism cases
that occurred in the previous year;
Primary Users: Clinicians, laboratory professionals, and
epidemiologists involved in diagnosing botulism;
Primary Providers of Data: Federal public health officials; annual
report is compiled from data provided by state health departments;
Status: System is operational;
FY 2009 Costs (thousands): $250;
Diseases of Concern; Botulism;
Disease Information; Botulism is a rare but serious paralytic illness
caused by a nerve toxin that is produced by theneurotoxin producing
Clostridia. There are four types of botulism. Foodborne botulism is
caused by eating foods that contain the botulinum toxin. Wound
botulism is caused by toxin produced from a wound infected with
Clostridium botulinum. Infant botulism is caused by consuming the
spores of the botulinum bacteria, which then grow in the intestines
and release toxin. Finally, Adult Colonization is a rare form of
botulism, similar to Infant Botulism, and results from ingestion of
spores by susceptible persons and subsequent growth and toxin
production in the intestines. All forms of botulism can be fatal and
are considered medical emergencies. Foodborne botulism can be
especially dangerous because many people can be poisoned by eating a
contaminated food.
National Notifiable Diseases Surveillance System:
HHS; CDC;
Domain: Human Health;
Description; CDC has responsibility for the collection and publication
of data concerning nationally notifiable diseases. All 50 states, 5
territories, the District of Columbia, and New York City participate
in the National Notifiable Diseases Surveillance System. The Council
of State and Territorial Epidemiologists, with input from CDC, makes
recommendations annually for additions and deletions to the list of
nationally notifiable diseases. Reporting of nationally notifiable
diseases to CDC by the states is voluntary. Reporting is currently
mandated (i.e., by state legislation or regulation) only at the state
level. The list of diseases that are considered notifiable, therefore,
varies slightly by state. All states generally report the
internationally quarantinable diseases (i.e., cholera, plague, and
yellow fever) in compliance with the World Health Organization's
International Health Regulations;
Primary Users: State and local public health officials and CDC
officials;
Primary Providers of Data: Public health officials in 50 states, 5
territories, the District of Columbia and New York City;
Status: System is operational;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Diseases affecting humans;
Disease Information; Most states have a list of notifiable diseases
that approximates a national list of notifiable diseases maintained by
the Council of State and Territorial Epidemiologists. This national
list is reviewed and revised annually with input from CDC. States may
modify their list of notifiable diseases to reflect the public health
needs of their region.
National Molecular Subtyping Network for Foodborne Disease
Surveillance (PulseNet):
HHS; CDC;
Domain: Human Health;
Description; PulseNet is an early warning system for outbreaks of
foodborne diseases. The network has participants from public health
laboratories in all 50 states, federal regulatory agencies, and some
state agricultural laboratories and is coordinated by CDC. PulseNet
contributes to the identification and investigation of outbreaks of
foodborne and bacterial diseases through comparison of the molecular
"fingerprints" of foodborne pathogens from patients and their food,
water, and animal sources. Once an outbreak is detected, PulseNet
identifies patients who are infected with isolates that have the
outbreak DNA "fingerprint" and thus are likely to be part of the
outbreak. If a foodborne pathogen is isolated from a suspected
vehicle, PulseNet also links it to the outbreak if it displays the
outbreak "fingerprint." Finally, PulseNet provides leadership,
expertise, training, and education in the field of foodborne and
bacterial diseases;
Primary Users: PulseNet participants include the state public health
laboratories in all 50 states as well as other city, county,
agricultural, and other federal food safety laboratories;
Primary Providers of Data: PulseNet participants enter data into the
system using standardized equipment and methods;
Status: System is operational;
FY 2009 Costs (thousands): $4,400;
Diseases of Concern; Foodborne illnesses;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For example, the
2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
National Outbreak Reporting System:
HHS; CDC;
Domain: Human Health, Animals, Food, Water;
Description; The National Outbreak Reporting System is a Web-based
application for states to report foodborne, waterborne, and other
outbreaks electronically. Information collected includes the number
ill, dates and places of outbreak, percent of cases by age group and
gender, symptoms, incubation period and duration of illness,
implicated food or water item, contributing factors leading to food or
water contamination, source of implicated food or water, and food
recall or other public health response. Data are used for annual
summary reports of foodborne illness as well as for the monitoring of
multistate outbreaks. The National Outbreak Reporting System was
developed by CDC as a successor system to the Electronic Foodborne
Outbreak Reporting System;
Primary Users: State public health, CDC, USDA, FDA, and EPA officials;
Primary Providers of Data: 50 state and 15 territorial reporting areas
provide information on the number and characteristics of foodborne,
waterborne and other enteric disease outbreaks in their area;
Status: System is operational;
FY 2009 Costs (thousands): $600;
Diseases of Concern; Foodborne, waterborne and other enteric disease
outbreaks;
Disease Information; Foodborne, waterborne and other enteric disease
outbreaks have myriad causes (e.g., bacteria, viruses, parasites,
toxins and chemicals). These agents cause a range of human illnesses
through toxicity (toxins or chemicals) or by infection (pathogens).
National Respiratory and Enteric Virus Surveillance System:
HHS; CDC;
Domain: Human Health;
Description; The National Respiratory and Enteric Virus Surveillance
System is a laboratory-based system that monitors temporal and
geographic patterns associated with the detection of respiratory
viruses including respiratory synctial virus, human parainfluenza
viruses, respiratory and enteric adenoviruses, and rotaviruses.
Influenza detections are also reported to the system, but are
integrated with CDC influenza surveillance. Users upload data to the
National Respiratory and Enteric Virus Surveillance System through a
Web-based or telephone dial-in system;
Primary Users: State public health officials and professionals;
Primary Providers of Data: Commercial, public health, and clinical
laboratories;
Status: System is operational;
FY 2009 Costs (thousands): $131;
Diseases of Concern; Respiratory and enteric viruses;
Disease Information; Respiratory viruses tracked in the system are
generally transmitted through direct or close contact with
contaminated secretions that are spread through droplets in the air or
by contact with contaminated environmental surfaces. Enteric
infections tracked in the system enter the body through the mouth and
intestinal tract and are usually spread through contaminated food and
water or by contact with vomit or feces.
OutbreakNet:
HHS; CDC;
Domain: Human Health, Food;
Description; OutbreakNet is a national network of epidemiologists and
other public health officials coordinated by CDC who investigate
outbreaks of foodborne, waterborne, and other enteric illnesses in the
United States. OutbreakNet ensures rapid, coordinated detection and
response to multistate outbreaks of foodborne illness and to promote
more comprehensive outbreak surveillance. OutbreakNet seeks to improve
the collaboration and partnership among officials in local, state, and
federal agencies who work with foodborne and diarrheal disease
outbreak surveillance and response. OutbreakNet works in partnership
with U.S. state and local health departments, USDA, FDA, and PulseNet
(a national surveillance network made up of state and local public
health laboratories and federal food regulatory agency laboratories);
Primary Users: Public health and food safety officials at FDA, USDA,
CDC, and state and local health departments;
Primary Providers of Data: Local, state and federal officials with
responsibility for investigating and reporting foodborne, waterborne
and other enteric diseases outbreaks;
Status: System is operational;
FY 2009 Costs (thousands): $1,500;
Diseases of Concern; Foodborne, waterborne and other enteric diseases;
Disease Information; Foodborne, waterborne and other enteric disease
outbreaks have myriad causes (e.g., bacteria, viruses, parasites,
toxins and chemicals). These agents cause a range of human illnesses
through toxicity (toxins or chemicals) or by infection (pathogens).
Public Health Information Network:
HHS; CDC;
Domain: Human Health;
Description; The Public Health Information Network is an effort
initiated by CDC to provide interoperability across public health
functions and organizations, such as state and federal agencies, local
health departments, public health labs, vaccine clinics, clinical
care, and first responders. It is intended to, among other things, (1)
deliver industry standard data to public health, (2) investigate
bioterrorism detection, (3) provide disease tracking analysis and
response, and (4) support local, state, and national data needs. It
builds on existing CDC investments in other surveillance systems. The
Public Health Information Network will not replace any of these
systems but will provide an "umbrella" to support the interoperability
of existing CDC surveillance, communications, and reporting systems;
Primary Users: Other federal agencies, national public health
organizations, and state and local public health agencies;
Primary Providers of Data: Information standards are contributed by
CDC;
Status: Network is operational;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Not applicable;
Disease Information; Not applicable.
Quarantine Activity Reporting System:
HHS; CDC;
Domain: Human Health;
Description; CDC'S United States Quarantine Stations seek to limit the
importation of infectious diseases into the United States by working
with key partners to identify ill persons and potentially infectious
items. Quarantine Stations enter reports into the Quarantine Activity
Reporting System in real time to CDC-Atlanta that summarizes port
activities at 20 ports of entry and land-border crossings where
international travelers arrive. The reports are analyzed and evaluated
daily and relevant information is captured and disseminated as part of
a Disease and Activity Report which is sent to CDC leadership and
relevant external partners. During 2009 Quarantine Station staff
reported 3, 847 illnesses and 125 deaths, conducted 122 airline
contact investigations involving 95 index cases, forwarded 9,778
migrant packets, processed 205 non-human primate shipments, released
125 drug shipments, and participated in 1,510 activities with external
partners;
Primary Users: CDC personnel;
Primary Providers of Data: CDC's Quarantine Stations report data
gathered from airline staff, state and local health departments,
Customs and Border Protection personnel, emergency responders, and
other first responders to infectious disease outbreaks;
Status: System is operational;
FY 2009 Costs (thousands): $568;
Diseases of Concern; Infectious diseases affecting humans;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
Unexplained Deaths and Critical Illnesses Surveillance System:
HHS; CDC;
Domain: Human Health;
Description; As part of CDC's Emerging Infections Program, the
Unexplained Deaths and Critical Illnesses Surveillance System is
expected to contain limited epidemiological and clinical information
on previously healthy persons aged 1 to 49 years who have illnesses
with possible infectious causes. It is also expected to provide active
population-based surveillance through coroners and medical examiners
at limited sites. National and international surveillance will be
passive for clusters of unexplained deaths and illnesses;
Primary Users: Epidemiologists at CDC;
Primary Providers of Data: Not available;
Status: System is in development;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Diseases affecting humans;
Disease Information; A catastrophic biological event, such as a
terrorist attack with a weapon of mass destruction or a naturally
occurring pandemic could cause thousands of casualties or more, weaken
the economy, damage public morale and confidence, and threaten
national security.
Electronic Laboratory Exchange Network, (eLEXNET):
HHS; Food and Drug Administration (FDA);
Domain: Human Health, Food;
Description; eLEXNET provides a Web-based system for real-time sharing
of food safety laboratory data among federal, state, and local
agencies. It allows public health officials at multiple government
agencies engaged in food safety activities to compare and coordinate
laboratory analysis findings in a secure setting. eLEXNET captures
food safety sample and test result data from participating
laboratories and uses them for risk assessment and decision support
purposes, improving the early detection of problem products;
Primary Users: Public health and agricultural food safety officials;
Primary Providers of Data: FDA's Center for Food Safety and Applied
Nutrition manages eLEXNET, which has 1,800 users including 203
participating labs, 150 of which are FERN labs;
Status: System is operational;
FY 2009 Costs (thousands): $1,097;
Diseases of Concern; Foodborne illnesses;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance, the
2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Food Emergency Response Network:
HHS and USDA; FDA and the Food Safety and Inspection Service at USDA;
Domain: Food;
Description; The Food Emergency Response Network is a coordinated
initiative between USDA's Food Safety and Inspection Service and FDA
to develop an integrated laboratory network capable of responding to
national emergencies. Laboratories participating in the network are
responsible for detecting and identifying biological, chemical, and
radiological agents in food. The primary objectives of the Food
Emergency Response Network are to prevent attacks on the food supply
through surveillance; to prepare for emergencies by strengthening lab
capabilities; to respond to threats, attacks, and emergencies in the
food supply; and to assist in recovery. Participating laboratories
conduct investigations of terrorism-related events involving food and
play a major role in method development and validation for detecting
foodborne contamination;
Primary Users: Officials at FDA and USDA's Food Safety and Inspection
Service;
Primary Providers of Data: State food testing laboratories are the
primary providers of data. Some federal, local, and county food
testing laboratories also provide data;
Status: System is operational;
FY 2009 Costs (thousands): USDA: $10,223; HHS: $18,758;
Diseases of Concern; Foodborne illnesses;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance, the
2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Center for Animal Health Information and Analysis:
USDA; Animal and Plant Health Inspection Service;
Domain: Animal;
Description; The Center for Animal Health Information and Analysis
analyzes biosurveillance data on animal diseases by conducting all-
source intelligence and issue assessment of threats, identification of
the hazards posed by animal diseases, analysis of risk and modeling of
the spread of an animal disease, and the issuance of recommendations
to target surveillance resources to animal threats. The center is
organized into three teams: Global Intelligence and Forecasting
focuses on improving animal health through intelligence and analysis;
Risk Analysis identifies methods and approaches for estimating risks
of animal disease outbreaks; and Spatial Epidemiology develops
geospatial methods to collect and analyze data on farm animal
locations and livestock concentration;
Primary Users: Alerts and advisories are issued to selected federal
agencies and international organizations, including USDA, DHS, the
United Nations Food and Agriculture Organization, and the World
Organization for Animal Health;
Primary Providers of Data: Officials from the center analyze data from
a variety of sources and issue alerts;
Status: Operational;
FY 2009 Costs (thousands): $4,586;
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
Emergency Management Response System:
USDA; Animal and Plant Health Inspection Service;
Domain: Animals;
Description; The Emergency Management Response System is used to
manage investigations of outbreaks of animal diseases in the United
States. This Web-based task management system was designed to automate
many of the tasks that are routinely associated with disease outbreaks
and animal emergencies. The Emergency Management Response System is
used for routine reporting of foreign investigations of animal
disease, state-specific disease outbreaks or control programs,
national responses, or natural disasters involving animals. The system
also has a mapping feature, which allows for real-time identification
of outbreaks to enable responders to respond more quickly by providing
high-resolution maps to decision makers, government agencies, and the
public. The system interfaces with state and federal diagnostic
laboratories for reporting test results;
Primary Users: Federal and state animal health agencies;
Primary Providers of Data: State and federal animal health officials;
Status: System is operational;
FY 2009 Costs (thousands): $463;
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
The emerging Veterinary event database:
USDA; Animal and Plant Health Inspection Service;
Domain: Animals;
Description; The emerging Veterinary event database stores syndromic
surveillance information regarding adverse animal health events.
USDA's Center for Animal Health Information and Analysis uses publicly
available information sources to gather information on these events.
The database is used to establish a baseline for animal disease and
catalog reports of adverse animal health events. Analysts use this
information to produce reports on emerging disease. Access to the
database is not restricted to personnel from the Center for Animal
Health Information and Analysis;
Primary Users: USDA Center for Emerging Issues officials and
Veterinary Services staff;
Primary Providers of Data: Open source material is collected from
electronic sources, such as newspapers, Web sites, and listervs;
Status: System has been operational since 1999;
FY 2009 Costs (thousands): Minimal costs associated with employee time
for maintenance;
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
National Agriculture Pest Information System:
USDA; Animal and Plant Health Inspection Service;
Domain: Plants;
Description; The National Agricultural Pest Information System is a
database for collection, summarization, and standardized information
on plant pests such as insects, diseases, weeds, and nematodes. Data
are gathered by each of the states and by USDA's Plant Protection and
Quarantine. Emphasis is given to surveys for exotic pests, pests that
may impact export of U.S. agricultural products, as well as pest and
biological control agents identified by Plant Protection and
Quarantine program officials. The National Agricultural Pest
Information System facilitates data management coordination for the
plant pest survey data gathered on a national, regional, and/or state
scale as part of the Cooperative Agricultural Pest Survey program
sponsored by USDA;
Primary Users: Plant health officials administering the Cooperative
Agricultural Pest Survey program;
Primary Providers of Data: States participating in the Cooperative
Agricultural Pest Survey enter data into the system;
Status: System is operational;
FY 2009 Costs (thousands): $499.91;
Diseases of Concern; Exotic pests affecting plants;
Disease Information; Plant resources in the United States, including
crops, rangelands, and forests, are vulnerable to endemic, introduced,
and emerging pathogens. More than 50,000 plant diseases occur in the
United States, caused by a variety of pathogens. Increasing
globalization and international trade activities create a strong
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years.
National Animal Health Laboratories Network:
USDA; Animal and Plant Health Inspection Service; National Institute
of Food and Agriculture;
Domain: Animal;
Description; The National Animal Health Laboratories Network was
established as part of a strategy to coordinate and network the
diagnostic testing capabilities of federal veterinary diagnostic
laboratories with state and university diagnostic laboratories to
improve early detection of, response to, and recovery from animal
health emergencies, including bioterrorist events, newly emerging
diseases, and foreign animal disease agents. The network is composed
of 58 laboratories in 45 states. Current activities include a training
program for technicians who test for certain high-risk diseases such
as food and mouth disease and conducting surveillance for animal
diseases, such as swine influenza virus and pseudorabies;
Primary Users: Program managers and state and federal animal health
officials;
Primary Providers of Data: State and university veterinary diagnostic
labs; [Empty];
Status: Operational since 2002;
FY 2009 Costs (thousands): $8,125; (excludes funding provided to labs
for testing, sample collection, or training);
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
National Animal Health Monitoring System:
USDA; Animal and Plant Health Inspection Service;
Domain: Animal;
Description; The mission of the National Animal Health Monitoring
System is to deliver information and knowledge about animal health by
conducting studies that generally focus on food animals, dairy,
livestock, and poultry commodities. The studies are designed to gather
information about industry practices, biosecurity, and prevalence of
endemic diseases. The studies are conducted about every 5 years or
more depending on budget/resources and needs of commodity
stakeholders, and the results are published in an annual Animal Health
Report. This information is used for surveillance planning to identify
risk factors, so that surveillance can be targeted to key areas of
concern;
Primary Users: Data are used by animal health officials within USDA
and other federal agencies, state and local partners such as state
veterinarians and animal health agencies, and international partners
such as the World Organization for Animal Health;
Primary Providers of Data: Data is provided by industries that are
selected through the National Agricultural Statistics Service;
Status: System is operational;
FY 2009 Costs (thousands): $4,157;
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
National Animal Health Reporting System:
USDA; Animal and Plant Health Inspection Service;
Domain: Animal;
Description; The National Animal Health Reporting System was designed
to provide data from chief State animal health officials on the
presence or absence of confirmed World Organization for Animal Health
reportable diseases in specific commercial livestock, poultry, and
aquaculture species in the United States. Within a state, data about
animal disease occurrence are gathered from as many verifiable sources
as possible and consolidated into a monthly report submitted to the
National Surveillance Unit, where the information is verified,
summarized, and compiled into a national report. The commodities
currently covered are cattle, sheep, goats, equine, swine, commercial
poultry, and commercial food fish. The National Animal Health
Reporting System is a joint effort of the U.S. Animal Health
Association, American Association of Veterinary Laboratory
Diagnosticians, and USDA's Animal and Plant Health Inspection Service;
Primary Users: Epidemiology and veterinary health officials at USDA;
Primary Providers of Data: State personnel utilize multiple data
sources (i.e., program disease information, Foreign Animal Disease
investigations, veterinarians, veterinary labs, public health labs,
and other agencies) in completion of monthly reports;
Status: System is operational;
FY 2009 Costs (thousands): Federal cost is a portion of the overall
budget of the National Surveillance Unit;
Diseases of Concern; Infectious disease affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
National Surveillance Unit:
USDA; Animal and Plant Health Inspection Service;
Domain: Animal;
Description; The objective of the National Surveillance Unit includes
developing and improving methods for surveillance and analysis of
animal health related data; analyze surveillance data to provide
actionable information; designing and evaluating national animal
health surveillance systems; and communicating surveillance
information to key partners. The National Surveillance Unit is the
coordinating entity for the National Animal Health Surveillance
System. The goal of the unit is to create a comprehensive, integrated
national surveillance system for animal health. The National
Surveillance Unit has created an inventory of biosurveillance systems
focused on animal health which allows users to search for animal
health surveillance systems by species, disease, source of data,
sample type, category of system, and agency administering the system;
Primary Users: The National Surveillance Unit's reports are used by
officials within USDA, state regulators, researchers and the public.
The Surveillance Unit also reports the presence of confirmed disease
outbreaks to the World Organization for Animal Health. Strategic
surveillance planning and analysis are used by federal regulators for
decision making;
Primary Providers of Data: States, National Animal Laboratory Network
Laboratories, and USDA animal disease programs report data to the
National Surveillance Unit;
Status: NSU was founded in 2003 and is operational;
FY 2009 Costs (thousands): $2,418;
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
Offshore Pest Information System:
USDA; Animal and Plant Health Inspection Service;
Domain: Plants;
Description; The Offshore Pest Information System is a Web-based
information-sharing tool that allows users to communicate in an
organized manner about offshore animal and plant health events and
issues. The system is a key instrument used to meet the goals of the
International Safeguarding Information Program. This program is risk-
focused and designed to collect, synthesize/analyze, communicate, and
utilize relevant offshore animal and plant disease or pest
information. The Offshore Pest Information System is secure and
enables multiple users to access, respond to, and act upon information
about international events that affect animal and plant health. Weekly
reports are generated from events in the system's database that are
distributed to the system's users and stakeholders;
Primary Users: Officials at USDA, DHS's Customs and Border Protection,
and state Departments of Agriculture. Other users interested in plant
pests may also subscribe to alerts;
Primary Providers of Data: Officials in select components of USDA's
Animal and Plant Health Inspection Service;
Status: System is operational;
FY 2009 Costs (thousands): $1,750;
Diseases of Concern; Animal and plant emerging diseases and pests;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national
economies. Plant resources in the United States, including crops,
rangelands, and forests, are vulnerable to endemic, introduced, and
emerging pathogens. More than 50,000 plant diseases occur in the
United States, caused by a variety of pathogens. Increasing
globalization and international trade activities create a strong
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years.
Rapid Syndrome Validation Project for Animals (RSVP-A):
USDA; Animal and Plant Health Inspection Service;
Domain: Animal;
Description; Rapid Syndrome Validation Project for Animals is a
syndromic surveillance system to facilitate the early detection,
reporting, and response to an infectious disease outbreak in animals.
Veterinarians collect syndromic data on animals--such as neurologic
dysfunction, birth defects, or unexpected death--on hand-held
computers and send the data to a central database. USDA officials and
other practitioners analyze the data and create alerts of a disease
outbreak or summarize normal disease occurrence;
Primary Users: USDA officials and state and local animal health
practitioners;
Primary Providers of Data: Data is contributed by participating
practicing veterinarians;
Status: Operational in pilot project phase;
FY 2009 Costs (thousands): $334;
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
Integrated Pest Management Pest Information Platform for Extension and
Education:
USDA; National Institute of Food and Agriculture;
Domain: Plants;
Description; The Integrated Pest Management Pest Information Platform
for Extension and Education is a system to analyze threats to plant
health. The system utilizes modeling technology that allows
stakeholders to access data online for the location of plant threats,
as well as their severity, distribution, forecasting, and state-
specific control recommendations. Data included are all hazards, and
include weather patterns, observations of plant disease occurrences,
and the results of sample testing that are contributed by the system's
users. The system is active in 41 states, 5 Canadian provinces, and
Mexico;
Primary Users: ipmPIPE members include international federal, and
local officials involved in agricultural health as well as land grant
university;
Primary Providers of Data: Cooperative Extension System;
Status: System has been operating since 2005;
FY 2009 Costs (thousands): $150;
Diseases of Concern; Plant pests and pathogens;
Disease Information; Plant resources in the United States, including
crops, rangelands, and forests, are vulnerable to endemic, introduced,
and emerging pathogens. More than 50,000 plant diseases occur in the
United States, caused by a variety of pathogens. Increasing
globalization and international trade activities create a strong
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years.
National Plant Diagnostic Network:
USDA; National Institute of Food and Agriculture;
Domain: Plants;
Description; The mission of the National Plant Diagnostic Network is
to safeguard U.S. plant agriculture against introduced pests and
pathogens by enhancing diagnostic and detection capabilities;
improving communication among federal, state, and local agencies
involved in monitoring for plant pests and pathogens; and delivering
educational programs regarding the threats posed by their
introduction. A single database captures data from voluntary
information given to laboratories, such as from grower samples, bugs
brought into laboratories, or from citizen complaints. The network,
for example, funds diagnostic labs in all 50 states and sponsors
training for individuals in the plant industry (from nursery owners to
home gardeners). The National Plant Diagnostic Network also maintains
a national database with plant disease reports, charts, and mapping
tools;
Primary Users: Federal, state, local, and tribal officials involved in
plant health;
Primary Providers of Data: University diagnostic laboratories;
Status: System has been operating since 2002;
FY 2009 Costs (thousands): $4,400;
Diseases of Concern; Plant pests and pathogens;
Disease Information; Plant resources in the United States, including
crops, rangelands, and forests, are vulnerable to endemic, introduced,
and emerging pathogens. More than 50,000 plant diseases occur in the
United States, caused by a variety of pathogens. Increasing
globalization and international trade activities create a strong
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years.
Automated Import Information System:
USDA; Food Safety and Inspection Service;
Domain: Food;
Description; Upon arrival at a U.S. port-of-entry, all meat and
poultry shipments must be reinspected by a Food Safety and Inspection
Service import inspector before they are allowed into this country.
Every lot of product is given a visual inspection for appearance and
condition, and checked for certification and label compliance. In
addition, the Automated Import Information System assigns various
other types of inspection including product examinations and microbial
and chemical laboratory analysis based on statistical and trend
analysis of the product's origin;
Primary Users: Food Safety and Inspection Service officials;
Primary Providers of Data: Importers of meat and poultry products
submit reports to the system;
Status: System is operational;
FY 2009 Costs (thousands): $104;
Diseases of Concern; Biological agents that can contaminate meat and
poultry products;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance the
2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Food Safety and Inspection Service Incident Management System:
USDA; Food Safety and Inspection Service;
Domain: Food;
Description; The Food Safety and Inspection Service's Incident
Management System is a web-based common operating platform that,
according to USDA officials, allows program managers and users to
rapidly identify, respond to, and track the agency's response to
significant incidents such as suspected tampering of products, threats
to facilities, natural disasters, and Class 1 recalls with illness;
Primary Users: Food Safety and Inspection Service officials;
Primary Providers of Data: Food Safety and Inspection Service
Emergency Management Committee members and personnel granted access to
the system;
Status: System is operational;
FY 2009 Costs (thousands): $548;
Diseases of Concern; Foodborne illnesses;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance the
2006 outbreak of E. coli O157:H7 linked to bagged spinach resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Import Alerts Tracking System:
USDA; Food Safety and Inspection Service;
Domain: Animal, Food;
Description; In April 2008, the Food Safety and Inspection Service
implemented the Import Alert Tracking System, an automated data system
that allows field employees to record information related to
ineligible, illegal, or smuggled shipments of imported meat, poultry,
or egg products found in commerce. The system enables better
coordination in enforcement actions through quicker access to
information collected on illegal entries. The system has been designed
to automate the processes of incident notifications between Food
Safety and Inspection Service program areas and creation of an
incident report when appropriate;
Primary Users: Food Safety and Inspection Service officials in the
Office of International Affairs;
Primary Providers of Data: Data are contributed by Import Surveillance
Liaison Officers at U.S. points of entry;
Status: System is operational since 2005;
FY 2009 Costs (thousands): No direct costs - costs are included under
the Food Safety and Inspection Service's Incident Management System;
Diseases of Concern; Foodborne illnesses;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance the
2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Laboratory Electronic Application for Results Notification:
USDA; Food Safety and Inspection Service;
Domain: Food;
Description; The Laboratory Electronic Application for Results
Notification program provides Food Safety and Inspection Service
personnel, establishments, and state officials with reports on the
status of meat, poultry, and egg product test samples. The application
is an automated process that tracks each sample as it is received,
analyzed, and results are reported. The Laboratory Electronic
Application for Results Notification program allows field inspectors
and agency staff to check on the status of individual samples or view
circuit, district, and management summaries of results. Establishment
and state officials will not have access to the intranet site, but
they may receive e-mail reports on the status of individual samples;
Primary Users: Sample collectors at USDA;
Primary Providers of Data: Food Safety and Inspection Service
Laboratories; Status: System is operational;
FY 2009 Costs (thousands): $25;
Diseases of Concern; Foodborne illnesses;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance the
2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Microbiological and Residue Computer Information System:
USDA; Food Safety and Inspection Service;
Domain: Food;
Description; The Microbiological and Residue Computer Information
System contains sample identification information and results for
analyses submitted by inspection personnel to laboratories. These
samples consist of meat, poultry, and egg products; and they are
analyzed to ensure that they are safe, wholesome, unadulterated, and
properly labeled. The samples are tested because they bear or contain
residues of drugs, pesticides, other chemicals, or microbiological
pathogens. Test results are used to alert agency personnel and the
industry of contaminations and threats to consumer health and the need
for protective actions such as product recalls. The Microbiological
and Residue Computer Information System is also used for risk
assessment and decision support purposes, improving early detection of
problem products, enabling active food safety surveillance, and
evaluating potential threats to the food supply;
Primary Users: Food Safety and Inspection Service officials;
Primary Providers of Data: Food Safety and Inspection Service
Laboratories;
Status: System is operational;
FY 2009 Costs (thousands): $32;
Diseases of Concern; Foodborne illnesses;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance the
2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Pathogen Reduction Enforcement Program:
USDA; Food Safety and Inspection Service;
Domain: Food;
Description; The Pathogen Reduction Enforcement Program schedules
tests, tracks food samples, and generates a series of reports
concerning food testing eligibility and the status of food sample
testing results. It collects and stores food manufacturing
establishment addresses and product information, as well as the
establishment's performance in previous food safety tests. It uses
this information to schedule and request the collection of food
samples for testing. These tests results are used to alert agency
personnel and the industry of contaminations, so an appropriate
response can be issued. The Pathogen Reduction Enforcement Program is
also used for risk assessment and decision support purposes, improving
early detection of problem products, enabling active food safety
surveillance, and evaluating potential threats to the U.S. food supply;
Primary Users: USDA's Data Administration Branch, Office of Program
Evaluation, Enforcement and Review;
Primary Providers of Data: Food Safety and Inspection Service
Laboratories;
Status: System is operational;
FY 2009 Costs (thousands): $25;
Diseases of Concern; Foodborne illnesses;
Disease Information; Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance the
2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Agriculture Quarantine Inspection Program:
USDA; Plant Protection and Quarantine;
Domain: Plants;
Description; The Agriculture Quarantine Inspection Program partners
with Customs and Border Protection to conduct hands-on inspection of
agricultural commodities entering the United States to confirm that
imports are free of pests and disease. Specifically, Customs and
Border Protection officers inspect any incoming agricultural
commodities, including plants, animals, food, or other miscellaneous
goods--such as automobile parts where pests might hide and enter the
United States--for the presence of pests. The Agriculture Quarantine
Inspection Program operates Plant Inspection Stations, which process
the pest interceptions made by Customs and Border Protection officers
at ports, and identify pests and diseases on imported goods. This
information is also filtered into USDA's Plant Protection and
Quarantine databases;
Primary Users: USDA and CBP officials;
Primary Providers of Data: USDA and CBP officials enter data into the
system;
Status: The system is planned to be replaced by a more user-friendly
system in the next five years;
FY 2009 Costs (thousands): $1100;
Diseases of Concern; Plant pests; Animal diseases;
Disease Information; Plant resources in the United States, including
crops, rangelands, and forests, are vulnerable to endemic, introduced,
and emerging pathogens. More than 50,000 plant diseases occur in the
United States, caused by a variety of pathogens. Increasing
globalization and international trade activities create a strong
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years. Animal diseases can affect wildlife
as well as livestock, pets, and companion animals. Some of these
diseases may affect humans. Animal disease outbreaks can cause
significant and potentially disruptive losses for animal producers,
put financial strain on response systems, and affect regional and
national economies.Outbreaks of foodborne illness can harm human
health, undermine consumer confidence in the safety of the nation's
food supply, and have serious economic consequences. For instance the
2006 outbreak of E. coli O157:H7 linked to bagged spinach, resulted in
205 confirmed illnesses, 3 deaths, and an estimated $100 million loss
to industry.
Cooperative Agricultural Pest Survey:
USDA; Plant Protection and Quarantine;
Domain: Plants;
Description; The mission of the Cooperative Agricultural Pest Survey
program is to identify exotic plant pests in the United States deemed
to be of regulatory significance to USDA, state departments of
agriculture, tribal governments, and cooperators. It facilitates this
mission by working to confirm the presence or absence of
environmentally and/or economically harmful plant pests. These pests
can impact agriculture or the environment. The Cooperative
Agricultural Pest Survey program also establishes and maintains a
comprehensive network of cooperators and stakeholders to facilitate a
plant protection mission;
Primary Users: CAPS has established partnerships with all 50 states
and some U.S. territories;
Primary Providers of Data: States provide information on plant pests
and deliver samples for testing to USDA's Plant Protection and
Quarantine for further analysis. Results are disseminated back to
participating states after testing has concluded;
Status: System is operational;
FY 2009 Costs (thousands): $9,098 was allocated to support pest
detection activities. Of this, approximately $8,453.50 was given to
the states via cooperative agreements to conduct pest detection
activities;
Diseases of Concern; Plant pests;
Disease Information; Plant resources in the United States, including
crops, rangelands, and forests, are vulnerable to endemic, introduced,
and emerging pathogens. More than 50,000 plant diseases occur in the
United States, caused by a variety of pathogens. Increasing
globalization and international trade activities create a strong
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years.
Exotic Pest Information Collection and Analysis:
USDA; Plant Protection and Quarantine;
Domain: Plants;
Description; The purpose of Exotic Pest Information Collection and
Analysis is to conduct plant pest biosurveillance for USDA's Plant
Protection and Quarantine. The program continuously gathers,
evaluates, and communicates open-source information on quarantine-
significant plant pests worldwide. The program also produces concise
articles about relevant pieces of pest news, placing the news into a
safeguarding context and providing important background information.
The articles are distributed weekly in an e-mail notification and are
archived in a Web-accessible, fully-searchable database (known as the
Global pest and Disease Database);
Primary Users: USDA Plant Protection and Quarantine officials;
Primary Providers of Data: The Exotic Pest Information Collection and
Analysis program team gathers publicly available information from the
World Wide Web, including scientific journals, Web sites, listervs,
and blogs;
Status: System is operational;
FY 2009 Costs (thousands): $231;
Diseases of Concern; Plant pests such as arthropods, nematodes,
pathogens, mollusks, and weeds;
Disease Information; Plant resources in the United States, including
crops, rangelands, and forests, are threatened by exotic plant pests.
Globalization and international trade increase the likelihood of
exotic pest introduction into the United States. According to USDA, up-
to-date pest information is essential for preparedness and early
response.
Global Pest and Disease Database:
USDA; Plant Protection and Quarantine;
Domain: Plants;
Description; The Global Pest and Disease Database is an archive of
exotic pest information specific to Plant Protection Quarantine needs,
for uses including the prioritization of pest threats to the United
States, conducting risk assessments of plant pests, and completing
domestic exotic pest surveys. The Exotic Pest Information Collection
and Analysis program contains information on over 600 plant and animal
plant pests not native to the United States. The Exotic Pest
Information Collection and Analysis program is primarily intended for
use within USDA but DHS officials, other federal agencies, and state
agricultural agencies also have access to the system;
Primary Users: Users include APHIS, state agricultural agencies, and
other federal agencies such as DHS;
Primary Providers of Data: Other USDA biosurveillance systems, such as
the Exotic Pest Information Collection and Analysis system, the
Offshore Pest Information System, and the New Pest Advisory Group;
Status: System is operational;
FY 2009 Costs (thousands): $399;
Diseases of Concern; Plant pests not known to occur in the United
States or in limited distribution in the United States;
Disease Information; Plant resources in the United States, including
crops, rangelands, and forests, are vulnerable to endemic, introduced,
and emerging pathogens. More than 50,000 plant diseases occur in the
United States, caused by a variety of pathogens. Increasing
globalization and international trade activities create a strong
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years.
National Animal Health Surveillance System:
USDA; Animal and Plant Health Inspection Service;
Domain: Animal;
Description; The National Animal Health Surveillance System is a USDA
initiative to integrate existing animal health monitoring programs and
surveillance activities into a national, comprehensive, and
coordinated system and develop new surveillance systems, methodology,
and approaches. The system is an interdisciplinary network of partners
working together to protect animal health and promote free trade
through surveillance, control, and prevention of foreign, emerging,
and endemic diseases;
Primary Users: Federal and state animal health agencies, as well as
industry;
Primary Providers of Data: State and federal officials involved in
surveillance programs, accredited private veterinarians, and livestock
producers;
Status: The system is a multicomponent network. Many components are
functional, others are under development;
FY 2009 Costs (thousands): Federal cost is a portion of the overall
budget of the National Surveillance Unit;
Diseases of Concern; Exotic and endemic infectious diseases affecting
animals and public health;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
National Wildlife Health Center Wildlife Mortality Database (EPIZOO):
DOI; U.S. Geological Survey National Wildlife Health Center;
Domain: Human, Animal;
Description; The USGS National Wildlife Center's EPIZOO database is a
data set that documents information on epidemics in wildlife. EPIZOO
tracks die-offs throughout the United States and territories,
primarily in migratory birds and endangered species. Data include
locations, dates, species involved, history, population numbers, total
sick and dead, and diagnostic information. The data are collected from
a reporting network developed at the National Wildlife Health Center
as well as from collaborators across the North American continent;
Primary Users: Officials at NWHC, as well as natural resource
managers, regulators, the scientific community, and state and local
environmental protection officials;
Primary Providers of Data: NWHC partners;
Status: Regular data are available from 1975 to the present; some data
sets are available from earlier years;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
Wildlife Health Diagnostic Database:
DOI; U.S. Geological Survey National Wildlife Health Center;
Domain: Human, Animal;
Description; The Wildlife Health Diagnostic Database is a computerized
record of specimens sent to the National Wildlife Health Center for
processing and diagnostic testing. Data include history and
recordkeeping information, types of tests run, and some initial
diagnostic and testing results. Data from the system cannot be used as
a representative sample of animal health diseases that exist in the
wild, but it may be used to determine if a disease or animal health
syndrome has occurred in the wild;
Primary Users: Officials at U.S. Geological Survey's National Wildlife
Health Center;
Primary Providers of Data: Data is provided by National Wildlife
Health Center personnel and others involved with gathering samples of
wild animals for diagnostic testing;
Status: Data have been available since 1975;
FY 2009 Costs (thousands): Not available;
Diseases of Concern; Infectious diseases affecting animals;
Disease Information; Animal diseases can affect wildlife as well as
livestock, pets, and companion animals. Some of these diseases may
affect humans. Animal disease outbreaks can cause significant and
potentially disruptive losses for animal producers, put financial
strain on response systems, and affect regional and national economies.
Forest Health Protection Program:
USDA; US Forest Service;
Domain: Plants;
Description; The U.S. Forest Service Forest Health Protection program
is responsible for detection and monitoring of forest health
conditions on all forested lands in the United States. The program
annually conducts aerial surveys of nearly 500 million acres of
forested lands for unusual activities of forest insects and pathogens.
The Forest Health Protection Program has developed a suite of forest
health indicators that are to monitor forest health and facilitate the
detection of the introduction of foreign pests. Pest risk assessments
are used to target detection surveys in areas that are particularly
vulnerable to invasion and establishment of invasive pests. Annual
reports at the state, regional, and national levels assess trends in
forest condition and highlight new or expanding outbreaks of forest
pests;
Primary Users: Federal, state, tribal, and private landowners; as well
as officials from the Departments of Agriculture, Defense, and
Interior;
Primary Providers of Data: Officials from the Forest Health Protection
Program, as well as state agencies such as state Departments of
Natural Resources;
Status: System is operational;
FY 2009 Costs (thousands): $14,000;
Diseases of Concern; Invasive pests;
Disease Information; Plant resources in the United States, including
crops, rangelands, and forests, are vulnerable to endemic, introduced,
and emerging pathogens. More than 50,000 plant diseases occur in the
United States, caused by a variety of pathogens. Increasing
globalization and international trade activities create a strong
likelihood that many other exotic plant pathogens will arrive in the
United States in the coming years.
Biohazard Detection System
USPS; [Empty];
Domain: Air;
Description; The Biohazard Detection System deployed by the USPS is a
decentralized locally networked automated collection and
identification system and is used to detect the biological agent
causing anthrax that could be present in first-class mail. The system
is installed in mail processing facilities nationwide. The system is
integrated with mail processing and letters are automatically fed into
the system where it detects the presence of anthrax. The detecting
process runs continuously and alerts system operators if a presumptive
positive case of anthrax is detected;
Primary Users: USPS mail processing facilities;
Primary Providers of Data: Automated Screening and Detection;
Status: System has been deployed since November 2005;
FY 2009 Costs (thousands): Annual Operation and Maintenance Costs:
$73.5M;
Diseases of Concern; Anthrax;
Disease Information; Anthrax is an acute infectious disease caused by
a bacterium commonly found in the soil. Although anthrax can infect
humans, it occurs most commonly in plant-eating animals. Human anthrax
infections have usually resulted from occupational exposure to
infected animals or from contaminated animal products. Anthrax
infection can take one of three forms: coetaneous, usually through a
cut or abrasion; gastrointestinal, usually by ingesting undercooked
contaminated meat; or inhalation, by breathing airborne anthrax spores
into the lungs. The symptoms are different for each form and usually
occur within 7 days of exposure. Anthrax can be treated with
antibiotics and a vaccine is available. In 2001, U.S. Postal Service
employees and customers contracted anthrax after a domestic
bioterrorism incident that spread anthrax spores through the U.S. mail
and resulted in five deaths.
[End of table]
[End of section]
Appendix V: Comments from the Department of Homeland Security:
U.S. Department of Homeland Security:
Washington, DC 20528:
June 21, 2010:
William 0. Jenkins, Jr.
Director, Homeland Security and Justice Issues:
U.S. Government Accountability Office:
441 G St., N.W.
Washington, D.C. 20548:
Dear Mr. Jenkins:
The Department of Homeland Security (DHS) appreciates the opportunity
to review and provide comments on the Government Accountability
Office's (GAO) draft report titled, Biosurveillance Efforts to Develop
a National Biosurveillance Capability Need a National Strategy and a
Designated Leader (GA0-10-645).
DHS has reviewed the draft report and concurs with its observations
regarding the need for a national strategy for biosurveillance that
encompasses all biological domains as well as generally concurring
with its comments regarding the National Biosurveillance Integration
System (NBIS) and the National Biosurveillance Integration Center
(NBIC).
Under the direction of the DHS Assistant Secretary and Chief Medical
Officer, the NBIC has been leading an NBIS interagency review to
revise and refine the collaborative activities associated with our
shared biosurveillance mission responsibilities. The results of this
review will help to improve the value of NBIS interaction with
federal, state, local, tribal and territorial departments and
agencies. As a part of the ongoing interagency review, the NBIS
participants have now also recognized critical strategic planning
gaps. These gaps such as multi-agency program procurement/management
efforts or interagency analyst training initiatives were also
identified among the recommendations presented by the 9/11 Commission
and the 2010 bipartisan Congressional Commission on the Prevention of
Weapons of Mass Destruction, Proliferation and Terrorism. However,
NBIC and NBIS enabling legislation such as Public Law 110-53 or
associated Executive Directives (such as Homeland Security
Presidential Directives (14SPD) 9, 10, and 21) did not require either
NBIC or NBIS to address such gaps and accordingly, during these
initial years of both NBIC's and NBIS's development, no strategies to
close gaps were developed.
In the report, GAO recommended the "White House Homeland Security
Council" (WHHSC) task the National Security Staff to "establish the
appropriate leadership mechanism to provide a focal point with
authority and accountability for developing a national biosurveillance
capability" and that focal point be charged with "the responsibility
for developing, in conjunction with relevant federal agencies, a
national biosurveillance strategy." Public Law 110-53 assigns specific
responsibilities to the NBIC Director and details seven legislative
and executive branch expectations cited as responsibilities of the
NBIS federal participants. These responsibilities and expectations can
serve as guideposts to any WHHSC established "leadership mechanism."
As the NBIC is acknowledged in documents such as the Department of
Health and Human Services authored National Biosurveillance Strategy
for Human Health for its integrative cross-domain leadership role,
NBIC along with other federal NBIS participants look forward to
serving as active participants in producing a national biosurveillance
strategy.
The DHS Office of Health Affairs, specifically NBIC, agree on the need
to develop a national strategy for biosurveillance. This strategy will
likely serve as a keystone to the long-term success of the shared
federal biosurveillance mission.
We appreciate the opportunity to review and provide comments on this
draft report and we look forward to working with you on future
homeland security issues.
Sincerely,
Signed by:
Jerald E. Levine:
Director:
Departmental GAO/OIG Liaison:
[End of section]
Appendix VI: GAO Contacts and Staff Acknowledgments:
GAO Contact:
William O. Jenkins, Jr., (202) 512-8777 or jenkinswo@gao.gov:
Acknowledgments:
In addition to the contact named above, Anne Laffoon, Assistant
Director; Michelle Cooper; Kathryn Godfrey; Amanda Krause,;Steven
Banovac; and Susanna Kuebler made significant contributions to the
work. Keira Dembowski, Jessica Gerrard-Gough, and Patrick Peterson
also provided support. Tina Cheng assisted with graphic design. Amanda
Miller and Russ Burnett assisted with design, methodology, and
analysis. Tracey King provided legal support. Linda Miller provided
communications expertise.
[End of section]
Related GAO Products:
National Security: Key Challenges and Solutions to Strengthen
Interagency Collaboration. [hyperlink,
http://www.gao.gov/products/GAO-10-822T]. Washington D.C.: June 9,
2010.
Biosurveillance: Developing a Collaboration Strategy Is Essential to
Fostering Interagency Data and Resource Sharing. [hyperlink,
http://www.gao.gov/products/GAO-10-171]. Washington D.C.: December 18,
2009.
Influenza Pandemic: Monitoring and Assessing the Status of the
National Pandemic Implementation Plan Needs Improvement. [hyperlink,
http://www.gao.gov/products/GAO-10-73]. Washington D.C.: November 24,
2009.
Interagency Collaboration: Key Issues for Congressional Oversight of
National Security Strategies, Organizations, Workforce, and
Information Sharing. [hyperlink,
http://www.gao.gov/products/GAO-09-904SP]. Washington D.C.: September
25, 2009.
Food Safety: Agencies Need to Address Gaps in Enforcement and
Collaboration to Enhance Safety of Imported Food. [hyperlink,
http://www.gao.gov/products/GAO-09-873]. Washington D.C.: September
15, 2009.
Influenza Pandemic: Gaps in Pandemic Planning and Preparedness Need to
Be Addressed. [hyperlink, http://www.gao.gov/products/GAO-09-909T].
Washington D.C.: July 29, 2009.
Veterinarian Workforce: The Federal Government Lacks a Comprehensive
Understanding of Its Capacity to Protect Animal and Public Health.
[hyperlink, http://www.gao.gov/products/GAO-09-424T]. Washington D.C.:
February 26, 2009.
Seafood Fraud: FDA Program Changes and Better Collaboration among Key
Federal Agencies Could Improve Detection and Prevention. [hyperlink,
http://www.gao.gov/products/GAO-09-258]. Washington, D.C.: February
19, 2009.
Veterinarian Workforce: Actions Are Needed to Ensure Sufficient
Capacity for Protecting Public and Animal Health. [hyperlink,
http://www.gao.gov/products/GAO-09-178]. Washington D.C.: February 4,
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Health Information Technology: More Detailed Plans Needed For the
Centers for Disease Control and Prevention's Redesigned BioSense
Program. [hyperlink, http://www.gao.gov/products/GAO-09-100].
Washington D.C.: November 20, 2008.
Influenza Pandemic: HHS Needs To Continue Its Actions And Finalize
Guidance for Pharmaceutical Interventions. [hyperlink,
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30, 2008.
Food Safety: Improvements Needed in FDA Oversight of Fresh Produce.
[hyperlink, http://www.gao.gov/products/GAO-08-1047]. Washington D.C.:
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United States Postal Service: Information on the Irradiation of
Federal Mail in the Washington D.C., Area. [hyperlink,
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Biosurveillance: Preliminary Observations on Department of Homeland
Security's Biosurveillance Initiatives. [hyperlink,
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2008.
Homeland Security: First Responders' Ability to Detect and Model
Hazardous Releases in Urban Areas Is Significantly Limited.
[hyperlink, http://www.gao.gov/products/GAO-08-180]. Washington D.C.:
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Emergency Preparedness: States Are Planning for Medical Surge, but
Could Benefit from Shared Guidance for Allocating Scarce Medical
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Washington D.C.: June 13, 2008.
Federal Oversight of Food Safety: FDA Has Provided Few Details on the
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Food Safety: Selected Countries' Systems Can Offer Insights into
Ensuring Import Safety and Responding to Foodborne Illness.
[hyperlink, http://www.gao.gov/products/GAO-08-794]. Washington D.C.:
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Federal Oversight of Food Safety: FDA's Protection Plan Proposes
Positive First Steps, but Capacity to Carry Them Out is Critical.
[hyperlink, http://www.gao.gov/products/GAO-08-435T]. Washington D.C.:
January 29, 2008.
Project Bioshield: Actions Needed to Avoid Repeating Past Problems
with Procuring New Anthrax Vaccine and Managing the Stockpile of
Licensed Vaccine. [hyperlink, http://www.gao.gov/products/GAO-08-88].
Washington D.C.: October 23, 2007.
Global Health: U.S. Agencies Support Programs to Build Overseas
Capacity for Infectious Disease Surveillance. [hyperlink,
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Global Health: U.S. Agencies Support Programs to Build Overseas
Capacity Overseas Capacity for Infectious Disease Surveillance.
[hyperlink, http://www.gao.gov/products/GAO-07-1186]. Washington D.C.:
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Methods and to Develop a Next-Generation Anthrax Vaccine. [hyperlink,
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Agriculture Production: USDA Needs to Build on 2005 Experience to
Minimize the Effects of Asian Soybean Rust in the Future. [hyperlink,
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USPS: Guidance on Suspicious Mail Needs Further Refinement.
[hyperlink, http://www.gao.gov/products/GAO-05-716]. Washington D.C.:
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Information Technology: Federal Agencies Face Challenges in
Implementing Initiatives to Improve Public Health Infrastructure.
[hyperlink, http://www.gao.gov/products/GAO-05-308]. Washington D.C.:
June 10, 2005.
Homeland Security: Much Is Being Done to Protect Agriculture from a
Terrorist Attack, but Important Challenges Remain. [hyperlink,
http://www.gao.gov/products/GAO-05-214]. Washington D.C.: March 8,
2005.
Drinking Water: Experts' Views on How Federal Funding Can Best Be
Spent To Improve Security. [hyperlink,
http://www.gao.gov/products/GAO-04-1098T]. Washington D.C.: September
30, 2004.
Emerging Infectious Diseases: Review of State and Federal Disease
Surveillance Efforts. [hyperlink,
http://www.gao.gov/products/GAO-04-877]. Washington D.C.: September
30, 2004:
Federal Food Safety and Security: Fundamental Restructuring is Needed
to Address Fragmentation and Overlap. [hyperlink,
http://www.gao.gov/products/GAO-04-588T]. Washington D.C.: March 30,
2004.
Combating Terrorism: Evaluation of Selected Characteristics in
National Strategies Related to Terrorism. [hyperlink,
http://www.gao.gov/products/GAO-04-408T]. Washington D.C.: February 3,
2004.
Drinking Water: Experts Views on How Future Funding Can Be Best Spent
To Improve Security. [hyperlink,
http://www.gao.gov/products/GAO-04-29]. Washington D.C.: October 31,
2003.
Infectious Diseases: Gaps Remain in Surveillance Capabilities of State
and Local Agencies. [hyperlink,
http://www.gao.gov/products/GAO-03-1176T]. Washington D.C.: September
24, 2003.
Bioterrorism Information Technology Strategy Could Strengthen Federal
Agencies' Abilities to Respond to Public Health Emergencies.
[hyperlink, http://www.gao.gov/products/GAO-03-139]. Washington D.C.:
May 30, 2003.
Combating Terrorisms Selected Challenges and Recommendations.
[hyperlink, http://www.gao.gov/products/GAO-01-822]. Washington D.C.:
September 20, 2001.
Food Safety: CDC Is Working to Address Limitations in Several of Its
Foodborne Disease Surveillance Systems. [hyperlink,
http://www.gao.gov/products/GAO-01-973]. Washington D.C.: September 7,
2001.
Global Health: Challenges in Improving Infectious Disease Surveillance
Systems. [hyperlink, http://www.gao.gov/products/GAO-01-722].
Washington D.C.: August 31, 2001.
West Nile Virus Outbreak: Lessons for Public Health Preparedness.
[hyperlink, http://www.gao.gov/products/GAO/HEHS-00-180]. Washington
D.C.: September 11, 2000.
Global Health: Framework for Infectious Disease Surveillance.
[hyperlink, http://www.gao.gov/products/NSIAD-00-205R]. Washington
D.C.: July 20, 2000.
[End of section]
Footnotes:
[1] Pub. L. No. 110-53, §§ 1851-59, 121 Stat. 266, 501-04 (2007).
[2] Bob Graham and Jim Talent, Commission on the Prevention of Weapons
of Mass Destruction Proliferation and Terrorism, Prevention of WMD
Proliferation and Terrorism Report Card (Washington, D.C.: Jan. 26,
2010).
[3] Homeland Security Presidential Directive 21: Public Health and
Medical Preparedness (Washington, D.C.: Oct. 18, 2007).
[4] See Exec. Order 13,228 66 Fed. Reg. 51,812(Oct. 8, 2001).
[5] Pub. L. No. 107-296 § 901, 116 Stat. 2135, 2258 (Nov. 25, 2002).
On May 26, 2009, the President announced the full integration of White
House staff supporting national security and homeland security. The
Homeland Security Council will be maintained as the principal venue
for interagency deliberations on issues that affect the security of
the homeland.
[6] Pub. L. No. 110-53 § 1101, 121 Stat. 266, 375-79 (2007) (codified
at 6 U.S.C. § 195b).
[7] § 1102, 121 Stat. at 379.
[8] See GAO, Biosurveillance: Developing a Collaboration Strategy Is
Essential to Fostering Interagency Data and Resource Sharing,
[hyperlink, http://www.gao.gov/products/GAO-10-171] (Washington, D.C.:
Dec. 18, 2009).
[9] Pub. L. No. 107-296, 116 Stat. 2135 (2002).
[10] Pub. L. No. 107-188, 116 Stat. 594 (2002).
[11] Pub. L. No. 109-417, 120 Stat. 2831 (2006).
[12] HSPD-9, Defense of United States Agriculture and Food, was issued
in January 2004 to establish a national policy to defend the
agriculture and food system against terrorist attacks, major
disasters, and other emergencies. HSPD-10, Biodefense for the 21st
Century, issued in April 2004, discusses the threat of bioterrorism;
establishes the four pillars of biodefense--(1) threat awareness, (2)
prevention and protection, (3) surveillance and detection, and (4)
response and recovery--and describes actions underway or to be taken
to strengthen each pillar. HSPD-21, Public Health and Medical
Preparedness, was issued in October 2007 to establish a National
Strategy for Public Health and Medical Preparedness, which builds upon
principles set forth in HSPD-10 with the goal of transforming the
national approach to protecting the health of the American people
against all disasters.
[13] See GAO, Combating Terrorism: Selected Challenges and Related
Recommendations, [hyperlink, http://www.gao.gov/products/GAO-01-822]
(Sept. 20, 2001) and Combating Terrorism: Evaluation of Selected
Characteristics in National Strategies Related to Terrorism,
[hyperlink, http://www.gao.gov/products/GAO-04-408T] (Washington,
D.C.: Feb. 3, 2004) and Interagency Collaboration: Key Issues for
Congressional Oversight of National Security Strategies,
Organizations, Workforce, and Information Sharing, [hyperlink,
http://www.gao.gov/products/GAO-09-904SP] (Washington, D.C.: Sept. 25,
2009).
[14] See GAO, Food Safety: Selected Countries' Systems Can Offer
Insights into Ensuring Import Safety and Responding to Foodborne
Illness, [hyperlink, http://www.gao.gov/products/GAO-08-794]
(Washington, D.C.: June 10, 2008).
[15] See GAO, Homeland Security: Much Is Being Done to Protect
Agriculture from a Terrorist Attack, but Important Challenges Remain,
[hyperlink, http://www.gao.gov/products/GAO-05-214] (Washington, D.C.:
Mar. 8, 2005).
[16] [hyperlink, http://www.gao.gov/products/GAO-05-214].
[17] See GAO, Drinking Water: Experts' Views on How Future Funding Can
Best Be Spent To Improve Security, [hyperlink,
http://www.gao.gov/products/GAO-04-29] (Washington D.C.: Oct. 31,
2003).
[18] [hyperlink, http://www.gao.gov/products/GAO-09-904SP].
[19] See Association of Schools of Public Health, ASPH Policy Brief:
Confronting the Public Health Workforce Crisis (Washington, D.C.:
December 2008). This projection is based on a ratio of 220 public
health workers for every 100,000 U.S. residents, which was the public
health force ratio in 1980.
[20] See Institute of Medicine and National Research Council of the
National Academies, Committee on Effectiveness of National
Biosurveillance Systems: BioWatch and the Public Health System,
BioWatch and Public Health Surveillance: Evaluating Systems for the
Early Detection of Biological Threats: Abbreviated Version: Summary
(Washington, D.C.: 2009).
[21] We previously reported on the need to maintain a veterinarian
workforce with sufficient expertise to help protect public and animal
health. See GAO, Veterinarian Workforce: Actions Are Needed to Ensure
Sufficient Capacity for Protecting Public and Animal Health,
[hyperlink, http://www.gao.gov/products/GAO-09-178] (Washington, D.C.:
Feb. 4, 2009). In 2005, we also reported that USDA faced a challenge
helping states to prepare for animal and plant emergencies because of
an insufficient number of Area and Regional Emergency Coordinators.
See [hyperlink, http://www.gao.gov/products/GAO-05-214].
[22] In response to HSPD-21's charge for HHS to enhance
biosurveillance for human health, CDC has created the National
Biosurveillance Strategy for Human Health with input from federal and
other partners. The strategy identifies six focus areas for enhancing
biosurveillance. The six are: (1) electronic health information
exchange, (2) electronic laboratory information exchange, (3)
unstructured data, (4) integrated biosurveillance information, (5)
global disease detection and collaboration, and (6) biosurveillance
workforce of the future. More information on the National
Biosurveillance Strategy for Human Health appears later in this report.
[23] Informatics is the study and application of information science.
It involves collection, classification, storage, retrieval, and
dissemination of recorded knowledge.
[24] [hyperlink, http://www.gao.gov/products/GAO-09-178].
[25] [hyperlink, http://www.gao.gov/products/GAO-09-178].
[26] See Institute of Medicine and National Research Council of the
National Academies, Committee on Effectiveness of National
Biosurveillance Systems: BioWatch and the Public Health System,
BioWatch and Public Health Surveillance: Evaluating Systems for the
Early Detection of Biological Threats: Abbreviated Version: Summary
(Washington, D.C.: 2009).
[27] We reported in March 2005 that this USDA accreditation process
does not require veterinarians to demonstrate their ability to
recognize or diagnose basic clinical signs of foreign animal diseases.
Furthermore, once granted, accreditation is valid for life and no
continuing education is required. USDA recognized the need to
modernize its accreditation process. See GAO, Homeland Security: Much
Is Being Done to Protect Agriculture from a Terrorist Attack, but
Important Challenges Remain, [hyperlink,
http://www.gao.gov/products/GAO-05-214] (Washington, D.C.: Mar. 8,
2005). In 2009, USDA issued a final rule in the Federal Register
amending the regulations regarding the National Veterinary
Accreditation Program with the intent of increasing the level of
training and skill of accredited veterinarians in the areas of disease
prevention and preparedness. Pursuant to the rule, the accreditation
process includes completing an orientation program for foreign animal
disease. The rule also requires that veterinarians renew their
accreditation every 3 years by completing supplemental training. 74
Fed. Reg. 64, 998 (Dec. 9, 2009).
[28] The biodefense HSPDs, as well as the Pandemic and All-Hazards
Preparedness Act, address systems as an element to help support the
timely detection and situational awareness goals of biosurveillance.
HSPD-9 calls for the Secretaries of the Interior, Agriculture, Health
and Human Services, the Administrator of the Environmental Protection
Agency, and the heads of other appropriate federal departments to
build upon and expand current monitoring and surveillance programs to
develop robust, comprehensive, and fully coordinated surveillance and
monitoring systems. HSPD-10 notes that early warning, detection, or
recognition of biological weapons attacks to permit a timely response
to mitigate their consequences is an essential component of
biodefense, and that development of an integrated and comprehensive
attack warning system to rapidly recognize and characterize the
dispersal of biological agents in human and animal populations, food,
water, agriculture, and the environment will permit the recognition of
a biological attack at the earliest possible moment and permit
initiation of a robust response to prevent unnecessary loss of life,
economic losses, and social disruption. HSPD-21 calls for the robust
and integrated biosurveillance capability previously discussed. The
Pandemic and All-Hazards Preparedness Act calls for an interoperable
network of systems to support a nationwide situational awareness
capability. Pub. L. No. 109-417, § 202(2), 120 Stat. 2831, 2845 (2006).
[29] HSPD-21 and the 9/11 Commission Act each specifically point to
the need to integrate data from across various domains, such as human
health, animal health, agricultural, meteorological, environmental,
and intelligence data. Pub. L. No. 110-53, § 1101, 121 Stat. 266, 375-
79 (2007).
[30] Emerging zoonotic disease outbreaks have brought increased
attention to the need for disease surveillance that links and provides
information across human and animal health sectors for early detection
and response. See G. T. Keusch, M. Pappaioanou, M. C. Gonzalez, K. A.
Scott, and P. Tsai, Editors, National Research Council of the National
Academies, Committee on Achieving Sustainable Global Capacity for
Surveillance and Response to Emerging Diseases of Zoonotic Origin,
Sustaining Global Surveillance and Response to Emerging Zoonotic
Diseases (Washington, D.C.: 2009).
[31] We previously reported on NBIC and the challenges it has faced in
obtaining data and resources from its NBIS partners. See [hyperlink,
http://www.gao.gov/products/GAO-10-171].
[32] The Homeland Security Information Network is a comprehensive,
nationally secure and trusted Web-based platform able to facilitate
Sensitive but Unclassified information sharing and collaboration among
federal, state, local, tribal, private sector, and international
partners.
[33] GAO, Bioterrorism: Information Technology Strategy Could
Strengthen Federal Agencies' Abilities to Respond to Public Health
Emergencies, [hyperlink, http://www.gao.gov/products/GAO-03-139]
(Washington, D.C.: May 30, 2003).
[34] In 2001, letters laced with anthrax were sent through the mail to
two U.S. senators and members of the media. The letters led to the
first cases of anthrax disease related to bioterrorism in the United
States.
[35] See GAO, Emerging Infectious Diseases: Review of State and
Federal Disease Surveillance Efforts, [hyperlink,
http://www.gao.gov/products/GAO-04-877] (Washington, D.C.: September
30, 2004) and GAO, Health Information Technology: More Detailed Plans
Needed For the Centers for Disease Control and Prevention's Redesigned
BioSense Program, [hyperlink, http://www.gao.gov/products/GAO-09-100]
(Washington, D.C.: November 20, 2008).
[36] See, for example, [hyperlink,
http://www.gao.gov/products/GAO-10-171] and [hyperlink,
http://www.gao.gov/products/GAO-09-904SP] and National Security: Key
Challenges and Solutions to Strengthen Interagency Collaboration,
[hyperlink, http://www.gao.gov/products/GAO-10-822T] (Washington,
D.C.: June 9, 2010).and G.T. Keusch, M. Pappaioanou, M.C. Gonzalez,
K.A. Scott, and P. Tsai, Editors, National Research Council of the
National Academies, Committee on Achieving Sustainable Global Capacity
for Surveillance and Response to Emerging Diseases of Zoonotic Origin,
Sustaining Global Surveillance and Response to Emerging Zoonotic
Diseases (Washington, D.C.: 2009) and Improving the Nation's Ability
to Detect and Respond to 21st Century Urgent Health Threats: First
Report to the National Biosurveillance Advisory Subcommittee. Health
and Human Services, Centers for Disease Control and Prevention,
(Washington, D.C.: April 30, 2009). Health and Human Services, Centers
for Disease Control and Prevention, (Washington, D.C.: Apr. 30, 2009).
[37] See [hyperlink, http://www.gao.gov/products/GAO-10-171]. We
recommended that the Director of NBIC work with its interagency
partners to finalize a collaboration strategy that clearly defines
NBIC's mission and purpose, along with the value of participating for
each agency partner; addresses challenges to sharing data and
personnel, including clearly and properly defining roles and
responsibilities in accordance with the unique skills and assets of
each agency; and develops joint strategies, procedures, and policies
for working across agency boundaries. DHS concurred with our
recommendations. DHS's Chief Medical Officer, who is the head of the
organizational unit that houses NBIC, testified in March 2010 that
NBIC was working to implement the recommendations and that he recently
convened interagency partners to begin discussing the challenges we
outlined.
[38] [hyperlink, http://www.gao.gov/products/GAO-10-171].
[39] HSPD-9 calls for nationwide laboratory networks for food,
veterinary, plant health, and water quality that integrate existing
federal and state laboratory resources, that are interconnected, and
use standardized diagnostic protocols and procedures. HSPD-21 also
calls for strengthening laboratory diagnostic capabilities and
capacity in order to recognize threats as early as possible. GAO has
previously reported concerns with specific laboratory network
procedures and integration efforts. See [hyperlink,
http://www.gao.gov/products/GAO-05-214] and Agriculture Production:
USDA Needs to Build on 2005 Experience to Minimize the Effects of
Asian Soybean Rust in the Future, [hyperlink,
http://www.gao.gov/products/GAO-06-337] (Washington, D.C.: Feb. 24,
2006). However, it was beyond the scope of this report to evaluate the
individual laboratory networks' capabilities. The ICLN is included
here as an illustrative example of efforts agencies are taking to
enhance detection and situational awareness.
[40] Signatory federal agencies to this agreement include the
Departments of Agriculture, Commerce, Defense, Energy, Health and
Human Services, Homeland Security, Interior, Justice, State and the
Environmental Protection Agency.
[41] For example, HSPD-10 states the following: Deterrence is the
historical cornerstone of defense, and attribution--the identification
of the perpetrator as well as method of attack--forms the foundation
upon which deterrence rests. Biological weapons, however, lend
themselves to covert or clandestine attacks that could permit the
perpetrator to remain anonymous. The nation is enhancing deterrence
posture by improving attribution capabilities, the ability to perform
technical forensic analysis, and the capability to assimilate all-
source information to enable attribution assessments.
[42] See GAO, Drinking Water: Experts' Views on How Future Federal
Funding Can Be Best Spent To Improve Security, [hyperlink,
http://www.gao.gov/products/GAO-04-29] (Washington D.C.: Oct. 31,
2003).
[43] It is beyond the scope of this report to assess the effectiveness
of these sensor-based technologies. Previous GAO reports have
discussed some of these technologies in more detail. See GAO, Homeland
Security: First Responders' Ability to Detect and Model Hazardous
Releases in Urban Areas is Significantly Limited. GAO-08-180
(Washington, D.C.: June 27, 2008) and Institute of Medicine and
National Research Council of the National Academies, Committee on
Effectiveness of National Biosurveillance Systems: BioWatch and the
Public Health System, BioWatch and Public Health Surveillance:
Evaluating Systems for the Early Detection of Biological Threats:
Abbreviated Version: Summary (Washington, D.C.: 2009).
[44] As currently operated, BioWatch filters are collected every 24
hours and delivered to local laboratories, where they are analyzed
according to prescribed protocols. If this analysis recognizes one of
the biothreat agents that the system is designed to detect, the
laboratories report the results to local public health officials, who
must then decide how to respond. DHS is developing new detection
technology known as Generation 3.0 which would replace the existing
technology used by the BioWatch program. This new technology is to
provide a fully automated detector which not only collects air samples
but also analyzes them for threats.
[45] See Biosurveillance: Preliminary Observations on Department of
Homeland Security's Biosurveillance Initiatives, [hyperlink,
http://www.gao.gov/products/GAO-08-960T] (Washington, D.C.: July 16,
2008).
[46] [hyperlink, http://www.gao.gov/products/GAO-01-822] and
[hyperlink, http://www.gao.gov/products/GAO-04-408T].
[47] [hyperlink, http://www.gao.gov/products/GAO-01-822].
[48] [hyperlink, http://www.gao.gov/products/GAO-04-408T].
[49] At the time of our review, officials from DOI also said they were
in the process of developing a strategic framework to integrate a
wildlife disease component in the biosurveillance enterprise but did
not yet have a draft they could share with us.
[50] See Institute of Medicine and National Research Council of the
National Academies, Committee on Effectiveness of National
Biosurveillance Systems: BioWatch and the Public Health System,
BioWatch and Public Health Surveillance: Evaluating Systems for the
Early Detection of Biological Threats: Abbreviated Version: Summary
(Washington, D.C.: 2009).
[51] Improving the Nation's Ability to Detect and Respond to 21st
Century Urgent Health Threats: First Report to the National
Biosurveillance Advisory Subcommittee,. Health and Human Services,
Centers for Disease Control and Prevention (Washington, D.C.: Apr. 30,
2009).
[52] GAO, Biosurveillance: Developing a Collaboration Strategy Is
Essential to Fostering Interagency Data and Resource Sharing,
[hyperlink, http://www.gao.gov/products/GAO-10-171] (Washington, D.C.:
December 18, 2009). We recommended that NBIC develop a strategy for
collaboration based on key collaboration practices that, among other
things, defines roles and responsibilities for its partner agencies.
DHS stated it is in the process of implementing this recommendation.
[53] [hyperlink, http://www.gao.gov/products/GAO-04-408T].
[54] [hyperlink, http://www.gao.gov/products/GAO-01-822].
[55] CDC has outlined various proposed governance models for human
health biosurveillance activities in the Concept Plan for the
Implementation of the National Biosurveillance Strategy for Human
Health, Health and Human Services, Centers for Disease Control and
Prevention (Washington, D.C.: January 2010).
[56] Pub. L. No. 110-53, § 1102, 121 Stat. 266, 379 (2007).
[57] GAO, Biosurveillance: Developing a Collaboration Strategy Is
Essential to Fostering Interagency Data and Resource Sharing,
[hyperlink, http://www.gao.gov/products/GAO-10-171] (Washington, D.C.:
Dec. 18, 2009).
[58] Pub. L. No. 107-296, 116 Stat. 2135 (2002).
[59] Pub. L. No. 107-188, 116 Stat. 594 (2002).
[60] Pub. L. No. 109-417, 120 Stat. 2831 (2006).
[61] Pub. L. No. 110-53, 121 Stat. 266 (2007).
[62] Pub. L. No. 110-53, § 1101, 121 Stat. 266, 375 (2007).
[63] See GAO, Bioterrorism: Information Technology Strategy Could
Strengthen Federal Agencies' Ability to Respond to Public Health
Emergencies, [hyperlink, http://www.gao.gov/products/GAO-03-139]
(Washington, D.C.: May 30, 2003).
[64] See GAO, Emerging Infectious Diseases: Review of State and
Federal Disease Surveillance Efforts, [hyperlink,
http://www.gao.gov/products/GAO-04-877] (Washington, D.C.: Sept. 30,
2004).
[65] See GAO, Infectious Diseases: Gaps Remain in Surveillance
Capabilities of State and Local Agencies, [hyperlink,
http://www.gao.gov/products/GAO-03-1176T] (Washington, D.C.: Sept. 24,
2003) and Emerging Infectious Disease: Consensus on Needed Laboratory
Capacity Could Strengthen Surveillance, [hyperlink,
http://www.gao.gov/products/GAO/HEHS-99-26] (Washington, D.C.: Feb.5,
1999).
[66] See Institute of Medicine and National Research Council of the
National Academies, Committee on Emerging Microbial Threats to Health
in the 21st Century, Microbial Threats To Health: Emergence,
Detection, and Response (Washington, D.C.: 2003).
[67] See GAO, Homeland Security: Much Is Being Done to Protect
Agriculture from a Terrorist Attack, but Important Challenges Remain,
[hyperlink, http://www.gao.gov/products/GAO-05-214] (Washington, D.C.:
Mar. 8, 2005).
[68] [hyperlink, http://www.gao.gov/products/GAO-05-214].
[69] See GAO, Avian Influenza: USDA Has Taken Important Steps to
Prepare for Outbreaks, but Better Planning Could Improve Response,
[hyperlink, http://www.gao.gov/products/GAO-07-652] (Washington, D.C.:
June 11, 2009) and National Animal Identification System: USDA Needs
to Resolve Several Key Implementation Issues to Achieve Rapid and
Effective Disease Traceback, [hyperlink,
http://www.gao.gov/products/GAO-07-592] (Washington, D.C.: July 6,
2009) and Veterinarian Workforce: Actions Are Needed to Ensure
Sufficient Capacity for Protecting Public and Animal Health,
[hyperlink, http://www.gao.gov/products/GAO-09-178] (Washington, D.C.:
Feb. 4, 2009).
[End of section]
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