An Overview of the U.S. Public Health System in the Context of Emergency Preparedness
Congressional research reportMar 17, 2005
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An Overview of the U.S. Public Health System
in the Context of Emergency Preparedness
Updated March 17, 2005
name redacted
Specialist in Public Health and Epidemiology
Domestic Social Policy Division
Congressional Research Service ˜ The Library of Congress
An Overview of the U.S. Public Health System
in the Context of Emergency Preparedness
Summary
This report describes the U.S. public health infrastructure: the structure,
organization, and legal basis of domestic public health activities. In contrast with
healthcare, public health practice is aimed at decreasing the burden of illness and
injury in populations, rather than individuals. Public health agencies use
epidemiologic investigation, laboratory testing, information technology, public and
provider education, and other tools to support their mission, activities that in turn rely
on an adequate and well-trained public health workforce. Federal leadership for
public health is based in the Department of Health and Human Services (HHS) and
in particular at the Centers for Disease Control and Prevention (CDC). Most public
health authority, such as mandatory disease reporting, licensing of healthcare
providers and facilities, and quarantine authority, is actually based with states as an
exercise of their police powers. Local and municipal health agencies vary in size,
governance, and authority, but they are the front line in responding to public health
threats.
In 2001, terrorist attacks on the nation brought the weaknesses of our public
health system into sharp focus. Prior to the 2001 terrorist attacks, Congress passed
the Public Health Threats and Emergencies Act (P.L. 106-505), to address the
decaying public health infrastructure and to prepare for bioterrorism and other public
health emergencies. After the 2001 attacks, Congress passed the Public Health
Security and Bioterrorism Preparedness and Response Act (P.L. 107-188), expanding
grants to state health departments and adding a new national hospital preparedness
program, as well as adding new food safety and security authorities, protections for
water infrastructure, and other provisions. Congress also passed the Homeland
Security Act (P.L. 107-296), creating the new Department of Homeland Security
(DHS) to serve as a coordination point for homeland security activities and to house
certain public health preparedness programs.
This report describes the nation’s public health infrastructure and authorities at
the federal, state, and local levels. It provides a history of relevant legislation and
appropriations, both prior to and after the 2001 terrorist attacks. In addition, it
describes selected public health preparedness programs at HHS and DHS.
This report also discusses a number of issues in ensuring public health
preparedness. Specific challenges include: ensuring the coordinated planning for
and response to emergencies by a variety of public health and other governmental
actors, given that public health authority rests principally with states rather than the
federal government; setting goals and standards for preparedness at the federal, state,
and local levels; ensuring programmatic and fiscal accountability, and steady
progress toward goals; and training and sustaining a skilled workforce for public
health at all levels of government. The overarching challenge for policymakers is in
making sound trade-offs with finite resources; ensuring all-hazards preparedness for
a variety of emergencies, while balancing resources appropriately between emergency
preparedness and the prevention of injuries and chronic diseases that kill millions
annually. This report will be updated periodically.
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Public Health Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Legal Framework for Public Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Federal Public Health Role and Organization . . . . . . . . . . . . . . . . . . . . . . . . 7
Department of Health and Human Services (HHS) . . . . . . . . . . . . . . . . 7
Department of Homeland Security (DHS) . . . . . . . . . . . . . . . . . . . . . . . 9
State Public Health Role and Organization . . . . . . . . . . . . . . . . . . . . . . . . . 11
Local Public Health Role and Organization . . . . . . . . . . . . . . . . . . . . . . . . 12
How Is Public Health Funded? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Recent Congressional Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
The 109th Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Major Legislation in the 107th and 108th Congresses . . . . . . . . . . . . . . . . . . 15
Major Legislation Prior to the 2001 Terrorist Attacks . . . . . . . . . . . . . . . . . 17
Appropriations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Issues for the 109th Congress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Coordination Across Agencies and Levels of Government . . . . . . . . . . . . . 22
Defining Goals, Setting Standards, and Measuring Progress . . . . . . . . . . . 23
CDC and HRSA Critical Benchmarks . . . . . . . . . . . . . . . . . . . . . . . . . 23
Next Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Fiscal Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Supplanting of Funds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Pass-Through of Funds to Local Governments and Hospitals . . . . . . . 27
Public Health Workforce Shortages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Appendix A: Selected Programs in the Department of Health and
Human Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Programs That Build Federal or National Capacity . . . . . . . . . . . . . . . . . . . 33
Project BioShield (OPHEP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Biosurveillance Initiative/BioSense (CDC) . . . . . . . . . . . . . . . . . . . . . 34
Laboratory Response Network (CDC) . . . . . . . . . . . . . . . . . . . . . . . . . 35
Select Agent Program (CDC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Strategic National Stockpile (CDC) . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Food Safety Programs (FDA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Programs That Build State and Local Capacity . . . . . . . . . . . . . . . . . . . . . . 40
State and Local Preparedness Grants (CDC) . . . . . . . . . . . . . . . . . . . . 40
Hospital Preparedness Grants (HRSA) . . . . . . . . . . . . . . . . . . . . . . . . 42
Cities Readiness Initiative (CDC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Information Technology Programs (CDC) . . . . . . . . . . . . . . . . . . . . . 44
Appendix B: Selected Programs in the Department of Homeland Security . . . . 46
Metropolitan Medical Response System (OSLGCP) . . . . . . . . . . . . . . . . . . 46
National Disaster Medical System (EPR) . . . . . . . . . . . . . . . . . . . . . . . . . . 46
BioWatch (S&T) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Appendix C: Focus Areas, Critical Benchmarks, and Priority Areas for the
CDC and HRSA Public Health and Hospital Preparedness Grants,
FY2002 through FY2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
List of Tables
Table 1. Appropriations for Selected Public Health Preparedness Programs . . . 19
An Overview of the U.S. Public Health
System in the Context of
Emergency Preparedness
Introduction
The terrorist attacks of 2001, in particular the anthrax mailings, made clear that
terrorism and other public health emergencies pose unique challenges to the nation’s
healthcare and public health systems. The threat of bombings and similar overt
events requires that communities plan for the triage, transport, and treatment of large
numbers of casualties. In contrast, the health impacts of a biological or chemical
attack can be covert, unfolding gradually over time. The speed, accuracy, and
coordination of both the healthcare and public health responses therefore have a
direct impact on the number of casualties from either type of event. Terrorism may
pose the threat of both events simultaneously, the covert event deliberately enveloped
within the overt. Responding to health events of this type is new to the public health
and healthcare communities, and requires a level of planning and coordination not
seen before.
Improving public health preparedness is expected to offer protection not only
from terrorist attacks, but also from naturally occurring public health threats. This
concept is often called dual-use. Public health officials are increasingly concerned
about the spread of infectious diseases because of global travel, increased global
trade in food and other commodities, and the emergence of antibiotic-resistant
pathogens. They argue that if well-designed, the strong infrastructure needed to
respond to natural disease threats such as West Nile virus and pandemic influenza
will also improve the response to the threat of terrorism. Some have argued that
much of the needed capability (improved information technology systems, or a larger
workforce, for example) is so versatile that it could improve the public health
response to chronic disease threats such as heart disease, asthma, and cancer as well.
On the other hand, some specific scenarios, such as smallpox and pandemic
influenza, have been considered to pose an especially serious threat, and each has
been the subject of specific planning activities within the context of broader, dual-use
planning.
Prior to the 2001 terrorist attacks, several reports described the increasing threat
posed by emerging infectious diseases and terrorism, and the continued erosion of the
public health system. Among the problems cited were health department closures,
outmoded technology and information systems, a limited workforce with inadequate
training to address new threats, poor coordination among responsible parties, and
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inadequate capacity in hospitals and laboratories to respond to a mass casualty event.1
A number of federal public health programs to prepare for bioterrorism were
actually in place prior to 2001. The Department of Health and Human Services
(HHS), through the Centers for Disease Control and Prevention (CDC), launched a
comprehensive program to combat emerging infectious diseases in the early 1990s,
followed by a bioterrorism initiative in the late 1990s. In 2000, Congress passed the
Public Health Threats and Emergencies Act (P.L. 106-505), which provided funding
for state bioterrorism preparedness programs, bioterrorism training programs, and
programs to combat antimicrobial resistance, among other measures. This followed
earlier legislation to control the shipment of potentially dangerous pathogens.
Following the terror attacks of 2001, Congress expanded its commitment to
public health preparedness in the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 (P.L. 107-188) and through greatly enhanced
appropriations for public health. These actions included expanding a number of
programs at CDC, such as grants for state and local public health capacity, and
programs to stockpile medications and to control the possession of potentially
dangerous pathogens. Congress authorized and funded several new programs, such
as a state program to bolster hospital preparedness, and expanded food safety
authorities for the Food and Drug Administration (FDA). Congress also created the
Department of Homeland Security (DHS) to serve as a coordination point for many
emergency preparedness programs, and for enhancement of funding for public health
preparedness programs throughout the federal government.
Despite a variety of efforts at the federal, state, and local levels since 2001,
serious challenges remain in ensuring national preparedness for public health threats.
The biggest challenge for federal policymakers is to move beyond planning for each
worrisome scenario toward a strategy based on analysis of threats and vulnerabilities
— in short, to understand which are the top priorities in a sea of competing urgent
priorities. This task is complicated by the decentralized nature of public health, in
which states and localities, rather than the federal government, are the seat of most
authority and responsibility for public health. In addition, states claim, legitimately,
that a nationwide priority list would fail to address the variety of different
vulnerabilities that exist from state to state. Many feel that versatile or all-hazards
capabilities make the most efficient use of resources, at least until there is a more
mature strategic approach to prioritize scenario-based planning.
The public health community faces a number of specific challenges as well.
They include: ensuring the coordinated planning for and response to emergencies by
1
See, for example, Institute of Medicine (IOM), The Future of the Public Health in the 21st
Century, The National Academies, Nov. 2002 (Hereafter cited as IOM Report), General
Accounting Office (GAO, called the Government Accountability Office as of July, 2004),
Emerging Infectious Diseases: Consensus on Needed Laboratory Capacity Could
Strengthen Surveillance, GAO/HEHS-99-26, Feb. 1999; Amy E. Smithson, and Leslie-Anne
Levy, Ataxia: The Chemical and Biological Terrorism Threat and the U.S. Response, Henry
L. Stimson Center, Report no. 35, Oct. 2000; and Eileen Salinsky, “Public Health
Emergency Preparedness: Fundamentals of the ‘System,’” National Health Policy Forum
Background Paper, Apr. 3, 2002 (hereafter cited as Salinsky NHPF Paper).
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a variety of public health and other governmental actors; setting goals and standards
for preparedness at the federal, state and local levels; ensuring programmatic and
fiscal accountability, and steady progress toward goals; and training and maintaining
a skilled workforce for public health at all levels of government.
This report describes the public health infrastructure: the structure,
organization, and legal basis of domestic public health activities. It discusses recent
congressional activity in authorizing and appropriations for public health. It
describes a number of public health programs within the Departments of Health and
Human Services and Homeland Security. Finally, it discusses a number of issues and
challenges in ensuring public health preparedness.
Public Health Infrastructure
Overview
The mission of public health is to promote physical and mental health and
prevent disease, injury, and disability.2 The U.S. public health system comprises a
wide array of governmental and nongovernmental entities, including:
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over 3,000 county and city health departments and local boards of
health;
59 state and territorial health departments;
tribal health departments;
more than 160,000 public and private laboratories;
parts of multiple federal departments and agencies;
hospitals and other healthcare providers; and
volunteer organizations such as the Red Cross.
Definitions vary but, in practical terms, public health infrastructure is the
federal, state, and local public health organizations and the resources they need to
operate effectively.3 These governmental organizations form “the nerve center of the
public health system”and interact with a wide array of other partners to ensure public
health.4
In the context of emergency preparedness, some key functions of the public
health infrastructure include: disease surveillance to detect outbreaks and to monitor
2
U.S. Department of Health and Human Services (HHS), Public Health Functions Project,
1999, at [http://www.health.gov/phfunctions/].
3
See Edward L. Baker and Jeffrey Koplan, “Strengthening the Nation’s Public Health
Infrastructure: Historic Challenge, Unprecedented Opportunity,” Health Affairs, vol. 21,
no. 6, Nov./Dec. 2002; and HHS, Centers for Disease Control and Prevention, Public
Health’s Infrastructure: A Status Report, prepared for the U.S. Senate Appropriations
Committee, Mar. 2001 (hereafter cited as CDC Infrastructure Status Report).
4
B.J. Turnock, Public Health — What It Is and How It Works, 2d ed. (Gaithersburg, MD:
Aspen Publishers, 2001).
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trends; specialized laboratory testing to identify bioagents, both in individuals and
in environments; epidemiologic methods to identify persons at risk and to monitor
the effectiveness of prevention and treatment measures; knowledge of disease
processes in populations to determine appropriate responses such as quarantine,
decontamination or the dissemination of treatment recommendations; and
coordination with partners to establish effective planning and response.
To accomplish these tasks, the public health infrastructure relies on a number
of interdependent parts that encompass all levels of government, as well as both the
public and private sectors. One element is the public health workforce: typically
this includes individuals employed in governmental public health, though this group
interacts with individuals employed in the healthcare sector, in academia, and in
volunteer organizations. Another element is the healthcare sector, which includes
hospitals, clinics, pharmacies, emergency medical services, a host of ancillary
services, and a diverse healthcare workforce. Another element is the national
complement of laboratories, which function on three levels; clinical laboratories,
which conduct testing on individual patients within the healthcare system; public
health laboratories, which conduct testing to support population-based programs and
may involve testing of individuals as well as environmental assessment during a
terrorist event; and research laboratories, in which the study of biological agents, the
effects of treatments, or other pursuits are not directly linked to detection and
response in specific incidents but which provide the scientific basis to guide ongoing
and future response efforts. Another element is the information technology
infrastructure that supports disease surveillance and the rapid dissemination of
information during potential emergencies. The extent to which these elements, and
others, are competent, well-coordinated, and otherwise adequate for national
preparedness is a matter of considerable discussion. These elements are discussed
in greater detail in subsequent sections that describe federal public health programs
and issues in preparedness.
Legal Framework for Public Health5
Public health practice is governed by federal, state, and local law. The federal
government can influence public health practice through its funding decisions and by
exercising its jurisdiction over interstate commerce. However, most public health
authority rests with the states. This section will review the legal authorities of
federal, state, and local governments in public health.
Most public health authority is based in the states, as an exercise of their police
powers.6 States use this authority in a number of ways to protect public health, from
enforcing safety and sanitary codes, to conducting inspections, to mandating the
5
Much of the material in this section is found in Frank P. Grad, The Public Health Law
Manual, 3rd ed., American Public Health Association, 2004; and CRS Report RL31333,
Federal and State Isolation and Quarantine Authority, by Angie A. Welborn.
6
The term police powers derives from the 10th Amendment to the Constitution, which
reserves to the states those rights and powers not delegated to the United States.
Historically these have been interpreted to include authority over the welfare, safety, health,
and morals of the public.
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reporting of certain diseases to state authorities, to compelling isolation or
quarantine, to licensing healthcare workers and facilities. Local governments are
often responsible for some of these activities, using powers largely derived from
delegation of state authority. Since states are the basis for most authority in public
health, the traditional relationship of state and federal agencies has placed states in
a leading role, with CDC providing support through funding, training, and technical
assistance, advanced laboratory support and data analysis, and other activities. The
Public Health Service Act grants the Secretary of HHS the authority to declare a
situation a public health emergency, which triggers an expansion of federal authority
(such as federal quarantine authority) as needed. The only such declaration made in
recent memory was on September 11, 2001. On the other hand, even though states
already have considerable power in responding to public health events, most can also
declare public health emergencies and expand their powers further.7 Following the
terrorist attacks of 2001, CDC awarded a contract for the development of a Model
State Emergency Health Powers Act, and encouraged states to use the model in
revamping state laws to ensure that they are adequate to meet the threats of terrorism
and other public health emergencies.8 The updated legal authorities, particularly
isolation and quarantine authority, proved helpful to certain states in managing
Severe Acute Respiratory Syndrome (SARS) in 2003.
Though most public health authority is based in state law, the federal
government nonetheless exerts a strong influence on public health practice through
its ability to tax and spend and its responsibility for regulating interstate commerce.
Using its commerce authority, the federal government can act to protect the
environment, ensure food and drug safety, and promote occupational health and
safety. The power to tax allows the federal government to encourage certain
behaviors (e.g., deductibility of employee health insurance costs encourages
employers to provide insurance) and to discourage others (e.g., raising taxes on
cigarettes discourages smoking). The federal government can also set conditions on
the expenditure of federal funds. For example, states must set 21 as the minimum
age for the legal consumption of alcohol in order to qualify for federal highway
funds. Federal public health recommendations, while lacking the force of law,
nonetheless often exert considerable influence on medical and public health practice,
and may be incorporated into state laws.
The federal government also has authority for disease control functions
concerning entries of persons, goods and conveyances from other countries, where
its activities to compel disease reporting and impose quarantine mirror the activities
carried out by states within their borders. These activities are carried out by the CDC
Division of Global Migration and Quarantine, which operates a number of quarantine
stations at major ports. Recently the Division has been involved in evaluating
7
For a discussion of the exercise of federal and state authorities in response to the recent
shortage of influenza vaccine, see CRS Report RL32655, Influenza Vaccine Shortages and
Implications, by (name redacted).
8
Information on the Model State Emergency Health Powers Act and state implementation
is available from the Center for Law and the Public’s Health at Georgetown and Johns
Hopkins Universities at [http://www.publichealthlaw.net/Resources/Modellaws.htm].
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inbound international passengers for SARS and ordering a prohibition on the
importation of certain African rodents to prevent monkeypox.9
A number of federal statutes address public health in departments across the
federal government. Most federal public health activity is based in HHS through
authorities in the Public Health Service Act (PHSA) and the Federal Food, Drug and
Cosmetic Act (FFDCA). In general, the PHSA authorizes the activities of the public
health service agencies10 and creates important vehicles for federal funding of public
health activities in states and communities. The FFDCA authorizes the FDA to
regulate the safety of food and cosmetics, and the safety and effectiveness of
pharmaceuticals, biologics, and medical devices.
In addition to HHS, most other departments have authorities relevant for public
health, though they may be specific or limited in scope. Three separate statutes grant
authority to the U.S. Department of Agriculture (USDA) to ensure the safety of meat,
poultry, and processed eggs. Important environmental health authorities are
contained in the National Environmental Policy Act, as well as a number of related
laws that authorize the Environmental Protection Agency (EPA) to regulate the safety
of the air, water, and the ecological system. Important occupational health authorities
are found in the Occupational Safety and Health (OSHA) and Mine Safety Acts. The
Departments of Defense and Veterans Affairs exercise authorities to protect the
health of the specific populations they serve, as does the Federal Bureau of Prisons
in the Justice Department. The Departments of Energy and Transportation also act
to protect public health through specific authorities, such as those governing
radiation safety and highway safety, respectively. Independent agencies such as the
Consumer Product Safety Commission, the National Transportation Safety Board,
and the Nuclear Regulatory Commission also exercise federal authorities that, at least
in part, protect public health. These examples are illustrative but by no means
exhaustive. They do not encompass all of the many threads of federal activity that
ultimately benefit the public’s health.
Other provisions of federal law address emergency preparedness and response.
The Homeland Security Act created the Department of Homeland Security (DHS),
and grants the Secretary of DHS a broad leadership role in planning for and
responding to emergencies, as well as several specific authorities for public health
(discussed in subsequent sections). The Stafford Act establishes provisions for
federal assistance to states in the event of a disaster. The act requires the governor
of an affected state to request a declaration of a disaster, and vests the President with
9
For more information, see CDC Division of Global Migration and Quarantine Home Page
at [http://www.cdc.gov/ncidod/dq/index.htm], and section on Protection Against
Communicable Diseases in CRS Report RL32399, Border Security: Inspections Practices,
Policies, and Issues, coordinated by (name redacted).
10
Public health service agencies are those agencies whose activities are authorized in the
Public Health Service Act, namely the Agency for Healthcare Research and Quality, CDC,
FDA, the Health Resources and Services Administration, the Indian Health Service, the
National Institutes of Health, and the Substance Abuse and Mental Health Services
Administration, as well as a variety of activities in the Office of the Secretary of HHS.
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the authority to make such a declaration and charge federal agencies to provide
support to state and local efforts.
The diversity of federal authorities for public health, and the dispersion of
responsibilities across almost every federal department, mean that many different
agencies may be involved in protecting public health in emergencies. In creating the
Department of Homeland Security, Congress called on its Secretary to consolidate
existing federal emergency response plans into a single coordinated national response
plan, so that multiple federal agencies would work effectively with each other and
with states and localities in a response. The new National Response Plan is discussed
further in a subsequent section on Issues for the 109th Congress.
Some have suggested that the threat of terrorism has made public health a
national security issue and that the federal government should therefore play a
stronger role. Others worry that a stronger federal role will reduce flexibility. They
emphasize that the first response to any event is local, that localities have differing
needs, and that they therefore must have a strong role in resource allocation
decisions. While the primacy of states in matters of health and safety is deeply
rooted in the Constitution, laws, and judicial opinions of the United States
government, this decentralized approach to public health will continue to pose a
challenge in achieving national preparedness for emergencies.
Federal Public Health Role and Organization
The 2002 report from the Institute of Medicine, The Future of Public Health in
the 21st Century, identifies six main areas where the federal government plays a role
in population health. The six areas are policy making, financing, public health
protection, collecting and disseminating information about health and healthcare
delivery systems, capacity building for population health, and direct management of
services.11
The Department of Health and Human Services (HHS) bears primary
responsibility for public health activities at the federal level. Other key activities are
located in the Department of Homeland Security (DHS), the Environmental
Protection Agency (EPA), the Department of Agriculture (USDA), the Department
of Defense (DoD), and the Department of Veterans Affairs (VA). This section will
describe the missions of various agencies within HHS and DHS that have
responsibilities for public health preparedness. Selected programs within these
agencies are described in greater detail in subsequent sections.
Department of Health and Human Services (HHS). The Office of the
Assistant Secretary for Public Health Emergency Preparedness (OPHEP), within the
Office of the Secretary (OS), was created in legislation (P.L. 107-188) following the
2001 terror attacks. The Assistant Secretary directs and coordinates HHS
preparedness activities.
Other public health agencies within HHS with
responsibilities for emergency preparedness and response include the Centers for
Disease Control and Prevention (CDC), the Health Resources and Services
11
IOM Report.
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Administration (HRSA), the National Institutes of Health (NIH), the Food and Drug
Administration (FDA), and the Agency for Healthcare Research and Quality
(AHRQ). Specific public health preparedness programs at HHS are discussed in
Appendix A.
The Centers for Disease Control and Prevention (CDC) is the center of
federal public health activities. The CDC works with states, localities, and other
nations to detect, investigate, and prevent disease and injury, to develop and
implement prevention strategies, to monitor the effect of environmental conditions
on health, and to study illness and injury in the workplace. In 2000, CDC published
a strategic plan for biological and chemical terrorism preparedness and response,
which among other things prioritized potential bioterrorism agents in categories
according to their ease of dissemination and potential for causing high mortality, and
laid out a blueprint for a national laboratory network for bioterrorism.12 State and
local public health agencies receive support from the CDC in a variety of ways,
including training programs, technical assistance and expert consultation,
sophisticated laboratory services, research activities, and standards development.
CDC also provides financial assistance for a wide range of public health activities,
from controlling West Nile virus to providing childhood immunizations. One of the
key vehicles for support of state and local public health agencies is the state and local
preparedness grant program, established in 1999. The program was greatly expanded
following the 2001 terrorist attacks. After the attacks, CDC also created a public
Emergency Preparedness and Response website, [http://www.bt.cdc.gov], which
contains information on biological, chemical, and radiological agents, diagnostic and
treatment guidelines, program descriptions, and other materials. The site has also
been used to relay information about naturally occurring public health threats such
as Severe Acute Respiratory Syndrome (SARS) and hurricane-related health
concerns.
The Health Resources and Services Administration (HRSA) is responsible
for improving and expanding access to healthcare in the United States, including
improving healthcare and public health systems. HRSA administers the state grant
program for hospital preparedness, created after the terror attacks of 2001 to ensure
that hospitals and other healthcare facilities have the capacity to respond to public
health emergencies. HRSA is also generally responsible for healthcare workforce
development, including programs for training in emergency medicine and trauma
services, as well as a program to improve medical school curricula in the area of
bioterrorism recognition.
The Food and Drug Administration (FDA) is responsible for ensuring the
availability of safe and effective drugs, vaccines, blood products, medical devices,
radiological products, and animal drugs. The FDA is also responsible for ensuring
the safety of most types of foods. (The FDA works in partnership with the
Department of Agriculture, which is responsible for the safety of meat, poultry, and
processed egg products.) The FDA operates by establishing guidance, setting
regulatory requirements, conducting inspections, and removing unsafe products from
12
CDC, “Biological and Chemical Terrorism: Strategic Plan for Preparedness and
Response,” MMWR 49(RR04), pp. 1-14, Apr. 21, 2000.
CRS-9
commerce. The FDA is supported by 3,000 state and local offices responsible for
monitoring retail food establishments and their employees.13
The National Institutes of Health (NIH) conducts and supports biomedical
research, including research to develop countermeasures, which are drugs, vaccines,
rapid tests and other tools to detect, prevent, or treat illness from biological,
chemical, or radiological threats, whether natural or intentional. Within NIH, the
National Institute of Allergy and Infectious Diseases (NIAID) bears primary
responsibility for bioterrorism-related research.14 In February 2002, NIAID released
a research strategic plan, a research portfolio aimed at a better understanding of the
agents of bioterrorism, the host response to them, and ways to translate this
knowledge into effective interventions.15
The Agency for Healthcare Research and Quality (AHRQ) sponsors and
conducts research designed to improve the quality of healthcare. An area of research
emphasis is the establishment of the evidence base to guide medical and public health
practice. In the area of bioterrorism, AHRQ’s research focuses particularly on
improving the clinical preparedness of healthcare providers. For example, the agency
has studied how best to communicate with physicians and other private healthcare
providers in the event of a public health emergency and has assessed the most
effective methods for training physicians about bioterrorist threats.
Department of Homeland Security (DHS). Congress created the
Department of Homeland Security (DHS) in P.L. 107-296, the Homeland Security
Act of 2002, to serve as the coordinating point for domestic preparedness and
response activities. The law stipulated the role of the Secretary of Homeland
Security in coordinating the processes of priority-setting and strategic planning for
a variety of activities with public health components, including biodefense research
on human countermeasures, and coordinated delivery of services to areas affected by
emergencies. Specific public health programs at DHS are discussed in Appendix B.
During legislative debate, there was considerable discussion about the role of
the new department in managing public health programs for emergency preparedness,
and of transferring a number of programs, activities, and authorities from HHS to
DHS. In the end, only three existing public health programs were transferred from
HHS to DHS. The management of most of the public health programs under
discussion (which were at CDC or NIH, primarily) remained at HHS. Of the three
programs that were transferred, one was subsequently returned to HHS, and another
was subsequently moved within DHS. But initially all three were moved to the
Emergency Preparedness and Response Directorate (EPR) of DHS.16 The EPR’s
13
A description of FDA’s counterterrorism activities can be found at [http://www.fda.gov/
oc/opacom/hottopics/bioterrorism.html].
14
See the NIAID Biodefense Home Page at [http://www2.niaid.nih.gov/biodefense/].
15
NIH, NIAID, NIAID Strategic Plan for Biodefense Research, NIH, Feb. 2002, at
[http://www2.niaid.nih.gov/biodefense/research/strategic.pdf].
16
The Metropolitan Medical Response System (MMRS), the National Disaster Medical
(continued...)
CRS-10
mission is to improve the nation’s capability to reduce losses from all disasters,
including terrorist attacks.17
The Office of State and Local Government Coordination and Preparedness
(OSLGCP) at DHS administers a number of grant programs for first responders and
municipal preparedness, and is the current home of the Metropolitan Medical
Response System (MMRS) grants which began at HHS. Some OSLGCP grants allow
state and local public health agencies to receive pass-through funding for eligible
activities, and many involve these agencies in some way in planning activities.18
The Science and Technology Directorate (S&T) in the new department
coordinates numerous research, development, and detection activities that have
implications for public health. These include certain types of biodefense research
(generally related to behavior or detection of bioweapons agents in the environment,
rather than in humans) and the BioWatch program of urban air monitoring.19
The Information Analysis and Infrastructure Protection Directorate (IA/IP)
in the new department coordinates programs to assist the private sector in
“hardening” installations of critical national importance. Examples include
protecting the banking industry from cyber attack, or the electricity grid from
sabotage. Relevant programs for public health include those to improve the security
of food handling, shipping, and storage facilities, in which FDA and IA/IP coordinate
in providing guidance and assistance to the private sector. IA/IP is also the proposed
site of data-mining activities for the Biosurveillance Initiative (discussed further in
Appendix A), in which health data from a variety of sources will be analyzed as a
mechanism for the possible early detection of large-scale health events such as
bioterrorism.20
16
(...continued)
System (NDMS) and budget authority for the Strategic National Stockpile (SNS) were
transferred to DHS from HHS in P.L. 107-296, the Homeland Security Act. The SNS has
since been transferred back to HHS, and the MMRS has been transferred to the Office of
State and Local Government Coordination and Preparedness (OSLGCP) in DHS.
17
For more information on the DHS Emergency Preparedness and Response Directorate, see
CRS Report RS22023, Organization and Mission of the Emergency Preparedness and
Response Directorate: Issues During the 109th Congress, by (name redacted)
18
For more information on DHS grant programs, see CRS Report RL32348, Selected
Federal Homeland Security Assistance Programs: A Summary, by (name redacted).
19
For more information on the DHS Science and Technology Directorate, see CRS Report
RL31914, Research and Development in the Department of Homeland Security, by (name
redacted).
20
For more information on the DHS Information Analysis and Infrastructure Protection
Directorate, see CRS Report RL30153, Critical Infrastructures: Background, Policy, and
Implementation, by (name redacted).
CRS-11
State Public Health Role and Organization
States have considerable autonomy in delivering public health services.
Authorities for professional licensing, domestic isolation and quarantine, contact
tracing, and mandatory disease reporting are based largely in state statute and
regulation. Historically, CDC has funded state public health agencies through
cooperative agreements, in which both parties (and ideally local jurisdictions and
other stakeholders as well) are involved in setting goals and defining priorities.
Public health services can be broadly classified into two types: traditional
population-based services, such as food inspection, and personal health services. In
the latter case, some state health departments provide clinical services directly to
certain groups and may be providers-of-last-resort for indigent individuals. States
often deliver public health services through a number of different state agencies.
Thirty-five states have free-standing state public health agencies, while in others
public health is part of a larger agency that is responsible for a wider range of
activities (including, for example, Medicaid programs).21 Some important public
health activities may be housed outside the state’s primary public health agency. For
example, in 36 states, the environmental health agency is separate from the public
health agency. Emergency medical services may be housed in the public safety
department or governed by a separate EMS authority or board when they are not
housed in the public health agency. In many states, food safety testing is performed
by multiple government agencies, namely in the departments of public health,
agriculture, and environmental quality.
States differ in the amount of authority they delegate to local governments.
Some states provide local governments with very little authority, while others offer
local jurisdictions “home rule” over public health matters. Delegation of public
health authority can be classified into three categories: (1) a centralized approach in
which states have extensive legal and operational control over local authorities, (2)
a decentralized approach in which local governments are delegated significant
control, and (3) a hybrid approach in which some public health responsibilities are
provided directly by the state, while others are assumed by the localities.
States also differ in how long they have focused on bioterrorism. A number of
states received funding under CDC’s Bioterrorism Initiative beginning in 1999 for
a variety of different capacity-building activities. While state governments vary in
both the breadth and depth of services they provide and the degree to which they
delegate to local governments, they nevertheless play a central role in emergency
preparedness and response. Except in the largest metropolitan public health
departments, local health officials will generally call on the state to provide advanced
laboratory capability and epidemiologic expertise, and to serve as a conduit for
federal assistance.
Officials in state and local health departments affiliate in nonprofit organizations
representing all 50 states and the territories, in order to develop consensus on
procedures and standards, deliver training programs, and facilitate other activities
21
Salinsky NHPF Paper.
CRS-12
where national consistency is important. For example, the Council of State and
Territorial Epidemiologists, in collaboration with CDC, develops a list of Nationally
Notifiable Diseases, those diseases for which states are advised to mandate reporting
to the health department by providers and laboratories.22 These groups, which
include state epidemiologists, state public health laboratory directors, immunization
program directors, county health officials within states, and others, conduct capacity
assessments and other public health activities through these associations. The groups
in turn work with their umbrella organization, the Association of State and Territorial
Health Officials (ASTHO).23 These associations may receive substantial funding
through cooperative agreements from the CDC to facilitate their work in assessing
and strengthening the national public health infrastructure. As a result, their
activities often reflect their pseudo-governmental role rather than the role of a
traditional health advocacy group.
Local Public Health Role and Organization
Local health departments are on the front line in responding to public health
emergencies. The role and organization of local health departments varies
considerably across the United States, and this variation may have important
implications for public health preparedness. The diversity of local public health
agencies (LPHAs) can be illustrated with a few statistics from a 2000 survey
conducted by the National Association of County and City Health Officials
(NACCHO).24
Local public health agencies vary by type of jurisdiction. The most common
arrangement is a LPHA serving a single county, but 40% of LPHAs serve other types
of jurisdictions. County LPHAs range in size from sparsely populated rural counties
to dense metropolitan ones such as Los Angeles County. County LPHAs may or may
not serve all geographic areas within the county. For example, a city within a county
may be served by its own municipal LPHA. In some cases, a city and its surrounding
county join together to form one LPHA. Township health departments are usually
located in states with strong “home-rule” or “town-meeting” political systems such
as Connecticut, Massachusetts, and New Jersey. Finally, some health departments
serve more than one county, and may span large geographic areas in the western
United States. Multicounty LPHAs may also include regional or district LPHAs
whose health directors may report to multiple county boards of health.
22
States gather data on “reportable” diseases and may use this information for a number of
disease control and prevention activities. In addition, when states gather information on
Nationally Notifiable Diseases, they submit this information to CDC for analysis,
publication, and formulation of national guidelines and recommendations. While states may
mandate the reporting of certain diseases by providers, the states’ reporting to CDC is
voluntary.
23
More information about the Association of State and Territorial Health Officials
(ASTHO), its affiliate groups, and links to state health departments may be found at
[http://www.astho.org/].
24
National Association of County and City Health Officials (NACCHO), Local Public
Health Agency Infrastructure: A Chartbook, Oct. 2001, at [http://www.naccho.org/
pubs/detail.cfm?id=169] (hereafter cited as NACCHO Chartbook).
CRS-13
Local public health agencies vary by the size of the population served. Over
two-thirds of LPHAs serve fewer than 50,000 people. In contrast, 4% of LPHAs
serve 500,000 or more. Not surprisingly, the number of workers employed by
LHPAs also varies tremendously. The average staff of a metropolitan LPHA is 108
full-time equivalent personnel (FTEs). However, half of metropolitan LPHAs have
28 or fewer FTEs. In nonmetropolitan areas, the average number of FTEs is 31, but
half of the LPHAs have 13 or fewer FTEs. Administrative and clerical staff,
environmental health specialists, and public health nurses are the occupational
categories most commonly used by LPHAs to describe the staff they employ.
The scope of services for which LPHAs are responsible also varies. In some
areas, the LPHA is responsible only for septic systems and restaurant inspections,
while in others the LPHAs may support a variety of public health programs as well
as run a county hospital. The most common bioterrorism-related programs and
services provided by LPHAs include epidemiology and surveillance, communicable
disease control, food safety, and restaurant inspections. The NACCHO survey shows
that over 70% of LPHAs provide adult and child immunizations, tuberculosis testing,
community health assessment, community outreach and education, environmental
health services, and health education.
How Is Public Health Funded?
Funding for public health comes from a variety of sources including local, state,
and federal government programs, foundations, insurance reimbursements, and
patient and regulatory fees. As noted above, vast differences exist in the scope of
activities, size of population served, and organization of the governmental public
health infrastructure at the state and local levels. Differences in accounting practices
and in definitions of public health activities make it difficult to gather comparable
national information on public health expenditures from all sources. One specific
difficulty involves counting all expenditures related to a common set of public health
activities (for example, environmental health) regardless of where they are in the
governmental structure.
Another particularly difficult problem is separating expenditures and receipts
for direct medical care services to individuals from those for population-based
services. A pilot study of two state and two local health departments, conducted in
1996, found that more than two-thirds of public health spending overall went toward
providing personal health care services rather than to population-based services,
though there was considerable variability between sites.25 This finding was used to
generate recently published estimates that showed total federal, state, and local
expenditures for population-based public health services of $17.1 billion,
representing 1.3% of total national health spending, for 2000.26 (While that reported
percentage had risen from a baseline of 0.7% in 1960, uncertainty in the estimates
means that this may not represent real growth. In any case, whatever growth may
25
Public Health Foundation, Measuring Expenditures for Personal Health Care Services
Rendered by Public Health Departments, Apr. 1997, at [http://www.phf.org/Reports.htm].
26
Senator Bill Frist, “Public Health and National Security: The Critical Role of Increased
Federal Support,” Health Affairs, vol. 21, no. 6, Nov./Dec. 2002, p. 117.
CRS-14
have occurred in public health spending over the years, it is dwarfed by spending
growth in other healthcare activities such as long-term care or prescription drugs.)
Federal spending accounted for 29% of public health spending, with state and local
spending making up the remainder. Estimates from a state-sponsored survey of nine
states done in the early 1990s yielded similar results, with 32% of spending for
population-based public health activities coming from federal sources, 50% from
states, and 18% from local sources.27 These estimates predated the terrorist attacks
of 2001 and therefore do not reflect the subsequent infusion of federal funds for
population-based public health preparedness activities.
A separate analysis of local health agency funding sources shows that, on
average, 44% of LPHA funding came from local sources, while 30% came from state
sources including pass-throughs of federal funding. An additional 3% of funding
came directly from the federal government to LPHAs and 19% came from fees or
service reimbursement.28 Metropolitan LPHAs tended to receive a larger share of
funding from local sources than did nonmetropolitan LPHAs.
HHS has provided support to a collaborative effort among state and local public
health associations to explore methods to measure actual public health expenditures
at the state and local level. Initial feasibility studies show some promise, but no
systematic accounting is currently conducted on a regular basis.29 With the recent
influx of federal funds for state preparedness for health department and hospitals,
Congress barred states from using the new federal funds to supplant existing statefunded programs, a requirement often referred to as maintenance of effort. Ensuring
compliance with this mandate has proven troublesome in the absence of consistent
terminology, program descriptions, and accounting systems from state to state. (For
a broader discussion of this problem, see the subsequent section on Fiscal
Accountability.)
Recent Congressional Action
The terror attacks of 2001, and especially the anthrax attacks, focused attention
on the critical role of the nation’s public health infrastructure, and in particular the
vulnerabilities at the state and local levels. Authorizing legislation and
appropriations passed after 2001 reflected new priorities in public health
preparedness. In some cases, new programs were created and funded. In other cases,
existing programs that were developed throughout the 1990s were expanded, both in
scope and in funding. This section discusses relevant authorizing legislation for HHS
and the Department of Homeland Security (DHS), and appropriations for selected
programs within these departments.
27
Public Health Foundation, Measuring Expenditures for Essential Public Health Services,
Nov. 1996, at [http://www.phf.org/Reports/Expend1/exec_summ.htm].
28
NACCHO Chartbook.
29
IOM Report.
CRS-15
The 109th Congress
A Senate leadership proposal, S. 3, The Protecting America in the War on
Terror Act of 2005 (Gregg), would provide expanded authorities to promote the
development of countermeasures (drugs, vaccines, biologics, other treatments and
tests for biological and chemical agents), begun with P.L. 108-276, the Project BioShield Act. The 109th Congress is likely to consider additional incentives for
countermeasures development, such as intellectual property incentives and protection
of manufacturers from litigation resulting from adverse reactions to countermeasures.
Congress is likely also to debate the scope of the federal role in spurring
technological innovation. (Project BioShield is described further in Appendix A.)
In addition, S. 3 would expand other public health preparedness programs,
including readiness for pandemic influenza, enhanced surveillance and border
inspections for human and animal diseases, and loan repayment programs to bolster
the workforce in governmental public health. The bill was referred to the Senate
Finance Committee.
A number of programs in P.L. 107-188, the Bioterrorism Act, are authorized
through 2006 and may therefore be considered for extension by the 109th Congress.
These programs include the Office of the Assistant Secretary for Public Health
Emergency Preparedness, the CDC state capacity grants, and the HRSA hospital
preparedness grants.
Authority for HRSA health professions programs in Title VII of the Public
Health Service Act expired in 2002, and may be considered for extension by the 109th
Congress. These programs are primarily intended to alleviate shortages and
maldistributions of healthcare workers, while the public health workforce has
received little federal attention over the years. Congress may wish to consider Title
VII programs in the context of preparedness in both the public health and healthcare
sectors. Public health workforce issues may also be discussed during consideration
of S. 3 or other vehicles. (Public health workforce issues are discussed in greater
depth in a subsequent section on Issues for the 109th Congress.)
Major Legislation in the 107th and 108th Congresses
Following the terror attacks of 2001, Congress passed the Public Health
Security and Bioterrorism Preparedness and Response Act (P.L. 107-188, signed
in June 2002, often called “the Bioterrorism Act”) to improve the nation’s readiness
for bioterrorism, emerging infectious diseases, and other public health threats and
emergencies. The program of CDC grants for state and local public health capacity
was reauthorized at $1.08 billion for FY2003, and such sums as may be necessary
through 2006.30 (The program had previously been authorized at $50 million for
30
The authorization for FY2002 funds was signed in June 2002, after the actual emergency
supplemental appropriation for FY2002 was passed in January 2002 and distribution of
awards to states was imminent. Conferees reported (in H.Rept. 107-481, accompanying P.L.
107-188) that they did not intend to delay or disrupt the ongoing awards process, and
(continued...)
CRS-16
FY2001, prior to the terrorist attacks.) The law stipulated a funding formula,
including a base amount plus an amount determined by population, with the intent
that every state and territory receive funding for a variety of core public health
preparedness activities. Under prior statutory authority, the grants had been
competitive.
The Bioterrorism Act also established, for the first time, a program of grants to
states to prepare hospitals, clinics and other healthcare facilities for bioterrorism and
other mass-casualty events, to be administered by the Health Resources and Services
Administration (HRSA). Congress authorized $520 million for this program in
FY2003, and such sums as may be necessary through 2006.
The Bioterrorism Act contained a number of other provisions for public health
preparedness. Title I of the Act included numerous additional provisions for building
federal public health capacity, including creation of the position of Assistant
Secretary for Public Health Emergency Preparedness (ASPHEP) at HHS, and
expansion of security and preparedness activities at CDC. Title I also expanded the
program for the national stockpile of drugs to treat potential victims of terrorism or
other public health emergencies, and changed its name from the National
Pharmaceutical Stockpile to the Strategic National Stockpile (SNS). Title II of the
Act called on the Secretary of HHS to register facilities (e.g., laboratories) and
individuals in possession of Select Agents, those biological agents and toxins that
pose a severe threat to public health and safety, and to promulgate new safety and
security requirements for such facilities and individuals. Title III contained several
provisions to protect the nation’s food and drug supply and enhance agricultural
security. Finally, Title IV of the act included provisions aimed at protecting the
nation’s drinking water supply, including authorizing $160 million to provide
financial assistance to community water systems to conduct vulnerability assessments
and prepare response plans.31
In creating the new Department of Homeland Security, Congress considered a
variety of public health preparedness programs and where they would best be located.
In the end, the Homeland Security Act (P.L. 107-296, signed in November 2002)
left most public health activities in HHS. P.L. 107-296 directed the Secretary of HHS
to collaborate with the Secretary of DHS in setting priorities for human-healthrelated countermeasures research and development and for all public-health-related
activities to improve state, local, and hospital preparedness and response, though
these programmatic activities remained at HHS.
The Project BioShield Act of 2004 (P.L. 108-276, signed in July 2004), created
market incentives for the development of drugs, vaccines, biologics, other treatments,
and tests for biological and chemical agents (collectively called countermeasures)
30
(...continued)
directed the Administration to continue its current approach to the awards.
31
For a summary of P.L. 107-188, see CRS Report RL31263, Public Health Security and
Bioterrorism Preparedness and Response Act (P.L. 107-188): Provisions and Changes to
Preexisting Law, by (name redacted), (name redacted), and Mary E. Tiemann.
CRS-17
that would not otherwise be attractive to entrepreneurs.32 In addition, budget
authority for the Strategic National Stockpile (SNS) was transferred from DHS back
to HHS in the Project BioShield Act, though both the Secretaries of HHS and of
DHS retain authority to deploy SNS assets in an emergency. CDC continues to
provide administrative management of the Stockpile, as it always has.
Major Legislation Prior to the 2001 Terrorist Attacks
Prior to the terrorist attacks of 2001, Congress passed the Public Health
Threats and Emergencies Act of 2000 (Title I of the Public Health Improvement
Act, P.L. 106-505) to address growing concerns about bioterrorism and emerging
infectious diseases, and about the ability of the public health system to respond.
Among other provisions, the law authorized $50 million for FY2001 (and such sums
as may be necessary through FY2006) for competitive grants to build capacity in
state and local health departments. This and other provisions would augment several
public health infrastructure programs begun by CDC in the 1990s, including grants
to states for epidemiology and laboratory capacity, and the creation of the Laboratory
Response Network for Bioterrorism to coordinate nationwide testing during an event.
In the Antiterrorism and Effective Death Penalty Act of 1996 (P.L. 104-132,
signed in April 1996), Congress called on the Secretary of HHS to establish a
program to identify and list specific infectious agents that could be used for
bioterrorism, and to require the registration of facilities (typically laboratories)
shipping those agents. The resultant Select Agent program is overseen by the CDC
and was expanded in scope in both law and regulation following the 2001 terrorist
attacks.
Appropriations
Following the 2001 terrorist attacks, an amendment to the FY2002 Defense
appropriations bill (P.L. 107-117), signed on January 10, 2002, provided HHS with
a total of $2.8 billion for bioterrorism-related activities in emergency supplemental
funds for FY2002. This included $940 million for CDC grants to states for public
health capacity, $135 million for a new program of HRSA grants to states for hospital
preparedness, and expanded funding for numerous federal activities including
biodefense research and the Strategic National Stockpile. In FY2003, the CDC
grants to states were maintained at $939 million and the HRSA hospital preparedness
program funding was increased to $514 million. Both the CDC and HRSA programs
have received funding at fairly comparable levels for FY2004 and FY2005, though
both were proposed for reduction in the Administration budget proposal for FY2005,
and again in FY2006.
In May 2004, before distributing public health capacity funds to the states, HHS
advised appropriators of a planned reallocation of the FY2004 CDC funds. In a letter
32
For more information on Project BioShield, see CRS Report RS21507, Project BioShield,
by (name redacted), and CRS Report RL32549,
Project BioShield: Legislative History and
Side-by-Side Comparison of H.R. 2122, S. 15, and S. 1504, by (name redacted) and Eric
Fischer.
CRS-18
to appropriators, former HHS Secretary Tommy G. Thompson requested redirection
of funds for CDC state capacity grants to create the Cities Readiness Initiative (CRI),
a plan to directly fund 21 major cities to ensure their ability to rapidly deploy
countermeasures from the Strategic National Stockpile in an emergency.33 (The CRI
is discussed in greater depth in a subsequent section.) In the letter, Thompson
expressed concern about delays in state planning and expenditure of funds for this
activity. Under the reallocation, which was approved, states received about $54.9
million less overall, about $1.08 million less per state. The 21 cities received funds
that included a base amount plus a supplement determined by population.34 Of the
reprogrammed $54.9 million, $27 million went to the designated cities, and $12
million to the U.S. Postal Service to explore the use of the postal service in delivering
countermeasures. The remaining $15.9 million went to certain federal programs,
some of which were first proposed in the FY2005 budget: these programs included
enhanced border inspection, integrated health surveillance, and expansion of the
BioWatch program of urban air monitoring.35 The HRSA grants to states for hospital
preparedness were not affected by the reallocation.
Some members of Congress, state governors, and stakeholder groups voiced
support for the premise of the CRI while arguing that funding should not have been
taken from the state public health capacity budget to fund it. Both the House and
Senate Committees on Appropriations upheld the prior CDC funding levels for state
and local capacity (i.e., levels before the reallocation) in FY2005 appropriations,
while providing additional funds to continue the CRI in funding for the
Biosurveillance Initiative.
Table 1 shows federal funding for selected public health preparedness programs
in HHS for FY2002 through FY2005, and proposed levels for FY2006.
33
Secretary of HHS Tommy G. Thompson, letter to congressional appropriators regarding
proposal to reallocate CDC funds, May 19, 2004.
34
Final FY2004 amounts distributed to states and cities through the CDC program are
tabulated at CDC, Continuation Guidance for Cooperative Agreement on Public Health
Preparedness and Response for Bioterrorism — Budget Year Five, FY2004 Funding
Distribution Chart — Attachment M, June 14, 2004, at [http://www.bt.cdc.gov/planning/
continuationguidance/index.asp].
35
For a discussion of these newly proposed programs, see HHS, President’s Budget Includes
$274 Million To Further Improve Nation’s Bio-Surveillance Capabilities, press release, Jan.
29, 2004.
CRS-19
Table 1. Appropriations for Selected Public Health Preparedness Programs
(dollars in millions)
Agency and Program
FY2002
enacteda
FY2003
enacteda
FY2004
enactedb
FY2005
enactedc
FY2006
requestd
HHS Office of the Secretary (OS)
$57
$62
$114
$163
$204
Influenza preparedness (non-add)e
NA
NA
(50)
(99)
(120)
State and local public health preparedness
940
1,039f
934g
927
797
Biosurveillance Initiative
NA
NA
22
79
79
CDC capacity/ anthrax research
160
176
175
159
140
CDC physical security and facilities
0
20
0
0
0
Independent studies
2
2
0
0
0
1,157i
398
398
396
600
NA
NA
NA
NA
(50)
$2,259
$1,635
$1,529
$1,560
$1,616
Hospital preparedness and infrastructure
135
514
515
491
483
Emergency Response Demonstration (non-add, new in FY2006)
NA
NA
NA
NA
(25)
Medical curriculum incentives
NA
28
28
28
28
Smallpox vaccination compensation program
NA
42
0
0
0
Subtotal, HRSA
$135
$584
$543
$519
$511
Centers for Disease Control and Prevention (CDC)
Strategic National Stockpile (SNS)h
Federal Mass Casualty Initiative (non-add, new in FY2006)
Subtotal, CDC
Health Resources and Services Administration (HRSA)
CRS-20
NA: Not applicable. Programs not yet implemented, or activities not yet being funded through a discrete budget line.
Note: Columns may not add due to rounding.
a. Source: Except where otherwise noted, HHS Budget in Brief for FY2004, Feb. 2003, section on Public Health and Social Services Emergency Fund, and H.Rept. 107-342, Conference
Report on appropriations for Labor, Health and Human Services and Education for FY2002, Dec. 19, 2001.
b. Source: HHS Budget in Brief for FY2005, Feb. 2004, section on Public Health and Social Services Emergency Fund, and H.Rept. 108-401, Conference Report on appropriations
for Labor, Health and Human Services and Education for FY2004, Nov. 25, 2003.
c. Source: Congressional Budget Justifications for CDC, HRSA, and HHS General Departmental Management for FY2006.
d. Source: HHS Budget in Brief for FY2006, Feb. 2005, section on Public Health and Social Services Emergency Fund.
e. Amount designated for year-round influenza vaccine production and pandemic preparedness, does not include a variety of HHS research and public health activities in influenza
detection, prevention, and control, principally at CDC and NIH.
f. Includes one-time funding of $100 million for the smallpox vaccination program from the FY2003 supplemental appropriation, P.L. 108-11, Apr. 16, 2003.
g. This was the amount available for distribution to states before reprogramming. With reprogramming, each state received approximately $1 million less than in the FY2003
distribution. The remaining funds were retained by HHS for the Biosurveillance Initiative, border inspection, and other activities, or distributed directly to 21 cities as part of
the Cities Readiness Initiative.
h. Comparable amounts, funds transferred from HHS to the Department of Homeland Security (DHS) for FY2003, and from DHS to HHS for FY2005. The SNS, formerly called the
National Pharmaceutical Stockpile, is administered by CDC.
I. Amount includes $52 million appropriated in P.L. 107-116, appropriations for Labor, Health and Human Services, and Education for FY2002, plus an additional $593 million for
general Stockpile activities and $512 million for smallpox vaccine purchase in P.L. 107-117, the Department of Defense and Emergency Supplemental Appropriations for
Recovery from and Response to Terrorist Attacks on the United States Act of 2002.
CRS-21
Issues for the 109th Congress
Overview
Since the 2001 terrorist attacks, Congress has authorized new programs, granted
new regulatory authorities, legislated reorganizations, and substantially increased
funding for homeland security activities across the executive branch. As a result,
areas ripe for programmatic and fiscal oversight are abundant, as are the challenges
in spending wisely and crafting programs that truly make the nation safer.
One such challenge is determining whether the right balance has been struck
between prevention, detection, and response, given that they often fall to different
departments or levels of government. Concerns about newly proposed surveillance
systems such as BioWatch and the Biosurveillance Initiative are illustrative. These
concerns include whether the systems will perform well enough to achieve their goal
of speeding detection of large-scale events, and therefore whether they are a good use
of resources, given competing demands. There is concern about federal and state
roles in conducting surveillance for the Biosurveillance Initiative, in particular
whether information from the system may bypass the states (which have traditionally
been the central collection points for public health data) and be collected directly by
federal agencies. State officials note that they may therefore be unaware of incidents
within their state until they are informed by federal authorities: hence, they are
interested in the means by which salient findings will be defined by federal agencies
and communicated to state and local officials and others needing to know. (Both
programs are discussed further in Appendix A.)
Despite the efforts that have gone into setting up or expanding a host of
preparedness programs at all levels of government, there are larger strategic questions
that remain without answers at this time. Should the emphasis be on specific
scenarios such as a smallpox attack or pandemic influenza, or should it instead be on
broader, all-hazards preparedness activities? Is bioterrorism preparedness properly
balanced with preparedness for chemical or radiological threats? Is the emphasis on
public health emergency preparedness in balance with efforts to prevent and control
major killers like cardiovascular disease and cancer? Threat assessments are vital
aids in these deliberations, but are often not available, or do not incorporate the
breadth of analysis needed to inform these larger trade-offs.36 In addition, setting
national priorities for preparedness in public health is always complicated by its
decentralized nature, with states rather than the federal government playing the lead
role in response. Congress is likely to continue its consideration of the place of
preparedness at the table of competing national priorities.
Some specific policy challenges are discussed in the following sections.
36
On April 21, 2004, President George W. Bush signed Homeland Security Presidential
Directive 10 (HSPD-10), which is classified. Among other activities, the directive requires
DHS to conduct ongoing capability assessments for biodefense, and a periodic national “net
assessment” of biodefense effectiveness and vulnerabilities. A non-classified summary of
HSPD-10 is available at [http://www.nimsonline.com/presidential_directives/hspd_10.htm].
CRS-22
Coordination Across Agencies and Levels of Government
In Title V of the Homeland Security Act, Congress called on the Under
Secretary for Emergency Preparedness and Response to build a comprehensive
national incident management system, and to consolidate existing federal government
response plans into a single, coordinated national response plan. On February 28,
2003, President Bush issued Homeland Security Presidential Directive/HSPD-5,
regarding the management of domestic incidents. HSPD-5 directed the Secretary of
Homeland Security to develop and administer a National Incident Management
System (NIMS), a consistent approach for federal, state, and local governments to
work effectively together in planning and response. The NIMS would establish a
common set of concepts, principles, and terminology to allow for unified command
during emergencies. HSPD-5 also directed the Secretary to develop and implement
a National Response Plan (NRP), to supersede the existing Federal Response Plan,
recognizing the need for integration of federal, state, and local governments in
responding to incidents. The NRP would designate federal agencies in lead or support
roles depending on the type of emergency, and would lay out the responsibilities of
federal agencies as well as those of state and local agencies. HSPD-5 also stipulated
that beginning in FY2006, federal departments and agencies must make adoption of
the NIMS guidelines a requirement, to the extent permitted by law, for recipients of
federal preparedness assistance through grants, contracts, or other activities. Public
health preparedness programs such as the CDC and HRSA state grants will be
affected by this requirement.
On March 1, 2004, former Homeland Security Secretary Tom Ridge announced
approval of the NIMS, following a protracted process of stakeholder review.37 The
National Response Plan was released on January 6, 2005.38 In a press release, former
Secretary of HHS Tommy G. Thompson announced that the plan maintains HHS as
the lead federal agency in providing public health and medical services during major
disasters and emergencies.39
In evaluating the NIMS and NRP as planning and response models, Congress
is likely to be interested in how well they meet their goals of improving nationwide
emergency preparedness and response, and how well states are meeting the
requirement to orient their activities toward the NIMS model. Congress, as a coequal branch of government, may also wish to consider the ramifications of
separation of powers on the response to emergencies on Capitol Hill. While the
legislative and judicial branches enjoy the prerogative to opt out of executive branch
37
DHS, “Department of Homeland Security Secretary Tom Ridge Approves National
Incident Management System (NIMS),” press release, Mar. 1, 2004. See also
[http://www.nimsonline.com/], a privately run website for NIMS stakeholders.
38
DHS, National Response Plan, Dec. 2004, at [http://www.dhs.gov/dhspublic/interapp/
editorial/editorial_0566.xml].
39
HHS, “HHS Maintains Lead Federal Role for Emergency Public Health and Medical
Response,” press release, Jan. 6, 2005.
CRS-23
preparedness activities, they may nonetheless depend on the executive branch for a
variety of activities and assets when incidents occur.40
Defining Goals, Setting Standards, and Measuring Progress
The term “bioterrorism” is often used as a catch-all for a variety of public health
threats and emergencies, including mass casualty events, chemical terrorism, and
infectious diseases that are naturally occurring. In P.L. 107-188, the Bioterrorism
Act, Congress required that preparedness be prioritized first to “bioterrorism or acute
outbreaks of infectious diseases,” and then to “other public health threats and
emergencies.” A persistent challenge is establishing the minimum level of capacity
that must exist in every locality, versus capacity that should be created on a more
consolidated basis at state, regional, or federal levels. Goals and priorities could be
informed by threat assessments conducted by national security and law enforcement
personnel, but health officials may not have access to this information, or may lack
experience in applying it to public health activities.
CDC and HRSA Critical Benchmarks. P.L. 107-188 calls for the Secretary
of HHS to collaborate with state and local governments to achieve national public
health preparedness, and to develop and implement a coordinated strategy that
includes specific benchmarks and outcome measures. In guidance for grantees
accompanying the FY2002 though FY2004 funds, HHS, CDC, and HRSA laid out
required activities, called Critical Benchmarks, intended to balance state autonomy
and disparate levels of preparedness with an obligation to assure responsible use of
federal resources and adequate preparedness nationwide. (Critical Benchmarks for
FY2002 through FY2004 are listed in Appendix C.) They were grouped by type of
activity, such as epidemiology, or communications and information technology,
called Focus Areas in CDC guidance and Priority Areas in HRSA guidance. In
addition, a series of Cross-Cutting Benchmarks required that certain activities be
coordinated across both funding programs, including Incident Management planning,
pandemic influenza preparedness, formation of a joint advisory committee to oversee
the CDC and HRSA cooperative agreements, and other activities.
Many of the benchmarks call for analyses, assessments, and plans to be
conducted or prepared by grantees. For example, a CDC Critical Benchmark for
FY2003 and FY2004 calls on states to “assess annually the adequacy of public health
response to catastrophic diseases (e.g., pandemic influenza), outbreaks, and other
public health emergencies.” Few of the benchmarks quantify specific needs such as
types of equipment or training of personnel. An example of a quantitative
requirement is the HRSA hospital preparedness Critical Benchmark for FY2004 that
requires states to “ensure that all participating hospitals have the capacity to maintain,
in negative pressure isolation, at least one suspected case of a highly infectious
disease.”
40
The National Response Plan states, on p. 7, that the executive branch may provide
assistance to the legislative and judicial branches during incidents. For more information
on Continuity of Operations in the Legislative Branch, see CRS Report RL31594,
Congressional Continuity of Operations (COOP): An Overview of Concepts and
Challenges, by (name redacted).
CRS-24
The General Accounting Office (GAO) commented on the lack of specificity
and utility of the benchmarks, noting that a lack of standards and performance
measures has hampered state preparedness efforts, leading to unfocused activities,
suboptimal use of funds, and gaps in readiness. The GAO said about the state
capacity grants, “State and local officials told us that specific benchmarks would help
them determine whether they were adequately prepared to respond to a bioterrorist
attack.”41 With respect to hospital preparedness, GAO was told by representatives
of the American Hospital Association that specific benchmarks for hospitals to use
in planning were lacking.42 And, noting the wide variations in information
technology (IT) readiness in state health departments, GAO said, “IT can more
effectively facilitate emergency response if standards are developed and implemented
that allow systems to be interoperable.”43
At a 2004 public meeting of the Secretary’s Council on Public Health
Preparedness, HHS reported aggregated results of its evaluations of state compliance
with Critical Benchmarks for the CDC and HRSA programs for FY2002.44 Also in
2004, GAO published aggregate results of its evaluation of state progress in meeting
the benchmarks for FY2002.45 Results of the two evaluations appear to concur, to
the extent that it can be determined from the often highly-aggregated results.
Individual states are not identified, which GAO cites as being due to security
concerns. Both reports group the benchmarks by higher or lower compliance rates,
clearly noting that some benchmarks proved more difficult to meet than others.
While GAO stated clearly that no state met all 14 CDC benchmarks, this cannot be
inferred from the corresponding CDC presentation. Except for GAO, no other parties
outside of HHS are known to have access to the full suite of state proposals, budgets,
and progress reports associated with the CDC and HRSA grants, and except for the
limited presentations of compliance with benchmarks from HHS and GAO, there are
no publicly available analyses of the range of elements of state and local
preparedness envisioned in the grant guidance for the two programs.
Next Steps. There are two goals in developing performance standards — that
they be measurable and that they be meaningful. The former task, discussed above,
is dwarfed in complexity by the latter. To develop standards that will measure actual
preparedness in a meaningful way begins with national intelligence activity to assess
threats, and incorporates a web of related activities such as assessments of
vulnerability and capability. Strategic planning of this scope is beginning at the
41
GAO, Bioterrorism: Preparedness Varied Across State and Local Jurisdictions, GAO03-373, Apr. 2003, p. 5.
42
GAO, Hospital Preparedness: Most Urban Hospitals Have Emergency Plans but Lack
Certain Capacities for Bioterrorism Response, GAO-03-924, Aug. 2003, pp. 9-10.
43
GAO, Information Technology Strategy Could Strengthen Federal Agencies’ Abilities to
Respond to Public Health Emergencies, GAO-03-19, May 2003.
44
See, for example, presentations of Donna Knutson and Melissa Sanders on the CDC and
HRSA programs respectively at the meeting of the Secretary’s Council on May 3-4, 2004,
at [http://www.hhs.gov/ophep/council.html ].
45
GAO, HHS Bioterrorism Preparedness Programs: States Reported Progress but Fell
Short of Program Goals for 2002, GAO-04-360R, Feb. 10, 2004.
CRS-25
Department of Homeland Security as a requirement of Homeland Security
Presidential Directive 10 (HSPD-10), but it is limited to biodefense readiness, rather
than all-hazards.46 Further, setting priorities and developing a strategy to meet goals
must be carried out at the national level, but also must be flexible enough to apply
to the states, with their various strengths and vulnerabilities.
The RAND Corporation has conducted a series of studies of public health
preparedness in California, designed as much to develop assessment tools as to
conduct the actual assessment. In one of its reports, RAND noted that:
The Little Hoover Commission, an advisory body to the California state
legislature, asked the RAND Corporation to assess gaps in California’s public
health infrastructure, beginning with an assessment of preparedness for a public
health emergency manifested as a contagious infectious disease. Note that there
are currently neither established standards for preparedness nor agreed-upon
methods and measures for assessing it.47
CDC was reported in 2003 to be developing a new set of indicators to measure
the progress of state and local jurisdictions, and was using a contractor to conduct
site visits and evaluate states.48 CDC has not made the proposed indicators publicly
available. But the agency did ask the Institute of Medicine’s (IOM’s) Committee on
Smallpox Vaccination Program Implementation, to evaluate the proposed indicators.
In December 2003, the Committee reported in a letter to the CDC Director that the
dual goals of the indicators — to measure grantees’ compliance with the cooperative
agreements and to measure state and local preparedness — could lead to an overly
large set of indicators that serve neither purpose well. The Committee cautioned that
evaluations based on outcomes require a longer-term, national deliberative process.49
The Committee also opined that separate indicators should be developed and applied
to state versus local jurisdictions, and that federal agencies themselves should also
be held accountable through similar evaluations. In addition, based on feedback from
a variety of stakeholders in response to the indicators, the Committee noted the need
for greater emphasis on communication and collaboration across jurisdictions and
levels of government, and commented that the proposed indicators did not support
this objective.
46
A non-classified summary of HSPD-10 is available at [http://www.nimsonline.com/
presidential_directives/hspd_10.htm].
47
Nicole Lurie et al., “Public Health Preparedness in California: Lessons Learned from
Seven Health Jurisdictions,” Technical Report 81, RAND Corporation, Aug. 2004, at
[http://www.rand.org/publications/index.html].
48
See Jonathan Radow, “CDC Develops Bioterror Scenarios to Evaluate Preparedness
Indicators,” Washington Fax, Nov. 19, 2003; and “Preparedness; U.S. Plans to Grade States’
Bioterrorism Plans,” Medical Letter on the CDC and FDA, Dec. 7, 2003.
49
IOM, Committee on Smallpox Vaccination Program Implementation, Review of the
Centers for Disease Control and Prevention’s Smallpox Vaccination Program
Implementation, Letter Report #5, Dec. 19, 2003, at [http://books.nap.edu/html/
smallpox_vac/letter_report5.pdf].
CRS-26
CDC and HRSA are scheduled to release updated grant guidance for FY2005
funds in the Spring of 2005. For CDC, the cooperative agreement program is slated
for a complete revision, and the agency reportedly continues to work toward a
meaningful set of performance measures for the program, to replace the Critical
Benchmarks. Because the two programs are closely intertwined, HRSA is expected
to remodel its guidance to remain compatible with the CDC program. (In the past,
the agencies shared a set of Cross-cutting Benchmarks in guidance for common
activities. These are found in Appendix C.) Both agencies are expected to reflect
in their program guidance the new requirement that recipients of federal preparedness
grants be compliant with the National Incident Management System for FY2006.
Congress may be interested in reviewing the revised CDC and HRSA guidance
documents for FY2005 to determine whether they reflect sufficient progress in the
development of meaningful performance measures for public health preparedness,
and whether the new measures will allow Congress to better assess how much
progress has been made since funding was enhanced in FY2002. In addition,
Congress may wish to review the use of the enhanced preparedness funds to date, and
may for example request that the Secretary of HHS provide information such as the
breakdowns of funds used according to Focus or Priority Areas, or for specific
functions such as equipment, personnel, and contracts. Congress may also be
interested in evaluating the process by which HHS, CDC, and HRSA review state
plans and progress reports. Finally, Congress may wish to evaluate state activities
to determine whether certain concerns it voiced in the Bioterrorism Act have been
adequately addressed, such as consideration of the special needs of children and other
vulnerable populations, preparedness in rural areas, coordination with tribal nations
and foreign governments, and preparedness for the mental health consequences of
disasters.
Fiscal Accountability
Supplanting of Funds. In P.L. 107-188, the Bioterrorism Act, Congress
authorized $1.6 billion in appropriations for the CDC and HRSA programs to prevent
or respond to “bioterrorism or acute outbreaks of infectious diseases” and “other
public health threats and emergencies.” Congress did not impose a matching
requirement on use of these funds, but it did direct that the amounts appropriated
“shall be used to supplement and not supplant other State and local public funds
provided for activities under this section.” (This requirement to sustain state funding
levels is often referred to as maintenance of effort.) But some states, facing acrossthe-board budget pressure, have cut health department funding coincident with the
influx of federal funds.50 Appropriations Committees in both the House and Senate
expressed concern about supplanting in their reports on HHS appropriations for
FY2004. In December 2004, Trust for America’s Health (TFAH), a public health
advocacy group, issued a state preparedness report card in which it found that 15
50
See Stephen Smith, “Anthrax vs. the Flu,” Boston Globe, July 29, 2003, p. C4; and
Rebecca Cook, “Budget Cuts Imperil Health,” Associated Press, in The Seattle Times, Mar.
12, 2003.
CRS-27
states had cut their state budgets for public health since 2003.51 TFAH had
previously reported that 32 states had cut their state public health budgets from 2002
to 2003, and recommended that CDC institute measurable preparedness standards for
state and local health departments to ensure accountability and efficient distribution
of funding.
In 2004, the HHS Inspector General (IG) published an audit of 17 states’ use of
CDC capacity funds and reported:
In response to our questionnaire and during our onsite interviews, officials from
all 17 awardees asserted that Federal bioterrorism program funding had not
supplanted existing State or local bioterrorism programs... . We did not validate
their assertions. We have scheduled in-depth reviews at selected awardees that
will include an analysis of the supplanting issue.52
Ensuring compliance with the prohibition against supplanting has proven
troublesome in the absence of consistent terminology, program descriptions, and
accounting systems from state to state. The Office of the IG prepared an audit guide
for states to assist them in managing the grants, in which it was stated that evidence
of supplanting will exist when there have been decreases in state or other nonfederal
revenues or person-hours in any public health programs in “infectious diseases,
bioterrorism, or emergency preparedness and response.”53 (These categories roughly
correspond to priorities in authorizing language.) Given this broad definition of
relevant programs, if states are cutting immunization and other infection control
programs, as news reports suggest, then it appears that the types of trade-offs
Congress intended to avoid are occurring.
In FY2003, HHS required states to adopt a comprehensive tracking system to
account for federal funds from the CDC and HRSA preparedness programs. While
this is likely to improve an understanding of the fate of federal dollars, it is not likely
to illuminate the matter of supplanting, since it will not track health department
revenues from other sources. Future IG audits may offer a more critical analysis of
budgets in each state. But there remains the need for consistent terminology and
definitions of programs for which maintenance of effort is required, and a consistent
approach to budget documentation in every state. Until this is accomplished it is not
clear how, as a practical matter, the prohibition against supplanting might be
enforced.
Pass-Through of Funds to Local Governments and Hospitals.
Concerns have been expressed that CDC and HRSA funds do not filter down from
states to a variety of sub-recipients, including municipal and local health
51
Trust for America’s Health, Ready or Not: Protecting the Public’s Health in the Age of
Bioterrorism 2004, Dec. 2004, at [http://healthyamericans.org/reports/bioterror04/].
52
HHS, Office of Inspector General, “Nationwide Audit of State and Local Government
Efforts to Record and Monitor Subrecipients’ Use of Public Health Preparedness and
Response for Bioterrorism Program Funds” (A-05-04-00027), Aug. 5, 2004.
53
HHS, Office of the Inspector General, Office of Audit Services, “Review of Public Health
Preparedness and Response for Bioterrorism Program Funds, Audit Guide,” Oct. 24, 2002.
CRS-28
departments, smaller healthcare facilities, and tribal nations. In P.L. 107-188,
Congress provided that:
... for fiscal year 2003, the Secretary (of HHS) shall in making awards under this
section ensure that appropriate portions of such awards are made available to
political subdivisions, local departments of public health, hospitals (including
children’s hospitals), clinics, health centers or primary care facilities, or
consortia of such entities.
In accompanying report language, Congress requested that HHS report to the
Committees on Appropriations detailing the amounts of FY2002 funds that are
provided to subrecipients.54
CDC guidance does not stipulate a specific pass-through amount for local health
departments, though the intent that they be adequately supported is noted in guidance
for FY2003 as follows:
Applications shall provide evidence of a process that demonstrates consensus,
approval or concurrence between state and local health officials for the proposed
use of these funds. ... Because of the high degree of variability in financing,
organization, and governance in state and local health departments across the
United States, there is no single best approach for achieving such consensus; ...
Local capacity can be built through direct allocation of funds to local levels and
through allocations to support state or sub-state regional capacities that directly
benefit local communities. Even in those states that operate local health
departments, appropriate local capacity development must be ensured. The focus
of funding allocations should be on benefit achieved, not on who spends the
dollars.55
HRSA guidance does require a specific pass-through amount, as follows:
At least 80% of the funds awarded for direct costs must be clearly allocated to
hospitals, outpatient facilities, EMS systems and poison control centers, through
written contractual agreements or purchase orders.56
In a June 2003 report to Congress, HHS reported that it surveyed grantees (but
did not review their progress reports on this matter) and found that overall, 41% of
funds were directly allocated by states to local health departments or jurisdictions
(“local agencies”), and an additional 33% were spent or planned to be spent by states
for the benefit of local jurisdictions.57 HHS noted that respondents had difficulty
54
H.Rept. 108-10, the conference report to accompany H.J. Res 2, “Making Further
Continuing Appropriations for Fiscal Year 2003, and for Other Purposes,” Feb. 13, 2003,
p. 1121.
55
CDC guidance, Program Announcement 99051, May 2, 2003, p. 1, at
[http://www.bt.cdc.gov/planning/continuationguidance/index.asp].
56
HRSA, National Bioterrorism Hospital Preparedness Program, Cooperative Agreement
Guidance, May 2, 2003, pp. 25-26.
57
U.S. Department of Health and Human Services, Office of the Secretary, Report to
(continued...)
CRS-29
interpreting both “local agency,” reflecting the nationwide diversity of systems of
local health jurisdiction, and “benefit,” noting that while the CDC provides general
guidance that “benefit” refers to purchase of goods or services, many states may have
chosen a broader interpretation.
CDC and HRSA guidance for FY2003 included a new requirement, designated
as Critical Benchmark #1 and repeated in FY2004, for states to develop and maintain
financial accounting systems capable of tracking expenditures by focus area, critical
capacity or priority area, and of tracking funds provided to subrecipients. The new
benchmark was developed to improve HHS’s ability to compare proposed versus
actual expenditures, monitor the outflow of funds to hospitals and local health
departments, and otherwise improve accountability.
Congress may be interested in evaluating states’ use of public health
preparedness funds, and may consider requesting information from the Secretary of
HHS on specific matters such as pass-through funding. Congress may wish to ensure
state maintenance of effort by determining whether states may be required to provide
certain information about state budget activities in order to receive federal funds, or
through use of special studies, surveys, or demonstration projects to explore
alternative accounting procedures for states. In addition, Congress may wish to
consider alternative means to assure that federal funds are used to augment rather
than supplant existing state activities, such as a requirement for state matching funds.
Public Health Workforce Shortages
Since the terror attacks of 2001, the need for a responsive public health
workforce is apparent, but ensuring and sustaining a competent workforce for
governmental public health is a challenge. GAO reported in 2002 that “shortages of
personnel existed in state and local health departments, laboratories, and hospitals
and were difficult to remedy.”58 In its 2003 report, Major Management Challenges
and Program Risks: Department of Health and Human Services, GAO noted:
Increasing staffing of public health departments and laboratories is a top priority
for enhancing preparedness in many areas. Officials told us that they did not
have enough trained epidemiologists, laboratory technicians, and other
professionals to respond to the anthrax incidents while meeting normal, day-today responsibilities ... .59
Federal, state, and local governments may be in competition for a finite group
of workers, as CDC Director Julie L. Gerberding noted, saying, “We’re competing
57
(...continued)
Congress: FY2002 Bioterrorism State and Local Preparedness Funding, undated,
transmitted to the U.S. House of Representatives Committee on Appropriations on June 13,
2003.
58
GAO, Bioterrorism: Preparedness Varied Across State and Local Jurisdictions, GAO03-373, Apr. 2003, p. 17.
59
GAO, Major Management Challenges and Program Risks: Department of Health and
Human Services, GAO-03-101, Jan. 2003.
CRS-30
over the same group of talented people. It takes time to hire and train people and our
pipeline in our schools is not a torrent. It’s more like a trickle.”60 The Partnership
for Public Service reported that the federal government was unable to match salary
growth in the private sector since 2001, resulting in migration of talent away from
public service, and that nearly half of all federal employees in biodefense-related
positions will be eligible for retirement within five years.61 A 2003 survey of the
state public health workforce showed an average age of 46.6 years (older than the
average for all state government workers and the general U.S. workforce), higherthan-average rates of retirement eligibility, high turnover rates, persistent vacancies,
and chronic shortages of public health nurses, epidemiologists, laboratory scientists
and environmental health professionals.62
The public health workforce encompasses a wide range of professional
disciplines and occupations. Some of the most common are physicians, nurses,
environmental specialists, laboratorians, health educators, disease investigators,
outreach workers and managers. Recent attempts to enumerate the public health
workforce yielded estimates of roughly 450,000 workers employed approximately
evenly at the local, state, and national levels.63 Enumeration is tricky because public
health workers are not captured in the standard categories used by the Department of
Labor.64 They are likely to be counted as physicians, nurses, technicians, or other
practitioners, depending on which degrees they may hold (if any), but the
classification scheme misses the fact that their “practice” is on populations rather
than individuals. An analysis of efforts to enumerate workers in the nation’s local
health departments found that Department of Labor statistics did not correspond in
meaningful ways with actual workers and their roles, and concluded that “no state or
national system is in place to track local public health workers in any way.”65 Efforts
to bolster the public health workforce suffer from this basic failure to understand who
these workers are. What types of training do these individuals have? What
60
Testimony of CDC Director Julie L. Gerberding in the U.S. Congress, Senate Committee
on Health, Education, Labor and Pensions, Federal Biodefense Readiness, 108th Cong., 1st
sess., July 24, 2003 (hereafter cited as Testimony of CDC Director, Biodefense Readiness).
61
Partnership for Public Service, Homeland Insecurity: Building the Expertise to Defend
America from Bioterrorism, July 2003, at [http://www.ourpublicservice.org/].
62
Association of State and Territorial Health Officials, State Public Health Employee
Worker Shortage Report: A Civil Service Recruitment and Retention Crisis, 2004, at
[http://www.astho.org/pubs/Workforce-Survey-Report-2.pdf], hereafter cited as ASTHO
workforce report.
63
HHS, Health Resources and Services Administration, Bureau of Health Professions, The
Public Health Workforce: Enumeration 2000, Dec. 2000, available at [http://bhpr.hrsa.gov/
healthworkforce/reports/default.htm].
64
For a broader discussion of this problem, see CRS Report RL32546, Title VII Health
Professions Education and Training: Issues in Reauthorization, section on “Defining and
Enumerating the Health Workforce,” by (name redacted), (name redacted), and
Sharon Kearney Coleman.
65
Michael R. Fraser, “The Local Public Health Agency Workforce: Research Needs and
Practical Realities,” Journal of Public Health Management and Practice, vol. 9, no. 6, 2003,
pp. 496-499.
CRS-31
proportion of their time is spent solely on public health practice, versus personal
health care, teaching, or research?
CDC maintains a public health workforce program that looks broadly at the
problem from a “pipeline” perspective. Its most recent strategic plan for public
health workforce development predates the 2001 terror attacks, though activities are
ongoing to bolster the workforce in the context of terrorism and emergency
preparedness, and workforce development is one of the strategic imperatives in
CDC’s strategy for terrorism preparedness and emergency response.66
Though HRSA has conducted analyses of the health workforce, its emphasis has
been on healthcare rather than on public health functions such as surveillance,
outbreak investigation, and facility inspections. More recently HRSA is funding
studies of the public health workforce in several states. In addition, the agency
supports a number of programs to train public health professionals on the job. Since
the terror attacks of 2001, HRSA has provided grants for a new Bioterrorism
Training and Curriculum Development Program, to train healthcare providers in
recognition and treatment of diseases related to bioterrorism.
Despite these efforts, there have been repeated calls for a national strategy aimed
at ensuring a skilled, sustainable workforce for public health preparedness, without
it coming at the expense of routine public health activities.
In 2002 the Institute of Medicine proposed a plan for educating public health
professionals for the 21st century, recommending degree programs in schools of
public health, medicine, and nursing. The Association of State and Territorial Health
Officials (ASTHO) responded that training programs alone will not remedy public
health worker shortages, and that the problem requires a strategy that takes into
account the human resources systems, salary structures, and incentives in
governmental public health.67 In a 2004 report on shortages of state public health
workers, ASTHO called for “a well-coordinated effort on the part of the public health
agencies, legislatures, institutes of higher learning, and the federal government to
help improve the outlook for the future workforce.”68 The Association of Public
Health Laboratories has said that “the nationwide shortage of skilled laboratorians
cannot be addressed through short-term funding support, but requires a long-term
national strategy.”69 The Partnership for Public Service noted, “There is no
governmentwide planning effort that develops a coordinated recruitment plan for the
numerous federal agencies responsible for biodefense. ...We have seen no analysis
66
See CDC, Office of Workforce Policy and Planning Home Page, at
[http://www.phppo.cdc.gov/owpp/], and testimony of CDC Director, Biodefense Readiness.
67
Institute of Medicine, Who Will Keep the Public Healthy? Educating Public Health
Professionals for the 21st Century, Nov. 2002, and Who Will Keep the Public Healthy?,
workshop summary, Aug. 4, 2003, at [http://www.iom.edu].
68
69
ASTHO workforce report, p. 13.
Association of Public Health Laboratories, “Public Health Laboratory Issues In Brief:
Bioterrorism Capacity,” Oct. 2002, at [https://www.aphl.org/docs/BTIssuebrief%
20final%20Oct02.pdf].
CRS-32
that identifies the numbers and types of employees needed in response to the most
likely bioterrorist threats.”70 The Gilmore Commission recommended in 2002 that
“(HHS) fund studies aimed at modeling the size and scope of the healthcare and
public health workforce needed to respond to a range of public health emergencies
and day-to-day public health issues.”71 With the release of its fifth and final report
one year later, the Commission noted that this recommendation was one of few that
had not yet been implemented.72
Congress may wish to consider whether federal leadership to develop a national
strategy for a prepared public health workforce should properly reside at CDC, at
HRSA, or elsewhere. This discussion may take place in consideration of S. 3, the
Protecting America in the War on Terror Act of 2005 (Gregg), which contains a
provision for loan repayment programs to bolster the workforce in governmental
public health. It may also be considered in the reauthorization of HRSA health
professions programs in Title VII of the Public Health Service Act, which is expected
during the 109th Congress, or in other venues.
Conclusion
The events of fall 2001 have heightened concern about the nation’s ability to
respond to terrorist attacks. The strength of the public health infrastructure at the
federal, state, and local levels is an important determinant of the speed and
effectiveness with which a response occurs and, therefore, of the severity of the
consequences in terms of number of people affected. Recent congressional action
has provided funding and guidance to improve national public health capacity.
Serious challenges remain in balancing competing priorities, maintaining
accountability, and coordinating efforts between and across levels of government.
70
GAO, Major Management Challenges and Program Risks: Department of Health and
Human Services, GAO-03-101, Jan. 2003.
71
Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving
Weapons of Mass Destruction, Fourth Annual Report to the President and Congress, Dec.
2002, p. 55, at [http://www.rand.org/nsrd/terrpanel/]. Commonly known as the Gilmore
Commission after its chair, former Virginia Governor James S. Gilmore III, the Panel was
established in the National Defense Authorization Act for FY1999 to assess the federal,
state and local capabilities for responding to terrorist incidents in the United States.
72
Advisory Panel to Assess Domestic Response Capabilities for Terrorism Involving
Weapons of Mass Destruction, Fifth Annual Report to the President and Congress, Dec.
2003, at [http://www.rand.org/nsrd/terrpanel/].
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Appendix A: Selected Programs in the Department
of Health and Human Services
In general, public health preparedness programs are coordinated by the HHS
Office of Public Health Emergency Preparedness (OPHEP),73 which may also serve
as the lead for specific programs (e.g., Project BioShield). The OPHEP may also
coordinate with other entities in the Secretary’s Office. For example, according to
the HHS Draft Pandemic Influenza Preparedness and Response Plan, the Assistant
Secretary for Health (ASH) is responsible for pandemic preparedness activities and
monitoring, while the Assistant Secretary for Public Health Emergency Preparedness
(ASPHEP) is responsible for pandemic response activities.74 The ASPHEP is
advised by the Secretary’s Council on Public Health Preparedness.75
This section will discuss key HHS programs to build the nation’s public health
capacity for responding to terrorism and other emergencies. For each program one
agency typically serves in a lead role, and this agency is stated. For many homeland
security programs, other agencies have complementary roles, and these are discussed
as appropriate. The section is organized into two parts: programs that principally
build federal or national public health capacity, and programs that principally build
state and local public health capacity. These categories are selected for convenience
and should not be overinterpreted. Most programs build capacity at both levels: for
example, the CDC grant program for state and local capacity, by building capacity
in all the states, also therefore builds capacity nationally.
Programs That Build Federal or National Capacity
Project BioShield (OPHEP). Project BioShield was announced by President
Bush in his State of the Union address on January 28, 2003. The purpose of the
program is to accelerate the research, development, purchase, and availability of
countermeasures (e.g., drugs, vaccines, and antidotes) against biological, chemical,
and radiological threats. (Often these products are unattractive to the pharmaceutical
industry because they are not likely to have routine uses.) Three legislative proposals
were considered in the 108th Congress, and the Project BioShield Act of 2004 (P.L.
108-276) was signed on July 21, 2004. The law includes provisions to relax
procedures for bioterrorism-related procurement, hiring, and awarding of research
grants; to guarantee a government market for new countermeasures; and to permit
emergency use of unapproved countermeasures. The 109th Congress is likely to
consider additional incentives for countermeasures development, such as intellectual
73
For more information, see the OPHEP Home Page at [http://www.hhs.gov/ophep/
index.html]. The role of the OPHEP is further explained in HHS, “Office of Public Health
Emergency Preparedness Statement of Organization, Functions, and Delegations of
Authority,” 70 Federal Register 5183, Feb. 1, 2005.
74
HHS, Draft Pandemic Influenza Preparedness and Response Plan, Core Document, Aug.
2004, p. 20, available at [http://www.hhs.gov/nvpo/pandemicplan/index.html].
75
The charter, membership, and meeting information for the Secretary’s Council on Public
Health Preparedness is at [http://www.hhs.gov/ophep/council.html ].
CRS-34
property incentives, and protection of manufacturers from litigation resulting from
adverse reactions to countermeasures. Congress is likely also to debate the scope of
the federal role in spurring technological innovation.76
Biosurveillance Initiative/BioSense (CDC). On January 29, 2004, in
anticipation of the Administration budget proposal for FY2005, the Secretaries of
Homeland Security and HHS announced a new Biosurveillance Initiative (BI),
involving their departments and the Department of Agriculture.77 The initiative
would gather data from existing sources of anonymous or de-identified health
information, such as hospital laboratory reports and sales of over-the-counter drugs.
(Collection and analysis of this type of pre-diagnostic health data is often called
syndromic surveillance.) Environmental monitoring data, such as food testing results
and findings of the BioWatch network of urban air monitors, would be integrated as
well. The project is intended to gather, integrate, and analyze these data in real-time.
The BI is one of a number of public health data mining activities proposed since
the terror attacks of 2001.78 The initiative would expand the BioSense program at the
CDC, which integrates traditional and novel sources of public health data to
“enhance detection, quantification and localization of possible bioterrorism attacks
and outbreaks ... [and to] support subsequent case identification, epidemiological
investigation, response, medical consequence management and recovery
operations.”79 Some reports have suggested that eventually data mining for the
initiative will be conducted by the Department of Homeland Security, but that this
activity is in its early stages and is currently performed at CDC.
In addition to improving detection and response to health emergencies, other
potential benefits of the BI may include strengthening of the public health
infrastructure in general, and better coordination of response partners at the local,
state, and federal levels. In particular, the initiative is a means to improve ongoing
collaborations between the public health and healthcare sectors. As with other eventdetection systems, the trade-off for enhanced detection is the generation of falsepositive findings to which state and local public health agencies must respond. This
must be incorporated in program implementation.
Criticisms of the initiative are similar to those for other newly proposed
surveillance systems such as BioWatch. These include concerns about whether the
76
For more information, see CRS Report RS21507: Project BioShield, by (name redacted);
and CRS Report RL32549: Project BioShield: Legislative History and Side-by-Side
Comparison of H.R. 2122, S. 15, and S. 1504, by (name redacted) and Eric Fischer.
77
HHS, President’s Budget Includes $274 Million To Further Improve Nation’s
Bio-Surveillance Capabilities, press release, Jan. 29, 2004.
78
The proposal was listed among data mining projects identified by the GAO in Data
Mining: Federal Efforts Cover a Wide Range of Uses, GAO-04-548, May 4, 2004. For more
information on data mining and examples of other federal programs, see CRS Report
RL31798, Data Mining: An Overview, by (name redacted).
79
CDC, “BioSense: Update for Secretary’s Council,” presentation by John Loonsk to HHS
Secretary’s Council on Public Health Preparedness, May 4, 2004.
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system will perform well enough to achieve its goal of speeding detection of largescale events, and therefore whether it is a good use of resources, given competing
demands. There is concern about federal and state roles in conducting surveillance,
in particular the fact that certain information would bypass the states (which have
traditionally been the central collection points for public health data) and be collected
directly by federal agencies. State officials note that they may therefore be unaware
of incidents within their state until they are informed by federal authorities: hence,
they are interested in the means by which salient findings will be defined by federal
agencies and communicated to state and local officials and others needing to know.
In addition, while the proposed system is intended to detect health events rather than
individuals (be they victims or perpetrators), there may nonetheless be privacy
concerns.
Laboratory Response Network (CDC).80 The CDC established the
Laboratory Response Network (LRN) in response to Presidential Decision Directive
39 (PDD-39), issued by President Clinton in 1995 following the bombing of a federal
building in Oklahoma City. PDD-39 outlined national antiterrorism policies and
assigned specific missions to federal departments and agencies. CDC, along with the
Federal Bureau of Investigation (FBI) and the Association of Public Health
Laboratories, launched an operational network of local, state, and federal government
laboratories in 1999. The network provides coordinated sample collection, transport,
testing, surge capacity, and training for laboratory readiness to identify key biological
and chemical agents.
The LRN was in place when the anthrax attacks occurred in 2001. Nonetheless,
the attacks challenged the network’s resources and exposed a gap in planning for
communication of results. Between October and December 2001, the LRN processed
more than 125,000 samples for anthrax (resulting in more than 1 million individual
analyses), including testing directly related to anthrax cases and exposures in seven
states and the District of Columbia, and testing of threat samples in all the remaining
states.
Most clinical laboratories, which serve hospitals, clinics, and other first-pointsof-contact for victims, are not familiar with or are not equipped to handle pathogens
likely to be used in a bioterrorist attack. According to LRN protocol, clinical lab
personnel contact state public health laboratories when they encounter suspected
bioterrorism agents, and the state labs conduct testing to confirm the presence of the
agents. At this time, more than 100 labs, including all 50 state public health labs,
some large metropolitan public health labs, and labs at numerous federal agencies
serve as reference laboratories in the LRN. CDC develops the confirmatory or
reference tests, and transfers technology to the reference labs. In this way, reference
testing is decentralized and accessible in most states within a day’s drive. In
addition, advanced training in the identification of rare bioterrorism agents, the
specialized test methods often required to identify them, and the safety and security
measures required by law when handling these organisms, need only be available in
the reference labs, not in the thousands of clinical labs nationwide. LRN labs at CDC
80
Information for this section is found on the CDC LRN Home Page and supporting
materials at [http://www.bt.cdc.gov/lrn/].
CRS-36
and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)
at Fort Detrick in Maryland, which have BioSafety Level-4 (BSL-4) facilities to
handle the most dangerous pathogens, can provide advanced technical support such
as microbial forensic analysis during an event.
The LRN incorporated chemical testing following the 2001 terrorist attacks,
using a different model in which CDC and five state labs provide national reference
testing for a variety of agents, while the majority of the remaining states provide
limited testing for cyanide and some toxic metals. The states that provide the full
menu of testing are California, Michigan, New Mexico, New York, and Virginia.
Federal funding to support state laboratory capacity for biological and chemical
testing required by the LRN is provided in the CDC state capacity grants for Focus
Area C (biological) and Focus Area D (chemical). The funding is used to assist
states in meeting Critical Benchmarks for laboratory preparedness, such as having
BioSafety Level 3 (BSL-3) capability in all states. (See Critical Benchmarks for
Focus Areas C and D in Appendix C.)
Select Agent Program (CDC).81 The Select Agent Program was first
established by the Antiterrorism and Effective Death Penalty Act of 1996 (P.L. 104132). The law required the Secretary of HHS to regulate the transfer (though not the
possession) of so-called select agents, organisms and toxins that could potentially be
used for bioterrorist attacks. The initial Select Agent regulation (42 C.F.R. § 72.6),
administered by the CDC, required the registration of any laboratory shipping or
receiving the agents, and documentation of these transfers. The CDC developed a
list of select agents, which are those viruses, bacteria, fungi, and toxins that may pose
a severe threat to public health and safety.
The Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (P.L. 107-188) expands the scope of the Select Agent provisions by requiring
all facilities possessing select agents, not just those shipping or receiving them, to
register with CDC. In addition, P.L. 107-188 instructs the HHS Secretary, in
consultation with the Attorney General, to establish lab safety and security
requirements for registered facilities “commensurate with the level of risk to public
health and safety,” and to institute background screening for all persons seeking
access to select agents. It also mandates the creation of a national database with
information on all facilities and persons handling select agents, and directs HHS to
review and, if necessary, revise the list of select agents biennially. In P.L. 107-188,
the Select Agent program was authorized through 2007 with an indefinite
appropriation.
P.L. 107-188 gives the Department of Agriculture (USDA) similar authority to
develop a list of biological agents and toxins that may pose a severe threat to crops
and livestock and to regulate facilities that possess, use, or transfer those agents and
toxins. The law instructs HHS and USDA to coordinate their activities regarding
so-called overlap agents, those agents that affect both human and animal health and
that therefore appear on both agencies’ lists. Both the bioterrorism law and the USA
81
See the CDC Select Agent Program Home Page at [http://www.cdc.gov/od/sap].
CRS-37
PATRIOT Act (P.L. 107-56) prohibit certain groups of individuals — based on
criminal history, immigration status, and other factors — from having access to select
agents.
P.L. 107-188 grants the Secretary of HHS authority to waive Select Agent
requirements as necessary in the face of a public health emergency, or when
requested by the Secretary of Agriculture in the face of an agricultural emergency, in
order to facilitate response activities. This emergency waiver was granted for
soybean rust, a serious plant pathogen that entered the United States in the Fall of
2004.82
In December 2002, HHS and USDA issued interim final regulations to
implement the expanded program. (The HHS regulation is codified at 42 C.F.R.
§ 73.0, and the USDA regulation at 7 C.F.R. Part 331 and 9 C.F.R. Part 121). All
labs possessing select agents were required to submit detailed security, training, and
record-keeping plans in order to be registered by either HHS or USDA. (Those in
possession of only the overlap agents need only register with one or the other, not
both.) In addition, researchers had to undergo security background checks by the
FBI.
Institutions were to be in full compliance by November 12, 2003. An institution
that had not been granted a certificate of registration by that date would not be
permitted to possess, use, receive, or transfer select agents. Researchers, biosafety
experts, and lab administrators complained that the deadline was unrealistic and that
the substantial work needed for compliance might interrupt, delay, and possibly
discourage research. In fact, the FBI was unable to complete all the security checks,
and HHS and USDA were unable to finish reviewing all the applications, in time to
meet the deadline. Thus, on November 3, 2003, in order to avoid a disruption of
ongoing select agent research, CDC and USDA issued revised regulations allowing
labs and researchers to obtain a “provisional” certification, provided they had
submitted all the appropriate paperwork. The agencies are now reported to have
processed their backlogs, and have certified those laboratories and individuals that
met the criteria laid out in the regulation. The agencies are now able to work on new
applications.
P.L. 107-188 prohibits federal agencies from releasing information about
registered facilities. There was initially some confusion as to whether this provision
applied to sharing information with state governments, which could use the
information to identify in-state vulnerabilities for emergency planning purposes.
While states and individual labs are not subject to the prohibition, CDC urges them
to consider security risks that may result from disclosing information about
possession of select agents. Such disclosures, as well as the informal sharing of
research samples, were part of the routine conduct of scientific inquiry prior to the
Select Agent regulation.
82
For more information, see the USDA Select Agent program website at
[http://www.aphis.usda.gov/programs/ag_selectagent/index.html].
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Congress expanded the Select Agent program in response to concerns that the
anthrax used in the 2001 mail attacks may have been obtained from a U.S. research
facility. Alarmed by reports of weak security at labs where researchers study
potentially deadly viruses and bacteria, lawmakers sought to improve lab security
without unduly impeding vital biomedical and biodefense research. While some
academic and industry scientists have praised the government for striking an
appropriate balance between science and security, many in the research community
are critical.
Some scientists have discontinued research on select agents because of the
security requirements and out of fear that breaking the new law, even inadvertently,
could result in stiff criminal penalties. As the anthrax attacks were unfolding in the
fall of 2001, officials at the Iowa State University destroyed their research collection
of anthrax strains, collected over decades, fearing they would not have the resources
to properly safeguard the collection in the new security climate.83 Scientists lamented
the loss of this rich source of information, which could potentially have been helpful
in biodefense research and in the response to possible future anthrax attacks.
Clinical laboratories, which may happen upon select agents in the course of their
diagnostic work, are required to either transfer or destroy the agents within a week
to be exempt from registration, a mandate that may also lead to problems. For
example, an agricultural lab recently destroyed cattle tissue samples that tested
positive for brucellosis before the results could be confirmed by a state-run lab,
leading to confusion about the state’s brucellosis-free status.84 The bacterium that
causes brucellosis (Brucella abortus) is a select agent, and the lab had elected to
destroy the samples (as clinical laboratories are permitted to do under the regulation)
rather than transfer them or register with USDA and comply with the strict
regulations for storage.
Strategic National Stockpile (CDC). The Strategic National Stockpile
(SNS), formerly the National Pharmaceutical Stockpile, was created in 1999 to
ensure the availability of antibiotics, antidotes, antitoxins, life-support medications,
airway maintenance supplies, and other medical and surgical items needed to respond
to bioterrorism or other mass-casualty events. The SNS is meant to augment state,
local, and private resources during an emergency. Funds for the SNS are used to
purchase, store, and rotate supplies, to assist states and localities in developing plans
for deployment, and to provide training and simulation exercises for state and local
officials in the use and distribution of deployed SNS assets.85
83
See Peter J. Boyer, “The Ames Strain,” The New Yorker, Nov. 12, 2001.
84
Associated Press, “Wyoming Case Could Lead to Lab Changes,” Dec. 6, 2004.
85
For more information on the SNS, see CDC SNS Home Page at [http://www.bt.cdc.gov/
stockpile/index.asp], testimony of James M. Hughes, Director, CDC’s National Center for
Infectious Diseases, before the Committee on Government Reform, Subcommittee on
National Security, Veterans Affairs, and International Relations, U.S. House of
Representatives, May 1, 2001, at [http://www.cdc.gov/washington/testimony/bioterro.htm],
and the section on state SNS activities in CDC guidance to states, “Continuation Guidance
for Cooperative Agreement on Public Health Preparedness and Response for Bioterrorism
(continued...)
CRS-39
In 2003, budget authority for the SNS, handled by the CDC prior to 2001, was
transferred to the Department of Homeland Security in the Homeland Security Act
(P.L. 107-296), with CDC retaining program management responsibilities. In its
FY2005 budget proposal, the Administration proposed to transfer budget authority
back to HHS, to take advantage of its medical and scientific expertise and its
established relationship with state and local health agencies. Authority was
transferred back to HHS in July 2004, in P.L. 108-276, the Project BioShield Act.
Stockpile contents are determined through a consultative process involving both
medical experts in infectious diseases and toxicology, and experts in intelligence and
national security. The SNS is for this reason a good model of preparedness planning,
in that it incorporates threat assessment throughout the planning process.
Information about the process of determining SNS contents, the decisions made, the
locations of the caches, and related information, is classified or otherwise protected
from public access.
The SNS has two components, Push Packages and Vendor-Managed
Inventories. Push Packages are federally owned caches of supplies and medications
that can be delivered to affected locales within 12 hours of request. Caches are
maintained in numerous secure locations around the country, to facilitate their rapid
delivery, and they are moved periodically to further safeguard them. VendorManaged Inventories (VMI) allow private vendors to maintain stockpiles of supplies
and medications in reserve, for federal purchase only if needed. VMI caches contain
frequently used products that the vendors rotate to maintain shelf-life, and are
intended to be deliverable to affected locales within 36 hours.
When deployed, SNS assets are transferred to state and local public health
authorities for distribution. Through the CDC state and local capacity grants, funds
have been made available to health departments to prepare for distribution. The SNS
has been deployed on several occasions, including the anthrax attacks of 2001 and
a false-positive finding of anthrax contamination in a District of Columbia mailroom
in 2003.
The most common concern about the SNS is skepticism about the ability of state
and local public health agencies to rapidly disseminate stockpile contents in an
emergency. States are required to prepare and submit plans to the CDC outlining how
they would accomplish this task, which would require a substantial complement of
personnel, involve numerous logistical tasks in patient screening and dispensing, and
require the presence of public safety officials. States are also encouraged to test this
capability through tabletop or “wet” exercises.86
85
(...continued)
— Budget Year Five,” Focus Area A: Preparedness Planning and Readiness Assessment,
June 21, 2004, at [http://www.bt.cdc.gov/planning/continuationguidance/index.asp].
86
For more information, see Association of State and Territorial Health Officials, Exercising
the Strategic National Stockpile: Lessons Learned and Tools for Application, Jan. 2004, at
[http://www.astho.org/pubs/Exercisingthestockpile.pdf].
CRS-40
Food Safety Programs (FDA). Title III of the Public Health Security and
Bioterrorism Preparedness and Response Act (P.L. 107-188) contains several
provisions to protect the nation’s food supply from intentional contamination. The
act authorizes FDA to hire new border inspectors, develop new methods of detecting
contaminated foods, and coordinate with state food safety regulators. The act also
grants FDA several new regulatory authorities. For the first time, all foreign and
domestic food facilities are required to register with the agency. Also, FDA now
requires prior notice of all imported food shipments and may detain suspicious foods
for inspection.
While many feel that these new authorities were essential to further the agency’s
mission in an age of terror threats, others are concerned about implementation of the
new regulations and possible adverse effects on commerce. Some feel that new
recordkeeping requirements will pose a burden for industry but will not substantially
improve food safety. Further, there was initial concern that FDA would not be able
to review declarations of imported food shipments expediently, and that the
shipments would be delayed as a result. The FDA established phased-in
implementation plans for this and some other provisions of the law, in an effort to
minimize commercial disruptions.87
Programs That Build State and Local Capacity
State and Local Preparedness Grants (CDC). In 1999, the CDC
launched a program to fund state health departments for bioterrorism preparedness,
recognizing that without a dedicated source of funds to prepare for diseases not
routinely seen, some states might not be able to prioritize these activities. The
program, officially called the Cooperative Agreement on Public Health Preparedness
and Response for Bioterrorism, was announced in the Spring of 1999. Technically,
funding through this program is made available not through grants but through
cooperative agreements between the CDC and states, in which the parties cooperate
in designating activities to be performed. Commonly these funds are referred to as
grants, though, as they will be in this report. This specific program is often referred
to in HHS documents and elsewhere as “state and local capacity” or “state and local
preparedness” grants for public health.
Authority for this program is established in the Public Health Service Act under
provisions for public health emergencies (42 U.S.C. § 247d-3). When the program
began in 1999, grants were to be competitively awarded to eligible entities, which
included states, subdivisions of states, or consortia of states. Funds were to be used
to address core public health capacity needs through planning, training, and
laboratory and information technology improvements. The funds were not strictly
limited to bioterrorism preparedness but rather were to be used to prepare for public
health emergencies, including significant outbreaks of infectious diseases or
bioterrorism. The program was reauthorized in the Public Health Threats and
Emergencies Act of 2000 (Title I of the Public Health Improvement Act, P.L. 106-
87
For more information on new food safety and security provisions, see CRS Report
RL31853, Food Safety Issues in the 109th Congress, by (name redacted).
CRS-41
505), and funding was authorized at $50 million for FY2001 and such sums as may
be necessary through 2006.
Following the 2001 terrorist attacks, the program was reauthorized in the Public
Health Security and Bioterrorism Preparedness and Response Act (P.L. 107-188),
signed in June 2002, with funding authorized at $1.08 billion for FY2002 and such
sums as may be necessary through 2006. This latest reauthorization converted the
program to formula grants for states, with a base amount per state and an additional
amount according to population. All states were to receive annual awards according
to this formula, as were the District of Columbia and the Commonwealth of Puerto
Rico. The territories were each to receive awards based on a different formula. In
addition, the Secretary of HHS was permitted to designate for awards three additional
political subdivisions “that have a substantial number of residents, have a substantial
local infrastructure for responding to public health emergencies, and face a high
degree of risk from bioterrorist attacks or other public health emergencies.” The
three most populous U.S. cities, Chicago, Los Angeles County, and New York City,
were designated, and the populations of these cities were subtracted from the
population of the respective states in calculating the state awards.
In the FY2002 Defense appropriations bill (P.L. 107-117), signed in January
2002, Congress provided $940 million in supplemental funds for the program. Funds
were distributed to awardees contingent on their completion of spending proposals,
to be administered by the senior health officials in each state, territory or
municipality. Most of the funds were available to awardees by August 2002. CDC
expanded the existing cooperative agreement guidance for the program to reflect the
increased funding level. Guidance was released in the Spring of 2002, directed at
improving capacity in six Focus Areas:
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Focus Area A: preparedness planning and readiness assessment;
Focus Area B: surveillance and epidemiology;
Focus Area C: laboratory capacity for biologic agents;
(Focus Area D: not funded for all states in 2002. See below.)
Focus Area E: Health Alert Network, communications and
information technology;
Focus Area F: risk communication and health information
dissemination; and
Focus Area G: education and training.
Focus Areas F and G were added in 2002, but Focus Areas A through E were created
in guidance when the program began in 1999. Focus Area D, laboratory capacity for
chemical agents, was funded in four states in 1999 and a fifth in 2000, and was
continued exclusively for those five states through 2002, eventually expanding to
other states in subsequent years.88 To prioritize activities for FY2002 funds, the CDC
designated 14 Critical Benchmarks for preparedness, activities the states were
required to perform. The benchmarks for FY2002 through FY2004 are listed in
Appendix C.
88
States first funded for chemical terrorism laboratory preparedness were CA, MI, NM, NY,
and VA.
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CDC guidance for FY2003 funds followed the same general framework as the
FY2002 guidance, but with some differences that reflect both the natural progression
in an ongoing program and experience gained over the prior year. In January 2004,
CDC presented a review of state compliance with FY2002 Critical Benchmarks as
of August 2003, finding that almost all states had completed initial planning for all
14 benchmarks, and were on their way toward achieving the goals set for FY2003
funds as well.89 While the FY2002 guidance focused mainly on planning, the
FY2003 guidance placed greater emphasis on activities that would demonstrate
improved preparedness. The main differences included: availability of funding to
increase laboratory capacity for chemical agents; more specific guidance on smallpox
preparedness activities; and explicit recommendations and requirements that planning
activities address mental health needs associated with terrorist attacks. The FY2003
guidance also required that states implement a more rigorous fiscal accounting
system, and document that a significant portion of local public health officials concur
with the proposed use of funds.
As seen in Appendix C, benchmarks did not change appreciably between
FY2003 and FY2004,90 partly because states were having some difficulty meeting the
requirements and partly because HHS and CDC were working toward an alternative
method of programmatic accountability. An exception was the addition of a new
Cross-cutting Benchmark (i.e., it applied to both CDC and HRSA grant program
activities) for pandemic influenza preparedness. The cooperative agreement was
written in 1999 to cover a five-year period and is to be entirely rewritten for the
FY2005 funding cycle. New guidance, expected in Spring 2005, may no longer be
organized by Focus Areas, and is expected to include a new set of performance
measures that are intended to better measure actual preparedness, and to reflect the
mandate that federal fund recipients plan their activities in compliance with the
National Incident Management System guidelines released in March 2004 (discussed
in greater depth in the section on Issues for the 109th Congress).
Hospital Preparedness Grants (HRSA). A program of grants to states for
hospital preparedness was first authorized in P.L. 107-188, the Bioterrorism Act, and
begun in 2002. The National Bioterrorism Hospital Preparedness Program is
administered by HRSA. The goal is to improve the ability of communities to respond
to emergencies that cause mass casualties, including natural disasters, explosions,
and biological or chemical attacks. The funds (which are awarded as cooperative
agreements but are commonly called grants) are to be used for planning, training,
equipment and other activities to coordinate the variety of healthcare entities in a
community, including hospitals, clinics, EMS services, laboratories, pharmacies, and
others. Program priorities in law are the same as those for the CDC grants, namely
preparedness for bioterrorism, other infectious diseases, and other public health
threats and emergencies. Funds are awarded according to a formula of a base amount
plus an amount according to population, to the same awardees as the CDC grants (50
89
CDC, State and Local Preparedness — Progress in Achieving Critical Benchmarks,
presented by Joseph M. Henderson at the meeting of the HHS Secretary’s Council on Public
Health Emergency Preparedness, Jan. 22, 2004, at [http://www.hhs.gov/ophep/council.html].
90
The FY2004 guidance document is available at [http://www.bt.cdc.gov/planning/
continuationguidance/index.asp].
CRS-43
states, the District of Columbia, territories, and the cities of New York and Chicago,
and Los Angeles County), and are also administered by the state, territorial or
municipal health officials.
The program was first funded in FY2002 at $135 million, and grants were to be
distributed to states contingent upon submission of a planning proposal. The grant
guidance for FY2002 contained three required preparedness activities called Critical
Benchmarks, along with a number of additional optional activities. (Critical
Benchmarks are listed in Appendix C.)
The program was funded at $514 million for FY2003, and the subsequent grant
guidance was more extensive, reflecting both the increased funding level and
experience gained over the first year of the program. Guidance was expanded in
some notable areas, including the directive for states to assure surge capacity to care
for victims of different types of events. Specifically, guidance called for planning for
surges in bed capacity, isolation, workforce, pharmacy/dispensing, mass
decontamination and mental health care. The 2003 guidance set sixteen Critical
Benchmarks across six Priority Areas. The Priority Areas are:
!
!
!
!
!
!
Administration;
Regional surge capacity;
Emergency medical services;
Linkages to public health departments;
Education and preparedness training; and
Terrorism preparedness activities.
The guidance also stipulated that 80% of the funding awarded to state health
departments should be passed through to hospitals, emergency medical systems, and
other healthcare entities.
In January 2004, HRSA reported progress toward achieving Critical
Benchmarks in the hospital preparedness program.91 Despite this, the program has
been charged over the years with lacking sufficient focus to adequately direct funds
in meaningful directions, or with failing to assure that emergency healthcare services
will be available consistently across jurisdictions. The healthcare sector, in response
to growing costs and constrained revenues, is marching to an ever-louder drumbeat
of efficiency, and eliminating unused capacity. Ensuring that unused assets (e.g. beds,
workers, equipment) will be held in reserve for a crisis will remain a challenge.
Cities Readiness Initiative (CDC). In May 2004, the Cities Readiness
Initiative (CRI) was announced as a means for the federal government to provide
direct assistance to cities to facilitate their ability to deliver medicines and supplies
91
HRSA, National Bioterrorism Hospital Preparedness Program: Progress Toward
Achieving Critical Benchmarks, presented by Rick Smith at the meeting of the HHS
Secretary’s Council on Public Health Emergency Preparedness, Jan. 22, 2004, at
[http://www.hhs.gov/ophep/council.html].
CRS-44
from the Strategic National Stockpile during a catastrophic event.92 Twenty-one
cities were funded initially. City selection was based on a number of factors,
including population size. Some believe the cities chosen may be those with
deployed BioWatch programs in place, though this cannot be confirmed through
publicly available information.
Stated objectives for the CRI include building the capacity for cities to provide
antibiotics to the city’s population within 48 hours of a decision to do so, and
integration of all of a city’s relevant emergency services, which include Fire, Police,
EMS, and health departments. One element of the program is to explore the use of
the postal delivery system to meet the distribution goal. Proponents note that the
U.S. Postal Service already delivers to every U.S. mailing address six days a week.
Concerns have been raised about the feasibility of the proposal and its many
interdependent elements, such as the willingness of postal workers to enter
quarantine zones in an emergency, and whether stockpiled medicines should be
stored locally or centrally.93
Information Technology Programs (CDC). Several related information
technology programs at CDC are designed to improve inter-connectivity and to speed
data and information sharing between agencies and across levels of government, to
facilitate planning, response and recovery in health emergencies. These programs are
incorporated in the CDC grant program for state and local public health capacity.94
The Health Alert Network (HAN) is a nationwide information and
communications system for distribution of health alerts, prevention guidelines and
other information, distance learning, national disease surveillance, and electronic
laboratory reporting. The HAN program allows states and localities to improve
communication with CDC and each other. States are required to have 90% of key
stakeholders involved in a public health emergency (e.g., local health departments,
hospitals and EMS services) in their state integrated into HAN, as a requirement of
the CDC grants for state public health capacity. (See Critical Benchmarks for Focus
Area E in Appendix C.)
The National Electronic Disease Surveillance System (NEDSS): NEDSS is
an initiative to standardize data and information systems in public health. The goal
is to have integrated surveillance systems that can transfer public health, laboratory,
and clinical data efficiently and securely over the Internet.
92
See CDC, Cities Readiness Initiative Home Page, at [http://www.bt.cdc.gov/cri/], and
Secretary of HHS Tommy G. Thompson, letter to congressional appropriators regarding
proposal to reallocate CDC funds, May 19, 2004.
93
For example, see Ian Urbina, “City Weighs Plans to Deliver Medicine to Public After
Attack,” The New York Times, Feb. 7, 2005.
94
More information on these programs is available on CDC websites as follows: for the
HAN network, [http://www.bt.cdc.gov/documentsapp/HAN/han.asp], for the NEDSS
program, [http://www.cdc.gov/nedss/index.htm], and for Epi-X, [http://www.cdc.gov/epix/].
CRS-45
The Epidemic Information Exchange (Epi-X) is a secure Web-based
communications network for federal, state, and local epidemiologists, laboratorians
and other individuals in the public health community who are designated by their,
agencies. Epi-X provides the capacity for instant notification about urgent public
health events and a searchable database with information on outbreaks and unusual
health events.
CRS-46
Appendix B: Selected Programs in the Department
of Homeland Security
Public health-related programs in DHS are found in the Office of State and
Local Government Coordination and Preparedness (OSLGCP), the Emergency
Preparedness and Response Directorate (EPR), and the Science and Technology
Directorate (S&T).
Metropolitan Medical Response System (OSLGCP)
The Metropolitan Medical Response System (MMRS) is a program of contracts
with major cities to assist the coordination of local government entities in
preparedness. The program began in 1995 in HHS, and was transferred to the EPR
Directorate at DHS in the Homeland Security Act, effective in March 2003. In 2004
it was moved to OSLGCP, where other DHS state and local grant programs are
administered. The goal of MMRS is to coordinate the efforts of local law
enforcement, firefighters, HAZMAT teams, EMS, hospital, public health and other
personnel to improve all-hazards response capabilities. MMRS awards allow local
governments to purchase equipment and supplies (such as local stockpiles of medical
countermeasures), and contracts require the development of detailed plans showing
how the variety of local government entities will coordinate response to a biological
or chemical event. Currently, more than 120 cities have received MMRS awards.95
Stating that MMRS activities can be funded through other DHS grant programs,
the Administration slated the program for elimination for FY2005. Congress
continued funding the program at $30 million for FY2005, which was decreased from
$50 million in FY2004. In 2002 the Institute of Medicine published the report of its
evaluation of the program, which discussed, among other things, the complex task
of developing performance measures for preparedness programs.96
National Disaster Medical System (EPR)
The National Disaster Medical System (NDMS) was established in HHS in
1984 to provide medical and ancillary services when a disaster overwhelms local
emergency services. NDMS was most recently reauthorized through 2006 in P.L.
107-188, the Bioterrorism Act, and was transferred to DHS in the Homeland Security
Act effective in March 2003. NDMS is a partnership of HHS, DHS, the Departments
of Defense and Veterans Affairs, state and local governments, and the private sector.
The system consists of a number of response teams that can deploy to a scene rapidly
and set up self-sustained response operations for 72 hours, until additional federal
support arrives. NDMS also provides for transportation of large numbers of
casualties from an impacted site to distant locations for care. There are multiple
teams in a number of “specialties,” including Disaster Medical Assistance Teams
(DMATs) of physicians, nurses, support personnel and supplies, Disaster Mortuary
95
96
See the MMRS Home Page at [http://mmrs.fema.gov/].
Institute of Medicine, Preparing for Terrorism: Tool for Evaluating the Metropolitan
Medical Response System Program, 2002.
CRS-47
Teams (DMORTs) that assist in mass mortality and victim identification efforts, as
well as nursing, pharmacy, and veterinary teams. NDMS teams can be requested by
the Secretary of HHS, who is in the lead for public health and medical services
during a disaster according to the National Response Plan. Medical professionals on
the teams must be licensed to practice in at least one U.S. jurisdiction and are not
generally federal employees unless deployed, at which time they are considered
“federalized” for liability and compensation purposes.97
The NDMS is appropriated through the “Public Health Programs” budget line
of the EPR Directorate, and received funding of $34 million in both FY2004 and
FY2005.
BioWatch (S&T)
The Department of Homeland Security (DHS) Science and Technology
Directorate (S&T) is responsible for the BioWatch program, a network of
environmental sensors to detect possible aerosol releases of bioterrorism agents in
several major cities. The program has three main elements, sampling, analysis, and
response, each coordinated by different agencies. The Environmental Protection
Agency (EPA) maintains the sampling component, the sensors that collect airborne
particles. The CDC coordinates the laboratory testing of the samples, though much
of the testing is actually carried out in state and local public health laboratories.
Local jurisdictions are responsible for the public health response to positive findings.
The FBI is designated as the lead agency for the law enforcement response if a
bioterrorism event is detected. At least 30 cities have been chosen as locations for
these sensors.98
97
98
See the NDMS Home Page at [http://www.ndms.dhhs.gov/].
For more information, see CRS Report RL32152, The BioWatch Program: Detection of
Bioterrorism, by (name redacted) and (name redacted).
CRS-48
Appendix C: Focus Areas, Critical Benchmarks, and Priority Areas for the CDC and
HRSA Public Health and Hospital Preparedness Grants, FY2002 through FY2004
Focus or Priority Area
Critical Benchmarks, FY2002
Critical Benchmarks, FY2003
Critical Benchmarks, FY2004
CDC Public Health Preparedness Program
CDC Focus Area A:
Preparedness Planning and Readiness
Assessment
1. Designate Senior Public Health Official
within State health department as Executive
Director of State Bioterrorism Preparedness
and Response Program.
1. Develop and maintain a financial
accounting system, tracking expenditures by
focus area, critical capacity, and funds
provided to local health agencies.
1. Develop and maintain a financial
accounting system capable of tracking
expenditures by focus area, critical capacity,
and funds provided to local health agencies.
2. Establish advisory committee with
members from a variety of health agencies
and first responders.
2. Develop or enhance scalable plans that
support local, statewide, and regional
response to incidents of bioterrorism,
catastrophic infectious disease, such as
pandemic influenza, other infectious disease
outbreaks, and other public health threats
and emergencies.
2. Develop or enhance scalable plans that
support local, statewide, and regional
response to incidents of bioterrorism,
catastrophic infectious disease, such as
pandemic influenza, other infectious disease
outbreaks, and other public health threats
and emergencies.
3. Maintain system for 24/7 notification or
activation of the public health emergency
response system.
3. Maintain system for 24/7 notification or
activation of the public health emergency
response system.
4. Exercise all plans annually to demonstrate
proficiency in responding to bioterrorism,
other infectious disease outbreaks, and other
public health threats and emergencies.
4. Exercise all plans annually to
demonstrate proficiency in responding to
bioterrorism, other infectious disease
outbreaks, and other public health threats
and emergencies.
3. Prepare timeline for development of
statewide plan for preparedness and
response for bioterrorist events, infectious
disease outbreaks, or other public health
emergencies.
4. Prepare a timeline for the assessment of
statutes, regulations, and ordinances within
the state and local public health jurisdictions
regarding emergency public health
measures.
5. Prepare timeline for the development of a
statewide plan for responding to incidents of
bioterrorism.
6. Prepare timeline for the development of
regional plans to respond to bioterrorism.
7. Develop an interim plan to receive and
manage items from the National
5. Review and comment on documents
regarding the National Incident Management
System, and maintain description of roles
and responsibilities of public health
departments, hospitals, and other healthcare
entities in the statewide Incident
Management System.
5. Review the National Incident
Management System (NIMS) and complete
an assessment of conforming changes
needed, if any, for your state health
department and partner agencies.
CRS-49
Focus or Priority Area
Critical Benchmarks, FY2002
Critical Benchmarks, FY2003
Critical Benchmarks, FY2004
Pharmaceutical Stockpile, including mass
distribution of antibiotics, vaccines, and
medical materiel.
6. Develop or maintain a Strategic National
Stockpile preparedness program.
6. Develop or maintain a Strategic National
Stockpile preparedness program.
7. Develop/maintain a system to receive and
evaluate urgent disease reports on a 24/7
basis.
7. Complete development and maintain a
system to receive and evaluate urgent
disease reports on a 24/7 basis.
8. Maintain a list of physicians and other
providers with experience in the diagnosis
and treatment of infectious, chemical or
radiological conditions (including
psychological and behavioral) that may
result from terrorism.
8. Maintain a list of physicians and other
providers with experience in the diagnosis
and treatment of infectious, chemical, or
radiological conditions (including
psychological and behavioral) that may
result from terrorism.
9. Establish a secure, Web-based disease
reporting and notification system.
9. Establish a secure, Web-based disease
reporting and notification system.
10. Assess annually the 24/7 capacity to
respond to urgent reports of outbreaks and
other public health emergencies.
10. Assess annually, the 24/7 capacity to
respond to urgent reports of outbreaks and
other public health emergencies.
11. Assess annually the adequacy of public
health response to catastrophic diseases (e.g.,
pandemic influenza), outbreaks, and other
public health emergencies.
11. Assess annually the adequacy of public
health response to catastrophic diseases
(e.g., pandemic influenza), outbreaks, and
other public health emergencies.
8. Prepare timeline for developing a system
to receive and evaluate urgent disease
reports from all parts of the state (or city)
and local public health jurisdictions on a
24/7 basis.
CDC Focus Area B:
Surveillance and Epidemiology
Capacity
9. Assess current epidemiologic capacity
and prepare timeline for providing at least
one epidemiologist for each metropolitan
area with a population greater than 500,000.
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Focus or Priority Area
Critical Benchmarks, FY2002
Critical Benchmarks, FY2003
Critical Benchmarks, FY2004
CDC Focus Area C:
Laboratory Capacity — Biological
Agents
10. Develop a plan to improve working
relationships and communication between
Level A (clinical ) laboratories and Level
B/C laboratories (i.e., Laboratory Response
Network laboratories), as well as other
public health officials.
12. Implement an integrated response plan
for public health, hospital-based, foodtesting, veterinary, and environmental
laboratories during a public health
emergency.
12. Implement an integrated response plan
for public health, hospital-based, foodtesting, veterinary, and environmental
laboratories during a public health
emergency.
13. Ensure that capacity exists for LRNvalidated testing as methods are approved.
13. Ensure that capacity exists for LRNvalidated testing as methods are approved.
14. Conduct at least one exercise annually
that specifically tests laboratory readiness.
14. Conduct at least one exercise annually
that specifically tests laboratory readiness.
(States can choose to meet one of three levels
of preparedness, noted below. All states
must achieve at least Level One
preparedness.)
(States can choose to meet one of three
levels of preparedness, noted below. All
states must achieve at least Level One
preparedness.)
15. (Level One) Hire and train a chemical
terrorism laboratory coordinator and
assistant coordinator. (Six states sought
funding for Level One status for FY2003:
KY, MT, OH, OK, OR and WY, as well as the
cities of Chicago, Los Angeles and New
York.)
15. (Level One) Hire and train a chemical
terrorism laboratory coordinator and
assistant coordinator.
16. (Level Two) Participate in at least one
exercise annually that specifically tests
chemical terrorism laboratory readiness to
identify at least one chemical threat agent.
(Most states — all those not mentioned as
seeking Level One or Level Three status, as
well as the District of Columbia, requested
funding for Level Two status for FY2003.)
16. (Level Two) Participate in at least one
exercise annually that specifically tests
chemical terrorism laboratory readiness to
identify at least one chemical threat agent.
CDC Focus Area D:
Laboratory Capacity — Chemical
Agents
(Focus Area D was not funded for all states
in FY2002. Only those states previously
funded, CA, MI, NY, NM, and VA, continued
to receive funding for laboratory readiness
for chemical terrorism.)
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Focus or Priority Area
CDC Focus Area E:
Health Alert Network/
Communications and Information
Technology
CDC Focus Area F:
Risk Communication and Health
Information Dissemination (Public
Information and Communication)
Critical Benchmarks, FY2002
Critical Benchmarks, FY2003
Critical Benchmar
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